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LSPedia 的全球序列化系列
序列化不是一刀切的。由于美国、欧盟、亚洲和中东的规定各不相同,公司必须应对复杂的要求网络。您为全球合规做好准备了吗?
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欢迎来到 LspEdia,在这里,创新与奉献精神相结合。
如果你热衷于有所作为并在协作环境中茁壮成长,LspEdia 就是你的不二之选。


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序列化不是一刀切的。由于美国、欧盟、亚洲和中东的规定各不相同,公司必须应对复杂的要求网络。您为全球合规做好准备了吗?
.avif)
如果你热衷于有所作为并在协作环境中茁壮成长,LspEdia 就是你的不二之选。

在阿根廷,国家食品和医疗技术管理局(ANMAT)通过强有力的监管措施在保护公共健康方面发挥着关键作用。ANMAT的药品可追溯性要求是该国承诺确保药品供应链中药品的真实性和安全性的基石。

ANMAT 要求对药品进行序列化,要求每个单位都有唯一的标识符。该标识符允许在整个配送网络中进行精确的跟踪和追踪,从而确保供应链的完整性。
制药实体有义务在供应链的各个阶段向ANMAT提交详细数据。这包括有关生产、分销和销售的信息。全面的数据报告系统使ANMAT能够有效监控药品的流动,及时发现违规行为并强制遵守法规。
ANMAT 执行严格的合规措施,确保遵守可追溯性法规。进行了严格的检查和审计,以评估制药实体对序列化和数据报告要求的遵守情况。违规行为可能会导致处罚,包括罚款和监管行动。
Our team of compliance experts possesses in-depth knowledge of iTS and Turkish pharmaceutical regulations. From serialization strategies to data reporting, we guide your organization through the intricacies of compliance, ensuring a smooth and informed journey.
Leverage our state-of-the-art compliance solution, designed to integrate seamlessly with iTS requirements. Our technology ensures accuracy, efficiency, and real-time visibility, empowering your organization to meet and exceed compliance expectations.
Compliance is not just about meeting today's standards; it's about preparing for the future. Our solution is designed to evolve with regulatory changes, ensuring that your organization remains at the forefront of compliance in the dynamic Turkish pharmaceutical landscape.
We believe in transparent collaboration. Partner with us, and we'll work closely with your team to implement and maintain compliance measures. Our goal is to build a resilient, compliant, and future-ready pharmaceutical supply chain together.


要满足 ANMAT 的可追溯性要求,需要采取战略性和明智的方法。我们的专业团队为寻求实施和维护强大的可追溯系统的制药实体提供量身定制的解决方案。从序列化策略到数据集成,我们指导组织实现合规,促进透明和安全的药品供应链。

由于阿根廷强调药品可追溯性是公共卫生的基本支柱,因此与ANMAT的法规保持一致不仅是一项法律义务,也是对患者安全的承诺的证明。与我们合作,了解复杂的ANMAT可追溯性要求,确保您在阿根廷制药领域成为负责任和合规的参与者。立即联系我们,踏上通往卓越药品安全和监管的旅程。




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