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Press release: MHRA grants landmark registration for Traditional Herbal Medicine

Press release

Date: 08 Nov 2006
Time: 10:00
Subject: MHRA grants Landmark Registration for Traditional Herbal Medicine
Contact: Press Office 020 3080 7651
or press.office@mhra.gsi.gov.uk
Out-of-hours 07770 446 189

The Medicines and Healthcare products Regulatory Agency (MHRA) has granted the first UK product registration under the European Directive on traditional herbal medicinal products. 

The new traditional herbal registration scheme provides enhanced information for consumers, for example directions for use, Do’s and Don’ts and information about possible side effects.

Under the traditional herbal registration scheme products are required to meet assured standards of quality, safety and patient information.  Minor claims are permitted on the basis of evidence of traditional usage.  To get a product registered, companies have to submit a dossier to the MHRA demonstrating that it meets the requirements of the scheme.

The first product to be registered is Atrogel Arnica Gel: an arnica gel traditionally used for the symptomatic relief of muscular aches and pains, stiffness, sprains, bruises and swelling after contusions. The product registration has been granted to Bioforce (UK) Ltd.

Professor Kent Woods, Chief Executive of the MHRA said: “This first product registration is an important landmark.  We hope that Atrogel Arnica Gel  will be the first of many products to receive a traditional herbal registration.  Our aim is to enable those consumers who wish to take herbal medicines to make an informed choice from a wide range of products which have been made to assured standards of safety, quality and patient information.
The MHRA will continue to work closely with the herbal sector to enable them to understand and meet the requirements of the new scheme.”

Notes to Editor

  1. Under the European Directive on traditional herbal medicinal products, all manufactured traditional herbal medicines placed on the market will now have to meet the requirements of the Directive. There is transitional protection until 2011 for products that were legally on the UK market before April 2004. The MHRA expects a progressive build up in the number of products registered as we move towards 2011.
  2. Currently most herbal medicines on the UK market are unlicensed, and standards in this sector vary greatly.  There are also a number of licensed herbal medicines that are made to assured standards.
  3. Products with a Traditional Herbal Registration have a “THR” number on the label.  Licensed medicines have a PL number (Product Licence).
  4. When the MHRA grants a traditional herbal registration this means that the company concerned has permission to market a particular product.  It is for the company to decide how quickly they can make the product available for sale.
  5. The MHRA is the government agency that is responsible for ensuring that medicines and medical devices work, and are acceptably safe. We keep watch over medicines and devices, and we take any necessary action to protect the public promptly if there is a problem. No product is risk-free. Underpinning all our work lie robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks.
Page last modified: 08 November 2006