No unlicensed herbal supplements allowed - UK medicine regulator

27 November 2013 | News | By Bureau Report

Unlicensed herbal food supplements cannot be sold in United Kingdom (UK) after April 30, 2014. UK’s Medicines and Healthcare products Regulatory Agency (MHRA) said in recently released statement. The MHRA is responsible for regulating all medicines and medical devices in the UK.

MHRA has announced that after the deadline, 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. 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 in an 18-24 month window - 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, the MHRA says these unlicensed herbal medicines are still being sold and 30th April 2014 is fixed as the deadline for retailers to stop selling these products.


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