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AgVetLink: Number 67, April 2008

Review of Veterinary Medicine Classification/Access

The ACVM Group has been working with an AVMAC subcommittee working party to review the operational policy on access to veterinary medicines.

Current classification

Currently, veterinary medicines are classified as either over-the-counter (OTC) or prescription animal remedies (PAR).

OTC veterinary medicines can be promoted and sold by any person to any person. They can be used by any person as long as those uses are consistent with the conditions of registration for those products. This does mean that they must be promoted and sold only for the intended purpose.

The promotion and sale of PAR veterinary medicines are restricted. The trader in PARs must be approved by the ACVM Group and the sale is subject to veterinary authorisation. PAR products have been subclassified (Classes I, II, III) according to the level of veterinary supervision required.

PAR classification

The PAR classification is not sustainable into the future in its present form. Firstly, the term PAR in no longer appropriate. Not all veterinary authorisations are ‘prescriptions’ so the term misrepresents the actual situation. The term ‘animal remedies’ is no longer relevant. It was appropriate when the products were controlled under the Animal Remedies Act, but the current term recognised under the ACVM Act is ‘veterinary medicine’.

‘Restricted‘ classification

Therefore, it is proposed to classify veterinary medicines with limitations on who can sell, authorise the sale of, and use them as ‘restricted (R) veterinary medicines’. The term ‘PAR‘ will be discontinued.

While the name change aligns the classification with the ACVM Act terminology, that is not the primary reason for the review. The main reason for change is that the subclassification of products (Class I, II and III) based on the level of veterinary oversight is not flexible enough to allow for essential or desirable alternative controls.

‘Unrestricted‘ classification

It is proposed to maintain the current policy that access to veterinary medicines should not be restricted for ACVM Act reasons unless there is a risk management necessity. The working group has noted that in some cases products that are not restricted from an ACVM Act point of view may still not be sold OTC for marketing or product stewardship reasons. As at present, this is not a concern under the ACVM Act as risks remain adequately covered.

Issues for working party

At this stage there is general agreement on the intent of regulatory control, but parties are working through the issues to ensure that the new system is:

• practical as well as adequately flexible to allow alternative forms of oversight

• likely to provide the public with the necessary oversight to ensure risks relevant to the ACVM Act are avoided and products can be used safely and appropriately

• adequate to maintain appropriate product stewardship

• consistent with the Code of Professional Conduct of the Veterinary Council of New Zealand where veterinarians are expected to play a role

• implemented in a reasonable manner to avoid unnecessary disruption and costs, especially in relation to label changes.

As is usually the case, change is uncomfortable and new terminology can cause confusion. The working party is in the process of clarifying the proposals to make them easy to understand. When this is done the operational policy will be put out for wider discussion before finalising.