Regulatory Requirements

Pharma Track & Trace Requirements in Russia Decrypted

The Adents Team Written by The Adents Team
09-May-2019

One of the main differentiators of the Russian track & trace system is the crypto verification system, which adds another layer of security to unique product identification. 

In Russia, serialization, aggregation and event reporting along the supply chain will be mandatory for all medicinal products (RX and OTC) manufactured in Russia or imported into Russia from January 1st, 2020. Operator of the Russian Drug Circulation Monitoring System is the public-private organization CRPT.

Unique Product Identification (UPID) in Russia

UPID requirements for medicines supposed to enter the Russian Supply Chain are specified in government decree No 1556. Unlike in many other countries, Unique Product Identification in Russia consists of two parts. A unit of sale is identified through the combination of Global Trade Item Number (GTIN) and Serial Number. Additionally, a so called two-part crypto tail makes the unique identifier more secure.

Crypto verification as an added layer of UPID security

The crypto tail consists of a verification key and an electronic signature. The verification key consists of four numbers, lower and upper case letters (Latin alphabet). The application identifier used is 91. The electronic signature or crypto code is a sequence of 88 characters including numbers, special symbols, lower and upper case letters of the Latin alphabet. The application identifier is 92.

Crypto verification allows to unequivocally establish the legality of the applied identification code as the combination GTIN/ Serial Number/Crypto key/Crypto signature is next to impossible to guess and reproduce. 

How do I get the crypto tail?

The verification key and crypto code are not generated by the licence holder (MAH) or the drug manufacturer but attributed by the system operator (CRPT). Licence holders send an application to the CRPT (incl. sGTINs or GTINs & Serial Numbers and other relevant data specified in governmental decree 1556). Through the relevant combination of the GTIN and the serial number, the crypto code issuer uses an asymmetric encryption algorithm to create the verification code for each item.

To facilitate communication, the system operator will provide data exchange devices for production sites in Russia and set up a Cloud system for manufacturers outside Russia to connect via an API (application program interface). More and more manufactures in Russia are requesting remote access to the code generation system as well though. 

Serialization requirements in Russia: The way forward

The crypto tail was not part of the industry pilot running since Febuary 2017. Therefore, manufacturers will have to test their print & verify modules as the additional information to be encoded in the datamatrix might impact its readability. The pharma industry is pushing for a shorter crypto code but no decision has been made to date. Despite these additional requirements, the ultimate deadline for implementation (January 2020) has not changed, which does not leave much time for testing and, if new material needs to be acquired, qualification. 

How Adents can help?

Adents offers a highly configurable end-to-end traceability solution natively embedding the main codification standards. Adents’ solution enables pharmaceutical companies, Contract Manufacturing Organizations (CMOs) and their Supply Chain Partners adapt to market changes and ensure compliance with virtually any serialization requirements in the world and adapt quickly to market changes. Need more info on serialization requirements in Russia, simply contact our experts

Want to learn more? Download an infographic illustrating the global serialization landscape for pharmaceutical products for a complete overview of the different laws and regulations for serialization and aggregation around the world.

The Adents Team
The Adents Team

The Adents Team: your serialization experts. With over 25 years of experience in different fields of product traceability, supply chain, big data and pharmaceutical serialization, our team members bring a wealth of knowledge to help you better understand the challenges and opportunities of serialization.

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