Starting July 1, 2026, Government Resolution of the Russian Federation No. 1392 dated September 10, 2025, “On Amendments to Government Resolution of the Russian Federation No. 719 dated July 17, 2015,” will enter into force. The resolution introduces a points-based system for determining the country of origin of pharmaceutical products.
To implement this resolution, the Ministry of Industry and Trade of Russia, with the participation of the business and expert communities, has developed and approved methodological guidelines for assessing technological processes involved in the manufacture of medicinal products for medical use.
The guidelines are aimed at standardizing the preparation of documentation required from manufacturers to confirm production stages. The document provides a detailed description of approaches to various types of reactions and the wide range of technological processes involved.
The methodological guidelines and the points-based system for determining the country of origin of pharmaceutical products will enter into force simultaneously.
The methodological guidelines have been published on the website of the Ministry of Industry and Trade of Russia.
Source: Press Service of the Ministry of Industry and Trade of Russia, January 19, 2026.
