The U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) has announced that beginning April 30, 2014, all manufactured herbal medicines must be registered under the Traditional Herbal Registration (THR) scheme before they may be legally supplied or sold in the United Kingdom. The requirements for the THR scheme are listed in the Traditional Herbal Medicinal Products Directive, which was introduced in 2004 and took effect April, 30, 2011. At that time, MHRA instituted a transition period to (i) allow retailers to "sell through" their stock, anticipating that the products would be sold within an 18- to 24- month period—the average shelf-life of these products; and (ii) permit manufacturers to bring production up to the required standards to meet the directive.
Noting that unlicensed herbal medicines were still being sold, the agency launched a July 2013 consultation seeking input about ending the sell-through period. "It is now nearly ten years since the implementation of the European Directive on herbal medicines," said an MHRA spokesperson. "Companies have had this time to bring products up to appropriate standards and apply for a THR registration."
Products registered under the THR scheme must meet safety and quality standards and include patient information about the product and how it should be used. Registered products will also feature a THR logo and number on the label. See MHRA News Release, November 21, 2013.