§ Mr. Spearingasked the Secretary of State for Social Services what inspection procedures are applied in respect of quality and consistency of pharmaceutical products imported into the United Kingdom.
440W
§ Mr. Kenneth ClarkeOverseas manufacturers of pharmaceutical products intended for the United Kingdom market must, in general, comply with conditions which equate to those applicable to United Kingdom manufacturers. Control is exercised by our Department's Medicines Inspectorate which follows a programme of inspections confirming that the same standards of good pharmaceutical manufacturing practice are observed whether the manufacturer operates in the United Kingdom or overseas, and co-operate with inspectorates in other countries.
An additional check is imposed on products imported from non-EC countries in that the importer is obliged to ensure that full quantitative and qualitative analyses are carried out before marketing, so as to confirm that the products comply with their specifications. Manufacturers within the EC are themselves required to carry out these control tests.
At present, certain parallel imports of products already licensed here can be excluded from these arrangements if one of the exemptions under the Medicines Act is invoked by the importer. The Government announced on 8 December proposals, now subject to statutory consultation, to restrict this exemption and provide additional safeguards.—[Vol. 50, c. 477–87.]