This document aims to provide guidance on how to present the application for registration of traditional herbal medicinal products (THMPs) in the Common Technical Document (CTD) format, providing information to help applicants in their submissions. Revision 2 pertains to the presentation and content of Modules 2, 4 and 5 of dossiers for THMPs, to help applicants in their submissions. More detailed clarifications have therefore been introduced mainly in sections 1.5, 2.4, 2.5, 5.3 and 5.4. In addition, minor editorial corrections and amendments have been introduced in other sections.



Posted on the EMA website on 9 April 2015