In the cases referred to in Article 107i of Directive 2001/83/EC, the competent higher federal authority shall take the measures provided for therein.
In den Fällen von Artikel 107i der Richtlinie 2001/83/EG ergreift die zuständige Bundesoberbehörde die dort vorgesehenen Maßnahmen.
Articles 107i to 107k of Directive 2001/83/EC shall apply to the procedure.
Für das Verfahren gelten die Artikel 107i bis 107k der Richtlinie 2001/83/EG.
Background: Pharmacovigilance and GxP obligations · 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.