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ARGOM Appendix 2: Guidelines on quality aspects of OTC applications
1. Application format and content
The preferred format for OTC product registration applications is the Common Technical Document (CTD). A detailed description of the CTD format can be found on the Therapeutic Goods Administration (TGA) web site
For many OTC product registration applications, not all parts of the CTD will be relevant. In these cases, the absence of the specific information should be identified in the application, for example by means of a statement such as ‘not applicable’ against the relevant heading in the Table of Contents.
The CTD document, International Conference on Harmonisation (ICH) M4Q Common Technical Document for the Registration of Pharmaceuticals for Human Use - Quality (CPMP/ICH/2887/99 Rev 1), provides guidance in preparing the quality section (Module 3) of the application and the critical summary (Module 2.3, Quality Overall Summary).
Further guidance on specific quality matters, such as assay validation and design of stability studies can also be found in the relevant European Union (EU) guidelines that have been adopted by the TGA (some with TGA annotations).