Sch 5ATherapeutic goods exempt from operation of Parts 3‑2 and 3‑2A of Act subject to conditions

Schedule 5A—Therapeutic goods exempt from operation of Parts 3‑2 and 3‑2A of Act subject to conditions (subregulations 12(2) and (3)) | Column 1Item | Column 2Therapeutic goods | Column 3Conditions | | ------------ | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | 1 | Therapeutic goods imported into Australia, if:(a) the goods are not any of the following:(i) disposable therapeutic vapes (other than disposable therapeutic vapes that are, or include, medicinal cannabis products);(ii) therapeutic vaping substances (other than therapeutic vaping substances that are medicinal cannabis products);(iii) therapeutic vaping substance accessories (other than therapeutic vaping substance accessories that are, or include, medicinal cannabis products);(iv) a therapeutic vaping kit (other than a therapeutic vaping kit where each good in the kit is, or includes, a medicinal cannabis product);(v) goods in a therapeutic vaping pack; and(b) the goods are held under the direct control of the sponsor, until the goods are:(i) the subject of a notification under item 3; or(ii) approved for importation into Australia under subsection 19(1), section 19A, subsection 32CK(1) or section 32CO of the Act; or(iii) authorised for supply under subsection 19(5) or 32CM(1) of the Act; or(iv) authorised for supply under rules made under subsection 19(7A) or 32CM(7A) of the Act; or(v) dispensed as a medicine or biological prescribed for a Category A patient within the meaning of subregulation 12A(5); or(vi) exported from Australia | (a) the supply of the goods must be in accordance with the relevant notification, approval, authorisation or prescription; and(b) the goods must be kept in a warehouse or a properly secured area under the control of the sponsor; and(c) the sponsor must:(i) keep records relating to the source and supply of the goods; and(ii) if requested by the Secretary, give the records to the Secretary | | 1A | Therapeutic goods imported into Australia and held under the direct control of the sponsor, until a decision is made under section 25, 26, 26A, 26AE, 32DB, 32DC, 32DF or 32DG of the Act about the goods | (a) the sponsor must:(i) keep records about the source of the goods; and(ii) if requested by the Secretary, give the records to the Secretary; and(iii) have lodged an application under section 23, 32DA or 32DD of the Act for the goods before their importation; and(b) if the goods are not registered, listed, or included in the Register under Part 3‑2A of the Act:(i) in the case of therapeutic goods other than biologicals—the goods must be destroyed; or(ii) in the case of biologicals—the biologicals must be destroyed or returned to the consignor of the biologicals within 1 month of the decision not to include the biologicals | | 1B | Therapeutic goods imported into Australia that are needed for dispensing as a medicine prescribed for persons who are seriously ill with a condition from which premature death is reasonably likely to occur in the absence of early treatment | (a) the goods must be supplied to a person covered by column 2 in circumstances where subparagraphs 12A(2)(a)(ii) and (iii) and paragraph 12A(2)(b) of these Regulations are satisfied; and(b) until the goods need to be so supplied, either or both of the following apply:(i) the goods are kept in a warehouse or a properly secured area under the control of the sponsor;(ii) the goods are kept at a hospital or other healthcare facility after being delivered to the hospital or facility by, or on behalf of, the sponsor; and(c) the sponsor must:(i) keep records relating to the source, and delivery, of the goods; and(ii) if requested by the Secretary, give the records to the Secretary | | 2 | Therapeutic goods that are medicinal cannabis products manufactured in Australia under a licence granted under Part 3‑3 of the Act and are held under the direct control of the sponsor, until the goods are:(a) the subject of a notification under item 3; or(b) approved for supply in Australia under subsection 19(1) or section 19A of the Act; or(c) authorised for supply under subsection 19(5) of the Act; or(d) authorised for supply under rules made under subsection 19(7A) of the Act | (a) the supply of the goods must be in accordance with the relevant notification, approval or authorisation; and(b) the goods must be kept in a warehouse or a properly secured area under the control of the sponsor; and(c) the sponsor must:(i) keep records relating to the source and supply of the goods; and(ii) if requested by the Secretary, give the records to the Secretary | | 2A | Therapeutic goods that are medicinal cannabis products manufactured in Australia under a licence granted under Part 3‑3 of the Act and are held under the direct control of the sponsor, until a decision is made under section 25 or 26 of the Act about the goods | the sponsor must:(a) keep records about the source of the goods; and(b) if requested by the Secretary, give the records to the Secretary; and(c) have lodged an application under section 23 of the Act for the goods before their manufacture | | 3 | Therapeutic goods to be used in a clinical trial solely for experimental purposes in humans | (a) the sponsor must notify the Secretary:(i) in a form approved by the Secretary; and(ii) in accordance with the requirements (if any) determined by the Secretary for the form of notification;about the trial and the therapeutic goods covered by the trial and must do so before:(iii) the goods begin to be used in the trial, unless subparagraph (iv) applies; or(iv) if the sponsor seeks the Secretary’s agreement to the notification being given before the end of a period nominated by the sponsor and the Secretary agrees to this—the end of that nominated period; andthat the sponsor intends to sponsor a clinical trial using specified goods; and(b) the notification referred to in paragraph (a) must be accompanied by the relevant notification fee referred to in paragraph (a) of column 2 of item 14 in the table in clause 3 of Schedule 9 or paragraph (a) of the column headed “Matter” in item 17 of the table in Part 2 of Schedule 9A; and | | | | (c) the approval of the goods for this purpose must be given by the sponsor (if the sponsor is conducting the trial), or by the body or organisation conducting the trial for the sponsor, having regard to the advice of the ethics committee that has, or will assume, responsibility for monitoring the conduct of the trial; and(d) the terms of the approval by the sponsor, body or organisation referred to in paragraph (c) must be no less restrictive than the terms advised by the ethics committee; and(e) the Secretary must not, at any time:(i) have become aware that to conduct or continue the trial would be contrary to the public interest; and(ii) have directed that the trial not be conducted, or be stopped; and | | | | (f) the sponsor (if the sponsor is conducting the trial), or the body or organisation conducting the trial for the sponsor, must not receive, or have received, advice from the ethics committee that is inconsistent with the continuation of the trial; and(g) the conditions set out in regulation 12AD must be complied with, as if that regulation applied to a person using therapeutic goods under this item; and(h) the goods are not either or both of the following:(i) a Class 4 biological that has not received clinical trial approval for an equivalent indication from a national regulatory agency with comparable regulatory requirements;(ii) a Class 4 biological that does not have a history of previous usage that is supported by clinical evidence received by the TGA; and(ha) the sponsor must notify the Secretary:(i) in a form approved by the Secretary; and(ii) in accordance with the requirements (if any) determined by the Secretary for the form of notification;about any trial site not covered by the notification referred to in paragraph (a) and must do so before:(iii) the goods begin to be used at that site, unless subparagraph (iv) applies; or(iv) if the sponsor seeks the Secretary’s agreement to the notification being given before the end of a period nominated by the sponsor and the Secretary agrees to this—the end of that nominated period; and(hb) the notification referred to in paragraph (ha) must be accompanied by the relevant notification fee referred to in paragraph (b) of column 2 of item 14 in the table in clause 3 of Schedule 9 or paragraph (b) of the column headed “Matter” in item 17 of the table in Part 2 of Schedule 9A; and(i) the sponsor must comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial (whether or not the sponsor is conducting the trial); and(j) if a body or organisation is conducting the trial for the sponsor, that body or organisation must comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and(k) the sponsor (if the sponsor is conducting the trial), or the body or organisation conducting the trial for the sponsor, must allow an authorised officer to do the things mentioned in regulation 12AC | | 4 | Therapeutic goods that are imported by a member of a group of persons | (a) the group must be visiting Australia to participate in a national or an international sporting event; and(b) the goods must be for use in the treatment of a member or members of that group; and(c) the importation of the goods must not be prohibited under the Customs (Prohibited Imports) Regulations 1956; and(d) the goods must not be supplied to, or used in the treatment of, a person who is not a member of the visiting group; and(e) any portion of the goods that is unused at the end of the visit must be destroyed or removed from Australia; and(f) a member of the group must be responsible for the control and custody of the goods while the group is in Australia; and(g) the person referred to in paragraph (f) must:(i) carry a list, in English, of the quantity and nature of the therapeutic goods imported; and(ii) for each of the goods that is not a biological—include in the list the generic name and strength of the active ingredient of the goods; and(iii) keep a record of the use of the goods while the group is in Australia; and(iv) produce the list or the record for inspection at the request of a customs officer | | 5 | Therapeutic goods, if:(a) the goods are not:(i) biologicals; or(ii) goods referred to in item 3; and(b) the goods are manufactured by a person under a contract between the person and a private hospital, a public hospital in a State or Territory or a public institution (the relevant institution); and(c) the manufacture is in accordance with a formulation specified by the relevant institution; and(d) the goods are for use by, or in connection with, a patient of:(i) the relevant institution; or(ii) if the relevant institution is a public hospital in a State or Territory—another public hospital in the State or Territory | (a) there are no listed goods or registered goods that, in all relevant respects, are substantially similar to the goods; and(b) the person:(i) manufactures the goods at premises in Australia; and(ii) holds a licence, required by the Act, that authorises the manufacture, or a step in the manufacture, of the goods at those premises; and(c) the person notifies the Secretary, in accordance with a form approved by the Secretary and within 15 days of the end of a quarter, of:(i) the goods manufactured under the contract during that quarter; and(ii) the relevant institution that entered the contract | | 7 | Therapeutic goods, or parts of therapeutic goods, that form part of a medicine delivery system in which the medicine is supplied in a device that acts as a container | (a) none of the goods, or any part of the goods are separately supplied in Australia; and(b) if the component and kit manufacturer are the same manufacturer and the components are not separately supplied outside the kit by the kit sponsor; and(c) if the kit sponsor or the manufacturer obtains components from other manufacturers and the kit manufacturer’s licence covers quality control of those components | | 8 | Therapeutic goods imported by a member of a group of persons | (a) the group must be members of the military forces of another country, visiting Australia for military training; and(b) the goods must be for use in the treatment of a member or members of that group; and(c) the goods must not be supplied to, or used in the treatment of, a person other than a member of:(i) the visiting group; or(ii) the Australian Defence Force; and(d) any portion of the goods that is unused at the end of the visit must be destroyed or removed from Australia; and(e) a member of the group to whom the goods have been issued must be responsible for the control and custody of the goods while the group is in Australia; and(f) the person mentioned in paragraph (e) must:(i) carry a list, in English, of the quantity and nature of the therapeutic goods imported; and(ii) for each of the goods that is not a biological—include in the list the generic name and strength of the active ingredient of the goods; and(iii) keep a record of the use of the goods while the group is in Australia; and(iv) produce the list or the record for inspection at the request of a customs officer | | 9 | Unused emergency goods or unused emergency biologicals directed by the Secretary, under clause 7 of Schedule 5B, to be exported | the provisions of Schedule 5B continue to apply to the goods or biologicals, as if the goods or biologicals were not exempt from the operation of section 30G or 32CG of the Act | | 10 | Therapeutic goods imported into Australia by a medical practitioner or a member of a medical team (being 1 or more persons under the professional supervision of a medical practitioner) | (a) the medical practitioner or medical team must be accompanying a person to Australia who:(i) has a critical illness; and(ii) is under the direct care and supervision of the practitioner or team; and(b) the goods must be for use in the treatment of the person who has the critical illness; and(c) the importation of the goods must not be prohibited under the Customs (Prohibited Imports) Regulations 1956; and(d) the quantity of the goods must be consistent with the quantity required for the treatment of the person mentioned in paragraph (b); and(e) the goods must not be supplied to, or used in the treatment of, a person other than the person mentioned in paragraph (b); and(f) any portion of the goods that is unused at the end of the visit must be destroyed or removed from Australia; and(g) the medical practitioner, or a member of the medical team, must be responsible for the control and custody of the goods while the practitioner or team is in Australia; and(h) the person mentioned in paragraph (g) must:(i) carry a list, in English, of the quantity and nature of the therapeutic goods imported; and(ii) for each of the goods that is not a biological—include in the list the generic name and strength of the active ingredient of the goods; and(iii) keep a record of the use of the goods while the medical practitioner or medical team is in Australia; and | | | | (iv) produce the list or record for inspection at the request of a customs officer | | 11 | Therapeutic goods imported into Australia by a member of a group of persons | (a) the group must include a person who is the Head of State or Head of Government of a foreign country and senior Government officials of that country, who are visiting Australia on official business; and(b) the goods must be for use in the treatment of a member or members of the visiting group; and(c) the importation of the goods must not be prohibited under the Customs (Prohibited Imports) Regulations 1956; and(d) the goods must not be supplied to, or used in the treatment of, a person other than a member of the visiting group; and(e) any portion of the goods that is unused at the end of the visit must be destroyed or removed from Australia; and(f) a member of the visiting group must be responsible for the control and custody of the goods while the group is in Australia; and(g) the person mentioned in paragraph (f) must:(i) carry a list, in English, of the quantity and nature of the therapeutic goods imported; and(ii) for each of the goods that is not a biological—include in the list the generic name and strength of the active ingredient of the goods; and(iii) keep a record of the use of the goods while the group is in Australia; and | | | | (iv) produce the list or record for inspection at the request of a customs officer | | 12 | Therapeutic goods that are part of the medical supplies of a ship (including a yacht or other marine vessel) or aircraft visiting Australia | (a) the goods must be for use in the treatment of a passenger or a member of the crew travelling on the ship or aircraft; and(b) the importation of the goods must not be prohibited under the Customs (Prohibited Imports) Regulations 1956; and(c) the quantity of the goods must be consistent with the quantity required for the treatment of passengers and members of the crew travelling on the ship or aircraft; and(d) the goods must not be supplied to, or used in the treatment of, a person other than a passenger or a member of the crew travelling on the ship or aircraft; and(e) the goods must not be removed from the ship or aircraft while the ship or aircraft is in Australia; and(f) the master of the ship or the pilot of the aircraft must be responsible for the control and custody of the goods while the ship or aircraft is in Australia; and(g) the person mentioned in paragraph (f) must:(i) carry a list, in English, of the quantity and nature of the therapeutic goods imported; and(ii) for each of the goods that is not a biological—include in the list the generic name and strength of the active ingredient of the goods; and(iii) keep a record of the use of the goods while the ship or aircraft is in Australia; and | | | | (iv) produce the list or record for inspection at the request of a customs officer | | 13 | Therapeutic goods in relation to which all of the following paragraphs apply:(a) the goods comprise, contain or are derived from human cells or human tissues collected from a patient who is under the clinical care of a medical or dental practitioner;(b) the goods were manufactured by, or under the professional supervision of, the practitioner;(c) the single indication of the goods is homologous use:(i) on that patient; and(ii) in a single clinical procedure; and(iii) by, or under the professional supervision of, that practitioner;(d) the goods have been subjected to only minimal manipulation;(e) the practitioner is registered in a State or internal Territory | if the sponsor knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB | | 14 | Therapeutic goods in packs, if:(a) the packs contain tampons or menstrual cups; and(b) any other therapeutic goods in the packs are included in the Register; and(c) the packaging of any individually packaged medical devices or medicines in the pack is intact; and(d) the packs do not contain any of the following:(i) a biological;(ii) a medicine mentioned in Part 1 of Schedule 10;(iii) a medical device (other than an IVD medical device) that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher;(iv) an IVD medical device or in‑house IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher | the packs must not be supplied:(a) by persons other than charities; or(b) for a charge; or(c) to persons other than homeless or disadvantaged women | | 15 | Therapeutic goods, if:(a) the goods are:(i) therapeutic vaping substances; or(ii) therapeutic vaping substance accessories; or(iii) a therapeutic vaping kit; or(iv) goods in a therapeutic vaping pack; and(b) the goods are not, or do not include, any medicinal cannabis products; and(c) the only indications of the goods are use for smoking cessation or the management of nicotine dependence; and(d) for goods other than therapeutic vaping devices, or therapeutic vaping device accessories, in a therapeutic vaping pack—the sponsor of the goods, and any other person involved in the wholesale or retail supply of the goods, intend the goods to be supplied to the ultimate consumer of the goods in accordance with an approval or authority under section 19 of the Act; and(e) the sponsor has given the Secretary a notice (the sponsor notice) stating that:(i) the goods conform with each standard (as in force from time to time) that is applicable to the goods, or are imported or supplied (as the case may be) with the consent of the Secretary under section 14 or 14A of the Act; and(ii) the only indications of the goods are use for smoking cessation or the management of nicotine dependence; and(f) the sponsor notice has not been withdrawn by the sponsor by a notice (the withdrawal notice) given to the Secretary, with the withdrawal taking effect:(i) on the day specified in the withdrawal notice, being a day that is later than the day that notice is given to the Secretary; or(ii) otherwise—on the day the withdrawal notice is given; and(g) the goods are not the subject of a determination, by the Secretary and published on the Department’s website, that the supply of the goods be stopped or should cease because:(i) the Secretary is satisfied that the supply compromises public health and safety; or(ii) the Secretary is satisfied that the goods do not conform with a standard applicable to the goods; or(iii) the sponsor has failed to comply with a request by the Secretary under paragraph (e) of column 3 of this item | (a) the sponsor must give the sponsor notice to the Secretary in a form approved in writing by the Secretary; and(b) the sponsor notice must be given as follows:(i) for goods imported into Australia on or after 1 March 2024—before the goods are imported;(ii) for goods imported into Australia before 1 March 2024—before the earlier of the time the goods are supplied to the ultimate consumer and the end of the period of 2 months beginning on the day Schedule 1 to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024 commences; and(iii) for goods manufactured in Australia on or after 1 March 2024—before the goods are first supplied in Australia; and(iv) for goods manufactured in Australia before 1 March 2024—before the earlier of the time the goods are supplied to the ultimate consumer and the end of the period of 2 months beginning on the day Schedule 1 to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024 commences; and(c) the sponsor holds information or evidence to support:(i) the statement made in the sponsor notice under subparagraph (e)(ii) of column 2 of this item; and(ii) if the sponsor has not given a notice under paragraph (e) of this column of this item—the statement made in the sponsor notice under subparagraph (e)(i) of column 2 of this item; and(iii) if the sponsor has given one or more notices under paragraph (e) of this column of this item—the statement made in the most recent of those notices;including, in relation to a statement that the goods conform with each standard (as in force from time to time) that is applicable to the goods, to demonstrate that the goods continue to so conform; and(d) the following statements are, and continue to be, correct:(i) the statement made in the sponsor notice under subparagraph (e)(ii) of column 2 of this item;(ii) if the sponsor has not given a notice under paragraph (e) of this column of this item—the statement made in the sponsor notice under subparagraph (e)(i) of column 2 of this item;(iii) if the sponsor has given one or more notices under paragraph (e) of this column of this item—the statement made in the most recent of those notices;including, in relation to a statement that the goods conform with each standard (as in force from time to time) that is applicable to the goods, that the goods continue to so conform; and(e) the sponsor must:(i) if requested by the Secretary, give the Secretary a notice, in a form approved in writing by the Secretary, stating either that the goods conform with each standard (as in force from time to time) that is applicable to the goods or that the goods are being imported or supplied (as the case may be) with the consent of the Secretary under section 14 or 14A of the Act; and(ii) do so within the period requested by the Secretary (which must be at least 5 working days starting on the day on which the Secretary’s request is made); and(f) the sponsor must:(i) if requested by the Secretary, give the Secretary the information or evidence referred to in paragraph (c); and(ii) do so within the period requested by the Secretary (which must be at least 5 working days starting on the day on which the Secretary’s request is made); and(fa) the sponsor must:(i) if requested by the Secretary, give the Secretary a reasonable number of samples of the goods; and(ii) do so within the period requested by the Secretary (which must be at least 5 working days starting on the day on which the Secretary’s request is made); and(fb) the sponsor must allow an authorised officer:(i) to enter, at any reasonable time, any premises (including premises outside Australia) at which the sponsor or any other person deals with the goods; and(ii) while on those premises, to inspect those premises and the goods and to examine, take measurements of, conduct tests on, require tests to be conducted on or take samples of the goods or any thing on those premises that relates to the goods; and(iii) while on those premises, to make any still or moving image or any recording of those premises or any thing on those premises; and(fc) the sponsor must, if requested to do so by an authorised officer, produce to the authorised officer such documents relating to the goods as the authorised officer requires and allow the authorised officer to copy the documents; and(fd) if the sponsor is not the manufacturer of the goods, the sponsor must have procedures in place to ensure that the manufacturer of the goods allows an authorised officer:(i) to enter, at any reasonable time, any premises (including premises outside Australia) at which the manufacturer or any other person deals with the goods; and(ii) while on those premises, to inspect those premises and the goods and to examine, take measurements of, conduct tests on, require tests to be conducted on or take samples of the goods or any thing on those premises that relates to the goods; and(iii) while on those premises, to make any still or moving image or any recording of those premises or any thing on those premises; and(fe) if the sponsor is not the manufacturer of the goods, the sponsor must have procedures in place to ensure that the manufacturer of the goods, if the manufacturer is requested to do so by an authorised officer, produces to the authorised officer such documents relating to the goods as the authorised officer requires and allow the authorised officer to copy the documents; and(g) for goods manufactured in Australia—either of the following apply:(i) the goods are manufactured by a person who is the holder of a licence in force under Part 3‑3 of the Act that authorises the manufacture of the goods, or the carrying out of the step in the manufacture of the goods, at the manufacturing site where the manufacture, or the step, is carried out;(ii) the goods are manufactured by a person who is exempt in accordance with subsection 34(2) of the Act from the operation of Part 3‑3 of the Act in relation to the manufacture of the goods and the Secretary has given the person a consent under subsection 41RC(1) of the Act to manufacture the goods, or carry out the step in the manufacture of the goods, and the manufacture, or the step, is carried out in accordance with the consent; and(h) the goods may be supplied to a person who is not the ultimate consumer of the goods only if:(i) the person (the recipient) to whom the goods are supplied is the holder of a licence in force under Part 3‑3 of the Act that authorises a step in the manufacture of the goods; or(ii) the recipient is a wholesaler, pharmacist, medical practitioner or nurse practitioner who is the holder of a licence, or is otherwise authorised, to supply one or more substances included in Schedule 3 to the current Poisons Standard under a law of the State or Territory in which the recipient carries on a business, practises or is employed; or(iii) the Secretary has given the recipient a consent under subsection 41RC(1) of the Act to supply the goods; or(iv) in the case of goods that are covered by a determination made by the Minister under section 41R of the Act—the recipient is specified in the determination, or is included in a class of persons specified in the determination, in relation to those goods; and(i) the goods may be supplied to the ultimate consumer of the goods only if:(i) the goods are supplied as a finished product; and(ii) the supply is by a pharmacist, medical practitioner or nurse practitioner who is the holder of a licence, or is otherwise authorised, to supply one or more substances included in Schedule 3 to the current Poisons Standard under a law of the State or Territory in which the recipient carries on a business, practises or is employed; and(iii) for goods other than therapeutic vaping devices, or therapeutic vaping device accessories, in a therapeutic vaping pack—the supply is in accordance with an approval or authority under section 19 of the Act; and(iv) if the supply is by a person authorised as described in subparagraph (ii), the supply is in accordance with that authorisation; and(j) the sponsor must:(i) keep records relating to the source and supply of the goods; and(ii) if requested by the Secretary, give a copy of the records to the Secretary within the period requested by the Secretary (which must be at least 5 working days starting on the day on which the Secretary’s request is made); and(iii) if the Secretary requests information about the supply of the goods during a specified period—give the information to the Secretary within the period requested by the Secretary (which must be at least 5 working days starting on the day on which the Secretary’s request is made) and in a form approved in writing by the Secretary; and(k) the sponsor must provide information of a kind mentioned in subsection 29A(2) or 29AA(2) of the Act relating to the goods to the Secretary within the following periods:(i) if the information relates to an event or other occurrence that represents a serious threat to public health—48 hours after the sponsor becomes aware of the event or occurrence;(ii) if the information relates to an event or other occurrence that led to the death, or a serious deterioration in the state of health, of a patient, a user of the goods, or another person—10 days after the sponsor becomes aware of the event or occurrence;(iii) if the information relates to an event or other occurrence a recurrence of which might lead to the death, or a serious deterioration in the state of health, of a patient, a user of the goods, or another person—30 days after the sponsor becomes aware of the event or occurrence;(iv) in any other case—60 days after the sponsor becomes aware of the information | | 16 | Therapeutic goods imported into Australia, if:(a) the goods are nicotine in solution as a starting material for use in the manufacture of a therapeutic vaping substance, a therapeutic vaping substance accessory or any other therapeutic good; or(b) the goods are any other starting materials that are ingredients or components for use in the manufacture of a therapeutic vaping substance or a therapeutic vaping substance accessory | (a) the sponsor must give the Secretary a notice (the sponsor notice), in a form approved in writing by the Secretary, stating that the goods are for use in the manufacture, in accordance with the requirements of the Act, of another therapeutic good by a manufacturer that holds all relevant licences or approvals (however described) required under the following:(i) Part 3‑3 of the Act;(ii) the law of the State or Territory in which the manufacture is to occur; and(b) the sponsor notice must be given before importing the goods; and(ba) the sponsor must:(i) if requested by the Secretary, give the Secretary a reasonable number of samples of the goods; and(ii) do so within the period requested by the Secretary (which must be at least 5 working days starting on the day on which the Secretary’s request is made); and(c) the goods may be supplied only for use in manufacture as referred to in paragraph (a) | ## 1 Early end of exemption—notice of goods held #### 1 Early end of exemption—notice of goods held (1) This clause applies if: (a) the Minister makes an exemption under subsection 18A(1) of the Act in relation to specified therapeutic goods or therapeutic goods in a specified class; and (b) a person is given a copy of a revocation or variation of the exemption under paragraph 18A(9B)(b) of the Act. (2) The person must give the Secretary: (a) notice, in writing, of the quantity and location of: (i) for a revocation—the goods over which the person has control that have not been used; or (ii) for a variation—the goods mentioned in the variation over which the person has control that have not been used; and (b) a copy of any records about the goods that the person is required to keep under a condition of the exemption. (3) The person must comply with subclause (2) in relation to the goods within 7 days after the day the exemption ends for the goods. ## 1A Early cessation of exemption—notice of biologicals held #### 1A Early cessation of exemption—notice of biologicals held (1) A person who is given notice under paragraph 32CE(b) of the Act must give to the Secretary: (a) notice, in writing, of the quantity and location of any unused emergency biologicals over which the person has control; and (b) a copy of any records about the biologicals that, under a condition of the exemption, the person is required to keep. (2) Subclause (1) must be complied with: (a) if the notice under paragraph 32CE(b) of the Act is given before the exemption ceases to have effect for the biologicals—within 7 days after the exemption ceases; or (b) in any other case—within 7 days after the notice is given. ## 2 Expiration of period of exemption—notice of goods held #### 2 Expiration of period of exemption—notice of goods held A person who has been importing, manufacturing, supplying or exporting therapeutic goods under an exemption under subsection 18A(1) of the Act must, within 7 days after the exemption ceases to have effect under paragraph 18A(4)(a) of the Act, give to the Secretary: (a) notice, in writing, of the quantity and location of any unused emergency goods over which the person has control; and (b) a copy of any records about the goods that, under a condition of the exemption, the person is required to keep. ## 2A Expiration of period of exemption—notice of biologicals held #### 2A Expiration of period of exemption—notice of biologicals held A person who has been importing, manufacturing, supplying or exporting biologicals under an exemption under subsection 32CB(1) of the Act must, within 7 days after the end of the period specified in the exemption under subsection 32CB(4), give to the Secretary: (a) notice, in writing, of the quantity and location of any unused emergency biologicals over which the person has control; and (b) a copy of any records about the biologicals that, under a condition of the exemption, the person is required to keep. ## 3 Storage and disposal of unused emergency goods and unused emergency biologicals #### 3 Storage and disposal of unused emergency goods and unused emergency biologicals (1) A person who has control over unused emergency goods or unused emergency biologicals must ensure that those unused emergency goods or unused emergency biologicals are stored in a way that ensures that: (a) the goods or biologicals are only accessible for supply, export, use or disposal in accordance with the Act and these Regulations; and (b) the security of the goods or biologicals is appropriate to the level of risk that the goods or biologicals could pose to the public and the environment; and (c) the integrity of the condition of the goods or biologicals is maintained. (2) A person may dispose of unused emergency goods or unused emergency biologicals only in accordance with a direction given by the Secretary under subclause 4(1). ## 4 Direction for disposal of unused emergency goods and unused emergency biologicals #### 4 Direction for disposal of unused emergency goods and unused emergency biologicals (1) The Secretary may direct, in writing, any person who has control over unused emergency goods or unused emergency biologicals to dispose of the unused emergency goods or unused emergency biologicals in the manner directed. (2) A direction given under subclause (1) must be in accordance with clause 5, 6, 7 or 8. (3) A person who has been given a direction under subclause (1) must comply with the direction. ## 5 Relocation of unused emergency goods and unused emergency biologicals #### 5 Relocation of unused emergency goods and unused emergency biologicals If storage of particular unused emergency goods or unused emergency biologicals at a particular location poses, or would pose, a risk to the public or the environment, the Secretary may direct that the goods or biologicals be stored at a specified location that will ensure compliance with subclause 3(1). ## 6 Disposal of unused emergency goods and unused emergency biologicals—destruction #### 6 Disposal of unused emergency goods and unused emergency biologicals—destruction (1) The Secretary may direct that unused emergency goods or unused emergency biologicals be destroyed within the time specified in the direction if any of the following applies: (a) the goods or biologicals have passed their expiry date; (b) the goods or biologicals no longer conform to a standard that applies to the goods or biologicals; (c) use of the goods or biologicals poses, or would pose, a risk to public health; (d) storage of the goods or biologicals at their current location and any other location poses, or would pose, a risk to the public or the environment; (e) for unused emergency goods—within 12 months after the exemption ceases to have effect in relation to the goods, the goods have not become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication): (iv) goods that are the subject of an approval under section 19A of the Act; (ea) for unused emergency biologicals—within 12 months after the exemption ceases to have effect in relation to the biologicals, the biologicals have not become (whether in relation to an indication for which the biologicals could have been used under the exemption or in relation to a different indication): (ii) exempt biologicals under section 32CA of the Act; or (iii) biologicals that are the subject of an approval or authority under section 32CK or 32CM of the Act; or (iv) biologicals that are the subject of an approval under section 32CO of the Act; (f) the person who has control over the goods or biologicals requests that the goods or biologicals be destroyed. (2) A person directed to destroy the goods or biologicals may destroy the goods or biologicals only in a way, approved by the Secretary, that ensures that the destruction avoids or minimises harm to the public and the environment. ## 7 Disposal of unused emergency goods and unused emergency biologicals—export #### 7 Disposal of unused emergency goods and unused emergency biologicals—export (1) This clause applies to unused emergency goods or unused emergency biologicals to which any of paragraphs 6(1)(a) to (e) applies. (2) The Secretary may direct that the goods or biologicals be exported to a country, instead of directing that they be destroyed, if a relevant authority of the country has confirmed, in writing or by electronic communication, its willingness to accept the goods or biologicals. (3) A person directed to export the goods or biologicals must ensure that, during exportation: (a) the goods or biologicals are only accessible for purposes relating to the export; and (b) the security of the goods or biologicals is appropriate to the level of risk that the goods or biologicals could pose to the public and the environment; and (c) the integrity of the condition of the goods or biologicals is maintained. (4) In this clause: > electronic communication has the meaning given by subsection 5(1) of the Electronic Transactions Act 1999. ## 8 Disposal of unused emergency goods and unused emergency biologicals—supply #### 8 Disposal of unused emergency goods and unused emergency biologicals—supply (1) This clause applies to unused emergency goods or unused emergency biologicals that have become (whether in relation to an indication for which the unused emergency goods or unused emergency biologicals could have been used under the exemption or in relation to a different indication): (a) registered goods or listed goods; or (aa) biologicals included in the Register under Part 3‑2A of the Act; or (b) goods that are the subject of an approval or authority under section 19 of the Act; or (ba) biologicals that are the subject of an approval or authority under section 32CK or 32CM of the Act; or (c) goods that are the subject of an approval under section 19A of the Act; or (d) biologicals that are the subject of an approval under section 32CO of the Act. (2) The Secretary may direct that the goods or biologicals be supplied to an authorised person (otherwise than by way of administration to, or application in the treatment of, the person). (3) In this clause: > authorised person means, as appropriate, a person: (a) in relation to whom the registered goods or listed goods are registered or listed; or (aa) in relation to whom the biologicals are included in the Register under Part 3‑2A of the Act; or (b) to whom the approval under subsection 19(1) or section 32CK of the Act, or the authority under subsection 19(5) or 32CM(1) of the Act, is given; or (ba) who is included in a class of health practitioners specified in rules made under subsection 19(7A) or 32CM(7A) of the Act; or (c) to whom the approval under section 19A or 32CO of the Act is given. ## 9 Owner to be paid for goods or biologicals supplied #### 9 Owner to be paid for goods or biologicals supplied A direction given under clause 7 or 8 does not affect a person’s liability to pay the owner of the goods or biologicals for the export or supply of the goods or biologicals to the person. ## 10 Records about unused emergency goods and unused emergency biologicals #### 10 Records about unused emergency goods and unused emergency biologicals A person who has, or has had, control over unused emergency goods or unused emergency biologicals must: (a) ensure that records are kept that include the following information: (i) the quantities of the goods or biologicals under the person’s control; (ii) how the goods or biologicals are stored before being disposed of; (iii) if a direction under subclause 4(1) has been received—what actions have been taken to dispose of the goods or biologicals as directed and when the actions were taken; (iv) if the goods or biologicals have been exported or supplied—to whom they were exported or supplied and in what quantity; and (b) retain the records for 7 years after the last entry is made; and (c) if the Secretary so requests in writing—give to the Secretary a copy of a record mentioned in paragraph (a): (i) within 14 days after being notified of the Secretary’s request; or (ii) if the information is required to establish whether the goods or biologicals pose imminent risk to the public or the environment—within 24 hours, or any shorter period, specified by the Secretary. ## 11 Failure to comply with this Schedule #### 11 Failure to comply with this Schedule If a person who has control over any unused emergency goods or unused emergency biologicals has not complied with a provision of this Schedule, the Secretary may direct, in writing, that the unused emergency goods or unused emergency biologicals be destroyed by another person. ## Part 1 Interpretation ## Part 1—Interpretation ## 1 Definitions #### 1 Definitions (1) In this table: > C1 (section 9D) application means a request made under subsection 9D(1), (2) or (3) of the Act to vary information included in an entry in the Register for a registered OTC medicine, that is made in accordance with a form, and in the manner, approved by the Secretary under subsection 9D(6) of the Act for a C1 (section 9D) application. > C1 (section 23) application means an application made under section 23 of the Act to register an OTC medicine that is made in accordance with the form, or in the manner, approved by the Secretary under paragraph 23B(2)(a) of the Act for a C1 (section 23) application. > C2 (section 9D) application means a request made under subsection 9D(3) of the Act to vary information included in an entry in the Register for a registered OTC medicine, that is made in accordance with a form, and in the manner, approved by the Secretary under subsection 9D(6) of the Act for a C2 (section 9D) application. > C2 (section 23) application means an application made under section 23 of the Act to register an OTC medicine that is made in accordance with the form, or in the manner, approved by the Secretary under paragraph 23B(2)(a) of the Act for a C2 (section 23) application. > C3 (section 9D) application means a request made under subsection 9D(3) of the Act to vary information included in an entry in the Register for a registered OTC medicine, that is made in accordance with a form, and in the manner, approved by the Secretary under subsection 9D(6) of the Act for a C3 (section 9D) application. > C3 (section 23) application means an application made under section 23 of the Act to register an OTC medicine that is made in accordance with the form, or in the manner, approved by the Secretary under paragraph 23B(2)(a) of the Act for a C3 (section 23) application. > C4 (section 9D) application means a request made under subsection 9D(3) of the Act to vary information included in an entry in the Register for a registered OTC medicine, that is made in accordance with a form, and in the manner, approved by the Secretary under subsection 9D(6) of the Act for a C4 (section 9D) application. > C4 (section 23) application means an application made under section 23 of the Act to register an OTC medicine that is made in accordance with the form, or in the manner, approved by the Secretary under paragraph 23B(2)(a) of the Act for a C4 (section 23) application. > haematopoietic progenitor cells means primitive pluripotent haematopoietic cells capable of self‑renewal as well as maturation into any of the haematopoietic lineages, including committed and lineage‑restricted progenitor cells. > major variation, for therapeutic goods of a particular kind, means a change to: (a) the strength, as recorded in the entry in the Register; or (b) the dosage, the recommended dose regimen or the maximum daily dose; or (c) the dosage form; or (d) the route of administration; or (e) the intended patient group. > minor variation, for therapeutic goods of a particular kind, means a change (other than a change that is a major variation) to: (a) the formulation, composition or design specification; or (b) the container for the goods; or (c) any other attribute of the goods that results in the goods being separate and distinct. > N1 application means an application made under section 23 of the Act to register an OTC medicine that is made in accordance with the form, or in the manner, approved by the Secretary under paragraph 23B(2)(a) of the Act for an N1 application. > N2 application means an application made under section 23 of the Act to register an OTC medicine that is made in accordance with the form, or in the manner, approved by the Secretary under paragraph 23B(2)(a) of the Act for an N2 application. > N3 application means an application made under section 23 of the Act to register an OTC medicine that is made in accordance with the form, or in the manner, approved by the Secretary under paragraph 23B(2)(a) of the Act for an N3 application. > N4 application means an application made under section 23 of the Act to register an OTC medicine that is made in accordance with the form, or in the manner, approved by the Secretary under paragraph 23B(2)(a) of the Act for an N4 application. > N5 application means an application made under section 23 of the Act to register an OTC medicine that is made in accordance with the form, or in the manner, approved by the Secretary under paragraph 23B(2)(a) of the Act for an N5 application. > new chemical entity means: (a) a chemical, biological or radiopharmaceutical substance that has not previously been included in the Register; or (b) an isomer, mixture of isomers, complex of, derivative of or salt of, a registered chemical substance that, having previously been included in the Register, differs from the registered substance in having different safety or efficacy properties; or (c) a biological substance that, having previously been included in the Register, differs from the registered substance: (i) in having a different molecular structure; or (ii) in deriving from source material of a different nature or from a different manufacturing process; or (d) a radiopharmaceutical substance that: (i) is a radionucleide or ligand that has not previously been included in the Register; or (ii) has a coupling mechanism, linking the molecule and radionucleide, that has not previously been included in the Register; or (e) a fixed combination of active substances that have not previously been included in the Register as that fixed combination. > page means: (a) a legible photocopy of 1 side of 1 leaf of a published work, diagram or chart; or (b) in respect of any other work—1 side of 1 leaf (or a copy of 1 side of 1 leaf): (i) that has a maximum length of 297 millimetres and a maximum width of 210 millimetres; and (ii) that has a left‑hand margin that is at least 25 millimetres in width; and (iii) the information on which is typed or printed in legible characters at least 8 points in size; and (iv) that, if it is part of a document exceeding 1 page in length—is paginated. > primary site means the principal manufacturing premises in the capital city of each State and Territory where human blood and blood components are manufactured. (2) For paragraph (a) of item 2A and items 2B, 2C, 2CA and 4 in Part 2, an application for registration, or variation of the registration, of therapeutic goods of a kind mentioned in Part 1 of Schedule 10 is taken to be a submission. (3) A person making more than 1 application of a kind mentioned in subclause (2), simultaneously, is taken to be making a submission that includes all of those applications if the goods concerned contain the same active ingredient. ## 2 Part 2 fees do not apply in relation to applications etc. covered by Part 3 or 4 #### 2 Part 2 fees do not apply in relation to applications etc. covered by Part 3 or 4 The fees prescribed in Part 2 do not apply in relation to applications, evaluations and requests covered by Part 3 or 4. ## Part 2 Table of fees other than for applications etc. covered by Part 3 or 4 ## Part 2—Table of fees other than for applications etc. covered by Part 3 or 4 ## 3 Table of fees #### 3 Table of fees The following table sets out particular fees other than fees for applications, evaluations and requests covered by Part 3 or 4. | Column 1Item | Column 2Matter | Column 3Fee $ | | ------------ | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | | 1A | Application fee for processing an application for consent under section 14 or 14A of the Act: | | | | (a) for an application relating to goods to which a single entry in the Register relates | 583 (for all the goods to which the application relates) | | | (b) for an application relating to goods to which both of the following apply:(i) there are separate entries in the Register in relation to the goods;(ii) the way in which the goods do not conform with a standard applicable to the goods is the same for all the goods | 583 for the first entry plus 117 for each additional entry | | | (c) for an application relating to goods to which no entry in the Register relates | 3,831 | | 1 | Evaluation fee for the purposes of subparagraph 19(2)(b)(iii) of the Act | | | | (a) if:(i) the goods are medicines for use solely for experimental purposes in humans; and(ii) the evaluation consists of the consideration of:(A) a summary of chemical, pharmaceutical and biological information about the goods; and(B) descriptive information about the proposed clinical trial of the goods; and(C) information about adverse events associated with the use of the goods; and(D) information about the goods provided to the relevant ethics committee;—for each medicine | 2,111 | | | (b) if the goods are medicines for use solely for experimental purposes in humans (other than medicines to which paragraph (a) applies)—for each medicine | 26,240 | | 1AAA | Fee for the purposes of paragraph 19(4B)(e) of the Act, for a request under subsection 19(4B) to vary the therapeutic goods specified in an approval to use those goods solely for experimental purposes in humans, or to vary the conditions of such an approval: | | | | (a) if the request relates to:(i) goods that are medicines; and(ii) paragraph (a) of item 1 applied to the evaluation of the application for approval | 580 | | | (b) if the request relates to:(i) goods that are medicines; and(ii) paragraph (b) of item 1 applied to the evaluation of the application for approval | 7,162 | | 1AA | Application fee for the purposes of paragraph 22C(2)(b) of the Act for an application under subsection 22C(1) of the Act | 15,279 | | 1AB | Application fee for the purposes of paragraph 22E(4)(c) of the Act for an application under subsection 22E(3) of the Act | 5,540 | | 1ABA | Fee for the purposes of paragraph 22G(8)(b) of the Act for a request under section 22G of the Act | 10,099 | | 1AC | Application fee for the purposes of paragraph 23B(2)(b) of the Act for an application under section 23 of the Act for registration of a medicine in relation to which a provisional determination under section 22D of the Act is in force: | | | | (a) if the application relates to a new prescription medicine | 58,779 | | | (b) if the application relates to a new indications medicine | 35,105 | | 1AD | Evaluation fee for the purposes of subsection 24(1A) of the Act for an application under section 23 of the Act for registration of a medicine in relation to which a provisional determination under section 22D of the Act is in force: | | | | (a) if the evaluation relates to a new prescription medicine | 306,723 | | | (b) if the evaluation relates to a new indications medicine | 202,344 | | 1AE | Application fee for the purposes of paragraph 23B(2)(b) of the Act for an application under section 23 of the Act for registration of a medicine that is provisionally registered to be included in the part of the Register for goods known as registered goods | 34,988 | | 1AF | Evaluation fee for the purposes of subsection 24(1A) of the Act for an application under section 23 of the Act for registration of a medicine that is provisionally registered to be included in the part of the Register for goods known as registered goods | 147,530 | | 1AG | Application fee for the purposes of paragraph 29(5)(d) of the Act for an application under subsection 29(4) of the Act | 21,110 | | 1B | Application fee for the purposes of paragraph 25AAA(3)(d) of the Act for therapeutic goods (priority applicant) determination in relation to a medicine | 15,279 | | 2 | Application fee for the purposes of paragraph 23B(2)(b) of the Act for registration of therapeutic goods (if regulation 43A does not apply): | | | | (ba) for an application relating to a medicine in relation to which an evaluation fee is payable under paragraph (a) of item 4 | 58,663 | | | (bb) for an application relating to a medicine in relation to which an evaluation fee is payable under subparagraph (aa)(i) or (ii) of item 4 | 19,476 | | | (bc) for an application relating to a medicine in relation to which an evaluation fee is payable under subparagraph (aa)(iii) of item 4 | 39,068 | | | (bca) for an application relating to a medicine in relation to which an evaluation fee is payable under paragraph (ab) of item 4 | 62,161 | | | (bcb) for an application relating to a medicine in relation to which an evaluation fee is payable under paragraph (ac) of item 4 | 1,341 | | | (bd) for an application relating to a medicine in relation to which an evaluation fee is payable under paragraph (b) of item 4 | 34,988 | | | (be) for an application relating to a medicine in relation to which an evaluation fee is payable under subparagraph (bb)(i) or (ii) of item 4 for an evaluation of: | | | | (i) an extension of indications | 11,628 | | | (ii) a major variation | 7,591 | | | (bf) for an application relating to a medicine in relation to which an evaluation fee is payable under subparagraph (bb)(iii) of item 4 for an evaluation of: | | | | (i) an extension of indications | 23,442 | | | (ii) a major variation | 15,162 | | | (bfa) for an application relating to a medicine in relation to which an evaluation fee is payable under paragraph (bd) of item 4 | 36,969 | | | (bg) for an application relating to a medicine in relation to which an evaluation fee is payable under paragraph (c) of item 4 | 22,625 | | | (bh) for an application relating to a medicine in relation to which an evaluation fee is payable under paragraph (d) of item 4 | 3,697 | | | (bi) for an application relating to a medicine in relation to which an evaluation fee is payable under paragraph (g) of item 4 | 22,859 | | | (bj) for an application relating to a medicine in relation to which an evaluation fee is payable under paragraph (h) of item 4 | 1,341 | | | (bk) for an application relating to a medicine in relation to which an evaluation fee is payable under paragraph (bc) of item 4 | 1,341 | | | (c) subject to paragraph (d), for an application in any other case | 5,341 | | | (d) if a person submits more than one application at the same time and:(i) the additional application is in relation to goods that contain the same therapeutically active ingredient; and(ii) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous evaluation of the goods to be made | 2,659—for each additional application, up to a maximum amount payable of 15,512 (including the fee payable under paragraph (c)) | | 2A | Fee for varying an entry in the Register (not including evaluation of data) under section 9D (other than subsection 9D(2C)) of the Act, if the variation is for: | | | | (a) a registered medicine that is mentioned in Part 1 of Schedule 10—for each submission | 2,053 | | | (b) a listed medicine | 512 | | | (c) a disinfectant | 1,513 | | | (d) a Class 3 or Class 4 IVD medical device that is not covered by paragraph (g) | 1,891 | | | (e) an IVD medical device that is not:(i) a Class 3 or Class 4 IVD medical device; and(ii) covered by paragraph (g) | 1,081 | | | (f) a medical device that is not:(i) an IVD medical device; and(ii) covered by paragraph (g) | 1,081 | | | (g) a medical device, if the following are satisfied:(i) the reason for the variation is that the kind of medical device is affected by the EU transition (within the meaning of subregulation 9.1AA(3) of the Therapeutic Goods (Medical Devices) Regulations 2002);(ii) the variation only relates to an update to the manufacturer’s evidence for the medical device recorded in the entry in the Register for that kind of medical device;(iii) the request is to vary one or more entries in the Register and the manufacturer’s evidence to which the update relates is the same for each of the entries | 205 per 10 entries (or part thereof) | | 2AC | Application fee for an application under subsection 9D(3) of the Act to which regulation 16D applies | 1,341 | | 2B | Evaluation fee in relation to an application under subsection 9D(3) of the Act to which regulation 16F applies, for the evaluation of data—for each submission | 6,694 | | 2C | Evaluation fee in relation to an application under subsection 9D(3) of the Act to which regulation 16D applies, for the evaluation of data—for each submission | 5,353 | | 2CA | Evaluation fee in relation to an application under subsection 9D(2) of the Act, for the evaluation of data—for each submission | 6,694 | | 2CB | Fee for a request under subsection 9D(2C) of the Act (other than a request to which item 2CC, 2CD or 2CE applies) to make one or more variations of one or more entries in the Register in relation to a medicine: | | | | (a) for each entry, unless paragraph (b) applies | 980 | | | (b) in the case of a single entry in the Register, if the request is made together with a request of a kind mentioned in item 5 of Part 3 in relation to the same entry | Nil | | 2CC | Fee for a request under subsection 9D(2C) of the Act to make the same variation or variations of 2 or more entries in the Register that each relate to a registered complementary medicine—for each group of up to 7 entries | 980 | | 2CD | Fee for a request under subsection 9D(2C) of the Act to make the same variation or variations of 2 or more entries in the Register that each relate to a registered OTC medicine: | | | | (a) for each group of up to 7 entries, unless paragraph (b) applies | 980 | | | (b) for each group of up to 20 entries, if the request is made together with a request of a kind mentioned in item 5 of Part 3, in relation to the same group of entries | Nil | | 2CE | Fee for a request under subsection 9D(2C) of the Act to make the same variation or variations of 2 or more entries in the Register if:(a) each entry relates to a prescription medicine or a biological medicine; and(b) 2 or more of those medicines have the same active ingredient | The sum of:(a) for each group of entries relating to medicines with the same active ingredient—980; and(b) for any other entry—980 | | 3 | Application fee for paragraph 23C(2)(c) of the Act for the listing of therapeutic goods (other than for an application to which regulation 43A applies) if the goods are: | | | | (a) a disinfectant | 2,377 | | | (b) a medicine | 1,014 | | 3AB | Fee for a notice and declaration under subregulation 43AAE(2) relating to an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year: | | | | (a) if the notice and declaration relate to not more than 5 entries in the Register | 512 | | | (b) if the notice and declaration relate to 6 or more entries in the Register | 512 for the first 5 entries plus 59 for each additional entry | | 4 | Evaluation fee, for subsection 24(1A) of the Act, under a submission for evaluation relating to: | | | | (a) a new chemical entity (other than an entity to which paragraph (aa), (ab) or (ac) of this item, paragraph (a) of item 1AD or item 1AF applies) | 235,115 | | | (aa) a new chemical entity incorporated as an ancillary medicinal component of a medical device if the evaluation of the new chemical entity involves an evaluation of: | | | | (i) documentation setting out the chemistry, quality control and manufacturing of the new chemical entity; or | 78,489 | | | (ii) documentation relating to pre‑clinical studies; or | 78,489 | | | (iii) documentation mentioned in subparagraphs (i) and (ii) | 156,394 | | | (ab) a new prescription medicine in relation to which a therapeutic goods (priority applicant) determination is in force | 248,644 | | | (ac) a vaccine for COVID‑19, respiratory syncytial virus (RSV) or influenza that is a new chemical entity, if:(i) the vaccine is a new chemical entity only because the vaccine is for a new strain; and(ii) the vaccine is a closely related form of an existing vaccine, for another strain, in the Register in relation to which the applicant is the sponsor | 5,353 | | | (b) an extension of indications (other than an extension of indications to which paragraph (bb), (bc) or (bd) of this item, paragraph (b) of item 1AD or item 1AF applies) | 139,483 | | | (bb) an extension of indications or a major variation in respect of a medicine incorporated as an ancillary medicinal component of a medical device if the evaluation of the medicine involves an evaluation of: | | | | (i) documentation setting out the chemistry, quality control and manufacturing of the medicine; or | for an evaluation relating to:(a) an extension of indications—46,533(b) a major variation—30,206 | | | (ii) documentation relating to pre‑clinical studies; or | for an evaluation relating to:(a) an extension of indications—46,533(b) a major variation—30,206 | | | (iii) documentation mentioned in subparagraphs (i) and (ii) | for an evaluation relating to:(a) an extension of indications—92,949(b) a major variation—60,762 | | | (bc) an extension of indications that is the subject of an application to which regulation 16G applies | 5,353 | | | (bd) a new indications medicine in relation to which a therapeutic goods (priority applicant) determination is in force | 147,880 | | | (c) a new generic product | 89,801 | | | (d) an additional trade name | 14,695 | | | (g) a major variation (that is not a variation mentioned in any of paragraphs (a) to (d)) | 90,967 | | | (h) a minor variation (that is not a variation mentioned in any of paragraphs (a) to (d)) | 5,353 | | 6AA | Fee for processing of data in relation to goods, a step in the manufacture of which was carried out outside Australia (in addition to any other fee prescribed in this Schedule in relation to the application) to determine whether the manufacturing and quality control procedures used in the manufacture of the goods are acceptable:(a) for the purposes of subsection 9D(1), (2) or (3) of the Act; or(b) for the purposes of paragraph 25(1)(g), 26(1)(g), 31(1)(e) or 31(2)(d) of the Act | 781 | | 6AB | Fee for Department obtaining evidence from overseas regulatory authority of the manufacturing and quality control procedures used in the manufacture of goods, a step in the manufacture of which was carried out outside Australia (in addition to fee prescribed in item 6AA) | 840 | | 6ABA | Fee for desk audit of overseas compliance certification to identify third party certifications and review the overseas compliance certification by examining the underlying audit report and obtaining information from the overseas regulators | 2,987 | | 6AC | Fee for reinstatement of acceptance status of data relating to the manufacturing and quality control procedures used in the manufacture of goods, a step in the manufacture of which was carried out outside Australia (in addition to fee prescribed in items 6AA and 6ABA) | 1,411 | | 6B | Fee for evaluation of data, under subsection 9D(1), (2) or (3) of the Act, about an entry in the Register relating to disinfectants | 4,489 | | 6BA | Application fee for a request, under subsection 30A(1) of the Act, for the revocation of the cancellation of the registration or listing of therapeutic goods from the Register: | | | | (a) if the request relates to one registration or listing; | 187 | | | (b) if the request relates to more than one registration or listing | 187 for the first registration or listing plus 59 for each additional registration or listing | | 6BB | Application fee for a request, under subsection 30AA(1) of the Act, for the revocation of the cancellation of the registration or listing of therapeutic goods: | | | | (a) if the request relates to one registration or listing; | 187 | | | (b) if the request relates to more than one registration or listing | 187 for the first registration or listing plus 59 for each additional registration or listing | | 6C | Fee for evaluating documents and other information, relating to the safety of a medicine, obtained under paragraph 31(2)(f) of the Act (other than an evaluation to which item 6D applies) | 9,749 | | 6D | Fee for evaluating documents and other information, relating to the safety, quality and efficacy of a medicine, obtained under paragraphs 31(2)(f) and (h) of the Act, if the total number of pages of the evaluation documentation is: | | | | (a) not over 50 pages | 12,829 | | | (b) over 50 pages, but not over 250 pages | 16,561 | | | (c) over 250 pages, but not over 500 pages | 22,625 | | | (d) over 500 pages, but not over 1 000 pages | 29,972 | | | (e) over 1 000 pages, but not over 2 000 pages | 44,900 | | | (f) over 2 000 pages, but not over 3 000 pages | 59,828 | | | (g) over 3 000 pages | 89,801 | | 7A | Fee for evaluation under paragraph 16GA(1)(a): | | | | (a) if the evaluation documentation does not contain clinical or toxicological information(b) if the evaluation documentation contains clinical or toxicological information, and the total number of pages is: | 12,829 | | | (i) not over 50 pages | 12,829 | | | (ii) over 50 pages, but not over 250 pages | 16,561 | | | (iii) over 250 pages, but not over 500 pages | 22,625 | | | (iv) over 500 pages, but not over 1 000 pages | 29,972 | | | (v) over 1 000 pages, but not over 2 000 pages | 44,900 | | | (vi) over 2 000 pages, but not over 3 000 pages | 59,828 | | | (vii) over 3 000 pages | 89,801 | | 7B | Fee for evaluation, under paragraph 16GA(1)(b), in relation to 1 or more new excipients for use in particular therapeutic goods: | | | | (a) if the evaluation documentation does not contain clinical or toxicological information(b) if the evaluation documentation contains clinical or toxicological information, and the total number of pages is: | 12,829 | | | (i) not over 50 pages | 12,829 | | | (ii) over 50 pages, but not over 250 pages | 16,561 | | | (iii) over 250 pages, but not over 500 pages | 22,625 | | | (iv) over 500 pages, but not over 1 000 pages | 29,972 | | | (v) over 1 000 pages, but not over 2 000 pages | 44,900 | | | (vi) over 2 000 pages, but not over 3 000 pages | 59,828 | | | (vii) over 3 000 pages | 89,801 | | 7C | Application fee for the purposes of paragraph 26BJ(2)(d) of the Act | 1,270 | | 8 | (a) Application fee for the purposes of paragraph 37(1)(g) of the Act, for a licence for: | 957 | | | (i) the manufacture of therapeutic goods; or | | | | (ii) one or more steps in the manufacture of therapeutic goods; or | | | | (iii) the manufacture of ingredients or components for use in the manufacture of therapeutic goods; or | | | | (iv) the manufacture of herbal or homoeopathic preparations; | | | | unless paragraph (b) applies | | | | (b) Application fee for the purposes of paragraph 37(1)(g) of the Act, for a licence for: | 1,248 | | | (i) the manufacture of haematopoietic progenitor cells; or | | | | (ii) the manufacture of human blood and blood components (other than haematopoietic progenitor cells) | | | 8A | Application fee for the purposes of paragraph 40B(2)(g) of the Act, for an application under subsection 40B(1) of the Act (addition of manufacturing sites) for the variation of a licence to which paragraph (a) of item 8 applies | 957 | | 8B | Application fee for the purposes of paragraph 40B(7)(d) of the Act, for an application under subsection 40B(6) of the Act for the variation of the manufacturing site authorisation in relation to a licence to which paragraph (a) of item 8 applies | 957 | | 8C | Application fee for the purposes of paragraph 40B(9B)(c) of the Act, for an application under subsection 40B(9A) of the Act (removal of manufacturing sites) for the variation of a licence to which paragraph (a) of item 8 applies | 957 | | 9 | (a) Fee for paragraphs 38(1)(c) and 58(3)(b) of the Act for inspection within Australia (except for therapeutic goods mentioned in items 9AA, 9AB, 9AC and 9ACA), per hour, per inspector, for: | 1,190 | | | (i) the manufacture of therapeutic goods; or | | | | (ii) one or more steps in the manufacture of therapeutic goods; or | | | | (iii) the manufacture of ingredients or components for use in the manufacture of therapeutic goods; or | | | | (iv) the manufacture of herbal or homoeopathic preparations | | | | (b) Fee for inspection outside Australia, per hour, per inspector, for inspection of a kind mentioned in paragraph (a) | 1,668 | | 9AA | Fee for inspection (including an inspection for paragraph 58(3)(b) of the Act) of manufacturing premises or operations for the preparation of haematopoietic progenitor cells under licence, for each inspector engaged per hour, or part of an hour | 815 | | 9AB | Fee for inspection (including an inspection for paragraph 58(3)(b) of the Act) of manufacturing premises or operations for the preparation of human blood and blood components (other than haematopoietic progenitor cells) under licence, at the primary site covered by the licence, for each inspector engaged per hour, or part of an hour | 1,108 | | 9AC | Fee for inspection (including an inspection for paragraph 58(3)(b) of the Act) of manufacturing premises or operations for the preparation of human blood and blood components (other than haematopoietic progenitor cells) under licence, at a site covered by the licence (other than a site to which item 9AB applies), for each inspector engaged per hour, or part of an hour | 815 | | 9ACA | Fee for inspection (including an inspection for paragraph 58(3)(b) of the Act) of manufacturing premises or operations for the preparation of human tissues under licence, for each inspector engaged per hour, or part of an hour | 815 | | 9AD | Fee for paragraph 25(1)(g) or (h), or 26(1)(g) or (h) of the Act (and, in relation to associated inspections, for paragraphs 38(1)(c), 41(1)(f) and 58(3)(b) of the Act), in respect of the evaluation of the manufacture of human blood and blood components prepared under licence by reference to data contained in files known as technical master files or plasma master files, where the total number of pages of each file referred to is: | | | | (a) not over 10 pages | 1,610 | | | (b) over 10 pages, but not over 50 pages | 13,645 | | | (c) over 50 pages, but not over 100 pages | 30,788 | | | (d) over 100 pages, but not over 1 000 pages | 41,402 | | | (e) over 1 000 pages, but not over 3 000 pages | 64,493 | | | (f) over 3 000 pages, but not over 4 000 pages | 85,952 | | | (g) over 4 000 pages | 104,845 | | 9D | Fee for evaluation, under subsection 9D(1), (2) or (3), subsection 24(1A) or paragraph 26(1)(d) of the Act, of data relating to the device component, to which Chapter 4 of the Act applies, of a medicine (in addition to the fee prescribed in item 4, or in Part 3 of this Schedule, for evaluating the medicine) | The fee applicable, under item 1.9, 1.10, 1.12 or 1.16 (and, if applicable, clause 2.2) of Schedule 5 to the Therapeutic Goods (Medical Devices) Regulations 2002, to the kind of work to be undertaken | | 10 | Fee for an application for certification under paragraph 58(3)(a) of the Act | 211 multiplied by the number of certifications sought in the application | | 11 | Fee for the inspection of manufacturing operations other than for the purposes of Part 3‑3 of the Act | The fee applicable under item 9 for that step of manufacture | | 12 | Fee for evaluation of data in relation to therapeutic goods specified in Schedule 10 for the purposes of subsection 9D(1), (2) or (3) of the Act that is not covered by another item in this Part | The fee applicable under item 1, 4 or 5 for an evaluation of that nature | | 13 | Fee for an evaluation under subsection 66(4) of the Act | The fee applicable under item 1, 4 or 5 for an evaluation of that nature | | 14 | Fee for notification required under item 3 of Schedule 5A: | | | | (a) of intention to sponsor a clinical trial at a trial site using a specified medicine | 443 | | | (b) for each notification of an additional trial site or additional trial sites | 443 | | 16 | Fee, including deposit, for an application under subsection 61(6) of the Act | The amount, including a deposit, that would be payable under the Freedom of Information Act 1982 and the Freedom of Information (Fees and Charges) Regulations for a request if the application were a request under section 15 of that Act | | 18 | Fee for providing advice in relation to a prescription medicine at the request of the sponsor of the medicine for the purpose of listing the medicine as a pharmaceutical benefit | 2,706 | ## Part 3 Table of fees for applications etc. in relation to certain OTC medicines ## Part 3—Table of fees for applications etc. in relation to certain OTC medicines ## 4 Table of fees #### 4 Table of fees The following table sets out particular fees for applications, evaluations and requests in relation to OTC medicines that are, or are to be, registered goods. <table cellspacing="0" cellpadding="0" style="width:100%; border-collapse:collapse"><thead><tr><td colspan="3" style="border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="TableHeading"><span>Fees</span></p></td><td style="border-bottom:0.75pt solid #000000; vertical-align:top"></td></tr><tr><td style="width:13.34%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Column 1</span><br><span>Item</span></p></td><td style="width:62.12%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Column 2</span><br><span>Matter</span></p></td><td colspan="2" style="border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Column 3</span><br><span>Fee $</span></p></td></tr></thead><tbody><tr><td style="width:13.34%; border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>1</span></p></td><td style="width:62.12%; border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Application fee under paragraph</span><span> </span><span>23B(2)(b) of the Act:</span></p></td><td colspan="2" style="border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span></span></p></td></tr><tr><td style="width:13.34%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span></span></p></td><td style="width:62.12%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tablea"><span>(a) for an N1 application</span></p></td><td colspan="2" style="padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>1,982</span></p></td></tr><tr><td style="width:13.34%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span></span></p></td><td style="width:62.12%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tablea"><span>(b) for an N2 application</span></p></td><td colspan="2" style="padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>1,982</span></p></td></tr><tr><td style="width:13.34%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span></span></p></td><td style="width:62.12%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tablea"><span>(c) for an N3 application</span></p></td><td colspan="2" style="padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>3,185</span></p></td></tr><tr><td style="width:13.34%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span></span></p></td><td style="width:62.12%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tablea"><span>(d) for an N4 application</span></p></td><td colspan="2" style="padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>4,653</span></p></td></tr><tr><td style="width:13.34%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span></span></p></td><td style="width:62.12%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tablea"><span>(e) for an N5 application</span></p></td><td colspan="2" style="padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>6,893</span></p></td></tr><tr><td style="width:13.34%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span></span></p></td><td style="width:62.12%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tablea"><span>(f) for a C1 (section</span><span> </span><span>23) application</span></p></td><td colspan="2" style="padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>1,982</span></p></td></tr><tr><td style="width:13.34%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span></span></p></td><td style="width:62.12%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tablea"><span>(g) for a C2 (section</span><span> </span><span>23) application</span></p></td><td colspan="2" style="padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>1,982</span></p></td></tr><tr><td style="width:13.34%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span></span></p></td><td style="width:62.12%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tablea"><span>(h) for a C3 (section</span><span> </span><span>23) application</span></p></td><td colspan="2" style="padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>1,982</span></p></td></tr><tr><td style="width:13.34%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span></span></p></td><td style="width:62.12%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tablea"><span>(i) for a C4 (section</span><span> </span><span>23) application</span></p></td><td colspan="2" style="border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>3,185</span></p></td></tr><tr><td style="width:13.34%; border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>2</span></p></td><td style="width:62.12%; border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Evaluation fee under subsection</span><span> </span><span>24(1A) of the Act:</span></p></td><td colspan="2" style="border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span></span></p></td></tr><tr><td style="width:13.34%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span></span></p></td><td style="width:62.12%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tablea"><span>(a) for an N1 application</span></p></td><td colspan="2" style="padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>4,898</span></p></td></tr><tr><td style="width:13.34%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span></span></p></td><td style="width:62.12%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tablea"><span>(b) for an N2 application</span></p></td><td colspan="2" style="padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>6,963</span></p></td></tr><tr><td style="width:13.34%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span></span></p></td><td style="width:62.12%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tablea"><span>(c) for an N3 application</span></p></td><td colspan="2" style="padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>10,730</span></p></td></tr><tr><td style="width:13.34%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span></span></p></td><td style="width:62.12%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tablea"><span>(d) for an N4 application</span></p></td><td colspan="2" style="padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>17,843</span></p></td></tr><tr><td style="width:13.34%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span></span></p></td><td style="width:62.12%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tablea"><span>(e) for an N5 application</span></p></td><td colspan="2" style="padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>26,240</span></p></td></tr><tr><td style="width:13.34%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span></span></p></td><td style="width:62.12%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tablea"><span>(f) for a C2 (section</span><span> </span><span>23) application</span></p></td><td colspan="2" style="padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>4,898</span></p></td></tr><tr><td style="width:13.34%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span></span></p></td><td style="width:62.12%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tablea"><span>(g) for a C3 (section</span><span> </span><span>23) application</span></p></td><td colspan="2" style="padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>8,222</span></p></td></tr><tr><td style="width:13.34%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span></span></p></td><td style="width:62.12%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tablea"><span>(h) for a C4 (section</span><span> </span><span>23) application</span></p></td><td colspan="2" style="border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>10,730</span></p></td></tr><tr><td style="width:13.34%; border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>3</span></p></td><td style="width:62.12%; border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>If, at the time a person submits an application of a kind mentioned in paragraph</span><span> </span><span>(a), (b), (c), (d) or (e) of item</span><span> </span><span>1:</span></p></td><td colspan="2" style="border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span></span></p></td></tr><tr><td style="width:13.34%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span></span></p></td><td style="width:62.12%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tablea"><span>(a) the person also submits an additional application or applications of the same kind; and</span></p></td><td colspan="2" style="padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span></span></p></td></tr><tr><td style="width:13.34%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span></span></p></td><td style="width:62.12%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tablea"><span>(b) each application relates to goods that contain the same therapeutically active ingredient; and</span></p></td><td colspan="2" style="padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span></span></p></td></tr><tr><td style="width:13.34%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span></span></p></td><td style="width:62.12%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tablea"><span>(c) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made;</span></p></td><td colspan="2" style="padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span></span></p></td></tr><tr><td style="width:13.34%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span></span></p></td><td style="width:62.12%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>the application fee under paragraph</span><span> </span><span>23B(2)(b) of the Act for each additional application is:</span></p></td><td colspan="2" style="padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span></span></p></td></tr><tr><td style="width:13.34%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span></span></p></td><td style="width:62.12%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tablea"><span>(d) for an additional N1 application</span></p></td><td colspan="2" style="padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>1,003</span></p></td></tr><tr><td style="width:13.34%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span></span></p></td><td style="width:62.12%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tablea"><span>(e) for an additional N2 application</span></p></td><td colspan="2" style="padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>1,003</span></p></td></tr><tr><td style="width:13.34%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span></span></p></td><td style="width:62.12%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tablea"><span>(f) for an additional N3 application</span></p></td><td colspan="2" style="padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>1,599</span></p></td></tr><tr><td style="width:13.34%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span></span></p></td><td style="width:62.12%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tablea"><span>(g) for an additional N4 application</span></p></td><td colspan="2" style="padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>1,599</span></p></td></tr><tr><td style="width:13.34%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span></span></p></td><td style="width:62.12%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tablea"><span>(h) for an additional N5 application</span></p></td><td colspan="2" style="border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>1,599</span></p></td></tr><tr><td style="width:13.34%; border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>4</span></p></td><td style="width:62.12%; border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>If, at the time a person submits an application of a kind mentioned in paragraph</span><span> </span><span>(c), (d) or (e) of item</span><span> </span><span>2:</span></p></td><td colspan="2" style="border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span></span></p></td></tr><tr><td style="width:13.34%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span></span></p></td><td style="width:62.12%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tablea"><span>(a) the person also submits an additional application or applications of the same kind; and</span></p></td><td colspan="2" style="padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span></span></p></td></tr><tr><td style="width:13.34%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span></span></p></td><td style="width:62.12%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tablea"><span>(b) each application relates to goods that contain the same therapeutically active ingredient; and</span></p></td><td colspan="2" style="padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span></span></p></td></tr><tr><td style="width:13.34%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span></span></p></td><td style="width:62.12%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tablea"><span>(c) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous evaluation of the goods to be made;</span></p></td><td colspan="2" style="padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span></span></p></td></tr><tr><td style="width:13.34%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span></span></p></td><td style="width:62.12%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>the evaluation fee under subsection</span><span> </span><span>24(1A) of the Act for each additional application is:</span></p></td><td colspan="2" style="padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span></span></p></td></tr><tr><td style="width:13.34%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span></span></p></td><td style="width:62.12%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tablea"><span>(d) for an additional N3 application</span></p></td><td colspan="2" style="padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>5,435</span></p></td></tr><tr><td style="width:13.34%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span></span></p></td><td style="width:62.12%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tablea"><span>(e) for an additional N4 application</span></p></td><td colspan="2" style="padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>5,435</span></p></td></tr><tr><td style="width:13.34%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span></span></p></td><td style="width:62.12%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tablea"><span>(f) for an additional N5 application</span></p></td><td colspan="2" style="border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>5,435</span></p></td></tr><tr><td style="width:13.34%; border-top:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>5</span></p></td><td style="width:62.12%; border-top:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>Application fee under paragraph</span><span> </span><span>9D(7)(f) of the Act, for any of the following requests in relation to up to 20 entries in the Register:</span></p></td><td colspan="2" style="border-top:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span></span></p></td></tr><tr><td style="width:13.34%; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span></span></p></td><td style="width:62.12%; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tablea"><span>(a) a C1 (section</span><span> </span><span>9D) application</span></p></td><td colspan="2" style="padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>1,982</span></p></td></tr><tr><td style="width:13.34%; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span></span></p></td><td style="width:62.12%; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tablea"><span>(b) a C2 (section</span><span> </span><span>9D) application</span></p></td><td colspan="2" style="padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>6,893</span></p></td></tr><tr><td style="width:13.34%; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span></span></p></td><td style="width:62.12%; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tablea"><span>(c) a C3 (section</span><span> </span><span>9D) application</span></p></td><td colspan="2" style="padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>10,216</span></p></td></tr><tr><td style="width:13.34%; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span></span></p></td><td style="width:62.12%; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tablea"><span>(d) a C4 (section</span><span> </span><span>9D) application</span></p></td><td colspan="2" style="border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>13,878</span></p></td></tr><tr><td style="width:13.34%; border-top:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>7</span></p></td><td style="width:62.12%; border-top:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>Fee for providing advice in relation to a registered OTC medicine at the request of the sponsor of the medicine for the purpose of listing the medicine as a pharmaceutical benefit:</span></p></td><td colspan="2" style="border-top:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span></span></p></td></tr><tr><td style="width:13.34%; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span></span></p></td><td style="width:62.12%; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tablea"><span>(a) if the request does not contain clinical data</span></p></td><td colspan="2" style="padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>1,947</span></p></td></tr><tr><td style="width:13.34%; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span></span></p></td><td style="width:62.12%; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tablea"><span>(b) if the request contains clinical data or a justification as to why such data is not needed</span></p></td><td colspan="2" style="border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>9,984</span></p></td></tr><tr style="height:0pt"><td style="width:56.9pt"></td><td style="width:264.85pt"></td><td style="width:103.6pt"></td><td style="width:1pt"></td></tr></tbody></table> ``` ## Part 4 Table of fees for applications etc. in relation to certain complementary medicines and certain other listed medicines ## Part 4—Table of fees for applications etc. in relation to certain complementary medicines and certain other listed medicines ## 5 Table of fees #### 5 Table of fees The following table sets out particular fees for applications, evaluations and requests in relation to certain medicines. <table cellspacing="0" cellpadding="0" style="width:100%; border-collapse:collapse"><thead><tr><td colspan="3" style="border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Fees</span></p></td></tr><tr><td style="width:7.56%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Item</span></p></td><td style="width:79.48%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Column 1</span></p><p class="TableHeading"><span>Matter</span></p></td><td style="width:12.96%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading" style="text-align:right"><span>Column 2</span></p><p class="TableHeading" style="text-align:right"><span>Fee $</span></p></td></tr></thead><tbody><tr><td style="width:7.56%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>1A</span></p></td><td style="width:79.48%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Application fee under paragraph</span><span> </span><span>9D(7)(f) of the Act for an L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style="width:12.96%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="text-align:right"><span>2,390</span></p></td></tr><tr><td style="width:7.56%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>1B</span></p></td><td style="width:79.48%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Application fee under paragraph</span><span> </span><span>9D(7)(f) of the Act for an L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style="width:12.96%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="text-align:right"><span>10,439</span></p></td></tr><tr><td style="width:7.56%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>1C</span></p></td><td style="width:79.48%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Application fee under paragraph</span><span> </span><span>9D(7)(f) of the Act for an L(A)CN (section</span><span> </span><span>9D) request</span></p></td><td style="width:12.96%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="text-align:right"><span>957</span></p></td></tr><tr><td style="width:7.56%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>1D</span></p></td><td style="width:79.48%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Application fee under paragraph</span><span> </span><span>23B(2)(b) of the Act for an L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style="width:12.96%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="text-align:right"><span>1,108</span></p></td></tr><tr><td style="width:7.56%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>1E</span></p></td><td style="width:79.48%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Application fee under paragraph</span><span> </span><span>23B(2)(b) of the Act for an L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style="width:12.96%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="text-align:right"><span>1,108</span></p></td></tr><tr><td style="width:7.56%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>1F</span></p></td><td style="width:79.48%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Application fee under paragraph</span><span> </span><span>23B(2)(b) of the Act for an L(A)CN (section</span><span> </span><span>23) application</span></p></td><td style="width:12.96%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="text-align:right"><span>957</span></p></td></tr><tr><td style="width:7.56%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>1G</span></p></td><td style="width:79.48%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Evaluation fee under subsection</span><span> </span><span>26AC(2) of the Act for an L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style="width:12.96%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="text-align:right"><span>1,284</span></p></td></tr><tr><td style="width:7.56%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>1H</span></p></td><td style="width:79.48%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Evaluation fee under subsection</span><span> </span><span>26AC(2) of the Act for an L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style="width:12.96%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="text-align:right"><span>9,330</span></p></td></tr><tr><td style="width:7.56%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>1</span></p></td><td style="width:79.48%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Application fee under paragraph</span><span> </span><span>9D(7)(f) of the Act for an RCMC1 (section</span><span> </span><span>9D) request</span></p></td><td style="width:12.96%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="text-align:right"><span>1,739</span></p></td></tr><tr><td style="width:7.56%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>2</span></p></td><td style="width:79.48%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Application fee under paragraph</span><span> </span><span>9D(7)(f) of the Act for an RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style="width:12.96%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="text-align:right"><span>5,866</span></p></td></tr><tr><td style="width:7.56%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>3</span></p></td><td style="width:79.48%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Application fee under paragraph</span><span> </span><span>9D(7)(f) of the Act for an RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style="width:12.96%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="text-align:right"><span>8,712</span></p></td></tr><tr><td style="width:7.56%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>4</span></p></td><td style="width:79.48%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Application fee under paragraph</span><span> </span><span>9D(7)(f) of the Act for an RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style="width:12.96%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="text-align:right"><span>12,363</span></p></td></tr><tr><td style="width:7.56%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>5</span></p></td><td style="width:79.48%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Application fee under paragraph</span><span> </span><span>23B(2)(b) of the Act for an RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style="width:12.96%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="text-align:right"><span>1,739</span></p></td></tr><tr><td style="width:7.56%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>6</span></p></td><td style="width:79.48%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Application fee under paragraph</span><span> </span><span>23B(2)(b) of the Act for an RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style="width:12.96%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="text-align:right"><span>910</span></p></td></tr><tr><td style="width:7.56%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>7</span></p></td><td style="width:79.48%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Evaluation fee under subsection</span><span> </span><span>24(1A) of the Act for an RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style="width:12.96%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="text-align:right"><span>4,944</span></p></td></tr><tr><td style="width:7.56%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>8</span></p></td><td style="width:79.48%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Application fee under paragraph</span><span> </span><span>23B(2)(b) of the Act for an RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style="width:12.96%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="text-align:right"><span>980</span></p></td></tr><tr><td style="width:7.56%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>9</span></p></td><td style="width:79.48%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Evaluation fee under subsection</span><span> </span><span>24(1A) of the Act for an RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style="width:12.96%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="text-align:right"><span>7,744</span></p></td></tr><tr><td style="width:7.56%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>10</span></p></td><td style="width:79.48%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Application fee under paragraph</span><span> </span><span>23B(2)(b) of the Act for an RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style="width:12.96%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="text-align:right"><span>1,003</span></p></td></tr><tr><td style="width:7.56%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>11</span></p></td><td style="width:79.48%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Evaluation fee under subsection</span><span> </span><span>24(1A) of the Act for an RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style="width:12.96%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="text-align:right"><span>11,441</span></p></td></tr><tr><td style="width:7.56%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>12</span></p></td><td style="width:79.48%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Application fee under paragraph</span><span> </span><span>23B(2)(b) of the Act for an RCM1 application</span></p></td><td style="width:12.96%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="text-align:right"><span>665</span></p></td></tr><tr><td style="width:7.56%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>13</span></p></td><td style="width:79.48%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Evaluation fee under subsection</span><span> </span><span>24(1A) of the Act for a RCM1 application</span></p></td><td style="width:12.96%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="text-align:right"><span>3,813</span></p></td></tr><tr><td style="width:7.56%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>14</span></p></td><td style="width:79.48%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Application fee under paragraph</span><span> </span><span>23B(2)(b) of the Act for an RCM2 application</span></p></td><td style="width:12.96%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="text-align:right"><span>2,390</span></p></td></tr><tr><td style="width:7.56%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>15</span></p></td><td style="width:79.48%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Evaluation fee under subsection</span><span> </span><span>24(1A) of the Act for a RCM2 application</span></p></td><td style="width:12.96%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="text-align:right"><span>25,540</span></p></td></tr><tr><td style="width:7.56%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>16</span></p></td><td style="width:79.48%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Application fee under paragraph</span><span> </span><span>23B(2)(b) of the Act for an RCM3 application</span></p></td><td style="width:12.96%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="text-align:right"><span>2,390</span></p></td></tr><tr><td style="width:7.56%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>17</span></p></td><td style="width:79.48%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Evaluation fee under subsection</span><span> </span><span>24(1A) of the Act for a RCM3 application</span></p></td><td style="width:12.96%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="text-align:right"><span>25,540</span></p></td></tr><tr><td style="width:7.56%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>18</span></p></td><td style="width:79.48%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Application fee under paragraph</span><span> </span><span>23B(2)(b) of the Act for an RCM4 application</span></p></td><td style="width:12.96%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="text-align:right"><span>3,160</span></p></td></tr><tr><td style="width:7.56%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>19</span></p></td><td style="width:79.48%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Evaluation fee under subsection</span><span> </span><span>24(1A) of the Act for a RCM4 application</span></p></td><td style="width:12.96%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="text-align:right"><span>34,755</span></p></td></tr><tr><td style="width:7.56%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>20</span></p></td><td style="width:79.48%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Application fee under paragraph</span><span> </span><span>23B(2)(b) of the Act for an RCM5 application</span></p></td><td style="width:12.96%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="text-align:right"><span>3,463</span></p></td></tr><tr><td style="width:7.56%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>21</span></p></td><td style="width:79.48%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Evaluation fee under subsection</span><span> </span><span>24(1A) of the Act for a RCM5 application</span></p></td><td style="width:12.96%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="text-align:right"><span>44,317</span></p></td></tr><tr><td style="width:7.56%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>22</span></p></td><td style="width:79.48%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Application fee under paragraph</span><span> </span><span>23B(2)(b) of the Act for an L(A)1 application</span></p></td><td style="width:12.96%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="text-align:right"><span>537</span></p></td></tr><tr><td style="width:7.56%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>23</span></p></td><td style="width:79.48%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Evaluation fee under subsection</span><span> </span><span>26AC(2) of the Act for an L(A)1 application</span></p></td><td style="width:12.96%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="text-align:right"><span>2,041</span></p></td></tr><tr><td style="width:7.56%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>24</span></p></td><td style="width:79.48%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Application fee under paragraph</span><span> </span><span>23B(2)(b) of the Act for an L(A)2 application</span></p></td><td style="width:12.96%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="text-align:right"><span>2,204</span></p></td></tr><tr><td style="width:7.56%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>25</span></p></td><td style="width:79.48%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Evaluation fee under subsection</span><span> </span><span>26AC(2) of the Act for an L(A)2 application</span></p></td><td style="width:12.96%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="text-align:right"><span>16,911</span></p></td></tr><tr><td style="width:7.56%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>26</span></p></td><td style="width:79.48%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Application fee under paragraph</span><span> </span><span>23B(2)(b) of the Act for an L(A)3 application</span></p></td><td style="width:12.96%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="text-align:right"><span>2,204</span></p></td></tr><tr><td style="width:7.56%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>27</span></p></td><td style="width:79.48%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Evaluation fee under subsection</span><span> </span><span>26AC(2) of the Act for an L(A)3 application</span></p></td><td style="width:12.96%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="text-align:right"><span>16,911</span></p></td></tr><tr><td style="width:7.56%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>28</span></p></td><td style="width:79.48%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Application fee under paragraph</span><span> </span><span>26BD(3)(c) of the Act for an IN1 application</span></p></td><td style="width:12.96%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="text-align:right"><span>1,307</span></p></td></tr><tr><td style="width:7.56%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>29</span></p></td><td style="width:79.48%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Evaluation fee under paragraph</span><span> </span><span>26BE(3)(b) of the Act for an IN1 application</span></p></td><td style="width:12.96%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="text-align:right"><span>17,611</span></p></td></tr><tr><td style="width:7.56%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>30</span></p></td><td style="width:79.48%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Application fee under paragraph</span><span> </span><span>26BD(3)(c) of the Act for an IN2 application</span></p></td><td style="width:12.96%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="text-align:right"><span>1,307</span></p></td></tr><tr><td style="width:7.56%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>31</span></p></td><td style="width:79.48%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Evaluation fee under paragraph</span><span> </span><span>26BE(3)(b) of the Act for an IN2 application</span></p></td><td style="width:12.96%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="text-align:right"><span>17,611</span></p></td></tr><tr><td style="width:7.56%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>32</span></p></td><td style="width:79.48%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Application fee under paragraph</span><span> </span><span>26BD(3)(c) of the Act for an IN3 application</span></p></td><td style="width:12.96%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="text-align:right"><span>3,463</span></p></td></tr><tr><td style="width:7.56%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>33</span></p></td><td style="width:79.48%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Evaluation fee under paragraph</span><span> </span><span>26BE(3)(b) of the Act for an IN3 application</span></p></td><td style="width:12.96%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="text-align:right"><span>28,690</span></p></td></tr><tr><td style="width:7.56%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>34</span></p></td><td style="width:79.48%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Application fee under paragraph</span><span> </span><span>26BD(3)(c) of the Act for an IN4 application</span></p></td><td style="width:12.96%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="text-align:right"><span>3,463</span></p></td></tr><tr><td style="width:7.56%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>35</span></p></td><td style="width:79.48%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>Evaluation fee under paragraph</span><span> </span><span>26BE(3)(b) of the Act for an IN4 application</span></p></td><td style="width:12.96%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="text-align:right"><span>28,690</span></p></td></tr></tbody></table> ```