Full-cycle production as the cross-cutting criterion: what Resolutions No. 969 and No. 999 lock in

Two resolutions issued a week apart formally belong to different domains - public procurement and registration - but set the same criterion: production of all stages within the EAEU (or Russia), including synthesis of the active molecule. Resolution No. 969 of 3 August 2026 (published 6 August 2026) rewrote the pharmaceutical block of Resolution No. 1875 on the national regime; Resolution No. 999 of 10 August 2026 (in force from 20 August 2026) introduced the full-cycle criterion into Resolution No. 593 on registration in case of drug shortages. For localisation planning this means production depth now affects both access to tenders and access to accelerated registration.

Resolution No. 969: a pause until 1 December, new mechanics thereafter

Until 1 December 2026 sub-paragraph 'f' of paragraph 4 of Resolution No. 1875 - the 'second one out' mechanism itself for medicines in Section I of the strategically important medicines (SIM) list - is suspended. The transition period for VED-list procurement under the old rules has been extended: tenders whose notices are published on or before 30 November 2026 proceed under the previous procedure.

From 1 December, confirmation of full-cycle production changes form. Instead of documents on production stages, the customer is shown a registry entry number - in the register of Russian industrial products (scored at no fewer than 100 points under Resolution No. 719) or in the Eurasian register of industrial goods (likewise at least 100 points). The points scale for pharmaceuticals was introduced by Resolution No. 1392 of 10 September 2025: 50 points for manufacturing the finished dosage form in the EAEU and another 50 for manufacturing the active pharmaceutical ingredient with the key technological stages performed there. The threshold for 'Russian product' status is 50 points; the threshold for 'full cycle' for procurement purposes is 100.

Registry entries formed on or before 30 November 2026 remain usable for tenders announced up to and including 30 April 2027 - a buffer for those who do not manage to re-register entries by December.

The confirmed batch: a new mandatory condition

The key novelty is a requirement for not just a registry entry but an actually produced batch. For Section I of the SIM list, 'second one out' will trigger from 1 December only if a bid is submitted with a full-cycle product for which the Ministry of Industry and Trade website carries information on at least one batch (of that product or another under the same INN) whose entire production chain has been confirmed through the state track-and-trace system. A bid with a full-cycle product but no confirmed batch is treated as foreign - on a par with partially localised products.

For Section II an additional preference has been introduced (sub-paragraph 'u.1'): a bid with a full-cycle product and a confirmed batch receives a second layer of 15% price preference on top of the standard preference for EAEU goods. In other words, for Section II full-cycle localisation yields up to 30% price advantage; for Section I, it yields rejection of competitors.

The obligations carry into the contract: a supplier that has received the preference must deliver from confirmed batches and, on acceptance, provide the customer with evidence of publication on the Ministry of Industry and Trade website; substituting a full-cycle product with a partially localised one during the contract is not permitted.

Different deadlines for different INNs

For the 61 INNs in the original wording of Section I (Directive No. 942-r of 23 April 2026), 'second one out' applies to tenders announced from 1 December 2026. For the 39 INNs added to Section I by Directive No. 1748-r of 7 July 2026, it applies only from 1 September of the second year after the year of inclusion - that is, from 1 September 2028; until then the double preference applies, as for Section II. This rule will become the standard for all future additions to Section I: every new INN gets roughly two years before the 'hard' mechanism kicks in.

Resolution No. 999: full cycle in the shortage criteria

Since 2022 Resolution No. 593 has allowed products to be registered under a special procedure in case of a shortage, or risk of shortage, caused by sanctions. Resolution No. 999 added two elements. First: when determining a shortage, the interdepartmental commission now takes into account the absence in Russia of production of all stages (including molecule synthesis) for the INN in question - meaning that the mere existence of production with incomplete localisation no longer rules out a shortage finding. Second: a Russian applicant filing under the special procedure for a product not previously manufactured in the country on a full-cycle basis must submit localisation details: for biologicals, all stages including synthesis; for other products, manufacture of the finished dosage form, primary and secondary packaging and release quality control.

The practical meaning: accelerated registration on shortage grounds becomes a tool for deep-localisation projects rather than for the quick introduction of imported analogues through a Russian legal entity.

What to do before 1 December

First, check the portfolio against the current wording of the SIM list (No. 942-r as amended by No. 1748-r) and sort items into three groups: Section I original wording (hard regime from 1 December 2026), Section I July additions (double preference until 31 August 2028), Section II (double preference from 1 December 2026). Second, for localised items verify that there is a registry entry with 100 points and at least one batch confirmed in the track-and-trace system and published by the Ministry of Industry and Trade: without a batch, full-cycle status does not work in procurement. Third, for imported and partially localised Section I items, assess whether a full-cycle competitor with a confirmed batch exists for the INN: its appearance is what triggers rejection. Fourth, for localisation projects via the shortage route, factor the new depth-of-stages requirements into the registration dossier.

Sources

Government Resolution No. 969 of 3 August 2026 (pravo.gov.ru, No. 0001202608060024); Government Resolution No. 1875 of 23 December 2024; Government Resolution No. 999 of 10 August 2026; Government Resolution No. 593 of 5 April 2022; Government Resolution No. 1392 of 10 September 2025 (amendments to Resolution No. 719); Government Directives No. 942-r of 23 April 2026 and No. 1748-r of 7 July 2026; Russian Ministry of Finance information letter No. 24-01-06/8697 of 31 January 2025 (on the size of the preference); Garant.ru (10 August 2026); Vademecum (1 September 2026); GxP News, PharmMedProm (August 2026).