BfArM

German: Bundesinstitut für Arzneimittel und Medizinprodukte.

Federal Institute for Drugs and Medical Devices. Higher federal authority responsible for the authorisation of medicinal products.

BfArM authorisation

Authorisation of medicinal products by the Federal Institute for Drugs and Medical Devices (BfArM) after intensive benefit/risk assessment (quality, efficacy and safety) of the documentation to be supplied by the pharmaceutical entrepreneur.