Concept paper on the second revision of the guideline on the use of the CTD format in the preparation of a registration application for traditional herbal medicinal products

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Download document Concept paper on the second revision of the guideline on the use of the CTD format in the preparation of a registration application for traditional herbal medicinal products
Reference number EMA/HMPC/555178/2013
Status draft: consultation closed
First published 03/12/2013
Last updated 03/12/2013

Summary

This concept paper is concerned with the revision of the clinical and non-clinical sections of the guideline on the use of the Common Technical Document (CTD) format in the preparation of a registration application for traditional herbal medicinal products (EMA/HMPC/71049/2007 Rev. 1).