Your European Track & Trace Vendor Left Russia. Now What?

A practical guide for Russian pharma manufacturers navigating CRPT, MDLP, and Chestny ZNAK compliance after losing their serialization partner.

After 2022, a number of Western European serialization and track and trace vendors — businesses that had sold Russian pharma manufacturers on expensive, multi-year compliance programmes — quietly exited the Russian market.

Some gave notice.

Many did not.

Manufacturers who had spent years implementing Chestny ZNAK compliance through these vendors suddenly found themselves with orphaned equipment, no support contracts, and an MDLP system that still expected them to report every product movement.

Russia’s Markirovka track and trace system does not take breaks.

The Centre for Research in Perspective Technologies — CRPT — still issues crypto codes.

The Drug Circulation Monitoring System — MDLP, or IS MDLP — still expects 52 categories of notification, from batch production registration through to dispensing at the pharmacy point of sale.

The OMS still charges 0.5 roubles per code.

None of that infrastructure paused when European vendors packed up and left.

What MDLP and CRPT Actually Require From You

For any manufacturer selling pharmaceuticals in Russia, the obligations under Federal Law 425-FZ are not optional.

Every prescription and OTC medicine must carry a GS1 Data Matrix code encoding the GTIN, serial number, batch number, expiry date, FEACN code, a 4-digit verification key, and a crypto code of 44 or 88 numerical digits supplied directly by CRPT via the OMS.

This crypto code is what distinguishes Russia’s serialization system from EU-FMD or DSCSA.

Generating it requires an active, verified OMS connection.

The code is written into the Data Matrix at print time and must meet a minimum print quality grade of C under GS1 standards, which in practice means the vision verification system on the line has to be calibrated and working correctly.

Above the line, the L4 system is responsible for serial number lifecycle management and the full chain of MDLP event reporting: production utilisation reports, batch release notifications to AIZ RZN, 415 move orders when product ships, 701 confirmations when product is received, and the 531 or 10511 messages when product is dispensed or sold at pharmacy level.

Miss any of these, and you have a compliance gap that Roszdravnadzor takes seriously.

The Problem With a Vendor Disappearing

Most track and trace lines installed in Russia before 2022 were sold as integrated systems — hardware and software from the same vendor, with the MDLP reporting logic locked inside a proprietary L3 or L4 platform.

When the vendor exits, the reporting logic goes with them.

The physical equipment — conveyors, cameras, print engines — usually still works.

The compliance capability does not.

This is not a hypothetical.

Russian pharmaceutical manufacturers are dealing with this right now.

The choice they face is presented to them as binary: buy a new line, or continue running on a broken support model with a vendor who is no longer contractually obligated to keep you compliant.

Neither option is acceptable.

There is a third path.

Reviving an Orphaned Line — What Is Actually Possible

In most cases, the hardware on an existing track and trace line is not the problem.

The cameras, the print engines, the conveyors — these components have useful life remaining.

What has been lost is the software integration layer and the service relationship behind it.

A competent serialization partner with genuine Russia-market capability can audit the existing hardware, retain what is serviceable, replace only what is necessary, and install a new software stack — at the L3 and L4/L5 levels — that restores full CRPT OMS connectivity and MDLP reporting capability.

This is not a workaround.

It is a proper engineering solution that delivers a line that is better documented, more maintainable, and served by a support team that is actually present.

Why the L4/L5 Layer Matters as Much as the Line

Manufacturers who focus only on the physical line often discover that the L4 and L5 systems — plant management and enterprise traceability — are where the real ongoing compliance burden sits.

Schema updates from CRPT come regularly.

MDLP has released multiple major version updates since mandatory serialization began in 2020.

Each update requires changes to the reporting software.

An L4/L5 system running on Yandex Cloud, integrated with your ERP or SAP instance, and maintained by a vendor with an active Russia service presence is what insulates your business from these changes.

The alternative — managing manual MDLP submissions or relying on workarounds — is not sustainable at scale.

What to Look For in a Russia-Ready Serialization Partner

When evaluating options, the questions that matter are not about product brochures.

They are operational:

• Do you have engineers physically present in Russia, with response SLAs that reflect that?
• Is your L4/L5 platform hosted on Yandex Cloud or another Russia-compliant infrastructure?
• Do you have a live, certified OMS connection for crypto code retrieval from CRPT?
• Can you demonstrate MDLP reporting across all 52 notification types?
• What is your committed lead time for spare parts, and are you stocking components locally?
• Do you offer 24×7 helpdesk support with Russian-language capability?

If a prospective vendor cannot answer each of these questions with specifics rather than generalities, that tells you something important about their actual readiness.

Jekson Vision’s Position in the Russian Market

Jekson Vision’s REETRAK serialization platform and REESOURCE L4/L5 traceability system are both compliant for CRPT OMS integration and full MDLP compliance.

The company has maintained service operations inside Russia continuously, with 24×7 helpdesk support and in-country engineers.

Deployments run on Yandex Cloud for full data residency compliance.

For manufacturers looking at a line revival — rather than a full replacement — Jekson Vision has a structured approach: audit first, recommend only what is needed, commit to a defined scope and timeline, and stand behind it with a real SLA.

To discuss your specific situation: marketing@jeksonvision.com | www.jeksonvision.com