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ANMAT pharmaceutical and medical regulatory changes

Updated 2 times since CLSTR started tracking revisions of this situation.

What changed

2026-09-24 11:07 UTC → 2026-09-24 20:38 UTC · added removed

Argentina’s National Administration of Medicines, Food and Medical Technology (ANMAT) has introduced new several regulatory measures affecting the pharmaceutical and medical device sectors. Under Disposition 5461/2026, ANMAT implemented new import tariffs on high-cost medications and complex medical devices. The regulation imposes a general rate of 1.5% on the FOB value of imported goods, with a reduced rate of 1.25% for higher-volume operations, alongside specific payment caps. operations. This measure has faced criticism from healthcare sectors and unions, as the lack of defined operational procedures for these taxes has reportedly stalled essential import requests for life-sustaining treatments and medical devices. Following these fiscal changes, ANMAT also took administrative action regarding requests. Regarding product registrations. Through registrations, Disposition 5866/2026, 5866/2026 resulted in the agency canceled cancellation of 25 medicine registration certificates belonging to 15 pharmaceutical companies, including CSL Behring, Takeda, and Laboratorio Elea Phoenix. This decision followed a technical audit which determined determining that the certificates had expired without the required renewal applications being filed within the mandatory 30-day window. Consequently, the affected Affected companies are prohibited from manufacturing or commercializing the specific products until their status is regularized. Additionally, ANMAT has prohibited the sale, distribution, and advertisement of any products containing ‘retatrutide’ or ‘retatrutida’. The agency identified these products being sold via websites and messaging apps, noting that the ingredient is currently in clinical research stages and has not been approved for human use. The regulator warned that the substance poses a health risk as its efficacy and safety are unproven and manufacturing processes remain unknown. unproven. In a separate enforcement action, ANMAT revoked the sanitary licenses of the drugstore Royal Farma S. A. in Buenos Aires after discovering the company had submitted a fraudulent establishment registration certificate during a provincial procurement process.

Versions

  1. 2026-09-24 20:38 UTC ANMAT pharmaceutical and medical regulatory changes
  2. 2026-09-24 11:07 UTC ANMAT pharmaceutical and medical regulatory changes
  3. 2026-09-23 16:36 UTC ANMAT pharmaceutical and medical regulatory changes

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