A new self-help tool for veterinary product registration

21 May 2013

Every year hundreds of new veterinary products are developed for the Australian marketplace. Many of these, but not all, need to be registered by the APVMA.

To help potential applicants or veterinary product developers navigate the complexities of the Agvet Code, which determines the need to register particular products, the APVMA has today introduced a web-based resource—a Registration Self-assessment Tool (veterinary)—that will simplify this process.

This self-assessment tool will help hundreds of people with new ideas for animal health and wellbeing cut through some quite complex legal definitions about what is—or isn't—a veterinary product under Australia's agvet legislation.

Equally, anyone who has concerns about whether or not certain unregistered products should in fact be registered can quickly enter a few pertinent details into the self-assessment tool and receive an immediate assessment of whether the product should be registered. Ongoing concerns can be reported to the APVMA

Some products can be clearly and unambiguously identified as veterinary products that require registration, for example they may have an obvious dose or defined clinical use, while others are not so clear cut.

It is equally clear that products such as pet toothpastes and things that are purely cosmetic in nature (and which don't make therapeutic claims) will not need to be registered. 
The APVMA reminds product owners and developers that it's not just a question of the chemical makeup of the product, but the health or therapeutic claims that are made for that product which determine registration requirements under Australian law.

Some products require careful consideration: an example is Vitamin E. When added to animal feed to supplement diets where levels may be low, it is exempt from registration. However, when added to feed to prevent or treat a disease, requires registration.

The new self-assessment tool is supported by an online 'user guide' that explains the legal issues that underpin the self-assessment tool. The user guide also provides helpful information about the types of claims that can and can't be used for products that don't require registration.

This registration self-assessment tool and user guide replace a previous process of making an enquiry to the APVMA via a downloadable document titled Does your product require registration? The APVMA will no longer accept requests for advice using this format and process.

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