Brussels, 21 January 2002
The European Commission has proposed a registration scheme for herbal medicinal products with a history of traditional use in order to improve quality checks and harmonise standards across the EU. It has also proposed the creation of a committee for herbal medicinal products to ensure the involvement of experts.
Many herbal medicinal products have been used for a long time despite a lack of scientific literature on the products which means that a well-established medicinal use cannot be demonstrated. New tests and trials on the products create a financial burden for the companies concerned, particularly as the majority of companies in this industry are SMEs (small and medium sized enterprises). The tests are also 'difficult to justify where the traditional use of the medicinal product is of such a nature as to allow sound conclusions on its safety and efficacy,' reads the explanatory memorandum accompanying the Commission proposal.
Apart from a few multinational companies, many enterprises in the herbal medicine industry are SMEs, and over 50 per cent of the EU market is located in France and Germany.
The Directive proposed by the Commission provides for a special registration procedure allowing the marketing of certain traditional herbal medicines without the need for documents on safety and efficacy tests and trials. Instead of providing the results of these tests and trials, applicants would be required to present bibliographical or expert evidence on the traditional medicinal use of the product, as well as a bibliographic review of safety data and an expert report. The applicant must also provide evidence that the product has been used within the Community for the last 30 years. If the product has not been available within the Community for that long, the applicant can provide evidence of it having been used within the Community for the last 15 years, and outside the Community for 30 years.
A list of herbal substances which fulfil the conditions of eligibility for the registration procedure is to be compiled. Manufacturers will be obliged to include a notice on the product label and in any advertising, stating that it is a traditional herbal medicinal product and its efficacy has not been clinically proven.
The Committee for herbal medicinal products will be set up within the European agency for the evaluation of medicinal products. The committee will be made up of one representative from each EU Member State, nominated by their country of origin. One of the organisation's main tasks will be to establish Community herbal monographs containing information for herbal medicinal products, such as a definition, ingredients, clinical information, pharmacological properties and bibliographical references.
In the proposals, the Commission states that all Member States should take the necessary measures to comply with the Directive by 31 December 2004. For traditional herbal medicinal products which are already on the market, the relevant authorities should apply the provisions within five years of the Directive coming into force.
To see the proposal, please consult the following web address: