Updates on serialization and aggregation requirements for Russia

In the last two to three weeks some clarification were published, which help us to plan more precisely.

Schematic representation of the serialization process in Russia (Markirovka)

By now we all know about most of the requirements for Russia. Serialization even for OTC drugs, mandated aggregation, however no requirement for tamper evident seals, are some of the main differences to the US DSCSA or the EUF FMD.

Oh, is there a need to mention the crypto code again?
Yes, because some updates have been published that will help us in our further planning!

The Russian Government signed the resolution 577, which is defining the price for Cryptocodes from the IS MDLP (also known as Markirovka). It is set for now to 50 Kopeks. Drugs with a sell price of 20 rubles or less are exempted. A translation of the full legislation is available for example here.

The agreement on the national system will be signed for a 15 year period for 13 product groups. It will be a private public partnership model—the respective resolution (Amendment to the Federal Law. “Contract System in the Sphere of Procurement of Goods, Works and Services for State and Municipal Needs”) that is available here.

 

Contact us for further information

 

Please note that only the original legislation from the Russian Government is valid.