§ Mr. Simon HughesTo ask the Secretary of State for Health (1) what clinical trials conducted under a clinical trials exemption certificate were terminated between 1 October 1995 and 30 November 1995 at the request of the licensing authority on grounds of safety; [12922]
(2) if regulatory action relating to clinical trials involving the use of medicinal products containing (a) desogestrel and (b) gestodene has now been completed. [12971]
§ Mr. MaloneAny company, or investigator, wishing to conduct a clinical trial with third generation progestogens or their metabolites, would have to apply to the Medicines Control Agency in accordance with the Medicines Act 1968 and its secondary legislation, and would have to provide a justification for the use of third generation progestogens taking into account the recent advice of the Committee on Safety of Medicines in its letter dated 18 October 1995. Any regulatory action relating to clinical trials is treated in confidence between the licensing authority and the company or investigator concerned.