'Second one out' postponed to 1 December 2026: what changes for suppliers
The Government has pushed back the launch of the 'second one out' mechanism for strategically important medicines from 1 July to 1 December 2026. A pause is not a cancellation: the SIM list is expanding, and landing in its first section changes a product's fate at tender.
Update of 12 September 2026
This text has been updated against the final wording of the resolution. At the time of publication (26 July 2026) the postponement existed as draft amendments to Resolution No. 1875 put forward by the Ministry of Industry and Trade in late June; it was enacted by Government Resolution No. 969 of 3 August 2026 (published 6 August 2026). The final text refined the mechanics: the points system (Resolution No. 1392) was not postponed - what moved to 1 December is the switch to registry-based confirmation of full-cycle production; the cut-off for INNs in the original wording of Section I is Directive No. 942-r of 23 April 2026, and for later additions the rule applies from 1 September of the second year after the year of inclusion. The references and wording below have been aligned with the adopted document. A detailed analysis of Resolution No. 969 is in our review 'Full-cycle production as the cross-cutting criterion'.
The Government is postponing the launch of the 'second one out' mechanism for procurement of medicines on the list of strategically important medicines (SIM) from 1 July to 1 December 2026. The Ministry of Industry and Trade published the draft amendments to Resolution No. 1875 on the national regime in public procurement in late June; the postponement was enacted by Government Resolution No. 969 of 3 August 2026. In step with it, the switch to the registry-based model for confirming full-cycle production has been moved to 1 December.
How the mechanism will work
For medicines in the first section of the SIM list the construction is strict: if a supplier bids with a product whose full production cycle within the EAEU is confirmed, bids with a shallower degree of localisation are rejected. The second section provides an additional price preference for localised full-cycle products - up to 30% in total. From 1 December, localisation will be confirmed by a registry entry number in the register of Russian or Eurasian industrial products with a score of at least 100 points on the Resolution No. 1392 scale - until that date the ST-1 certificate remains valid.
An important transitional detail: from 1 December the enhanced mechanism applies to INNs in the original wording of Section I of the SIM list (Directive No. 942-r of 23 April 2026). For INNs added to Section I later, the rule will apply from 1 September of the second year after the year of inclusion - for the July additions, that is 1 September 2028.
The SIM list keeps growing
The pause until December does not freeze the list itself. On 8 June the Ministry of Health commission reviewed proposals to update it - 194 INNs in total. It is proposed to add 39 INNs to the first section ('second one out'), bringing it to 100 items, and 110 INNs to the second (price preference), bringing it to 255. The expansion was approved by Government Directive No. 1748-r of 7 July 2026. The SIM list is effectively turning from a drug-security instrument into an instrument of industrial and procurement policy: what matters is not only whether an INN is included, but which section it lands in.
What to do before December
First, run a portfolio inventory against the updated SIM list: which INNs fall into the first section, which into the second, and whether localised competitors with a full EAEU production cycle exist for those items. Second, for at-risk positions, model the scenarios: localisation or contract manufacturing, partnership with a local producer, or a revised pricing strategy to counter the 30% preference enjoyed by competitors. Third, check readiness for the new contractual requirements: the obligation to supply only batches confirmed through the track-and-trace system comes in alongside the other changes.
Five months of deferral is time the market would not have had under a July launch. It is best spent on preparation rather than on waiting for another postponement: the December deadline is now fixed in law by Resolution No. 969.
Sources
Government Resolution No. 969 of 3 August 2026; Government Resolution No. 1875 of 23 December 2024; Government Resolution No. 1392 of 10 September 2025; Government Directives No. 942-r of 23 April 2026 and No. 1748-r of 7 July 2026; draft amendments to Resolution No. 1875 (regulation.gov.ru, June 2026); materials of the Ministry of Health commission session on the SIM list of 8 June 2026 (Garant.ru, GxP News, industry media).
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.