Decree No. 122/2014/ND-CP dated December 25, 2014 of the Government on Health Inspectorate

DECREE

ON THE ORGANIZATION AND OPERATION OF THE HEALTH INSPECTORATE

Pursuant to the December 25, 2001 Law on Organization of the Government;

Pursuant to the November 15, 2010 Law on Inspection;

Pursuant to the Law on Pharmacy dated June 14, 2005;

Pursuant to the Law on infectious disease prevention and control dated November 21, 2007;

Pursuant to the Law on Health Insurance dated November 14, 2008 and the Law on amendments to the Law on Health Insurance dated June 13, 2014;

Pursuant to the Law on Medical examination and treatment dated November 23, 2009;

Pursuant to the Law on Food Safety dated June 17, 2010;

Pursuant to the December 27, 2008 Ordinance on Population and the Ordinance on amending and supplementing Article 10 of the Ordinance on Population dated December 27, 2008;

At the proposal of the Minister of Health,

The Government promulgates the Decree on organization and operation of Health Inspectorate.

CHAPTER I

GENERAL PROVISION

Article 1. Scope of regulation

This Decree provides for the organization and operation of health inspection agencies; inspectors and persons assigned to perform specialized inspection and health inspection collaborators; and responsibilities of agencies, organizations and individuals in health inspection activities.

Article 2. Subject of application

1. Agencies, organizations and individuals subject to the state management by the Ministry of Health and provincial-level Health Departments.

2. Domestic and foreign agencies, organizations and individuals involved in medical activities shall have to abide by the law provisions in the fields under the State management by the Health Ministry and the provincial/municipal Health Services.

Article 3. International treaties application

In case the international treaties which the Socialist Republic of Vietnam has signed or acceded to otherwise provide for the organization and operation of the health inspectorate, the provisions of the international treaties shall apply.

CHAPTER II

ORGANIZATION, TASKS AND POWERS OF HEALTH INSPECTORATE

Article 4. Agencies performing health inspection

1. The state inspection agency:

a) Inspectorate of the Ministry of Health;

b) Inspectorate of Department of Health.

2. Agencies assigned to conduct specialized inspection:

a) General Office for Population and Family Planning; Department of Drug Administration of Vietnam; Health Environment Management Agency; Department of Preventive Medicine; Department of Food Safety (hereinafter collectively referred to as General Department and Department);

b) Population and Family Planning Division, Sub-Department of Safety and Food Hygiene (hereinafter referred to as Sub-department).

3. The Inspectorate of the Ministry of Health, the Inspectorate of the Department of Health has its own seal and account.

Article 5. Tasks and powers of the Inspectorate of the Ministry of Health

The Ministry of Health shall perform tasks and exercise powers specified in Article 18 of the Law on Inspection and Article 7 of the Government s Decree No. 86/2011/ND-CP of September 22, 2011, detailing and guiding a number of articles of the Law on Inspection (below referred to as Decree No. 86/2011/ND-CP ) and the following tasks and powers:

1. Assist the Minister of Health in state management of health inspection.

2. Take charge of or participate in formulating legislative documents as assigned by the Minister of Health.

3. Formulate annual health inspection plans and submit them to the Minister of Health for approval.

4. To guide the Inspectorate of provincial Health Departments and agencies assigned to perform specialized inspection function of the Ministry of Health to elaborate annual plans for health inspection.

5. To act as the standing body of citizen reception work in accordance with law.

6.To sum up and report to the Minister of Health and the Government Inspector General on the results of inspection work; to settle complaints and denunciations; to receive citizens; to prevent and combat corruption within the scope of management of the Ministry of Health according to law.

7. Scientific research, international cooperation on health inspection.

8. Perform other tasks and exercise other powers as prescribed by law or assigned by the Minister.

Article 6. Tasks and powers of the Chief Inspector of the Ministry of Health

Inspectorates of the Ministry of Health shall perform tasks and exercise powers specified in Article 19 of the Law on Inspection and Article 8 of Decree No. 86/2011/ND-CP  and the following tasks and powers:

1. To decide on the establishment of inspection teams according to inspection plans approved by the Health Minister. To decide on extraordinary inspection when detecting agencies, organizations and individuals showing signs of law violation or at the request of the settlement of complaints and denunciations; to prevent and combat corruption as assigned by the Health Minister.

2. To propose the Minister of Health to issue decisions on establishing Inspectorates, inter-sector administrative inspection teams according to approved or extraordinary inspection plans, for complicated cases and which are related to management responsibilities of different levels and sectors; to decide on the establishment of specialized inspection teams under approved or extraordinary inspection plans, for complicated cases and which are related to management responsibilities of many agencies, units, levels and sectors.

3. To assist the Minister of Health in examining, verifying, concluding and proposing the settlement of complaints under the competence of the Minister of Health when so assigned.

4. To organize citizen reception according to law provisions.

5. To assist the Minister of Health in monitoring, inspecting and urging the agencies under the direct management of the Minister of Health in the reception of citizens and the settlement of complaints and the implementation of legally effective decisions on the settlement of complaints.

6. Verify denunciation contents and conclude the verification contents and propose handling measures under the power of the Minister of Health when it is assigned.

7. To examine and conclude on the settlement of denunciations which the heads of agencies under the direct management of the Minister have settled but show signs of law violations; to settle denunciations of these agencies, propose the Minister of Health to consider and re-settle them.

8. Assist the Minister of Health in directing, expediting and inspecting the implementation of anti-corruption work by agencies and units under the direct management of the Minister of Health.

9. Request the Chief Inspector of the Department of Health and heads of agencies affiliated to the Ministry of Health to conduct specialized inspections to report on periodic or ad hoc inspections.

10. Other tasks and powers as prescribed by law.

Article 7. Tasks and powers of the Inspectorate of the Department of Health

Inspectorates of Services of Health shall perform tasks and exercise powers specified in Article 24 of the Law on Inspection and Article 13 of Decree No. 86/2011/ND-CP  and the following tasks and powers:

1. Formulate annual health inspection plans in accordance with the guidance of the Ministry of Health, and submit them to Director of Department of Health for approval; provide instructions for its affiliated Sub-Departments to formulate annual inspection plans.

2. To carry out citizen receptive work in accordance with law.

3. To synthesize and report to directors of provincial/municipal Health Services, the provincial Health Services chief inspectors on inspection results; to settle complaints and denunciations; to prevent and combat corruption within the scope of management of provincial/municipal Health Services according to law provisions.

4. Other tasks and powers as prescribed by law.

Article 8. Tasks and powers of the Chief Inspector of the Department of Health

Inspectorates of Services of Health shall perform tasks and exercise powers specified in Article 25 of the Law on Inspection and Article 14 of the Decree. No. 86/2011/ND-CP  and the following tasks and powers:

1. A decision to set up an inspection team under the inspection plan already approved by the Department of Health.

2.To decide on extraordinary inspection when detecting signs of law violation or when requested by the settlement of complaints and denunciations or prevention and combat of corruption, which are assigned by the directors of the provincial/municipal Health Services.

3. Request the Director of the Provincial Department of Health to issue the decision on establishment of the inspectorate, inter-sector inspection team according to the approved inspection plan or on request.

4. To assist the directors of the provincial/municipal Health Services in examining, verifying, making conclusions and proposing the settlement of complaints falling under the competence of the directors of the provincial/municipal Health Services when they are assigned to do so.

5. To organize the reception of citizens in accordance with law; to assist the directors of the provincial/municipal Health Services in monitoring, inspecting and urging the agencies under the direct management of the directors of the provincial/municipal Health Services in the reception of citizens and the settlement of complaints and the execution of the complaint-settling decisions which have taken legal effect.

6. Verify denunciation contents and make conclusion about verification contents and propose handling measures within the power of the Director of the Department of Health as assigned.

7. To examine and conclude on denunciation settlement, which the heads of the agencies under the direct management of the directors of the provincial/municipal Health Services have settled but show signs of law violations; in case there are grounds to believe that the settlement of denunciations by such agencies is at variance with law, to propose the directors of the provincial/municipal Health Services to consider and re-settle them.

8. Request heads of Sub-departments to conduct surprise inspections to submit periodic or ad hoc reports on specialized inspection.

9. Other tasks and powers as prescribed by law.

Article 9. Tasks and powers of General Departments and Departments affiliated to the Ministry of Health assigned to conduct specialized inspection

General Departments and Departments affiliated to the Ministry of Health shall be assigned to carry out the function of specialized inspection on tasks and powers specified in Article 10 of the Decree No. 07/2012/ND-CP  dated February 09, 2012 of the Government on the agencies assigned to carry out the specialized inspection and specialized inspection activities (hereinafter referred to as the Decree No. 07/2012/ND-CP ) and the following tasks and powers:

1. Formulate and send the annual inspection plan within their competence to the Inspectorate of the Ministry of Health for aggregation and submission to the Minister of Health for approval; organize the implementation of the inspection plan after it is approved; cooperate with the Inspectorate of Department of Health in guiding the Sub-Department to carry out the function of annual inspection.

2. To coordinate with the Inspectorate of the Health Services in monitoring and examining the implementation of the inspection conclusions, recommendations and decisions of the branches assigned to conduct specialized inspection.

3. Consolidate and report the results of specialized inspection to the Inspectorate of the Ministry of Health.

4. Other tasks and powers as prescribed by law.

Article 10. Tasks and powers of General Directors, Directors

Heads of agencies affiliated to the Ministry of Health shall be assigned to carry out the function of specialized inspection on duty within their competence specified in Article 11 of the Decree No. 07/2012/ND-CP  and the following tasks and powers:

1. To sanction administrative violations in accordance with law.

2. To propose competent state agencies to amend, supplement or issue regulations to meet management requirements; to propose suspension or cancellation of unlawful regulations detected through inspection work.

3. To assign civil servants to conduct specialized inspection to join inspection teams of the Ministry of Health and concerned inspection agencies upon request.

4. Other tasks and powers as prescribed by law.

Article 11. Tasks and powers of Sub-Departments affiliated to Health Departments assigned to conduct specialized inspection

The Sub-Department assigned to carry out the function of specialized inspection shall perform the tasks and powers specified in Article 10 of the Decree No.07/2012/ND-CP  and the following tasks and powers:

1. Formulate and send the annual inspection plan within their competence to the Inspectorate of Department of Health for aggregation and submission to Director of Department of Health for approval; organize the implementation of the inspection plan after it is approved.

2. Send a consolidated report on results of specialized inspection to Inspectorate of Services of Health.

3. To assign civil servants to conduct specialized inspection to join inspection teams of the Health Service s Inspectorate and concerned inspection agencies upon request.

4. Other tasks and powers as prescribed by law.

Article 12. Tasks and powers of the sub-department directors

The Sub-department shall perform the tasks and exercise the powers specified in Article 11 of the Decree No. 07/2012/ND-CP  and the following tasks and powers:

1. To report and propose directors of provincial-level Health Departments and chief inspectors of provincial-level Health Departments to handle overlapping in the scope, subjects, contents and time of inspection within the specialized management scope of district-level Customs Departments.

2. To propose competent state agencies to amend, supplement or issue regulations to meet management requirements; to propose suspension or cancellation of unlawful regulations detected through inspection work.

3. To sanction administrative violations in accordance with law.

4. Other tasks and powers as prescribed by law.

Article 13. Department of Health shall preside over and cooperate with Departments of Health and Sub departments affiliated to the Ministry of Health in requesting the Provincial Department of Health to organize the inspection.

1. The specialized inspection bureau under the General Department of Population and Family Planning shall be organized under the Legal and Inspection Department: various Departments under the Ministry of Health shall be organized after the model: at the sub-departments organized under the decisions of the competent authorities.

2. A specialized inspection consulting division shall assist the head of the agency assigned to perform specialized inspection function to perform the following tasks:

a) Act as the focal point in coordinating with concerned units and departments under their agencies in formulating inspection programs and plans for submission to heads of their direct managing agencies;

b) To act as the focal point in implementing inspection under plans; to regularly inspect and irregularly inspect when assigned by heads of agencies;

c) Act as the focal point in summarizing, evaluating and reporting on specialized inspection results within the scope and competence of their agencies;

c) Monitoring, urging and examination of the implementation of conclusions, recommendations and handling decisions of heads of agencies assigned to conduct specialized inspection;

dd) To propose the sanctioning of acts of violation as prescribed by law;

e) Perform other tasks assigned by heads of agencies and under law.

CHAPTER III

INSPECTION ACTIVITIES

Article 14. Administrative inspection activities

1. To inspect the implementation of policies, laws, tasks and powers of agencies, organizations and individuals specified in Clause 1, Article 2 of this Decree.

2. Inspectorates of the heads of agencies, organizations or individuals under the Ministry of Health or provincial-level Health Departments.

3. To inspect and settle complaints and denunciations, and prevent and combat corruption in accordance with law.

4. Administrative inspection activities shall be conducted according to inspection teams and law provisions on administrative inspection.

Article 15. Specialized inspection activities

1. To inspect the implementation of policies and laws by agencies, organizations and individuals specified in Clause 2, Article 2 of this Decree.

2. Specialized inspection activities shall be conducted by inspection teams or by inspectors or civil servants tasked to conduct independent inspection and must comply with specialized inspection regulations.

Article 16. Contents of specialized inspection in preventive medicine, food safety and health environment

1. The specialized health inspectorate on preventive health care:

a) To inspect the implementation of regulations on preservation and use of vaccines and medical bio-products in prophylaxis and treatment;

b) To inspect the implementation of regulations on technical standards and regulations applicable to insecticidal and germicidal chemicals and preparations for domestic and medical use;

c) To inspect the observance of regulations on the grant, suspension or withdrawal of circulation registration certificates and the observance of regulations on information and advertisement of insecticidal and germicidal chemicals and preparations for domestic and medical use;

d) Inspect the implementation of regulations on bio-safety in laboratories;

e) Inspect the implementation of regulations on prevention and control of infectious diseases and social diseases;

e) Inspect the implementation of border health quarantine regulations;

g) Inspect the implementation of regulations on environmental hygiene, occupational health, occupational disease prevention, school health, community nutrition, quality of drinking water and domestic water;

h) To inspect the implementation of regulations on prophylaxis activities; the implementation of regulations and policies on preventive medicine;

i) Conduct inspections of implementation of regulations on prevention and control of diseases in case of absence of reasons.

2. Specialized food safety inspectorate:

a) To inspect the implementation of technical regulations, food safety regulations promulgated by competent state management agencies for import, production, trading of food and food products by competent state management agencies under the Ministry of Health s state management;

b) To inspect the implementation of the standards related to food safety announced by the producing organizations and individuals, applicable to food production and trading and food products;

c) Inspect the implementation of the regulations on advertisement and labeling of food under the management of the Ministry of Health;

d) To inspect the implementation of the regulations on certification of food safety conformity, testing of food safety and other law provisions on food safety;

e) The irregular inspection of the entire process of production, export, import and trading under the management of the other Ministries as prescribed in Clause 3, Article 26 of the Decree No. 38/2012/ND-CP dated April 25, 2012 of the Government detailing the implementation of some articles of the Law of Food safety.

3. Health environment inspectorate:

a) To inspect the implementation of regulations on management of medical wastes and radiation safety;

b) Inspect the implementation of regulations on environmental protection in burying, cremating and quality of medical environment;

c) Inspect the implementation of regulations on environmental protection in health activities.

Article 17. Contents of specialized inspection in the field of medical examination and treatment, traditional medicine and health insurance

1. Specialized medical examination and treatment inspectorate

a) To inspect the implementation of the law on medical examination and treatment;

b) Conduct inspections over the implementation of professional and technical regulations, processes and guidelines and specialized management rules in the field of medical examination and treatment;

c) Inspect the issuance and revocation of practising certificates to medical practitioners and operation licenses to medical facilities;

d) To inspect the implementation of regulations on information, advertisement of medical examination and treatment;

e) Inspect the implementation of procedures and regulations on restoration of functions, forensic examination, forensic medicine, medical examination and treatment, massage services, aesthetic surgery;

e) Inspect the implementation of the regulations on laboratory quality control; provide regulations on nutrition and dietetics for patients;

g) To inspect the implementation of regulations on radiation application in medical examination and treatment.

2. Traditional medicine and pharmacy inspectorate:

a) To inspect the observance of professional regulations in medical examination and treatment with traditional medicine;

b) Inspect the implementation of regulations on information and advertisement of contents of medical examination and treatment by traditional medicine;

c) Conduct inspections of implementation of procedures and regulations on medical examination and treatment by traditional medicine;

d) To inspect the observance of regulations on rational and safe use of herbal ingredients, traditional medicine and pharmacy at medical examination and treatment establishments.

3. Specialized health insurance inspection:

a) To inspect the implementation of regulations on objects, payment levels and methods of payment by medical insurance participants;

b) To inspect the implementation of the regulations on health insurance-covered medical insurance levels;

c) To inspect the implementation of the regulations on medical examination and treatment organization;

d) To inspect the implementation of the regulations on medical examination and treatment contracts; medical examination and treatment procedures; and medical insurance assessment;

e) Inspect the implementation of regulations on payment of medical costs between the Social Security and medical facilities;

e) Inspect the implementation of regulations on direct payment of costs of medical examination and treatment between the health insurance and the insured.

Article 18. Contents of specialized inspection in the field of pharmacy, cosmetics and medical equipment

1. The Pharmaceutical Inspectorate:

a) To inspect the observance of the pharmaceutical professional regulation and activities on drug production, import and trading;

b) Inspect the implementation of regulations on management of narcotic drugs, psychotropic drugs and precursor drugs;

c) Inspect the implementation of medicine price management regulations;

d) Inspect the implementation of regulations on management of quality of counterfeit drugs and drugs of inferior quality;

e) Inspect the implementation of regulations on drug information and advertising; implementation of regulations on drug registration;

e) Inspect the implementation of regulations on assurance of supply, bidding and purchase of drugs at health facilities;

g) To inspect the implementation and maintenance of the drug-dealing conditions;

h) Inspect the implementation of hospital s regulations.

2. Specialized cosmetic inspection:

a) Inspect the implementation of Good Manufacturing Practices principles and standards;

b) The inspectorate shall inspect the implementation of the provisions on the announcement of cosmetic products.

c) To inspect the implementation of regulations on import, wholesale and retail of cosmetics;

d) Conduct inspection of application for registration of cosmetic product information;

e) Conduct inspection of the implementation of information, advertising and cosmetic labeling.

3. Specialized health equipment inspection:

a) inspect the compliance with regulations on production, import and trading of medical equipment;

b) inspect the compliance with regulations on medical equipment information and advertising;

c) inspect the implementation of the regulations on declaration of standard conformity of medical devices;

d) Inspect the implementation of regulations on bidding, purchasing and using medical equipment at public medical facilities.

Article 19. Contents of specialized inspection of population and family planning

1. Inspection of the implementation and implementation of policies and laws on national target programs, schemes, projects and models of population - family planning, covering the following fields: population size, population structure, quality of the population, public service activities on population - family planning.

2. To inspect the implementation of regulations and guidance by competent authorities on the national target program on population and family planning.

3. To inspect the implementation of regulations on ban on sex selection in any form; law-prescribed to ensure gender balance according to the law on natural heritage.

4. To inspect the implementation of regulations on management and use of contraceptive devices.

5. To inspect the implementation of regulations and guidance on prenatal and neonatal screening tests.

6. To inspect the management and use of specialized equipment in service of the national target program on population and family planning.

7. To inspect the implementation of professional process and guidance on population and family planning.

Article 20. Competence to issue inspection decisions

1. The state inspection agency:

a) The Chief Inspector of the Ministry of Health shall issue decisions on administrative and specialized inspection to agencies, organizations and individuals under the state management of the Ministry of Health;

b) The Chief Inspector of the Department of Health shall issue the decision on administrative and specialized inspection to agencies, organizations and individuals under the state management of the Department of Health.

2. Agencies assigned to conduct specialized inspection:

a) General Director of General Department of Population and Family Planning and Directors of Departments affiliated to the Ministry of Health assigned to conduct specialized inspection shall issue the decision on specialized inspection to agencies, organizations and individuals in the fields assigned by the Minister of Health;

b) The Director of the Sub-department of Health shall be assigned to carry out the function of specialized inspection to make the decision on specialized inspection of agencies, organizations and individuals in relevant sectors as assigned by the Director of the Department of Health.

Article 21. Formulation and approval of annual inspection plans

1. The Inspectorate of the Ministry of Health shall base on the requirements of its work and the orientation of the inspection program and the guidance of the Inspector General to propose the Minister of Health to approve the subsequent year s medical inspection plan.

2. The General Department and Departments assigned to perform the function of specialized inspection shall draw up the inspection plan for their units and send it to the Inspectorate of the Ministry of Health no later than November 01 of the year. Based on the orientation of the inspection program and the guidance of the Inspector General of the Government, the Minister of Health and the requirements of management, the Inspectorate of the Ministry of Health shall summarize the inspection plan for submission to the Minister of Health for approval.

The Minister of Health shall approve the annual inspection plan of the Ministry of Health not later than November 25 of the year.

3. Branches assigned to conduct specialized inspection shall formulate inspection plans of their units and send them to Inspectorates of provincial Health Departments no later than December 1 of every year.

4. The Inspectorate of Provincial Departments of Health shall summarize the inspection plans of Provincial Departments of Health and Sub-Departments assigned to carry out the function of specialized inspection of formulation of annual inspection plans to submit them to Directors of Provincial Departments of Health not later than December 05 of every year.

Directors of provincial-level Health Departments shall approve inspection plans of provincial-level Health Departments not later than December 15 every year and send them to the Health Ministry s Inspectorate no later than December 25 every year.

5. Approved inspection plans shall be reported to heads of agencies competent to approval for adjustment.

Article 22. Synthesizing reports on health inspection

1. General Departments and Departments affiliated to the Ministry of Health shall be assigned to carry out the function of specialized inspection to report to the Inspectorate of the Ministry of Health on specialized inspection, settlement of complaints and denunciations, and prevention and combat of corruption within their competence.

2. The Chief Inspector of the Ministry of Health shall synthesize and report to the Minister of Health and the Government Inspectorate on inspection work, settlement of complaints and denunciations, and prevention and combat against corruption within their competence.

3. Branches under the provincial/municipal Health Services assigned to conduct specialized inspection shall report to the provincial/municipal Health Services Inspectorates on specialized inspection work; complaint and denunciation settlement; and corruption prevention and combat within the scope of their responsibilities and, at the same time to the General Departments and Departments under the Health Ministry, for sum-up reports within the scope of responsibility of the General Departments and Departments under the Health Ministry.

4. The Chief Inspector of the provincial Department of Health shall report the Chief Inspector of the provincial Department of Health, the Chief Inspector of the Ministry of Health on the inspection, settlement of complaints and denunciation, and prevention and combat of corruption within their competence.

Article 23. Working relationship relations

1. The Inspectorate of the Ministry of Health is subject to the professional direction and guidance from the Government Inspectorate; shall be responsible for providing professional guidance for the Inspectorate of the Department of Health, General Departments and Departments affiliated to the Ministry of Health; provide guidance on or preside over the interdisciplinary inspection; provide instructions for the internal inspection.

2. The provincial Health Services inspectorates shall submit to the direction and guidance on administrative inspection work and operations of provincial inspectorates, the direction and guidance on specialized inspection operations of the Health Ministry; provide professional guidance on specialized inspection operations of provincial/municipal Health Services; appoint inspectors to join inspections organized by the Health Ministry s Inspectorate or organize extraordinary inspections at the request of the Health Ministry s Inspectorate.

3. General Departments and Departments under the Ministry of Health that are assigned to perform specialized inspection tasks shall be subject to professional direction and guidance by the Inspectorate of the Ministry of Health; coordinate with the Inspectorate of the Department of Health in guiding sub-departments under the Department of Health assigned to perform specialized inspection function to formulate inspection plans and organize the implementation thereof; assign civil servants to perform specialized inspection function to participate in inspections organized by the Ministry of Health or organize extraordinary inspections at the request of the Ministry of Health.

4. Branches of the Department of Health that are assigned to carry out the tasks of specialized inspection shall be subject to professional direction and guidance by the Inspectorate of the Department of Health and the General Departments, the Departments affiliated to the Ministry of Health shall be assigned to carry out the function of specialized inspection; appoint officials to carry out the specialized inspection to take part in the inspection held by the Inspectorate of the Department of Health or organize irregular inspections at the request of the Inspectorate of the Department of Health.

5. The health inspectorate shall, within the ambit of its tasks and powers, coordinate with the police offices, market management bodies, other specialized inspectors, People s Committees at all levels and concerned agencies and organizations in preventing, detecting and handling law violations in general and law-breaking acts in medical activities in particular.

6. Police offices, border guards, market management offices, other specialized inspectors, People s Committees at all levels and related agencies and organizations shall, within the ambit of their respective tasks and powers, coordinate with medical examination and treatment agencies in preventing, detecting and handling law violations in medical activities.

Article 24. Handling overlapping inspections

1. In case of any overlapping between the inspection plans of inferior officers and those of superior offices, the ones of the superior offices shall be applied.

2. The Chief Inspector of the Ministry of Health is responsible for handling overlapping related to the scope, subjects, contents and time of inspection between the General Departments and Departments affiliated to the Ministry of Health that are assigned to conduct specialized inspection; cooperating with Chief Inspector of Ministries and ministerial-level agencies in handling overlapping in inspection activities between inspectors of Ministries and ministerial-level agencies; cooperating with Chief Inspector of provinces in handling overlapping in medical inspection activities with local inspection agencies; requesting the Minister of Health to consider and make decision when necessary.

3. The Chief Inspector of the provincial Department of Health shall report to the Chief Inspector of the provincial Department on the handling of overlapping in inspection activities with inspection agencies of local areas. In case of overlapping with agencies assigned to perform medical inspection function, coordinate to handle; report to the Chief Inspector of the Ministry of Health for consideration and decision when necessary.

Article 25. Implementation Provisions

1. The power to re-inspect the cases which have been concluded but the violations of law in medical sector are detected as follows:

a) The Chief Inspector of the Ministry of Health shall decide to re-inspect the cases that have been assigned by the President of the provincial People s Committee, Director General and Director of the agency assigned to perform the function of specialized inspection of the Ministry of Health to conclude and state management competence of the Ministry of Health but detect signs of violations of law as assigned by the Minister of Health;

b) The Chief Inspector of the Department of Health shall decide to re-inspect the cases that have been assigned by the Director of Department of Health to conduct the function of specialized inspection concluded by the Department of Health under the state management authority of the Department of Health but discover signs of violation of law as assigned by the Director of the Department of Health.

2.Re-inspection decision shall compromise contents prescribed in Clause 1 Article 51 of the Law on Inspector.Within 03 working days from the date of signing the re-inspection decision, the person who issues the re-inspection decision must send the inspection decision back to the person who signed the inspection conclusion and the object of re-inspection.

3. Re-inspection, re-inspection statute, time limit for re-inspection, tasks, powers of the person who has made the re-inspection decision, the chief of the inspectorate, members of the inspectorate, and report on the re-inspection result shall comply with the Law on Inspection and Decree No. 86/2011/ND-CP  and Decree No. 07/2012/ND-CP .

4. The inspection decision issuer shall issue a re-inspection conclusion. Contents of a re-inspection conclusion comply with the inspection law.

5. The Ministry of Health s inspection conclusion shall be sent to the Minister of Health, the Government Inspectorate; the Inspector General; the Inspector s conclusion shall be sent to the Director of Department of Health, the Chief Inspector of the Ministry of Health.

Chapter IV

INSPECTOR, SPECIALIZED INSPECTION CIVIL SERVANTS,  AND INSPECTION COLLABORATOR

Article 26. Inspectors

1. Inspectors are state employees appointed to the inspection rank to perform administrative inspection and specialized inspection in medical sector at the Ministry of Health or Department of Health and perform other tasks assigned by the Chief Inspector of the Ministry of Health or Chief Inspector of the Department of Health.

2. Tasks, powers and criteria of inspectors specified in the Inspection Law and Decree No. 97/2011/ND-CP  of October 21, 2011, on inspectors and inspection collaborators (below referred to as Decree No. 97/2011/ND-CP) and other conditions and criteria suitable to sectors and fields as prescribed by the Minister of Health.

Article 27. Specialized inspection civil servants

1. A specialized inspection civil servant is a civil servant on the payroll of the General Department, Departments under the Ministry of Health, sub-departments under the Department of Health that are assigned to perform the function of specialized inspection and assigned by the head of the agency directly managing the performance of the specialized inspection tasks within the management of the General Department, Departments and Sub-Departments.

2. Duties, powers and standards of specialized inspection officials specified in the Law on Inspection and Decree No. 07/2012/ND-CP and other conditions and standards are conformable with sectors and fields of the Minister of Health.

3. When conducting inspection, specialized inspection officials shall be sanctioned administrative violations according to law provisions. In case of ultra vires, they shall report to competent persons for consideration and handling in accordance with law.

Article 28. Inspection collaborators

1. An inspection collaborator is not on the payroll of a state agency in charge of health sector, which is requisitioned to the inspectorate.

2. An inspection collaborator must possess moral qualities; must have a sense of responsibility and be upright, honest, impartial and objective sense; and must have professional qualifications meeting inspection requirements and tasks of the requisitioning agency.

3.Inspection collaborators have the tasks, powers and responsibilities as specified in Article 24 of the Decree No. 97/2011/ND-CP and other relevant legal documents.

4.An inspection collaborator shall enjoy regimes and policies specified in Article 25 of the Decree No. 97/2011/ND-CP  and other relevant legal documents.

Chapter V

RESPONSIBILITIES OF AGENCIES, ORGANIZATIONS AND INDIVIDUALS IN THE HEALTH INSPECTION

Article 29. Responsibilities of the Minister of Health

1. To lead, direct inspection activities within the management scope of the Ministry of Health.

2. Approve annual inspection programs and plans.

3. To handle timely inspection conclusions and recommendations.

4. To strengthen the organization and arrangement of civil servants with capability and moral quality to perform medical inspection work; to organize, direct and ensure conditions for medical inspection work.

5. Provide adequate funding and working conditions for inspection authorities affiliated to the Ministry of Health.

6. To periodically request the inspection agencies under their management to report and periodically report to the superior State management agencies on inspection work. To settle in time difficulties and problems regarding inspection work; to handle overlap in inspection and examination activities under their management.

7. Other tasks prescribed by law.

Article 30. Responsibilities of Chairperson of the People s Committees of provinces

1. To organize, direct and strengthen the organizational structure, payroll and equipment, material and technical facilities, costume and operational fund of the Inspectorate of the Department of Health at the request of Director of Department of Health.

2. To promulgate the regulation on coordination among Inspectorates of provincial-level Health Departments and public security agencies, market management and other specialized inspection agencies, People s Committees at all levels and related agencies and organizations in health sector.

Article 31. Responsibilities of the Director of the Department of Health

1. To lead, direct inspection activities under the Department of Health s management.

2. Follow responsibilities specified in Clauses 2, 3, 4, 6 and 7 Article 29 of this Decree.

Article 32. Responsibilities of agencies, organizations and individuals

1.Responsibilities and rights of agencies, organizations and individuals subject to inspection and relevant agencies, organizations and individuals comply with Article 10 of the Law on Inspection.

2. Responsibilities of medical agencies, organizations and individuals:

a) Agencies, organizations and individuals in the health sector, heads of agencies of the health sector shall promptly, fully and accurately provide information and documents at the request of health inspection agencies to serve inspection activities; and coordinate with medical inspection agencies in performing health inspection functions when so requested;

b) Within the scope of their assigned responsibilities, the heads of the health agencies shall have to consider and handle the cases according to their competence or assist the Minister of Health in considering and promptly handling violations committed by individuals, agencies and units detected through inspection.

Chapter VI

IMPLEMENTATION PROVISIONS

Article 33. Effect

This Decree takes effect on February 27, 2015 and replaces the Government s Decree No. 77/2006/ND-CP dated August 03, 2006.

To annul the Decree No.79/2008/ND-CP  dated July 18, 2008 of the Government stipulating the organizational system of management, inspection and testing of food hygiene and safety.

Article 34. Implementation responsibility

Ministers, heads of ministerial-level agencies, heads of government-attached agencies, chairpersons of provincial-level People s Committees, heads of health inspection agencies, and related agencies, organizations and individuals shall implement this Decree.-

For the Government

The Prime Minister

Nguyen Tan Dung