The Eurasian Economic Union has published on its official legal website the Order No. 34 dated 08.04.2025 approving the draft decision on the extension of temporary measures related to specifics of medicines circulation in connection with special economic measures (“Draft Decision”).
The Draft Decision provides for amendments to the Decision of the Council of the Eurasian Economic Commission No. 96 dated 10.06.2022 “On temporary measures to establish special rules for circulation of medicinal products for medical use” (“Decision”).
The period established by subpar. “a” of par. 1 of the Decision, during which the authorised bodies of the EAEU member states are entitled to establish a temporary procedure for circulation of medicines (including registration of medicines and amendments to the registration dossier), which has expired at the end of 2024, is to be extended until 31 December 2027.
The Draft Decision provides for a retrospective clause stating that its provisions apply to relations arising from 1 January 2025. This is not a new practice, previously the extension of the above provisions till the end of 2024 was approved only in September 2024.
The formal extension of the period will come into force upon 10 calendar days from the date of its publication. However, in the Russian Federation, the Decree of the Russian Government No. 593 dated 05.04.2022, which establishes the specifics of circulation of medicines under restrictive economic measures, was already extended in December 2024 until 31 December 2027. Thus, the approval of the Draft Decision by the EEC will first of all eliminate the formal inconsistency between the national rules and the EAEU acts.
It should also be noted that the Draft Decision does not provide for amendments to the provisions of subpar. “b” of par. 1 of the Decision, which allowed the authorised bodies of the member states to extend the validity of marketing authorisations and GMP certificates in case of shortages risks until 31 December 2024.
In fact, the Ministry of Industry and Trade of Russia has turned to this opportunity only once, when extending the validity of GMP certificates until the end of 2023 in its Order No. 1987 dated 18.05.2022.