You are here

Fees and charges: summary from 1 July 2019

Version 1.1, July 2019

25 July 2019

Book pagination

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 $1,110 Item 3
Initial manufacturing audit - inspection fee for Australian and overseas manufacturing sites $21,900 Item 12
Subsequent manufacturing audit - inspection fee for Australian and overseas manufacturing sites $16,600 Item 13
Inspection fee for each hour of preparation by each inspector for an inspection conducted outside Australia $680/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.

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 $680 Regulation 7(3)(a)
Class 2, 3, 4 biological annual charge for ARTG inclusion $6,760 Regulation 7(3)(b)

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

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 $23,900 Item 7
Class 1 biological - application fee for inclusion in ARTG $1,110 Item 1
Class 2, 3, 4 biological - application fee for inclusion in ARTG $1,110 Item 2
Variation application fee - all classes $1,110 Item 8
Class 2 biological - evaluation fee for inclusion in ARTG $73,700 Item 4
Class 2 biological - evaluation fee for variation to ARTG entry $6,760 Item 9
Class 3 biological - evaluation fee for inclusion in ARTG $147,400 Item 5
Class 4 biological - evaluation fee for inclusion in ARTG $239,500 Item 6
Class 3 or 4 biological - evaluation fee for major variation to ARTG entry $34,900 Item 11
Class 3 or 4 biological - evaluation fee for minor variation to ARTG entry $17,800 Item 10
Safety related variations - evaluation of application under section 9D(3AA) $6,760 Item 8A

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

Book pagination