Russia pharma serialization has been underway for a little more than three years. The country’s National Track and Trace Digital System, which is known as Chestny ZNAK and covers a dozen industries, has been continually tweaked and refined since it was created a little more than three years ago.
Some important updates to Russia pharma serialization were made public toward the end of 2020. Here’s a quick rundown of what the government announced.
“Notification mode” will simplify Russia pharma serialization processes
As we noted last year, Russia’s Drug Circulation Monitoring System (MDLP) was compelled to develop new reporting requirements after technical problems created serious issues in the pharma supply chain.
In late October, the MDLP moved into so-called “notification mode” to help supply chain actors continue importing, distributing, and selling medicines in the event of errors or failures in Chestny ZNAK’s reporting system. This applied to over-the-counter and prescription medicines manufactured in Russia or imported into the country, including from the Eurasian Economic Union (EAEU).
Then, in early November, Decree 1779, “On Amendments to the Regulation on the Monitoring System for the Movement of Medicines for Medical Use,” consolidated measures to simplify and expedite reporting. This is why notification mode has also been referred to as “simplification mode” for Russia pharma serialization.
In essence, stakeholders can proceed with distribution or dispensing 15 minutes after they submit the required product information to the Government Information System for Marking (GIS MT), which catalogs all marked goods, even if they do not receive confirmation that the information has been accepted/approved in the system. (The “product information” pertains to Russia pharma serialization requirements, such as serial numbers and Global Trade Item Numbers.) The decree also simplifies importation, giving custom officials a 2-hour window to request product information.
For now, these Russia pharma serialization rules are to remain in effect until July 1, 2021. After that, notification mode will stop.
Final thoughts
As the leader in Russia pharma serialization, rfxcel knows the regulations are stringent and challenging. To help, we offer useful resources online, like this refresher course and white papers and webinars that explain the regulations in easy-to-understand language.
These are great places to start, but the best way to ensure you’re prepared to comply with Russia pharma serialization laws is to talk with us directly. Consider our credentials:
- We’re an official integration, software, and tested solution partner with the CRPT.
- We’ve demonstrated that our solutions, including our signature rfxcel Traceability System (rTS) and Compliance Management (rCM), can meet the stringent Russia pharma serialization requirements and ensure you stay compliant.
- rTS works seamlessly with Chestny ZNAK, including a Russian-language user interface that makes integration and startup much quicker.
- We’ve prepared for Russia pharma serialization and Chestny ZNAK since 2018.
- We’re one of the few providers with active pharma implementations in Russia.
- We’ve tripled our workforce in Russia over the last year. Our team in Moscow provides our clients, which include major global pharmaceutical and consumer goods companies, the quickest time to market while fully automating their compliance reporting.
Contact us today learn more about how we can help you with Russia pharma serialization and Chestny ZNAK compliance. No matter how far along you are in your preparations to comply, you should talk to us — even if you’re already working with another provider. Our powerful software ensures you’ll be prepared and always be compliant with Russia’s complex regulations.
