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CTD Module 1

3 August 2020

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2.3.R / 3.2.R Regional information

Any additional drug substance/active substance and/or drug product information specific to Australia should be provided in section R of the application. Applicants should consult the appropriate TGA guidelines for additional guidance.

2.3.R Regional information

A brief description of the information specific to the region, as provided under 3.2.R should be included, where appropriate.

3.2.R Regional information

Any additional drug substance and/or drug product information specific to Australia should be provided in section 3.2.R of the application.

Where similar or relevant information has been provided in another section of Module 3 or where there is supporting or related information from other modules of the application, the applicant is encouraged to clearly cross-reference to the location of that information. Cross-referencing should be sufficiently detailed, so as to allow the appropriate information to be easily located within the dossier.

Applicants should include the following information in Module 3.2.R, where appropriate:

When to include certificates of suitability

Include when:

  • the initial registration of the active ingredient for the sponsor makes reference to one or more Certificate of Suitability of Monographs of the European Pharmacopoeia (CEPs).
  • subsequent regulatory activities for a new registration or a variation to an existing registration requires a new or amended CEP.

How to prepare information about certificates of suitability

  • Include a copy of each certificate of suitability (including any annexes) referenced in the application in Module 3.2.R.

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