Review of pharmaceutical regulations – August 2025

The deadline for entering data into the medical device testing register has been shortened

The Federal Service for Supervision of Public Health and Social Development has approved the Procedure for maintaining a register of permits issued for clinical trials of medical devices.
Order No. 4484 dated July 22, 2025, has been published on the legal information portal.

Entries are now made in the register:

– on the day of the decision to issue a permit for a clinical trial of a medical device (previously, this period was three days);

– within a period not exceeding three working days from the date of receipt of notification of the start of the trial.

Also, instead of the medical device manufacturer, an authorized representative can now submit a notification of the start of the trial through their personal account on the Unified Portal of State and Municipal Services (Functions).

Order No. 4484 will be in effect until December 31, 2026.

Link: http://publication.pravo.gov.ru/document/0001202508220006

August 28, 2025

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Transition period for making changes to registration dossiers for medical devices extended

Decree of the Government of the Russian Federation No. 1206 dated August 13, 2025, “On Amendments to Decree of the Government of the Russian Federation No. 1684 dated November 30, 2024,” has been published.

Decree No. 1684 of November 30, 2024, introduced revised Rules for State Registration of Medical Devices, effective March 1, 2025.

The main changes introduced are as follows:
– Simplified procedure for making changes: for manufacturers of low-risk devices who have voluntarily undergone a quality management system audit, mandatory expert review is no longer required when amending the registration dossier.
– requirements for foreign manufacturers: foreign companies are now required to appoint an authorized representative in the Russian Federation who is responsible for the product’s distribution.
The new document extends the transition period: the deadline for updating information about the authorized representative in the registration dossier is now September 1, 2026.

The resolution was published on the official legal information portal on August 15, 2025, and the document came into force upon publication.

Link: http://publication.pravo.gov.ru/document/0001202508150021

August 19, 2025

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The experiment on labeling medical devices has been extended

By Government Decree No. 1172 dated August 5, 2025, the experiment on labeling certain medical devices has been extended until February 28, 2026.

This experiment has been conducted since September 1, 2024. The list includes medical masks, syringes, infusion systems, napkins, test tubes, infusion systems, equipment for ozone, oxygen, and aerosol therapy, artificial respiration, or other therapeutic respiratory equipment, incubators for newborns, fillers, and cosmetic threads. The experiment was scheduled to end on August 31, 2025.

The objectives of the experiment included the initial filling of the national catalog of marked goods subsystem with information about the goods for the identification of the product unit, as well as the determination of medical device codes in accordance with the nomenclature classification of medical devices, codes of the unified Commodity Nomenclature for Foreign Economic Activity of the Eurasian Economic Union (TN VED EAEU) and the codes of the All-Russian Classifier of Products by Economic Activity for medical devices subject to mandatory labeling with identification means (OKPD).

During the experiment, discrepancies were noted between the data and terminology used in the GS1 Russia and National Product Catalog systems. It was determined that all participants in the process needed to be given sufficient time to achieve the required level of technical and organizational readiness.
Extending the experiment gives manufacturers and other organizations extra time to adapt to the new mandatory labeling requirements. Successful completion of the experiment will prevent counterfeit products from entering the market.

Reference: http://publication.pravo.gov.ru/document/0001202508080019

August 11, 2025

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Certain substances containing methanol have been exempted from the provisions of the Law “On State Regulation of the Circulation of Methanol and Methanol-Containing Liquids.”

The Government of the Russian Federation, by its Order No. 2035-r of July 29, 2025, established a list of liquids containing methanol exempt from the restrictions established by Federal Law No. 108-FZ of May 23, 2025, “On State Regulation of the Circulation of Methanol and Methanol-Containing Liquids.”

The list includes 59 items, among which are:

– modified technical isopropyl alcohol;
– modified technical isopropanol;
– polyvinyl acetate alcohol;
– concentrated formalin with reduced methanol content;
– formalin in the form of a solution;
– technical formalin;
– formaldehyde, aqueous solution;
– formidron;
– chemical reagents for general laboratory use;
– bactericidal compounds;
– non-food solutions based on alcohols.
The regulatory act will come into force on September 1, 2025.

Reference: http://publication.pravo.gov.ru/document/0001202508010027

August 7, 2025

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State fees for the registration of veterinary medicinal products have been approved

Federal Law No. 299-FZ of July 31, 2025, “On Amendments to Article 333_32.1 of Part Two of the Tax Code of the Russian Federation” (adopted by the State Duma on July 17, 2025, and approved by the Federation Council on July 25, 2025) was signed by the President and published on July 31, 2025, on the official legal information portal.

The federal law establishes the amounts of state fees for actions taken by the authorized federal executive authority related to the registration of veterinary drugs for the purpose of forming a common market for drugs within the Eurasian Economic Union in accordance with the law of the Eurasian Economic Union.

The document shall enter into force on August 31, 2025.

Links: http://www.kremlin.ru/acts/news/77617
http://publication.pravo.gov.ru/document/0001202507310044

August 1, 2025