Site notifications

Sub menu

 

 

CTD Module 1: Administrative information for assessed listed medicines

Applicable to applications received by the TGA from September 2020

Guidance about the administrative information to support assessed listed medicine applications.

Published
Last updated

Note

This Guidance is directly referenced in legislation and must be presented in its original publication format. You can contact nonprescriptionmedicines@health.gov.au for any questions about this guidance. 

Downloads

Product types

Page history

Show all page updates (2)

Version 1.1: 

  • Updated Introduction and module 1.2, 1.2.5, 1.3.3 and 1.11.
  • Removed duplication under module 1.0.1.
  • Added module 1.5.8 Umbrella brand assessment.
  • Module 1.9.1, updated link to ‘summary of a bioavailability or bioequivalence study form’.
  • Other minor amendments to improve clarity of document.

Version 1.0: Original publication. 

Version 1.1: 

  • Updated Introduction and module 1.2, 1.2.5, 1.3.3 and 1.11.
  • Removed duplication under module 1.0.1.
  • Added module 1.5.8 Umbrella brand assessment.
  • Module 1.9.1, updated link to ‘summary of a bioavailability or bioequivalence study form’.
  • Other minor amendments to improve clarity of document.

Version 1.0: Original publication.