Brussels, 02/05/2011 (Agence Europe) - After 1 May 2011, the public may be sure that traditional herbal medicines sold in the EU are safe and effective, the Commission says in a press release which notes that the seven-year transition period set by the directive on this kind of product (Directive 2004/24/EC) was coming to an end. This means that only medicinal products which have been registered or authorised can remain on the EU market. The 2004 Herbal Directive introduces a simpler registration procedure than for other medicinal products, given the long history of use of traditional herbal medicinal products.
All medicinal products, including traditional herbal medicinal products, need a marketing authorisation to be placed on the EU market. The simplified procedure introduced by the Herbal Directive allows these products to be registered without the safety tests and clinical trials that a full marketing authorisation procedure would involve. Instead, an applicant who wishes to register a traditional herbal medicinal product must provide documentation showing that the product in question is not harmful in the specified conditions of use and also provide evidence that the product has a proven track record, i.e. that it has been used safely for at least 30 years - 15 of these in the EU.
The 2004 directive provided for an exceptionally long transition period of 7 years for manufacturers to register their traditional herbal products already on the EU market when the directive came into force. Applicants, then, have had 7 years to apply to the competent authority in the member states(s) where they wanted to market their product. If, by 30 April 2011, a herbal medicinal product has not been registered or authorised, it may not be put on the EU market after 1 May 2011. After this date, producers of traditional herbal medicines can still apply for a registration through the simplified registration procedure.
In its press release, the Commission notes and highlights that the directive on herbal medicines “does not ban traditional medicines … does not ban vitamins, mineral supplements and herbal teas (and) does not ban alternative therapies and therapists, homeopathy, plants or books on plants”. (O.L./transl.rt)