5.1.4. federal state supervision in the field of circulation medicines(for medicines for medical use) through:
5.1.4.1. organizing and conducting audits of compliance by the subjects of medicines circulation with those established by the Federal Law "On the Circulation of Medicines" and other regulatory documents adopted in accordance with it legal acts Russian Federation requirements for preclinical studies of medicinal products, clinical trials medicines storage, transportation, dispensing, sale of medicines, use of medicines, destruction of medicines;
5.1.4.2. organizing and conducting conformity checks of medicines in civil circulation established mandatory requirements for their quality;
5.1.4.4. application, in accordance with the procedure established by the legislation of the Russian Federation, of measures to suppress identified violations mandatory requirements and (or) elimination of the consequences of such violations, including the adoption of a decision on the presence of medicinal products for medical use in circulation, the issuance of orders to eliminate the identified violations of mandatory requirements and the prosecution of persons who have committed such violations;
Information about changes:
The regulation was supplemented by subparagraph 5.1.4.5 from November 27, 2019 - Decree of the Government of Russia of November 15, 2019 N 1459
5.1.4.5. holding test purchases in order to verify compliance by the Subjects of Medicines Circulation carrying out retail medicinal products for medical use, rules for dispensing medicinal products for medical use and (or) a ban on the sale of counterfeit medicines, substandard medicines and counterfeit medicines;
5.1.4(1). selective quality control of medicines for medical use by:
5.1.4(1).1. processing information, without fail provided by the subjects of circulation of medicinal products for medical use, on series, batches of medicinal products entering the civil circulation in the Russian Federation;
5.1.4(1).2. sampling of medicinal products for medical use from the subjects of circulation of medicinal products for medical use in order to test for their compliance with the requirements normative documentation or regulatory documents;
5.1.4(1).3. making a decision on the further civil circulation of the relevant medicinal product for medical use based on the results of the tests;
5.1.4(1).4. making a decision to transfer the medicinal product for medical use to serial sampling quality control of medicinal products for medical use in case of repeated detection of non-compliance of the quality of the medicinal product for medical use with the established requirements and (if necessary) to check the subject of circulation of medicinal products for medical use;
5.1.4(2). organization and (or) inspection of the subjects of circulation of medicines for medical use for compliance with the rules of good laboratory practice, the rules of good clinical practice, the rules of good practice for the storage and transportation of medicines, the rules of good distribution practice, the rules of good pharmacy practice;
5.1.6. control of:
5.1.6.3. implementation of regional programs for the modernization of healthcare in the constituent entities of the Russian Federation and measures for the modernization public institutions providing medical care, government agencies implementing measures to introduce information systems to healthcare;
5.1.6.4. reliability of primary statistical data provided by medical organizations and individual entrepreneurs carrying out medical activities;
Information about changes:
5.4.1. gives out:
5.4.1.2. permission to import into the Russian Federation medical devices for the purpose of their state registration;
5.4.1.4. certificate of a specialist to persons who have received medical or pharmaceutical education in foreign countries;
Information about changes:
The regulation was supplemented by subparagraph 5.4.1.5 from November 15, 2018 - Resolution
5.4.1.5. conclusion ( permit document) for import into the Russian Federation and export from the Russian Federation of samples of human biological materials (with the exception of human biological material obtained during a clinical trial of a medicinal product for medical use, and human biological material obtained during a clinical trial of a biomedical cell product, for its study for the purposes of this clinical trial), hematopoietic stem cells, bone marrow, donor lymphocytes for unrelated transplant purposes, germ cells and embryos;
Information about changes:
The regulation was supplemented by subparagraph 5.4.1.6 from November 15, 2018 - Decree of the Government of Russia of November 3, 2018 N 1315
5.4.1.6. conclusion (permit document) for obtaining a license for the right to import into the Russian Federation and export from the Russian Federation human organs and tissues, blood and its components (with the exception of samples of human biological materials, hematopoietic stem cells, bone marrow, donor lymphocytes for the purpose of unrelated transplantation , germ cells and embryos);
Information about changes:
The regulation was supplemented by subparagraph 5.4.1.7 from November 29, 2019 - Decree of the Government of Russia of November 26, 2019 N 1510
5.5.1. leads State Register medical devices and organizations (individual entrepreneurs) engaged in the production and manufacture of medical devices, and places it on the official website of the Service on the Internet;
Information about changes:
Information about changes:
Decree of the Government of the Russian Federation of January 31, 2017 N 114 The Regulation was supplemented by clause 5.7.1
5.7.1. based on the results of monitoring the safety of biomedical cell products, post on its official website on the Internet information on the decision to suspend the use of the biomedical cell product and (or) a related decision on the possible resumption of the use of the biomedical cell product;
5.8. implements in in due course verification of the activities of medical and pharmacy organizations, drug wholesalers, other organizations and individual entrepreneurs operating in the healthcare sector;
5.8.1. takes part within the competence in the conduct of federal information systems, federal bases data in the field of healthcare, including ensuring the confidentiality of personal data contained therein in accordance with the legislation of the Russian Federation;
Information about changes:
Decree of the Government of the Russian Federation of September 6, 2014 N 913 The Regulation was supplemented by subparagraph 5.8.2
5.8.2. in case of detection of violations of the legislation of the Russian Federation on the circulation of medicines and in the field of health protection, issues mandatory instructions and holds accountable for these violations, draws up protocols on administrative offenses and consideration of cases in accordance with the legislation of the Russian Federation on administrative offenses;
Information about changes:
Decree of the Government of the Russian Federation of September 6, 2014 N 913 The Regulation was supplemented by subparagraph 5.8.3
5.8.3. posts on the official website of the Service on the Internet information about scientific events, other events aimed at raising the professional level medical workers or to provide information related to the monitoring of the safety of medicinal products organized by organizations involved in the development, production and (or) sale of medicinal products for medical use, organizations that have the rights to use the trade name of a medicinal product for medical use, drug wholesalers , pharmacy organizations, representatives of these organizations and (or) financed at the expense of the funds of these organizations and their representatives;
Information about changes:
Decree of the Government of the Russian Federation of September 6, 2014 N 913 The Regulation was supplemented by subparagraph 5.8.4
5.8.4. forms a commission for the settlement of conflicts of interest in the implementation of medical activities and pharmaceutical activities;
Information about changes:
Decree of the Government of the Russian Federation of September 6, 2014 N 913 The Regulation was supplemented by subparagraph 5.8.5
5.8.5. receives and records notifications of the commencement of activities in the field of circulation of medical devices (with the exception of carrying out clinical trials medical devices, their production, installation, adjustment, application, operation, including Maintenance, as well as repair);
5.8.7. establishes the procedure for pharmacovigilance of medicinal products for medical use;
Information about changes:
Decree of the Government of the Russian Federation of January 31, 2017 N 114 The Regulation was supplemented by subparagraph 5.8.8
5.8.8. establishes the procedure for monitoring the safety of biomedical cell products;
Information about changes:
Decree of the Government of the Russian Federation of January 31, 2017 N 114 The Regulation was supplemented by subparagraph 5.8.9
5.8.9. establishes the procedure for the implementation of the owners registration certificates biomedical cell products, by legal entities in whose name permissions to conduct clinical research biomedical cell products, or other legal entities authorized by them to receive, record, process, analyze and store biomedical cell products and organs received from the subjects of circulation state power reports of side effects, adverse reactions, serious adverse reactions, unexpected adverse reactions when using biomedical cell products, the features of their interaction with drugs, medical devices, food products, other biomedical cell products, about individual intolerance, as well as other facts and circumstances that pose a threat to human life or health or affect the change in the ratio of the expected benefit to the possible risk of using biomedical cell products;
5.9. performs the functions of the main manager and recipient of funds federal budget provided for the maintenance of the Service and the implementation of the functions assigned to it;
5.10. ensures, within its competence, the protection of information constituting a state secret;
5.11. organizes the reception of citizens, ensures timely and complete consideration of citizens' appeals, makes decisions on them and sends answers to applicants within the period established by the legislation of the Russian Federation;
5.12. organizes and provides mobilization training and mobilization of the Service, manages the organization of activities for mobilization training and mobilization of its territorial bodies, as well as organizations whose activities are related to the activities of the Service or which are under its jurisdiction, have mobilization tasks or perform tasks for mobilization work;
5.17. performs other functions in the established field of activity, if such functions are provided for federal laws, regulatory legal acts of the President of the Russian Federation or the Government of the Russian Federation.
6. federal Service for supervision in the field of healthcare, in order to exercise powers in the established field of activity, has the right to:
6.1. organize the necessary inspections, studies, tests, examinations, analyzes and evaluations, as well as scientific research for implementation state control(supervision) in the established field of activity;
6.1.1. according to the results of monitoring the safety of medical devices upon receipt and confirmation of information about side effects not specified in the instructions for use or the instruction manual for the medical device, adverse reactions during its use, about the features of the interaction of medical devices with each other, about the facts and circumstances that create threat to the life and health of citizens and medical workers when using and operating registered medical devices, consider the issue of suspending the use or withdrawing such a medical device from circulation, making an appropriate decision and posting information about decisions taken on the official website of the Service on the Internet;
6.11. create advisory and expert bodies (councils, commissions, groups, colleges) in the established field of activity.
7. The Federal Service for Surveillance in the Sphere of Healthcare is not entitled to carry out in the established field of activity legal regulation, except for cases established by decrees of the President of the Russian Federation and resolutions of the Government of the Russian Federation, as well as the management state property and provision of paid services.
The restrictions on the powers of the Service established by the first paragraph of this clause do not apply to the powers of the head of the Service for managing the property of the Service assigned to it by right. operational management, solving personnel issues and issues of organizing the activities of the Service.
III. Organization of activities
8. The Federal Service for Surveillance in the Sphere of Healthcare is headed by a head appointed to and dismissed by the Government of the Russian Federation on the proposal of the Minister of Health of the Russian Federation.
The head of the Federal Service for Surveillance in Health Care is personally responsible for the implementation of the tasks and functions assigned to the Service.
The head of the Federal Service for Surveillance in the Sphere of Healthcare has deputies appointed to and dismissed by the Government of the Russian Federation on the proposal of the Minister of Health of the Russian Federation.
The number of deputy heads of the Service is established by the Government of the Russian Federation.
9. Head of the Federal Service for Surveillance in Healthcare:
9.1. distributes duties among his deputies;
9.2. submits to the Minister of Health of the Russian Federation:
9.2.1. draft regulation on the Service;
9.2.2. proposals on the maximum number and wage fund of employees of the central office and territorial bodies of the Service;
9.2.3. proposals for the appointment and dismissal of the Deputy Head of the Service;
9.2.4. proposals for the appointment and dismissal of the heads of the territorial bodies of the Service;
9.2.5. a draft annual plan and forecast performance indicators of the Service, as well as a report on their implementation;
9.2.6. proposals for the formation of a draft federal budget in terms of financial support activities of the Service;
9.2.7. proposals for submission for awarding state awards of the Russian Federation, Honorary diploma of the President of the Russian Federation, Certificate of Honor of the Government of the Russian Federation, to encouragement in the form of an announcement of gratitude from the President of the Russian Federation, an announcement of gratitude from the Government of the Russian Federation, on awarding a departmental insignia of the Ministry of Health of the Russian Federation, giving the right to confer the title "Veteran of Labour", employees of the central office of the Service , its territorial bodies and subordinate organizations, as well as other persons carrying out activities in the established area;
9.3. appoints and dismisses employees of the central office of the Service and deputy heads of its territorial bodies;
9.4. decides, in accordance with the legislation of the Russian Federation on public service, issues related to the passage of the federal public service in the Federal Service for Surveillance in Healthcare;
9.5. approves the structure and staffing of the central office of the Service within the limits of the payroll fund and the number of employees established by the Government of the Russian Federation, the cost estimate for the maintenance of the central office of the Service within the limits approved for the corresponding period of appropriations provided for in the federal budget;
9.6. approves the number and wage fund of employees of the territorial bodies of the Service within the limits of the indicators established by the Government of the Russian Federation, as well as the cost estimate for their maintenance within the limits approved for the corresponding period of appropriations provided for in the federal budget;
9.7. on the basis of and in pursuance of the Constitution of the Russian Federation, federal constitutional laws, federal laws, acts of the President of the Russian Federation, the Government of the Russian Federation and the Ministry of Health of the Russian Federation, issues orders on issues within the competence of the Service.
10. Financing of expenses for the maintenance of the central office and territorial bodies of the Federal Service for Supervision in the Sphere of Health Care is carried out at the expense of funds provided for in the federal budget.
11. The Federal Service for Surveillance in Health Care is a legal entity, has a seal with the image of the State Emblem of the Russian Federation and with its name, other seals, stamps and standard forms, as well as accounts opened in accordance with the legislation of the Russian Federation.
The Federal Service for Surveillance in Healthcare has the right to have a heraldic sign - an emblem, a flag and a pennant, established by the Ministry of Health of the Russian Federation in agreement with the Heraldic Council under the President of the Russian Federation.
12. Location of the Federal Service for Surveillance in Healthcare - Moscow.
RosZdravNadzor controls the quality of social, medical services, over the circulation of medicines, products and their compliance with safety standards, pricing of vital and essential drugs, observance of patients' rights. To improve the quality of work government agency the official website roszdravnadzor ru was opened. It is necessary both for the consumer and for persons providing medical and social services.
Why RosZdravNadzor.ru is needed
To answer this question, you need to consider the structure of the site. The resource contains a large number of sections. The developers have divided the information fields for doctors, patients, and applicants. This is done for ease of use and quick search for the necessary information.
Patients access the site in the following situations:
- To get acquainted with the results of inspections of medicines and products for quality, compliance with standards.
- When receiving drug benefits. Can get acquainted in detail with the legislative base, the procedure for processing documents.
- In case of violation of the patient's rights.
- For more information on the OMS system.
For medical workers, the following sections are distinguished:
- Reports on monitoring drugs, medical equipment, prices for vital and essential drugs.
- Analysis of the activities of the regulatory body.
The Federal Service for Surveillance in the Sphere of Healthcare checks the activities of medical institutions, beauty salons, and other facilities for the provision of services according to the plan.
- Issuance of a certificate to specialists, requirements for medical institutions, restrictions in professional activity.
RosZdravNadzor checks social workers, medical field. Without monitoring, attestation, a license cannot be issued. Requirements, the legislative framework detailed in the dedicated sections. In the same way, inspections of centers, laboratories conducting drug trials are carried out.
The section for Applicants contains the following required information:
- Regulatory base to regulate the import and export of medicines of all groups.
- The procedure for licensing medical equipment, preparations, institutions.
- Issuance of professional certificates.
- Regulatory framework on the rights of the patient and the obligations of medical workers.
The company ROSZDRAVNADZOR 7710537160 is registered under legal address 109074, MOSCOW CITY, SLAVYANSKAYA SQUARE, 4, 1. The company was registered on 04/12/2004. organization was awarded the All-Russian State Registration number: 1047796244396. The full name of the company is FEDERAL SERVICE FOR SUPERVISION IN THE SPHERE OF HEALTH. According to the documents, the main activity is the activities of federal government bodies, except for authorized representatives of the President of the Russian Federation and territorial bodies of federal bodies executive power. The head is the ACTING DIRECTOR PARKHOMENKO DMITRY VSEVOLODOVYCH. For more detailed information, you need to go to the company card and check the counterparty for reliability.
Interdistrict Inspectorate of the Federal tax service No. 46 in Moscow carried out registration with ROSZDRAVNADZOR on 12.04.2004. Registration procedure in the State Institution - Head Office pension fund RF No. 10 Office No. 2 for Moscow and the Moscow Region municipal area Basmannoye in Moscow was started on 03/31/2006. Branch No. 20 of the State Institution - the Moscow Regional Branch of the Social Insurance Fund of the Russian Federation registered the company on 12/20/2016 00:00:00. In the Unified State Register of Legal Entities, the last entry about the organization has the following content: Change of information about legal entity contained in the Unified State Register of Legal Entities.
The Federal Service for Surveillance in Healthcare (Roszdravnadzor) was established in accordance with the Decree of the President of the Russian Federation of March 9, 2004 No. 314 "On the system and structure of federal executive bodies" and is a federal executive body that exercises control and supervision functions in the healthcare sector.
Roszdravnadzor is under the jurisdiction of the Ministry of Health of the Russian Federation and is guided in its activities by the Constitution of the Russian Federation, federal constitutional laws, federal laws, acts of the President of the Russian Federation and the Government of the Russian Federation, international treaties Russian Federation, acts of the Ministry of Health of the Russian Federation, as well as the Regulations "On the Federal Service for Surveillance in Healthcare", approved resolution Government of the Russian Federation dated June 30, 2004 No. 323.
The Service carries out its activities directly and through its territorial bodies in cooperation with other federal authorities executive authorities, executive authorities of the constituent entities of the Russian Federation, authorities local government, public associations and other organizations.
At present, the structure of the Federal Service for Surveillance in Healthcare includes the central office (10 departments), 78 territorial bodies in the constituent entities of the Russian Federation and 3 federal state budgetary institutions.
Roszdravnadzor exercises the following powers:
1. State control:
For circulation of medical devices;
The quality and safety of medical activities through inspections;
When handling medicines:
For the application of prices for medicines included in the list of vital and essential medicines;
For the implementation of regional programs for the modernization of healthcare in the constituent entities of the Russian Federation and measures to modernize state institutions providing medical care, state institutions implementing measures to introduce information systems in healthcare;
Reliability of primary statistical data provided by medical organizations and individual entrepreneurs engaged in medical activities.
2. Control and supervision over the completeness and quality of the implementation by the state authorities of the constituent entities of the Russian Federation of the powers delegated to them to implement the annual cash payment persons awarded with a badge " Honorary Donor Russia", with the right to send orders to eliminate the identified violations, as well as to bring to responsibility officials acting in the exercise of the delegated authority.
3. Conducts:
Monitoring the range and prices of vital and essential drugs (VED);
Monitoring the safety of medical devices, registration of side effects, adverse reactions when using medical devices, facts and circumstances that create a threat of harm to life and health of people when handling registered medical devices.
4. Carries out licensing certain types activities related to the competence of the Service.
5. Issues:
Permission for the transit through the territory of the Russian Federation of potent substances that are not precursors of narcotic drugs and psychotropic substances;
Permission to import medical devices into the Russian Federation for the purpose of their state registration;
Certificate for the right to import (export) narcotic drugs, psychotropic substances and their precursors;
Specialist certificate for persons who have received medical or pharmaceutical education in foreign countries.
6. Exercises state registration medical products;
7. Keeps the state register of medical devices and organizations engaged in the production and manufacture of medical devices;
8. Places information on the decisions made based on the results of drug safety monitoring;
9. Carries out an audit of the activities of organizations operating in the field of healthcare;
10. Organizes the reception of citizens, ensures timely and complete consideration of citizens' applications;
11. Performs other functions regulated by the Regulations on Roszdravnadzor, as well as functions provided for by federal laws, regulatory legal acts of the President of the Russian Federation or the Government of the Russian Federation.