Argentina ANMAT Compliance

(Sistema Nacional de Trazabilidad de Medicamentos – SNT)

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Global Regulations

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Labelling

Products are required to display information in writing.

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Unit Level Traceability

Sellable units are uniquely identified enabling a more granular traceability.

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Aggregation

The packaging hierarchy of products is required to be identified and documented.

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Central repository

The traceability documentation is required to be centralized in a unique system.

Summary

Argentina operates a national pharmaceutical traceability program managed by Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT).

The system is called the National Medicines Traceability System (Sistema Nacional de Trazabilidad de Medicamentos – SNT) and tracks medicines from manufacturer or importer through distribution to dispensing. The objective is to prevent counterfeit medicines and allow regulators to monitor product movement in real time across the supply chain.

All supply chain participants including manufacturers, importers, distributors, logistics operators, pharmacies, and hospitals must report traceability events to ANMAT’s central database.  

Unlike many modern systems, Argentina’s program focuses on event reporting rather than full hierarchical aggregation, but serialized identifiers must still be maintained across distribution activities.

Labelling Requirements 

Every saleable pharmaceutical pack included in the traceability program must carry a unique serialized identifier compliant with GS1 standards.

Typical barcode structure:

Data carrier

GS1-128 or GS1 DataMatrix (commonly used today)

Required data elements

  • GTIN (product identifier)
  • Serial Number (unique per unit)
  • Batch / Lot Number
  • Expiry Date

The serialized code must follow GS1 application identifiers such as:

(01) GTIN
(21) Serial Number

Serial numbers may contain up to 20 alphanumeric characters depending on implementation.

Human readable information must match the encoded data.

Regulatory Timeline 

  • 2011 – Resolution 435/2011 established the National Medicines Traceability System. (anmat.gob.ar)
  • 2011 – Initial phase implemented for a limited list of high risk medicines.
  • 2012–2013 – Additional pharmaceutical ingredients added to the traceability list.  
  • 2015 onward – Expanded coverage across more medicines and supply chain participants.
  • Today – System remains fully operational and enforced nationwide.

Reporting Requirements 

Operation
Data to Report
When to Report
Commission
GTIN, Serial Number, Batch, Expiry
At packaging / release
Import
Shipment details and serial numbers
Before distribution in Argentina
Distribution
Sender GLN, Receiver GLN, Serial list
When transferring product
Reception
Serial numbers received
At receipt by distributor or pharmacy
Dispensing
Serial number dispensed
At patient supply
Return
Serial and reference transaction
When product is returned
Decommission
Serial and reason
When product is destroyed or withdrawn

Every participant in the supply chain must report the movement or status change of each serialized unit. (Argentina)

The model resembles a centralized event reporting system rather than a verification network like EU FMD.

Operational Timelines for Industry 

  • Register company and facilities with ANMAT.
  • Obtain GS1 identifiers and configure serialization capability.
  • Serialize each pack during packaging.
  • Report commissioning data to the ANMAT database.
  • Report distribution events when product moves between supply chain actors.
  • Report dispensing events when supplied to the patient.
  • Submit return and decommission events where applicable.

Reporting Hub

All traceability data must be reported to the ANMAT National Medicines Traceability System (SNT).

Key characteristics:

  • Central government database
  • Real time event monitoring
  • API based reporting
  • Web portal available for manual reporting

The system allows regulators to monitor each medicine from manufacturing through dispensing to patients. (Argentina)

Participants must register their facilities and identifiers such as:

GLN (Global Location Number) from GS1
CUFE (physical establishment code assigned by ANMAT)

Aggregation Requirements 

Aggregation is not mandatory in the Argentina system.

However:

Many companies implement case and pallet aggregation internally to simplify logistics and reporting.
Serial level reporting remains mandatory regardless of aggregation.

The system tracks products primarily through individual serialized units rather than SSCC hierarchies.  

Common Errors to Avoid 

  • Incorrect GTIN configuration for registered products.
  • Failure to report distribution or receipt events between supply chain partners.
  • Mismatch between printed serial numbers and reported data.
  • Using unregistered facility identifiers in traceability reports.
  • Late reporting of dispensing events by pharmacies.

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