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Fees and charges: summary from 1 July 2019
Version 1.1, July 2019
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.
|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.
Annual charges for sponsoring biologicals
There are annual charges for including a biological in the ARTG.
|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
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