v. 14 – 2020/02

Market Executive Summary
  • Full Track and Trace system, using central government database with complex reporting requirements involving all stakeholders (complex choreography of reporting).
  • Coding includes two cryptographic elements sourced from central system.
  • Official deadline for serialization is the 1st of July, 2020, though industry is pushing for an extension of the deadline not least because of the coronavirus pandemic
  • All medicines (including non-serialised), produced before July 1, 2020 (High cost nosologies, produced before December 31, 2019) “… are subject to storage, transportation, dispensing, sale, transfer, use without application of identification means until the expiration date…”.
  • Important: all non-serialized medicines have to enter into circulation to Russian market before July 1, 2020.
  • Despite strong advocating from the industry, the Duma confirmed the application date of the 1st of July 2020 with a 6 months flexible period for penalties (soft launch) even if there are still several areas unclear to fully implement the system.
  • Subsequently, an additional change was announced, the extension of the timeline for product manufactured outside Russia exempt from the marking requirements to October 1, 2020.
Key Dates
  • January 1, 2017
  • April 1, 2018
  • October 1, 2019
  • November 1, 2019
  • July 1, 2020
  • October 1, 2020
  • January 1, 2021 (soft launch)