Assessment of clinical safety and efficacy in the preparation of Community herbal monographs for well-established and of Community herbal monographs/entries to the Community list for traditional herbal medicinal products/substances/preparations

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Current effective version

Adopted guideline

Currently under revision - see below

Reference numberEMEA/HMPC/104613/05
Effective from01/03/2007
KeywordsHerbal medicinal products, clinical safety, efficacy, traditional use registration, Community herbal monographs, Community list of traditional herbal substances
DescriptionThis document describes the criteria for assessment of data that are used for preparing Community monographs on herbal medicinal products and the Community list of traditional herbal substances, preparations and combinations thereof. It addresses well-established herbal medicinal products and traditional herbal medicinal products.

Document history

Revision 1

In progress

Draft guideline



Concept paper

Published: 01/09/2016

Deadline for comments: 30/11/2016


Published: 16/10/2015

First version

Current version

Adopted guideline

Overview of comments

In operation: 01/03/2007–present

Published: 07/09/2006

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