Statutory criteria

We must grant an application for approval, registration or variation if we are satisfied that the statutory criteria, including the safety criteria, efficacy criteria, trade criteria and labelling criteria have been met. In addressing the criteria, the applicant may provide information, or valid scientific argument that might address a specific criterion.

Active constituent

Criteria for demonstrating that an active constituent is safe.

Chemical product

For a chemical product, the APVMA must be satisfied that the product meets the safety criteria, the efficacy criteria, the trade criteria, and the labelling criteria.

Satisfying the statutory criteria

You must indicate in your application how you expect us to be satisfied that the statutory criteria relevant to your application have been addressed.

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