Guideline on the use of the CTD format in the preparation of a registration application for traditional herbal medicinal products

Current effective version

PDF iconRevision 2 - Adopted guideline

Reference numberEMA/HMPC/71049/2007 Rev. 2
Published27/06/2016
Effective from05/04/2016
KeywordsHerbal medicinal products (HMPs) ; traditional herbal medicinal products (THMPs); CTD; traditional use simplified registration; HMPC
DescriptionThis 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 the applicant in their submissions.

Revision history

Revision 2
Current version

PDF iconAdopted guideline

PDF iconOverview of comments

PDF iconDraft guideline

PDF iconConcept paper

In operation: 05/04/2016–present

Published: 27/06/2016

Published: 09/04/2015

Published: 23/07/2009

Revision 1

PDF iconAdopted guideline

PDF iconOverview of comments

PDF iconDraft guideline

PDF iconConcept paper

Published: 13/05/2013

Published: 13/05/2013

Published: 08/08/2012

Published: 01/06/2011

First version

PDF iconAdopted guideline

PDF iconOverview of comments

In operation: 10/08/2011-12/05/2013

Published: 10/01/2008

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