J Ethnopharmacol. 2014 Dec 2;158 Pt B:471-86. doi: 10.1016/j.jep.2014.07.015. Epub 2014 Jul 17.
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.
Copyright © 2014. Published by Elsevier Ireland Ltd.
Copyright © 2014. Published by Elsevier Ireland Ltd.
KEYWORDS:
Community herbal monographs; Directive 2004/24/EC; European herbal medicines regulation; Traditional use registration- PMID:
- 25043780
- [PubMed - in process]
