Paul-Ehrlich-Institut

Information on the Use of Cookies

In order to operate and optimise our website, we would like to collect and analyse statistical information completely anonymously. Will you accept the temporary use of statistics cookies?

You can revoke your consent at any time in our privacy policy.

OK

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).

Updated: 21.11.2019