|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.
- In return, the Russian government and CRPT, the operator of MDLP, reacted to the demonstrated issues with three main corrective measures:
- CRPT announced that Cryptocodes for drugs produced from November 2020 till February 2021 were free of charge.
- New addendum 1779 dated February 11, 2020 to Decree 1556 was endorsed introducing the Notification mode of MDLP reporting. Key objective was to accelerate physical products move in supply chain regardless of the reporting status.
- The new scheme of 702 and 703 reports simplifying the acceptance of goods were introduced => applicable mainly for Importers and participants inside of Russia.
- Methodological recommendations were issued on usage of scheme 702, 703.
- IS MDLP performance still indicates periods of instability which impact dramatically goods import to Russia (especially first week of February 2021).
- The voluntary pilotfor serialization of biologically active food additives is launched from May 1, 2021 until August 31, 2022.
- Russian government plan to introduced criminal liability for counterfeit of marking codes (the law will come into force on December 1, 2021)
- 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.
- The possibility to obtain the static authorization token will be disabled. All static tokens obtained previously will remain operational (later updated to October 1, 2021, but CRPT strongly recommends the change asap).
- June 30, 2021: deadline for MDLP reporting Simplified mode
- June 2021: There is a Draft in place of Addendum to Decree 1556. Main points:
- Notification mode is extended from 01 July 2021 till February 1, 2022, usage of Simplified mode for report 702 and report scheme 703 has been discontinued from July 1, 2021;
- July 2021: Decree N 1069 in place: confirmation of Notification mode extension, report 702 is not any more applicable for imported medicines
- February 1, 2022: deadline for MDLP reporting Notification mode
Other pilot projects to mention:
- May 1, 2021-August 31, 2022: voluntary pilot for serialization of biologically active food additives. Guidelines have been published.
- August 1 2021- August 31, 2022: the serialization pilot of antiseptics. More details in the Law N 1240 from June 21, 2021.
- Draft Law on Medical Devices pilot (from August 1, 2021 to 28 February, 2023), which is still under discussion