ANMAT reclassifies ten medications as over-the-counter in Argentina

The National Administration of Drugs, Food and Medical Technology (ANMAT) has reclassified ten groups of medications to over-the-counter (OTC) status in Argentina. Under Disposition 4714/2026, these drugs no longer require a medical prescription due to demonstrated safety and efficacy over at least five years of market use.

ANMAT justified the decision based on the low risk of serious adverse reactions and the drugs' ability to treat easily recognizable symptoms. The agency also cited regulatory precedents from health authorities in the United States, Brazil, Colombia, Spain, and France. Active ingredients included in the change are trimebutine maleate, levocetirizine dihydrochloride, fexofenadine hydrochloride, dimenhydrinate, and carboxymethylcysteine.

While the move aims to facilitate access to low-risk treatments, it carries financial implications for consumers. Because these medications are now sold without a prescription, they will no longer be eligible for discounts through social security (obras sociales) or private health insurance (prepagas), potentially increasing out-of-pocket costs for users.