Multas ANVISA por Falta de Rastreabilidade de Medicamentos
Definition
Brazil's ANVISA enforces serialization and traceability for pharmaceuticals, requiring unique identifiers and reporting, with non-compliance resulting in fines, shipment rejections, and supply disruptions.
Key Findings
- Financial Impact: R$10.000 - R$100.000 per violation (statutory ANVISA fines); 20-50 hours/month manual rework
- Frequency: Per non-compliant batch or audit failure
- Root Cause: Lack of automated serialization systems matching ANVISA specs, leading to data mismatches in track & trace
Why This Matters
The Pitch: Wholesale Drugs players in Brasil 🇧🇷 waste R$50.000+ annually on ANVISA penalties and rework. Automation of serialization compliance eliminates this risk.
Affected Stakeholders
Gerente de Logística, Controlador Fiscal, Auditor de Qualidade
Deep Analysis (Premium)
Financial Impact
Financial data and detailed analysis available with full access. Unlock to see exact figures, evidence sources, and actionable insights.
Current Workarounds
Financial data and detailed analysis available with full access. Unlock to see exact figures, evidence sources, and actionable insights.
Get Solutions for This Problem
Full report with actionable solutions
- Solutions for this specific pain
- Solutions for all 15 industry pains
- Where to find first clients
- Pricing & launch costs
Methodology & Sources
Data collected via OSINT from regulatory filings, industry audits, and verified case studies.
Related Business Risks
Custos Extras com Sistemas Manuais de Serialização
Perda de Capacidade por Atrasos em Validação de Serialização
Multas ANVISA por Falha em Cadeia Fria
Perda de Produtos por Excursão Térmica
Custos Excessivos de Qualificação Térmica
Multas por Não Cumprimento da Logística Reversa de Medicamentos
Request Deep Analysis
🇧🇷 Be first to access this market's intelligence