Assessment of clinical safety and efficacy in the preparation of EU herbal monographs for well-established and traditional herbal medicinal products

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Current effective version

Adopted guideline - Revision 1

Reference numberEMA/HMPC/104613/2005 Rev. 1
Effective from28/11/2017
KeywordsHerbal medicinal products, clinical safety, efficacy, traditional use registration, marketing authorisation, European Union herbal monographs, European Union list of traditional herbal substances, preparations or combinations thereof
DescriptionThis guideline describes the legal background and recommendations for the assessment of data that are used to prepare European Union herbal monographs (formerly called Community herbal monographs) on herbal medicinal products and the European Union list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products. The areas of herbal medicinal products with well-established medicinal use and traditional herbal medicinal products are addressed.

Document history

Revision 1

Current version

Adopted guideline


Overview of comments


Draft guideline



Concept paper

In operation: 28/11/2017-present


Published: 28/11/2018


Published: 01/09/2016

Deadline for comments: 30/11/2016


Published: 16/10/2015

First version


Adopted guideline

Overview of comments

In operation: 01/03/2007-28/11/2017

Published: 07/09/2006

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