Pre-submission planning

Pre-submission planning for your biologicals application.

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

6 January 2020

Forms

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

More information