Review of pharmaceutical regulations – March 2026

New regulations governing pharmaceutical inspections and the maintenance of a registry of GMP certificates for manufacturers of veterinary drugs

Pursuant to Resolution No. 295 of the Government of the Russian Federation dated March 19, 2025, systemic changes have been introduced into the regulatory framework governing the circulation of veterinary medicinal products, providing for a redistribution of authority between the Ministry of Agriculture of the Russian Federation and the Federal Service for Veterinary and Phytosanitary Surveillance (Rosselkhoznadzor).

This regulatory act assigns to Rosselkhoznadzor exclusive functions for exercising state control over ensuring that the production of veterinary drugs complies with the standards of good manufacturing practice (GMP) established within the framework of the Eurasian Economic Union (EAEU).

Specifically, the agency has been entrusted with the following key responsibilities:

1. Organizing and conducting pharmaceutical inspections of manufacturing sites operated by veterinary drug manufacturers to verify their compliance with the EAEU GMP regulations.
2. Administering the lifecycle of GMP certificates, including procedures for their issuance, suspension, reinstatement, revocation, and amendments to issued documents.
3. Establishing and maintaining a state registry of GMP certificates confirming the compliance of production sites with established standards.
4. Approval of the procedure for certifying pharmaceutical inspectors authorized to conduct pharmaceutical inspections of the production of medicinal products for veterinary use.

The document entered into force on March 27, 2026.

Link: http://publication.pravo.gov.ru/document/0001202603190012

March 31, 2026 г

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Rules and criteria for compiling a list of strategically important medicines have been approved

On March 24, 2026, the Russian Federation Government Decree No. 277 of March 17, 2026, “On the Approval of the Rules for Compiling the List of Strategically Important Medicines,” was published, establishing the rules and criteria for compiling the list of strategically important medicines.

The primary purpose of compiling this list is to identify the range of medicinal products that are of priority importance to the national healthcare system and that ensure the treatment and prevention of socially significant and particularly dangerous diseases. A key requirement for medicinal products included in the list is that they must be manufactured through a full production cycle within the territory of the Russian Federation.

In accordance with the approved rules, the following categories of medicinal products are to be included in the list:

• Essential and critical medicines (ECM).
• Vaccines included in the national routine immunization schedule and the immunization schedule for epidemic indications.
• Blood products, blood substitutes, and infusion solutions.
• Narcotic and psychotropic analgesics.
• Medicines intended for the treatment of particularly dangerous infections, as well as diseases that pose a danger to others.

The document stipulates that the production of medicines included in this list will be supported by government measures. In addition, such medicines will be given priority in procurement for state and municipal needs.

The formation and maintenance of the list is entrusted to an interdepartmental commission comprising representatives of the Ministry of Health of the Russian Federation, the Ministry of Industry and Trade of the Russian Federation, the Ministry of Finance of the Russian Federation, the Federal Medical and Biological Agency (FMBA), the Ministry of Economic Development of the Russian Federation, the Federal Antimonopoly Service (FAS), the Federal Service for Supervision in Healthcare (Roszdravnadzor), and the Federal Service for Supervision of Consumer Rights Protection and Human Well-being (Rospotrebnadzor).

Effective date of the document: March 24, 2026

Link: http://publication.pravo.gov.ru/document/0001202603240038

March 25, 2026 г

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The procedure for implementing amendments to the technical regulations on perfumery and cosmetic products has been approved

The Board of the Eurasian Economic Commission (EEC) adopted Decision No. 31 of March 10, 2026, regulating the procedure for bringing into force amendments to the Customs Union Technical Regulation “On the Safety of Perfumery and Cosmetic Products” (TR CU 009/2011).

These amendments were previously approved by Decision No. 74 of the EEC Council dated September 12, 2025, and are scheduled to enter into force on October 28, 2026.

Decision No. 31 of the Board dated March 10, 2026, “On the Procedure for Enacting Amendments to the Technical Regulation of the Customs Union ‘On the Safety of Perfumery and Cosmetic Products’ (TR CU 009/2011)” shall enter into force 30 calendar days after the date of its official publication, but not earlier than the date of entry into force of Decision No. 74 of the Council of the Commission dated September 12, 2025.

The document establishes the following transitional provisions:

1. Declarations of conformity and certificates of state registration (CSR) issued for perfumery and cosmetic products prior to the effective date of the amendments remain legally valid until the expiration of the validity period specified therein.
2. During the validity period of these authorizing documents, the manufacture and release into circulation of the relevant products within the customs territory of the Union are permitted.
3. Products released in accordance with previously applicable regulations may remain in circulation throughout their entire shelf life.

It should be noted that these transitional provisions do not apply to previously issued indefinite certificates of state registration. Issues related to the validity of such documents have already been addressed by the Decision of the EEC Board dated March 4, 2025, concerning previous amendments to the technical regulation (adopted by the Decision of the EEC Council dated November 29, 2024).

Links:
https://docs.eaeunion.org/documents/463/10557/

https://docs.eaeunion.org/documents/447/10246/

https://docs.eaeunion.org/documents/435/9762/

March 10, 2026 г

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The Russian government has extended the pilot program for the labeling of medical devices until 2027

Decree No. 204 of the Government of the Russian Federation dated February 28, 2026, “On Amending Decree No. 620 of the Government of the Russian Federation dated May 17, 2024,” revises the regulations governing the conduct of the pilot program on the labeling of medical devices with identification marks.

The key provision of this document is the extension of the duration of the experiment. The completion date of the pilot project has been moved from February 28, 2026, to February 28, 2027.

To ensure the phased implementation of the pilot project, the regulatory act establishes a three-phase structure for its conduct and sets deadlines for the preparation of supporting documentation and reporting:

• For the second phase, the deadline for approving the methodological guidelines and the schedule is June 15, 2026.
• For the third phase, the same set of documents must be approved by October 15, 2026.
• The deadline for submitting final reports on the results of the second phase to the Government of the Russian Federation is set for July 31, 2026.
• The report on the results of the third phase must be prepared by January 31, 2027.

The list of medical devices included in the pilot program has also been revised and is now divided into phases:

1. Phase 1 (September 1, 2024, to August 31, 2026): syringes, infusion sets, medical wipes, test tubes, mechanical ventilators (MV) and respiratory equipment, neonatal incubators, as well as implants for plastic surgery (including fillers and cosmetic threads) and medical masks.
2. Phase Two (March 2, 2026, to August 31, 2026): blood glucose meters, glucose test strips, blood pressure monitors, and various types of rapid tests.
3. Phase Three (from April 2, 2026, to February 28, 2027): reagent kits and reagents for in vitro diagnostics intended for laboratory testing.

The document took effect on the date of its official publication.

Link: http://publication.pravo.gov.ru/document/0001202602280005

March 4, 2026 г

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Amendments to the Rules Governing the Circulation of Veterinary Medicines within the EAEU Have Been Approved

The Council of the Eurasian Economic Commission (EEC) has approved amendments to the Rules Governing the Circulation of Veterinary Medicines within the Customs Territory of the Eurasian Economic Union.

Key changes:

• Extension of the Transition Period: The period during which national registrations remain valid has been extended until December 31, 2030. During this time, it remains possible to register such medicinal products under the national legislation of participating countries, with the right to market them within the territory of a specific EAEU member state.
• Conditions for existing registrations: The sale of medicinal products registered prior to the entry into force of the EAEU’s common rules is permitted, provided that their registration is confirmed or changes are made to the dossier during the transition period.
• Mutual recognition of documents: A provision has been introduced regarding the mutual recognition of GMP (Good Manufacturing Practice) certificates issued by national authorities for facilities located in third countries.
• Creation of a list of reference products: The Eurasian Commission will compile and update a list of reference veterinary medicines.

The measures taken are aimed at streamlining operations and reducing the financial and administrative burden on manufacturers and government agencies.

Link: https://docs.eaeunion.org/documents/461/10590/

April 2, 2026 г