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GENERAL OVERVIEW QUESTIONNAIRE on the IMPLEMENTATION of the MEDICRIME CONVENTION Answers of the Russian Federation

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GENERAL OVERVIEW QUESTIONNAIRE on the IMPLEMENTATION of the MEDICRIME CONVENTION Answers of the Russian Federation The MEDICRIME Convention La Convention MÉDICRIME COURTESY TRANSLATION GENERAL OVERVIEW QUESTIONNAIRE ON THE IMPLEMENTATION OF THE MEDICRIME CONVENTION Answers of the Russian Federation As adopted by the Bureau of the MEDICRIME Committee on 7 July 2020 Replies should be addressed to the MEDICRIME Committee Secretariat by 23 September 2020 ([email protected]) F - 67075 Strasbourg Cedex | [email protected] | Tel: +33 3 88 41 2000 | www.coe.int/medicrime I. INTRODUCTION II. PRELIMINARY REMARKS Public authorities/institutions which responsible for collecting answers to the questions of this questionnaire: Federal Service for Surveillance in Healthcare (Roszdravnadzor) Public authorities/institutions which contribute to these answers: • The Ministry of Health of the Russian Federation (Minzdrav of Russia) • Federal Service for Surveillance in Healthcare (Roszdravnadzor) • The Prosecutor General's Office of the Russian Federation • Federal Customs Service of Russia • Ministry of Internal Affairs of the Russian Federation (MIA of Russia) III. GENERAL FRAMEWORK Question 1: Definitions a. Does the understanding of "medical product" under your internal law correspond to that set out in Article 4, letter (a), i.e. "medicinal products and medical devices"? There is no definition of the term "medical product" in Russian legislation. All Russian legal acts contain the terms "medicinal product" and / or "medical device. b. Does the understanding of “medicinal product” under your internal law correspond to that set out in Article 4, letter (b), i.e. “medicines for human and veterinary use which may be: i. any substance or combination of substances presented as having properties for treating or preventing disease in humans or animals; ii. any substance or combination of substances which may be used in or administered to human beings or animals either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis; iii. an investigational medicinal product”? Corresponds. Article 4 of the Federal Law of 12.04.2010 N 61-FZ "On the circulation of medicinal products": "Medicinal products are substances or their combinations that come into contact with the human or animal body, penetrate 2 the organs, tissues of the human or animal body, used for prophylaxis, diagnostics (with the exception of substances or their combinations that are not in contact with the human or animal body), treatment of diseases, rehabilitation, for the preservation, prevention or termination of pregnancy and obtained from blood, blood plasma, from organs, tissues of the human or animal body, plants, minerals by methods of synthesis or using biological technologies. Medicinal products include active substances and medicines" c. Does the understanding of “active substance” under your internal law correspond to that set out in Article 4, letter (c), i.e. “any substance or mixture of substances that is designated to be used in the manufacture of a medicinal product, and that, when used in the production of a medicinal product, becomes an active ingredient of the medicinal product”? Corresponds. Article 4 of the Federal Law of 12.04.2010 N 61-FZ "On the circulation of medicinal products": "Active substance is a medicinal product in the form of one or more active ingredient with pharmacological activity, regardless of the nature of the origin, which is intended for the production, manufacture of medicines and determines their effectiveness" d. Does the understanding of “excipient” under your internal law correspond to that set out in Article 4, letter (d), i.e. “any substance that is not an active substance or a finished medicinal product, but is part of the composition of a medicinal product for human or veterinary use and essential for the integrity of the finished product”? Corresponds. Article 4 of the Federal Law of 12.04.2010 N 61-FZ ""On the circulation of medicinal products": «excipients are substances of inorganic or organic origin used in the production process, manufacturing of medicines to give them the necessary physical and chemical properties» e. Does the understanding of “medical devices” under your internal law correspond to that set out in Article 4, letter (e), i.e. “any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software, designated by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, designated by the manufacturer to be used for human beings for the purpose of: i. diagnosis, prevention, monitoring, treatment or alleviation of disease; ii. diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap; 3 iii. investigation, replacement or modification of the anatomy or of a physiological process; iv. control of conception; and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means”? Corresponds. Article 38, p. 1 of the Federal Law of 21.11.2011 N 323-FZ (as amended on 31.07.2020) "On the basics of health protection of citizens in the Russian Federation": "Medical devices are any tools, apparatus, devices, equipment, materials and other products used for medical purposes separately or in combination with each other, as well as together with other accessories necessary for the use of these products for their intended purpose, including special software, and intended by the manufacturer for the prevention, diagnosis, treatment and medical rehabilitation of diseases, monitoring the state of the human body , carrying out medical research, restoration, replacement, changes in the anatomical structure or physiological functions of the body, prevention or termination of pregnancy, the functional purpose of which is not realized by pharmacological, immunological, genetic or metabolic effects on the human body" Currently, the harmonization of national legislation is being carried out with the legislation of the Eurasian Economic Union, which provides the following definition: "Medical devices - any instruments, apparatus, devices, equipment, materials and other products that are used for medical purposes separately or in combination with each other, as well as with accessories necessary for the use of these products for their intended purpose (including special software), are intended by manufacturer for the prevention, diagnosis, treatment of diseases, medical rehabilitation and monitoring of the state of the human body, medical research, restoration, replacement, changes in the anatomical structure or physiological functions of the body, prevention or termination of pregnancy and the functional purpose of which is not realized by pharmacological, immunological, genetic or metabolic effects on the human body, however, it can be assisted by means of medicinal products" (Agreement on uniform principles and rules for the circulation of medical devices (medical devices and medical equipment) within the framework of Eurasian Economic Union (Ratified by Federal Law of 31.01.2016 N 4-FZ) f. Does the understanding of “accessory” under your internal law correspond to that set out in Article 4, letter (f), i.e. “an article which whilst not being a medical device is 4 designated specifically by its manufacturer to be used together with a medical device to enable it to be used in accordance with the use of the medical device intended by the manufacturer of the medical device”? Corresponds. p. 3.2 GOST 31508-2012 “Medical devices. Classification according to the potential risk of use. General requirements": "Accessories are items that are not independently medical devices and are used for their intended purpose in conjunction with a medical device or in their composition so that a medical device can be used in accordance with its intended purpose". g. Do the understanding of “parts” and “materials” under your internal law correspond to that set out in Article 4, letter (g), i.e. “all parts and materials constructed and designated to be used for medical devices and that are essential for the integrity thereof”? Corresponds. Material is any synthetic or natural polymer, metal, alloy, ceramic or other non-viable material, including non-viable biological tissue, used as a medical device or part thereof. (p. 2.2 GOST ISO 10993-1-2011 Medical devices. Evaluation of the biological effect of medical devices. Part 1. Evaluation and researches"). A spare part is a component part of a product intended for replacing the same part that was in operation in order to maintain or restore the good condition or operability of the product (GOST 18322-78 "System of technical maintenance and repair of equipment. Terms and definitions"). A spare part is a separate unit, device or element designed to replace worn out, faulty or failed component parts of an object in order to maintain or restore its working condition (article 3.5.14 GOST 27.002-2015 "Reliability in technology (SSNT). Terms and definitions"). Spare parts, tools and accessories (SPTA) - a set of stocks of material resources, formed depending on the purpose and features of the use of the object and intended for its operation, maintenance and repair (article 3.5.15 GOST 27.002-2015 "Reliability in technology (SSNT). Terms and definitions"). Consumable materials are materials and products intended for periodic replacement,
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