§ Mr. HealdTo ask the Secretary of State for Health what(a) strengthened warnings, (b) restrictions on the terms of marketing authorisations and (c) revocations of medicines have been issued by the Medicines Control Agency in the current financial year. [22086]
§ Ms Blears[holding answer 13 December 2001]In the current financial year (1 April 2001 to 10 December 2001), there have been 1,083 changes to individual sections of the summary of product characteristics to strengthen safety warnings and to restrict the conditions of their use; these relate to 805 licensed medicinal products. Of these, 595 amendments were initiated by the Medicines Control Agency while 488 were initiated by the marketing authorisation holder. In addition, five licences for two nationally authorised products, amfepramone and phentermine, and two products authorised through the European centralised procedure, Trovan and Turvel, have been revoked. Specific details of this large number of regulatory actions can be provided only at disproportionate cost.