Multas por Não Cumprimento da Logística Reversa de Medicamentos
Definition
Failure to set up collection points, report volumes, or transport expired drugs properly triggers penalties under PNRS and specific decree obligations.
Key Findings
- Financial Impact: R$10.000 - R$100.000 per infraction (typical ANVISA/IBAMA fines); 20-50 hours/month manual compliance per site
- Frequency: Annual audits; phased rollout deadlines (e.g., Phase 1 within 180 days of decree)
- Root Cause: Manual tracking of waste manifests and lack of centralized reporting for multiple pharmacies
Why This Matters
The Pitch: Wholesale Drugs players in Brasil waste R$50.000+ annually on fines and audits for reverse logistics failures. Automation of collection tracking and NF-e reporting eliminates this risk.
Affected Stakeholders
Gerente de Distribuição, Farmacêutico Responsável, Compliance Officer
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
Perdas por Desvio de Produtos Expirados e Recall
Rejeição de NF-e em Devoluções de Produtos Recall/Expirados
Multas ANVISA por Falha em Cadeia Fria
Perda de Produtos por Excursão Térmica
Custos Excessivos de Qualificação Térmica
Multas ANVISA por Falta de Rastreabilidade de Medicamentos
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