Source: https://www.tga.gov.au/book-page/non-prescription-medicines-3
Timestamp: 2019-04-26 01:25:21
Document Index: 772082360

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Fees and charges: summary - from 1 July 2018: Non-prescription medicines | Therapeutic Goods Administration (TGA)
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Fees and charges: summary - from 1 July 2018
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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.
On this page: Listed medicines | Assessed listed complementary medicines | New substances | Registered complementary medicines | Registered OTC medicines
Listed medicines include listed complementary medicines and sunscreens.
For listed export-only medicines go to Export.
The following fees and charges apply to medicines listed under section 26A of the Act.
Listed medicine fee or charge
Annual charge $1,120 Therapeutic Goods (Charges) Regulations 2018, regulations 7(1)(c)(i) and 7(2)(c)(i)
Application fee $820 Therapeutic Goods Regulations 1990, Schedule 9, Part 2, Item 3(b)
Processing fee (variation to an existing listing) $420 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 $470 Item 1A
'The Act' refers to the Therapeutic Goods Act 1989.
Permitted indication list
Applications for a new permitted indication have an application fee, which is in Schedule 9, Therapeutic Goods Regulations 1990.
Item in Schedule 9, Part 2
Application fee for a new indication to be added to the permitted indication list $1,040 Item 7C
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 categories are not available for ingredients in:
listed medicines that are not complementary medicines, such as sunscreens
An application to vary the permitted ingredients list has both an application fee and an evaluation fee. These fees are in Schedule 9, Therapeutic Goods Regulations 1990.
Item in Schedule 9, Part 4
IN1 $1,070 $14,300 Items 28 and 29
IN2 $1,070 $14,300 Items 30 and 31
IN3 $2,820 $23,300 Items 32 and 33
IN4 $2,820 $23,300 Items 34 and 35
Annual charge for assessed listed medicines
Assessed listed applications
Applications for assessed listed complementary medicines (under section 26AE of the Act) have both an application fee and an evaluation fee. These fees are in Schedule 9, Therapeutic Goods Regulations 1990.
L(A)1 $440 $1,670 Items 22 and 23
L(A)2 $1,790 $13,700 Items 24 and 25
L(A)3 $1,790 $13,700 Items 26 and 27
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:
There are evaluation fees, but no application fees for new substance applications. These fees are in Schedule 9, Therapeutic Goods Regulations 1990.
Pages of nonclinical and clinical data
0-50 $10,500 Items 7A(a), 7A(b)(i), 7B(a), 7B(b)(i)
51-250 $13,500 Items 7A(b)(ii), 7B(b)(ii)
251-500 $18,400 Items 7A(b)(iii), 7B(b)(iii)
501-1000 $24,400 Items 7A(b)(iv), 7B(b)(iv)
1001-2000 $36,600 Items 7A(b)(v), 7B(b)(v)
2001-3000 $48,800 Items 7A(b)(vi), 7B(b)(vi)
>3000 $73,200 Items 7A(b)(vii), 7B(b)(vii)
Annual charge $1,460 Regulation 7(1)(a)(i) and 7(2)(a)(i)
Application and evaluation fees for registered complementary medicines
Applications for registered complementary medicines have both an application fee and an evaluation fee. These fees are in Schedule 9, Therapeutic Goods Regulations 1990.
RCM1 $540 $3,120 Items 12 and 13
RCM2 $1,950 $20,900 Items 14 and 15
RCM3 $1,950 $20,900 Items 16 and 17
RCM4 $2,580 $28,300 Items 18 and 19
RCM5 $2,820 $36,200 Items 20 and 21
Changes: applications under section 23
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).
RCM change application category
RCMC1 $1,410 N/A Item 5
RCMC2 $740 $4,040 Items 6 and 7
RCMC3 $790 $6,310 Items 8 and 9
RCMC4 $810 $9,330 Items 10 and 11
Changes: applications under section 9D
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 Australian Regulatory Guidelines for Complementary Medicines (ARGCM).
Refund if no evaluation
Item and Part in Schedule 9
Notification requests $790 N/A Part 2, items 2CC and 2CB
RCMC1 $1,410 N/A Part 4, item 1
RCMC2 $4,780 $4,040
Part 4, item 2
Regulation 43ACA(2)(a)
RCMC3 $7,100 $6,310
Part 4, item 3
Regulation 43ACA(2)(b)
RCMC4 $10,100 $9,330
Part 4, item 4
Regulation 43ACA(2)(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 $470 Item 1A, Part 2, 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.
Registered OTC medicine $1,460 Regulations 7(1)(a)(i) and 7(2)(a)(i)
New registered OTC medicine applications
For information on application types, go to OTC application categorisation framework.
Item in Schedule 9 Part 3
N1 application $1,620 $4,000 Items 1(a) and 2(a)
N1 concurrent application per additional application (as described in item 3, Part 3, Schedule 9 of the Regulations) $810 $4,000 Items 3(d) and 2(a)
N2 application $1,620 $5,680 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) $810 $5,680 Items 3(e) and 2(b)
N3 application $2,600 $8,750 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) $1,300 $4,430 Item 3(f) and 4(d)
N4 application $3,790 $14,500 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) $1,300 $4,430 Items 3(g)and 4(e)
N5 application $5,620 $21,500 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) $1,300 $4,430 Items 3(h) and 4(f)
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.
C1 (section 23) application $1,620 n/a Item 1(f)
C2 (section 23) application $1,620 $4,000 Items 1(g) and 2(f)
C3 (section 23) application $1,620 $6,710 Items 1(h) and 2(g)
C4 (section 23) application $2,600 $8,750 Items 1(i) and 2(h)
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.
CN (section 9D) notification request $790 n/a Schedule 9 Part 2 items 2CD and 2CB
C1 (section 9D) application $1,620 n/a Schedule 9 Part 3 Item 5
C2 (section 9D) application $5,620 $4,000
Schedule 9 Part 3 Item 6(a)
Regulation 43AC (2)(a)
C3 (section 9D) application $8,330 $6,710
Schedule 9 Part 3 Item 6(b)
Regulation 43AC (2)(b)
C4 (section 9D) application $11,400 $8,750
Schedule 9 Part 3 Item 6(c)
Regulation 43AC (2)(c)
Registered OTC medicine request
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 $1,590 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 $8,140 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. $470 Item 1A
URL:https://www.tga.gov.au/node/842966