This document addresses the selection of materials for genotoxicity testing in support of applications for traditional herbal medicinal products/ herbal medicinal products.

Keywords: Herbal medicinal products, traditional herbal medicinal products, herbal substances, herbal preparations, extracts, genotoxicity testing

Current effective version

Guideline on the assessment of genotoxicity of herbal substances/preparations

AdoptedLegal effective date: Reference Number: EMEA/HMPC/107079/2007

English (EN) (127.85 KB - PDF)

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Concept paper on the revision of the guideline on the assessment of genotoxicity of herbal substances/preparations (EMEA/HMPC/107079/2007)

Consultation dates: to Draft: consultation closedReference Number: EMA/HMPC/41456/2022

English (EN) (190.94 KB - PDF)

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Document history - First version (current)

Guideline on the assessment of genotoxicity of herbal substances/preparations

AdoptedLegal effective date: Reference Number: EMEA/HMPC/107079/2007

English (EN) (127.85 KB - PDF)

First published: Last updated:
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Overview of comments received on draft guideline on the assessment of genotoxic constituents in herbal substances/ preparations (EMEA/HMPC/107079/2007)

Reference Number: EMEA/HMPC/232888/2008

English (EN) (169.13 KB - PDF)

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Draft guideline on the assessment of genotoxic constituents in herbal substances/preparations

Draft: consultation closedReference Number: EMEA/HMPC/107079/2007

English (EN) (140.42 KB - PDF)

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Concept paper on the development of a guideline on the assessment of genotoxic constituents in herbal substances/preparations

Draft: consultation closedReference Number: EMEA/HMPC/413271/2006

English (EN) (44.67 KB - PDF)

First published: Last updated:
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