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European Coalition on Homeopathic & Anthroposophic Medicinal Products


EMA consultation on non-clinical documentation for licensing of herbal medicines

Sep 05, 2017

The European Medicines Agency (EMA) has released for public consultation a draft guideline on non-clinical documentation in applications for marketing authorisation or registration of well-established and traditional herbal medicinal products.

This guideline is intended to give advice for preparing and assessing applications for marketing authorisation of well-established herbal medicinal products and for the registration of traditional herbal medicinal products. It clarifies certain aspects of the general requirements set out by Directive 2001/83/EC, in particular its Annex I, and general methodological requirements published by the EMA.

 This is the first update of the guideline for 10 years, and it takes into account experiences gained during the use of this guideline in national and European procedures and also during establishment of EU herbal monographs. It also refers to related guidelines introduced since the publication of the first version: Assessment of genotoxicity of herbal substances/preparations, Selection of test materials for genotoxicity testing, Limits of genotoxic impurities and ICH S2 (R1) on Genotoxicity testing and data interpretation for pharmaceuticals intended for human use.

 The document is available on the EMA website.

If you want ECHAMP to submit comments please send your input to by 13 October 2017.