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Fees and charges: summary from 1 July 2020
Version 1.3, November 2020
Manufacturing medicines and OTGs
The section applies to the manufacture of:
- all medicines
- other therapeutic goods (OTGs), listed and registered
Annual charges for manufacturing licences
Manufacturing licences have an annual charge.
Annual charges for manufacturing licences | Charge | Regulations |
---|---|---|
Manufacturing licence charge for medicines, ingredients, components, herbal and homeopathic preparations and containers | $4,770 | Item 7(5)(a), Item 7(5)(b), Item 7(5)(c) and Item 7(5)(e) |
This charge is in the Therapeutic Goods (Charges) Regulations 2018
Manufacturing inspections
Australian manufacturing licences
Applications for Australian manufacturing licences have application, variation and inspection fees.
Fees related to Australian manufacturing licences | Fee | Schedule 9 Part 2 |
---|---|---|
Australian manufacturing sites - application fee for a manufacturing licence | $810 | Item 8(a) |
Variation application for a manufacturing licence | $810 | Item 8A |
Australian manufacturing sites - inspection fee | $1,010 /hour/inspector | Item 9(a) |
These fees are in Schedule 9, Therapeutic Goods Regulations 1990
Overseas manufacturing site inspections
There is no application fee for GMP certification of overseas manufacturing sites.
Overseas manufacturing site inspections | Fee | Schedule 9 Part 2 |
---|---|---|
Overseas manufacturing sites - inspection fee | $1420 /hour/inspector | Item 9(b) |
Inspection fees to cover costs and reasonable expenses by each inspector, including costs for accommodation and allowance outside Australia | Costs and reasonable expenses |
These fees are in Schedule 9, Therapeutic Goods Regulations 1990
GMP clearance fees
There is no application fee for GMP clearance. See GMP clearance guidance for information on this process.
GMP clearance of overseas manufacturers | Fee | Schedule 9 Part 2 |
---|---|---|
GMP clearance application processing fee (per manufacturer, per site, per sponsor) | $660 | Item 6AA |
Obtaining evidence from an overseas regulatory authority (per manufacturer, per site, per sponsor) | $710 | Item 6AB |
Compliance verification (in lieu of an overseas GMP inspection) | $2,530 | Item 6ABA |
Reinstatement of expired GMP clearance approval (per manufacturer, per site, per sponsor) - in addition to relevant fees above | $1,200 | Item 6AC |
These fees are in Schedule 9, Therapeutic Goods Regulations 1990
Issuing manufacturing certificates
There are fees for issuing manufacturing certificates.
Certificate | Fee |
---|---|
Certificate of GMP compliance | $180 |
Mutual Recognition Agreement certificate | $350 |
Certified copy of:
|
$70 |