Recent changes in European Union legislation on medicinal products. Legislation of the European Union (EU) on drug registration was recently modified in Directives 2004/27/EC and 2004/24/EC and in Regulation (EC) 726/2004. New elements introduced by these instruments are described including changes in the centralized procedure and the mutual recognition (decentralized) procedure. Other recent changes in the EU legislation related to medicinal products are also reviewed.