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Herbal medicines regulation

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Stay safe using herbal remedies

Did you know…?
40% people think herbal medicines are safe because they are natural.
Ipsos MORI / MHRA, 2008

This section of the site is aimed at anyone wishing to place herbal medicines on the UK market and outlines the different regulatory requirements.

The new European Traditional Herbal Medicinal Products Directive (THMPD) 2004/24/EC came into effect on 30 April 2011. The Directive establishes a regulatory approval process for herbal medicines in the European Union (EU). It requires each EU Member State to set up a traditional herbal registration scheme for manufactured traditional herbal medicines that are suitable for use without medical supervision.

Companies are no longer able to sell manufactured unlicensed herbal medicines unless they have an appropriate product licence, either:

a full marketing authorisation (MA) based on the safety, quality and efficacy of the product, as with any regular medicine, or
a traditional herbal registration (THR) based on the safety, quality and evidence of traditional use of the product.

Traditional Herbal Medicines Registration Scheme

The Traditional Herbal Medicines Registration Scheme, introduced on 30 October 2005, helps 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 (2204/24/EC).

Go to the section on the Traditional Herbal Medicines Registration Scheme

Prohibited or restricted herbal ingredients

This section provides a consolidated list of herbal ingredients which are subject to restrictions.

Go to the page on prohibited or restricted herbal ingredients

Is your herbal product a medicine?

Not all herbal products are medicines; many can be legally sold as food or cosmetics for example. It is therefore important that you begin by establishing whether your product is classified as a medicine. This section will help you determine whether your product is medicinal and where to go for advice.

For further information on establishing if your product is classified as a medicine please see our borderline products section

Marketing authorisations for 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.

Go to the section on marketing authorisations for herbal medicines

Unlicensed herbal medicines supplied by a practitioner following a one-to-one consultation

Information for practitioners who prepare herbal medicines following a one-to-one consultation.

Go to the page on unlicensed herbal medicines supplied by a practitioner following a one-to-one consultation

Advice for consumers on using herbal medicines safely

Information and advice about using herbal medicines can be found in our herbal medicines consumer information section

Go to advice for consumers on using herbal medicines safely

Page last modified: 12 December 2011