Overview
- Disposición 5866/2026 was published in the Boletín Oficial on Wednesday and signed by ANMAT director Luis Eduardo Fontana to formalize the cancellations after an internal records review.
- The action affects 15 firms and 25 REM entries, with Lafedar and Laboratorio Internacional Argentino carrying five cancellations each and CSL Behring and Terumo BCT listed with two each.
- ANMAT's Dirección de Gestión de Información Técnica found registration expiries dated between March 2019 and May 2025 and determined companies had not begun the required reinscription process.
- Under the Ley de Medicamentos, authorizations last five years and must be reinscribed within 30 days before expiry, so ANMAT cancelled the approvals and notified companies they may seek administrative reconsideration or appeal within the law’s time frames and begin judicial action within 180 days.
- The cancellations stop affected products from being produced or sold until reinscription is regularized, a move that could disrupt supply for patients and is part of broader market policing that recently included a nationwide prohibition of CAFLAB products for lacking sanitary authorization.