Resolution of the Council of Ministers of the Republic of Belarus
No. 1446 dated October 28, 2011
On issues of the Ministry of Health of the Republic of Belarus
(Extract)
Recent changes and additions:
Resolution of the Council of Ministers of the Republic of Belarus No. 611 dated October 27, 2020 (National Legal Internet Portal of the Republic of Belarus, 10/30/2020, 5/48461) <C22000611>
 
On grounds of paragraphs two and four of subparagraph 6.3 of paragraph 6 of the Decree of the President of the Republic of Belarus No. 360 "On improving the system of public administration of the pharmaceutical industry in the Republic of Belarus" dated August 11, 2011, the Council of Ministers of the Republic of Belarus RESOLVES:
1. To approve the Regulation on the Ministry of Health of the Republic of Belarus (attached).
11. Determine the list of state organizations subordinate to the Ministry of Health of the Republic of Belarus, according to the appendix.
2. Reassign:
2. 1. from the composition of the Belarusian State Concern for the production and sale of pharmaceutical and microbiological products (hereinafter referred to as the concern "Belbiopharm") to be subordinated to the Ministry of Health Republican Unitary Production Enterprise "Belmedpreparaty", Minsk, the Production Republican Unitary Enterprise "Minskintercaps", Research and Design Republican Unitary Enterprise "MBI", Minsk, Scientific and Production Republican Unitary Enterprise "LOTIOS", Minsk;
2.2. belonging to the Republic of Belarus shares of:
2.2.1. Open Joint Stock Companies "Borisov Plant of Medical Preparations", "Nesvizh Plant of Medical Preparations", "Exon" and Joint Public Limited Company "Ferein" under the management of the Ministry of Health;
2.2.2. Open Joint Stock Company "Enzim" under the management of the Belarusian State Concern of the Food Industry "Belgospischeprom" (hereinafter - the concern "Belgospischeprom").
3. Incorporate the Republican Unitary Production Enterprise “Ekzon-Glukoza” and the Republican Unitary Enterprise "Integrated plant for the production of medical and alcohol-containing products "Ethanol" into the concern "Belgospischeprom", excluding these enterprises from the concern "Belbiopharm".
4. Introduce into the Charter of the Belarusian State Concern of the Food Industry “Belgospischeprom”, approved by the Resolution of the Council of Ministers of the Republic of Belarus No. 1683 “Issues of the Belarusian State Concern of the Food Industry Belgospischeprom“ dated November 2, 2000 (National Register of Legal Acts of the Republic of Belarus No. 108, 5/4523, 2000; No. 83, 5/27452, 2008; No. 3, 5/29025, 2009; No. 118, 5/29724; No. 197, 5/30308; No. 149, 5/32072, 2010; No. 262, 5/32739; No. 33, 5/33460, 2011; No. 75, 5/34072; No. 101, 5/34406), the following additions:
4.1. Appendix 1 to this Charter shall be supplemented with paragraphs forty-eighth and forty-ninth as follows:
Republican Unitary Production Enterprise “Ekzon-Glukoza”
Republican Unitary Enterprise "Integrated plant for the production of medical and alcohol-containing products "Ethanol";
4.2. Appendix 2 to this Charter shall be supplemented with paragraph thirty-seven as follows:
Open Joint Stock Company "Enzim".
5. Declare to be no longer in force the Resolution of the Council of Ministers of the Republic of Belarus in accordance with the appendix.
6. Concern "Belbiopharm" together with the National Academy of Sciences of Belarus within two months shall ensure in the prescribed manner the solution of issues related to the transfer of the Bobruisk Republic Unitary enterprise “Hydrolytic Plant” to the jurisdiction of the National Academy of Sciences of Belarus from the concern "Belbiopharm".
7. The Ministry of Health and the concern "Belgospischeprom", within two months shall:
amend the Charters (approve Charters) of the organizations specified in subparagraph 2.1 of paragraph 2 and paragraph 3 of this resolution;
take other measures to implement this resolution.
8. This Resolution comes into force on November 1, 2011.
 
Prime Minister of the Republic of Belarus	M. Myasnikovich	
 
…

 	APPROVED
Resolution of 
the Council of Ministers
 of the Republic of Belarus
No. 1446 dated October 28, 2011	
REGULATION
 on the Ministry of Health of the Republic of Belarus
1. The Ministry of Health of the Republic of Belarus (hereinafter - the Ministry of Health) is a republican government body and is subordinate to the Council of Ministers of the Republic of Belarus.
2. The structure of the central apparatus of the Ministry of Health includes head departments, departments, branches, sectors.
3. In its activities, the Ministry of Health is guided by the Constitution of the Republic of Belarus, the Law of the Republic of Belarus No. 2435-XII "On health care" dated June 18, 1993, other legislative acts, including this Regulation.
4. The main tasks of the Ministry of Health are:
4.1. implementation of a unified state policy in the field of healthcare;
4.2. organization of medical assistance to the population of the Republic of Belarus;
4.3. organization of ensuring the sanitary and epidemiological well-being of the population and taking measures to ensure the sanitary and epidemiological well-being of the population, exercising state control (supervision) over compliance with legislation in the field of sanitary and epidemiological well-being of the population, as well as international legal acts that constitute the regulatory legal framework of the Customs Union and the Single economic space, and (or) acts constituting the law of the Eurasian Economic Union, including technical regulations of the Customs Union, the Eurasian Economic Union, containing sanitary and epidemiological, hygienic requirements and procedures;
4.4. organization of pharmaceutical supply for the population of the Republic of Belarus;
4.5. organization of scientific research, training of highly qualified academic specialists in institutions of the state health care system, implementing educational programs of postgraduate education, introducing the achievements of science and technology into medical practice;
4.6. coordination of the activities of other republican government bodies and other government organizations subordinate to the Government of the Republic of Belarus, local executive and administrative bodies, legal entities and individuals in the field of health care and (or) control over such activities in the manner prescribed by law;
4.7. implementation of state policy in the field of psychological assistance, with the exception of state policy in the field of psychological assistance in the education system;
4.8. ensuring the fulfillment of the indicators of the forecast of socio-economic development of the Republic of Belarus, approved in accordance with legislative acts;
4.9. attraction of investments, including foreign ones, in the sphere of healthcare and industrial production of medicinal products;
4.10. coordination of activities to organize and ensure the production, structure and range of medicinal products, as well as to improve its quality and competitiveness, develop the export potential of the domestic pharmaceutical industry;
4.11. pursuing state policy to protect the economic interests of domestic medicinal products manufacturers in the foreign and domestic markets as well as state support for their export;
4.12. implementation of information support and pursuing of state policy in the field of healthcare by interacting with the media, promoting information on the global computer network Internet.
5. The Ministry of Health conducts its activities in cooperation with republican government bodies and other state organizations subordinate to the Government of the Republic of Belarus, local Councils of Deputies, local executive and administrative bodies, international and other organizations.
6. The Ministry of Health is a state body responsible for the results of medical and pharmaceutical activities of health care organizations under the jurisdiction of other republican government bodies and other organizations.
7. The system of the Ministry of Health includes:
the head health departments of the regional executive committees and the health committee of the Minsk city executive committee;
regional medical and rehabilitation expert commissions, Minsk city medical and rehabilitation expert commission;
regional centers of hygiene, epidemiology and public health, the Minsk city center of hygiene and epidemiology, city, district, zonal and district centers of hygiene and epidemiology in cities;
government organizations subordinate to the Ministry of Health.
8. The Ministry of Health, in accordance with the assigned tasks, conducts the following functions:
8.1. studies the health status of the population, develops and, together with other republican government bodies, regional executive committees and the Minsk city executive committee, takes measures to prevent diseases, reduce morbidity, disability and mortality, increase the life expectancy of the population;
8.2. takes measures to improve the quality of medical care, medical examinations, conducts monitoring, evaluates the quality of medical care, medical examinations, determines the procedure for their implementation and establishes criteria for assessing the quality of medical care and medical examinations;
8.21. determines the procedure for organizing the provision of medical care by legal entities and individual entrepreneurs by groups of diseases, types, methods of providing medical care and establishes a minimum list of medicinal products and (or) medical equipment, medical devices necessary for the provision of such assistance, basic functional and other requirements for given medical equipment, medical products;
8.22. determines the levels of medical care, depending on the volume, type of medical care and therapeutic and diagnostic capabilities of healthcare organizations, medical scientific organizations, their structural (separate) divisions;
8.3. develops and approves clinical protocols, determines the procedure and conditions for the application of methods of medical care;
8.31. establishes the procedure and conditions for the medical use of original medicinal products to ensure early access for patients to new methods of treatment;
8.4. determines the list of medical services, medical interventions (with the exception of paid medical services provided in state healthcare institutions);
8.5. conducts methodological management of medical and pharmaceutical activities of health care organizations, including those under the jurisdiction of other republican government bodies and other organizations, the activities of the head health departments of regional executive committees and the health committee of the Minsk city executive committee, as well as activities in the field of health care of structural units of republican government bodies, whose functions include issues of organizing health care in a particular industry (field of activity), coordinates and controls such activities;
8.6. makes a decision on sending citizens of the Republic of Belarus outside the Republic of Belarus to receive medical care in the absence of the possibility of providing them with the necessary medical care in the Republic of Belarus;
8.7. takes measures to:
organization and development of medical expertise and medical rehabilitation;
organization of medical assistance to minors, women during pregnancy, childbirth and in the recovery period after childbirth;
ensuring the reproductive health of the population;
8.8. establishes a list of complications in pregnancy, childbirth and the postpartum period, in which a medical certificate of incapacity for work is issued for a period of 14 calendar days as an extension of a certificate of incapacity for work issued in connection with pregnancy and childbirth;
8.81. establishes a list of medical indications and medical contraindications for spa treatment, as well as medical contraindications for health improvement;
8.82. together with the republican government bodies subordinated to the Government of the Republic of Belarus, approves the lists of medical indications and medical contraindications for the provision of social services in subordinate (subordinate, part of the system) organizations providing social services;
8.83. together with the Ministry of Labor and Social Protection approves the list of medical indications and medical contraindications for the provision of social services in social service institutions;
8.84. approves a list of diseases that prevent citizens from staying in medical and labor dispensaries;
8.85. establishes:
the procedure for preventive medical examination of the adult and child population of the Republic of Belarus;
the procedure for rendering emergency and planned medical care;
the procedure and conditions for the transportation (evacuation) of citizens by special cars, the functional purpose of which is to ensure the provision of medical, including ambulance, assistance and sanitary and anti-epidemic measures, as well as cases and procedure for reimbursing costs associated with the organization and implementation of this transportation (evacuation);
in coordination with the Ministry of Internal Affairs and the Ministry of Transport and Communications, the procedure for compulsory medical examination of candidates for drivers of power-driven vehicles (except for wheeled tractors) and mandatory medical re-certification of drivers of power-driven vehicles (except for wheeled tractors);
in coordination with the Ministry of Internal Affairs and the Ministry of Agriculture and Food, the procedure for compulsory medical examination of candidates for drivers of wheeled tractors and self-propelled vehicles and mandatory medical re-examination of drivers of wheeled tractors and self-propelled vehicles;
the procedure for the provision of medical care on an outpatient, inpatient basis, in a day care unit, as well as outside a healthcare organization;
the procedure for conducting medical examinations;
the procedure for conducting a medical inspection;
the volume and procedure for the provision of medical care to patients by medical workers with secondary specialized medical education;
the procedure for the creation and operation of medical consulting and other commissions;
the procedure for informing the population about the provision of medical care in health care organizations and the procedure for referral to receive medical care;
in coordination with the Ministry of Labor and Social Protection, the procedure for conducting mandatory medical examinations of workers, as well as extraordinary medical examinations in case of deterioration of their health;
in cooperation with the Ministry of Defense, the procedure for medical examination of minors entering the Suvorov Military School;
Republican formulary of medicinal products;
Republican formulary of medical devices;
a list of diseases and contraindications that impede the operation of power-driven vehicles, self-propelled vehicles, as well as the conditions under which persons on medical indications are allowed to drive;
a list of medical contraindications to work in the professions (positions) of employees of public railway transport organizations that directly support the transportation process, as well as a list of methods of mandatory medical examination for persons employed in the professions (positions) of employees of public railway transport organizations directly providing the transportation process, preliminary (upon admission to work) mandatory medical examinations for employees of public railway transport organizations directly providing the transportation process, periodic (during employment) mandatory medical examinations;
in coordination with the Ministry of Labor and Social Protection, a list of medical indications and medical contraindications for providing citizens with technical means of social rehabilitation;
a list of enclosures in a first-aid kit for providing medical care to children in health camps, with the determination of the order of its completion;
list of medical indications for medical and genetic counseling and diagnostics of citizens;
list of medical indications for ultrasound examination of the fetus in the medical genetic center (department, consultations);
list of medical indications for invasive prenatal diagnostics for pregnant women;
lists of diseases, in the presence of which persons cannot be adoptive parents, foster parents, parent-educators of a family-type children's home, children's village (town), caretakers and trustees;
8.86. determines:
the procedure for rendering medical assistance to citizens of the Republic of Belarus outside their place of residence (place of stay);
the procedure for the provision of sociomedical and palliative medical care, as well as a list of medical indications and medical contraindications for the provision of sociomedical and palliative care;
the procedure for passing a medical examination by persons entering training in cadet schools, and a list of medical contraindications for training in cadet schools;
the procedure for medical examination of ship drivers of small motor boats, the engine power of which exceeds 3.7 kilowatts (5 horsepower), and a list of medical contraindications that impede the operation of small motor boats, the engine power of which exceeds 3.7 kilowatts (5 horsepower), as well as conditions subject to which persons on medical indications are admitted to operate such vessels;
the procedure for appointment and conducting medical and genetic counseling and diagnostics of citizens in public health institutions;
the procedure for giving written consent of the patient or persons specified in part two of Article 18 of the Law of the Republic of Belarus "On Health Care" to the processing of personal data of the patient and information constituting medical secrets in information systems, information resources, databases (banks) of data and (or) registries (registers) in healthcare, the form of this consent and the form of refusal by the patient or specified persons to process such personal data and information;
8.87. determines:
the procedure for organizing the activities of the ambulance service;
Instruction on the procedure for the temporary disability examination;
in coordination with the concerned state bodies, the procedure and conditions for placing children in the infant orphanage and discharge from it;
Regulation on the infant orphanage;
8.9. organizes medical support for traffic safety and operation of public railway transport;
8.91. establishes, in coordination with the Ministry of Transport and Communications:
the procedure for organizing medical services for employees of public railway transport directly supporting the transportation process;
the procedure for conducting preliminary (upon admission to work) compulsory medical examinations of persons employed in the professions (positions) of employees of public railway transport organizations that directly provide the transportation process, and periodic (during employment) compulsory medical examinations of employees of public railway transport organizations directly supporting the transportation process, as well as a list of professions (positions) of such workers;
the procedure for conducting pre-trip or pre-shift medical examinations of employees of public railway transport organizations directly supporting the transportation process;
8.92. organizes medical support for flights of civil aircraft, including:
medical examination of civil aviation personnel;
conducting pre-flight (pre-shift) medical examinations of civil aviation personnel;
medical supervision of civil aviation personnel during the period between medical examinations;
timely provision of necessary medical assistance to civil aviation personnel, aircraft passengers and other persons in the territory of the airport;
carrying out sanitary and anti-epidemic measures;
psycho-physiological training of civil aviation personnel;
8.10. develops state minimum social standards in the field of health care and monitors their implementation;
8.11. conducts a unified state policy in the field of industrial production of medicinal products;
8.12. coordinates the activities for organizing the study, summary and dissemination of domestic and foreign best practices in the field of industrial production of medicinal products;
8.13. organizes and monitors the provision of the population and healthcare organizations with medicinal products, medical devices and medical equipment, spare parts for them;
8.131. conducts a comprehensive analysis and marketing research of the pharmaceutical market, the market for medical devices and spare parts for them, analysis of the practice of pricing medicinal products, medical devices and spare parts for them;
8.14. conducts State Registration (confirmation of State Registration) of medicinal products, conditional State Registration (confirmation of conditional State Registration) of medicinal products, State Registration of medicinal products in a simplified manner, amendments to the master file, formation of the State Register of Medicines of the Republic of Belarus, as well as registration (registration confirmation) and other procedures related to the registration of medicinal products within the framework of the Eurasian Economic Union;
8.141. determines:
a package of preliminary technical works related to the conduct of examinations, approbation of methods for quality control of a medicinal product and quality control of this medicinal product using such techniques, other studies preceding State Registration (confirmation of State Registration) of medicinal products, conditional State Registration (confirmation of conditional State Registration) of medicinal products, State Registration of medicinal products under simplified procedure, amendments to the master file, the procedure for organizing and carrying out these works;
a package of examinations carried out during registration (confirmation of registration) and other procedures related to the registration of medicinal products within the framework of the Eurasian Economic Union, the procedure for their organization and conduct;
the procedure for technical support for maintaining the State Register of Medicines of the Republic of Belarus;
8.142. determines:
regulations on the Commission on medicinal products and determines its composition;
regulation on an Independent Ethics Committee;
Good Pharmacy Practice;
Good Storage Practice for medicines;
Good Manufacturing Practice;
inspection plan (pharmaceutical inspection) for compliance with Good Pharmacy Practice in the field of medicine circulation;
8.143. creates the Pharmaceutical Inspectorate of the Ministry of Health and approves its organizational structure;
8.15. approves general and particular pharmacopeial articles included in the State Pharmacopoeia of the Republic of Belarus;
8.16. conducts State Control over the quality of medical devices and medical equipment;
8.17. determines:
a list of testing laboratories accredited in the National Accreditation System of the Republic of Belarus for testing medicinal products;
the procedure and conditions for quality control of medicinal products, including those manufactured in a pharmacy before sale, as well as medicinal products in circulation in the territory of the Republic of Belarus;
the procedure and cases of inspection (pharmaceutical inspection) of industrial production of medicinal products for compliance with the requirements of Good Manufacturing Practice;
requirements and procedure for certification of authorized persons of manufacturers of medicinal products of the Republic of Belarus;
the procedure for the formation and maintenance of the Register of Authorized Persons of medicinal products manufacturers of the Republic of Belarus;
procedure for the formation and maintenance of the Register of Pharmaceutical Inspectors of the Republic of Belarus;
the procedure and conditions for the inspection (pharmaceutical inspection) of the pharmacy manufacture of the identified low-quality medicinal product for compliance with the requirements of Good Pharmacy Practice and Pharmacopoeia Articles of the State Pharmacopoeia of the Republic of Belarus;
the procedure and conditions for conducting clinical trials of drugs, medical devices, biomedical cell products, including the procedure for admitting medical and pharmaceutical workers to conduct them;
the procedure and conditions for the inspection (pharmaceutical inspection) of clinical trials of medicinal products for compliance with the requirements of the Rules of Good Clinical Practice of the Eurasian Economic Union;
the procedure for organizing the pharmacovigilance system and the procedure for inspecting (pharmaceutical inspection) for the compliance of the organization and functioning of the pharmacovigilance system of holders of the registration certificate with the requirements of the Rules of Good Pharmacovigilance Practice of the Eurasian Economic Union;
the procedure and conditions for informing medical and pharmaceutical workers by representatives of manufacturers of medicinal products about medicinal products included in the State Register of Medicinal products of the Republic of Belarus or in the Unified Register of registered medicinal products of the Eurasian Economic Union;
the procedure and conditions for maintaining the list "A", which includes medicinal products, the toxicological properties of which pose a potential danger to human health and require special storage conditions;
cases and procedure for retail sale of medicinal products in places where international thematic exhibitions, international sport or cultural events are held;
the procedure for retail sale of medicinal products by a medical worker of a state healthcare organization or its structural unit located in rural settlements, as well as by such a medical worker during field medical examinations of the population;
List of Essential Medicines;
List of Medicines to be sold without a doctor's prescription;
the procedure for a doctor to prescribe medicines, including in the form of an electronic document, and forms of doctor's prescriptions for medicines, with the exception of the procedure for issuing doctor's prescriptions for medicines and forms of doctor's prescriptions for preferential, including free medicines;
requirements for the documents that make up the master file;
criteria for trade names of medicinal products;
the procedure for medical and pharmaceutical workers to submit information on identified adverse reactions to medicinal products;
in coordination with the Ministry of Labor and Social Protection and the Ministry of Finance:
tariff categories, lists of incentive (except for bonuses) and compensatory payments, their amounts (except for the allowance for work experience in budgetary organizations) and the procedure for making such payments for the positions of medical, pharmaceutical workers, as well as employees employed in healthcare and pharmaceutical activities, regardless of departmental subordination of budgetary organizations;
lists of incentive and compensatory payments, as well as the amount and procedure for making these payments to employees of budgetary organizations subordinated to and (or) included in the system of the Ministry of Health, as well as employees of budgetary organizations subordinate to local executive and regulatory bodies related to the sphere of activity of the Ministry of Health;
8.18. organizes the implementation of state pharmaceutical supervision over the compliance of the inspected entities with the requirements of the legislation on the circulation of medicines, including in terms of the conditions of industrial production, pharmacy production, sale, storage, transportation and medical use in healthcare organizations;
8.19. organizes and (or) conducts inspection (pharmaceutical inspection) of the stages (processes) of medicine circulation for compliance with the requirements of Good Pharmacy Practice in the field of medicine circulation;
8.191. conducts organizational and methodological guidance for conducting inspections for compliance with the Rules of Good Distribution Practice within the framework of the Eurasian Economic Union;
8.192. issues an opinion on compliance with the Rules of Good Distribution Practice within the framework of the Eurasian Economic Union;
8.20. makes a decision:
on the suspension of the sale and medical use of medicinal products;
on the withdrawal from circulation of medicinal products, medical devices, biomedical cell products;
on the resumption of the sale and medical use of the medicinal product;
on the prohibition of the activities of a legal entity related to industrial production, quality control and sale of a medicinal product, if, during an inspection (pharmaceutical inspection) of industrial production of medicinal products, facts are revealed that pose a threat of harm to the life or health of the population;
8.21. organizes a pharmacovigilance system;
8.211. conducts monitoring of adverse reactions to biomedical cell products used in the provision of medical care to patients;
8.22. establishes lists of enclosures into first-aid kits and medicine boxes as well as determines the order they shall be completed;
8.221. establishes the nomenclature of dosage forms;
8.23. excluded;
8.231. determines the procedure for exercising state control over the production, storage, sale and quality of medical devices (medical devices and medical equipment);
8.24. establishes requirements for the premises of pharmacy warehouses, pharmacies, and also determines the categories of pharmacies;
8.241. excluded;
8.242. conducts State Registration of biomedical cell products, as well as maintains the State Register of biomedical cell products of the Republic of Belarus;
8.243. determines the package of preliminary technical works related to the conduct of examinations, inspections, tests and other studies preceding the state registration of biomedical cell products, amendments to the master file for biomedical cell products previously registered in the Republic of Belarus, the procedure for organizing and carrying out these works, as well as the procedure for technical support for maintaining the State Register of Biomedical Cell Products of the Republic of Belarus;
8.244. approves the regulation on the commission on biomedical cell products and its composition;
8.25. conducts State Registration (re-registration) of medical devices and medical equipment, maintains the State register of medical devices and medical equipment of the Republic of Belarus, as well as registration, amendments to the master file and other procedures related to the registration of medical devices within the framework of the Eurasian Economic Union;
8.251. determines the package of preliminary technical works related to the conduct of examinations, inspection of industrial production of medical devices and medical equipment, tests and other studies preceding State Registration (re-registration) of medical devices and medical equipment, amendments to the master file for medical devices and medical equipment previously registered in the Republic of Belarus, the procedure for organizing and carrying out these works, as well as the procedure for technical support for maintaining the State Register of Medical Products and Medical Equipment of the Republic of Belarus;
8.252. approves the regulation on the commission for medical devices and medical equipment and its composition;
8.253. determines the organization authorized to carry out a set of technical work related to the conduct of examinations, inspection of the production of medical devices, tests and other studies for registration, amending the master file and other procedures related to the registration of medical devices within the framework of the Eurasian Economic Union;
8.254. makes a decision on classifying products as medical devices and medical equipment and determines the criteria and procedure for classifying products as medical devices and medical equipment;
8.26. approves the procedure for organizing maintenance and repair of medical equipment;
8.27. carries out in the prescribed manner the issuance of:
special permits (licenses) for medical, pharmaceutical activities and activities related to the circulation of narcotic drugs, psychotropic substances and their precursors, forms and maintains registers of issued special permits (licenses);
conclusions (permits) for the import of unregistered medicinal products intended for State Registration, use as exhibition samples without the right to their further sale, provision of medical care according to the vital indications of a specific patient or provision of medical care to a limited contingent of patients with proven ineffectiveness or intolerance to registered medicinal products, either with orphan (rare) diseases and (or) life-threatening diseases, or with severe disabling diseases, providing patients with early access to new methods of treatment;
conclusions (permits) for the import of registered and unregistered medicinal products intended for preclinical (nonclinical) studies, confirmation of State Registration without the right to their further sale, clinical trials (trials), prevention and elimination of the consequences of natural and man-made emergencies, including epidemic diseases, as well as imported as foreign gratuitous aid;
registration certificate based on the results of State Registration (confirmation of State Registration) of a medicinal product, State Registration of medicinal products in a simplified manner or conditional State Registration (confirmation of conditional State Registration) of a medicinal product;
a document (certificate) confirming the compliance of the industrial production of medicinal products with the requirements of Good Manufacturing Practice and (or) the requirements of the Rules of Good Manufacturing Practice of the Eurasian Economic Union;
pharmaceutical product certificate;
permits to conduct clinical trials (studies) of medicinal products;
conclusions (permits) for the import into the customs territory of the Eurasian Economic Union of plant protection agents and other persistent organic pollutants to be used in laboratory-scale studies and as a reference standard, as well as their duplicates;
8.28. exercises control, within its competence, over the activities of legal entities and individual entrepreneurs who have special permits (licenses) issued by the Ministry of Health for medical, pharmaceutical activities as well as activities related to the circulation of narcotic drugs, psychotropic substances and their precursors;
8.29. organizes and implements, within its competence, State Control over the circulation of narcotic drugs, psychotropic substances and their precursors;
8.291. establishes the procedure for the acquisition, sale, release (distribution) of narcotic drugs and psychotropic substances in health care organizations and their structural units for medical purposes;
8.30. develops and approves, in coordination with the Ministry of Internal Affairs and the State Committee for Forensic Expertise, a republican list of narcotic drugs, psychotropic substances and their precursors, subject to State Control in the Republic of Belarus;
8.301. organizes, in cooperation with the Ministry of Internal Affairs, educational events aimed at preventing the consumption of alcoholic, low-alcoholic beverages, beer, the consumption of narcotic drugs, psychotropic substances, their analogues, toxic or other intoxicating substances, tobacco products, the use of electronic smoking systems, systems for tobacco consumption;
8.31. organizes State Sanitary Supervision;
8.311. defines a package of preliminary technical works for conducting examinations, tests (studies), assessing the safety of products and related production processes, preceding State Registration and issuing (reissuing, replacing) certificates of State Registration for products, the procedure and conditions for organizing and carrying out these works, as well as the procedure for technical support for maintaining the Register of certificates of State Registration of the Republic of Belarus for goods subject to sanitary and epidemiological supervision (control) at the customs border and the customs territory of the Eurasian Economic Union;
8.312. issues permits for work with potentially pathogenic microorganisms and pathogenic biological agents;
8.313. conducts accreditation of legal entities to carry out a toxicological and hygienic assessment of plant protection agents subject to State Registration;
8.314. approves draft technical regulations of the Republic of Belarus and the Eurasian Economic Union, establishing requirements for the safety and harmlessness of products, processes related to the life cycle of products, for the life and health of the population;
8.315. issues conclusions on standard education plans in cases determined by legislative acts;
8.316. coordinates the implementation of health measures provided for by the International Health Regulations;
8.32. approves:
sanitary norms and rules;
in cooperation with the Ministry of Agriculture and Food, the State Committee for Standardization, the Belarusian State Concern of the Food Industry "Belgospischeprom", other concerned government bodies, the regulation on the procedure and conditions for the State Sanitary and Hygienic Examination, with the exception of the State Sanitary and Hygienic Examination of the activities of a business entity for the production of food products;
a list of bodies and institutions carrying out State Sanitary Supervision, authorized to conduct State Registration of products;
a list of products that pose a potential danger to the life and health of the population;
in cooperation with the Ministry of Labor and Social Protection, the Ministry of Natural Resources and Environmental Protection, the Ministry of Agriculture and Food, the Ministry of Anti-monopoly Regulation and Trade, the Ministry of Education, the Ministry of Housing and Communal Services, the Ministry of Defense, the Ministry of Internal Affairs, Committee for State Security, the State Border Committee, the Property Management Directorate of the President of the Republic of Belarus, the Committee on National Statistics, local executive and administrative bodies, regulations on the procedure for conducting social and hygienic monitoring;
regulations on the procedure for conducting sanitary and epidemiological audit;
8.33. establishes the procedure for conducting state sanitary and epidemiological regulation;
8.331. determines:
the procedure for registering cases of infectious diseases and suspected infectious diseases by healthcare organizations;
the procedure for conducting risk analysis;
methodology for the development of sanitary norms and rules, hygienic standards;
8.332. establishes:
a list of paid sanitary and epidemiological services provided in the prescribed manner by organizations, individuals, including individual entrepreneurs, bodies and institutions exercising State Sanitary Supervision, state bodies managing activities in the field of sanitary and epidemiological well-being of the population, medical scientific organizations;
a list of potentially pathogenic microorganisms and pathogenic biological agents;
the procedure and safety requirements for the recording, storage, transfer and transportation of potentially pathogenic microorganisms and pathogenic biological agents;
the nomenclature of goods, works and services necessary for carrying out preventive measures against the spread of socially dangerous diseases, the human immunodeficiency virus;
8.34. organizes preventive immunizations and vaccinations;
8.35. ensures the maintenance of the Register of certificates of State Registration of the Republic of Belarus for goods subject to sanitary and epidemiological supervision (control) at the customs border and in the customs territory of the Eurasian Economic Union;
8.351. conducts State Registration of chemical products, notifies new chemicals, and also maintains the national part of the Register of Chemicals and Mixtures of the Eurasian Economic Union in accordance with the requirements of the technical regulation of the Eurasian Economic Union "On the safety of chemical products";
8.352. determines the package of preliminary technical works related to the conduct of examinations, tests and other studies preceding the State Registration of chemical products, notification of new chemicals, the procedure for organizing and carrying out these works, as well as determines the organization, authorized to conduct them and to maintain the national part of the Register of Chemicals and Mixtures of the Eurasian Economic Union in accordance with the requirements of the technical regulations of the Eurasian Economic Union "On the safety of chemical products";
8.36. gathers health statistics in accordance with the legislation, reconciles data on deaths with data from medical certificates of death (stillbirth) received by the territorial bodies of state statistics;
8.37. develops and establishes forms of medical documents, approves instructions for their filling;
8.38. in cooperation with the Ministry of Labor and Social Protection, establishes the forms of the medical certificate of incapacity for work and certificate of temporary incapacity for work, determines the procedure for their issuance and registration;
8.381. organizes, in the manner prescribed by law, the issuance, registration and production of forms of the medical certificates of incapacity for work, and also establishes the procedure for the provision and use of forms of the medical certificates of incapacity for work;
8.39. conducts forecasting and assessment of the sanitary and epidemiological situation in areas of emergency situations, develops and carries out sanitary and anti-epidemic measures;
8.391. analyzes the effectiveness of measures to prevent the development of antibiotic resistance in healthcare organizations, medical scientific organizations, and other organizations carrying out medical activities;
8.40. ensures the readiness of specialized units of emergency medical care, organizes work to provide such assistance in emergency areas;
8.41. creates stocks of medical equipment and medicinal products necessary for emergency management;
8.42. coordinates the work on the evacuation of injured persons from emergency zones;
8.43. collects, summarizes, analyzes and presents, within the framework of the functioning of the information management system of the State System for the Prevention and Elimination of Emergencies, data on injured persons in emergency zones;
8.44. develops methodological foundations of education and training of the population to provide first aid in emergency situations;
8.45. organizes and implements, in accordance with the legislation, activities to minimize the medical consequences of the disaster at the Chernobyl nuclear power plant, including conducting medical examination of the population;
8.46. creates a unified state system for monitoring and recording radiation doses to the population and ensures its functioning;
8.47. evaluates the medical consequences of radiation exposure of the population;
8.471. manages the activities of subordinate organizations in the field of protecting the population and territories from natural and man-made emergencies, ensuring fire and industrial safety of organizations belonging to the Ministry of Health system by analyzing their work and developing proposals to improve its efficiency within the powers provided for by legislative acts;
8.48. organizes and coordinates research and development work in the field of health care, the implementation of educational programs of postgraduate education of I and II levels in institutions of the state health system;
8.49. secures the continuity of scientific and practical activities in the field of health care and industrial production of medicinal products;
8.50. takes, within the limits of its competence, participation in scientific forums, conferences, seminars, symposia and other events, including those held by international organizations;
8.51. develops and approves:
standards for the amount of medical care to the population by type of delivery;
staff standards for medical, pharmaceutical, pedagogical and other employees of bodies and organizations of the state health care system and the procedure for their application;
standard hours, material consumption rates, standards of service in public health organizations;
in cooperation with the Ministry of Finance, norms and standards for material and technical, medicinal, staffing provision, as well as food standards, provision of special clothing and footwear, sanitary clothes, soft stock in public health institutions, the procedure for providing sanitary clothes;
standard hours and material consumption rates for paid medical services provided by legal entities, regardless of their form of ownership and subordination, as well as by individual entrepreneurs;
nomenclature of positions of medical, pharmaceutical workers and profiles of medical, pharmaceutical specialties, lists of internship specialties, clinical residency;
standards of medical ethics and doctor-patient relationship;
8.511. establishes, in accordance with the legislation, the number of employees of state institutions directly subordinate to the Ministry of Health;
8.52. determines the requirements for occupying the positions of medical and pharmaceutical workers;
8.53. develops and implements a unified economic policy in the field of health care, ensures control over its implementation;
8.54. in accordance with the established procedure, carries out foreign economic and other international activities, provides assistance to state organizations subordinate to the Ministry of Health (hereinafter referred to as Subordinate Organizations) in establishing international relations;
8.55. issues permits for the implementation of international research projects, the object of research of which is the state of health of the population of the Republic of Belarus;
8.56. represents, within its competence, the interests of the Republic of Belarus at the international level, establishes and develops relations with health authorities of other states, the World Health Organization, and other international organizations;
8.57. develops draft international treaties of the Republic of Belarus on issues falling within the competence of the Ministry of Health;
8.58. interacts with local executive and administrative bodies in solving sanitary-epidemiological, economic, social and other problems related to the activities of healthcare organizations, takes joint measures with regional executive committees and the Minsk City Executive Committee to improve the activities and develop the healthcare sector and industrial production of medicinal products;
8.59. coordinates, in accordance with the legislation, the provisions on the head health departments of the regional executive committees, the health committee of the Minsk City Executive Committee;
8.591. approves model regulations on structural (separate) subdivisions of health care organizations and other organizations carrying out medical and pharmaceutical activities;
8.60. conducts state management of labor protection in the field of health care and industrial production of medicinal products;
8.61. develops and implements a system of measures to improve working conditions, prevent industrial injuries, occupational diseases;
8.62. organizes training and knowledge testing of managers and specialists of Subordinate Organizations on labor protection issues;
8.63. determines the structure and scope of training of medical, pharmaceutical workers, taking into account the needs of healthcare organizations of the Republic of Belarus, as well as the group of positions of medical, pharmaceutical workers, providing for the performance of related labor functions;
8.64. annually, in coordination with the Ministry of Education, sets target figures for admission to state institutions of higher education and state institutions of secondary specialized education that train personnel in the education profile "Healthcare", and also informs the Ministry of Education, educational institutions, organizations interested in training personnel of the specified profile, the number of places to get education on the basis of targeted training;
8.65. coordinates the rules for admission to subordinate state institutions of higher education training personnel in the education profile "Healthcare";
8.66. establishes the specifics of teaching activities by specialists with higher and (or) secondary specialized medical, pharmaceutical education, in educational institutions and (or) other state organizations subordinate to the Ministry of Health;
8.67. determines the procedure for attracting and admitting persons who are mastering educational programs of secondary specialized, higher, postgraduate education and additional education for adults in the specialties of the education profile "Healthcare", to be involved in the provision of medical care, to engage in activities related to the circulation of medicinal products, pharmaceutical substances and herbal substances;
8.68. organizes and determines the procedure for advanced training, internships and retraining of medical and pharmaceutical workers in the field of health care and industrial production of medicinal products;
8.69. determines the procedure for assignment (reduction, deprivation) of qualification categories to medical, pharmaceutical workers, other persons holding the positions of medical and pharmaceutical workers in the prescribed manner;
8.70. determines the procedure for the development of regional plans of state guarantees for providing citizens of the Republic of Belarus with affordable medical care;
8.71. conducts planning of expenses for the maintenance of Subordinate Organizations, the property of which is in republican ownership;
8.72. determines the amount of financing and material and technical support of Subordinate Organizations within the allocated budgetary funds;
8.73. manages the activities of the organizations included in the system of the Ministry of Health by regulating their activities and exercising the powers of the owner, analyzing the efficiency of these organizations and developing proposals for improving;
8.74. carries out management of Subordinate Organizations, ensuring, together with the executive heads of these organizations, their effective performances;
8.75. implements, in accordance with the legislation, the rights to own, use and dispose of property in republican ownership;
8.76. takes measures in accordance with the procedure established by the legislation to ensure the effective use of state property assigned to Subordinate State Organizations on the basis of the right of economic management or operational management of state property;
8.77. considers, within its competence, in the manner prescribed by law, appeals (proposals, applications, complaints) of citizens, including individual entrepreneurs, and legal entities (hereinafter referred to as Appeals), takes measures to improve this kind of work, conducts personal reception of citizens, their representatives, representatives of legal entities on issues within the competence of the Ministry of Health;
8.78. excluded;
8.79. excluded;
8.80. for each case of inappropriate consideration of Appeals by the head health departments of the regional executive committees and the health committee of the Minsk City Executive Committee, state organizations subordinate to the Ministry of Health, regional centers of hygiene, epidemiology and public health, the Minsk City Center for Hygiene and Epidemiology, sends notices to their executive heads with a request of disciplinary action against officials who have committed a violation the procedure for considering Appeals;
8.81. coordinates, in the prescribed manner, work on upgrading and replenishing the facilities and resources of organizations of the Ministry of Health with the attraction of the necessary investments, on energy saving in the field of healthcare and industrial production of medicinal products, as well as maintaining of buildings and structures of healthcare facilities;
8.811. in accordance with the established procedure, forms an off-budget centralized investment fund, monitors the targeted use of the resources of this fund;
8.82. participates in the implementation of a unified state policy in the field of accounting and reporting;
conducts methodological management of accounting and reporting in organizations carrying out such types of economic activity in the field, in which, in accordance with this Regulation, the Ministry of Health conducts state regulation and management;
adopts, in coordination with the Ministry of Finance, regulatory legal acts establishing the specifics of accounting and reporting in organizations engaged in economic activities in the field, in which, in accordance with these Regulations, the Ministry of Health conducts state regulation and management;
in coordination with the Ministry of Finance, develops and adopts regulatory legal acts governing the procedure for carrying out activities with precious metals in the field of health care;
8.83. conducts in the prescribed manner purchases of goods (works, services) at the expense of the republican budget within the estimate for the next financial year;
8.84. within its competence:
participates in the development and implementation of an external emergency plan;
coordinates technical normative legal acts in the field of atomic energy use;
introduces restrictions on economic activities in the sanitary protection zone and the observation zone established around the area of the nuclear installation and (or) the storage facility for nuclear materials and radioactive waste;
develops hygienic standards, specific sanitary and epidemiological requirements:
to the maintenance and operation of radiological objects, facilities for the use of atomic energy, facilities that are sources of non-ionizing radiation, facilities of the agro-industrial complex and industrial facilities whose activities are potentially dangerous for the population, healthcare organizations, other organizations and individual entrepreneurs engaged in medical, pharmaceutical activities, educational institutions, therapeutic resort and recreational organizations, social service institutions, hostels and other places of residence, sources and systems of drinking water supply, as well as facilities under construction and reconstruction;
to the establishment of sanitary protection zones of objects having impact on human health and the environment, the organization and implementation of sanitary and anti-epidemic measures, procedures for their control, working conditions of employees;
8.85. participates in the creation and functioning of the Uniformity measurement system of the Republic of Belarus, creates a metro-logical service and determines the procedure for its activities, organizes the development of measurement techniques (methods);
8.86. approves, in coordination with interested parties, the regulation on the Interdepartmental Commission on Medical, Psychological and Social Rehabilitation of Persons with Sex Denial Syndrome under the Ministry of Health and its composition;
8.861. establishes the procedure for the work of a special medical commission of a healthcare organization providing drug dependency treatment as well as medical examination of persons sent to medical and labor dispensaries;
8.862. determines:
the procedure for conducting individual preventive work with minors whose consumption of narcotic drugs, psychotropic substances, their analogues, toxic or other intoxicating substances as well as the use of alcoholic, low-alcoholic beverages or beer has been established;
the procedure for organizing the activities of offices for the provision of drug dependency treatment to minors;
the procedure for actions of state health organizations when receiving information on the identification of minors whose consumption of narcotic drugs, psychotropic substances, their analogues, toxic or other intoxicating substances as well as the use of alcoholic, low-alcoholic beverages or beer has been established;
8.863. in coordination with the Ministry of Education and the Ministry of Internal Affairs, determines the procedure for the actions of employees of educational or health care institutions as well as internal affairs officers in identifying risk factors for suicidal actions in minors;
8.864. determines the procedure for medical supervision, medical assistance to minors who use narcotic drugs, psychotropic substances, their analogues, toxic or other intoxicating substances, alcoholic, low-alcoholic drinks or beer;
8.865. arranges the production, placement (distribution) of social advertising in order to form a healthy lifestyle, control non-infectious diseases, prevent drunkenness, alcoholism, drug addiction and consumption of tobacco, tobacco products, use of electronic smoking devices, devices for tobacco consumption;
8.866. determines the procedure for conducting a compulsory examination of persons who have committed a crime in order to make a decision on applying compulsory security measures and treatment in accordance with Article 107 of the Criminal Code of the Republic of Belarus;
8.87. determines the procedure for changing and correcting gender at the request of an adult patient in public health organizations;
8.88. determines, in coordination with the Ministry of Education, medical indications and (or) medical contraindications for education, and also establishes a list of contraindications to work in the chosen (received, acquired) specialty (specialization), profession and assigned (assigned) qualifications;
8.89. conducts in cooperation with the Ministry of Education, methodological guidance in the field of psychological assistance;
8.90. determines, in cooperation with the Ministry of Education, the procedure and conditions for the application of methods and techniques for the provision of psychological assistance, as well as a list of methods and techniques for the provision of psychological assistance permitted for use;
8.91. participates:
in the creation of a program for the development of the education system, the work of interdepartmental councils in various areas in the field of education;
in the development of educational standards, teach-ware documentation of educational programs, the National Classifier of the Republic of Belarus "Specialties and Qualifications";
in the formation of a data-bank of documents on education;
8.92. develops a long-term plan for staffing, forecasting the needs of the healthcare sector in personnel;
8.93. within its competence, conducts scientific and methodological support of education;
8.94. in accordance with the procedure established by law, ensures the provision of the first workplace to graduates of state institutions of higher education and state institutions of secondary specialized education providing personnel training programme "Healthcare";
8.95. participates in planning the release of educational publications for state institutions of higher education, state institutions of secondary specialized education and state institutions of additional education for adults providing personnel training programme "Healthcare";
8.96. excluded;
8.961. develops and implements, within its competence, measures to develop the export of medical and other services in organizations of the Ministry of Health;
8.962. determines the procedure for retail sale of goods by medical workers of a state health organization (its structural unit) located in a rural area;
8.963. determines the procedure for participation in public procurement procedures, sale and use of medicinal products and medical devices that are not registered in the prescribed manner;
8.964. determines the procedure for organizing dietary nutrition for patients, students and other persons;
8.97. performs other functions provided by law.
9. The Ministry of Health has the right to:
9.1. in accordance with the established procedure within its competence (if necessary), in coordination with other republican government bodies and (or) in coordination with concerned state bodies (organizations), to adopt regulatory legal acts in the field of health care, psychological assistance and industrial production of medicinal products, as well as in the field of sanitary and epidemiological welfare of the population;
9.2. conclude international treaties within their competence in the manner prescribed by law;
9.3. create commissions, councils, working or expert groups on issues within the competence of the Ministry of Health, approve the relevant regulations and compositions;
9.4. hold conferences, seminars, meetings, congresses and other events on issues within the competence of the Ministry of Health, including international ones;
9.5. request information on issues within the competence of the Ministry of Health from the republican government bodies and other government organizations subordinated to the Government of the Republic of Belarus, local executive and administrative bodies, other organizations, in the manner prescribed by law;
9.6. make, in accordance with the legislation, decisions on the creation, reorganization and liquidation of subordinate organizations, to approve their charters, to make changes and additions to them;
9.7. submit to the Council of Ministers of the Republic of Belarus proposals on the cancellation or suspension of normative legal acts of republican government bodies on issues within the competence of the Ministry of Health;
9.8. delegate powers of organizational, technical and informational nature to subordinate organizations;
9.9. exercise other rights provided for by law.
10. The Ministry of Health is headed by the Minister of Health, appointed and dismissed by the President of the Republic of Belarus.
The Minister has a First Deputy Minister and Deputy Ministers, appointed and dismissed in accordance with the established procedure.
11. The Minister of Health conducts his/her activities in accordance with the Regulation on the Minister of the Republic of Belarus, approved by the Decree of the President of the Republic of Belarus No. 692 dated November 21, 2001.
12. In the Ministry of Health, a Collegium is formed consisting of the Minister (Chairman of the Collegium), the First Deputy Minister and Deputy Ministers. On the resolution of the Council of Ministers of the Republic of Belarus, it may include other senior officials of the central office of the Ministry of Health or Subordinate Organizations, as well as employees of local executive and administrative bodies, other state bodies and organizations, representatives of public associations and other organizations in the field of health care.
The number of the Collegium members shall be approved by the Council of Ministers of the Republic of Belarus.
The Collegium considers topical issues of the development of the healthcare sector, discusses other issues within the framework of the activities of the Ministry of Health and Subordinate Organizations.
The decisions of the Collegium shall be formalized by its resolutions. At the same time, decisions of the Collegium concerning the rights, freedoms and duties of citizens or having an interdepartmental nature are formalized by resolutions of the Ministry of Health, and those concerning the intra-sectoral activities of the Ministry of Health and on licensing issues, generally, by orders of the Minister.
In the event of disagreement between the Minister and the members of the Collegium, the decision shall be made by the Minister which reports it to the Council of Ministers of the Republic of Belarus. The members of the Collegium have the right to inform the Council of Ministers of the Republic of Belarus about their position.
13. Financing of the central office of the Ministry of Health shall be effected on account of the republican budget, and the organizations subordinate to the Ministry of Health - in the manner prescribed by law.
14. The Ministry of Health is a legal entity, has a seal with the image of the State Emblem of the Republic of Belarus and with its name.