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Fees and charges: summary from 1 July 2020
Version 1.3, November 2020
6 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 |