It is the purpose of this Act, in the interest of ensuring a proper supply of medicinal products to the population, to ensure safety in the trade in medicinal products, in particular the quality, efficacy and safety of medicinal products, in accordance with the following provisions.
Es ist der Zweck dieses Gesetzes, im Interesse einer ordnungsgemäßen Versorgung der Bevölkerung mit Arzneimitteln für die Sicherheit im Verkehr mit Arzneimitteln, insbesondere für die Qualität, Wirksamkeit und Unbedenklichkeit der Arzneimittel, nach Maßgabe der folgenden Vorschriften zu sorgen.
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.