The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a final cut-off date for the ‘sell through’ of unlicensed herbal medicines.
The Agency announced yesterday (20 November) that from April 30 2014 retailers will longer be able to sell unlicensed herbal medicines that are not registered under the Traditional Herbal Registration (THR) scheme in the UK.
Under an agreement with industry the MHRA has allowed retailers to sell through herbal medicines that were on the UK market before April 2011 (the date when the transition period of the Traditional Herbal Medicinal Products Directive (THMPD) ended).
The Agency anticipated that all products still on shelves were likely to be sold within an 18-24 month period. But it says many products are still on shelves in 2013 and it is now taking action to remove them.
Dr Linda Anderson, MHRA Licensing Division, said: “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. ”
Industry will read this development as a signal that the MHRA is about to step up its enforcement of the herbals category.
Manufacturers and trade associations meanwhile are continuing to lobby for a wider group of herbs and plants to be afforded the status of ‘botanicals’, allowing products containing them to be marketed as supplements and regulated under food law. They argue that the law remains unclear on the products occupying the borderline between medicinal herbs and botanicals.
Some companies have separately warned that the entire herbal category risks being damaged if ‘non-therapeutic’ versions of popular and trusted medicinal herbs are placed on the market. And one brand owner told Natural Products that ‘botanical supplements’ was a “meaningless term being used simply to get around the law”.