Decree No. 122/2014/ND-CP On the organization and operation of health inspection

DECREE

Vinspection, supervision of the banking industry, Thealth inspectionpolicies

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

Based on the Inspection Law dated November 15, 2010;

Pursuant to the Drug Law dated June 14, 2005;

Based on the Law on Prevention and Control of Infectious Diseases dated November 21, 2007;

BASED ON the Health Insurance Law dated November 14, 2008 and the Law Amending and Supplementing Certain Articles of the Health Insurance Law dated June 13, 2014;

Pursuant to the Law on Medical Examination and Treatment dated November 23, 2009;

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

BASED ON the Population Law dated January 9, 2003 and the Law Amending Article 10 of the Population Law dated December 27, 2008;

At the proposal of the Minister of Health,

At the proposal of ISSUES THE DECREE on the organization and operation of health inspections.

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

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

Article 2. Inspection Objects

1. Agencies, organizations, and individuals subject to the management of the Ministry of Health and the Department of Health.

2. Domestic and foreign agencies, organizations, and individuals participating in activities within the healthcare sector shall comply with legal regulations in areas under the management of the Ministry of Health and the Department of Health.

Article 3. Application of International Treaties

In cases where international treaties to which the Socialist Republic of Vietnam is a party provide different provisions regarding the organization and operation of health inspections, such treaty provisions shall apply.

Chapter II

ORGANIZATION, TASKS, POWERS OF HEALTH INSPECTION

Article 4. Agencies performing health inspection functions

a) The Ministry of Labor - War Invalids and Social Affairs Inspection (hereinafter referred to as the Ministry Inspection);

a) The Ministry of Health's Inspectorate;

b) The Department of Health's Inspectorate.

a) Vocational Education General Administration;

a) The General Bureau of Population and Family Planning; the Drug Administration; the Medical Examination and Treatment Management Bureau; the Environmental Health Management Bureau; the Preventive Medicine Bureau; the Food Safety and Control Bureau (hereinafter referred to collectively as the General Bureaus and Bureaus);

b) The Population and Family Planning Sub-bureau; the Food Safety and Sanitation Sub-bureau (hereinafter referred to collectively as the Sub-bureaus).

3. The Ministry of Health's Inspectorate and the Department of Health's Inspectorate shall have their own seals and separate accounts.

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

The Ministry of Health's Inspectorate performs the tasks and powers prescribed in Article 18 of the Inspection Law, Article 7 of Government Decree No. 86/2011/ND-CP dated September 22, 2011 detailing and guiding the implementation of certain articles of the Inspection Law (hereinafter referred to as Decree No. 86/2011/ND-CP), and the following tasks and powers:

1. Assist the Minister of Health in managing state administration over health inspection work.

2. Take the lead or participate in drafting normative legal documents according to the division of labor by the Minister of Health.

3. Draft the annual health inspection plan for approval by the Minister of Health.

4. Guide the Department of Health's Inspectorate and agencies assigned to perform specialized inspection functions under the Ministry of Health in drafting the annual health inspection plan.

5. Maintain regular public reception activities in accordance with the law.

6. Summarize and report to the Minister of Health and the Chief Inspector of the Government on the results of inspection work; complaints and grievances resolution; public reception; anti-corruption efforts within the scope of the Ministry of Health's management as prescribed by law.

7. Conduct scientific research and international cooperation on health inspection work.

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

Article 6. Tasks and powers of the Head of the Ministry of Health's Inspectorate

The Head of the Ministry of Health's Inspectorate performs the tasks and powers prescribed in Article 19 of the Inspection Law, Article 8 of Decree No. 86/2011/ND-CP, and the following tasks and powers:

1. Decide to establish inspection teams according to the approved annual inspection plan by the Minister of Health. Decide to conduct surprise inspections when discovering signs of law violations by agencies, organizations, or individuals, or upon request for handling complaints, grievances; anti-corruption efforts assigned by the Minister of Health.

2. Propose the Minister of Health to issue decisions establishing inspection teams, inter-ministerial administrative inspection teams according to the approved annual inspection plan or surprise inspections for particularly complex cases involving the responsibility of multiple levels and sectors; decide to establish specialized inspection teams according to the approved annual inspection plan or surprise inspections for complex cases involving the responsibility of multiple agencies, units, multiple levels, and sectors.

3. Assist the Minister of Health in checking, verifying, concluding, and recommending solutions for complaints within the Minister's jurisdiction when assigned.

4. Organize citizen reception in accordance with the law.

5. Assist the Minister of Health in overseeing, inspecting, and urging agencies directly managed by the Minister in receiving the public, resolving complaints, and implementing effective complaint resolution decisions.

6. Verify the content of accusations, conclude the verification content, and recommend measures to handle accusations within the Minister's jurisdiction when assigned.

7. Review and conclude the resolution of accusations that heads of agencies directly managed by the Minister have resolved but show signs of legal violations; if there is evidence that the resolution of these agencies violates the law, recommend the Minister of Health to reconsider and resolve again.

8. Assist the Minister of Health in directing, urging, and inspecting the implementation of anti-corruption efforts by agencies and units directly managed by the Minister.

9. Require the Heads of the Department of Health's Inspectorate and heads of agencies under the Ministry of Health assigned to perform specialized inspection functions to report periodically or unexpectedly on health inspection and specialized inspection work.

10. Other tasks and powers as prescribed by law.

Article 7. Duties and Authorities of the Health Department Inspectorate

The Health Department Inspectorate performs duties and authorities as prescribed in Article 24 of the Inspection Law, Article 13 of Decree No. 86/2011/NĐ-CP, and the following duties and authorities:

1. Develops the annual health inspection plan in accordance with the guidelines of the Ministry of Health for approval by the Director of the Health Department; guides the Centers assigned to perform specialized inspection functions under the Health Department to develop their annual inspection plans.

2. Receives citizens in accordance with the provisions of the law.

3. Summarizes and reports to the Director of the Health Department, the Chief Inspector of the Ministry of Health, and the Chief Inspector of the province on the results of inspection work; handles complaints and denunciations; prevents and combats corruption within the scope of management of the Health Department in accordance with the provisions of the law.

4. Other duties and powers as prescribed by law.

Article 8. Duties and Authorities of the Chief Inspector of the Health Department

The Chief Inspector of the Health Department performs duties and authorities as prescribed in Article 25 of the Inspection Law, Article 14 of Decree No. 86/2011/NĐ-CP, and the following duties and authorities:

1. Decides to establish inspection teams according to the approved annual inspection plan by the Director of the Health Department.

2. Decides to conduct surprise inspections when signs of law violations are detected or as required for handling complaints and denunciations, preventing and combating corruption, as instructed by the Director of the Health Department.

3. Proposes the Director of the Health Department to issue decisions to establish inspection teams or inter-agency inspection teams according to the approved inspection plan or as required for surprise inspections.

4. Assists the Director of the Health Department in checking, verifying, concluding, and recommending solutions for handling complaints within the authority of the Director of the Health Department when assigned.

5. Organizes citizen reception in accordance with the law; assists the Director of the Health Department in supervising, inspecting, and urging departments directly managed by the Director of the Health Department in citizen reception, complaint resolution, and enforcement of effective complaint resolution decisions.

6. Verifies the content of denunciations, concludes the verified content, and recommends measures to handle denunciations within the authority to resolve complaints of the Director of the Health Department when assigned.

7. Reviews and concludes the resolution of denunciations that have been resolved by heads of departments directly managed by the Director of the Health Department but show signs of law violations; if there is evidence that the resolution of denunciations by these departments violates the law, recommends the Director of the Health Department to review and resolve again.

8. Requests the heads of Centers assigned to perform specialized inspection functions to report on specialized inspection work regularly or unexpectedly.

9. Other duties and authorities as prescribed by law.

Article 9. Duties and Authorities of the General Bureau and Bureaus under the Ministry of Health Assigned to Perform Specialized Inspection Functions

The General Bureau and Bureaus under the Ministry of Health assigned to perform specialized inspection functions perform duties and authorities as prescribed in Article 10 of Decree No. 07/2012/NĐ-CP dated February 9, 2012, of the Government on agencies assigned to perform specialized inspection functions and specialized inspection activities (hereinafter referred to as Decree No. 07/2012/NĐ-CP), and the following duties and authorities:

1. Develops the annual inspection plan within the assigned scope and sends it to the Ministry of Health Inspectorate for consolidation and submission to the Minister of Health for approval of the annual health inspection plan; implements the inspection plan after approval; collaborates with the Health Department Inspectorate in guiding Centers assigned to perform specialized inspection functions to develop their annual inspection plans.

2. Collaborates with the Health Department Inspectorate to monitor and inspect the implementation of inspection conclusions, recommendations, and penalty decisions made by Centers assigned to perform specialized inspection functions.

3. Summarizes and reports to the Ministry of Health Inspectorate on the results of specialized inspection work.

4. Other duties and powers as prescribed by law.

Article 10. Tasks and Authorities of the Director General, Bureau Chief

The heads of agencies under the Ministry of Health shall perform the specialized inspection functions as prescribed in Article 11 of Decree No. 07/2012/NĐ-CP and the following tasks and authorities:

1. Impose administrative penalties according to the provisions of the law.

2. Propose to competent state agencies to amend, supplement, or promulgate regulations in accordance with management requirements; propose to suspend or revoke regulations found to be contrary to the law through inspection work.

3. Appoint civil servants assigned to perform specialized inspection tasks to participate in inspection teams of the Ministry of Health Inspectorate and related inspection agencies when requested.

4. Other duties and powers as prescribed by law.

Article 11. Tasks and Authorities of the Health Sub-Department under the Department of Health assigned to perform specialized inspection functions

The Sub-Department assigned to perform specialized inspection functions shall carry out the tasks and authorities as prescribed in Article 10 of Decree No. 07/2012/NĐ-CP and the following tasks and authorities:

1. Develop annual inspection plans within the scope and authority granted, submit them to the Department of Health Inspectorate for consolidation and submission to the Director of the Department of Health for approval of the health inspection plan; organize the implementation of the approved inspection plan.

2. Consolidate and report to the Department of Health Inspectorate the results of specialized inspection work.

3. Appoint civil servants assigned to perform specialized inspection tasks to participate in inspection teams of the Department of Health Inspectorate and related inspection agencies when requested.

4. Other duties and powers as prescribed by law.

Article 12. Tasks and Authorities of the Sub-Department Chief

The Sub-Department Chief shall perform the tasks and authorities as prescribed in Article 11 of Decree No. 07/2012/NĐ-CP and the following tasks and authorities:

1. Report and propose to the Director of the Department of Health and the Head of the Department of Health Inspectorate to handle overlapping issues regarding the scope, objects, contents, and timeframes of inspections within the specialized management jurisdiction of the Sub-Department.

2. Propose to competent state agencies to amend, supplement, or promulgate regulations in accordance with management requirements; propose to suspend or revoke regulations found to be contrary to the law through inspection work.

3. Administer administrative penalties according to the provisions of the law.

4. Other duties and powers as prescribed by law.

Article 13. Specialized Inspection Advisory Units under the General Bureau, Bureaus under the Ministry of Health, and Sub-Districts under the Department of Health

1. The specialized inspection advisory unit at the General Bureau of Population and Family Planning is organized within the Legal Affairs and Inspection Department; at the Bureaus under the Ministry of Health, it is organized as a Section; at the Sub-Districts, it is organized as a Section according to the decision of the competent authority.

2. The specialized inspection advisory unit assists the head of the agency assigned to perform specialized inspection functions in carrying out the following tasks:

a) Serve as the focal point to coordinate with relevant units and departments within the agency to develop inspection programs and plans for submission to the direct supervisory authority;

b) Serve as the focal point to implement inspections according to the plan; regular inspections; and surprise inspections when assigned by the head of the agency;

c) Serve as the focal point to consolidate, evaluate, and report on the results of specialized inspection work within the scope and authority of the agency;

d) Assist in monitoring, urging, and inspecting the implementation of conclusions, proposals, and decisions on inspections made by the head of the agency assigned to perform specialized inspection functions;

đ) Propose penalties for violations according to the provisions of the law;

e) Perform other tasks assigned by the head of the agency and as stipulated by the law.

Chapter III

HEALTH INSPECTION ACTIVITIES

Article 14. Administrative Inspection Activities

1. Inspect the implementation of policies, laws, tasks, and authorities of agencies, organizations, and individuals as prescribed in Clause 1, Article 2 of this Decree.

2. Inspect the responsibility of heads of agencies, organizations, and individuals within the scope of management of the Ministry of Health and the Department of Health.

3. Inspect the handling of complaints and denunciations and anti-corruption activities as prescribed by law.

4. Administrative inspection activities shall be conducted through inspection teams and in accordance with the provisions of the law on administrative inspection.

Article 15. Specialized inspection activities

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

2. Specialized inspection activities shall be conducted by Inspection Teams or independently by specialized inspectors and civil servants assigned to perform such inspections, and must comply with the provisions of the law on specialized inspections.

Article 16. Contents of specialized inspections in the fields of preventive health care, food safety, and medical environment

1. Specialized inspection in preventive health care:

a) Inspect the implementation of regulations concerning the storage and use of vaccines and medical products for prevention and treatment;

b) Inspect the implementation of standards and technical specifications for chemicals, insecticides, and bactericides used in household and medical fields;

c) Inspect the implementation of regulations related to issuing, suspending, and revoking certificates of circulation registration, and the implementation of regulations regarding information and advertising of chemicals, insecticides, and bactericides used in household and medical fields;

d) Inspect the implementation of biosafety regulations in laboratories;

đ) Inspect the implementation of regulations on preventing and controlling infectious diseases and social diseases;

e) Inspect the implementation of regulations on border health quarantine;

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

h) Inspect the implementation of regulations on the prevention of non-communicable diseases; the implementation of regulations on policies and benefits for preventive healthcare;

i) Inspect the implementation of regulations on preventing and controlling diseases of unknown causes.

2. Specialized inspection in food safety:

a) Inspect the implementation of technical specifications and regulations on food safety issued by competent state management agencies for import, production, and trade of food and food products under the Ministry of Health's jurisdiction;

b) Inspect the implementation of standards related to food safety published and applied by organizations and individuals for the production and trade of food and food products;

c) Inspect the implementation of regulations on advertising and labeling for food under the Ministry of Health's jurisdiction;

d) Inspect the implementation of conformity certification, food safety testing, and other regulations of the Food Safety Law;

đ) Conduct surprise inspections of the entire process of production, export, import, and trade of food under the jurisdiction of other ministries as stipulated in Clause 3, Article 26 of Government Decree No. 38/2012/NĐ-CP dated April 25, 2012, detailing certain provisions of the Food Safety Law.

3. Specialized inspection in medical environment:

a) Inspect the implementation of regulations on medical waste management and radiation safety;

b) Inspect the implementation of regulations on environmental protection in funeral and cremation activities and medical environment quality;

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

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

1. Specialized inspection in medical examination and treatment

a) Inspect the implementation of legal provisions concerning the field of medical examination and treatment;

b) Inspect the implementation of regulations, procedures, guidelines on professional techniques and specialized management rules in the field of medical examination and treatment;

c) Inspect the issuance and revocation of practice certificates for medical practitioners and permits for medical examination and treatment facilities;

d) Inspect the implementation of regulations on information and advertising related to medical examination and treatment;

đ) Inspect the implementation of procedures and regulations on rehabilitation, forensic medical examinations, forensic psychiatric examinations, medical appraisals, health check-ups, and massage, acupressure, and cosmetic surgery services;

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

g) Inspect the implementation of regulations on the application of ionizing radiation in medical examination and treatment.

2. Specialized inspection in traditional medicine:

a) Inspect the implementation of regulations on professional rules in medical examination and treatment using traditional medicine;

b) Inspect the implementation of regulations on information and advertising related to medical examination and treatment using traditional medicine;

c) Inspect the implementation of procedures and regulations on medical examination and treatment using traditional medicine;

d) Inspect the implementation of regulations on the rational, safe, and effective use of medicinal herbs, traditional medicines, and medicines derived from medicinal herbs at traditional medicine medical examination and treatment facilities.

3. Specialized inspection in health insurance:

a) Inspect the implementation of regulations on the target groups, contribution levels, and methods of health insurance contributions;

b) Inspect the implementation of regulations on health insurance benefits;

c) Inspect the implementation of regulations on organizing health insurance medical examination and treatment;

d) Inspect the implementation of regulations on medical examination and treatment contracts; procedures for health insurance medical examination and treatment; health insurance appraisals;

đ) Inspect the implementation of regulations on payment of medical examination and treatment costs between the Social Insurance and healthcare facilities;

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

Article 18. Contents of specialized inspection in the fields of pharmaceuticals, cosmetics, and medical equipment

1. Specialized inspection in pharmaceuticals:

a) Inspect the implementation of regulations on pharmaceutical professional rules and activities related to drug production, importation, and sales;

b) Inspect the implementation of regulations on the management of addictive drugs, psychotropic drugs, precursor chemicals used in drugs, and radioactive drugs;

c) Inspect the implementation of regulations on drug pricing;

d) Inspect the implementation of regulations on drug quality management and prevention of counterfeit, substandard, and unauthorized drugs;

đ) Inspect the implementation of regulations on drug information and advertising; the implementation of regulations on drug registration for circulation;

e) Inspect the implementation of regulations on ensuring drug supply, bidding, and purchasing at medical examination and treatment facilities;

g) Inspect the implementation and maintenance of conditions for drug business operations;

h) Inspect the implementation of regulations on hospital pharmacies.

2. Specialized inspection in cosmetics:

a) Inspect the implementation of good manufacturing practices principles and standards for cosmetics;

b) Inspect the implementation of regulations on cosmetic product notifications;

c) Inspect the implementation of regulations on cosmetic importation, wholesale, and retail;

d) Inspect the implementation of regulations on cosmetic product information files (PIFs) as prescribed;

đ) Inspect the implementation of regulations on cosmetic information, advertising, and labeling.

3. Specialized inspection in medical equipment:

a) Inspect the implementation of regulations on medical equipment production, importation, and sales;

b) Inspect the implementation of regulations on medical equipment information and advertising;

c) Inspect the implementation of regulations on medical equipment product standard notifications;

d) Inspect the implementation of regulations on bidding, procurement, and use of medical equipment at public healthcare facilities.

Article 19. Contents of specialized inspection in the field of population - family planning

1. Inspect the implementation of policies and laws on national target programs, projects, models on population - family planning, including areas such as population size, population structure, population quality, public services activities related to population - family planning.

2. Inspect the implementation of regulations and guidelines issued by competent authorities regarding the National Target Program on Population - Family Planning.

3. Inspect the implementation of prohibitions on selecting the sex of the fetus under any form; legal provisions to ensure gender balance according to natural reproductive laws.

4. Inspect the implementation of regulations on management and use of contraception devices.

5. Inspect the implementation of regulations and guidelines on prenatal and newborn screening.

6. Inspect the management and use of specialized equipment serving the National Target Program on Population - Family Planning.

7. Inspect the implementation of professional procedures and guidelines on population - family planning.

Article 20. Authority to issue inspection decisions

1. State administrative inspection agency

a) The Inspector General of the Ministry of Health issues decisions on administrative inspections and specialized inspections for agencies, organizations, and individuals within the scope of state management of the Ministry of Health;

b) The Inspector General of the Department of Health issues decisions on administrative inspections and specialized inspections for agencies, organizations, and individuals within the scope of state management of the Department of Health.

2. Agencies assigned to perform specialized inspection functions.

a) The Director of the General Office of Population and Family Planning and the Directors of Bureaus under the Ministry of Health, assigned to perform specialized inspection functions, issue decisions on specialized inspections for agencies, organizations, and individuals within the specialized fields assigned by the Minister of Health;

b) The Heads of Sub-offices under the Department of Health, assigned to perform specialized inspection functions, issue decisions on specialized inspections for agencies, organizations, and individuals within the specialized fields assigned by the Director of the Department of Health.

Article 21. Building and Approving Annual Inspection Plans

1. The Inspectorate of the Ministry of Health bases on work requirements, tasks, and guidance on inspection programs from the Chief Inspector General of the Government to prepare and submit the annual health inspection plan to the Minister of Health for approval.

2. The General Office and Bureaus assigned to perform specialized inspection functions develop their inspection plans and send them to the Inspectorate of the Ministry of Health no later than November 1st of each year. Based on guidance on inspection programs from the Chief Inspector General of the Government, the Minister of Health, and management requirements, the Inspectorate of the Ministry of Health is responsible for compiling and building the next year's inspection plan to be submitted to the Minister of Health for approval.

The Minister of Health approves the annual inspection plan of the Ministry of Health no later than November 25th of each year.

3. Sub-offices assigned to perform specialized inspection functions develop their inspection plans and send them to the Inspectorate of the Department of Health no later than December 1st of each year.

4. The Inspectorate of the Department of Health is responsible for consolidating its own inspection plan and those of Sub-offices assigned to perform specialized inspection functions to build the next year's inspection plan to be submitted to the Director of the Department of Health for approval no later than December 5th of each year.

The Director of the Department of Health approves the inspection plan of the Department of Health no later than December 15th of each year; sends it to the Inspectorate of the Ministry of Health no later than December 25th of each year.

5. Any adjustments to approved inspection plans must be reported to the head of the competent authority for approval of the adjustment.

Article 22. Consolidation of Health Inspection Work Reports

1. The General Department and the Departments under the Ministry of Health shall perform their specialized inspection functions and report to the Inspectorate of the Ministry of Health on their specialized inspection work, complaint resolution, accusation handling, and anti-corruption efforts within their respective responsibilities.

2. The Head of the Inspectorate of the Ministry of Health shall consolidate and report to the Minister of Health and the Chief Inspector of the Government on inspection work, complaint resolution, accusation handling, and anti-corruption efforts within his responsibility.

3. The District Centers assigned to perform specialized inspection functions shall report to the Inspectorate of the Department of Health on their specialized inspection work; complaint resolution; accusation handling; and anti-corruption efforts within their respective responsibilities, while also sending reports to the General Department and the Departments under the Ministry of Health for consolidation and reporting within the scope of their responsibilities.

4. The Head of the Inspectorate of the Department of Health shall report to the Head of the Inspectorate of the Province, the Director of the Department of Health, and the Head of the Inspectorate of the Ministry of Health on inspection work; complaint resolution; accusation handling; and anti-corruption efforts within his responsibility.

Article 23. Relationship of Work

1. The Inspectorate of the Ministry of Health shall be subject to the direction and guidance on inspection work and inspection procedures from the Inspectorate of the Government; it shall have the responsibility to guide specialized inspection procedures for the Inspectorates of the Departments of Health, the General Department, and the Departments under the Ministry of Health; organize or lead joint inspections; and guide internal inspection work.

2. The Inspectorate of the Department of Health shall be subject to the direction and guidance on administrative inspection work from the Inspectorate of the Province and the direction and guidance on specialized inspection work from the Inspectorate of the Ministry of Health; it shall guide specialized inspection procedures for the District Centers under the Department of Health; and it shall be responsible for assigning inspectors to participate in inspections organized by the Inspectorate of the Ministry of Health or organizing surprise inspections at the request of the Inspectorate of the Ministry of Health.

3. The General Department and the Departments under the Ministry of Health assigned to perform specialized inspection tasks shall be subject to the direction and guidance on inspection procedures from the Inspectorate of the Ministry of Health; they shall cooperate with the Inspectorates of the Departments of Health in guiding the District Centers assigned to perform specialized inspection functions to develop inspection plans and implement them; and they shall assign civil servants performing specialized inspection functions to participate in inspections organized by the Inspectorate of the Ministry of Health or organize surprise inspections at the request of the Inspectorate of the Ministry of Health.

4. The District Centers assigned to perform specialized inspection tasks shall be subject to the direction and guidance on inspection procedures from the Inspectorate of the Department of Health and the General Department and the Departments under the Ministry of Health assigned to perform specialized inspection functions; they shall assign civil servants performing specialized inspection tasks to participate in inspections organized by the Inspectorate of the Department of Health or organize surprise inspections at the request of the Inspectorate of the Department of Health.

5. Health inspection agencies within their respective duties and authorities shall be responsible for coordinating with public security agencies, market management agencies, other specialized inspection agencies, People's Committees at all levels, and related agencies and organizations in preventing, detecting, and handling violations of laws generally and specifically in health activities.

6. Public security agencies, border guards, market management agencies, other specialized inspection agencies, People's Committees at all levels, and related agencies and organizations within their respective duties and authorities shall be responsible for coordinating with health inspection agencies in preventing, detecting, and handling violations of laws in health activities.

Article 24. Handling Overlap in Health Inspection Activities

1. If the inspection plan of a subordinate agency overlaps with that of a superior agency, it shall be implemented according to the plan of the superior agency.

2. The Director of the Ministry of Health Inspectorate is responsible for leading the handling of overlap regarding scope, subjects, content, and time of inspection between the General Department, and the Departments under the Ministry of Health assigned to perform specialized inspection functions; coordinating with the Directors of Inspectors of other Ministries and ministerial-level agencies to resolve overlap in inspection activities between inspection agencies of these ministries and ministerial-level agencies; coordinating with the Provincial Inspectorate Directors to resolve overlap in health inspection activities with local inspection agencies; submitting to the Minister of Health for consideration and decision when necessary.

3. The Director of the Health Inspectorate of the Department of Health shall report to the Provincial Inspectorate Director to handle overlap in inspection activities with local inspection agencies. In cases of overlap with agencies assigned to perform health inspection functions, they shall coordinate to handle such overlap; reporting to the Director of the Ministry of Health Inspectorate for consideration and decision when necessary.

Article 25. Re-inspection of Health Inspection Conclusions

1. The authority to re-inspect cases that have been concluded but show signs of violation of laws in the healthcare sector is as follows:

a) The Director of the Ministry of Health Inspectorate decides to re-inspect cases that have been concluded by the Chairman of the People's Committee at the provincial level, the General Department Director, or the Department Director assigned to perform specialized inspection functions under the Ministry of Health within the scope and management authority of the Ministry of Health, but which show signs of violation of laws upon assignment by the Minister of Health.

b) The Director of the Health Inspectorate of the Department of Health decides to re-inspect cases that have been concluded by the Director of the Inspection Sub-department assigned to perform specialized inspection functions within the scope and management authority of the Department of Health, but which show signs of violation of laws upon assignment by the Director of the Department of Health.

2. The decision to re-inspect includes contents prescribed in Clause 1, Article 52 of the Law on Inspection. Within the latest three working days from the date of signing the re-inspection decision, the person issuing the re-inspection decision must send the re-inspection decision to the person who signed the inspection conclusion and the subject of re-inspection.

3. Re-inspection, the statute of limitations for re-inspection, the period for re-inspection, the duties and powers of the person issuing the re-inspection decision, the Head of the re-inspection team, members of the re-inspection team, and reporting the results of re-inspection shall be carried out in accordance with the provisions of the Law on Inspection, Decree No. 86/2011/ND-CP, and Decree No. 07/2012/ND-CP.

4. The person issuing the re-inspection decision issues a re-inspection conclusion. The content of the re-inspection conclusion is regulated by the law on inspection.

5. The re-inspection conclusion of the Director of the Ministry of Health Inspectorate is sent to the Minister of Health and the Chief Inspector General; the re-inspection conclusion of the Director of the Health Inspectorate of the Department of Health is sent to the Director of the Department of Health and the Director of the Ministry of Health Inspectorate.

Chapter IV

INSPECTORS, INSPECTION CIVIL SERVANTS

 SPECIALIZED, INSPECTION ASSOCIATES

Article 26. Inspectors

1. Inspectors are civil servants appointed to the inspector rank to perform administrative inspection and specialized inspection tasks in the health sector at the Ministry of Health or the Department of Health and to carry out other tasks assigned by the Director of the Ministry of Health Inspectorate or the Director of the Health Inspectorate of the Department of Health.

2. The duties, powers, and standards of inspectors are stipulated in the Law on Inspection, Decree No. 97/2011/ND-CP dated October 21, 2011 of the Government on Inspectors and Inspection Associates (hereinafter referred to as Decree No. 97/2011/ND-CP), and other conditions and standards appropriate to the industry and field as prescribed by the Minister of Health.

Article 27. Professional Inspectors

1. Professional inspectors are civil servants belonging to the establishment of the General Department, Departments under the Ministry of Health, and Centers under the Health Services who are assigned by the direct management authority to perform specialized inspection functions within the scope of management of the General Department, Departments, and Centers.

2. The duties, powers, and standards for professional inspectors are stipulated in the Inspection Law, Decree No. 07/2012/ND-CP, and other conditions and standards appropriate to the industry and field as prescribed by the Minister of Health.

3. When conducting inspections, professional inspectors may impose administrative penalties according to the provisions of the law. In cases exceeding their authority, they must report to those with authority for examination and handling according to the law.

Article 28. Inspection Collaborators

1. Inspection collaborators are individuals not belonging to the establishment of the health sector's state inspection agency who are called upon to participate in the Inspection Team.

2. Inspection collaborators must have good moral character; be conscientious, honest, impartial, fair, and objective; and possess professional qualifications suitable for the inspection requirements and tasks of the calling agency.

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

4. Inspection collaborators are entitled to benefits and policies as stipulated in Article 25 of Decree No. 97/2011/ND-CP and other relevant legal documents.

Chapter V

RESPONSIBILITIES OF ORGANIZATIONS AND INDIVIDUALS IN HEALTH INSPECTION ACTIVITIES

INDIVIDUALS IN HEALTH INSPECTION ACTIVITIES

Article 29. Responsibilities of the Minister of Health

1. Leading and directing inspection activities within the scope of management of the Ministry of Health.

2. Approving annual inspection programs and plans.

3. Timely address conclusions and recommendations regarding inspection work.

4. Strengthening organizational structure, arranging competent and morally sound civil servants for health inspection work; organizing, directing, and ensuring conditions for health inspection activities.

5. Ensuring funding and working conditions for agencies performing inspection functions of the Ministry of Health.

6. Regularly requiring subordinate inspection agencies to report and periodically reporting to higher-level state management agencies on inspection work. Timely addressing difficulties and issues related to inspection work; resolving overlapping issues in inspection and supervision activities within their jurisdiction.

7. Other tasks as prescribed by law.

Article 30. Responsibilities of the Chairman of the People's Committee at the provincial level

1. Organizing and directing the implementation of organizational restructuring, staffing, equipment, infrastructure, technical facilities, uniforms, and operational funding of the Health Service Inspection Agency according to the proposal of the Director of the Health Service.

2. Issuing regulations on cooperation between the Health Service Inspection Agency and public security agencies, market management agencies, other specialized inspection agencies, People's Committees at all levels, and related agencies and organizations in the health sector within their jurisdiction.

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

Article 31. Responsibilities of the Director of the Health Service

1. Leading and directing inspection activities within the scope of management of the Health Service.

Article 32. Responsibilities of agencies, organizations, and individuals

1. The responsibilities and rights of agencies, organizations, and individuals that are the subjects of inspection and those related to such inspections shall be implemented in accordance with Article 10 of the Inspection Law.

2. Responsibilities of agencies, organizations, and individuals in the health sector:

a) Agencies, organizations, and individuals within the health sector, and heads of agencies under the health sector shall have the responsibility to provide promptly, fully, and accurately all information and documents requested by agencies performing health inspection functions for the purpose of inspection activities; cooperate with agencies performing health inspection functions when required.

b) Within the scope of their assigned responsibilities, heads of agencies in the health sector shall have the responsibility to examine and handle violations discovered through inspection work according to their authority or assist the Minister of Health in examining and handling such violations promptly.

Chapter VI

IMPLEMENTING PROVISIONS

Article 33. Effective Date

This Decree takes effect from February 27, 2015, and replaces Government Decree No. 77/2006/NĐ-CP dated August 3, 2006, on the organization and operation of health inspections.

Abolish Government Decree No. 79/2008/NĐ-CP dated July 18, 2008, on the system of management, inspection, and testing for food safety and hygiene.

Article 34. Responsibility for Implementation

Ministers, heads of ministerial-level agencies, heads of agencies under the Government, Chairpersons of provincial People's Committees directly under the central government, heads of agencies performing health inspection functions, and related agencies, organizations, and individuals are responsible for implementing this Decree./.