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Herbal Medicine: Licensing

Volume 482: debated on Tuesday 11 November 2008

To ask the Secretary of State for Health what discussions he has had with the Medicines and Healthcare Products Regulatory Agency on its proposals for increasing charges for herbal product registrations under the provisions of the Traditional Herbal Medicinal Products Directive; what assessment the Agency has made of the impact of such increases on small and medium-sized manufacturers of herbal remedies; and what assessment he has made of the effect of those increases on the costs of compliance with the provisions of the Directive. (233503)

I recently approved the proposals of the Medicines and Healthcare products Regulatory Agency (MHRA) to consult on increasing its fees from 1 April 2009. Those proposals affect all sectors of the pharmaceutical industry and include a general increase in fees for the traditional herbal sector of around 4 per cent. The consultation letter, including an impact assessment of the proposals, was published on 15 October 2008 and all sectors of the pharmaceutical industry have been alerted and invited to comment. The consultation exercise closes on 7 January 2009 and the MHRA would particularly welcome comments from smaller and medium sized companies. A copy of the consultation letter including the impact assessment proposals has been placed in the Library.