Overview
- The Chamber of Deputies approved the Sistema Nacional de Alerta y Trazabilidad de Eventos Críticos en Salud by 241 votes to 1 with five abstentions on Wednesday and sent the bill to the Senate for final sanction.
- The bill creates SNATECS under ANMAT and requires digital, end‑to‑end records from import and manufacture through administration to a patient, plus simultaneous notifications to the nation and provinces within 24 hours.
- When inspectors have sufficient evidence ANMAT would have up to six hours to trigger a national sanitary alert and immobilize suspect lots, and the measure raises penalties with fines reported near 192 million pesos earmarked for ANMAT.
- The reform was prompted by the April 2025 fentanyl contamination that killed about 90 people and led to a federal probe by Judge Ernesto Kreplak that has produced prosecutions of former ANMAT officials.
- Lawmakers and victims’ families praised the bipartisan agreement but warned the law will not prevent future cases without major boosts to ANMAT’s field inspection capacity, technical systems to link batch records to patient IDs, and coordinated federal‑provincial implementation through COFESA.