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Fees and charges: summary from 28 October 2021

Version 1.1, October 2021

18 November 2021

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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

$1,140

Item 3

Initial manufacturing audit - inspection fee for Australian and overseas manufacturing sites

$22,500

Item 12

Subsequent manufacturing audit - inspection fee for Australian and overseas manufacturing sites

$17,100

Item 13

Inspection fee for each hour of preparation by each inspector for an inspection conducted outside Australia

$700/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

$700

Item 7(3)(a)

Class 2, 3, 4 biological annual charge for ARTG inclusion

$6,960

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

$24,700

Item 7

Class 1 biological - application fee for inclusion in ARTG

$1,140

Item 1

Class 2, 3, 4 biological - application fee for inclusion in ARTG

$1,140

Item 2

Variation application fee - all classes

$1,140

Item 8

Class 2 biological - evaluation fee for inclusion in ARTG

$75,900

Item 4

Class 2 biological - evaluation fee for variation to ARTG entry

$6,960

Item 9

Class 3 biological - evaluation fee for inclusion in ARTG

$151,900

Item 5

Class 4 biological - evaluation fee for inclusion in ARTG

$246,800

Item 6

Class 3 or 4 biological - evaluation fee for major variation to ARTG entry

$36,000

Item 11

Class 3 or 4 biological - evaluation fee for minor variation to ARTG entry

$18,300

Item 10

Safety related variations - evaluation of application under section 9D(3AA)

$6,960

Item 8A

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

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