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§21a AMG Compassionate Use – Germany

BfArM CU Application§21a Arzneimittelgesetz (AMG)30 days

Contents

  1. 1. Description & Eligibility
  2. 2. Countries Using This Pathway

Description & Eligibility

Compassionate use under §21a of the German Medicinal Products Act (AMG), authorised by BfArM for patients with serious or life-threatening diseases who cannot be adequately treated with authorised medicines.

Eligibility Criteria

Serious or life-threatening condition with no locally registered alternative

Legal Reference / Source

BfArM Compassionate Use Guidance

Countries Using This Pathway (1)

DE
Germany
DE
§21a AMG Compassionate Use – Germany
Approval FormBfArM CU Application
Timeline30 days
Legal Status§21a Arzneimittelgesetz (AMG)
Source Ref.BfArM Compassionate Use Guidance
Countries1 countries
Compliance Check
Legal Review3/11/2026
Global ValidityVerified