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Pharmaceutical Benefit Assessment Ordinance · Pharmaceutical Benefit Assessment Ordinance
Section 11

Entry into force

§ 11 AM-NutzenV · Inkrafttreten

Arzneimittel-Nutzenbewertungsverordnung (AM-NutzenV) · German text as of 29 October 2026 · translation edited by Alexander Baranov

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This Ordinance shall enter into force on 1 January 2011.

Diese Verordnung tritt am 1. Januar 2011 in Kraft.

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Background: The AMNOG dossier: timeline and cost · AMNOG explained · EU JCA vs AMNOG. We explain what this provision means for your launch, price and timeline — fixed price, in writing.

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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.