Fees and charges: summary - from 1 July 2018
Version 1.1, October 2018
Manufacturing medicines and OTGs
The section applies to the manufacture of:
- all medicines
- other listed and registered therapeutic goods (OTGs).
Annual charges: manufacturing licences
These charges are in the Therapeutic Goods (Charges) Regulations 2018.
|Annual charges for manufacturing licences||Charge||Therapeutic Goods (Charges) Regulations 1990|
|Manufacturing licence charge for medicines, ingredients, components, herbal and homeopathic preparations and containers||$4,590||Regulation 7(5)(a-c, e)|
|Manufacturing licence charge for therapeutic device (other therapeutic good)||$6,380||Regulation 7(5)(d)|
Only highest applicable charge is payable.
Australian manufacturing licences
These fees are in Schedule 9, Therapeutic Goods Regulations 1990.
|Fees related to Australian manufacturing licences||Fee||Item in Schedule 9 Part 2|
|Australian manufacturing sites - application fee for a manufacturing licence||$770||Item 8(a)|
|Application for variation of a manufacturing licence||$770||Item 8A|
|Australian manufacturing sites - inspection fee||$970/hour/inspector||Item 9(a)|
Overseas manufacturing site inspections
There is no application fee for GMP certification of overseas manufacturing sites.
|Overseas manufacturing site inspections||Fee|
|Overseas manufacturing sites - inspection fee||$1,360/hour/inspector|
|Inspection fees to cover costs and reasonable expenses by each inspector, including costs for accommodation and allowance outside Australia||costs and reasonable expenses|
GMP clearance fees
There is no application fee for GMP clearance. These fees are in Schedule 9, Therapeutic Goods Regulations 1990.
|GMP clearance of overseas manufacturers||Fee||Item in Schedule 9 Part 2|
|GMP clearance application processing fee (per manufacturer, per site, per sponsor)||$400||Item 6AA|
|Obtaining evidence from an overseas regulatory authority (per manufacturer, per site, per sponsor)||$690||Item 6AB|
|Compliance verification (in lieu of an overseas GMP inspection)||$2,070||Item 6ABA|
|Reinstatement of expired GMP clearance approval (per manufacturer, per site, per sponsor) - in addition to relevant fees above||$1,160||Item 6AC|
Issuing manufacturing certificates
|Certificate of GMP compliance||$180|
|Mutual Recognition Agreement certificate||$330|
Certified copy of: