Meet the new serialization and aggregation requirements for the Russian market

Even if counterfeit medicines only occasionally enter regular drug distribution, they still pose an immense risk to patients. In order to better protect the legal supply chain from this risk, an IT-based protection system is currently being set up in Russia.

Government Regulation No. 792-r requires various product types to be serialised and tracked from manufacturer to consumer. Decree No. 1018 extends the pilot project for pharmaceuticals until the end of 2019. It formalizes the role of the CRPT (Center for Research in Perspective Technologies), as operator of the MDLP (Monitoring of Medical Preparates Movement), or Markirovka. For manufacturers within the Russian Federation, the CRPT provides an emissions register (black box). However, all foreign locations receive a distribution service via the “cloud”. 

Your Partner – TRAXEED

  • Offers serialization solutions for the entire pharma production process from a single source (incl. consulting, implementation from Level 1—5, full validation documentation and support)
  • Keeps an eye on the pharmaceutical market and offers expert solutions to meet present and future requirements
  • Has already successfully implemented solutions at several leading Russian pharmaceutical companies
  • Has decades of experience in vision technology, and keeps close contacts with printing technology suppliers, which grants you access to complete Crypto Code inline printing and verification solutions
  • Offers excellent service management, which allows for easy updating or upgrading of all existing TRAXEED machines when new requirements must be fulfilled

 

Contact us for further information

 

What makes the Russian Crypto Code special?

  • The signature is created using an asymmetric encryption method based on Russian cryptographic technologies
  • Its provided by a closed (sub-) system
  • It implies the obligatory printing of encrypted information, such as the public key (4 numeric digits), and the Crypto Code Signature (88 alphanumeric characters, which corresponds to 64 bits)
  • A GS1 Application identifier 91 for Crypto Code public key, and AI 92 for Crypto Code Signature is used
  • Indubitably verifies the correctness of the identification features, even in offline mode
  • The code is planned to cost producers a certain amount of money for each generated code, according to Mikhail Dubin, a CEO of the CRPT
  • Min. DMC size = 40 × 40 modules (total digits = 130) // Max. DMC size = 44 × 44 modules (total digits = 169)

Components of the Crypto Code

Data Matrix Code
AI
Format
Requirement
GTIN114 numericObligatory
Serial Number2113 alphanumericObligatory
Batch Number1020 alphanumericOptional
Expiration Date176 Digits: YYMMDDOptional
Customs Commodity Code2404 numericOptional
Crypto Code Public Key914 numericObligatory
Crypto Code Signature9288 alphanumericObligatory

 

Impact on Coding and Verification

Coding of a GS1 Data Matrix with 44 × 44 modules requires smaller module sizes to fit onto the common layouts

Implications:

  • Higher camera resolution is required for online grading
  • Line upgrade or code pre-print might be necessary