Nghị định 75/2017/NĐ-CP chức năng nhiệm vụ quyền hạn cơ cấu tổ chức Bộ Y tế

• Số hiệu: 75/2017/ND-CP
• Loại văn bản: Nghị định
• Nơi ban hành: Chính phủ
• Người ký: Nguyễn Xuân Phúc
• Ngày ban hành: 20/06/2017

THE GOVERNMENT ------------	THE SOCIALIST REPUBLIC OF VIETNAM Independence – Freedom – Happiness ---------------------
No.: 75/2017/ND-CP	Hanoi, June 20, 2017

DECREE

DEFINING FUNCTIONS, TASKS, POWERS AND ORGANIZATIONAL STRUCTURE OF MINISTRY OF HEALTH

Pursuant to the Law on Government Organization dated June 19, 2015;

Pursuant to the Government’s Decree No. 123/2016/ND-CP dated September 01, 2016 defining Functions, Tasks, Powers and Organizational Structures of Ministries and Ministerial-level Agencies;

At the request of the Minister of Health;

The Government promulgates a Decree defining the functions, tasks, powers and organizational structure of Ministry of Health.

Article 1. Position and functions

Ministry of Health is a governmental agency performing the state management of healthcare services, including the following fields and sectors: Preventive medicine; medical diagnosis and treatment, rehabilitation; medical examination, forensic examination and forensic psychiatric assessment; traditional medicine; reproductive health; medical equipment; pharmaceutical products & cosmetics; food safety; health insurance; population; state management of public services within the scope of its management.

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Ministry of Health shall fulfill the tasks and exercise the powers prescribed in the Government’s Decree No. 123/2016/ND-CP dated September 01, 2016 defining Functions, Tasks, Powers and Organizational Structures of Ministries and Ministerial-level Agencies, and the following specific tasks and powers:

1. Submit the following documents to the Government, including bills and draft resolutions of the National Assembly, draft ordinances and draft resolutions of the Standing Committee of the National Assembly, draft decrees of the Government in conformity with the approved annual law-making program or plan of the Ministry as well as other projects and/or schemes as assigned by the Government or the Prime Minister; submit the annual, medium-term and long-term development strategies and/or plans, and nationally significant projects and/or programs in the healthcare and population sector within the scope of its management to the Government or the Prime Minister for consideration as regulated by law.

2. Submit draft decisions, draft directives and other legislative documents in the fields and sectors under its management or as assigned to the Prime Minister for consideration.

3. Promulgate circulars, decisions, directives and other legislative documents on state management of fields and sectors within the scope of its management.

4. Instruct and organize the implementation of legislative documents, strategies, plans, national target programs, and nationally significant projects after obtaining approval; organize propagation, dissemination and education in laws on fields and sectors within the scope of its management as well as supervise the implementation of such laws.

5. With regard to preventive medicine:

a) Formulate and promulgate within its competence or request competent authorities to promulgate legislative documents, professional regulations, national technical standards and regulations in the following sectors:  Monitoring, prevention and control of infectious diseases, HIV/AIDS, non-communicable diseases, occupational diseases, accidents and injuries; inoculation; biosafety in laboratories; border health quarantine; environmental health and hygiene, occupational sanitation, school hygiene and healthcare; drinking water and tap water quality and hygiene; community nutrition; tobacco; insecticidal and germicidal chemicals and preparations for household and medical use;

b) Promulgate, review and modify lists of infectious diseases in groups and list of infectious diseases subject to mandatory use of vaccines and biological products, and organize the provision or vaccines and biological products to eligible entities as per the law;

c) Take charge and cooperate with relevant ministries to promulgate and amend health standards by occupation, the list of diseases requiring long-term treatment under which the employees are entitled to enjoy sickness benefits and the list of occupational diseases under which the employees are entitled to enjoy occupational disease benefits in Vietnam;

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dd) Request competent authorities to make decisions or make decisions within its competence on implementation of epidemic and pandemic prevention and control measures; inspect and assist local agencies and governments in implementing epidemic and pandemic prevention and control measures; formulate and organize the implementation of public health emergency response plans;

e) Conduct border health quarantine activities at border checkpoints; provide timely information and reports on dangerous infectious diseases and public health matters worldwide so as to actively take prevention and control measures;

g) Instruct the appraisal of health impact assessment reports of projects on investment and construction of industrial parks, urban areas or concentrated residential areas, or infectious diseases treatment facilities;

g) Manage, instruct and conduct workplace environment monitoring activities; direct the workplace environment monitoring at industrial parks or clusters posing high risks of occupational diseases; evaluate, monitor and manage harmful factors at workplaces; establish workplace environment monitoring database, announce the list of eligible providers of workplace environment monitoring services and the suspended ones as per the law;  

i) Provide instructions within its competence on management of occupational sanitation, health examination for employees, examination for early detection of occupational diseases and monitoring of employees’ health at workplaces; take charge of managing the issuance of professional and training certificates of occupational health, workplace first aid and emergency skills in accordance with the laws;

k) Instruct the provision of primary healthcare services for people;

l) Issue, re-issue and revoke Certificates of biosafety level 3 and level 4 laboratories, excluding laboratories under the management of Ministry of National Defence;

m) Issue, re-issue, supplement, extend, suspend and revoke registration numbers, import licenses, certificates of free sales of insecticidal and germicidal chemicals and preparations for household and medical use; issue receipt notes of applications for declaration of eligibility to conduct testing or experiment on insecticidal and germicidal chemicals and preparations for household and medical use; issue certificates of approval for advertising contents for insecticidal and germicidal chemicals and preparations for household and medical use as per the law;

n) Organize or authorize affiliated authorities to issue, modify or revoke certificates of eligibility to run HIV confirmatory tests and suspend  HIV confirmatory tests of ineligible HIV testing laboratories;

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p) Manage and instruct treatment for opioid and tobacco addiction nationwide;    

q) Instruct and inspect the compliance with professional regulations and national technical regulations on preventive medicine nationwide;

r) Instruct, inspect and evaluate the implementation of HIV/AIDS prevention and control action programs nationwide.

6. With regard to medical diagnosis and treatment, and rehabilitation:

a) Formulate and promulgate within its competence or request competent authorities to promulgate legislative documents, professional regulations, national technical standards and regulations, and technical – economic norms on medical diagnosis and treatment, blood transfusion safety, nursing, rehabilitation, clinical nutrition, cosmetic surgery, medical examination, forensic examination, and forensic psychiatric assessment in accordance with laws;

b) Appraise and give permission to health facilities to adopt new medical techniques or procedures which are applied in Vietnam for the first time in accordance with laws; 

c) Take charge and cooperate with relevant ministries to perform state management of prices of medical services in accordance with laws;

d) Consistently manage the issuance, re-issuance and revocation of practicing certificates and licenses in medical examination and treatment sector; organize the issuance, re-issuance and revocation of practicing certificates of persons working at health facilities affiliated to the Ministry of Health, and those working at health facilities affiliated to other ministries (except for Ministry of National Defence), and foreigners practicing in medical sector in Vietnam; issue, re-issue, modify and revoke operating licenses of health facilities affiliated to the Ministry of Health, private hospitals and those affiliated to other ministries (except for Ministry of National Defence) in accordance with laws;

dd) Issue certificates of approval for advertising contents for medical diagnosis and treatment services within its competence in accordance with laws;

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7. With regard to traditional medicine:

a) Formulate and submit mechanisms and policies on inheritance, preservation, promotion and modernization of traditional medicine, and combination of traditional medicine and modern medicine to competent authorities for promulgation;

b) Formulate and promulgate or submit legislative documents, professional regulations, national technical standards and regulations on traditional medicine to competent authorities for promulgation;  

c) Issue and re-issue practicing certificates in traditional medicine; issue, re-issue, modify and revoke certificates of family remedies/ medicines and operating licenses of traditional medicine facilities in accordance with laws;

d) Issue certificates of approval for advertising contents for traditional medicine in accordance with laws;

dd) Instruct and inspect the implementation of mechanisms, policies, legislative documents, professional regulations and national technical regulations on traditional medicine, and combination of traditional medicine and modern medicine.

8. With regard to medical equipment and constructions:

a) Formulate and submit national standards on medical equipment to competent authorities for promulgation; Promulgate professional regulations and national technical regulations on medical equipment;

b) Promulgate the list of essential medical equipment for health facilities;

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d) Take charge and cooperate with relevant authorities to instruct and inspect the compliance with regulations on production, trading, classification, provision of technical consultancy, testing and calibration services, management and use of medical equipment;

dd) Take charge and cooperate with relevant authorities to formulate and promulgate technical regulations and standards on designs – model designs of medical constructions; standards on designs of specialized departments/divisions of medical constructions.

9. With regard to pharmaceutical products and cosmetics:

a) Formulate and promulgate or submit legislative documents, professional regulations and national technical regulations on pharmaceutical products and cosmetics, national criteria on medicine, Vietnamese Pharmacopoeia and National Pharmacopoeia to competent authorities for promulgation;

b) Issue, re-issue, modify and revoke pharmacy practice certificates by attending and passing examinations; certificates of eligibility for pharmacy business for facilities manufacturing, importing or exporting drugs or medicinal ingredients, providers of drug/ medicinal ingredient storage services, providers of drug/ medicinal ingredient testing services, providers of clinical trial or bioequivalence study services for drugs; issue, renew, modify and revoke certificates of free sale of drug/ medicinal ingredients, licenses to import/ export drug/ medicinal ingredients, Good Manufacturing Practice (GMP) Certificates, Good Laboratory Practice (GLP) Certificates, Good Storage Practice (GSP) Certificate in accordance with laws; issue and nullify certificates of declaration of enterprise having drugstore chain meeting GPP standards;

c) Issue and revoke Cosmetics Good Manufacturing Practice (CGMP) Certificates; issue receiving numbers of applications for declaration of cosmetics products; issue receiving numbers of applications for declaration of compliance with good agricultural and collection practices for medicinal plants, and certificates of pharmaceutical products for traders in pharmaceutical products or cosmetics in accordance with laws;

d) Manage quality of drugs, medicinal ingredients and cosmetics; make decisions on suspension of sale or recall of drugs, medicinal ingredients and cosmetics in accordance with laws; cooperate with relevant authorities to prevent and fight against production or sale of counterfeit or poor quality drugs, medicinal ingredients and cosmetics as well as the smuggling of drugs, medicinal ingredients and cosmetics;

dd) Organize pharmacovigilance and drug information system; issue certificates of approval for advertising contents for drugs;

e) Take charge and cooperate with Ministry of Finance and other ministries, ministerial-level agencies, the Government's affiliates and Provincial-level People’s Committees to manage the selling prices of drugs in accordance with laws; organize bulk purchasing of drugs at national level and take charge of drug-price negotiation in accordance with laws;

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h) Instruct and inspect the compliance with regulations on pharmaceutical products and cosmetics.

10. With regard to food safety:

a) Take charge of formulating and promulgating or requesting competent authorities to promulgate legislative documents on food safety within the scope of management by Ministry of Health;

b) Take charge or formulating and promulgating national technical regulations or stipulating safe limits and criteria on:  All kinds of foods, micronutrients, food additives, food processing aids, devices and materials for directly packaging or storing foods in accordance with laws;

c) Formulate and request competent authorities to promulgate regulations on general food safety requirements for foods manufacturing and/or trading establishments, and regulations on specific food safety requirements for:  Establishments manufacturing and/or trading functional foods, foods fortified with micronutrients, natural mineral water, bottled water, edible ice, micronutrients, food additives, food processing aids, devices and materials for directly packaging or storing foods, industrial kitchens, restaurants of hotels, resorts, other restaurants, foods and drinks trading establishments and street foods services providers;

d) Designate certification bodies to assess the conformity of foods products, foods additives, food processing aids, devices and materials for directly packaging or storing foods to applicable technical regulations which are promulgated by consulting relevant ministries;

dd) Take charge of propagation, dissemination and education of laws on food safety;

e) Take charge of conducting activities of inspection, risk assessment, prevention, investigation and cooperation in preventing food poisoning and responding to food safety incidents within the scope of its management;

g) Manage the compliance with regulations on food safety in course of production, preparation, processing, preservation, transportation, import, export and trading in functional foods, micronutrient fortified foods (excluding wheat flour, vegetable oil, and micronutrient fortified salt), bottled water, natural mineral water, food additives, micronutrients, food processing aids, devices and materials for directly packaging or storing foods in accordance with laws;

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i) Issue, suspend, revoke and re-issue certificates of approval for advertising contents for: Functional foods, micronutrient fortified foods (excluding wheat flour, vegetable oil, and micronutrient fortified salt), bottled water, natural mineral water, micronutrients, food additives, food processing aids, devices and materials for directly packaging or storing foods and other foods products within the scope of its management;

k) Issue and revoke Certificates of fulfillment of food safety requirements for producers and traders of products within the scope of its management, Good Manufacturing Practice (GMP) Certificates of functional foods, certificates of completion of food safety training programs for owners and persons directly involved in production and trading foods within the scope of its management in accordance with laws; take charge of managing the compliance with regulations on food safety by any producer of foods products of different kinds under the management of two or more ministries one of which is the Ministry of Health;

l) Issue Certificates of Free Sale and Certificates of Origin for:  Functional foods, micronutrient fortified foods (excluding wheat flour, vegetable oil, and micronutrient fortified salt), bottled water, natural mineral water, micronutrients, food additives, food processing aids, devices and materials for directly packaging or storing foods and other foods products within the scope of its management;

m) Issue health certificates and other certificates for exported foods products in accordance with laws;

n) Impose eligibility requirements on foods testing facilities, and designate units to participate in the testing of foods serving state management tasks within the scope of its management; designate qualified units to take charge of reference testing/ arbitration testing and give final testing results in cases where there is a difference between foods testing results provided by foods testing facilities specialized in health sector or not; issue, suspend and revoke certificates of sale of rapid test kits for the purpose of testing for food safety parameters;

o) Designate agencies to take charge of state inspection of food safety of imported foods products within the scope of its management;

p) Instruct, organize and inspect the implementation of laws on foods safety within the scope of its management;

q) Prepare and submit periodic and non-period reports on food safety management on the basis of supervising and consolidating reports submitted by supervisory ministries and local authorities.

11. With regard to population and reproductive health:

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b) Formulate and promulgate or request competent authorities to promulgate legislative documents and national standards on population, family planning and reproductive health; formulate and promulgate population and reproductive health criteria and indicator systems, professional regulations and national technical regulations on reproductive healthcare services, population and family planning services;

c) Give permission to population and family planning consultancy service providers to operate in accordance with laws;

d) Appraise and make decisions on certification of health facilities' eligibility to conduct in vitro fertilization and surrogacy procedures for humanitarian purpose; give permission to health facilities to conduct sex reassignment procedures in accordance with laws;

dd) Instruct and inspect the implementation of legislative documents, professional regulations, national technical regulations, policies, programs and projects on population, family planning and reproductive healthcare services.

12. With regard to health insurance:

a) Formulate and promulgate or request competent authorities to promulgate legislative documents, mechanisms and policies on health insurance;

b) Take charge and cooperate with relevant ministries to promulgate the list of covered drugs, chemicals, medical supplies and medical technical services, payment percentage and conditions;

c) Promulgate the basic health services package covered by the health insurance fund;

d) Promulgate specific regulations on medical techniques, medical examination and treatment process, referrals between health facilities covered by health insurance fund;

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e) Formulate and request competent authorities to adopt solutions for ensuring the balance of health insurance fund;

g) Instruct and inspect the implementation of regulations of the law on health insurance.

13. With regard to environment protection in healthcare sector:

a) Take charge and cooperate with relevant ministries to formulate and request competent authorities to promulgate legislative documents on environment protection in healthcare sector and sanitation in the process of preservation of the dead bodies, lying in state, embalming, bury, cremation and transport of dead bodies or remains in accordance with laws;

b) Organize the appraisal of strategic environmental assessment reports of strategies or plans within the scope of approval by the Ministry of Health; organize the appraisal of environmental impact assessment reports and detailed environment protection schemes of projects whose investment proposals are approved by the Ministry of Health in accordance with laws;

c) Instruct monitoring of environmental impacts of medical activities, classification, storage and management of biomedical waste in health facilities, waste statistics, pollution level assessment, and waste treatment by hospitals and health facilities in accordance with laws;

d) Instruct the implementation of measures to protect human health from climate change, environmental pollution and adverse environmental factors;

dd) Instruct and inspect the implementation of regulations of the law on environmental protection in healthcare sector, management of biomedical waste in health facilities and sanitation in the process of preservation of the dead bodies, lying in state, embalming, bury, cremation and transport of dead bodies or remains in accordance with laws.

14. With regard to management of officials working in medicine, pharmacy and population sectors:

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b) Instruct determination of job positions, payroll and structure of officials according to professional titles in public healthcare service providers;

c) Take charge and cooperate with relevant authorities in formulating, promulgating and amending regulations on standards, conditions, contents and forms of examination or consideration for promotion of professional titles of officials working in medicine, pharmacy and population sectors; organize examinations or consider promoting professional titles of officials working in medicine, pharmacy and population sectors in accordance with laws;

d) Take charge and cooperate with relevant authorities to formulate and request competent authorities to promulgate or amend policies for officials working in medicine, pharmacy and population sectors;

dd) Promulgate detailed regulations on contents, programs, forms and duration of training for officials working in medicine, pharmacy and population sectors in conformity with standards of their professional titles, and instruct and organize the implementation of such regulations.

15. With regard to healthcare personnel training:

a) Formulate and promulgate within its competence or request competent authorities to promulgate legislative documents and plans for healthcare personnel training as well as specific mechanisms and policies on healthcare personnel training and instruct the implementation thereof;

b) Formulate and promulgate qualification criteria for healthcare personnel to use as the basis for construction and development of expected learning outcomes for healthcare personnel training levels; cooperate with Ministry of Education and Training, and Ministry of Labour, War Invalids and Social Affairs to construct expected learning outcomes for each healthcare personnel training vocation and level;

c) Formulate and promulgate requirements for ensuring learning quality and expected learning outcomes for training courses in medical specialties (excluding higher education levels) and ensuring continuous training for healthcare personnel;  

d) Manage training in medical specialties and continuous training for medical personnel in accordance with laws;

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e) Instruct, inspect and evaluate within its competence the implementation of regulations on healthcare personnel training;

g) Stipulate and instruct the organization of examinations for granting practicing certificates in healthcare sector in accordance with laws.

16. With regard to science and technology in healthcare sector:

a) Formulate and request competent authorities to promulgate legislative documents, mechanisms, policies, strategies and plans on scientific research, technological innovation and development, and technology transfer in sectors and fields within the scope of management of Ministry of Health;

b) Manage, instruct and organize biomedical research on human participants;

c) Instruct and inspect the compliance with laws in course of fulfilling science and technology tasks; conducting technology transfer and disseminating/applying findings on scientific research and technological development in sectors and fields within the scope of management of Ministry of Health; give approval and concluding agreements for performance of ministerial-level science and technology tasks;

d) Organize the implementation of regulations of laws on intellectual property and initiative activities within the scope of management of Ministry of Health;

dd) Manage the formulation and promulgation of national technical regulations on healthcare activities in accordance with laws; instruct and inspect the dissemination and compliance with national technical standards and/or regulations in healthcare activities;

e) Organize the implementation of Technical Barriers to Trade (TBT) Agreement with respect to healthcare activities.

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a) Formulate strategies and plans on development and application of information technology to healthcare activities, and organize the implementation of such strategies and plans;

b) Formulate and promulgate technical regulations on development and application of information technology to healthcare activities;

c) Formulate, promulgate and organize the implementation of regulations on electronic healthcare and security of electronic medical information;

d) Formulate and promulgate regulations on application of information technology and shared codes serving the management of medical examination and treatment activities, assessment and payment of expenses of covered medical services;  

dd) Instruct and organize the application of information technology to healthcare activities nationwide.

18. Formulate, instruct and inspect the implementation of programs/plans on healthcare communications and education as well as provision of healthcare-related information.

19. Perform state management of public services in fields and sectors within the scope of its management in accordance with laws; formulate and request competent authorities to promulgate or promulgate within its competence mechanisms and policies on provision of public services in healthcare sector; promulgate technical – economic norms on public healthcare services under the state management; stipulate criteria and standards of quality of public healthcare services; mechanisms for inspection and assessment of quality of public healthcare services and operational efficiency of public health facilities.

20. Take charge and cooperate with relevant authorities to provide emergency aid or treatment for disaster victims.

21. Formulate and organize the implementation of plans on national reserves of drugs, chemicals, medical equipment, means for prevention and elimination of epidemics, disaster recovery according to the list of national reserves approved by the Government and in accordance with laws.

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23. Formulate and instruct the implementation of plans on administrative reform of Ministry of Health based on the objectives and contents of the Master program on state administrative reform adopted by the Government.

24. Manage its organizational apparatus, payroll, officials and public employees; implement salary regimes and policies on preferential treatment, commendation and reward, and enforce disciplinary measures against officials and public employees within the scope of its management in accordance with laws.

25. Conduct international cooperation in sectors and fields within the scope of its management in accordance with laws.

26. Manage financial sources and assigned assets as well as manage the use of allocated state budget in accordance with law regulations.

27. Conduct inspections of the implementation of laws and resolve complaints, denunciations and petitions concerning fields and sectors within the scope of its management; perform anti-corruption actions and handle violations against regulations in sectors and fields within the scope of its management in accordance with laws.

28. Formulate and promulgate the set of statistical indicators and policies on reporting and statistics in healthcare sector in accordance with laws; collect, consolidate, analyze, manage and store statistical records in healthcare sector; establish healthcare database.

29. Perform other tasks and powers as assigned by the Government or the Prime Minister and as prescribed by law.

Article 3. Organizational structure

1. Department of Communications, Emulation and Commendation.

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3. Department of Health Equipment and Works.

4. Department of Health Insurance.

5. Department of Planning and Finance.

6. Organization and Personnel Department.

7. Department of International Cooperation.

8. Legal Department.

9. Ministry Office.

10. Ministry Inspectorate.

11. General Department of Preventive Medicine.

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13. Agency of Food Safety.

14. Health Environment Management Agency.

15. Administration of Science Technology and Training.

16. Agency of Health Examination and Treatment.

17. Traditional Medicine Administration of Vietnam.

18. Drug Administration of Vietnam.

19. Agency of Information Technology.

20. General Office for Population and Family Planning.

21. Health Strategy and Policy Institute.

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23. Journal of Medicine and Pharmacy.

The organizations referred to in Clauses 1-20 of this Article shall assist the Minister of Health in performing the state management functions; the organizations referred to in Clauses 21-23 are administrative units serving the Ministry of Health’s state management functions.

Department of Planning and Finance may organize 05 divisions; General Department of Preventive Medicine may organize 04 divisions and an office; HIV/AIDS Prevention Agency may organize 03 divisions and an office; Agency of Food Safety may organize 05 divisions and an office; Health Environment Management Agency may organize 03 divisions and an office; Administration of Science Technology and Training may organize 02 divisions and an office; Agency of Health Examination and Treatment may organize 05 divisions and an office; Traditional Medicine Administration of Vietnam may organize 03 divisions and an office; Drug Administration of Vietnam may organize 06 divisions and an office; Agency of Information Technology may organize 02 divisions and an office; Ministry Office may organize 05 divisions; Ministry Inspectorate may organize 05 divisions.   

Minister of Health shall be responsible for requesting the Prime Minister to give approval for Decision on defining the functions, tasks, powers and organizational structure of the General Office for Population and Family Planning; promulgate the list of other public service providers affiliated to the Ministry of Health.

Minister of Health shall be responsible for defining the functions, tasks, powers and organizational structures of its affiliated agencies, excluding General Office for Population and Family Planning.

Article 4. Entry into force

This Decree shall come into force as from the date on which it is signed.

This Decree supersedes the Government’s Decree No. 63/2012/ND-CP dated August 31, 2012 defining Functions, Tasks, Powers and Organizational Structure of Ministry of Health.

General Office for Population and Family Planning shall continue performing functions, tasks, powers and organizational structure in accordance with applicable regulations until the Prime Minister makes decision on defining its functions, tasks, powers and organizational structure.

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Ministers, heads of ministerial-level agencies, heads of the Government’s affiliates, Chairpersons of People’s Committees of Central-affiliated Cities or Provinces shall be responsible for implementing this Decree./.

ON BEHALF OF THE GOVERNMENT
PRIME MINISTER




Nguyen Xuan Phuc