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, 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.

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.

Evidence of Good Manufacturing Practice (GMP) for veterinary chemical products

Unless an exemption or exclusion applies, each Australian-based manufacturing site must hold a current licence that is appropriate for the specific type of product.

Guidance for preparing information lists

The APVMA's expectations on how to compile an information list.

Dossiers

How to put together a dossier to support an application.

Required information

What information is required to support your application including how we can be satisfied that it meets the relevant statutory criteria.

Statutory criteria

Information about meeting the statutory criteria for approvals, registrations and variations.

Ag Labelling Code

The Agvet Code requires that all agricultural chemical products supplied to the marketplace have an approved label attached to the container.

Vet Labelling Code

The Agvet Code requires that all veterinary chemical products supplied to the marketplace have an approved label attached to the container.

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