The Federal Ministry of Health shall, by 31 December 2027, prepare a report containing a concept for the establishment of an indication-related register for advanced therapy medicinal products within the meaning of section 4 subsection (9) of the Medicinal Products Act (Arzneimittelgesetz) within the remit of the Federal Ministry of Health.
Das Bundesministerium für Gesundheit hat bis zum 31. Dezember 2027 einen Bericht mit einem Konzept zur Schaffung eines indikationsbezogenen Registers für Arzneimittel für neuartige Therapien nach § 4 Absatz 9 des Arzneimittelgesetzes im Geschäftsbereich des Bundesministeriums für Gesundheit zu erarbeiten.
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.