Placing a herbal medicine on the UK market

Is your herbal product a medicine?
Not all herbal products are medicines. Many herbal products can legally be sold as food or cosmetics for example. It is therefore important that you begin by establishing whether your product is classified as a medicine. If it isn’t, you don’t have to comply with medicines legislation (although you will have to comply with other legislation relevant to your product). Guidance on what is a medicine is available in our 'Borderline products' section to help you determine whether your product is medicinal. Advice from the Agency's Borderline Unit on whether your product is likely to be medicinal can be obtained by completing an borderline advice request form.

How herbal medicines can reach the market
If your herbal product is classified as a medicine, there are three possible regulatory routes by which you can legally supply your herbal medicine.  You will need to ensure that your product complies with the necessary requirements.

1. Unlicensed herbal remedies
Most herbal medicines in the UK currently reach the consumer as unlicensed herbal remedies. Where these are not industrially produced, they are exempt from the normal requirements for a medicine to hold a product licence or marketing authorisation through an exemption set out in Section 12 of the Medicines Act 1968.
Section 12(1) of the Medicines Act  permits unlicensed herbal remedies to be supplied to individual patients following a face-to-face consultation.

Unlicensed herbal remedies supplied under Section 12(2) of the Medicines Act do not require a consultation. This is the regulatory route currently used for manufactured unlicensed herbal remedies that are sold as over-the-counter products. In order to use this exemption, products must meet specific exemption conditions.  In particular products must be made from simple processes only, and have no brand name and no claims.  Section 12(2) arrangements are being phased out (see below).

2.  Registered traditional herbal medicines
30 October 2005 marked the introduction of a new scheme, the Traditional Herbal Medicines Registration Scheme, which will help protect public health by requiring specific standards of safety and quality for traditional herbal medicines. This scheme is required by the European Directive on Traditional Herbal Medicinal Products (2004/24/EC).

Transitional arrangements for products sold under section 12(2):  Since 30 April 2004 unlicensed manufactured herbal medicines can no longer be placed on the market under Section 12 (2) of the Medicines Act.  They now need to comply with the requirements of the scheme or, alternatively obtain a marketing authorisation.  Unlicensed manufactured herbal medicines placed on the market under Section 12(2) of the Medicines Act before 30 April 2004, will need to comply with the requirements of this scheme by April 2011 or obtain a marketing authorisation (see below).
The Agency has produced a guidance note on the transitional arrangements set out in Directive 2004/24/EC. 

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

3.  Licensed herbal medicines
Around 500 herbal medicines hold a marketing authorisation (a product licence). To get a marketing authorisation a product needs to meet standards of safety, quality and efficacy (or effectiveness). When seeking a licence for herbal medicines, many companies have had difficulty meeting conventional requirements to prove efficacy. This was one factor that led to the introduction of the Traditional Herbal Registration Scheme and many products are likely to follow that regulatory route. However, it will continue to be possible to obtain a marketing authorisation for herbal medicines where the required levels of efficacy as well as safety and quality can be demonstrated. A number of herbal medicines with marketing authorisations are not currently marketed. Please see advice about the impact of the Sunset Clause on these products and an option that may be open to companies to ask for the effect of the Sunset Clause deferred if they are considering transferring the product to traditional herbal registration status.

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.

Herbal Medicines Advisory Committee
The Herbal Medicines Advisory Committee advises Ministers directly on issues relating to registration of traditional herbal medicinal products under the Traditional Herbal Medicines Registration Scheme and the safety and quality of unlicensed herbal remedies under the regime flowing from Section 12 of the Medicines Act 1968. The Committee operates as a Section 4 committee under the Medicines Act 1968.

Traditional Herbal Medicines Registration Scheme: Guidance for Retailers, Wholesalers, Importers and Manufacturers on the Requirements of the THMRS
The MHRA has produced the following guidance document ‘Guidance for Retailers, Wholesalers, Importers and Manufactures on Registering Herbal Medicine under the THMR scheme’  which provides an overview of the key elements of the current regulations.

Contacts for further information
For further guidance on whether your herbal product is a medicine please contact our Borderline Section, 16-1, MHRA, Market Towers, 1 Nine Elms Lane, London SW8 5NQ, telephone 020. 7084 2759, fax 020. 7084 2439 or e-mail info@mhra.gsi.gov.uk.

For further information on the regulation of herbal medicines in the UK contact Judith Thompson, judith.m.thompson@mhra.gsi.gov.uk, telephone 020 7084 2945.