Drug and Therapeutics Bulletin 1994;32:89-90; doi:10.1136/dtb.1994.321289
Copyright © 1994 by the BMJ Publishing Group Ltd.

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European Medicines Evaluation Agency and the new licensing arrangements

Since September 1971 the Medicines Act has provided the legal basis for controlling the manufacture, sale, supplyand marketing of medicines in the UK.¹ The law has been modified by Parliament and the incorporation of Europeandirectives, 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)² and the introduction of marketing arrangements for medicines that will be binding across the EuropeanUnion (EU). The EMEA, which will be based in London, will act as a coordinating centre, housing and servicing theCommittee for Proprietary Medicinal Products (CPMP; equivalent to our Committee on Safety of Medicines), thebody that will advise the European licensing authority (European Commission). The new arrangements will covermedicines and vaccines (including blood products and radiopharmaceuticals) for both human and veterinary use.3This article outlines the workings of the new system and discusses how they might affect the provision of medicinesfor human use in the UK.