Data guidelines

These data guidelines provide applicants with guidance on what data and information to prepare and provide to support their application. For the APVMA to grant an approval or registration, the APVMA must be satisfied that the safety, trade and efficacy criteria relevant to the particular product or active are met.

The guidelines also increase the transparency—and predictability—of APVMA decision making under the Agvet Code. The guidelines are not intended to be prescriptive and should not be perceived as APVMA requirements.

The data guidelines can undergo review at any time and the APVMA will provide consultation opportunities on significant changes. Changes made will be communicated through regulatory updates and on the website.