One bid now beats every foreign offer in Russian state tenders — here’s what changed for pharma and medtech
Previously, a foreign supplier could easily participate in a tender as long as two competitors from the EAEU (Eurasian Economic Union) offering the same product hadn’t submitted bids. A single bid from a Russian manufacturer made no difference. Now, just one such bid that passes verification under formal requirements is enough to automatically reject all offers containing imported goods, regardless of price or quality.
For regulatory and tender departments of pharmaceutical companies and medical device manufacturers, this changes the entire logic of participating in state procurement. Here’s what exactly has changed, where the rule applies more strictly for specific product categories, and how to prepare a portfolio for the new deadlines.
How Bids for Imported Medicines Were Rejected Before
Prior to 2025, national treatment in the procurement of medicines and medical devices relied on fragmented decrees. Decree of the Government of the RF dated 30 November 2015 No. 1289 applied to medicinal products, while Decree dated 5 February 2015 No. 102 applied to medical devices. Both documents operated under a similar logic, colloquially known in the market as the tretiy lishniy rule (literally, the «third is superfluous» rule).
The mechanics were straightforward. A purchaser rejected all bids with imported goods only if two conditions were met at once: at least two bids with goods from EAEU countries were submitted for the tender, and these bids came from manufacturers that did not belong to the same group of persons. If only one Russian or Eurasian supplier showed up, the foreign participant retained the right to compete for the contract.
Confirmation of Eurasian origin mainly relied on the ST-1 form certificate. The threshold requirement for the number of competitors left room to maneuver: for many items, a second qualifying competitor from the EAEU simply never appeared, so the rule was never triggered.
A Unified National Treatment Scheme Instead of Scattered Decrees
Federal Law No. 318-FZ dated 8 August 2024 revised Article 14 of Law No. 44-FZ and synchronized it with Law No. 223-FZ. Instead of the previous split into fragmented admission measures, the law established three unified instruments — prohibition, restriction, and preference — identical for the contract system and for procurement by state-owned corporations. The rule took effect on 1 January 2025.
The specific lists of goods and the procedure for applying these three measures are set out in Decree of the Government of the RF No. 1875 dated 23 December 2024. It directly replaced Decree No. 1289 and Decree No. 102: both acts lost legal force. By July 2026, more than a dozen amendment packages had already been added to Decree No. 1875. When working with the document, it matters to consult the current active version — the December 2024 text is long outdated.
Decree No. 1875 is built around three annexes:
Annex No. 1 — a full prohibition on purchasing imported goods. Besides industrial products and fabrics, this includes specific medical devices: artificial lung ventilators of certain codes, vacuum blood collection tubes (IVD), and part of the medical furniture category.
Annex No. 2 — restriction of admission. This covers broad-spectrum medical devices (items 362-432) and medicinal products from the ZhNVLP list (Vital and Essential Drugs, item 433).
Annex No. 3 — the minimum mandatory share of purchases of Russian-made goods. Applies only to procurement under Law No. 223-FZ, for state-owned business entities that are not part of the defense-industrial complex and are not natural monopolies.
By scale, these lists are fairly large: Annex No. 1 covers around 150 positions after recent amendments, and Annex No. 2 reaches up to 465 positions. Since its adoption in December 2024, the decree has been amended more than ten times, including revisions in February, June, August, September, and November, three times in December 2025, and again in January, February, May, and July 2026. For a tender department, that means a regular cross-check against the active version at every new procurement. Reading the document once at its release quickly loses its value.
This is where the rule change happened. Under Part 4 of Article 14 of Law No. 44-FZ, once a restriction applies, all bids containing imported goods are rejected if at least one bid containing Russian-origin goods is found compliant with the notice requirements. A second bid from another EAEU manufacturer is no longer needed. The market has adopted the colloquial term vtoroy lishniy («second is superfluous») for this mechanism.
For bids containing only Russian-origin goods, the law also provides a price preference: a conditional 15% price reduction during bid evaluation, while the contract is awarded at the price the participant actually offered, with no real deduction.
Confirmation of origin changed too. Instead of the ST-1 certificate, a supplier now needs an entry number in the Registry of Russian Industrial Products (under Article 17.1 of the Law «On Industrial Policy») or in the Eurasian Registry of Industrial Goods. For a subset of items entered into the registry before 10 October 2023, 10 August 2025, or 30 June 2026 (depending on the specific code), transitional periods still allow the ST-1 certificate together with a Chamber of Commerce and Industry (CCI) certificate of expert examination.
What This Means for Medical Devices
The restriction under Annex No. 2 applies to medical devices in items 362-432. A purchaser must reject all bids with an imported device if at least one bid with a Russian or Eurasian device carrying a registry entry number is found.
Restriction and prohibition are not the same thing. The full prohibition under Annex No. 1 covers a specific list of items: artificial lung ventilators of certain classification codes, vacuum blood collection tubes, part of the medical furniture category, and ward furniture. For these items, imported goods cannot take part in the tender at all, even if no competing Russian bid is submitted.
The decree also bars combining goods from different Annex No. 2 categories with goods outside those categories in a single tender lot. For medical devices, a separate lot-formation rule applies under Government Decree No. 620 dated 19 April 2021, and for medicines with different International Nonproprietary Names (INNs), maximum lot-price thresholds apply under Decree No. 929 dated 17 October 2013.
What This Means for Pharmaceuticals and Strategically Important Drugs
For medicinal products, an additional layer of rules applies. Item 433 of Annex No. 2 extends the restriction to drugs on the ZhNVLP list. Beyond that, the decree gives an added preference to bids offering a drug made through a full production cycle within the EAEU, including synthesis of the active pharmaceutical ingredient (API), over bids where the drug is only packaged or filled in the EAEU.
For standard ZhNVLP drugs not on the list of Strategically Important Medicines (SZLS), this rule is already in force. For the SZLS list itself, the government set a separate, later start date: first announced for 1 September 2025, then pushed to 1 January 2026, then to 1 July 2026. Under a decree that took effect on 13 July 2026, the date has been pushed back again, to 1 December 2026. Until then, the full-cycle requirement for SZLS drugs is applied under the transitional rules meant for standard ZhNVLP products.
At the same time, the government is changing how full-cycle production gets confirmed: instead of a Ministry of Industry and Trade document describing the production stages, a registry entry with a localization score of at least 100 points will be used, and delivery of a specific drug batch will need to be confirmed through the «Chestny ZNAK» track-and-trace system. For drugs added to the SZLS list after the decree took effect, the transition is softer: the full-cycle requirement takes effect for them from 1 September of the second year following the year they were added to the list.
Since 27 September 2025, one more rule has applied: Russian legal entities providing services listed in items 147-151 of Annex No. 1 (audit, accounting, tax, and financial consulting services) are treated as foreign entities if a foreign person owns, directly or indirectly, more than 10% of their voting shares or equity. This rule is limited to the consulting services named above. There is no broader capital-structure requirement for suppliers of medicines and medical devices in the text of the decree.
How Purchasers Reject Bids in Practice
Practice around the new rule has already settled, and three grounds for rejecting a bid come up more often than the rest: the bid doesn’t state the product’s country of origin, it states a foreign country of origin while a competing Russian bid is on file, or the registry entry in the Registry of Russian Industrial Products is missing or invalid.
The Ministry of Industry and Trade has clarified that a purchaser should not reject a bid just because the GISP catalog (State Information System of Industry) lacks enough detail to match the product against the procurement description, as long as the participant’s product actually meets the national treatment requirements. Court practice in 2026 backs this up: minor technical inaccuracies in the structured part of a bid don’t trigger automatic rejection if the origin is otherwise clear from the accompanying documents.
The picture looks different once the contract is underway. Substituting a registry entry, or delivering a product batch other than the one declared in the bid, counts as a breach of national treatment and can lead to unilateral termination of the contract. The real risk for a supplier sits here, at the acceptance stage, not at the bidding stage.
If a bid is rejected without proper grounds, the supplier can file a complaint with the regional office of the Federal Antimonopoly Service (FAS). Decree No. 1875 also lets a purchaser skip the restriction in specific cases — for example, when buying spare parts for equipment already in use, matched to that equipment’s technical documentation, or when the item is needed as a single unit and its price is under a set threshold. Before filing a complaint, it’s worth checking whether the rejection falls under one of these exceptions, in which case it would be lawful.
Below is a comparison of the old and new frameworks.
| Parameter | Tretiy lishniy rule (before 2025) | Restriction under Decree No. 1875 (since 2025) |
|---|---|---|
| Number of EAEU bids needed to reject foreign offers | At least 2 | 1 |
| Legal basis | Decree No. 1289 and Decree No. 102 separately | Single Decree No. 1875 for Law 44-FZ and Law 223-FZ |
| Confirmation of origin | ST-1 certificate | Entry number in the Registry of Russian Industrial Products or the Eurasian registry |
| Price preference | Admission terms under the old rules | 15%, a single rule under Art. 14 of Law No. 44-FZ |
| Full production cycle for medicines | Not a factor | Preference for ZhNVLP already active; for SZLS — from 1 December 2026 |
What to Do
Check the registry status of every drug and device. Find the registry entry number in the Registry of Russian Industrial Products or the Eurasian Registry for each item in the portfolio that takes part in state procurement. Without a number, a bid is treated as foreign at the review stage.
Split the portfolio into ZhNVLP and SZLS. This decides when the full-cycle production requirement actually kicks in. For strategically important drugs, plan around 1 December 2026, but build in the risk of another delay — the government has already pushed this date back three times.
Line up full-cycle confirmation early. If a drug is made in the EAEU but the active ingredient is synthesized outside it, start moving synthesis in-region before the points-based system takes effect, so the price preference isn’t lost.
Check lot formation against Decree No. 929 and Decree No. 620. Medicines with different INNs and medical devices each have their own rules for combining items into a single lot. A mistake here can put an entire procurement at risk, not just one bid.
Check medical devices against the full-prohibition list. Some items (certain ventilator models, vacuum tubes, medical furniture) are closed to imports altogether, regardless of whether a competing Russian bid is submitted.
Set up regular monitoring of Decree No. 1875’s revisions. The document changes several times a year, and item numbers in the annexes get reshuffled. Check the active version before every major procurement — a version read at the start of the year may no longer hold by summer.
While the market is still discussing another delay for strategic drugs, the requirement already applies to standard ZhNVLP drugs and medical devices under the new rule. Companies that registered their goods and confirmed full-cycle production get predictable access to contracts. Those still counting on the old logic of two competitors risk losing out to a single bid from a local rival.
Regulatory framework:
1. No longer in force: Decree of the Government of the RF No. 1289 of 30 November 2015; Decree of the Government of the RF No. 102 of 5 February 2015
2. Federal Law No. 44-FZ of 5 April 2013, «On the Contract System for Procurement of Goods, Works, and Services for State and Municipal Needs» (Art. 14 as amended by Law No. 318-FZ)
3. Federal Law No. 223-FZ of 18 July 2011, «On the Procurement of Goods, Works, and Services by Certain Types of Legal Entities»
4. Federal Law No. 318-FZ of 8 August 2024
5. Decree of the Government of the RF No. 1875 of 23 December 2024, «On Measures to Provide National Treatment in Procurement of Goods, Works, and Services for State and Municipal Needs and in Procurement by Certain Types of Legal Entities» (current version, as amended through 13 July 2026)
6. Decree of the Government of the RF No. 719 of 17 July 2015, «On Confirming the Production of Russian Industrial Products»
7. Decree of the Government of the RF No. 929 of 17 October 2013 (maximum lot price for medicines with different INNs)
8. Decree of the Government of the RF No. 620 of 19 April 2021 (lot formation for medical device procurement)