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This article originally appeared in Bristows' Life Sciences e-newsletter, On The Pulse.

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has introduced the Traditional Herbal Registration (THR) certification mark to indicate that a herbal medicine has been registered under the UK's THR scheme meets the criteria laid down by the Traditional Herbal Medicinal Products Directive. From 19 October 2009, any company that has registered a product under the THR scheme can apply to the MHRA for permission to use the THR certification mark with that product.

Traditional herbal medicines are generally registered for use in minor self limiting conditions that are suitable for self management and do not require the intervention of a doctor. As of 20 October 2009, 92 UK applications had been filed and 45 were granted. Many more applications are expected, particularly given the expiry of transitional protection in 2011. Products registered under the THR scheme must meet established standards of safety and quality for medicines. However, instead of the recognised efficacy standards required for a marketing authorisation of a typical medicine, the product must have been used for at least 30 years, at least 15 of which must normally have been within the EU, to demonstrate long standing traditional use in the specified conditions. While all products registered under the THR scheme must display a THR registration number on the container or packaging, it is recognised that some consumers may have difficulty identifying registered products.

The new certification mark is expected to help consumers distinguish products which have a registration under the THR scheme from those that do not. Use of the mark is not obligatory, although it is recommended by the MHRA. The mark may be displayed only once on the pack or the patient information leaflet, or both. It should be subordinate in placement and prominence to the statutory information, and it cannot be used without indicating that it is a certification mark. Where a herbal medicine carries the THR certification mark this means that the MHRA has assessed the product to ensure that is acceptably safe when used as intended, is manufactured to the quality standards the MHRA sets and is accompanied by reliable and accurate product information for the public and patients. The authorised usage and dosage of the medicine is based on evidence of its traditional use but the effectiveness is not assessed by the MHRA.

In addition to the general rules applicable to the promotion of medicines, the advertising of registered traditional herbal medicines must include a statement informing the consumer that the efficacy of the product for the stated indications is not scientifically supported but is based exclusively on evidence of long standing use. Statements that imply that efficacy has been demonstrated, such as "clinically proven", "effective for" or "works fast to relieve", are unlikely to be acceptable.

Misuse of the THR certification mark and other breaches of the rules on promotion of medicines will be dealt with under the combination of statutory measures, self regulatory regimes and the Advertising Standards Authority rules.