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Consultation on administration of the ACVM Act

March 2008

In light of the recently amended Agricultural Compounds and Veterinary Medicines (ACVM) Act 1997, the ACVM Group is reviewing the way it administers the Act. Policies and procedures will be adjusted to fit the new provisions of the Act and to reflect the lessons learned to date.

The following topics of special interest to you as a veterinarian will reach the stage of public consultation in the next six months.

Proposals for new advertising/promotion regulations

Advertising and promotion of agricultural compounds, including veterinary medicines, are being examined. Of interest to vets, proposals here will try to clarify:

• the responsibilities of people who provide information about products and their use, but are not advertising or promoting products for sale

• the situation of providing information on off-label uses of products.

Proposals for new manufacturing regulations

Proposals for new regulations governing the manufacture of all agricultural compounds, including veterinary medicines, are being developed. These proposals will likely affect you if you (or your practice) compound your own preparations for sale. Minimum labelling requirements for veterinary medicines will also be included.

Proposals for new ‘generic substances’ regulations

Another area of interest to vets is use of generic chemicals or substances (i.e. ones sold/supplied with no stated agricultural use) as agricultural compounds. Proposals in this area are likely to include:

• prohibitions on the sale of such chemicals or substances with an implied agricultural use

• requirements covering veterinarians who compound preparations as part of the veterinary services they offer.

Proposal to replace PAR system

To fit the amended Act, we will be proposing to replace the prescription animal remedy (PAR) system with a restricted (R) veterinary medicine system.

If unrestricted access to a particular veterinary medicine would pose unacceptable risks in any area relevant to the ACVM Act, access will be restricted (through a condition when the product is registered). These products will be referred to as restricted (R) veterinary medicines.

The new system will be similar to the PAR system in effect, but it will be more specific about the nature of the restriction on access and the reason why it was decided that the product could not be classed as over-the-counter (OTC) access.

The restricted veterinary medicine policy is being developed with the assistance of a working party from the Agricultural Compounds and Veterinary Medicines Advisory Council (AVMAC), including representatives from the veterinary pharmaceutical industry, Federated Farmers of New Zealand, New Zealand Veterinary Association, Veterinary Council of New Zealand and the ACVM Group. The operational policy should be out for public discussion by June 2008. Your input is welcome.

If you have questions or comments, use the ‘contact this person’ option at the bottom of the VetQuickSearch home page to email us.