The Federal Government shall issue, with the consent of the Bundesrat, the general administrative regulations required for the implementation of this Act.
Die Bundesregierung erlässt mit Zustimmung des Bundesrates die zur Durchführung dieses Gesetzes erforderlichen allgemeinen Verwaltungsvorschriften.
Insofar as these are addressed to the competent higher federal authority, the general administrative regulations shall be issued by the Federal Ministry.
Soweit sich diese an die zuständige Bundesoberbehörde richten, werden die allgemeinen Verwaltungsvorschriften von dem Bundesministerium erlassen.
Background: Pharma market access in Germany · Four routes to a German marketing authorisation. 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.