Marketing Authorisation (Human)

Medicinal products to be marketed in Germany require regulatory approval in the form of a national marketing authorisation or an authorisation by the European Commission.

The competent national authorities for the granting of authorisations for medicinal products for human use in Germany are the Paul-Ehrlich-Institut (PEI) and the Federal Institute for Drugs and Medical Devices (BfArM).

European authorisations are coordinated by the European Medicines Agency (EMA, Amsterdam).

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