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Argentina ANMAT regulatory actions

Updated 4 times since CLSTR started tracking revisions of this situation.

What changed

2026-07-28 18:40 UTC → 2026-07-28 18:58 UTC · added removed

Since June 2026 ANMAT has stepped up intensified enforcement across cosmetics, cleaning agents, medical devices and pharmacy sales. In July the regulator barred three sunscreen sales, barring several products and a botulinum‑toxin preparation for lacking proper sanitary registration, and ordered a nationwide recall of all Clean Laby registration and Clorquim recalling contaminated cleaning‑product batches for the same reason. batches. It also tightened qualifications for technical directors of medical‑device firms, revoked certifications for 15 non‑compliant companies, advanced a presidential decree to create an Administration of National Health Establishments, certifications, and circulated a draft law to amend pharmacy‑sales rules, advanced legislation on pharmacy sales, including provisions for digital sales. provisions. On 27 July 2026 ANMAT issued Disposition 4714/2026, formally authorising over‑the‑counter sales of ten active‑ingredient groups under the conditions set out in Ministry of Health Resolution 284/2024. Eligible products had to show that have demonstrated safety, efficacy, a wide therapeutic margin and at least five years of prescription‑only marketing without serious adverse events. Existing stock may remain on shelves, but new New batches must display bear a QR code linking to a digital prospectus. prospectus, while existing stock may remain on shelves. The authorised ingredients include trimebutine maleate, levocetirizine, fexofenadine, dimenhydrinate, a nafazolina + feniramina combination, olopatadine, carbocisteine, aluminum‑chloride hexahydrate, a calcium‑carbonate‑arnica‑silver‑nitrate blend and topical ivermectin 0.5 % lotion. Professional bodies such as COLFARMA warned of potential health‑risk issues, while and pharmacists in Santa Cruz echoed concerns; retailers and kiosk owners warned that broader self‑medication could pose health risks, whereas merchants in San Juan welcomed the commercial opportunity. These actions illustrate ANMAT’s The parallel crackdown on unsafe products and its effort to broaden safe medication availability. expansion of vetted OTC medicines illustrates ANMAT’s dual strategy of consumer protection and market liberalisation.

Versions

  1. 2026-07-28 18:58 UTC Argentina ANMAT regulatory actions
  2. 2026-07-28 18:40 UTC Argentina ANMAT regulatory actions
  3. 2026-07-28 17:44 UTC Argentina ANMAT regulatory actions
  4. 2026-07-28 16:01 UTC Argentina ANMAT regulatory actions
  5. 2026-07-27 11:47 UTC Argentina ANMAT product bans

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