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Argentina ANMAT

Nationale Verwaltung für Lebensmittel und Medizintechnik Argentiniens

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.

Förderung der pharmazeutischen Sicherheit: Argentiniens ANMAT-Rückverfolgbarkeitsmandat

In Argentina spielt die Nationale Behörde für Lebensmittel und Medizintechnik (ANMAT) eine zentrale Rolle beim Schutz der öffentlichen Gesundheit durch robuste Regulierungsmaßnahmen. The requirements of ANMAT and the rückverfolgbarkeit of drugs are a eckpfeiler of compliance of country, the fact and security of drugs within the pharma supply chain.

Hinweis zur Einhaltung gesetzlicher Vorschriften

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Argentina ANMAT

Die wichtigsten Grundsätze des Rückverfolgbarkeitsmandats von ANMAT

Serialization and eindeutige Identifikatoren

ANMAT schreibt vor der Serialisierung pharmazeutischer Produkte, wobei jede Einheit eine eindeutige Kennzeichnung tragen muss. This marking allows a precise tracking and return tracking in the complete distribution network, and ensure the integrity of the supply chain.

Umfasst Datenberichterstattung

Pharmazeutische Unternehmen sind verpflichtet, ANMAT in verschiedenen Phasen der Lieferkette detaillierte Daten zu übermitteln. There are information to production, distribution and sales. The comprehensive data reporting system allows ANMAT, the transport of drugs efficient surveillance, unregelmäßigkeiten instant detect and compliance compliance.

Strenge Compliance-Massnahmen

ANMAT sets strict compliance measures through to ensure the compliance of the regulations for return. Strenge Inspektionen und Audits werden durchgeführt, um zu überprüfen, ob pharmazeutische Unternehmen die Serialisierungs- und Datenberichtspflichten einhalten. The non-compliance can lead to strafs as public and administrative measures.

Why Choose Our iTS Compliance Solution

Speak With a Compliance Expert

Unsere Expertise im Bereich ANMAT-Compliance

Um die Rückverfolgbarkeitsanforderungen von ANMAT zu erfüllen, ist ein strategischer und informierter Ansatz erforderlich. Unser spezialisiertes Team bietet maßgeschneiderte Lösungen für pharmazeutische Unternehmen, die robuste Rückverfolgbarkeitssysteme implementieren und aufrechterhalten möchten. Fon serialization strategies to hin to data integration we supports company with the compliance of compliance and promote a transparent and safe pharmatical supply chain.

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Fazit

Argentina betont, dass die Rückverfolgbarkeit von Pharmazeutika eine grundlegende Säule der öffentlichen Gesundheit ist. Also ist die Einhaltung der ANMAT-Vorschriften nicht nur eine gesetzliche Verpflichtung, sondern auch ein Beweis für das Engagement für die Patientensicherheit. Work with us together, to manage the feinheiten der ANMAT-Anforderungen an die Rückverfolgbarkeit, and your position as responsibility bewusster and law conformer actor in the argentinical pharma environment. Contact us now, to go to take a travel in richtung pharmazeutical security and regulatory excellent.

Hinweis zur Einhaltung gesetzlicher Vorschriften

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Die führenden Unternehmen der Branche vertrauen LSpedia.

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We invite you to learn more about how LSPedia can support your compliance and supply chain needs. For more information about our solutions, partnership opportunities, or to speak with one of our experts.

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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.

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.

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)

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

‍

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.

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.

Trusted by Industry Leaders

Smooth and Successful

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

Constant Commitment

LSPedia shows a constant commitment to improvement; whether it's their support or their product...they're always leveling up. The support team provides consistently thorough follow-up and clear, articulate communication. the support we receive represents a meaningful step up in service and is genuinely appreciated.

Zac Sweeny

EPCIS Data Encoder,Capital Wholesale Drug

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Argentina ANMAT

Nationale Verwaltung für Lebensmittel und Medizintechnik Argentiniens

Global Regulations

Förderung der pharmazeutischen Sicherheit: Argentiniens ANMAT-Rückverfolgbarkeitsmandat

Die wichtigsten Grundsätze des Rückverfolgbarkeitsmandats von ANMAT

Serialization and eindeutige Identifikatoren

Umfasst Datenberichterstattung

Strenge Compliance-Massnahmen

Why Choose Our iTS Compliance Solution

Unsere Expertise im Bereich ANMAT-Compliance

Fazit

Die führenden Unternehmen der Branche vertrauen 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

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