Serialization Requirements in Russia

Regulatory requirements pertaining to drug serialization in Russia are regularly updated. For the latest info, please click here. 

To make the pharmaceutical supply chain safer and ensure patients get the medicines they need, the Russian Ministry of Health intends to put in place serialization and aggregation requirements for drugs.

The ”Federal State Information System for Monitoring of Drugs Circulation from a Manufacturer to a Final Consumer with the Use of Labeling (FSIS DCM)” sets out requirements for pharmaceuticals produced for the Russian market. However, despite the fact that a pilot program is running, there are still discussions as to what exactly the FSIS DCM will entail.

While the law does not explicitly define standards that are to be used for identification and marking or for data reporting, industry associations and manufacturers recommend the use of GS1 standards and 2D datamatrix for unique product identification to encode serialization and aggregation data. Serialization shall ultimately allow traceability from the manufacturer all the way through the medical supply chain. Events like drug production, sale, write-off/withdrawal from circulation/disposal, sampling or quality checks will have to be recorded and reported.

Drug manufacturers and their supply chain partners will have to report above mentioned events to Russian authorities via standard protocols and electronic interfaces. The Russian Ministry of Health is therefore developing a rather complex reporting system and database including several functional and infrastructural subsystems. Management of the different FSIS DCM components are intended to be carried out with the use of specialized management automated working stations (AWS).

Russia aims for a phased implementation by drug groups starting with the seven high-spending disease classes, such as medicines for treatment of haemophilia or multiple sclerosis and drugs administered after organ transplantation for example, to be serialized in Q1 2018. Implemented in four steps depending on sale price, the law is supposed to ultimately apply to all medicines for human use released into circulation from Q4 2018.

While there is still clarification and guidance necessary, the pilot program will hopefully contribute to the development of clear and concise instructions. However, given that there is still some uncertainty, it is questionable whether the majority of pharmaceutical manufacturers will be able to meet the Russian deadlines.