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 in 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. 

Latest traditional herbal registration application numbers - updated 23 March 2011
The following table sets out the cumulative totals for traditional herbal registration (THR) applications received and grants made for each year since the introduction of the THR scheme in October 2005. From April 2009 onwards the table includes products entering the review of herbal product licences.

All THR applications not shown as granted remain under assessment. In the event that THR applications are rejected a new line in the table will be introduced to show this.

Information about the products which have been granted a THR can be found in the Public Assessment Reports for Herbal medicines section

THMRS latest news

April 2011: Latest traditional herbal registration application numbers
The total number of applications received since the start of the THR scheme now stands at 211. One hundred and one applications have so far been granted. This includes 12 of which are transfers from product licence (PL) status to THR. The variety of herbal ingredients used continues to grow with 36 different herbs used in one or more applications granted to date. The total number of herbs in all applications stands at 76. Information on the registered products can be found in the public assessment reports which are available in the section on Public Assessment Reports for herbal medicines.

Other news
New guidance to THR applicants and registration holders labelling of organic products registered under the THR scheme (30Kb)

23 February 2011: Six month suspended sentence for selling and supplying herbal medicines without marketing authorisation
A 48-year-old man was sentenced yesterday to six months imprisonment suspended for two years and 200 hours of unpaid work for selling and supplying herbal medicines to the public without a marketing authorisation.

Press release: Six month suspended sentence for selling and supplying herbal medicines without marketing authorisation

February 2011: Department of Health (DH) announcement about regulation of practitioners
On 16 February 2011, a DH announcement was made about regulation of practitioners (external link).

The Health Professions Council (HPC) will establish a statutory register for practitioners supplying unlicensed herbal medicines. Registration of practitioners will be underpinned by strengthened medicines legislation. The announcement follows the DH consultation exercise which was launched on 3 August 2009 on whether practitioners of acupuncture, herbal medicine and traditional Chinese medicine should be regulated.

Questions and answers about the DH announcement on the regulation of practitioners

A summary analysis of the consultation (external link) is also published on the DH website.

November 2010: Latest traditional herbal registration application numbers
The total number of applications received since the start of the THR scheme now stands at 166. Seventy eight applications have so far been granted; five of which are transfers from product licence (PL) status to THR. The variety of herbal ingredients used continues to grow with 32 different herbs used in applications granted to date. Information on the registered products can be found in the public assessment reports which are available in the section on Public Assessment Reports for herbal medicines.

November 2010: Other news
Consultation Document MXL 372: MXL 372 relates to two sets of proposals. The first proposal concerns changes to the current legal arrangements for podiatrists to sell, supply and administer medicines. The second covers proposals to revoke the exemption from licensing requirements for unlicensed herbal remedies contained in section 12(2) of the Medicines Act 1968. The intention to revoke section 12(2) was originally set out in the 2005 consultation document MLX 325 on the implementation of the European Directive (2004/24/EC) on traditional herbal medicinal products. Regulations made at the time provided transitional protection to certain products legally supplied under Section 12(2), ending on 30 April 2011. The current proposal has no new practical effect and is put forward so as to avoid any doubt about the ending of the transitional period. Responses to the consultation can be emailed to: part3@mhra.gsi.gov.uk and must arrive no later than 17 January 2011.

August 2010: Latest traditional herbal registration application numbers
Since the beginning of this financial year, the MHRA has received 31 THR applications, bringing the total applications received since the start of the THR scheme to 152. Sixty nine applications have so far been granted. The most recent grants include the first two products to be transferred from product licence (PL) status to THR, and two products using a combination of five herbs; the total number of different herbs used in granted products is now 27. Information on the registered products can be found in the public assessment reports which are available in the section on Public Assessment Reports for herbal medicines.

August 2010: Other news
Transitional protection under the traditional herbal medicinal products Directive (Directive 2004/24/EC): The guidance on transitional protection has been updated to provide additional advice on the end of the transitional period and how this will operate. The new material reflects questions received by the MHRA in recent months. Changes include the addition of a section on the impact on herbal practitioners and their suppliers. The additional questions start at question 15 onwards.

Guidance on Transitional arrangements for the Directive on traditional herbal medicinal products (Directive 2004/24/EC, amending Directive 2001/83/EC) (120Kb)

New guidance on consumer advertising for registered traditional herbal medicines: The guidance on consumer advertising consulted on during 2009 has been finalised and can be found here.

Consumer advertising for registered traditional herbal medicines (77Kb) 

October 2009: Introduction of the Traditional Herbal Registration certification mark
The Traditional Herbal Registration (THR) certification mark is a type of trade mark. It indicates that the herbal medicine has been registered with the MHRA under the Traditional Herbal Registration (THR) scheme and meets the required standards relating to its quality, safety, evidence of traditional use and other criteria as set out under the Traditional Herbal Medicinal Products Directive (THMPD) 2004/24/EC.

For further information please see:
Traditional Herbal Registration certification mark

May 2009: Outcome measures for herbal strategy
We are making a table availble 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 (eg in public understanding and attitude) can only realistically be measured over a number of years.

As with other areas of public policy monitoring, interpreting the results 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: 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 on our website 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, we will use this webpage to provide information on progress and to give any further guidance that may prove helpful.
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)

Following case-by-case consideration, the review may lead to the transfer of some of these products into the category of traditional herbal registration. The purpose of the review is to ensure that 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, we 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 by Ipsos MORI on behalf of the MHRA to identify the public's view on herbal medicines revealed that 77% of adults agree that it is important that herbal medicines are regulated.
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)

December 2007: Guidance on the use of Committee on Herbal Medicinal Products (HMPC) monographs to demonstrate safety and traditional use
The MHRA has produced  Guidance on Use of HMPC Monographs to Demonstrate Safety and Traditional Use (73Kb).  The guidance provides advice on the extent to which applicants can refer to monographs prepared by the HMPC 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 European Medicines Agency (EMEA) website (external link).

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 a draft report on the experience acquired as a result of the early operation of the Directive on traditional herbal medicinal products for public consultation. 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)