§ Sir Dudley Smithasked the Secretary of State for Social Services (1) whether the level of scrutiny given to applications for product licences for parallel imported pharmaceutical products is identical with that given to abridged applications for product licences originated in the United Kingdom;
(2) whether he will indicate the level of medical or pharmaceutical scrutiny now being given to applications for product licences for parallel imported pharmaceutical products.
§ Mr. Kenneth ClarkeAll applications for product licences under the Medicines Act 1968 are subjected to the level of scrutiny necessary for the licensing authority to be satisfied of the safety, quality and efficacy of the product. This varies from case to case depending upon the nature of the product and the quality of the application and the supporting data. In the case of an application for a licence to cover a parallel import from within the European Community and already licenced there, our medical and pharmaceutical advisers concentrate upon establishing that the product concerned is the same as or not therapeutically different from one already licensed in the United Kingdom but their scrutiny may extend to other matters and involve inquiries of the marketing authority in the EC exporting country if necessary. We also ensure that the product fully satisfies the labelling requirements of the Medicines Act and regulations.