Manufacturing Veterinary Medicines
There are three kinds of exemptions from registration in the Agricultural Compounds and Veterinary Medicines (Exemptions and Prohibited Substances) Regulations 2011 based on:
- kind of product
- scope of claims.
The first relates only to veterinarians (using human medicines, compounding preparations, or using under Ministry for Primary Industries permit).
The second relates to the way the product is made or the ingredients used (ie homeopathic and herbal preparations).
The third relates to the claims made about the product (eg to treat a kind of condition, coughing, diarrhoea, minor injuries and skin abnormalities, etc).
The three exemptions are not mutually exclusive. A veterinarian could be compounding a herbal preparation for the topical treatment of a minor injury in an animal.
Three separate entries in the Regulations provide exemption from registration.
However there must be at least one relevant entry in the Regulations relevant to what a veterinarian is doing (or making) or else the resulting preparation must be registered.
A number of the activities involved in compounding and manufacturing are the same (eg developing the master formulation, formulation, packaging and labelling, quality testing).
The distinction between the two is that the outcome of manufacturing is a trade name product destined for general sale, while the outcome of compounding is a preparation designed to treat a particular animal (or group of animals) in a particular case.
By virtue of a prescribed exemption from registration, veterinarians can compound a preparation that would otherwise require registration. The preparation must be for a particular animal (group of animals) in a particular case. For example, a veterinarian can prepare a solution for treating corneal ulcers for an animal under his or her care. The other condition that must be met is that any approved operating plan must be complied with. That second condition will be deleted in the next amendment to the Regulations, and replaced with a reference to the Code of Professional Conduct.
Conversely, a veterinarian cannot manufacture a preparation for general sale as a trade name product under the same prescribed exemption from registration for compounded preparations. The same solution for treating corneal ulcers would require registration before it could be manufactured and offered for sale as a trade name product. A veterinarian would have to meet the same requirements for registration as any other registrant/manufacturer.
A veterinarian, like anyone else, can manufacture a trade name product that fits any of the product groups (based on scope of claims) specified in schedule 1 or 2 of the ACVM Regulations 2011. For example, a veterinarian can manufacture, without registration, a saddle sore trade name products to be applied topically, as long as the ingredients are not absorbed systemically, and do not include prescription medicines (ref Medicines Act), antibiotics, hormones or any substance prohibited by countries importing NZ primary produce. The directions for use must make it clear that it is for the treatment of minor injuries or to prevent dermatological abnormalities. Claims to treat more serious problems would nullify the exemption from registration.
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