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:
- Process validation scheme for the drug product
- Certificates of suitability (including any annexes)
Reference: Guidance 11: Drug Master Files and Certificates of Suitability of a Monograph of the European Pharmacopoeia for drug substances - Risk of transmitting animal spongiform encephalopathy agents
Reference: Note for Guidance on Minimising the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Human and Veterinary Medicinal Products EMA/410/01 Rev 3 and the Transmissible Spongioform Encephalopathies (TSE): TGA approach to minimising the risk of exposure - Certified product details
Reference: Guidance 7: Certified product details - Supplier's declarations regarding compliance with packaging standards and colouring standards.
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.
This webpage on the TGA website was printed on 18 Sep 2024. Printed content may be out of date. For up-to-date information, always refer to the digital version: https://www.tga.gov.au/resources/resource/guidance/ctd-module-1/23r-32r-regional-information