What evidence of GMP compliance is acceptable to the APVMA?
Acceptable evidence is considered to be as detailed in the table Guidelines and Requirements for Providing Evidence of GMP Compliance (PDF, 228kb). In general, acceptable evidence is considered to be as follows: • Where manufacture occurs in a country with which Australia has a Mutual Recognition Agreement on Conformity Assessment with respect to veterinary chemical products, the evidence required is a current and acceptable Certificate of GMP Compliance of a Manufacturer from the relevant competent authority. See EU-Australia MRA List of Competent Authorities (PDF, 63kb). • Where manufacture occurs in another country whose GMP program is recognised by the APVMA, eg USA, NZ and Canada, the evidence required is a current and acceptable certificate of GMP compliance, a licence and/or an audit report from a Recognised Authority. In some instances, the APVMA will also recognise audit reports from competent authorities that are members of the Pharmaceutical Inspection Convention/Cooperation
