Scope

The scheme only covers products that are classified as medicines. While many herbal products are medicines, others are not, and so do not require a registration under the Traditional Herbal Medicines Registration Scheme (THMRS). For more information on the definition of a medicine please see our section on Borderline Products and MHRA Guidance Note 8, 'A guide to what is a medicinal product'

It is a common situation to find 'borderline' products containing the same ingredients which can be regarded either as medicines or as foods or cosmetics, depending on presentation. There are a number of herbal ingredients that have accepted usage in a range of different regulatory categories besides medicines, including food, cosmetics or general consumer products. If a product is currently sold legally as a food, cosmetic or general consumer product, companies can continue to sell their products under these regimes.

However, it may be that in some cases companies might welcome an opportunity to present the product as a medicine and make minor medicinal claims based on traditional use. Companies could modify the presentation of a product currently sold legally as a food or cosmetic and apply for a registration under the scheme. There is no reason to prevent a company applying for a traditional use registration for any product that could meet the various requirements of the THMRS.

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.

Potency and intended use
Registrations under the THMRS are restricted to herbal medicines that are intended and designed for use without the supervision of a medical practitioner for diagnostic purposes or for prescription or monitoring of treatment. Medicines requiring the supervision of a medical practitioner are not covered by the scheme.
A list of substances authorised for general sale (without prescription) is available.

Route of administration
Registration is suitable for herbal medicines that are taken orally, for external use or inhalation. Herbal medicines intended for injection will not receive a registration under the scheme.

Non-herbal ingredients
The scheme allows traditional herbal remedies to be combined with vitamins and minerals, where there is evidence of safety and where the action of the nutrient is ancillary to the herb. Products containing other non-herbal ingredients, other than excipients, are not covered by the THMRS.

Plausibility of indication
A registration may be refused 'if data on traditional use is insufficient, especially if pharmacological effects or efficacy are not plausible on the basis of long-standing use and experience'. We expect that evidence that a herbal remedy had an accepted use within a herbal tradition over a significant period would generally represent reasonable evidence that a degree of efficacy in relation to the relevant traditional use indication was at least plausible. Circumstances where 'plausibility' might, however, be an issue include situations where the proposed indication was in direct contradiction to the known activity of the ingredients or the ingredient most associated with the proposed indication was omitted from the medicine.

Efficacy
The Directive says that where the competent authorities judge that a medicine fulfils the criteria for a marketing authorisation (in this context the efficacy requirements will be particularly relevant) they should not grant a traditional use registration.

For some herbal medicines there is sufficient evidence in the public domain for an applicant to be able to obtain a marketing authorisation under the provisions for products containing active substances with 'well established' by referring to appropriate scientific literature. Where this is the case the MHRA will not grant a traditional use application but will instead ask the applicant to apply for a marketing authorisation. Based on the MHRA's experience it is likely that this would apply in only a minority of cases.

In considering this issue the MHRA will need to consider in the round all the relevant details of the proposed product. The MHRA will not take the view that a product ought to follow the 'well established' route to a marketing authorisation simply because the medicine contains a particular herbal ingredient. It may well be that there are some herbal medicines that have several accepted indications, of which one might be appropriate for a marketing authorisation under the 'well established use' provisions while another is suitable for traditional use registration.

Likewise it may be that the 'well established use' provisions are applicable to a range of products that use a particular herbal ingredient. However, traditional use might be applicable where that ingredient is used in combination with other active herbal ingredients, particularly for other therapeutic indications. Such combinations would need to satisfy the requirements for traditional use registration including that efficacy is plausible based on long use and experience.

Potential applicants need to be aware that historically, in relation to herbal medicines, there have been some differences of interpretation of the 'well established' provisions between regulatory authorities in different EU member states. Advice given in other EU Member States will not necessarily be applicable in the UK and vice versa. Potential applicants wishing to register products in the UK are advised to check with the MHRA whether or not they are should seek a marketing authorisation rather than a traditional use registration for any of their products. Such discussions can best take place where applicants use the MHRA's voluntary pre-application notification scheme Word file (opens in new window) (156Kb).

Isolated chemical constituents
Products which are manufactured from isolated chemical constituents of plants would not be regarded as a traditional herbal medicinal product and would not receive a registration.

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

 

 




Page last modified: 08 May 2008