Homoeopathic medicines

A homoeopathic medicinal product is defined in European legislation (Article 1(5) of  Directive 2001/83/EC as amended by 2004/27/EC as: 'Any medicinal product prepared from substances called homeopathic stocks in accordance with a homeopathic manufacturing procedure described  by the European Pharmacopoeia or, in the absence thereof, by the pharmacopoeias currently used officially in the Member States.  A homeopathic medicinal product may contain a number of principles'.

Background
Product Licences of Right (PLRs) were issued to all medicinal products on the market at the time that the Medicines Act 1968 was implemented (in 1971). Homoeopathic products covered by PLRs may have indications. The Simplified Registration Scheme was introduced in 1992 and does not allow indications.  The National Rules Scheme was therefore introduced to regularise these inconsistencies and allows homoeopathic products to be indicated for the relief or treatment of mild, self-limiting conditions. Companies are encouraged to register new products in this scheme and to re-register their existing PLR products.

Current regime
Currently there are two ways in which new homoeopathic products may be registered in the UK.  They may be:

• Registered under the Simplified Scheme
• From the 1 September 2006, registered under the National Rules Scheme.

The Simplified Scheme
In 1992 Directive 92/73/EC introduced a Simplified Scheme for homoeopathic products.  It is regarded as simplified because although the safety and quality of products has to be demonstrated, products are not permitted to make medical claims.  The Scheme is restricted to products for oral and external use and does not allow indications (the descriptions of diseases or conditions for which the medicine is intended to be used).  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.

Guidance notes and application form
› Herbal or homoeopathic registration application form (375Kb)
› The Homoeopathic Registration Scheme: Guidance for manufacturers and suppliers (MHRA Guidance Note 17) (September 2003)
› The manufacture and control of dosage forms for homoeopathics  (July 2003)
› The control and quality of homoeopathic stocks (July 2003)
› Note on labelling requirements for homoeopathic products (March 2004)

The National Rules Scheme
This Scheme was introduced on 1 September 2006, following a public consultation (MLX 312).  The purpose of the Scheme is to enable homoeopathic medicinal products to be registered with indications for the relief or treatment of minor symptoms and conditions (those that can ordinarily be relieved or treated without the supervision or intervention of a doctor).  Applications under the National Rules Scheme must be supported by a dossier of data on quality, safety and efficacy, together with appropriate product labelling and product literature.

Guidance notes and application form
› Herbal or homoeopathic registration application form (375Kb)
› The Homoeopathic National Rules Scheme: Brief guidance for manufacturers and suppliers (September 2006)
› The Medicines for Human Use (National Rules for Homoeopathic Products) Regulations 2006 - SI 2006 No 1952 - this Statutory Instrument implemented the National Rules Scheme

Conventional medicinal products for human use are licensed with a “marketing authorisation”. 

Contact for further information
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 3528, fax 020 7084 2323 or e-mail info@mhra.gsi.gov.uk.