Assessment of genotoxicity of herbal substances/preparations

Current effective version

PDF iconAdopted guideline

Reference number EMEA/HMPC/107079/07
Published 21/05/2008
Effective from 01/12/2008
Keywords Herbal medicinal products, traditional herbal medicinal products, herbal substances, herbal preparations, extracts, genotoxicity testing
Description This document addresses the selection of materials for genotoxicity testing in support of applications for traditional herbal medicinal products/ herbal medicinal products.

Document history

First version

Current version

PDF iconAdopted guideline


PDF iconOverview of comments


PDF iconDraft guideline


PDF iconConcept paper

In operation: 01/12/2008–present


Published: 18/01/2010


Published: 08/01/2009


Published: 15/07/2008

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