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Chestnye Znak

Advancing Pharmaceutical Security: Russia's Chestny ZNAK Traceability System

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.

Central repository

The traceability documentation is required to be centralized in a unique 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.

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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

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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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Russia Medicines Compliance

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Summary

Russia enforces mandatory pharmaceutical traceability through the MDLP national track and trace system, part of the Chestny ZNAK program. Every medicine pack must carry a GS1 DataMatrix that includes a unique serial number and a government issued cryptographic code (KIZ). All serialization, aggregation, customs, ownership changes, and lifecycle events must be reported to MDLP using defined transaction codes. Products cannot clear customs, enter circulation, or be sold unless reporting is complete and consistent with physical activities.

Labelling Requirements

Each sellable unit must carry a GS1 DataMatrix containing:

GTIN

Serial Number

Cryptographic Code (KIZ)

Batch Number

Expiry Date

Human readable information must match the encoded data.

Cases and pallets must carry SSCC barcodes to support mandatory aggregation.

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Reporting Requirements

Reporting must follow the physical flow of goods. The key MDLP reports are listed below in logical sequence.

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

Aggregation Requirements

Aggregation is mandatory for MDLP.

All parent child relationships must be reported and validated.

Aggregation must be completed before shipment, customs, or distribution.

Incorrect or missing aggregation blocks downstream transactions.

Regulatory Timeline

2017 – Pilot serialization and crypto tracking launched.

2019 – Mandatory serialization and KIZ usage introduced.

July 2020 – Full aggregation and movement reporting enforced.

2021 onward – Strict enforcement across customs, wholesale, and retail.

Operational Timelines for Industry

Request cryptographic codes before packaging.

Apply KIZ and serialize packs during production.

Report import and customs events for inbound goods.

Release goods into circulation only after clearance.

Report all domestic transfers, ownership changes, and exports.

Submit withdrawal and destruction reports as required.

Common Errors to Avoid

Applying KIZ before requesting or validating codes.

Reporting serialization after physical shipment.

Missing or incorrect aggregation hierarchy.

Attempting market release before customs clearance.

Confusing ownership change with physical movement.

Reusing serials or cryptographic codes.

Late or rejected reports causing sales and customs blocks.

Reporting Hub

Reporting is done to the MDLP National Track and Trace System.

MDLP operates under the Chestny ZNAK infrastructure.

Reporting is completed through secure APIs using digital certificates.

All manufacturers, importers, distributors, and pharmacies must be registered and authorized.

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Serialization and Code Management

10300 – Code Emission: Request cryptographic codes (KIZ).

210 – Query KIZ Info: Check status or details of issued codes.

10311 – Skzkm Register End Packing: Report KIZ applied for domestically manufactured products.

10319 – Skzkm Foreign Emission: Report KIZ applied for products manufactured outside Russia.

313 – Register Product Emission: Register serialized products in specific or simplified cases.

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Aggregation and Hierarchy Management

911 – Unit Pack: Aggregate individual packs into cases or pallets.

914 – Unit Append: Add units to an existing aggregation.

915 – Multi Pack: Create bundled or promotional packs.

912 – Unit Unpack: Disassemble an aggregated hierarchy.

913 – Unit Extract: Remove selected units from an aggregation.

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Import and Customs

332 – Foreign Import: Report arrival of imported goods into customs zone.

334 – Customs Move: Report movement under customs control.

335 – FTS Data: Confirm customs clearance using Federal Customs Service data.

341 – Receive Importer: Importer confirms receipt after clearance.

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Market Release

342 – Release in Circulation: Release goods into the Russian civil market.

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Domestic Distribution and Ownership

415 – Move Order: Domestic shipment to another legal entity.

416 – Receive Order: Confirmation of domestic shipment receipt.

381 – Move Owner: Ownership change without physical movement.

701 – Accept: General acceptance transaction.

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Export and EEU Transfers

331 – Foreign Shipment: Export shipment out of Russia.

461 – Move EEU: Shipment to another Eurasian Economic Union country.

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Transfer Corrections

251 – Refusal Sender: Sender cancels or refuses a transfer.

252 – Refusal Receiver: Receiver rejects a shipment.

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Withdrawal and Disposal

552 – Withdrawal: Withdraw products from circulation.

541 – Move Destruction: Move products to licensed destruction facility.

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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

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Lead Pharmacist, Pioneer Pharmacy Services

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