Penalties — Interdição, Multa, Cancelamento de Registro
ANVISA and state VISA bodies have broad enforcement powers under Lei 6.437/1977 and RDC 753/2022. Penalties for GMP non-compliance and other health surveillance infractions in Brazil can be severe.
| Penalty | Description |
|---|---|
| Notificação de infração (auto de infração) | Formal written notice of infraction — triggers the penalty process |
| Multa (fine) | Financial penalty, calculated based on the severity of the infraction and company revenue |
| Interdição de produto (product interdiction) | Seizure of specific batches or products pending investigation |
| Interdição de estabelecimento (establishment closure) | Temporary closure of the manufacturing or distribution site |
| Remove this editorial comment from the published page. The penalty table should clarify: 'Interdição de estabelecimento (establishment closure)' = Temporary closure of the manufacturing or distribution site pending investigation or corrective action. 'Revocation of the company's operating authorisation' = Permanent cancellation of the Autorização de Funcionamento (AFE) issued by ANVISA or state VISA. | Revocation of the company's operating authorisation |
| Cancelamento de Registro | Revocation of the product's marketing authorisation |
| Criminal liability | In cases of serious harm or fraud — referral to public prosecutors |
Appeal rights: All ANVISA penalties can be appealed through ANVISA's administrative appeals process. The appeal must be filed within the period stated in the penalty notice.
Verify all information against official ANVISA sources before making regulatory decisions.
Administrative appeals of ANVISA penalties must be filed within 15 business days from receipt of the penalty notice. The appeal should be submitted via Peticionamento Eletrônico and must include supporting documentation and legal arguments. ANVISA will issue a decision on the appeal, which may be further appealed to higher administrative bodies.