Types of licence/certificate: Homoeopathic medicines

Blueline Last updated 25/02/05

What is a homoeopathic medicine?

A homoeopathic medicinal product is defined in European legislation (Article 1 Directive 92/73EEC) as
"Any medicinal product prepared from products, substances or composition called homoeopathic stocks in accordance with a homoeopathic manufacturing procedure described by the European Pharmacopoeia or, in the absence thereof, by the pharmacopoeias currently used officially in the Member States".

Homoeopathic products may contain single stocks or a number of stocks. The latter are called complexes.

What is a homoeopathic medicine?

Background to the legislation on licensing of homoeopathic products

Current legislation for homoeopathic medicines

Application form for a registration certificate for a homoeopathic product (MLA 201 HR) Word icon

Contact for further information


Background to the legislation on licensing of homoeopathic products

Until the introduction of the homoeopathic registration scheme in 1994 the only homoeopathic medicines available on the market were those granted product licences of right (PLRs) when the Medicines Act came into force in 1971. Attempts to acquire marketing authorisations for new homoeopathic medicines were unsuccessful owing to difficulties in proving efficacy in conventional clinical trials.

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Current legislation for homoeopathic medicines

The homoeopathic registration scheme, implemented under a European Directive 92/73 EEC, is a simplified regulatory procedure, whereby products are assessed for their quality and safety and can then be marketed without specific medical claims. The simplified registration scheme thus enables a rapid introduction of new homoeopathic medicines onto the UK market.

Registration under the scheme is compulsory only in respect of homoeopathic products new to the UK market. Products that were previously on the market by virtue of PLRs continue to be available.

Registration criteria

In order to qualify for registration the products must:

  • be for oral or external use. This includes all methods of administration with the exception of injections;
  • be sufficiently dilute to guarantee their safety;
  • make no therapeutic claims.

We hope to include guidance notes on applying for a homoeopathic registration certificate at this site soon.

Application form for a registration certificate for a homoeopathic product (MLA 201 HR) Word icon

 

Contact for further information

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For further information on this part of our site, please contact our Homoeopathics Unit, 11-1, MHRA, Market Towers, 1 Nine Elms Lane, London SW8 5NQ, telephone 020-7084 2322, fax 020-7084 2323 or e-mail info@mhra.gov.uk


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