(2001; 200 pages)
Directives on homeopathic products
The first phase of European Union legislative harmonization in homeopathy was the adoption of two European Directives that came into force on 1 January 1994 (282) - one on homeopathic products for humans and one on homeopathic veterinary products. These Directives ensure a single European Market for homeopathic products and outline provisions regulating their manufacture, inspection, marketing, and labelling. They also establish a simplified registration procedure for medications containing less than one part per 10 000 of undiluted tincture or less than 1/100th of the smallest dose used in allopathic medicine (281). According to the 1995 European Commission report to the Parliament and the Council on the application of Directives 92/73 and 92/74, however, the existing level of legislative harmonization is insufficient.
The EEC Directive regulates the marketing of proprietary medicinal products (283). However, individual countries are free to restrict the licensing of herbal medicines.
Germany and the United Kingdom have chosen to restrict such licences in order to protect their populations from the possible carcinogenic effects of pyrolizidine alkaloids, which occur in a number of medicinal herbs.