Multa (Fines) — Calculation & Appeal
Fine calculation
Fines (multas) for health surveillance infractions are calculated under Lei 6.437/1977 based on:
- Severity of the infraction — minor, serious, very serious, or grave;
- Company size — small companies and microenterprises receive reduced fines;
- Previous violations — repeat violations lead to higher fines;
- Degree of harm — actual harm to patients increases the fine; and
- Cooperation — cooperation with ANVISA investigators may reduce fines.
Fine ranges (indicative)
| Infraction severity | Fine range (BRL) |
|---|---|
| Minor infraction | BRL 2,000 – BRL 75,000 |
| Serious infraction | BRL 75,000 – BRL 450,000 |
| Very serious infraction | BRL 450,000 – BRL 1,500,000 |
| Grave infraction (causing serious harm) | Up to BRL 1,500,000+ |
Fine values are updated periodically by ANVISA.
Appeal process
All fines can be appealed through ANVISA's administrative appeals process:
- Preliminary defence (defesa prévia) — within 10 working days of the infraction notice;
- First administrative appeal — within 10 working days of the first decision;
- Second administrative appeal (to ANVISA's collegiate board) — final administrative instance.
After exhausting administrative appeals, judicial review is available in the Brazilian federal courts.
Official sources
Verify all information against official ANVISA sources before making regulatory decisions.