Therapeutic Goods Regulations 1990

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

611 (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

611 for the first entry plus 123 for each additional entry

(c) for an application relating to goods to which no entry in the Register relates

4,015

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

2,212

(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

27,500

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

608

(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

7,506

1AA

Application fee for the purposes of paragraph 22C(2)(b) of the Act for an application under subsection 22C(1) of the Act

16,012

1AB

Application fee for the purposes of paragraph 22E(4)(c) of the Act for an application under subsection 22E(3) of the Act

5,806

1ABA

Fee for the purposes of paragraph 22G(8)(b) of the Act for a request under section 22G of the Act

10,584

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

61,600

(b) if the application relates to a new indications medicine

36,790

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

321,446

(b) if the evaluation relates to a new indications medicine

212,057

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

36,667

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

154,611

1AG

Application fee for the purposes of paragraph 29(5)(d) of the Act for an application under subsection 29(4) of the Act

22,123

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

16,012

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

61,479

(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

20,411

(bc) for an application relating to a medicine in relation to which an evaluation fee is payable under subparagraph (aa)(iii) of item 4

40,943

(bca) for an application relating to a medicine in relation to which an evaluation fee is payable under paragraph (ab) of item 4

65,145

(bcb) for an application relating to a medicine in relation to which an evaluation fee is payable under paragraph (ac) of item 4

1,405

(bd) for an application relating to a medicine in relation to which an evaluation fee is payable under paragraph (b) of item 4

36,667

(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

12,186

(ii) a major variation

7,955

(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

24,567

(ii) a major variation

15,890

(bfa) for an application relating to a medicine in relation to which an evaluation fee is payable under paragraph (bd) of item 4

38,744

(bg) for an application relating to a medicine in relation to which an evaluation fee is payable under paragraph (c) of item 4

23,711

(bh) for an application relating to a medicine in relation to which an evaluation fee is payable under paragraph (d) of item 4

3,874

(bi) for an application relating to a medicine in relation to which an evaluation fee is payable under paragraph (g) of item 4

23,956

(bj) for an application relating to a medicine in relation to which an evaluation fee is payable under paragraph (h) of item 4

1,405

(bk) for an application relating to a medicine in relation to which an evaluation fee is payable under paragraph (bc) of item 4

1,405

(c) subject to paragraph (d), for an application in any other case

5,597

(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

2,787—for each additional application, up to a maximum amount payable of 16,257 (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

2,152

(b) a listed medicine

537

(c) a disinfectant

1,586

(d) a Class 3 or Class 4 IVD medical device that is not covered by paragraph (g)

1,982

(e) an IVD medical device that is not:

(i) a Class 3 or Class 4 IVD medical device; and

(ii) covered by paragraph (g)

1,133

(f) a medical device that is not:

(i) an IVD medical device; and

(ii) covered by paragraph (g)

1,133

(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

215 per 10 entries (or part thereof)

2AC

Application fee for an application under subsection 9D(3) of the Act to which regulation 16D applies

1,405

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

7,015

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

5,610

2CA

Evaluation fee in relation to an application under subsection 9D(2) of the Act, for the evaluation of data—for each submission

7,015

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

1,027

(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

1,027

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

1,027

(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—1,027; and

(b) for any other entry—1,027

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

2,491

(b) a medicine

1,063

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

537

(b) if the notice and declaration relate to 6 or more entries in the Register

537 for the first 5 entries plus 62 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)

246,401

(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

82,256

(ii) documentation relating to pre‑clinical studies; or

82,256

(iii) documentation mentioned in subparagraphs (i) and (ii)

163,901

(ab) a new prescription medicine in relation to which a therapeutic goods (priority applicant) determination is in force

260,579

(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

5,610

(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)

146,178

(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—48,767

(b) a major variation—31,656

(ii) documentation relating to pre‑clinical studies; or

for an evaluation relating to:

(a) an extension of indications—48,767

(b) a major variation—31,656

(iii) documentation mentioned in subparagraphs (i) and (ii)

for an evaluation relating to:

(a) an extension of indications—97,411

(b) a major variation—63,679

(bc) an extension of indications that is the subject of an application to which regulation 16G applies

5,610

(bd) a new indications medicine in relation to which a therapeutic goods (priority applicant) determination is in force

154,978

(c) a new generic product

94,111

(d) an additional trade name

15,400

(g) a major variation (that is not a variation mentioned in any of paragraphs (a) to (d))

95,333

(h) a minor variation (that is not a variation mentioned in any of paragraphs (a) to (d))

5,610

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

818

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)

880

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

3,130

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)

1,479

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

4,704

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;

196

(b) if the request relates to more than one registration or listing

196 for the first registration or listing plus 62 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;

196

(b) if the request relates to more than one registration or listing

196 for the first registration or listing plus 62 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)

10,217

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

13,445

(b) over 50 pages, but not over 250 pages

17,356

(c) over 250 pages, but not over 500 pages

23,711

(d) over 500 pages, but not over 1 000 pages

31,411

(e) over 1 000 pages, but not over 2 000 pages

47,055

(f) over 2 000 pages, but not over 3 000 pages

62,700

(g) over 3 000 pages

94,111

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:

13,445

(i) not over 50 pages

13,445

(ii) over 50 pages, but not over 250 pages

17,356

(iii) over 250 pages, but not over 500 pages

23,711

(iv) over 500 pages, but not over 1 000 pages

31,411

(v) over 1 000 pages, but not over 2 000 pages

47,055

(vi) over 2 000 pages, but not over 3 000 pages

62,700

(vii) over 3 000 pages

94,111

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:

13,445

(i) not over 50 pages

13,445

(ii) over 50 pages, but not over 250 pages

17,356

(iii) over 250 pages, but not over 500 pages

23,711

(iv) over 500 pages, but not over 1 000 pages

31,411

(v) over 1 000 pages, but not over 2 000 pages

47,055

(vi) over 2 000 pages, but not over 3 000 pages

62,700

(vii) over 3 000 pages

94,111

7C

Application fee for the purposes of paragraph 26BJ(2)(d) of the Act

1,331

8

(a) Application fee for the purposes of paragraph 37(1)(g) of the Act, for a licence for:

1,003

(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:

1,308

(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

1,003

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

1,003

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

1,003

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:

1,247

(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)

1,748

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

854

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

1,161

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

854

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

854

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

1,687

(b) over 10 pages, but not over 50 pages

14,300

(c) over 50 pages, but not over 100 pages

32,266

(d) over 100 pages, but not over 1 000 pages

43,389

(e) over 1 000 pages, but not over 3 000 pages

67,589

(f) over 3 000 pages, but not over 4 000 pages

90,078

(g) over 4 000 pages

109,878

9B

Fee for application for approval of a master file or approval of an annual update of a master file under clause 3 of Schedule 5A, where the total number of pages of the file is:

(a) not over 10 pages

1,687

(b) over 10 pages, but not over 50 pages

14,300

(c) over 50 pages, but not over 100 pages

32,266

(d) over 100 pages, but not over 1,000 pages

43,389

(e) over 1,000 pages, but not over 3,000 pages

67,589

(f) over 3,000 pages, but not over 4,000 pages

90,078

(g) over 4,000 pages

109,878

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

221 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

464

(b) for each notification of an additional trial site or additional trial sites

464

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

2,836