On January 1, 2026, the pharmaceutical market of the Eurasian Economic Union (EAEU) shifted to a fundamentally new model for determining the country of origin of goods. The Council of the Eurasian Economic Commission (EEC), through Decision No. 117, has implemented a points-based localization assessment system. The document radically changes the rules for access to government tenders, requiring manufacturers not just to declare production, but to mathematically confirm the depth of technological processes.
Pharmaceuticals: The “50-Point Gold Standard”
For the pharmaceutical industry, the rules now include a new special section — “XVIII. Pharmaceutical Products”. The key change is that for a drug to be considered produced in the EAEU and to qualify for preferences in tenders, it must score a minimum of 50 points.
The regulator has proposed a flexible scheme for accumulating these points, incentivizing either a full cycle or deep processing stages:
- 50 points are awarded for the production of a finished dosage form from raw materials (including imported ones), provided that the processing results in a change of the TN VED code (at the level of the first 4 digits).
- 50 points are assigned for the synthesis of a pharmaceutical substance (chemical synthesis, extraction from natural sources) within the Union territory.
- 50 points can be obtained for biotechnological stages: creation of cell banks, fermentation, and isolation/purification.
Effectively, performing one of the key stages of deep production is now the “pass” to the EAEU public procurement market.
Medical Devices: A Ladder of Requirements until 2029
For medical devices, a differentiated scale from 70 to 350 points has been introduced, which provides for annual tightening of requirements. This creates a long-term trend towards import substitution of components and raw materials.
An analysis of the annex to the Decision shows the dynamic growth of requirements for key product groups:
- Diabetes: For glucose test strips, the entry threshold in 2026 is 135 points, but by 2027 it will rise to 225 points. Manufacturers will be forced to localize cutting processes, reagent application, and the use of local packaging.
- Rehabilitation: Requirements for colostomy and urostomy bags are rising in stages. For example, for two-component urostomy bags, the bar raises from 250 points in 2026 to 290 points in 2029.
- High-tech: For microprocessor-controlled prosthetic hand joints, requirements tighten from 90 points (2026) to 160–180 points (2029), depending on the materials used.
Points are awarded for specific operations (PCB assembly, plastic molding, sterilization) and the use of raw materials from EAEU countries (e.g., 20 points for using local polymers or steel).
Transition Period: Shock Protection
To avoid supply chain collapses, the regulator has provided for a soft transition. For certain medical devices, the option to confirm the country of origin under the old rules has been extended:
- Until June 30, 2026 (including microsurgical instruments).
- Until December 31, 2026 (including slit lamps).
This decision reduces regulatory risks for companies currently in the process of modernizing lines or re-registering documents.
Analytical Conclusion
The introduction of the points-based system is a logical continuation of the trend towards digitalization and transparency in the industry, which PHARMPROM wrote about earlier in the context of the Unified Register of Manufacturers. While the Register helps filter out non-compliant sites (via GMP checks), the new EEC system answers the question of technological sovereignty.
Now, a “domestic” drug or device is not just one packaged in the EAEU, but one that has scored the required points for actual production operations. For business, this means the necessity of reviewing supply chains and investing in R&D, for which points are now also awarded.
