Russia | Review of pharmaceutical regulations – May 2026

The Ministry of Agriculture has repealed the regulations governing clinical trials of veterinary drugs

On May 22, 2026, Order No. 256 of the Ministry of Agriculture of Russia, dated April 15, 2026, was officially published (registered with the Ministry of Justice of Russia on May 21, 2026, under No. 86580).

This document repeals the previously effective Order No. 153 of March 14, 2025, “On the Approval of Rules for Conducting Preclinical Studies of Veterinary Medicinal Products, Clinical Studies of Veterinary Medicinal Products, and Bioequivalence Studies of Veterinary Medicinal Products.”

This decision signals a transition to unified regulation within the framework of the Eurasian Economic Union (EAEU).

Effective March 1, 2026, preclinical and clinical trials of veterinary medicinal products, as well as bioequivalence studies, are conducted in accordance with EAEU law.

Preclinical and clinical trials of veterinary medicinal products are now conducted in accordance with supranational regulations, specifically the Rules for the Registration and Evaluation of Medicinal Products for Human Use and the Good Clinical Practice (GCP) Rules, which harmonize requirements across the EAEU.

Order No. 256 of the Ministry of Agriculture of Russia enters into force on June 2, 2026.

Link: http://publication.pravo.gov.ru/document/0001202605220003

May 22, 2026

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Optimizing Inspections in the EAEU

On April 27, 2026, the Council of the Eurasian Economic Commission (EEC) approved amendments to the Requirements for the Implementation, Maintenance, and Evaluation of a Quality Management System (QMS) for Medical Devices.

The document was published on May 19, 2026, and enters into force on June 18, 2026.

One of the changes concerns the procedure for inspecting sterilization facilities used by various medical device manufacturers.

Previously, if several manufacturers used the same sterilization facility for their medical devices, the production conditions at that facility had to be inspected multiple times for each client. This created an excessive administrative and financial burden.

The amendments eliminate the need for duplicate inspections. Now, the results of the assessment of production conditions at the sterilization facility, obtained during the inspection of one manufacturer, can be recognized and used by other manufacturers.

To apply this mechanism, the manufacturer must have a valid report on the results of the inspection of its production, which contains information about the sterilization facility in question.

Implications for the industry:

1. For manufacturers: the financial and time costs associated with inspections are significantly reduced, as there is no longer a need to commission a separate inspection to verify the quality of sterilization services.
2. For inspection bodies: this creates an opportunity to allocate resources more efficiently, avoiding duplicate inspections and focusing on new facilities.
3. For the healthcare systems of EAEU member states: the availability of medical devices on the market increases through the optimization of regulatory procedures and a reduction in manufacturers’ costs.

In addition, according to the approved amendments, all inspection procedures must involve not only the manufacturer of the medical device but also its officially authorized representative, who is entitled to:

• submit requests for inspections;
• coordinate with accredited inspection bodies;
• sign contracts for the conduct of inspection activities.

The Requirements have also been clarified to reflect current legal practice.

Link: https://docs.eaeunion.org/documents/461/10669/

May 19, 2026

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Rules for verifying the place of manufacture of labeled goods have been approved

Russian Federation Government Resolution No. 526 of May 7, 2026, amends Russian Federation Government regulations regarding the assessment of manufacturers of goods subject to mandatory identification marking. This regulatory act, in particular, applies to pharmaceutical products and introduces a mechanism for verifying the information declared by manufacturers when placing goods into circulation.

The Resolution establishes two forms of inspection to be conducted by the labeling system operator (CRPT):

• Remote inspection: The manufacturer is required to provide, within three days, photographs and/or video footage documenting the production process via a specialized mobile app.
• On-site inspection: Requires the manufacturer’s prior consent (given five days in advance) for an inspector to visit the actual location of the production facilities.

The check is initiated by the operator if any of the following criteria are met:

• When registering the product, the method of entry into circulation was declared as “manufactured in the Russian Federation”;
• There is no information in the State Industrial Information System (GISP) confirming that the product was manufactured in the Russian Federation;
• More than 12 months have passed since the last on-site assessment was conducted.

If the required documents are not submitted by the deadline, or if an inspection reveals that no production is taking place at the declared site, the operator will issue a formal decision denying confirmation of the production site. This decision will result in sanctions, including the denial of labeling codes and the subsequent suspension of product distribution.

Entring into force:

• General provisions: This regulation will take effect 60 days after its official publication.
• Specific categories: Changes regarding labeling requirements for cosmetics, skin antiseptics, dietary supplements, household chemicals, and children’s products will take effect on the date of the document’s official publication.

Link: http://publication.pravo.gov.ru/document/0001202605070016

May 13, 2026

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Roszdravnadzor has abolished paper registration certificates for medical devices

The Federal Service for Surveillance in Healthcare (Roszdravnadzor) issued Order No. 310 dated April 3, 2026, which repeals a number of previously effective departmental regulations.

In particular, the documents regulating the forms and procedure for issuing paper registration certificate forms are repealed, specifically Roszdravnadzor Orders No. 40-Pr/13 dated January 16, 2013, No. 3380-Pr/13 dated July 23, 2013, No. 1636 dated March 3, 2017, and No. 4510 dated July 10, 2018. These orders approved the forms of registration certificates for medical devices.

This document takes effect on May 17, 2026; from that date forward, the sole evidence confirming the state registration of a medical device is the entry of the relevant record in the state registry.

Proof of registration is provided by information from:

1. The State Register of Medical Devices and Organizations Engaged in the Production and Manufacture of Medical Devices.
2. The Register of Licenses for the Production and Maintenance of Medical Equipment (in the relevant section).

Consequently, the issuance of a separate paper document is discontinued.

An entry in the registry now serves as primary and sufficient proof of state registration.

To confirm their right to market a medical device, manufacturers and distributors need only provide an extract from the state registry, either in electronic or printed form. The new procedure applies to all medical devices, including those for which registration documents were submitted to Roszdravnadzor prior to the effective date of Russian Government Resolution No. 1684 of November 30, 2024.

Link: http://publication.pravo.gov.ru/document/0001202605060010

May 8, 2026

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Law on Mobile Pharmacies Published

Federal Law No. 125-FZ of May 2, 2026, “On Amending the Federal Law ‘On the Circulation of Medicines,’” has been published. The law pertains to the conduct of a pilot program for the retail sale of medicines using mobile formats.

The document enters into force on September 1, 2029; the experimental legal regime is introduced for the period from September 1, 2026, to September 1, 2029. Its scope of application extends to rural settlements lacking pharmacy organizations, individual entrepreneurs licensed for pharmaceutical activities, medical organizations licensed for pharmaceutical activities, and their separate divisions.

The document introduces the concept of a “mobile pharmacy,” which is a structural unit of a pharmacy organization subject to the following requirements:

• conducting business outside a permanent retail facility,
• using a specially equipped, enclosed module,
• mounting the module on a vehicle platform equipped with a separate driver’s cab (which ensures compliance with health and safety standards and proper storage conditions).

Mobile pharmacy stations are prohibited by law from selling medications containing narcotic and psychotropic substances, potent and radiopharmaceutical drugs, immunobiological agents, medications requiring storage at temperatures below 15 degrees Celsius, as well as alcohol-containing preparations with an ethyl alcohol content exceeding 25%.

The detailed procedure for conducting the experiment, including requirements for participants, rules for dispensing medications, and reporting requirements, will be established by a separate regulatory act of the Government of the Russian Federation.

The inclusion of a constituent entity of the Russian Federation in the experiment and its exclusion from the experiment will occur by order of the Government of the Russian Federation based on a request from the region’s highest-ranking official.

Link: http://publication.pravo.gov.ru/document/0001202605020010?index=2

May 5, 2026