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NHS: Drugs

Volume 460: debated on Wednesday 23 May 2007

To ask the Secretary of State for Health what steps her Department plans to take to decrease the time-lag between the conclusion of clinical trials and subsequent licensing of orphan medicines for the treatment of serious, life threatening or chronically debilitating illnesses and their availability to patients. (131655)

Applications for marketing authorisations for designated orphan medicinal products are required to be submitted via the European centralised procedure and hence applications for national United Kingdom marketing authorisations are not possible. The time taken from submission of a Marketing Authorisation application to licence issue is therefore outside of the control of the UK and follows the timetable for European centralised applications.

However, where there is a clear clinical need there is the possibility that orphan medicinal products can be made available to patients, prior to the grant of a marketing authorisation, under a compassionate use programme authorised by the European Medicines Agency and there is the possibility for accelerated consideration of a marketing authorisation application by that agency.