Advancing Pharmaceutical Security: Zambia's ZAMRA Traceability Framework

Zambia's ZAMRA Traceability Framework

In Zambia, the Zambia Medicines Regulatory Authority (ZAMRA) plays a pivotal role in safeguarding public health through comprehensive regulatory measures. ZAMRA's pharmaceutical traceability requirements serve as a cornerstone in the country's commitment to ensuring the authenticity and safety of medicinal products throughout the pharmaceutical supply chain. Based on the Medicines and Allied Substances Act No. 3 of 2013 and subsequent regulations, Zambia has established a robust framework to combat counterfeit medicines and enhance patient safety.

Key Tenets of ZAMRA's Traceability Framework

Mandatory Human-Readable Information

ZAMRA explicitly requires all pharmaceutical products to display critical information in human-readable text format alongside machine-readable barcodes. This dual-labeling approach ensures that essential product information—including product name, strength, batch/lot number, expiry date, and unique serial number—is legible without scanning equipment. The human-readable component is mandatory for all packaging levels, making critical safety information accessible to all stakeholders throughout the supply chain, from healthcare professionals to patients, even when electronic systems are unavailable.

Serialization and Granular Traceability

ZAMRA mandates that each sellable unit must bear a unique identifier, enabling true item-level traceability. This granular approach allows individual units to be tracked from manufacture through distribution to dispensing, providing unprecedented visibility into the pharmaceutical supply chain. The unique serialization of each sellable unit facilitates precise verification, efficient recalls, and enhanced anti-counterfeiting measures. With complete serialization required by July 2028, Zambia's system will enable authorities to trace the exact journey of each individual medicine package throughout its lifecycle, significantly improving patient safety and supply chain security.

Comprehensive Data Reporting

Pharmaceutical entities are obligated to submit detailed master data to ZAMRA's centralized traceability platform (WMS Expert). This includes 65 product attributes (13 mandatory) linked to GTINs and GLNs during product registration. Manufacturers, distributors, and service delivery points must maintain batch traceability in their electronic systems and share serialized data with the national repository before products enter the market. This comprehensive data reporting system empowers ZAMRA to effectively monitor pharmaceutical movement, detect irregularities promptly, and enforce regulatory compliance.

Standardized Barcoding Technology

ZAMRA's regulations specify the use of GS1 DataMatrix barcodes for primary and secondary packaging, with either GS1-128 or DataMatrix for tertiary packaging, and GS1-128 (SSCC) for logistic units. All barcode symbols must meet print quality standards (Grade C or above), with human-readable information displayed alongside machine-readable barcodes. This standardization ensures interoperability with global systems and facilitates accurate data capture throughout the supply chain.

Why Choose Our iTS Compliance Solution

Expert Guidance

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.

Cutting-Edge Technology

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.

Future-Ready Operations

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.

Transparent Collaboration

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.

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LSPedia's Expertise in ZAMRA Compliance

Navigating ZAMRA's traceability requirements necessitates a strategic and informed approach. LSPedia's specialized team offers tailored solutions for pharmaceutical entities seeking to implement and maintain robust traceability systems in Zambia. Our comprehensive compliance platform seamlessly integrates with ZAMRA's centralized system, ensuring proper data exchange and reporting. From serialization strategies to master data management, we guide organizations toward full compliance with Zambia's evolving pharmaceutical regulations. Our solutions address both the human-readable labeling requirements and granular unit-level serialization mandated by ZAMRA. With LSPedia's expertise, pharmaceutical companies can establish transparent and secure supply chains while minimizing compliance risks in the Zambian market.

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