(2002; 166 pages)
Regulation of homoeopathic products in the United Kingdom
Dr Ian Hudson, United Kingdom
Homoeopathic products are commonly used in the United Kingdom. About 20% of the UK population have used homoeopathic products and the sales are reported to be about ¡Ì25 million per year.
Registration of homoeopathic products in the UK dates back to 1971 when the Medicines Act was first implemented. Existing homoeopathic products were issued with Product Licences of Right. They are subject to labelling and advertising restrictions and are constantly reviewed for conformity with current safety and quality standards.
In 1994, the Special Simplified Registration Scheme was implemented, which avoids considerations of efficacy. Restrictions are placed on the route of administration, degree of dilution, therapeutic claims and the use of trade names. Assessment is based on issues of quality, safety and labelling. If expert opinions are necessary, an application will be referred to the Advisory Board on the Registration of Homoeopathic Products.
Recent challenges in the regulation of homoeopathic products include pressure from consumers for more information on their use. In addition, debates have been stirred up on how to deal with products not previously used in traditional UK homoeopathy, and on the problems in quality and safety evaluations owing to the high dilution.
One future goal is the establishment of specific national rules in the UK for those homoeopathic products not eligible for the simplified scheme. More collaboration and harmonization within member states of the EU are also necessary.