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Agvetlink Special Issue for Veterinarians March 2005

The ACVM Regulations – Relevance to Veterinarians

Background

Under the Miscellaneous Provisions of the Agricultural Compounds and Veterinary Medicines (ACVM) Act 1997 there is the ability for Regulations to be made to allow the importation, manufacture, sale or use of substances meeting the definition of a veterinary medicine without prior registration.

The ACVM Regulations 2001 describe the groups of veterinary medicines and agricultural compounds that are considered suitable for exemption from the requirement for registration.  The product groups are included only because registration is not considered necessary for ACVM Act risks to be managed.  Conversely, any product that poses a risk to animal welfare (either through some intrinsic property or inefficacy), animal product residue management or agricultural security will not be considered for exemption.

The ACVM Regulations can be viewed at the following website (Adobe Acrobat Reader required): http://www.nzfsa.govt.nz/acvm/legislation/

The document is composed of nine Regulations and seven Schedules.  Schedules 1 to 4 describe the groups of veterinary medicines that are exempt.  Varying conditions are applied, and these must be met for the exemption to be valid.

Schedule 1

•    Includes substances that are very low risk or for which traditional regulatory risk management is impractical.

•    If a code of practice specific to the exemption has been approved by the ACVM Group, it must be complied with.

•    Includes products like non-medicated shampoos and in vitro diagnostics.

 

Schedule 2

•    Includes products for which some specific conditions are considered necessary to manage ACVM Act risks.

•    Minimum labelling requirements are specified in addition to exemption group specific conditions.

•    Includes oral and topical herbal and homeopathic preparations, first aid products, human and compounded medicines used by veterinarians  (see article, page 5).

Schedule 3

•    The products currently in this schedule were identified as possibly having greater regulatory interest than those products in Schedules 1and 2 when the Regulations were developed.  There is a notification requirement attached to products exempted in Schedule 3 and the ACVM Group must be advised the first time the product is imported or sold in New Zealand. Experience has shown that notification is unnecessary and it is planned to delete this requirement.

•    Products are required to be manufactured according to the principles of Good Manufacturing Practice. Minimum labelling requirements are specified in addition to exemption group specific conditions.

•    Includes products such as non-medicated anti-diarrhoeal and laxative products, and urinary tract modifiers.

Schedule 4

•    Relates entirely to oral nutritional compounds.

•    Conditions cover minimum labelling requirements, ‘fit for purpose’ status, allowance for inclusion of pharmacological or therapeutic substances and the requirements relating to feed additives (all of which must be included on the Generally Regarded As Safe or ‘GRAS’ list).

Veterinarians are encouraged to familiarise themselves with the groups of products that are likely to be considered exempt from the requirement for registration.  It is illegal for any person to import, sell or use an unregistered veterinary medicine if it is required to be registered.