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AgVetLink: Number 55, April 2006

Trans-Tasman Co-operation Project

The ACVM Group recently met with the Australian Pesticides and Veterinary Medicines Authority (APVMA) to progress the development of a memorandum of understanding (MoU) that will align (as far as practical) the registration processes in both countries. The intention is to facilitate access to a wider range of veterinary medicines and plant compounds by:

• ensuring that registration requirements are only what are necessary and sufficient to assess the safety and appropriateness of trade name products; and

• making the requirements in both countries as close to the same as is practical, given the differences in circumstances.

As part of the MoU, the ACVM Group and APVMA are developing a five year workplan to progress the alignment of particular standards or processes. Already the Authorities have established an understanding in regard to recognition of each other’s approvals for manufacturers of veterinary medicines. This in itself simplifies the registration process in some cases in regard to manufacturing dossiers required for an application.

Good Manufacturing Practice (GMP) approval is not required at this stage for plant compounds, but a GMP approval condition has been imposed on vertebrate toxic agent products that contain active ingredients such as 1080 and cyanide.

Another exercise that has commenced is a side-by-side comparison of the assessments of registrations. Five representative veterinary medicine products that have been registered in both countries in the last two years will be selected, and the registration processes will be compared to identify similarities and differences. The outcome of the comparison will be used to assist alignment of both standards/requirements and processes for veterinary medicines. A second exercise will be carried out on agricultural chemical products.

The scope of the alignment is comprehensive and is intended to lead to access to a wider range of veterinary medicines and plant compounds that might not be available in New Zealand because the cost of registration would be prohibitive, given the size of the market in this country.