Non-clinical documentation for herbal medicinal products in applications for marketing authorization

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Current effective version

Adopted guideline

Currently under revision - see below

Reference numberEMEA/HMPC/32116/05
Effective from13/07/2006
KeywordsHerbal medicinal products, non-clinical, traditional use registration, Community herbal monographs, Community list of herbal substances, toxicity, genotoxicity, carcinogenicity, reproduction
DescriptionThis document provides guidance on the minimum requirements for non-clinical data for wellestablished herbal medicinal products. It applies to bibliographical and mixed applications for marketing authorisations and to applications for simplified registration.

Document history

Revision 1

In progress

Draft guideline



Concept paper

Published: 22/08/2017

Deadline for comments: 30/11/2017



Published: 02/09/2016

First version

Current version

Adopted guideline



Overview of comments

In operation: 13/07/2006–present



Published: 01/11/2007

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