🇧🇷Brazil

Penalidades por Não-Conformidade ao SNGPC (Portaria 344/1998)

4 verified sources

Definition

Pharmacies face fines for incomplete or delayed SNGPC reporting, failure to maintain required records for controlled substances, and discrepancies between physical inventory and SNGPC declarations. Responsibilities include maintaining updated ANVISA registration, correct registration of all movements, and accurate retention of medical prescriptions (Portaria 344/1998, Art. 37-42).

Key Findings

  • Financial Impact: LOGIC-based estimate: Typical ANVISA administrative fines for non-compliance range R$ 5,000–R$ 50,000 per violation; larger networks face R$ 100,000+ for systemic SNGPC failures. Operational costs from license suspensions or revocation: loss of controlled-substance revenue (15–30% of pharmacy revenue), estimated R$ 50,000–R$ 500,000+ per pharmacy per month during suspension.
  • Frequency: Ongoing risk; audit cycles typically annual or triggered by complaints.
  • Root Cause: Manual SNGPC entry prone to human error; lack of real-time synchronization between point-of-sale and SNGPC; insufficient training on Portaria 344 obligations; delayed batch reporting vs. real-time requirement.

Why This Matters

The Pitch: Brazilian pharmacy chains waste millions annually on audit remediation, legal defense, and operational shutdowns due to SNGPC compliance failures. Automation of real-time SNGPC submission and transaction verification eliminates manual data-entry errors that trigger ANVISA enforcement actions.

Affected Stakeholders

Responsável Técnico (Pharmacist), SNGPC Data Entry Operator, Pharmacy Manager, 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.

Evidence Sources:

Related Business Risks

Atraso Operacional por Registro Manual no SNGPC (Sistema Nacional de Gerenciamento de Produtos Controlados)

LOGIC-based estimate: 2–5 minutes per controlled-substance transaction × 20–50 controlled transactions/day per pharmacy × 22 working days/month = 14.6–110 hours/month of technician time (R$ 880–R$ 6,600/month at R$ 60/hour blended cost). For pharmacy networks with 50+ locations: R$ 44,000–R$ 330,000/month in lost labor capacity.

Risco de Desvio e Furto de Medicamentos Controlados por Falta de Rastreabilidade em Tempo Real

LOGIC-based estimate: Average shrinkage rate 1–3% of controlled-substance inventory. For a mid-sized pharmacy (R$ 100,000/month in controlled-substance revenue): R$ 1,000–R$ 3,000/month loss. For pharmacy network (50 locations): R$ 50,000–R$ 150,000/month undetected shrinkage. Annual impact: R$ 600,000–R$ 1.8M per network.

Erros de Decisão por Falta de Visibilidade em Tempo Real sobre Estoque de Medicamentos Controlados

LOGIC-based estimate: 2–5% inventory waste (expiration/spoilage) on R$ 100,000/month controlled-substance revenue = R$ 2,000–R$ 5,000/month. 5–10% stock-out-driven lost sales = R$ 5,000–R$ 10,000/month forgone margin. Combined: R$ 7,000–R$ 15,000/month per pharmacy. Network (50 locations): R$ 350,000–R$ 750,000/month. Annual: R$ 4.2M–R$ 9M.

Multa por Violação de LGPD e Privacidade do Consumidor

R$ 8,497,500.00 (confirmed fine); potential industry exposure: R$ 50,000–R$ 3,000,000 per administrative proceeding depending on scale and intent.

Risco de Recusa de Cobertura de Plano de Saúde por Violação de Dados Sensíveis

Per-customer litigation cost: R$ 10,000–R$ 50,000; churn impact: 2–5% customer base loss annually; class action risk: R$ 5,000,000+.

Perda por Vencimento de Medicamentos (Product Expiration Waste)

Estimated: R$ 2,000–25,000 annually per pharmacy (2–5% of typical inventory value of R$ 100,000–500,000). Pharmacy chains with 10+ locations: R$ 20,000–250,000+ annually.

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