Serialization Countdown in Russia: 4 months to go
Serialization requirements in Russia are among the most complex in the world. Not only is the timeline very tight – October 1, 2019 for the 12 high-cost nosologies and January 1, 2020 for the rest of the medicinal products, the technical sophistication of the requirements is very ambitious as well.
Consumer protection on a different level
Pharma serialization and track & trace systems’ ultimate goal is to protect patients from falsified medicines. Russia goes a lot further and aims to track and trace products across all industries by 2024. Additionally, consumers will be able to play their part as well and get access to product data and verification information through a mobile application developed by system operator CRPT.
Serialization requirements in Russia are more complex than what you know from the US DSCSA or EU FMD. In addition to a Global Trade Item Number (GTIN) and Serial Number, Russia has opted for a crypto verification system, consisting of a crypto key and electronic signature based on the serialized GTIN.
Serialization requirements in Russia: Different requirements, different challenges
The fact that an additional 48* characters (4 character crypto key plus 44 character signature) have to be encoded in the data matrix, makes said data matrix very dense, even if you choose to leave out batch number and expiry date. Batch number and expiry date can be included in the data matrix but this is not mandatory to be compliant with Russian serialization requirements. A denser than usual data matrix means that manufactures will have to ensure that their print and verify equipment is capable of handling Russian coding requirements.
Is the printing quality good enough to properly print the dense data matrix without making it unreadable? Is the scanning equipment able to read very dense data matrixes? Licence holders will also need to check with their system providers how to adapt their serialization solutions to Russian requirements.
Reporting requirements for Russia
In Russia, products will be traced all along the supply chain. Many transaction types touching all participants of the pharmaceutical supply chain are to be reported, including repackaging and all changes in aggregation. Non-Russian licence holders (or their representatives in Russia) have to report before product enters the Russian supply chain and even before product enters Russian territory, for example Product Master Data, batch release and when product enters Russia « as part of importing » as per Art 37 of Decree 1556.
How Adents can help
We are keeping track of regulatory news. Stay tuned for further information and download our Global Serialization Landscape for pharmaceuticals in the meantime or sign up for our regular Open Mic sessions and webinars.
* Information dating May 2019 which may still be subject to change