Fees and charges: summary - from 1 July 2018

Version 1.1, October 2018

12 October 2018

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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.

Manufacturing biologicals: annual charges

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

Manufacturing biologicals: fees

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

Manufacturing biologicals Fee Item in Schedule 9A Part 2
Australian manufacturing sites - application fee for a manufacturing licence $1,090 Item 3
Initial manufacturing audit - inspection fee for Australian and overseas manufacturing sites $21,500 Item 12
Subsequent manufacturing audit - inspection fee for Australian and overseas manufacturing sites $16,300 Item 13
Inspection fee for each hour of preparation by each inspector for an inspection conducted outside Australia $670/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 charges are in the Therapeutic Goods (Charges) Regulations 2018.

ARTG inclusion of biologicals Amount Therapeutic Goods (Charges) Regulations
Class 1 biological annual charge for ARTG inclusion $670 Regulation 7(3)(a)
Class 2, 3, 4 biological annual charge for ARTG inclusion $6,620 Regulation 7(3)(b)

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

Sponsoring biologicals Fee Item in Schedule 9A Part 2
Ingredient or component of a biological to be evaluated under regulation 16GF - evaluation fee $23,400 Item 7
Class 1 biological - application fee for inclusion in ARTG $1,090 Item 1
Class 2, 3, 4 biological - application fee for inclusion in ARTG $1,090 Item 2
Variation application fee - all classes $1,090 Item 8
Class 2 biological - evaluation fee for inclusion in ARTG $72,200 Item 4
Class 2 biological - evaluation fee for variation to ARTG entry $6,620 Item 9
Class 3 biological - evaluation fee for inclusion in ARTG $144,400 Item 5
Class 4 biological - evaluation fee for inclusion in ARTG $234,700 Item 6
Class 3 or 4 biological - evaluation fee for major variation to ARTG entry $34,200 Item 11
Class 3 or 4 biological - evaluation fee for minor variation to ARTG entry $17,400 Item 10
Safety related variations - evaluation of application under section 9D(3AA) $6,620 Item 8A

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