🇩🇪Germany

Lieferengpass-Meldepflicht & Lagerhaltung ohne Automatisierung

1 verified sources

Definition

ALBVVG (Arzneimittel-Lieferengpassbekämpfungs- und Versorgungsverbesserungsgesetz) now requires mandatory shortage reporting and, for pediatric/generic medicines, 6-month stockpiling commitments in rebate agreements. A pharmacy without automated shortage tracking must manually verify stock levels, email BfArM, and document proof. Manual process: 2–3 hours/day (shortage verification + notification + confirmation). Cost: €30/hour × 150 hours/year = €4,500/year. Penalty for late/missed reporting: €5,000–€50,000 per incident (BfArM discretion).

Key Findings

  • Financial Impact: €4,500–€6,000/year manual process overhead; €5,000–€50,000 per missed shortage report (penalty)
  • Frequency: Daily (stock monitoring); Weekly (BfArM submissions); Quarterly (Betriebsprüfung audit risk)
  • Root Cause: No integrated shortage-alert system; manual BfArM portal submissions; no automated compliance audit trail.

Why This Matters

This pain point represents a significant opportunity for B2B solutions targeting Retail Pharmacies.

Affected Stakeholders

Warehouse Manager, Pharmacy Manager, Compliance Officer

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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.

Evidence Sources:

Related Business Risks

Apothekenrabatt-Margin-Erosion durch Regeländerung

€0.23–€0.50 per prescription; typical 50-pharmacy chain: €40,000–€120,000/year margin leakage

ePA-Dokumentationspflicht & Datenschutzverstöße durch manuelle Verarbeitung

DSGVO penalty range: €5,000–€300,000 per audit; typical ePA compliance overhead: 10–20 hours/month (€1,200–€2,400/month) for audit trail reconciliation

Import-Arzneimittel: UK-Kennzeichnung & RPi-Compliance-Overhead

€2,000–€3,500/month per distribution center (manual verification + label auditing)

HTA/AMNOG-Dokumentation für Apotheken-Reimbursement-Verhandlungen

€5,000–€12,500 per rejected/repriced pharmaceutical; annual: €60,000–€150,000 per 50-pharmacy chain

Fehlende Abrechnung von Zuschlägen bei Generika-Substitution

€2,000–€8,000/year per pharmacy (estimated 4,000–16,000 generic substitutions/year × 50% capture rate gap × €0.50 allowance)

Abweichungen in der Berechnung der obligatorischen Apothekenrabatte

€5,000–€15,000/year per pharmacy (500–1,000 prescriptions/month × €1.77 discount × 12 months × 0.5–1.5% error/dispute rate)

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