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Compliance

3 Relationship with other agencies

In order to maximise effectiveness, the ACVM Group will cooperate to the maximum extent possible with other parts of NZFSA (the Science Group, Verification Agency and NZ Standards Group), and with other regulatory agencies. There is a clear interface with other legislation. Memoranda of Understanding (MoUs) will be used to clarify operational roles and responsibilities with:

• MAF Biosecurity (Animal, Plants and Forestry Groups)

• MAF Animal Welfare Group

• The Environmental Risk Management Authority (ERMA NZ)

• The Ministry of Health

• The Veterinary Council of New Zealand.

It is also expected that operational agreements will clarify the interface roles and responsibilities with MAF Biosecurity New Zealand (MAFBNZ) (who provide border services) and with NZFSA Verification Agency (who provide some on farm services).

In addition to working closely with other regulatory agencies in New Zealand, the ACVM Group will cooperate fully with the regulatory agencies from other countries wherever this is appropriate. The ACVM Group has an operational agreement with the Australian Pesticides and Veterinary Medicines Authority (APVMA) to cover GMP compliance issues.

New Zealand already has a mutual recognition agreement (MRA) with the European Union that covers the area of Good Manufacturing Practice (GMP) for the manufacture of veterinary medicines. New Zealand has an MoU with Australia for GMP. VICH ³ is also working on a number of standards to harmonise pharmacovigilance activities. New Zealand will seek opportunities to work with other regulatory agencies to align in the area of compliance.

³ VICH is an international process to harmonise the data requirements for veterinary medicines between the member countries (Japan, the United States and the European Union) and the observer countries (Australia, New Zealand and Canada).