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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.

journal_name

J Ethnopharmacol

journal_title

Journal of ethnopharmacology

authors

Peschel W

doi

10.1016/j.jep.2014.07.015

subject

Has Abstract

pub_date

2014-12-02 00:00:00

pages

471-86

eissn

0378-8741

issn

1872-7573

pii

S0378-8741(14)00519-4

journal_volume

158 Pt B

pub_type

杂志文章

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