How to submit an international assessment

For an internal assessment, you should submit the following information with your registration application through the Australian Pesticides and Veterinary Medicines Authority's (APVMA) Online Services Portal:

  • A copy of the label or full information on the use that the assessments addressed
  • A copy of the dossier that was submitted to the assessment authority
  • A copy of the full assessment report produced by the authority including assessments all of submitted studies. We will not accept summaries or outcomes of assessments
  • Evidence of ownership of the data and dossier, or a letter of access
  • A reasoned justification of the relevance of the assessment to the proposed use in Australia.
  • Details of any specific conditions on use imposed by the overseas registration and whether they are relevant to the use in Australia
  • A declaration that all the data considered by the assessment authority has been submitted to the APVMA
  • A listing of any additional data that has been submitted to the APVMA that was not considered in the overseas assessment

Uploading files to the Online Services Portal

When uploading files to the Online Services Portal, you will be asked to specify using the options provided if the file is an international assessment, international data with or without an international assessment, Australian data or another type of file.

If selecting international assessment as file type, before completing the application, you’ll also be asked to:  

  • declare whether all of the data submitted to the international body in support of the international assessment is included with your APVMA application, along with any other required data
  • specify the country of origin of the international assessment (see above list of countries and official bodies from which we accept international assessments).
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