The Government of the Russian Federation has decided to maintain the mechanism ensuring the stability of drug supply. The special procedure allowing the circulation of foreign drugs in their original packaging has been extended until December 31, 2027. The corresponding decree was signed by Prime Minister Mikhail Mishustin.
Essence of the Regulatory Decision
The signed document (Decree No. 2219 dated December 30, 2025) amends the existing regulations approved in April 2022. The key goal is to mitigate the risks of drug shortages arising from logistical or geopolitical factors.
Under the approved procedure, manufacturers and distributors retain the right to:
- Import and sell registered foreign medicinal products in Russia in foreign packaging.
- Mandatory condition: presence of a self-adhesive label with information in Russian on the packaging.
Market Access Mechanism
The procedure is not automatic for all importers. The decision on the applicability of the special order is made individually for specific trade names.
| Decision-Making Body | Commission Composition | Approval Criteria |
|---|---|---|
| Special Interdepartmental Commission | Representatives of the Ministry of Health, Roszdravnadzor, Ministry of Industry and Trade, Ministry of Finance, FAS, and the Federal Customs Service | Risk of shortage of the drug in the Russian market |
“The decision will allow maintaining the stability of supplies of significant medications to pharmacies, polyclinics, and hospitals,” the Cabinet’s press service noted in an official statement.
This measure is part of a package of anti-crisis solutions. Previously, the Government also extended the simplified state registration procedure for certain groups of medicinal products and the most in-demand medical devices. This allows for the prompt replacement of unavailable items while the Russian pharmaceutical industry ramps up local production volumes.
Source: Government of Russia
