Decree of the Government of the Russian Federation No. 853 dated June 1, 2021, approved the new Rules for the Import of Medicines for Medical Use into the Russian Federation and revoked several prior government acts and specific provisions. Notably, this decree superseded Government Decree No. 771 dated September 29, 2010, "On the Procedure for Importing Medicines for Medical Use into the Territory of the Russian Federation." The new regulatory framework governing the importation of pharmaceutical products into Russian territory took effect on September 1, 2021.

Under the new regulations, pharmaceutical market participants may submit applications for import permits via the Unified Portal of State and Municipal Services (Gosuslugi).

Importers may introduce medicines into the Eurasian Economic Union (EAEU) customs territory provided that such products are listed in the Single Register of Registered Medicines of the EAEU or the respective national register of the member state. Cross-border operations remain strictly subject to compliance with the specific regulatory requirements established by each individual EAEU member state.

The following entities are authorized to import medicines into the Russian Federation:

• Pharmaceutical manufacturers sourcing materials or active substances for their own production needs;
• Wholesale distributors of pharmaceutical and medicinal products;
• Foreign drug developers and international manufacturers conducting clinical trials, product registration, or expert evaluations of medicines intended for commercialization in Russia or the broader EAEU territory;
• Research institutions, higher education organizations, and commercial drug manufacturers engaged in the development, testing, or safety, quality, and efficacy control of medicines, subject to obtaining the requisite regulatory opinion;
• Healthcare institutions and the aforementioned entities providing life-saving medical care to specific patients or addressing the needs of a restricted patient population with rare and/or exceptionally severe pathologies, subject to obtaining the requisite regulatory opinion.

The regulations mandate that, save for specific statutory exceptions, importing medicines into Russia requires a regulatory opinion (import permit) issued by the Ministry of Health. Applicants must submit the relevant documentation electronically, and the Ministry records both the applications and subsequent administrative decisions in a specialized digital register.

The Ministry of Health may deny the issuance of an import permit on the following grounds:

• Submission of incomplete, inaccurate, or misleading information within the documentation package provided by the applicant;
• A regulatory ban within the EAEU territory covering the specific medicine designated for import and medical use in Russia;
• Omission of the applicant legal entity from the relevant decree of the Government of the Russian Federation that authorizes the import of unregistered medicines for a restricted patient population with rare and/or exceptionally severe pathologies.

The importation of medicines unregistered in Russia to provide medical care to a restricted patient population with rare and/or exceptionally severe pathologies proceeds under a Ministry of Health regulatory opinion. Issued pursuant to an explicit government decree, this opinion must specify the authorized importing legal entity, the International Nonproprietary Name (INN) of the medicine, its dosage form, strength, and volume, alongside the specific medical condition or pathology of the target patient cohort.

This new framework does not govern the importation of narcotics, psychotropic substances, or their precursors, which remain subject to a separate, highly specialized regulatory regime.

The enforcement landscape strictly prohibits the importation of falsified, sub-standard, or counterfeit medicines into the country.