§ Norman BakerTo ask the Secretary of State for Health on what date, and for what reasons the licence held by Regent GM Laboratories was suspended by the Medicines Control Agency; and on what date, and for what reason, it was subsequently reinstated. [4320]
§ Ms Blears[holding answer 17 July 2001]: The Manufacturer's Licence ML 13994 for Regent GM Laboratories was suspended by the Medicines Control Agency (MCA) on 18 December 1998.
The licence was suspended because the company had contravened the provisions of the licence and had failed to a critical extent to comply with the principles and guidelines of good manufacturing practice.
The suspension was lifted and the licence reinstated on 3 December 1999 following inspection of the manufacturing facilities in August 1999 and November 1999 when the licensing authority was satisfied that the deficiencies identified prior to the suspension had been rectified.