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Medicines and Healthcare products Regulatory Agency

November 6, 2006

Question written on 06/11/2006

To ask the Secretary of State for Health if she will make a statement on the operation of the Medicines and Healthcare products Regulatory Agency’s national rules scheme for homeopathic medicines.

Answered by Andy Burnham

The national rules scheme for homeopathic products was launched on 1 September 2006. It complements current arrangements for the authorisation of homeopathic products used for minor symptoms or conditions within the tradition of homeopathy practised in the United Kingdom.Before the introduction of the new scheme, homeopathic products either held product licences of right (PLRs) or were registered under a simplified scheme. PLR licences were issued to all medicinal products on the market at the time that the Medicines Act 1968 was implemented in 1971. Homeopathic PLRs are allowed to carry descriptions of the symptom or condition that the product is used to treat, called indications. In 1992 European Union legislation introduced a simplified scheme for homeopathic products, so-called because the safety and quality of products have to be demonstrated, but there is no requirement to demonstrate efficacy. The simplified scheme is restricted to products for oral and external use and does not allow indications.Products authorised under the new national rules scheme will comply with all the requirements placed on conventional medicines, with the exception of those relating to preclinical tests and clinical trials. This will enhance the information available to consumers on homeopathic products authorised under the new scheme while continuing to ensure their safety and quality. The new scheme will also enable products to carry indications for minor symptoms or conditions. In addition, over the next seven years the homeopathic PLRs will be reviewed.