v. 26 – Q2 2023
|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. (At the end the pilot phase has been frozen).
Non-serialized medicines, put into circulation before the deadline, will remain until their expiration (as per Draft Law, from Oct 8, 2021).
Following the re-orientation of the programme earlier in the year, the 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.