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.
Schematic representation of the serialization process in Russia (Markirovka)
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
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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 (44 alphanumeric characters)
- 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 = 36 x 36 modules (obligatory information only) / max. DMC size 40 x 40 modules (obligatory and all optional information)
- In future, key and signature will expire automatically 180 days after their generation. The following two models will come into effect:
1. Pre-paid account: The MAH has a pre-paid account with the CRPT, from which the costs for generating the key and signature are debited directly. In this case there will be no expiration of the serial numbers.
2. Payment when reporting back to CRPT: The MAH only pays the serial numbers reported back to CRPT. In this case key and signature will expire 180 days after generation. After this period, the combination may no longer be used and reported back
Impact on Coding and Verification
Coding of a GS1 Data Matrix with 36 × 36 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