Legal Status of Traditional Medicine and Complementary/Alternative Medicine: A Worldwide Review
(2001; 200 pages) View the PDF document
Table of Contents
View the documentAcknowledgements
View the documentForeword
Open this folder and view contentsIntroduction
Open this folder and view contentsAfrica
Open this folder and view contentsThe Americas
Open this folder and view contentsEastern Mediterranean
Open this folder and view contentsEurope
Open this folder and view contentsSouth-East Asia
Open this folder and view contentsWestern Pacific
View the documentReferences
Close this folderAnnex I. The European Union
View the documentGeneral principles
View the documentDirectives on homeopathic products
View the documentFree movement of patients and practitioners and insurance coverage of complementary/alternative medicine products and treatments

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.

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