data lists for applications

A data list is required whenever data is submitted to the APVMA in connection with an application for active constituent approval or product registration; or in connection with an application for variation. Data lists are required to satisfy data protection and/or transparency requirements.

The APVMA has three tools available for the preparation of data lists, a Data List Editor (preferred), as well as Microsoft Word and Rich Text Format templates. Applicants must use one of these tools to compile a data list in accordance with the relevant instructions for use. If an applicant does not provide a data list in the required format the application may be rejected.

For more information download Application Requirements for Data Protection, Applications Summaries and Advice _(PDF - 46KB)

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