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German health law in English
Pharmaceutical Benefit Assessment Ordinance

AM-NutzenV in English: the AMNOG benefit assessment ordinance

Arzneimittel-Nutzenbewertungsverordnung (AM-NutzenV)

11 provisions, complete · English side by side with the current German text · German text as of 29 October 2026 · translation edited by Alexander Baranov

The AM-NutzenV sets out how the AMNOG early benefit assessment under section 35a SGB V works: what the dossier must contain, how added benefit and the appropriate comparator therapy are determined, G-BA advice, publication and the link to the EU joint clinical assessment.

Each page shows the English and the German side by side, sentence by sentence, with a link to every provision. The German text is copied from the official consolidated version; our English is an unofficial working translation.

In practice: The AMNOG dossier: timeline and cost · AMNOG explained · EU JCA vs AMNOG.

Pharmaceutical Benefit Assessment Ordinance

  1. § 1ScopeGeltungsbereich
  2. § 2DefinitionsBegriffsbestimmungen
  3. § 3Scope of application of the benefit assessment under section 35a SGB VAnwendungsbereich der Nutzenbewertung nach § 35a SGB V
  4. § 4Dossier of the pharmaceutical companyDossier des pharmazeutischen Unternehmers
  5. § 5Added benefitZusatznutzen
  6. § 6Appropriate comparator therapyZweckmäßige Vergleichstherapie
  7. § 7Benefit assessmentNutzenbewertung
  8. § 8AdviceBeratung
  9. § 9DisclosureOffenlegung
  10. § 10Transitional provisionsÜbergangsregelungen
  11. § 11Entry into forceInkrafttreten

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.