Commonwealth Consolidated Regulations Commonwealth Consolidated Regulations(regulation 43)
(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
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
The following table sets out particular fees other than fees for applications, evaluations and requests covered by Part 3 or 4.
Column 1 | Column 2 | Column 3
|
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 | 540 (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 | 540 for the first entry plus 108 for each additional entry |
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 | 1,954 |
| (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 | 24,285 |
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 | 537 |
| (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 | 6,628 |
1AA | Application fee for the purposes of paragraph 22C(2)(b) of the Act for an application under subsection 22C(1) of the Act | 14,140 |
1AB | Application fee for the purposes of paragraph 22E(4)(c) of the Act for an application under subsection 22E(3) of the Act | 5,127 |
1ABA | Fee for the purposes of paragraph 22G(8)(b) of the Act for a request under section 22G of the Act | 9,347 |
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 | 54,399 |
| (b) if the application relates to a new indications medicine | 32,489 |
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 | 283,870 |
| (b) if the evaluation relates to a new indications medicine | 187,268 |
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 | 32,381 |
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 | 136,538 |
1AG | Application fee for the purposes of paragraph 29(5)(d) of the Act for an application under subsection 29(4) of the Act | 19,537 |
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 | 14,140 |
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 | 54,292 |
| (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 | 18,025 |
| (bc) for an application relating to a medicine in relation to which an evaluation fee is payable under subparagraph (aa)(iii) of item 4 | 36,158 |
| (bca) for an application relating to a medicine in relation to which an evaluation fee is payable under paragraph (ab) of item 4 | 57,530 |
| (bcb) for an application relating to a medicine in relation to which an evaluation fee is payable under paragraph (ac) of item 4 | 1,241 |
| (bd) for an application relating to a medicine in relation to which an evaluation fee is payable under paragraph (b) of item 4 | 32,381 |
| (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 | 10,761 |
| (ii) a major variation | 7,026 |
| (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 | 21,695 |
| (ii) a major variation | 14,032 |
| (bfa) for an application relating to a medicine in relation to which an evaluation fee is payable under paragraph (bd) of item 4 | 34,215 |
| (bg) for an application relating to a medicine in relation to which an evaluation fee is payable under paragraph (c) of item 4 | 20,939 |
| (bh) for an application relating to a medicine in relation to which an evaluation fee is payable under paragraph (d) of item 4 | 3,421 |
| (bi) for an application relating to a medicine in relation to which an evaluation fee is payable under paragraph (g) of item 4 | 21,156 |
| (bj) for an application relating to a medicine in relation to which an evaluation fee is payable under paragraph (h) of item 4 | 1,241 |
| (bk) for an application relating to a medicine in relation to which an evaluation fee is payable under paragraph (bc) of item 4 | 1,241 |
| (c) subject to paragraph (d), for an application in any other case | 4,943 |
| (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 | 2,461--for each additional application, up to a maximum amount payable of 14,356 (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 | 1,900 |
| (b) a listed medicine | 474 |
| (c) a disinfectant | 1,400 |
| (d) a Class 3 or Class 4 IVD medical device that is not covered by paragraph (g) | 1,750 |
| (e) an IVD medical device that is not: (i) a Class 3 or Class 4 IVD medical device; and (ii) covered by paragraph (g) | 1,000 |
| (f) a medical device that is not: (i) an IVD medical device; and (ii) covered by paragraph (g) | 1,000 |
| (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 | 190 per 10 entries (or part thereof) |
2AC | Application fee for an application under subsection 9D(3) of the Act to which regulation 16D applies | 1,241 |
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 | 6,195 |
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 | 4,954 |
2CA | Evaluation fee in relation to an application under subsection 9D(2) of the Act, for the evaluation of data--for each submission | 6,195 |
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 | 907 |
| (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 | 907 |
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 | 907 |
| (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--907; and (b) for any other entry--907 |
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 | 2,200 |
| (b) a medicine | 939 |
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 | 474 |
| (b) if the notice and declaration relate to 6 or more entries in the Register | 474 for the first 5 entries plus 54 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) | 217,598 |
| (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 | 72,641 |
| (ii) documentation relating to pre - clinical studies; or | 72,641 |
| (iii) documentation mentioned in subparagraphs (i) and (ii) | 144,742 |
| (ab) a new prescription medicine in relation to which a therapeutic goods (priority applicant) determination is in force | 230,118 |
| (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 | 4,954 |
| (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) | 129,091 |
| (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--43,066 (b) a major variation--27,955 |
| (ii) documentation relating to pre - clinical studies; or | for an evaluation relating to: (a) an extension of indications--43,066 (b) a major variation--27,955 |
| (iii) documentation mentioned in subparagraphs (i) and (ii) | for an evaluation relating to: (a) an extension of indications--86,024 (b) a major variation--56,235 |
| (bc) an extension of indications that is the subject of an application to which regulation 16G applies | 4,954 |
| (bd) a new indications medicine in relation to which a therapeutic goods (priority applicant) determination is in force | 136,862 |
| (c) a new generic product | 83,110 |
| (d) an additional trade name | 13,600 |
| (g) a major variation (that is not a variation mentioned in any of paragraphs (a) to (d)) | 84,189 |
| (h) a minor variation (that is not a variation mentioned in any of paragraphs (a) to (d)) | 4,954 |
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 | 723 |
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) | 777 |
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 | 2,764 |
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) | 1,306 |
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 | 4,155 |
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; | 173 |
| (b) if the request relates to more than one registration or listing | 173 for the first registration or listing plus 54 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; | 173 |
| (b) if the request relates to more than one registration or listing | 173 for the first registration or listing plus 54 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) | 9,023 |
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 | 11,873 |
| (b) over 50 pages, but not over 250 pages | 15,327 |
| (c) over 250 pages, but not over 500 pages | 20,939 |
| (d) over 500 pages, but not over 1 000 pages | 27,739 |
| (e) over 1 000 pages, but not over 2 000 pages | 41,555 |
| (f) over 2 000 pages, but not over 3 000 pages | 55,371 |
| (g) over 3 000 pages | 83,110 |
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: | 11,873 |
| (i) not over 50 pages | 11,873 |
| (ii) over 50 pages, but not over 250 pages | 15,327 |
| (iii) over 250 pages, but not over 500 pages | 20,939 |
| (iv) over 500 pages, but not over 1 000 pages | 27,739 |
| (v) over 1 000 pages, but not over 2 000 pages | 41,555 |
| (vi) over 2 000 pages, but not over 3 000 pages | 55,371 |
| (vii) over 3 000 pages | 83,110 |
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: | 11,873 |
| (i) not over 50 pages | 11,873 |
| (ii) over 50 pages, but not over 250 pages | 15,327 |
| (iii) over 250 pages, but not over 500 pages | 20,939 |
| (iv) over 500 pages, but not over 1 000 pages | 27,739 |
| (v) over 1 000 pages, but not over 2 000 pages | 41,555 |
| (vi) over 2 000 pages, but not over 3 000 pages | 55,371 |
| (vii) over 3 000 pages | 83,110 |
7C | Application fee for the purposes of paragraph 26BJ(2)(d) of the Act | 1,176 |
8 | (a) Application fee for the purposes of paragraph 37(1)(g) of the Act, for a licence for: | 885 |
| (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: | 1,155 |
| (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 | 855 |
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 | 855 |
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 | 855 |
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: | 1,101 |
| (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) | 1,543 |
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 | 755 |
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 | 1,026 |
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 | 755 |
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 | 755 |
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 | 1,490 |
| (b) over 10 pages, but not over 50 pages | 12,628 |
| (c) over 50 pages, but not over 100 pages | 28,494 |
| (d) over 100 pages, but not over 1 000 pages | 38,317 |
| (e) over 1 000 pages, but not over 3 000 pages | 59,688 |
| (f) over 3 000 pages, but not over 4 000 pages | 79,548 |
| (g) over 4 000 pages | 97,033 |
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 | 195 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 | 410 |
| (b) for each notification of an additional trial site or additional trial sites | 410 |
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 | 2,504 |
Part 3 -- Table of fees for applications etc. in relation to certain OTC medicines
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.
Fees | |||
Column 1 | Column 2 | Column 3 | |
1 | Application fee under paragraph 23B(2)(b) of the Act: |
| |
| (a) for an N1 application | 1,835 | |
| (b) for an N2 application | 1,835 | |
| (c) for an N3 application | 2,947 | |
| (d) for an N4 application | 4,307 | |
| (e) for an N5 application | 6,379 | |
| (f) for a C1 (section 23) application | 1,835 | |
| (g) for a C2 (section 23) application | 1,835 | |
| (h) for a C3 (section 23) application | 1,835 | |
| (i) for a C4 (section 23) application | 2,947 | |
2 | Evaluation fee under subsection 24(1A) of the Act: |
| |
| (a) for an N1 application | 4,533 | |
| (b) for an N2 application | 6,444 | |
| (c) for an N3 application | 9,930 | |
| (d) for an N4 application | 16,514 | |
| (e) for an N5 application | 24,285 | |
| (f) for a C2 (section 23) application | 4,533 | |
| (g) for a C3 (section 23) application | 7,609 | |
| (h) for a C4 (section 23) application | 9,930 | |
3 | If, at the time a person submits an application of a kind mentioned in paragraph (a), (b), (c), (d) or (e) of item 1: |
| |
| (a) the person also submits an additional application or applications of the same kind; and |
| |
| (b) each application relates to goods that contain the same therapeutically active ingredient; and |
| |
| (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; |
| |
| the application fee under paragraph 23B(2)(b) of the Act for each additional application is: |
| |
| (d) for an additional N1 application | 928 | |
| (e) for an additional N2 application | 928 | |
| (f) for an additional N3 application | 1,479 | |
| (g) for an additional N4 application | 1,479 | |
| (h) for an additional N5 application | 1,479 | |
4 | If, at the time a person submits an application of a kind mentioned in paragraph (c), (d) or (e) of item 2: |
| |
| (a) the person also submits an additional application or applications of the same kind; and |
| |
| (b) each application relates to goods that contain the same therapeutically active ingredient; and |
| |
| (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; |
| |
| the evaluation fee under subsection 24(1A) of the Act for each additional application is: |
| |
| (d) for an additional N3 application | 5,030 | |
| (e) for an additional N4 application | 5,030 | |
| (f) for an additional N5 application | 5,030 | |
5 | Application fee under paragraph 9D(7)(f) of the Act, for any of the following requests in relation to up to 20 entries in the Register: |
| |
| (a) a C1 (section 9D) application | 1,835 | |
| (b) a C2 (section 9D) application | 6,379 | |
| (c) a C3 (section 9D) application | 9,455 | |
| (d) a C4 (section 9D) application | 12,844 | |
7 | 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: |
| |
| (a) if the request does not contain clinical data | 1,802 | |
| (b) if the request contains clinical data or a justification as to why such data is not needed | 9,240 | |
The following table sets out particular fees for applications, evaluations and requests in relation to certain medicines.
Fees | ||
Item | Column 1 Matter | Column 2 Fee $ |
1A | Application fee under paragraph 9D(7)(f) of the Act for an L(A)C1 (section 9D) request | 2,212 |
1B | Application fee under paragraph 9D(7)(f) of the Act for an L(A)C2 (section 9D) request | 9,661 |
1C | Application fee under paragraph 9D(7)(f) of the Act for an L(A)CN (section 9D) request | 885 |
1D | Application fee under paragraph 23B(2)(b) of the Act for an L(A)C1 (section 23) application | 1,026 |
1E | Application fee under paragraph 23B(2)(b) of the Act for an L(A)C2 (section 23) application | 1,026 |
1F | Application fee under paragraph 23B(2)(b) of the Act for an L(A)CN (section 23) application | 885 |
1G | Evaluation fee under subsection 26AC(2) of the Act for an L(A)C1 (section 23) application | 1,188 |
1H | Evaluation fee under subsection 26AC(2) of the Act for an L(A)C2 (section 23) application | 8,635 |
1 | Application fee under paragraph 9D(7)(f) of the Act for an RCMC1 (section 9D) request | 1,609 |
2 | Application fee under paragraph 9D(7)(f) of the Act for an RCMC2 (section 9D) request | 5,429 |
3 | Application fee under paragraph 9D(7)(f) of the Act for an RCMC3 (section 9D) request | 8,063 |
4 | Application fee under paragraph 9D(7)(f) of the Act for an RCMC4 (section 9D) request | 11,442 |
5 | Application fee under paragraph 23B(2)(b) of the Act for an RCMC1 (section 23) application | 1,609 |
6 | Application fee under paragraph 23B(2)(b) of the Act for an RCMC2 (section 23) application | 842 |
7 | Evaluation fee under subsection 24(1A) of the Act for an RCMC2 (section 23) application | 4,576 |
8 | Application fee under paragraph 23B(2)(b) of the Act for an RCMC3 (section 23) application | 907 |
9 | Evaluation fee under subsection 24(1A) of the Act for an RCMC3 (section 23) application | 7,167 |
10 | Application fee under paragraph 23B(2)(b) of the Act for an RCMC4 (section 23) application | 928 |
11 | Evaluation fee under subsection 24(1A) of the Act for an RCMC4 (section 23) application | 10,588 |
12 | Application fee under paragraph 23B(2)(b) of the Act for an RCM1 application | 615 |
13 | Evaluation fee under subsection 24(1A) of the Act for a RCM1 application | 3,529 |
14 | Application fee under paragraph 23B(2)(b) of the Act for an RCM2 application | 2,212 |
15 | Evaluation fee under subsection 24(1A) of the Act for a RCM2 application | 23,637 |
16 | Application fee under paragraph 23B(2)(b) of the Act for an RCM3 application | 2,212 |
17 | Evaluation fee under subsection 24(1A) of the Act for a RCM3 application | 23,637 |
18 | Application fee under paragraph 23B(2)(b) of the Act for an RCM4 application | 2,925 |
19 | Evaluation fee under subsection 24(1A) of the Act for a RCM4 application | 32,165 |
20 | Application fee under paragraph 23B(2)(b) of the Act for an RCM5 application | 3,205 |
21 | Evaluation fee under subsection 24(1A) of the Act for a RCM5 application | 41,015 |
22 | Application fee under paragraph 23B(2)(b) of the Act for an L(A)1 application | 497 |
23 | Evaluation fee under subsection 26AC(2) of the Act for an L(A)1 application | 1,889 |
24 | Application fee under paragraph 23B(2)(b) of the Act for an L(A)2 application | 2,040 |
25 | Evaluation fee under subsection 26AC(2) of the Act for an L(A)2 application | 15,651 |
26 | Application fee under paragraph 23B(2)(b) of the Act for an L(A)3 application | 2,040 |
27 | Evaluation fee under subsection 26AC(2) of the Act for an L(A)3 application | 15,651 |
28 | Application fee under paragraph 26BD(3)(c) of the Act for an IN1 application | 1,209 |
29 | Evaluation fee under paragraph 26BE(3)(b) of the Act for an IN1 application | 16,299 |
30 | Application fee under paragraph 26BD(3)(c) of the Act for an IN2 application | 1,209 |
31 | Evaluation fee under paragraph 26BE(3)(b) of the Act for an IN2 application | 16,299 |
32 | Application fee under paragraph 26BD(3)(c) of the Act for an IN3 application | 3,205 |
33 | Evaluation fe e under paragraph 26BE(3)(b) of the Act for an IN3 application | 26,552 |
34 | Application fee under paragraph 26BD(3)(c) of the Act for an IN4 application | 3,205 |
35 | Evaluation fee under paragraph 26BE(3)(b) of the Act for an IN4 application | 26,552 |