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

May 2009: Outcome measures for herbal strategy
We are making available a table of the outcome measures used in relation to the MHRA's strategy for bringing herbal medicines into effective regulation. These cover a variety of categories ranging from measures that are already monitored frequently, to others where we have baseline data but where changes (e.g. in public understanding and attitude) can only realistically be measured over a number of years. As with other areas of public policy monitoring, interpretation of the results of policy monitoring will need to be undertaken with care as figures and trends are often open to more than one interpretation.
› Outcome measures of MHRA strategy to bring herbal medicine into effective regulation (121Kb)

April 2009: Consultation by the Committee of Advertising Practice (CAP)
The Committee of Advertising Practice (CAP) and the Broadcast Committee of Advertising Practice (BCAP) have recently launched a public consultation on the content of their Codes.

The document includes a proposal specifically on advertising of THRs – this can be found on page 53 of the document. The consultation documents are available on the CAP website (external link). The consultation will close at 5.00 pm on Friday 19 June 2009.

April 2009: Latest traditional herbal registration application numbers
As of 22 April the MHRA have received 67 applications for registration under the THR Scheme. The applications cover single and combination products using 34 different herbs. So far 30 registrations have been granted. 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.

April 2009: New guidance on consumer advertising for registered traditional herbal medicines
Draft guidance for companies advertising registered traditional herbal medicines to the public. Comments by 31 August 2009 to advertising@mhra.gsi.gov.uk.
› New guidance on consumer advertising for registered traditional herbal medicines

March 2009: Transfer of herbal marketing authorisations to traditional herbal registration status
This new section has been specifically created to provide guidance and information to those operating within the herbal medicine sector who, in the course of the review of existing herbal product licences (PLs), may wish to apply for a traditional herbal registration (THR) under simplified arrangements to replace their existing PL.

As the review proceeds the MHRA will use this webpage to provide information on progress and to give any further guidance that may prove helpful in the light of experience.
› Transfer of herbal marketing authorisations to traditional herbal registration status

January 2009: Review of product licences (marketing authorisations) for herbal products
Following the consultation launched in August 2008 the MHRA has issued guidance on the review of herbal product licences (marketing authorisations). (803Kb) The review may lead, following case by case consideration, to the transfer of some of these products into the category of traditional herbal registration. The purpose of the review is to ensure that ultimately herbal products are in the appropriate regulatory category so that it is clear to the consumer which products are licensed on the basis of evidence of efficacy and which are registered on the basis of evidence of traditional use. (Both categories of product meet standards of safety, quality and patient information.) The guidance sets out MHRA expectations of companies, gives advice and provides a contact point for companies to raise any queries and to submit their provisional plans under the review. As the review proceeds the MHRA will use the website to provide periodic information on progress and to give any further guidance that may prove helpful in the light of experience. For this review a full impact assessment was not necessary. However, an outline impact assessment (242Kb) has been prepared.

January 2009: Ipsos MORI report shows that 77% of adults agree that it is important that herbal medicines are regulated
The findings of a programme of research carried out to identify the public's view on herbal medicines, by Ipsos MORI on behalf of the MHRA.
› Press release: Ipsos MORI report shows that 77% of adults agree that it is important that herbal medicines are regulated
› Public Perceptions of Herbal Medicines: General Public Qualitative and Quantitative Research (410Kb)

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)