DISASTER MEDICINE No. 3 •2025

https://doi.org/10.33266/2070-1004-2025-3

PUBLIC HEALTH AND HEALTHCARE

Original article 

Ensuring Drug Safety when Providing Medical Care to Victims: Legal Basis for Registration of Medicines in the Russian Federation and Other States of the Eurasian Economic Union

Shepel R.N.1, Naumov P.Y.2, Kuptsov S.A.2, Kholikov I.V.3

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1 National Medical Research Centre for Therapy and Preventive Medicine of the Ministry of Health of the Russian Federation, Moscow, Russian Federation

2 Main Military Clinical Hospital of the National Guard Troops of the Russian Federation, Balashikha City, Moscow Region, Russian Federation

3 Institute of Legislation and Comparative Law under the Government of the Russian Federation, Moscow, Russian Federation

UDC 614.256

P. 34-41

 

Summary. The objective of the study is to analyze the legal basis for registration of medicines in Russia and in the Eurasian Economic Union (EAEU) in order to ensure drug safety and quality control of medical care in the elimination of medical and sanitary consequences of armed conflicts and natural and man-made disasters.

Research materials and methods. Research materials – regulatory legal documents on the topic of the study in the Russian Federation and the countries of the Eurasian Economic Union and the EAEU standards, scientific publications on the issues considered.

Research methods: system and functional analysis, analogy, abstraction, synthesis, generalization, conceptualization, deductive and comparative legal methods.

Research results and their analysis. Modern scientific concepts and regulatory legal acts (other documents), structural and substantive characteristics of the legal basis for registration of medicines in the Russian Federation and in the Eurasian Economic Union are formulated. The effectiveness and timeliness of the introduced standards are noted, their compliance with the criteria of completeness, fairness and the needs of society in the EAEU is indicated.

Key words: countries of the Eurasian Economic Union, development of legislation, drug safety, legal framework, medical care, Russian Federation, victims

For citation: Shepel R.N., Naumov P.Y., Kuptsov S.A., Kholikov I.V. Ensuring Drug Safety when Providing Medical Care to Victims: Legal Basis for Registration of Medicines in the Russian Federation and Other States of the Eurasian Economic Union. Meditsina Katastrof = Disaster Medicine. 2025;3:34-41 (In Russ.). https://doi.org/10.33266/2070-1004-2025-3-34-41

 

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The material was received 16.12.24; the article after peer review procedure 23.06.25; the Editorial Board accepted the article for publication 22.09.25