Table 3. Marketing authorization procedures for medicinal products in the European Union (EU).

National procedure through which the medicinal product is authorized only in the respective member state.

Mutual recognition procedure if the preparation is already authorized in a member state of the EU and the authorization is to be extended to further member states.

Decentralized procedure if the medicinal product does not yet have a national marketing authorization and is to be authorized in parallel in several EU member states.

Centralized procedure (simultaneous marketing authorization in all EU member states), which must be applied when it comes to medicinal products that are named in the appendix to EC Regulation 726/2004 (e.g., medicinal products manufactured using biotechnological processes); it can also be used for other medicinal products under certain conditions. These are coordinated by the European Medicines Agency (EMA).