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

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Download document Draft guideline on non-clinical documentation in applications for marketing authorisation/registration of well-established and traditional herbal medicinal products - Revision 1
Reference number EMEA/HMPC/32116/2005 Rev.1
Status draft: consultation open
First published 2017-08-22
Last updated 2017-08-22
Consultation start date 2017-08-22
Consultation end date 2017-11-30
Email address for submissions hmpcsecretariat@ema.europa.eu

Summary

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.