Global Market Intelligence Service (GMIS) News Article:
“The Russian Federation Closes in on a Serialized Track and Trace Model”
On January 24, 2017, the Government of the Russian Federation and several government agencies announced and released a decree to implement a system for the identification and monitoring of all pharmaceutical products in the Russian market, known as the “Medicines Quality and Safety” project. A voluntary pilot program has been conducted since January and is expected to conclude by December 31, 2017, click here for a list of the Russian Serialization Pilot participants.
The pilot program has had participation from various manufacturers, distributors, pharmacies and hospitals in Russia. The organizations involved in the pilot throughout 2017 have engaged in serializing product using a unique identification code via a GS1 2D DataMatrix, aggregating product to the pallet level, as well as capturing and reporting event data to the Russian Centralized Repository as the product moves through the supply chain. The requirements drafted in the decree and established in the proposed law align with Emerging Global Standards for a full track and trace model with single point data reporting to a centralized database.
As of December 26, 2017, the federal law has been approved and passed through the State Duma and Federation Council and sent to the President for final approval and official publication of the law “On the circulation of medicines.” It is expected the law will be officially signed by the end of 2017.
Originally expected to begin in January of 2018, the timeline for implementation of the track and trace system has been revised and is expected to take full effect on January 1, 2020. There is a possibility that high priority drugs will have an expedited implementation deadline in 2019, however this has not been officially announced. The Russian government is expected to conduct an evaluation of progress on implementation in July of 2018 and will determine if an earlier deadline is feasible. Pending final approval by President Vladimir Putin, it is expected the law will be enacted and preparations will begin as early as January of 2018.
As technical details for the Russian Central Repository (FSIS MDC – Federal State Information System for Monitoring of Drugs Circulation) are released, links will be posted on the GMIS Russian Serialization Summary page. Also, a link to the translated of the “On Amendments to the Federal Law”, on circulation of medical products document will be added to the GMIS Russian Serialization Summary page soon. A link to the unofficial translated version of the original draft Russian Serialization Legislation FSIS MDC can be found in the Additional Notes section on the GMIS Russian Serialization page.
Ministry of Healthcare of the Russian Federation Content
- Russian MOH official release – Federal Law No. 425-FZ “On Amendments to the Federal Law,” on circulation of medical products
Contact Excellis Health Solutions & GMIS