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January 19, 2026
Approximately 5 minutes
Management of Supply Shortages of Medicinal Products at BfArM
Management of Supply Shortages of Medicinal Products at BfArM
Legal Framework and Notification Obligations
In Germany, supply shortages of medicinal products are regulated under the German Medicines Act (AMG) and related ordinances. Marketing authorisation holders (MAHs) are legally required to notify BfArM immediately of any actual or anticipated supply bottlenecks or shortages that may lead to supply disruptions lasting more than two weeks or affecting critical medicines. Notifications must include reasons for the shortage, expected duration, affected strengths/pack sizes, and any alternative supply options. Supply shortages - BfArM
Federal Supply Shortage Database
BfArM maintains the public Federal Supply Shortage Database (Versorgungsengpässe-Datenbank), which lists current and resolved shortages of human medicinal products. The database includes:
- Product name, strength, and pharmaceutical form
- Marketing authorisation holder
- Start and expected end dates of the shortage
- Reasons for the shortage
- Information on alternative products or import options
Healthcare professionals, pharmacies, and patients can access this database to check availability and plan accordingly.
Coordination and Mitigation Measures
- BfArM assesses reported shortages for potential impact on patient care.
- For critical shortages, BfArM may coordinate with federal and state authorities, MAHs, and wholesalers to facilitate imports of equivalent products or authorise temporary alternatives.
- Collaboration occurs with the Federal Joint Committee (G-BA) and health insurance funds when shortages affect reimbursable medicines.
- In severe cases, exceptional import authorisations or quota adjustments may be granted.
Reporting by Healthcare Professionals and Pharmacies
BfArM encourages pharmacies and healthcare professionals to report observed supply difficulties or shortages via the database or direct notification, providing real-world insights that complement MAH reports and help identify emerging issues early.
Practical Implications
Timely notification and transparent publication of shortages enable better planning by healthcare providers and patients, reduce risks of treatment interruptions, and support regulatory efforts to maintain supply continuity. BfArM’s system aligns with EU initiatives on medicine shortages, contributing to improved resilience in pharmaceutical supply chains. Supply shortages - BfArM
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