Russia also requires a Foreign Economic Activity Common Nomenclature (FEACN) code encoded on all 2D codes, along with GTIN, Serial Number, Batch Number and expiry date, verification keys, and verification codes (crypto code).
This is applicable to all medications, including OTC (Over-the-counter). It has specific norms for multi-level serialization & aggregation, i.e., individual units must be serialized, and a 2D barcode must be placed on the box or bottle; each batch must also be serialized with a 2D barcode on the box.
The owner of pharma goods must also create Universal Transfer Documents (UTD) at the moment of ownership and then transfer them to the CRPT. They require scannable codes on drug packaging and electronic reporting of transactions throughout the supply chain.
When you receive the crypto code from CRPT, print it as a 2D Matrix code with a minimum grade of C or higher as a print quality.
To establish the authenticity of digital identification codes, it is crucial to include crypto verification. The combination of GTIN/Crypto key/Serial Number/Crypto signature is extremely difficult to reproduce or guess.
It is also possible to authenticate offline through a secret algorithm that doesn’t require a database or internet access.
The Federal State Information System for Monitoring Drug Circulation (FSIS MDC) will oversee the serialization process. All supply chain members must register with the FSIS MDC and report all batch and serial numbers.
The regulations apply to contract manufacturing organizations (CMOs) and contract packaging organizations (CPOs) that import or produce drugs in Russia.
Manufacturers must be able to receive documents and notifications from the Russian Drug Circulation Monitoring System (MDLP), which is an electronic drug monitoring system managed by Russia’s Center for Research in Perspective Technologies (CRPT).
Manufacturers also need to communicate with Russia’s Order Management System (OMS) to manage the generation, receipt, and reporting of crypto codes.
Adhering to these comprehensive requirements is very complex, and your technical teams will need assistance. Jekson Vision is one of the leading service providers which has a proven track record in implementing Russia Serialization.
Connect with us at marketing@jeksonvision.com or WhatsApp us at +919328233954
