# ANMAT pharmaceutical and medical regulatory changes

> Live situation record from CLSTR: https://clstr.news/situations/anmat-pharmaceutical-and-medical-regulatory-changes
> Updated: 2026-09-23T10:59:00.000Z. Sources: 32. Developments: 2.

Argentina’s National Administration of Medicines, Food and Medical Technology (ANMAT) has introduced 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. This measure has faced criticism from healthcare sectors and unions, as the lack of defined operational procedures has reportedly stalled essential import requests.

Regarding product registrations, Disposition 5866/2026 resulted in the cancellation of 25 medicine registration certificates belonging to 15 pharmaceutical companies, including CSL Behring, Takeda, and Laboratorio Elea Phoenix. This followed a technical audit determining that certificates had expired without renewal applications being filed within the mandatory 30-day window. 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.

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.

## Timeline

### 2026-09-23: ANMAT bans retatrutide products and cancels 25 drug registrations in Argentina

Argentina's ANMAT has banned products containing the experimental weight-loss compound retatrutide and canceled 25 drug certificates due to expired registrations, while also revoking a drugstore's licenses.

22 sources. https://clstr.news/cluster/anmat-cancels-25-medicine-registrations-in-argentina

### 2026-09-21: ANMAT implements new import tariffs on high-cost medicines

ANMAT has introduced new import tariffs on high-cost medicines and medical devices in Argentina, causing delays in essential treatments for patients with disabilities due to administrative bottlenecks.

11 sources. https://clstr.news/cluster/anmat-bans-specific-insulin-pump-supplies-following-theft

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Cite as: ANMAT pharmaceutical and medical regulatory changes. CLSTR, https://clstr.news/situations/anmat-pharmaceutical-and-medical-regulatory-changes
