The Federal Institute for Drugs and Medical Devices (BfArM) shall charge fees and expenses for individually attributable public services in accordance with the following provisions.
Das Bundesinstitut für Arzneimittel und Medizinprodukte erhebt für individuell zurechenbare öffentliche Leistungen Gebühren und Auslagen nach Maßgabe der folgenden Vorschriften.
Background: The DiGA fast-track · DiGA timeline and cost · Data security: GDPR and BSI. We explain what this provision means for your launch, price and timeline — fixed price, in writing.
Unofficial translation for information only. Only the German text is legally binding. German text: consolidated version from gesetze-im-internet.de, retrieved 29 October 2026. Where German statutes use “soll”, “shall” denotes an obligation that admits exceptions in atypical cases. Not legal advice.