This content is current only at the time of printing. This document was printed on 31 March 2017. A current copy is located at http://apvma.gov.au/node/470
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The application fees for manufacturing licences issued under section 122 of the Agvet Code are outlined below.
|Activity||Fee||Maximum pre-application assistance rebate|
|New licence application submitted||$900||Nil|
|Licence variation application submitted (applies for all partial audits for extension of licence scope). This fee covers assessment of the application and audit.||$1,800||Nil|
Annual fees cover the cost of:
- monitoring the timely conduct and closure of all audits of Australian-based manufacturers
- preparing pre-audit information for auditors
- reviewing audit reports
- addressing disputes
- answering manufacturer queries
- updating licences for routine changes (such as changes to personnel)
- initiating compliance enforcement action where necessary.
|Licence category||Annual fee|
|Category 1 licensed manufacturers||$7,500|
|Multi-category licences (manufacturers who hold licences to manufacture category 2 and 3, category 2 and 4, category 2, 3, and 4 or category 3 and 4 products)||$7,500|
|Single-category manufacturers (category 2, 3 or 4 products only)||$5,000|
|Category 6 (single step)||$1,800|
Some low-income veterinary chemical product manufacturers may be eligible for reduced fees.
Licensed manufacturers producing products with a notional wholesale value of less than $50,000 in the previous financial year are eligible to apply for a 50% reduction in fees. They must provide the APVMA with a Commonwealth Statutory Declaration to support the application.
Notional wholesale value, in relation to a chemical product, means the amount that the collecting agency determines would have been received:
- if the product is an Australian product—by the manufacturer
- if the product is an imported product—by the importer.
- if the product had been sold by the manufacturer or importer wholesale to a person with whom the manufacturer or importer was dealing at arm’s length.
|Manufacturer category||Reduced fee|
|Category 1 and multi-category||$3,750|
Overseas GMP compliance assessment fee
Registrants of veterinary chemical products fully or partially manufactured overseas are required to pay an annual overseas GMP compliance assessment fee for every overseas site used to manufacture those products.