This section provides information on the background to Directive 2004/24/EC and its European negotiations. The Directive introduced a registration scheme for finished over-the-counter herbal remedies, suitable for use without the intervention of a medical practitioner. Products are required to meet specific standards of safety and quality and improved information on the safe use of herbal products.
Introduction
In January 2002, the European Commission adopted formal proposals for a Directive on Traditional Herbal Medicinal products. The MHRA held a full public consultation (MLX 283) during the summer of 2002 which was extended following a request from Ministers for a greater degree of dialogue between the herbal sector and the Agency. Informal consultation continued through 2003 with representatives of the herbal sector attending meetings to discuss many aspects of the Directive, as proposed at that time.
European negotiations
The MHRA and the herbal sector agreed that the key priorities in the negotiations were additional provisions enabling acceptance of evidence of traditional use from outside the European Union, and the possibility for companies to include vitamins and minerals with traditional herbal remedies. These objectives were achieved in European negotiations.
A consultation document, MLX 325: Consultation on the Implementation of the Directive on Traditional Herbal Medicinal Products: Directive 2004/24/EC was launched by the Agency on 16 June 2004. A summary of the consultation returns and the Agency's response to the issues raised are available.
The Directive
Directive 2004/24/EC amends Directive 2001/83/EC, the Community code on medicinal products for human use, to introduce the THMRS. It also applies many of the existing requirements in Directive 2001/83/EC to traditional herbal medicinal products. Directive 2001/83/EC was separately amended by Directive 2004/27/EC. Applicants will need to be aware of the requirements of Directive 2001/83/EC and 2004/27/EC since these amendments came into effect at the same time as the traditional use scheme.
Further information
For further information on the Traditional Herbal Medicines Registration Scheme, please see our 'Where to go for further advice' section.
