Non-clinical documentation in applications for marketing authorisation / 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 should be read in conjunction with the general requirements set out by Directive 2001/83/EC, in particular its Annex I, and general methodological requirements published by the EMA.

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).

Changes have been introduced accordingly in all sections of the guideline

Keywords: Herbal medicinal products, non-clinical documentation, traditional use registration, marketing authorisation, European Union herbal monographs, European Union list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products, toxicity, genotoxicity, carcinogenicity, toxicity to reproduction

How useful was this page?

Add your rating