|End of transition period set out in Directive 2004/24/EC|
The European Commission's Directorate General for Health and Consumer Policy (DG SANCO) has published a question and answer document on the registration of traditional herbal medicinal products and the end of the transition period on 30 April 2011. Described in Directive 2004/24/EC, national competent authorities in the member states are responsible for applying the provisions of the Directive.
The way herbal medicinal products are licensed and marketed in Europe is changing following a 2004 European Parliament and the Council Directive (Directive 2004/24/EC of the European Parliament and of the Council, amending, as regards Traditional Herbal Medicinal Products, Directive 2001/83/EC on the European Union Code relating to Medicinal Products for Human Use).
This Directive aims to protect public health and at the same time secure the free movement of herbal medicinal products within the European Union. While most individual herbal medicinal products will continue to be licensed nationally by Member States, the process for licensing and information on herbal substances and, preparations will be increasingly harmonised across the European Union.
One impact of Directive 2004/24/EC is that all Member States will be able to refer to one unique set of information on a herbal substance or herbal preparation when evaluating marketing applications for herbal medicinal products from companies. This reference information includes the therapeutic uses and a set of recommended safe conditions of use. The Directive also introduces a subcategory of herbal medicinal products, the so-called ‘traditional herbal medicinal products’. While safety needs to be shown for products within this category, efficacy does not - only the traditional indications in specified conditions must be plausible.
Market access for herbal medicinal products in the European Union
Today under European medicines legislation, medicinal products containing herbal substances/preparations must fall within one of the following three categories to reach the market:
- a product can be classified under traditional medicinal use provisions (‘traditional use’) accepted on the basis of sufficient safety data and plausible efficacy: the product is granted a traditional use registration (simplified registration procedure) by a Member State,
- a product can be classified under well-established medicinal use provisions (‘well-established use’). This is demonstrated with the provision of scientific literature establishing that the active substances of the medicinal products have been in well-established medicinal use within the Union for at least ten years, with recognised efficacy and an acceptable level of safety. As a result the product is granted a marketing authorisation usually by a Member State or by the European Medicines Agency.
(While both classification have specific requirements, both regulatory paths involve the assessment of mostly bibliographic safety and efficacy data)
- a product can be authorised after evaluation of a marketing authorisation application consisting of only safety and efficacy data from the company’s own development (‘stand alone’) or a combination of own studies and bibliographic data (‘mixed application’). As a result the product is granted a marketing authorisation by a Member State or by the Agency via the centralised procedure if all requirements are met.
Irrespective of the regulatory pathway to access the market, the quality of the herbal medicinal product must always be demonstrated.
European Union herbal monographs prepared by the Committee on Herbal Medicinal Products (HMPC) at the Agency are relevant for the traditional use registration as well as the well-established use marketing authorisation.
For more information on the procedures for placing a herbal medicinal product on the market, please refer to the national competent authority of the Member State where market access is intended. For the exceptional cases of centralised European procedures for Herbal Medicinal Products you may check the possibility of scientific advice and the use of specific provisions in support of small and medium enterprises (SME) provided by the Agency.
The Directive provides definitions for herbal medicinal products, herbal preparations and herbal substances.
From a herbal substance (e.g. valerian root) different herbal preparations (e.g. a valerian root extract using 70% ethanol) can be made. Both can represent the active ingredient in anindividual herbal medicinal product.
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The European Medicines Agency is not responsible for registering traditional herbal medicinal products in the European Union Member States nor for authorising herbal medicinal products unless the centralised procedure applies.
Finding a herbal medicine
The Committee on Herbal Medicinal Products (HMPC)
Key EU legislation
- Directive 2004/24/EC of the European Parliament and of the Council of 31 March 2004 amending, as regards traditional herbal medicinal products
- Directive 2001/83/EC on the Community code relating to medicinal products for human use
- Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004
- European Commission: Paola Testori Coggi, Director General of DG Health and Consumers, explains the Herbals Directive