The APVMA expects applicants to submit applications that are complete, free of errors, and accompanied by the required information and the prescribed fee (if applicable). Where relevant, applications need to contain information that satisfies us that they meet the statutory criteria (safety, efficacy, trade and labelling).

We expect applicants to fully consider the regulatory responsibilities of becoming a holder of an approval or registration prior to submitting an application.

We also expect applicants to familiarise themselves with our application requirements so that high-quality applications are made.

You will find it useful to refer to this section as you complete the registration application.