- Traditional Medicine > Traditional, Complementary and Herbal Medicine
- Quality and Safety: Medicines > Regulatory Support
(1998; 49 pages) [French] [Spanish]
The requirements of the licensing system in the United Kingdom are set out in Part II of the Medicines Act 1968. Without the appropriate licence it is an offence to manufacture, sell, supply, export or import a medicine into the United Kingdom, unless some exemption is provided in the Act or regulations .
Exemptions from licensing for certain herbal remedies are contained in Section 12 of the Medicines Act, namely:
- the plant has been subjected only to the processes of drying, crushing or comminuting in producing the remedy;
- it is sold or supplied by its botanical name with reference to the process of manufacture; and
- it is sold or supplied without any written therapeutic recommendation .
The review of herbal medicines was completed in 1990. An information sheet on the review for licence holders was published in October 1985 by the Medicines Control Agency . Herbal medicines indicated for conditions capable of self-diagnosis were granted a licence when sufficient evidence of efficacy was established, and the authority required the product label to include the statements "a herbal remedy traditionally used for the symptomatic relief of..." and "if symptoms persist consult your doctor". Combination products containing a large number of herbal ingredients or mixtures of herbal and other ingredients were not accepted, and licence holders were invited to consider to which ingredients the therapeutic claim related and to adjust the formulations .
Medicines which can, with reasonable safety, be sold or supplied otherwise than by or under the supervision of a pharmacist are listed in the General Sales List. The exemption from licensing for certain herbal remedies described above is modified by the Retail Sale or Supply of Herbal Remedies Order , the purpose of which is to control the use of toxic plants by removing them from the general sale list category of medicines and making them "pharmacy only", or by limiting the dose or route of administration for use outside a pharmacy setting. The plants listed in Part I of the schedule may only be sold or supplied in a registered pharmacy; those listed in Part II and Part III may be used by practitioners who sell or supply herbal remedies where they are for administration to a particular person following a personal consultation (after being requested by or on behalf of that person to use his own judgement as to treatment required), but are not for retail in circumstances other than through a pharmacy.
In December 1995, "A guide to what is a medicinal product" was published by the Medicines Control Agency. In accordance with Directive 65/65/EEC it tries to give examples for clarification where the borderline lies between medicinal products and products such as cosmetics and foodstuffs, taking into consideration the claims for the product, the properties of its ingredients, the labelling, promotional literature, product form and whether there are similar licensed products on the market. The new guideline does not intend to affect the status of products legally sold without a licence, nor does it affect the current exemptions for herbal remedies .