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Pre-submission planning

Pre-submission planning for your biologicals application.

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A pre-submission meeting can help both the applicant and TGA to:

  • obtain a common understanding of the therapeutic good and:
    • what supporting documentation is needed to evaluate the application
    • any issues to resolve before submitting applications
  • plan for the submission and to manage both timeframes and resources.

Guidance and resources

  • Request for advice - Biologicals

    Forms
    This form guides you through the classification of biologicals and captures sufficient information about your product for us to provide advice

More information

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