The application must be accurately completed and the application must be accompanied by the prescribed fee. The legislation includes penalties for the provision of false or misleading information.

You will be required to provide certain information to support your application including how we can be satisfied that it meets the relevant statutory criteria. When the application is made, the following information may be required:

  • Information that will allow us to consider our satisfaction against the safety criteria, efficacy criteria and trade criteria.
  • For the appointment or variation of a nominated agent: written consent from the proposed nominated agent.
  • A justification as to why a product registration or variation application has not been made.
  • A justification as to why the permit application is for a minor use, emergency use or research permit.
  • For a manufacturing permit: a justification as to why a licence application or variation to a licence application has not been made.
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