This content is current only at the time of printing. This document was printed on 25 February 2017. A current copy is located at http://apvma.gov.au/node/10606
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User guide: What is or isn't a veterinary product?
The simplest way to find out whether or not your veterinary product might require registration is to use our self-assessment tool, which will ask you a series of questions about your product and provide advice as to whether registration is required.
This user guide provides more detailed information on what types of products are considered to be veterinary products that might require registration by the APVMA.
When considering applications to register a veterinary product we follow the requirements of our governing legislation.
In simple terms, veterinary products requiring APVMA registration include (but are not limited to):
- pharmaceutical products (including parasitological and antibiotic products)
- immunobiological products (including polypeptide and DNA constructs)
- complementary animal health products (including herbal, nutraceutical, direct-fed microbial and homeopathic remedies).
Products that generally do not require registration include:
- devices and other equipment used on animals
- animal cosmetic products
- animal feed products
- other products specified as exempt in the Regulations or not requiring registration.
Although the APVMA may not regulate some of these products, they may be subject to regulation by other Commonwealth, state or territory authorities.
This legal definition means that both the chemical nature of your product and the claims made about it are considered when deciding whether your product needs to be registered.
In the Agvet Code, the phrase ‘represented as being suitable for’ refers to any written or spoken words in or on the product label or other promotional material (including websites) that indicates the purpose or use of the product and when and how it can be used.
The Agvet Code defines claims as ‘any statement’. This means that a product claim is not limited to a specific therapeutic claim. Product claims include any statement on the label including when and how the product should be used, the product name, the ingredients, general instructions, or other information. A claim can be a word, a sentence, or a paragraph.
The legal definition of veterinary products also includes some specific substances and excludes other specific substances, as listed in the Agvet Code Regulations.