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Herbal Medicine: EC Law

Volume 464: debated on Wednesday 17 October 2007

To ask the Secretary of State for Health (1) what estimate he has made of the numbers of herbal products currently on sale in the United Kingdom which will require registration under the Traditional Herbal Medicinal Products Directive if they are to remain on the market; by what date applications for registrations must be made to ensure continuity of supply; and by what date the products will become illegal if not successfully registered; (157225)

(2) how many applications for registration have been received by the Medicines and Healthcare Products Regulatory Agency; and how many positive decisions the Agency has taken to register herbal products under the Traditional Herbal Medicinal Products Directive;

(3) what assessment he has made of the number of herbal products which are likely to become unavailable to specialist retailers as a result of the inability or reluctance of manufacturers to submit applications for registration of such products under the Traditional Herbal Medicinal Products Directive; and if he will make a statement;

(4) what steps are being taken by the Medicines and Healthcare Products Regulatory Agency to maximise the opportunities afforded under the Traditional Herbal Medicines Products Directive and other legislation to allow the continued availability of long-established herbal products whilst maintaining appropriate safety standards.

The Medicines and Healthcare products Regulatory Agency (MHRA) has so far received applications for traditional herbal registration in relation to 29 products from a total of nine different companies. Five registrations have been granted and the other 24 applications are under assessment. In the light of discussions with individual companies, the MHRA expects steady growth in the number of applications received and registrations granted. The rate of build up of the scheme is reflective of the extent to which many companies needed to acquire expertise, for example in the manufacture of herbal medicines to systematic quality standards, before they could be in a position to submit applications.

Under provisions in Directive 2004/24 /EC, unlicensed herbal medicines legally on the United Kingdom market at 30 April 2004 under section 12(2) of the Medicines Act 1968 received transitional protection until 30 April 2011. Following discussions with industry and the former Better Regulation Task Force the MHRA decided not to require companies to notify the agency of products for which transitional protection was claimed. Accordingly, there is no estimate of the number of products on the UK market being sold legally under section 12(2) but which cannot legally be placed on the market after 30 April 2011.

We do not believe it is realistic to specify a date by which applications need to be made in order to secure continuity of supply. Time taken by the MHRA to assess applications depends on a number of factors including the quality of the application and how quickly the applicant responds to queries raised by the MHRA. The MHRA is giving extensive help to the industry through individual company meetings. Guidance to industry has stressed the importance of companies progressing their applications now if they wish to ensure continuity of supply.