Russia | Review of pharmaceutical regulations – June 2026

Roszdravnadzor has approved new administrative regulations governing the issuance of extracts from the medical device registry

By Order of the Federal Service for Health Supervision (Roszdravnadzor) No. 252 dated March 20, 2026, new Administrative Regulations were approved for the provision of the public service “Issuance of extracts from the state register of medical devices and organizations (individual entrepreneurs) engaged in the production and manufacture of medical devices.”

The Regulations were developed in accordance with Federal Law No. 210-FZ dated July 27, 2010, “On the Organization of the Provision of State and Municipal Services,” and Resolution of the Government of the Russian Federation No. 1650 dated September 30, 2021.

Individuals, legal entities, sole proprietors, and their authorized representatives—provided they have a properly executed power of attorney—are entitled to receive the extract.

A strict procedural deadline has been established: no more than 5 business days from the date the application is registered with the agency.

The extract is provided to the applicant on paper or in the form of an electronic document signed with an enhanced qualified electronic signature (EQES) by an authorized official of Roszdravnadzor, which confers legal validity on it in accordance with Federal Law No. 63-FZ of April 6, 2011, “On Electronic Signatures.”

Information from the registry is provided free of charge; no regulatory act provides for the collection of state fees or other payments for this public service.

The only grounds for refusing to provide the service is the applicant’s failure to meet the requirements of paragraph 16 of the Rules for Maintaining the State Register (approved by Resolution of the Government of the Russian Federation No. 1650 dated September 30, 2021). In accordance with that clause, a refusal is lawful if the requested information is not available in the registry (for example, because the product lacks a registration certificate) or if the application is submitted by a person whose authority is not documented.

The order takes effect on July 6, 2026, and remains in force until February 29, 2028.

Link: http://publication.pravo.gov.ru/document/0001202606250018?pageSize=100&index=1

June 30, 2026

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New Requirements for the Disposal of Methanol and Methanol-Containing Liquids

On July 12, 2026, Resolution No. 731 of the Government of the Russian Federation, dated June 12, 2026, was published, introducing significant amendments to the Rules for the Disposal of Methanol and Methanol-Containing Liquids, approved by Resolution No. 1965 of the Government of the Russian Federation, dated November 29, 2025.

The regulatory act takes effect on March 1, 2027.

As of that date, the following additional requirements apply to legal entities and individual entrepreneurs engaged in the handling (including disposal) of methanol:

Business entities are required to formalize the procedure for granting authorization to employees to independently perform methanol disposal operations. Authorization is granted only after the relevant training has been conducted. From an occupational safety perspective, this requires amendments to the company’s local regulations (occupational safety instructions, training logs).

It is now mandatory to monitor methanol vapor concentrations in the air of the work area in sections where toxic substances may be released. The organization is required to independently establish the frequency of measurements and approve the type of gas analyzer used to ensure the accuracy of the measurements. These measures must be included in the workplace monitoring program for compliance with health and safety regulations.

A mandatory deadline for destruction is established—no later than 30 calendar days from the date of the administrative decision on disposal. The decision itself must contain a comprehensive list of identifying details: the exact quantity of the product, the date, the location, and the specific method of its destruction.

Until the new rules take effect, entities involved in the distribution of methanol and methanol-containing liquids should conduct a preventive audit of their disposal processes for such substances to avoid potential administrative liability under Article 6.3 of the Code of Administrative Offenses of the Russian Federation or environmental legislation.

Link: http://publication.pravo.gov.ru/document/0001202606120016

June 16, 2026

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Two orders regulating the quality of biomedical cell products are being repealed

The Ministry of Health of the Russian Federation issued Order No. 330n dated April 30, 2026, which repeals the regulatory acts governing quality control procedures for biomedical cell products (BCPs).

As of the date the order takes effect, the following cease to be in force:

• Order of the Russian Ministry of Health No. 839n dated October 20, 2017, “On the Approval of the Rules for the Collection of Samples of Biomedical Cell Products for Quality Control, Research, and Testing”;
• Order of the Russian Ministry of Health No. 127n dated March 27, 2018, “On the Approval of the Procedure for Conducting Selective Quality Control of Biomedical Cell Products”;
• Paragraph 13 of the amendments approved by Order of the Russian Ministry of Health No. 30n dated January 30, 2019.

Order No. 330n is intended to update the regulatory framework governing the circulation of advanced therapeutic products.

The repeal of the aforementioned documents means that the special procedures for laboratory verification of the compliance of advanced therapeutic products with established quality requirements are no longer in effect.

Until a replacement regulatory document is issued, entities involved in the distribution of these products should be guided by the general provisions of Federal Law No. 180-FZ of June 23, 2016, “On Biomedical Cell Products,” and the basic principles of Good Manufacturing Practice (GMP); however, the absence of detailed instructions on sample collection may create uncertainty during inspections by Roszdravnadzor.

Order No. 330n takes effect on June 17, 2026.

Link: http://publication.pravo.gov.ru/document/0001202606060002

June 11, 2026

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New Procedures for Monitoring the Safety of Medical Devices

On May 30, 2026, the Ministry of Health of the Russian Federation published Order No. 540n dated May 26, 2026, “On the Approval of the Procedure for Monitoring the Safety of Medical Devices, with the Exception of Medical Devices Registered in Accordance with International Treaties and Acts Constituting the Law of the Eurasian Economic Union.”

The limitation of the scope of application to products registered exclusively at the national level means that a separate pharmacovigilance procedure, approved by Decision No. 174 of the Council of the Eurasian Economic Commission dated December 22, 2015, continues to apply to EAEU products.

Organizations are required to appoint a responsible official. This official’s responsibilities include submitting notifications to Roszdravnadzor, monitoring the agency’s informational letters, and implementing corrective measures to prevent harm to the life and health of citizens.

The procedure for reviewing incident reports has been established:

Roszdravnadzor notifies the manufacturer of the receipt of an initial report;

the marketing authorization holder is required to submit detailed information about the event and the results of an internal investigation;

The expert agency has three business days to conduct a preliminary assessment of the causal relationship and forty business days to prepare the final expert opinion.

Roszdravnadzor is authorized to take preventive measures without waiting for the completion of the full cycle of medical device review. The regulator has the right to immediately decide to suspend the distribution of specific models, series, or batches of a medical device until a full response is received from the manufacturer. Based on the results of the analysis of the materials, unscheduled control (supervisory) measures may also be initiated.

The document will be in effect from September 1, 2026, through September 1, 2032, inclusive.

Link: http://publication.pravo.gov.ru/document/0001202606010056

June 2, 2026

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New Procedures for Reporting Adverse Events Associated with the Use of Medical Devices

On May 30, 2026, in accordance with the provisions of Articles 95 and 96 of Federal Law No. 323-FZ of November 21, 2011, “On the Fundamentals of Public Health Protection in the Russian Federation,” the Ministry of Health of the Russian Federation issued Order No. 541n of May 26, 2026, “On the Approval of the Procedure for Monitoring the Safety of Medical Devices,” which establishes a mandatory procedure for the collection, processing, and transmission by market participants of information on adverse events at all stages of a medical device’s circulation within the territory of the Russian Federation and the territories of other states.

This regulatory legal act establishes a mandatory procedure for market participants (manufacturers, their authorized representatives, and organizations operating the devices) to notify Roszdravnadzor of any adverse events. The scope of the regulation covers all stages of a device’s life cycle: technical and toxicological testing, clinical evaluation, state registration, manufacturing, storage, transportation, installation, commissioning, operation (including maintenance), repair, and disposal.

This regulatory act establishes a mandatory procedure for market participants (manufacturers, their authorized representatives, and organizations that use the products) to notify Roszdravnadzor of any adverse events identified at any stage of a product’s life cycle—from technical testing to disposal.

Alternative methods of transmitting information (mail, email) are excluded. Market participants (medical organizations, manufacturers) are required to submit reports on adverse events exclusively through Roszdravnadzor’s Automated Information System (AIS).

The date on which the AIS records the report will be considered the date of fulfillment of this obligation, which is important for calculating the time limits for administrative proceedings under Article 19.7.8 of the Code of Administrative Offenses of the Russian Federation.

Regarding the reporting of adverse events. A uniform deadline is being introduced for the submission of annual reports on the results of clinical monitoring. For manufacturers (or their authorized representatives) monitoring high-risk Class 3 devices, as well as Class 2b implantable devices, the deadline is no later than February 1 of the year following the reporting year.

This regulatory act shall enter into force on September 1, 2026, and shall remain in effect through September 1, 2032, inclusive.”

Link: http://publication.pravo.gov.ru/document/0001202605300004?index=2

June 1, 2026