Advice to consumers - The Traditional Herbal Medicines Registration Scheme

Introduction
This section provides general information for consumers on the Traditional Herbal Medicines Registration Scheme (THMRS). Detailed information on the scope and  key requirements of the scheme can be found on the Traditional Herbal Medicines Registration Scheme pages of this website. 

The Traditional Herbal Medicinal Products Directive (THMPD) 2004/24/EC establishes a regulatory approval process for herbal medicines in the European Union (EU).  It requires each EU Member State to set up a traditional herbal registration scheme, for manufactured traditional herbal medicines that are suitable for use without medical supervision.

The UK Traditional Herbal Medicines Registration Scheme came into force 30 October 2005.

Background
For many years most herbal remedies on the UK market where sold as unlicensed medicines under section 12 of the Medicines Act 1968.  This legislation provided very little in the way of safeguards and meant that the products could be sold with little regard to safety, quality or to the provision of useful patient information. 

In recent years, we have seen a substantial growth in the popularity of over-the-counter (OTC) herbal medicinal products; due in part to the belief by some people that herbal and natural products are safer than what are seen as “synthetic” medicines. 

Alongside the increased popularity and regular usage of herbal medicines has been an increase in understanding about the possibilities for side effects and interactions between herbal and other medicines; growing concern about the safety and quality of some unlicensed products and about the lack of reliable information; as well as concerns about the professionalism of some practitioners. 

Headline catching incidents have highlighted adverse, sometimes life threatening, effects which have resulted from use of OTC herbal medicinal products tainted with anything from microbial contaminants, heavy metals, chemical toxins, or adulterated with pharmaceutical drugs. More information on these problems can be found under the Herbal safety advice section. 

The MHRA recognises that many unlicensed herbal medicines on the UK market are manufactured to reasonable standards. However, the MHRA is concerned that it is impossible for consumers to identify which unlicensed products are made to acceptable standards.  This puts the public at risk and penalises responsible companies.  These concerns led to the EU Directive on traditional herbal medicinal products.

The EU Directive on traditional herbal medicinal products
As a result of Directive 2004/24/EC, all over-the-counter herbal medicines in the UK, will require either a Traditional Herbal Medicines Registration (THR) or a full Marketing Authorisation (MA). However, products legally on the market prior to 30 April 2004, which complied fully with the requirements of Section 12(2) of the Medicines Act 1968, will benefit from transitional protection and can be sold as unlicensed herbal remedies until 30 April 2011.

Under the Directive, a company needs to demonstrate the safety of the herbal medicine by providing bibliographic evidence of a minimum of 30 years of traditional use for the product.  At least 15 of the 30 years must have been within the EU. This replaces the requirement to demonstrate efficacy and serves as the basis for permitting minor therapeutic claims; regulators can however ask for more data where they have any specific safety concerns.  Further, the herbal medicine must now be manufactured under GMP (Good Manufacturing Practice), pharmacovigilance(safety monitoring) requirements apply, as do the normal rigorous quality standards for medicines with a Marketing Authorisation (MA).  Systematic patient information is required as for any typical over the counter medicine; in addition there is a requirement for a statement on labels and in advertisements that the indication (medicinal claim) is based on traditional usage.

Latest developments
The Medicines and Healthcare products Regulatory Agency (MHRA) granted the first UK product registration under the European Directive on traditional herbal medicinal products in October 2006. As at August, 19 products have been registered. Information on these products can be found in the public assessment reports which are made available on Public Assessment Reports for herbal medicines page of the website.  In addition key safety information on the main herbal ingredient used in these products can also be found on the 'Herbal Safety News'  page.

While it may take some time before these products appear on the market following their registration, you should expect to see a steady stream of such product appearing between now and the end of the Transitional Period (30 April 2011).  To help you identify which products have been registered under the scheme the product container or packaging will include registration number starting with the letters THR.