The requirements of the licensing system in the United Kingdom are set out in Part II of the above act. Without the appropriate licence it is an offence to manufacture, sell, supply, export or import a medicine into UK, unless some exemption is provided in the act or regulations. However unprocessed plant material, without any written therapeutic recommendation, sold or supplied by its botanical name with reference to the process of manufacture are exempt from licensing requirements.

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 mention traditional use. Combination products containing a large number of herbal ingredients or mixtures of herbal and non-herbal ingredients were not accepted and licence holders were asked to consider retaining ingredients attributed with therapeutic activity . 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 such as cosmetics and foodstuffs, taking into consideration 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 or the current exemptions for herbal remedies.