Argentine pharmaceutical regulatory actions

The Argentine National Administration of Drugs, Food and Medical Technology (ANMAT) has implemented significant regulatory changes regarding pharmaceutical accessibility and safety.

In August 2026, ANMAT reclassified ten groups of medications to over-the-counter (OTC) status under Disposition 4714/2026. This decision, based on the demonstrated safety and efficacy of ingredients such as levocetirizine dihydrochloride and fexofenadine hydrochloride, allows these drugs to be sold without a medical prescription. While intended to facilitate access to low-risk treatments, the move means these medications are no longer eligible for discounts through private health insurance or social security.

By September 2026, the agency shifted focus toward enforcement and quality control. ANMAT issued a preventive inhibition against Laboratorio Trifarma S. R. L. and Ugal Farmacéutica S. A., prohibiting the sale and distribution of all their products nationwide. These measures followed inspections that revealed non-compliance with production standards, including issues with technical direction at Trifarma and critical deficiencies in Good Manufacturing Practices and sterile medication control at Ugal Farmacéutica.