v. 19 – Q3 2021

Market Executive Summary Initial implementation phase: 2019-2020

August 2019: as per Ministry of Health: from January 2021 to the end of 2022, mandatory labelling should be introduced, but not for all medicines and systematically. Stage-wise implementation will be defined in consultation with manufacturers and their opinion on those medicines for which marking should be mandatory , will be considered.

Next stage- from January 1, 2023: mandatory labelling of all drugs in Ukraine. Pilot stage is from Sep 1, 2019 -until end of 2020.

May 2020: The start of pilot is postponed until the 1st of Nov 2020, with official deadline of mandatory serialization on Nov 1, 2021.

Non-serialized medicines, put into circulation before the deadline, will remain until their expiration.

Following the re-orientation of the programme earlier in the year, the current status is on ongoing debate about the preferred model (Use of Cryptocode vs. EU FMD style coding) with a likely preference to follow EU-FMD example.

May 2020: Indications that Ukrainian serialization process will follow EU FMD model requirements.

September 2021: Ukraine parliament started the revision of pharmaceutical legislation in line with EU legislation:1st reading of Law is under debates, especially the question to decide on whether the verification system will follow the EU model or as a governmental body.

Key Dates
  • Anticipated Mandatory drug traceability for all drugs is January 1, 2023
  • Mandatory drug traceability will be introduced in stages from January 2022
  • Pilot postponed until November 1, 2020
  • Official launch of pilot was November 1, 2020, but limited reports on progress: It is likely that the pilot is currently on hold
  • Pilot is postponed until November 1, 2020
  • Timetable phased implementation 2019 to 2024
  • July 1, 2016 / July 1, 2017

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