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Mutual Recognition of Good Manufacturing Practice

The development of two mutual recognition agreements for the assessment of good manufacturing practice (GMP) for animal remedies are under way, one with Australia and one with the European Union.

Collaboration between the ACVM Group and the Australian National Registration Authority (NRA) over a number of years has resulted in the informal recognition of each other’s inspection processes for GMP. The Registration Management Committee comprising MAF and NRA appointees, which was set up to harmonise registration procedures, has asked for the informal arrangement to be developed into a formal mutual recognition arrangement.

An exchange of documents is proposed in December 1999. The National Manager (ACVM Verification) attended a two day workshop in Canberra in August at which GMP inspection procedures and issues were reviewed.

A similar process is being progressed with the European Union but in this case a three year implementation phase has been provided under the mutual recognition agreement to allow New Zealand and the European Union to build confidence in each other’s inspection systems. A visit to Brussels is planned for November to discuss with European regulators the process that needs to be followed to achieve agreement on assessment of GMP compliance.