Konsu Administrator

New procedure for reporting all cases of adverse events identified at all stages of a medical device’s use

Effective September 1, 2026, Order No. 541n of the Ministry of Health of the Russian Federation, dated May 26, 2026, will take effect. This order establishes a new procedure for entities involved in the distribution of medical devices to report cases of adverse events identified at all stages of the devices’ life cycle.

This regulatory act was developed in accordance with the provisions of Article 96 of Federal Law No. 323-FZ of November 21, 2011, “On the Fundamentals of Public Health Protection in the Russian Federation,” which governs the safety monitoring of medical devices.

From a regulatory specialist’s perspective, the key provisions of the new regulation are:

• Subject Matter: Establishment of uniform requirements for reporting to Roszdravnadzor all cases of adverse events identified during the use (operation) and storage of medical devices, both within the Russian Federation and abroad.
• Responsible parties: The obligation to submit a notification rests with market participants—manufacturers (or their authorized representatives)—as well as organizations engaged in the import, sale, storage, use, and maintenance of such products.

The order will remain in effect until September 1, 2032, fully replacing the previously applicable regulations.

The implementation of this document will require registration certificate holders to revise their standard operating procedures (SOPs) for pharmacovigilance of medical devices, including updating internal reporting forms, establishing deadlines for submitting data to the agency’s information system, and training staff on incident reporting procedures.

Link: http://publication.pravo.gov.ru/document/0001202605300004

August 28, 2026

The criteria for defects and the requirements for local production have been revised for drug registration

On August 12, 2026, the Russian Government published Resolution No. 999 of August 10, 2026, “On Amending Resolution No. 593 of the Government of the Russian Federation of April 5, 2022.”

This regulatory act specifies the conditions for applying a special procedure for handling medicinal products in the event of a shortage or the risk of a shortage arising in connection with the introduction of restrictive economic measures.

In terms of regulatory requirements for the localization of production and the preparation of registration dossiers, the document introduces the following changes:

Clarification of Defect Criteria

Paragraph 2 of the Rules has been supplemented with a new basis for recognizing the existence of a generic drug. Now, the special registration procedure applies only if there is no production within the Russian Federation at any stage of the manufacturing process—including the synthesis of the active ingredient for pharmaceutical substances—under the corresponding International Nonproprietary Name (INN). This precludes the possibility of simplified registration of generics when a complete local synthesis cycle for the active pharmaceutical ingredient exists.

Requirements for Verifying Localization as Part of the Registration Dossier

The list of documents has been expanded to include new subparagraphs that differentiate requirements based on the nature of the drug:

For biological drugs, the applicant must provide information confirming that all stages of production are carried out within the Russian Federation, including the synthesis of the active ingredient molecule.

For other medicinal products, it is necessary to confirm the availability of manufacturing facilities for the production of the finished dosage form, the performance of primary (secondary) packaging, and the conduct of release quality control within the Russian Federation.

These rules regarding the submission of information to confirm localization apply exclusively in cases where the production of the relevant product, covering the specified stages of the manufacturing process for a given INN, has not previously been carried out within Russia. These measures are aimed at encouraging the establishment of full production cycles for innovative biologics.

Link: http://publication.pravo.gov.ru/document/0001202608120021

August 14, 2026

Regulations on the destruction of substandard and counterfeit drugs have been adopted

On August 7, 2026, the Government of the Russian Federation published Resolution No. 968, “On the Approval of the Rules for the Destruction of Seized Counterfeit, Substandard, and Pirated Medicines,” dated August 1, 2026.

This regulatory act takes effect on March 1, 2027, and remains in force for five years (until March 1, 2032). It establishes a uniform procedure for the removal from circulation and subsequent destruction of the specified categories of drugs (with the exception of narcotic, psychotropic, and radiopharmaceutical drugs).

Key regulatory provisions of the document:

• Grounds for Seizure

The decision to seize counterfeit and substandard drugs is made by an authorized federal executive agency (Roszdravnadzor, Rosselkhoznadzor) or a court. The seizure of counterfeit drugs is carried out exclusively on the basis of a court decision that has entered into legal force.

• Grounds and Procedure for Destruction

Counterfeit and substandard drugs are subject to destruction based on an administrative order issued by the regulatory authority or at the owner’s discretion. Counterfeit products are destroyed only by court order. The owner is required to ensure that such products are isolated in a specially designated area (quarantine) for six months prior to their actual destruction by a specialized organization. All costs associated with transportation, storage, and destruction are borne by the owner.

• Sanitary and Epidemiological Requirements

The physical destruction procedure must be carried out in compliance with sanitary and epidemiological requirements for the handling of medical waste. Upon completion of the operation, a destruction report is prepared. The document must contain detailed information regarding the name, dosage form, dosage, batch number, manufacturer, and owner, as well as the method and location of destruction.

• Documentation

The certificate is signed by all participants in the procedure on the very day of destruction and is certified with the seal of the executing organization. The owner is required to submit a certified copy of the certificate to the authorized federal executive agency within five business days via electronic means. If the destruction takes place in the absence of the owner’s representative, the responsibility for submitting a copy of the certificate falls on the contractor.

Link: http://publication.pravo.gov.ru/document/0001202608070023

August 10, 2026

Regulations governing the oversight of drug manufacturing and clinical trials have been revised

Federal Law No. 324-FZ of August 4, 2026, “On Amending the Federal Law ‘On the Circulation of Medicines’ and Certain Legislative Acts of the Russian Federation,” has significantly revised the regulatory framework for the pharmaceutical industry.

The main changes introduced by this regulatory act are as follows:

Licensing Oversight of Manufacturing

Federal Law No. 61-FZ of April 12, 2010, “On the Circulation of Medicines” (hereinafter referred to as Law No. 61-FZ) has been amended by Article 8_3, which establishes a special procedure for suspending a license for the manufacture of medicines and an EAEU GMP certificate. If critical nonconformities are identified that have resulted in adverse consequences for the life and health of citizens, the authorized body has the right to decide to suspend the validity of these documents. The duration of such a measure is up to 120 days, with the possibility of extension for an additional 60 days. Sanctions may be applied either to the manufacturer’s operations as a whole or on a differentiated basis to individual production sites or specific stages of the manufacturing process.

Clinical Trials and Quality Validation

Significant clarifications have been made to the procedure for obtaining authorization to conduct a clinical trial of a drug. According to the new version of Article 39 of Law No. 61-FZ, it is mandatory to submit preclinical study data demonstrating the safety of the proposed dosages for first-time use in humans. At the same time, the requirements for documentation on medicinal products (with the exception of biological products) manufactured for the purposes of clinical trials have been revised (Article 17 of Law No. 61-FZ).

Distribution of Veterinary Drugs and Inspection Activities

Provisions have been made to remove unnecessary barriers in related segments of the drug distribution chain:

• Amendments have been made to Article 45 of Law No. 61-FZ, permitting the use of pharmaceutical substances included in the State Register of Medicines for Medical Use in the manufacture of veterinary drugs.
• The procedure for importing samples of medicinal products selected by an inspector during a pharmaceutical inspection of manufacturing facilities to verify compliance with the Eurasian Economic Union’s Good Manufacturing Practice (GMP) requirements has been simplified. These samples are exempt from a number of standard requirements to ensure prompt quality control.

Harmonization of Legislation and Efficiency of Oversight

To harmonize legal provisions, technical amendments have been made to Federal Law No. 99-FZ of May 4, 2011, “On the Licensing of Certain Types of Activities.” The most significant change affected Federal Law No. 248-FZ of July 31, 2020, “On State Control (Supervision) and Municipal Control in the Russian Federation.” Now, the receipt of information regarding violations within the framework of licensing control over production serves as grounds for the immediate initiation of an unscheduled control (supervisory) measure. The supervisory authority is required to initiate an inspection within seventy-two hours, which significantly improves the speed with which supervisory authorities can respond to the risk of substandard products entering the market.

The document takes effect on August 15, 2026.

Link: http://publication.pravo.gov.ru/document/0001202608040068

August 7, 2026

The Russian government has extended the transition periods for medical device manufacturers regarding the appointment of authorized representatives and the cancellation of registration

On August 3, 2026, Resolution No. 974 of the Government of the Russian Federation, “On Amending Resolution No. 1684 of the Government of the Russian Federation dated November 30, 2024,” was published.

The Rules for State Registration of Medical Devices, approved by Government Resolution No. 1684 and in effect since March 2025, reflected the transition from paper documents to a registry-based system for issuing registration certificates.

Under the new Resolution No. 974, the effective dates of certain provisions of the Rules for State Registration of Medical Devices have been adjusted:

• Regarding the revocation of registration certificates: the effective date of subparagraph “e” of paragraph 137 of the Rules—which establishes the grounds for the authorized body to issue a decision to revoke state registration—has been postponed (from September 1, 2026, to September 1, 2027). This provision provides for the revocation of state registration of a medical device if the information about the manufacturer is found to be inconsistent with the data in the state information systems of the country of origin.
• Regarding compliance with requirements for market participants: the deadline for fulfilling the requirement under paragraph 5(1) of the Rules has been extended until September 1, 2027. During this period, manufacturers (producers) whose place of business is not located within the territory of the Russian Federation are required to ensure that up-to-date information about the manufacturer’s authorized representative is included in the registration dossier. This requirement corresponds to the provisions of paragraph 16 of the Rules, according to which a foreign manufacturer is required to appoint such a representative or update the information about the representative if it is missing or no longer current.

According to the explanatory note accompanying the draft resolution, the postponement of the deadlines is due, in part, to requests from market participants. Foreign manufacturers are experiencing difficulties in preparing documents confirming the authority of their representatives in Russia.

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

Link: http://publication.pravo.gov.ru/document/0001202608030043

August 3, 2026