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