This content is current only at the time of printing. This document was printed on 22 October 2018. A current copy is located at https://apvma.gov.au/node/102
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Manufacturing licences
Manufacturers of veterinary chemical products in Australia must be appropriately licensed by the APVMA. This applies to anyone in Australia involved in any step of manufacture of a veterinary chemical product, unless specifically exempt.
Manufacturers must apply to the APVMA to obtain a licence—or to vary an existing one—before performing any step of manufacture. The APVMA must be satisfied the applicant’s site of manufacture is suitable and complies with Good Manufacturing Practice (GMP). It must also be satisfied the manufacturer will be able to comply with licence conditions and the Manufacturing Principles.
The APVMA does not have jurisdiction to license overseas manufacturers. However, registrants and applicants of veterinary chemical products must provide evidence of overseas GMP compliance before a product can be registered and supplied in Australia.