Drug product registration and marketing authorization procedures in EU-A perspective

There are 27 European Union (EU) member states, 3 European Economic Area (EEA) andEuropean Free Trade Association (EFTA) states. For a company willing to market the me-dicinal product in to the EEA, marketing authorization (MA) for the respective product mustbe issued by competent authority of member state or authorization granted according toRegulation (EC) No. 726/2004 for entire community. Europe constitutes large population andEuropean government is alert regarding safety of the public in EU. There are changes in theprocedures for the marketing authorization by the EU. Different types of procedures for theapplication of marketing authorization are available in the EU and these procedures are dis-cussed here