Non-clinical documentation in applications for marketing authorisation / registration of well-established and traditional herbal medicinal products

25 février 2019


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. Revision 1 pertains to an update of the guideline after 10 years taking into account experiences gained during the use of this guideline in national and European procedures and also during establishment of EU herbal monographs. Other related guidelines not yet available at time of the first version have been taken into consideration: Assessment of genotoxicity of herbal substances/preparations (EMEA/HMPC/107079/2007), Selection of test materials for genotoxicity testing for Traditional Herbal Medicinal Products/Herbal Medicinal Products (EMEA/HMPC/67644/2009), and ICH S2 (R1) on Genotoxicity testing and data interpretation for pharmaceuticals intended for human use (CHMP/ICH/126642/2008).


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