Serialization of medicines in Russia: Deadline is officially extended!
Just before New Year, the Russian federal law No. 346344-7 amending Government Decree 1556 “On approval of the Regulations on the system of monitoring the movement of medicines for medical use” was officially signed and published. This text brings long awaited clarification on several issues, especially the extension of the serialization deadline for medicinal products in Russia.
Serialization deadline for medicines in Russia is finally extended
The new text pushes the deadline for drug track & trace requirements in Russia to July 2020.
Pharma track & trace requirements in Russia go beyond serialization. In addition to serial numbers, product identifiers for units of sale, regulatory requirements also include a two-part crypto verification. These crypto codes are generated and allocated by the Russian system provider (CRPT), based on reported serialized GTINs. Furthermore, aggregation and extensive supply chain reporting are required.
Drugs manufactured after 01 July 2020 will only be allowed for dispensation (even free of charge) if they bear unique identification and if the dispensing entity can authenticate and decommission them.
This is a very welcome deadline extension, especially as further technical clarifications were published only very recently. Stocks of medicines produced before 1 July 2020 (31 December 2019 for the twelve high cost nosologies) can be used up until the end of their shelf-life.
Crypto code cost and availability
As the drug traceability system – including crypto code allocation – is seemingly ready, unique product identification including the use of the crypto verification codes is optional from January 2020, the original deadline. This means that pharmaceutical companies ready before July 2020 might be able to save money by getting serialization-ready early, as payment should only apply from July 2020. At a cost of 50 kopecks (1/2 Ruble, approx. 0,007€) per code this might be a real financial incentive to get ready as early as possible, even before the extended deadline.
Be there or be square – it’s not just about serialization
A product bearing a unique product identifier should be reported to the track and trace system MDLP. Therefore, pharmaceutical companies choosing to serialize before July 2020 should ensure that all connections to the crypto code order management system as well as the MDLP are operational. Only then can they be compliant with Russian crypto verification and reporting requirements.
How Adents can help?
Adents offers the most flexible and fully integrated serialization and traceability solution covering all levels of technology.
• Adents Seriza, a 100% configurable and quickly deployable serialization solution for manufacturing sites, selected as preferred solution by Siemens for its customers.
• Adents Prodigi, a highly flexible entrerprise Cloud solution jointly developed with Microsoft and empowered by Azure technologies, allows for secure data exchange with supply chain partners or authorithies and helps leverage the power of serialization data for end-to-end traceability in the supply chain.
From crypto codes management, unit-level serialization and aggregation as per Russian regulatory requirements to event reporting, Adents enables pharmaceutical companies to fully comply with the Russian government decree No 1556.