Key requirements

This section details the key requirements of the Traditional Herbal Medicines Registration Scheme.

Traditional use
The normal requirement for medicines to be proven to be efficacious, as required under Directive 2001/83/EC, is replaced by a requirement to demonstrate 30 years traditional use for the required medicinal indication.

If you are planning to apply for a traditional use registration, you will therefore need to demonstrate that the herbal medicine or 'corresponding' (that is, comparable) product(s) has been in medicinal use for 30 years preceding the date of the application. Normally, at least 15 years of this usage must have been within the European Union (EU).

Corresponding products are ones that have the same active ingredients, the same or similar intended purpose, the same or similar route of administration, and equivalent strength.

Evidence of traditional use
Applicants will need to produce bibliographic or expert evidence of traditional use. There is a wide range of possible sources which, taken together as necessary, potentially could provide the required evidence. These include: authoritative literature on herbalism; the practical evidence of numerous licensed or unlicensed manufactured products on the market in many Member States; the long-standing lists of herbal medicines accepted as traditional by regulatory authorities in a number of Member States; and the testimony of recognised experts on herbalism. The last source may be particularly helpful in confirming the patterns of usage of combinations of herbal ingredients.

For the purposes of demonstrating traditional use it is acceptable for the number or quantity of ingredients of the medicine or corresponding product(s) to have been reduced during the qualifying period of traditional use. Also the excipients need not be the same.

Herbal remedies made up by practitioners to meet the needs of individual patients are as much medicinal products as a typical manufactured over-the-counter herbal medicine. It should therefore be possible to draw from evidence of traditional use relating to either type of product.

The Directive allows for a transitional period of seven years before existing products before existing products, on the market on 30 April 2004, are required to comply with the terms of the Directive. The implementing regulations - the Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 2005 - use this flexibility in its entirety, allowing evidence of traditional usage to be accumulated during this period. Thus, it could be that a traditional herbal remedy from a non EU tradition that first had EU usage in the mid 1990s could have acquired evidence of 15 years EU usage by the end of the transitional period, on 30 April 2011.

For more information on evidence on traditional use see our briefing note on sources of evidence of traditional use which may be acceptable under the Directive.

The MHRA has produced the following guidance note Guidance on Use of HMPC Monographs to Demonstrate Safety and Traditional Use 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).

The European Committee for Herbal Medicinal Products
Directive 2004/24/EC allows us (the MHRA) to refer a product to the European Committee for Herbal Medicinal Products (HMPC) under certain conditions. Such a referral would be possible if the product, or corresponding product(s), has been used for 30 years and meets the other requirements set out in the Directive but would otherwise be refused a registration because it does not have 15 years' usage in the EU. The HMPC has the discretion to lower the requirement for 15 years' use in such individual cases.

Safety
If you intend applying for a traditional use registration, you will need to provide a bibliographic review of safety data together with an expert report.

We may request additional data necessary for assessing the safety of the medicinal product. The types of circumstances when this request may be made include if the ingredient(s) or medicine is relatively unfamiliar to science, there are specific concerns remaining as to the safety of the product or the medicine has been used predominantly in settings where systems of reporting of adverse incidents are not well developed.

An important element of safety is that the products, including their indications, must be suitable for over the counter sale and use without medical supervision

Quality
The normal quality requirements applicable to licensed medicines will apply. We will apply the provisions of the Directive and any relevant European guidelines in a way that is appropriate to the nature of the product under consideration.

Compliance with Good Manufacturing Practice (GMP) would be required and there would also be a requirement to hold a manufacturer's licence, a wholesale dealer's licence or a wholesale dealer's (import) licence where appropriate.

The quality requirements specified in Directive 2004/24/EC are designed to ensure that the product contains the correct ingredients of acceptable quality, free from unacceptable contamination; and that the claimed shelf life of the product can be supported.

The guidance notes on quality in our 'Guidance Notes' section may be of help to you when considering the quality aspects of your product(s).

Product information
Labelling and leaflets for products with a traditional use registration would be required to include information and instructions about the safe use of the product, as with any licensed medicine. In addition, it would be made clear to the consumer that the indications are based on information obtained from its long-standing use and experience. There would also be advice that the user should consult a doctor or a qualified healthcare practitioner if the symptoms persist during the use of the medicinal product or if adverse effects not mentioned in the package leaflet occur.

More information on product information

European positive list
The new European Committee, the Committee on Herbal Medicinal Products (HMPC), will establish the European positive list, provided for in Directive 2004/24/EC. The list will contain herbal substances, herbal preparations and combinations thereof, for which traditional usage and safety were accepted.

There would be an agreed list of herbal substances which will include therapeutic indications, specified strengths, routes of administration and any relevant information necessary for the safe use of the herbal medicine. When the list is available, applicants can then refer to the list in suitable cases rather than have to demonstrate traditional use and safety. The applicant would still need to demonstrate quality. The development of the list is a major task that is likely to be carried out in stages rather than as a one off exercise. It is not clear when the list will start to become available. This may mean that companies will need to make a commercial judgement as to whether to wait for a particular item to be included in the list.

Further information
For further information on the Traditional Herbal Medicines Registration Scheme, please see our 'Where to go for further advice' section.

Information about products registered under the scheme can be found in the public assessment reports which are made available in the Public Assessment Reports for herbal medicines section.

The Public Assessment Reports are compiled and edited in accordance with EC Directive 2004/27/EC. They provide an overview of the key information provided as part of the product dossier and as such will give you a good idea of the types of products and associated indications that can be considered under the scheme as well as the amount of information that you will need to supply in your application for a THR.


Page last modified: 07 July 2010