v. 15 – Q3 2020

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 July 1, 2020, though industry is pushing for an extension of the deadline not least because of the coronavirus pandemic
  • All medicines (including non-serialized), produced (see note 14) 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…” (for Russian manufacturers)
  • Important: all non-serialized medicines have to enter into circulation to Russian market before July 1, 2020 (for foreign manufacturers)
  • Despite strong advocating from the industry, the Duma confirmed the application date of the July 1, 2020 and a 6 months flexible period for penalties has not been legally endorsed by law and 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 before October 1, 2020 to be exempt from the marking requirements for 45 days until January 1, 2021
Key Dates
  • January 1, 2021: No more exemption
  • October 1, 2020: Products/batches need to have been produced before October 1 in order to be eligible for an exemption
  • July 1, 2020: Official date of obligatory serialization with a possibility of an exemption
  • November 1, 2019
  • October 1, 2019
  • April 1, 2018
  • January 1, 2017

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