When can modules 2.6 and 2.7 be omitted?

For applications for approval according to Art. 14, para. 1, letter a^bis, modules 2.4 and 2.5 are required in accordance with the guidelines, in which the evidence must be scientifically substantiated, summarized, and evaluated. The submission of modules 2.6 and 2.7 is not explicitly mentioned. However, according to Q&A Question 1.9, Swissmedic has previously also required Modules 2.6 and 2.7. In response to our inquiry, Swissmedic has stated that modules 2.6 and 2.7 are always required when submitting own non-clinical and clinical studies (reports). If the application is exclusively literature-based (bibliographic), i.e. does not contain any clinical study reports, modules 2.6 and 2.7 are not required. The reason for this is that, in purely literature-based dossiers, modules 2.6 and 2.7 largely duplicate the information contained in modules 2.4 and 2.5.

Applications according to Art. 14, para.1, abis - TPA

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