Chestnye Znak

Advancing Pharmaceutical Security: Russia's Chestny ZNAK Traceability System

Advancing Pharmaceutical Security

In Russia, the Chestny ZNAK system represents a comprehensive national track and trace framework designed to ensure pharmaceutical authenticity and combat counterfeit medications. Established under Federal Law No. 425-FZ in December 2017, this robust regulatory system has undergone phased implementation since 2019, creating one of the world's most stringent pharmaceutical traceability networks aimed at protecting public health and ensuring supply chain integrity.

Chestny ZNAK Traceability System

Key Tenets of Russia's Chestny ZNAK Traceability System

Comprehensive Serialization and Cryptographic Security

Chestny ZNAK mandates that every pharmaceutical product bear a unique 2D Data Matrix code containing critical identifiers including the Global Trade Item Number (GTIN), randomized serial number, batch information, expiration date, and FEACN code. Most notably, each code incorporates a 44-character cryptographic security element, creating a sophisticated digital passport that accompanies products throughout their lifecycle.

End-to-End Supply Chain Visibility

The system creates complete visibility from production to point-of-sale through mandatory reporting at each transfer of ownership. The Center for Research in Perspective Technologies (CRPT) issues unique codes to manufacturers or importers, with all subsequent movements tracked in the Federal State Information System for Monitoring Drug Circulation (FSISMDC). This comprehensive approach enables real-time monitoring of pharmaceutical products and swift identification of irregularities.

Rigorous Verification and Decommissioning

When medicines reach pharmacies, hospitals, or clinics, they must be scanned and registered in the Chestny ZNAK system prior to dispensing. The point-of-sale scanning process effectively decommissions the product from circulation, preventing unauthorized resale or substitution with counterfeit products. This verification mechanism extends to consumers, who can authenticate products using the Chestny ZNAK mobile application.

Strict Compliance Framework with Significant Penalties

Russia has established a rigid compliance framework with substantial consequences for violations. Non-adherence to Chestny ZNAK requirements can result in market exclusion, significant financial penalties, and even imprisonment under certain circumstances. This enforcement mechanism underscores Russia's commitment to pharmaceutical security and patient safety.

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.

Speak With a Compliance Expert

Our Expertise in Chestny ZNAK Compliance

Navigating Russia's complex pharmaceutical traceability landscape requires specialized knowledge and technological sophistication. LSPedia's comprehensive compliance solutions are engineered to address the unique challenges of the Chestny ZNAK system. Our platform can seamlessly integrate with the FSISMDC reporting infrastructure, ensure accurate cryptographic code management, and facilitate the mandatory aggregation requirements that distinguish the Russian system. From implementing compliant serialization systems to managing the extensive reporting demands for foreign manufacturers, our team provides end-to-end support throughout the compliance journey. With LSPedia's expertise, pharmaceutical organizations can confidently navigate Russia's rigorous regulatory environment while maintaining operational efficiency and ensuring uninterrupted market access.

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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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