Regulatory Requirements

CRPT is now the Operator of the Russian Drug Circulation Monitoring System (IS MDLP)

The Adents Team Written by The Adents Team

On November 1, 2018 the Russian pilot system for monitoring of medical products circulation, known as Markirovka or IS MDLP, moved under the responsibility of the new operator, CRPT. According to CRPT, all functionality of the web portal and interfaces remained the same to make such a move seamless.

This move was expected after the government decrees published in April, 2018 and the announcements that followed. Government decree No. 792-r listed several product types to be serialized and tracked from manufacturer to consumer, including tobacco, car tires, perfume, jewelry, various closing items and others. Another government decree, No. 791-r, published at the same time, described the key principles of the central unified product identification labeling system of Russian Federation. This decree also introduced the unique to Russia requirement of crypto-codes for each serial number/GTIN pair. During the summer months it was then announced that CRPT will become the operator of this unified system.

Decree No. 792-r notably did not mention medicinal products, which were covered by a different law that was already in place. This stirred up conversations in late spring – early summer, regarding applicability of the crypto-code requirement to medicinal products. However, it became clear that it was a matter of time before medicinal products joined the list of other products, for which crypto-code was a requirement.

In August all doubts were put to rest with the government decree No. 1018, which extended the pilot for the medicinal products to the end of 2019 and formalized the role of CRPT as operator of IS MDLP, Markirovka, beginning November 1, 2018. 

Earlier this year, CRPT announced that they will invest close to 3 billion dollars to support this very ambitious government initiative. The interest for CRPT is the payment they will collect for each generated crypto-code, paid for by the manufacturers. In addition, collection of production, product movement and sales data for billions of products offers lucrative opportunities. While CRPT assured the industry that they are under strict controls and limitations imposed by the government dictating what CRPT can do with the collected data, there are still vast opportunities to analyze that data and build sophisticated models predicting market behavior. Such models will work without any proprietary data and could be monetized successfully in the future.

So far, CRPT has been doing an excellent job conducting webinars and roadshows to connect with various industry sectors, answer questions, and explore solutions with industry representatives. Having followed the Russian government initiative on securing the supply chain of medicinal products since 2016, now that CRPT is leading this effort, there is an evident ramp up of supporting activities aimed at industry education, process development and equipment testing. 

At Adents we believe that providing expertise and future-proof serialization and traceability solutions are what the industry needs. To support knowledge sharing, Adents worked with CRPT to promote their first English webinar aimed at pharmaceutical manufacturers residing outside of Russian Federation. In case you missed the webinar or have questions about Russian regulations, feel free to contact us and we will be happy to help.

Want to take a look to the global serialization landscape?

The Adents Team
The Adents Team

The Adents Team: your serialization experts. With over 25 years of experience in different fields of product traceability, supply chain, big data and pharmaceutical serialization, our team members bring a wealth of knowledge to help you better understand the challenges and opportunities of serialization.


Serialization of medicines in Russia: Deadline is officially extended!
Serialization of medicines in Russia: Deadline is officially extended!
Just before New Year, the 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
EU FMD: new FAQ document gives guidance on safety features for medicinal products
EU FMD: new FAQ document gives guidance on safety features for medicinal products
The EU commission has released version 16 of the FAQS related to the EU Falsified Medicines Directive including recommendations on coding requirements and serial number generation.