Traditional Herbal Medicines Registration Scheme

It covers specific and detailed information about the regulation of herbal medicines including the scope of the Legislation, restrictions that apply, who is responsible for applying for registration or other relevant licenses and what these processes involve. 

Information on the background to the Directive 2004/24/EC and its European negotiations is available at our “Background and policy” section.

Guidance for Retailers, Wholesalers, Importers and Manufacturers on Registering Herbal Medicine under the THMR Scheme 
The MHRA has produced the following guidance document ‘Guidance for Retailers, Wholesalers, Importers and Manufacturers on Registering Herbal Medicine under the THMR Scheme’ (169Kb) which provides an overview of the key elements of the current regulations.  You can print this document to read offline.  It can also be used online to help you navigate through the relevant sections of the registration scheme web pages. 

THMRS latest news

October 2008: Nelsons becomes the latest company to be awarded its first THR
The company has recently been granted two THRs: for Echina-Relief Tincture, traditionally used to relieve the symptoms of the common cold and influenza type infections; and for Hyperi-lift Tincture, traditionally used to relieve the symptoms of slightly low mood and mild anxiety.

The total number of THR applications received has risen to 45, and so far 21 THRs have been granted.

August 2008: Review of marketing authorisations for herbal products
The MHRA intends to review existing herbal marketing authorisations that may come within the scope of the Directive on traditional herbal medicinal products. It may be that a proportion of herbal products currently with a marketing authorisation would more appropriately come within the category of traditional herbal registration. The MHRA has prepared draft guidance (777Kb) and an outline impact assessment (221Kb) on a programme designed to ensure that regulated herbal medicines ultimately are placed within the correct regulatory category. The MHRA is seeking feedback on these practical arrangements. Any comments on the documents should be sent to richard.woodfield@mhra.gsi.gov.uk by Friday 7 November 2008.

August 2008: Dr. Willmar Schwabe GmbH & Co. KG. granted a THR for the first Rhodiola rosea product and Natures Aid granted their first THR for EchinEeze
Schwabe’s product, Vitano, is a film-coated tablet made from Rhodiola rosea roots and rhizomes. The product is traditional used for the temporary relief of symptoms associated with stress such as fatigue, exhaustion and mild anxiety.

The Natures Aid product, EchinEeze, is an Echinacea product traditionally used to relieve the symptoms of the common cold and influenza type infections. With this grant, Natures Aid becomes the first UK company to have achieved both a Manufactures Licence (ML) and THR; to date other THR grants have been established companies who already hold Product and Manufactures licences.

July 2008: UK company Bio-Health Ltd receives its first THR for Valdrian
Valdrian is a valerian root product traditionally used for the temporary relief of symptoms of mild anxiety and to aid sleep. The traditional herbal registration scheme continues to grow steadily. To date the MHRA have received 37 applications to register products from a total of 13 companies and further applications are expected. The Agency has so far granted registrations to a total of 17 products, with the other applications under assessment. The latest registration, the first granted to the small UK company Bio-Health Ltd, illustrates that the regulatory standards to assure the consumer of standards of safety, quality and information, although demanding, are achievable by a range of businesses.

June 2008: ECHINAFLU becomes 16th herbal medicinal product to be granted a THR.
Produced by SWISS CAPS GMBH, ECHINAFLU is an Echinacea purpurea product traditionally used to relieve the symptoms of the common cold and influenza type infections. SWISS CAPS GMBH is the fifth company to receive a registration under the THR scheme.

During May, Bioforce (UK) Ltd received their fifth registration under the Traditional Herbal Registration scheme for Hyperiforce: a St Johns Wort product traditionally used for the relief of symptoms of slightly low mood and mild anxiety.

May 2008: Fourth company granted a traditional herbal registration.
PASCOE PHARMAZEUTISCHE PRAPARATE GMBH has become the fourth company to be granted a registration for a herbal medicinal product under the Traditional Herbal Registration Scheme. Their product Botanova is a film-coated tablet containing dry extracts of St John's Wort herb, Valerian Root and Passion Flower Herb which have been traditionally used to relieve slightly low mood and mild anxiety and sleep disturbances due to symptoms of mild anxiety.

April 2008: Twelfth traditional herbal registration granted.
The MHRA has granted a traditional herbal registration for Umcka; a Pelargonium product traditionally used for the relief of symptoms of upper respiratory tract infections including common cold, such as sore throat, cough and blocked or runny nose. This is the twelfth product to be granted a registration and the first to Dr. Willmar Schwabe GmbH & Co. KG.

February 2008: MHRA grants traditional herbal registration for a St John's Wort product.
The MHRA has granted a traditional herbal registration for HyperiCalm tablets which contain an extract from St John's Wort (Hypericum perforatum). The registration has been granted to MH Pharma (UK) Ltd trading as MedicHerb. The product is indicated, on the basis of evidence of traditional use only, for the relief of symptoms of slightly low mood and mild anxiety. Under the UK traditional herbal registration scheme, before a product can be registered a company must demonstrate to the MHRA that the product meets standards of safety, quality and information. Reliable patient information is especially important with herbal products such as St John's Wort which may interact with other medicines. Currently most St John's Wort products on the UK market for internal use are unlicensed products - and standards of such products, and the accompanying information, may vary.

In total the MHRA has so far received 35 applications to register herbal products under the THR scheme from a total of 12 different companies. To date 10 product registrations have been granted covering a total of 9 different herbs; the remaining applications are under assessment. The granting of a registration represents a permission to market a specific product; there may be an interval after the granting of a registration before a company is in a position to market the product.

January 2008: A total of seven products have now been registered under the Traditional Herbal Medicines Registration scheme
As at December 2007 the MHRA had received 33 applications to register products from 10 companies. To date, seven have been granted registrations and the rest are under assessment. Information on the registered products can be found in the public assessment reports which are available in the Public Assessment Reports for herbal medicines section.

December 2007: Guidance on Use of HMPC Monographs to Demonstrate Safety and Traditional Use
The MHRA has produced the following guidance note Guidance on Use of HMPC Monographs to Demonstrate Safety and Traditional Use (73Kb) which provides advice on the extent to which applicants can refer to  monographs prepared by the Committee on Herbal Medicinal Products (HMPC) as evidence of safety and traditional use when applying for a traditional herbal registration.

Details of the Herbal Monographs so far prepared by the HMPC can be found on the EMEA website (external link).

October 2007: Five products registered under the scheme
The MHRA granted the first UK product registration under the European Directive on traditional herbal medicinal products in October 2006.  As at September 2007 the MHRA had received 29 applications to register products.  Of these, five have so far been granted registrations and the rest are under assessment.  Information on these registered products can be found in the public assessment reports which are available on the Public Assessment Reports for herbal medicines page of the website.

June 2007: Review of the early operation of the Directive on traditional herbal medicinal products - Updated April 2008
The European Commission (DG Enterprise and Industry) issued for public consultation a draft report on the experience acquired as a result of the early operation of the Directive on traditional herbal medicinal products. The consultation period has now closed but you can still read the consultation document and MHRA’s response.
› The invitation for all interested parties to comment on the operation of the Directive on traditional herbal medicinal products and MHRA’s response

A summary of the public consultation responses is available below:
› Report on the experience acquired as a result of the application of the provisions of Chapter 2a of Directive 2001/83/ec (introduced by Directive 2004/24/ec) on specific provisions applicable to traditional herbal medicinal products, as required under Article 16i of Directive 2001/83/ec (external link)