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AgVetLink: Number 52, October 2005

Australia/New Zealand harmonisation of approvals

The ACVM Group recently met with the Chief Executive Officer of the Australian Pesticides and Veterinary Medicines Authority (APVMA) to discuss plans to harmonise their market approval processes for agrichemicals and veterinary medicines. Both parties agree that mutual recognition of market approvals is not a likely option at this time, but believe they can work together more closely in several areas to facilitate common approaches. This will eventually lead to acceptance of product evaluations between Australia and New Zealand.

The reasons why agrichemicals and veterinary medicines were permanent exemptions from the Trans Tasman Mutual Recognition Arrangement remain valid. Nevertheless, the countries have reached an agreement on mutual recognition of Good Manufacturing Practice (GMP) approvals and find that there is little material difference between their chemistry standards.

The agencies will meet again on 28 October to progress a five-year plan based on three stages. The first stage will be to become familiar with each other’s marketing approval processes and to align chemistry, pesticide manufacturing, safety and efficacy standards as well as research/trial standards and good laboratory/clinical/field practice (GLP/GCP/GFP) requirements. The second stage will be to work toward acceptance of data assessment reports, develop information sharing processes and possibly acceptance of evaluation reports for products not used on food-producing animals, e.g. companion animal products. The third stage will be to work toward acceptance of a wider range of evaluation reports.

Alignment of standards, information requirements, data assessments and evaluation reports will provide pre-market approval processes and requirements quite similar in both markets, while still allowing each country to make final market approvals and impose conditions on those approvals that are most appropriate for each country.