To ask the Secretary of State for Health when the Criminal Investigation Unit of the Medicines and Healthcare products Regulatory Agency first began investigating the withholding of data from clinical trials of paroxetine; when she expects the Criminal Investigation Unit to take a decision on whether to refer the case to the police; whether she has the ultimate authority to decide whether a matter under investigation by the Criminal Investigation Unit is referred to the police; and if she will make a statement. (118142)

The criminal investigation into whether GlaxoSmithKline PLC withheld from the Medicines and Healthcare products Regulatory Agency (MHRA) information from paediatric clinical trials of their drug Seroxat (the United Kingdom brand name for paroxetine) was commenced by the Enforcement and Intelligence Group of the MHRA on 1 October 2003.The investigation is ongoing.

Criminal investigations into alleged breaches of medicines regulations are the statutory responsibility of the Secretary of State and are carried out by authorised officers in the Enforcement and Intelligence Group at MHRA.