European Medicines Evaluation Agency and the new licensing arrangements

doi:10.1136/dtb.1994.321289

Drug and Therapeutics Bulletin 1994;32:89-90; doi:10.1136/dtb.1994.321289

European Medicines Evaluation Agency and the new licensing arrangements

Since September 1971 the Medicines Act has provided the legalbasis for controlling the manufacture, sale, supplyand marketingof medicines in the UK.¹ The law has been modified by Parliamentand the incorporation of Europeandirectives, but until now itsinterpretation and implementation have remained matters forUK authorities.From 1 January 1995 the position changes withthe establishment of the European Medicines Evaluation Agency(EMEA)²and the introduction of marketing arrangements for medicinesthat 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 MedicinalProducts (CPMP; equivalent to our Committee on Safety of Medicines),thebody that will advise the European licensing authority (EuropeanCommission). The new arrangements will covermedicines and vaccines(including blood products and radiopharmaceuticals) for bothhuman and veterinary use.3This article outlines the workingsof the new system and discusses how they might affect the provisionof medicinesfor human use in the UK.