Russia tightened drug localization rules in 2026. Packaging alone no longer secures a procurement preference
A pharmaceutical company invested in a packaging line at a site near Kaluga, obtained an ST-1 certificate, and expected an advantage in procurement. Such a calculation no longer works. The customer checks the country where the active substance molecule was synthesized. The country of packaging no longer matters for this evaluation.
Government Decree No. 1875 has rewritten the rules of the national regime and introduced a separate criterion for the completeness of the production cycle for medicines. Companies that perform only packaging or quality control in Russia are equated to foreign suppliers when procuring strategically important drugs. The difference in status determines the outcome of the tender, and since January 1, 2026, this rule already applies to drugs from the list of strategically important medicines.
The National Regime Rested on a Dozen Fragmented Decrees
Until 2025, each product group had its own separate act. Procurement of medicines from the list of Vital and Essential Drugs (hereinafter, VED) was regulated by Decree No. 1289 of 2015. Medical devices were subject to a separate Decree No. 102, also from 2015, with its own list of items and amendments published almost annually.
The general principle of preference for Russian goods was secured by Decree No. 925 of 2016. Industrial goods outside of medicine were separately subject to Decree No. 616 (prohibition) and Decree No. 617 (restriction). The minimum mandatory share of procurement of domestic products was calculated according to Decrees No. 2013 and No. 2014. A price preference of 15% or 20% for goods under 44-FZ was provided by Ministry of Finance Order No. 126n of 2018.
A regulatory manager had to keep six different acts in mind for a single procurement; each act had its own list of goods, its own set of supporting documents, and its own deadlines for amendments to take effect. Checking a tender application took hours simply to verify which of the acts to apply to a specific OKPD2 code and what preference resulted from it.
The weak point of this system remained the depth of localization. Formal confirmation of origin via a certificate of origin under the CIS form, known as the ST-1 certificate, allowed a drug to be considered Russian even if only secondary packaging took place in the country while active substance synthesis remained abroad. A company could receive a preference for years for an operation that created almost no added value within the country, while actual technology transfer for substance synthesis remained optional.
Decree No. 1875 Combined Prohibition, Restriction, and Advantage
The fragmented acts were replaced by Government Decree No. 1875 of December 23, 2024, «On Measures to Provide a National Regime» (hereinafter, Decree No. 1875), which entered into force on January 1, 2025, and applies as amended as of September 27, 2025. Ministry of Finance Order No. 126n expired on the same date due to the reform of 44-FZ and 223-FZ; the price preference of 15% and 20% ceased to be applied as a standalone tool.
The new system is built on three mechanisms listed in Paragraph 1 of Decree No. 1875.
| Tool | What It Means | Application to Medicines and Medical Devices |
|---|---|---|
| Prohibition | Complete exclusion of imported goods from the list in Annex No. 1 | Does not affect the main portion of medicines and medical devices |
| Restriction | A foreign bid is rejected if at least one bid with a product from the EAEU is submitted | Applies to medicines (item 433) and medical devices (items 362-432) of Annex No. 2 |
| Advantage | Priority to a bid with a product of fully Russian origin when competing with any foreign proposal | Applies to goods outside Annexes No. 1 and No. 2; for medicines it is supplemented by the full-cycle criterion |
Separately, for a number of customers under 223-FZ, a minimum mandatory procurement share of Russian goods from Annex No. 3 applies. It also affects part of the medical equipment: for CT scanners, the share is 30%; for X-ray machines, 75%; for ultrasound scanners, 80%; for air and steam sterilizers, 95%.
Not all medical devices fall into the restriction category. Some items are classified under the stricter prohibition category in Annex No. 1, where a foreign bid is rejected without exception, regardless of the number of competing domestic proposals. This category includes mechanical ventilators, vacuum blood collection tubes, and medical masks. The difference between the two categories determines whether a foreign supplier is admitted to the procurement at all, or only loses when an EAEU competitor is present. Before submitting a bid, it is worth checking which exact annex a specific OKPD2 code falls into.
Proof of origin is also divided by territory. For goods from Russia, an entry in the register of Russian industrial products, maintained according to the rules of Decree No. 719, is required. For goods from Belarus, Kazakhstan, Armenia, or Kyrgyzstan, proof is provided by an entry in the Eurasian Register of Industrial Goods, which EAEU law governs separately. Until full practice is formed under this register, ST-1 is temporarily accepted for some items, but for most medical devices this temporary option closed along with the 2025 transition period.
A Separate Threshold for Localization Depth Applies to Medicines
The most significant change affects the method of proving origin. The list of goods remained almost the same. Subparagraph «u» of Paragraph 4 of Decree No. 1875 has been in effect since January 1, 2025, and introduces a rule for drugs from the VED list (Directive No. 2406-r). If a bid offers a medicine produced in the EAEU, but not all stages of production, including the synthesis of the active substance molecule, were performed within the Union, such a bid is treated as a bid with a foreign product for the purposes of the advantage mechanism. A competitor with a full cycle wins if its bid passes selection under the remaining procurement requirements.
Subparagraph «f» of the same paragraph extends this rule to drugs from the list of strategically important medicines (Directive No. 1141-r). This rule entered into force on January 1, 2026, and is active today. For drugs added to the strategic list later, the deadline shifts to September 1 of the second year following inclusion, leaving the manufacturer a buffer of time to restructure the substance supply chain.
The Decree also protects procurement results at the contract execution stage. Subparagraph «b» of Paragraph 7 prohibits substituting a full-cycle drug with a drug where some stages were performed outside the EAEU during contract execution, provided the contract was concluded specifically for the supply of full-cycle products. Confirmation of the substance origin is issued by the Ministry of Industry and Trade upon request from the manufacturer; the document records specific stages of the technological process, including the synthesis of the active substance.
For medical devices, a simpler proof logic applies. For most items, a registry entry number from the register of Russian industrial products or the Eurasian register is sufficient. The transition period, during which ST-1 was accepted alongside a registry entry, ended on December 31, 2025, for the bulk of medical devices and medicines. For breathing circuits and donor plasmapheresis consumables, the transition period closed earlier, on August 31, 2025.
For six groups of medical devices, including blood transfusion devices and blood storage containers, a registry entry is insufficient. Annex No. 4 to Decree No. 1875 additionally requires confirmation of the share of foreign materials in the price of the finished product: for blood transfusion devices and blood substitutes, the threshold is 20%; for donor blood storage containers and ventilator consumables, 10%; for donor plasmapheresis sets and heart-lung machines, 40%; for urinary and ostomy pouches, 20%. Exceeding the threshold means the product is considered foreign for procurement purposes, even if assembled in Russia.
What to Do
Check the status of the drug against both lists. Verify whether the drug is included in the VED list under Directive No. 2406-r and simultaneously in the list of strategically important medicines under Directive No. 1141-r. If so, the full-cycle rule already applies to it as of January 1, 2026.
Request a document on production stages from the Ministry of Industry and Trade. Submit the request in advance, as without this document a bid for the procurement of a strategic drug risks losing its full-cycle status and conceding to a competitor.
Review the wording of current contracts. If a contract provides for the supply of a full-cycle drug, make sure the substance supplier has no plans to move synthesis outside the EAEU. Replacement during contract execution is prohibited by Subparagraph «b» of Paragraph 7 of Decree No. 1875.
Update origin documents for medical devices. Replace old-style ST-1 certificates with a registry entry number from the register of Russian industrial products; the validity period of transitional documents for most items expired on December 31, 2025.
For six groups of medical devices, check the share of foreign materials in the price. Blood transfusion devices, donor blood storage containers, ventilator and plasmapheresis consumables, as well as urinary and ostomy pouches require an additional document under Annex No. 4 to Decree No. 1875; a registry entry alone is insufficient for them.
Verify the OKPD2 code of diagnostic equipment against Annex No. 3. For CT scanners, X-ray machines, and ultrasound scanners, a minimum mandatory procurement share for customers under 223-FZ may apply, separate from the general restriction mechanism.
Clarify whether your medical device falls under prohibition or restriction. For mechanical ventilators, vacuum tubes, and medical masks from Annex No. 1, a foreign bid is rejected without exception. For such items, production localization becomes a mandatory condition for admission to procurement.
The difference between packaging in Russia and production in Russia has ceased to be a matter of terminology and has become a matter of tender outcome. Companies that can document where the substance was synthesized today gain an advantage over those that postpone this work until the customer’s first audit.
Regulatory Framework
1. Government Decree of the Russian Federation of December 23, 2024, No. 1875, «On Measures to Provide a National Regime in the Procurement of Goods, Works, and Services for State and Municipal Needs, and Procurements of Goods, Works, and Services by Certain Types of Legal Entities» (as amended on September 27, 2025)
2. Government Decree of the Russian Federation of July 17, 2015, No. 719, «On Confirmation of Production of Russian Industrial Products»
3. Federal Law of April 5, 2013, No. 44-FZ, «On the Contract System in the Field of Procurement of Goods, Works, and Services for State and Municipal Needs»
4. Federal Law of July 18, 2011, No. 223-FZ, «On Procurement of Goods, Works, and Services by Certain Types of Legal Entities»
5. Government Directive of the Russian Federation of October 12, 2019, No. 2406-r (VED list)
6. Government Directive of the Russian Federation of July 6, 2010, No. 1141-r (list of strategically important medicines)