Question
What assessment they have made of the numbers of herbal products that have historically been marketed under Section 12(2) of the Medicines Act 1968 as medicines exempt from the need for a licence; how many and what percentage of those products they anticipate will need to secure registrations under the traditional herbal medicinal products directive (2004/24/EC); and what steps they are taking to assist manufacturers with this process; 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. In its regulatory impact assessment of the THR scheme, the MHRA estimated that typically the costs of registering a product under the scheme could be several tens of thousand pounds but that the figure would vary widely according to specific circumstances, not least depending on whether companies already had systematic quality control systems in place. This assessment has not changed. A steadily expanding THR scheme, alongside the availability of licensed herbal medicines, will offer consumers wide choice of over-the-counter herbal medicines made to assured standards of safety, quality and product information. The likelihood of increased consumer confidence in the standards of products, including the reliability of product information, could also be of benefit to responsible specialist manufacturers and retailers. 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 THR. 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 MHRA continues to provide a range of help to companies aimed at assisting them to progress plans to register products, including holding meetings with companies to discuss the progress of actual or prospective applications under the THR scheme and providing a range of detailed advice via the agency’s website. From 30 April 2011 no herbal medicine within the scope of directive 2004/24/EC may be placed on the UK market or distributed by way of wholesale dealing without 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. We have no plans to ask the European Commission to propose legislation extending the deadline in directive 2004/24/EC. The current fees for registering applications for products under the traditional herbal registration scheme range from £555 for a single existing ingredient to £7,480 for complex new products. The fees charged by the MHRA are set at a level to reflect fairly the cost related to each activity. These fee levels and costs are reviewed closely every year. This is in line with Treasury guidance. MHRA fees for registering herbal products are significantly lower than those levied on pharmaceutical companies for the registration of other medicines. The fees are based on an estimate of the amount of time it takes to undertake each of the activities and the costs of the relevant staff required to undertake these activities. Applications that are more complex take longer to assess and can require staff with more experience to undertake the work. These costs are reflected in the fee charged. The fee of £7,480 for processing applications for registration of complex herbal products containing two or more ingredients not previously assessed by the agency reflects the additional work necessary when assessing ingredients for the first time.