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Herbal medicines
There are three possible routes for herbal medicines to be placed on the UK market:
1. as an unlicensed herbal remedy (no longer applicable after 2011)
2. registered under the Traditional Herbal Medicines Registration Scheme
3. licensed with a marketing authorisation as a herbal medicine.
Full details of these alternative routes and the relevant legislation are available on the website.
Placing a herbal medicine on the UK market
Homeopathic medicines
A homeopathic medicinal product is defined in European legislation (Article 1(5) of Directive 2001/83/EC (external link) as amended by 2004/27/EC (external link) 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'.
Currently, there are two ways in which new homeopathic products may be registered in the UK:
1. the Simplified Scheme.
2. the National Rules Scheme (in operation since September 2006).
The Simplified Scheme
In 1992, Directive 92/73/EC (external link) 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.
The National Rules Scheme
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 documents on both schemes are available on the website.
