ANMAT revokes Royal Farma's authorizations due to forged certificate

The National Administration of Drugs, Foods and Medical Devices (ANMAT) has revoked the authorizations of ROYAL FARMA S.A. to carry out the interjurisdictional transit of medications, medicinal specialties, medical products, and “in vitro” diagnostic products without a cold chain. The decision was formalized in ANMAT Provision 6139/2026 (DI-2026-6139-APN-ANMAT#MS), signed on September 22, 2026, and published in the Official Gazette on September 24, 2026, First Section (official reference 347922). The measure originated from the detection of a forged establishment certificate submitted by the company in bidding processes in the province of Santa Fe.

The forged certificate that triggered the investigation

According to file EX-2026-14299714-APN-DGA#ANMAT, the Technical Information Management Directorate (DGIT) received an email inquiry from CPN Alejandrina Macedo, General Coordinator of Suppliers of the Undersecretariat of Procurement and Asset Management of the Ministry of Economy of the Province of Santa Fe, regarding the authorization of ROYAL FARMA Sociedad Anónima (CUIT 30-70858423-8), a firm participating in several bidding processes.

The Establishment Registration Certificate provided by the company was attached to that inquiry, and the DGIT corroborated that the document “turned out to be forged.” The firm has its registered office and warehouse at Luzuriaga St. No. 818, Autonomous City of Buenos Aires.

Expired authorizations and lack of renewal

Official records showed authorizations that had already expired:

• Interjurisdictional Transit of Medical Products and “in vitro” Diagnostic Products without a cold chain, per ANMAT Provision 1290/2015 (February 9, 2015), File No. 511, whose Establishment Registration Certificate expired on February 3, 2020.
• Interjurisdictional Transit of Medications and Medicinal Specialties, per ANMAT Provision 2872/2016 (March 22, 2016), File No. 511, whose Certificate of Compliance with Good Distribution Practices for Medications expired on March 22, 2021.

The National Institute of Medical Products (INPM) reported via note NO-2026-14194677-APN-DFYGREPM#ANMAT that a search in the Electronic Document Management system yielded no initiation of a renewal process. Similarly, the Directorate of Evaluation and Management of Health Product Monitoring (DEYGMPS), via note NO-2026-14147524-APN-DVPS#ANMAT, pointed out that the firm did not initiate the renewal of the good distribution practices certificate and that it “is not authorized to distribute medications, whether for profit or free of charge, outside the Autonomous City of Buenos Aires.”

Judicial precedent and scope of the revocation

The provision cites as a precedent file EX-2024-46228321-APN-DVPS#ANMAT, through which the DEYGMPS filed a complaint regarding forged documents in 2024, assigned by lottery to the Federal Criminal and Correctional Court No. 2 under No. CFP 1816/2024.

The National Sub-administrator of ANMAT, Gabriel Leonardo Barbagallo, consequently resolved:

• To revoke the authorizations of ROYAL FARMA S.A. for interjurisdictional transit, pursuant to File No. 511.
• To cancel the certificate granted by ANMAT Provision 2872/2016.
• To cancel the certificate granted by ANMAT Provision 1290/2015.
• To communicate the measure to the provincial health authorities, the Government of the Autonomous City of Buenos Aires, the INPM, the Directorate of Legal Affairs, and the Directorate of Information Management.

The act was issued in exercise of the powers of Decree No. 1490/1992 and its amendments, within the framework of Law No. 16.463.

Deadlines for Appeal

Article 4 establishes that the provision exhausts the administrative route. The company may opt for a motion for reconsideration, an administrative appeal, or judicial action, pursuant to Decree No. 1759/72 (T.O. 2017) and Article 25 of Law No. 19.549:

• Motion for reconsideration: 20 administrative business days.
• Administrative appeal: 30 administrative business days.
• Judicial action: 180 judicial business days.

The deadlines are computed from the day following the notification of the act.

The revocation leaves ROYAL FARMA S.A. without authorization to move medications and medical products between jurisdictions, which affects its capacity to supply public procurement and obliges bidding agencies—such as those in Santa Fe—to verify the validity of their providers’ health certificates. The case further exposes the risk of forged certificates slipping into provincial procurement processes, a precedent that has already resulted in a federal criminal case in 2024.

Source: Official Gazette of the Argentine Republic, First Section, September 24, 2026 (official reference: 347922).