Russia | Review of pharmaceutical regulations – April 2026
The Russian government has approved an updated list of strategically important medicines
On April 29, 2026, a new list was published, comprising 206 items. These medicines address the healthcare system’s key needs in the prevention and treatment of the most dangerous and socially significant diseases. Order No. 942-r of April 23, 2026, was signed by the Chairman of the Russian Government.
The list includes:
- essential and critical medicines (ECM);
- vaccines included in the national immunization schedule and the schedule for vaccination based on epidemic indications;
- blood products, blood substitutes, and infusion solutions;
- narcotic analgesics;
- medications for the treatment of particularly dangerous infections and diseases that pose a threat to others.
All drugs on the list must be produced entirely within Russia. The government will provide support to companies that manufacture these drugs. In addition, these drugs will be given priority in government procurement.
These measures are aimed at strengthening the country’s pharmaceutical independence, ensuring a stable supply of medicines to healthcare facilities, and developing the export potential of the domestic pharmaceutical industry.
The document takes effect on April 27, 2026.
Link: http://publication.pravo.gov.ru/document/0001202604270047
April 29, 2026
The Russian government has approved quality and efficacy criteria for dietary supplements, taking into account their impact on human health
The relevant Resolution No. 398, dated April 13, 2026, was published on the official legal information portal on April 23, 2026.
For a dietary supplement to be recognized as high-quality, all four of the following conditions must be met simultaneously:
- the manufacturer holds a valid certificate of state product registration;
- the dietary supplement is labeled with identification marks, and information about it has been entered into the monitoring system;
- safety indicators and the content of active ingredients comply with the technical documentation, as confirmed by an accredited Russian laboratory;
- the product meets the requirements of the technical regulations of the Eurasian Economic Union (EAEU).
In addition, the document establishes criteria for the efficacy of dietary supplements based on the extent of their effect on the body. One of three approaches may be used to confirm efficacy:
- publications in scientific journals;
- the inclusion of information on the use of dietary supplements in current clinical guidelines;
- the manufacturer’s provision of its own data on studies of the supplement’s efficacy.
Effective Date - 01.05.2026.
Link: http://publication.pravo.gov.ru/document/0001202604230044
April 23, 2026
The EEC Council has postponed the launch of the single market for veterinary drugs by three years
The Council of the Eurasian Economic Commission (EEC) has approved amendments to the rules governing the circulation of veterinary medicines within the Eurasian Economic Union (EAEU). The relevant EEC Council Decision No. 33 of February 24, 2026, has been published on the EAEU legal portal.
The amendments are being made to EEC Council Decision No. 1 of January 21, 2022, which introduced uniform standards for the veterinary drug market. The key change is the extension of the transition period from 2027 to 2030.
By the end of 2030:
- Manufacturers may register veterinary drugs in accordance with national regulations;
- Registration certificates issued prior to the introduction of uniform standards remain valid;
- Companies are required to bring the dossiers for previously registered drugs into compliance with EAEU requirements.
If the rights holder fails to submit an application to update the dossier by the specified deadline, their registration (including indefinite registration) will be revoked as of January 1, 2031 (previously, as of 2028).
The option to conduct pharmaceutical inspections both in person and remotely is being introduced. Remote inspections are permitted in the following cases:
- the threat of, or response to, emergencies, natural disasters, man-made disasters, and epidemics;
- force majeure or other circumstances beyond the parties’ control that may endanger the life or health of the inspectors (e.g., political or medical risks).
The changes also affect Good Manufacturing Practice (GMP) certificates. Certificates issued by national authorities before January 1, 2021, will now remain valid until the end of 2028.
The procedure for replacing GMP certificates has also been regulated. They may be replaced without a new inspection in the event of a change in the manufacturer’s name or address, as well as in the event of technical errors. The new certificate will remain valid until the expiration of the previous one, and the decision to replace it is made within 10 business days.
Date of Publication of ECE Council Decision No. 33: March 25, 2026
Date of Entry into Force: April 24, 2026
Link https://docs.eaeunion.org/documents/461/10590/
April 14, 2026
The Russian government has approved the timeline for implementing mandatory labeling for an expanded list of medical devices
Russian Federation Government Resolution No. 375 of April 6, 2026, published on the official legal information portal, amends the previously effective document No. 894 of May 31, 2023.
Under the new rules, effective September 1, 2026, mandatory labeling will apply to the following types of medical devices:
- hearing aids;
- orthopedic shoes and insoles;
- incontinence products;
- medical gloves.
In addition, the list includes:
- respiratory equipment;
- incubators for newborns;
- syringes and infusion sets;
- medical wipes and test tubes;
- implants for plastic surgery;
- medical masks.
In the final version of the resolution, condoms—which had been included in the draft document—were removed from the list.
The pilot program for labeling certain medical devices began on September 1, 2024, and was originally scheduled to end on August 31, 2025. It covered, among other items, syringes, fillers, infusion sets, test tubes, and medical masks. In August 2025, the pilot program was extended until the end of February 2026.
The document also specifies that the registration of participants in the pilot program within the monitoring system will automatically be recognized when mandatory labeling is implemented. However, if a participant’s data is incomplete or out of date, it must be updated by September 30, 2026.
Effective from April 6, 2026, to September 1, 2026, pursuant to Russian Federation Government Resolution No. 375.
Link: http://publication.pravo.gov.ru/document/0001202604070004
April 13, 2026
The Board of the Eurasian Economic Commission has approved guidelines for the inspection of medical device manufacturing
On April 10, 2026, EEC Board Recommendation No. 6 of April 7, 2026, “On Methodological Guidelines for Inspecting the Production of Medical Devices,” was published. It is intended to standardize approaches to the assessment of manufacturers’ quality management systems (QMS) within the Eurasian Economic Union (EAEU).
As part of the inspection, special attention is paid to the following key processes:
- product design and development;
- document control;
- manufacturing operations and final quality control;
- implementation of corrective and preventive actions;
- interaction with customers and handling of customer inquiries.
The guidelines also establish criteria for identifying “critical” suppliers.
For Class 3 (highest) risk medical devices, inspection of design processes is not possible if the manufacturer does not conduct the relevant design activities. For Class 1, 2a, and 2b devices in a similar situation, inspection is permitted only on the basis of available technical documentation.
Link: https://docs.eaeunion.org/documents/462/10612/
April 10, 2026
The EEC Board has updated the lists of narcotic drugs, psychotropic substances, and their precursors
The Board of the Eurasian Economic Commission has updated the list of narcotic drugs, psychotropic substances, and their precursors that are subject to a licensing procedure for import and/or export into the customs territory of the Eurasian Economic Union (approved by Decision No. 30 of the EEC Board dated April 21, 2015).
The EEC made this decision taking into account that the EAEU member states, as parties to three international conventions, contribute to achieving the goal of protecting the health and well-being of the population. These are the Single Convention on Narcotic Drugs of 1961, as amended by the 1972 Protocol, the Convention on Psychotropic Substances of 1971, and the United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances of 1988.
Following the decisions of the Commission on Narcotic Drugs, certain substances already subject to international control have been added to the lists of narcotic drugs and psychotropic substances regulated within the EAEU.
The document was published on April 10, 2026
The decision will enter into force on May 10, 2026, 30 calendar days after the date of its official publication.
Links:
https://docs.eaeunion.org/documents/463/10610/
April 10, 2026
The Russian Ministry of Health has approved a new professional retraining program in clinical pharmacology
Order No. 152n of the Ministry of Health of the Russian Federation, dated March 3, 2026, established a standard continuing education program for professionals with advanced medical degrees. Previously, in October 2025, a draft of this order was submitted for public comment.
Training will be conducted in a face-to-face format, although the partial use of electronic and distance learning technologies is permitted. The total duration of the program is 576 academic hours. The draft previously specified 648 hours, but the final version was reduced by 72 hours by shortening the practical component.
The program consists of four training modules and a final assessment:
- General Clinical Pharmacology — 108 hours.
- Specialized Clinical Pharmacology — 216 hours.
- Clinical Practice — 216 hours.
- Emergency Medical Care — 30 hours.
- Final Assessment — 6 hours.
Upon completion of the program, participants will have acquired the following key competencies:
- advising physicians and patients on the selection and use of medications;
- monitoring the safety of drug therapy and participating in initiatives to reduce antibiotic resistance;
- analyzing the use of medications and evaluating their cost-effectiveness;
- organizing medication supply in healthcare facilities;
- participating in disease prevention and promoting a healthy lifestyle;
- maintaining medical records and organizing work processes;
- provision of emergency medical care.
The effective date of this document is April 13, 2026.
Link http://publication.pravo.gov.ru/document/0001202604020018
April 7, 2026
Review of pharmaceutical regulations – February 2026
Requirements for applicants seeking a license to conduct pharmaceutical activities are changing
On March 1, 2026, Russian Government Resolution No. 232 of February 26, 2025, will come into force, amending the Regulations on the Licensing of Pharmaceutical Activities.
The changes concern the requirements for license applicants and licensees who are individual entrepreneurs. The requirements for persons engaged in the distribution of veterinary drugs have been supplemented with a requirement for accreditation as a specialist in the field of veterinary medicine.
Link: publication.pravo.gov.ru/document/0001202502260017
February 27, 2026
New regulations for the disposal of medications have been developed
A draft resolution of the Government of the Russian Federation titled “On the Approval of Rules for the Destruction of Counterfeit, Substandard, and Pirated Medicines Withdrawn from Circulation” has been submitted for public comment.
The document is available on the website regulation.gov.ru under number 165550.
According to the draft, the basis for the withdrawal and destruction of counterfeit and substandard medicines are decisions by Roszdravnadzor (for medical devices), Rosselkhoznadzor (for veterinary drugs), or a court. In accordance with paragraph 3 of the rules, counterfeit drugs are subject to destruction exclusively by court order. The owner of substandard products is obligated, at their own expense, to ensure their destruction within the established timeframe at specialized facilities holding the appropriate license.
The new rules specify in detail the content of the drug destruction report, including information about the destroyed drugs, their manufacturer, owner, and the method of destruction. The document must be signed by all participants in the procedure and submitted by the owner to the authorized body within five business days via postal mail in paper form or electronically via email.
If adopted, the resolution will take effect on September 1, 2026, and remain in force until September 1, 2032.
Link: https://regulation.gov.ru/projects/165550/
February 26, 2026
Amendments to the Agreement on Uniform Principles and Rules for the Circulation of Medical Devices within the EAEU Have Been Approved
The member states of the Eurasian Economic Union have approved the Protocol amending the Agreement on Uniform Principles and Rules for the Circulation of Medical Devices (medical products and medical equipment) within the Eurasian Economic Union dated December 23, 2014. The new document amends and supplements the list of medical devices not subject to mandatory state registration in the EAEU.
The amendments concern several categories of medical devices exempt from the registration procedure:
- devices manufactured to individual patient orders exclusively for personal use;
- devices imported for the provision of medical care based on the life-saving needs of a specific patient;
- devices manufactured in EAEU member states for export to third countries.
The changes also apply to kits, sets, and first-aid kits composed of registered medical devices and medicines and intended for distribution within the territory of a specific state.
The Protocol shall be provisionally applied as of February 19, 2026, and shall enter into force on the date the Commission receives the final written notification that member states have completed the internal procedures necessary for its entry into force.
Link: https://docs.eaeunion.org/en/documents/236/10499/
February 17, 2026
Changes are planned to the certification rules for medical and pharmaceutical professionals
The Ministry of Health of the Russian Federation intends to amend the rules governing the certification of doctors and pharmacists. The corresponding draft order of the Ministry of Health
of the Russian Federation has been posted on the website regulation.gov.ru under number 165139.
The draft order of the Russian Ministry of Health "On Amending the Procedure and Timelines for Medical and Pharmaceutical Workers to Undergo Certification to Obtain a Qualification Category, Approved by Order of the Ministry of Health of the Russian Federation No. 458n of August 31, 2023 No. 458n" proposes amendments to the current Order of the Ministry of Health of the Russian Federation No. 458n dated August 31, 2023, which regulates the procedure and deadlines for the certification of medical and pharmaceutical workers for the assignment of qualification categories.
Key changes include extending the retention period for records of meetings of the certification committee and the expert commission from six to ten years. A candidate may lose the right to obtain certification if they fail to pass a personal interview. For those applying for certification through the government services portal, the list of required documents will be reduced. In addition, a new reporting requirement regarding the work performed by a mentor (if such activity took place) is being introduced.
The drafters of the document emphasized that the proposed measures are aimed at automating and optimizing the procedures for monitoring and licensing medical and pharmaceutical activities.
Link: https://regulation.gov.ru/projects/165139/
February 16, 2026
A draft of new qualification requirements for medical and pharmaceutical professionals with higher and secondary education has been prepared
The Ministry of Health of the Russian Federation has submitted a draft of new qualification requirements for medical and pharmaceutical professionals with higher and secondary education for public comment.
The current qualification requirements for medical and pharmaceutical professionals with secondary medical and pharmaceutical education were approved in 2016.
Qualification requirements for medical and pharmaceutical professionals with higher education were adopted in 2023. Initially, they were valid until September 1, 2025, but were later extended until September 1, 2026.
The new list includes a total of 115 specialties for pharmacists and medical professionals with higher education, and 38 specialties for professionals with secondary vocational education.
If the new document is adopted, it will take effect on September 1, 2026, and remain in force until
September 1, 2032, at which point the following regulatory acts will be repealed:
- Order of the Ministry of Health of the Russian Federation No. 83n of February 10, 2016, “On the Approval of Qualification Requirements for Medical and Pharmaceutical Workers with Secondary Medical and Pharmaceutical Education” (registered by the Ministry of Justice of the Russian Federation on March 9, 2016, Reg. No. 41337);
- Order of the Ministry of Health of the Russian Federation No. 206n dated May 2, 2023, “On the Approval of Qualification Requirements for Medical and Pharmaceutical Workers with Higher Education” (registered by the Ministry of Justice of the Russian Federation on June 1, 2023, Reg. No. 73677);
- Order of the Ministry of Health of the Russian Federation No. 72n dated February 19, 2024, “On Amending the Qualification Requirements for Medical and Pharmaceutical Workers with Higher Education, Approved by Order of the Ministry of Health of the Russian Federation No. 206n dated May 2, 2023” (registered by the Ministry of Justice of the Russian Federation on March 25, 2024, Reg. No. 77616);
- Order of the Ministry of Health of the Russian Federation No. 515n of August 29, 2025, “On Amending Order of the Ministry of Health of the Russian Federation No. 206n of May 2, 2023, and Order of the Ministry of Health of the Russian Federation No. 72n of February 19, 2024” (registered by the Ministry of Justice of the Russian Federation on August 29, 2025, Reg. No. 83410).
Link: https://regulation.gov.ru/projects/165144/
February 13, 2026
A bill imposing fines for the sale of expired dietary supplements has passed its first reading
The State Duma passed Bill No. 1096260-8 in its first reading, which proposes amendments to the Code of Administrative Offenses of the Russian Federation to establish fines for the sale of labeled goods past their expiration date.
The proposed amendments would be made to Article 14.43 of the Code of Administrative Offenses of the Russian Federation, adding a new Part 4 that establishes liability for the sale of goods past their expiration date if the seller was warned of the prohibition on such sales through the State Labeling System (GIS MT) but violated the prohibition anyway.
According to the draft law, if the state information system for monitoring the circulation of goods detects the sale of expired labeled goods,
a legal entity may be fined 20,000 rubles for each item sold, and an individual entrepreneur may be fined 10,000 rubles for each item sold.
As stated in the explanatory note to the draft law, in order to reduce the administrative burden on retailers, the bill provides for the phased introduction of administrative liability.
It is planned that administrative liability under this article will be applied in two stages: from March 1, 2026, to June 30, 2026, fines will apply only to the sale of expired dietary supplements and certain low-alcohol beverages, and starting July 1, 2026, if the draft law is finally approved, it will apply to all goods subject to mandatory labeling.
Link: https://sozd.duma.gov.ru/bill/1096260-8
February 12, 2026
The Russian government has revised the grounds for suspending the validity of documents issued by EAEU member states
Decree No. 87 of the Government of the Russian Federation, dated February 6, 2026, amends Decrees No. 936 and No. 1856, expanding the list of grounds for suspending and terminating the validity of conformity assessment documents issued by certification bodies of EAEU member states within the territory of the Russian Federation. This applies to documents that were registered or issued in other EAEU countries in violation of regulations.
These measures are aimed at preventing substandard and unsafe products from entering the market.
State control authorities now have the right to suspend the validity of declarations and certificates of conformity for goods if the Federal Customs Service (FCS) reports that the import of product samples for testing has not been confirmed.
Under the new rules, Rosaccreditation has the right to suspend the validity of these documents if any of the following circumstances apply:
- Customs authorities have determined that the actual safety performance of the products does not comply with the requirements of the EAEU technical regulations, or that there is no confirmation that samples of the goods were imported for testing. Previously, before the amendments were made, the basis for suspension was information from customs authorities regarding the import of products without test reports; this rule remains in effect.
- The national accreditation body of another EAEU member state reported that the testing laboratory had not issued a report (test report) on the basis of which a certificate of conformity could have been issued.
If the validity of declarations issued by a single authority of another EAEU member state is suspended three or more times in a year, Rosaccreditation will revoke the validity in the Russian Federation of all declarations issued by that authority that are registered within the 12 months following the date of the last suspension. A similar rule applies to certificates of conformity.
Information on suspended and revoked documents must be posted on the website https://pub.fsa.gov.ru/reaec/conformityDoc Росаккредитации.
Link: http://publication.pravo.gov.ru/document/0001202602070004
https://pub.fsa.gov.ru/reaec/conformityDoc
February 10, 2026
A bill has been introduced to require that research on imported veterinary drugs be conducted exclusively in Russia
A bill has been submitted to the State Duma for consideration that would require clinical trials of imported veterinary drugs to be conducted exclusively within Russia if they have not been registered in the country.
The bill proposes amending Article 12 of Federal Law No. 61-FZ of April 12, 2010, “On the Circulation of Medicinal Products” (hereinafter “Law No. 61-FZ”) to establish the requirement for conducting clinical trials of veterinary medicinal products within the Russian Federation if a veterinary medicinal product with such an international nonproprietary name or group name has not previously been registered as a veterinary medicinal product in accordance with Law No. 61-FZ.
The document also provides for amendments to Law of the Russian Federation No. 4979-1 of May 14, 1993, “On Veterinary Medicine,” and Federal Law No. 123-FZ of August 3, 1995, “On Breeding Livestock.”
As the authors of the bill note, the proposed amendment will make it possible to ensure, in a more objective manner, uniform quality requirements for imported veterinary drugs subject to state registration in the Russian Federation, and to monitor the mandatory processes regulated by Federal Law No. 61-FZ, which, in turn, serves the interests of breeders and animal owners. These measures will help develop and improve the domestic infrastructure for conducting clinical trials of veterinary drugs.
If adopted, the law will take effect on September 1, 2026.
Link: https://sozd.duma.gov.ru/bill/1136619-8
February 3, 2026
The list of registered medicinal products subject to excise taxation, which use the pharmaceutical substance ethyl alcohol (ethanol) as a raw material in their production, has been updated
Pursuant to Order No. 35 of the Ministry of Health of Russia dated January 21, 2026 "On Amending the List of Medicines and/or Medicinal Products Registered in Accordance with the Law of the Eurasian Economic Union and/or the Legislation of the Russian Federation, for the Production of Which (or in the Production Process of Which) the Pharmaceutical Substance Ethyl Alcohol (Ethanol) Is Used as a Raw Material, approved by Order of the Ministry of Health of the Russian Federation No. 746 dated December 28, 2024," the list of registered medicinal products containing ethanol has been supplemented with a new entry—Meloxicam, a product manufactured in the form of a gel for external use in primary packaging of 30, 50, and 100 g.
February 2, 2026
