This content is current only at the time of printing. This document was printed on 23 June 2021. A current copy is located at http://www.plural-consulting.com/node/470
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The application fees for manufacturing licences issued under section 122 of the Agricultural and Veterinary Chemicals Code scheduled to the Agricultural and Veterinary Chemicals Code Act 1994 (Cth) (Agvet Code) can be found in the timeframe and fees section on our website.
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?
- initiating compliance enforcement action where necessary.
Fees per licence category can be found in the timeframe and fees section on our website.
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 percent reduction in fees. They must provide the APVMA with evidence documenting quantities and financial particulars of agvet chemical products manufactured under the licence during the time period for which they are being invoiced. This may include, but is not limited, to:
- batch, financial, or sales records
- export documents,
- reports from the company’s financial management information system.
A letter, preferably on company letterhead, should accompany evidence with advice to the effect that no manufacture of agvet chemical products occurred outside that for which evidence has been provided.
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.
Fees for low-income veterinary chemical product manufacturers can be found in the timeframe and fees section on our website.
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.