Products approved for human use under the Medicines Act 1981 can be used as veterinary medicines only when prescribed by a veterinarian and used in accordance with this standard. This comprises of medicines, new medicines, pharmacy-only, prescription and restricted medicines and substances.
Human medicines have not been evaluated for safety or efficacy in animals, nor have they been appraised with respect to potential residues if used in food-producing animals. They would have been manufactured in accordance with good manufacturing practices but they may not have been manufactured in facilities approved by the ACVM Group.
They are not necessarily prepared or packaged appropriately for use as veterinary medicines, they could include forbidden substances (see www.nzfsa.govt.nz/acvm for current list), and their labelling is probably irrelevant to their use as veterinary medicines.
This therefore means that there is no information evaluated by the ACVM Group that endorses the use of human medicines as veterinary medicines. However, they may be used as such when a veterinarian accepts full responsibility for their use and is very careful with respect to managing the risks. Although they are not registered PAR products, but even then they may be used as veterinary medicines only if approved by a veterinarian.
Specially compounded veterinary medicines: Specially compounded veterinary medicines are either compounded by a veterinarian, or by a skilled and experienced manufacturer, or a contracted compounding pharmacist on behalf of that veterinarian. They must be prescribed for a particular clinical need recognized in a veterinary consultation for animals under the observation of that veterinarian. In fact, specially compounded veterinary medicines may be prescribed only by the veterinarian who directed compounding in the first place.
This class does not take account of preparations formulated by veterinarians for common sale or for sale to other veterinarians or traders. The latter products must be registered except when they are specifically exempt from the need to be registered. The authority to compound and the freedom from registration has been provided to make sure that veterinarians can address a particular clinical need. The provision must not be used by veterinarians to avoid the product registration process.
This class does not take in the decanted or broken down proprietary veterinary medicines when there is no change in the product itself. These are a part of unregistered veterinary medicines.
The compounding specifications corresponding to the manufacturing specifications, such as preparation, packaging, and labelling, is according to the instructions of the veterinarian as specified in a compounding order issued by that veterinarian. If the specially compounded medicinal preparation is formulated by someone other than the veterinarian, the instructions must be detailed in that compounding order.
Like human medicines, specially compounded veterinary medicines are not evaluated by the ACVM Group, so there is no information appraised by the Group that endorses their use as veterinary medicines. Yet, they may be used per se when a veterinarian accepts full responsibility for their use and takes due care to deal with the risks. Even though they are not registered PAR products, they may be used as veterinary medicines only if prescribed by a veterinarian.
Unregistered veterinary medicine trade name products: There are several proprietary veterinary medicine trade name products registered in many other countries that are not registered in New Zealand. The accessibility of these products is promoted internationally and they can be bought overseas or ordered by electronic means or by email. However, they must not be imported without aforementioned approval of the ACVM Group.
Under normal circumstances, trade name products that are not registered under the Agricultural Compounds and Veterinary Medicines Act 1997, or particularly exempted from the requirement to be registered under the Agricultural Compounds, and Veterinary Medicines Regulations 2001 should not be used as veterinary medicines in New Zealand.
On the other hand, under very special circumstances approval for their use and, subsequently, approval to import will be issued by the ACVM Group. In this instance, approval will be issued only if there is an instant welfare need that cannot be successfully met by using a product that is currently approved in New Zealand.
This class also takes in decanted or broken down registered veterinary medicines for the reason that products that have been modified are no longer the registered products.
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