28/07/2026 06:30 - Salud
The Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT)—Argentina's equivalent of the U.S. FDA or the European EMA—has approved a long-awaited and beneficial measure to improve healthcare access for all Argentines. Through Disposition 4714/2026, published in the Boletín Oficial (the country's official government gazette) on July 28, 2026, ten low-complexity medications are now classified as over-the-counter (OTC), eliminating the need for a medical prescription to purchase them.
The regulation comes into effect on Wednesday, July 29, 2026, and covers antihistamines, digestive aids, motion sickness remedies, cough treatments, and topical products. To make this decision, ANMAT evaluated that these products have been sold under prescription for at least five years in Argentina without serious adverse effects, demonstrating a wide therapeutic margin and proven safety in the National Pharmacovigilance System and the WHO database.
The OTC authorization applies only to the specific concentrations, presentations, and routes of administration listed in the disposition. Here is the complete list:
| Active Ingredient / Combination | Concentration and Presentation | Primary Use |
|---|---|---|
| Trimebutine maleate | 100 mg, oral tablets or capsules | Digestive disorders |
| Levocetirizine dihydrochloride | 5 mg and 5 mg/ml, tablets, capsules or oral solution | Antihistamine (allergies) |
| Fexofenadine hydrochloride | 60 mg, 120 mg and 6 mg/ml, oral | Antihistamine (allergies) |
| Dimenhydrinate | 50 mg, oral tablets or capsules | Motion sickness and dizziness |
| Naphazoline hydrochloride + Pheniramine maleate | Sterile ophthalmic solution (0.025% / 0.3%) | Eye allergies / ophthalmology |
| Olopatadine hydrochloride | Sterile ophthalmic solution (0.1% and 0.2%) | Eye allergies / ophthalmology |
| Carbocisteine | 5% syrup or oral solution | Cough and expectorant |
| Aluminum chloride hexahydrate | 20% topical lotion | Excessive sweating (hyperhidrosis) |
| Calcium carbonate, Arnica montana, and Silver nitrate | Oral/topical powder | Topical / oral use |
| Ivermectin | 0.5% topical lotion only | Parasitic skin conditions |
Laboratories may continue selling existing batches already in pharmacies before the effective date without changing labels or leaflets. However, new batches released from July 29, 2026 onward must:
ANMAT based its decision on precedents from international regulatory agencies such as the U.S. FDA, the European EMA, and authorities in Spain, France, Brazil (ANVISA), and Colombia (INVIMA), where these medications are already sold without a prescription. This is a very positive development aimed at expanding access and promoting responsible use of products with proven safety and efficacy.
Sources: TN, La Nación, Infobae, and Derecho en Zapatillas.
Alfredo S. Quiroga
