title: The use of community herbal monographs to facilitate registrations and authorisations of herbal medicinal products in the European Union 2004-2012.
abstract: The provisions for the simplified registration of traditional herbal medicinal products in the European Union were introduced by Directive 2004/24/EC amending Directive 2001/83/EC (Chapter 2a) in 2004. Since implementation in the European member states until December 2012 a total of 1015 registrations (traditional use) and 514 authorisations (well-established use) have been granted for products containing substances/ preparations from about 200 different herbal drugs. The overall number of received applications with more than one third still under assessment suggests a further increase for the next years. This review summarises the main features of registered and authorised herbal medicinal products in the EU and evaluates available data against provisions of Directive 2004/24/EC and European standards established by the Committee on Herbal Medicinal Products at the European Medicines Agency. The supportive function of Community herbal monographs is described as regards availability and their use in national procedures, which is complemented by an analysis of specific future challenges from experiences made with the implementation of Directive 2004/24/EC so far.
authors.affiliation: HMPC Secretariat, European Medicines Agency, 7 Westferry Circus, Canary Wharf, London E14 4HB - United Kingdom. Electronic address: wieland.peschel@ema.europa.eu.
authors.forename: Wieland
authors.initials: W
authors.lastname: Peschel
mesh_terms: D017277:Drug Approval / Q000331:legislation & jurisprudence*; D005062:European Union; D006801:Humans; D007880:Legislation, Drug; D008519:Medicine, Traditional / Q000592:standards; D008517:Phytotherapy / Q000592:standards; D028321:Plant Preparations / Q000592:standards*
chemical_list: D028321:Plant Preparations
keywords: Community herbal monographs; Directive 2004/24/EC; European herbal medicines regulation; Traditional use registration