AI Article Synopsis
- The EU introduced simplified registration for traditional herbal medicinal products through Directive 2004/24/EC in 2004, amending earlier regulations.
- By December 2012, there were 1,015 registrations for traditional use and 514 authorizations for well-established use across around 200 herbal drugs, with a growing number of applications still in review.
- The review examines the compliance of these products with EU guidelines, discusses the role of Community herbal monographs, and addresses future challenges based on the directive's implementation experiences.
Article 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.
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| http://dx.doi.org/10.1016/j.jep.2014.07.015 | DOI Listing |
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