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:
- 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
- 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.