Proceedings of the Tenth International Conference of Drug Regulatory Authorities (ICDRA) - Hong Kong, China, 24 - 27 June 2002
(2002; 166 pages) View the PDF document
Table of Contents
View the documentAbbreviations and acronyms used in this report
Open this folder and view contentsOpening ceremony
Open this folder and view contentsHerbal medicines
Open this folder and view contentsKeynote address
Open this folder and view contentsSafety of blood-derived products
Open this folder and view contentsAntimicrobial resistance - new initiatives
Open this folder and view contentsHarmonization I
Open this folder and view contentsHarmonization II
Open this folder and view contentsProtection of trial subjects in clinical trials
Open this folder and view contentsRegulating biotechnology products
Open this folder and view contentsRegulatory challenges: health sector reform and drug regulatory capacity
Open this folder and view contentsAccess to drugs and vaccines I
Open this folder and view contentsAccess to drugs and vaccines II
Open this folder and view contentsCounterfeit pharmaceutical products
Close this folderHomoeopathy
View the documentRegistration criteria for homoeopathic medicinal products in the United Arab Emirates
View the documentThe regulatory framework for homoeopathic medicinal products in Germany and in the European Union
View the documentRegulation of homoeopathic products in the United Kingdom
View the documentRecommendations
Open this folder and view contentsSafety monitoring
Open this folder and view contentsE-Commerce
Open this folder and view contentsCurrent topics
Open this folder and view contentsRegulatory challenges of new technologies
View the documentList of participants
View the documentBack cover
 

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.

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