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AgVetLink March 2004 - Special Issue for Veterinarians: Page 2

Unravelling the ACVM Matrix

This section will become a permanent feature of the AgVetLink special editions for veterinarians. It will be presented in a ‘Question and Answer’ format, and should be considered a forum through which veterinarians can ask any general questions relating to the ACVM Act and veterinary medicines anonymously. Chances are, if you don’t know, there will be others in the same situation.

All questions should be sent to: Jennie Moran ACVM Group, NZFSA PO Box 2835, Wellington Email: jennie.moran@nzfsa.govt.nz

Because this is the first appearance of the ACVM Matrix some basic principles of the ACVM Act will be explored and, hopefully, unravelled.

What happened to the Animal Remedies Act?

Answer

The Animal Remedies (AR) Act was passed in 1967. There have been many changes since then with respect to how veterinary medicines are manufactured, sold and used. The Agricultural Compounds and Veterinary Medicines (ACVM) Act was passed in 1997 and requires a risk management rather than prescriptive approach to the control of veterinary medicine use. In addition, it manages the manufacture, sale and use of plant compounds.

The ACVM Act came into force in July 2001, at which time the Animal Remedies Act was repealed. However, because all animal remedies could not be immediately updated to fulfil the requirements of the new Act, the ACVM Act included transitional provisions that allowed ‘status quo’ for licensed animal remedies for a maximum period of three years from the date of the ACVM Act’s commencement. This period will expire in July this year.

The ACVM Group is busy updating products to meet the requirements of the ACVM Act. In some cases this has resulted in changes to label content and conditions. Veterinarians are reminded that this is an intense period of change and that no veterinary products should be prescribed or used unless the label has been read thoroughly.

What are the risks of interest to veterinarians that are managed by the ACVM Act?

Answer

The risks are described in section 4 of the ACVM Act. Of direct interest to veterinarians are the requirements to manage risks to trade in primary produce and prevent breaches to domestic food residue standards (residues) and risks to animal welfare (product safety and efficacy).

In addition, the Act requires the provision of sufficient consumer information about veterinary medicines. The consumer in this case is the user of the veterinary medicine, not the consumer of animal or plant produce. Sufficient information is considered to be enough information to use a product correctly and safely. This means that the ACVM Group will be approving label content related not only to the risk areas mentioned above but also content related to security, safe handling and disposal to protect the health of people and the safety of the environment. Veterinarians have a role to play here.

What is a veterinary medicine? 

Answer

Products that were identified as animal remedies under the AR Act are now called veterinary medicines under the ACVM Act. Veterinary medicines are themselves a subset of agricultural compounds. The definition of ‘agricultural compound’ is included in the Act but, in essence, if a substance or mixture of substances is used in the direct management of an animal, that substance is considered a veterinary medicine. Unlike the AR Act, which excluded ‘food for animals’, any products fed to animals for the purpose of providing nutrition (oral nutritional compounds) are considered veterinary medicines.

Products that require a veterinary prescription are called prescription animal remedy veterinary medicines or PARs. Products that can be purchased without a prescription are called over-the-counter veterinary medicines or OTCs.

The terms ‘PAR’ and ‘OTC’ relate only to access. Other terms are used to describe veterinary medicines according to their intended use. Products that make claims to prevent or treat abnormal or disease conditions are therapeutic veterinary medicines. If claims are made to modify physiological functions, the products are called pharmacological veterinary medicines. Products that are used to provide nutrition to animals are called oral nutritional compound veterinary medicines and include animal feeds and pet foods, feed additives and nutritional supplements.

These product groups are general and are not mutually exclusive. For example, a product may be basically an oral nutritional compound but it may have one or more therapeutic substances added and therapeutic claims are made about the product. That product would be both an oral nutritional compound veterinary medicine and a therapeutic veterinary medicine.

There are substances (e.g. glucosamine and chondritoin) that may be found naturally in some animal feeds that are considered to have some therapeutic effect. If no claims are made about these substances and the concentrations do

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