Herbal medicines regulation

Herbal tablets and plants

Stay safe using herbal remedies

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

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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:

Traditional Herbal Medicines Registration Scheme

Herbal pills in a bottle
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 (2004/24/EC).
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Prohibited or restricted herbal ingredients

Red berries
This section provides a consolidated list of herbal ingredients which are subject to restrictions.
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Is your herbal product a medicine?

Cranberry tablets
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.
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Marketing authorisations for herbal medicines

Hand holding herbal tablets

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.

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

Doctor with elderly male patient
Information for practitioners who prepare herbal medicines following a one-to-one consultation.

Advice for consumers on using herbal medicines safely

Close up of herbal pills
Information and advice about using herbal medicines can be found in our herbal medicines consumer information section
Page last modified: 30 April 2014