Guidelines for therapeutic pet foods that require registration as veterinary chemical products

Many veterinary products, but not all, need to be registered by the APVMA before they can be sold in Australia.. It’s important that anyone wanting to develop or market a new veterinary product understands the rules that determine whether their product needs to be registered. If your product does need registration, Australian law requires you to register your veterinary product before it can be sold in the Australian marketplace, or you will face severe penalties.

By veterinary products, the APVMA means items that are defined by the legislative framework as 'veterinary chemical products'. Veterinary chemical products may also be known as veterinary medicines and may include veterinary chemical products that may be excluded from registration.

Some products clearly and unambiguously need to be registered—for example, those with an obvious dose or defined clinical use—while others are not so clear cut. In between these very clear cases, a number of factors must be considered to work out whether a particular product needs to be registered before it can be legally sold in the Australian marketplace.

This guideline helps applicants to determine which pet-food products are likely to require registration with the APVMA. This guideline also advises you what information you should submit with an application for a therapeutic pet food.

Many pet food products will be excluded from the scope of the APVMA’s regulation by the requirements of the 2015 reforms which come into effect on 5 in March 2015. These products, which are referred to as ‘excluded nutritional or digestive products’, will not require registration.

To be excluded under the 2015 reforms, a pet food must be one that is fed to, and voluntarily consumed by an animal and must meet certain requirements for ingredients, claims, labelling and manufacture. These requirements are summarised here. You can also use the Registration self-assessment tool (veterinary) for guidance on whether an animal feed requires registration.

 

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