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AgVetLink: Number 1M, January 2007

Recognition of overseas manufacturers

The ACVM Group will recognise overseas manufacturers for their GMP status rather than grant an approval in the form of a GMP certificate. This recognition will be based on evidence of GMP compliance from another regulatory authority where there is a MRA (EC) or a MOU (Australia). For those countries where certificates from the local authorities are not accepted (e.g.China), GMP certificates issued by recognised inspection authorities (e.g. FDA) will be accepted.

The GMP certificate supplied should be current. It should quote the date of the last audit as well as the steps of manufacture (all manufacturing steps or quality control testing only) and the types of products inspected.