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Argentina's FDA (ANMAT) Authorizes Over-the-Counter Sale of 10 Medications

28/07/2026 15:56 - Salud

Easier Access to Essential Medications in Argentina

The official measure aims to speed up the purchase of drugs for minor ailments.


On July 28, 2026, the National Administration of Medicines, Food and Medical Technology (known by its Spanish acronym ANMAT, Argentina's equivalent to the US FDA) officially announced through Disposition 4714/2026 an expansion of the over-the-counter (OTC) sale regime for ten groups of medications. This regulation, published in the Official Gazette, will go into effect on July 29, 2026. Its main objective is to facilitate citizens' access to low-complexity treatments, promoting responsible use and greater competition in the pharmaceutical market.

According to official sources, the decision is framed within Resolution 284/2024 of the Ministry of Health. The Minister of Health, Mario Lugones, highlighted the initiative, stating that it seeks to expand options and favor access to safe and effective medications. However, it is important to note that products becoming OTC will no longer have discounts through 'obras sociales' or 'prepagas'. For context, 'obras sociales' are trade union-based health insurance funds that cover the vast majority of Argentine workers, while 'prepagas' are private health insurance plans.

The 10 Authorized Medications and Their Uses

The disposition covers medicinal specialties registered in the Registry of Medicinal Specialities (REM) that comply with approved concentrations and pharmaceutical forms. Here is the detailed list:

Active IngredientPresentationPrimary Use
Trimebutine maleateTablets/capsules 100 mgGastrointestinal disorders and spasms
Levocetirizine dihydrochlorideTablets or oral solution 5 mgAntihistamine / Allergy relief
Fexofenadine hydrochlorideTablets or oral solution (60/120 mg)Antihistamine / Allergy relief
DimenhydrinateTablets/capsules 50 mgNausea, vomiting, and motion sickness
Naphazoline + PheniramineSterile ophthalmic solutionEye irritation and allergy
Olopatadine hydrochlorideSterile ophthalmic solution (0.1% - 0.2%)Allergic conjunctivitis
CarbocisteineSyrup or oral solution 5%Mucolytic for respiratory secretions
Aluminum chloride hexahydrateTopical lotion 20%Antiperspirant for excessive sweating
Calcium carbonate + Arnica + Silver nitrateOral/topical powderHealing and anti-inflammatory for mucous membranes and skin
IvermectinTopical lotion 0.5%Treatment for pediculosis (lice)

What Were ANMAT's Criteria?

To authorize the change in sales conditions, ANMAT rigorously evaluated that the medications:

  • Had been marketed under prescription in the country for at least the last five years.
  • Did not present reports of serious adverse events that would alter the risk-benefit balance.
  • Had the backing of international regulatory agencies such as the FDA (USA), EMA (Europe), ANVISA (Brazil), and INVIMA (Colombia).
  • Demonstrated efficacy in alleviating symptoms easily recognizable by users.

New batches must adapt their presentation, include a QR code with the corresponding package insert, and the 'Over-the-Counter' (Venta Libre) label. Batches released previously may continue to be marketed without modifications.

Pharmacists' Perspective

Despite the convenience for the public, the measure sparked debate in the pharmaceutical sector. The College of Pharmacists of the Province of Buenos Aires (COLFARMA) in La Plata expressed concern that the measure could affect public health by encouraging self-medication.

Similarly, Pablo Yáñez, president of the College of Pharmacists of the Province of Santa Cruz, indicated in an interview with El Mediador that the measure poses a risk to patients by potentially masking symptoms of major pathologies. However, Yáñez acknowledged that, economically, pharmacies might benefit from the measure since health insurances are not involved, but reiterated the importance of professional advice.

A Step Towards Deregulation with Responsibility

This initiative by the national government seeks to replicate successful experiences, such as that of so-called proton pump inhibitors (prazoles), which between May 2024 and June 2026 registered price increases below accumulated inflation, demonstrating that greater availability can translate into a reduction in real prices.

The Ministry of Health assures that the measure is designed so that citizens can quickly resolve mild symptoms, freeing up medical time for more complex cases. Authorities insist that responsible use and consultation with the pharmacist remain key to safe treatment.


Sources:
Today's News
Alfredo's Column Alfredo S. Quiroga

Alfredo S. Quiroga