Herbal medicine – all change

As of 30 April 2011, an EU Directive on traditional herbal medicinal products will come fully into force in the UK,1 making it illegal for manufacturers, wholesalers and importers to sell unlicensed herbal medicines either to retailers or directly to consumers.1 This, and other recent changes, will have major implications for how herbal medicines are regarded by healthcare professionals.

The Directive states that no traditional herbal medicinal product shall be placed on the market, or be distributed by way of ‘wholesale dealing’, unless a traditional herbal registration (THR) has been granted by the licensing authority.1 ‘Herbal exemption’ from licensing under Section 12(2) of the Medicines Act 1968 will no longer be available.1 However, stocks of products already legally on the market before 30 April 2011 will not need to be recalled. The THR scheme, which began on 30 October 2005, requires that herbal medicinal products meet specific standards of safety and quality, and are accompanied by agreed indications based on traditional usage (but not evidence of efficacy), and patient information leaflets.2 They must also fulfil all of the following criteria: the traditional usage is shown to be plausible and not to be harmful; there is evidence of traditional medicinal use for 30 years or more (15 years of which must have occurred within the EU); the indications and composition are suitable for use without supervision of a medical practitioner; the product has a specified strength and posology; and it is available for oral, external or inhalation use.

Apart from products with a THR, the only other manufactured herbal medical products that will be legally allowed will be those with a full marketing authorisation (product licence).2 For these, like other medicinal products, efficacy, safety and quality will usually need to have been demonstrated. However, it …