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AgVetLink June 2003

SPECIAL ISSUE FOR VETERINARIANS

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Product ‘legality’ under the ACVM Act

The purposes of the ACVM Act that are relevant to veterinarians are:

1 managing risks to animal welfare, biosecurity and trade;

2 avoiding violative residues in food;

3 providing sufficient information to consumers of veterinary medicines.

All veterinary medicines must be assessed to evaluate risks and determine what conditions must be imposed on them to ensure safe, appropriate use. They must be either registered or specifically exempted from registration. A veterinary medicine that is not registered or exempted from registration is illegal.

It is a veterinarian’s responsibility to:

• use only products that are legal under the ACVM Act; and
• comply with the relevant conditions of registration.

How can I tell if a product is ‘legal’?

Firstly, and most importantly, any registered product in New Zealand is required to have a registration statement and number on the label. At the present time this will indicate that a product is licensed under the Animal Remedies Act or registered under the ACVM Act.

In addition to this, there is a searchable list of all registered products on the ACVM part of the NZFSA website (https://eatsafe.nzfsa.govt.nz/web/public/acvm-register/). This list is updated every fortnight and it can be searched by active ingredient, by trade name (or part of the name), by registration number or by registrant.

How can I tell what conditions are placed on a product?

Under the ACVM Act products can be used only according to the conditions of registration. These conditions, which will be on the label of a registered product, will state if a veterinarian may use the product in a discretionary manner (‘off-label’) or if a particular use is prohibited.

Veterinarians frequently use IVS for product information, but we have found that IVS may not always be correct (see article, page 3) and should not be relied on at this stage.

There is a facility to view the approved label (or the approved label content) of all products that have been updated to ACVM registrations. The label content and the list of conditions provide the most up-to-date information on registered products.

What if a product doesn't have a registration number?

A veterinarian must be aware of the kinds of products that can be exempted from registration. Obviously, these products will not have a number.

When products are exempted from the need for registration, the exemption is for a group of products rather than for specific, recognisable trade names, so it is not as straightforward to check a particular product.

Exemption categories, definitions and conditions are in the Schedules of the Agricultural Compounds and Veterinary Medicines Regulations 2001, which is available on the website (http://www.nzfsa.govt.nz/acvm/legislation/ ). (These Schedules may change over time, so it is advisable to check periodically.) 

The current categories of exempted products that are likely to be used in veterinary practice are:

• topical preparations (not able to be absorbed through the skin), used solely to prevent dermatological abnormalities;
• non-medicated (no pharmacological or therapeutic ingredients) anti-diarrhoea preparations;
• non-medicated oral laxatives and lubricants;
• cauterising preparations;
• urinary tract modifiers (acidifiers and alkalisers) that are oral preparations used solely for modification of urinary pH;
• respiratory tract modifiers (expectorants and cough suppressants) that have a locally acting, superficial effect on the respiratory tract; and are given orally, applied to the nose or inhaled; and are used solely in companion animals to promote mucolysis, cough suppression (by alleviating only irritation) and relieve compromised airways and upper respiratory tract congestion;
• homeopathic oral and topical preparations that do not claim to prevent, control or cure a specific disease characterised by pain or distress in animals;
• herbal oral and topical preparations that do not claim to prevent, control or cure a specific disease characterised by pain or distress in animals;
• over-the-counter first aid preparations, including general disinfectants, antiseptics and sanitisers;
• preparations scheduled as pharmacy only, prescription or restricted medicines under the Medicines Act 1981, used as veterinary medicines;
• preparations compounded by a veterinarian and used by that veterinarian;
• oral nutritional compounds, defined as non-medicated substances ingested by animals as feed or nutrition preparations to achieve a nutritional benefit that make no therapeutic or pharmacological claim other than improving nutrition.

What if I am unsure about a product?

If you have a product without a registration number, the supplier of the product should be able to provide an ACVM ‘class determination’ confirming its status. This must be less than two years old to be valid. If you are unsure about a product, contact the ACVM Group (phone 04 463 2550) to find out if it is legal to use – in most cases there is no charge for this service.