Table 4.

Marketing authorization procedures* for medicinal products in the European Union (EU)

National procedure, when marketing authorization is granted for a medicinal product in the respective member state only

Mutual recognition procedure, when a preparation already has marketing authorization in one EU member state and this authorization should be extended to other member states

Decentralized procedure, when a medicinal product does not yet have national marketing authorization and seeks parallel marketing authorization in several EU member states

Central procedure (simultaneous marketing authorization in all EU member states), necessary in the case of medicinal products cited in the Appendix to EU Regulation 726/2004 (e.g., medicinal products which are manufactured by using biotechnological processes); can also be used for other medicinal products under certain conditions

*All procedures resulting in marketing authorization in several or all European countries are coordinated by the European Medicines Agency (EMA).