Veterinarians and Veterinary Medicines
If you are a veterinarian, provisions of the APVMA legislation apply directly to you unless you are dispensing to animals under your care.
Download the Veterinarians and Veterinary Medicines fact sheet (PDF, 214kb).
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Background
In Australia, veterinary chemicals that are supplied for use in the prevention and treatment of animal diseases, must be registered by the Australian Pesticides and Veterinary Medicines Authority (APVMA).
The registration process ensures that chemicals on the market have been rigorously assessed and meet high standards for safety, quality and efficacy. The assessment, registration, manufacture, importation, promotion and supply of veterinary chemicals are regulated by national legislation the centrepiece of which is the Agricultural and Veterinary Chemicals Code, commonly called the Agvet Code.
During the course of their practice, veterinarians make professional judgments about the best and most effective treatment for a particular animal. This may involve obtaining veterinary chemicals which are not available in Australia and the preparation of a product or pack size also not generally available.
Veterinarians may also make treatment recommendations which are inconsistent with the instructions on labels of registered veterinary chemical products. The Agvet Code provides for these actions, as long as they are undertaken for animals under a veterinarian's care* and are allowed under State and Territory laws.
Veterinarians must be aware of other State, Territory and Australian government legislation dealing with veterinary chemicals (eg Health, Quarantine and Control of Use legislation). Veterinarians should obtain details of State and Territory laws and operate within the limitations of the prescribing privileges specified in those laws. Prescribing privileges may not extend to use in food producing species.
How the APVMA Legislation Affects Veterinarians
There are a number of practices undertaken by veterinarians which are impacted by the national legislation package and it is important for veterinarians to be aware of the following:
- Importation - The Agricultural and Veterinary Chemicals Administration Act 1992 prohibits the importation of unregistered veterinary chemicals. Veterinarians must seek consent to import unregistered veterinary chemicals for use on animals under their care.
- Supply - It is an offence under the Agvet Codes to supply an unregistered veterinary chemical. However veterinarians may supply certain unregistered veterinary chemicals for use on an animal under their care if this is allowed by State and Territory laws.
- Therapeutic claims - It is an offence under the Agvet Code to make a therapeutic claim that is inconsistent with an instruction on an approved label for a veterinary chemical. However veterinarians may make such claims when dispensing a veterinary chemical for use on an animal under their care if this is allowed by State and Territory laws.
Under the national legislation veterinarians may not import, manufacture, supply or make unregistered therapeutic claims about veterinary chemicals for use on animals that are not directly under their care.
Commercial Manufacture, Supply and Importation of Veterinary Chemicals
Some veterinarians have manufactured and supplied veterinary chemicals for commercial purposes and not necessarily for animals under their care. Under such circumstances it is necessary to have the chemicals registered and all the steps of manufacture licensed by the APVMA. The APVMA has prosecuted veterinarians for supply of unregistered veterinary chemicals to animals not directly under their care.
A manufacturer who supplies unregistered veterinary chemicals, including to veterinarians, is committing an offence under the Agvet Code.
Similarly, importation of unregistered veterinary chemicals is illegal unless a consent to import has been obtained from the APVMA. To obtain a notice of consent to import, the following information must be provided before the expected arrival of the veterinary chemical in Australia:
- name of the veterinary chemical;
- company responsible for importation;
- quantity of veterinary chemical to be imported;
- port of entry;
- the reason for importation;
- name and address of importing agent; and
- estimated time of arrival.
Evidence is required to demonstrate that the veterinary chemical to be imported is not already available in Australia, will be used to treat a condition or disease in an animal which is under the veterinarian's care and that such treatment does not contravene other laws. The APVMA may require the veterinarian to produce records (such as prescription details or consultation records) which demonstrate that the veterinary chemical was used in accordance with the conditions of a consent to importation.
Notes
- 'Animals under their care' requires that the veterinarians be engaged by a client and accept responsibility for the health of the animal(s) in question. The veterinarian should have either examined or have a recent history of consultation for the animals concerned to be able to supply or recommend the veterinary chemical in question. The veterinarian must also make appropriate emergency arrangements in the event of an adverse reaction or ineffective treatment. The care must therefore be real not nominal.
- Approved veterinary chemicals includes veterinary active constituents approved by the APVMA and/or veterinary chemical products registered by the APVMA.