The Medicines and Healthcare products Regulatory Agency (MHRA) is reminding herbal companies and retailers that, as of 1st May 2014, unlicensed manufactured herbal medicines without a traditional herbal registration (THR) or product licence (PL) can no longer be sold to consumers and must be removed from shelves.
With the introduction of Directive 2004/24/EC, all manufactured over-the-counter herbal medicines in the UK require either a Traditional Herbal Medicines Registration (THR) or a full Marketing Authorisation (MA). This includes manufactured Traditional Chinese Medicines and Ayurvedic medicines.
For those that were on the market before April 2011, when the traditional herbal registration scheme was implemented*, the MHRA allowed retailers to “sell through” their stock because it was anticipated that they would be sold within the average shelf-life of these products (18-24 months).
This sell through period has now ended and companies must ensure that they comply with the legislation.
Dr Linda Anderson, from the MHRA Licensing Division, said:
The aim of the THR scheme is to give people access to traditional herbal medicines that are safe, of good quality and have information on how to use the product correctly.
The public should only buy herbal medicines that they know have met standards which can be identified by the THR or PL number on the product. Most of the THR products also have the THR logo which can easily be identified on the packaging.
Natural doesn’t always mean safe. Some unlicensed herbal medicines can cause serious side effects or may interact with other medicines that a patient is taking.
Over 300 products are now registered under the THR scheme. This provides consumers with a wide range of products from which to choose.
Companies should no longer supply unlicensed manufactured herbal medicines. People also need to be aware that not all of the products they are using, fall under the MHRA’s licensing system. A herbal practitioner is allowed to make up an individual preparation following a consultation. And other products can legally be sold as foods, cosmetics or general consumer products.
Chairman of the British Herbal Medicines Association, Dick Middleton said:
The British Herbal Medicine Association is pleased that sell-through of unlicensed herbal medicines to the public is coming to an end. The availability exclusively of only regulated herbal medicines will ensure that consumers can safely choose to treat minor ailments appropriately, safe in the knowledge that they are of high quality with accompanying reliable information.
The MHRA press release may be read in full on their website.
*Clarification 30/11/14: The EU directive 2004/24/EC came into force in 2004 and the transitional period ended on 30th April 2011. See the MHRA website for further details.