SOURCE: European Parliament and Council
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 recommended the creation of a committee for herbal medicinal products to ensure the involvement of experts.
The Directive provides for a special registration procedure allowing the marketing of certain traditional herbal medicines with a thirty year history of safe use, without the need for documents on safety and efficacy tests and trials. Applicants would be required to present bibliographical or expert evidence on the traditional medicinal use of the product, as well as safety data and an expert report.
If the product has not been available within the Community for the thirty year period, 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 is to be compiled. Manufacturers must include a notice on the product label and in advertising which states that the product 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. A key task will be to establish Community herbal monographs containing information such as a definition, ingredients, clinical information, pharmacological properties and bibliographical references.
The complete text of the proposal can be found at:
Proposal Revising Directive for Tradional Herbal Medicinal Products