What to include in your application

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 and trade).

We expect applicants to fully consider the regulatory responsibilities of obtaining a permit prior to submitting an application.

We also expect applicants to familiarise themselves with our application requirements and adhere to the APVMA's customer service charter so that high-quality applications are made.

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

Data guidelines

The data guidelines provide guidance to applicants on what data could be submitted to support their applications and on how applicants may address the statutory criteria.

Dossiers

How to put together a dossier to support a permit application.

Required information

What information is required to support your application.

Statutory criteria

Information about meeting the statutory criteria for safety, efficacy and trade.

Labelling requirements

When assessing a permit that may require a condition that the product only be supplied with a particular label, we will assess whether it contains appropriate instructions.

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