Pharmacists allowed to work without mandatory accreditation until the end of 2026
The Russian Ministry of Health issued Order No. 34n dated January 20, 2026, establishing the circumstances under which pharmacists and medical workers will be able to carry out their activities without mandatory accreditation. This temporary regime will remain in effect until January 1, 2027.
Exemption from accreditation is granted, in particular, to specialists who worked in the field of pharmacy during 2025 and have a diploma or document confirming relevant training and education. In addition, a mandatory requirement is the possession of a specialist certificate (accreditation) that expired in 2025.
Link: http://publication.pravo.gov.ru/document/0001202601260014
January 28, 2026
The procedure for evaluating drug manufacturing technology has been established under Government Resolution No. 719
The Ministry of Industry and Trade of the Russian Federation has developed and approved methodological recommendations for verifying the technologies used in the production of medicinal products for medical use.
Order No. 33 of the Ministry of Industry and Trade dated January 13, 2026 introduces new approaches to the preparation by manufacturers of documentation confirming the stages of the production process for various types of medicinal products for medical use.
These recommendations were prepared in accordance with Russian Government Resolution No. 1392 of September 10, 2025, which introduces a new scoring system for determining the country of origin of medicinal products, effective July 1, 2026. The new methodology is applied in parallel with the existing country of origin assessment system, ensuring consistency of requirements and transparency of the certification process.
Thus, both documents will come into force simultaneously with the aim of improving the quality of regulation of pharmaceutical production and its compliance with established legal requirements.
http://publication.pravo.gov.ru/document/0001202509110015
January 21, 2026
The term of validity of the regulations on state registration of medical devices has been extended until 2028
Decree No. 2214 of the Government of the Russian Federation dated December 30, 2025 extends the validity of the Rules for State Registration of Medical Devices, provided for by Decree No. 1684 of the Government of the Russian Federation dated November 30, 2024, until December 31, 2028.
The government’s decision to extend the terms is due to the signing of a protocol containing amendments to the agreement on uniform principles for the circulation of medical devices in the EAEU.
At the same time, certain provisions of the Rules remain in force until the end of 2027. For example, paragraphs 63 and 87, which regulate the preparation of registration documents through the applicant’s personal account, will continue to apply. Paragraph 63 applies to products subject to clinical trials involving patients, while paragraph 87 regulates the registration procedures for products that do not require clinical trials, including medical devices with artificial intelligence. In addition, Russian manufacturers will still be able to submit documents in paper form, as specified in paragraph 101.
The document came into force on January 8, 2026.
Link: http://publication.pravo.gov.ru/document/0001202512310015
January 14, 2026
The rules for issuing licenses for the manufacture of medicines have changed
The Russian government, by Resolution No. 2143 dated December 25, 2025, amended the Regulations on Licensing the Production of Medicines.
The main changes relate to the reduction of the time required to obtain permits. Now, the maximum period for reviewing applications for licenses for medical drugs is no more than 27 business days, and for veterinary drugs, up to 30 business days.
If more than three addresses are specified for the licensed activity, the decision-making period may be extended by an additional 10 business days.
In addition, the rules regarding licensing supervision have been updated. Control (supervisory) measures in the exercise of licensing control are abolished. Control is exercised through preventive visits conducted by licensing authority employees in person at the production site or remotely via video conferencing systems and the Inspector mobile application.
During a preventive visit, the controlled entity is informed about the mandatory requirements for its activities, their compliance with risk criteria, recommended methods for reducing the risk category, and the types, content, and intensity of measures carried out in relation to the controlled entity based on its classification in the relevant risk category. and the official of the licensing authority familiarizes themselves with the object of control, collects the information necessary to classify the object of control into the appropriate risk category, and assesses the level of compliance with the mandatory requirements by the controlled person.
Link: http://publication.pravo.gov.ru/document/0001202512260060
January 12, 2026
National registration of medical devices will continue until the end of 2028
On December 29, the countries of the Eurasian Economic Union approved a protocol amending the Agreement on Common Principles and Rules for the Circulation of Medical Devices (medical devices and medical equipment) within the Eurasian Economic Union dated December 23, 2014, according to which the procedure for registering medical devices in accordance with the internal rules of the member states will remain in effect until 2028 inclusive.
The protocol allows applications for the examination and registration of medical devices to be submitted until December 31, 2027, in accordance with the national laws of the EAEU countries or the rules of the Union.
Previously, this period expired on December 31, 2025, after which it was planned to introduce mandatory registration exclusively according to the general standards of the Union.
This decision will ensure a smooth transition for member states to a unified system for registering medical devices within the EAEU.
The document will begin to be applied provisionally ten days after its signing and will enter into force after the Eurasian Economic Commission receives the last written notification of the completion of domestic procedures by member states.
Link: https://docs.eaeunion.org/documents/236/10430/
January 9, 2026
Author
Dmitriy Kovalev
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