{"id":"F2019L01542","name":"National Health (Take Home Naloxone) Special Arrangement 2019","slug":"national-health-take-home-naloxone-special-arrangement-2019","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":100382,"registerId":"commonwealth-F2019L01542-current","compilationNumber":null,"startDate":"2026-04-02","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"Part 1","sectionType":"part","heading":"Preliminary","content":"## Part 1—Preliminary","sortOrder":0},{"sectionNumber":"1","sectionType":"section","heading":"Name","content":"#### 1 Name\n\n  (1) This instrument is the National Health (Take Home Naloxone) Special Arrangement 2019.\n  (2) This instrument may also be cited as PB 97 of 2019.","sortOrder":1},{"sectionNumber":"3","sectionType":"section","heading":"Authority","content":"#### 3 Authority\n\n  This instrument is made under section 100 of the National Health Act 1953.","sortOrder":2},{"sectionNumber":"5","sectionType":"section","heading":"Simplified outline of this instrument","content":"#### 5 Simplified outline of this instrument\n\nThis instrument makes a special arrangement for the supply of naloxone to persons who are at risk of an opioid overdose and persons who are likely to be able to assist such persons.\n\nNaloxone will be supplied free of charge and without a prescription by hospitals, pharmacists, certain medical practitioners and other authorised persons and organisations.\n\nThis instrument also deals with payments for supplies of naloxone and administrative matters.\n\n> Note: Part VII of the Act, and regulations or other instruments made for the purposes of that Part, have effect subject to this instrument (see subsection 100(3) of the Act).","sortOrder":3},{"sectionNumber":"6","sectionType":"section","heading":"Definitions","content":"#### 6 Definitions\n\n> Note: A number of expressions used in this instrument are defined in the Act, including the following:\n\n    (a) hospital;\n    (b) premises;\n    (c) Secretary.\n  In this instrument:\n\n> Act means the National Health Act 1953.\n\n> approved ex‑manufacturer price of a listed brand of a pharmaceutical item has the same meaning as in Part VII of the Act.\n\n> approved hospital authority has the same meaning as in Part VII of the Act.\n\n> approved medical practitioner has the same meaning as in Part VII of the Act.\n\n> approved pharmacist has the same meaning as in Part VII of the Act.\n\n> approved supplier has the same meaning as in Part VII of the Act.\n\n> authorised alternative supplier means a person or organisation:\n\n    (a) that has premises in a jurisdiction; and\n    (b) that is authorised (however described) by an authority of the jurisdiction for the purposes of supplying designated pharmaceutical benefits in accordance with this instrument; and\n    (c) in relation to which the authority has given the Secretary a written notice stating:\n    (i) that the person or organisation is so authorised; and\n    (ii) the name and contact details of the person or organisation.\n\n> day admitted patient: a person is a day admitted patient of a hospital on a day if, on that day, the person:\n\n    (a) is admitted to the hospital (other than through the hospital’s emergency department); and\n    (b) receives treatment; and\n    (c) is discharged from the hospital;\n  in accordance with a pre‑existing plan for the person’s treatment.\n\n> designated person means:\n\n    (a) a person who is at risk of an opioid overdose; or\n    (b) a person who is likely to be able to assist such a person.\n\n> designated pharmaceutical benefit means a pharmaceutical benefit mentioned in Schedule 1.\n\n> excluded approved supplier means an approved supplier in a jurisdiction in relation to which there is in force a notice given by an authority of the jurisdiction to the Secretary and the supplier to the effect that the authority wants the supplier not to be able to supply designated pharmaceutical benefits in accordance with this instrument.\n\n> jurisdiction means a State or Territory.\n\n> listed brand of a pharmaceutical item has the same meaning as in Part VII of the Act.\n\n> pharmaceutical benefit has the same meaning as in Part VII of the Act.\n\n> pharmaceutical item has the same meaning as in Part VII of the Act.\n\n> special arrangement supply has the meaning given by section 7.\n\n> Territory has the same meaning as in Part VII of the Act.","sortOrder":4},{"sectionNumber":"Part 2","sectionType":"part","heading":"Special arrangement supplies of designated pharmaceutical benefits","content":"## Part 1—Preliminary\n\n#### 1 Name\n\n  (1) This instrument is the National Health (Take Home Naloxone) Special Arrangement 2019.\n  (2) This instrument may also be cited as PB 97 of 2019.\n\n#### 3 Authority\n\n  This instrument is made under section 100 of the National Health Act 1953.\n\n#### 5 Simplified outline of this instrument\n\nThis instrument makes a special arrangement for the supply of naloxone to persons who are at risk of an opioid overdose and persons who are likely to be able to assist such persons.\n\nNaloxone will be supplied free of charge and without a prescription by hospitals, pharmacists, certain medical practitioners and other authorised persons and organisations.\n\nThis instrument also deals with payments for supplies of naloxone and administrative matters.\n\n> Note: Part VII of the Act, and regulations or other instruments made for the purposes of that Part, have effect subject to this instrument (see subsection 100(3) of the Act).\n\n#### 6 Definitions\n\n> Note: A number of expressions used in this instrument are defined in the Act, including the following:\n\n    (a) hospital;\n    (b) premises;\n    (c) Secretary.\n  In this instrument:\n\n> Act means the National Health Act 1953.\n\n> approved ex‑manufacturer price of a listed brand of a pharmaceutical item has the same meaning as in Part VII of the Act.\n\n> approved hospital authority has the same meaning as in Part VII of the Act.\n\n> approved medical practitioner has the same meaning as in Part VII of the Act.\n\n> approved pharmacist has the same meaning as in Part VII of the Act.\n\n> approved supplier has the same meaning as in Part VII of the Act.\n\n> authorised alternative supplier means a person or organisation:\n\n    (a) that has premises in a jurisdiction; and\n    (b) that is authorised (however described) by an authority of the jurisdiction for the purposes of supplying designated pharmaceutical benefits in accordance with this instrument; and\n    (c) in relation to which the authority has given the Secretary a written notice stating:\n    (i) that the person or organisation is so authorised; and\n    (ii) the name and contact details of the person or organisation.\n\n> day admitted patient: a person is a day admitted patient of a hospital on a day if, on that day, the person:\n\n    (a) is admitted to the hospital (other than through the hospital’s emergency department); and\n    (b) receives treatment; and\n    (c) is discharged from the hospital;\n  in accordance with a pre‑existing plan for the person’s treatment.\n\n> designated person means:\n\n    (a) a person who is at risk of an opioid overdose; or\n    (b) a person who is likely to be able to assist such a person.\n\n> designated pharmaceutical benefit means a pharmaceutical benefit mentioned in Schedule 1.\n\n> excluded approved supplier means an approved supplier in a jurisdiction in relation to which there is in force a notice given by an authority of the jurisdiction to the Secretary and the supplier to the effect that the authority wants the supplier not to be able to supply designated pharmaceutical benefits in accordance with this instrument.\n\n> jurisdiction means a State or Territory.\n\n> listed brand of a pharmaceutical item has the same meaning as in Part VII of the Act.\n\n> pharmaceutical benefit has the same meaning as in Part VII of the Act.\n\n> pharmaceutical item has the same meaning as in Part VII of the Act.\n\n> special arrangement supply has the meaning given by section 7.\n\n> Territory has the same meaning as in Part VII of the Act.\n\n## Part 2—Special arrangement supplies of designated pharmaceutical benefits\n\n### Division 1—Preliminary\n\n#### 7 Definition of special arrangement supply\n\n  Supplies by approved hospital authorities\n  (1) A supply of a designated pharmaceutical benefit is a special arrangement supply of the benefit if the benefit is supplied:\n    (a) either:\n    (i) in New South Wales, Western Australia or South Australia on or after 1 December 2019; or\n    (ii) in Victoria, Queensland, Tasmania or a Territory on or after 1 July 2022; and\n    (c) by an approved hospital authority that is not an excluded approved supplier; and\n    (d) to a designated person who, at the time of the supply, is:\n    (i) a day admitted patient of a hospital of which the approved hospital authority is the governing body or proprietor; or\n    (ii) a patient on discharge from such a hospital; or\n    (iii) a non‑admitted patient of such a hospital; or\n    (iv) not a patient receiving treatment in or at such a hospital; and\n    (e) without a prescription.\n  Supplies by approved medical practitioners\n  (2) A supply of a designated pharmaceutical benefit is also a special arrangement supply of the benefit if:\n    (aa) the benefit is supplied:\n    (i) in New South Wales, Western Australia or South Australia on or after 1 December 2019; or\n    (ii) in Victoria, Queensland, Tasmania or a Territory on or after 1 July 2022; and\n    (a) the benefit is supplied:\n    (iii) to a designated person; and\n    (iv) without a prescription; and\n    (v) by an approved medical practitioner who is not an excluded approved supplier; and\n    (b) the benefit was not obtained by the approved medical practitioner under section 93 of the Act (prescriber bag supplies).\n  Supplies by approved pharmacists\n  (3) A supply of a designated pharmaceutical benefit is also a special arrangement supply of the benefit if the benefit is supplied:\n    (a) either:\n    (i) in New South Wales, Western Australia or South Australia on or after 1 December 2019; or\n    (ii) in Victoria, Queensland, Tasmania or a Territory on or after 1 July 2022; and\n    (c) to a designated person; and\n    (d) without a prescription; and\n    (e) by an approved pharmacist who is not an excluded approved supplier.\n  Supplies by authorised alternative suppliers\n  (4) A supply of a designated pharmaceutical benefit is also a special arrangement supply of the benefit if the benefit is supplied:\n    (a) either:\n    (i) in New South Wales, Western Australia or South Australia on or after 1 December 2019; or\n    (ii) in Victoria, Queensland, Tasmania or a Territory on or after 1 November 2022; and\n    (c) to a designated person; and\n    (d) by an authorised alternative supplier.\n  (5) However, a supply of a designated pharmaceutical benefit mentioned in subsection (4) is not a special arrangement supply of the benefit if:\n    (a) the authorised alternative supplier is the ambulance service of a jurisdiction; and\n    (b) the benefit supplied is administered to the designated person by an ambulance officer to treat the person for an opioid overdose.\n\n### Division 2—Special arrangement supplies of designated pharmaceutical benefits\n\n#### 8 Definition of value for safety net purposes for supplies\n\n  (1) The value for safety net purposes for a special arrangement supply of a designated pharmaceutical benefit is zero.\n  (2) This section applies despite the definition of value for safety net purposes in subsection 84(1) of the Act.\n\n#### 9 Designated persons entitled to receive supplies free of charge\n\n  (1) A designated person is entitled to receive a special arrangement supply of a designated pharmaceutical benefit without the payment or provision of money or other consideration.\n  (2) This section has effect in addition to section 86 of the Act.\n\n#### 10 Suppliers not to demand or receive payment for supplies or services\n\n  Approved suppliers\n  (1) An approved supplier must not demand or receive a payment (other than a payment from the Commonwealth) or other valuable consideration in respect of a special arrangement supply of a designated pharmaceutical benefit.\n  (2) An approved supplier must not demand or receive a payment or other valuable consideration in respect of any other service relating to a special arrangement supply of a designated pharmaceutical benefit.\n  (3) Subsection (1) has effect despite section 87 of the Act.\n  Authorised alternative suppliers\n  (4) An authorised alternative supplier must not demand or receive a payment or other valuable consideration in respect of:\n    (a) a special arrangement supply of a designated pharmaceutical benefit; or\n    (b) any other service relating to a special arrangement supply of a designated pharmaceutical benefit.\n\n#### 11 Supplies by approved hospital authorities\n\n  (1) A designated person is entitled to receive a special arrangement supply of a designated pharmaceutical benefit by an approved hospital authority if:\n    (a) at the time of the supply, the designated person is:\n    (i) a day admitted patient of a hospital of which the approved hospital authority is the governing body or proprietor; or\n    (ii) a patient on discharge from such a hospital; or\n    (iii) a non‑admitted patient of such a hospital; or\n    (iv) not a patient receiving treatment in or at such a hospital; and\n    (b) the approved hospital authority is not an excluded approved supplier.\n  (2) Subsection (1) has effect despite sections 89 and 94 of the Act.\n  (3) A designated person is entitled to receive a special arrangement supply of a designated pharmaceutical benefit by an approved hospital authority as mentioned in subsection (1) without a prescription.\n  (4) Subsection (3) has effect despite the Act and the National Health (Pharmaceutical Benefits) Regulations 2017.\n\n> Note 1: Sections 84AAA, 84D, 99 and 134 of the Act deal with the supply of pharmaceutical benefits by approved hospital authorities on prescription.\n\n> Note 2: Sections 18, 30, 41, 44, 45, 52 and 53 of the National Health (Pharmaceutical Benefits) Regulations 2017 deal with the supply of pharmaceutical benefits by approved hospital authorities on prescription.\n\n#### 12 Supplies by approved medical practitioners\n\n  (1) A designated person is entitled to receive a special arrangement supply of a designated pharmaceutical benefit by an approved medical practitioner who is not an excluded approved supplier without a prescription.\n  (2) This section has effect despite the National Health (Pharmaceutical Benefits) Regulations 2017.\n\n> Note: Sections 44, 48, 52 and 53 of the National Health (Pharmaceutical Benefits) Regulations 2017 deal with the supply of pharmaceutical benefits by approved medical practitioners on prescription.\n\n#### 13 Supplies by approved pharmacists\n\n  (1) A designated person is entitled to receive a special arrangement supply of a designated pharmaceutical benefit by an approved pharmacist who is not an excluded approved supplier without a prescription.\n  (2) This section has effect despite section 89 of the Act.\n\n#### 14 Supplies by authorised alternative suppliers\n\n  (1) A designated person is entitled to receive a special arrangement supply of a designated pharmaceutical benefit by an authorised alternative supplier.\n  (2) This section has effect despite section 89 of the Act.\n\n#### 15 Maximum quantity or number of units for supplies\n\n  The maximum quantity or number of units of the pharmaceutical item of a designated pharmaceutical benefit that may be supplied to a designated person in a special arrangement supply of the benefit on any one occasion is the quantity or number of units specified in the column headed “Maximum quantity or number of units” of the item of the table in clause 1 of Schedule 1 for the pharmaceutical benefit.\n\n#### 16 No limit on number of occasions for supplies\n\n  There is no limit on the number of occasions on which a designated person is entitled to receive a special arrangement supply of a designated pharmaceutical benefit.\n\n### Division 3—Payment for special arrangement supplies of designated pharmaceutical benefits\n\n#### 17 Supplies by approved hospital authorities to certain patients\n\n  (1) An approved hospital authority that wants to receive payment from the Commonwealth in relation to a special arrangement supply by the approved hospital authority of a designated pharmaceutical benefit to any of the following must make a claim for payment in accordance with section 20:\n    (a) a day admitted patient of a hospital of which the approved hospital authority is the governing body or proprietor;\n    (b) a patient on discharge from such a hospital;\n    (c) a non‑admitted patient of such a hospital.\n\n> Note: See subsection 99(4) of the Act for the entitlement of an approved hospital authority to payment for the supply of pharmaceutical benefits to patients receiving treatment in or at a hospital in respect of which the authority is approved.\n\n  (2) This section has effect despite section 99AAA of the Act.\n\n#### 18 Supplies by approved hospital authorities to persons who are not patients\n\n  Entitlement to payment\n  (1) Subject to this section, an approved hospital authority is entitled to payment from the Commonwealth in respect of a special arrangement supply by the approved hospital authority of a designated pharmaceutical benefit to a person who is not a patient receiving treatment in or at a hospital in respect of which the authority is approved.\n  Rates and conditions for payment\n  (2) The payment is at the rates and subject to the conditions determined by the Minister under subsection 99(4) of the Act in respect of the supply of designated pharmaceutical benefits.\n  Claims for payment\n  (3) If an approved hospital authority wants to receive a payment to which it is entitled under this section, the authority must make a claim for payment in accordance with section 20.\n\n#### 19 Supplies by approved medical practitioners and approved pharmacists\n\n  (1) An approved medical practitioner or an approved pharmacist who wants to receive payment from the Commonwealth in relation to a special arrangement supply by the approved medical practitioner or approved pharmacist of a designated pharmaceutical benefit must make a claim for payment in accordance with section 20.\n\n> Note: See section 99 of the Act for the entitlement of approved medical practitioners and approved pharmacists to payment for the supply of pharmaceutical benefits.\n\n  (2) This section has effect despite section 99AAA of the Act.\n\n#### 20 Claims for payment by approved suppliers\n\n  For the purposes of subsections 17(1), 18(3) and 19(1), a claim for payment by an approved supplier in relation to a special arrangement supply of a designated pharmaceutical benefit must:\n    (a) be made, in writing, to the Secretary; and\n    (b) include the following information:\n    (i) the benefit supplied;\n    (ii) the date the benefit was supplied;\n    (iii) the postcode in which the benefit was supplied;\n    (iv) the title of the individual who interacted with the person to whom the benefit was supplied;\n    (v) whether the person to whom the benefit was supplied consented to the use of their de‑identified data for ongoing monitoring of the supply of designated pharmaceutical benefits in accordance with this instrument; and\n    (c) if the person to whom the benefit was supplied consented as mentioned in subparagraph (b)(v)—include the following information:\n    (i) whether the person had previously received a supply of a designated pharmaceutical benefit;\n    (ii) if the person had previously received a supply of a designated pharmaceutical benefit—the reason for receiving a further supply of a designated pharmaceutical benefit.\n\n#### 21 Supplies to authorised alternative suppliers\n\n  Entitlement to payment\n  (1) Subject to this section, a person who supplies a designated pharmaceutical benefit to an authorised alternative supplier (for the purpose of the authorised alternative supplier making a special arrangement supply of the designated pharmaceutical benefit) is entitled to payment from the Commonwealth.\n  Amount of payment\n  (2) The amount of the payment is the approved ex‑manufacturer price of the listed brand of the pharmaceutical item of the designated pharmaceutical benefit that was applicable on the day the person supplied the benefit to the authorised alternative supplier.\n  Claims for payment\n  (3) If a person wants to receive a payment to which the person is entitled under this section, the person must make a claim for payment in accordance with subsection (4).\n  (4) The claim must:\n    (a) be made, in writing, to the Secretary; and\n    (b) include the name of the authorised alternative supplier; and\n    (c) include, for each day covered by the claim on which the person supplied a designated pharmaceutical benefit to the authorised alternative supplier, the volume of each designated pharmaceutical benefit supplied on the day.\n\n#### 22 Secretary to determine and pay claims\n\n  The Secretary must determine the amount payable for a claim made under this Part and make any payment relating to the claim.\n\n### Division 4—Administration\n\n#### 23 Secretary may request information from authorised alternative suppliers\n\n  (1) The Secretary may, in writing, ask an authorised alternative supplier to give the Secretary the information mentioned in paragraphs 20(b) and (c) in relation to any special arrangement supply of a designated pharmaceutical benefit made by the supplier.\n  (2) A request for information must:\n    (a) be in writing; and\n    (b) specify a day for complying with the request which is at least 28 days after the day of the request.\n\n#### 24 Authorised alternative suppliers to supply information on request\n\n  If an authorised alternative supplier receives a request for information under section 23, the supplier must comply with the request by the day specified in the request.\n\n#### 25 Secretary may authorise persons to perform functions or exercise powers\n\n  (1) The Secretary may, in writing, authorise persons having suitable qualifications and experience to perform any of the Secretary’s functions, or exercise any of the Secretary’s powers, under the following provisions on behalf of the Secretary:\n    (a) the definitions of authorised alternative supplier and excluded approved supplier in section 4 (receiving notices);\n    (b) section 20 and subsection 21(4) (receiving claims for payment);\n    (c) section 22 (determining and paying claims);\n    (d) section 23 (requesting information).\n  (2) Without limiting subsection (1), an authorisation under this section may be in the form of a contract entered into by the Secretary on behalf of the Commonwealth.\n  (3) A person who is authorised under this section must comply with any directions of the Secretary in the performance of the functions or exercise of the powers specified in the authorisation.\n\n#### 26 Review by Secretary of decisions of persons authorised under section 25\n\n  Application for review\n  (1) A person who is affected by a decision of a person who is authorised under section 25 may apply to the Secretary for review of the decision.\n  (2) An application for review must:\n    (a) be in writing; and\n    (b) be made within:\n    (i) 28 days after the day the decision first came to the notice of the applicant; or\n    (ii) if the Secretary allows a longer period (whether before or after the end of the 28‑day period referred to in subparagraph (i))—that longer period.\n  Review of decision\n  (3) On receiving an application, the Secretary must:\n    (a) review the decision; and\n    (b) affirm, vary or set aside the decision; and\n    (c) if the Secretary sets aside the decision—make a new decision in substitution for the decision set aside.\n  (4) The decision (the decision on review) of the Secretary takes effect:\n    (a) on the day specified in the decision on review; or\n    (b) if a day is not specified—on the day the decision on review was made.\n  Notice of decision\n  (5) After the Secretary makes a decision under this section, the Secretary must give the applicant a written notice stating the following:\n    (a) the terms of the decision;\n    (b) the reasons for the decision.\n\n## Part 3—Application, saving and transitional provisions\n\n#### 27 Saving of authorisations—National Health (Take Home Naloxone Pilot) Special Arrangement Amendment (2020 Measures No. 1) Instrument 2020\n\n  An authorisation that was in force under section 25 immediately before the commencement of the National Health (Take Home Naloxone Pilot) Special Arrangement Amendment (2020 Measures No. 1) Instrument 2020 has effect, on and after that commencement, as if it had been made under that section as amended by that instrument.\n\n#### 28 Application of amendments—National Health (Take Home Naloxone Pilot) Special Arrangement Amendment (2021 Measures No. 1) Instrument 2021\n\n  The amendments of section 20 made by the National Health (Take Home Naloxone Pilot) Special Arrangement Amendment (2021 Measures No. 1) Instrument 2021 apply in relation to a claim for payment made on or after 1 July 2021 in respect of a special arrangement supply of a designated pharmaceutical benefit made before, on or after that date.\n\n#### 29 Application of amendments—National Health (Take Home Naloxone Pilot) Special Arrangement Amendment (2022 Measures No. 1) Instrument 2022\n\n  The amendment of section 20 made by the National Health (Take Home Naloxone Pilot) Special Arrangement Amendment (2022 Measures No. 1) Instrument 2022 applies in relation to a claim for payment made on or after 1 July 2022 in respect of a special arrangement supply of a designated pharmaceutical benefit made on or after that date.","sortOrder":5},{"sectionNumber":"Division 1","sectionType":"division","heading":"Preliminary","content":"## Part 1—Preliminary\n\n#### 1 Name\n\n  (1) This instrument is the National Health (Take Home Naloxone) Special Arrangement 2019.\n  (2) This instrument may also be cited as PB 97 of 2019.\n\n#### 3 Authority\n\n  This instrument is made under section 100 of the National Health Act 1953.\n\n#### 5 Simplified outline of this instrument\n\nThis instrument makes a special arrangement for the supply of naloxone to persons who are at risk of an opioid overdose and persons who are likely to be able to assist such persons.\n\nNaloxone will be supplied free of charge and without a prescription by hospitals, pharmacists, certain medical practitioners and other authorised persons and organisations.\n\nThis instrument also deals with payments for supplies of naloxone and administrative matters.\n\n> Note: Part VII of the Act, and regulations or other instruments made for the purposes of that Part, have effect subject to this instrument (see subsection 100(3) of the Act).\n\n#### 6 Definitions\n\n> Note: A number of expressions used in this instrument are defined in the Act, including the following:\n\n    (a) hospital;\n    (b) premises;\n    (c) Secretary.\n  In this instrument:\n\n> Act means the National Health Act 1953.\n\n> approved ex‑manufacturer price of a listed brand of a pharmaceutical item has the same meaning as in Part VII of the Act.\n\n> approved hospital authority has the same meaning as in Part VII of the Act.\n\n> approved medical practitioner has the same meaning as in Part VII of the Act.\n\n> approved pharmacist has the same meaning as in Part VII of the Act.\n\n> approved supplier has the same meaning as in Part VII of the Act.\n\n> authorised alternative supplier means a person or organisation:\n\n    (a) that has premises in a jurisdiction; and\n    (b) that is authorised (however described) by an authority of the jurisdiction for the purposes of supplying designated pharmaceutical benefits in accordance with this instrument; and\n    (c) in relation to which the authority has given the Secretary a written notice stating:\n    (i) that the person or organisation is so authorised; and\n    (ii) the name and contact details of the person or organisation.\n\n> day admitted patient: a person is a day admitted patient of a hospital on a day if, on that day, the person:\n\n    (a) is admitted to the hospital (other than through the hospital’s emergency department); and\n    (b) receives treatment; and\n    (c) is discharged from the hospital;\n  in accordance with a pre‑existing plan for the person’s treatment.\n\n> designated person means:\n\n    (a) a person who is at risk of an opioid overdose; or\n    (b) a person who is likely to be able to assist such a person.\n\n> designated pharmaceutical benefit means a pharmaceutical benefit mentioned in Schedule 1.\n\n> excluded approved supplier means an approved supplier in a jurisdiction in relation to which there is in force a notice given by an authority of the jurisdiction to the Secretary and the supplier to the effect that the authority wants the supplier not to be able to supply designated pharmaceutical benefits in accordance with this instrument.\n\n> jurisdiction means a State or Territory.\n\n> listed brand of a pharmaceutical item has the same meaning as in Part VII of the Act.\n\n> pharmaceutical benefit has the same meaning as in Part VII of the Act.\n\n> pharmaceutical item has the same meaning as in Part VII of the Act.\n\n> special arrangement supply has the meaning given by section 7.\n\n> Territory has the same meaning as in Part VII of the Act.\n\n## Part 2—Special arrangement supplies of designated pharmaceutical benefits\n\n### Division 1—Preliminary\n\n#### 7 Definition of special arrangement supply\n\n  Supplies by approved hospital authorities\n  (1) A supply of a designated pharmaceutical benefit is a special arrangement supply of the benefit if the benefit is supplied:\n    (a) either:\n    (i) in New South Wales, Western Australia or South Australia on or after 1 December 2019; or\n    (ii) in Victoria, Queensland, Tasmania or a Territory on or after 1 July 2022; and\n    (c) by an approved hospital authority that is not an excluded approved supplier; and\n    (d) to a designated person who, at the time of the supply, is:\n    (i) a day admitted patient of a hospital of which the approved hospital authority is the governing body or proprietor; or\n    (ii) a patient on discharge from such a hospital; or\n    (iii) a non‑admitted patient of such a hospital; or\n    (iv) not a patient receiving treatment in or at such a hospital; and\n    (e) without a prescription.\n  Supplies by approved medical practitioners\n  (2) A supply of a designated pharmaceutical benefit is also a special arrangement supply of the benefit if:\n    (aa) the benefit is supplied:\n    (i) in New South Wales, Western Australia or South Australia on or after 1 December 2019; or\n    (ii) in Victoria, Queensland, Tasmania or a Territory on or after 1 July 2022; and\n    (a) the benefit is supplied:\n    (iii) to a designated person; and\n    (iv) without a prescription; and\n    (v) by an approved medical practitioner who is not an excluded approved supplier; and\n    (b) the benefit was not obtained by the approved medical practitioner under section 93 of the Act (prescriber bag supplies).\n  Supplies by approved pharmacists\n  (3) A supply of a designated pharmaceutical benefit is also a special arrangement supply of the benefit if the benefit is supplied:\n    (a) either:\n    (i) in New South Wales, Western Australia or South Australia on or after 1 December 2019; or\n    (ii) in Victoria, Queensland, Tasmania or a Territory on or after 1 July 2022; and\n    (c) to a designated person; and\n    (d) without a prescription; and\n    (e) by an approved pharmacist who is not an excluded approved supplier.\n  Supplies by authorised alternative suppliers\n  (4) A supply of a designated pharmaceutical benefit is also a special arrangement supply of the benefit if the benefit is supplied:\n    (a) either:\n    (i) in New South Wales, Western Australia or South Australia on or after 1 December 2019; or\n    (ii) in Victoria, Queensland, Tasmania or a Territory on or after 1 November 2022; and\n    (c) to a designated person; and\n    (d) by an authorised alternative supplier.\n  (5) However, a supply of a designated pharmaceutical benefit mentioned in subsection (4) is not a special arrangement supply of the benefit if:\n    (a) the authorised alternative supplier is the ambulance service of a jurisdiction; and\n    (b) the benefit supplied is administered to the designated person by an ambulance officer to treat the person for an opioid overdose.\n\n### Division 2—Special arrangement supplies of designated pharmaceutical benefits\n\n#### 8 Definition of value for safety net purposes for supplies\n\n  (1) The value for safety net purposes for a special arrangement supply of a designated pharmaceutical benefit is zero.\n  (2) This section applies despite the definition of value for safety net purposes in subsection 84(1) of the Act.\n\n#### 9 Designated persons entitled to receive supplies free of charge\n\n  (1) A designated person is entitled to receive a special arrangement supply of a designated pharmaceutical benefit without the payment or provision of money or other consideration.\n  (2) This section has effect in addition to section 86 of the Act.\n\n#### 10 Suppliers not to demand or receive payment for supplies or services\n\n  Approved suppliers\n  (1) An approved supplier must not demand or receive a payment (other than a payment from the Commonwealth) or other valuable consideration in respect of a special arrangement supply of a designated pharmaceutical benefit.\n  (2) An approved supplier must not demand or receive a payment or other valuable consideration in respect of any other service relating to a special arrangement supply of a designated pharmaceutical benefit.\n  (3) Subsection (1) has effect despite section 87 of the Act.\n  Authorised alternative suppliers\n  (4) An authorised alternative supplier must not demand or receive a payment or other valuable consideration in respect of:\n    (a) a special arrangement supply of a designated pharmaceutical benefit; or\n    (b) any other service relating to a special arrangement supply of a designated pharmaceutical benefit.\n\n#### 11 Supplies by approved hospital authorities\n\n  (1) A designated person is entitled to receive a special arrangement supply of a designated pharmaceutical benefit by an approved hospital authority if:\n    (a) at the time of the supply, the designated person is:\n    (i) a day admitted patient of a hospital of which the approved hospital authority is the governing body or proprietor; or\n    (ii) a patient on discharge from such a hospital; or\n    (iii) a non‑admitted patient of such a hospital; or\n    (iv) not a patient receiving treatment in or at such a hospital; and\n    (b) the approved hospital authority is not an excluded approved supplier.\n  (2) Subsection (1) has effect despite sections 89 and 94 of the Act.\n  (3) A designated person is entitled to receive a special arrangement supply of a designated pharmaceutical benefit by an approved hospital authority as mentioned in subsection (1) without a prescription.\n  (4) Subsection (3) has effect despite the Act and the National Health (Pharmaceutical Benefits) Regulations 2017.\n\n> Note 1: Sections 84AAA, 84D, 99 and 134 of the Act deal with the supply of pharmaceutical benefits by approved hospital authorities on prescription.\n\n> Note 2: Sections 18, 30, 41, 44, 45, 52 and 53 of the National Health (Pharmaceutical Benefits) Regulations 2017 deal with the supply of pharmaceutical benefits by approved hospital authorities on prescription.\n\n#### 12 Supplies by approved medical practitioners\n\n  (1) A designated person is entitled to receive a special arrangement supply of a designated pharmaceutical benefit by an approved medical practitioner who is not an excluded approved supplier without a prescription.\n  (2) This section has effect despite the National Health (Pharmaceutical Benefits) Regulations 2017.\n\n> Note: Sections 44, 48, 52 and 53 of the National Health (Pharmaceutical Benefits) Regulations 2017 deal with the supply of pharmaceutical benefits by approved medical practitioners on prescription.\n\n#### 13 Supplies by approved pharmacists\n\n  (1) A designated person is entitled to receive a special arrangement supply of a designated pharmaceutical benefit by an approved pharmacist who is not an excluded approved supplier without a prescription.\n  (2) This section has effect despite section 89 of the Act.\n\n#### 14 Supplies by authorised alternative suppliers\n\n  (1) A designated person is entitled to receive a special arrangement supply of a designated pharmaceutical benefit by an authorised alternative supplier.\n  (2) This section has effect despite section 89 of the Act.\n\n#### 15 Maximum quantity or number of units for supplies\n\n  The maximum quantity or number of units of the pharmaceutical item of a designated pharmaceutical benefit that may be supplied to a designated person in a special arrangement supply of the benefit on any one occasion is the quantity or number of units specified in the column headed “Maximum quantity or number of units” of the item of the table in clause 1 of Schedule 1 for the pharmaceutical benefit.\n\n#### 16 No limit on number of occasions for supplies\n\n  There is no limit on the number of occasions on which a designated person is entitled to receive a special arrangement supply of a designated pharmaceutical benefit.\n\n### Division 3—Payment for special arrangement supplies of designated pharmaceutical benefits\n\n#### 17 Supplies by approved hospital authorities to certain patients\n\n  (1) An approved hospital authority that wants to receive payment from the Commonwealth in relation to a special arrangement supply by the approved hospital authority of a designated pharmaceutical benefit to any of the following must make a claim for payment in accordance with section 20:\n    (a) a day admitted patient of a hospital of which the approved hospital authority is the governing body or proprietor;\n    (b) a patient on discharge from such a hospital;\n    (c) a non‑admitted patient of such a hospital.\n\n> Note: See subsection 99(4) of the Act for the entitlement of an approved hospital authority to payment for the supply of pharmaceutical benefits to patients receiving treatment in or at a hospital in respect of which the authority is approved.\n\n  (2) This section has effect despite section 99AAA of the Act.\n\n#### 18 Supplies by approved hospital authorities to persons who are not patients\n\n  Entitlement to payment\n  (1) Subject to this section, an approved hospital authority is entitled to payment from the Commonwealth in respect of a special arrangement supply by the approved hospital authority of a designated pharmaceutical benefit to a person who is not a patient receiving treatment in or at a hospital in respect of which the authority is approved.\n  Rates and conditions for payment\n  (2) The payment is at the rates and subject to the conditions determined by the Minister under subsection 99(4) of the Act in respect of the supply of designated pharmaceutical benefits.\n  Claims for payment\n  (3) If an approved hospital authority wants to receive a payment to which it is entitled under this section, the authority must make a claim for payment in accordance with section 20.\n\n#### 19 Supplies by approved medical practitioners and approved pharmacists\n\n  (1) An approved medical practitioner or an approved pharmacist who wants to receive payment from the Commonwealth in relation to a special arrangement supply by the approved medical practitioner or approved pharmacist of a designated pharmaceutical benefit must make a claim for payment in accordance with section 20.\n\n> Note: See section 99 of the Act for the entitlement of approved medical practitioners and approved pharmacists to payment for the supply of pharmaceutical benefits.\n\n  (2) This section has effect despite section 99AAA of the Act.\n\n#### 20 Claims for payment by approved suppliers\n\n  For the purposes of subsections 17(1), 18(3) and 19(1), a claim for payment by an approved supplier in relation to a special arrangement supply of a designated pharmaceutical benefit must:\n    (a) be made, in writing, to the Secretary; and\n    (b) include the following information:\n    (i) the benefit supplied;\n    (ii) the date the benefit was supplied;\n    (iii) the postcode in which the benefit was supplied;\n    (iv) the title of the individual who interacted with the person to whom the benefit was supplied;\n    (v) whether the person to whom the benefit was supplied consented to the use of their de‑identified data for ongoing monitoring of the supply of designated pharmaceutical benefits in accordance with this instrument; and\n    (c) if the person to whom the benefit was supplied consented as mentioned in subparagraph (b)(v)—include the following information:\n    (i) whether the person had previously received a supply of a designated pharmaceutical benefit;\n    (ii) if the person had previously received a supply of a designated pharmaceutical benefit—the reason for receiving a further supply of a designated pharmaceutical benefit.\n\n#### 21 Supplies to authorised alternative suppliers\n\n  Entitlement to payment\n  (1) Subject to this section, a person who supplies a designated pharmaceutical benefit to an authorised alternative supplier (for the purpose of the authorised alternative supplier making a special arrangement supply of the designated pharmaceutical benefit) is entitled to payment from the Commonwealth.\n  Amount of payment\n  (2) The amount of the payment is the approved ex‑manufacturer price of the listed brand of the pharmaceutical item of the designated pharmaceutical benefit that was applicable on the day the person supplied the benefit to the authorised alternative supplier.\n  Claims for payment\n  (3) If a person wants to receive a payment to which the person is entitled under this section, the person must make a claim for payment in accordance with subsection (4).\n  (4) The claim must:\n    (a) be made, in writing, to the Secretary; and\n    (b) include the name of the authorised alternative supplier; and\n    (c) include, for each day covered by the claim on which the person supplied a designated pharmaceutical benefit to the authorised alternative supplier, the volume of each designated pharmaceutical benefit supplied on the day.\n\n#### 22 Secretary to determine and pay claims\n\n  The Secretary must determine the amount payable for a claim made under this Part and make any payment relating to the claim.\n\n### Division 4—Administration\n\n#### 23 Secretary may request information from authorised alternative suppliers\n\n  (1) The Secretary may, in writing, ask an authorised alternative supplier to give the Secretary the information mentioned in paragraphs 20(b) and (c) in relation to any special arrangement supply of a designated pharmaceutical benefit made by the supplier.\n  (2) A request for information must:\n    (a) be in writing; and\n    (b) specify a day for complying with the request which is at least 28 days after the day of the request.\n\n#### 24 Authorised alternative suppliers to supply information on request\n\n  If an authorised alternative supplier receives a request for information under section 23, the supplier must comply with the request by the day specified in the request.\n\n#### 25 Secretary may authorise persons to perform functions or exercise powers\n\n  (1) The Secretary may, in writing, authorise persons having suitable qualifications and experience to perform any of the Secretary’s functions, or exercise any of the Secretary’s powers, under the following provisions on behalf of the Secretary:\n    (a) the definitions of authorised alternative supplier and excluded approved supplier in section 4 (receiving notices);\n    (b) section 20 and subsection 21(4) (receiving claims for payment);\n    (c) section 22 (determining and paying claims);\n    (d) section 23 (requesting information).\n  (2) Without limiting subsection (1), an authorisation under this section may be in the form of a contract entered into by the Secretary on behalf of the Commonwealth.\n  (3) A person who is authorised under this section must comply with any directions of the Secretary in the performance of the functions or exercise of the powers specified in the authorisation.\n\n#### 26 Review by Secretary of decisions of persons authorised under section 25\n\n  Application for review\n  (1) A person who is affected by a decision of a person who is authorised under section 25 may apply to the Secretary for review of the decision.\n  (2) An application for review must:\n    (a) be in writing; and\n    (b) be made within:\n    (i) 28 days after the day the decision first came to the notice of the applicant; or\n    (ii) if the Secretary allows a longer period (whether before or after the end of the 28‑day period referred to in subparagraph (i))—that longer period.\n  Review of decision\n  (3) On receiving an application, the Secretary must:\n    (a) review the decision; and\n    (b) affirm, vary or set aside the decision; and\n    (c) if the Secretary sets aside the decision—make a new decision in substitution for the decision set aside.\n  (4) The decision (the decision on review) of the Secretary takes effect:\n    (a) on the day specified in the decision on review; or\n    (b) if a day is not specified—on the day the decision on review was made.\n  Notice of decision\n  (5) After the Secretary makes a decision under this section, the Secretary must give the applicant a written notice stating the following:\n    (a) the terms of the decision;\n    (b) the reasons for the decision.\n\n## Part 3—Application, saving and transitional provisions\n\n#### 27 Saving of authorisations—National Health (Take Home Naloxone Pilot) Special Arrangement Amendment (2020 Measures No. 1) Instrument 2020\n\n  An authorisation that was in force under section 25 immediately before the commencement of the National Health (Take Home Naloxone Pilot) Special Arrangement Amendment (2020 Measures No. 1) Instrument 2020 has effect, on and after that commencement, as if it had been made under that section as amended by that instrument.\n\n#### 28 Application of amendments—National Health (Take Home Naloxone Pilot) Special Arrangement Amendment (2021 Measures No. 1) Instrument 2021\n\n  The amendments of section 20 made by the National Health (Take Home Naloxone Pilot) Special Arrangement Amendment (2021 Measures No. 1) Instrument 2021 apply in relation to a claim for payment made on or after 1 July 2021 in respect of a special arrangement supply of a designated pharmaceutical benefit made before, on or after that date.\n\n#### 29 Application of amendments—National Health (Take Home Naloxone Pilot) Special Arrangement Amendment (2022 Measures No. 1) Instrument 2022\n\n  The amendment of section 20 made by the National Health (Take Home Naloxone Pilot) Special Arrangement Amendment (2022 Measures No. 1) Instrument 2022 applies in relation to a claim for payment made on or after 1 July 2022 in respect of a special arrangement supply of a designated pharmaceutical benefit made on or after that date.","sortOrder":6},{"sectionNumber":"7","sectionType":"section","heading":"Definition of special arrangement supply","content":"#### 7 Definition of special arrangement supply\n\n  Supplies by approved hospital authorities\n  (1) A supply of a designated pharmaceutical benefit is a special arrangement supply of the benefit if the benefit is supplied:\n    (a) either:\n    (i) in New South Wales, Western Australia or South Australia on or after 1 December 2019; or\n    (ii) in Victoria, Queensland, Tasmania or a Territory on or after 1 July 2022; and\n    (c) by an approved hospital authority that is not an excluded approved supplier; and\n    (d) to a designated person who, at the time of the supply, is:\n    (i) a day admitted patient of a hospital of which the approved hospital authority is the governing body or proprietor; or\n    (ii) a patient on discharge from such a hospital; or\n    (iii) a non‑admitted patient of such a hospital; or\n    (iv) not a patient receiving treatment in or at such a hospital; and\n    (e) without a prescription.\n  Supplies by approved medical practitioners\n  (2) A supply of a designated pharmaceutical benefit is also a special arrangement supply of the benefit if:\n    (aa) the benefit is supplied:\n    (i) in New South Wales, Western Australia or South Australia on or after 1 December 2019; or\n    (ii) in Victoria, Queensland, Tasmania or a Territory on or after 1 July 2022; and\n    (a) the benefit is supplied:\n    (iii) to a designated person; and\n    (iv) without a prescription; and\n    (v) by an approved medical practitioner who is not an excluded approved supplier; and\n    (b) the benefit was not obtained by the approved medical practitioner under section 93 of the Act (prescriber bag supplies).\n  Supplies by approved pharmacists\n  (3) A supply of a designated pharmaceutical benefit is also a special arrangement supply of the benefit if the benefit is supplied:\n    (a) either:\n    (i) in New South Wales, Western Australia or South Australia on or after 1 December 2019; or\n    (ii) in Victoria, Queensland, Tasmania or a Territory on or after 1 July 2022; and\n    (c) to a designated person; and\n    (d) without a prescription; and\n    (e) by an approved pharmacist who is not an excluded approved supplier.\n  Supplies by authorised alternative suppliers\n  (4) A supply of a designated pharmaceutical benefit is also a special arrangement supply of the benefit if the benefit is supplied:\n    (a) either:\n    (i) in New South Wales, Western Australia or South Australia on or after 1 December 2019; or\n    (ii) in Victoria, Queensland, Tasmania or a Territory on or after 1 November 2022; and\n    (c) to a designated person; and\n    (d) by an authorised alternative supplier.\n  (5) However, a supply of a designated pharmaceutical benefit mentioned in subsection (4) is not a special arrangement supply of the benefit if:\n    (a) the authorised alternative supplier is the ambulance service of a jurisdiction; and\n    (b) the benefit supplied is administered to the designated person by an ambulance officer to treat the person for an opioid overdose.","sortOrder":7},{"sectionNumber":"Division 2","sectionType":"division","heading":"Special arrangement supplies of designated pharmaceutical benefits","content":"## Part 1—Preliminary\n\n#### 1 Name\n\n  (1) This instrument is the National Health (Take Home Naloxone) Special Arrangement 2019.\n  (2) This instrument may also be cited as PB 97 of 2019.\n\n#### 3 Authority\n\n  This instrument is made under section 100 of the National Health Act 1953.\n\n#### 5 Simplified outline of this instrument\n\nThis instrument makes a special arrangement for the supply of naloxone to persons who are at risk of an opioid overdose and persons who are likely to be able to assist such persons.\n\nNaloxone will be supplied free of charge and without a prescription by hospitals, pharmacists, certain medical practitioners and other authorised persons and organisations.\n\nThis instrument also deals with payments for supplies of naloxone and administrative matters.\n\n> Note: Part VII of the Act, and regulations or other instruments made for the purposes of that Part, have effect subject to this instrument (see subsection 100(3) of the Act).\n\n#### 6 Definitions\n\n> Note: A number of expressions used in this instrument are defined in the Act, including the following:\n\n    (a) hospital;\n    (b) premises;\n    (c) Secretary.\n  In this instrument:\n\n> Act means the National Health Act 1953.\n\n> approved ex‑manufacturer price of a listed brand of a pharmaceutical item has the same meaning as in Part VII of the Act.\n\n> approved hospital authority has the same meaning as in Part VII of the Act.\n\n> approved medical practitioner has the same meaning as in Part VII of the Act.\n\n> approved pharmacist has the same meaning as in Part VII of the Act.\n\n> approved supplier has the same meaning as in Part VII of the Act.\n\n> authorised alternative supplier means a person or organisation:\n\n    (a) that has premises in a jurisdiction; and\n    (b) that is authorised (however described) by an authority of the jurisdiction for the purposes of supplying designated pharmaceutical benefits in accordance with this instrument; and\n    (c) in relation to which the authority has given the Secretary a written notice stating:\n    (i) that the person or organisation is so authorised; and\n    (ii) the name and contact details of the person or organisation.\n\n> day admitted patient: a person is a day admitted patient of a hospital on a day if, on that day, the person:\n\n    (a) is admitted to the hospital (other than through the hospital’s emergency department); and\n    (b) receives treatment; and\n    (c) is discharged from the hospital;\n  in accordance with a pre‑existing plan for the person’s treatment.\n\n> designated person means:\n\n    (a) a person who is at risk of an opioid overdose; or\n    (b) a person who is likely to be able to assist such a person.\n\n> designated pharmaceutical benefit means a pharmaceutical benefit mentioned in Schedule 1.\n\n> excluded approved supplier means an approved supplier in a jurisdiction in relation to which there is in force a notice given by an authority of the jurisdiction to the Secretary and the supplier to the effect that the authority wants the supplier not to be able to supply designated pharmaceutical benefits in accordance with this instrument.\n\n> jurisdiction means a State or Territory.\n\n> listed brand of a pharmaceutical item has the same meaning as in Part VII of the Act.\n\n> pharmaceutical benefit has the same meaning as in Part VII of the Act.\n\n> pharmaceutical item has the same meaning as in Part VII of the Act.\n\n> special arrangement supply has the meaning given by section 7.\n\n> Territory has the same meaning as in Part VII of the Act.\n\n## Part 2—Special arrangement supplies of designated pharmaceutical benefits\n\n### Division 1—Preliminary\n\n#### 7 Definition of special arrangement supply\n\n  Supplies by approved hospital authorities\n  (1) A supply of a designated pharmaceutical benefit is a special arrangement supply of the benefit if the benefit is supplied:\n    (a) either:\n    (i) in New South Wales, Western Australia or South Australia on or after 1 December 2019; or\n    (ii) in Victoria, Queensland, Tasmania or a Territory on or after 1 July 2022; and\n    (c) by an approved hospital authority that is not an excluded approved supplier; and\n    (d) to a designated person who, at the time of the supply, is:\n    (i) a day admitted patient of a hospital of which the approved hospital authority is the governing body or proprietor; or\n    (ii) a patient on discharge from such a hospital; or\n    (iii) a non‑admitted patient of such a hospital; or\n    (iv) not a patient receiving treatment in or at such a hospital; and\n    (e) without a prescription.\n  Supplies by approved medical practitioners\n  (2) A supply of a designated pharmaceutical benefit is also a special arrangement supply of the benefit if:\n    (aa) the benefit is supplied:\n    (i) in New South Wales, Western Australia or South Australia on or after 1 December 2019; or\n    (ii) in Victoria, Queensland, Tasmania or a Territory on or after 1 July 2022; and\n    (a) the benefit is supplied:\n    (iii) to a designated person; and\n    (iv) without a prescription; and\n    (v) by an approved medical practitioner who is not an excluded approved supplier; and\n    (b) the benefit was not obtained by the approved medical practitioner under section 93 of the Act (prescriber bag supplies).\n  Supplies by approved pharmacists\n  (3) A supply of a designated pharmaceutical benefit is also a special arrangement supply of the benefit if the benefit is supplied:\n    (a) either:\n    (i) in New South Wales, Western Australia or South Australia on or after 1 December 2019; or\n    (ii) in Victoria, Queensland, Tasmania or a Territory on or after 1 July 2022; and\n    (c) to a designated person; and\n    (d) without a prescription; and\n    (e) by an approved pharmacist who is not an excluded approved supplier.\n  Supplies by authorised alternative suppliers\n  (4) A supply of a designated pharmaceutical benefit is also a special arrangement supply of the benefit if the benefit is supplied:\n    (a) either:\n    (i) in New South Wales, Western Australia or South Australia on or after 1 December 2019; or\n    (ii) in Victoria, Queensland, Tasmania or a Territory on or after 1 November 2022; and\n    (c) to a designated person; and\n    (d) by an authorised alternative supplier.\n  (5) However, a supply of a designated pharmaceutical benefit mentioned in subsection (4) is not a special arrangement supply of the benefit if:\n    (a) the authorised alternative supplier is the ambulance service of a jurisdiction; and\n    (b) the benefit supplied is administered to the designated person by an ambulance officer to treat the person for an opioid overdose.\n\n### Division 2—Special arrangement supplies of designated pharmaceutical benefits\n\n#### 8 Definition of value for safety net purposes for supplies\n\n  (1) The value for safety net purposes for a special arrangement supply of a designated pharmaceutical benefit is zero.\n  (2) This section applies despite the definition of value for safety net purposes in subsection 84(1) of the Act.\n\n#### 9 Designated persons entitled to receive supplies free of charge\n\n  (1) A designated person is entitled to receive a special arrangement supply of a designated pharmaceutical benefit without the payment or provision of money or other consideration.\n  (2) This section has effect in addition to section 86 of the Act.\n\n#### 10 Suppliers not to demand or receive payment for supplies or services\n\n  Approved suppliers\n  (1) An approved supplier must not demand or receive a payment (other than a payment from the Commonwealth) or other valuable consideration in respect of a special arrangement supply of a designated pharmaceutical benefit.\n  (2) An approved supplier must not demand or receive a payment or other valuable consideration in respect of any other service relating to a special arrangement supply of a designated pharmaceutical benefit.\n  (3) Subsection (1) has effect despite section 87 of the Act.\n  Authorised alternative suppliers\n  (4) An authorised alternative supplier must not demand or receive a payment or other valuable consideration in respect of:\n    (a) a special arrangement supply of a designated pharmaceutical benefit; or\n    (b) any other service relating to a special arrangement supply of a designated pharmaceutical benefit.\n\n#### 11 Supplies by approved hospital authorities\n\n  (1) A designated person is entitled to receive a special arrangement supply of a designated pharmaceutical benefit by an approved hospital authority if:\n    (a) at the time of the supply, the designated person is:\n    (i) a day admitted patient of a hospital of which the approved hospital authority is the governing body or proprietor; or\n    (ii) a patient on discharge from such a hospital; or\n    (iii) a non‑admitted patient of such a hospital; or\n    (iv) not a patient receiving treatment in or at such a hospital; and\n    (b) the approved hospital authority is not an excluded approved supplier.\n  (2) Subsection (1) has effect despite sections 89 and 94 of the Act.\n  (3) A designated person is entitled to receive a special arrangement supply of a designated pharmaceutical benefit by an approved hospital authority as mentioned in subsection (1) without a prescription.\n  (4) Subsection (3) has effect despite the Act and the National Health (Pharmaceutical Benefits) Regulations 2017.\n\n> Note 1: Sections 84AAA, 84D, 99 and 134 of the Act deal with the supply of pharmaceutical benefits by approved hospital authorities on prescription.\n\n> Note 2: Sections 18, 30, 41, 44, 45, 52 and 53 of the National Health (Pharmaceutical Benefits) Regulations 2017 deal with the supply of pharmaceutical benefits by approved hospital authorities on prescription.\n\n#### 12 Supplies by approved medical practitioners\n\n  (1) A designated person is entitled to receive a special arrangement supply of a designated pharmaceutical benefit by an approved medical practitioner who is not an excluded approved supplier without a prescription.\n  (2) This section has effect despite the National Health (Pharmaceutical Benefits) Regulations 2017.\n\n> Note: Sections 44, 48, 52 and 53 of the National Health (Pharmaceutical Benefits) Regulations 2017 deal with the supply of pharmaceutical benefits by approved medical practitioners on prescription.\n\n#### 13 Supplies by approved pharmacists\n\n  (1) A designated person is entitled to receive a special arrangement supply of a designated pharmaceutical benefit by an approved pharmacist who is not an excluded approved supplier without a prescription.\n  (2) This section has effect despite section 89 of the Act.\n\n#### 14 Supplies by authorised alternative suppliers\n\n  (1) A designated person is entitled to receive a special arrangement supply of a designated pharmaceutical benefit by an authorised alternative supplier.\n  (2) This section has effect despite section 89 of the Act.\n\n#### 15 Maximum quantity or number of units for supplies\n\n  The maximum quantity or number of units of the pharmaceutical item of a designated pharmaceutical benefit that may be supplied to a designated person in a special arrangement supply of the benefit on any one occasion is the quantity or number of units specified in the column headed “Maximum quantity or number of units” of the item of the table in clause 1 of Schedule 1 for the pharmaceutical benefit.\n\n#### 16 No limit on number of occasions for supplies\n\n  There is no limit on the number of occasions on which a designated person is entitled to receive a special arrangement supply of a designated pharmaceutical benefit.\n\n### Division 3—Payment for special arrangement supplies of designated pharmaceutical benefits\n\n#### 17 Supplies by approved hospital authorities to certain patients\n\n  (1) An approved hospital authority that wants to receive payment from the Commonwealth in relation to a special arrangement supply by the approved hospital authority of a designated pharmaceutical benefit to any of the following must make a claim for payment in accordance with section 20:\n    (a) a day admitted patient of a hospital of which the approved hospital authority is the governing body or proprietor;\n    (b) a patient on discharge from such a hospital;\n    (c) a non‑admitted patient of such a hospital.\n\n> Note: See subsection 99(4) of the Act for the entitlement of an approved hospital authority to payment for the supply of pharmaceutical benefits to patients receiving treatment in or at a hospital in respect of which the authority is approved.\n\n  (2) This section has effect despite section 99AAA of the Act.\n\n#### 18 Supplies by approved hospital authorities to persons who are not patients\n\n  Entitlement to payment\n  (1) Subject to this section, an approved hospital authority is entitled to payment from the Commonwealth in respect of a special arrangement supply by the approved hospital authority of a designated pharmaceutical benefit to a person who is not a patient receiving treatment in or at a hospital in respect of which the authority is approved.\n  Rates and conditions for payment\n  (2) The payment is at the rates and subject to the conditions determined by the Minister under subsection 99(4) of the Act in respect of the supply of designated pharmaceutical benefits.\n  Claims for payment\n  (3) If an approved hospital authority wants to receive a payment to which it is entitled under this section, the authority must make a claim for payment in accordance with section 20.\n\n#### 19 Supplies by approved medical practitioners and approved pharmacists\n\n  (1) An approved medical practitioner or an approved pharmacist who wants to receive payment from the Commonwealth in relation to a special arrangement supply by the approved medical practitioner or approved pharmacist of a designated pharmaceutical benefit must make a claim for payment in accordance with section 20.\n\n> Note: See section 99 of the Act for the entitlement of approved medical practitioners and approved pharmacists to payment for the supply of pharmaceutical benefits.\n\n  (2) This section has effect despite section 99AAA of the Act.\n\n#### 20 Claims for payment by approved suppliers\n\n  For the purposes of subsections 17(1), 18(3) and 19(1), a claim for payment by an approved supplier in relation to a special arrangement supply of a designated pharmaceutical benefit must:\n    (a) be made, in writing, to the Secretary; and\n    (b) include the following information:\n    (i) the benefit supplied;\n    (ii) the date the benefit was supplied;\n    (iii) the postcode in which the benefit was supplied;\n    (iv) the title of the individual who interacted with the person to whom the benefit was supplied;\n    (v) whether the person to whom the benefit was supplied consented to the use of their de‑identified data for ongoing monitoring of the supply of designated pharmaceutical benefits in accordance with this instrument; and\n    (c) if the person to whom the benefit was supplied consented as mentioned in subparagraph (b)(v)—include the following information:\n    (i) whether the person had previously received a supply of a designated pharmaceutical benefit;\n    (ii) if the person had previously received a supply of a designated pharmaceutical benefit—the reason for receiving a further supply of a designated pharmaceutical benefit.\n\n#### 21 Supplies to authorised alternative suppliers\n\n  Entitlement to payment\n  (1) Subject to this section, a person who supplies a designated pharmaceutical benefit to an authorised alternative supplier (for the purpose of the authorised alternative supplier making a special arrangement supply of the designated pharmaceutical benefit) is entitled to payment from the Commonwealth.\n  Amount of payment\n  (2) The amount of the payment is the approved ex‑manufacturer price of the listed brand of the pharmaceutical item of the designated pharmaceutical benefit that was applicable on the day the person supplied the benefit to the authorised alternative supplier.\n  Claims for payment\n  (3) If a person wants to receive a payment to which the person is entitled under this section, the person must make a claim for payment in accordance with subsection (4).\n  (4) The claim must:\n    (a) be made, in writing, to the Secretary; and\n    (b) include the name of the authorised alternative supplier; and\n    (c) include, for each day covered by the claim on which the person supplied a designated pharmaceutical benefit to the authorised alternative supplier, the volume of each designated pharmaceutical benefit supplied on the day.\n\n#### 22 Secretary to determine and pay claims\n\n  The Secretary must determine the amount payable for a claim made under this Part and make any payment relating to the claim.\n\n### Division 4—Administration\n\n#### 23 Secretary may request information from authorised alternative suppliers\n\n  (1) The Secretary may, in writing, ask an authorised alternative supplier to give the Secretary the information mentioned in paragraphs 20(b) and (c) in relation to any special arrangement supply of a designated pharmaceutical benefit made by the supplier.\n  (2) A request for information must:\n    (a) be in writing; and\n    (b) specify a day for complying with the request which is at least 28 days after the day of the request.\n\n#### 24 Authorised alternative suppliers to supply information on request\n\n  If an authorised alternative supplier receives a request for information under section 23, the supplier must comply with the request by the day specified in the request.\n\n#### 25 Secretary may authorise persons to perform functions or exercise powers\n\n  (1) The Secretary may, in writing, authorise persons having suitable qualifications and experience to perform any of the Secretary’s functions, or exercise any of the Secretary’s powers, under the following provisions on behalf of the Secretary:\n    (a) the definitions of authorised alternative supplier and excluded approved supplier in section 4 (receiving notices);\n    (b) section 20 and subsection 21(4) (receiving claims for payment);\n    (c) section 22 (determining and paying claims);\n    (d) section 23 (requesting information).\n  (2) Without limiting subsection (1), an authorisation under this section may be in the form of a contract entered into by the Secretary on behalf of the Commonwealth.\n  (3) A person who is authorised under this section must comply with any directions of the Secretary in the performance of the functions or exercise of the powers specified in the authorisation.\n\n#### 26 Review by Secretary of decisions of persons authorised under section 25\n\n  Application for review\n  (1) A person who is affected by a decision of a person who is authorised under section 25 may apply to the Secretary for review of the decision.\n  (2) An application for review must:\n    (a) be in writing; and\n    (b) be made within:\n    (i) 28 days after the day the decision first came to the notice of the applicant; or\n    (ii) if the Secretary allows a longer period (whether before or after the end of the 28‑day period referred to in subparagraph (i))—that longer period.\n  Review of decision\n  (3) On receiving an application, the Secretary must:\n    (a) review the decision; and\n    (b) affirm, vary or set aside the decision; and\n    (c) if the Secretary sets aside the decision—make a new decision in substitution for the decision set aside.\n  (4) The decision (the decision on review) of the Secretary takes effect:\n    (a) on the day specified in the decision on review; or\n    (b) if a day is not specified—on the day the decision on review was made.\n  Notice of decision\n  (5) After the Secretary makes a decision under this section, the Secretary must give the applicant a written notice stating the following:\n    (a) the terms of the decision;\n    (b) the reasons for the decision.\n\n## Part 3—Application, saving and transitional provisions\n\n#### 27 Saving of authorisations—National Health (Take Home Naloxone Pilot) Special Arrangement Amendment (2020 Measures No. 1) Instrument 2020\n\n  An authorisation that was in force under section 25 immediately before the commencement of the National Health (Take Home Naloxone Pilot) Special Arrangement Amendment (2020 Measures No. 1) Instrument 2020 has effect, on and after that commencement, as if it had been made under that section as amended by that instrument.\n\n#### 28 Application of amendments—National Health (Take Home Naloxone Pilot) Special Arrangement Amendment (2021 Measures No. 1) Instrument 2021\n\n  The amendments of section 20 made by the National Health (Take Home Naloxone Pilot) Special Arrangement Amendment (2021 Measures No. 1) Instrument 2021 apply in relation to a claim for payment made on or after 1 July 2021 in respect of a special arrangement supply of a designated pharmaceutical benefit made before, on or after that date.\n\n#### 29 Application of amendments—National Health (Take Home Naloxone Pilot) Special Arrangement Amendment (2022 Measures No. 1) Instrument 2022\n\n  The amendment of section 20 made by the National Health (Take Home Naloxone Pilot) Special Arrangement Amendment (2022 Measures No. 1) Instrument 2022 applies in relation to a claim for payment made on or after 1 July 2022 in respect of a special arrangement supply of a designated pharmaceutical benefit made on or after that date.","sortOrder":8},{"sectionNumber":"8","sectionType":"section","heading":"Definition of value for safety net purposes for supplies","content":"#### 8 Definition of value for safety net purposes for supplies\n\n  (1) The value for safety net purposes for a special arrangement supply of a designated pharmaceutical benefit is zero.\n  (2) This section applies despite the definition of value for safety net purposes in subsection 84(1) of the Act.","sortOrder":9},{"sectionNumber":"9","sectionType":"section","heading":"Designated persons entitled to receive supplies free of charge","content":"#### 9 Designated persons entitled to receive supplies free of charge\n\n  (1) A designated person is entitled to receive a special arrangement supply of a designated pharmaceutical benefit without the payment or provision of money or other consideration.\n  (2) This section has effect in addition to section 86 of the Act.","sortOrder":10},{"sectionNumber":"10","sectionType":"section","heading":"Suppliers not to demand or receive payment for supplies or services","content":"#### 10 Suppliers not to demand or receive payment for supplies or services\n\n  Approved suppliers\n  (1) An approved supplier must not demand or receive a payment (other than a payment from the Commonwealth) or other valuable consideration in respect of a special arrangement supply of a designated pharmaceutical benefit.\n  (2) An approved supplier must not demand or receive a payment or other valuable consideration in respect of any other service relating to a special arrangement supply of a designated pharmaceutical benefit.\n  (3) Subsection (1) has effect despite section 87 of the Act.\n  Authorised alternative suppliers\n  (4) An authorised alternative supplier must not demand or receive a payment or other valuable consideration in respect of:\n    (a) a special arrangement supply of a designated pharmaceutical benefit; or\n    (b) any other service relating to a special arrangement supply of a designated pharmaceutical benefit.","sortOrder":11},{"sectionNumber":"11","sectionType":"section","heading":"Supplies by approved hospital authorities","content":"#### 11 Supplies by approved hospital authorities\n\n  (1) A designated person is entitled to receive a special arrangement supply of a designated pharmaceutical benefit by an approved hospital authority if:\n    (a) at the time of the supply, the designated person is:\n    (i) a day admitted patient of a hospital of which the approved hospital authority is the governing body or proprietor; or\n    (ii) a patient on discharge from such a hospital; or\n    (iii) a non‑admitted patient of such a hospital; or\n    (iv) not a patient receiving treatment in or at such a hospital; and\n    (b) the approved hospital authority is not an excluded approved supplier.\n  (2) Subsection (1) has effect despite sections 89 and 94 of the Act.\n  (3) A designated person is entitled to receive a special arrangement supply of a designated pharmaceutical benefit by an approved hospital authority as mentioned in subsection (1) without a prescription.\n  (4) Subsection (3) has effect despite the Act and the National Health (Pharmaceutical Benefits) Regulations 2017.\n\n> Note 1: Sections 84AAA, 84D, 99 and 134 of the Act deal with the supply of pharmaceutical benefits by approved hospital authorities on prescription.\n\n> Note 2: Sections 18, 30, 41, 44, 45, 52 and 53 of the National Health (Pharmaceutical Benefits) Regulations 2017 deal with the supply of pharmaceutical benefits by approved hospital authorities on prescription.","sortOrder":12},{"sectionNumber":"12","sectionType":"section","heading":"Supplies by approved medical practitioners","content":"#### 12 Supplies by approved medical practitioners\n\n  (1) A designated person is entitled to receive a special arrangement supply of a designated pharmaceutical benefit by an approved medical practitioner who is not an excluded approved supplier without a prescription.\n  (2) This section has effect despite the National Health (Pharmaceutical Benefits) Regulations 2017.\n\n> Note: Sections 44, 48, 52 and 53 of the National Health (Pharmaceutical Benefits) Regulations 2017 deal with the supply of pharmaceutical benefits by approved medical practitioners on prescription.","sortOrder":13},{"sectionNumber":"13","sectionType":"section","heading":"Supplies by approved pharmacists","content":"#### 13 Supplies by approved pharmacists\n\n  (1) A designated person is entitled to receive a special arrangement supply of a designated pharmaceutical benefit by an approved pharmacist who is not an excluded approved supplier without a prescription.\n  (2) This section has effect despite section 89 of the Act.","sortOrder":14},{"sectionNumber":"14","sectionType":"section","heading":"Supplies by authorised alternative suppliers","content":"#### 14 Supplies by authorised alternative suppliers\n\n  (1) A designated person is entitled to receive a special arrangement supply of a designated pharmaceutical benefit by an authorised alternative supplier.\n  (2) This section has effect despite section 89 of the Act.","sortOrder":15},{"sectionNumber":"15","sectionType":"section","heading":"Maximum quantity or number of units for supplies","content":"#### 15 Maximum quantity or number of units for supplies\n\n  The maximum quantity or number of units of the pharmaceutical item of a designated pharmaceutical benefit that may be supplied to a designated person in a special arrangement supply of the benefit on any one occasion is the quantity or number of units specified in the column headed “Maximum quantity or number of units” of the item of the table in clause 1 of Schedule 1 for the pharmaceutical benefit.","sortOrder":16},{"sectionNumber":"16","sectionType":"section","heading":"No limit on number of occasions for supplies","content":"#### 16 No limit on number of occasions for supplies\n\n  There is no limit on the number of occasions on which a designated person is entitled to receive a special arrangement supply of a designated pharmaceutical benefit.","sortOrder":17},{"sectionNumber":"Division 3","sectionType":"division","heading":"Payment for special arrangement supplies of designated pharmaceutical benefits","content":"## Part 1—Preliminary\n\n#### 1 Name\n\n  (1) This instrument is the National Health (Take Home Naloxone) Special Arrangement 2019.\n  (2) This instrument may also be cited as PB 97 of 2019.\n\n#### 3 Authority\n\n  This instrument is made under section 100 of the National Health Act 1953.\n\n#### 5 Simplified outline of this instrument\n\nThis instrument makes a special arrangement for the supply of naloxone to persons who are at risk of an opioid overdose and persons who are likely to be able to assist such persons.\n\nNaloxone will be supplied free of charge and without a prescription by hospitals, pharmacists, certain medical practitioners and other authorised persons and organisations.\n\nThis instrument also deals with payments for supplies of naloxone and administrative matters.\n\n> Note: Part VII of the Act, and regulations or other instruments made for the purposes of that Part, have effect subject to this instrument (see subsection 100(3) of the Act).\n\n#### 6 Definitions\n\n> Note: A number of expressions used in this instrument are defined in the Act, including the following:\n\n    (a) hospital;\n    (b) premises;\n    (c) Secretary.\n  In this instrument:\n\n> Act means the National Health Act 1953.\n\n> approved ex‑manufacturer price of a listed brand of a pharmaceutical item has the same meaning as in Part VII of the Act.\n\n> approved hospital authority has the same meaning as in Part VII of the Act.\n\n> approved medical practitioner has the same meaning as in Part VII of the Act.\n\n> approved pharmacist has the same meaning as in Part VII of the Act.\n\n> approved supplier has the same meaning as in Part VII of the Act.\n\n> authorised alternative supplier means a person or organisation:\n\n    (a) that has premises in a jurisdiction; and\n    (b) that is authorised (however described) by an authority of the jurisdiction for the purposes of supplying designated pharmaceutical benefits in accordance with this instrument; and\n    (c) in relation to which the authority has given the Secretary a written notice stating:\n    (i) that the person or organisation is so authorised; and\n    (ii) the name and contact details of the person or organisation.\n\n> day admitted patient: a person is a day admitted patient of a hospital on a day if, on that day, the person:\n\n    (a) is admitted to the hospital (other than through the hospital’s emergency department); and\n    (b) receives treatment; and\n    (c) is discharged from the hospital;\n  in accordance with a pre‑existing plan for the person’s treatment.\n\n> designated person means:\n\n    (a) a person who is at risk of an opioid overdose; or\n    (b) a person who is likely to be able to assist such a person.\n\n> designated pharmaceutical benefit means a pharmaceutical benefit mentioned in Schedule 1.\n\n> excluded approved supplier means an approved supplier in a jurisdiction in relation to which there is in force a notice given by an authority of the jurisdiction to the Secretary and the supplier to the effect that the authority wants the supplier not to be able to supply designated pharmaceutical benefits in accordance with this instrument.\n\n> jurisdiction means a State or Territory.\n\n> listed brand of a pharmaceutical item has the same meaning as in Part VII of the Act.\n\n> pharmaceutical benefit has the same meaning as in Part VII of the Act.\n\n> pharmaceutical item has the same meaning as in Part VII of the Act.\n\n> special arrangement supply has the meaning given by section 7.\n\n> Territory has the same meaning as in Part VII of the Act.\n\n## Part 2—Special arrangement supplies of designated pharmaceutical benefits\n\n### Division 1—Preliminary\n\n#### 7 Definition of special arrangement supply\n\n  Supplies by approved hospital authorities\n  (1) A supply of a designated pharmaceutical benefit is a special arrangement supply of the benefit if the benefit is supplied:\n    (a) either:\n    (i) in New South Wales, Western Australia or South Australia on or after 1 December 2019; or\n    (ii) in Victoria, Queensland, Tasmania or a Territory on or after 1 July 2022; and\n    (c) by an approved hospital authority that is not an excluded approved supplier; and\n    (d) to a designated person who, at the time of the supply, is:\n    (i) a day admitted patient of a hospital of which the approved hospital authority is the governing body or proprietor; or\n    (ii) a patient on discharge from such a hospital; or\n    (iii) a non‑admitted patient of such a hospital; or\n    (iv) not a patient receiving treatment in or at such a hospital; and\n    (e) without a prescription.\n  Supplies by approved medical practitioners\n  (2) A supply of a designated pharmaceutical benefit is also a special arrangement supply of the benefit if:\n    (aa) the benefit is supplied:\n    (i) in New South Wales, Western Australia or South Australia on or after 1 December 2019; or\n    (ii) in Victoria, Queensland, Tasmania or a Territory on or after 1 July 2022; and\n    (a) the benefit is supplied:\n    (iii) to a designated person; and\n    (iv) without a prescription; and\n    (v) by an approved medical practitioner who is not an excluded approved supplier; and\n    (b) the benefit was not obtained by the approved medical practitioner under section 93 of the Act (prescriber bag supplies).\n  Supplies by approved pharmacists\n  (3) A supply of a designated pharmaceutical benefit is also a special arrangement supply of the benefit if the benefit is supplied:\n    (a) either:\n    (i) in New South Wales, Western Australia or South Australia on or after 1 December 2019; or\n    (ii) in Victoria, Queensland, Tasmania or a Territory on or after 1 July 2022; and\n    (c) to a designated person; and\n    (d) without a prescription; and\n    (e) by an approved pharmacist who is not an excluded approved supplier.\n  Supplies by authorised alternative suppliers\n  (4) A supply of a designated pharmaceutical benefit is also a special arrangement supply of the benefit if the benefit is supplied:\n    (a) either:\n    (i) in New South Wales, Western Australia or South Australia on or after 1 December 2019; or\n    (ii) in Victoria, Queensland, Tasmania or a Territory on or after 1 November 2022; and\n    (c) to a designated person; and\n    (d) by an authorised alternative supplier.\n  (5) However, a supply of a designated pharmaceutical benefit mentioned in subsection (4) is not a special arrangement supply of the benefit if:\n    (a) the authorised alternative supplier is the ambulance service of a jurisdiction; and\n    (b) the benefit supplied is administered to the designated person by an ambulance officer to treat the person for an opioid overdose.\n\n### Division 2—Special arrangement supplies of designated pharmaceutical benefits\n\n#### 8 Definition of value for safety net purposes for supplies\n\n  (1) The value for safety net purposes for a special arrangement supply of a designated pharmaceutical benefit is zero.\n  (2) This section applies despite the definition of value for safety net purposes in subsection 84(1) of the Act.\n\n#### 9 Designated persons entitled to receive supplies free of charge\n\n  (1) A designated person is entitled to receive a special arrangement supply of a designated pharmaceutical benefit without the payment or provision of money or other consideration.\n  (2) This section has effect in addition to section 86 of the Act.\n\n#### 10 Suppliers not to demand or receive payment for supplies or services\n\n  Approved suppliers\n  (1) An approved supplier must not demand or receive a payment (other than a payment from the Commonwealth) or other valuable consideration in respect of a special arrangement supply of a designated pharmaceutical benefit.\n  (2) An approved supplier must not demand or receive a payment or other valuable consideration in respect of any other service relating to a special arrangement supply of a designated pharmaceutical benefit.\n  (3) Subsection (1) has effect despite section 87 of the Act.\n  Authorised alternative suppliers\n  (4) An authorised alternative supplier must not demand or receive a payment or other valuable consideration in respect of:\n    (a) a special arrangement supply of a designated pharmaceutical benefit; or\n    (b) any other service relating to a special arrangement supply of a designated pharmaceutical benefit.\n\n#### 11 Supplies by approved hospital authorities\n\n  (1) A designated person is entitled to receive a special arrangement supply of a designated pharmaceutical benefit by an approved hospital authority if:\n    (a) at the time of the supply, the designated person is:\n    (i) a day admitted patient of a hospital of which the approved hospital authority is the governing body or proprietor; or\n    (ii) a patient on discharge from such a hospital; or\n    (iii) a non‑admitted patient of such a hospital; or\n    (iv) not a patient receiving treatment in or at such a hospital; and\n    (b) the approved hospital authority is not an excluded approved supplier.\n  (2) Subsection (1) has effect despite sections 89 and 94 of the Act.\n  (3) A designated person is entitled to receive a special arrangement supply of a designated pharmaceutical benefit by an approved hospital authority as mentioned in subsection (1) without a prescription.\n  (4) Subsection (3) has effect despite the Act and the National Health (Pharmaceutical Benefits) Regulations 2017.\n\n> Note 1: Sections 84AAA, 84D, 99 and 134 of the Act deal with the supply of pharmaceutical benefits by approved hospital authorities on prescription.\n\n> Note 2: Sections 18, 30, 41, 44, 45, 52 and 53 of the National Health (Pharmaceutical Benefits) Regulations 2017 deal with the supply of pharmaceutical benefits by approved hospital authorities on prescription.\n\n#### 12 Supplies by approved medical practitioners\n\n  (1) A designated person is entitled to receive a special arrangement supply of a designated pharmaceutical benefit by an approved medical practitioner who is not an excluded approved supplier without a prescription.\n  (2) This section has effect despite the National Health (Pharmaceutical Benefits) Regulations 2017.\n\n> Note: Sections 44, 48, 52 and 53 of the National Health (Pharmaceutical Benefits) Regulations 2017 deal with the supply of pharmaceutical benefits by approved medical practitioners on prescription.\n\n#### 13 Supplies by approved pharmacists\n\n  (1) A designated person is entitled to receive a special arrangement supply of a designated pharmaceutical benefit by an approved pharmacist who is not an excluded approved supplier without a prescription.\n  (2) This section has effect despite section 89 of the Act.\n\n#### 14 Supplies by authorised alternative suppliers\n\n  (1) A designated person is entitled to receive a special arrangement supply of a designated pharmaceutical benefit by an authorised alternative supplier.\n  (2) This section has effect despite section 89 of the Act.\n\n#### 15 Maximum quantity or number of units for supplies\n\n  The maximum quantity or number of units of the pharmaceutical item of a designated pharmaceutical benefit that may be supplied to a designated person in a special arrangement supply of the benefit on any one occasion is the quantity or number of units specified in the column headed “Maximum quantity or number of units” of the item of the table in clause 1 of Schedule 1 for the pharmaceutical benefit.\n\n#### 16 No limit on number of occasions for supplies\n\n  There is no limit on the number of occasions on which a designated person is entitled to receive a special arrangement supply of a designated pharmaceutical benefit.\n\n### Division 3—Payment for special arrangement supplies of designated pharmaceutical benefits\n\n#### 17 Supplies by approved hospital authorities to certain patients\n\n  (1) An approved hospital authority that wants to receive payment from the Commonwealth in relation to a special arrangement supply by the approved hospital authority of a designated pharmaceutical benefit to any of the following must make a claim for payment in accordance with section 20:\n    (a) a day admitted patient of a hospital of which the approved hospital authority is the governing body or proprietor;\n    (b) a patient on discharge from such a hospital;\n    (c) a non‑admitted patient of such a hospital.\n\n> Note: See subsection 99(4) of the Act for the entitlement of an approved hospital authority to payment for the supply of pharmaceutical benefits to patients receiving treatment in or at a hospital in respect of which the authority is approved.\n\n  (2) This section has effect despite section 99AAA of the Act.\n\n#### 18 Supplies by approved hospital authorities to persons who are not patients\n\n  Entitlement to payment\n  (1) Subject to this section, an approved hospital authority is entitled to payment from the Commonwealth in respect of a special arrangement supply by the approved hospital authority of a designated pharmaceutical benefit to a person who is not a patient receiving treatment in or at a hospital in respect of which the authority is approved.\n  Rates and conditions for payment\n  (2) The payment is at the rates and subject to the conditions determined by the Minister under subsection 99(4) of the Act in respect of the supply of designated pharmaceutical benefits.\n  Claims for payment\n  (3) If an approved hospital authority wants to receive a payment to which it is entitled under this section, the authority must make a claim for payment in accordance with section 20.\n\n#### 19 Supplies by approved medical practitioners and approved pharmacists\n\n  (1) An approved medical practitioner or an approved pharmacist who wants to receive payment from the Commonwealth in relation to a special arrangement supply by the approved medical practitioner or approved pharmacist of a designated pharmaceutical benefit must make a claim for payment in accordance with section 20.\n\n> Note: See section 99 of the Act for the entitlement of approved medical practitioners and approved pharmacists to payment for the supply of pharmaceutical benefits.\n\n  (2) This section has effect despite section 99AAA of the Act.\n\n#### 20 Claims for payment by approved suppliers\n\n  For the purposes of subsections 17(1), 18(3) and 19(1), a claim for payment by an approved supplier in relation to a special arrangement supply of a designated pharmaceutical benefit must:\n    (a) be made, in writing, to the Secretary; and\n    (b) include the following information:\n    (i) the benefit supplied;\n    (ii) the date the benefit was supplied;\n    (iii) the postcode in which the benefit was supplied;\n    (iv) the title of the individual who interacted with the person to whom the benefit was supplied;\n    (v) whether the person to whom the benefit was supplied consented to the use of their de‑identified data for ongoing monitoring of the supply of designated pharmaceutical benefits in accordance with this instrument; and\n    (c) if the person to whom the benefit was supplied consented as mentioned in subparagraph (b)(v)—include the following information:\n    (i) whether the person had previously received a supply of a designated pharmaceutical benefit;\n    (ii) if the person had previously received a supply of a designated pharmaceutical benefit—the reason for receiving a further supply of a designated pharmaceutical benefit.\n\n#### 21 Supplies to authorised alternative suppliers\n\n  Entitlement to payment\n  (1) Subject to this section, a person who supplies a designated pharmaceutical benefit to an authorised alternative supplier (for the purpose of the authorised alternative supplier making a special arrangement supply of the designated pharmaceutical benefit) is entitled to payment from the Commonwealth.\n  Amount of payment\n  (2) The amount of the payment is the approved ex‑manufacturer price of the listed brand of the pharmaceutical item of the designated pharmaceutical benefit that was applicable on the day the person supplied the benefit to the authorised alternative supplier.\n  Claims for payment\n  (3) If a person wants to receive a payment to which the person is entitled under this section, the person must make a claim for payment in accordance with subsection (4).\n  (4) The claim must:\n    (a) be made, in writing, to the Secretary; and\n    (b) include the name of the authorised alternative supplier; and\n    (c) include, for each day covered by the claim on which the person supplied a designated pharmaceutical benefit to the authorised alternative supplier, the volume of each designated pharmaceutical benefit supplied on the day.\n\n#### 22 Secretary to determine and pay claims\n\n  The Secretary must determine the amount payable for a claim made under this Part and make any payment relating to the claim.\n\n### Division 4—Administration\n\n#### 23 Secretary may request information from authorised alternative suppliers\n\n  (1) The Secretary may, in writing, ask an authorised alternative supplier to give the Secretary the information mentioned in paragraphs 20(b) and (c) in relation to any special arrangement supply of a designated pharmaceutical benefit made by the supplier.\n  (2) A request for information must:\n    (a) be in writing; and\n    (b) specify a day for complying with the request which is at least 28 days after the day of the request.\n\n#### 24 Authorised alternative suppliers to supply information on request\n\n  If an authorised alternative supplier receives a request for information under section 23, the supplier must comply with the request by the day specified in the request.\n\n#### 25 Secretary may authorise persons to perform functions or exercise powers\n\n  (1) The Secretary may, in writing, authorise persons having suitable qualifications and experience to perform any of the Secretary’s functions, or exercise any of the Secretary’s powers, under the following provisions on behalf of the Secretary:\n    (a) the definitions of authorised alternative supplier and excluded approved supplier in section 4 (receiving notices);\n    (b) section 20 and subsection 21(4) (receiving claims for payment);\n    (c) section 22 (determining and paying claims);\n    (d) section 23 (requesting information).\n  (2) Without limiting subsection (1), an authorisation under this section may be in the form of a contract entered into by the Secretary on behalf of the Commonwealth.\n  (3) A person who is authorised under this section must comply with any directions of the Secretary in the performance of the functions or exercise of the powers specified in the authorisation.\n\n#### 26 Review by Secretary of decisions of persons authorised under section 25\n\n  Application for review\n  (1) A person who is affected by a decision of a person who is authorised under section 25 may apply to the Secretary for review of the decision.\n  (2) An application for review must:\n    (a) be in writing; and\n    (b) be made within:\n    (i) 28 days after the day the decision first came to the notice of the applicant; or\n    (ii) if the Secretary allows a longer period (whether before or after the end of the 28‑day period referred to in subparagraph (i))—that longer period.\n  Review of decision\n  (3) On receiving an application, the Secretary must:\n    (a) review the decision; and\n    (b) affirm, vary or set aside the decision; and\n    (c) if the Secretary sets aside the decision—make a new decision in substitution for the decision set aside.\n  (4) The decision (the decision on review) of the Secretary takes effect:\n    (a) on the day specified in the decision on review; or\n    (b) if a day is not specified—on the day the decision on review was made.\n  Notice of decision\n  (5) After the Secretary makes a decision under this section, the Secretary must give the applicant a written notice stating the following:\n    (a) the terms of the decision;\n    (b) the reasons for the decision.\n\n## Part 3—Application, saving and transitional provisions\n\n#### 27 Saving of authorisations—National Health (Take Home Naloxone Pilot) Special Arrangement Amendment (2020 Measures No. 1) Instrument 2020\n\n  An authorisation that was in force under section 25 immediately before the commencement of the National Health (Take Home Naloxone Pilot) Special Arrangement Amendment (2020 Measures No. 1) Instrument 2020 has effect, on and after that commencement, as if it had been made under that section as amended by that instrument.\n\n#### 28 Application of amendments—National Health (Take Home Naloxone Pilot) Special Arrangement Amendment (2021 Measures No. 1) Instrument 2021\n\n  The amendments of section 20 made by the National Health (Take Home Naloxone Pilot) Special Arrangement Amendment (2021 Measures No. 1) Instrument 2021 apply in relation to a claim for payment made on or after 1 July 2021 in respect of a special arrangement supply of a designated pharmaceutical benefit made before, on or after that date.\n\n#### 29 Application of amendments—National Health (Take Home Naloxone Pilot) Special Arrangement Amendment (2022 Measures No. 1) Instrument 2022\n\n  The amendment of section 20 made by the National Health (Take Home Naloxone Pilot) Special Arrangement Amendment (2022 Measures No. 1) Instrument 2022 applies in relation to a claim for payment made on or after 1 July 2022 in respect of a special arrangement supply of a designated pharmaceutical benefit made on or after that date.","sortOrder":18},{"sectionNumber":"17","sectionType":"section","heading":"Supplies by approved hospital authorities to certain patients","content":"#### 17 Supplies by approved hospital authorities to certain patients\n\n  (1) An approved hospital authority that wants to receive payment from the Commonwealth in relation to a special arrangement supply by the approved hospital authority of a designated pharmaceutical benefit to any of the following must make a claim for payment in accordance with section 20:\n    (a) a day admitted patient of a hospital of which the approved hospital authority is the governing body or proprietor;\n    (b) a patient on discharge from such a hospital;\n    (c) a non‑admitted patient of such a hospital.\n\n> Note: See subsection 99(4) of the Act for the entitlement of an approved hospital authority to payment for the supply of pharmaceutical benefits to patients receiving treatment in or at a hospital in respect of which the authority is approved.\n\n  (2) This section has effect despite section 99AAA of the Act.","sortOrder":19},{"sectionNumber":"18","sectionType":"section","heading":"Supplies by approved hospital authorities to persons who are not patients","content":"#### 18 Supplies by approved hospital authorities to persons who are not patients\n\n  Entitlement to payment\n  (1) Subject to this section, an approved hospital authority is entitled to payment from the Commonwealth in respect of a special arrangement supply by the approved hospital authority of a designated pharmaceutical benefit to a person who is not a patient receiving treatment in or at a hospital in respect of which the authority is approved.\n  Rates and conditions for payment\n  (2) The payment is at the rates and subject to the conditions determined by the Minister under subsection 99(4) of the Act in respect of the supply of designated pharmaceutical benefits.\n  Claims for payment\n  (3) If an approved hospital authority wants to receive a payment to which it is entitled under this section, the authority must make a claim for payment in accordance with section 20.","sortOrder":20},{"sectionNumber":"19","sectionType":"section","heading":"Supplies by approved medical practitioners and approved pharmacists","content":"#### 19 Supplies by approved medical practitioners and approved pharmacists\n\n  (1) An approved medical practitioner or an approved pharmacist who wants to receive payment from the Commonwealth in relation to a special arrangement supply by the approved medical practitioner or approved pharmacist of a designated pharmaceutical benefit must make a claim for payment in accordance with section 20.\n\n> Note: See section 99 of the Act for the entitlement of approved medical practitioners and approved pharmacists to payment for the supply of pharmaceutical benefits.\n\n  (2) This section has effect despite section 99AAA of the Act.","sortOrder":21},{"sectionNumber":"20","sectionType":"section","heading":"Claims for payment by approved suppliers","content":"#### 20 Claims for payment by approved suppliers\n\n  For the purposes of subsections 17(1), 18(3) and 19(1), a claim for payment by an approved supplier in relation to a special arrangement supply of a designated pharmaceutical benefit must:\n    (a) be made, in writing, to the Secretary; and\n    (b) include the following information:\n    (i) the benefit supplied;\n    (ii) the date the benefit was supplied;\n    (iii) the postcode in which the benefit was supplied;\n    (iv) the title of the individual who interacted with the person to whom the benefit was supplied;\n    (v) whether the person to whom the benefit was supplied consented to the use of their de‑identified data for ongoing monitoring of the supply of designated pharmaceutical benefits in accordance with this instrument; and\n    (c) if the person to whom the benefit was supplied consented as mentioned in subparagraph (b)(v)—include the following information:\n    (i) whether the person had previously received a supply of a designated pharmaceutical benefit;\n    (ii) if the person had previously received a supply of a designated pharmaceutical benefit—the reason for receiving a further supply of a designated pharmaceutical benefit.","sortOrder":22},{"sectionNumber":"21","sectionType":"section","heading":"Supplies to authorised alternative suppliers","content":"#### 21 Supplies to authorised alternative suppliers\n\n  Entitlement to payment\n  (1) Subject to this section, a person who supplies a designated pharmaceutical benefit to an authorised alternative supplier (for the purpose of the authorised alternative supplier making a special arrangement supply of the designated pharmaceutical benefit) is entitled to payment from the Commonwealth.\n  Amount of payment\n  (2) The amount of the payment is the approved ex‑manufacturer price of the listed brand of the pharmaceutical item of the designated pharmaceutical benefit that was applicable on the day the person supplied the benefit to the authorised alternative supplier.\n  Claims for payment\n  (3) If a person wants to receive a payment to which the person is entitled under this section, the person must make a claim for payment in accordance with subsection (4).\n  (4) The claim must:\n    (a) be made, in writing, to the Secretary; and\n    (b) include the name of the authorised alternative supplier; and\n    (c) include, for each day covered by the claim on which the person supplied a designated pharmaceutical benefit to the authorised alternative supplier, the volume of each designated pharmaceutical benefit supplied on the day.","sortOrder":23},{"sectionNumber":"22","sectionType":"section","heading":"Secretary to determine and pay claims","content":"#### 22 Secretary to determine and pay claims\n\n  The Secretary must determine the amount payable for a claim made under this Part and make any payment relating to the claim.","sortOrder":24},{"sectionNumber":"Division 4","sectionType":"division","heading":"Administration","content":"## Part 1—Preliminary\n\n#### 1 Name\n\n  (1) This instrument is the National Health (Take Home Naloxone) Special Arrangement 2019.\n  (2) This instrument may also be cited as PB 97 of 2019.\n\n#### 3 Authority\n\n  This instrument is made under section 100 of the National Health Act 1953.\n\n#### 5 Simplified outline of this instrument\n\nThis instrument makes a special arrangement for the supply of naloxone to persons who are at risk of an opioid overdose and persons who are likely to be able to assist such persons.\n\nNaloxone will be supplied free of charge and without a prescription by hospitals, pharmacists, certain medical practitioners and other authorised persons and organisations.\n\nThis instrument also deals with payments for supplies of naloxone and administrative matters.\n\n> Note: Part VII of the Act, and regulations or other instruments made for the purposes of that Part, have effect subject to this instrument (see subsection 100(3) of the Act).\n\n#### 6 Definitions\n\n> Note: A number of expressions used in this instrument are defined in the Act, including the following:\n\n    (a) hospital;\n    (b) premises;\n    (c) Secretary.\n  In this instrument:\n\n> Act means the National Health Act 1953.\n\n> approved ex‑manufacturer price of a listed brand of a pharmaceutical item has the same meaning as in Part VII of the Act.\n\n> approved hospital authority has the same meaning as in Part VII of the Act.\n\n> approved medical practitioner has the same meaning as in Part VII of the Act.\n\n> approved pharmacist has the same meaning as in Part VII of the Act.\n\n> approved supplier has the same meaning as in Part VII of the Act.\n\n> authorised alternative supplier means a person or organisation:\n\n    (a) that has premises in a jurisdiction; and\n    (b) that is authorised (however described) by an authority of the jurisdiction for the purposes of supplying designated pharmaceutical benefits in accordance with this instrument; and\n    (c) in relation to which the authority has given the Secretary a written notice stating:\n    (i) that the person or organisation is so authorised; and\n    (ii) the name and contact details of the person or organisation.\n\n> day admitted patient: a person is a day admitted patient of a hospital on a day if, on that day, the person:\n\n    (a) is admitted to the hospital (other than through the hospital’s emergency department); and\n    (b) receives treatment; and\n    (c) is discharged from the hospital;\n  in accordance with a pre‑existing plan for the person’s treatment.\n\n> designated person means:\n\n    (a) a person who is at risk of an opioid overdose; or\n    (b) a person who is likely to be able to assist such a person.\n\n> designated pharmaceutical benefit means a pharmaceutical benefit mentioned in Schedule 1.\n\n> excluded approved supplier means an approved supplier in a jurisdiction in relation to which there is in force a notice given by an authority of the jurisdiction to the Secretary and the supplier to the effect that the authority wants the supplier not to be able to supply designated pharmaceutical benefits in accordance with this instrument.\n\n> jurisdiction means a State or Territory.\n\n> listed brand of a pharmaceutical item has the same meaning as in Part VII of the Act.\n\n> pharmaceutical benefit has the same meaning as in Part VII of the Act.\n\n> pharmaceutical item has the same meaning as in Part VII of the Act.\n\n> special arrangement supply has the meaning given by section 7.\n\n> Territory has the same meaning as in Part VII of the Act.\n\n## Part 2—Special arrangement supplies of designated pharmaceutical benefits\n\n### Division 1—Preliminary\n\n#### 7 Definition of special arrangement supply\n\n  Supplies by approved hospital authorities\n  (1) A supply of a designated pharmaceutical benefit is a special arrangement supply of the benefit if the benefit is supplied:\n    (a) either:\n    (i) in New South Wales, Western Australia or South Australia on or after 1 December 2019; or\n    (ii) in Victoria, Queensland, Tasmania or a Territory on or after 1 July 2022; and\n    (c) by an approved hospital authority that is not an excluded approved supplier; and\n    (d) to a designated person who, at the time of the supply, is:\n    (i) a day admitted patient of a hospital of which the approved hospital authority is the governing body or proprietor; or\n    (ii) a patient on discharge from such a hospital; or\n    (iii) a non‑admitted patient of such a hospital; or\n    (iv) not a patient receiving treatment in or at such a hospital; and\n    (e) without a prescription.\n  Supplies by approved medical practitioners\n  (2) A supply of a designated pharmaceutical benefit is also a special arrangement supply of the benefit if:\n    (aa) the benefit is supplied:\n    (i) in New South Wales, Western Australia or South Australia on or after 1 December 2019; or\n    (ii) in Victoria, Queensland, Tasmania or a Territory on or after 1 July 2022; and\n    (a) the benefit is supplied:\n    (iii) to a designated person; and\n    (iv) without a prescription; and\n    (v) by an approved medical practitioner who is not an excluded approved supplier; and\n    (b) the benefit was not obtained by the approved medical practitioner under section 93 of the Act (prescriber bag supplies).\n  Supplies by approved pharmacists\n  (3) A supply of a designated pharmaceutical benefit is also a special arrangement supply of the benefit if the benefit is supplied:\n    (a) either:\n    (i) in New South Wales, Western Australia or South Australia on or after 1 December 2019; or\n    (ii) in Victoria, Queensland, Tasmania or a Territory on or after 1 July 2022; and\n    (c) to a designated person; and\n    (d) without a prescription; and\n    (e) by an approved pharmacist who is not an excluded approved supplier.\n  Supplies by authorised alternative suppliers\n  (4) A supply of a designated pharmaceutical benefit is also a special arrangement supply of the benefit if the benefit is supplied:\n    (a) either:\n    (i) in New South Wales, Western Australia or South Australia on or after 1 December 2019; or\n    (ii) in Victoria, Queensland, Tasmania or a Territory on or after 1 November 2022; and\n    (c) to a designated person; and\n    (d) by an authorised alternative supplier.\n  (5) However, a supply of a designated pharmaceutical benefit mentioned in subsection (4) is not a special arrangement supply of the benefit if:\n    (a) the authorised alternative supplier is the ambulance service of a jurisdiction; and\n    (b) the benefit supplied is administered to the designated person by an ambulance officer to treat the person for an opioid overdose.\n\n### Division 2—Special arrangement supplies of designated pharmaceutical benefits\n\n#### 8 Definition of value for safety net purposes for supplies\n\n  (1) The value for safety net purposes for a special arrangement supply of a designated pharmaceutical benefit is zero.\n  (2) This section applies despite the definition of value for safety net purposes in subsection 84(1) of the Act.\n\n#### 9 Designated persons entitled to receive supplies free of charge\n\n  (1) A designated person is entitled to receive a special arrangement supply of a designated pharmaceutical benefit without the payment or provision of money or other consideration.\n  (2) This section has effect in addition to section 86 of the Act.\n\n#### 10 Suppliers not to demand or receive payment for supplies or services\n\n  Approved suppliers\n  (1) An approved supplier must not demand or receive a payment (other than a payment from the Commonwealth) or other valuable consideration in respect of a special arrangement supply of a designated pharmaceutical benefit.\n  (2) An approved supplier must not demand or receive a payment or other valuable consideration in respect of any other service relating to a special arrangement supply of a designated pharmaceutical benefit.\n  (3) Subsection (1) has effect despite section 87 of the Act.\n  Authorised alternative suppliers\n  (4) An authorised alternative supplier must not demand or receive a payment or other valuable consideration in respect of:\n    (a) a special arrangement supply of a designated pharmaceutical benefit; or\n    (b) any other service relating to a special arrangement supply of a designated pharmaceutical benefit.\n\n#### 11 Supplies by approved hospital authorities\n\n  (1) A designated person is entitled to receive a special arrangement supply of a designated pharmaceutical benefit by an approved hospital authority if:\n    (a) at the time of the supply, the designated person is:\n    (i) a day admitted patient of a hospital of which the approved hospital authority is the governing body or proprietor; or\n    (ii) a patient on discharge from such a hospital; or\n    (iii) a non‑admitted patient of such a hospital; or\n    (iv) not a patient receiving treatment in or at such a hospital; and\n    (b) the approved hospital authority is not an excluded approved supplier.\n  (2) Subsection (1) has effect despite sections 89 and 94 of the Act.\n  (3) A designated person is entitled to receive a special arrangement supply of a designated pharmaceutical benefit by an approved hospital authority as mentioned in subsection (1) without a prescription.\n  (4) Subsection (3) has effect despite the Act and the National Health (Pharmaceutical Benefits) Regulations 2017.\n\n> Note 1: Sections 84AAA, 84D, 99 and 134 of the Act deal with the supply of pharmaceutical benefits by approved hospital authorities on prescription.\n\n> Note 2: Sections 18, 30, 41, 44, 45, 52 and 53 of the National Health (Pharmaceutical Benefits) Regulations 2017 deal with the supply of pharmaceutical benefits by approved hospital authorities on prescription.\n\n#### 12 Supplies by approved medical practitioners\n\n  (1) A designated person is entitled to receive a special arrangement supply of a designated pharmaceutical benefit by an approved medical practitioner who is not an excluded approved supplier without a prescription.\n  (2) This section has effect despite the National Health (Pharmaceutical Benefits) Regulations 2017.\n\n> Note: Sections 44, 48, 52 and 53 of the National Health (Pharmaceutical Benefits) Regulations 2017 deal with the supply of pharmaceutical benefits by approved medical practitioners on prescription.\n\n#### 13 Supplies by approved pharmacists\n\n  (1) A designated person is entitled to receive a special arrangement supply of a designated pharmaceutical benefit by an approved pharmacist who is not an excluded approved supplier without a prescription.\n  (2) This section has effect despite section 89 of the Act.\n\n#### 14 Supplies by authorised alternative suppliers\n\n  (1) A designated person is entitled to receive a special arrangement supply of a designated pharmaceutical benefit by an authorised alternative supplier.\n  (2) This section has effect despite section 89 of the Act.\n\n#### 15 Maximum quantity or number of units for supplies\n\n  The maximum quantity or number of units of the pharmaceutical item of a designated pharmaceutical benefit that may be supplied to a designated person in a special arrangement supply of the benefit on any one occasion is the quantity or number of units specified in the column headed “Maximum quantity or number of units” of the item of the table in clause 1 of Schedule 1 for the pharmaceutical benefit.\n\n#### 16 No limit on number of occasions for supplies\n\n  There is no limit on the number of occasions on which a designated person is entitled to receive a special arrangement supply of a designated pharmaceutical benefit.\n\n### Division 3—Payment for special arrangement supplies of designated pharmaceutical benefits\n\n#### 17 Supplies by approved hospital authorities to certain patients\n\n  (1) An approved hospital authority that wants to receive payment from the Commonwealth in relation to a special arrangement supply by the approved hospital authority of a designated pharmaceutical benefit to any of the following must make a claim for payment in accordance with section 20:\n    (a) a day admitted patient of a hospital of which the approved hospital authority is the governing body or proprietor;\n    (b) a patient on discharge from such a hospital;\n    (c) a non‑admitted patient of such a hospital.\n\n> Note: See subsection 99(4) of the Act for the entitlement of an approved hospital authority to payment for the supply of pharmaceutical benefits to patients receiving treatment in or at a hospital in respect of which the authority is approved.\n\n  (2) This section has effect despite section 99AAA of the Act.\n\n#### 18 Supplies by approved hospital authorities to persons who are not patients\n\n  Entitlement to payment\n  (1) Subject to this section, an approved hospital authority is entitled to payment from the Commonwealth in respect of a special arrangement supply by the approved hospital authority of a designated pharmaceutical benefit to a person who is not a patient receiving treatment in or at a hospital in respect of which the authority is approved.\n  Rates and conditions for payment\n  (2) The payment is at the rates and subject to the conditions determined by the Minister under subsection 99(4) of the Act in respect of the supply of designated pharmaceutical benefits.\n  Claims for payment\n  (3) If an approved hospital authority wants to receive a payment to which it is entitled under this section, the authority must make a claim for payment in accordance with section 20.\n\n#### 19 Supplies by approved medical practitioners and approved pharmacists\n\n  (1) An approved medical practitioner or an approved pharmacist who wants to receive payment from the Commonwealth in relation to a special arrangement supply by the approved medical practitioner or approved pharmacist of a designated pharmaceutical benefit must make a claim for payment in accordance with section 20.\n\n> Note: See section 99 of the Act for the entitlement of approved medical practitioners and approved pharmacists to payment for the supply of pharmaceutical benefits.\n\n  (2) This section has effect despite section 99AAA of the Act.\n\n#### 20 Claims for payment by approved suppliers\n\n  For the purposes of subsections 17(1), 18(3) and 19(1), a claim for payment by an approved supplier in relation to a special arrangement supply of a designated pharmaceutical benefit must:\n    (a) be made, in writing, to the Secretary; and\n    (b) include the following information:\n    (i) the benefit supplied;\n    (ii) the date the benefit was supplied;\n    (iii) the postcode in which the benefit was supplied;\n    (iv) the title of the individual who interacted with the person to whom the benefit was supplied;\n    (v) whether the person to whom the benefit was supplied consented to the use of their de‑identified data for ongoing monitoring of the supply of designated pharmaceutical benefits in accordance with this instrument; and\n    (c) if the person to whom the benefit was supplied consented as mentioned in subparagraph (b)(v)—include the following information:\n    (i) whether the person had previously received a supply of a designated pharmaceutical benefit;\n    (ii) if the person had previously received a supply of a designated pharmaceutical benefit—the reason for receiving a further supply of a designated pharmaceutical benefit.\n\n#### 21 Supplies to authorised alternative suppliers\n\n  Entitlement to payment\n  (1) Subject to this section, a person who supplies a designated pharmaceutical benefit to an authorised alternative supplier (for the purpose of the authorised alternative supplier making a special arrangement supply of the designated pharmaceutical benefit) is entitled to payment from the Commonwealth.\n  Amount of payment\n  (2) The amount of the payment is the approved ex‑manufacturer price of the listed brand of the pharmaceutical item of the designated pharmaceutical benefit that was applicable on the day the person supplied the benefit to the authorised alternative supplier.\n  Claims for payment\n  (3) If a person wants to receive a payment to which the person is entitled under this section, the person must make a claim for payment in accordance with subsection (4).\n  (4) The claim must:\n    (a) be made, in writing, to the Secretary; and\n    (b) include the name of the authorised alternative supplier; and\n    (c) include, for each day covered by the claim on which the person supplied a designated pharmaceutical benefit to the authorised alternative supplier, the volume of each designated pharmaceutical benefit supplied on the day.\n\n#### 22 Secretary to determine and pay claims\n\n  The Secretary must determine the amount payable for a claim made under this Part and make any payment relating to the claim.\n\n### Division 4—Administration\n\n#### 23 Secretary may request information from authorised alternative suppliers\n\n  (1) The Secretary may, in writing, ask an authorised alternative supplier to give the Secretary the information mentioned in paragraphs 20(b) and (c) in relation to any special arrangement supply of a designated pharmaceutical benefit made by the supplier.\n  (2) A request for information must:\n    (a) be in writing; and\n    (b) specify a day for complying with the request which is at least 28 days after the day of the request.\n\n#### 24 Authorised alternative suppliers to supply information on request\n\n  If an authorised alternative supplier receives a request for information under section 23, the supplier must comply with the request by the day specified in the request.\n\n#### 25 Secretary may authorise persons to perform functions or exercise powers\n\n  (1) The Secretary may, in writing, authorise persons having suitable qualifications and experience to perform any of the Secretary’s functions, or exercise any of the Secretary’s powers, under the following provisions on behalf of the Secretary:\n    (a) the definitions of authorised alternative supplier and excluded approved supplier in section 4 (receiving notices);\n    (b) section 20 and subsection 21(4) (receiving claims for payment);\n    (c) section 22 (determining and paying claims);\n    (d) section 23 (requesting information).\n  (2) Without limiting subsection (1), an authorisation under this section may be in the form of a contract entered into by the Secretary on behalf of the Commonwealth.\n  (3) A person who is authorised under this section must comply with any directions of the Secretary in the performance of the functions or exercise of the powers specified in the authorisation.\n\n#### 26 Review by Secretary of decisions of persons authorised under section 25\n\n  Application for review\n  (1) A person who is affected by a decision of a person who is authorised under section 25 may apply to the Secretary for review of the decision.\n  (2) An application for review must:\n    (a) be in writing; and\n    (b) be made within:\n    (i) 28 days after the day the decision first came to the notice of the applicant; or\n    (ii) if the Secretary allows a longer period (whether before or after the end of the 28‑day period referred to in subparagraph (i))—that longer period.\n  Review of decision\n  (3) On receiving an application, the Secretary must:\n    (a) review the decision; and\n    (b) affirm, vary or set aside the decision; and\n    (c) if the Secretary sets aside the decision—make a new decision in substitution for the decision set aside.\n  (4) The decision (the decision on review) of the Secretary takes effect:\n    (a) on the day specified in the decision on review; or\n    (b) if a day is not specified—on the day the decision on review was made.\n  Notice of decision\n  (5) After the Secretary makes a decision under this section, the Secretary must give the applicant a written notice stating the following:\n    (a) the terms of the decision;\n    (b) the reasons for the decision.\n\n## Part 3—Application, saving and transitional provisions\n\n#### 27 Saving of authorisations—National Health (Take Home Naloxone Pilot) Special Arrangement Amendment (2020 Measures No. 1) Instrument 2020\n\n  An authorisation that was in force under section 25 immediately before the commencement of the National Health (Take Home Naloxone Pilot) Special Arrangement Amendment (2020 Measures No. 1) Instrument 2020 has effect, on and after that commencement, as if it had been made under that section as amended by that instrument.\n\n#### 28 Application of amendments—National Health (Take Home Naloxone Pilot) Special Arrangement Amendment (2021 Measures No. 1) Instrument 2021\n\n  The amendments of section 20 made by the National Health (Take Home Naloxone Pilot) Special Arrangement Amendment (2021 Measures No. 1) Instrument 2021 apply in relation to a claim for payment made on or after 1 July 2021 in respect of a special arrangement supply of a designated pharmaceutical benefit made before, on or after that date.\n\n#### 29 Application of amendments—National Health (Take Home Naloxone Pilot) Special Arrangement Amendment (2022 Measures No. 1) Instrument 2022\n\n  The amendment of section 20 made by the National Health (Take Home Naloxone Pilot) Special Arrangement Amendment (2022 Measures No. 1) Instrument 2022 applies in relation to a claim for payment made on or after 1 July 2022 in respect of a special arrangement supply of a designated pharmaceutical benefit made on or after that date.","sortOrder":25},{"sectionNumber":"23","sectionType":"section","heading":"Secretary may request information from authorised alternative suppliers","content":"#### 23 Secretary may request information from authorised alternative suppliers\n\n  (1) The Secretary may, in writing, ask an authorised alternative supplier to give the Secretary the information mentioned in paragraphs 20(b) and (c) in relation to any special arrangement supply of a designated pharmaceutical benefit made by the supplier.\n  (2) A request for information must:\n    (a) be in writing; and\n    (b) specify a day for complying with the request which is at least 28 days after the day of the request.","sortOrder":26},{"sectionNumber":"24","sectionType":"section","heading":"Authorised alternative suppliers to supply information on request","content":"#### 24 Authorised alternative suppliers to supply information on request\n\n  If an authorised alternative supplier receives a request for information under section 23, the supplier must comply with the request by the day specified in the request.","sortOrder":27},{"sectionNumber":"25","sectionType":"section","heading":"Secretary may authorise persons to perform functions or exercise powers","content":"#### 25 Secretary may authorise persons to perform functions or exercise powers\n\n  (1) The Secretary may, in writing, authorise persons having suitable qualifications and experience to perform any of the Secretary’s functions, or exercise any of the Secretary’s powers, under the following provisions on behalf of the Secretary:\n    (a) the definitions of authorised alternative supplier and excluded approved supplier in section 4 (receiving notices);\n    (b) section 20 and subsection 21(4) (receiving claims for payment);\n    (c) section 22 (determining and paying claims);\n    (d) section 23 (requesting information).\n  (2) Without limiting subsection (1), an authorisation under this section may be in the form of a contract entered into by the Secretary on behalf of the Commonwealth.\n  (3) A person who is authorised under this section must comply with any directions of the Secretary in the performance of the functions or exercise of the powers specified in the authorisation.","sortOrder":28},{"sectionNumber":"26","sectionType":"section","heading":"Review by Secretary of decisions of persons authorised under section 25","content":"#### 26 Review by Secretary of decisions of persons authorised under section 25\n\n  Application for review\n  (1) A person who is affected by a decision of a person who is authorised under section 25 may apply to the Secretary for review of the decision.\n  (2) An application for review must:\n    (a) be in writing; and\n    (b) be made within:\n    (i) 28 days after the day the decision first came to the notice of the applicant; or\n    (ii) if the Secretary allows a longer period (whether before or after the end of the 28‑day period referred to in subparagraph (i))—that longer period.\n  Review of decision\n  (3) On receiving an application, the Secretary must:\n    (a) review the decision; and\n    (b) affirm, vary or set aside the decision; and\n    (c) if the Secretary sets aside the decision—make a new decision in substitution for the decision set aside.\n  (4) The decision (the decision on review) of the Secretary takes effect:\n    (a) on the day specified in the decision on review; or\n    (b) if a day is not specified—on the day the decision on review was made.\n  Notice of decision\n  (5) After the Secretary makes a decision under this section, the Secretary must give the applicant a written notice stating the following:\n    (a) the terms of the decision;\n    (b) the reasons for the decision.","sortOrder":29},{"sectionNumber":"Part 3","sectionType":"part","heading":"Application, saving and transitional provisions","content":"## Part 3—Application, saving and transitional provisions","sortOrder":30},{"sectionNumber":"27","sectionType":"section","heading":"Saving of authorisations—National Health (Take Home Naloxone Pilot) Special Arrangement Amendment (2020 Measures No. 1) Instrument 2020","content":"#### 27 Saving of authorisations—National Health (Take Home Naloxone Pilot) Special Arrangement Amendment (2020 Measures No. 1) Instrument 2020\n\n  An authorisation that was in force under section 25 immediately before the commencement of the National Health (Take Home Naloxone Pilot) Special Arrangement Amendment (2020 Measures No. 1) Instrument 2020 has effect, on and after that commencement, as if it had been made under that section as amended by that instrument.","sortOrder":31},{"sectionNumber":"28","sectionType":"section","heading":"Application of amendments—National Health (Take Home Naloxone Pilot) Special Arrangement Amendment (2021 Measures No. 1) Instrument 2021","content":"#### 28 Application of amendments—National Health (Take Home Naloxone Pilot) Special Arrangement Amendment (2021 Measures No. 1) Instrument 2021\n\n  The amendments of section 20 made by the National Health (Take Home Naloxone Pilot) Special Arrangement Amendment (2021 Measures No. 1) Instrument 2021 apply in relation to a claim for payment made on or after 1 July 2021 in respect of a special arrangement supply of a designated pharmaceutical benefit made before, on or after that date.","sortOrder":32},{"sectionNumber":"29","sectionType":"section","heading":"Application of amendments—National Health (Take Home Naloxone Pilot) Special Arrangement Amendment (2022 Measures No. 1) Instrument 2022","content":"#### 29 Application of amendments—National Health (Take Home Naloxone Pilot) Special Arrangement Amendment (2022 Measures No. 1) Instrument 2022\n\n  The amendment of section 20 made by the National Health (Take Home Naloxone Pilot) Special Arrangement Amendment (2022 Measures No. 1) Instrument 2022 applies in relation to a claim for payment made on or after 1 July 2022 in respect of a special arrangement supply of a designated pharmaceutical benefit made on or after that date.","sortOrder":33}],"analysis":{"flash_summary":{"complexity_score":6,"scope_assessment":{"changed":true,"description":"The instrument has expanded beyond a simple pilot supply rule. The base instrument (2019) established free, no‑prescription naloxone supplies to designated persons. Subsequent amendments and clauses in the text (explicitly referenced at ss27–29) broadened and operationalised the arrangement: adding and clarifying authorised alternative suppliers, setting detailed claims and data‑reporting requirements, specifying payment mechanics for suppliers who sell to authorised alternative suppliers (s21), and staging rollouts by jurisdiction with later start dates. The Secretary’s delegation and review powers (ss25–26) and the Schedule’s product/quantity specifications further extend administrative control. Those additions move the instrument from a narrow supply exception towards a structured national reimbursement and monitoring scheme, increasing administrative scope and monitoring obligations compared with the original narrow pilot intent."},"complexity_factors":["Extensive cross‑references to the National Health Act 1953 and the National Health (Pharmaceutical Benefits) Regulations 2017 (multiple 'despite' clauses).","Staggered commencement dates by jurisdiction and by supplier type (s7), increasing conditional logic.","Multiple defined terms with operational impact (approved supplier, authorised alternative supplier, excluded approved supplier, designated person, special arrangement supply).","Conditional exceptions within definitions (e.g. ambulance/administration exclusion at s7(5)).","Schedule 1 table listing multiple product forms, brands and bespoke maximum quantities (operational detail external to main text).","Claims process with conditional reporting fields (s20): certain fields required only if recipient consented to de‑identified data use.","Delegation and authorisation powers for the Secretary with an internal review mechanism (ss25–26).","Several amendment/transitional clauses referencing later instruments and retroactive application windows (ss27–29).","Prohibition on charging combined with Commonwealth reimbursement rules — creates interplay between regulatory prohibition and payment mechanics (ss10, 17–22).","Administrative enforcement and data request powers with specified timelines (ss23–24)."],"plain_english_summary":"**What this instrument does (mechanics first)\n\n- Creates a special arrangement, under the National Health Act 1953, that treats specified supplies of naloxone as \"special arrangement supplies\". That classification lets a range of health providers supply naloxone free and without a prescription and be paid by the Commonwealth for certain supplies (see section 7 and Schedule 1).\n\n- Identifies who can supply and who may receive the drug:\n  - Who may supply: approved hospital authorities, approved medical practitioners, approved pharmacists (unless they have been \"excluded\" by their State/Territory), and \"authorised alternative suppliers\" (a body authorised by a State/Territory and notified to the Commonwealth) (s7).\n  - Who may receive: any \"designated person\" — defined as someone at risk of opioid overdose or someone likely to be able to assist such a person (s6; ss7, 9).\n\n- Removes prescription and fee barriers for these supplies: designated persons can receive naloxone without a prescription and without paying money or other consideration. Suppliers (including authorised alternative suppliers) are expressly prohibited from charging the recipient (s9–13; s10).\n\n- Sets maximum units per occasion and allows unlimited repeat occasions: the Schedule lists the permitted naloxone products, forms and maximum units per supply (e.g. injectable ampoules, pre‑filled syringe, nasal spray) and clause 16 says there is no limit on how often a person may receive a supply (s15–16; Schedule 1).\n\n- Payment and claims architecture:\n  - Suppliers who want to be paid by the Commonwealth must submit written claims to the Secretary with specified data points (what was supplied, date, postcode, title of staff member who interacted, and whether the recipient consented to use of their de‑identified data; if consented, some follow‑up fields are required) (s17–21; s20).\n  - Suppliers who sell to authorised alternative suppliers are paid at the approved ex‑manufacturer price for the listed brand (s21).\n  - The Secretary determines and pays claims and may delegate functions and receive information from authorised alternative suppliers (ss22–25; 23–24).\n\n- Administrative and transitional features: the Secretary may authorise persons to exercise specified powers, and there is a Secretary review process for decisions made by those authorised persons. The instrument contains staging dates for different jurisdictions and transitional savings/amendment application clauses for earlier pilot authorisations and subsequent amendments (ss25–29).\n\nOfficial purpose claim (as stated in the instrument)\n\n- The instrument is presented as a measure to make naloxone available free of charge and without prescription to people at risk of opioid overdose and to people likely to assist them, and to set out payment and administrative arrangements.\n\nPractical implications, costs, incentives and trade‑offs (testing the claim)\n\n- Who pays: the Commonwealth pays suppliers who make approved claims (ss17–22). Recipients pay nothing (s9) and suppliers are forbidden from charging recipients (s10). This shifts the direct financial cost away from recipients to the Commonwealth budget.\n\n- Who decides and where discretion sits: the Secretary determines payments and may delegate many administrative functions (ss22–25). State or Territory authorities decide which non‑traditional bodies may act as \"authorised alternative suppliers\" and must notify the Secretary (definition and s4 notes). States/Territories may also ask an approved supplier to be excluded (definition of excluded approved supplier), which affects market participants.\n\n- Behavioural and market effects:\n  - For suppliers: approved pharmacists, medical practitioners and hospital authorities must supply free and without prescription when conditions are met (ss11–13). They can recover money only via Commonwealth claims (ss17–21). That removes ordinary retail pricing and prescription steps for these items and replaces them with a public reimbursement process.\n  - For authorised alternative suppliers (e.g. community agencies once authorised by a jurisdiction): they may distribute naloxone without charging recipients but will rely on either supplies bought from commercial suppliers (who can claim ex‑manufacturer price under s21) or other arrangements. The instrument permits jurisdictions to extend distribution beyond traditional pharmacy/clinical settings (s7(4)).\n\n- Compliance, administrative and data burdens:\n  - Claiming payment requires written claims to the Secretary with postcode and staff title and conditional reporting of prior supplies if the recipient consents to de‑identified data use (s20). That imposes a recordkeeping and reporting obligation and potentially extra administration on small providers and community organisations.\n  - The Secretary can request the same information from authorised alternative suppliers and requires compliance within at least 28 days (ss23–24).\n\n- Regulatory interactions and conditionality:\n  - The instrument operates \"despite\" (i.e. overrides in the specific context) certain provisions of the National Health Act and the Pharmaceutical Benefits Regulations, removing prescription rules and some PBS constraints for these supplies (multiple \"has effect despite\" notes: ss11(2), 12(2), 14(2), 10(3), etc.). That makes this arrangement a narrow exception to existing PBS rules.\n  - Supplies to and from ambulance services are treated specially: if an ambulance service administers naloxone to treat an overdose, that supply is excluded from the special arrangement for authorised alternative suppliers (s7(5)).\n\n- Distributional and incentive effects:\n  - Concentrated benefits: suppliers and authorised alternative suppliers who participate get Commonwealth reimbursement and may receive predictable procurement prices (s21). Recipients receive direct, costless access.\n  - Diffuse costs: Commonwealth bears the financial cost of supply and administration; taxpayers ultimately pay. The administrative burden is borne by suppliers and by the Department (claims processing and monitoring).\n  - Potential substitution effects: the instrument reduces barriers to non‑pharmacy distribution channels (authorised alternative suppliers), which could substitute some community distribution for retail pharmacy provision, depending on jurisdiction authorisations (s7(4)).\n\nImplementation risks and opportunities\n\n- Implementation requires: State/Territory notifications for authorised alternative suppliers, supplier familiarity with claims process, recordkeeping, and Department capacity to process claims and enforce the prohibition on charging recipients.\n- The staged commencement dates by jurisdiction (different start dates in s7) create a phased national rollout which reduces simultaneity risk but requires managing multiple timelines.\n\nKey sections to scan quickly: definition of special arrangement supply and who supplies/receives it (s7); prohibition on charging (s10); entitlement and prescription exceptions (ss9, 11–14); claims and data requirements (s20); supplier payment rules for authorised alternative suppliers (s21); Schedule 1 listing products and maximum quantities.\n"},"flash_summary_failed":{"failed":true,"reason":"A positive credit balance is required for all requests, including BYOK, so fallback providers remain available. Add credits at https://vercel.com/d?to=%2F%5Bteam%5D%2F%7E%2Fai%3Fmodal%3Dtop-up to continue.","source":"analysis-cron"},"kimi_summary":{"_metrics":{"provider":"moonshot","completionTokens":2251},"content_quality":"ok","complexity_score":4,"scope_assessment":{"changed":true,"description":"The instrument began as a pilot program (evidenced by amendment instrument names in Part 3 referencing 'Take Home Naloxone Pilot') limited to specific jurisdictions (initially NSW, WA and SA). It has since expanded in scope to become a national arrangement covering all States and Territories, with expanded supplier categories including 'authorised alternative suppliers' added in later amendments. The temporal extension from 2019 through to 2022 amendments indicates evolution from a time-limited pilot to an ongoing national program."},"complexity_factors":["Multiple defined terms (12+ in section 6) that rely on external definitions from Part VII of the National Health Act 1953","Four distinct supply pathways (hospitals, medical practitioners, pharmacists, authorised alternative suppliers) with slightly different eligibility conditions and commencement dates","Jurisdiction-specific temporal triggers (NSW/WA/SA from 1 Dec 2019; Vic/Qld/Tas/Territories from 1 July 2022 for most suppliers, but 1 Nov 2022 for alternative suppliers)","Nested exception in section 7(5) excluding ambulance services when administering naloxone to treat an active overdose","Cross-references to the National Health Act 1953 and National Health (Pharmaceutical Benefits) Regulations 2017, including 'despite' clauses that override standard PBS rules","Distinction between 'approved suppliers' (hospitals, doctors, pharmacists) and 'authorised alternative suppliers' with different payment claim mechanisms","Data collection requirements for payment claims including consent handling for de-identified data"],"plain_english_summary":"This instrument creates a national special scheme providing naloxone free and without prescription to \"designated persons\" — people at risk of opioid overdose and their potential responders — with no limit on supplies per person. It covers injectable and nasal products.\n\nSuppliers include hospitals, approved pharmacists and medical practitioners, and government‑authorised community services; the Commonwealth reimburses suppliers. Suppliers must claim payments and submit basic de‑identified supply data. The scheme rolled out from Dec 2019 and expanded across jurisdictions in 2022."}},"importantCases":[],"_links":{"self":"/api/acts/national-health-take-home-naloxone-special-arrangement-2019","history":"/api/acts/national-health-take-home-naloxone-special-arrangement-2019/history","analysis":"/api/acts/national-health-take-home-naloxone-special-arrangement-2019/analysis","conflicts":"/api/acts/national-health-take-home-naloxone-special-arrangement-2019/conflicts","importantCases":"/api/acts/national-health-take-home-naloxone-special-arrangement-2019/important-cases","documents":"/api/acts/national-health-take-home-naloxone-special-arrangement-2019/documents"}}