Laws of Vietnam

THE GOVERNMENT

DECREES:

Article 1.- Position and functions

The Ministry of Health is a governmental agency performing the function of state management of people's health care and protection, including preventive medicine; medical examination and treatment; functional rehabilitation; medical assessment, forensic examination and psychiatric examination; traditional medicine and pharmacy; pharmacy; cosmetics; food safety and hygiene; medical equipment; health insurance; population and family planning; reproductive health; and state management of public services in the domains under the Ministry's management.

Article 2.- Tasks and powers

The Ministry of Health shall perform the tasks and powers prescribed in the Government's Decree No. 178/2007/ND-CP of December 3, 2007, defining the functions, tasks, powers and organizational structures of ministries and ministerial-level agencies, and the following specific tasks and powers:

1. To submit to the Government bills and draft ordinances and draft resolutions and decrees of the Government according to its approved legislative programs and plans, and other schemes on the domains under the Ministry's management as assigned by the Government.

2. To submit to the Prime Minister for approval strategies, master plans, long-term, five-year and annual plans, national target programs, important works and projects in the domains under the Ministry's state management; and draft decisions and directives of the Prime Minister.

3. To assume the prime responsibility for, and coordinate with the Ministry of Finance in, submitting to the Prime Minister for decision a list of national reserves; to organize the building of national reserves of drugs, chemicals, medical equipment, equipment for prevention and control of epidemics and natural disasters in accordance with law.

4. To promulgate according to its competence decisions, directives and circulars on the domains under the Ministry's state management.

5. To direct, guide, inspect and organize the implementation of legal documents, strategies, plannings and plans and national target programs after they are approved; to communicate, propagate, disseminate and educate about laws on the domains under the Ministry's state management and on health-related issues.

6. Regarding preventive medicine

a/ To submit to competent authorities for decision or decide according to its competence on the implementation of special anti-epidemic measures;

b/ To formulate national standards and submit them to competent authorities for announcement and promulgation regulations on technical decentralization, professional rules, national technical regulations in the areas of prevention and control of infectious diseases, HIV/AIDS, social diseases, non-infectious diseases, occupational diseases, injuries; environmental health, school health, labor sanitation and health; community nutrition; border quarantine; chemicals and preparations used as insecticides and disinfectants in domestic and health domains;

c/ To assume the prime responsibility for, and coordinate with the Ministry of Labor, War Invalids and Social Affairs in, promulgating a list of substances subject to strict labor safety and sanitation requirements and a list of occupational diseases;

d/ To grant, cancel and withdraw circulation registration certificates of chemicals and preparations used as insecticides and disinfectants in domestic and health domains in accordance with law;

e/ To appraise professional contents registered for advertising chemicals and preparations used as insecticides and disinfectants in domestic and health domains;

f/ To direct, guide, examine, supervise and evaluate the observance of professional regulations and national technical regulations in the domain of preventive medicine nationwide;

g/ To act as the standing body of the National HIV/AIDS Committee in HIV/AIDS prevention and control work and in drug and prostitution prevention and control work; to direct, manage, organize, supervise and evaluate the implementation of anti-HIV/AIDS activities nationwide.

7. Regarding medical examination and treatment and functional rehabilitation

a/ To promulgate regulations on conditions for, standards, establishment, merger, reorganization and dissolution of medical examination and treatment establishments;

b/ To formulate national standards and submit to competent authorities for announcement and promulgation regulations on technical decentralization, professional rules and national technical regulations on the areas of medical examination and treatment, convalescence, functional rehabilitation, medical assessment; forensic examination, and psychiatric examination;

c/ To evaluate and permit the application of new techniques in medical examination and treatment, convalescence and functional rehabilitation establishments in accordance with law;

d/ To grant, cancel and withdraw private medicine practice certificates and certificates of eligibility for private medicine practice with respect to private hospitals and foreign-invested private medicine practice establishments in accordance with law;

e/ To direct, guide, examine and evaluate the observance of professional regulations and national technical regulations by medical examination and treatment, functional rehabilitation, medical assessment, forensic examination and psychiatric examination establishments.

8. Regarding traditional medicine and pharmacy

a/ To formulate and submit to competent authorities for promulgation mechanisms and policies for inheriting, preserving, developing and modernizing traditional medicine and pharmacy and combining traditional medicine and pharmacy with modern medicine and pharmacy;

b/ To promulgate professional rules and national technical regulations in the domain of traditional medicine and pharmacy;

c/ To direct, guide and supervise the implementation of policies and laws on traditional medicine and pharmacy combination of traditional medicine and pharmacy with modern medicine and pharmacy;

d/ To grant, cancel and withdraw practice certificates and certificates of eligibility for private traditional medicine and pharmacy practice with respect to private traditional medicine hospitals and foreign-invested private traditional medicine practice establishments in accordance with law.

9. Regarding pharmaceuticals and cosmetics

a/ To promulgate professional rules and national technical regulations on pharmaceuticals and cosmetics; to promulgate the Vietnam Pharmacopoeia and national pharmaceutical book;

b/ To grant, cancel and withdraw pharmacy practice certificates with respect to individuals registering to practice pharmacy with foreign investment; certificates of eligibility for drug trading to drug manufacturing units and drug preservation and testing service establishments; drug circulation permits; drug import and export permits; certificates of satisfaction of standards of good manufacture practice (GMP), good laboratory practice; good storing practice (GSP), good practice of clinical trial of drugs, good practice of raising or cultivation and harvests of drug materials; permits of registration of drug activities in Vietnam to foreign enterprises supplying drugs into Vietnam in accordance with law;

c/ To manage drug and cosmetics quality; to guide and supervise the observation of legal provisions on announcement of cosmetics quality; to prevent and combat production and circulation of fake and poor-quality drugs and cosmetics, and prevent and combat the smuggling of drugs and cosmetics;

d/ To appraise professional contents registered for drug information and advertisement;

e/ To assume the prime responsibility for, and coordinate with the Ministry of Finance and concerned ministries and branches in, performing state management of drug prices; to take measures for stabilizing market prices of drugs; to organize the building and decide on the use of drug reserves;

f/ To direct and organize the provision of guidance on reasonable, safe and effective use of drugs;

g/ To direct, organize, supervise and evaluate the implementation of legal provisions on pharmaceuticals and cosmetics.

10. Regarding food hygiene and safety

a/ To formulate and submit to competent authorities for announcement national standards of food hygiene and safety; to promulgate national technical regulations on food hygiene and safety under the Ministry's state management.

To direct, guide and organize the implementation of national standards of and national technical regulations on food hygiene and safety;

b/ To promulgate lists of and prescribe conditions of food hygiene and safety on: high-risk food; radiation-preserved food and radiation limits; food using genetic technology; food additives, food processing support substances and food directly affecting health;

c/ To promulgate food hygiene and safety conditions in the food processing and consumption and consumption hygiene at restaurants, hotels, supermarket, collective kitchens and street food shops;

d/ To assume the prime responsibility for, and coordinate with concerned ministries and branches in, promulgating substances that contaminate food products (pathogenous microorganisms, chemicals affecting human health). To analyze and assess the risk of food contamination; to prevent and overcome food poisoning and food-borne diseases;

e/ To grant, cancel and withdraw certificates of satisfaction of food hygiene and safety conditions with respect to establishments producing and trading in: functional food, food reinforced with micronutrients, supplementary food, food additives, natural mineral water and cigarettes; and medical certificates for exported food products;

f/ To certify food standard announcement documents for products: bottled natural mineral water, cigarettes, functional food, food reinforced with micronutrients, supplementary food and imported food being food additives, processing support substances, raw materials or thermally treated products in accordance with law; to accredit and certify the hazard analysis and critical control points system (HACCP), good laboratory practice, good hygiene practice and other food-related issues under the Ministry's state management in accordance with law;

g/ To receive and appraise professional contents registered for advertisement of food and food additives for which the Ministry of Health receives dossiers of announcement of food quality, hygiene and safety standards; to supervise, inspect and process information on food hygiene and safety related to health;

h/ To prescribe criteria for and evaluate and accredit qualified laboratories for checking, testing and conducting tests related to food hygiene and safety;

i/ To assume the prime responsibility for, and coordinate with line ministries in, managing imported food products, designating agencies in charge of inspecting imported food hygiene and safety or accredited testing laboratories to conduct related tests;

j/ To direct, guide, inspect, supervise and evaluate the implementation of legal provisions on food safety and hygiene; to conduct specialized inspection of food hygiene and safety;

k/ To act as the standing body of the inter-branch steering committee for food hygiene and safety and exercise the right to make final conclusion on food hygiene and safety.

11. Regarding medical equipment and facilities

a/ To formulate and submit to competent authorities for announcement national standards of medical equipment. To promulgate professional rules and national technical regulations of medical equipment;

b/ To promulgate a list of standard medical equipment for health units and establishments;

c/ To grant, cancel and withdraw import permits for medical equipment directly affecting health on the list issued by the Ministry of Health; to receive dossiers of announcement of quality of medical equipment; to appraise professional contents registered for information and advertisement of medical equipment in accordance with law;

d/ To direct, guide, examine and supervise the implementation of legal provisions on medical equipment;

e/ To assume the prime responsibility for, and coordinate with concerned agencies in, studying and promulgating design standards and model designs for medical facilities;

f/ To guide, supervise and monitor the execution of work construction investment projects under the Ministry's state management.

12. Regarding population and family planning and reproductive health

a/ To assume the prime responsibility for, and coordinate with concerned agencies in, submitting to the Government for promulgation population policies concerning population size, structure, distribution and quality;

b/ To formulate national standards of population and family planning and reproductive health and submit them to competent authorities for promulgation; to issue a system of population criteria and indicators, regulations on technical decentralization, professional rules and national technical regulations on reproductive health, family planning, maternal, child, juvenile, youth and elderly people health care services. To direct, guide and supervise the implementation thereof;

c/ To appraise and permit the provision of counseling services by population and family planning counseling service establishments in accordance with law;

d/ To appraise and permit health establishments to re-determine gender and help couples have babies by scientific methods in accordance with law;

e/ To direct, organize, guide, supervise and evaluate the implementation of policies, programs, schemes, projects and models related to population and family planning and reproductive health care.

13. Regarding health insurance

a/ To assume prime responsibility for, and coordinate with concerned ministries and branches in formulating and submitting to the Government for promulgation legal documents, mechanisms and policies on health insurance;

b/ To promulgate regulations, professional rules and national technical regulations on health insurance;

c/ To promulgate a list of drugs, medical supplies and a list of technical services to be covered by the health insurance fund;

d/ To direct, guide and examine health establishments, organizations and individuals in their observance of legal provisions on health insurance.

14. Regarding health personnel training

a/ To submit to the Prime Minister for approval plans on development of the system of health personnel training and specific and special mechanisms and policies regarding training and employment of health personnel and talents;

b/ To submit to competent authorities for promulgation national technical regulations on infrastructure, human resources and equipment of health personnel training establishments and guide and organize the implementation thereof;

c/ To direct the formulation of training programs and textbooks for health personnel within the training system in the health sector in the form of formal, informal and continuing training;

To manage teaching contents and programs in accordance with law.

d/ To make and implement plans on professional training and retraining of cadres, public employees and civil servants of the health sector and training of health personnel trainers at central and local levels;

e/ To manage the postgraduate specialized training specific to the health sector, including training of First Degree specialists, Second Degree specialists and resident physicians. To guide the development, evaluation and promulgation of training programs and supervise training activities in accordance with law;

f/ To manage medical and pharmaceutical universities and medicine science schools according to regulations of the Government and the Prime Minister.

15. Regarding science and technology

a/ To formulate professional rules and national technical regulations for appraisal, evaluation, take-over test and application of scientific and technological research results in the health sector; regulations on clinical trial of drugs, medical equipment and ethical codes in bio-medical research;

b/ To make short-term and long-term plans and organize the implementation of scientific research plans, application of scientific and technological advances in the domains under the Ministry's state management, management organization and health policies;

c/ To make, and direct the implementation of, plans and regulations on application and development of health information technology; to prescribe conditions on the online operation of health information technology;

d/ To organize the implementation of the treaty on technical barriers in trade (TBT) in the health sector and participate in the system of Enquiry Points on technical barriers in the economic integration related to health.

16. Management of the health sector's public servants in accordance with law:

a/ To submit to competent authorities for promulgation and guide the implementation of specific regimes and policies on recruitment, management and employment of cadres and civil servants in the health sector;

b/ To organize rank promotion examinations for civil servants in the health sector from the doctor or pharmacist rank to the principal doctor or pharmacist rank or equivalent and from the principal rank to the senior rank in accordance with law;

c/ To promulgate professional criteria for titles and ranks of civil servants in the health sector and the structure of ranks of civil servants in the health sector after obtaining evaluation opinions of the Ministry of Home Affairs.

17. Regarding the representation of the owner of state capital in state-invested enterprises

a/ To formulate schemes on rearrangement and reorganization and transformation of ownership of state enterprises under the Ministry's management and submit them to the Prime Minister for decision, and direct and organize the implementation of these schemes after they are approved;

b/ To approve according to its competence or submit to the Prime Minister for approval organization and operation charters, appointment and relief from office of management board members, leading managers and chief accountants of state enterprises not yet equitized under the Ministry's management.

18. To assume the prime responsibility for, and coordinate with concerned ministries and branches in, prescribing criteria for classification and rating of non-business health units. To organize the classification and rating and manage and direct the operation of non-business units attached to the Ministry of Health.

19. To direct, guide and supervise the management and destruction of medical wastes and environmental protection work in the health sector's establishments and environmental protection in burial activities in accordance with law.

20. To assume the prime responsibility for, and coordinate with ministries and branches in preventing and controlling natural disasters and rendering first aid and treatment to their victims.

21. To decide on specific guidelines and measures and direct and guide the implementation of the operation mechanism at public service organizations under the Ministry's state management.

22. To guide and create conditions for associations and non-governmental organizations to participate in activities under the Ministry's state management; to supervise the implementation of state regulations on associations and non-governmental organizations, handle or propose competent state agencies to handle illegal acts of associations or non-government organizations in accordance with law.

23. To decide on and organize the implementation of overall administrative reform plans of the health sector in accordance with the objectives and contents of the overall state administrative reform program already approved by the Government and the Prime Minister.

24. To manage organizational apparatuses, payrolls, cadres, public employees and civil servants, and implement salary regimes and regimes and policies on preferential treatment, commendation and disciplining of cadres, public employees and civil servants under the Ministry's management in accordance with law.

25. To undertake international cooperation in the domains under the Ministry's state management in accordance with law.

26. To formulate and propose mechanisms, policies and solutions related to the health sector's finance. To make its annual budget estimates; to coordinate with the Ministry of Finance in making budget revenue and expenditure estimates for the branches and domains under its management for submission by the Government to the National Assembly. To manage and organize state budget implementation and settlement according to regulations. To evaluate, approve, and examine the execution of, the health sector's development investment projects under the Ministry's management and perform other tasks of managing public property and financial sources assigned by the State in accordance with law.

To socialize and mobilize various financial sources for healthcare work.

27. To inspect and supervise the observance of legal provisions on the domains under the Ministry's state management by organizations and individuals nationwide. To inspect the compliance with policies, laws and tasks by organizations and individuals under its direct management. To settle citizen complaints, denunciations and petitions related to the domains under the Ministry's management; and to organize citizen receptions in accordance with law.

28. To perform other tasks and exercise other powers assigned by the Government and the Prime Minister.

Article 3.- Organizational structure

1. The Health Insurance Department.

2. The Science and Training Department.

3. The Maternal and Child Health Department.

4. The Traditional Medicine and Pharmacy Department.

5. The Medical Equipment and Facilities Department.

6. The Planning and Finance Department.

7. The Organization and Personnel Department.

8. The Legal Department.

9. The International Cooperation Department.

10. The Office.

11. The Inspectorate.

12. The Preventive Medicine and Environment Department.

13. The HIV/AIDS Prevention and Control Department.

14. The Medical Examination and Treatment Management Department.

15. The Drug Administration of Vietnam.

16. The Food Safety and Hygiene Administration.

17. The representative agency of the Ministry of Health in Ho Chi Minh City.

18. The General Department of Population and Family Planning.

19. The Health Strategy and Policy Institute.

20. The Health and Life newspaper.

21. The Practical Medicine journal.

22. The Pharmacology journal.

The Organization and Personnel; Planning and Finance; and International Cooperation Departments, the Inspectorate and the Office may organize sections.

The units defined in Clause 1 thru Clause 18 of this Article shall assist the Minister in performing the state management function, units defined in Clause 19 thru Clause 22 of this Article are non-business units under the Ministry.

The Minister of Health shall submit to the Prime Minister for promulgation regulations on the functions, tasks, powers and organizational structure of the General Department of Population and Family Planning; and issue a list of other remaining non-business units of the Ministry.

Article 4.- Implementation effect

This Decree takes effect 15 days after its publication in "CONG BAO;" to annul the Government's Decree No. 49/2003/ND-CP of May 15, 2003, defining the functions, tasks, powers and organizational structure of the Ministry of Health, and the Government's Decree No. 94/2002/ND-CP of November 11, 2002, defining the functions, tasks, powers and organizational structure of the Population, Family and Children Committee, and all previous provisions contrary to this Decree.

Article 5.- Implementation responsibilities

Ministers, heads of ministerial-level agencies, heads of government-attached agencies, and presidents of provincial/municipal People's Committees shall implement this Decree.