v.28 – Q4 2023

v.28 Q4 2023 update: Additional products in scope, e-PIL updated.

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 Serialisation was the July 1, 2020, though industry was 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 had 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 1st of July 2020, and a 6-month flexible period for penalties had not been legally endorsed by law and there were still several areas unclear to fully implement the system.
  • Subsequently an additional change was announced, the extension condition for products manufactured outside Russia before October 1, 2020 to be exempt from the marking requirements for 45 days till January 1, 2021.
  • Autumn 2020 characterised with massive blockage of reports transactions and total unsustainability of IS MDLP that had led to increasing numbers of medical products being blocked in the supply chain and resulting in shortage of medicaments in pharmacies during the pandemic period to which the Russian government and CRPT responded with temporary correction measures (see notes)
  • Pilot projects:
    • The voluntary pilot for serialization of biologically active food additives is launched from May 1,2021 until August 31, 2022 (until August 1, 2022 as per Draft Law from Feb 23, 2020)
    • The pilot for medical devices is started on February 15, 2022
    • Draft Law (from Mar 29, 2022) on the extension of all ongoing pilot projects , such as food additives and antiseptics, until February 28, 2023
Key Dates
  • July 1, 2020: official date of obligatory serialization with a possibility of an exemption
  • October 1, 2020: products/batches need to have been produced before October 1st to be eligible for an exemption
  • January 1, 2021: no more exemption
  • 2021: reporting/authentication modes changes
    • Before July 1, 2021: two types of authentication mode are supported by CRPT with static token (current) and with dynamic token (new process)
    • From July 1, 2021 (later updated to October 1, 2021:): OMS will support the authentication with dynamic client tokens only. Static client tokens support will be discontinued for all participants.
    • December 1, 2021: The Law on criminal liability for Counterfeiting marking codes comes into force, concerns also reporting (fines) and involves criminal responsibility for falsified labelling
  • January 31, 2022: Decree 73/2022 came into force and allows to use Notification mode permanently

Other pilot projects to mention:

  • May 1, 2021 – February 28, 2023: voluntary pilot for serialization of biologically active food additives (Decree N 1466 from August 20, 2022). Guidelines have been published (GIS MT system). The mandatory deadline of serialization is confirmed from October 1, 2023 (Decree 886 from May 31, 2023), registration in GIS MT starts from September 1, 2023.
  • August 1, 2021 – February 28, 2023: the serialization pilot of antiseptics. More details are in the Decree N 1466 from August 20, 2022.
  • February 15, 2022 – February 23, 2023: pilot of medical devices serialization (Decree 137/2022, from Feb 9, 2022). Decree 894 from May 31, 2023 contains serialization deadlines: October 1, 2023 for air purifies, orthopaedic footwear & corrective inserts; March 1, 2024: hearing aids (excl. parts & accessories), coronary stents, computer tomographs, incontinence products. Registration in GIS MT is from September 1, 2023.
  • March 2023 – March 2026: (law N 405 FZ from October 19 2022) pilot project of online sale of prescription drugs in Russia (on volunteer base)
  • December 25, 2023 – August 31, 2024: pilot project on veterinary medicines (Decree N 2222 from Dec 21, 2023)
  • In Draft Status: December 1, 2023 – February 28, 2025: pilot project on cosmetics (including toothpaste) and house cleaning products.

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