Herbal medicines regulation and safety

What you need to know as a consumer
Herbal medicines are medicines in their own right. As with any other medicine they are likely to have an effect on the body and should be used with care. Our sections on 'Safety of herbal medicines' provide general non-product specific advice on the safe use of herbal remedies. The current weak regulation of herbal remedies in the UK has led to specific safety concerns which are also highlighted in this section.

There are three possible regulatory routes by which a herbal remedy can reach you as a consumer. These are as:

1. Unlicensed herbal remedies.
   These products don’t have to meet specific standards of safety and quality and so standards can vary widely. In addition they are not required to be accompanied by the necessary information for you to use them safely such safety warnings and contraindications. Because this does not help the public to make informed choice or offer effective protection against low grade and dangerous products, by April 2011 all manufactured herbal medicines will be required to have either a traditional herbal registration or a product licence (see below).
   
2. Registered traditional herbal medicines.
   A simplified registration scheme, the Traditional Herbal Medicines Registration Scheme, began on 30 October 2005.  Products are required to meet specific standards of safety and quality and be accompanied by agreed indications, based on traditional usage, and systematic patient information allowing the safe use of the product. Consumers can find general advice on the operation of the Traditional Herbal Medicines registration scheme within the Herbal safety advice pages of this website.
   
3. Licensed herbal medicines.
   Some herbal medicines in the UK hold a product licence or marketing authorisation just like any other medicine. These are required to demonstrate safety, quality and efficacy (or effectiveness) and be accompanied by the necessary information for safe usage. These products can be identified by a distinctive nine number Product Licence (PL) number on the product container or packaging which is pre-fixed by the letters PL.

Further information on these three routes is available in the section on 'How herbal medicines can reach the market'.

How can I tell if a product has been registered under the Traditional Herbal Medicines Registration Scheme?
A number of products have now been registered under the Traditional Herbal Registration Scheme.  While it may take some time before these products appear on the market following their registration, you should expect to see a steady stream of such product appearing in the coming months and years.

To help you identify which products have been registered under the scheme the product container or packaging will include a nine digit registration number starting with the letters THR.  This will enable you to differentiate between these and other herbal remedies. You can also find Information about the registered products in the public assessment reports which are made available on Public Assessment Reports for herbal medicines page of the website.  In addition key safety information on the main herbal ingredient used in these products can also be found under the Herbal safety advice section.

What you need to know if you are seeking to place a herbal medicine on the UK market
Manufactured herbal medicines placed on the UK market are required to have either a Traditional Herbal Registration (THR) or a Marketing Authorisation (MA). This applies whether the product is marketed to consumers, herbal practitioners, retailers, or wholesalers.

The following guidance document ‘Guidance for Retailers, Wholesalers, Importers and Manufacturers on Registering Herbal Medicine under the THMR Scheme’ which provides an overview of the key elements of the current regulations.  It covers whether a product can be placed on the UK market, the restrictions that apply, who is responsible for applying for registration or other relevant licences and what these processes involve.  The document also provides links to more specific and detailed information about the regulation of herbal medicines that can be found on other areas of this site.

Free e-mail alerting service
If you would like to receive an e-mail notification when any of the pages of the 'Herbal medicines' section are updated, please subscribe to our free e-mail alerting service (under 'Herbal medicines information'):
› MHRA e-mail alerting service

Contacts for further information
For further information on the regulation of herbal medicines in the UK contact Judith Thompson, telephone 020 7084 2945. For further information on safety aspects affecting herbal remedies please contact Leigh Henderson, telephone 020 7084 2156, MHRA, Market Towers, 1 Nine Elms Lane, London SW8 5NQ.