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Policy on prescription animal remedies

The prescription animal remedy (PAR) classification system will continue to be used under the ACVM Act (see page 6). Such trade name products will be known as prescription animal remedies and will be the subset of veterinary medicines that are com-monly considered to be drugs or medications.

The criteria used when imposing prescription status to trade name products were originally established by the Animal Remedies Board in 1983/84. These criteria will continue to be relevant under the ACVM Act but two additional criteria (last two bullet points below) have been added to manage risks that were uncommon when the Board set the original criteria.

A trade name product will be given a PAR status when:

• it includes in the formulation a drug that is a controlled drug within the meaning of the Misuse of Drugs Act 1975, e.g. morphine, pethidine;
• there is a possibility of acute or long-term toxic effects or development of hypersensitivity in humans, e.g. Brucella vaccine, streptomycin, DMSO;
• animal safety or welfare may be threatened, e.g. succinyl choline;
• the trade name product could mask disease, e.g. Brucella ovis vaccine;
• use of the trade name product demands a veterinary diagnosis and or monitoring of the animal’s response, e.g. iodine, copper, corticosteroid, anaesthetics;
• the administration of the trade name product requires the skill of a registered veterinarian to manage animal welfare concerns, e.g. intrauterine, intra-articular administration;
• there is an increased risk of development of bacterial resistance to antibacterial agents used in human or veterinary medicine;
• the trade name product contains a human medicine, or a prodrug of that human medicine, which is available only on prescription, unless specifically exempted by the Ministry of Health;
• directions for sale and correct use of the animal remedy cannot be adequately conveyed by the product labelling and must be used by or under the control of a registered veterinarian;
• the trade name product is to be used as part of an official national scheme to monitor, control or eradicate disease;
• use of the trade name product is a  threat to trade, and market access conditions require prescription use, and control e.g. hormonal growth promotants, antibiotics etc.

It must be noted that PAR status is recognised as a significant limitation on access and use of a trade name product. It will be imposed only when it is justifiable from a risk management perspective.

Agricultural compounds exempt from registration

The following groups of trade name products have been prescribed as exempt from the requirement to be registered under the ACVM Act. Only a group title has been made. The full description of the group should be used in determining if a particular trade name product fits any of the definitions in schedules 1, 2 or 3 in the Regulations. Any expansion of the uses or claims beyond what is provided for in the definitions will exclude a trade name product from exemption from registration.

Schedule 1

• Products made for own use
• Commercial compressed gases
• Non-medicated hoof preparations
• Non-medicated skin preparations for skin quality
• Masking agents for odour
• Cleaning agents
• In-vitro diagnostics
• Plant material
• Fertilisers and fertiliser additives that are raw or composted biological wastes

Schedule 2

• Non-medicated oral nutritional compounds
• Homeopathic preparations without disease specific claims
• Herbal preparations without disease specific claims
• Markers, paints and dyes
• First aid preparations
• Human medicines used by veterinarians
• Preparations compounded by veterinarians for their own use

Schedule 3

• Topical skin medications
• Non-medicated anti-diarrhoea preparations
• Oral laxatives and lubricants
• Cauterising preparations
• Urinary tract modifiers
• Respiratory tract modifiers
• Spray markers
• Plant compound adjuvants
• Repellants
• Anti-transpirants
• Frost protectants
• Sunblocks