European Medicines Evaluation Agency and the new licensing arrangements.

Abstract

Since September 1971 the Medicines Act has provided the legal basis for controlling the manufacture, sale, supply and marketing of medicines in the UK. The law has been modified by Parliament and the incorporation of European directives, but until now its interpretation and implementation have remained matters for UK authorities. From 1 January 1995 the position changes with the establishment of the European Medicines Evaluation Agency (EMEA) and the introduction of marketing arrangements for medicines that will be binding across the European Union (EU). The EMEA, which will be based in London, will act as a coordinating centre, housing and servicing the Committee for Proprietary Medicinal Products (CPMP; equivalent to our Committee on Safety of Medicines), the body that will advise the European licensing authority (European Commission). The new arrangements will cover medicines and vaccines (including blood products and radiopharmaceuticals) for both human and veterinary use. This article outlines the workings of the new system and discusses how they might affect the provision of medicines for human use in the UK.