§ Mr. WilsonTo ask the Secretary of State for Health what powers she or the Medicines Control Agency has to terminate or vary a product licence held by a pharmaceutical manufacturer; and under what circumstances those powers may be used.
§ Mr. SackvilleSection 28 of the Medicines Act 1968 sets out the powers of the licensing authority—United Kingdom Health Ministers—to suspend, revoke or vary a medicinal product licence. Section 28 also specifies the grounds on which the powers can be used. The procedures to be followed when the licensing authority proposes such action are contained in section 29 and schedule 2 of the Medicines Act. The licensing authority also complies with the requirements of the European Directive 65/65.