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New action on unlicensed herbal medicines

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In a move to help people buy and use safe herbal medicines that meet acceptable standards of safety and quality, the Medicines and Healthcare products Regulatory Agency (MHRA) has announced that from 30 April 2014, all manufactured herbal medicines will have to be authorised in order to be sold and supplied lawfully in the UK.

This means that after this date herbal retailers will no longer be able to sell unlicensed herbal medicines that are not registered under the Traditional Herbal Registration (THR) scheme in the UK. 

Products registered under the THR scheme meet safety and quality standards and are accompanied by patient information about the product and how it should be used. Registered products can be identified by the THR logo and a THR number on their label.

Dr Linda Anderson, MHRA Licensing Division, said:

“Natural doesn’t always mean safe and some unlicensed herbal products can be harmful and some may have serious side effects.

“We know that people buy and use herbal medicines, so it’s only right that they have access to products that are safe and meet good quality standards. And that’s where we come in – our THR scheme can help assure you that these products meet these standards.

”It is now nearly ten years since the implementation of the European Directive on herbal medicines. Companies have had this time to bring products up to appropriate standards and apply for a THR registration. ”

The requirements for the THR scheme are set out in the Traditional Herbal Medicinal Products Directive (THMPD) which was introduced in 2004 and came into effect on 30 April 2011.

For those herbal medicines that were on the UK market before April 2011, the MHRA allowed retailers to “sell through” their stock because it was anticipated that they would be sold within an 18-24 month period - the average shelf-life of these products. This transitional protection also allowed manufacturers to bring their production up to the required standards to meet the directive.

However, these unlicensed herbal medicines are still being sold and in July 2013, the MHRA launched a consultation to seek views about ending the sell-through period. The responses have now been considered and 30 April 2014 is the deadline for retailers to stop selling these products.

MHRA press release