Penalties — Interdição, Multa, Cancelamento de Registro
BR-unique
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 |
| The proper term is 'Cancelamento da Autorização de Funcionamento' or 'Interdição de estabelecimento' — 'AFE' is not standard regulatory terminology. The page already lists 'Interdição de estabelecimento' separately, so this row may be redundant or should clarify the distinction between temporary closure (interdição) and permanent revocation of operating authorization. | 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.
Official sources
Verify all information against official ANVISA sources before making regulatory decisions.