Marketing authorisations after 31 December 2025: reading the EAEU transition period
National marketing authorisations are formally a thing of the past, but in practice a complex matrix of transitional statuses applies. The Ministry of Health clarified the rules in Letter No. 25-6/894 - we break down which deadlines apply to which categories of products.
On 31 December 2025 the deadline expired for filing applications to bring registration dossiers compiled under national rules into line with EAEU requirements. Formally, from 1 January 2026 the Union procedure is the only valid form of registration. In practice, the status of a specific product depends on what its marketing authorisation holder managed to do before the end of 2025 - and several fundamentally different scenarios apply, which the Ministry of Health systematised in Letter No. 25-6/894 of 29 January 2026.
Four scenarios for MA status
Scenario 1: an alignment application was filed before 31 December 2025 and the procedure is not yet complete. The marketing authorisation remains valid for the duration of the procedure - up to 3 years from the filing date in the reference state, plus up to 2 more years in the states of recognition (provided the application there was filed in time).
Scenario 2: no application was filed, but the product had been placed on the Russian market for at least three years. Circulation in Russia is permitted until 1 January 2027 under the concessionary terms of Government Resolution No. 353.
Scenario 3: no application was filed and no concessionary grounds apply. The authorisation is deemed to have expired on 31 December 2025. Products released into circulation before that date may remain on the market until their shelf life ends.
Scenario 4: the product was registered under the anti-crisis procedure of Resolution No. 593 - such authorisations remain valid until 31 December 2027.
Details that are easy to miss
Once the dossier alignment procedure is complete, production under the 'old' national authorisation is still permitted for 180 calendar days - a window for planning production campaigns and packaging stock. The Ministry instructs that the authoritative expiry date is the entry in the State Register of Medicines: it is the register status, not the paper certificate, that counterparties and state customers should rely on.
For products whose alignment was completed in the reference state before 31 December 2025, the authorisation in the declared states of recognition is extended for the duration of the procedure there, but for no more than 2 years from 31 December 2025.
Practical takeaways
Portfolio holders should audit against all four scenarios: verify authorisation statuses in the state register, fix the cut-off dates for every item, and build an alignment completion schedule with a margin - the three-year limit runs from the filing date, not from the start of the assessment. For products circulating under the Resolution No. 353 concession, the planning horizon is short: 1 January 2027 is a hard date, and for such items the decision on Union registration is economically sensible now, given how long the procedure takes.
A separate workstream is communication with distributors and state customers: practice shows that counterparties decline to purchase when an authorisation's register status is unclear, even where legal grounds for circulation exist. Proactive confirmation of status removes that risk.
Sources
Letter of the Russian Ministry of Health No. 25-6/894 of 29 January 2026; EEC Council Decisions No. 78, No. 77 and No. 34; Government Resolutions No. 353 of 12 March 2022 and No. 593; State Register of Medicines.
This material is for information purposes only and does not constitute legal advice. Decisions on the inclusion of medicines in reimbursement lists are made by the authorised state bodies.
Questions on market access in Russia and the EAEU? Talk to the WIT Pharma team. Full texts of the documents mentioned are available in the key regulations section.