DRW Monthly
February 2007
Issue No. 3

UK Implementation of the EU Directive on Traditional Herbal Medicinal Products

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) granted its first product registration in November 2006 under the European Directive on Traditional Herbal Medicinal Products (2004/24/EC). The product, Atrogel Arnica Gel registered by Bioforce (UK) Ltd., contains the herbal ingredient arnica which has been traditionally used to relieve muscular aches and pains and to reduce the inflammation of severe bruising and swelling.

The Directive 2004/24/EC came into force on 30 April 2004 and was implemented in the UK on 30 October 2005 by the Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 2005 (SI 2005 No. 2750). The directive introduced the Traditional Herbal Medicines Registration Scheme (THMRS), a simplified registration process that requires finished over-the-counter herbal remedies to meet appropriate safety and quality standards and be accompanied by agreed indications and patient safety information. Because the normal requirement for medicines to demonstrate efficacy can be costly and difficult for herbal medicines to meet, the THMRS replaced this obligation with a requirement to demonstrate 30 years traditional use for the specified medicinal indication. "Registration under THMRS is restricted to herbal medicines which are intended and designed for use without the supervision of a medical practitioner for diagnostic purposes or for prescription or monitoring of treatment."(1) The European Medicines Agency's Herbal Medicinal Product Committee will also be creating Community herbal monographs as well as a positive list that will contain herbal substances for which traditional use and safety will not need to be demonstrated, although the quality requirements will need to be met.

Currently, most herbal medicinal products are on the UK market under an exemption from the usual licensing requirements laid down in Section 12 of the Medicines Act 1968. Section 12(2) of the act permits manufactured unlicensed herbal remedies to be sold to individual patients as over-the-counter products without requiring a face-to-face medical consultation. Companies that can prove their products were legally on the UK market under Section 12(2) as of 30 April 2004 have been given a seven-year transitional protection period which means that their products do not need to be registered until 30 April 2011. Once the transition period is over, however, all manufacturers, importers and wholesale dealers of traditional medicinal herbal products will ultimately need to be registered under the THMRS.

The MHRA's primary objectives with the implementation of this directive are to provide the highest level of public health protection and to be strongly positioned to advise consumers, companies and medical practitioners about herbal remedies that may pose a risk to human health. Prior to the passage of this regulation, the MHRA lacked the regulatory authority to manage various safety issues that have emerged as a result of the rapidly expanding herbal medicinal products market. The formal registration scheme created under the THMRS has raised the status and recognition of herbal medicines by requiring consistent standards and proper consumer information and has established a framework within which the MHRA can address important public health issues.

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