This content is current only at the time of printing. This document was printed on 20 June 2018. A current copy is located at https://apvma.gov.au/node/19986
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The data guidelines provide applicants with guidance on what data and information to prepare and provide to support their application.
Applications need to address a range of criteria such as safety, trade and efficacy. For the APVMA to grant an approval or registration, it must be satisfied the applicant’s data and information satisfies all the criteria relevant to the particular product or active.
The guidelines also increase the transparency—and predictability—of APVMA decision making under the Agvet Code.
The data guidelines are intended to provide guidance to applicants on what data could be submitted to support their applications. The guidelines are not intended to be prescriptive and should not be perceived as APVMA requirements.
Updates to the data guidelines
The data guidelines have been published as living documents—meaning they can undergo review at any time.
The review process will be ongoing and the APVMA will provide consultation opportunities on significant changes. Changes following any consultation process will be communicated through the regulatory update process and on the website.