BfArM-Meldepflichtverletzungen und Bußgelder
Definition
Pharmaceutical companies, including those in alternative medicine, face mandatory pharmacovigilance reporting under AMG. Failure to document and report ADRs promptly results in fines from BfArM, operational disruptions, and potential license issues. Manual processes increase error rates and delays.
Key Findings
- Financial Impact: €5.000–50.000 Bußgeld pro Verstoß; 20–40 Stunden/Monat manuelle Dokumentation
- Frequency: Bei jeder ADR (0.4–1.2% der Patienten)
- Root Cause: Manuelle ADR-Dokumentation ohne Integration in EMR-Systeme
Why This Matters
This pain point represents a significant opportunity for B2B solutions targeting Alternative Medicine.
Affected Stakeholders
Inhaber, Arzt, Pharmacovigilance-Beauftragter
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
Manuelle ADR-Berichterstattung Overhead
Betrug durch unkontrollierte Barzahlungen
Kosten für ärztliches Attest und Führungszeugnis
Verlorene Rechnungen bei Paketabrechnung
DSGVO Bußgelder bei Mitgliederabrechnung
Verzögerte Zahlungseingänge bei Barzahlungspaketen
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