Homeopathy is a system of complementary medicine in which disease is treated by minute doses of substances that in large quantities would produce symptoms of the disease.
In this section...
A homeopathic 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'.
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Homeopathic hCG (human chorionic gonadotrophin) being promoted as an aid to help weight loss It has been brought to the MHRA's attention that there are a number of websites promoting and/or selling a product containing a homeopathic dilution of hCG (human chorionic gonadotrophin) as an aid to help promote weight loss. Homeopathic hCG is not authorised or registered for use in the UK and it is an unlicensed medicine. The promotion and/or sale of unlicensed medicines is not permitted. The quality and safety of unlicensed medicines have not been assessed by the MHRA and it is recommended that consumers do not purchase unlicensed homeopathic medicines, including homeopathic hCG in the UK. |
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). Homeopathic 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 homeopathic 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 homeopathic 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 homeopathic 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 homeopathic registration application form 
(375Kb)
The Homeopathic Registration Scheme: Guidance for manufacturers and suppliers (MHRA Guidance Note 17)
(333Kb) (September 2003)
The manufacture and control of dosage forms for homeopathics (114Kb) (July 2003)
The control and quality of homeopathic stocks (117Kb) (July 2003)
Note on labelling requirements for homeopathic products (64Kb) (October 2009)
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 homeopathic 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 homeopathic registration application form (58Kb)
The Homeopathic National Rules Scheme: Brief guidance for manufacturers and suppliers (58Kb) (September 2006)
The Medicines for Human Use (National Rules for Homoeopathic Products) Regulations 2006 - SI 2006 No 1952 (54Kb) - this Statutory Instrument implemented the National Rules Scheme
Note on labelling requirements for homeopathic products (64Kb) (October 2009)
Conventional medicinal products for human use are licensed with a 'marketing authorisation'.
Registered or authorised products
This section provides a listing of homeopathic medicines, both those registered under the Simplified Scheme and those authorised under the National Rules Scheme.
Contact for further information
If you have any questions about this list or require more information on specific products, please contact Information Services (info@mhra.gsi.gov.uk).
Homeopathic registrations (24Kb)
Contact for further information
For further information on this part of our site, please contact our Homeopathics Unit, MHRA, 151 Buckingham Palace Road, Victoria, London, SW1W 9SZ, telephone 020 3080 7400 or email info@mhra.gsi.gov.uk
