§ Mr. Corbett
asked the Secretary of State for Social Services whether he will set down the criteria used to test the safety, efficacy and quality of medicinal products under section 19 of the Medicines Act 1968.
§ Mr. Hayhoe
The licensing authority does not carry out tests of samples in connection with applications for medicinal product licences but requires applicants to submit data on the safety, efficacy and quality of their products in accordance with comprehensive guide lines. These data are evaluated by the licensing authority. It is not possible to set down precise criteria for this evaluation as they will depend on proposed use and and the conditions they are intended to treat, ranging from minor ailments to life-threatening conditions. In reaching decisions on188W particular applications, the licensing authority is able to call upon the advice of one of the specialist advisory committees established under section 4 of the Medicines Act.