Nghị định 117/2020/ND-CP

Decree No. 117/2020/ND-CP dated September 28, 2020 on prescribing penalties for administrative violations in medical sector

Nội dung toàn văn Decree 117/2020/ND-CP prescribing penalties for administrative violations in medical sector


THE GOVERNMENT
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THE SOCIALIST REPUBLIC OF VIETNAM
Independence – Freedom – Happiness
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No.: 117/2020/ND-CP

Hanoi, September 28, 2020

 

DECREE

PRESCRIBING PENALTIES FOR ADMINISTRATIVE VIOLATIONS IN MEDICAL SECTOR

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

Pursuant to the Law on penalties for administrative violations dated June 20, 2012;

Pursuant to the Law on HIV/AIDS prevention and control dated June 29, 2006;

Pursuant to the Law on donation, removal and transplantation of human tissues and organs, and body donation dated November 29, 2006;

Pursuant to the Law on prevention and control of infectious diseases 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 prevention and control of tobacco harms dated June 18, 2012;

Pursuant to the Law on pharmacy dated April 06, 2016;

Pursuant to the Law on prevention and control of harmful effects of alcoholic beverages dated June 14, 2019;

Pursuant to the Ordinance on population dated January 09, 2003 and the Ordinance on amendments to Article 10 of the Ordinance on population dated December 27, 2008;

At the request of the Minister of Health;

The Government promulgates a Decree prescribing penalties for administrative violations in medical sector.

Chapter I

GENERAL PROVISIONS

Article 1. Scope

1. This Decree deals with administrative violations, penalties, fines, remedial measures against each violation, the power to impose penalties, fines imposed by each authorized title holder and the power to record administrative violations in medical sector.

2. Administrative violations in medical sector prescribed herein are wrongful acts committed by organizations and individuals that contravene regulations on state management of medical sector but do not constitute criminal offences and are punishable by administrative penalties, including:

a) Violations against regulations on preventive healthcare, and HIV/AIDS prevention and control;

b) Violations against regulations on medical examination and treatment;

c) Violations against regulations on pharmacy and cosmetics;

d) Violations against regulations on medical devices;

dd) Violations against regulations on health insurance;

e) Violations against regulations on population.

3. Other administrative violations in medical sector which are not prescribed herein shall be penalized in accordance with the Decrees in which they are mentioned.

4. When detecting the violations in Point c Clause 3 Article 7, Point e Clause 5, Point b Clause 6 Article 38, Points a, b Clause 7 Article 44, Clause 6 Article 48, Point a Clause 2 Article 52, Clause 3 Article 53, Point a Clause 1 Article 54, Point c Clause 4 Article 56, Point d Clause 5, Clause 7 Article 57, Clause 7 Article 58, Clause 7 Article 59, Point a Clause 4 Article 60, Point c Clause 5 Article 67, Clause 3 Article 68, Point b Clause 2 Article 70, Points a, b Clause 3 Article 73, Clause 4 Article 80, Points d, dd, e, g, h Clause 2 Article 85, Points d, dd, e, g, h, i Clause 2 Article 86 or the repeating of the violations in Points a, b Clause, 3 Article 7, Clause 9 Article 15, Clause 6 Article 40, Point a Clause 6 Article 44, Point b Clause 5 Article 67 and Clauses 2, 3 Article 80 hereof, the competent persons who are handling such cases shall transfer the case files to competent criminal proceedings agencies for initiating criminal prosecution in accordance with the provisions in Clauses 1, 2 and 4 Article 62 of the Law on penalties for administrative violations. If the relevant criminal proceedings agency decides not to institute criminal proceedings in accordance with the provisions of the Criminal Procedure Code, the case file shall be returned to the person competent to impose penalties who has transferred it to the criminal proceedings agency as prescribed in Clause 3 Article 62 of the Law on penalties for administrative violations for imposing administrative penalties in accordance with the provisions hereof.

Article 2. Regulated entities

1. Vietnamese and foreign organizations and individuals (hereinafter referred to as “entities”) that commit administrative violations in the medical sector, persons competent to make records of violations, those competent to impose penalties and other relevant entities.

2. Organizations that are the entities incurring penalties as prescribed herein include:

a) Economic organizations that are duly established under the Law on enterprises, including: Sole proprietorships, joint-stock companies, limited liability companies, partnerships and their affiliates (including branches and representative offices);

b) Co-operatives and cooperative unions that are duly established under the Law on co-operatives;

c) Organizations that are duly established under the Law on investment or the Law on commerce, including: Domestic and foreign investors (except individual investors) and foreign-invested economic organizations; representative offices and branches of foreign traders in Vietnam; representative offices of foreign trade promotion organizations in Vietnam;

d) Social organizations, socio-political organizations, socio-political-professional organizations, and socio-professional organizations;

dd) Public service providers, people’s armed forces and agencies of the Communist Party of Vietnam;

e) Regulatory authorities committing the violations which are not related to their assigned management tasks;

g) Artels;

h) Other organizations as prescribed by law.

3. Household businesses, family businesses, domestic and foreign individual investors shall be liable to the same penalties as those imposed upon individuals for committing the administrative violations prescribed herein.

Article 3. Penalties and remedial measures

1. Primary penalties:

a) Warning;

b) Fines.

2. Depending on the nature and severity of each administrative violation, the violating entity may face one or some of the following additional penalties:

a) Suspension of the following licenses or practicing certificates for a fixed period of 01-24 months, including: certificate of eligibility for pharmacy business, license for medical operations, certificate of satisfaction of level-3 biosafety standards, certificate of eligibility to provide HIV testing, certificate of eligibility to produce cosmetics, license to trade in alcoholic beverages, license to operate tissue bank, pharmacy practicing certificate and medical examination and treatment practicing certificate;

b) Confiscation of exhibits and instrumentalities used for committing administrative violations in medical sector;

c) Suspension of operations for a fixed period of 01 - 24 months;

d) Deportation.

3. In addition to the primary and additional penalties, the violating entity may, depending on the nature and severity of each administrative violation, be liable to one or some of the remedial measures specified in Points c, d, dd, e, g, h and i Clause 1 Article 28 of the Law on penalties for administrative violations and the following remedial measures:

a) Enforced return of amounts of money collected against regulations of law. Any amounts of money which cannot be returned to payers shall be paid to state budget as prescribed by law;

b) Enforced implementation of cleaning, disinfection and sterilization measures and other measures for prevention and control of infectious diseases;

c) Enforced organization of medical isolation, implementation of coercive measures for medical isolation, health inspection and control;

d) Enforced implementation of measures for cleaning of clean water supply and distribution system;

dd) Enforced making of direct apologies to HIV-positive persons and their families and correction of information published on means of mass media at the place where the HIV patient is living within 03 days as prescribed by law, unless the HIV patient rejects public apologies;

e) Enforced receipt and burial or cremation of corpses or remains of HIV infected persons;

g) Enforced receipt of HIV-positive persons;

h) Enforced making of direct apologies to persons who are discriminated against, practitioners, and patients;

i) Enforced re-appointment to previous job positions;

k) Enforced provision of legitimate rights and benefits to HIV-infected employees;

l) Enforced cancellation of decisions to discipline or expel pupil or student for HIV infection;

m) Enforced payment of interests on different amounts due to false declarations or late payment of compulsory contributions; enforced making of payments due to evasion or commission of frauds in payment of compulsory contributions; enforced return of amounts of money which have been used against regulations;

n) Enforced payment of all costs of medical services;

o) Enforced return of entire different amounts. Any payments which cannot be made to payers shall be paid to state budget in accordance with regulations of law;

p) Enforced reimbursement of amounts of money as compensation for damage suffered by health insurance purchasers (if any); enforced reimbursement of amounts of money as compensation for damage suffered by health facilities (if any). Any payments which cannot be made to payers shall be paid to state budget in accordance with regulations of law;

q) Enforced transfer of amounts of money involving in the violations to the dedicated account of the health insurance fund (if any);

r) Enforced removal of intrauterine devices and contraceptive implants;

s) Enforced revocation of practicing certificates, license for medical operations, license to import medical devices and medical face masks, certificate of eligibility for pharmacy business, certificate of free sale of domestically manufactured medical devices, certificate of registration of drugs/pharmaceutical starting materials, receipt number of cosmetic product declaration, acknowledgement of receipt of declaration dossier, certificate of registration of drugs/pharmaceutical starting materials, certificate of registration of type B, C, D medical devices.

Article 4. Fines

1. The maximum fine imposed for a violation against regulations on population is VND 30.000.000 if committed by an individual or VND 60.000.000 if committed by an organization.

2. The maximum fine imposed for a violation against regulations on preventive medicine and HIV/AIDS prevention and control is VND 50.000.000 if committed by an individual or VND 100.000.000 if committed by an organization.

3. The maximum fine imposed for a violation against regulations on health insurance is VND 75.000.000 if committed by an individual or VND 150.000.000 if committed by an organization.

4. The maximum fine imposed for a violation against regulations on medical examination and treatment, pharmacy, cosmetics or medical devices is VND 100.000.000 if committed by an individual or VND 200.000.000 if committed by an organization.

5. The fines prescribed in Chapter II hereof are imposed on violating individuals. The fine imposed on an organization is twice as much as that imposed on an individual for the same administrative violation.

6. Fines imposed by the competent officials prescribed in Chapter VIII hereof are incurred by violating individuals; a competent official who has the power to impose fines shall have the right to impose a fine twice as much as that imposed upon an individual upon a violating organization for the same administrative violation.

Chapter II

ADMINISTRATIVE VIOLATIONS, PENALTIES AND REMEDIAL MEASURES

Section 1. VIOLATIONS AGAINST REGULATIONS ON PREVENTIVE HEALTHCARE, AND HIV/AIDS PREVENTION AND CONTROL

Article 5. Violations against regulations on dissemination of information and education in prevention and control of infectious diseases

1. The following fines shall be imposed for failing to organize dissemination of information and education about prevention and control of infectious diseases for employees at the request of competent authorities:

a) A fine ranging from 1.000.000 to VND 3.000.000 shall be imposed upon a violating establishment using less than 100 employees;

b) A fine ranging from 3.000.000 to VND 5.000.000 shall be imposed upon a violating establishment using from 100 to under 300 employees;

c) A fine ranging from 5.000.000 to VND 7.000.000 shall be imposed upon a violating establishment using from 300 to under 500 employees;

d) A fine ranging from 7.000.000 to VND 10.000.000 shall be imposed upon a violating establishment using from 500 to under 1.000 employees;

dd) A fine ranging from 10.000.000 to VND 15.000.000 shall be imposed upon a violating establishment using from 1.000 to under 1.500 employees;

e) A fine ranging from 15.000.000 to VND 20.000.000 shall be imposed upon a violating establishment using from 1.500 to under 2.500 employees;

g) A fine ranging from 20.000.000 to VND 25.000.000 shall be imposed upon a violating establishment using 2.500 employees or more.

2. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for failing to implement or improperly implementing regulations on broadcasting time or volume or capacity or location for publishing information on prevention and control of infectious diseases.

3. A fine ranging from VND 10.000.000 to VND 15.000.000 shall be imposed for commission of one of the following violations:

a) Failing to provide accurate and timely information on an epidemic upon declaration of epidemic or declaration of end of epidemic according to contents provided by competent health agencies;

b) Charging for the provision of information and education about prevention and control of infectious diseases on means of mass media, unless payments are made under signed contracts for implementation of programs/projects or such activities are sponsored by domestic and/or foreign entities.

4. Remedial measures:

a) The entity committing the violation in Point a Clause 3 of this Article is compelled to correct false information via means of mass media at the place where the false information has been published within at least 03 consecutive days as prescribed by law;

b) The entity committing the violation in Point b Clause 3 of this Article is compelled to return any amounts of money collected against regulations of law. The amounts of money which cannot be returned to payers shall be paid to state budget in accordance with regulations of law.

Article 6. Violations against regulations on sanitation and hygiene for prevention of infectious diseases

1. A warning or a fine ranging from VND 200.000 to VND 500.000 shall be imposed for failing to implement hygiene measures at residences, public areas, vehicles and domestic waste storage areas for preventing infectious diseases.

2. A fine ranging from VND 1.000.000 to VND 3.000.000 shall be imposed for failing to implement hygiene measures at residences, public areas, vehicles and domestic waste storage areas and thus causing or spreading an infectious disease.

3. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for commission of one of the following violations:

a) Failing to provide adequate drink water and clean domestic water that meet quality standards in an educational institution as prescribed by law;

b) Failing to build or building sanitation works which do not meet hygiene requirements in an educational institution as prescribed by law;

c) Failing to provide adequate lighting in an educational institution as prescribed by law;

d) Failing to educate learners in hygiene measures for prevention of infectious diseases, including personal hygiene, hygiene in daily life, labour hygiene and environmental sanitation;

dd) Failing to disseminate information on hygiene and sanitation for disease prevention or failing to inspect and supervise environmental sanitation activities; failing to implement measures for prevention and control of infectious diseases in educational institutions.

4. A fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed for failing to implement measures for ensuring hygiene in manufacturing/business establishment, treatment of industrial waste and other hygiene measures as prescribed by law, and thus causing or spreading an infectious disease.

5. Remedial measure:

The entity committing the violation in Clause 2 or 4 of this Article is compelled to implement cleaning, disinfection and sterilization measures.

Article 7. Violations against regulations on infectious disease surveillance

1. A fine ranging from VND 500.000 to VND 1.000.000 shall be imposed for concealing, failing to report or delaying the reporting when detecting a person infected with an infectious disease as prescribed by law, except the case prescribed in Point a Clause 3 of this Article.

2. A fine ranging from VND 1.000.000 to VND 3.000.000 shall be imposed for commission of one of the following violations:

a) Failing to perform tests at the request of competent health agencies during the infectious disease surveillance;

b) Failing to submit reports or submitting reports which do not contain adequate information on infectious disease surveillance as prescribed by law;

c) Concealing, failing to report or delaying the reporting on the infection with an infectious disease of oneself, except the case prescribed in Point a Clause 3 of this Article.

3. A fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed for commission of one of the following violations:

a) Concealing, failing to report or delaying the reporting on the status of infection with a group-A infectious disease of oneself or another person;

b) Deliberately providing false reports or information on a group-A infectious disease;

c) Deliberately spreading pathogens causing group-A infectious diseases.

Article 8. Violations against regulations on laboratory biosafety

1. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for commission of one of the following violations:

a) Failing to meet one of requirements for biosafety level 1 laboratory after self-declaration of satisfaction of biosafety level 1 laboratory standards;

b) Failing to assess risks of biosafety incidents at testing laboratories;

c) Performing tests beyond the professional scope after declaration of satisfaction of biosafety level 1 or level 2 laboratory standards;

d) Failing to formulate and organize the implementation of regulations on internal biosafety inspection as prescribed by law;

dd) Failing to make and keep records of handled less serious biosafety incidents at the testing laboratory.

2. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for commission of one of the following violations:

a) Failing to meet one of requirements for biosafety level 2 laboratory after self-declaration of satisfaction of biosafety level 2 laboratory standards;

b) Failing to formulate a plan for prevention and handling of biosafety incidents or formulating a plan that does not contain adequate contents as prescribed by law;

c) Failing to disinfect or sterilize waste generated from testing activities before putting it into the waste collection system or temporary waste storage area of a biosafety level 2 laboratory.

3. A fine ranging from VND 10,000,000 to VND 20,000,000 shall be imposed for commission of one of the following violations:

a) Failing to mobilize or delaying the mobilization of human resources and equipment for handling a biosafety incident according to the plan for prevention and handling of biosafety incidents as prescribed by law;

b) Collecting, transporting, maintaining, storing, using, researching, exchanging and destroying pathological samples carrying infectious agents against regulations on management of infectious disease samples;

c) Failing to submit reports to the relevant Provincial Department of Health on serious biosafety incidents and measures taken against such incidents.

4. A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed for commission of one of the following violations:

a) Failing to meet one of requirements for biosafety level 3 laboratory after obtaining the certificate of satisfaction of biosafety level 3 laboratory standards;

b) Maintaining, storing, using, researching, exchanging and destroying samples of a group-A infectious disease without meeting edibility requirements;

c) Failing to disinfect or sterilize waste generated from testing activities before putting it into the waste collection system or temporary waste storage area of a biosafety level 3 laboratory.

5. A fine ranging from VND 30.000.000 to VND 40.000.000 shall be imposed for commission of one of the following violations:

a) Failing to organize annual drills of biosafety incident prevention and handling by a biosafety level 3 laboratory;

b) Performing tests before completing procedures for self-declaration of satisfaction of biosafety level 1 or level 2 laboratory standards, or before obtaining a certificate of satisfaction of biosafety level 3 laboratory standards, or when the certificate of satisfaction of biosafety level 3 laboratory standards has expired.

6. Additional penalties:

a) The operation of the biosafety laboratory shall be suspended for a fixed period of 01 – 03 months in case of commission of the violation in Point a or c Clause 1, Point a Clause 2 or Point b Clause 4 of this Article;

b) The operation of the biosafety level 1 or 2 laboratory shall be suspended for a fixed period of 03 – 06 months in case of commission of the violation in Point b Clause 5 of this Article;

c) The certificate of satisfaction of biosafety level 3 laboratory standards shall be suspended for a fixed period of 01 – 03 months in case of commission of the violation in Point a or c Clause 4 or Point b Clause 5 of this Article.

Article 9. Violations against regulations on use of vaccines and biologicals

1. A warning or a fine ranging from VND 300.000 to VND 500.000 shall be imposed for commission of one of the following violations:

a) Failing to provide or obstructing children or pregnant women in using vaccines and biologicals compulsory for infectious diseases included in an expanded immunization program;

b) Failing to provide counseling for vaccine recipients, parents, families or guardians of children getting vaccinated before vaccination; failing to provide counseling on benefits and risks related to vaccination;

c) Failing to give instructions to vaccinees or families of children getting vaccinated on how to monitor and treat vaccine reactions;

d) Failing to submit reports or submitting inadequate reports on vaccination as prescribed by law.

2. A fine ranging from VND 1.000.000 to VND 3.000.000 shall be imposed for commission of one of the following violations:

a) Failing to use or obstructing the use of vaccines and biologicals for vaccine-preventable diseases for people susceptible to infectious diseases in epidemic zones or for people sent to epidemic zones at the request or according to guidelines of competent authorities;

b) Failing to issue and keep physical or electronic personal vaccination records of people vaccinated at the vaccination clinic;

c) Failing to compile the list of people vaccinated at the vaccination clinic;

d) Failing to monitor vaccinees for at least 30 minutes after vaccination and instruct them or their facilities to monitor vaccine reactions for at least 24 hours later;

dd) Failing to prepare adequate relevant documents as requested to enable the provincial advisory council to verify the eligibility for compensation for a serious injury or death from vaccination;

e) Failing to retain and manage documents concerning vaccination and post-vaccination reactions as prescribed by law.

3. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for commission of one of the following violations:

a) Failing to provide pre-vaccination screening or insufficiently providing pre-vaccination screening for people getting vaccinated;

b) Failing to strictly comply with regulations on receipt, transport and storage of vaccines;

c) Failing to strictly comply with regulations of law and professional guidance on vaccine safety and vaccinee management;

d) Failing to immediately stop the vaccination session in case of a serious injury occurring after vaccination;

dd) Failing to record adequate information on serious injuries in accordance with regulations of the Minister of Health and submit a report to the Provincial Department of Health within 24 hours from the occurrence of the injury;

e) Failing to organize vaccination against epidemics at the request of competent authorities by a health facility that has registered with the provincial Department of Health for participation in the expanded immunization program;

g) Including costs covered by state budget in vaccination prices under expanded immunization programs and vaccinations against epidemics;

h) Selling vaccines and biologicals included in an expanded immunization program.

4. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for commission of one of the following violations:

a) Failing to follow prescriptions and ensure safety during vaccination;

b) Failing to give emergency treatment and find the causes of a serious injury after vaccination;

c) Failing to give the patient suffering from a serious injury after vaccination to the nearest health facility if the case is beyond the capacity of the vaccination clinic;

d) Failing to give emergency and medical treatments to the patient suffering from a serious injury after vaccination, and submit a report to the Provincial Department of Health within 24 hours from the time of receipt of the patient;

dd) Failing to meet one of requirements for a fixed vaccination clinic after having made a declaration of eligibility for vaccination.

5. A fine ranging from VND 10,000,000 to VND 20,000,000 shall be imposed for commission of one of the following violations:

a) Using vaccines and biologicals at a facility that fails to meet eligibility requirements;

b) Giving vaccinations before completing procedures for declaration of eligibility for vaccination.

6. A fine ranging from VND 30.000.000 to VND 40.000.000 shall be imposed for using vaccines which are not granted certificate of registration, expired vaccines or substandard vaccines.

7. Additional penalties:

a) All or part of operations of the violating entity shall be suspended for a fixed period of 01 – 03 months in case of commission of one of the violations in Point a, b, c and d Clause 3, Clause 4, Clause 5 and Clause 6 of this Article;

b) The medical examination and treatment practicing certificate shall be suspended for a fixed period of 01 – 03 months in case of commission of the violation in Point a, b, c or d Clause 3 or Point a, b, c or d Clause 4 of this Article.

8. Remedial measures:

a) The entity committing the violation in Point g or h Clause 3 of this Article is compelled to return any amounts of money collected against regulations of law. Any payments which cannot be made to payers shall be paid to state budget in accordance with regulations of law;

b) Vaccines involving the violation in Clause 6 of this Article shall be destroyed.

Article 10. Violations against prevention of transmission of infectious diseases in health facilities

1. A fine ranging from VND 1.000.000 to VND 3.000.000 shall be imposed for commission of one of the following violations:

a) Failing to report or untruthfully reporting personal infectious disease development to doctors and healthcare workers;

b) Failing to register for health monitoring with the medical station of commune, ward or communal-level town where the person infected with a group-A infectious disease resides after he is discharged or completes treatment at a health facility;

c) Failing to provide counseling on measures for prevention and control of infectious diseases for patients and their families.

2. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for commission of one of the following violations:

a) Failing to provide information on persons infected with infectious diseases receiving medical services at the health facility to the preventive medicine agency of the same level;

b) Failing to monitor the health of doctors and healthcare workers who directly provide medical examination and treatment for persons infected with group-A infectious diseases;

c) Failing to implement measures for prevention and control of the spread of infectious diseases from infected persons;

d) Failing to clean, disinfect, sterilize and implement other measures for prevention and control of infectious diseases when detecting environment carrying pathogens causing group B or C infectious diseases, persons infected with, or suspected of infection with, group B or C infectious diseases, or persons carrying pathogens causing group B or C infectious diseases.

3. A fine ranging from VND 5.000.000 to VND 7.000.000 shall be imposed for failing to notify competent health agencies when detecting environment carrying pathogens causing group A infectious diseases, persons infected with, or suspected of infection with, group A infectious diseases, or persons carrying pathogens causing group A infectious diseases.

4. A fine ranging from VND 7.000.000 to VND 10.000.000 shall be imposed for failing to clean, disinfect, sterilize and implement other measures for prevention and control of infectious diseases when detecting environment carrying pathogens causing group A infectious diseases, persons infected with, or suspected of infection with, group A infectious diseases, or persons carrying pathogens causing group A infectious diseases.

5. Remedial measure:

The entity committing the violation in Point d Clause 2 or Clause 4 of this Article is compelled to implement cleaning, disinfection, sterilization and other measures for prevention and control of infectious diseases.

Article 11. Violations against regulations on medical isolation and coercive medical isolation

1. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for commission of one of the following violations:

a) Failing to organize or force medical isolation in case of compulsory medical isolation prescribed by law, except the case prescribed in Point a Clause 2 of this Article;

b) Refusing or evading medical isolation or coercive medical isolation measures implemented by competent authorities, except case prescribed in Point b Clause 2 of this Article;

c) Failing to compile the list and monitor health of persons in close contact with persons who are managed under isolation or coercive isolation as prescribed by law.

2. A fine ranging from VND 15.000.000 to VND 20.000.000 shall be imposed for commission of one of the following violations:

a) Failing to organize medical isolation of persons infected with group A infectious diseases;

b) Refusing or evading the implementation of a competent authority’s decision on medical isolation or coercive medical isolation of persons infected with group A infectious diseases, border health quarantine subjects infected with group A infectious diseases or at the request of a competent authority;

c) Organizing medical isolation or coercive medical isolation at an unqualified location.

3. Remedial measure:

Enforced organization of medical isolation or coercive medical isolation if one of the violations in Points a, b Clause 1 and Points a, b Clause 2 of this Article is committed.

Article 12. Violations against regulations on epidemic management measures

1. A fine ranging from VND 1.000.000 to VND 3.000.000 shall be imposed for commission of one of the following violations:

a) Failing to adopt personal protective measures by persons participating in epidemic management and susceptible persons according to guidance of health agencies;

b) Failing to submit reports on infection cases to People’s Committee or local preventive medicine agency as prescribed by law.

2. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for commission of one of the following violations:

a) Concealing the status of infection with an infectious disease declared as an epidemic of oneself or another person;

b) Failing to implement or refusing to implement cleaning, disinfection and sterilization measures in an epidemic zone;

c) Failing to participate in epidemic management activities according to a mobilization decision issued by the steering committee for epidemic management;

d) Charging for the provision of medical examination and treatment services to persons infected with group A infectious diseases;

dd) Failing to implement decisions on compulsory destruction of animals, plants and other things which are regarded as vectors, except the cases prescribed in Point c Clause 4 and Point d Clause 5 of this Article.

3. A fine ranging from VND 10,000,000 to VND 20,000,000 shall be imposed for commission of one of the following violations:

a) Failing to implement decisions on temporary closure of public eating establishments that may cause the spread of epidemic in an epidemic zone;

b) Failing to implement decisions on prohibition of trading or use of foods which are regarded as vectors;

c) Failing to implement decisions on restrictions on public gatherings or temporary suspension of business and services at public places.

4. A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed for commission of one of the following violations:

a) Failing to implement decisions on health inspection, surveillance and control before entering or leaving epidemic areas of a group A infectious disease;

b) Transporting articles, animals, plants, foods and other goods that may cause the spread of epidemic out of an epidemic area of a group A infectious disease;

c) Failing to implement decisions on compulsory destruction of animals, foods, plants and other things which are regarded as vectors of group A infectious diseases.

5. A fine ranging from VND 30.000.000 to VND 40.000.000 shall be imposed for commission of one of the following violations:

a) Failing to comply with requests for health inspection and control of vehicles before they are moved out of an epidemic zone in the state of epidemic emergency;

b) Failing to implement a decision on prohibition of gatherings in an area where the state of epidemic emergency is declared;

c) Transporting unauthorized persons or vehicles to disease clusters in an area where the state of epidemic emergency is declared;

d) Failing to implement decisions on compulsory destruction of animals, foods, plants and other things that may cause the spread of disease to people in an area where the state of epidemic emergency is declared.

6. Remedial measures:

a) The entity committing the violation in Point b Clause 2 of this Article is compelled to implement cleaning, disinfection and sterilization measures;

b) The entity committing the violation in Point d Clause 2 of this Article is compelled to return any amounts of money collected against regulations of law. Any payments which cannot be made to payers shall be paid to state budget in accordance with regulations of law;

c) Animals, foods, plants and other things shall be destroyed in case of commission of the violation in Point dd Clause 2, Point b or c Clause 4 or Point d Clause 5 of this Article;

d) The health control of vehicles shall be carried out in case of commission of the violation in Point a Clause 5 of this Article.

Article 13. Violations against regulations on border health quarantine

1. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for commission of one of the following violations:

a) Failing to submit a written report to the Ministry of Health on carving, re-carving, revocation, destruction, invalidation or loss of the health quarantine seal;

b) Failing to make a record of specimen health quarantine seals;

c) Failing to prepare and keep documents when carving or re-carving a health quarantine seal as prescribed;

d) Failing to immediately contact the border health quarantine unit in the checkpoint area if a passenger or aircrew member on board an aircraft or a ship displays signs or symptoms of an infectious disease before the aircraft takes off or lands or the ship enters a port;

dd) Deliberately embarking or disembarking, unloading or receiving goods when a ship anchors pending heath quarantine or is quarantined, unless the ship is in distress.

2. A fine ranging from VND 5.000.000 to VND 7.000.000 shall be imposed for commission of one of the following violations:

a) Failing to follow the health inspection and control carried out by the border health quarantine unit as prescribed by law, except the case prescribed in Clause 4 of this Article;

b) Failing to strictly comply with regulations on quarantine signs for incoming ships;

c) Erasing, repairing or lending symbols, badges, cards or uniforms of health quarantine officers, or traditional flags of border health quarantine units for serving other purposes;

d) Failing to make health declaration or making untruthful declaration of border health quarantine as prescribed by law.

3. A fine ranging from VND 7.000.000 to VND 10.000.000 shall be imposed for commission of one of the following violations:

a) Transporting corpses, remains, body ashes, microorganism samples, biological products, tissues, body organs, blood or its components through the border without inspection by a health quarantine unit;

b) Importing samples of blood, serum, plasma, urine, fecal, body fluids or other human materials that contain or may contain infectious agents, microorganism species or samples containing microorganisms that may human diseases for reserve, diagnosis or medical examination without the import permit.

4. A fine ranging from VND 15.000.000 to VND 20.000.000 shall be imposed for failing to comply with medical isolation, coercive medical isolation and health control of people, vehicles, goods and other health quarantine subjects carrying pathogens causing any group-A infectious diseases.

5. Remedial measures:

a) The entity committing the violation in Point a Clause 2 of this Article is compelled to follow the health inspection and control;

b) The health control shall be carried out in case of commission of the violation in Point a Clause 3 of this Article. If requirements for prevention and control of infectious diseases are not met, the violating subjects/articles shall be removed from the territory of the Socialist Republic of Vietnam or re-exported;

c) The violating entity is compelled to remove from the territory of the Socialist Republic of Vietnam or re-export the subjects/articles involving the violation in Point b Clause 3 of this Article;

d) Enforced organization/implementation of medical isolation, coercive medical isolation and health control of people, vehicles, goods and goods carrying pathogens causing any group-A infectious diseases in case of commission of the violation in Clause 4 of this Article.

Article 14. Violations against other regulations on preventive medicine

1. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for employing persons infected with infectious diseases to directly do the jobs that may cause the spread of such infectious diseases to others or to the public, unless they directly engage in production or trading of foods, food additives, food processing aids, food containers or primary packages of foods, or directly provide food and beverage services.

2. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for failing to comply with measures for prevention and control of infectious diseases at the request of competent authorities, except the cases prescribed in Article 5 through 13 hereof.

3. A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed for taking advantage of epidemics for imposing irrational prices of drugs, medical devices, pharmaceutical starting materials, and materials used in manufacturing of medical devices serving prevention and management of epidemics.

4. Additional penalties:

a) The certificate of eligibility for pharmacy business, pharmacy practicing certificate, or operation of the violating entity shall be suspended for a fixed period of 06 – 12 months in case of commission of the violation in Clause 3 of this Article;

b) The certificate of eligibility for pharmacy business, pharmacy practicing certificate, or operation of the violating entity shall be suspended for a fixed period of 12 – 24 months if the violation in Clause 3 of this Article involves goods worth more than VND 50.000.000 or re-committed.

5. Remedial measure:

The violating entity is compelled to return any different amounts to buyers or sellers in case of commission of the violation in Clause 3 of this Article. Any payments which cannot be made to payers shall be paid to state budget in accordance with regulations of law.

Article 15. Violations against regulations on domestic water quality

1. A fine ranging from VND 1.000.000 to VND 3.000.000 shall be imposed for failing to submit reports on water quality to competent authorities as prescribed.

2. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for supplying water with a design capacity of less than 1.000 m3/24 hours or serving fewer than 500 households in one of the following cases:

a) The testing of water quality parameters of each water sample is not performed by an accredited laboratory or certification body as prescribed by law;

b) Testing results of water quality parameters are not made publicly available as prescribed by law;

c) 01 – 05 parameters of each water sample are not tested.

3. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for supplying water with a design capacity of less than 1.000 m3/24 hours or serving fewer than 500 households in one of the following cases:

a) Domestic water supplied does not meet the requirements laid down in national technical regulations on domestic water quality;

b) 06 or more parameters of each water sample are not tested.

4. A fine ranging from VND 10.000.000 to VND 15.000.000 shall be imposed for supplying water with a design capacity of 1.000 m3/24 hours or more or serving 500 households or more in one of the following cases:

a) The testing of water quality parameters of each water sample is not performed by an accredited laboratory or certification body as prescribed by law;

b) Testing results of water quality parameters are not made publicly available as prescribed by law;

c) 01 – 05 parameters of each water sample are not tested.

5. A fine ranging from VND 15.000.000 to VND 20.000.000 shall be imposed for supplying water with a design capacity of 1.000 m3/24 hours or more or serving 500 households or more in one of the following cases:

a) Domestic water supplied does not meet the requirements laid down in national technical regulations on domestic water quality;

b) 06 or more parameters of each water sample are not tested.

6. A fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed for failing to take adequate samples as required for each testing by a water supplier that has a design capacity of less than 1.000 m3/24 hours or serves fewer than 500 households.

7. A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed for commission of one of the following violations:

a) Failing to perform periodic testing of water quality parameters by a water supplier that has a design capacity of less than 1.000 m3/24 hours or serves fewer than 500 households;

b) Failing to take adequate samples as required for each testing by a water supplier that has a design capacity of 1.000 m3/24 hours or more or serves 500 households or more.

8. A fine ranging from VND 30.000.000 to VND 40.000.000 shall be imposed for failing to perform periodic testing of water quality parameters by a water supplier that has a design capacity of 1.000 m3/24 hours or more or serves 500 households or more.

9. The fine shall be doubled but not exceed VND 50.000.000 if the water supplier committing one of the violations in Clause 1 through 7 of this Article has two or more water production plants.

Article 16. Violations against regulations on burial and cremation

1. A warning or a fine ranging from VND 300.000 to VND 500.000 shall be imposed for failing to keep records of information on funerals taken place at a funeral home or crematorium.

2. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for failing to meet hygiene conditions by a funeral home or crematorium.

3. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for commission of one of the following violations:

a) Failing to implement or insufficiently implementing regulations on hygiene in lying in state, embalming, transporting, preserving corpses or remains of persons who have died from any group-A infectious diseases or some group-B infectious diseases included in the list of infectious diseases requiring medical isolation;

b) Failing to handle corpses of persons who have died from any group-A infectious diseases or some group-B infectious diseases included in the list of infectious diseases requiring medical isolation;

c) Failing to strictly comply with regulations on mass-grave burials.

4. A fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed for failing to strictly comply with regulations on safe handling of corpses, remains and surroundings when moving corpses and remains from a relocated cemetery before appropriate time for reinterment.

5. A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed for using cremation technology that fails to meet waste treatment requirements as prescribed by law.

6. Remedial measure:

Enforced implementation of measures for treatment of environmental pollution caused by one of the violations in Clauses 2, 3, 4 and 5 of this Article.

Article 17. Violations against regulations on occupational health, diseases and accidents

1. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed upon a health facility for commission of one of the following violations:

a) Failing to consolidate results of screening examinations for occupation diseases or periodic examinations for workers having occupational diseases at the end of each examination as prescribed by law;

b) Failing to compile an occupational disease dossier for the worker who is diagnosed with an occupational disease;

c) Failing to submit reports on occupational disease cases or annual reports on occupational disease examination to competent authorities as prescribed by law;

d) Failing to submit annual reports on victims of occupational accidents receiving medical examination and treatment at the health facility to competent authorities as prescribed by law.

2. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed upon a health facility for commission of one of the following violations:

a) Failing to submit reports on medical units providing training in first aid and emergency aid or training for issuance of professional certificates/certifications of occupational health to competent authorities as prescribed by law;

b) Providing training in first aid and emergency aid with inadequate training duration or contents.

3. The following fines shall be imposed for violations against regulations on examination and treatment of occupational diseases:

a) A fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed for providing false results of occupational disease examination and treatment;

b) A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed for providing results of occupational disease examination and treatment without providing occupational disease examination and treatment as prescribed by law.

4. Additional penalty:

The medical examination and treatment practicing certificate shall be suspended for a fixed period of 01 - 03 months in case of commission of the violation in Clause 3 of this Article.

Article 18. Violations against other regulations on health environment

A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for failing to build, or failing to meet hygiene conditions for, hygienic handwashing and toilet areas in offices, medical facilities and other public establishments.

Article 19. Violations against regulations on dissemination of information and education about HIV/AIDS prevention and control

1. A warning or the following fines shall be imposed for failing to organize education and dissemination of information about HIV/AIDS prevention and control measures at the request of competent authorities:

a) A warning or fine ranging from 300.000 to VND 500.000 shall be imposed upon a violating establishment using less than 50 employees;

b) A fine ranging from 1.000.000 to VND 2.000.000 shall be imposed upon a violating establishment using from 50 to under 100 employees;

c) A fine ranging from 2.000.000 to VND 3.000.000 shall be imposed upon a violating establishment using from 100 to under 200 employees;

d) A fine ranging from 3.000.000 to VND 5.000.000 shall be imposed upon a violating establishment using from 200 to under 500 employees;

dd) A fine ranging from 5.000.000 to VND 10.000.000 shall be imposed upon a violating establishment using from 500 to under 1.000 employees;

e) A fine ranging from 10.000.000 to VND 15.000.000 shall be imposed upon a violating establishment using from 1.000 to under 1.500 employees;

g) A fine ranging from 15.000.000 to VND 20.000.000 shall be imposed upon a violating establishment using from 1.500 to under 2.000 employees;

h) A fine ranging from 20.000.000 to VND 25.000.000 shall be imposed upon a violating establishment using from 2.000 to under 2.500 employees;

i) A fine ranging from 25.000.000 to VND 30.000.000 shall be imposed upon a violating establishment using 2.500 employees or more.

2. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for commission of one of the following violations:

a) Providing inaccurate information on the HIV/AIDS pandemic compared to the data announced by competent authorities;

b) Failing to follow the preferred time and duration for broadcasting of information and educational contents about HIV/AIDS prevention and control on radio and television stations and content ratio and column positions in printed newspapers, television newspapers and online newspapers.

3. A fine ranging from VND 10.000.000 to VND 15.000.000 shall be imposed for commission of one of the following violations:

b) Failing to give priority to time and duration for broadcasting of information and educational contents about HIV/AIDS prevention and control on radio and television stations and content ratio and column positions in printed newspapers, television newspapers and online newspapers;

b) Charging for the provision of information and education about HIV/AIDS prevention and control, unless payments are made under signed contracts for implementation of national HIV/AIDS prevention and control programs or such activities are sponsored by domestic and/or foreign entities;

c) Disclosing a patient’s HIV status to a third party without having the patient's consent, unless information is provided to serve HIV/AIDS epidemiological surveillance purposes and when giving HIV test results as prescribed by law.

4. A fine ranging from VND 15.000.000 to VND 20.000.000 shall be imposed for disclosing name, address and photo of a person infected with HIV without having his/her consent, unless information is provided to serve HIV/AIDS epidemiological surveillance purposes and when giving HIV test results as prescribed by law.

5. Remedial measures:

a) The entity committing the violation in Point a Clause 2 of this Article is compelled to correct inaccurate information via means of mass media at the place where the inaccurate information has been published within at least 03 consecutive days as prescribed by law;

b) The entity committing the violation in Point b Clause 3 of this Article is compelled to return any amounts of money collected against regulations of law. Any payments which cannot be made to payers shall be paid to state budget in accordance with regulations of law;

c) The entity committing the violation in Point c Clause 3 or Clause 4 of this Article is compelled to make direct apologies to HIV patients/their families and correction of information on means of mass media at the place where the HIV patient is living within at least 03 consecutive days as prescribed by law, unless the HIV patient rejects public apologies.

Article 20. Violations against regulations on HIV testing and counseling

1. A fine ranging from VND 1.000.000 to VND 3.000.000 shall be imposed for commission of one of the following violations:

a) Hindering the access to counseling on HIV/AIDS prevention and control;

b) Failing to provide HIV/AIDS counseling when providing healthcare or treatment for HIV-infected women during pregnancy or breastfeeding or persons exposed to HIV;

c) Failing to comply with pre- and post-HIV test counseling procedures/contents;

d) Providing pre- and post-HIV test counseling before completing training course in HIV/AIDS counseling;

dd) Providing HIV/AIDS counseling at a counseling facility that fails to meet eligibility requirements set by law;

e) Failing to provide or providing the list of HIV-infected persons for HIV/AIDS surveillance against regulations of law;

g) Failing to retain or improperly retaining HIV test results, blood samples, blood bags, blood products and specimens used for HIV testing;

h) Failing to dispose of or disposing of blood samples, blood bags, blood products and specimens used for HIV testing against regulations of law;

i) Contravening regulations on HIV/AIDS reporting.

2. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for commission of one of the following violations:

a) Failing to provide pre- and post-HIV test counseling;

b) Failing to notify positive HIV test results within the prescribed time limit;

c) Failing to comply with procedures for notification of positive HIV test results;

d) Transporting or delivering positive HIV test reports against regulations of law;

dd) Failing to report on discovered substandard biologicals and equipment used for HIV testing to competent authorities;

e) Failing to strictly comply with the Ministry of Health’s regulations on sterilization, antisepsis and waste treatment when performing surgical, injection or acupuncture procedures for HIV prevention and control;

g) Failing to notify relevant parties and take appropriate measures upon discovery of unconformable HIV testing;

h) Charging for HIV tests performed in case of solicitation for judicial expertise or according to a decision of the investigating authority, people’s procuracy or people’s court or HIV tests for pregnant women of which costs are covered by other funding sources.

3. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for commission of one of the following violations:

a) Confirming positive HIV test results without obtaining certificate of eligibility to perform HIV confirmatory tests from a competent authority;

b) Failing to comply with instructions of the Ministry of Health when conducting HIV tests;

c) Failing to satisfy one of the conditions for HIV testing after obtaining the certificate of eligibility to perform HIV tests;

d) Confirming positive HIV test results within the period of suspension of HIV confirmatory tests;

dd) Notifying positive HIV test results to entities other than the ones prescribed by law or disclosing positive HIV test results which must be kept confidential as prescribed by law;

e) Performing HIV tests for persons aged under 16 or incapacitated persons without obtaining written consent of their parents or legal guardians, except emergency cases prescribed in the Law on medical examination and treatment.

4. A fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed for commission of one of the following violations:

a) Forcing persons who are not subjects of HIV/AIDS epidemiological surveillance and mandatory HIV testing to be tested for HIV;

b) Performing HIV testing without obtaining the certificate of eligibility to perform HIV tests;

c) Failing to perform testing for blood bags and blood products before use.

5. Additional penalties:

a) The certificate of eligibility to perform HIV tests shall be suspended for a fixed period of 01 – 03 months in case of commission of the violation in Point e Clause 2 or Point b Clause 3 of this Article;

b) The certificate of eligibility to perform HIV tests shall be suspended for a fixed period of 03 - 06 months in case of commission of the violation in Point c or d Clause 3 of this Article;

c) Operations of the violating entity shall be suspended for a fixed period of 03 - 06 months in case of commission of the violation in Point b Clause 4 of this Article.

6. Remedial measures:

a) The entity committing the violation in Point h Clause 2 of this Article is compelled to return any amounts of money collected against regulations of law. Any payments which cannot be made to payers shall be paid to state budget in accordance with regulations of law;

b) The violating entity is compelled to return any benefits illegally obtaining from the violation in Point b Clause 4 of this Article.

Article 21. Violations against regulations on treatment and care of HIV patients, pre-exposure and post-exposure prophylaxis of HIV

1. A fine ranging from VND 1.000.000 to VND 3.000.000 shall be imposed for commission of one of the following violations:

a) Writing prescriptions of antiretroviral drugs for HIV patients, persons exposed to HIV or pre-exposure prophylaxis before completing training courses in HIV/AIDS treatment according to regulations of the Minister of Health;

b) Failing to comply with HIV/AIDS treatment procedures and regimen promulgated by the Minister of Health when writing prescriptions of antiretroviral drugs.

2. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for commission of one of the following violations:

a) Treating for HIV with antiretroviral drugs at a facility that fails to meet eligibility requirements set by law;

b) Failing to strictly comply with regulations on prioritized access to antiretroviral drugs;

c) Failing to organize management, care and counseling for HIV patients at rehabilitation centers as prescribed by law;

d) Failing to give instructions on post-exposure prophylaxis to persons exposed to HIV;

dd) Failing to monitor, provide treatment and implement other measures for reducing mother-to-child transmission of HIV for pregnant women having HIV.

3. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for commission of one of the following violations:

a) Failing to monitor and treat for HIV-infected pregnant women under management;

b) Failing to provide post-exposure prophylaxis to persons exposed to HIV;

c) Hindering a HIV patient from caring for another HIV patient or accessing HIV treatment and care services;

d) Failing to ensure medical care policies for HIV infected people at social protection centers;

dd) Charging for treatment of persons exposed to HIV, persons infected with HIV due to occupational accidents or risks of medical procedures, HIV-infected women during pregnancy and HIV-infected children aged under 6 for whom antiretroviral drugs are provided free of charge by the State.

e) Charging for HIV drugs which are provided free of charge.

4. A fine ranging from VND 10.000.000 to VND 15.000.000 shall be imposed for refusing to give antiretroviral therapy for qualified HIV-infected persons as prescribed by law.

5. Remedial measure:

The entity committing the violation in Point dd or e Clause 3 of this Article is compelled to return any amounts of money collected against regulations of law. The amounts of money which cannot be returned to payers shall be paid to state budget in accordance with regulations of law.

Article 22. Violations against regulations on harm reduction interventions for HIV prevention

1. A warning or a fine ranging from VND 200.000 to VND 500.000 shall be imposed upon community access specialists for the commission of one of the following violations:

a) Failing to carry community access specialist’s card when performing harm reduction intervention activities for HIV prevention;

b) Using an expired community access specialist’s card when performing harm reduction intervention activities for HIV prevention, unless such use of expired card is permitted by the issuing authority pending the issuance of a new card;

c) Altering, erasing or lending the community access specialist’s card to another person.

2. A fine ranging from VND 500.000 to VND 1.000.000 shall be imposed for commission of one of the following violations:

a) Failing to give a prior notification of harm reduction intervention activities for HIV prevention to the People’s Committee and police authority of commune where such activities are performed;

b) Failing to introduce and transfer copies of treatment documents of the HIV patient who is receiving antiretroviral therapy to a new treatment facility appropriate to his/her working and living conditions;

c) Failing to receive treatment documents, which are valid as prescribed by law, of the HIV patient who is receiving antiretroviral therapy transferred from another treatment facility;

d) Terminating opioid replacement therapy, unless it is terminated as prescribed by law.

3. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for commission of one of the following violations:

a) Using a community access specialist’s card for wrong purposes, beyond scope of operations or against provisions of the program/project for harm reduction intervention for HIV prevention;

b) Failing to cooperate with local HIV/AIDS prevention and control agencies in performing harm reduction intervention measures for HIV prevention;

c) Failing to comply with procedures for selection of patients eligible for opioid replacement therapy.

4. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for commission of one of the following violations:

a) Failing to comply with professional guidelines for opioid replacement therapy as prescribed by law;

b) Failing to treat for the patient who is receiving opioid replacement therapy transferred from another treatment facility;

c) Failing to provide condoms by an accommodation facility as prescribed by law.

5. A fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed for commission of one of the following violations:

a) Failing to satisfy one of eligibility requirements after completing procedures for declaration of eligibility to provide opioid replacement therapy;

b) Failing to submit the list of patients, their health status and compliance with opioid replacement therapy to competent authorities as prescribed by law;

c) Selling condoms, syringes with needles, drugs and biologicals which are provided free of charge as prescribed by law or which are subsidized at higher prices;

d) Providing opioid replacement therapy to ineligible persons;

dd) Forcing persons dependent on opioid to receive opioid replacement therapy in any form.

6. A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed for commission of one of the following violations:

a) Providing opioid replacement therapy at a facility that does not complete procedures for declaration of eligibility to provide opioid replacement therapy;

b) Failing to print the phrase “cung cấp miễn phí, không được bán” (“provided free of charge. Not for sale”) on packages or auxiliary labels of condoms and syringes with needles of the program/projects on harm reduction intervention for HIV prevention;

c) Providing opioid replacement therapy with using drugs which are not yet permitted for sale in Vietnam.

7. Additional penalties:

a) The medical examination and treatment practicing certificate shall be suspended for a fixed period of 01 – 03 months in case of commission of the violation in Point a or b Clause 4 or Point d or dd Clause 5 of this Article;

b) Operation of the violating entity shall be suspended for a fixed period of 01 – 03 months in case of commission of the violation in Point a Clause 5 or Point a or c Clause 6 of this Article;

c) The exhibit of the violation in Point b or c Clause 1 of this Article which is the community access specialist’s card shall be confiscated.

8. Remedial measures:

a) The violating entity is compelled to return any benefits illegally obtained from the commission of the violation in Point c Clause 5 or Point a Clause 6 of this Article;

b) The drugs involving the violation in Point c Clause 6 of this Article shall be destroyed.

Article 23. Violations against HIV anti-discrimination regulations

1. A fine ranging from VND 500.000 to VND 1.000.000 shall be imposed for commission of one of the following violations:

a) Requesting pupils, students, trainees or applicants for admission to undergo HIV tests or provide their HIV test reports;

b) Hindering pupils, students or trainees from participating in an educational institution’s activities/services because they themselves or their family members are living with HIV;

c) Obstructing the admission of social protection beneficiaries to a social protection center because they are living with HIV;

d) Refusing to receive bodies of persons died from HIV/AIDS for burial or cremation.

2. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for commission of one of the following violations:

a) Requesting applicants for job to undergo HIV tests or present their HIV test reports, or refusing to employ them because they are infected with HIV, except some jobs for which applicants are required to undergo pre-employment HIV tests as prescribed by the Government;

b) Refusing admission of pupils, students or trainees who are infected with HIV;

c) Refusing admission of social protection beneficiaries to a social protection center because they are living with HIV;

d) Abandoning HIV-infected juvenile children or HIV-infected wards;

dd) Isolating, restricting or prohibiting HIV-infected pupils, students or trainees to/from a facility/institution’s activities and/or services;

e) Practicing discrimination in care and treatment of HIV patients;

g) Arranging jobs/works inappropriate to health status and qualification of HIV-infected workers.

3. A fine ranging from VND 10,000,000 to VND 20,000,000 shall be imposed for commission of one of the following violations:

a) Terminating signed employment contracts or public employee contracts or causing difficulties to employees during employment because they are infected with HIV;

b) Forcing employees who are still fit for their current job positions to transfer to other job positions because they are infected with HIV;

c) Refusing to accept pay raise/promotion claims or failing to ensure lawful rights and benefits of employees who are infected with HIV;

d) Discipline or expel pupils, students or trainees for HIV infection;

dd) Using images/media messages that discriminate against HIV-infected persons and/or their family members.

4. Remedial measures:

a) Enforced receipt and burial or cremation of HIV-infected bodies or remains in case of commission of the violation in Point d Clause 1 of this Article;

b) Enforced admission of HIV-infected persons in case of commission of the violation in Point b or c Clause 2 or Point a Clause 3 of this Article;

c) The violating entity is compelled to make direct apologies to persons who have been unfairly discriminated against in case of commission of the violation in Point e Clause 2 or Point dd Clause 3 of this Article;

d) The entity committing the violation in Point b Clause 3 of this Article is compelled to re-assign employees to their previous job positions;

dd) Enforced provision of lawful rights and benefits to HIV-infected employees in case of commission of the violation in Point c Clause 3 of this Article;

e) The entity committing the violation in Point d Clause 3 of this Article is compelled to abrogate the decision to discipline or expel pupil, student or trainee for HIV infection;

g) Enforced removal of violating elements in case of commission of the violation in Point dd Clause 3 of this Article. If violating elements cannot be removed, medical products shall be destroyed.

Article 24. Violations against other regulations on HIV/AIDS prevention and control

1. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for hindering employees from participating in HIV/AIDS prevention and control activities.

2. A fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed for commission of one of the following violations:

a) Threatening to transmit HIV to others;

b) Taking advantage of HIV/AIDS prevention and control for profiteering.

3. Remedial measure:

The violating entity is compelled to return any benefits illegally obtained from the commission of the violation in Point b Clause 2 of this Article.

Article 25. Violations against regulations on non-smoking areas

1. A warning or a fine ranging from VND 200.000 to VND 500.000 shall be imposed for smoking in non-smoking areas. Acts of in-light smoking shall be penalized in accordance with regulations on penalties for administrative violations in civil aviation sector.

2. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for commission of one of the following violations:

a) Failing to display “non-smoking” words or signs at non-smoking areas as prescribed by law;

b) Failing to organize, instruct, inspect and expedite the implementation of smoking bans in areas under management.

3. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for commission of one of the following violations in designated smoking areas:

a) Failing to provide rooms and air ventilation systems separate from non-smoking areas;

b) Failing to provide containers of tobacco butts and ashes;

c) Failing to display signs at suitable and prominent positions;

d) Failing to provide firefighting equipment.

Article 26. Violations against regulations on sale and supply of tobacco

1. A fine ranging from VND 1.000.000 to VND 3.000.000 shall be imposed for failing to display the notice stating “It is illegal to sell tobacco products to anyone under the age of 18” at points of sale of a tobacco wholesale or retail dealer.

2. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for commission of one of the following violations:

a) Displaying more than one pack, carton or box of a tobacco brand at a tobacco retail agent or point of sale;

b) Selling or supplying tobacco products to persons aged under 18;

c) Selling or supplying tobacco products which are not labeled or whose packages do not indicate health warning as prescribed by law. If tobacco products which are not labeled or whose packages do not indicate health warning are illegally imported, the violation shall be penalized in accordance with regulations on penalties for administrative violations against regulations on commerce, production and trade in counterfeit and prohibited goods, and protection of consumer rights.

3. Additional penalty:

Business operations involving the violation in Clause 2 of this Article shall be suspended for a fixed period of 01 – 03 months.

4. Remedial measure:

The entity committing the violation in Point c Clause 2 of this Article is compelled to recall and remove violating elements of tobacco products which are not labeled or whose packages do not indicate health warning. If violating elements cannot be removed, tobacco products shall be destroyed.

Article 27. Violations against regulations on labeling and printing of health warnings on tobacco packages

1. A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed for commission of one of the following violations:

a) Failing to comply with the prescribed form, position, area and color of the health warning printed on tobacco packages;

b) Failing to change the health warning printed on tobacco packages for every 2 years as prescribed by law;

c) Failing to indicate the quantity of cigarettes on each cigarette pack or the weight on other tobacco products;

d) Using words or phrases that mislead readers or users into believing that tobacco only causes little harm, or cause them to misunderstand the harms of tobacco and tobacco smoke to human health.

2. A fine ranging from VND 30.000.000 to VND 40.000.000 shall be imposed for commission of one of the following violations:

a) Failing to print health warnings on packages of tobacco products manufactured or imported for sale in Vietnam;

b) Signing contracts for production of foreign-branded for sale in Vietnam without obtaining a permit from a competent authority.

3. Additional penalty:

Business operations involving the violation in Clause 2 of this Article shall be suspended for a fixed period of 03 – 06 months.

4. Remedial measures:

a) The entity committing the violation in Clause 1 or Point a Clause 2 of this Article is compelled to recall tobacco products and rectify or remove violating elements. If violating elements cannot be rectified, tobacco products shall be destroyed.

b) The violating entity is compelled to return any benefits illegally obtained from the commission of the violation in Point b Clause 2 of this Article.

Article 28. Violations against regulations on smoking cessation

A fine ranging from VND 1,000,000 to VND 2,000,000 shall be imposed for commission of one of the following violations:

1. Failing to have a separate place for providing direct smoking cessation counseling as prescribed by law.

2. Failing to prepare media documents on smoking cessation and smoking cessation counseling.

3. Failing to equip telephones, internet or other means of communication to serve the provision of indirect smoking cessation counseling.

4. Failing to give a written notification before providing smoking cessation or smoking cessation counseling services to the Department of Health of province where such services are provided.

Article 29. Violations against other regulations on prevention and control of tobacco harms

1. A warning or a fine ranging from VND 200.000 to VND 500.000 shall be imposed upon a person aged from 16 to under 18 for tobacco use.

2. A fine ranging from VND 500.000 to VND 1.000.000 shall be imposed for commission of one of the following violations:

a) Encouraging or forcing others to use tobacco;

b) Requesting persons aged under 18 to buy tobacco products.

3. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for commission of one of the following violations:

a) Using tobacco images on newspapers or publications for children;

b) Providing information without scientific grounds or inaccurate information on tobacco and its harms;

c) Failing to include contents about prevention and control of tobacco harms in annual operation plan or failing to include workplace smoking bans in internal regulations;

d) Failing to impose restriction on tobacco use in theatrical and cinematographic works as prescribed by law.

4. A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed for commission of one of the following violations:

a) Using name, brand and symbols of tobacco products on other products/services;

b) Performing direct marketing of tobacco products to consumers in any forms;

c) Allowing the provision of direct-to-consumer tobacco marketing at facilities under management;

d) Delaying payment of compulsory contributions as prescribed by law;

dd) Making false statements resulting in insufficient payment of compulsory contributions as prescribed by law;

e) Using funds provided by the Fund for prevention and control of tobacco harms against regulations of law;

g) Disseminating information or notices of sponsoring by tobacco traders.

5. A fine ranging from VND 30.000.000 to VND 40.000.000 shall be imposed for commission of one of the following violations:

a) Sponsoring in any form, unless permitted by law;

b) Evading or cheating on payment of compulsory contributions as prescribed by law.

6. Remedial measures:

a) The entity committing the violation in Point a, b or d Clause 3 or Point a Clause 4 of this Article is compelled to recall tobacco products and rectify or remove violating elements. If violating elements cannot be rectified, tobacco products shall be destroyed.

b) The entity committing the violation in Point d Clause 4 of this Article is compelled to pay interests on late payment of compulsory contributions;

c) The entity committing the violation in Point e Clause 4 of this Article is compelled to return any amounts of money used against regulations of law;

d) The entity committing the violation in Point dd Clause 4 or Point b Clause 5 of this Article is compelled to pay compulsory contributions and any interests arising from false declaration, evasion or cheating on payment of compulsory contributions.

Article 30. Violations against regulations on consumption of alcoholic beverages and places where alcoholic beverage consumption is not allowed

1. A warning or a fine ranging from VND 200.000 to VND 500.000 shall be imposed upon a person aged from 16 to under 18 for consumption of alcoholic beverages.

2. A fine ranging from VND 500.000 to VND 1.000.000 shall be imposed for commission of one of the following violations:

a) Consuming alcoholic beverages at places where the alcoholic beverage consumption is not allowed;

b) Inciting or persuading others to consume alcoholic beverages.

3. A fine ranging from VND 1.000.000 to VND 3.000.000 shall be imposed for commission of one of the following violations:

a) Consuming alcoholic beverages before or during working or learning hours or break times;

b) Forcing others to consume alcoholic beverages.

Article 31. Violations against regulations on sale and supply of alcoholic beverages

1. A fine ranging from VND 1.000.000 to VND 3.000.000 shall be imposed for commission of one of the following violations:

a) Selling or supplying alcoholic beverages to persons aged under 18;

b) Failing to post a notice stating that “It’s is illegal to sell alcoholic beverages to anyone under the age of 18” at a prominent place in the establishment that sells alcoholic beverages.

2. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for commission of one of the following violations:

a) Selling alcoholic beverages at places where the sale of alcoholic beverage is not allowed;

b) Establishing a new on-premise establishment within a radius of 100 m from the outer boundary of a health facility, kindergarten, nursery school, pre-school or general education school.

3. A fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed for failing to satisfy one of the eligibility requirements when selling alcoholic beverages through e-commerce.

4. Additional penalty:

The license to trade alcoholic beverages shall be suspended for a fixed period of 01 - 03 months in case of commission of the violation in Point b Clause 2 or Clause 3 of this Article.

Article 32. Violations against regulations on sales promotion of alcoholic beverages

A fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed for commission of one of the following violations:

1. Offering discounts on alcoholic beverages to persons aged under 18.

2. Running sales promotions of alcoholic beverages having at least 15% ABV.

3. Using alcoholic beverages having at least 15% ABV to run sales promotion in any form.

4. Failing to comply with regulations on sales promotion when running sales promotions of alcoholic beverages having less than 15% ABV.

Article 33. Violations against regulations on advertising of alcoholic beverages

1. A fine ranging from VND 15.000.000 to VND 20.000.000 shall be imposed for employing persons aged under 18 to directly engage in advertising of alcoholic beverages.

2. A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed for one of the following acts of advertising spirits having less than 15% ABV and beer products:

a) An advertisement contains information/images aimed at encouraging alcoholic beverage consumption, saying that alcoholic beverages may enable the maturity, success, friendliness and sex appeal, or being directed towards children, students, adolescents and pregnant women;

b) An advertisement uses objects, images, symbols, music, movie characters and brands of products intended for children, pupils and students, or uses images of persons aged under 18;

c) Alcoholic beverages are advertised in advertising events or through advertising facilities/products that are intended for persons aged under 18, pupils, students, adolescents and pregnant women;

d) Alcoholic beverages are advertised on vehicles;

dd) Alcoholic beverages are advertised on audio or visual newspapers before, during or after a children's program, or from 18:00 PM to 21:00 PM daily, unless permitted by law;

e) Alcoholic beverages are advertised through outdoor advertising facilities that violate regulations on sizes and placement distance from educational institutions, nursing care centers and recreational centers intended for persons aged under 18;

g) An advertisement does not contain warnings against harmful effects of alcoholic beverages as prescribed by law;

h) Failing to run a filtering system or access control software to prevent persons aged under 18 from accessing and searching for information about alcoholic beverages when running advertisements on online newspapers, websites, electronic equipment, terminal devices and other telecommunications equipment.

3. A fine ranging from VND 30.000.000 to VND 40.000.000 shall be imposed for one of the following acts of advertising spirits having from 5.5 to less than 15% ABV and beer products having at least 5.5% ABV:

a) Advertisements are displayed in art performance or sports programs;

b) Advertisements are placed on outdoor advertising facilities, except for signboards of alcoholic beverage traders.

4. Additional penalty:

The advertising of alcoholic beverages shall be suspended for a fixed period of 01- 03 months in case of commission of the violation in Point h Clause 2 of this Article.

5. Remedial measure:

Advertisements shall be taken back and have their violating elements removed in case of commission of one of the violations in Clauses 1, 2 and 3 of this Article.

Article 34. Violations against regulations on responsibilities of heads of agencies/organizations for prevention and control of harmful effects of alcoholic beverages

1. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for commission of one of the following violations:

a) Failing to organize the implementation of measures for preventing and controlling harmful effects of alcoholic beverages;

b) Failing to organize the implementation of regulations on prohibition on consumption of alcoholic beverages during working hours and at workplaces;

c) Failing to warn or request persons who consume or sell alcoholic beverages at places where the consumption or sale of alcoholic beverages is not allowed under their management to stop their violations;

d) Failing to organize, instruct, inspect and expedite the implementation of regulations on prohibition on consumption and sale of alcoholic beverages at places under their management.

2. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed upon a head of transport company or vehicle owner for failing to implement measures for detecting and preventing vehicle operators from consuming alcoholic beverages before and while driving.

Article 35. Violations against regulations on responsibilities of alcoholic beverage traders

1. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for commission of one of the following violations:

a) Failing to provide adequate and accurate information on their business at the request of competent authorities;

b) Failing to remind or post a sign warning customers not to drive after drinking.

2. A fine ranging from VND 10.000.000 to VND 15.000.000 shall be imposed for commission of one of the following violations:

a) Employing persons aged under 18 to directly engage in trading of alcoholic beverages.

b) Providing inaccurate information or information without scientific grounds about alcoholic beverages.

3. Remedial measure:

The violating entity is compelled to remove violating elements on alcoholic beverage products (if any) and correct inaccurate information in case of commission of the violation in Point b Clause 2 of this Article.

Article 36. Violations against regulations on dissemination of information and education about prevention and control of harmful effects of alcohol beverages

1. A fine ranging from VND 500.000 to VND 1.000.000 shall be imposed for failing to educate, supervise and remind family members aged under 18 not to consume alcoholic beverages.

2. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for failing to ensure accuracy, objectivity and rationality when disseminating and providing information and education about prevention and control of harmful effects of alcoholic beverages.

3. A fine ranging from VND 10.000.000 to VND 15.000.000 shall be imposed for providing inaccurate or misleading information on affects of alcoholic beverages on health.

4. Remedial measure:

The violating entity is compelled to rectify or remove inaccurate information in case of commission of the violation in Clause 2 or 3 of this Article.

Article 37. Violations against regulations on alcoholic beverage sponsorship

A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed for providing alcoholic beverages as part of the sponsorship.

Section 2. VIOLATIONS AGAINST REGULATIONS ON MEDICAL EXAMINATION AND TREATMENT

Article 38. Violations against regulations on practicing and use of practicing certificates by medical practitioners

1. A warning or a fine ranging from VND 200.000 to VND 500.000 shall be imposed for commission of one of the following violations:

a) Failing to wear name tags;

b) Failing to wear personal protective equipment as prescribed by law.

2. A fine ranging from VND 500.000 to VND 1.000.000 shall be imposed for commission of one of the following violations:

a) Failing to conclude an internship contract with a new intern of the health facility or failing to use the prescribed form of internship contract;

b) Failing to issue a decision to assign practical instructor or failing to use the prescribed form of decision to assign practical instructor;

c) Assigning a practical instructor to instruct more than 05 interns at the same time.

3. A fine ranging from VND 1.000.000 to VND 3.000.000 shall be imposed for commission of one of the following violations:

a) Failing to report a competent person or failing to introduce the patient to another health facility when refusing to provide medical examination and treatment in case a disease is beyond the capacity or practicing scope of the medical practitioner;

b) Requesting patients to pay costs of medical services which are not publicly posted as prescribed by law;

c) Disclosing health status, information provided by the patient and medical record, unless they are disclosed with the patient’s consent or for sharing information/experience for improving quality of diagnosis, healthcare and treatment of the patient between practitioners who directly treat the patient or in other cases prescribed by law;

d) Issuing certificate of internship completion without using the form prescribed by law.

4. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for commission of one of the following violations:

a) Registering for practicing at multiple health facilities for the same period of time; working overtime exceeding the maximum period of overtime work prescribed in the Labor Code; failing to comply with the practicing period approved by a competent authority;

b) Failing to issue the certificate of internship completion after the intern has successfully completed his/her internship as prescribed by law;

c) Issuing a certificate of internship completion that contains inaccurate or untruthful contents or that is not suitable for qualifications of the intern;

d) Assigning unqualified practical instructors to instruct interns.

5. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for commission of one of the following violations:

a) Preventing patients who are eligible for mandatory treatment from entering the health facility;

b) Requesting patients to use medical services or suggesting them for other health facilities for personal interests;

c) Taking advantage of the job to offend honor or dignity of, or bodily harm the patient;

d) A foreigner directly provides medical examination and treatment in Vietnamese but does not obtain a certificate of proficiency in Vietnamese issued by a medical training institution designated by the Minister of Health, or in a language other than Vietnamese which is not yet registered;

dd) Prescribing in a language other than Vietnamese which is not yet registered or of which the translator is unqualified to translate it into Vietnamese;

e) Falsifying information on medical examination and treatment by erasing or altering medical records;

g) Using superstitious forms when providing medical examination and treatment;

h) Acting as the chief physician of two or more health facilities;

i) Acting as the head of two or more clinical departments of the same health facility or of multiple health facilities;

k) The chief physician of a health facility concurrently acts as the head of a department of that health facility which is not appropriate to the practicing scope specified in his/her practicing certificate;

l) The chief physician of a health facility does not authorize another during his/her absence from the health facility during its operation period.

6. A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed for commission of one of the following violations:

a) Selling drugs to patients in any forms, except for the sale of traditional drugs as prescribed by law;

b) Offering, taking or brokering bribes in medical examination and treatment.

7. A fine ranging from VND 30.000.000 to VND 40.000.000 shall be imposed for commission of one of the following violations:

a) Providing medical examination and treatment without obtaining a practicing certificate;

b) Providing medical examination and treatment while the practicing certificate is suspended or revoked;

c) Providing medical examination and treatment beyond the practicing scope specified in the practicing certificate, except emergency cases and provision of additional medical procedures which have been permitted as prescribed by law;

d) Using a rented or borrowed medical examination and treatment practicing certificate;

dd) Renting or lending a medical examination and treatment practicing certificate;

e) Failing to provide first aids, emergency treatment or medical treatment to patients in a timely manner;

g) Refusing to provide medical examination and treatment for patients, except cases of refusal prescribed by law.

8. Additional penalties:

a) The medical examination and treatment practicing certificate shall be suspended for a fixed period of 01 – 03 months in case of commission of the violation in Point b, c, d, dd, e, g, h, i, k or l Clause 5 of this Article;

b) The medical examination and treatment practicing certificate shall be suspended for a fixed period of 03 - 06 months in case of commission of the violation in Clause 6 of this Article;

c) The medical examination and treatment practicing certificate shall be suspended for a fixed period of 06 - 09 months in case of commission of the violation in Point e or g Clause 7 of this Article;

d) The medical examination and treatment practicing certificate shall be suspended for a fixed period of 22 - 24 months in case of commission of the violation in Point b, c, d or dd Clause 7 of this Article;

dd) Foreigners who re-commit the violation in Clause 7 of this Article shall be deported.

9. Remedial measures:

a) The entity committing the violation in Point c Clause 5 of this Article is compelled to make direct apologies to patients;

b) The violating entity is compelled to return any benefits illegally obtained from the commission of the violation in Point b Clause 6 or Point a, b, c, d or dd Clause 7 of this Article;

c) Enforced revocation of medical examination and treatment practicing certificate in case of commission of the violation in Point d or dd Clause 7 of this Article.

Article 39. Violations against regulations on eligibility requirements and use of license for medical operations

1. A fine ranging from VND 1.000.000 to VND 3.000.000 shall be imposed for commission of one of the following violations:

a) Failing to hang a signboard or hanging a signboard which does not contain adequate primary information as prescribed by law;

b) Failing to post or insufficiently posting prices of medical services;

c) Using names of departments/wards of the health facility other than those specified in the application for license for medical operations which has been approved by a competent authority.

2. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for commission of one of the following violations:

a) Failing to report the replacement of the chief physician of the health facility to the licensing authority;

b) Failing to report replacement of practitioners to competent authorities as prescribed by law;

c) Charging medical services at prices higher than the ones posted;

d) Charging covered medical services at prices higher than those reimbursed by the health insurance fund, except differences due to use of services provided upon request or beyond the coverage scope of health insurance fund;

dd) Failing to satisfy one of eligibility requirements after obtaining the license for medical operations or send a written notification of satisfaction of eligibility requirements to a competent authority, except polyclinics and hospitals.

3. A fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed for commission of one of the following violations:

a) Deliberately providing mandatory treatment for persons who are ineligible for mandatory disease treatment;

b) A polyclinic fails to satisfy one of eligibility requirements after obtaining the license for medical operations.

4. A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed for commission of one of the following violations:

a) Employing a practitioner who does not possess any practicing certificate or whose practicing certificate has been revoked or suspended;

b) Failing to comply with personnel arrangement decisions issued by competent authorities in case of disasters or dangerous epidemics;

c) A hospital with fewer than 100 beds fails to satisfy one of eligibility requirements after obtaining the license for medical operations.

5. A fine ranging from VND 30.000.000 to VND 40.000.000 shall be imposed for commission of one of the following violations:

a) Using a rented or borrowed license for medical operations;

b) Renting or lending a license for medical operations;

c) A hospital with 100 to 500 beds fails to satisfy one of eligibility requirements after obtaining the license for medical operations.

6. A fine ranging from VND 40.000.000 to VND 50.000.000 shall be imposed for commission of one of the following violations:

a) Providing medical services without obtaining license for medical operations, or during the suspension period of the license for medical operations, or at a location which is not specified in the license for medical operations;

b) Providing medical services beyond the scope of the license for medical operations, except emergency cases;

c) Applying new medical procedures without obtaining permission from the Minister of Health or Director of the relevant Provincial Department of Health;

d) A hospital with more than 500 beds fails to satisfy one of eligibility requirements after obtaining the license for medical operations;

dd) Providing cosmetological services before sending written notification of satisfaction of eligibility requirements to competent authorities as prescribed by law;

e) Providing inpatient treatment without obtaining permission for inpatient treatment services, unless outpatients are kept for health monitoring as prescribed by law.

7. Additional penalties:

a) The license for medical operations shall be suspended for a fixed period of 02 – 04 months in case of commission of the violation in Point dd Clause 2, Point b Clause 3, Point a or c Clause 4, Point c Clause 5 or Point b, c, d or e Clause 6 of this Article;

b) The license for medical operations shall be suspended for a fixed period of 12 - 24 months in case of commission of the violation in Point a or b Clause 5 of this Article;

c) Operations of the violating entity shall be suspended for a fixed period of 12 - 24 months in case of commission of the violation in Point a or dd Clause 6 of this Article;

d) The medical examination and treatment practicing certificate shall be suspended for a fixed period of 01 – 03 months in case of commission of the violation in Point a Clause 3 or Point c Clause 6 of this Article;

dd) The medical examination and treatment practicing certificate of the chief physician of the health facility shall be suspended for a fixed period of 01 – 03 months in case of commission of the violation in Point a Clause 4 or Point b or e Clause 6 of this Article.

8. Remedial measures:

a) The entity committing the violation in Point c or d Clause 2 of this Article is compelled to return any amounts of money collected against regulations of law. Any payments which cannot be made to payers shall be paid to state budget in accordance with regulations of law;

b) The violating entity is compelled to return any benefits illegally obtained from the commission of the violation in Point a or b Clause 5 of this Article;

c) Enforced revocation of the license for medical operations in case of commission of the violation in Point a or b Clause 5 of this Article.

Article 40. Violations against regulations on technical and professional qualifications

1. A fine ranging from VND 1.000.000 to VND 3.000.000 shall be imposed for commission of one of the following violations:

a) Failing to prepare or preparing medical records which do not contain clear and adequate contents as those included in the medical record form prescribed by law;

b) Failing to issue or issuing an outpatient’s medical examination book which does not contain clear and adequate personal details of the patient, diagnosis, treatment indications, prescriptions and follow-up examination;

c) Failing to retain medical records as prescribed by law;

d) Failing to submit reports on medical operations as prescribed by law.

2. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for commission of one of the following violations:

a) Abandoning patients who do not have relatives;

b) Abandoning dead patients;

c) Failing to keep or organize watch at a health facility as prescribed;

d) Failing to organize medical nutrition therapy or failing to give diet indications for patients or failing to provide nutrition counseling for patients as prescribed by law.

3. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for commission of one of the following violations:

a) Failing to hold medical consultations about a disease that is beyond the capacity of the practitioner or health facility;

b) Failing to hold medical consultations about a disease that does not respond well to treatment or becomes more severe.

4. A fine ranging from VND 10.000.000 to VND 15.000.000 shall be imposed for failing to transfer emergency patients to appropriate health facilities when their medical conditions are beyond the health facility’s capacity.

5. A fine ranging from VND 15.000.000 to VND 20.000.000 shall be imposed for commission of one of the following violations:

a) Performing surgeries, minor surgeries or other surgical interventions of class III or higher without obtaining the patient or his/her representative's written consent, unless the patient's life will be threatened if the surgery or surgical intervention is not performed;

b) Failing to equip sufficient and appropriate means of emergency transport; medical equipment/devices and essential medicines to provide timely emergency treatment to patients.

6. A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed for using drugs, substances or equipment for interventions in human body (surgeries, minor surgeries, interventions involving injection, pumping, ray emission, firing or other interventions) that change the color of skin, shape, weight and shortcomings of body parts (skin, nose, eyes, lips, face, belly, buttock and other parts) or providing services of doing tattoos or spraying or embroidering pictures on the surface of the skin with injection of anesthetics at a facility other than a hospital with cosmetological specialty, specialized cosmetological clinic, or a health facility with cosmetological specialty.

7. A fine ranging from VND 40.000.000 to VND 50.000.000 shall be imposed for committing a violation against regulations on technical and professional qualifications in medical examination and treatment that causes harms or injuries to patients.

8. Additional penalties:

a) The medical examination and treatment practicing certificate shall be suspended for a fixed period of 01 – 03 months in case of commission of the violation in Point a or b Clause 1, Point c Clause 2, Clause 3 or Clause 4 of this Article;

b) The medical examination and treatment practicing certificate shall be suspended for a fixed period of 03 - 06 months in case of commission of the violation in Clause 5 or 7 of this Article;

c) The license for medical operations shall be suspended for a fixed period of 01 – 03 months in case of re-commission of one of the violations in Clauses 1, 2, 3, 4 and Point a Clause 5 of this Article, or commission of 03 or more of the said violations at the same time;

d) A part of operations (ward, department, center, unit or division committing the violation) or the license for medical operations of the violating entity (if the violation influences on all of its operations) shall be suspended for a fixed period of 03 - 06 months in case of commission of the violation in Point b Clause 5 or Clause 7 of this Article;

dd) Operations of the violating entity shall be suspended for a fixed period of 03 - 06 months in case of commission of the violation in Clause 6 of this Article.

9. Remedial measure:

The violating entity is compelled to pay entire costs of medical services in case of commission of the violation in Clause 3 or 7 of this Article.

Article 41. Violations against regulations on use of drugs by health facilities providing inpatient treatment and for outpatients who are kept at health facilities for health monitoring

1. A fine ranging from VND 1.000.000 to VND 2.000.000 shall be imposed for commission of one of the following violations:

a) Failing to clearly and adequately write names of drugs, their quantity, content, dosage, administration route and period of using drugs in prescriptions or medical records as prescribed by law;

b) Failing to check prescriptions, medication request forms, content, dosage, administration route, names and quality of drugs before dispensing drugs to patients;

c) Failing to compare prescriptions with information on concentration, content and quantity of drugs when receiving drugs and expiry dates specified in medication request forms and drug labels when dispensing drugs to patients;

d) Failing to check full names of patients, names of drugs, dosage forms, content, dosage, administration route and times to take drugs before administering drugs to patients;

dd) Failing to fully record times of dispensing drugs to patients;

e) Failing to track and record clinical happening of patients after taking drugs in medical records; failing to punctually detect and report drug use-related complications to treating physicians when dispensing drugs to patients.

2. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for failing to monitor drug’s effectiveness and punctually handle drug use-related complications in patients receiving direct treatment from and using drugs as indicated by the physician.

3. A fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed for commission of one of the following violations:

a) Prescribing proprietary drugs which are expensive and unnecessary for treatment for personal interests;

b) Writing out prescriptions which are not conformable with medical diagnosis results and the severity of illness;

c) Writing out prescriptions for products for which the prescription is not allowed;

d) Writing out prescriptions clinical guidelines on diagnosis and treatment or clinical guidelines on HIV/AIDS treatment and care promulgated or recognized by the Ministry of Health, clinical guidelines on diagnosis and treatment formulated by the health facility, package inserts accompanied with drugs licensed for sale or the National Pharmacopoeia of Vietnam.

4. A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed for using expired or substandard drugs or drugs which are not yet granted import license or certification of drug registration, except drugs of which certificate of registration is not required as prescribed by law.

5. Additional penalty:

The medical examination and treatment practicing certificate shall be suspended for a fixed period of 01 – 03 months in case of commission of the violation in Point e Clause 1, Clause 2, Clause 3 or Clause 4 of this Article.

6. Remedial measure:

The violating entity is compelled to pay entire costs of medical services in case of commission of the violation in Clause 2 of this Article.

Article 42. Violations against regulations on in-vitro fertilization (IVF)

1. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for failing to submit reports on the provision of IVF and surrogacy services to the Ministry of Health as prescribed by law.

2. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for failing to perform medical examination and testing of sperm and egg donors for infectious diseases, mental disorder or another health condition that makes them lose their awareness or control of their acts, and HIV infection.

3. A fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed for commission of one of the following violations:

a) Providing names, addresses or images of sperm donors or sperm or embryo recipients;

b) Using sperm or eggs of a donor for two or more recipients, except unsuccessful childbirth;

c) Failing to destroy or donate unused donor sperm or eggs to scientific research institutes in case of successful childbirth;

d) Failing to encode donor sperm and eggs, or failing to specify characteristics of donors, especially their race, of encoded donor sperm and eggs;

dd) Storing sperm, eggs or embryos at a health facility that is not allowed to perform IVF;

e) Failing to destroy sperm, eggs or embryos when receiving a notice and a lawful copy of the death certificate of the depositor from his/her family, unless the depositor's spouse makes a written request for continued storage and still pays storage and preservation charges;

g) Destroying sperm, eggs or embryos of a depositor who has died while his/her spouse has submitted a written request for continued storage and still pays storage and preservation charges;

h) Failing to destroy sperm or eggs at the request of the depositor who gets divorced;

i) Failing to destroy embryos at the written request of the couple after they gets divorced;

k) Destroying embryos of a depositor who gets divorced but has submitted a written request for continued storage and still pays storage and preservation charges;

l) Failing to adhere to the principle of anonymity of gamete donors when donating and receiving sperm/embryos; failing to encode information on depositors who donate their deposited sperm, eggs or embryos to the storage facility for further use for others, unless they are donated to scientific research purposes;

m) Accepting requests for storage of sperm, eggs or embryos in cases other than those prescribed by law.

4. A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed for commission of one of the following violations:

a) Donating sperm or eggs at two or more health facilities qualified to perform IVF as certified by the Ministry of Health;

b) Failing to comply with technical procedures or regulations on health standards of persons receiving IVF treatment, having pregnancy and giving birth adopted by the Minister of Health;

c) Providing IVF treatment for a person who is ineligible to receive sperm, egg or embryo as prescribed by law;

d) Using surplus embryos for perform IVF without valid donation contracts;

dd) Using surplus embryos donated under a donation contract for two or more other recipients, except unsuccessful childbirth;

e) Failing to destroy or donate surplus embryos to the health facility for scientific research purposes in case of successful childbirth;

g) Using surplus embryos donated under donation contracts without the approval of the head of the health facility.

5. A fine ranging from VND 30.000.000 to VND 40.000.000 shall be imposed for commission of one of the following violations:

a) Performing IVF without obtaining certification of eligibility to perform IFV as prescribed by law;

b) Failing to satisfy one of eligibility requirements after obtaining certification of eligibility to perform IFV.

6. Additional penalties:

a) The provision of IVF treatment shall be suspended for a fixed period of 01 – 03 months in case of commission of 03 or more of the violations in Clauses 1, 2, 3 and Points c, d, dd, e, g Clause 4 of this Article;

b) The provision of IVF treatment shall be suspended for a fixed period of 06 – 12 months in case of commission of the violation in Point b Clause 4 or Clause 5 of this Article.

Article 43. Violations against regulations on altruistic surrogacy

1. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for commission of one of the following violations:

a) Providing health counseling for the intended parents and surrogate by a person who is not a qualified obstetrician;

b) Failing to possess a bachelor’s degree in psychology or higher when providing psychological counseling for the intended parents and surrogate;

c) Failing to possess a bachelor of laws degree or higher when providing legal counseling for the intended parents and surrogate;

d) Failing to provide adequate counseling contents for the intended parents and surrogate.

2. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for commission of one of the following violations:

a) Failing to provide health, legal and psychological counseling for the intended parents, except cases where such counseling is not required as prescribed by law;

b) Failing to provide health, legal and psychological counseling for the surrogate, except cases where such counseling is not required as prescribed by law;

c) Failing to sign and specify full name, position, working place and counseling date on the written certification of counseling contents.

3. A fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed for providing name, age, address or images of the intended parents, surrogate or the child born through altruistic surrogacy.

4. A fine ranging from VND 30.000.000 to VND 40.000.000 shall be imposed for commission of one of the following violations:

a) Performing altruistic surrogacy technique without obtaining certification of eligibility to perform altruistic surrogacy technique;

b) Failing to satisfy one of eligibility requirements after obtaining certification of eligibility to perform altruistic surrogacy technique.

5. Additional penalties:

a) The provision of altruistic surrogacy service shall be suspended for a fixed period of 01 – 03 months in case of commission of 03 or more of the violations in Clauses 1, 2, 3 of this Article;

b) Operations involving the violation in Clause 4 of this Article shall be suspended for a fixed period of 06 – 12 months.

Article 44. Violations against regulations on donation, removal and transplantation of human tissues and organs, and body donation

1. A fine ranging from VND 1.000.000 to VND 2.000.000 shall be imposed for commission of one of the following violations:

a) Failing to provide direct counseling on donation and removal of tissues and organs for the donor when receiving a notice from Vietnam National Coordinating Center for Human Organ Transplantation;

b) Failing to give instructions to complete the donation registration form when receiving a notice from Vietnam National Coordinating Center for Human Organ Transplantation;

c) Failing to perform health check for a living donor before removing a tissue or organ from his/her body;

d) Failing to submit the list of registered living donors to the Vietnam National Coordinating Center for Human Organ Transplantation;

dd) Failing to provide health and social psychological counseling for the living donor or failing to check biological parameters of the living donor before removing a tissue or organ from his/her body.

2. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for charging post-donation healthcare and periodic health check-ups provided for a living donor.

3. A fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed for failing to satisfy one of operating conditions after obtaining the license to operate tissue bank.

4. A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed for running a tissue bank without possessing a valid license.

5. A fine ranging from VND 30.000.000 to VND 40.000.000 shall be imposed for commission of one of the following violations:

a) Disclosing information or personal privacy of the donor and recipient, unless agreed in writing by the persons concerned or otherwise prescribed by law;

b) Removing a non-regenerable organ from a living body without obtaining a written approval from the advisory council for human organ transplantation of the health facility;

c) Storing human tissues and organs for commercial purposes.

6. A fine ranging from VND 60.000.000 to VND 80.000.000 shall be imposed for commission of one of the following violations:

a) Removing, transplanting or using human tissues and organs for commercial purposes, except trading or appropriation of human tissues and organs;

b) Removing or transplanting human tissues/organs at a facility that fails to meet eligibility requirements set by law.

7. A fine ranging from VND 80.000.000 to VND 100.000.000 shall be imposed for commission of one of the following violations:

a) Forcing others to donate their human tissues/organs or removing human tissues/organs from involuntary donors;

b) Removing human tissues/organs from living donors aged under 18;

c) Transplanting human tissues/organs removed from persons infected with diseases included in the list of diseases issued by a competent authority.

8. Additional penalties:

a) The license to operate tissue bank shall be suspended for a fixed period of 03 - 06 months in case of commission of the violation in Clause 3 or Point c Clause 5 of this Article;

b) Partial operations of the health entity involving the violation in Point c or dd Clause 1 or Point b Clause 5 of this Article shall be suspended for a fixed period of 01 – 03 months;

c) The license for medical operations shall be suspended for a fixed period of 03 - 06 months in case of commission of the violation in Clause 6 or 7 of this Article.

9. Remedial measures:

a) The entity committing the violation in Clause 2 of this Article is compelled to return any amounts of money collected against regulations of law. Any payments which cannot be made to payers shall be paid to state budget in accordance with regulations of law;

b) The violating entity is compelled to pay entire costs of medical services provided for damaged person in case of commission of the violation in Clause 7 of this Article. The amounts of money which cannot be returned to payers shall be paid to state budget in accordance with regulations of law.

Article 45. Violations against regulations on sex reassignment

1. A fine ranging from VND 2.000.000 to VND 5.000.000 shall be imposed for commission of one of the following violations:

a) Disclosing information on sex reassignment of others;

b) Discriminating against a person whose sex is reassigned.

2. A fine ranging from VND 30.000.000 to VND 40.000.000 shall be imposed for performing sex reassignment without obtaining permission from the Minister of Health or Director of the relevant Provincial Department of Health.

3. Remedial measures:

a) The entity committing the violation in Point b Clause 1 of this Article is compelled to make direct apologies to persons who are discriminated against;

b) The violating entity is compelled to return any benefits illegally obtained from the commission of the violation in Clause 2 of this Article.

Article 46. Violations against regulations on health examination

1. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for commission of one of the following violations:

a) Providing health check report without performing the actual examination as requested;

b) Classifying health unconformable with the health condition of the person undergoing heath check.

2. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for failing to satisfy one of eligibility requirements for health check facility.

3. A fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed for providing health check without announcing the eligibility to provide health check service.

4. Additional penalties:

a) The provision of health check service shall be suspended for a fixed period of 01 - 03 months in case of commission of the violation in Clause 2 of this Article;

b) The license for medical operations shall be suspended for a fixed period of 01 - 03 months in case of commission of the violation in Clause 3 of this Article.

Article 47. Violations against regulations on infection control in health facilities

1. A fine ranging from VND 500.000 to VND 1.000.000 shall be imposed for commission of one of the following violations:

a) Failing to provide counseling on infection control measures for patients and their relatives;

b) Failing to comply with regulations of law and of the health facility on infection control by persons working in the health facility, patients and other persons entering the health facility.

2. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for commission of one of the following violations:

a) Failing to implement or insufficiently implementing infection control measures at the health facility;

b) Failing to ensure material facilities, equipment, personal protective clothing and hygiene for persons working in the health facility, patients and other persons entering the health facility in conformity with infection control requirements in the health facility.

3. Additional penalties:

a) The medical examination and treatment practicing certificate shall be suspended for a fixed period of 01 - 03 months in case of commission of the violation in Point b Clause 1 of this Article;

b) The license for medical operations shall be suspended for a fixed period of 01 - 03 months in case of commission of the violation in Clause 2 of this Article.

Article 48. Violations against principles of medical examination and treatment practicing

1. A warning or a fine ranging from VND 200.000 to VND 500.000 shall be imposed for commission of one of the following violations:

a) Failing to respect or cooperate with practitioners during the medical examination and treatment;

b) Failing to respect patient’s rights as prescribed by law;

c) Failing to comply with the practitioner’s indications for diagnosis and treatment, except prescribed cases of refusal to receive treatment.

2. A fine ranging from VND 500.000 to VND 1.000.000 shall be imposed for commission of one of the following violations:

a) Failing to provide truthful information on personal health condition or failing to cooperate with practitioners and health facility;

b) Failing to comply with the health facility’s internal regulations;

c) Failing to provide prioritized medical examination and treatment for emergency patients, children aged under 06, persons with severe disabilities, persons aged 80 or older, persons with meritorious services to the revolution and pregnant women.

3. A fine ranging from VND 1.000.000 to VND 3.000.000 shall be imposed for commission of one of the following violations:

a) Harming honor or dignity of practitioners during medical examination and treatment;

b) Failing to strictly comply with code of conduct for health practitioners as prescribed by law;

c) Discriminating unfairly against patients.

4. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for commission of one of the following violations:

a) Failing to pay costs of medical services, except cases of exemption and reduction prescribed by law;

b) Failing to establish a specialized council to evaluate whether the unintended complication is resulted from a medical error in case of settlement of a medical dispute.

5. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for failing to strictly comply with technical and professional regulations in medical examination and treatment, except the violation prescribed in another part of this Section.

6. A fine ranging from VND 30.000.000 to VND 40.000.000 shall be imposed for bodily harming or threatening the life of practitioners while they are providing medical examination and treatment.

7. Additional penalties:

a) The medical examination and treatment practicing certificate shall be suspended for a fixed period of 01 - 03 months in case of commission of the violation in Clause 5 of this Article;

b) A part of operations (ward, department, center, unit or division committing the violation) or the license for medical operations of the violating entity (if the violation influences on all of its operations) shall be suspended for a fixed period of 01 - 03 months in case of commission of the violation in Clause 5 of this Article.

8. Remedial measures:

a) The entity committing the violation in Point a Clause 1, Point a Clause 3 or Clause 6 of this Article is compelled to make direct apologies to practitioners;

b) The entity committing the violation in Point b Clause 1 or Point c Clause 3 of this Article is compelled to make direct apologies to patients.

Article 49. Violations against regulations on dissemination of information and education about infant feeding, nutritious products for infants and breastfeeding benefits

1. A fine ranging from VND 1.000.000 to VND 3.000.000 shall be imposed for releasing documents providing information or educating about use of nutritious products for infants without complying with regulations on one of the following contents:

a) Guidelines for selection and use of appropriate nutritious products for infants;

b) Guidelines for cleaning and sterilization of infant feeding equipment;

c) Guidelines for cup feeding and spoon feeding;

d) Possible risks associated with the use of pacifiers, bottle feeding or complementary feeding for infant under 06 months of age;

dd) Possible risks of infection and contamination from bottle feeding and incorrect preparation and feeding of infant formulas;

e) Potential costs associated with formula feeding.

2. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for releasing documents providing information or educating about infant feeding without complying with regulations on one of the following contents:

a) Benefits and superiority of breastfeeding, affirming that breast milk is the best food for health and complete growth of infants; antibacterial elements, especially antibodies, only included in breast milk, which help prevent and control diarrhea, respiratory infection and some other infectious diseases;

b) Instructions on exclusive breastfeeding for 06 months and then continued breastfeeding for 24 months or as long as mother and baby desire, and appropriate complementary feeding from 07 months;

c) Disadvantages of formula feeding, including: The infant formula does not have immunity factors as those in breast milk, formula feeding takes time and money, incorrect preparation may pose a potential risk of infection to infants, and other disadvantages as prescribed by law;

d) Negative effects of bottle feeding, use of pacifiers or complementary feeding for infant under 06 months of age;

dd) Instructions on preparation, storage, selection and use of complementary foods at home through simple ways to ensure safety and rational nutrition with available foods;

e) Instructions on diet for breastfeeding mothers.

3. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for releasing documents providing information or educating about infant feeding but containing one of the following contents:

a) Images, words or other communication forms to encourage the formula feeding or bottle feeding or discourage the breastfeeding;

b) Comparisons leading to the conclusion that the infant formula is as good as or better than breast milk;

c) Names or logos of infant formulas, feeding bottles or pacifiers.

4. A fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed for failing to prioritize the dissemination of information and education about breastfeeding benefits and infant feeding methods in programs on dissemination of information and education about maternal and child health protection and child nutrition improvement.

5. Remedial measure:

Communication documents shall be recollected in case of commission of the violation in Clause 1, 2 or 3 of this Article.

Article 50. Violations against regulations on advertising for nutritious products for infants

1. A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed for failing to meet the following requirements when advertising for complementary foods for infants under 24 months of age:

a) The first part of an advertisement must contain the phrase "Sữa mẹ là thức ăn tốt nhất cho sức khỏe và sự phát triển toàn diện của trẻ nhỏ" “Breast milk is the best food for health and complete growth of infants”;

b) The advertisement must contain the phrase “Sản phẩm này là thức ăn bổ sung và được ăn thêm cùng với sữa mẹ dùng cho trẻ trên 06 tháng tuổi” (“This product is a complementary food and is combined with breast milk fed to infants after 06 months of age”).

2. A fine ranging from VND 40.000.000 to VND 50.000.000 shall be imposed for using foetus or infant images in advertisements for milk products for pregnant women.

3. Remedial measure:

Violating elements must be removed in case of commission of the violation in Clause 1 or Clause 2 of this Article.

Article 51. Violations against regulations on trading and use of nutritious products for infants

1. A fine ranging from VND 1.000.000 to VND 3.000.000 shall be imposed for commission of one of the following violations:

a) Giving instructions on formula feeding for infants under 06 months of age, except cases prescribed by doctors;

b) Informing pregnant women, nursing mothers or their family members that formula feeding is as good as or better than breastfeeding.

2. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for commission of one of the following violations:

a) Failing to provide accurate and scientific information on and correct usage of nutritious products for infants to physicians, healthcare workers and consumers;

b) Sending employees to directly or indirectly contact nursing mothers, pregnant women or their family members in or outside health facilities for advertising or encouraging the use of infant formulas;

c) Failing to disseminate information on and provide counseling on breastfeeding to pregnant women, nursing mothers, and their family members at antenatal care rooms, labor and delivery rooms, postpartum rooms, nutrition counseling rooms or at noticeable places where there are lots of pregnant women, nursing mothers, and their family members;

d) Receiving infant formulas, material benefits or utensils bearing names or logos of infant formulas which are given by infant formula producers or traders;

dd) Allowing infant formula producers or traders to give sample products or gifts related to their infant formulas;

e) Providing lists of names, ages, addresses and telephone numbers of nursing mothers and pregnant women to employees of infant formula producers or traders for contacting them at health facilities.

3. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for commission of one of the following violations:

a) Selling or allowing the sale of infant formulas at health facilities, except hospital drugstores;

b) Granting scholarships or providing funds for scientific research, training courses, conferences, seminars, music concerts, contests, stage performances, making of films or video clips, telephone counseling services or other forms in order to disseminate or introduce infant formulas, or promote the sale or use of infant formulas;

c) Allowing infant formula producers or traders to display or post up utensils or equipment bearing names or logos of their formula products, feeding bottles and pacifiers at health facilities;

d) Allowing employees of infant formula producers or traders to contact nursing mothers and pregnant women in any form.

4. A fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed for commission of one of the following violations:

a) Organizing display of infant formulas and/or complementary foods for infants under 06 months of age at health facilities; displaying names or logos of infant formulas on banners, posters and other advertising leaflets in supermarkets, retail stores and health facilities;

b) Applying sales promotion methods for infant formulas such as giving free samples, coupons, rewards, gifts, point accumulation for rewards, discount or any other forms;

c) Providing or supporting the provision of information and education about infant feeding so as to disseminate on, introduce or promote the sale or use of infant formulas.

Section 3. VIOLATIONS AGAINST REGULATIONS ON PHARMACY AND COSMETICS

Article 52. Violations against regulations on pharmacy practicing

1. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for commission of one of the following violations:

a) The chief pharmacist of a drug retailer is absent throughout its operation, except for authorization cases prescribed by law;

b) Failing to comply with decisions issued by competent authorities in case of disasters or dangerous epidemics;

c) Failing to complete the training program and refresher program in pharmacy within 03 years from the issuance date of the pharmacy practicing certificate or the issuance date of the latest certificate of completion of training program and refresher program in pharmacy;

d) Replacing drugs in a prescription with other drugs that have the same active ingredients, usage, and dose without the buyer’s consent.

2. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for commission of one of the following violations:

a) Forging one of required documents in the application for the pharmacy practicing certificate;

b) Practicing pharmacy without obtaining the pharmacy practicing certificate or while the pharmacy practicing certificate at the job position requiring the pharmacy practicing certificate has been suspended;

c) Acting as the chief pharmacist of two or more pharmacy business establishments or at two or more pharmacy business locations;

d) Practicing pharmacy beyond the scope written on the pharmacy practicing certificate and technical and professional regulations;

dd) The institution providing training and refresher programs in pharmacy fails to meet eligibility requirements set by law;

e) The organization that administers the examination for the pharmacy practicing certificate fails to meet eligibility requirements set by law;

g) Renting, lending or allowing others to use the pharmacy practicing certificate.

3. A fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed for using a rented or borrowed pharmacy practicing certificate.

4. Additional penalties:

a) The pharmacy practicing certificate shall be suspended for a fixed period of 01 - 03 months in case of commission of the violation in Point c or d Clause 2 of this Article;

b) The pharmacy practicing certificate and certificate of eligibility for pharmacy business shall be suspended for a fixed period of 06 - 09 months in case of commission of the violation in Point b Clause 1 of this Article.

5. Remedial measures:

a) The violating entity is compelled to return any benefits illegally obtained from the commission of the violation in Point g Clause 2, or Clause 3 of this Article;

b) Enforced revocation of pharmacy practicing certificate in case of commission of the violation in Point b or c Clause 1, Point a or g Clause 2, or Clause 3 of this Article.

Article 53. Violations against regulations on pharmacy business establishments and eligibility requirements to run pharmacy business

1. A fine ranging from VND 1.000.000 to VND 3.000.000 shall be imposed for commission of one of the following violations:

a) A mobile drug retailer fails to meet eligibility requirements set by law;

b) A mobile drug retailer fails to send a written notification to the Department of Health of the province where the mobile retailer will operate.

2. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed upon a business establishment that has a drug cabinet for failing to meet one of eligibility requirements set by law;

3. A fine ranging from VND 10.000.000 to VND 15.000.000 shall be imposed for forging any of the required documents in the application for listing of business establishment that has a drug cabinet.

4. A fine ranging from VND 15.000.000 to VND 20.000.000 shall be imposed for failing to adopt isolation measures or put the following drugs/pharmaceutical starting materials at quarantine areas, except the case prescribed in Point dd Clause 4 Article 59 hereof:

a) Substandard drugs or pharmaceutical starting materials;

b) Drugs or pharmaceutical starting materials subject to a recall notification of a competent authority;

c) Expired drugs or pharmaceutical starting materials;

d) Drugs or pharmaceutical starting materials of unknown origin.

5. Additional penalties:

a) Business operations involving the violation in Point a Clause 1 or Clause 2 of this Article shall be suspended for a fixed period of 01 – 03 months;

b) Business operations involving the violation in Clause 3 of this Article shall be suspended for a fixed period of 06 – 12 months.

6. Remedial measure:

All drugs and pharmaceutical starting materials involving the violation in Clause 4 of this Article shall be destroyed, except those in Point a and b Clause 4 of this Article which are allowed by competent authorities to be re-exported or remedied as prescribed by law.

Article 54. Violations against regulations on certificate of eligibility for pharmacy business

1. A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed for commission of one of the following violations:

a) Forging or altering any documents or papers issued by competent authorities or relevant organizations/individuals included in the application for issuance of the certificate of eligibility for pharmacy business;

b) Using rented or borrowed certificate of eligibility for pharmacy business, or renting, lending or allowing others to use certificate of eligibility for pharmacy business.

2. Additional penalty:

b) The certificate of eligibility for pharmacy business shall be suspended for a fixed period of 24 months in case of commission of the violation in Clause 1 of this Article.

3. Remedial measures:

a) The violating entity is compelled to return any benefits illegally obtained from the commission of the violation in Point b Clause 1 of this Article;

b) Enforced revocation of certificate of eligibility for pharmacy business in case of commission of the violation in Clause 1 of this Article.

Article 55. Violations against regulations on rights and responsibilities of pharmacy business establishments

1. A fine ranging from VND 1.000.000 to VND 3.000.000 shall be imposed for commission of one of the following violations:

a) Failing to report to the Ministry of Health or Provincial Department of Health or failing to fulfill the obligations in case of suspension of pharmacy business for 06 months or longer or shutdown;

b) Failing to notify or update the list of practitioners possessing pharmacy practicing certificates to the competent authority as prescribed by law;

c) Failing to submit periodic reports or ad hoc reports at the request of competent pharmacy authorities;

d) Failing to post wholesale and retail prices in Vietnamese dong, or posting them in an insufficient, improper and ambiguous manner that misleads customers at places where drugs are sold.

2. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for commission of one of the following violations:

a) Failing to openly post pharmacy practicing certificates in cases where the pharmacy practicing certificate is required or the certificate of eligibility for pharmacy business in the premises;

b) Failing to pay compensation for entities that suffer damage caused by the drug/pharmaceutical starting material retailer as prescribed by law.

3. A fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed for failing to pay compensation for entities that suffer damage caused by the establishment as prescribed by law, except the case prescribed in Point b Clause 2 of this Article.

4. The fine shall be 1.5 times or twice as much as the fine imposed for the violation in Point c Clause 1 of this Article but not exceed VND 100.000.000 if the violation involves drugs or active ingredients on the List of banned substances in some fields and sectors, combined drugs that contain narcotic substances, psychotropic ingredients or precursors or radiopharmaceuticals, or involves narcotic drugs, psychotropic drugs, precursor drugs, pharmaceutical starting materials that are narcotic substances or psychotropic ingredients or drug precursors respectively.

5. Additional penalty:

Business operations involving the violation in Point a Clause 1 of this Article shall be suspended for a fixed period of 01 – 03 months.

Article 56. Violations against regulations on registration of drugs and pharmaceutical starting materials

1. A fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed for commission of one of the following violations:

a) Failing to report or provide information on registration of drugs in Vietnam according to regulations on obligations of applicants for drug registration and of drug manufacturers or at the request of competent authorities, unless a written representation is provided and accepted by competent authorities;

b) Failing to follow procedures for adjustment of certificate of registration before the sale of drugs/pharmaceutical starting materials in case of minor variations only requiring notification;

c) Failing to notify competent authorities of suspension of manufacture or supply of drugs or of the scarcity or threat of scarcity of drugs or pharmaceutical starting materials.

2. A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed for commission of one of the following violations:

a) Failing to retain documents related to the drug/medicinal ingredient registration or failing to provide information on the registered drug when there is information or evidence about the safety and efficacy of the drug during the effective period of its marketing authorization to competent authorities at their request;

b) Failing to publish information about the recalled drug or failing to organize the recall and receive the recalled drug as prescribed by law;

c) Failing to update standards on quality of drugs/pharmaceutical starting materials as prescribed by law.

3. A fine ranging from VND 30.000.000 to VND 50.000.000 shall be imposed for committing one of the following violations:

a) Failing to maintain the satisfaction of operating conditions during the effective period of the certificate of registration of drug/pharmaceutical starting material;

b) Failing to implement the approved risk management plan included in the application for issuance or renewal of certificate of registration of vaccine;

c) Failing to follow procedures for adjustment of certificate of registration before the sale of drugs/pharmaceutical starting materials in case of major/minor variations requiring approval;

d) Manufacturing or selling drug/pharmaceutical starting material in case there are changes compared to the approved application for registration which require following procedures for issuance of certificate of registration .

4. A fine ranging from VND 50.000.000 to VND 70.000.000 shall be imposed for commission of one of the following violations:

a) Failing to notify competent authorities of the case where the drug/pharmaceutical starting material granted certificate of registration in Vietnam is recalled in any country other than the manufacturing country or reference country issuing the Certificate of Pharmaceutical Product (CPP) included in the application for registration;

b) Failing to notify competent authorities of the case where the drug/pharmaceutical starting material granted certificate of registration in Vietnam is recalled in the manufacturing country or reference country issuing the Certificate of Pharmaceutical Product (CPP) included in the application for registration;

c) The application for registration of drug/pharmaceutical starting material includes documents or information that are/is not based on research findings or manufacturer’s actual production, or fraudulent documents according to the conclusion given a competent authority.

 5. Remedial measures:

a) Enforced recall of drug/pharmaceutical starting material in case of commission of the violation in Point c Clause 4 of this Article;

b) Enforced revocation of certificate of registration of drug/pharmaceutical starting material in case of commission of the violation in Point b or c Clause 4 of this Article.

Article 57. Violations against regulations on manufacturing of drugs and pharmaceutical starting materials

1. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for commission of one of the following violations:

a) A vaccine manufacturer fails to report before making changes or repairing the manufacturing premises as prescribed by law;

b) Failing to cooperate or obstructing quality inspection agency in taking samples of drugs or pharmaceutical starting materials to serve quality inspection tasks;

c) Failing to submit report on recall of drug/pharmaceutical starting material as prescribed by law.

2. A fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed for commission of one of the following violations:

a) Failing to send a notification to competent authorities when manufacturing drug/pharmaceutical starting material in case there are minor variations compared to the approved application for registration which requires notification;

b) Failing to obtain an approval from a competent authority when manufacturing drug/pharmaceutical starting material in case there are minor variations compared to the approved application for registration which requires an approval from a competent authority;

c) Failing to retain samples of drug/pharmaceutical starting material when performing drug/pharmaceutical starting material testing as prescribed by law;

d) Failing to retain or inadequately retaining documents about manufacturing of drug/pharmaceutical starting material as prescribed by law.

3. A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed for commission of one of the following violations:

a) Failing to comply with the drug/pharmaceutical starting material manufacturing or testing process included in the approved application for registration;

b) Manufacturing drug in violation of quality regulations at level 3;

c) Failing to perform testing for pharmaceutical starting materials and primary packages before they are used in the manufacturing of drugs;

d) Failing to have drugs tested by a testing laboratory designated by a competent authority before the sale of drugs which must be tested as prescribed by law;

dd) Failing to obtain an approval when manufacturing drug/pharmaceutical starting material in case there are major variations compared to the approved application for registration;

e) Manufacturing the drug while the certificate of registration has been expired, unless permitted by law;

g) Using pharmaceutical starting material/herbal ingredient which is not granted certificate of registration, is not included in the announced list of pharmaceutical starting materials, or of which quality standards are not yet announced as prescribed by law.

4. A fine ranging from VND 30.000.000 to VND 40.000.000 shall be imposed for commission of one of the following violations:

a) Failing to recall drug/pharmaceutical starting material at the request of a competent authority or when finding that the manufactured drug falls in cases where a drug must be recalled;

b) Manufacturing drug in violation of quality regulations at level 2;

c) Manufacturing drugs with using substandard primary packages;

d) Manufacturing the pharmaceutical starting material which fails to meet quality standards;

dd) Making changes in the main/important manufacturing equipment that may significantly affect the manufacturing process or quality of drug/pharmaceutical starting material without following procedures for issuance of certificate of eligibility for pharmacy business or reporting such changes as prescribed by law;

e) Making changes in auxiliary system or principles of design or operation of utility systems that may affect the manufacturing environment without following procedures for issuance of certificate of eligibility for pharmacy business or reporting such changes as prescribed by law;

g) Failing to submit reports on GMP (Good manufacturing practices) compliance as prescribed by law;

h) Failing to perform testing of drug/pharmaceutical starting material before release as prescribed by law.

5. A fine ranging from VND 40.000.000 to VND 60.000.000 shall be imposed for commission of one of the following violations:

a) Manufacturing drug in violation of quality regulations at level 1;

b) Manufacturing drug/pharmaceutical starting material at a location other than the registered one by adopting the production line which has been certified by a competent authority to be conformable with GMP;

c) Failing to reporting changes in case of expansion of the existing factory or major repairs or changes in structure or floor plan of the premises or production line;

d) Forging or altering any documents, papers or certifications issued by competent authorities and other entities during the manufacturing of drug/pharmaceutical starting material;

dd) Manufacturing drug/pharmaceutical starting material beyond the scope specified in the certificate of eligibility for pharmacy business or scope of inspection of GMP compliance;

e) Only maintaining the GMP compliance at level 4.

6. A fine ranging from VND 60.000.000 to VND 80.000.000 shall be imposed for commission of one of the following violations:

a) Manufacturing and selling drug/pharmaceutical starting material that is not granted certificate of registration in Vietnam, except drugs/pharmaceutical starting materials which are not required to be registered as prescribed by law;

b) Manufacturing drugs using pharmaceutical starting materials which are substandard, subject to a recall notice given by a competent authority, of unknown origin, or have been expired;

c) Manufacturing drug/pharmaceutical starting material at a location other than the one specified in the approved application for registration, except the violation in Point b Clause 5 of this Article;

d) Manufacturing drug/pharmaceutical starting material at an establishment that is not issued with the certificate of eligibility for pharmacy business or does not pass the inspection of GMP compliance as prescribed by law;

dd) Manufacturing drug/pharmaceutical starting material while business operation or the certificate of eligibility for pharmacy business is suspended;

e) Manufacturing products which are not drugs on the production line, except the manufacturing of health supplements on the herbal or traditional drug production line or other cases prescribed by the Minister of Health;

g) Manufacturing, processing or preparing a traditional drug containing an active ingredient which is not licensed by a competent authority as prescribed by law.

7. The fine shall be 1.5 times or twice as much as the fine imposed for the violation in Point dd Clause 5 or Point c, d or dd Clause 6 of this Article but not exceed VND 100.000.000 if the violation involves drugs or active ingredients on the List of banned substances in some fields and sectors, combined drugs that contain narcotic substances, psychotropic ingredients or precursors or radiopharmaceuticals, or involves narcotic drugs, psychotropic drugs, precursor drugs, medicinal ingredients that are narcotic substances or psychotropic ingredients or drug precursors respectively.

8. Additional penalties:

a) Business operations involving the violation in Point c Clause 3 or Point h Clause 4 of this Article shall be suspended for a fixed period of 01 – 03 months;

b) The production line involving the violation in Point dd or e Clause 4 or Point a or c Clause 5 of this Article shall be suspended for a fixed period of 01 – 03 months;

c) Business operations involving the violation in Point b or dd Clause 5 or Point a or c Clause 6 of this Article shall be suspended for a fixed period of 03 – 06 months;

d) Operations shall be suspended until the violating entity submits required reports to the Ministry of Health but for a period not exceeding 24 months in case of commission of the violation in Point g Clause 4 of this Article;

dd) The certificate of eligibility for pharmacy business shall be suspended for a fixed period of 09 - 12 months in case of commission of the violation in Point e or g Clause 6 of this Article;

e) The certificate of eligibility for pharmacy business shall be suspended for a fixed period of 03 - 06 months in case of commission of the violation in Point d Clause 5 or Point b Clause 6 of this Article;

g) Operations of the pharmacy business establishment directly involving the violation in Point e Clause 5 of this Article shall be suspended for a fixed period of 03 – 06 months.

9. Remedial measures:

a) All drugs/pharmaceutical starting materials shall be destroyed in case of commission of the violation in Point c Clause 3, Point b or c Clause 4, Point a or d Clause 5, Clause 6 or Clause 7 of this Article;

b) Enforced revocation of certificate of eligibility for business pharmacy in case of commission of the violation in Point e Clause 5 of this Article; upon the end of the suspension period, if the violating entity fails to rectify deficiencies, its operations shall be suspended until it successfully completes rectification of such deficiencies;

c) Enforced revocation of certificate of eligibility for pharmacy business in case of commission of the violation in Point d Clause 5 or Point e or g Clause 6 of this Article.

Article 58. Violations against regulations on wholesaling of drugs and pharmaceutical starting materials

1. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for commission of one of the following violations:

a) Expanding the existing warehouse or repairing or having significant changes in structure or floor plan of the warehouse of a drug/pharmaceutical starting material wholesaler without submitting a report on such changes, accompanied by relevant technical documents;

b) Failing to cooperate or obstructing the quality inspection agency in taking samples of drugs or pharmaceutical starting materials to serve quality inspection tasks;

c) Failing to submit reports on drug recall at the request of a competent authority;

d) Trading drug in violation of quality regulations at level 3;

dd) Trading drugs that belong to a national target program, drugs as emergency aid and other drugs banned from selling;

e) Failing to retain all documents about each batch/shipment of drugs/ pharmaceutical starting materials for a period prescribed by law.

2. A fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed for commission of one of the following violations:

a) Trading drugs/pharmaceutical starting materials as samples for registration, testing, scientific research, or display at a fair or exhibition;

b) Selling or buying drugs, pharmaceutical starting materials, vaccines or biologicals to or from an establishment beyond its business scope specified in the certificate of eligibility for pharmacy business;

c) Trading drug in violation of quality regulations at level 2;

d) Failing to recall drugs/pharmaceutical starting materials at the request of a competent authority.

3. A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed for commission of one of the following violations:

a) Selling or buying drugs, pharmaceutical starting materials, vaccines or biologicals to or from an establishment that does not hold a valid certificate of eligibility for pharmacy business, except non-commercial pharmacy business establishments;

b) Failing to submit reports on GDP (Good distribution practices) compliance as prescribed by law;

c) Failing to have equipment and computers connected to the Internet and use software to manage distribution activities;

d) Failing to adopt mechanism for transmission of information on distribution and quality of drugs between a manufacturer and its clients, and transmission of information to relevant regulatory authorities at their request;

dd) Only maintaining the GDP compliance at level 3.

4. A fine ranging from VND 30.000.000 to VND 40.000.000 shall be imposed for commission of one of the following violations:

a) Trading drug in violation of quality regulations at level 1;

b) Failing to meet quality standards as prescribed by competent authorities when trading in herbal ingredients which have been preliminarily processed;

c) Storing drugs/pharmaceutical starting materials against the conditions written on the labels;

d) Changing the location of the existing warehouse or opening a new warehouse at the same business location of the drug/pharmaceutical starting material wholesaler without submitting a report on such changes, accompanied by relevant technical documents as prescribed by law;

dd) Making changes in the auxiliary system or principles of design or operation of utility systems that may affect storage requirements or conditions without submitting a report on such changes, accompanied by relevant technical documents as prescribed by law.

5. A fine ranging from VND 40.000.000 to VND 60.000.000 shall be imposed for buying or selling drugs/pharmaceutical starting materials:

a) without a valid certificate of eligibility for pharmacy business;

b) at a location other than the one specified in the issued certificate of eligibility for pharmacy business; or

c) while business operation or the certificate of eligibility for pharmacy business is suspended.

6. The following fines shall be imposed for buying or selling drugs/pharmaceutical starting materials which are subject to recall decisions issued by competent authorities, which have been expired, or which are not issued with the import license or certificate of registration, except drugs/pharmaceutical starting materials which are not required to be registered as prescribed by law:

a) A fine ranging from VND 5.000.000 to VND 7.000.000 shall be imposed for the violation involving goods worth less than VND 5.000.000;

b) A fine ranging from VND 7.000.000 to VND 10.000.000 shall be imposed for the violation involving goods worth from VND 5.000.000 to under VND 10.000.000;

c) A fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed for the violation involving goods worth from VND 10.000.000 to under VND 20.000.000;

d) A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed for the violation involving goods worth from VND 20.000.000 to under VND 30.000.000;

dd) A fine ranging from VND 30.000.000 to VND 40.000.000 shall be imposed for the violation involving goods worth from VND 30.000.000 to under VND 40.000.000;

e) A fine ranging from VND 40.000.000 to VND 50.000.000 shall be imposed for the violation involving goods worth from VND 40.000.000 to under VND 50.000.000;

g) A fine ranging from VND 50.000.000 to VND 60.000.000 shall be imposed for the violation involving goods worth from VND 50.000.000 to under VND 60.000.000;

h) A fine ranging from VND 60.000.000 to VND 70.000.000 shall be imposed for the violation involving goods worth from VND 60.000.000 to under VND 70.000.000;

i) A fine ranging from VND 70.000.000 to VND 80.000.000 shall be imposed for the violation involving goods worth from VND 70.000.000 to under VND 80.000.000;

k) A fine ranging from VND 80.000.000 to VND 90.000.000 shall be imposed for the violation involving goods worth from VND 80.000.000 to under VND 100.000.000;

l) A fine ranging from VND 90.000.000 to VND 100.000.000 shall be imposed for the violation involving goods worth VND 100.000.000 or more.

7. The fine shall be 1.5 times or twice as much as the fine imposed for the violation in Point e Clause 1, Point a or b Clause 2, Point a Clause 3, Point d Clause 4, Clause 5 or Clause 6 of this Article but not exceed VND 100.000.000 if the violation involves active ingredients or drugs banned in some fields and sectors, combined drugs that contain narcotic substances, psychotropic ingredients or precursors or radiopharmaceuticals, or involves narcotic drugs, psychotropic drugs, precursor drugs, pharmaceutical starting materials that are narcotic substances or psychotropic ingredients or drug precursors respectively.

8. Additional penalties:

a) The certificate of eligibility for pharmacy business shall be suspended for a fixed period of 01 - 02 months in case of re-commission of the violation in Point c or d Clause 3 of this Article;

b) The pharmacy practicing certificate shall be suspended for a fixed period of 03 – 06 months in case of commission of the violation in Point a or c Clause 2, Clause 4, Point b Clause 5 or Clause 6 of this Article;

c) Operations of the violating entity shall be suspended for a fixed period of 06 - 09 months in case of commission of the violation in Point dd Clause 3, Point a or c Clause 5 or Clause 6 of this Article;

d) Operations shall be suspended until the violating entity submits required reports to the Ministry of Health but for a period not exceeding 24 months in case of commission of the violation in Point b Clause 3 of this Article.

9. Remedial measure:

All drugs/pharmaceutical starting materials shall be destroyed in case of commission of the violation in Point a or b Clause 5 or Clause 6 of this Article.

Article 59. Violations against regulations on retailing of drugs and herbal ingredients

1. A fine ranging from VND 1.000.000 VND 3.000.000 shall be imposed for commission of one of the following violations:

a) Failing to meet quality standards as prescribed by competent authorities when selling herbal ingredients which have been preliminarily processed;

b) A pharmacist who directly engages in the drug retailing fails to possess a professional qualifications as prescribed by law;

c) Failing to use records or computers for managing the warehousing, dispatching, inventory, batch number, expiry date, origin of drugs and other relevant information as prescribed by law;

d) Trading drug in violation of quality regulations at level 3;

dd) Failing to specify the drug name, content and expiry date when retailing drugs without secondary packages; failing to specify the dose and usage when selling drugs without a prescription;

e) Failing to retain all documents about each batch/shipment of drugs/ pharmaceutical starting materials for a period prescribed by law;

g) Failing to cooperate or obstructing the quality inspection agency in taking samples of drugs or pharmaceutical starting materials to serve quality inspection tasks.

2. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for commission of one of the following violations:

a) Relocating the drug retailer’s premises at the same business location or expanding the premises or making major repairs or changes in structure of the premises without submitting a report on such changes, accompanied by relevant technical documents as prescribed by law;

b) Failing to provide a separate area for displaying products other than drugs or failing to put a notice indicating that "sản phẩm này không phải là thuốc" (“This is not a drug”) at the separate area for cosmetics, functional foods and medical devices as prescribed by law;

c) Trading drug in violation of quality regulations at level 2.

3. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for commission of one of the following violations:

a) Failing to recall drugs/herbal ingredients at the request of a competent authority;

b) Failing to have a separate room for making extemporaneous preparations or failing to have a separate area for washing preparation devices if preparing drugs according to prescriptions;

c) Failing to have a storage facility which has been registered by the drug retailer, or storing drugs against the storage conditions specified in the drug labels or against GPP (Good pharmacy practices) requirements;

d) Storing or retailing drugs beyond the business scope specified in the certificate of eligibility for pharmacy business, drugs that belong to a national target program, drugs as emergency aid and other drugs banned from selling;

dd) Selling vaccines or selling prescription drugs without a prescription presented;

e) Failing to submit reports on GPP compliance as prescribed by law;

g) Failing to have appropriate IT equipment, apply IT, make network connection or control origin, prices and sources of drugs bought and sold as prescribed by law, except herbal ingredient retailers;

h) Failing to transmit information about the drug purchase and sale, and drug quality between suppliers and customers; failing to transmit information to relevant regulatory authorities at their request, except herbal ingredient retailers;

i) Only maintaining GPP compliance at level 3.

4. A fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed for commission of one of the following violations:

a) Buying or selling drugs for clinical trial;

b) Buying or selling drugs manufactured or prepared according to prescriptions for use within health facilities, unless permitted by law;

c) Buying or selling modern drugs prepared according to prescriptions from other drugstores;

d) Buying or selling drugs on the list of drugs restricted from retailing without obtaining permission as prescribed by law;

dd) Failing to adopt isolation measures or put the following drugs/herbal ingredients at quarantine areas: substandard drugs/herbal ingredients; drugs/herbal ingredients subject to a recall notification of a competent authority; expired drugs/herbal ingredients; drugs/herbal ingredients of unknown origin;

e) Trading drug in violation of quality regulations at level 1.

5. A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed for buying or selling drugs/herbal ingredients:

a) without a valid certificate of eligibility for pharmacy business;

b) at a location other than the one specified in the issued certificate of eligibility for pharmacy business; or

c) while business operation or the certificate of eligibility for pharmacy business is suspended.

6. The following fines shall be imposed for buying or selling drugs/herbal ingredients which are subject to recall decisions issued by competent authorities, which have been expired, or which are not issued with the import license or certificate of registration, except drugs/pharmaceutical starting materials which are not required to be registered as prescribed by law:

a) A fine ranging from VND 1.000.000 to VND 2.000.000 shall be imposed for the violation involving goods worth less than VND 1.000.000;

b) A fine ranging from VND 2.000.000 to VND 3.000.000 shall be imposed for the violation involving goods worth from VND 1.000.000 to under VND 2.000.000;

c) A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for the violation involving goods worth from VND 2.000.000 to under VND 5.000.000;

d) A fine ranging from VND 5.000.000 to VND 7.000.000 shall be imposed for the violation involving goods worth from VND 5.000.000 to under VND 10.000.000;

dd) A fine ranging from VND 7.000.000 to VND 10.000.000 shall be imposed for the violation involving goods worth from VND 10.000.000 to under VND 15.000.000;

e) A fine ranging from VND 10.000.000 to VND 15.000.000 shall be imposed for the violation involving goods worth from VND 15.000.000 to under VND 30.000.000;

g) A fine ranging from VND 15.000.000 to VND 20.000.000 shall be imposed for the violation involving goods worth from VND 30.000.000 to under VND 40.000.000;

h) A fine ranging from VND 20.000.000 to VND 25.000.000 shall be imposed for the violation involving goods worth from VND 40.000.000 to under VND 50.000.000;

i) A fine ranging from VND 25.000.000 to VND 30.000.000 shall be imposed for the violation involving goods worth from VND 50.000.000 to under VND 70.000.000;

k) A fine ranging from VND 30.000.000 to VND 40.000.000 shall be imposed for the violation involving goods worth from VND 70.000.000 to under VND 100.000.000;

l) A fine ranging from VND 40.000.000 to VND 50.000.000 shall be imposed for the violation involving goods worth VND 100.000.000 or more.

7. The fine shall be 1.5 times or twice as much as the fine imposed for the violation in Point c or e Clause 1, Point a Clause 2, Point d Clause 3, Clause 5 or Clause 6 of this Article but not exceed VND 100.000.000 if the violation involves drugs or active ingredients banned in some fields and sectors, combined drugs that contain narcotic substances, psychotropic ingredients or precursors or radiopharmaceuticals, or involves narcotic drugs, psychotropic drugs, precursor drugs, pharmaceutical starting materials that are narcotic substances or psychotropic ingredients or drug precursors respectively.

8. Additional penalties:

a) The certificate of eligibility for pharmacy business shall be suspended for a fixed period of 01 - 02 months in case of re-commission of the violation in Point g or h Clause 3 of this Article;

b) The pharmacy practicing certificate and certificate of eligibility for pharmacy business shall be suspended for a fixed period of 01 - 03 months in case of commission of the violation in Point b, c or d Clause 4 of this Article;

c) The pharmacy practicing certificate shall be suspended for a fixed period of 03 - 06 months in case of commission of the violation in Point b Clause 5 or Clause 6 of this Article;

d) Operations of the violating entity shall be suspended for a fixed period of 01 - 03 months in case of commission of the violation in Point a Clause 2 of this Article;

dd) Operations of the violating entity shall be suspended for a fixed period of 06 - 09 months in case of commission of the violation in Point dd or i Clause 3 or Point c Clause 5 of this Article.

9. Remedial measures:

a) The violating entity is compelled to return any benefits illegally obtained from the commission of one of the violations in Clause 5 or 6 of this Article;

b) All substandard drugs/herbal ingredients shall be destroyed in case of commission of the violation in Point e Clause 4 of this Article;

c) All drugs/herbal ingredients shall be destroyed in case of commission of the violation in Point a Clause 5 or Clause 6 of this Article.

Article 60. Violations against regulations on import and export of drugs and medicinal ingredients

1. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for commission of one of the following violations:

a) Failing to submit reports on recall of drugs/pharmaceutical starting materials at the request of a competent authority;

b) Failing to cooperate or obstructing the quality inspection agency in taking samples of drugs or pharmaceutical starting materials to serve quality inspection tasks.

2. A fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed for commission of one of the following violations:

a) Failing to submit reports on GSP (Good storage practices) compliance as prescribed by law;

b) Failing to send a written notification to the Ministry of Health of the wholesaler that distributes drugs/pharmaceutical starting materials imported into Vietnam by an entity that is entitled to import but not entitled to distribute drugs/pharmaceutical starting materials in Vietnam before starts to sell or stops selling drugs to that wholesaler;

c) Failing to retain documents concerning the drug/pharmaceutical starting material shipment for a period prescribed by law;

d) Selling drugs that belong to a national target program, drugs as emergency aid and other drugs banned from selling;

dd) Exporting drugs/pharmaceutical starting materials without possessing a certificate of eligibility for pharmacy business or while business operation or the certificate of eligibility for pharmacy business is suspended;

e) Exporting drugs/pharmaceutical starting materials that are subject to a recall notification as prescribed by law;

g) Exporting drugs/pharmaceutical starting materials beyond the scope specified in the certificate of eligibility for pharmacy business;

h) Exporting herbal ingredients included in the list of controlled rare and special herbs without obtaining permission from a competent authority.

3. A fine ranging from VND 40.000.000 to VND 50.000.000 shall be imposed for commission of one of the following violations:

a) Storing drugs/pharmaceutical starting materials at a warehouse facility that fails to meet GSP requirements or at a location other than the one specified in the certificate of eligibility for pharmacy business, except cases of use of storage services;

b) Only maintaining GSP compliance at level 3;

c) Importing drugs/pharmaceutical starting materials with a quantity exceeding that written on the import license given by a competent authority;

d) Failing to re-export all drugs/pharmaceutical starting materials imported under the import license for display at a medicinal, pharmaceutical or medical device exhibition or fair upon the end of the exhibition or fair;

dd) Exporting controlled drugs without the export license;

e) Importing drugs/pharmaceutical starting materials whose shelf life contravenes regulations on remaining shelf life of drugs/pharmaceutical starting materials when they arrive at Vietnam’s port without obtaining permission from the Minister of Health;

g) Failing to recall drugs/pharmaceutical starting materials at the request of a competent authority;

h) Importing drugs/pharmaceutical starting materials beyond the scope specified in the certificate of eligibility for pharmacy business;

i) Expanding the existing warehouse, making major repairs or changes in structure or floor plan of the warehouse, or changing the auxiliary system or principle of design or operation of utility systems that may affect storage requirements or conditions without submitting a report on such changes, accompanied by relevant technical documents as prescribed by law.

4. A fine ranging from VND 50.000.000 to VND 70.000.000 shall be imposed for commission of one of the following violations:

a) Using fraudulent documents in the approved application for drug/pharmaceutical starting material import license according to the conclusion given by the competent authority;

b) Importing drugs/pharmaceutical starting materials manufactured at a location other than that specified in the approved application for the drug import license;

c) Submitting an application for import license containing information on the drug/pharmaceutical starting material which is not based on research findings or the manufacturer’s actual production.

5. A fine ranging from VND 70.000.000 to VND 80.000.000 shall be imposed for commission of one of the following violations:

a) Importing drugs/pharmaceutical starting materials without possessing a certificate of eligibility for pharmacy business or while business operation or the certificate of eligibility for pharmacy business is suspended;

b) Importing drugs/pharmaceutical starting materials subject to a recall notification of a competent authority;

c) Importing drugs/pharmaceutical starting materials without the import license or certificate of registration, except drugs/pharmaceutical starting materials which are not required to be registered or do not require the import license;

d) Performing activities related to the distribution of drugs/pharmaceutical starting materials in Vietnam by an entity is entitled to import but not entitled to distribute drugs/pharmaceutical starting materials in Vietnam, except drugs and pharmaceutical starting materials it manufactures in Vietnam.

6. The following fines shall be imposed for importing drugs/pharmaceutical starting materials which have been expired:

a) A fine ranging from VND 1.000.000 to VND 3.000.000 shall be imposed for the violation involving goods worth less than VND 2.000.000;

b) A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for the violation involving goods worth from VND 2.000.000 to under VND 5.000.000;

c) A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for the violation involving goods worth from VND 5.000.000 to under VND 10.000.000;

d) A fine ranging from VND 10.000.000 to VND 15.000.000 shall be imposed for the violation involving goods worth from VND 10.000.000 to under VND 20.000.000;

dd) A fine ranging from VND 15.000.000 to VND 20.000.000 shall be imposed for the violation involving goods worth from VND 20.000.000 to under VND 130.000.000;

e) A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed for the violation involving goods worth from VND 30.000.000 to under VND 40.000.000;

g) A fine ranging from VND 30.000.000 to VND 40.000.000 shall be imposed for the violation involving goods worth from VND 40.000.000 to under VND 50.000.000;

h) A fine ranging from VND 40.000.000 to VND 50.000.000 shall be imposed for the violation involving goods worth from VND 50.000.000 to under VND 60.000.000;

i) A fine ranging from VND 50.000.000 to VND 60.000.000 shall be imposed for the violation involving goods worth from VND 60.000.000 to under VND 80.000.000;

k) A fine ranging from VND 60.000.000 to VND 70.000.000 shall be imposed for the violation involving goods worth from VND 80.000.000 to under VND 100.000.000;

l) A fine ranging from VND 70.000.000 to VND 80.000.000 shall be imposed for the violation involving goods worth VND 100.000.000 or more.

7. The fine shall be 1.5 times or twice as much as the fine imposed for the violation in Point c, d, dd or g Clause 2, Point a, c, d or h Clause 3, or Point a or c Clause 5 of this Article but not exceed VND 100.000.000 if the violation involves drugs or active ingredients on the List of banned substances in some fields and sectors, combined drugs that contain narcotic substances, psychotropic ingredients or precursors or radiopharmaceuticals, or involves narcotic drugs, psychotropic drugs, precursor drugs, medicinal ingredients that are narcotic substances or psychotropic ingredients or drug precursors respectively.

8. Additional penalties:

a) The pharmacy practicing certificate of the chief pharmacist shall be suspended for a fixed period of 01 - 03 months in case of commission of the violation in Point b, c, dd, e or g Clause 2 of this Article;

b) The pharmacy practicing certificate of the chief pharmacist shall be suspended for a fixed period of 03 - 06 months in case of commission of the violation in Point a, c, d, dd, e, g or i Clause 3 of this Article;

c) The pharmacy practicing certificate of the chief pharmacist shall be suspended for a fixed period of 06 - 09 months in case of commission of the violation in Clause 5 of this Article;

d) The certificate of eligibility for pharmacy business shall be suspended for a fixed period of 18 - 24 months in case of commission of the violation in Point d Clause 5 of this Article;

dd) Business operations involving the violation in Point dd, e or g Clause 2 of this Article shall be suspended for a fixed period of 01 – 03 months;

e) Business operations involving the violation in Point b, c, dd or h Clause 3 or Point b Clause 4 of this Article shall be suspended for a fixed period of 03 – 06 months;

g) The import of drugs/pharmaceutical starting materials shall be suspended for a fixed period of 06 - 09 months in case of commission of the violation in Point a, b or c Clause 5 of this Article;

h) Operations shall be suspended until the violating entity submits required reports to the Ministry of Health but for a period not exceeding 24 months in case of commission of the violation in Point d Clause 2 of this Article.

9. Remedial measures:

a) The violating entity is compelled to remove from the Socialist Republic of Vietnam or re-export drugs/pharmaceutical starting materials involving the violation in Point d Clause 3 or Clause 4, 5, 6 or 7 of this Article. If these measures cannot be implemented, drugs/pharmaceutical starting materials shall be destroyed;

b) The violating entity is compelled to return any benefits illegally obtained from the commission of the violation in Point d Clause 2 of this Article.

Article 61. Violations against regulations on storage of drugs and pharmaceutical starting materials by drug/pharmaceutical starting material storage service providers and non-commercial pharmacy business establishments

1. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for commission of one of the following violations:

a) Failing to submit a report on changes, accompanied by relevant technical documents, to the receiving authority when changing the location of the existing warehouse or opening a new warehouse at the same business location;

b) Failing to submit a report on changes, accompanied by relevant technical documents, to the receiving authority when expanding the existing warehouse, making major repairs or changes in structure or floor plan of the warehouse, or changing the auxiliary system or principle of design or operation of utility systems that may affect storage requirements or conditions;

c) Failing to send a written notification of GSP compliance to the receiving authority, failing to comply with the roadmap for GSP application and compliance by establishments that store and supply vaccines, drugs and pharmaceutical starting materials by non-commercial pharmacy business establishments as prescribed by law;

d) Failing to cooperate or obstructing the quality inspection agency in taking samples of drugs or pharmaceutical starting materials to serve quality inspection tasks;

dd) Failing to retain all documents about each batch/shipment of drugs/ pharmaceutical starting materials for a period prescribed by law.

2. A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed for commission of one of the following violations:

a) Providing drug/pharmaceutical starting material storage services to ineligible entities;

b) Health facilities, vaccination clinics, vaccine storage facilities under the national expanded program on immunization of districts and provinces, facilities in charge of storage of drugs that belong to national health programs or people’s armed forces, vaccine storage facilities under the national expanded program on immunization at central level or regional level fail to submit written notifications of GSP compliance to receiving authorities before starting storage activities;

c) Failing to comply with storage conditions during the storage or transport of drugs/pharmaceutical starting materials;

d) Providing drug/pharmaceutical starting material storage services at an establishment that is not issued with the certificate of eligibility for pharmacy business with a scope appropriate to the drug/pharmaceutical starting material storage service provider.

3. A fine ranging from VND 30.000.000 to VND 40.000.000 shall be imposed for providing drug/pharmaceutical starting material storage services:

a) without a valid certificate of eligibility for pharmacy business;

b) at a location other than the one specified in the issued certificate of eligibility for pharmacy business; or

c) while business operation or the certificate of eligibility for pharmacy business is suspended;

d) Failing to submit reports on GSP compliance as prescribed by law;

dd) Only maintaining GSP compliance at level 3.

4. The fine shall be 1.5 times or twice as much as the fine imposed for the violation in Point a or dd Clause 1, Point a or d Clause 2, or Point a, b or c Clause 3 of this Article but not exceed VND 100.000.000 if the violation involves drugs or active ingredients on the List of banned substances in some fields and sectors, combined drugs that contain narcotic substances, psychotropic ingredients or precursors or radiopharmaceuticals, or involves narcotic drugs, psychotropic drugs, precursor drugs, medicinal ingredients that are narcotic substances or psychotropic ingredients or drug precursors respectively.

5. Additional penalties:

a) The pharmacy practicing certificate shall be suspended for a fixed period of 01 - 03 months in case of commission of the violation in Clause 2 of this Article;

b) Operations involving the violation in Clause 2 of this Article shall be suspended for a fixed period of 01 – 03 months;

c) Operations of the violating entity shall be suspended for a fixed period of 06 - 12 months in case of commission of the violation in Point a, b, c or dd Clause 3 of this Article.

6. Remedial measures:

a) All substandard drugs/pharmaceutical starting materials shall be destroyed in case of commission of the violation in Point a Clause 1 or Point c Clause 2 of this Article;

b) All drugs/pharmaceutical starting materials shall be destroyed in case of commission of the violation in Point a Clause 3 of this Article;

c) The violating entity is compelled to return any benefits illegally obtained from the commission of the violation in Point a, b or c Clause 3 of this Article.

Article 62. Violations against regulations on drug testing, clinical trial and bioequivalence study

1. A fine ranging from VND 10.000.000 to VND 15.000.000 shall be imposed for commission of one of the following violations:

a) Failing to submit a report on changes, accompanied by relevant technical documents, to the receiving authority when expanding the existing laboratory, making major repairs or changes in structure or floor plan of the laboratory, or changing the auxiliary system or principle of design or operation of utility systems that may affect the laboratory environment;

b) A drug testing service provider takes drug samples against regulations on drug sampling of the Ministry of Health.

2. A fine ranging from VND 15.000.000 to VND 20.000.000 shall be imposed for commission of one of the following violations:

a) Providing drug/pharmaceutical starting material testing service, bioequivalence study service or clinical trial service against or beyond the scope specified in the certificate of eligibility for pharmacy business or the scope of inspection of GLP (Good laboratory practices) compliance or GCP (Good clinical practice) compliance of a non-commercial pharmacy business establishment;

b) Disclosing personal information of participants in the bioequivalence study without their consent;

c) Concealing information or failing to provide participants with adequate and truthful information on the bioequivalence study, its procedures and possible risks.

3. A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed for commission of one of the following violations:

a) A non-commercial pharmacy business establishments provides bioequivalence study or clinical trial service without possessing a valid certificate of eligibility for pharmacy business or passing the inspection of GCP compliance;

b) Changing any documents included in the approved bioequivalence study dossier or bioequivalence study outline;

c) Failing to submit reports on GLP compliance as prescribed by law;

d) Only maintaining the GLP compliance at level 3;

dd) Failing to submit a report on changes, accompanied by relevant technical documents, to the authority receiving the application for inspection of GLP compliance when changing the location of the existing laboratory or opening a new laboratory within the same business location.

4. A fine ranging from VND 30.000.000 to VND 40.000.000 shall be imposed for forging or falsifying drug testing/analysis results.

5. The fine shall be 1.5 times or twice as much as the fine imposed for the violation in Point a Clause 2 or Point a or dd Clause 3 of this Article but not exceed VND 100.000.000 if the violation involves drugs or active ingredients on the List of banned substances in some fields and sectors, combined drugs that contain narcotic substances, psychotropic ingredients or precursors or radiopharmaceuticals, or involves narcotic drugs, psychotropic drugs, precursor drugs, medicinal ingredients that are narcotic substances or psychotropic ingredients or drug precursors respectively.

6. Additional penalties:

a) The certificate of eligibility for pharmacy business or operations of the violating non-commercial pharmacy business establishment shall be suspended for a fixed period of 01 – 03 months in case of commission of the violation in Clause 2, Point a, b or d Clause 3, or Clause 4 of this Article;

b) Operations shall be suspended until the violating entity submits required reports to the Ministry of Health but for a period not exceeding 24 months in case of commission of the violation in Point c Clause 3 of this Article.

Article 63. Violations against regulations on clinical trial of drugs

1. A fine ranging from VND 15.000.000 to VND 20.000.000 shall be imposed for commission of one of the following violations:

a) Disclosing personal information of participants in the clinical trial without their consent;

b) Failing to submit reports on clinical trial procedures; failing to publish clinical trial results as prescribed by law;

c) Failing to comply with GCP requirements.

2. A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed for commission of one of the following violations:

a) Conducting clinical trial without obtaining the scientific and ethical assessment record of the clinical trial dossier from the National Biomedical Ethics Committee and a written approval from the Minister of Health;

b) Changing any documents included in the clinical trial dossier or clinical trial outline approved by the Minister of Health.

3. A fine ranging from VND 30.000.000 to VND 40.000.000 shall be imposed for commission of one of the following violations:

a) Using drugs undergoing clinical trial for other purposes;

b) Forging others to participate in clinical trial.

4. The fine shall be twice as much as the fine imposed for the violation in Clause 2 or Clause 3 of this Article but not exceed VND 100.000.000 if the violation involves narcotic drugs, psychotropic drugs or precursor drugs.

5. Additional penalties:

a) The certificate of eligibility for pharmacy business or operations of the violating non-commercial pharmacy business establishment shall be suspended for a fixed period of 01 – 03 months in case of commission of the violation in Clause 1 or Clause 2 of this Article;

b) The certificate of eligibility for pharmacy business or operations of the violating non-commercial pharmacy business establishment shall be suspended for a fixed period of 03 – 06 months in case of commission of the violation in Clause 3 or Clause 4 of this Article.

Article 64. Violations against regulations on packages and labels of drugs and pharmaceutical starting materials

1. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for commission of one of the following violations:

a) Importing, buying or trading drugs/pharmaceutical starting materials whose commercial packages have been damaged, unless permitted by law;

b) Importing herbal ingredients whose secondary packages do not contain information on their origin.

2. A fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed for commission of one of the following violations:

a) Manufacturing or importing drugs/pharmaceutical starting materials whose packages are not conformable with those described in the approved application, except the case prescribed in Point b Clause 3 of this Article;

b) An applicant for registration or a pharmacy business establishment erasures or alters information about manufacturing date or batch number of drugs/pharmaceutical starting materials specified in their original labels;

c) Failing to update the drug-related information on labels and package inserts of drugs sold in Vietnam at the request of the Ministry of Health;

d) An importer, application for registration or domestic manufacturer sells/supplies drugs/pharmaceutical starting materials whose labels or package inserts are not conformable with the approved contents or do not correctly reflect the drug.

3. A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed for commission of one of the following violations:

a) Changing or altering the expiry date on the drug label;

b) Packaging material or method does not ensure the quality of drugs/pharmaceutical starting materials;

c) Failing to update information on contraindications and drug users as prescribed by law.

4. Additional penalty:

Business operations involving the violation in Point b Clause 2 or Clause 3 of this Article shall be suspended for a fixed period of 01 – 03 months.

5. Remedial measure:

All substandard drugs/pharmaceutical starting materials shall be recalled for reprocessing or destroyed in case of commission of the violation in Point b, c or d Clause 2 or Clause 3 of this Article.

Article 65. Violations against regulations on controlled drugs

1. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for commission of one of the following violations:

a) Storing, manufacturing, preparing, dispensing or using controlled drugs/pharmaceutical starting materials at a non-commercial pharmacy business establishment against regulations of law;

b) Transporting or delivering controlled drugs against regulations of law;

c) Destroying controlled drugs against regulations of law.

2. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed upon a drug retailer, or a fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed upon a provider of drug/pharmaceutical starting material storage service, clinical trial service, bioequivalence study service or testing service, or a fine ranging from VND 30.000.000 to VND 40.000.000 shall be imposed upon a drug/pharmaceutical starting material manufacturer, exporter, importer or wholesaler for commission of one of the following violations:

a) Failing to meet personnel and facility requirements to prevent controlled drugs from loss as prescribed by law;

b) Buying or selling materials that are narcotic substances, psychotropic ingredients or drug precursors without the order forms approved by competent authorities; buying or selling narcotic drugs, psychotropic drugs and precursor drugs without the order forms approved by competent authorities or bidding results or bidding plans approved by competent persons.

3. Additional penalty:

 Business operations involving the violation in Clause 2 of this Article shall be suspended for a fixed period of 01 – 03 months.

Article 66. Violations against regulations on management of drug prices

1. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for failing to submit an application for adjustment to information about a drug whose price has been declared or re-declared while the drug price is not adjusted.

2. A fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed for commission of one of the following violations:

a) Buying a drug for a drug retailer within the premises of a public health facility at a price higher than the successful bid for that drug at that health facility at the same time, except cases permitted by law;

b) Buying a drug for a drug retailer within the premises of a public health facility at a price higher than the highest successful bid for that drug at provincial and central health facilities within the last 12 months, or the price of that drug bought through local or national centralized bidding or price negotiation within the term of the contract or the framework agreement on centralized procurement before the time of buying drug, except cases permitted by law;

c) A drug retailer within the premises of a public health facility buys a drug which is not on the list of drugs supplied by successful bidders of that health facility, or the lists of drugs supplied by successful bidders of provincial and central health facilities within the last 12 months, or the lists of drugs supplied by successful bidders at local or national centralized bidding or price negotiation before the time of buying drug, except cases permitted by law;

d) A drug retailer within the premises of a public health facility retails drugs with a retail margin higher than the maximum one prescribed by law.

3. The following fines shall be imposed for wholesaling drugs whose prices are not yet declared by the manufacturer, outsourcing entity or importer, or are higher than declared or re-declared prices which are still valid as prescribed by law, except the case prescribed in Point a Clause 4 of this Article:

a) A fine ranging from VND 1.000.000 to VND 3.000.000 shall be imposed for the violation involving the drug whose selling price is not exceeding VND 1.000 per smallest packaging unit;

b) A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for the violation involving the drug whose selling price is exceeding VND 1.000 but not exceeding VND 5.000 per smallest packaging unit;

c) A fine ranging from VND 5.000.000 to VND 7.000.000 shall be imposed for the violation involving the drug whose selling price is exceeding VND 5.000 but not exceeding VND 100.000 per smallest packaging unit;

d) A fine ranging from VND 7.000.000 to VND 10.000.000 shall be imposed for the violation involving the drug whose selling price is exceeding VND 100.000 but not exceeding VND 1.000.000 per smallest packaging unit;

dd) A fine ranging from VND 10.000.000 to VND 15.000.000 shall be imposed for the violation involving the drug whose selling price is exceeding VND 1.000.000 per smallest packaging unit.

4. A fine ranging from VND 30.000.000 to VND 50.000.000 shall be imposed for commission of one of the following violations:

a) Failing to declare or re-declare prices of drugs before they are sold on the market;

b) Failing to submit a report on refusal to adjust the drug price at the written request of a drug pricing authority;

c) Failing to report accurate drug pricing elements as prescribed by law.

5. Remedial measure:

The violating entity is compelled to return any different amounts in case of commission of the violation in Clause 2, Clause 3 or Point b Clause 4 of this Article. Any payments which cannot be made to payers shall be paid to state budget in accordance with regulations of law.

Article 67. Violations against regulations on drug information

1. A warning or a fine ranging from VND 200.000 to VND 500.000 shall be imposed for commission of one of the following violations:

a) Failing to wear the pharmaceutical sales representative’s card while introducing drugs;

b) Introducing drugs without obtaining the practitioner’s consent.

2. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for commission of one of the following violations:

a) Failing to submit the lists of sales representatives issued with the sales representative’s card or whose sales representative’s card is revoked to the Department of Health of the province where the sales representative operates;

b) The sales representative introduces products which are not drugs;

c) The sales representative introduces a drug other than the one designated by the pharmacy business establishment.

3. A fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed for commission of one of the following violations when providing drug information to medical and pharmaceutical practitioners:

a) Providing information which is not yet certified by a competent authority or which is different from the one certified by a competent authority;

b) Providing drug information certified by a competent authority but the certification of drug information has been expired;

c) Comparing and affirming that its drug is better than that of others without providing any scientific documents approved by competent authorities;

d) The sales representative contacts patients, accesses their medical records or prescriptions, discuss or request for information related to patients;

dd) Failing to send a written notification of the time and location of the pharmaceutical conference which is held for providing drug information, accompanied by the copy of certification of drug information, to the Department of Health of the province where that conference is held.

4. A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed for commission of one of the following violations:

a) Failing to report and update competent authorities on information about quality, safety and efficacy of drugs produced, registered, sold, prepared or processed;

b) A sales representative performs activities related to the sale and purchase of drugs with medical practitioners.

5. A fine ranging from VND 30.000.000 to VND 40.000.000 shall be imposed for commission of one of the following violations:

a) Providing information, advertising, marketing, counseling, labeling, giving instructions that foods, cosmetics and other non-medicinal products can be used for prevention, treatment, diagnosis, alleviation of diseases or regulating human physiological functions, except for medical devices;

b) Using material or financial benefits to affect medicinal practitioners or drug users to make them to give more prescriptions or purchase more drugs;

c) Altering or forging legal documents issued by competent authorities in the application for certification of drug information or drug advertisement;

d) Using a certificate not recognized by the Ministry of Health or using material benefits, reputation of an organization or individual, symbols, images, positions, mails, letters of thanks to provide information about or advertise drugs;

dd) Using results of clinical trial or pre-clinical trial, testing results, results of bioequivalence study that are not recognized by the Ministry of Health to provide information about or advertise drugs;

e) Failing to apply for certification of drug information upon the occurrence of changes which requires certification.

6. Additional penalties:

a) Operations of the violating entity shall be suspended for a fixed period of 03 – 06 months in case of commission of the violation in Point a Clause 5 of this Article 03 times or more during a year;

b) The exhibits of the violation in Point b Clause 5 of this Article, which are material or financial benefits, shall be confiscated.

7. Remedial measure:

The entity committing the violation in Point a, b or c Clause 3 or Point a, d, dd or e Clause 5 of this Article is compelled to recall goods and remove violating elements. If violating elements cannot be removed, products shall be destroyed.

Article 68. Violations against regulations on cosmetic product notification

1. A fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed for commission of one of the following violations:

a) Failing to accurately complete items on the notification of cosmetic product;

b) Failing to obtain a written approval from a competent authority as prescribed by law when changing the contents which have been notified and issued with a number of acknowledgment of the notification of cosmetic product (hereinafter referred to as “notification number”).

2. A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed for marketing a cosmetic product which is not issued by a competent authority with a notification number or whose notification number has been expired.

3. A fine ranging from VND 30.000.000 to VND 40.000.000 shall be imposed for forging documents, using a counterfeit seal, or forging signature/seal of a competent authority of Vietnam, foreign competent authority, manufacturer or owner of the cosmetic product in the application for notification of cosmetic product.

4. Additional penalty:

Cosmetics business shall be suspended for a fixed period of 03 – 06 months in case of commission of the violation in Clause 2 or 3 of this Article.

5. Remedial measures:

a) Cosmetic products involving in the violation in Clause 2 or 3 of this Article shall be recalled and destroyed;

b) Enforced revocation of notification number in case of commission of the violation in Point a Clause 1 or Clause 3 of this Article.

Article 69. Violations against regulations on cosmetics advertising in conferences, meetings and events

A fine ranging from VND 30.000.000 to VND 40.000.000 shall be imposed for organizing a conference, meeting or event for introducing a cosmetic product:

1. without sending a prior notification to a competent authority as prescribed by law; or

2. whose contents are different from those notified to the competent authority.

Article 70. Violations against regulations on cosmetic manufacturing

1. A fine ranging from VND 30.000.000 to VND 40.000.000 shall be imposed for commission of one of the following violations:

a) Failing to adopt the quality management system according to the ASEAN Guidelines for Cosmetic Good Manufacturing Practice (CGMP-ASEAN);

b) Manufacturing a cosmetic product whose formulation is not conformable with that indicated in the application for notification of cosmetic product;

c) Manufacturing cosmetic products with expired or substandard raw materials;

d) Manufacturing cosmetic products that fail to meet quality standards;

dd) Carrying out manufacturing activities at a location other than the one specified in the certificate of eligibility for cosmetic manufacturing;

e) Carrying out manufacturing activities beyond the scope specified in the certificate of eligibility for cosmetic manufacturing;

g) Manufacturing cosmetic products that contain substances which are prohibited from use in cosmetic products or whose concentration exceeds the maximum authorized concentration prescribed by law.

2. A fine ranging from VND 40.000.000 to VND 50.000.000 shall be imposed for commission of one of the following violations:

a) Manufacturing cosmetic products without possessing a valid certificate of eligibility for cosmetic manufacturing;

b) Forging documents included in the application for issuance, re-issuance or modification of certificate of eligibility for cosmetic manufacturing;

c) Failing to satisfy one of eligibility requirements after obtaining certificate of eligibility for cosmetic manufacturing.

3. Additional penalties:

a) The cosmetic manufacturing shall be suspended until obtaining an approval for operations to be added to the certificate of eligibility for cosmetic manufacturing as prescribed by law but for a period not exceeding 24 months in case of commission of the violation in Point dd or e Clause 1 of this Article;

b) The cosmetic manufacturing shall be suspended until obtaining a certificate of eligibility for cosmetic manufacturing as prescribed by law but for a period not exceeding 24 months in case of commission of the violation in Point a Clause 2 of this Article;

c) The certificate of eligibility for cosmetic manufacturing shall be suspended for a fixed period of 01 - 03 months in case of commission of the violation in Point a or g Clause 1 of this Article;

d) The certificate of eligibility for cosmetic manufacturing shall be suspended for a fixed period of 03 - 06 months in case of commission of the violation in Point b Clause 2 of this Article.

4. Remedial measures:

a) All cosmetic products involving in the violation in Clause 1 or 2 of this Article shall be recalled and destroyed, except those failing to meet packaging weight or volume standards prescribed in Point d Clause 1 of this Article;

b) Enforced revocation of notification number in case of commission of the violation in Point a, b, c, dd or e Clause 1 or Point b or c Clause 2 of this Article.

Article 71. Violations against regulations on cosmetics trading in the field of cosmetics business

1. A fine ranging from VND 5.000.000 to VND 10.000.000, if the shipment is assessed at less than VND 20.000.000 according to their selling prices, or a fine ranging from VND 10.000.000 to VND 20.000.000, if the shipment is assessed at VND 20.000.000 or more according to their selling prices, shall be imposed for an entity other than the one responsible for placing cosmetic products in the market for commission of one of the following violations:

a) Trading in cosmetic products whose packages have been damaged;

b) Trading in expired cosmetic products;

c) Trading in cosmetic products subject to a recall notification of a competent authority.

2. A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed upon the entity responsible for placing the cosmetic product in the market for commission of one of the following violations:

a) Trading in the cosmetic product that is substandard or unsafe for use;

b) Trading in cosmetic products whose packages have been damaged;

c) Trading in expired cosmetic products;

d) Trading in cosmetic products subject to a recall notification of a competent authority.

3. A fine ranging from VND 30.000.000 to VND 40.000.000 shall be imposed upon the entity responsible for placing the cosmetic product in the market for commission of one of the following violations:

a) Trading in the cosmetic product that contains substances which are prohibited from use in cosmetic products or whose concentration exceeds the maximum authorized concentration prescribed by law;

b) Trading in the cosmetic product which does not have the Product Information File (PIF) or whose PIF is inadequate or is not presented at the request of a competent authority;

c) Trading in the cosmetic product whose formulation is not conformable with that specified in the approved application for notification of cosmetic product;

d) Failing to recall cosmetic products at the request of a competent authority.

4. Remedial measures:

a) Cosmetic products involving in the violation in Clause 1, Clause 2, or Point a, b or c Clause 3 of this Article shall be recalled and destroyed;

b) Enforced revocation of notification number in case of commission of the violation in Clause 3 of this Article.

Section 4. VIOLATIONS AGAINST REGULATIONS ON MEDICAL DEVICES

Article 72. Violations against regulations on classification of medical devices

1. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for commission of one of the following violations:

a) Failing to ensure the legitimacy of documents included in the application for issuance or modification of the medical device classification practicing certificate;

b) Failing to publish the issued medical device classification result;

c) The medical device classification result is signed by a person other than the one named in the acknowledgment of receipt of application for declaration of eligibility for medical device classification or the legal representative;

d) Failing to notify a competent authority of replacement of the person performing medical device classification in case the replacement has the same practicing scope with the replaced one.

2. A fine ranging from VND 10.000.000 to VND 15.000.000 shall be imposed for commission of one of the following violations:

a) Failing to comply with the rules of risk-based classification of medical devices;

b) Failing to ensure the legitimacy of documents included in the application for declaration of eligibility for medical device classification;

c) Performing the classification of medical devices beyond the scope of the medical device classification practicing certificate;

d) Failing to send reports to the customs authority that has granted customs clearance and the authority that has issued the registration number in case the medical device has been issued with the registration number that is based on the classification result subject to a recall notification given by the Ministry of Health and has granted the customs clearance but are not sold to customers;

dd) Failing to specify the quantity of medical device granted customs clearance in the report sent to the customs authority that has granted customs clearance in case the medical device has been issued with the registration number that is based on the classification result subject to a recall notification given by the Ministry of Health and has granted the customs clearance but are not sold to customers;

e) Failing to specify the quantity of medical device granted customs clearance and sales contracts (if any) in the report sent to the authority that has issued the registration number in case the medical device has been issued with the registration number that is based on the classification result subject to a recall notification given by the Ministry of Health and has granted the customs clearance but are not sold to customers;

g) Issuing a wrong classification result which reduces the risk level of the classified medical device;

h) Failing to repeat the procedures for declaration of eligibility for medical device classification upon the occurrence of change of the person performing medical device classification whose practicing scope is not yet specified in the previous application for declaration of eligibility for medical device classification.

3. A fine ranging from VND 15.000.000 to VND 20.000.000 shall be imposed for commission of one of the following violations:

a) Classifying the medical device or issuing the medical device classification result during the operation suspension period;

b) The registration number holder fails to suspend the sale of medical device, or fails to organize the recall of the medical device which has been issued with the registration number based on the classification result subject to a recall notification given by the Ministry of Health and has granted the customs clearance but are not sold to customers.

4. A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed for commission of one of the following violations:

a) Performing medical device classification without completing procedures for declaration of eligibility for medical device classification or while the acknowledgment of receipt of application for declaration of eligibility for medical device classification has been revoked;

b) Failing to satisfy eligibility requirements after having successfully completed procedures for declaration of eligibility for medical device classification.

5. Additional penalties:

a) Operation of the violating entity shall be suspended for a fixed period of 01 – 03 months in case of commission of the violation in Point b Clause 1 or Point a, c, g or h Clause 2 of this Article;

b) Operation of the violating entity shall be suspended for a fixed period of 03 - 06 months in case of commission of the violation in Point b Clause 3 of this Article;

c) Operation of the violating entity shall be suspended for a fixed period of 06 - 09 months in case of commission of the violation in Point b Clause 4 of this Article.

6. Remedial measures:

a) Enforced revocation of medical device classification practicing certificate in case of commission of the violation in Point a Clause 1 of this Article;

b) Enforced revocation of the acknowledgment of receipt of application for declaration of eligibility for medical device classification in case of commission of the violation in Point b Clause 2 or Point a Clause 3 of this Article.

Article 73. Violations against regulations on medical device manufacturing

1. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for failing to repeat the procedures for declaration of eligibility for medical device manufacturing upon the occurrence of changes in the submitted application for declaration.

2. A fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed for commission of one of the following violations:

a) Failing to ensure the legitimacy of documents included in the application for declaration of eligibility for medical device manufacturing;

b) Failing to satisfy one of eligibility requirements after having successfully completed procedures for declaration of eligibility for medical device manufacturing.

3. A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed for commission of one of the following violations:

a) Manufacturing medical devices that contain narcotic substances and precursors at a facility that fails to meet eligibility requirements set by law;

b) Manufacturing medical devices that contain narcotic substances and precursors from raw materials, which are narcotic substances and precursors, imported without the import license;

c) Manufacturing medical devices before obtaining the acknowledgment of receipt of application for declaration of eligibility for medical device manufacturing as prescribed by law.

4. Additional penalty:

Operation of the violating entity shall be suspended for a fixed period of 01 - 03 months in case of commission of the violation in Clause 1, Point b Clause 2 or Point a or b Clause 3 of this Article.

5. Remedial measures:

a) Enforced revocation of the acknowledgment of receipt of application for declaration of eligibility for medical device manufacturing in case of commission of the violation in Point a Clause 2 or Point a or b Clause 3 of this Article;

b) Medical devices involving in the violation in Clause 3 of this Article shall be recalled and destroyed or re-processed.

Article 74. Violations against regulations on registration of medical devices

1. A fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed for commission of one of the following violations:

a) Placing on the market a medical device which is not yet labeled or whose secondary label does not contain adequate information required by law;

b) Placing on the market a medical device which is not accompanied by technical documents serving the repair and maintenance, except single-use medical devices which must be disposed after use as prescribed by their owners;

c) Placing on the market a medical device without providing instructions for use in Vietnamese;

d) Placing on the market a medical device without providing information on the warranty center, warranty conditions and period, except single-use medical devices which must be disposed after use as prescribed by their owners or medical devices for which no warranty is provided as proved by specific documents;

dd) Failing to notify a competent authority of changes that occur during the sale of a medical device;

e) Failing to send a written notification to competent authorities and traders/users of the medical advice batch that has an adverse event posing a serious threat to public health or causing death of a user;

g) Placing on the market an imported medical device for which the manufacturer fails to obtain a certificate of conformity with quality control standards and which is not yet placed on any market on the world;

h) Placing on the market a medical device which is not conformable with national technical regulations or applied standards declared by the manufacturer.

2. A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed for commission of one of the following violations:

a) Failing to follow procedures for declaration of standards applied to Class A medical device;

b) Failing to establish, organize and manage the tracing of origin of medical devices placed on the market as prescribed by law;

c) Failing to retain adequate documents for after-sale management of medical devices as prescribed by law;

d) Failing to complete the recall of the entire batch of defective medical device within the time limit decided by a competent authority;

dd) Failing to establish a warranty center for medical devices as prescribed by law;

e) Failing to prepare and retain documents for monitoring medical devices as prescribed by law;

g) Failing to inform relevant Provincial Departments of Health and police authorities of any confusion or loss of medical devices containing narcotic substances and precursors or raw materials for production thereof.

h) Failing to provide information or providing inadequate or inaccurate information about the product on the label and instruction manual of the medical device as prescribed by law;

i) Failing to issue warnings or issuing late, inadequate or inaccurate warnings about risks to users’ health and the environment, and instructions for sellers and users on how to minimize the risks; failing to provide information about requirements for transport, storage and use of the medical devices;

k) Failing to stop placing on the market or failing to inform relevant parties; failing to take corrective or remedial actions or recall defective medical devices as prescribed by law;

l) Failing to maintain the validity of the certificate of free sale, power of attorney or certificate of warranty qualification during the effective period of the registration number as prescribed by law.

3. A fine ranging from VND 30.000.000 to VND 40.000.000 shall be imposed for commission of one of the following violations:

a) Failing to stop placing the medical device on the market in case of a determination that it has a defect which will be harmful to users’ health;

b) Altering or erasing the acknowledgement of receipt of declaration of standards applied to Class A medical device;

c) Altering or erasing the certificate of registration of Class B, C or D medical devices;

d) Failing to ensure the legitimacy of documents included in the application for declaration of standards applied to Class A medical devices;

dd) Failing to ensure the legitimacy of documents included in the application for issuance, re-issuance or renewal of certificate of registration of Class B, C or D medical devices.

4. A fine ranging from VND 40.000.000 to VND 50.000.000 shall be imposed for commission of one of the following violations:

a) Placing Class A medical devices on the market without obtaining the acknowledgement of receipt of the application for declaration of applied standards or the import license;

b) Placing Class B, C or D medical devices on the market without obtaining the number of certificate of registration or the import license;

c) Placing on the market a medical device which fails to meet the registered quality;

d) The warranty center fails to meet qualification requirements as specified in the certificate of warranty qualification provided by the medical device owner;

dd) Failing to stop placing on the market the medical device associated with an adverse event that poses a serious threat to public health or has caused death of a user;

e) Continuing placing the medical device issued with the registration number for 24 months after the medical device owner declares the termination of manufacturing of that medical device or is declared bankrupt or dissolved, but the holder of the registration number in Vietnam provides no commitment to provide warranty/maintenance and spare parts for replacing or serving the use of that medical device for 08 years, unless the registration number holder is a Vietnam-based representative office of the foreign medical device owner;

g) Continuing placing the medical device issued with the registration number for a period exceeding 24 months after the medical device owner declares the termination of manufacturing of that medical device or is declared bankrupt or dissolved.

5. Additional penalties:

a) The exhibits, including the acknowledgment of receipt, certificate and documents, shall be confiscated in case of commission of the violation in Point b, c, d or dd Clause 3 of this Article;

b) Operation of the violating entity shall be suspended for a fixed period of 01 - 03 months in case of commission of the violation in Clause 2, Point a Clause 3 or Clause 4 of this Article.

6. Remedial measures:

a) Medical devices involving in the violation in Point g or h Clause 1 of this Article shall be recalled and destroyed or re-processed;

b) Enforced revocation of the acknowledgment of receipt of the application for declaration of standards applied to Class A medical devices or certificate of registration of Class B, C or D medical devices in case of commission of the violation in Point b, c, d or dd Clause 3 of this Article.

Article 75. Violations against regulations on trading in medical devices

1. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for commission of one of the following violations:

a) Failing to adopt internal control measures for maintaining quality of medical devices according to requirements of the registration number holder;

b) Failing to provide or providing users with inadequate or late instructions for use of the medical device, and conditions for ensuring safety, storage, calibration, inspection and maintenance of the medical device;

c) Failing to inform or inadequately or lately informing users of the defective medical device;

d) Failing to keep documents for monitoring medical devices, tracing origin and recalling medical devices as prescribed by law;

dd) Failing to inform or lately informing the registration number holder and competent authorities of cases of defective medical device.

2. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for commission of one of the following violations:

a) Failing to repeat procedures for declaration of eligibility for trading in medical devices upon the occurrence of changes in the submitted application for declaration of eligibility as prescribed by law;

b) Failing to report or submitting reports of incorrect form or after the prescribed deadline to the relevant provincial Department of Health on any confusion or loss of medical devices containing narcotic substances and precursors or raw materials for production thereof;

c) Failing to report or submitting reports of incorrect form or after the prescribed deadline to competent authorities on the sale, export, import and transfer of medical devices containing narcotic substances and precursors, or raw materials for production thereof;

d) Failing to report or submitting a report of incorrect form or after the prescribed deadline on receipt, delivery, inventory and use of medical devices containing narcotic substances and precursors and raw materials for production thereof.

3. A fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed for commission of one of the following violations:

a) Failing to satisfy one of eligibility requirements for trading in Class B, C and D medical devices;

b) Trading in Class B, C or D medical devices without completing procedures for declaration of eligibility for trading in medical devices as prescribed by law;

c) Failing to ensure the legitimacy of documents included in the application for declaration of eligibility for trading in Class B, C or D medical devices;

d) Failing to ensure the legitimacy of documents included in the application for issuance of certificate of free sale of domestically manufactured medical devices.

4. Additional penalty:

Operation of the violating entity shall be suspended for a fixed period of 01 - 03 months in case of commission of the violation in Point a or d Clause 1, Point a Clause 2 or Point a, c or d Clause 3 of this Article.

5. Remedial measures:

a) Enforced revocation of the acknowledgment of receipt of application for declaration of eligibility for trading in Class B, C or D medical devices in case of commission of the violation in Point c Clause 3 of this Article;

b) Enforced revocation of certificate of free sale of domestically manufactured medical devices in case of commission of the violation in Point d Clause 3 of this Article.

Article 76. Violations against regulations on import of medical devices

1. A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed for commission of one of the following violations:

a) Failing to ensure the legitimacy of documents included in the application for the license to import medical devices;

b) Exporting or importing medical devices without satisfying eligibility requirements set by law.

2. A fine ranging from VND 30.000.000 to VND 40.000.000 shall be imposed for importing medical devices without a valid registration number or the import license as prescribed by law.

3. Additional penalty:

Operation of the violating entity shall be suspended for a fixed period of 01 - 03 months in case of commission of the violation in Clause 1 or Clause 2 of this Article.

4. Remedial measures:

a) The violating entity is compelled to remove from the territory of the Socialist Republic of Vietnam or re-export medical devices involving the violation in Clause 2 of this Article. If these measures cannot be implemented, medical violations shall be destroyed;

b) Enforced revocation of the license to import medical devices in case of commission of the violation in Clause 1 of this Article.

Article 77. Violations against regulations on counseling on medical devices

1. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for failing to repeat the procedures for declaration of eligibility to provide technical counseling on medical devices upon the occurrence of changes in the submitted application for declaration of eligibility.

2. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for commission of one of the following violations:

a) Failing to ensure the legitimacy of documents included in the application for declaration of eligibility to provide technical counseling on medical devices;

b) Providing counseling on medical devices before obtaining the acknowledgment of receipt of the application for declaration of eligibility;

c) Providing counseling services beyond the scope specified in the application for declaration of eligibility to provide technical counseling on medical devices.

3. Additional penalty:

Operation of the violating entity shall be suspended for a fixed period of 01 - 03 months in case of commission of the violation in Clause 1 or Clause 2 of this Article.

4. Remedial measure:

Enforced revocation of the acknowledgment of receipt of application for declaration of eligibility to provide technical counseling on medical devices in case of commission of the violation in Point a Clause 2 of this Article.

Article 78. Violations against regulations on information about medical devices

1. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for commission of one of the following violations:

a) Failing to provide information about levels of risks that patients are subjected to from Class C and D medical devices;

b) Failing to make information about levels of risks and use of medical devices publicly available;

c) Failing to disseminate information about levels of risks and use of medical devices in health facilities.

2. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for failing to keep the original label and stick a secondary label containing compulsory information in Vietnamese on the imported medical device whose label does not contain or insufficiently contains information required by law.

Article 79. Violations against regulations on management and use of medical devices in health facilities

1. A fine ranging from VND 500.000 to VND 1.000.000 shall be imposed for failing to submit reports on defective medical devices and other information at the request of competent authorities.

2. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for commission of one of the following violations:

a) Failing to prepare, manage and retain adequate documents on medical devices; failing to punctually and sufficiently record medical devices in kind and in cash in accordance with regulations of the laws on accounting and statistics and relevant laws;

b) Using and operating medical devices against instructions given by their owners.

3. A fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed for failing to carry out periodic maintenance, inspection and calibration of medical devices according to instructions given by their owners or as prescribed by law.

4. A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed for using medical devices without the certificate of registration or import license, or expired or substandard medical devices.

Section 5. VIOLATIONS AGAINST REGULATIONS ON HEALTH INSURANCE

Article 80. Violations against regulations on health insurance contributions

1. A warning or a fine ranging from VND 300.000 to VND 500.000 shall be imposed upon a compulsory health insurance policyholder for failing to make health insurance contributions.

2. The following fines shall be imposed upon an employer for failing to pay, insufficiently or lately paying health insurance contributions for his/her employees who are subjected to compulsory health insurance, or evading payment of health insurance contributions:

a) A fine ranging from VND 1.000.000 to VND 3.000.000 shall be imposed for the violation involving less than 10 employees;

b) A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for the violation involving from 10 to less than 50 employees;

c) A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for the violation involving from 50 to less than 100 employees;

d) A fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed for the violation involving from 100 to less than 500 employees;

dd) A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed for the violation involving from 500 to less than 1.000 employees;

e) A fine ranging from VND 30.000.000 to VND 40.000.000 shall be imposed for the violation involving from 1.000 employees or more.

3. The following fines shall be imposed for failing to pay sufficient amounts payable of health insurance contributions:

a) A fine ranging from VND 1.000.000 to VND 2.000.000 shall be imposed if the arrears are less than VND 5.000.000;

b) A fine ranging from VND 2.000.000 to VND 3.000.000 shall be imposed if the arrears are from VND 5.000.000 to less than VND 10.000.000;

c) A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed if the arrears are from VND 10.000.000 to less than VND 20.000.000;

d) A fine ranging from VND 5.000.000 to VND 7.000.000 shall be imposed if the arrears are from VND 20.000.000 to less than VND 40.000.000;

dd) A fine ranging from VND 7.000.000 to VND 10.000.000 shall be imposed if the arrears are from VND 40.000.000 to less than VND 60.000.000;

e) A fine ranging from VND 10.000.000 to VND 15.000.000 shall be imposed if the arrears are from VND 60.000.000 to less than VND 80.000.000;

g) A fine ranging from VND 15.000.000 to VND 20.000.000 shall be imposed if the arrears are from VND 80.000.000 to less than VND 120.000.000;

h) A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed if the arrears are from VND 120.000.000 to less than VND 160.000.000;

i) A fine ranging from VND 30.000.000 to VND 40.000.000 shall be imposed if the arrears are VND 160.000.000 or more.

4) A fine ranging from VND 10.000.000 to VND 15.000.000 shall be imposed for illegally obtaining health insurance payout.

5. Remedial measures:

a) The violating entity is compelled to make compensations for any damage incurred by health insurance policyholders in case of commission of the violation in Clause 2, 3 or 4 of this Article. Any payments which cannot be made to payers shall be paid to state budget in accordance with regulations of law;

b) Any benefits illegally obtained from the violation in Clause 2, 3 or 4 of this Article shall be paid to account of the health insurance fund.

Article 81. Inclusion of external persons in the list of policyholders

1. The following fines shall be imposed for including external persons in the list of policyholders against regulations of law:

a) A fine ranging from VND 1.000.000 to VND 2.000.000 per heath insurance card shall be imposed for the violation which does not cause damage to the health insurance fund;

b) A fine ranging from VND 2.000.000 to VND 3.000.000 per health insurance card shall be imposed if health insurance cards have been used resulting in damage to the health insurance fund.

2. The following fines shall be imposed for participating in health insurance at an agency or organization against regulations of law:

a) The fine ranging from VND 1.000.000 to VND 2.000.000 shall be imposed for each person holding the health insurance card which is not used;

b) The fine ranging from VND 2.000.000 to VND 3.000.000 shall be imposed for each person holding the health insurance card which has been used.

3. Additional penalty:

The exhibits, which are health insurance cards, used for committing the violation in Clause 1 or Clause 2 of this Article shall be confiscated.

4. Remedial measure:

The violating entity is compelled to transfer the amounts of money involving in the violation in Point b Clause 1 or Point b Clause 2 of this Article to the dedicated account of the health insurance fund.

Article 82. Certification of incorrect amounts of health insurance contributions

The following fines shall be imposed for certifying incorrect amounts of health insurance contributions:

1. A fine ranging from VND 1.000.000 to VND 2.000.000 shall be imposed if the incorrectly certified amount is less than VND 10.000.000.

2. A fine ranging from VND 2.000.000 to VND 3.000.000 shall be imposed if the incorrectly certified amount is from VND 10.000.000 to less than VND 20.000.000.

3. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed if the incorrectly certified amount is from VND 20.000.000 to less than VND 40.000.000.

4. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed if the incorrectly certified amount is from VND 40.000.000 to less than VND 60.000.000.

5. A fine ranging from VND 10.000.000 to VND 15.000.000 shall be imposed if the incorrectly certified amount is from VND 60.000.000 to less than VND 80.000.000.

6. A fine ranging from VND 15.000.000 to VND 20.000.000 shall be imposed if the incorrectly certified amount is from VND 80.000.000 to less than VND 100.000.000.

7. A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed if the incorrectly certified amount is from VND 100.000.000 to less than VND 120.000.000.

8. A fine ranging from VND 30.000.000 to VND 40.000.000 shall be imposed if the incorrectly certified amount is from VND 120.000.000 to less than VND 150.000.000.

9. A fine ranging from VND 40.000.000 to VND 50.000.000 shall be imposed if the incorrectly certified amount is VND 150.000.000 or more.

Article 83. Violations against regulations on preparation and transfer of list of policyholders issued with health insurance card

1. A fine ranging from VND 500.000 to VND 1.000.000 shall be imposed for commission of one of the following violations:

a) Preparing and transferring the list of policyholders issued with health insurance card after the prescribed deadline but the violation does not harm legitimate rights and benefits of policyholders;

b) Preparing and transferring the list of policyholders issued with health insurance card which does not contain all of persons eligible to participate in health insurance under management but the violation does not harm their rights and benefits.

2. The following fines shall be imposed for preparing and transferring the list of policyholders issued with health insurance card after the prescribed deadline and the violation has caused harm to legitimate rights and benefits of policyholders:

a) A fine ranging from VND 1.000.000 to VND 2.000.000 shall be imposed if the list is submitted fewer than 10 working days late after the prescribed deadline;

b) A fine ranging from VND 2.000.000 to VND 3.000.000 shall be imposed if the list is submitted 10 working days or more late after the prescribed deadline.

3. The following fines shall be imposed for preparing and transferring the list of policyholders issued with health insurance card which does not contain all of persons eligible to participate in health insurance under management and the violation has caused harm to their rights and benefits:

a) A fine ranging from VND 1.000.000 to VND 3.000.000 shall be imposed if the list lacks less than 50 persons eligible to participate in health insurance;

b) A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed if the list lacks from 50 to less than 100 persons eligible to participate in health insurance;

c) A fine ranging from VND 5.000.000 to VND 7.000.000 shall be imposed if the list lacks from 100 to less than 500 persons eligible to participate in health insurance;

d) A fine ranging from VND 7.000.000 to VND 10.000.000 shall be imposed if the list lacks from 500 to less than 1.000 persons eligible to participate in health insurance;

dd) A fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed if the list lacks 1.000 or more persons eligible to participate in health insurance.

4. Remedial measure:

The violating entity is compelled to make compensations for any damage incurred by health insurance policyholders in case of commission of the violation in Clause 2 or 3 of this Article. The amounts of money which cannot be returned to payers shall be paid to state budget in accordance with regulations of law.

Article 84. Violations against regulations on use of health insurance cards

1. The following fines shall be imposed for lending the health insurance card to another or using a borrowed health insurance card for using medical services:

a) A fine ranging from VND 1.000.000 to VND 2.000.000 shall be imposed of the violation does not cause damage to the health insurance fund;

b) A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed of the violation has caused damage to the health insurance fund.

2. Remedial measure:

The violating entity is compelled to transfer the amounts of money involving in the violation in Point b Clause 1 of this Article to the dedicated account of the health insurance fund.

Article 85. Violations against regulations on preparation of medical records and prescription for drugs covered by health insurance fund

1. A fine ranging from VND 200.000 to VND 500.000 shall be imposed for preparing medical records or writing out prescriptions without patients or for wrong patients if the damage caused by the violation is assessed at less than VND 1.000.000.

2. The following fines shall be imposed for preparing medical records or writing out prescriptions without patients or for wrong patients:

a) A fine ranging from VND 500.000 to VND 1.000.000 shall be imposed if the damage caused by the violation is assessed at from VND 1.000.000 to less than VND 2.000.000;

b) A fine ranging from VND 1.000.000 to VND 2.000.000 shall be imposed if the damage caused by the violation is assessed at from VND 2.000.000 to less than VND 5.000.000;

c) A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed if the damage caused by the violation is assessed at from VND 5.000.000 to less than VND 10.000.000;

d) A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed if the damage caused by the violation is assessed at from VND 10.000.000 to less than VND 15.000.000;

dd) A fine ranging from VND 10.000.000 to VND 15.000.000 shall be imposed if the damage caused by the violation is assessed at from VND 15.000.000 to less than VND 25.000.000;

e) A fine ranging from VND 15.000.000 to VND 20.000.000 shall be imposed if the damage caused by the violation is assessed at from VND 25.000.000 to less than VND 50.000.000;

g) A fine ranging from VND 20.000.000 to VND 25.000.000 shall be imposed if the damage caused by the violation is assessed at from VND 50.000.000 to less than VND 80.000.000;

h) A fine ranging from VND 25.000.000 to VND 30.000.000 shall be imposed if the damage caused by the violation is assessed at VND 80.000.000 or more.

3. Remedial measure:

The violating entity is compelled to transfer the amounts of money involving in the violation in Clause 1 or Clause 2 of this Article to the dedicated account of the health insurance fund.

Article 86. Violations against regulations on management of drugs, chemicals, medical supplies, technical services, costs of hospital bed days and other costs

1. A fine ranging from VND 500.000 to VND 1.000.000 shall be imposed for commission of one of the following violations which cause damage assessed at less than VND 1.000.000 to the health insurance fund:

a) Falsely increasing the quantity or types of drugs, chemicals, medical supplies, technical services, hospital bed days and other costs that are actually not used by patients;

b) Failing to provide adequate drugs, chemicals, medical supplies and technical services when providing covered medical services.

2. The following fines shall be imposed for falsely increasing the quantity or types of drugs, chemicals, medical supplies, technical services, hospital bed days and other costs that are actually not used by patients:

a) A fine ranging from VND 1.000.000 to VND 3.000.000 shall be imposed if the damage caused by the violation is assessed at from VND 1.000.000 to less than VND 3.000.000;

b) A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed if the damage caused by the violation is assessed at from VND 3.000.000 to less than VND 5.000.000;

c) A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed if the damage caused by the violation is assessed at from VND 5.000.000 to less than VND 10.000.000;

d) A fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed if the damage caused by the violation is assessed at from VND 10.000.000 to less than VND 20.000.000;

dd) A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed if the damage caused by the violation is assessed at from VND 20.000.000 to less than VND 30.000.000;

e) A fine ranging from VND 30.000.000 to VND 40.000.000 shall be imposed if the damage caused by the violation is assessed at from VND 30.000.000 to less than VND 40.000.000;

g) A fine ranging from VND 40.000.000 to VND 50.000.000 shall be imposed if the damage caused by the violation is assessed at from VND 40.000.000 to less than VND 50.000.000;

h) A fine ranging from VND 50.000.000 to VND 60.000.000 shall be imposed if the damage caused by the violation is assessed at from VND 50.000.000 to less than VND 60.000.000;

i) A fine ranging from VND 60.000.000 to VND 70.000.000 shall be imposed if the damage caused by the violation is assessed at VND 60.000.000 or more.

3. The following fines shall be imposed for failing to prescribe and provide adequate drugs, chemicals, medical supplies and technical services when providing covered medical services:

a) A fine ranging from VND 1.000.000 to VND 3.000.000 shall be imposed if the damage caused by the violation is assessed at from VND 1.000.000 to less than VND 10.000.000;

b) A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed if the damage caused by the violation is assessed at from VND 10.000.000 to less than VND 20.000.000;

c) A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed if the damage caused by the violation is assessed at from VND 20.000.000 to less than VND 40.000.000;

d) A fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed if the damage caused by the violation is assessed at from VND 40.000.000 to less than VND 80.000.000;

dd) A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed if the damage caused by the violation is assessed at from VND 80.000.000 to less than VND 120.000.000;

e) A fine ranging from VND 30.000.000 to VND 40.000.000 shall be imposed if the damage caused by the violation is assessed at from VND 120.000.000 to less than VND 160.000.000;

g) A fine ranging from VND 40.000.000 to VND 50.000.000 shall be imposed if the damage caused by the violation is assessed at VND 160.000.000 or more.

4. Remedial measures:

a) The violating entity is compelled to transfer the amounts of money involving in the violation in Clause 1 or Clause 2 of this Article to the dedicated account of the health insurance fund;

b) The violating entity is compelled to make compensations for any damage incurred by health insurance policyholders in case of commission of the violation in Clause 1, 2 or 3 of this Article. The amounts of money which cannot be returned to payers shall be paid to state budget in accordance with regulations of law.

Article 87. Violations against regulations on rights and benefits of health insurance policyholders

1. A warning or a fine ranging from VND 300.000 to VND 500.000 shall be imposed for committing a violation against regulations on rights and benefits of health insurance policyholders which involves an amount of less than VND 1.000.000.

2. The following fines shall be imposed for committing a violation against regulations on rights and benefits of health insurance policyholders:

a) A fine ranging from VND 1.000.000 to VND 2.000.000 shall be imposed if the damage caused by the violation is assessed at from VND 1.000.000 to less than VND 5.000.000;

b) A fine ranging from VND 2.000.000 to VND 3.000.000 shall be imposed if the damage caused by the violation is assessed at from VND 5.000.000 to less than VND 10.000.000;

c) A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed if the damage caused by the violation is assessed at from VND 10.000.000 to less than VND 15.000.000;

d) A fine ranging from VND 5.000.000 to VND 7.000.000 shall be imposed if the damage caused by the violation is assessed at from VND 15.000.000 to less than VND 20.000.000;

dd) A fine ranging from VND 7.000.000 to VND 10.000.000 shall be imposed if the damage caused by the violation is assessed at from VND 20.000.000 to less than VND 40.000.000;

e) A fine ranging from VND 10.000.000 to VND 15.000.000 shall be imposed if the damage caused by the violation is assessed at VND 40.000.000 or more.

3. Remedial measures:

a) The violating entity is compelled to make compensations for any damage incurred by health insurance policyholders in case of commission of the violation in Clause 1 or 2 of this Article. Any payments which cannot be made to payers shall be paid to state budget in accordance with regulations of law;

b) The violating entity is compelled to transfer the amounts of money involving in the violation in Clause 1 or Clause 2 of this Article to the dedicated account of the health insurance fund.

Article 88. Violations against regulations on reimbursement of costs of covered medical services

1. A warning or a fine ranging from VND 300.000 to VND 500.000 shall be imposed for setting incorrect prices or writing incorrect types, units and names of technical services upon reimbursement of costs of covered medical services if the damage caused by the violation is assessed at less than VND 1.000.000.

2. The following fines shall be imposed for setting incorrect prices or writing incorrect types, units and names of technical services upon reimbursement of costs of covered medical services:

a) A fine ranging from VND 1.000.000 to VND 2.000.000 shall be imposed if the damage caused by the violation is assessed at from VND 1.000.000 to less than VND 5.000.000;

b) A fine ranging from VND 2.000.000 to VND 3.000.000 shall be imposed if the damage caused by the violation is assessed at from VND 5.000.000 to less than VND 10.000.000;

c) A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed if the damage caused by the violation is assessed at from VND 10.000.000 to less than VND 20.000.000;

d) A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed if the damage caused by the violation is assessed at from VND 20.000.000 to less than VND 40.000.000;

dd) A fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed if the damage caused by the violation is assessed at from VND 40.000.000 to less than VND 80.000.000;

e) A fine ranging from VND 20.000.000 to VND 40.000.000 shall be imposed if the damage caused by the violation is assessed at from VND 80.000.000 to less than VND 120.000.000;

g) A fine ranging from VND 40.000.000 to VND 50.000.000 shall be imposed if the damage caused by the violation is assessed at VND 120.000.000 or more.

3. Remedial measures:

a) The violating entity is compelled to transfer the amounts of money involving in the violation in Clause 1 or Clause 2 of this Article to the dedicated account of the health insurance fund;

b) The violating entity is compelled to make compensations for any damage incurred by health insurance policyholders in case of commission of the violation in Clause 1 or 2 of this Article. The amounts of money which cannot be returned to payers shall be paid to state budget in accordance with regulations of law.

Article 89. Violations against regulations on contracts for provision of covered medical services

1. A fine ranging from VND 1.000.000 to VND 3.000.000 shall be imposed for commission of one of the following violations which do not yet cause damage to rights and benefits of health insurance policyholders, heath facilities and the health insurance fund:

a) Unilaterally terminating a contract for provision of covered medical services against regulations of law;

b) Entering into a contract for provision of covered medical services whose contents are contrary to regulations of law;

c) Entering into a contract for provision of covered medical services beyond the power prescribed by law.

2. The following fines shall be imposed for unilaterally terminating a contract for provision of covered medical services resulting in damage caused to rights and benefits of health insurance policyholders, heath facilities or heath insurance fund:

a) A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed if the damage is assessed at less than VND 50.000.000;

b) A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed if the damage is assessed at from VND 50.000.000 to less than VND 100.000.000;

c) A fine ranging from VND 10.000.000 to VND 15.000.000 shall be imposed if the damage is assessed at from VND 100.000.000 to less than VND 500.000.000;

d) A fine ranging from VND 15.000.000 to VND 20.000.000 shall be imposed if the damage is assessed at from VND 500.000.000 to less than VND 1.000.000.000;

dd) A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed if the damage is assessed at from VND 1.000.000.000 to less than VND 5.000.000.000;

e) A fine ranging from VND 30.000.000 to VND 40.000.000 shall be imposed if the damage is assessed at VND 5.000.000.000 or more.

3. The following fines shall be imposed for entering into a contract for provision of covered medical services whose contents are contrary to regulations of law or beyond the power prescribed by law resulting in damage caused to rights and benefits of health insurance policyholders, heath facilities and health insurance fund:

a) A fine ranging from VND 1.000.000 to VND 5.000.000 shall be imposed if the damage is assessed at less than VND 50.000.000;

b) A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed if the damage is assessed at from VND 50.000.000 to less than VND 100.000.000;

c) A fine ranging from VND 10.000.000 to VND 15.000.000 shall be imposed if the damage is assessed at from VND 100.000.000 to less than VND 500.000.000;

d) A fine ranging from VND 15.000.000 to VND 20.000.000 shall be imposed if the damage is assessed at from VND 500.000.000 to less than VND 1.000.000.000;

dd) A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed if the damage is assessed at from VND 1.000.000.000 to less than VND 5.000.000.000;

e) A fine ranging from VND 30.000.000 to VND 40.000.000 shall be imposed if the damage is assessed at VND 5.000.000.000 or more.

4. Remedial measures:

a) The violating entity is compelled to transfer the amounts of money involving in the violation in Clause 2 or Clause 3 of this Article to the dedicated account of the health insurance fund;

b) The violating entity is compelled to make compensations for any damage incurred by health insurance policyholders in case of commission of the violation in Clause 2 or 3 of this Article. Any payments which cannot be made to payers shall be paid to state budget in accordance with regulations of law;

c) The violating entity is compelled to make compensations for any damage incurred by the health facility in case of commission of the violation in Clause 3 of this Article. The amounts of money which cannot be returned to payers shall be paid to state budget in accordance with regulations of law.

Article 90. Determination of health insurance benefits inconsistently with information on health insurance cards

1. A warning or a fine ranging from VND 200.000 to VND 500.000 shall be imposed for determining health insurance benefits inconsistently with information on the health insurance card if the damage is assessed at less than VND 1.000.000.

2. The following fines shall be imposed for determining health insurance benefits inconsistently with information on the health insurance card:

a) A fine ranging from VND 1.000.000 to VND 2.000.000 shall be imposed if the damage is assessed at from VND 1.000.000 to less than VND 5.000.000;

b) A fine ranging from VND 2.000.000 to VND 3.000.000 shall be imposed if the damage is assessed at from VND 5.000.000 to less than VND 10.000.000;

c) A fine ranging from VND 3.000.000 to VND 4.000.000 shall be imposed if the damage is assessed at from VND 10.000.000 to less than VND 15.000.000;

d) A fine ranging from VND 4.000.000 to VND 5.000.000 shall be imposed if the damage is assessed at from VND 15.000.000 to less than VND 20.000.000;

dd) A fine ranging from VND 5.000.000 to VND 6.000.000 shall be imposed if the damage is assessed at from VND 20.000.000 to less than VND 40.000.000;

e) A fine ranging from VND 6.000.000 to VND 7.000.000 shall be imposed if the damage is assessed at VND 40.000.000 or more.

3. Remedial measures:

a) The violating entity is compelled to make compensations for any damage incurred by health insurance policyholders in commission of the violation in Clause 1 or 2 of this Article. Any payments which cannot be made to payers shall be paid to state budget in accordance with regulations of law;

b) The violating entity is compelled to make compensations for any damage incurred by the health facility in case of commission of the violation in Clause 1 or 2 of this Article. Any payments which cannot be made to payers shall be paid to state budget in accordance with regulations of law;

c) The violating entity is compelled to transfer the amounts of money involving in the violation in Clause 1 or Clause 2 of this Article to the dedicated account of the health insurance fund.

Article 91. Violations against regulations on reporting on implementation of health insurance policies to competent authorities

1. A warning or a fine ranging from VND 200.000 to VND 500.000 shall be imposed for submitting reports on implementation of health insurance policies after the prescribed deadline or with no data or incorrect data to competent authorities but the violation does not yet adversely affect management, implementation and formulation of health insurance policies.

2. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for submitting reports on implementation of health insurance policies after the prescribed deadline or with no data or incorrect data to competent authorities resulting in adverse effects on management, implementation and formulation of health insurance policies.

Article 92. Violations against regulations on provision of information about health insurance policyholders

1. A warning or a fine ranging from VND 200.000 to VND 500.000 shall be imposed for failing to provide or incorrectly or lately providing information about health insurance policyholders but the violation does not yet cause damage to the health insurance fund.

2. The following fines shall be imposed for failing to provide or incorrectly or lately providing information about health insurance policyholders resulting in damage caused to the health insurance fund:

a) A fine ranging from VND 1.000.000 to VND 3.000.000 shall be imposed if the damage is assessed at less than VND 50.000.000;

b) A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed if the damage is assessed at from VND 50.000.000 to less than VND 100.000.000;

c) A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed if the damage is assessed at from VND 100.000.000 to less than VND 200.000.000;

d) A fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed if the damage is assessed at VND 200.000.000 or more.

Article 93. Violations against regulations on provision of information for provision of health insurance benefits to patients at health facilities or direct reimbursement of medical costs to policyholders

1. A warning or a fine ranging from VND 200.000 to VND 500.000 shall be imposed for failing to provide or providing inadequate or incorrect information for provision of health insurance benefits to patients at health facilities or direct reimbursement of medical costs to policyholders but the violation does not yet cause damage to policyholders.

2. A fine ranging from VND 1.000.000 to VND 3.000.000 shall be imposed for failing to provide or providing inadequate or incorrect information for provision of health insurance benefits to patients at health facilities or direct reimbursement of medical costs to policyholders resulting in damage caused to policyholders.

3. Remedial measure:

The violating entity is compelled to make compensations for damage incurred by health insurance policyholders in case of commission of the violation in Clause 2 of this Article. The amounts of money which cannot be returned to payers shall be paid to state budget in accordance with regulations of law.

Article 94. Late submission of statements of costs of covered medical services

1. A fine ranging from VND 500.000 to VND 1.000.000 shall be imposed for submitting statements of costs of covered medical services less than 05 working days late after the prescribed deadline.

2. The following fines shall be imposed for late submission of statements of costs of covered medical services:

a) A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed if the statement is submitted from 05 to less than 20 working days late after the prescribed deadline;

b) A fine ranging from VND 5.000.000 to VND 7.000.000 shall be imposed if the statement is submitted 20 working days or more late after the prescribed deadline.

Article 95. Violations against other regulations on health insurance

1. A fine ranging from VND 500.000 to VND 1.000.000 shall be imposed for commission of one of the following violations:

a) Causing difficulties in or obstructing the provision of covered medical services but the violation does not yet cause damage to policyholders and health facilities;

b) Taking advantage of prescription or using drugs, chemicals, medical supplies, technical services and other medical services in excess of essential levels according to regulations on medical techniques and qualifications resulting in damage assessed at less than VND 1.000.000 caused to policyholders, health insurance fund and health facilities.

2. The following fines shall be imposed for causing difficulties in or obstructing the provision of covered medical services resulting in damage to policyholders and health facilities;

a) A fine ranging from VND 1.000.000 to VND 2.000.000 shall be imposed if the damage is assessed at from VND 1.000.000 to less than VND 5.000.000;

b) A fine ranging from VND 2.000.000 to VND 3.000.000 shall be imposed if the damage is assessed at from VND 5.000.000 to less than VND 10.000.000;

c) A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed if the damage is assessed at from VND 10.000.000 to less than VND 15.000.000;

d) A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed if the damage is assessed at from VND 15.000.000 to less than VND 20.000.000;

dd) A fine ranging from VND 10.000.000 to VND 15.000.000 shall be imposed if the damage is assessed at from VND 20.000.000 to less than VND 40.000.000;

e) A fine ranging from VND 15.000.000 to VND 20.000.000 shall be imposed if the damage is assessed at VND 40.000.000 or more.

3. The following fines shall be imposed for misusing covered medical services, including prescribing and using drugs, chemicals, medical supplies, technical services and other medical services in excess of the maximum norms or essential levels according to regulations on medical techniques and qualifications resulting in damage to policyholders, health facilities and health insurance fund:

a) A fine ranging from VND 1.000.000 to VND 2.000.000 shall be imposed if the damage is assessed at from VND 1.000.000 to less than VND 5.000.000;

b) A fine ranging from VND 2.000.000 to VND 3.000.000 shall be imposed if the damage is assessed at from VND 5.000.000 to less than VND 10.000.000;

c) A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed if the damage caused by the violation is assessed at from VND 10.000.000 to less than VND 20.000.000;

d) A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed if the damage caused by the violation is assessed at from VND 20.000.000 to less than VND 40.000.000;

dd) A fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed if the damage is assessed at from VND 40.000.000 to less than VND 60.000.000;

e) A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed if the damage is assessed at from VND 60.000.000 to less than VND 80.000.000;

g) A fine ranging from VND 30.000.000 to VND 40.000.000 shall be imposed if the damage is assessed at VND 80.000.000 or more.

4. A fine ranging from VND 1.000.000 to VND 3.000.000 shall be imposed for commission of one of the following violations:

a) Failing to register the specimen seal and signature of the practitioner licensed to sign certificates of incapacity and of the person authorized to sign and append the seal of the health facility on certificates with the competent social agency;

b) Failing to make connection for data sharing and prepare electronic documents in medical examination and treatment according to regulations on electronic transactions in health insurance sector.

5. Remedial measures:

a) The violating entity is compelled to make compensations for any damage incurred by the health facility in case of commission of the violation in Point b Clause 1, Clause 2 or Clause 3 of this Article. Any payments which cannot be made to payers shall be paid to state budget in accordance with regulations of law;

b) The violating entity is compelled to make compensations for any damage incurred by health insurance policyholders in commission of the violation in Point b Clause 1, Clause 2 or Clause 3 of this Article. Any payments which cannot be made to payers shall be paid to state budget in accordance with regulations of law;

c) The violating entity is compelled to transfer the amounts of money involving in the violation in Point b Clause 1 or Clause 3 of this Article to the dedicated account of the health insurance fund.

Section 6. VIOLATIONS AGAINST REGULATIONS ON POPULATION

Article 96. Violations against regulations on dissemination of information and counseling on population, reproductive health and birth control

1. A warning or a fine ranging from VND 200.000 to VND 500.000 shall be imposed for obstructing the dissemination and provision of information and counseling on population, reproductive health and birth control.

2. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for commission of one of the following violations:

a) Disseminating or providing information that is contrary to the Communist Party’s guidelines and policies, State law or elegant traditional heritages, or adversely affects the performance of population tasks and social life;

b) Disseminating information that is false or inaccurate or adversely affects the performance of population tasks, social life or other sectors;

c) Taking advantage of propagation activities and dissemination of information on population, reproductive health and birth control for disseminating documents/objects or performing other acts contrary to traditional customs and habits, and social ethics.

3. Additional penalty:

The exhibits, including documents and objects containing violating information, of the violation in Clause 2 of this Article shall be confiscated.

4. Remedial measures:

a) The exhibits used for committing the violation in Clause 2 of this Article shall be destroyed;

b) The violating entity is compelled to correct any information that is contrary to the Communist Party’s guidelines and policies, and State law on population in case of commission of the violation in Clause 2 of this Article.

Article 97. Violations against regulations on dissemination of information and counseling on sex selection methods

1. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for commission of one of the following violations:

a) Disseminating information on sex selection methods;

b) Providing counseling on sex selection methods.

2. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for commission of one of the following violations:

a) Selling, leasing, delivering or publishing on the internet publications or articles containing information on sex selection methods;

b) Publishing or broadcasting information on sex selection methods.

3. A fine ranging from VND 10.000.000 to VND 15.000.000 shall be imposed for translating, producing, printing, releasing, duplicating or photocopying publications or articles containing information on sex selection methods.

4. Additional penalty:

The exhibits, including publications, articles and documents used for propagation and information dissemination activities, of the violation in Clause 1, 2 or 3 of this Article shall be confiscated.

5. Remedial measure:

Violating elements must be removed in case of commission of the violation in Point a Clause 1 or Point b Clause 2 of this Article. If violating elements cannot be removed, products shall be destroyed.

Article 98. Violations against regulations on fetal sex diagnosis and determination

1. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for determining fetal sex by means of fortune-telling.

2. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for checking the pulse, giving ultrasound scan or performing tests for pregnant women for diagnosing and revealing/providing information on fetal sex, unless otherwise prescribed by law.

3. Additional penalty:

The license for medical operations and/or practicing certificate shall be suspended for a fixed period of 01 - 03 months in case of commission of the violation in Clause 2 of this Article.

Article 99. Violations against regulations on sex selection

1. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for threatening to use violence or mentally intimidating a person into adopting sex selection methods.

2. A fine ranging from VND 10.000.000 to VND 15.000.000 shall be imposed for using violence to force a person to adopt sex selection methods.

3. A fine ranging from VND 15.000.000 to VND 20.000.000 shall be imposed for commission of one of the following violations:

a) Prescribing or instructing a person to use drugs for selecting fetal sex;

b) Providing tools, drugs and supplies for selecting fetal sex;

c) Doing research on sex selection methods, unless otherwise prescribed by law.

4. Additional penalties:

a) Operations of the violating entity shall be suspended for a fixed period of 01 - 03 months in case of commission of the violation in Clause 3 of this Article;

b) The medical examination and treatment practicing certificate shall be suspended for a fixed period of 01 - 03 months in case of commission of the violation in Clause 3 of this Article.

5. Remedial measure:

Tools, drugs and supplies involving in the violation in Point b Clause 3 of this Article shall be destroyed.

Article 100. Sex-selective abortion

1. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for voluntarily deciding to have an abortion because of the predicted sex of the infant.

2. A fine ranging from VND 5.000.000 to VND 7.000.000 shall be imposed for persuading or inciting a pregnant woman to have an abortion because of the predicted sex of the infant.

3. A fine ranging from VND 7.000.000 to VND 10.000.000 shall be imposed for threatening to use violence or mentally intimidating a pregnant woman into an abortion because of the predicted sex of the infant.

4. A fine ranging from VND 10.000.000 to VND 12.000.000 shall be imposed for using violence to force a pregnant woman to have an abortion because of the predicted sex of the infant.

5. A fine ranging from VND 12.000.000 to VND 15.000.000 shall be imposed for commission of one of the following violations:

a) Providing chemicals and drugs for aborting the pregnancy in the knowledge that the abortion is sex-selective;

b) Prescribing for or instructing the use of chemicals and drugs or other measures for aborting the pregnancy in the knowledge that the abortion is sex-selective.

6. A fine ranging from VND 15.000.000 to VND 20.000.000 shall be imposed for performing an abortion in the knowledge that the abortion is sex-selective.

7. Additional penalties:

a) The license for medical operations and/or practicing certificate shall be suspended for a fixed period of 03 - 06 months in case of commission of the violation in Clause 5 of this Article;

b) The license for medical operations and/or practicing certificate shall be suspended for a fixed period of 06 - 12 months in case of commission of the violation in Clause 6 of this Article;

c) The certificate of eligibility for pharmacy business or operations of the violating non-commercial pharmacy business establishment shall be suspended for a fixed period of 01 – 03 months in case of commission of the violation in Point a Clause 5 of this Article.

Article 101. Violations against regulations on forced birth control

1. A warning or a fine ranging from VND 200.000 to VND 500.000 shall be imposed for commission of one of the following violations:

a) Failing to provide free of charge contraceptives for individuals who are eligible as prescribed by law and have registered for free-of-charge receipt of contraceptives;

b) Having or performing words or acts that offend the honor or dignity of persons adopting contraceptive methods or persons who only give birth to boys or girls.

2. A fine ranging from VND 1.000.000 to VND 2.000.000 shall be imposed for threatening to use violence or mentally intimidating others into using contraceptive methods.

3. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for commission of one of the following violations:

a) Threatening to use violence or mentally intimidating others into not using or stopping using contraceptive methods;

b) Threatening to use violence or mentally intimidating a woman who has only given birth to boys or girls into conceiving or giving birth.

4. A fine ranging from VND 5.000.000 to VND 7.000.000 shall be imposed for using violence to force others to use contraceptive methods.

5. A fine ranging from VND 7.000.000 to VND 10.000.000 shall be imposed for commission of one of the following violations:

a) Inserting intrauterine devices, injecting or implanting contraceptive without the user’s consent;

b) Using violence to force others not to use or to stop using contraceptive methods;

c) Using violence to force a woman who has only given birth to boys or girls into conceiving or giving birth.

6. A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed for performing sterilization procedure for a person without his/her consent.

7. Additional penalty:

The license for medical operations and/or medical examination and treatment practicing certificate shall be suspended for a fixed period of 01 - 03 months in case of commission of the violation in Clause 6 of this Article.

8. Remedial measure:

Intrauterine devices/implanted contraceptives shall be removed in case of commission of the violation in Point a Clause 5 of this Article.

Article 102. Violations against regulations on sale of contraceptives

1. A fine ranging from VND 1.000.000 to VND 3.000.000 shall be imposed for selling contraceptives which must be provided free of charge as prescribed by competent authorities.

2. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for selling contraceptives at prices higher than those fixed by competent authorities.

3. Additional penalty:

The exhibits that are contraceptives in the violation in Clause 1 of this Article shall be confiscated.

4. Remedial measure:

The entity committing the violation in Clause 1 or Clause 2 of this Article is compelled to return any amounts of money collected against regulations of law. The amounts of money which cannot be returned to payers shall be paid to state budget in accordance with regulations of law.

Chapter III

POWER TO IMPOSE PENALTIES FOR ADMINISTRATIVE VIOLATIONS IN MEDICAL SECTOR

Article 103. Power to impose penalties of Chairpersons of People’s Committees

1. Chairpersons of communal-level People’s Committees shall have the power to:

a) Issue warning;

b) Impose a fine up to VND 3.000.000 for the administrative violations against regulations on population, or up to VND 5.000.000 for the administrative violations against regulations on preventive medicine, HIV/AIDS prevention and control, health insurance, medical examination and treatment, pharmacy, cosmetics and medical devices;

c) Confiscate the exhibits and instrumentalities which have been used for committing administrative violations but are worth less than the corresponding fine in each sector specified in Point b of this Clause;

d) Enforce the remedial measures mentioned in Points c and dd Clause 1 Article 28 of the Law on actions against administrative violations.

2. Chairpersons of district-level People’s Committees shall have the power to:

a) Issue warning;

b) Impose a fine up to VND 15.000.000 for the administrative violations against regulations on population, up to VND 25.000.000 for the administrative violations against regulations on preventive medicine, HIV/AIDS prevention and control, up to VND 37.500.000 for the administrative violations against regulations on health insurance, or up to VND 50.000.000 for the administrative violations against regulations on medical examination and treatment, pharmacy, cosmetics and medical devices;

c) Suspend licenses/practicing certificates or operations for a fixed period;

d) Confiscate the exhibits and instrumentalities which have been used for committing administrative violations but are worth less than the corresponding fine in each sector specified in Point b of this Clause;

dd) Enforce the remedial measures mentioned in Points c, dd, e, h and i Clause 1 Article 28 of the Law on penalties for administrative violations and in Clause 3 Article 3 hereof.

3. Chairpersons of provincial-level People’s Committees shall have the power to:

a) Issue warning;

b) Impose a fine up to VND 30.000.000 for the administrative violations against regulations on population, up to VND 50.000.000 for the administrative violations against regulations on preventive medicine, HIV/AIDS prevention and control, up to VND 75.000.000 for the administrative violations against regulations on health insurance, or up to VND 100.000.000 for the administrative violations against regulations on medical examination and treatment, pharmacy, cosmetics and medical devices;

c) Suspend licenses/practicing certificates or operations for a fixed period;

d) Confiscate the exhibits and instrumentalities used for committing administrative violations;

dd) Enforce the remedial measures mentioned in Points c, d, dd, e, g, h and i Clause 1 Article 28 of the Law on penalties for administrative violations and in Clause 3 Article 3 hereof.

Article 104. Power to impose penalties of inspectors

1. On-duty inspectors and persons assigned to carry out specialized inspections shall have the power to:

a) Issue warning;

b) Impose a fine up to VND 300.000 for the administrative violations against regulations on population, or up to VND 500.000 for the administrative violations against regulations on preventive medicine, HIV/AIDS prevention and control, health insurance, medical examination and treatment, pharmacy, cosmetics and medical devices;

c) Confiscate the exhibits and instrumentalities which have been used for committing administrative violations but are worth less than the corresponding fine in each sector specified in Point b of this Clause;

d) Enforce the remedial measures mentioned in Points c and dd Clause 1 Article 28 of the Law on actions against administrative violations.

2. Chief Inspectors of provincial departments, Directors of Branches for Population and Family Planning affiliated to provincial Departments of Health, Directors of Branches of Vietnam Food Administration, heads of provincial-level specialized inspection teams, and heads of specialized inspection teams established by competent authorities assigned to perform specialized inspection functions shall have the power to:

a) Issue warning;

b) Impose a fine up to VND 15.000.000 for the administrative violations against regulations on population, up to VND 25.000.000 for the administrative violations against regulations on preventive medicine, HIV/AIDS prevention and control, up to VND 37.500.000 for the administrative violations against regulations on health insurance, or up to VND 50.000.000 for the administrative violations against regulations on medical examination and treatment, pharmacy, cosmetics and medical devices;

c) Suspend licenses/practicing certificates or operations for a fixed period;

d) Confiscate the exhibits and instrumentalities which have been used for committing administrative violations but are worth less than the corresponding fine in each sector specified in Point b of this Clause;

dd) Enforce the remedial measures mentioned in Points c, d, dd, e, g, h and i Clause 1 Article 28 of the Law on penalties for administrative violations and in Clause 3 Article 3 hereof.

3. Chief Inspectors of Ministries, Director General of General Office for Population and Family Planning, Director General of Drug Administration of Vietnam, Director General of Vietnam Administration of Medical Services, Director General of Health Environment Management Agency, Director General of General Department of Preventive Medicine, and holders of equivalent titles assigned by the Government to perform specialized inspection tasks shall have the power to:

a) Issue warning;

b) Impose a fine up to VND 30.000.000 for the administrative violations against regulations on population, up to VND 50.000.000 for the administrative violations against regulations on preventive medicine, HIV/AIDS prevention and control, up to VND 75.000.000 for the administrative violations against regulations on health insurance, or up to VND 100.000.000 for the administrative violations against regulations on medical examination and treatment, pharmacy, cosmetics and medical devices;

c) Suspend licenses/practicing certificates or operations for a fixed period;

d) Confiscate the exhibits and instrumentalities used for committing administrative violations;

dd) Enforce the remedial measures mentioned in Points c, d, dd, e, g, h and i Clause 1 Article 28 of the Law on penalties for administrative violations and in Clause 3 Article 3 hereof.

4. Heads of specialized inspection teams established by Ministries shall have the power to:

a) Issue warning;

b) Impose a fine up to VND 21.000.000 for the administrative violations against regulations on population, up to VND 35.000.000 for the administrative violations against regulations on preventive medicine, and HIV/AIDS prevention and control, up to VND 52.500.000 for the administrative violations against regulations on health insurance, or up to VND 70.000.000 for the administrative violations against regulations on medical examination and treatment, pharmacy, cosmetics and medical devices;

c) Suspend licenses/practicing certificates or operations for a fixed period;

d) Confiscate the exhibits and instrumentalities which have been used for committing administrative violations but are worth less than the fine specified in Point b of this Clause;

dd) Enforce the remedial measures mentioned in Points c, d, dd, e, g, h and i Clause 1 Article 28 of the Law on penalties for administrative violations and in Clause 3 Article 3 hereof.

Article 105. Power to impose penalties of market surveillance forces

1. Market controllers on duty shall have the power to:

a) Issue warning;

b) Impose a fine up to VND 500.000 for the administrative violations against regulations on population, preventive medicine, medical examination and treatment, pharmacy, cosmetics and medical devices.

2. Leaders of market surveillance teams shall have the power to:

a) Issue warning;

b) Impose a fine up to VND 25.000.000 for the administrative violations against regulations on population, preventive medicine, medical examination and treatment, pharmacy, cosmetics and medical devices;

c) Confiscate the exhibits and instrumentalities which have been used for committing administrative violations but are worth less than the fine specified in Point b of this Clause;

d) Enforce the remedial measures mentioned in Point dd, e, h and i Clause 1 Article 28 of the Law on penalties for administrative violations and those mentioned in Clause 3 Article 3 hereof.

3. Directors of Provincial Market Surveillance Departments and Director of Market Surveillance Operations Department affiliated to Vietnam Directorate of Market Surveillance shall have the power to:

a) Issue warning;

b) Impose a fine up to VND 30.000.000 for the administrative violations against regulations on population, or up to VND 50.000.000 for the administrative violations against regulations on preventive medicine, medical examination and treatment, pharmacy, cosmetics and medical devices;

c) Confiscate the exhibits and instrumentalities which have been used for committing administrative violations but are worth less than the fine specified in Point b of this Clause;

d) Suspend licenses/practicing certificates or suspend operations for fixed periods;

dd) Enforce the remedial measures mentioned in Points c, d, dd, e, g, h and i Clause 1 Article 28 of the Law on penalties for administrative violations and in Clause 3 Article 3 hereof.

4. Director General of Vietnam Directorate of Market Surveillance shall have the power to:

a) Issue warning;

b) Impose a fine up to VND 30.000.000 for the administrative violations against regulations on population, or up to VND 50.000.000 for the administrative violations against regulations on preventive medicine, or up to VND 100.000.000 for the administrative violations against regulations on medical examination and treatment, pharmacy, cosmetics and medical devices;

c) Confiscate the exhibits and instrumentalities used for committing administrative violations;

d) Suspend licenses/practicing certificates or suspend operations for fixed periods;

dd) Enforce the remedial measures mentioned in Points c, d, dd, e, g, h and i Clause 1 Article 28 of the Law on penalties for administrative violations and in Clause 3 Article 3 hereof.

Article 106. Power to impose penalties of people’s public security forces

1. On-duty soldiers of people’s police forces shall have the power to:

a) Issue warning;

b) Impose a fine up to VND 300.000 for the administrative violations against regulations on population, or up to VND 500.000 for the administrative violations against regulations on preventive medicine, HIV/AIDS prevention and control, medical examination and treatment, pharmacy, cosmetics and medical devices.

2. Heads of police stations and leaders of the soldiers mentioned in Clause 1 of this Article shall have the power to:

a) Issue warning;

b) Impose a fine up to VND 900.000 for the administrative violations against regulations on population, or up to VND 1.500.000 for the administrative violations against regulations on preventive medicine, HIV/AIDS prevention and control, health insurance, medical examination and treatment, pharmacy, cosmetics and medical devices.

3. Heads of communal police authorities and heads of police stations at checkpoints and export processing zones shall have the power to:

a) Issue warning;

b) Impose a fine up to VND 1.500.000 for the administrative violations against regulations on population, or up to VND 2.500.000 for the administrative violations against regulations on preventive medicine, HIV/AIDS prevention and control, health insurance, medical examination and treatment, pharmacy, cosmetics and medical devices;

c) Confiscate the exhibits and instrumentalities which have been used for committing administrative violations but are worth less than the fine specified in Point b of this Clause;

d) Enforce the remedial measures mentioned in Points c and dd Clause 1 Article 28 of the Law on actions against administrative violations.

4. Heads of District-level police forces, heads of operations divisions affiliated to the Police Department for Administrative Management of Social Order, heads of operations divisions affiliated to the Traffic Police Department, and heads of provincial-level police agencies, including: Heads of economic security departments, heads of police departments for administrative management of social order, heads of environment crime prevention and fighting police departments, heads of traffic police departments, heads of railway and road traffic police departments, heads of waterway traffic police departments, and heads of police departments for investigation into corruption, economy and smuggling-related crimes, shall have the power to:

a) Issue warning;

b) Impose a fine up to VND 6.000.000 for the administrative violations against regulations on population, up to VND 10.000.000 for the administrative violations against regulations on preventive medicine, and HIV/AIDS prevention and control, up to VND 15.000.000 for the administrative violations against regulations on health insurance, or up to VND 20.000.000 for the administrative violations against regulations on medical examination and treatment, pharmacy, cosmetics and medical devices;

c) Suspend licenses/practicing certificates or operations for a fixed period;

d) Confiscate the exhibits and instrumentalities which have been used for committing administrative violations but are worth less than the fine specified in Point b of this Clause;

dd) Enforce the remedial measures mentioned in Points c and dd Clause 1 Article 28 of the Law on penalties for administrative violations and in Clause 3 Article 3 hereof.

5. Directors of provincial-level Public Security Departments shall have the power to:

a) Issue warning;

b) Impose a fine up to VND 15.000.000 for the administrative violations against regulations on population, up to VND 25.000.000 for the administrative violations against regulations on preventive medicine, and HIV/AIDS prevention and control, up to VND 35.000.000 for the administrative violations against regulations on health insurance, or up to VND 50.000.000 for the administrative violations against regulations on medical examination and treatment, pharmacy, cosmetics and medical devices;

c) Suspend licenses/practicing certificates or operations for a fixed period;

d) Confiscate the exhibits and instrumentalities which have been used for committing administrative violations but are worth less than the fine specified in Point b of this Clause;

dd) Enforce the remedial measures mentioned in Points c, dd and i Clause 1 Article 28 of the Law on penalties for administrative violations and in Clause 3 Article 3 hereof.

e) Impose the deportation penalty in accordance with current regulations on imposition of deportation penalty under administrative procedures.

6. Directors of the Police Department for Administrative Management of Social Order, Economic Security Department, Environment Crime Prevention and Fighting Police Department, Traffic Police Department, and Police Department for Investigation into Corruption, Economy and Smuggling-related Crimes shall have the power to:

a) Issue warning;

b) Impose a fine up to VND 30.000.000 for the administrative violations against regulations on population, up to VND 50.000.000 for the administrative violations against regulations on preventive medicine, and HIV/AIDS prevention and control, up to VND 75.000.000 for the administrative violations against regulations on health insurance, or up to VND 100.000.000 for the administrative violations against regulations on medical examination and treatment, pharmacy, cosmetics and medical devices;

c) Suspend licenses/practicing certificates or operations for a fixed period;

d) Confiscate the exhibits and instrumentalities used for committing administrative violations;

dd) Enforce the remedial measures mentioned in Points c, dd and i Clause 1 Article 28 of the Law on penalties for administrative violations and in Clause 3 Article 3 herein.

Article 107. Power to impose penalties of customs agencies

1. Customs officials on duty shall have the power to:

a) Issue warning;

b) Impose a fine up to VND 500.000 for the administrative violations against regulations on preventive medicine, HIV/AIDS prevention and control, pharmacy, cosmetics and medical devices.

2. Team leaders of Customs Branches and team leaders of Post-clearance Audit Branches shall have the power to:

a) Issue warning;

b) Impose a fine up to VND 5.000.000 for the administrative violations against regulations on preventive medicine, HIV/AIDS prevention and control, pharmacy, cosmetics and medical devices.

3. Directors of Customs Branches, Directors of Post-clearance Audit Branches, leaders of customs control teams affiliated to Customs Departments of provinces, leaders of anti-smuggling control teams, commanders of marine control squads and leaders of intellectual property protection and control teams affiliated to Anti-smuggling and Investigation Department of General Department of Customs shall have the power to:

a) Issue warning;

b) Impose a fine up to VND 25.000.000 for the administrative violations against regulations on preventive medicine, HIV/AIDS prevention and control, pharmacy, cosmetics and medical devices;

b) Confiscate the exhibits and instrumentalities which have been used for committing administrative violations but are worth less than the fine specified in Point b of this Clause;

c) Enforce the remedial measures mentioned in Points d, dd and i Clause 1 Article 28 of the Law on penalties for administrative violations and in Clause 3 Article 3 hereof.

4. Directors of Anti-smuggling and Investigation Department and Post-clearance Audit Department affiliated to General Department of Customs, and Directors of Customs Departments of provinces shall have the power to:

a) Issue warning;

b) Impose a fine up to VND 50.000.000 for the administrative violations against regulations on preventive medicine, pharmacy, cosmetics and medical devices;

c) Suspend licenses/practicing certificates or operations for a fixed period;

d) Confiscate the exhibits and instrumentalities which have been used for committing administrative violation but are worth less than the fine specified in Point b of this Clause;

dd) Enforce the remedial measures mentioned in Points d, dd and i Clause 1 Article 28 of the Law on penalties for administrative violations and in Clause 3 Article 3 hereof.

5. Director General of General Department of Customs shall have the power to:

a) Issue warning;

b) Impose a fine up to VND 50.000.000 for the administrative violations against regulations on preventive medicine, or up to VND 100.000.000 for the administrative violations against regulations on pharmacy, cosmetics and medical devices;

c) Suspend licenses/practicing certificates or operations for a fixed period;

d) Confiscate the exhibits and instrumentalities used for committing administrative violations;

dd) Enforce the remedial measures mentioned in Points d, dd and i Clause 1 Article 28 of the Law on penalties for administrative violations and in Clause 3 Article 3 hereof.

Article 108. Power to impose penalties of border guard forces

1. On-duty soldiers of border guard forces shall have the power to:

a) Issue warning;

b) Impose a fine up to VND 300.000 for the administrative violations against regulations on population, or up to VND 500.000 for the administrative violations against regulations on preventive medicine, HIV/AIDS prevention and control, medical examination and treatment, pharmacy, cosmetics and medical devices.

2. Heads of border guard stations and leaders of soldiers of border guard forces shall have the power to:

a) Issue warning;

b) Impose a fine up to VND 1.500.000 for the administrative violations against regulations on population, or up to VND 2.500.000 for the administrative violations against regulations on preventive medicine, HIV/AIDS prevention and control, medical examination and treatment, pharmacy, cosmetics and medical devices.

3. Heads of border-guard posts, commanders of border-guard flotillas and commanders of port border guards shall have the power to:

a) Issue warning;

b) Impose a fine up to VND 6.000.000 for the administrative violations against regulations on population, or up to VND 10.000.000 for the administrative violations against regulations on preventive medicine, and HIV/AIDS prevention and control, or up to VND 20.000.000 for the administrative violations against regulations on medical examination and treatment, pharmacy, cosmetics and medical devices;

c) Confiscate the exhibits and instrumentalities which have been used for committing administrative violations but are worth less than the fine specified in Point b of this Clause;

d) Enforce the remedial measures mentioned in Points c and dd Clause 1 Article 28 of the Law on penalties for administrative violations and in Clause 3 Article 3 hereof.

4. Commanders of provincial-level border guard forces and commanders of border guard fleets affiliated to the Border Guard High Command shall have the power to:

a) Issue warning;

b) Impose a fine up to VND 30.000.000 for the administrative violations against regulations on population, or up to VND 50.000.000 for the administrative violations against regulations on preventive medicine, and HIV/AIDS prevention and control, or up to VND 100.000.000 for the administrative violations against regulations on medical examination and treatment, pharmacy, cosmetics and medical devices;

c) Suspend licenses/practicing certificates or operations for a fixed period;

d) Confiscate the exhibits and instrumentalities used for committing administrative violations;

dd) Enforce the remedial measures mentioned in Points c, dd and i Clause 1 Article 28 of the Law on penalties for administrative violations and in Clause 3 Article 3 hereof.

Article 109. Power to impose penalties of Vietnam marine police forces

1. Coast guard officers on duty shall have the power to:

a) Issue warning;

b) Impose a fine up to VND 600.000 for the administrative violations against regulations on population, or up to VND 1.500.000 for the administrative violations against regulations on preventive medicine, HIV/AIDS prevention and control, medical examination and treatment, pharmacy, cosmetics and medical devices.

2. Coastguard team leaders shall have the power to:

a) Issue warning;

b) Impose a fine up to VND 1.500.000 for the administrative violations against regulations on population, or up to VND 2.500.000 for the administrative violations against regulations on preventive medicine, and HIV/AIDS prevention and control, or up to VND 5.000.000 for the administrative violations against regulations on medical examination and treatment, pharmacy, cosmetics and medical devices.

3. Coastguard squad leaders and captains of coastguard stations shall have the power to:

a) Issue warning;

b) Impose a fine up to VND 3.000.000 for the administrative violations against regulations on population, or up to VND 5.000.000 for the administrative violations against regulations on preventive medicine, and HIV/AIDS prevention and control, or up to VND 10.000.000 for the administrative violations against regulations on medical examination and treatment, pharmacy, cosmetics and medical devices;

c) Enforce the remedial measures mentioned in Points c and dd Clause 1 Article 28 of the Law on penalties for administrative violations.

4. Commanders of coastguard platoons shall have the power to:

a) Issue warning;

b) Impose a fine up to VND 6.000.000 for the administrative violations against regulations on population, or up to VND 10.000.000 for the administrative violations against regulations on preventive medicine, and HIV/AIDS prevention and control, or up to VND 20.000.000 for the administrative violations against regulations on medical examination and treatment, pharmacy, cosmetics and medical devices;

c) Confiscate the exhibits and instrumentalities which have been used for committing administrative violations but are worth less than the fine specified in Point b of this Clause;

d) Enforce the remedial measures mentioned in Points c, d and dd Clause 1 Article 28 of the Law on penalties for administrative violations and in Clause 3 Article 3 hereof.

5. Commanders in chief of coastguard squadrons shall have the power to:

a) Issue warning;

b) Impose a fine up to VND 9.000.000 for the administrative violations against regulations on population, or up to VND 15.000.000 for the administrative violations against regulations on preventive medicine, and HIV/AIDS prevention and control, or up to VND 30.000.000 for the administrative violations against regulations on medical examination and treatment, pharmacy, cosmetics and medical devices;

c) Confiscate the exhibits and instrumentalities which have been used for committing administrative violations but are worth less than the fine specified in Point b of this Clause;

d) Enforce the remedial measures mentioned in Points c, d and dd Clause 1 Article 28 of the Law on penalties for administrative violations and in Clause 3 Article 3 hereof.

6. Commanders of Regional Coast Guards shall have the power to:

a) Issue warning;

b) Impose a fine up to VND 15.000.000 for the administrative violations against regulations on population, or up to VND 25.000.000 for the administrative violations against regulations on preventive medicine, and HIV/AIDS prevention and control, or up to VND 50.000.000 for the administrative violations against regulations on medical examination and treatment, pharmacy, cosmetics and medical devices;

c) Confiscate the exhibits and instrumentalities which have been used for committing administrative violations but are worth less than the fine specified in Point b of this Clause;

d) Enforce the remedial measures mentioned in Points c, d and dd Clause 1 Article 28 of the Law on penalties for administrative violations and in Clause 3 Article 3 hereof.

7. Commander of Vietnam Coast Guard shall have the power to:

a) Issue warning;

b) Impose a fine up to VND 30.000.000 for the administrative violations against regulations on population, or up to VND 50.000.000 for the administrative violations against regulations on preventive medicine, and HIV/AIDS prevention and control, or up to VND 100.000.000 for the administrative violations against regulations on medical examination and treatment, pharmacy, cosmetics and medical devices;

c) Suspend licenses/practicing certificates or operations for a fixed period;

d) Confiscate the exhibits and instrumentalities used for committing administrative violations;

dd) Enforce the remedial measures mentioned in Points c, d and dd Clause 1 Article 28 of the Law on penalties for administrative violations and in Clause 3 Article 3 hereof.

Article 110. Power of tax authorities

1. Tax officials on duty shall have the power to:

a) Issue warning;

b) Impose a fine up to VND 500.000 for the administrative violations against regulations on preventive medicine, and HIV/AIDS prevention and control.

2. Tax team leaders shall have the power to:

a) Issue warning;

b) Impose a fine up to VND 2.500.000 for the administrative violations against regulations on preventive medicine, and HIV/AIDS prevention and control.

3. Directors of Sub-departments of taxation shall have the power to:

a) Issue warning;

b) Impose a fine up to VND 25.000.000 for the administrative violations against regulations on preventive medicine, and HIV/AIDS prevention and control;

c) Confiscate the exhibits and instrumentalities which have been used for committing administrative violations but are worth less than the fine specified in Point b of this Clause;

d) Enforce the remedial measures mentioned in Points i and k Clause 1 Article 28 of the Law on penalties for administrative violations and in Clause 3 Article 3 hereof.

4. Directors of Departments of taxation shall have the power to:

a) Issue warning;

b) Impose a fine up to VND 50.000.000 for the administrative violations against regulations on preventive medicine, and HIV/AIDS prevention and control;

c) Confiscate the exhibits and instrumentalities which have been used for committing administrative violations but are worth less than the fine specified in Point b of this Clause;

d) Enforce the remedial measures mentioned in Points i and k Clause 1 Article 28 of the Law on penalties for administrative violations and in Clause 3 Article 3 hereof.

5. Director General of General Department of Taxation shall have the power to:

a) Issue warning;

b) Impose a fine up to VND 50.000.000 for the administrative violations against regulations on preventive medicine, and HIV/AIDS prevention and control;

c) Confiscate the exhibits and instrumentalities used for committing administrative violations;

d) Enforce the remedial measures mentioned in Points i and k Clause 1 Article 28 of the Law on penalties for administrative violations and in Clause 3 Article 3 hereof.

Article 111. Power to impose penalties of social security authorities

1. Directors of provincial-level social security authorities shall have the power to:

a) Issue warning;

b) Impose a fine up to VND 37.500.000 for the administrative violations against regulations on health insurance;

c) Suspend licenses/practicing certificates or operations for a fixed period;

d) Confiscate the exhibits and instrumentalities which have been used for committing administrative violations but are worth less than the fine specified in Point b of this Clause;

dd) Enforce the remedial measures mentioned in Points c, d, dd, e, g, h and i Clause 1 Article 28 of the Law on penalties for administrative violations and in Clause 3 Article 3 hereof.

2. General Director of Vietnam Social Security shall have the power to:

a) Issue warning;

b) Impose a fine up to VND 75.000.000 for the administrative violations against regulations on health insurance;

c) Suspend licenses/practicing certificates or operations for a fixed period;

d) Confiscate the exhibits and instrumentalities used for committing administrative violations;

dd) Enforce the remedial measures mentioned in Points c, d, dd, e, g, h and i Clause 1 Article 28 of the Law on penalties for administrative violations and in Clause 3 Article 3 hereof.

3. Heads of specialized inspection teams established by General Director of Vietnam Social Security shall have the power to:

a) Issue warning;

b) Impose a fine up to VND 52.500.000 for the administrative violations against regulations on health insurance;

c) Suspend licenses/practicing certificates or operations for a fixed period;

d) Confiscate the exhibits and instrumentalities which have been used for committing administrative violations but are worth less than the fine specified in Point b of this Clause;

dd) Enforce the remedial measures mentioned in Points c, d, dd, e, g, h and i Clause 1 Article 28 of the Law on penalties for administrative violations and in Clause 3 Article 3 hereof.

Article 112. Division of power to impose penalties

1. Chairpersons of people’s committees of all levels shall have the power to make records of, impose penalties, and enforce remedial measures against the administrative violations in Chapter II hereof within their competence prescribed in Article 103 hereof and within the ambit of their assigned functions, duties and powers.

2. Health inspectors competent to impose penalties and persons assigned to perform specialized health inspections shall have the power to make records of, impose penalties, and enforce remedial measures against the administrative violations in Chapter II hereof within their competence prescribed in Article 104 hereof, the administrative violations in medical sector within the competence of holders of equivalent titles prescribed in other Decrees prescribing penalties for administrative violations, and within the ambit of their assigned functions, duties and powers.

3. Officers competent to impose penalties of market surveillance forces shall have the power to make records of, impose penalties, and enforce remedial measures against the administrative violations in Articles 14, 25, 26, 27, 29, 30, 31, 32, 33, 34, 35, 36, 37, 49, 50, 51, 52, 53, 54, 55, 57, 58, 59, 60, 64, 65, 66, 67, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 102, Clause 4 Article 6, Point h Clause 3 Article 9, Clause 3, 4 Article 12, Point dd Clause 1, Point a, d Clause 2, Point a, b, c Clause 3, Clause 4 Article 61, Clause 2 Article 68 and Point a Clause 2 Article 97 within the ambit of their assigned functions, duties and powers, and their competence prescribed in Article 105 hereof.

4. Officers competent to impose penalties of people’s public security forces shall have the power to make records of, impose penalties, and enforce remedial measures against the administrative violations in Articles 7, 10, 11, 12, 13, 14, 15, 16, 18, 19, 22, 24, 25, 26, 27, 29, 30, 31, 32, 33, 34, 35, 36, 37, 54, 65, 66, 67, 69, 70, 76, 96, 97, 98, 99, 100, 101, 102; Point a Clause 3 Article 5; Clause 1, 2, 4 Article 6; Point a Clause 1, Point a Clause 2, Point h Clause 3 Article 9; Point a, c Clause 5, Point b Clause 6, Clause 7 Article 38; Point a Clause 7 Article 44; Point a Clause 1 Article 45; Point a Clause 1, Point b Clause 2 Article 48; Point a, g Clause 2 Article 52; Clause 3 Article 53; Clause 4 Article 55; Point c Clause 4 Article 56; Point d Clause 5, Clause 7 Article 57; Clause 7 Article 58; Clause 4, 5, 6, 7 Article 59; Point d, dd, e, g Clause 2, Point dd Clause 3, Clause 4, 5, 6, 7 Article 60; Clause 4 Article 61; Clause 5 Article 62; Clause 4 Article 63; Clause 1, 2, Point a, b Clause 3 Article 64; Clause 2, 3 Article 68; Point b Clause 2 Article 70; Point a Clause 2, Point a, b Clause 3 Article 73; Point g Clause 2, Clause 3 Article 74 and Point b, c, d Clause 2, Point c, d Clause 3 Article 75 hereof within the ambit of their assigned functions, duties and powers, and their competence prescribed in Article 106 hereof.

5. Officers competent to impose penalties of customs authorities shall have the power to make records of, impose penalties, and enforce remedial measures against the administrative violations in Articles 7, 11, 12, 13, 14, 25, 26, 27, 29, 30, 31, 32, 33, 34, 35, 36, 37, 60, 64, 71, 76; Clause 1, 2 Article 6; Point b Clause 1 Article 54; Clause 6, 7 Article 58; Clause 6, 7 Article 59; Point b Clause 1, Clause 2 Article 65 and Point c Clause 2 Article 75 hereof within the ambit of their assigned functions, duties and powers, and their competence prescribed in Article 107 hereof.

6. Officers competent to impose penalties of border guard forces shall have the power to make records of, impose penalties, and enforce remedial measures against the administrative violations in Article 5, 6, 7, 10, 11, 12, 13, 14, 19, 22, 24, 25, 26, 27, 30, 31, 32, 33, 34, 35, 36, 37, 60, 65, 76, 96, 97, 101, 102; Point b Clause 3 Article 8; Point b Clause 3 Article 9; Point a, b Clause 3 Article 16; Point g Clause 2, Point dd Clause 3 Article 23; Clause 1, 2, 3, Point a, b, c, g Clause 4, Point a Clause 5 Article 29; Point b Clause 4 Article 39; Point b Clause 3 Article 48; Point b Clause 1 Article 52 and Clause 1, Point b Clause 2, Point a, b Clause 3 Article 64 hereof within the ambit of their assigned functions, duties and powers, and their competence prescribed in Article 108 hereof.

7. Officers competent to impose penalties of coast guard forces shall have the power to make records of, impose penalties, and enforce remedial measures against the administrative violations in Articles 5, 6, 7, 10, 11, 12, 13, 14, 17, 19, 22, 24, 25, 26, 27, 30, 31, 32, 33, 34, 35, 36, 37, 60, 65, 71, 76, 80, 83, 96, 97, 101, 102; Point b Clause 3 Article 8; Point b Clause 3 Article 9; Point a, b Clause 3 Article 16; Point g Clause 2, Clause 3 Article 23; Clause 1, 2, 3, Point a, b, c, g Clause 4, Point a Clause 5 Article 29; Clause 1, 3, 5, 6, 7 Article 38; Point b Clause 4 Article 39; Clause 4 Article 40; Point b Clause 1 Article 45; Point b Clause 3 Article 48; Point b Clause 1 Article 52; Clause 1, Point b Clause 2, Point a, b Clause 3 Article 64; Clause 1 Article 74 and Point a Clause 1, Clause 2 Article 95 hereof within the ambit of their assigned functions, duties and powers, and their competence prescribed in Article 109 hereof.

8. Officers competent to impose penalties of tax authorities shall have the power to make records of, impose penalties, and enforce remedial measures against the administrative violations in Points d, dd, e Clause 4 and Point b Clause 5 Article 29 hereof within the ambit of their assigned functions, duties and powers, and their competence prescribed in Article 110 hereof.

9. Officers competent to impose penalties of social security authorities shall have the power to make records of, impose penalties, and enforce remedial measures against the administrative violations in Section 5 hereof within the ambit of their assigned functions, duties and powers, and their competence prescribed in Article 111 hereof.

10. Inspectors in the field of information and communications competent to impose penalties shall have the power to make records of, impose penalties, and enforce remedial measures against the administrative violations in Article 5, 19, 25, 26, 30, 32, 33, 34, 36, 37, 49, 50, 51, 67, 69, 78, 96, 97; Clause 2 Article 14; Clause 1, 2, 3, Point a, b, c, e, g Clause 4, Point a Clause 5 Article 29; Clause 3 Article 31 and Point b Clause 2 Article 35 hereof within the ambit of their assigned functions, duties and powers, and their competence prescribed in Article 104 hereof.

11. Inspectors in the field of culture, sports and tourism competent to impose penalties shall have the power to make records of, impose penalties, and enforce remedial measures against the administrative violations in Article 5, 19, 25, 26, 30, 32, 33, 34, 36, 37, 49, 50, 51, 67, 69, 78, 96, 97; Clause 2 Article 14; Clause 1, 2, 3, Point a, b, c, e, g Clause 4, Point a Clause 5 Article 29 and Point b Clause 2 Article 35 hereof within the ambit of their assigned functions, duties and powers, and their competence prescribed in Article 104 hereof.

12. Inspectors in the field of education, transport, agriculture and rural development, science and technology competent to impose penalties shall have the power to make records of, impose penalties, and enforce remedial measures against the administrative violations in Articles 5, 6, 18, 19, 23, 25, 26, 30, 31, 32, 33, 34, 36, 37; Clause 2 Article 14 and Clauses 1, 2, 3, Points a, b, c, e Clause 4, Point a Clause 5 Article 29 hereof within the ambit of their assigned functions, duties and powers, and their competence prescribed in Article 104 hereof.

13. Inspectors in the field of natural resources and environment competent to impose penalties shall have the power to make records of, impose penalties, and enforce remedial measures against the administrative violations in Articles 5, 6, 7, 10, 12, 15, 16, 18, 19, 23, 25, 26, 30, 31, 32, 33, 34, 36, 37, Point a Clause 5 Article 29 hereof within the ambit of their assigned functions, duties and powers, and their competence prescribed in Article 104 hereof.

Article 113. Power to record administrative violations

Persons that have the power to make records of administrative violations in medical sector include:

1. The persons having the power to impose administrative penalties prescribed this Decree shall have the power to record administrative violations within the ambit of their assigned functions, tasks and power.

2. Officials and public employees of health agencies and social security agencies, officials, public employees and persons of people’s army or people’s security forces, and officials, public employees working at the agencies specified in Article 112 hereof shall have the power to record administrative violations detected when they are on duty and within the ambit of their assigned functions, tasks and power.

Article 114. Violation detection facilities and equipment

1. Authorities and persons competent to impose penalties are entitled to use technical and operational facilities and equipment for detecting the administrative violations prescribed in Articles 25, 30, 31, 32, 33, 34, 35, 36, 37 hereof.

2. Management, use and list of violation detection facilities and equipment shall comply with regulations of laws in force.

Chapter IV

IMPLEMENTATION

Article 115. Effect

1. This Decree comes into force from November 15, 2020.

2. The following provisions come into force from the date of promulgation of this document, including:

a) Articles 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 47, 115, 116, 117 Point b Clause 1, Point b Clause 4 Article 52 and Point a, b Clause 2, Point b, dd Clause 3, Point b Clause 4 Article 57 hereof;

b) Articles 1, 2, 3, 4, 103, 104, 105, 106, 107, 108, 109, 110, 111, 112, 113 and 114 are applied to impose penalties for the administrative violations prescribed in Point a of this Clause.

3. The entire Government’s Decree No. 176/2013/ND-CP dated November 14, 2013 shall be null and void from November 15, 2020.

4. Articles 5, 6, 7, 8, 9, 10, 11, 12, 13 of the Government’s Decree No. 176/2013/ND-CP dated November 14, 2013 shall be null and void from the date of promulgation of this document.

Article 116. Transition

If this Decree does not contain legal liability or impose a less serious legal liability on an administrative violation in medical sector which is committed before the date of entry into force of this Decree but is detected afterwards or is under consideration, regulations hereof shall apply.

Article 117. Responsibility for guidance and implementation

1. The Minister of Health shall instruct and organize the implementation of this Decree.

2. Ministers, heads of ministerial agencies, heads of Governmental agencies, Chairpersons of people’s committees at all levels, and relevant authorities, organizations and individuals shall implement this Decree./.

 

 

ON BEHALF OF THE GOVERNMENT
THE PRIME MINISTER




Nguyen Xuan Phuc

 

 

 

 


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This translation is made by THƯ VIỆN PHÁP LUẬT and for reference purposes only. Its copyright is owned by THƯ VIỆN PHÁP LUẬT and protected under Clause 2, Article 14 of the Law on Intellectual Property.Your comments are always welcomed

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