BfArM Bußgelder bei Rückrufversäumnissen
Definition
Failure to promptly notify and quarantine under AMG exposes firms to BfArM penalties, compounded by 2025 digital evidence requirements in Betriebsprüfungen.
Key Findings
- Financial Impact: €5,000-€500,000 fine per violation; €3.7B industry-wide pharma cost controls[5]
- Frequency: Per non-compliance incident; audit-triggered
- Root Cause: Manual processes delaying BfArM reporting
Why This Matters
This pain point represents a significant opportunity for B2B solutions targeting Wholesale Drugs and Sundries.
Affected Stakeholders
Compliance Manager, Produktmanager
Deep Analysis (Premium)
Financial Impact
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Current Workarounds
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Methodology & Sources
Data collected via OSINT from regulatory filings, industry audits, and verified case studies.
Related Business Risks
Quarantäne-Lagerkosten und Abfall
Überlast durch manuelle Dokumentation und Mapping
Rückforderungen durch Preisfehler in Großhandelsverträgen
Verzögerte Zahlungen durch Chargeback-Streitigkeiten
Betrug durch manipulierte Rückforderungen
Betriebsprüfungsrisiken bei fehlender Kaltkettendokumentation
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