The situation with the forthcoming regulation for pharmaceutical marking and labeling in Russia is heating up.

 

Besides the weather conditions in the summer, the last months in Russia is getting hotter for the pharmaceutical industry. This is a fact as a result of the forthcoming regulation for mandatory marking and labeling of all medicines.

Considered for the most complex regulation all over the world, the serialization in Russia is introduced to each stakeholder – from the government to the end customer. Therefore, the full product traceability is in place and no falsified medicines can enter the market. Additionally, this could improve the tax collection process as well.

 

 

Track and Trace system like no other

 

Here are the main differentiators of the Russia Track and Trace compliance:

• All medicines are included, as well as nonprescription drugs (OTC)
• Additional sectors are identified for marking and labeling (serialization) such as tobacco, light industry, perfumes, etc.
• Case aggregation is required as per US DSCSA regulations.
• Pallet aggregation is recommended to facilitate product transfer through customs and to exploit the control.
• Unlike the EU FMD, the tamper-evident is not required
• Reporting is done to Russian HUB (IS MDLP / OMS)

 

All-in strategy: Participants in the Russia supply chain

 

The main participants in the supply chain are Marketing Authorization Holders (MAHs), Manufacturers, Importers, Customs, Wholesalers, Pharmacies, and Patients. The organization responsible for Russian serialization is CRPT (Centre of Research and Perspective Technology) and the centralized systems are MDLP and OMS. The MDLP monitors the pharmaceutical product circulation and order management system (OMS) oversees the generation of serial numbers and crypto protection.

Compared to European requirements, the Russian marking and labeling/serialization system has higher complexity as each location of the product within its supply chain in Russia should be reported to the government database.

 

 

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First steps for newcomers: Registration in MDLP system

 

How to get registered as foreign pharmaceutical Manufacturer/MAH in MDLP system

Case 1: The representative office of the pharmaceutical company is not registered in the Russian Federation

Apply for a personal registration account in MDLP system
Submit the original documents to Roszdravnadzor in 10 days
Receive approval by Roszdravnadzor (Federal Service for Surveillance in Healthcare)
MDLP support provides access to all necessary links in their system

 

 

Case 2: Registration of Russian manufacturers and foreign manufacturers with a representative office registered in the Russian Federation

Apply for a personal registration account in MDLP system (! The necessary documents for MDLP account registration are different)
Submit the original documents to Roszdravnadzor in 10 days
Receive approval by Roszdravnadzor (Federal Service for Surveillance in Healthcare)
MDLP support provides access to all necessary links in their system
Enhanced Qualified E-signature (EQES)

 

Final touch: Reporting to the MDLP system

 

At the end of the Track and Trace data exchange the serialization data should be reported. But in fact, the reporting in Russia is much more complicated than the reporting in Europe after the EU FMD and the American reporting with the US DSCSA.
Multiple reports are required to be sent to the MDLP system based on the action/process taken with the production. In the case of a destroyed or damaged product, the products have to be decommissioned. If there is an issue with the product pack or a specific batch, product withdraws, or batch recall are initiated. If there is a technical mistake a cancellation report is sent.
All variety of reports are anticipated in terms of production as moving transit or without customs inspection, or re-export by submitting a specific 335 reports and specifying its subtype. Disaggregation and reaggregation need also to be reported to MDLP.

 

GET THE FULL LIST OF REQUIRED DOCUMENTS AND FULL ROADMAP OF RUSSIA SERIALIZATION COMPLIANCE.