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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.

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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. 

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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. 

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