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

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

Current effective version

Guideline on non-clinical documentation in applications for marketing authorisation/registration of well-established and traditional herbal medicinal products - Revision 1

AdoptedReference Number: EMEA/HMPC/32116/2005 Rev.1

Document history

Draft guideline on non-clinical documentation in applications for marketing authorisation/registration of well-established and traditional herbal medicinal products - Revision 1

Consultation dates: 22/08/2017 to 30/11/2017Draft: consultation closedReference Number: EMEA/HMPC/32116/2005 Rev. 1Summary:

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/EC1, in particular its Annex I, and general methodological requirements published by the 29 EMA.

Concept paper on the revision of the 'Guideline on non-clinical documentation for herbal medicinal products in applications for marketing authorisation (bibliographical and mixed applications) and in applications for sim...

Consultation dates: 02/09/2016 to 30/11/2016Draft: consultation closedReference Number: EMA/HMPC/353983/2016Summary:

In 2006, the 'Guideline on non-clinical documentation for herbal medicinal products in applications for marketing authorisation (bibliographical and mixed applications) and in applications for simplified registration' was published. The purpose of the guideline was to harmonize the minimum requirements for non-clinical data for well-established herbal medicinal products in bibliographical applications for marketing authorisations and to provide guidance which non-clinical safety aspects should be addressed in the expert report for the simplified registration of traditional herbal medicinal products and which additional non-clinical safety tests might be necessary to prove safety. The guideline has now been available for approximately 10 years and a considerable practical experience has been gathered during the use of this Guideline in national and European applications and for the preparation of more than 150 monographs.

Guideline on non-clinical documentation for herbal medicinal products in applications for marketing authorization (bibliographical and mixed applications) and in applications for simplified registration - First version

AdoptedLegal effective date: 13/07/2006Reference Number: EMEA/HMPC/32116/2005

Overview of comments received on guideline on non-clinical documentation for herbal medicinal products in applications for autorisation (bibliographical and mixed applications) and in applications for simplified registra...

Reference Number: EMEA/HMPC/132154/2006