The document provides an overview of the marketing authorisation procedures for medicines in the European Union, with a focus on the centralised procedure. It discusses the historical development of regulation, the roles of the European Medicines Agency and other EU institutions. The centralised procedure is mandatory for certain drug classes and allows for a single marketing authorisation valid across all EU member states. The process involves evaluation of dossier submissions by scientific committees like CHMP and a decision on authorisation by the European Commission. Post-approval obligations include pharmacovigilance and risk management activities.