Amendments were made to the list of risk indicators for controlling the turnover of medical devices

27.05.2025 published the order of the Ministry of Health of the Russian Federation of April 17, 2025 № 218n “On Amendments to the list of risk indicators of violation of mandatory requirements used by the Federal Service for Supervision of Healthcare in the implementation of federal state control (supervision) over the circulation of medical devices, approved by the order of the Ministry of Health of the Russian Federation of July 17, 2023 № 368n”.

The Order excludes from the list the risk indicators of violation of mandatory requirements provided for in paragraphs 1, 3 and 4, namely:

– a twofold increase in the number of documents on clinical trials of medical devices in one year;

– employees working simultaneously for several licensees in different regions of Russia;

– renting premises for the maintenance of medical equipment from other organizations that have a license but have not notified Roszdravnadzor of changes to the register of licenses.

According to the text of the Order, it will become effective from June 7, 2025.

Reference: http://publication.pravo.gov.ru/document/0001202505270018

The Russian Ministry of Health has changed the procedure for expert examination of medicines

19.05.2025 the Order of the Ministry of Health of the Russian Federation No. 157n dated March 31, 2025 “On Amendments to the Order of the Ministry of Health of the Russian Federation No. 558n dated August 24, 2017 ”On Approval of the Rules for Expert Review of Medicinal Products for Medical Use and Specifics of Expert Review of Certain Types of Medicinal Products for Medical Use (Reference Medicinal Products, Reproduced Medicinal Products, Biological Medicinal Products, Bioanalog (Biosimilar) Medicinal Products)” was officially published.

This document introduces amendments to the rules of expertise and the specifics of expertise of certain types of medicines, specifies the procedure for sending a request if the materials submitted to the expert are insufficient, the procedure for expertise of documents submitted to determine the possibility of considering a medicinal product for medical use as an orphan medicinal product, drawing up the relevant conclusion and sending it to the Ministry of Health of Russia, the procedure for making a decision on conducting an expert examination of the quality of medicines, and the procedure for conducting an expert examination of the quality of medicines.

In particular, an expert can now request materials for expert examination from an applicant only by way of a request through the Unified State Information System (USIS). Expert conclusions are prepared in electronic format and signed with electronic signatures, and it is prohibited to make changes to them;

Changes are introduced to the timing of expert examinations:

– the examination period for determining the orphan status – no more than 30 working days. If the information is insufficient for the expert review, the expert organization sends a corresponding request via EGISZ, and the expert review period is resumed only after receiving the response;

– the expert examination period for determining the orphan status – no more than 30 working days. If there are insufficient materials, the expert organization sends a request via EGISZ, and the expert examination period is suspended until a response is received;

– term of quality expertise and the ratio of expected benefit to possible risk – not more than 110 working days;

– term of quality expertise of pharmaceutical substances – not more than 30 working days;

– term for expert examination of documents for authorization for clinical trials – not more than 25 working days.

This order shall enter into force on May 30, 2025, with the exception of certain provisions that will enter into force on January 1, 2026.

Reference: http://publication.pravo.gov.ru/document/0001202505190008

The instructions for linezolid and glucosamine were amended

Two letters have been published in the State Register of Medicinal Products (GRLS) – letter of FGBU “NESMP” of the Ministry of Health of Russia dated 14.04.2025 No. 9852 and letter of FTBU “NESMP” of the Ministry of Health of Russia dated 02.04.2025 No. 8754.

The letter states that in accordance with the current data based on the review of the Committee for Risk Assessment in Pharmacovigilance of the European Medicines Agency dated June 2020 (EMA/PRAC/624022/2020), it is necessary to include information on concomitant use with buprenorphine in the Instructions for Medical Use, General Characteristics of the medicinal product and leaflet-insert of medicinal products containing linezolid and glucosamine as an active substance.

The instructions for glucosamine in the form of powder for preparation of solution for oral administration, solution for intramuscular administration and concentrate for intramuscular administration should be brought in line with the latest information on the experience of clinical use. In the section “Indications for use” it should be stated that the drug is indicated for “adults for relief of symptoms of mild to moderate osteoarthritis of the knee joint”. In the section “Dosage regimen and route of administration” it is necessary to provide information according to the indications.

In the “Caution” section of the instructions and “Special Instructions and Precautions” section of the linezolid package insert, it should be stated that concomitant use with buprenorphine (alone or in combination with naloxone) may lead to the development of serotonin syndrome. It should also be noted that if such treatment is clinically justified, careful monitoring of the patient’s condition is required, especially at the beginning of treatment and during dose escalation. The “Other drugs and linezolid” section of the package insert should be supplemented with the information “opioids used in the treatment of pain – buprenorphine (alone or in combination with naloxone)”.

A draft law has been prepared on labeling of medicines the use of which is incompatible with driving a vehicle

A draft law has been submitted to the State Duma which provides for amendments to Federal Law No. 61-FZ dated 12.04.2010 “On Circulation of Medicines”.

Article 46 of Law No. 61-FZ is proposed to be supplemented with paragraph 13, stating that the instructions for the use of a drug the use of which is prohibited while driving a motor vehicle shall contain:

– the “entry prohibited” sign provided for in clause 3.1 of Annex 1 of the Traffic Rules in color or black-and-white image;

– information on narcotic drugs, psychotropic substances and their precursors contained in the composition of such medicinal product which are subject to control in the territory of the Russian Federation;

– information on the period of time these substances are in the human body, during which it is prohibited to drive a vehicle.

According to the author of the draft law, the development of this bill is due to the situation, as a result of which law-abiding citizens who take the right to drive vehicles for a period of one and a half to two years are brought to administrative responsibility under article 12.8 of the Code of Administrative Offenses of the Russian Federation (driving a vehicle by a driver who is intoxicated, transferring control of the vehicle to a person who is intoxicated) in the form of an administrative fine of thirty thousand RUB with deprivation of the right to drive vehicles for a period of one and a half to two years.

For example, such common medicines as Corvalol, Valokordin, Pentalgin-N, Valoserdin, Valoferin contain Phenobarbital, while Solpadein, Nurofen Plus, Caffetine, Sedalgin-Neo and Terpincod contain Codeine.

As stated in the explanatory note to the bill, according to the Resolution of the Government of the Russian Federation dated 30.06.1998 No. 681 “On Approval of the List of Narcotic Drugs, Psychotropic Substances and Their Precursors Subject to Control in the Russian Federation”, the substance ‘Phenobarbital’ refers to psychotropic substances, the circulation of which in the Russian Federation is limited, and the substance “Codeine” refers to narcotic substances and is also limited in circulation in our country.

The instructions for use of all these medicines do not contain a warning about the prohibition to drive a vehicle during the period of action of the drug that contains a narcotic or psychotropic substance, or it is indicated in small print (for example, in “Corvalol” and “Valocordine”) that during the period of treatment it is necessary to exercise caution when driving a vehicle.

At the same time, narcotic or psychotropic substances, which enter the human body together with medicines, may be contained in the human body from several days to several weeks, which must also be obligatorily reflected in the instructions to the medical product containing such substances in its composition.

The author of the bill notes that most people taking medicines prescribed by a doctor or without a prescription do not know and cannot know that some medicines contain narcotic or psychotropic substances, the use of which is incompatible with driving a vehicle, as in the case of an examination this will lead to the driver’s liability under Article 12.8 of the Code of Administrative Offenses of the Russian Federation.

It follows from the note to Article 12.8 of the Code of Administrative Offenses of the Russian Federation that in relation to narcotic and psychotropic substances the amount of the substance consumed is not taken into account, but simply the fact of the presence of such substances in the human body is important.

Currently, judicial practice is not in favor of drivers and practically all those who, based on the results of medical examination, were found to have traces of phenobarbital, codeine or other narcotic and psychotropic substances that entered the human body as a result of taking medications, are brought to administrative responsibility for driving in a state of drug intoxication. So the Supreme Court of the Russian Federation in the Decision of March 25, 2025 in case No. 5-AD25-24-K2 once again confirmed that when the results of medical examination of the driver reveal traces of substances that are contained in the relevant lists, the objective side of an administrative offense is formed. The appointment of a doctor and the use of medicines in this case does not affect the legal qualification of the act.

Clause 2.7 of the Traffic Rules, approved by the Resolution of the Council of Ministers – Government of the Russian Federation No. 1090 of 23.10.1993, contains a direct prohibition for drivers to drive a vehicle under the influence of drugs that impair reaction and attention.

Thus, the introduction in the instructions for the use of medicines containing narcotic or psychotropic substances, as well as causing deterioration of the driver’s reaction or attention, of the road sign “traffic is prohibited”, as well as additional information on the presence of narcotic or psychotropic substances in the medicinal product and the period of their presence in the human body, will make it possible to draw the attention of drivers to the need to refrain from driving a vehicle during the period of action of such a drug.

According to the text of the document, if approved, the changes would take effect on September 1, 2026.

Reference: https://sozd.duma.gov.ru/bill/909432-8

It is proposed to exclude qualification requirements for pharmaceutical workers

The Ministry of Health has prepared a draft decree amending the list containing regulatory acts on all types of state control adopted before January 1, 2020

The regulatory legal acts contained in the above list, approved by Decree of the Government of the Russian Federation No. 2467 of 31.12.2020, and the requirements set out in them are relevant until they need to be amended. Some of the documents from the list are valid until September 1, 2025. Until then, they must be updated or their validity extended.

The ordinance as prepared provides, among other things, for the complete removal of the following documents from said list on 01.09.2025:

  • Order of the Ministry of Health of the Russian Federation No. 83n of February 10, 2016 “On Approval of Qualification Requirements for Medical and Pharmaceutical Workers with Secondary Medical and Pharmaceutical Education” (paragraphs 300, 358 of the List);
  • Order of the Ministry of Health and Social Development of the Russian Federation No. 194n of April 24, 2008 “On Approval of Medical Criteria for Determining the Severity of Harm Caused to Human Health” (paragraph 234 of the List).

As stated in the explanatory note to the draft resolution, these documents are proposed to be excluded from the list, due to the fact that these normative legal acts do not contain mandatory requirements subject to inspection in the implementation of state control and supervision.

Document https://regulation.gov.ru/Regulation/Npa/PublicView?npaID=156685

Changes to the drug monitoring system came into force

Government Resolution No. 553 “On Amendments to Certain Acts of the Government of the Russian Federation” dated 24.04.2025, which came into force on 24.04.2025, amended the Regulation on the system for monitoring the movement of medicinal products for medical use, approved by Resolution No. 1556 of the Government of the Russian Federation dated December 14, 2018.

In accordance with the amendments, the system for monitoring the movement of medicinal products (MDLP) will now interact with the FGIS of northern importation, transmitting data on medicines, market participants and public procurement, the regulation on this was approved by the government.

The federal state information system for monitoring the northern importation will receive information on the circulation of medicines in the northern importation territories carried out by entities involved in the circulation of medicines in the following composition: information on participants in the northern importation, information on medicines registered in the monitoring system by entities involved in the circulation of medicines, the circulation of which takes place in the northern importation territories, information on the circulation of medicines in the northern importation territories.

The document also introduces changes to the structure of subsystems of the FGIS for monitoring the northern importation.

Document: http://publication.pravo.gov.ru/document/0001202504240019