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Fees and charges: summary from 1 July 2020

Version 1.3, November 2020

6 November 2020

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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 $1,160

Therapeutic Goods (Charges) Regulations 2018

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

Application fee $860

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. $490

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.

$490 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 $1,080 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.

Table 9: Permitted ingredients for listed medicines
Application Category Application fee Evaluation fee Schedule 9, Part 4
IN1 $1,110 $14,900 Item 28 and Item 29
IN2 $1,110 $14,900 Item 30 and Item 31
IN3 $2,940 $24,300 Item 32 and Item 33
IN4 $2,940 $24,300 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 $1,160

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.

Table 11: Assessed listed applications
Application Category Application fee Evaluation fee Schedule 9, Part 4
L(A)1 $460 $1,730 Item 22 and Item 23
L(A)2 $1,870 $14,300 Item 24 and Item 25
L(A)3 $1,870 $14,300 Item 26 and Item 27

These fees are in Schedule 9, Therapeutic Goods Regulations 1990

Variations to assessed listed medicines

Table 12: Section 23 applications
Application type Application fee Evaluation fee Schedule 9 Part 4
L(A)CN (section 23) application $810 n/a Item 1F
L(A)C1 (section 23) application $940 $1,090 Item 1D and 1G
L(A)C2 (section 23) application $940 $7,920 Item 1E and 1H

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

Table 13: Section 9D applications
Application type Upfront fee Refund if no evaluation Schedule 9 Part 4
L(A)CN (section 9D) notification request $810 n/a Item 1C
L(A)C1 (section 9D) application $2,030 $1,090 Item 1A, Item 1G
L(A)C2 (section 9D) application $8,860 $7,920 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 $1,520 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.

Table 15: Application and evaluation fees for registered complementary medicines
Application Category Application fee Evaluation fee Schedule 9, Part 4
RCM1 $560 $3,240 Item 12 and Item 13
RCM2 $2,030 $21,700 Item 14 and Item 15
RCM3 $2,030 $21,700 Item 16 and Item 17
RCM4 $2,680 $29,500 Item 18 and Item 19
RCM5 $2,940 $37,600 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 $1,470 n/a Item 5
RCMC2 $770 $4,200 Item 6 and Item 7
RCMC3 $830 $6,570 Item 8 and Item 9
RCMC4 $850 $9,710 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 $830 n/a

Part 2 Item 2CC

Part 2 Item 2CB

RCMC1 $1,470 n/a Part 4 Item 1
RCMC2 $4,980 $4,200 Part 4 Item 2 and Paragraph 43ACA(2)(a)*
RCMC3 $7,390 $6,570 Part 4 Item 3, and Paragraph 43ACA(2)(b)*
RCMC4 $10,500 $9,710 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 $490 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.

$490 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 $1,520 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 $1,680 $4,160 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) $850 $4,160 Item 3(d) and Item 2(a)
N2 application $1,680 $5,910 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) $850 $5,910 Item 3(e) and Item 2(b)
N3 application $2,700 $9,100 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) $1,360 $4,610 Item 3(f) and Item 4(d)
N4 application $3,950 $15,100 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) $1,360 $4,610 Item 3(g) and Item 4(e)
N5 application $5,850 $22,300 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) $1,360 $4,610 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 $1,680 n/a Item 1(f)
C2 (section 23) application $1,680 $4,160 Item 1(g) and Item 2(f)
C3 (section 23) application $1,680 $6,980 Item 1(h) and Item 2(g)
C4 (section 23) application $2,700 $9,100 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 $830 n/a Part 2 Item 2CB and Part 2 Item 2CD
C1 (section 9D) application $1,680 n/a Part 3 Item 5(a)
C2 (section 9D) application $5,850 $4,160 Part 3 Item 5(b) and Paragraph 43AC(2)(a)*
C3 (section 9D) application $8,670 $6,980 Part 3 Item 5(c) and Paragraph 43AC(2)(b)*
C4 (section 9D) application $11,800 $9,100 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 1990n/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 $1,650 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 $8,470 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 where the application relates to a single entry in the register. $490 Item 1A(a)
Application for consent of Secretary to importation into Australia, supply for use in Australia, or exportation from Australia of a medical device that does not conform to the essential principles where the application is for two or more medical devices.

$490 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 $10,900 Item 7A(a), Item 7A(b)(i), Item 7B(a) and Item 7B(b)(i)
51-250 $14,100 Item 7A(b)(ii) and Item 7B(b)(ii)
251-500 $19,200 Item 7A(b)(iii) and Item 7B(b)(iii)
501-1000 $25,400 Item 7A(b)(iv) and Item 7B(b)(iv)
1001-2000 $38,100 Item 7A(b)(v) and Item 7B(b)(v)
2001-3000 $50,800 Item 7A(b)(vi) and Item 7B(b)(iv)
>3000 $76,200 Item 7A(b)(vii) and Item 7B(b)(vii)

These fees are in Schedule 9, Therapeutic Goods Regulations 1990

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