§ Mr. AmosTo ask the Secretary of State for Health, pursuant to his reply of 18 July,Official Report, column 287, on what date his Department officially announced that RU486 was to receive a product licence in the United Kingdom; and if he will make a statement.
§ Mrs. Virginia BottomleyThe Department does not make immediate announcements about the issue of product licences. The licence for RU486 (Mifegyne) was granted to Roussel on 1 July. The company announced the following day that it had received a product licence.
Formal notification of decisions to grant product licences is via the London, Edinburgh and Belfast Gazettes. In the case of RU 486 (Mifegyne), publication will be at the end of August.
§ Mr. AmosTo ask the Secretary of State for Health what research, other than clinical trials, has been carried out on the safety aspects of the drug RU486.
§ Mrs. Virginia BottomleyAs for all new drugs, safety testing was undertaken according to the requirements of directive 75/318 EEC. The Committee on Safety of Medicines was fully reassured as to the safety of RU486 from the results of these tests.
§ Mr. FearnTo ask the Secretary of State for Health if he will give details of the new responsibilities in regard to the licensing of new drugs undertaken by the Medicines Control Agency since it was given independent status.
§ Mrs. Virginia BottomleyThe Medicines Control Agency is an executive agency of the Department of Health operating within a published policy and resources framework document.
The chief executive of this agency is responsible and accountable to my right hon. Friend the Secretary of State for the efficient management, overall performance and future development of the agency.
910WThe licensing of medicines, including new drugs, remains the responsibility of Ministers—"the United Kingdom licensing authority"—under the provisions of the Medicines Act 1968 and associated European directives.