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Fees and charges: summary from 1 July 2019

Version 1.1, July 2019

25 July 2019

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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.

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 Legislation
Annual charge $1,140

Therapeutic Goods (Charges) Regulations 2018

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

Application fee $840

Therapeutic Goods Regulations 1990, Schedule 9 Part 2

Item 3(b)

Processing fee (variation to an existing listing) $430

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 $480

Therapeutic Goods Regulations 1990, Schedule 9 Part 2

Item 1A

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 indication list

Applications for a new permitted indication have an application fee.

Table 8: Permitted indication list
Listed medicine fee or charge Amount Schedule 9, Part 2
Application fee for a new indication to be added to the permitted indication list $1,060 Item 7C

These fees are in Schedule 9, Therapeutic Goods Regulations 1990

Permitted ingredients for listed complementary medicines

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

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

The ingredient application pathway is not available for ingredients in:

  • listed medicines that are not complementary medicines, such as sunscreens
  • registered medicines

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

Table 9: Permitted ingredients for listed complementary medicines
Application Category Application fee Evaluation fee Schedule 9, Part 4
IN1 $1,090 $14,600 Item 28 and Item 29
IN2 $1,090 $14,600 Item 30 and Item 31
IN3 $2,880 $23,800 Item 32 and Item 33
IN4 $2,880 $23,800 Item 34 and Item 35

These fees are in Schedule 9, Therapeutic Goods Regulations 1990

Assessed listed complementary medicines

Annual charge for assessed listed medicines

Assessed listed complementary medicines have an annual charge.

Table 10: Annual charge for assessed listed medicines
Annual charge Amount Legislation
Annual charge $1,140 Part 2 Item 7(1)(c)(i) and Part 2 Item 7(2)(c)(i)

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

Assessed listed applications

Applications for assessed listed complementary 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 $450 $1,700 Item 22 and Item 23
L(A)2 $1,830 $14,000 Item 24 and Item 25
L(A)3 $1,830 $14,000 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 $790 n/a Item 1F
L(A)C1 (section 23) application $920 $1,070 Item 1D and 1G
L(A)C2 (section 23) application $920 $7,770 Item 1E and 1H

These fees are in the Therapeutic Goods Regulations 1990

Table 13: Section 9D applications
Application type Upfront fee Refund if no evaluation Schedule 9 Part 4
L(A)CN (section 9D) notification request $790 n/a Item 1C
L(A)C1 (section 9D) application $1,990 $1,070 Item 1A
L(A)C2 (section 9D) application $8,690 $7,770 Item 1B

These fees are in the Therapeutic Goods Regulations 1990

New substances

The new substances application pathway is available for applications for:

  • a new substance in a listed medicine that is not a complementary medicine, such as a sunscreen
  • a new substance for registered non-prescription medicines
  • multiple new excipients in listed or registered non-prescription medicines for dermal use

The new substance application pathway is not available for applications for ingredients in:

  • listed complementary medicines
  • assessed listed complementary medicines

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

Table 14: New substances
Pages of nonclinical and clinical data Evaluation fee Schedule 9, Part 2
0-50 $10,700 Item 7A(a), Item 7A(b)(i), Item 7B(a) and Item7B(b)(i)
51-250 $13,800 Item 7A(b)(ii) and Item 7B(b)(ii)
251-500 $18,800 Item 7A(b)(iii) and Item 7B(b)(iii)
501-1000 $24,900 Item 7A(b)(iv) and Item 7B(b)(iv)
1001-2000 $37,400 Item 7A(b)(v) and Item 7B(b)(v)
2001-3000 $49,800 Item 7A(b)(vi) and Item 7B(b)(vi)
>3000 $74,700 Item 7A(b)(vii) and Item 7B(b)(vii)

These fees are in Schedule 9, Therapeutic Goods Regulations 1990

Registered complementary medicines

Annual charges for registered complementary medicines

Registered complementary medicines have an annual charge.

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

Table 15: Annual charges for registered complementary medicines
Charge Amount Regulation
Annual charge $1,490 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 16: Application and evaluation fees for registered complementary medicines
Application Category Application fee Evaluation fee Item in Schedule 9, Part 4
RCM1 $550 $3,180 Item 12 and Item 13
RCM2 $1,990 $21,300 Item 14 and Item 15
RCM3 $1,990 $21,300 Items 16 and Item 17
RCM4 $2,630 $28,900 Item 18 and Item 19
RCM5 $2,880 $36,900 Item 20 and Item 21

These fees are in Schedule 9, Therapeutic Goods Regulations 1990

Section 23 application to change registered complementary medicines

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 the Australian Regulatory Guidelines for Complementary Medicines (ARGCM).

Table 17: Section 23 application to change registered complementary medicines
RCM change application category Application fee Evaluation fee Schedule 9, Part 4
RCMC1 $1,410 n/a Item 5
RCMC2 $760 $4,120 Item 6 and Item 7
RCMC3 $810 $6,440 Item 8 and Item 9
RCMC4 $830 $9,520 Item 10 and Item 11

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

Section 9D application to change registered complementary medicines

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 Complementary Medicines (ARGCM).

Table 18: Section 9D application to change registered complementary medicines
RCM change application category Upfront fee Refund if no evaluation Item and Part in Schedule 9
Notification requests $810 n/a Part 2, items 2CC and Part 2 Item 2CB
RCMC1 $1,440 n/a Part 4, Item 1
RCMC2 $4,880 $4,120

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

RCMC3 $7,250 $6,440

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

RCMC4 $10,300 $9,520

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 for registered complementary medicines

Table 19: 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 $480 Item 1A

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 Australian regulatory guidelines for OTC medicines.

Annual charges for registered OTC medicines

Registered OTC medicines have an annual charge.

Table 20: Annual charges for registered OTC medicines
Medicine type Charge Regulation
Registered OTC medicine $1,490 Item 7(1)(a)(i) and Item 7(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 21: New registered OTC medicine applications
Application type Application fee Evaluation fee Schedule 9 Part 3
N1 application $1,650 $4,080 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) $830 $4,080 Item 3(d) and Item 2(a)
N2 application $1,650 $5,800 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) $830 $5,800 Item 3(e) and Item 2(b)
N3 application $2,650 $8,930 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) $1,330 $4,520 Item 3(f) and Item 4(d)
N4 application $3,870 $14,800 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) $1,330 $4,520 Item 3(g)and Item 4(e)
N5 application $5,740 $21,900 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) $1,330 $4,520 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 22: Section 23 application to change registered OTC medicines
Application type Application fee Evaluation fee Schedule 9 Part 3
C1 (section 23) application $1,650 n/a Item 1(f)
C2 (section 23) application $1,650 $4,080 Item 1(g) and Item 2(f)
C3 (section 23) application $1,650 $6,850 Item 1(h) and Item 2(g)
C4 (section 23) application $2,650 $8,930 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 23: Section 9D application to change registered OTC medicines
Application type Upfront fee Refund if no evaluation Regulation
CN (section 9D) notification request $810 n/a Part 2 Item 2CB and Part 2 Item 2CD
C1 (section 9D) application $1,650 n/a Part 3 Item 5(a)
C2 (section 9D) application $5,740 $4,080

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

C3 (section 9D) application $8,500 $6,850

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

C4 (section 9D) application $11,600 $8,930

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

for registered OTC medicines

Table 24: 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 $1,620 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 $8,310 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. $480 Item 1A

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

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