ABSTRACT
In Europe, dietary supplements account for 15-20 per cent of the herbal market. Although regulations vary from country to country, in Europe, herbal products are generally considered as medicines. Therefore, full registration with a full dossier on quality, safety and efficacy has to be submitted for pre-market approval. Bibliographic documentation can be based on clinical trials, and the monographs of the European Pharmacopoeia (EP), World Health Organization (WHO), German Commission E and the European Scientific Cooperative on Phytotherapy (ESCOP). There is a simplified way of registering a herbal product as medicine with proof of efficacy based on long-term traditional use in countries like Germany, Austria, Belgium and France. In such a case, the medicine has to carry a disclaimer on the label stating that it is ‘traditionally used’ (Lawson and Bauer, 1998; Stott, 1998; Grünwald, 1999; Steinhoff, 2001).
