Question
What estimate the Medicines and Healthcare products Regulatory Agency has made of the number of herbal remedies currently marketed in the United Kingdom under Section 12(2) of the Medicines Act 1968; for how many and what percentage of those products an application has been received by the agency for registration under the traditional herbal medicinal products directive; and what will be the legal status of those products for which applications for registration have not been received by the end of the transition period in 2011; and
Answer
The Medicines and Healthcare products Regulatory Agency (MHRA) has so far received 38 applications from 14 companies to register products under the traditional herbal registration (THR) scheme. To date, 17 registrations have been granted and the remaining applications are under assessment. On the basis of discussions with individual companies, the MHRA anticipates that the number of applications will continue to rise steadily. Companies are not required to notify the MHRA of products marketed under Section 12(2) of the Medicines Act 1968; therefore no estimates are available in relation to these products. Following the expiry of the transitional period permitted under directive 2004/24/EC, manufactured herbal medicines placed on the market will require either a marketing authorisation or a traditional herbal registration. As now, there will continue to be some herbal products that potentially can be placed on the market either as medicinal products or under other product regulatory regimes depending on their presentation. The Government's objective in relation to over-the-counter herbal medicines is that the public should have access to a range of herbal medicines made to assured standards of safety and quality and accompanied by systematic information about the safe use of the product. The previous regulatory arrangements for unlicensed herbal remedies marketed under Section 12(2) left companies free to decide whether to meet any standards and put responsible companies, and in particular those with specialist expertise wishing to operate to high standards, at a significant disadvantage. Consumers were unable to tell which products were made to acceptable standards. The MHRA will continue to operate the THR scheme in a proportionate way, in line with the principles of better regulation. Thereby we expect to see a competitive market offering consumers a wide range of licensed and registered herbal medicines. Ministers have not visited the facilities of manufacturers to discuss the impact of the directive on traditional herbal medicinal products. However, the MHRA has had well over a hundred meetings with companies, including small and medium-sized businesses, to discuss the progress of actual or prospective applications under the THR scheme.