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CTD modules 2, 3, 4 and 5 for registered complementary medicine applications- Guidance for applicants

Formerly included in ARGCM V 8.0 Part D
20 May 2020
Download CTD modules 2, 3, 4 and 5 for registered complementary medicine applications- Guidance for applicants

Description

Guidance for applicants on information required for modules 2- 5 in dossiers for applications for registered complementary medicines to be consistent with the Common Technical Document (CTD) format.

The CTD modules 2 to 5 registered complementary medicines data requirements matrix at the end of the document provides a useful summary of the CTD module documents required for new registered complementary medicine applications.

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