§ Mr. GryllsTo ask the Secretary of State for Health whether all product licence applications for medicines distributed in the United Kingdom have included the submission of a full product specification.
§ Mrs. Virginia BottomleyAll product licence applications for medicinal products used in the United Kingdom are submitted in accordance with the Medicines Act 1968 and the relevant EC directives. These currently include the requirement that licence application must be supported either with or by reference to full data on the product particulars.