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Fees and charges: summary from 1 July 2020

Version 1.3, November 2020

6 November 2020

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Biologicals

Below are the fees and annual charges for manufacturing and sponsoring biologicals.

The Australian Regulatory Guidelines for Biologicals (ARGB) provide information on the legal arrangements in Australia for the supply and use of human cell and tissue-based therapeutic goods (collectively defined as 'biologicals').

For clinical trials supplying unapproved biologicals, go to Clinical trials.

Annual charges for manufacturing biologicals

There is no annual charge for a manufacturer who only manufactures biologicals [regulation 7(5)(j) Therapeutic Goods (Charges) Regulations 2018].

Manufacturing biologicals fees

There is an application fee and various inspection fees for manufacturing biologicals.

Table 34: Manufacturing biologicals fees
Manufacturing biologicals Fee Schedule 9A Part 2
Australian manufacturing sites - application fee for a manufacturing licence $1,130 Item 3
Initial manufacturing audit - inspection fee for Australian and overseas manufacturing sites $22,300 Item 12
Subsequent manufacturing audit - inspection fee for Australian and overseas manufacturing sites $16,900 Item 13
Inspection fee for each hour of preparation by each inspector for an inspection conducted outside Australia $690 /hour/inspector Item 14
Inspection fees to cover costs and reasonable expenses by each inspector, including costs for accommodation and allowance outside Australia Costs and reasonable expenses Item 15

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

Annual charges for sponsoring biologicals

There are annual charges for including a biological in the ARTG.

Table 35: Annual charges for sponsoring biological
ARTG inclusion of biologicals Amount Regulation
Class 1 biological annual charge for ARTG inclusion $690 Item 7(3)(a)
Class 2, 3, 4 biological annual charge for ARTG inclusion $6,890 Item 7(3)(b)

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

Fees for sponsoring biologicals

Table 36: Fees for sponsoring biologicals
Sponsoring biologicals Fee Schedule 9A Part 2
Ingredient or component of a biological to be evaluated under regulation 16GF - evaluation fee $24,400 Item 7
Class 1 biological - application fee for inclusion in ARTG $1,130 Item 1
Class 2, 3, 4 biological - application fee for inclusion in ARTG $1,130 Item 2
Variation application fee - all classes $1,130 Item 8
Class 2 biological - evaluation fee for inclusion in ARTG $75,100 Item 4
Class 2 biological - evaluation fee for variation to ARTG entry $6,890 Item 9
Class 3 biological - evaluation fee for inclusion in ARTG $150,300 Item 5
Class 4 biological - evaluation fee for inclusion in ARTG $244,200 Item 6
Class 3 or 4 biological - evaluation fee for major variation to ARTG entry $35,600 Item 11
Class 3 or 4 biological - evaluation fee for minor variation to ARTG entry $18,100 Item 10
Safety related variations - evaluation of application under section 9D(3AA) $6,890 Item 8A

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

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