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Fees and charges: summary from 1 July 2021

Version 1.0, June 2021

23 June 2021

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Non-prescription medicines

Non-prescription medicines include:

  • listed medicines
  • assessed listed medicines
  • registered complementary medicines, and
  • registered over-the-counter (OTC) medicines.

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

Listed medicines

Listed medicines are medicines that are not registered, for example:

For listed export-only medicines go to Export of therapeutic goods.

Listing applications

The following fees and charges apply to medicines listed under section 26A of the Act.

Table 7: Listing applications
Listed medicine fee or charge Amount Regulation

Annual charge

$1,170

Therapeutic Goods (Charges) Regulations 2018

Item 7(1)(c)(i) and Item 7(2)(c)(i)

Application fee

$870

Therapeutic Goods Regulations 1990, Schedule 9 Part 2

Item 3(b)

Processing fee (variation to an existing listing)

$440

Therapeutic Goods Regulations 1990, Schedule 9 Part 2

Item 2A(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 where the application relates to a single entry in the register.

$500

Therapeutic Goods Regulations 1990, Schedule 9, Part 2

Item 1A(a)

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 where the application relates to two or more entries in the register.

$500 for the first entry

plus $100 for each additional entry

Therapeutic Goods Regulations 1990, Schedule 9, Part 2

Item 1A(b)

These fees are in the Therapeutic Goods (Charges) Regulations 2018 and the Therapeutic Goods Regulations 1990
'The Act' refers to the Therapeutic Goods Act 1989.

Permitted indications

Applications for a new permitted indication have an application fee.

Table 8: Permitted indications
Listed medicine fee or charge Amount Schedule 9, Part 2

Application fee for a new indication to be added to the permitted indication list

$1,090

Item 7C

These fees are in Schedule 9, Therapeutic Goods Regulations 1990

Permitted ingredients

The ingredient application pathway is available for applications related to ingredients (new or variations) in:

  • listed medicines (under section 26A of the Act)
  • assessed listed medicines (under section 26AE of the Act)

An application to vary the permitted ingredients list has both an application fee and an evaluation fee.

For information on application types, see Applications for new substances in listed medicines.

Table 9: Permitted ingredients for listed medicines
Application Category Application fee Evaluation fee Schedule 9, Part 4

IN1

$1,120

$15,100

Item 28 and Item 29

IN2

$1,120

$15,100

Item 30 and Item 31

IN3

$2,970

$24,600

Item 32 and Item 33

IN4

$2,970

$24,600

Item 34 and Item 35

These fees are in Schedule 9, Therapeutic Goods Regulations 1990

Assessed listed medicines

Annual charge for assessed listed medicines

Assessed listed medicines have an annual charge.

Table 10: Annual charge for assessed listed medicines
Annual charge Amount Regulation

Annual charge

$1,170

Part 2 Item 7(1)(c)(i)

Part 2 Item 7(2)(c)(i)

These charges are in the Therapeutic Goods (Charges) Regulations 2018

Assessed listed applications

Applications for assessed listed medicines (under section 26AE of the Act) have both an application fee and an evaluation fee.

For information on application types, see Assessed listed medicines evidence guidelines.

Table 11: Assessed listed applications
Application Category Application fee Evaluation fee Schedule 9, Part 4

L(A)1

$460

$1,750

Item 22 and Item 23

L(A)2

$1,890

$14,500

Item 24 and Item 25

L(A)3

$1,890

$14,500

Item 26 and Item 27

These fees are in Schedule 9, Therapeutic Goods Regulations 1990

Variations to assessed listed medicines

Application made under section 23 of the Act to list a new medicine if:

  • new medicine is a changed from existing listed medicine, and
  • new and existing medicine are separate and distinct, but new medicine is part of same therapeutic group as existing medicine

For information on application types, see Changing a listed or assessed listed medicine, Application types and changes tables.

Table 12: Section 23 applications
Application type Application fee Evaluation fee Schedule 9 Part 4

L(A)CN

$820

n/a

Item 1F

L(A)C1

$950

$1,100

Item 1D and 1G

L(A)C2

$950

$8,000

Item 1E and 1H

These fees are in the Therapeutic Goods Regulations 1990
n/a: not applicable

Request made under subsection 9D of the Act to vary information included in an entry in the ARTG for a listed medicine

For information on application types, see Changing a listed or assessed listed medicine, Application types and changes tables.

Table 13: Section 9D applications
Application type Upfront fee Refund if no evaluation Schedule 9 Part 4

L(A)CN notification request

$820

n/a

Item 1C

L(A)C1 application

$2,050

$1,100

Item 1A, Item 1G

L(A)C2 application

$8,950

$8,000

Item 1B, Item 1H

These fees are in the Therapeutic Goods Regulations 1990
n/a: not applicable

Registered complementary medicines

Annual charges for registered complementary medicines

Registered complementary medicines have an annual charge.

Table 14: Annual charges for registered complementary medicines
Charge Amount Regulation

Annual charge

$1,540

Item 7(1)(a)(i) and Item7(2)(a)(i)

These charges are in the Therapeutic Goods (Charges) Regulations 2018

Application and evaluation fees for registered complementary medicines

Applications for registered complementary medicines have both an application fee and an evaluation fee.

For information on application types, see: Applications for registered complementary medicines

Table 15: Application and evaluation fees for registered complementary medicines
Application Category Application fee Evaluation fee Schedule 9, Part 4

RCM1

$570

$3,270

Item 12 and Item 13

RCM2

$2,050

$21,900

Item 14 and Item 15

RCM3

$2,050

$21,900

Item 16 and Item 17

RCM4

$2,710

$29,800

Item 18 and Item 19

RCM5

$2,970

$38,000

Item 20 and Item 21

These fees are in Schedule 9, Therapeutic Goods Regulations 1990

Variations to registered complementary medicines

Section 23 applications

For applications to change registered complementary medicines made under section 23 of the Therapeutic Goods Act 1989, there is an application fee and an evaluation fee for RCMC2, RCMC3 and RCMC4 applications.

For information on application types, go to the Australian Regulatory Guidelines for Listed Medicines and Registered Complementary Medicines (ARGLMRCM).

Table 16: Section 23 application to change registered complementary medicines
RCM change application category Application fee Evaluation fee Schedule 9, Part 4

RCMC1

$1,490

n/a

Item 5

RCMC2

$780

$4,240

Item 6 and Item 7

RCMC3

$840

$6,640

Item 8 and Item 9

RCMC4

$860

$9,810

Item 10 and Item 11

These fees are in Schedule 9, Therapeutic Goods Regulations 1990
n/a: not applicable

Section 9D applications

For applications to change registered complementary medicines made under section 9D of the Therapeutic Goods Act 1989, there is an application fee and a refund if no evaluation occurs for RCMC2, RCMC3 and RCMC4 applications.

For information on application types, go to the Australian Regulatory Guidelines for Listed Medicines and Registered Complementary Medicines (ARGLMRCM).

Table 17: Section 9D application to change registered complementary medicines
RCM change application category Upfront fee Refund if no evaluation* Regulation

Notification requests

$840

n/a

Part 2 Item 2CC

Part 2 Item 2CB

RCMC1

$1,490

n/a

Part 4 Item 1

RCMC2

$5,030

$4,240

Part 4 Item 2, and Paragraph 43ACA(2)(a)*

RCMC3

$7,470

$6,640

Part 4 Item 3, and Paragraph 43ACA(2)(b)*

RCMC4

$10,600

$9,810

Part 4 Item 4, and Paragraph 43ACA(2)(c)*

These fees are in Schedule 9, Therapeutic Goods Regulations 1990
* refund amounts are in Division 2 Part 7, Therapeutic Goods Regulations 1990

Other fees

Table 18: Other fees for registered complementary medicines
Type of fee or charge Amount Schedule 9 Part 2

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 where the application relates to a single entry in the register

$500

Item 1A(a)

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 where the application relates to two or more entries in the register.

$500 for the first entry,

plus $100 for each additional entry

Item 1A(b)

These fees are in Schedule 9, Therapeutic Goods Regulations 1990
'The Act' refers to the Therapeutic Goods Act 1989

Registered OTC medicines

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

Annual charges registered OTC medicines

Registered OTC medicines have an annual charge.

Table 19: Annual charges registered OTC medicines
Medicine type Charge Regulation

Registered OTC medicine

$1,540

Item 7(1)(a)(i) and Item7(2)(a)(i)

These charges are in Part 2 of the Therapeutic Goods (Charges) Regulations 2018

New registered OTC medicine applications

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

Table 20: New registered OTC medicine applications
Application type Application fee Evaluation fee Schedule 9 Part 3

N1 application

$1,700

$4,200

Item 1(a) and Item 2(a)

N1 concurrent application per additional application (as described in item 3, Part 3, Schedule 9 of the Regulations)

$860

$4,200

Item 3(d) and Item 2(a)

N2 application

$1,700

$5,970

Item 1(b) and Item 2(b)

N2 concurrent application per additional application (as described in item 3 of Part 3 Schedule 9 of the Regulations)

$860

$5,970

Item 3(e) and Item 2(b)

N3 application

$2,730

$9,200

Item 1(c) and Item 2(c)

N3 concurrent application per additional application (as described in item 3 and 4 of Part 3 Schedule 9 of the Regulations)

$1,370

$4,660

Item 3(f) and Item 4(d)

N4 application

$3,990

$15,300

Item 1(d) and Item 2(d)

N4 concurrent application per additional application (as described in item 3 and 4 of Part 3 Schedule 9 of the Regulations)

$1,370

$4,660

Item 3(g) and Item 4(e)

N5 application

$5,910

$22,500

Item 1(e) and Item 2(e)

N5 concurrent application per additional application (as described in item 3 and 4 of Part 3 Schedule 9 of the Regulations)

$1,370

$4,660

Item 3(h) and Item 4(f)

These fees are in Schedule 9, Therapeutic Goods Regulations 1990

Section 23 application to change registered OTC medicines

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.

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

Table 21: Section 23 application to change registered OTC medicines
Application type Application fee Evaluation fee Schedule 9 Part 3

C1 (section 23) application

$1,700

n/a

Item 1(f)

C2 (section 23) application

$1,700

$4,200

Item 1(g) and Item 2(f)

C3 (section 23) application

$1,700

$7,050

Item 1(h) and Item 2(g)

C4 (section 23) application

$2,730

$9,200

Item 1(i) and Item 2(h)

These fees are in Schedule 9, Therapeutic Goods Regulations 1990
n/a: not applicable

Section 9D application to change registered OTC medicines

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.

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

Table 22: Section 9D application to change registered OTC medicines
Application type Upfront Fee Refund if no evaluation* Regulation

CN (section 9D) notification request

$840

n/a

Part 2 Item 2CB and Part 2 Item 2CD

C1 (section 9D) application

$1,700

n/a

Part 3 Item 5(a)

C2 (section 9D) application

$5,910

$4,200

Part 3 Item 5(b) and Paragraph 43AC(2)(a)*

C3 (section 9D) application

$8,760

$7,050

Part 3 Item 5(c) and Paragraph 43AC(2)(b)*

C4 (section 9D) application

$11,900

$9,200

Part 3 Item 5(d) and Paragraph 43AC(2)(c)*

These fees are in Schedule 9, Therapeutic Goods Regulations 1990
* refund amounts are in Division 2 Part 7, Therapeutic Goods Regulations 1990
n/a: not applicable

Other fees for registered OTC medicines

Table 23: Other fees for registered OTC medicines
Registered OTC medicine request Fee 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

$1,670

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

$8,560

Item 7(b)

Application for consent by the Secretary under sections 14 and 14A of the Act to the import, export or supply a therapeutic good that does not comply with an applicable standard where the application relates to a single entry in the register.

$500

Item 1A(a)

Application for consent by the Secretary under sections 14 and 14A of the Act to import, export or supply in Australia, a therapeutic goods that do not comply with an applicable standard where the application is for two or more therapeutic goods.

$500 for the first entry,

plus $100 for each additional entry

Item 1A(b)

These fees are in Schedule 9, Therapeutic Goods Regulations 1990
'The Act' refers to the Therapeutic Goods Act 1989

New substances

This is an old provision from 2005 that remains in the Therapeutic Goods Regulations 1990 at R16GA that is now infrequently used. This pathway is still available for applications for:

  • a new substance in a listed medicine
  • a new substance for registered medicines
  • multiple new excipients in listed or registered medicines for dermal use.

There are evaluation fees, but no application fees for new substance applications.

Table 24: New substances
Pages of nonclinical and clinical data Evaluation fee Schedule 9, Part 2

0-50

$11,000

Item 7A(a), Item 7A(b)(i), Item 7B(a) and Item 7B(b)(i)

51-250

$14,200

Item 7A(b)(ii) and Item 7B(b)(ii)

251-500

$19,400

Item 7A(b)(iii) and Item 7B(b)(iii)

501-1000

$25,700

Item 7A(b)(iv) and Item 7B(b)(iv)

1001-2000

$38,500

Item 7A(b)(v) and Item 7B(b)(v)

2001-3000

$51,300

Item 7A(b)(vi) and Item 7B(b)(iv)

>3000

$77,000

Item 7A(b)(vii) and Item 7B(b)(vii)

These fees are in Schedule 9, Therapeutic Goods Regulations 1990

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