Picture of the day: digest of the main news from June 3, 2025
Main
#1 Regulators have issued several regulatory legal acts affecting the work of pharmaceutical market operators. Thus, the Russian Government has cancelled the Procedure for the introduction of medicines into civil circulation from 2019 and has established updated regulations, which, in particular, provide for the possibility of conducting tests provided for the first series or batches of medicines, as well as for annual control, remotely. The Ministry of Health has approved updated Rules of Good Pharmacy Practice and Rules for the Storage of Medicines for Medical Use. The first document will replace the regulation from 2016 - in particular, it excludes the requirement to place equipment at a distance of 0.5 m from the walls. In the second amendment, the department clarified the need to organize a zone for storing medicines into a single block.
#2 The RAEX rating agency presented the annual ranking of the best universities in Russia RAEX-100, which included 17 medical universities. In 2023, 18 such universities got into it, in 2024 - 19. Voronezh and Krasnoyarsk State Medical University significantly worsened their positions - they took 94th and 98th places against 86th and 88th last year. Last year's leaders of the ranking among medical universities remained in their places - these are Sechenov University (15th place in the overall ranking) and RNRMU named after N.I. Pirogov (21st place). Next is the First St. Petersburg State Medical University named after Academician I.P. Pavlov, which took 28th place overall (in 2024 - 27th).
Exclusively
At the request of Vademecum, the Pharmaceuticals and Healthcare practice of the law firm VERBA LEGAL prepared an overview of the regulatory legal acts that came into force in May 2025 concerning the circulation of medicines and medical devices. In addition, the lawyers spoke about some thematic draft regulatory legal acts that are currently being developed. More details about these documents are in the digest .
Organization of medical care
• From September 1 of this year, a new Procedure for conducting medical examinations for intoxication (alcohol, drugs or other toxic) and rules for chemical-toxicological studies will come into force. In the updated regulations, the Russian Ministry of Health clarified the variability in confirming the qualifications of doctors who must conduct an examination during a medical examination. It also defined the organizations in which chemical-toxicological studies can be conducted. The new rules will be in effect for six years.
• The Russian Ministry of Health has approved the Procedure for Conducting Forensic Psychiatric Examinations. In the new regulations, the department has changed the recommended staffing standards for the outpatient examination department, as well as the inpatient department - for those who are or are not in custody. In addition, the ministry has defined the requirements for health workers in various positions. For example, the head of the department must have a higher education in the specialty "forensic psychiatric examination" and at least three years of work experience in the specialty. The procedure is being updated for the first time since 2017. From September 1, 2025, it will replace the order of the Ministry of Health No. 3n and will be valid until the same date in 2031.
Regulators
• The Ministry of Health has issued a Procedure for Determining the Severity of Harm Caused to Human Health. The updated regulations have changed the medical criteria for determining the severity of harm to health, as well as the table of percentages of permanent loss of general working capacity as a result of various injuries, poisoning and exposure to external causes. The regulator has also made some clarifications to the document to eliminate “double interpretation of the applied formulations, modern medical classifications in order to prevent distortion of the results of forensic medical examinations.” The amendment will replace the order of the Ministry of Health No. 194n of April 24, 2008, will come into force on September 1, 2025 and will be valid until the same date in 2031.
• The Ministry of Health has defined the Procedure for Conducting Pathological-Anatomical Autopsies, which contains new forms of medical documentation used in such procedures. For example, the updated procedure, like the one still in effect, states that an autopsy may not be performed for religious reasons, except in cases provided for in Part 3 of Article 67 of No. 323-FZ (suspected violent death, stillbirth, death from an infectious disease, and other reasons). To do this, a close relative or legal representative of the deceased must write a written statement. The recommended form of such a statement is now provided in the updated procedure. The amendment will replace Order No. 354n of the Ministry of Health dated June 6, 2013, will come into force on September 1, 2025, and will be valid for six years.
Medical products market
The FAS Russia has found two St. Petersburg distributors, Alma-Med and Makrus, guilty of collusion in nine tenders for the supply of medical equipment for clinics in the Kaliningrad Region (OKB, regional oncology dispensary and dental clinic) and City Hospital No. 2 of St. Petersburg for a total of 621 million rubles. As the antimonopoly authorities established, in the tenders that came into the focus of the agency, the reduction in the initial maximum contract price was either 0% or 0.58% against 28.84% in other purchases of the same medical equipment and 15.77% if other players entered the tender. During the investigation, it was revealed that the companies used a single infrastructure for submitting applications, subsidized each other with interest-free loans, and the development director of Alma-Med worked under a civil-law contract at Makrus. Legal entities face a turnover fine of up to 50% of the initial maximum contract price under Article 14.32 of the Code of Administrative Offences, and their managers face criminal prosecution. The case materials have been transferred to law enforcement agencies for further procedural decisions.
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