'Second one out' postponed to 1 December 2026: what changes for suppliers

Government Resolution No. 835 of 3 July 2026 has amended Resolution No. 1875 on the national regime in public procurement. The key point for the pharmaceutical market: application of the 'second one out' mechanism to medicines on the list of strategically important medicines (SIM) has been postponed from 1 July to 1 December 2026 - for both sections of the list. The points-based localisation scoring system for pharmaceuticals (Resolution No. 1392) and the registry-based model for confirming production have been moved to 1 December in step.

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 a 30% price preference for localised products. 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 - until that date the ST-1 certificate remains valid.

An important transitional detail: from 1 December the enhanced mechanism applies to medicines that were on the SIM list as of 26 April 2026. For INNs added later, the rule will apply to contracts concluded from 1 September of the year following the year of inclusion.

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 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 draft 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 resolution has been signed, and the December deadline is now fixed in law.

Sources

Government Resolution No. 835 of 3 July 2026; Government Resolution No. 1875 of 23 December 2024; Government Resolution No. 1392; materials of the Ministry of Health commission session on the SIM list of 8 June 2026 (Garant.ru, GxP News, industry media).