Overview

• Disposición 6223/2025, published in the Boletín Oficial, brings estupefacientes and psychotropics into the national system, including fentanyl, morphine, oxycodone and methadone.
• Laboratories that make or sell affected medicines have 45 business days to adapt, after which every logistical movement must be recorded and available for ANMAT verification.
• ANMAT says the update enables real-time monitoring to detect irregularities, thefts or diversions early and to act quickly to protect public health.
• INAME is tasked with implementation and the marketing-authorization form is being replaced to add explicit traceability obligations across the supply chain.
• The shift reverses a 2016 exclusion that left fentanyl tracking to provinces via paper vouchers and comes after reports of 96 deaths tied to contaminated fentanyl and investigations into HLB Pharma.