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ANMAT Centralizes Drug Traceability, Bringing Fentanyl Into a Real-Time National System

The move responds to contaminated‑fentanyl deaths by shifting high‑risk medicines to a modern platform for early detection of diversion.

Overview

  • Disposición 6223/2025, published Wednesday, expands mandatory tracking to estupefacientes and psychotropics with a published list of 495 active ingredients.
  • Laboratories, importers and distributors have 45 business days to register and adapt their records to the national traceability platform.
  • Fentanyl and other opioids transition from provincial paper-voucher oversight to centralized digital monitoring after the system went largely unchanged since 2016.
  • Health officials say the upgrade enables real-time surveillance to detect irregularities, thefts or diversions to the black market and to trigger faster responses.
  • Regulatory actions and probes continue, including suspensions and market withdrawals tied to HLB/Ramallo and Rigecin following a WHO alert on contaminated fentanyl lots.