The Russian government has recognized the national rules for inspecting pharmaceutical manufacturers for compliance with Good Manufacturing Practice (GMP) as invalid. In addition to three government resolutions related to GMP certification, clause 36 of the state services list — concerning the inspection of pharmaceutical companies producing medicines outside Russia — will also be repealed. The resolution abolishing national GMP inspection rules will take effect on March 1, 2026. After this date, inspections and the issuance of compliance certificates will be conducted exclusively under EAEU GMP rules.

The following national resolutions are being invalidated:

– Resolution No. 1314 of December 3, 2015, “On Determining the Compliance of Pharmaceutical Manufacturers with Good Manufacturing Practice Requirements”, which established rules for inspections and supplemented the list of services provided by federal executive authorities.
– Resolution No. 789 of May 29, 2020, “On Amendments to the Rules for Inspecting Pharmaceutical Manufacturers for GMP Compliance and Issuing Compliance Certificates.”
– Resolution No. 1361 of September 5, 2020.

The Eurasian Economic Commission (EEC) began developing a unified system for inspecting pharmaceutical production in the EAEU in 2015. Russia formally approved these procedures through a government resolution in 2020.

In August 2024, the Ministry of Industry and Trade increased the fees for inspecting pharmaceutical manufacturers for compliance with EAEU GMP standards. According to the updated order, the inspection fee for domestic companies rose by 100,000 rubles — from 1.9 million to 2 million rubles. Travel allowances for the inspection commission also increased from 307,800 to 326,000 rubles. Inspections under EAEU rules can be carried out by authorized bodies from multiple Union member states.

Source: Vademecum, November 14, 2025.