Fees and charges: summary - from 4 December 2017

Version 2.2, December 2017

Book pagination

4 December 2017

Non-prescription medicines

Non-prescription medicines include complementary medicines, sunscreens and over-the-counter (OTC) medicines.

For clinical trials supplying unapproved non-prescription medicines, go to Clinical trials.

Listed medicines

Listed medicines include listed complementary medicines and sunscreens.

For listed export-only medicines go to Export.

Listed medicine fee or charge Amount Legislation
Annual charge $1,020 Therapeutic Goods (Charges) Regulations 1990, regulations 3(1)(c)(i) and 3(1A)(c)(i)
Application fee $800 Therapeutic Goods Regulations 1990, Schedule 9, Part 2, Item 3(b)
Processing fee (variation to an existing listing) $410 Therapeutic Goods Regulations 1990, Schedule 9, Part 2, Item 2A(c)
Application for consent by the Secretary under sections 14 and 14A of the Act to the import, export or supply of therapeutic goods that do not comply with an applicable standard $460 Item 1A
'The Act' refers to the Therapeutic Goods Act 1989.

New substances

There is no application fee for a new substance.

The evaluation fees below apply to:

  • a new substance for listed medicines
  • a new substance for registered non-prescription medicines
  • multiple new excipients in listed or registered non-prescription medicines for dermal use.

These fees are in Schedule 9, Therapeutic Goods Regulations 1990.

Pages of nonclinical and clinical data Evaluation fee Item in Schedule 9 Part 2
0-50 $10,300 Items 7A(a), 7A(b)(i), 7B(a), 7B(b)(i)
51-250 $13,200 Items 7A(b)(ii), 7B(b)(ii)
251-500 $18,100 Items 7A(b)(iii), 7B(b)(iii)
501-1000 $23,900 Items 7A(b)(iv), 7B(b)(iv)
1001-2000 $35,900 Items 7A(b)(v), 7B(b)(v)
2001-3000 $47,900 Items 7A(b)(vi), 7B(b)(vi)
>3000 $71,800 Items 7A(b)(vii), 7B(b)(vii)

Registered complementary medicines

Refer to the Australian Regulatory Guidelines for Complementary Medicines (ARGCM) for information on the data package required for an application for a registered complementary medicine.

Charges and application, notification and processing fees

Type of fee or charge Amount Legislation
Annual charge $1,430 Regulation 3(1)(a)(i), Therapeutic Goods (Charges) Regulations 1990
Application fee $1,530 Item 2(a), Part 2, Schedule 9, Therapeutic Goods Regulations 1990
Additional or concurrent application fee $680 Item 2(f), Part 2, Schedule 9, Therapeutic Goods Regulations 1990
Processing fee for variation $1,530 Item 2A(b), Part 2, Schedule 9, Therapeutic Goods Regulations 1990
Notification requests $780 Items 2CC and 2CB, Part 2, Schedule 9, Therapeutic Goods Regulations 1990
Application for consent by the Secretary under sections 14 and 14A of the Act to the import, export or supply of therapeutic goods that do not comply with an applicable standard $460 Item 1A, Part 2, Schedule 9, Therapeutic Goods Regulations 1990

Evaluation fees for registered complementary medicines

These evaluation fees are for registered complementary medicines. These fees are in Schedule 9, Therapeutic Goods Regulations 1990.

Pages of nonclinical and clinical data Evaluation fee Item in Schedule 9 Part 2
0-50 pages for a new product $10,300 Items 5(a) and 5(b)(i)
0-50 pages for a variation under section 9D(1), 9D(2) or 9D(3) of the Therapeutic Goods Act 1989 $3,710 Items 5(c) and 5(d)(i)
51-250 $13,200 Items 5(b)(ii) and 5(d)(ii)
251-500 $18,100 Items 5(b)(iii) and 5(d)(iii)
501-1000 $23,900 Items 5(b)(iv) and 5(d)(iv)
1001-2000 $35,900 Items 5(b)(v) and 5(d)(v)
2001-3000 $47,900 Items 5(b)(vi) and 5(d)(vi)
>3000 $71,800 Items 5(b)(vii) and 5(d)(vii)

Registered OTC medicines

For guidance on OTC applications, go to Australian regulatory guidelines for OTC medicines.

Annual charges

These charges are in the Therapeutic Goods (Charges) Regulations 1990.

Medicine type Charge Regulation
Registered OTC medicine $1,430 Regulations 3(1)(a)(i) and 3(1A)(a)(i)

New registered OTC medicine applications

These fees are in Schedule 9, Therapeutic Goods Regulations 1990.

For information on application types, go to OTC application categorisation framework.

Application type Application fee Evaluation fee Item in Schedule 9 Part 3
N1 application $1,590 $3,930 Items 1(a) and 2(a)
N1 concurrent application per additional application (as described in item 3, Part 3, Schedule 9 of the Regulations) $790 $3,930 Items 3(d) and 2(a)
N2 application $1,590 $5,570 Items 1(b) and 2(b)
N2 concurrent application per additional application (as described in item 3 of Part 3 Schedule 9 of the Regulations) $790 $5,570 Items 3(e) and 2(b)
N3 application $2,550 $8,590 Items 1(c) and 2(c)
N3 concurrent application per additional application (as described in item 3 and 4 of Part 3 Schedule 9 of the Regulations) $1,280 $4,350 Item 3(f) and 4(d)
N4 application $3,720 $14,200 Items 1(d)and 2(d)
N4 concurrent application per additional application (as described in item 3 and 4 of Part 3 Schedule 9 of the Regulations) $1,280 $4,350 Items 3(g)and 4(e)
N5 application $5,520 $21,100 Items 1(e) and 2(e)
N5 concurrent application per additional application (as described in item 3 and 4 of Part 3 Schedule 9 of the Regulations) $1,280 $4,350 Items 3(h) and 4(f)

Changes: applications under section 23

For applications to change registered OTC medicines made under section 23 of the Therapeutic Goods Act 1989, there is an application fee and an evaluation fee for C2, C3 and C4 applications.

These fees are in Schedule 9, Therapeutic Goods Regulations 1990.

For information on application types, go to OTC application categorisation framework.

Application type Application fee Evaluation fee Item in Schedule 9 Part 3
C1 (section 23) application $1,590 n/a Item 1(f)
C2 (section 23) application $1,590 $3,930 Items 1(g) and 2(f)
C3 (section 23) application $1,590 $6,580 Items 1(h) and 2(g)
C4 (section 23) application $2,550 $8,590 Items 1(i) and 2(h)

n/a: not applicable

Changes: applications under section 9D

For applications to change registered OTC medicines made under section 9D of the Therapeutic Goods Act 1989, there is a fee and a refund if no evaluation occurs for C2, C3 and C4 applications.

These fees are in Schedule 9, Therapeutic Goods Regulations 1990.

For information on application types, go to OTC application categorisation framework.

Application type Upfront fee Refund if no evaluation Therapeutic Goods Regulations 1990
CN (section 9D) notification request $780 n/a Schedule 9 Part 2 items 2CD and 2CB
C1 (section 9D) application $1,590 n/a Schedule 9 Part 3 Item 5
C2 (section 9D) application $5,520 $3,930

Schedule 9 Part 3 Item 6(a)

Regulation 43AC (2)(a)

C3 (section 9D) application $8,170 $6,580

Schedule 9 Part 3 Item 6(b)

Regulation 43AC (2)(b)

C4 (section 9D) application $11,140 $8,590

Schedule 9 Part 3 Item 6(c)

Regulation 43AC (2)(c)

n/a: not applicable

Other fees

These fees are in Schedule 9, Therapeutic Goods Regulations 1990.

Registered OTC medicine request Fee Item in Schedule 9 Part 3
Request for advice in relation to a registered OTC medicine for the purpose of listing the medicine as a pharmaceutical benefit that does not contain clinical data $1,560 Item 7(a)
Request for advice in relation to a registered OTC medicine for the purpose of listing the medicine as a pharmaceutical benefit that contains clinical data or a justification as to why such data is not needed $7,990 Item 7(b)
Application for consent by the Secretary under sections 14 and 14A of the Act to the import, export or supply of therapeutic goods that do not comply with an applicable standard $460 Item 1A

The 'Act' refers to the Therapeutic Goods Act 1989.

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