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Argentine ANMAT

Administration nationale des technologies alimentaires et médicales de l'Argentine

Global Regulations

Labelling

Products are required to display information in writing.

Unit Level Traceability

Sellable units are uniquely identified enabling a more granular traceability.

Aggregation

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

Améliorer la sécurité pharmaceutique : le mandat de traçabilité de l'ANMAT en Argentine

En Argentine, l'Administration nationale des technologies alimentaires et médicales (ANMAT) joue un rôle central dans la protection de la santé publique grâce à de solides mesures réglementaires. Les exigences de traçabilité pharmaceutique de l'ANMAT constituent la pierre angulaire de l'engagement du pays à garantir l'authenticité et la sécurité des médicaments au sein de la chaîne d'approvisionnement pharmaceutique.

Avis de conformité réglementaire

Pour les pays sanctionnés, LSPedia suit toutes les politiques gouvernementales américaines requises. Nous nous engageons à des fins commerciales uniquement lorsque nous avons un client actif approuvé par l'OFAC ayant des besoins commerciaux autorisés, qui enregistre LSPedia en tant que fournisseur de solutions. LSPedia demande et obtient ensuite l'autorisation de l'OFAC pour procéder au nom du client autorisé, garantissant ainsi le respect total de toutes les exigences réglementaires.

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Argentine ANMAT

Principaux principes du mandat de traçabilité de l'ANMAT

Sérialisation et identifiants uniques

L'ANMAT impose la sérialisation des produits pharmaceutiques, en exigeant que chaque unité porte un identifiant unique. Cet identifiant permet un suivi et une traçabilité précis sur l'ensemble du réseau de distribution, garantissant ainsi l'intégrité de la chaîne d'approvisionnement.

Rapports de données complets

Les entités pharmaceutiques sont obligées de soumettre des données détaillées à l'ANMAT à différentes étapes de la chaîne d'approvisionnement. Cela inclut des informations sur la production, la distribution et les ventes. Le système complet de communication des données permet à l'ANMAT de surveiller efficacement le mouvement des produits pharmaceutiques, de détecter rapidement les irrégularités et de faire respecter la conformité réglementaire.

Mesures de conformité strictes

L'ANMAT applique des mesures de conformité strictes pour garantir le respect des réglementations en matière de traçabilité. Des inspections et des audits rigoureux sont effectués pour évaluer la conformité des entités pharmaceutiques aux exigences de sérialisation et de communication des données. La non-conformité peut entraîner des sanctions, notamment des amendes et des mesures réglementaires.

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Notre expertise en matière de conformité à l'ANMAT

Pour répondre aux exigences de traçabilité de l'ANMAT, il faut adopter une approche stratégique et informée. Notre équipe spécialisée propose des solutions sur mesure aux entités pharmaceutiques qui souhaitent mettre en œuvre et maintenir des systèmes de traçabilité robustes. Des stratégies de sérialisation à l'intégration des données, nous guidons les organisations vers la conformité, en favorisant une chaîne d'approvisionnement pharmaceutique transparente et sécurisée.

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Conclusion

Alors que l'Argentine met l'accent sur la traçabilité des produits pharmaceutiques en tant que pilier fondamental de la santé publique, l'alignement sur les réglementations de l'ANMAT n'est pas seulement une obligation légale, mais aussi une preuve de son engagement en faveur de la sécurité des patients. Faites équipe avec nous pour naviguer dans les complexités des exigences de traçabilité de l'ANMAT, garantissant ainsi votre position en tant que participant responsable et conforme au paysage pharmaceutique argentin. Contactez-nous dès aujourd'hui pour vous lancer dans une aventure vers la sécurité pharmaceutique et l'excellence en matière de réglementation.

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Argentina ANMAT Compliance

(Sistema Nacional de Trazabilidad de Medicamentos – SNT)

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Global Regulations

Labelling

Products are required to display information in writing.

Unit Level Traceability

Sellable units are uniquely identified enabling a more granular traceability.

Aggregation

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

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.

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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.

Labelling Requirements

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.

Operation	Data to Report	When 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

Operational Timelines for Industry

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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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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Argentine ANMAT

Administration nationale des technologies alimentaires et médicales de l'Argentine

Global Regulations

Améliorer la sécurité pharmaceutique : le mandat de traçabilité de l'ANMAT en Argentine

Principaux principes du mandat de traçabilité de l'ANMAT

Sérialisation et identifiants uniques

Rapports de données complets

Mesures de conformité strictes

Why Choose Our iTS Compliance Solution

Notre expertise en matière de conformité à l'ANMAT

Conclusion

Les plus grandes entreprises du secteur font confiance à LSPedia.

Fill in the form for latest updates

Get In Touch

Please fill the form to access the datasheet

Argentina ANMAT Compliance

(Sistema Nacional de Trazabilidad de Medicamentos – SNT)

Global Regulations

Summary

Labelling Requirements

Regulatory Timeline

Reporting Requirements

Operational Timelines for Industry

Reporting Hub

Aggregation Requirements

Common Errors to Avoid

Trusted by Industry Leaders

Smooth and Successful

Constant Commitment

Fill in the form for latest updates

Get in Touch