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AgVetLink: Number 56, June 2006

Closer Alignment Between New Zealand and Australia

NZFSA has signed a memorandum of understanding (MoU) with the Australian Pesticides and Veterinary Medicines Authority (APVMA). The MoU establishes the operational relationship between the ACVM Group and the APVMA in regard to co-operation and regulatory control of veterinary medicines and agricultural compounds (known in Australia as agricultural chemicals).

The primary purpose of the MoU is to work towards aligned standards and requirements for the approval of agricultural and veterinary chemical products to the extent that is appropriate. The MoU will also enhance the way in which the APVMA and ACVM Group work together in achieving a common approach to the regulatory control of ACVM products.

The objectives of the MoU are to:

• work towards appropriate aligned regulatory standards and requirements relevant to the risks posed;

• share (with a medium-term view to accepting) product assessment reports where they are relevant to approval decisions in each country;

• in the longer term, move towards determining whether it is possible to recommend to Government that the ACVM Group and APVMA should accept registration decisions for specified products or kinds of products;

• establish effective lines of communication to allow sharing of information on approvals, compliance, surveillance and adverse experience reporting/pharmaco-vigilance; and

• develop a joint work programme with a set of defined milestones over a three-year period to establish common approaches to risk assessment methods and processes.

Workplan

The three-year workplan will initially focus on developing a sound understanding of each other’s registration processes. The agencies have started a side-by-side comparison of five veterinary products that have been registered in both countries in the last three years.

This comparison should highlight commonalities and differences that will help align registration requirements or standards. This is likely to be followed by a similar exercise for plant compound/agricultural chemical products.

Both agencies are confident that progress through the workplan will lead to a better understanding of the registration processes in both countries and is likely, over time, to facilitate the movement of products between the two countries.