Argentina ANMAT Compliance

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Summary

Labelling Requirements 

Reporting Requirements 

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.

OperationData to ReportWhen to Report

Commission 
Aggregation 
Shipping 

GTIN, Serial, Batch, Expiry  
Parent SSCC, Child Serials  
Sender GLN, Receiver GLN, SSCC or Serial List
During packaging before shipment 
When creating cases or pallets 
Before dispatch 
ReceivingImport Clearance
Supply to Pharmacy
GTIN, Serial, Batch, Expiry  
Parent SSCC, Child Serials  
Sender GLN, Receiver GLN, SSCC or Serial List
During packaging before shipment 
When creating cases or pallets 
Before dispatch 
Returns 
Decommission 
Serial status and reference 
Reason and serials 
When return is approved 
When product is destroyed or removed 

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.  

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.

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.

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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LSPedia didn’t just provide software; they ensured we were fully compliant. Anytime we had questions, the LSPedia team knew DSCSA inside and out and guided us step by step. That level of expertise made a huge difference during audits. Thanks to their expert team our audit was smooth and successful

Hussein Salman
Lead Pharmacist, Pioneer Pharmacy Services

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EPCIS Data Encoder,Capital Wholesale Drug

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