Decree 90/2026/ND-CP sanctioning of administrative violations in health sector

DECREE

On sanctioning of administrative violations in health sector

Pursuant to the Law on Organization of the Government No. 63/2025/QH15;

Pursuant to the Law on Handling of Administrative Violations No. 15/2012/QH13, amended and supplemented under Law No. 67/2020/QH14 and Law No. 88/2025/QH15;

Pursuant to the Law on Pharmacy No. 105/2016/QH13, amended and supplemented under Law No. 44/2024/QH15;

Pursuant to the Law on HIV/AIDS Prevention and Control
No. 64/2006/QH11, amended and supplemented under Law No. 71/2020/QH14;

Pursuant to the Law on Donation, Removal and Transplantation of Human Tissues and Organs and Donation and Recovery of Cadavers No. 75/2006/QH11;

Pursuant to the Law on Prevention and Control of Infectious Diseases No. 03/2007/QH12, amended and supplemented under Law No. 15/2008/QH12 and Law No. 35/2018/QH14;

Pursuant to the Law on Health Insurance No. 25/2008/QH12, amended and supplemented under Law No. 46/2014/QH13 and Law No. 51/2024/QH15;

Pursuant to the Law on Medical Examination and Treatment No. 15/2023/QH15;

Pursuant to the Law on Prevention and Control of Tobacco Harms No. 09/2012/QH13;

Pursuant to the Law on Prevention and Control of Harms of Liquor and Beer Abuse No. 44/2019/QH14;

Pursuant to the National Assembly's Resolution No. 173/2024/QH15 on questioning activities at the 8 session of the XV National Assembly;

Pursuant to the Population Ordinance No. 06/2003/PL-UBTVQH11, amended and supplemented under Ordinance No. 07/2025/UBTVQH15;

At the proposal of the Minister of Health;

The Government hereby promulgates the Decree on sanctioning of administrative violations in health sector.

Chapter I

GENERAL PROVISIONS

Article 1. Scope of regulation

1. This Decree stipulates acts of administrative violations, sanctioning forms and levels, remedial measures applied to each administrative violation; competence to make written records and sanction of administrative violations according to each position in health sector.

2. Administrative violations in health sector specified in this Decree are faulty acts which are committed by an individual or organization in violation of the state management law but does not constitute a crime and, therefore, must be administratively sanctioned in accordance with law, including:

a) Violation of regulations on preventive medicine and HIV/AIDS prevention and control;

b) Violation of regulations on medical examination and treatment;

c) Violation of regulations on pharmacy and cosmetics;

d) Violation of regulations on medical equipment;

dd) Violation of regulations on health insurance;

e) Violation of regulations on population.

3. Acts of administrative violations in health sector other than those specified in this Decree, but prescribed in other Decrees on sanctioning of administrative violations shall be sanctioned according to the provisions of such Decrees.

Article 2. Subjects of application

1. Vietnamese and foreign individuals and organizations (hereinafter collectively referred to as individuals and organizations) that commit administrative violations as prescribed in this Decree; persons competent to make written records, persons competent to sanction of administrative violations and relevant individuals and organizations.

2. Organizations that may be sanctioned according to this Decree include:

a) Economic organizations established in accordance with the law on enterprises, including: Sole proprietorships, partnerships, limited liability companies, joint stock companies and affiliated units of enterprises (branches and representative offices);

b) Cooperatives and unions of cooperatives established in accordance with the law on cooperatives;

c) Organizations established in accordance with the law on investment and commercial law, including: Domestic and foreign investors (except for 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) Non-business units;

e) State agencies that commit acts violations which do not fall under their assigned state management tasks;

g) Cooperative groups;

h) Other organizations as prescribed by law.

3. Business households, households, individual domestic and foreign investors committing administrative violations specified in this Decree shall be sanctioned like individuals.

Article 3. Forms of sanctioning administrative violations and remedial measures

1. Principal sanctions:

a) Warning;

b) Fine.

2. Additional sanctions specified in this Decree, including:

a) Deprivation of the right to use licenses, practice certificates for a definite term of between 1 month and 24 months;

b) Confiscation of material evidences of administrative violations or means used for commission of administrative violations in health sector (below collectively referred to as material evidences and means of administrative violations);

c) Suspension of operation for a definite time of between 1 and 24 months.

3. Remedial measures:

a) Remedial measures specified at Points c, d, dd, e, g, h and i Clause 1 Article 28 of the Law on Handling of Administrative Violations (as amended and supplemented in 2020 and 2025) (hereinafter referred to as the Law on Handling of Administrative Violations);

b) Other remedial measures as specified in Chapter II of this Decree.

4. The enforcement of forms of sanction and remedial measures prescribed in this Decree shall be carried out in accordance with the Law on Handling of Administrative Violations and guiding documents for implementation thereof. In case the period of suspension of operation expires but the violating entity fails to satisfy the required conditions, it shall continue to be administratively sanctioned in accordance with the law.

5. Completed administrative violations and in-progress administrative violations shall be determined in accordance with Clause 1 Article 8 of the Government's Decree No. 118/2021/ND-CP dated December 23, 2021, detailing a number of articles of, and measures to implement, the Law on Handling of Administrative Violations, as amended and supplemented under the Government's Decree No. 68/2025/ND-CP dated March 18, 2025, and Decree No. 190/2025/ND-CP dated July 01, 2025.

6. Organizations and individuals committing multiple administrative violations shall be sanctioned for each act of violation, except in cases of committing each act of violation specified at Point d Clause 1 Article 52; Clause 4 Article 53; Points b and c Clause 1 Article 55; Clauses 1, 2, 3 and 4 Article 56; Points a, c and d Clause 2, Points a, c, d, dd and h Clause 3, Point h Clause 4 Article 57; Points a, c, d, dd and e Clause 1, Points a, b and c Clause 2, Points a and d Clause 3, Points c, d and dd Clause 4, Clauses 5 and 6 Article 58; Points c, d, dd and e Clause 1, Points a, b, c and d Clause 2, Points c, d, dd, g, h, k, l and m Clause 3, Points a, b, c, d, dd, g, h, i, k and l Clause 4, Clauses 5 and 6 Article 59; Points a, c, d and dd Clause 1, Points b, c, d and dd Clause 2, Points a, c, d, dd, e, h and i Clause 3, Clauses 4, 5 and 6 Article 60; Points a, b and dd Clause 1, Points a, c and d Clause 2, Points a, b and c Clause 3 Article 61; Clauses 1 and 2 Article 65; Clauses 1, 2 and 3 Article 66; Clauses 1, 2, 3, 4 and 5 Article 67; Clauses 1, 2 and 3 Article 68; Clauses 1 and 2 Article 70; Clauses 1, 2 and 3 Article 71 of this Decree committed at different times where such violations have not yet been handled and the statute of limitations for handling has not expired but are detected and recorded in the same administrative violation record, in which case only one sanction shall be imposed for the act of violation, and concurrently the aggravating circumstance of repeated administrative violations prescribed at Point b Clause 1 Article 10 of the Law on Handling of Administrative Violations shall be applied.

7. The handling of administrative violations in the health sector in the electronic environment shall be carried out in accordance with Decree No. 118/2021/ND-CP, as amended and supplemented under Decree No. 68/2025/ND-CP and Decree No. 190/2025/ND-CP.

Article 4. Provisions on fines imposed on individuals and organizations

1. The maximum fine imposed for an act of administrative violation pertaining to population is VND 30,000,000, for individuals, and VND 60,000,000, for organizations.

2. The maximum fine imposed for an act of administrative violation pertaining to preventive medicine and HIV/AIDS prevention and control is VND 50,000,000, for individuals, and VND 100,000,000, for organizations.

3. The maximum fine for an act of administrative violation pertaining to health insurance is VND 75,000,000, for individuals, and VND 150,000,000, for organizations.

4. The maximum fine for an act of violation pertaining to medical examination and treatment, pharmacy, cosmetics, or medical equipment is VND 100,000,000, for individuals, and VND 200,000,000, for organizations.

5. The fines as prescribed in Chapter II of this Decree are that applicable to individuals. For the same act of administrative violation, the fine to be imposed on an organization is 2 times that of the fine imposed on an individual.

6. The competence to impose fines of the titles specified in Chapter III of this Decree is the competence to impose fines for an act of administrative violation committed by individuals, the competence to impose fines on an organization is twice as much as the competence to fine an individual.

Chapter II

ADMINISTRATIVE VIOLATIONS, SANCTIONING FORMS AND REMEDIAL MEASURES

Section 1

ADMINISTRATIVE VIOLATIONS IN PREVENTIVE MEDICINE AND HIV/AIDS PREVENTION AND CONTROL

Article 5. Violation of regulations on information, education and communication in infectious disease prevention and control

1. Fines shall be imposed for the acts of failing to organize the information, education and communication about infectious disease prevention and control for workers at requests of competent agencies according to one of the following levels:

a) A fine from VND 1,000,000 to VND 3,000,000 shall be imposed on the establishment employing less than 100 workers;

b) A fine from VND 3,000,000 to VND 5,000,000 shall be imposed on the establishment that employs from 100 to less than 300 workers;

c) A fine from VND 5,000,000 to VND 7,000,000 shall be imposed on the establishment that employs from 300 to less than 500 workers;

d) A fine from VND 7,000,000 to VND 10,000,000 shall be imposed on the establishment that employs from 500 to less than 1,000 workers;

dd) A fine from VND 10,000,000 to VND 15,000,000 shall be imposed on the establishment that employs from 1,000 to less than 1,500 workers;

e) A fine from VND 15,000,000 to VND 20,000,000 shall be imposed on the establishment that employs from 1,500 to less than 2,500 workers;

g) A fine from VND 20,000,000 to VND 25,000,000 shall be imposed on the establishment that employs 2,500 workers or more.

2. A fine from VND 3,000,000 to VND 5,000,000 shall be imposed for the act of failing to comply with, or improper compliance with, the provisions of law on broadcasting time or duration, or the volume or placement of information on prevention and control of infectious diseases.

3. A fine from VND 10,000,000 to VND 15,000,000 shall be imposed for any of the following violations:

a) Providing inaccurate or untimely information on the infectious disease epidemics after the declaration of an epidemic or the declaration of the end of an epidemic, contrary to the contents provided by a competent state health agency;

b) Charging fees for information, education, and communication on prevention and control of infectious diseases on mass media, except in cases where there is a separate contract with a program or project, or where such activities are funded by domestic or foreign organizations or individuals.

4. Remedial measures:

a) Forcible correction of untruthful information on mass media within the area where such information was previously disseminated for 3 consecutive days as prescribed by law, for the act specified at Point a, Clause 3 of this Article;

b) Forcible refund of amounts unlawfully collected for the act specified at Point b, Clause 3 of this Article. In case it cannot be refunded to the subject, it shall be remitted to the state budget in accordance with the law.

Article 6. Violation of regulations on sanitation for prevention and control of infectious diseases

1. A fine from VND 200,000 to VND 500,000 shall be imposed for the act of failing to take measures to ensure hygiene in residential places, public places, transport vehicles, or storage of domestic waste to prevent infectious diseases.

2. A fine from VND 1,000,000 to VND 3,000,000 shall be imposed for the act of failing to take measures to ensure hygiene in residential places, public places, transport vehicles, or storage of domestic waste, causing or spreading infectious diseases.

3. A fine from VND 3,000,000 to VND 5,000,000 shall be imposed for any of the following violations:

a) Failing to provide sufficient drinking water and clean water for domestic use meeting quality requirements in educational institutions as prescribed by law;

b) Failing to have or having sanitary facilities that do not meet hygiene requirements in educational institutions as prescribed by law;

c) Failing to ensure adequate lighting in educational institutions as prescribed by law;

d) Failing to provide education to learners on hygiene for prevention of infectious diseases, including personal hygiene, hygiene in daily activities, labor, and environmental hygiene;

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

4. A fine from VND 10,000,000 to VND 20,000,000 shall be imposed for the act of failing to ensure hygiene at production and business establishments, in industrial waste treatment, and other hygiene measures as prescribed by law, resulting in the occurrence or spread of infectious diseases.

5. Remedial measures:

Forcible application of measures of cleaning, disinfecting and decontaminating, for the acts of violation specified in Clauses 2 and 4 of this Article.

Article 7. Violation of regulations on infectious disease surveillance

1. A fine from VND 500,000 to VND 1,000,000 shall be imposed for the acts of concealing, failing to declare, or failing to timely declare upon detecting another person suffering from an infectious disease in accordance with the law, except for the case specified at Point a, Clause 3 of this Article.

2. A fine from VND 1,000,000 to VND 3,000,000 shall be imposed for any of the following violations:

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

b) Failing to report or reporting inaccurately on infectious disease surveillance as prescribed by law;

c) Concealing, failing to report or failing to timely report the infectious disease status of oneself, except for the case specified at Point a, Clause 3 of this Article.

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

a) Concealing, failing to report or failing to timely report infectious disease status of oneself or of another person suffering from a Group A infectious disease;

b) Deliberately declaring or providing false information regarding Group A infectious diseases;

c) Deliberately spreading agents causing Group A infectious diseases.

Article 8. Violations regulations on biosafety assurance at laboratories

1. A fine from VND 3,000,000 to VND 5,000,000 shall be imposed for any of the following violations:

a) Failing to satisfy one of the conditions of a level I biosafety laboratory after having declared conformity with level I biosafety standards;

b) Failing to assess the risk of biosafety incidents at the laboratory;

c) Conducting tests beyond the professional scope after being announced as meeting biosafety standards of levels I and II;

d) Failing to develop and organize the implementation of the Regulation on biosafety self-examination as prescribed by law;

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

2. A fine from VND 5,000,000 to VND 10,000,000 shall be imposed for any of the following violations:

a) Failing to ensure one of the conditions of a level II biosafety laboratory after having declared conformity with level II biosafety standards;

b) Failing to develop a prevention plan and a biosafety incident response plan, or developing such plans with incomplete contents as prescribed by law;

c) Failing to disinfect or sterilize waste used in testing before putting it into the waste collection system or temporary storage of level II biosafety laboratories.

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

a) Failing to mobilize or failing to properly mobilize human resources and equipment to handle biosafety incidents according to the biosafety incident prevention and response plan as prescribed by law;

b) Collecting, transporting, storing, preserving, using, researching, exchanging and destroying specimens related to agents of infectious diseases that fail to comply with regulations on management of infectious specimens;

c) Failing to report biosafety incidents and the measures taken to handle and overcome the serious biosafety incident to the Department of Health.

4. A fine from VND 20,000,000 to VND 30,000,000 shall be imposed for any of the following violations:

a) Failing to meet one of the requirements for biosafety level III establishments after the announcement of meeting biosafety standards of level III;

b) Preserving, storing, using, researching, exchanging, and destroying specimens of Group A infectious diseases without satisfying the required conditions;

c) Failing to disinfect or sterilize waste used in testing before putting it into the waste collection system or temporary storage of level III biosafety laboratories.

5. A fine from VND 30,000,000 to VND 40,000,000 shall be imposed for any of the following violations:

a) Failure to organize an annual biosafety incident prevention and remedy for level III biosafety establishments;

b) Conducting testing without carrying out procedures for self-declaration of conformity with level I or level II biosafety standards, or without having been granted a certificate of conformity with level III biosafety standards, or where such certificate has expired.

6. Additional sanctions:

a) Suspension of operation for a definite time of between 1 and 3 months, for a biosafety laboratory that commits acts of violations specified at Points a and c, Clause 1, Point a, Clause 2 and Point b, Clause 4 of this Article;

b) Suspension of operation for a definite time of between 3 and 6 months, for a level I or level II biosafety laboratory that commits acts of violations specified at Point b, Clause 5 of this Article;

c) Deprivation of the right to use the biosafety standard conformity certificate from 1 month to 3 months, for the acts specified at Points a and c, Clause 4, and Point b, Clause 5 of this Article.

Article 9. Violation of regulations on using vaccines and medical biological products

1. A warning shall be imposed for any of the following acts of violation:

a) Failing to use, or obstructing children or pregnant women from using compulsory vaccines or medical biological products for infectious diseases under the expanded program on immunization;

b) Failing to provide counseling to the vaccinated person, parents, or family members, or guardians of the vaccinated child prior to vaccination; failing to provide counseling on benefits and risks that may occur during vaccination;

c) Failing to guide the vaccinated person or the family of the vaccinated child on monitoring and handling post-vaccination reactions;

d) Failing to report, or reporting inaccurately on vaccination activities as prescribed by law.

2. A fine from VND 1,000,000 to VND 3,000,000 shall be imposed for any of the following violations:

a) Failing to use or obstructing the use of vaccines or medical biological products for diseases for which vaccines or medical biological products are available for prevention, in cases where there is a risk of infectious diseases in epidemic areas or when traveling to epidemic areas as required or guided by competent agencies;

b) Failing to issue and maintain individual vaccination records or electronic vaccination records for persons receiving vaccination at vaccination establishments;

c) Failing to compile a list of vaccinated persons at vaccination establishments;

d) Failing to monitor the vaccinated person for at least 30 minutes after vaccination and instruct the family or the vaccinated person to continue monitoring for at least 24 hours after vaccination;

dd) Failing to prepare adequate dossiers and relevant documents upon request to serve the provincial professional advisory council in determining cases eligible for compensation in cases of severe adverse events seriously affecting health or causing loss of life of vaccinated persons;

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

3. A fine from VND 3,000,000 to VND 5,000,000 shall be imposed for any of the following violations:

a) Failing to conduct screening examinations, or conducting incomplete screening examinations for persons to be vaccinated;

b) Failing to comply with the law on receipt, transportation, and storage of vaccines;

c) Failing to comply with the law, and provide professional guidance on vaccination safety and management of vaccinated persons;

d) Failing to fully record information related to cases of severe adverse events as prescribed by the Minister of Health and report to the Department of Health within 24 hours from the time such event occurs;

dd) Failing to organize epidemic-control vaccination when required by a competent state agency for medical examination and treatment establishments registered with the local Department of Health to carry out vaccination under the expanded program on immunization;

e) Including costs already covered by the state budget in the price of vaccination services under the expanded program on immunization or epidemic-control vaccination;

h) Selling vaccines and medical biological products of the expanded program on immunization.

4. A fine from VND 5,000,000 to VND 10,000,000 shall be imposed for any of the following violations:

a) Failing to administer vaccination in accordance with indications, or failing to ensure safety during vaccination;

b) Failing to immediately suspend the vaccination session when severe adverse events following immunization occur during implementation;

c) Failing to ensure one of the conditions of a fixed vaccination establishment after having declared the establishment as eligible for vaccination.

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

a) Using vaccines and medical biological products at an unsatisfactory establishment as prescribed by law;

b) Conducting vaccination without having declared the establishment as eligible for vaccination;

c) Failing to provide emergency care or diagnose the cause of severe adverse events following immunization;

d) Failing to transfer persons experiencing severe adverse events following immunization to the nearest medical examination and treatment establishment in cases exceeding capacity;

dd) Failing to provide emergency care and treatment to persons experiencing severe adverse events following immunization and to report to the Department of Health within 24 hours from the time of receiving such persons.

6. A fine from VND 30,000,000 to VND 40,000,000 shall be imposed for the acts of using vaccines without a marketing authorization, or using expired vaccines or using low quality vaccines.

7. Additional sanctions:

a) Suspension of operation, in whole or in part, of the establishment from 1 month to 3 months for the acts specified at Points a, b and c, Clause 3; Clause 4; Clause 5; and Clause 6 of this Article;

b) Deprivation of the right to use the license or medical practice certificate from 1 month to 3 months for the acts specified at Points a, b and c, Clause 3; Point a, Clause 4; and Points c, d and dd, Clause 5 of this Article.

8. Remedial measures:

a) Forcible refund of the money amount collected in contravention of law provisions, for the acts specified at Points e and g, Clause 3 of this Article. In case it cannot be refunded to the subject, it shall be remitted to the state budget in accordance with the law;

b) Forcible destruction of vaccines, for the acts specified in Clause 6 of this Article.

Article 10. Violation of regulations on prevention of transmission of infectious diseases at medical examination and treatment establishments

1. A fine from VND 1,000,000 to VND 3,000,000 shall be imposed for any of the following violations:

a) Failing to report or untruthfully report their own infectious disease development to medical practitioners and health workers;

b) Failing to register for health monitoring with health stations of communes, wards and townships where the person suffering from group A infectious diseases lives after discharging from hospital or after the treatment at medical examination and treatment establishment;

c) Failing to provide counseling on measures for prevention and control of infectious diseases to patients and their family members at medical examination and treatment establishments.

2. A fine from VND 3,000,000 to VND 5,000,000 shall be imposed for any of the following violations:

a) Failing to notify information related to persons suffering from infectious diseases examined and treated at their establishment to the preventive medicine agency of the same level;

b) Failing to monitor the health of the medical practitioners and health workers of the medical examination and treatment establishment directly involved in examination, care, and treatment of persons suffering from group A infectious diseases;

c) Failing to take transmission prevention and control measures for persons suffering from infectious diseases;

d) Failing to carry out cleaning, disinfection, decontamination, and other measures for prevention and control of infectious diseases upon detection of environments containing agents causing group B and group C infectious diseases; persons suffering from group B and group C infectious diseases; persons suspected of suffering from group B and group C infectious diseases; or carriers of group B and group C infectious disease agents.

3. A fine from VND 5,000,000 to VND 7,000,000 shall be imposed for the acts of failing to notify the competent health agency upon detecting environment with agents of group A infectious diseases, persons suffering from group A infectious diseases, persons suspected of suffering from group A infectious diseases or persons carrying agents of group A infectious diseases.

4. A fine from VND 7,000,000 to VND 10,000,000 shall be imposed for the acts of failing to clean, disinfect, decontaminate and take other transmission prevention and control measures upon detecting environment with agents of group A infectious diseases, persons suffering from group A infectious diseases, persons suspected of suffering from group A infectious diseases or persons carrying agents of group A infectious diseases.

5. Remedial measures:

Forcible application of measures of cleaning, disinfecting, decontaminating, and other transmission prevention and control measures, for the acts specified at Point d, Clause 2 and Clause 4 of this Article.

Article 11. Violation of regulations on medical isolation and forced medical isolation

1. A fine from VND 5,000,000 to VND 10,000,000 shall be imposed for any of the following violations:

a) Failing to organize the medical isolation or forced medical isolation when necessary as prescribed by law, except for the case specified at Point a, Clause 2 of this Article;

b) Refusing or avoiding to take medical isolation or forced medical isolation decided by competent state agencies, except for the case at Point b, Clause 2 of this Article;

c) Failing to make a list and monitor the health of the persons in contact with the persons subject to medical isolation or forced medical isolation as prescribed by law.

2. A fine from VND 15,000,000 to VND 20,000,000 shall be imposed for any of the following violations:

a) Failing to organize the medical isolation for persons suffering from group A infectious diseases;

b) Refusing or evading the implementation of decisions on medical isolation or forced medical isolation issued by competent state agencies for persons suffering from group A infectious diseases, border health quarantine subjects suffering from or carrying agents causing group A infectious diseases;

c) Carrying out medical isolation or forced medical isolation at locations not satisfying the conditions for implementation of medical isolation or forced medical isolation as prescribed by law.

3. Remedial measures:

Forcible implementation of medical isolation or forced medical isolation, for the acts specified at Points a and b, Clause 1 and Points a and b, Clause 2 of this Article.

Article 12. Violation of regulations on application of epidemic control measures

1. A fine from VND 1,000,000 to VND 3,000,000 shall be imposed for any of the following violations:

“a) Failing to take personal protection measures, for persons participating in anti-epidemic activities and persons at risk of infection according to instructions of health agencies, including wearing face masks, disinfecting, keeping a safe distance, making health declaration and other measures;

b) Failing to report to the local People’s Committee or preventive medicine agencies of the infection cases as prescribed by law.

2. A fine from VND 5,000,000 to VND 10,000,000 shall be imposed for any of the following violations:

a) Concealing one’s disease status or that of another person when suffering from an infectious disease that has been declared an epidemic;

b) Failing to carry out or refusing to carry out cleaning, disinfection, and decontaminating in the epidemic zone;

c) Failing to participate in the epidemic prevention under the mobilization decision of the competent person, except for the cases specified at Point m, Clause 5, Article 38 and Point b, Clause 4, Article 39 of this Decree;

d) Charging fees for medical examination and treatment for persons suffering from group A infectious diseases;

dd) Failing to implement the decision on forcible destruction of animals, plants and other articles that are disease transmission vectors, except for the case specified at Point c, Clause 4 and Point d, Clause 5 of this Article.

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

a) Failing to implement decisions on suspension of operation of public catering service establishments posing a risk of transmission of epidemic diseases in epidemic zones;

b) Failing to implement decisions on ban from trading in or use of food serving as disease transmission vectors;

c) Failing to implement decisions on restriction of mass gatherings or suspension of business and service activities at public places.

4. A fine from VND 20,000,000 to VND 30,000,000 shall be imposed for any of the following violations:

a) Failing to comply with decisions on medical inspection, surveillance and control when leaving or entering group-A epidemic zones;

b) Transporting from group A epidemic zones of articles, animals, plants, food and other commodities capable of transmitting the epidemic disease;

c) Failing to implement the decision on forcible destruction of animals, food, plants, and other articles that are disease transmission vectors of group A diseases.

5. A fine from VND 30,000,000 to VND 40,000,000 shall be imposed for any of the following violations:

a) Failing to comply with requirements for inspection or medical handling of means of transport before leaving epidemic zones in a state of emergency due to epidemic;

b) Failing to comply with the decision on prohibiting mass gatherings in the area already declared a state of emergency in case of epidemic according to resolutions, decisions, directives and other documents issued by competent agencies;

c) Bringing unauthorized persons or means of transport into epidemic clusters in areas where a state of emergency due to epidemic has been declared;

d) Failing to comply with the decision on forcible destruction of animals, food, plants, and other articles likely to transmit the epidemic disease to humans in the area where a state of emergency over the epidemic is declared.

6. Remedial measures:

a) Forcible application of measures of cleaning, disinfecting and decontaminating, for the acts specified at Point b, Clause 2 of this Article;

b) Forcible refund of amounts unlawfully collected for the act specified at Point d, Clause 2 of this Article. In case it cannot be refunded to the subject, it shall be remitted to the state budget in accordance with the law;

c) Forcible destruction of animals, food, plants and other articles, for the acts specified at Point dd, Clause 2; Points b and c, Clause 4 and Point d, Clause 5 of this Article;

d) Forcible medical handling of means of transport for the act specified at Point a, Clause 5 of this Article.

Article 13. Violation of regulations on border health quarantine

1. A fine from VND 3,000,000 to VND 5,000,000 shall be imposed for any of the following violations:

a) Failing to report in writing to the Ministry of Health after carving, re-carving, revoking, canceling, invalidating, or losing the health quarantine seals;

b) Failing to prepare book to keep health quarantine seal samples;

c) Failing to prepare and keep dossiers as prescribed when carving or re-carving health quarantine seals;

d) Failing to immediately contact the border health quarantine organization at the border gate if a passenger or crew member on board an aircraft or vessel shows symptoms or signs of an infectious disease before taking off, landing, or arriving at the port;

dd) Arbitrarily boarding or disembarking vessels, or carrying out loading, unloading, or receipt of goods during the period vessels are awaiting health quarantine or undergoing health quarantine, unless the vessels are in distress.

2. A fine from VND 5,000,000 to VND 7,000,000 shall be imposed for any of the following violations:

a) Failing to comply with medical inspection or medical handling by border health quarantine organizations as prescribed by law, except for the case specified at Clause 4 of this Article;

b) Failing to comply with regulations on health quarantine signal for vessels upon entry;

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

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

3. A fine from VND 7,000,000 to VND 10,000,000 shall be imposed for any of the following violations:

a) Transporting corpses, bones, body ash, bio-products, bacteria, tissues, human body organs, blood and constituents of blood through the border gate without inspection by heath quarantine units;

b) Importing blood samples, serum, plasma, urine, feces, human bodily secretions, and other human-derived samples containing or likely to contain agents causing infectious diseases in humans; microbial strains; samples containing microorganisms capable of causing diseases in humans for purposes of prevention, research, diagnosis, or treatment without an import permit.

4. A fine from VND 15,000,000 to VND 20,000,000 shall be imposed for the acts of failing to abide by medical isolation, forced medical isolation or medical handling for human, transport vehicles, goods and other subjects of health quarantine that contain agents of group A infectious disease.

5. Remedial measures:

a) Forcible implementation of measures of medical inspection and handling, for the acts specified at Point a, Clause 2 of this Article;

b) Forcible medical handling, for the acts specified at Point a, Clause 3 of this Article. In case of failing to meet requirements of infectious disease prevention and control, forcible bringing out of the territory of the Socialist Republic of Vietnam or forcible re-export shall be applied;

c) Forcible bringing out of the territory of the Socialist Republic of Vietnam or forcible re-export, for the acts of violation specified at Point b, Clause 3 of this Article;

c) Forcible implementation of medical isolation, forced medical isolation or medical handling for persons, transport vehicles, goods containing agents of group A infectious disease, for the acts of violation specified in Clause 4 of this Article.

Article 14. Violations of other regulations on preventive medicine

1. A fine from VND 3,000,000 to VND 5,000,000 shall be imposed for the act of employing persons suffering from infectious diseases to directly perform work posing a risk of transmission of infectious diseases to others or to the community, except for cases of direct participation in production or trading of food, food additives, food processing aids, utensils, packaging materials, containers in direct contact with food, and provision of food service business.

2. A fine from VND 5,000,000 to VND 10,000,000 shall be imposed for the acts of failing to abide by infectious disease prevention and control measures upon requests of competent agencies and organizations, except for the cases specified in Articles 5, 6, 7, 8, 9, 10, 11, 12 and 13 of this Decree.

Article 15. Violation of regulations on domestic water quality

1. A fine from VND 1,000,000 to VND 3,000,000 shall be imposed for the acts of failing to report competent agencies on water quality as prescribed by law.

2. A fine from VND 3,000,000 to VND 5,000,000 shall be imposed for any of the following violations:

a) Testing of water quality parameters for each required sample is not conducted at testing laboratories or certification organizations as prescribed by law;

b) Failing to publicly disclose testing results of water quality parameters for each testing as prescribed by law;

c) Failing to test from 01 to 05 parameters of each required water sample as prescribed by law.

3. A fine from VND 5,000,000 to VND 7,000,000 shall be imposed for any of the following violations:

a) Supplying water for domestic use that does not meet technical standards on quality of clean water for domestic use, where the cause is attributable to the water-using entity;

b) Failing to test 06 parameters or more of each required water sample as prescribed by law.

4. A fine from VND 3,000,000 to VND 5,000,000 shall be imposed on water supply units with a design capacity of under 1,000 m³/day-night or supplying water to fewer than 6,500 persons committing any of the following acts:

a) Testing of water quality parameters for each required sample is not conducted at testing laboratories or certification organizations as prescribed by law;

b) Failing to publicly disclose testing results of water quality parameters for each testing as prescribed by law;

c) Failing to test from 01 to 05 parameters of each required water sample as prescribed by law.

5. A fine from VND 5,000,000 to VND 10,000,000 shall be imposed on water supply units with a design capacity of under 1,000 m³/day-night or supplying water to fewer than 6,500 persons committing any of the following acts:

a) Supplying water for domestic use that does not meet technical standards on quality of clean water for domestic use;

b) Failing to test 06 parameters or more of each required water sample as prescribed by law.

6. A fine from VND 10,000,000 to VND 20,000,000 shall be imposed on water supply units with a design capacity of under 1,000 m³/day-night or supplying water to fewer than 6,500 persons, for failing to meet the required number of samples for each testing as prescribed by law.

7. A fine from VND 20,000,000 to VND 30,000,000 shall be imposed on water supply units with a design capacity of under 1,000 m³/day-night or supplying water to fewer than 6,500 persons, for failing to conduct periodic testing of water quality parameters for each required testing as prescribed by law.

8. A fine from VND 10,000,000 to VND 15,000,000 shall be imposed on water supply units with a design capacity from 1,000 m³/day-night to under 15,000 m³/day-night, or supplying water to from 6,500 to under 100,000 persons, committing any of the following acts:

a) Testing of water quality parameters for each required sample is not conducted at testing laboratories or certification organizations as prescribed by law;

b) Failing to publicize testing results of water quality parameters for each required testing as prescribed by law;

c) Failing to test from 01 to 05 parameters of each required water sample as prescribed by law.

9. A fine from VND 15,000,000 to VND 20,000,000 shall be imposed on water supply units with a design capacity from 1,000 m³/day-night to under 15,000 m³/day-night, or supplying water to from 6,500 to under 100,000 persons, committing any of the following acts:

a) Supplying water for domestic use that does not meet technical standards on quality of clean water for domestic use;

b) Failing to test 06 parameters or more of each required water sample as prescribed by law.

10. A fine from VND 20,000,000 to VND 30,000,000 shall be imposed on water supply units with a design capacity from 1,000 m³/day-night to under 15,000 m³/day-night, or supplying water to from 6,500 to under 100,000 persons, for failing to meet the required number of samples for each testing as prescribed by law.

11. A fine from VND 30,000,000 to VND 40,000,000 shall be imposed on water supply units with a design capacity from 1,000 m³/day-night to under 15,000 m³/day-night, or supplying water to from 6,500 to under 100,000 persons, for failing to conduct periodic testing of water quality parameters for each required testing as prescribed by law.

12. A fine from VND 20,000,000 to VND 30,000,000 shall be imposed on water supply units with a design capacity from 15,000 m³/day-night to under 30,000 m³/day-night, or supplying water to from 100,000 to under 200,000 persons, committing any of the following acts:

a) Testing of water quality parameters for each required sample is not conducted at testing laboratories or certification organizations as prescribed by law;

b) Failing to publicize testing results of water quality parameters for each required testing as prescribed by law;

c) Failing to test from 01 to 05 parameters of each required water sample as prescribed by law.

13. A fine from VND 30,000,000 to VND 40,000,000 shall be imposed on water supply units with a design capacity from 15,000 m³/day-night to under 30,000 m³/day-night, or supplying water to from 100,000 to under 200,000 persons, committing any of the following acts:

a) Supplying water for domestic use that does not meet technical standards on quality of clean water for domestic use;

b) Failing to test 06 parameters or more of each required water sample as prescribed by law.

14. A fine from VND 40,000,000 to VND 50,000,000 shall be imposed on water supply units with a design capacity from 15,000 m³/day-night to under 30,000 m³/day-night, or supplying water to from 100,000 to under 200,000 persons, committing any of the following acts:

a) Failing to meet the required number of testing samples for each testing as prescribed by law;

b) Failing to conduct periodic testing of water quality parameters for each required testing as prescribed by law.

15. A fine from VND 30,000,000 to VND 40,000,000 shall be imposed on water supply units with a design capacity of 30,000 m³/day-night or more, supplying water to 200,000 persons or more, committing any of the following acts:

a) Testing of water quality parameters for each required sample is not conducted at testing laboratories or certification organizations as prescribed by law;

b) Failing to publicize testing results of water quality parameters for each required testing as prescribed by law;

16. A fine from VND 40,000,000 to VND 50,000,000 shall be imposed on water supply units with a design capacity of 30,000 m³/day-night or more, supplying water to 200,000 persons or more, committing any of the following acts:

a) Supplying water for domestic use that does not meet technical standards on quality of clean water for domestic use;

b) Failing to test 06 parameters or more of each required water sample as prescribed by law;

c) Failing to meet the required number of testing samples for each testing as prescribed by law;

d) Failing to conduct periodic testing of water quality parameters for each required testing as prescribed by law.

Article 16. Violation of regulations on hygiene in burial and cremation

1. A fine from VND 3,000,000 to VND 5,000,000 shall be imposed for the acts of failing to ensure hygiene conditions at the funeral hall or crematorium as prescribed by law.

2. A fine from VND 5,000,000 to VND 10,000,000 shall be imposed for any of the following violations:

a) Failing to implement, or implementing incompletely, regulations of law on hygiene in lying in state and shrouding of corpses; transporting coffins containing corpses of persons who died from infectious diseases;

b) Failing to handle corpses of persons who died from infectious diseases;

c) Failing to comply with law regulations on mass burial.

3. A fine from VND 10,000,000 to VND 20,000,000 shall be imposed for the acts off failing to comply with regulations on hygiene in exhumation activities where the period from burial to exhumation is less than 36 months.

4. Remedial measures:

Forcible implementation of measures to remedy environmental pollution, for the acts of violation specified in Clauses 1, 2, and 3 of this Article.

Article 17. Violation of regulations on occupational health, occupational diseases and occupational accidents

1. A fine from VND 3,000,000 to VND 5,000,000 shall be imposed for medical examination and treatment establishments committing any of the following violations:

a) Failing to summarize the result of health check-up for detection of occupational diseases or periodic occupational disease examination after each health check-up session as prescribed by law;

b) Failing to prepare dossiers of occupational diseases for workers who are diagnosed with occupational diseases;

c) Failing to report cases of occupational diseases or failing to report the annually occupational disease examination situation to competent state agencies as prescribed by law;

d) Failing to report cases of occupational accident who are examined and treated annually at medical examination and treatment establishments to competent state agencies as prescribed by law.

2. A fine from VND 5,000,000 to VND 10,000,000 shall be imposed on agencies and units providing first aid and emergency training services committing any of the following acts:

a) Failing to report information of health units providing training in first aid, emergency care or providing training courses for the grant of qualifications and certificates of occupational health to the competent state agency as prescribed by law;

b) Conducting first aid and emergency training without sufficient duration and not in accordance with prescribed contents as prescribed by law.

3. Fines shall be imposed for violation of regulations on occupational medical examination and treatment as follows:

a) A fine from VND 10,000,000 to VND 20,000,000 shall be imposed for the acts of providing incorrect occupational medical examination and treatment results;

b) A fine from VND 20,000,000 to VND 30,000,000 shall be imposed for the acts of providing occupational medical examination and treatment result without conducting such examination and treatment as prescribed by law.

4. Additional sanctions:

Deprivation of the right to use the license or medical practice certificate for a definite time of between 01 month and 03 months, for the acts specified in Clause 3 of this Article.

Article 18. Violation of regulations on information, education and communication in HIV/AIDS prevention and control

1. A warning or a fine shall be imposed for the acts of failing to organize the propaganda, education about HIV/AIDS prevention and control measures at requests of competent agencies according to one of the following levels:

a) A fine from VND 1,000,000 to VND 3,000,000 shall be imposed on the establishment employing less than 50 workers;

b) A fine from VND 1,000,000 to VND 2,000,000 shall be imposed on the establishment that employs from 50 to less than 100 workers;

c) A fine from VND 2,000,000 to VND 3,000,000 shall be imposed on the establishment that employs from 100 to less than 200 workers;

d) A fine from VND 3,000,000 to VND 5,000,000 shall be imposed on the establishment that employs from 200 to less than 500 workers;

dd) A fine from VND 5,000,000 to VND 10,000,000 shall be imposed on the establishment that employs from 500 to less than 1,000 workers;

e) A fine from VND 10,000,000 to VND 15,000,000 shall be imposed on the establishment that employs from 1,000 to less than 1,500 workers;

g) A fine from VND 15,000,000 to VND 20,000,000 shall be imposed on the establishment that employs from 1,500 to less than 2,000 workers;

h) A fine from VND 20,000,000 to VND 25,000,000 shall be imposed on the establishment that employs from 2,000 to less than 2,500 workers;

i) A fine from VND 25,000,000 to VND 30,000,000 shall be imposed on the establishment that employs 2,500 workers or more.

2. A fine from VND 5,000,000 to VND 10,000,000 shall be imposed for any of the following violations:

a) Providing incorrect information about the HIV/AIDS epidemic situation in comparison with data announced by the competent state agency when conducting information, education, and communication on HIV/AIDS prevention and control;

b) Failing to comply with regulations on timing and duration of prioritized broadcasting, information, education, and communication on HIV/AIDS prevention and control on radio and television stations, and on volume and placement in print newspapers, audiovisual press, and electronic newspapers as prescribed by law.

3. A fine from VND 10,000,000 to VND 15,000,000 shall be imposed for any of the following violations:

a) Failing to implement priority requirements on timing and duration of broadcasting, information, education, and communication on HIV/AIDS prevention and control on radio and television stations, and on volume and placement in print newspapers, audiovisual press, and electronic newspapers as prescribed by law;

b) Charging fees for information, education, and communication on HIV/AIDS prevention and control, except where funded by domestic or foreign organizations or individuals;

c) Disclosing to others that a person is infected with HIV without that person’s consent, unless such information is provided to serve the HIV/AIDS epidemiological surveillance or when notifying a HIV test result as prescribed by law.

4. A fine from VND 15,000,000 to VND 20,000,000 shall be imposed for the acts of publicizing the name, address, or picture of an HIV-infected person without his/her consent, unless such information is provided to serve the HIV/AIDS epidemiological surveillance or when a HIV test result is notified as prescribed by law.

5. Remedial measures:

a) Forcible correction of untruthful information on mass media within the area where such information was previously disseminated for 2 consecutive days as prescribed by law, for the act specified at Point a, Clause 3 of this Article;

b) Forcible refund of amounts unlawfully collected for the act specified at Point b, Clause 3 of this Article. In case it cannot be refunded to the subject, it shall be remitted to the state budget in accordance with the law;

c) Forcible direct apology to the HIV-infected person and his/her family members and public correction of information on mass media where the HIV-infected person lives for 03 consecutive days as prescribed by law, for the acts of violation specified at Point c, Clause 3 and Clause 4 of this Article, unless the HIV-infected person does not agree to make a public apology.

Article 19. Violation of regulations on HIV testing and counseling

1. A fine from VND 1,000,000 to VND 3,000,000 shall be imposed for any of the following violations:

a) Obstructing another person’s right of access to counseling services on HIV/AIDS prevention and control;

b) Failing to provide counseling on HIV/AIDS prevention and control while providing care or treatment for pregnant or breastfeeding women infected with HIV or HIV-exposed persons;

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

d) Providing pre-test and post-test HIV counseling without being trained on HIV/AIDS prevention and control counseling;

dd) Providing counseling on HIV/AIDS prevention and control at an unsatisfactory establishment as prescribed by law;

e) Failing to notify positive HIV test results and to manage information of persons infected with HIV in accordance with regulations of law on HIV/AIDS surveillance.

2. A fine from VND 3,000,000 to VND 5,000,000 shall be imposed for any of the following violations:

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

b) Failing to notify positive HIV test results within the prescribed time as prescribed by law;

c) Failing to notify positive HIV test results in the prescribed form and procedure as prescribed by law;

d) Failing to report the competent agency upon detecting unqualified bio-products and equipment used for HIV testing;

dd) Failing to notify relevant parties and take measures to handle and remedy upon detecting the unqualified HIV testing;

e) Charging testing fees from persons subject to compulsory HIV testing under judicial expertise requests or decisions of investigation agencies, people’s procuracies, or people’s courts, or from pregnant women voluntarily undergoing HIV testing in cases where testing costs have been covered by funding sources;

c) Failing to access information of HIV-infected persons in the prescribed form and procedure as prescribed by law;

h) Failing to notify the organization of HIV/AIDS counseling activities as prescribed by law.

3. A fine from VND 5,000,000 to VND 10,000,000 shall be imposed for any of the following violations:

a) Confirming HIV positive cases without being recognized to be eligible for confirming HIV positive cases by competent agencies;

b) Failing to conduct HIV testing according to the Ministry of Health’s instructions;

c) Failing to meet one of the requirements for HIV-testing establishments after being granted a certificate of eligibility to conduct HIV testing;

d) Confirming HIV-positive test results during the period of suspension of activities for confirmation of HIV positive test results;

dd) Failing to notify positive HIV test results to subjects in accordance with regulations of law, or disclosing confidential information on positive HIV test results in case where the law requires confidentiality;

e) Conducting HIV-testing for a person under 15 years old, person who loses his/her civil act capacity, person who has difficulty in perceiving and controlling his/her acts, or person who has a limited civil act capacity without written consent of his/her parent, lawful guardian or representative, excepts for the emergency cases as prescribed by the law on medical examination and treatment;

g) Providing HIV/AIDS prevention and control counseling not satisfying conditions as prescribed by law.

4. A fine from VND 10,000,000 to VND 20,000,000 shall be imposed for any of the following violations:

a) Compulsorily conducting HIV testing for persons not subject to HIV/AIDS epidemiological surveillance or compulsory HIV testing as prescribed by law;

b) Conducting HIV testing without a certificate of eligibility to conduct HIV testing;

c) Failing to test blood bags and blood preparations before use;

d) Leasing, lending, or arbitrarily modifying the contents of the certificate of eligibility for confirmatory HIV testing or the decision designating reference confirmatory HIV testing establishments.

5. Additional sanctions:

Suspension of operation for a definite time of between 03 months and 06 months for an establishment committing violations specified at Point b, Clause 4 of this Article.

6. Remedial measures:

a) Forcible refund of amounts unlawfully collected for the acts specified at Point e, Clause 2 of this Article. In case it cannot be refunded to the subject, it shall be remitted to the state budget in accordance with the law;

b) Forcible refund of illicit profits, for the acts specified at Point b, Clause 4 of this Article.

Article 20. Violation of regulations on treatment and care of HIV-infected people, prophylactic treatment, and exposure HIV treatment

1. A fine from VND 1,000,000 to VND 3,000,000 shall be imposed for any of the following violations:

a) Prescribing anti-retroviral drugs for HIV-infected persons and HIV-exposed persons, providing prophylactic treatment without being trained about HIV/AIDS treatment according to the Ministry of Health’s regulations;

b) Failing to comply with HIV/AIDS treatment process and regimen issued by the Minister of Health when prescribing anti-retroviral drugs.

2. A fine from VND 3,000,000 to VND 5,000,000 shall be imposed for any of the following violations:

a) Treating with anti-retroviral drugs at an unsatisfactory establishment as prescribed by law;

b) Failing to comply with the law on prioritized access to anti-retroviral drugs;

c) Failing to organize the management, care and counseling for HIV-infected persons at compulsory drug rehabilitation centers as prescribed by law;

d) Failing to provide instructions on prophylactic treatment to prevent HIV infection for HIV-exposed persons;

dd) Failing to monitor, treat and take measures to reduce mother-to-child HIV transmission during pregnancy.

3. A fine from VND 5,000,000 to VND 10,000,000 shall be imposed for any of the following violations:

a) Failing to monitor and provide treatment for HIV-infected women during pregnancy under the management;

b) Failing to provide prophylactic treatment to prevent HIV infection for HIV-exposed persons;

c) Obstructing HIV-infected persons from caring for other HIV-infected persons, or obstructing them from assess healthcare and treatment services;

d) Failing to ensure medical care regimes for HIV-infected persons at social protection establishments;

dd) Charging for anti-retroviral drugs provided free of charge by the State as prescribed by law.

4. A fine from VND 10,000,000 to VND 15,000,000 shall be imposed for the acts of refusing treatment with anti-retroviral drugs for HIV-infected persons who are eligible for treatment as prescribed by law.

5. Remedial measures:

Forcible refund of amounts unlawfully collected for the acts specified at Point dd, Clause 3 of this Article. In case it cannot be refunded to the subject, it shall be remitted to the state budget in accordance with the law.

Article 21. Violation of regulations on harm reduction interventions in HIV transmission prevention

1. A fine from VND 200,000 to VND 500,000 shall be imposed for the act of failing to carry a community outreach worker card when performing harm reduction intervention activities in HIV transmission prevention.

2. A fine from VND 500,000 to VND 1,000,000 shall be imposed for any of the following violations:

a) Failing to introduce or transfer a copy of treatment record of persons being treated with anti-retroviral drugs to the new treatment establishment, which is more suitable to his/her working and living requirements;

b) Failing to receive valid medical records of the patients being treated with anti-retroviral drugs transferred from another establishment;

c) Terminating the treatment of opioid addiction with opioid substitution, unless otherwise permitted by law.

3. A fine from VND 3,000,000 to VND 5,000,000 shall be imposed for any of the following violations:

a) Using the community outreach worker card for improper purposes or beyond the scope of the program or project on harm reduction intervention to prevent HIV transmission;

b) Failing to cooperate with local agencies in charge of HIV/AIDS prevention and control in carrying out harm reduction intervention measures to prevent HIV transmission;

c) Failing to follow the procedure for receiving opioid-addicted person to be treated with substitution therapy;

c) Selling condoms, syringes and injection needles, drugs and bio-products that are supposed to be provided free of charge according to law, or selling drugs and bio-products at prices higher than subsidized prices.

4. A fine from VND 5,000,000 to VND 10,000,000 shall be imposed for any of the following violations:

a) Failing to provide treatment of opioid addiction in compliance with professional guidelines as prescribed by law;

b) Failing to provide treatment for patients being treated with anti-retroviral drugs transferred from another establishment;

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

a) Failing to ensure one of the conditions after the establishment has declared eligibility for treatment of opioid addiction;

b) Coercing the opioid-addicted person to treat his/her addiction in any form.

6. A fine from VND 20,000,000 to VND 30,000,000 shall be imposed for any of the following violations:

a) Providing treatment of opioid addiction at establishment which has not declared to be eligible to provide opioid addiction treatment;

b) Failing to print the text “Provided free of charge. Not for sale” on the packages or sub-labels of condoms, syringes and injection needles that belong to the program or project on harm reduction intervention to prevent HIV transmission;

c) Using drugs for opioid addiction treatment, which are not permitted for lawful circulation in Vietnam.

7. Additional sanctions:

a) Deprivation of the right to use the license or medical practice certificate from 01 month to 03 months, for the acts specified at Points a and b, Clause 4, and Point b, Clause 5 of this Article;

b) Suspension of operation for a definite time of between 01 month to 03 months, for the acts specified at Point a, Clause 5 and Points a and c, Clause 6 of this Article.

8. Remedial measures:

a) Forcible refund of illicit profits earned through the commission of violations specified at Point b, Clause 5 and Point a, Clause 6 of this Article;

b) Forcible destruction of drugs, for the acts specified at Point c, Clause 6 of this Article.

Article 22. Violation of regulations on prevention of stigma and discrimination against HIV-infected people

1. A fine from VND 500,000 to VND 1,000,000 shall be imposed for any of the following violations:

a) Requiring HIV testing or requiring presentation of HIV test results for pupils, students, trainees, or applicants for admission;

b) Obstructing pupils, students, or trainees from participating in activities or services provided by educational institutions on the ground of HIV infection or having a family member infected with HIV;

c) Obstructing the admission of social protection beneficiaries into social protection establishments on the ground of HIV infection;

d) Refusing burial or cremation of deceased persons on grounds related to HIV/AIDS.

2. A fine from VND 5,000,000 to VND 10,000,000 shall be imposed for any of the following violations:

a) Requiring HIV testing or presentation of HIV test results for job applicants, or refusing recruitment on the ground that the applicant is infected with HIV, except for certain occupations requiring HIV testing before recruitment as prescribed by the Government;

b) Refusing admission of pupils, students, or trainees on the ground that such persons are infected with HIV;

c) Refusing admission of social protection beneficiaries into social protection establishments on the ground of HIV infection;

d) Parents abandoning their HIV-infected minor children; guardians abandoning their HIV-infected wards;

dd) Segregating, restricting, or prohibiting pupils, students, or trainees from participating in activities or services of establishments on the ground that such persons are infected with HIV;

e) Discriminating in care and treatment of HIV-infected persons;

g) Assigning work not suitable to the health condition and professional qualifications of HIV-infected worker.

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

a) Terminating labor contracts or employment contracts, or causing difficulties in the course of work for workers on the ground that they are infected with HIV;

b) Forcing a physically fit worker to change his/her current position on the ground that such person is infected with HIV;

c) Refusing salary increases or promotion, or failing to ensure lawful rights and interests of workers on the ground that they are infected with HIV;

d) Disciplining or expelling pupils, students, or trainees on the ground that such persons are infected with HIV;

dd) Using images or communication messages that stigmatize or discriminate against HIV-infected persons or their family members.

4. Remedial measures:

a) Forcible acceptance and performance of burial or cremation of corpses or remains of HIV-infected persons, for the acts specified at Point d, Clause 1 of this Article;

b) Forcible acceptance/admission of HIV-infected persons, for the acts of violation specified at Points b and c, Clause 2 and Point a, Clause 3 of this Article;

c) Forcible direct apology to the discriminated persons, for the acts of violation specified at Point e, Clause 2 and Point dd, Clause 3 of this Article;

d) Forcible reassignment to the previous position, for the acts of violation specified at Point b, Clause 3 of this Article;

dd) Forcible performance of legitimate rights and interests of HIV-infected workers, for the acts of violation specified at Point c, Clause of this Article;

e) Forcible cancellation of a decision on disciplining or expelling a pupil, student or trainee on the ground that such person is infected with HIV, for the acts of violation specified at Point d, Clause 3 of this Article;

g) Forcible removal of infringing elements, for the acts of violation specified at Point dd, Clause 3 of this Article. Forcible destruction of communication products, in case where the infringing elements cannot be removed.

Article 23. Violations of other regulations on HIV/AIDS prevention and control

1. A fine from VND 3,000,000 to VND 5,000,000 shall be imposed for the acts of preventing workers from participating HIV/AIDS prevention and control activities.

2. A fine from VND 10,000,000 to VND 20,000,000 shall be imposed for any of the following violations:

a) Threatening to transmit HIV to another person;

b) Taking advantage of HIV/AIDS prevention and control activities for illicit gain.

3. Remedial measures:

Forcible refund of illicit profits earned through the commission of violations specified at Point b, Clause 2 of this Article.

Article 24. Violation of regulations on non-smoking areas

1. A fine from VND 200,000 to VND 500,000 shall be imposed for the acts of smoking in the areas where smoking is prohibited. The acts of smoking on aircraft shall be sanctioned according to regulations on handling of administrative violations in civil aviation.

2. A fine from VND 3,000,000 to VND 5,000,000 shall be imposed for any of the following violations:

a) Failing to put signs with text or symbol of “No smoking” signs at smoking prohibited areas in accordance with law;

b) Failing to organize implementation, provide guidance, inspect, and urge compliance with regulations on smoking prohibition at locations under management or operation.

3. A fine from VND 5,000,000 to VND 10,000,000 shall be imposed for any of the following acts at designated smoking areas:

a) Failing to have a room and ventilation system separated from non-smoking areas;

b) Failing to provide containers for cigarette butts and ashes;

c) Failing to display signs at appropriate and easily visible locations;

d) Failing to have fire prevention and firefighting equipment.

Article 25. Violation of regulations on sale and provision of tobacco

1. A fine from VND 1,000,000 to VND 3,000,000 shall be imposed for the acts of failing to display a notice prohibiting sale of tobacco to persons under 18 years of age at points of sale of wholesale and retail tobacco agents.

2. A fine from VND 3,000,000 to VND 5,000,000 shall be imposed for any of the following violations:

a) Displaying more than one pack, one carton, or one box of a single tobacco brand at retail agents or tobacco retail outlets;

b) Selling or providing tobacco to persons under 18 years of age;

c) Selling or providing tobacco without labels or without health warnings printed on tobacco packaging as prescribed by law. In case of selling tobacco without labels or without health warnings printed on packaging where such products are smuggled or counterfeit, penalties shall be imposed in accordance with the law on commercial activities, production and trading of counterfeit or prohibited goods, and protection of consumer rights.

3. Additional sanctions:

Suspension of business activities related to the violating acts for a period from 01 month to 03 months, for the acts specified in Clause 2 of this Article.

4. Remedial measures:

Forcible recall and removal of infringing elements from tobacco without labels or without health warnings printed on tobacco packaging, for the acts specified at Point c, Clause 2 of this Article. Forcible destruction shall be applied, if infringing elements cannot be removed.

Article 26. Violation of regulations on the use of, and harboring of, e-cigarettes and heated tobacco products

1. A fine from VND 3,000,000 to VND 5,000,000 shall be imposed for the act of using e-cigarettes or heated tobacco products.

2. A fine from VND 5,000,000 to VND 10,000,000 shall be imposed for the act of harboring others using e-cigarettes or heated tobacco products at locations under one’s ownership or management, except where the person harboring is a grandparent, parent, child, grandchild, sibling, or spouse of the violator.

3. Remedial measures:

Forcible destruction of e-cigarettes and heated tobacco products, for the act prescribed in Clause 1 of this Article.

Article 27. Violation of regulations on labeling and printing of health warnings on tobacco packaging

1. A fine from VND 20,000,000 to VND 30,000,000 shall be imposed for any of the following violations:

a) Manufacturing, importing, or ordering the printing of tobacco packaging using templates displaying health warning content not in conformity with prescribed forms, positions, sizes, or colors as prescribed by law; or printing establishments arbitrarily printing tobacco packaging with health warnings not in conformity with prescribed forms, positions, sizes, or colors as prescribed by law;

b) Failing to periodically change health warnings on tobacco packaging every 2 years as prescribed by law;

c) Failing to clearly indicate the number of cigarettes in packs or the weight for other types of tobacco products;

d) Using words or phrases that cause readers or users to believe tobacco is less harmful or to misunderstand the harmful effects of tobacco and tobacco smoke on human health.

2. A fine from VND 30,000,000 to VND 40,000,000 shall be imposed for any of the following violations:

a) Failing to print health warnings on tobacco packaging as prescribed by law for tobacco manufactured or imported for consumption in Vietnam;

b) Entering into contracts or manufacturing tobacco bearing foreign brands for domestic consumption without permission from competent state agencies.

3. Additional sanctions:

Suspension of business activities related to acts of violation for a period of between 03 month and 06 months, for the acts specified in Clause 2 of this Article.

4. Remedial measures:

a) Forcible recall of products and remediation or removal of infringing elements, for the acts specified in Clause 1 and Point a, Clause 2 of this Article. Forcible destruction shall be applied, if infringing elements cannot be remedied;

b) Forcible refund of illicit profits earned through the commission of violations specified at Point b, Clause 2 of this Article (if any).

Article 28. Violation of regulations on tobacco cessation

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

1. Failing to arrange a designated place for direct tobacco cessation counseling activities as prescribed by law.

2. Failing to have communication materials on tobacco cessation and tobacco cessation counseling.

3. Failing to have telephones, Internet and other means of communication for indirect tobacco cessation counseling.

4. Failing to notify in writing to the Department of Health of locality where such establishment operates before providing tobacco cessation or tobacco cessation counseling.

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

1. A fine from VND 200,000 to VND 500,000 shall be imposed on persons aged from full 16 years to under 18 years for using tobacco.

2. A fine from VND 500,000 to VND 1,000,000 shall be imposed for any of the following violations:

a) Encouraging, or coercing others to use tobacco;

b) Asking persons under 18 years old to buy tobacco.

3. A fine from VND 3,000,000 to VND 5,000,000 shall be imposed for any of the following violations:

a) Using images of tobacco on press or publications intended exclusively for children;

b) Providing information without scientific basis or inaccurate information on tobacco and its harmful effects;

c) Failing to include content on prevention and control of tobacco harms in annual operational plans, or failing to include regulations on smoking prohibition at workplaces in internal rules;

d) Failing to limit images of actors using tobacco in theatrical and cinematographic works as prescribed by law.

4. A fine from VND 20,000,000 to VND 30,000,000 shall be imposed for any of the following violations:

a) Using tobacco products’ names, brands, or symbols for other products or services;

b) Directly marketing tobacco to consumers in any form;

c) Allowing organizations or individuals to directly market tobacco to consumers at establishments under one’s management or operation;

d) Making late payment of compulsory contributions as prescribed by law;

dd) Making false declarations leading to underpayment of compulsory contributions as prescribed by law;

e) Using funds from the Tobacco Harm Prevention and Control Fund in contravention of the law;

g) Enterprises or mass media providing news or announcements on sponsorship by organizations or individuals trading in tobacco.

5. A fine from VND 30,000,000 to VND 40,000,000 shall be imposed for any of the following violations:

a) Conducting sponsorship activities in any form, unless otherwise permitted by the law;

b) Evading or committing fraud in respect of compulsory contributions as prescribed by law.

6. Remedial measures:

a) Forcible recall of products and forcible removal of infringing elements, for the acts of violation specified at Points a, b and d Clause 3 and Point a, Clause 4 of this Article. Forcible destruction shall be applied, if infringing elements cannot be remedied;

b) Forcible refund of interest amounts arising from late payment of compulsory contributions for the act specified at Point d, Clause 4 of this Article;

c) Forcible refund of the amount due to improper use, for the acts of violation specified at Point e, Clause 4 of this Article;

d) Forcible refund of the payable amount and interest amount (if any) due to incorrect declaration, evasion or fraud of the compulsory contribution, for the acts of violation specified at Point dd, Clause 4 and Point b, Clause 5 of this Article.

Article 30. Violation of regulations on liquor and beer consumption and liquor- and beer-free locations

1. A warning shall be imposed on persons aged between full 16 years and under 18 years, for the acts of drinking liquor or beer.

2. A fine from VND 500,000 to VND 1,000,000 shall be imposed for any of the following violations:

a) Drinking liquor or beers at places where liquor and beer drinking is prohibited as prescribed by law;

b) Inciting, instigating, or enticing others to drink liquor or beer.

3. A fine from VND 1,000,000 to VND 3,000,000 shall be imposed for any of the following violations:

a) Drinking liquor or beer before or during working or study hours, or during breaks between working or study hours;

b) Forcing other persons to drink liquor or beer.

Article 31. Violation of regulations on liquor and beer sale and provision

1. A fine from VND 1,000,000 to VND 3,000,000 shall be imposed for any of the following violations:

a) Selling or supplying liquor or beer to persons under 18 years old;

b) Failing to put up notice boards “no liquor and beer sale to under-18 persons” at noticeable places of liquor and beer selling establishments.

2. A fine from VND 5,000,000 to VND 10,000,000 shall be imposed for any of the following violations:

a) Selling liquor or beers at places where liquor and beer sale is banned as prescribed by law;

b) Setting up new shops for sale of liquor and beer for on-spot use within 100 meters from boundaries of the nearest health establishments, nursery schools, pre-primary schools, early childhood schools, and general education schools.

3. A fine from VND 10,000,000 to VND 20,000,000 shall be imposed for selling liquor and beer via e-commerce without implementing measures to prevent persons under 18 years of age from accessing, searching for information on, and purchasing liquor and beer in liquor and beer sale activities as prescribed by law.

4. Additional sanctions:

Deprivation of the right to use liquor or beer distribution, wholesale, or retail licenses for a period from 01 month to 03 months for the acts specified at Point b, Clause 2 and Clause 3 of this Article.

Article 32. Violation of regulations on liquor and beer sale promotion

A fine from VND 20,000,000 to VND 30,000,000 shall be imposed for any of the following violations:

1. Promoting liquor or beer to persons under 18 years of age.

2. Offering sales promotion in the trading of liquor or beer with an alcohol content of 15% or higher.

3. Using liquor or beer with an alcohol content of 15% or higher for sale promotion in any form.

4. Promoting alcohol or beer with an alcohol content of under 15% in contravention of the law on promotion.

Article 33. Violation of regulations on liquor and beer advertising

1. A fine from VND 15,000,000 to VND 20,000,000 shall be imposed for the acts of employing under-18 persons to directly take part in the liquor or beer advertising.

2. A fine from VND 20,000,000 to VND 30,000,000 shall be imposed for one of the acts of advertising liquor with an alcohol content of under 15% and advertising beer as follows:

a) Providing information or images that encourage consumption of liquor or beer; information or images suggesting that liquor or beer creates maturity, success, friendliness, or sexual attractiveness; targeting children, pupils, students, youth, or pregnant women;

b) Using objects, images, symbols, music, characters in films, or product labels intended for children, pupils, or students; using images of persons under 18 years of age in advertising liquor or beer;

c) Advertising at events, on advertising media, or in products intended for under-18 persons, pupils, students, adolescents and pregnant women;

d) Advertising on transport vehicles;

dd) Advertising on radio and television immediately before, during, and immediately after programs intended for children; during the time from 18:00 to 21:00 daily, unless otherwise prescribed by law;

e) Advertising on outdoor advertising media in violation of regulations on size and distance of placement of advertising media from premises of educational institutions, facilities or areas for care, nurturing, entertainment, and recreation for under-18 persons as prescribed by law;

g) Advertising without health warnings for prevention and control of harms of liquor or beer as prescribed by law;

h) Advertising on electronic newspapers, websites, electronic media, terminal devices, and other telecommunications devices without technological filtering systems or age control software to prevent persons under 18 years of age from accessing, searching for information on liquor or beer.

3. A fine from VND 30,000,000 to VND 40,000,000 shall be imposed for one of the acts of advertising liquor with an alcohol content of between 5.5% to under 15% and beer with an alcohol content of 5.5% or higher as follows:

a) Advertising in cultural programs or activities, stage performances, cinematographic works, or sports activities;

b) Advertising on outdoor advertising media, except signboards of liquor or beer trading establishments.

4. Additional sanctions:

Suspension of liquor or beer advertising activities for a period from 01 month to 03 months for the acts specified at Point h, Clause 2 of this Article.

5. Remedial measures:

Forcible recall or removal of advertisements to remove infringing elements, for the acts specified in Clauses 1, 2 and 3 of this Article.

Article 34. Violation of regulations on responsibilities of heads of organizations and agencies in prevention and control of harms of liquor and beer

1. A fine from VND 3,000,000 to VND 5,000,000 shall be imposed for any of the following violations:

a) Failing to organize the application of measures to prevent and control harms of liquor and beer in their organizations and agencies;

b) Failing to organize implementation of regulations on prohibition of liquor and beer consumption during working hours and at workplaces of agencies or organizations;

c) Failing to make warnings about and request stoppage of the acts of drinking or selling liquor and beer at places where consumption or sale of liquor and beer is prohibited under one’s management or operation;

d) Failing to organize the implementation, guide, inspect and urge everyone to strictly comply with the drinking ban or no liquor and beer sale at places under their management and administration.

2. A fine from VND 5,000,000 to VND 10,000,000 shall be imposed on heads of transportation enterprises and vehicle owners who fail to take measures to prevent and detect vehicle operators’ drinking liquors and beer before and while joining traffic.

Article 35. Violation of regulations on responsibilities of liquor and beer trading establishments

1. A fine from VND 3,000,000 to VND 5,000,000 shall be imposed for any of the following violations:

a) Providing insufficient and inaccurate information about their trading activities at the request of competent agencies;

b) Failing to remind buyers or failing to put up notice boards of no driving after drinking liquor or beer.

2. A fine from VND 10,000,000 to VND 15,000,000 shall be imposed for any of the following violations:

a) Employing under-18 persons to directly take part in liquor and beer trading activities;

b) Providing information on liquor or beer products that is inaccurate or lacks scientific basis.

3. Remedial measures:

Forcible removal of infringing elements on products (if any) and correction of untruthful information, for the acts of violation specified at Point b, Clause 2 of this Article.

Article 36. Violation of regulations on information, education and communications about the prevention and control of harms of liquor and beer

1. A fine from VND 500,000 to VND 1,000,000 shall be imposed for the act of failing to educate, supervise, or remind under-18 family members not to drink liquor and beer.

2. A fine from VND 3,000,000 to VND 5,000,000 shall be imposed for the acts of informing, educating and communicating about the prevention and control of harms of liquor and beer which is not accurate, objective and scientific.

3. A fine between VND 10,000,000 to VND 15,000,000 shall be imposed for the acts of providing inaccurate or untruthful information on the effects of liquor and beer on health.

4. Remedial measures:

Forcible correction and removal of untruthful information, for the acts of violation specified in Clauses 2 and 3 of this Article.

Article 37. Violation of regulations on liquor and beer sponsorship

A fine from VND 20,000,000 to VND 30,000,000 shall be imposed for the acts of sponsorship in the form of liquor or beer products.

Section 2

ADMINISTRATIVE VIOLATIONS IN MEDICAL EXAMINATION AND TREATMENT

Article 38. Violation of regulations on medical practice, and use of licenses or practice certificates, of medical practitioners

1. A fine from VND 200,000 to VND 500,000 shall be imposed for any of the following violations:

a) Failing to wear name badges;

b) Failing to use protective equipment prescribed by law.

2. A fine from VND 500,000 to VND 1,000,000 shall be imposed for any of the following violations:

a) Failing to enter into a practice contract with trainees at medical examination and treatment establishments, or entering into a practice contract not in the prescribed form as prescribed by law;

b) Failing to issue a decision on assignment of practice instructors or issuing a decision on assignment of practice instructors not in the prescribed form as prescribed by law;

c) Assigning a practice instructor to provide instruction for more than 05 trainees at the same time.

3. A fine from VND 1,000,000 to VND 3,000,000 shall be imposed for any of the following violations:

a) Refusing to provide medical examination and treatment in cases where the patient’s condition is assessed to exceed one’s professional capacity or fall outside one’s scope of practice but failing to refer the patient to another practitioner or another appropriate medical examination and treatment establishment, and failing to promptly provide first aid, emergency care, monitoring, care, and treatment for the patient until the patient is received by another practitioner or transferred to another medical examination and treatment establishment;

b) Requiring patients to pay for medical examination and treatment costs that have not been publicly listed as prescribed by law;

c) Disclosing the patient’s medical condition, information provided by the patient, and medical records, except where the patient consents or for the purpose of sharing information and experience to improve the quality of diagnosis, care, and treatment among practitioners directly involved in treating the patient or in other cases as prescribed by law;

d) Issuing certificates of completion of the practice period not in the prescribed form as prescribed by law.

4. A fine from VND 3,000,000 to VND 5,000,000 shall be imposed for any of the following violations:

a) Practicing medical examination and treatment outside the registered time or location of practice (hereinafter referred to as practice registration), except where practitioners are permitted to provide medical examination and treatment without practice registration as prescribed by law;

b) Failing to issue certificates of completion of the practice period to a trainee after he/she completes the practice period prescribed by law;

c) Issuing certificates of completion of the practice period with incorrect contents; untruthfully; or not consistent with the professional qualifications of the applicant for practice registration;

d) Assigning a practice instructor that does not fully satisfy conditions prescribed by law.

dd) The medical practitioner fails to register for medical practice in accordance with law.

5. A fine from VND 5,000,000 to VND 10,000,000 shall be imposed for any of the following violations:

a) Obstructing patients subject to compulsory treatment in admitting to medical examination and treatment establishments or intentionally providing compulsory medical treatment for those not subject to compulsory treatment;

b) Prescribing medicines, indicating use of medical examination and treatment services, or suggesting referral of patients to other medical examination and treatment establishments for illicit gain;

c) Abusing the profession to infringe upon the honor, dignity, or body of patients;

d) Foreigners directly providing medical examination and treatment in Vietnamese without having been assessed and recognized as proficient in Vietnamese by a medical training institution designated by the Minister of Health, or using a language other than Vietnamese that has not been registered for use;

dd) Indicating treatment or prescribing medicines in a language other than Vietnamese where such language has not been registered for use or where the interpreter has not been recognized as qualified to interpret into Vietnamese;

e) Erasing or altering medical records to distort information on medical examination and treatment;

g) Using superstitions in medical examination and treatment;

h) A medical practitioner is in charge of professional and technical operations at more than one medical examination and treatment establishment, except where the practitioner is professionally responsible for a commune-level health station;

i) Working as a person taking charge of two or more hospitals, centers, departments, or units within the same medical examination and treatment establishment, or concurrently working as a person taking charge of a hospital, center, department, or unit of another medical examination and treatment establishment during the same period of practice;

k) A practitioner who is professionally and technically responsible for a hospital concurrently managing a professional unit of that hospital not consistent with the scope of professional activities stated in the issued license or practice certificate;

l) A practitioner who is professionally and technically responsible for a medical examination and treatment establishment not being present at the establishment during its registered operating hours without authorizing another person as prescribed by law;

m) Refusing to participate in medical examination and treatment activities upon occurrence of natural disasters, catastrophes, group-A infectious disease outbreaks or states of emergency upon mobilization or assignment decisions of competent agencies or persons, except for practitioners in high-risk groups for epidemic diseases and other cases as prescribed by law;

n) Taking advantage of the practitioner's image or status to make statements, propaganda, or encourage patients to use unrecognized medical examination and treatment methods;

o) Failing to comply with professional and technical regulations; applying methods, professional and techniques, or using medical equipment without the competent agency’s permission.

6. A fine from VND 20,000,000 to VND 30,000,000 shall be imposed on medical practitioners selling medicines in any form, except in case where the practitioner is a traditional medicine doctor, traditional medicine assistant doctor, herb doctor selling traditional medicines, or owner of a traditional herbal remedy selling drugs according to the remedy already registered.

7. A fine from VND 30,000,000 to VND 40,000,000 shall be imposed for any of the following violations:

a) Practicing medical examination and treatment without possessing a license or medical practice certificate;

b) Providing medical examination and treatment during the period in which the license or practice certificate has been revoked or the practitioner has been suspended from practice;

c) Providing medical examination and treatment services outside the practice or operation scope permitted by the competent agency, except cases of emergency or providing medical examination and treatment services according to the mobilization or assignment of the competent agencies upon occurrence of natural disasters, catastrophes, group-A infectious disease outbreaks, or states of emergency;

d) Hiring or borrowing licenses or medical practice certificates for the purpose of practice;

dd) Allowing others to lease or borrow licenses or medical practice certificates;

e) Refusing or intentionally delaying emergency care for patients, except where refusal of medical examination and treatment is permitted as prescribed by law;

g) Infringing upon the life, health, dignity or honor of the practitioners and others working at medical examination and treatment establishments, damaging or destroying assets of medical examination and treatment establishments;

h) Posting attributable information about the responsibilities of practitioners and medical examination and treatment establishments when adverse events occur without conclusions of competent agencies.

8. Additional sanctions:

a) Deprivation of the right to use a license or medical practice certificate for a definite time of between 01 month and 03 months, for the acts specified at Points b, c, d, dd, e, g, h, i, k, l, m, n and o, Clause 5 of this Article;

b) Deprivation of the right to use the license or medical practice certificate for a definite time of between 03 month and 06 months, for the acts specified in Clause 6 of this Article;

c) Deprivation of the right to use the license or medical practice certificate for a definite time of between 06 month and 09 months, for the acts specified at Points c and g, Clause 7 of this Article;

d) Deprivation of the right to use the license or medical practice certificate for a definite time of between 22 month and 24 months, for the acts specified at Points d, dd and e, Clause 7 of this Article.

9. Remedial measures:

a) Forcible direct apology to patients for the acts specified at Point c, Clause 5 of this Article;

b) Forcible refund of illicit profits earned through the commission of violations specified at Points a, b, c, d and dd, Clause 7 of this Article (if any).

Article 39. Violation of regulations on conditions for operation and use of medical examination and treatment operation licenses

1. A fine from VND 1,000,000 to VND 3,000,000 shall be imposed for any of the following violations:

a) Operating without a signboard or with a signboard not containing basic information as prescribed by law;

b) Recording names of departments or units within medical examination and treatment establishments not consistent with the dossier of the medical examination and treatment operation license issued by competent agencies.

2. A fine from VND 3,000,000 to VND 5,000,000 shall be imposed for any of the following violations:

a) Failing to submit updated lists of registered practitioners to competent agencies for publication in cases of change of the person professionally and technically responsible for the medical examination and treatment establishment, or failing to submit updated lists of registered practitioners to competent agencies for publication in cases of change of practitioners as prescribed by law;

b) Failing to satisfy one of the conditions after having been granted a medical examination and treatment operation license for medical examination and treatment establishments, or after having notified competent state agencies for other health service establishments, except for the organizational forms of polyclinics and hospitals;

c) Failing to develop and promulgate regulations on establishment, updating, management, storage, use, and information security of electronic medical records as prescribed by law;

d) Failing to meet information technology requirements for implementation of electronic medical records.

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

a) Obstructing patients subject to compulsory treatment in admitting to medical examination and treatment establishments or intentionally providing compulsory medical treatment for those not subject to compulsory treatment;

b) Failing to satisfy one of the conditions, after having been granted a medical examination and treatment operation license for polyclinics.

4. A fine from VND 20,000,000 to VND 30,000,000 shall be imposed for any of the following violations:

a) Employing practitioners who do not have licenses or medical practice certificates, or who are within the period of deprivation or revocation of such licenses or practice certificates, or suspension from medical examination and treatment practice;

b) Refusing to participate in medical examination and treatment activities upon occurrence of natural disasters, catastrophes, group-A infectious disease outbreaks or states of emergency upon mobilization or assignment decisions of competent agencies or persons, except for pregnant practitioners, practitioners raising children under 24 months of age, in high-risk groups for epidemic diseases, or other cases as prescribed by law;

c) Failing to satisfy one of the conditions, after having been granted a medical examination and treatment operation license for hospitals with the scale of under 100 patient beds.

5. A fine from VND 30,000,000 to VND 40,000,000 shall be imposed for any of the following violations:

a) Hiring or borrowing medical examination and treatment operation licenses;

b) Leasing or lending medical examination and treatment operation licenses;

c) Failing to satisfy one of the conditions, after having been granted a medical examination and treatment operation license for hospitals with the scale of between 100 and 500 patient beds.

6. A fine from VND 40,000,000 to VND 50,000,000 shall be imposed for any of the following violations:

a) Providing medical examination and treatment services without medical examination and treatment operation license, or during the period of suspension of operations, or at a location not stated in the medical examination and treatment operation license;

b) Providing medical examination and treatment services beyond the permitted scope of professional activities, except in emergency cases or where providing medical examination and treatment upon mobilization or assignment decisions of competent agencies or persons in cases of natural disasters, catastrophes, group A infectious disease outbreaks, or states of emergency;

c) Applying a new technique or method to medical examination and treatment without permission of the Minister of Health or the Director of the Health Department;

d) Failing to satisfy one of the conditions, after having been granted a medical examination and treatment operation license for hospitals with the scale of more than 500 patient beds;

dd) Providing aesthetic services as prescribed by law or using products having pharmacological effects at establishments not licensed under one of the organizational forms of hospitals, polyclinics, or specialized clinics;

e) Providing inpatient treatment at medical examination and treatment establishments not permitted to provide inpatient treatment, except where outpatients are retained for monitoring as prescribed by law.

7. Additional sanctions:

a) Deprivation of the right to use a medical examination and treatment operation license for a definite time of between 02 months and 04 months, for the acts specified at Point b, Clause 2; Point b, Clause 3; Points a, b and c, Clause 4; Point c, Clause 5 and Points c, d and e, Clause 6 of this Article;

b) Deprivation of the right to use a medical examination and treatment operation license for a definite time of between 12 months and 24 months, for the acts specified at Points a and b, Clause 5 of this Article;

c) Suspension of operation of establishments for a period of between 12 month and 24 months, for the acts specified at Points a and dd, Clause 6 of this Article;

d) Deprivation of the right to use a license or medical practice certificate of the person responsible for professional operations of the establishment for a definite time of between 01 month and 03 months, for the acts specified at Point a, Clause 4 and Points b and e, Clause 6 of this Article.

8. Remedial measures:

Forcible refund of illicit profits earned through the commission of violations specified at Points a and b, Clause 5 of this Article (if any).

Article 40. Violation of professional and technical regulations in medical examination and treatment

1. A fine from VND 1,000,000 to VND 3,000,000 shall be imposed for any of the following violations:

a) Failing to prepare medical records, or preparing medical records without clearly and fully recording all items required in the medical record forms as prescribed by law;

b) Failing to preserve medical records as prescribed by law;

c) Failing to report on medical examination and treatment activities in accordance with law.

2. A fine from VND 3,000,000 to VND 5,000,000 shall be imposed for any of the following violations:

a) Failing to handle abandoned patients as prescribed by law;

b) Failing to handle cases of death as prescribed by law;

c) Failing to be on standby or failing to organize on-standby medical examination and treatment in accordance with law;

d) Failing to implement nutrition in medical examination and treatment as prescribed by law.

3. A fine from VND 5,000,000 to VND 10,000,000 shall be imposed for any of the following violations:

a) Failing to conduct consultations when the disease exceeds the diagnostic or treatment capacity of the practitioner or the medical examination and treatment establishment;

b) Failing to conduct consultations when treatment has been provided but the disease shows no improvement or worsens.

4. A fine from VND 10,000,000 to VND 15,000,000 shall be imposed for the act of failing to transfer emergency patients to an appropriate medical examination and treatment establishment when the patient’s condition exceeds the professional capacity or falls outside the scope of professional activities of the establishment.

5. A fine from VND 15,000,000 to VND 20,000,000 shall be imposed for any of the following violations:

a) Performing surgery, procedures, or invasive interventions without written consent of the patient or the patient’s representative, except in case where failure to perform such surgery or invasive intervention would directly threaten the patient’s life and it is not possible to obtain consent from the patient or the patient’s representative;

b) Failing to ensure adequate emergency transport means appropriate to the organizational form of the medical examination and treatment establishment, as well as essential medical equipment and medicines used in emergency cases.

6. A fine from VND 20,000,000 to VND 30,000,000 shall be imposed for the act of using medicines, substances, or equipment to intervene in the human body (including surgery, procedures, interventions involving injections, infusions, irradiation, waves, cauterization, or other invasive interventions) to alter skin color, shape, or weight, to correct defects, or to create desired aesthetic modifications of body parts (including skin, nose, eyes, lips, face, breasts, abdomen, buttocks, and other body parts), to regenerate or restore cells, body parts, or bodily functions, or to perform tattooing, spraying, or embroidery on the skin using injectable anesthetics at establishments other than hospitals, polyclinics, or other specialized clinics with a scope of professional activities in aesthetic specialties.

7. A fine from VND 40,000,000 to VND 50,000,000 shall be imposed for violation of regulations of law on professional and technical practices in medical examination and treatment which are determined by a Professional Council to constitute professional and technical errors at a level requiring revocation of the practice license in accordance with regulations on medical examination and treatment.

8. Additional sanctions:

a) Deprivation of the right to use the license or medical practice certificate for a definite time of between 03 month and 06 months, for the acts specified in Clause 5 of this Article;

b) Suspension of the establishment's operation for a definite time of between 03 months and 06 months, for the acts specified in Clause 6 of this Article.

9. Remedial measures:

Forcible payment of the entire medical examination and treatment expenses, for the acts prescribed in Clauses 3 and 7 of this Article;

Article 41. Violation of regulations on use of drugs at medical examination and treatment establishments providing inpatient treatment and during the period of retaining outpatients for monitoring

1. A fine from VND 1,000,000 to VND 2,000,000 shall be imposed for any of the following violations:

a) Failing to fully and clearly record in prescriptions or medical records information on drug name, strength, dosage, method of use, and duration of use as prescribed by law;

b) Failing to check prescriptions, drug requisition forms, drug names, concentrations, strength, dosages, and methods of use when dispensing medicines to patients;

c) Failing to compare prescriptions with information on drug name, concentration, strength, expiry date, and quantity when dispensing medicines to patients;

d) Failing to verify the patient’s full name, drug name, dosage form, concentration, strength, dosage, method of use, and duration of use before administering medicines to patients;

dd) Failing to fully record the time of dispensing medicines to patients;

e) Failing to monitor and promptly detect adverse events and notify the practitioner directly responsible for treatment when dispensing medicines to patients.

2. A fine from VND 10,000,000 to VND 20,000,000 shall be imposed for any of the following violations:

a) Prescribing medicines not appropriate to the diagnosis and condition of the patient;

b) Including in prescriptions products not permitted to be prescribed as prescribed by law;

c) Prescribing medicines not consistent with the package insert approved by the Ministry of Health, or with diagnostic and treatment guidelines issued or recognized by the Minister of Health, or with diagnostic and treatment guidelines developed by the medical examination and treatment establishment, or with the applicable Vietnamese National Drug Formulary.

3. A fine from VND 20,000,000 to VND 30,000,000 shall be imposed for the act of dispensing or selling drugs that are expired, improperly stored as indicated on the label, subject to recall notices by competent state agencies, or of unknown origin or source to users.

4. Additional sanctions:

Deprivation of the right to use the license or medical practice certificate for a definite time of between 01 month and 03 months, for the acts specified at Point e, Clause 1 and in Clauses 2, 3, of this Article.

5. Remedial measures:

Forcible payment of the entire medical examination and treatment expenses, for the acts prescribed in Clause 2 of this Article.

Article 42. Violation of regulations on giving birth through in vitro fertilization

1. A fine from VND 3,000,000 to VND 5,000,000 shall be imposed for the acts of failing to report on the implementation of assisted reproductive techniques as prescribed by law.

2. A fine from VND 5,000,000 to VND 10,000,000 shall be imposed for any of the following violations:

a) Failing to postpone embryo transfer for persons suffering from acute diseases until stabilization after treatment;

b) Failing to organize and carry out examination, consultation, and determination of sufficient health conditions to receive sperm, eggs, or embryos;

c) In case where the person depositing sperm, eggs, or embryos (hereinafter collectively referred to as samples) or the recipient of donated samples wishes to transfer samples from the storing establishment to another storage establishment but the storing establishment fails to advise the depositor/recipient on regulations on sample transportation, potential risks during transportation, or fails to provide written consent to the transfer of samples;

d) Failing to permit transfer of stored sperm, eggs, or embryos to another establishment upon request of the depositor, except where the receiving establishment refuses to accept the samples;

dd) The storing establishment fails to notify the depositor or recipient of donated samples, in case it is no longer eligible to continue storing samples and must transfer samples to another storage establishment;

e) The transferring establishment or the receiving establishment fails to provide written consent to the transfer or receipt of samples in accordance with the wishes of the depositor/owner of the samples or at the request of the transferring establishment.

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

a) Establishments storing sperm, eggs, or embryos fail to ensure confidentiality of information of donors and recipients of sperm, eggs, or embryos;

b) Storing sperm, eggs, or embryos without entering into a contract with the depositor in accordance with civil law with the sperm, egg, or embryo storage establishment, except in case where sperm, ova, or embryos are donated;

c) Failing to determine that sperm donors, egg donors, or embryo donors do not have hereditary diseases affecting subsequent generations; do not suffer from mental illness or other diseases that impair cognition or behavioral control; and are not infected with HIV;

d) Failing to encode information on donation of sperm, eggs, or embryos; failing to store donated sperm, eggs, or embryos and share such information with the shared database on assisted reproduction as prescribed by law;

dd) Failing to destroy sperm when the depositor dies, except in case where the wife wishes to have a child using the deceased husband’s sperm or where, prior to death, the depositor has a written statement expressing the wish to donate sperm to the storage establishment;

e) Destroying sperm when the depositor dies while the wife wishes to have a child using the deceased husband’s sperm or where, prior to death, the depositor has a written statement expressing the wish to donate sperm to the storage establishment;

g) Failing to destroy egg when the depositor dies, except where, prior to death, the depositor has a written statement expressing the wish to donate egg to the storage establishment;

h) Destroying egg when the depositor dies while, prior to death, the depositor has a written statement expressing the wish to donate egg to the storage establishment;

i) Failing to destroy embryos when the husband depositing embryos dies, except in case where the wife wishes to have a child using the embryos of both spouses; or the wife has a written statement donating the embryos to the storage establishment for scientific research purposes or for the performance of assisted reproductive techniques for a single woman or another married couple;

k) Destroying embryos when the husband depositing embryos dies while the wife wishes to have a child using the embryos of both spouses; or the wife has a written statement donating the embryos to the storage establishment for scientific research purposes or for the performance of assisted reproductive techniques for a single woman or another married couple;

l) Failing to destroy embryos when the wife in the couple or both spouses depositing embryos die, except where there is a written statement of both spouses expressing the wish to donate embryos to the storage establishment for scientific research or for use in assisted reproductive techniques for a single woman or another married couple;

m) Destroying embryos when the wife in the couple or both spouses depositing embryos die, while there is a written statement of both spouses expressing the wish to donate embryos to the storage establishment for scientific research or for use in assisted reproductive techniques for a single woman or another married couple;

n) Failing to destroy the stored embryos when the couple depositing embryos have divorced, except where there is a written agreement of both spouses requesting continued storage of embryos and committing to pay storage costs in accordance with the establishment’s regulations, or requesting donation of stored embryos to the storage establishment for use in scientific research or for assisted reproductive techniques for another couple or a single woman;

o) Destroying stored embryos when the couple have divorced while there is a written agreement of both spouses requesting continued storage of embryos and committing to pay storage costs in accordance with the establishment’s regulations, or requesting donation of stored embryos to the storage establishment for use in scientific research or for assisted reproductive techniques for another couple or a single woman;

p) Using embryos of a divorced couple to perform assisted reproductive techniques for the wife without written consent of both persons;

q) Failing to comply with the principle of anonymity between donors and recipients in donation and receipt of sperm and embryos;

r) Receiving cases of depositing sperm, eggs and embryos outside the cases permitted as prescribed by law;

s) Performing assisted reproductive techniques for couples not diagnosed as infertile or without medical indication;

t) Performing assisted reproductive techniques for recipients of sperm, eggs, or embryos who do not meet conditions as prescribed by law;

u) Allowing donation of sperm, eggs, or embryos by donors who do not meet conditions as prescribed by law;

v) Establishments storing sperm, eggs, or embryos, and medical examination and treatment establishments permitted to perform in vitro fertilization and altruistic gestational surrogacy, fail to encode or share information on donation and storage of sperm, eggs, or embryos with the shared database on assisted reproduction as prescribed by law.

4. A fine from VND 20,000,000 to VND 30,000,000 shall be imposed for any of the following violations:

a) Allowing donation of sperm, eggs, or embryos at more than one establishment permitted to store sperm, eggs, or embryos;

b) Performing artificial insemination using donor sperm not in compliance with principles for application of assisted reproductive techniques and altruistic gestational surrogacy as prescribed by law, or performing such procedures at establishments not permitted to conduct in vitro fertilization;

c) Storing sperm, eggs, or embryos at medical examination and treatment establishments not permitted by competent authorities to perform in vitro fertilization or at tissue banks in accordance with the law on donation, removal and transplantation of human tissues and organs and donation and recovery of cadavers;

d) Using donated sperm, eggs, or embryos to perform in vitro fertilization for two or more women or two or more married couples;

dd) Transporting sperm, eggs, or embryos not performed by medical personnel of the receiving establishment or the transferring establishment, or without participation of the depositor, the recipient of donated samples, or a lawful authorized representative, without authorization of the depositor/recipient for the receiving or transferring establishment;

e) During transportation, samples not preserved in specialized cryogenic storage equipment or not sealed by the transferring establishment;

g) Samples not handed over between two storage establishments, or handed over without accompanying required documents as prescribed by law;

h) The receiving establishment fails to check seals and accompanying documents before signing the sample handover record, or fails to deliver the sample handover record to the transferring party;

i) The storing establishment transfers samples to another storage establishment without notifying the depositor in writing of the sample transportation;

k) The storing establishment transfers samples to another storage establishment that fails to enter into a contract with the depositor in accordance with civil law;

l) Allowing use of surplus sperm, eggs, or embryos of a couple, or surplus eggs of a single woman for purposes without written consent of the couple or the single woman, or without clearly specifying the purpose of use as prescribed by law;

m) Allowing use of remaining donated sperm, eggs, or embryos of a couple or a single woman without written consent of the couple or the single woman; or using them for purposes other than the following: (i) Storing surplus sperm, eggs, or embryos and using them only for continued childbirth by that couple or that single woman; (ii) Donating surplus sperm, eggs, or embryos to establishments permitted to store them for scientific research; (iii) Destroying remaining donated sperm, eggs, or embryos.

5. A fine from VND 30,000,000 to VND 40,000,000 shall be imposed for any of the following violations:

a) Performing in vitro fertilization when the medical examination and treatment establishment has not been permitted to do so as prescribed by law;

b) Failing to ensure one of the conditions after having been recognized as a medical examination and treatment establishment permitted to perform in vitro fertilization.

6. Additional sanctions:

a) Suspension of in vitro fertilization activities for a period from 01 month to 03 months for establishments committing 03 or more violations among the acts specified in Clauses 1, 2, 3 and Points a, b, c, d, dd, g Clause 4 of this Article at the time the violations are detected;

b) Suspension of in vitro fertilization activities for a period from 06 months to 12 months for the act specified in Clause 5 of this Article.

Article 43. Violation of regulations on conditions for altruistic gestational surrogacy

1. A fine from VND 5,000,000 to VND 10,000,000 shall be imposed for any of the following violations:

a) A health counselor of a surrogacy-requesting couple or a surrogate is not an obstetrician-gynecologist;

b) A psychological counselor of a surrogacy-requesting couple or a surrogate is not a person holding a bachelor or higher degree in psychology or a physician holding a certificate of training in psychology;

c) A legal counselor of a surrogacy-requesting couple or a surrogate doesn’t hold a bachelor or higher degree in law;

d) The person providing psychological or legal counseling is not personnel of the medical examination and treatment establishment or personnel cooperating in accordance with law;

dd) An establishment permitted to perform altruistic gestational surrogacy techniques fails to provide a written response or fails to clearly state reasons for not performing surrogacy for the requesting party within 10 working days from receipt of a complete application dossier for altruistic gestational surrogacy techniques;

e) Failing to provide medical, legal, or psychological counseling to the gestational surrogacy-requesting couple, or providing counseling not covering all contents as prescribed by law;

g) Failing to provide medical, legal, or psychological counseling to the surrogate, or providing counseling not covering all contents as prescribed by law;

h) Failing to certify that counseling has been provided to the surrogacy-requesting party and/or the surrogate on medical, psychological, and legal matters;

i) Providing counseling to the surrogacy-requesting couple and the surrogate not covering all contents as prescribed by law;

k) Failing to conduct health examinations for the surrogate and the surrogacy-requesting couple, or failing to certify that the wife of the surrogacy-requesting couple is unable to conceive and give birth even when assisted reproductive techniques are applied, or failing to certify the surrogate’s capacity for gestation after receipt of a complete dossier as prescribed by law;

l) Failing to perform altruistic gestational surrogacy techniques in case where the surrogate and the surrogacy-requesting couple satisfy all health conditions for surrogacy.

2. A fine from VND 10,000,000 to VND 20,000,000 shall be imposed for the act of providing information or infringing upon the private life, personal secrets, or family secrets of the surrogacy-requesting couple, the surrogate, or the child born through altruistic gestational surrogacy.

3. A fine from VND 30,000,000 to VND 40,000,000 shall be imposed for any of the following violations:

a) Performing altruistic gestational surrogacy techniques at a medical examination and treatment establishment not permitted to perform such techniques;

b) Failing to ensure conditions after having been permitted to perform altruistic gestational surrogacy techniques, except for the condition of performing at least 500 in vitro fertilization cycles per year;

c) Performing altruistic gestational surrogacy techniques for persons not having sufficient dossiers as prescribed by law.

4. Additional sanctions:

a) Suspension of altruistic gestational surrogacy activities for a period from 01 month to 03 months for establishments committing 03 or more violations among the acts specified in Clauses 1 and 2 of this Article at the time the violations are detected;

b) Suspension of activities related to the violating acts for a period from 06 months to 12 months for the acts specified in Clause 3 of this Article.

Article 44. Violation of regulations on donation, removal, and transplantation of human tissues and organs and donation and recovery of cadavers

1. A fine from VND 1,000,000 to VND 2,000,000 shall be imposed for any of the following violations:

a) A health establishment fails to directly meet the donor to give counseling on information related to donation, removal of human tissue and organ when receiving a notice of the National Coordination Center for Organ Transplantation;

b) A health establishment fails to give guidance on the donation registration according to a set form when receiving a notice of the National Coordination Center for Organ Transplantation;

c) Failing to conduct health checks for the donor before removing tissues or organs from a living person;

d) Failing to report the list of persons registering for donation of tissues and organs from living persons to the National Coordinating Center for Human Organ Transplantation;

dd) Failing to provide health and psychosocial counseling to the donor or failing to examine biological parameters of the donor before to removal of tissues or organs from a living person.

2. A fine from VND 5,000,000 to VND 10,000,000 shall be imposed for the act of charging fees for post-donation care, recovery, and periodic health examinations for donors of human organs.

3. A fine from VND 10,000,000 to VND 20,000,000 shall be imposed for the act of failing to ensure one of the conditions for operation after having been granted a license for tissue bank operation.

4. A fine from VND 20,000,000 to VND 30,000,000 shall be imposed for the act of operating a tissue bank without license for tissue bank operation.

5. A fine from VND 30,000,000 to VND 40,000,000 shall be imposed for any of the following violations:

a) Disclosing information and secrets about donors and transplant recipients, except where there is written consent of the parties or otherwise as prescribed by law;

b) Removing non-regenerable organs from living donors without written opinion of the Counseling Council on Human Organ Removal and Transplantation of the health establishment;

c) Storing human tissues and organs for commercial purposes.

6. A fine from VND 60,000,000 to VND 80,000,000 shall be imposed for any of the following violations:

a) Removing, transplanting or using human tissues and organs for commercial purposes, except the cases of trading in or appropriating human tissues or organs;

b) Removing or transplanting human tissues and organs at an ineligible establishment in accordance with law.

7. A fine from VND 80,000,000 to VND 100,000,000 shall be imposed for any of the following violations:

a) Forcing other person to donate human tissues and organs or removing tissues and organs from a person who refuses to donate his/her tissues and organs, without being subject to criminal prosecution;

b) Removing tissues or organs from a living person under 18 years of age, without being subject to criminal prosecution;

c) Transplanting tissues or organs from persons infected with diseases on the list prescribed by competent state agencies.

8. Additional sanctions:

a) Deprivation of the right to use a license for tissue bank operation for a definite time of between 03 months and 06 months, for the acts of violation specified in Clause 3 and at Point c, Clause 5 of this Article;

b) Suspension of a part of the operation of the medical examination and treatment establishment related to the violations for a definite time of between 01 month and 03 months, for the acts specified at Point c, dd, Clause 1 and Point b, Clause 5 of this Article;

c) Deprivation of the right to use the medical examination and treatment operation license for a definite time of between 03 months and 06 months, for the acts of violation specified in Clauses 6 and 7 of this Article.

9. Remedial measures:

a) Forcible refund of amounts unlawfully collected for the act specified in Clause 2 of this Article. In case it cannot be refunded to the subject, it shall be remitted to the state budget in accordance with the law;

b) Forcible payment of all medical examination and treatment costs for the injured individual for the act specified in Clause 7 of this Article. In case it cannot be refunded to the subject, it shall be remitted to the state budget.

Article 45. Violation of regulations on gender reassignment

1. A fine from VND 2,000,000 to VND 5,000,000 shall be imposed for any of the following violations:

a) Disclosing information on another person’s gender reassignment;

b) Discriminating against a person who has undergone gender reassignment.

2. A fine from VND 30,000,000 to VND 40,000,000 shall be imposed for performing gender reassignment without permission from the Minister of Health or the Director of the Department of Health.

3. Remedial measures:

a) Forcible direct apology to the person subjected to discrimination, for the act specified at Point b, Clause 1 of this Article;

b) Forcible refund of illicit profits earned through commission of the act specified in Clause 2 of this Article.

Article 46. Violation of regulations on health check-up

1. A fine from VND 3,000,000 to VND 5,000,000 shall be imposed for any of the following violations:

a) Issuing health check-up certificates without conducting examination of all required contents;

b) Classifying health status inconsistently with the actual health condition of the person requesting the health check-up.

2. A fine from VND 5,000,000 to VND 10,000,000 shall be imposed for the act of failing to ensure one of the conditions of the establishment performing health check-up.

3. A fine from VND 10,000,000 to VND 20,000,000 shall be imposed for the act of conducting health check-ups without announcing the provision of health check-up services.

4. Additional sanctions:

a) Suspension of health check-up activities of the establishment for a period from 01 month to 03 months for the act specified in Clause 2 of this Article;

b) Deprivation of the right to use the medical examination and treatment operation license for a definite time of between 01 month and 03 months, for the acts of violation specified in Clauses 3 of this Article.

Article 47. Violation of regulations on infection control at medical examination and treatment establishments

1. A fine from VND 500,000 to VND 1,000,000 shall be imposed for any of the following violations:

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

b) Failing to comply with the law and regulations of medical examination and treatment establishments on infection control applicable to persons working at medical examination and treatment establishments, patients and other persons visiting medical examination and treatment establishments.

2. A fine from VND 5,000,000 to VND 10,000,000 shall be imposed for any of the following violations:

a) Failing to take or inadequately take infection control measures at medical examination and treatment establishments;

b) Failing to ensure physical facilities, equipment, protective clothing and personal hygiene conditions for persons working at medical examination and treatment establishments, patients and other persons visiting medical examination and treatment establishments in accordance with infection control requirements in such establishments.

3. Additional sanctions:

a) Deprivation of the right to use the license or medical practice certificate for a definite time of between 01 month and 03 months, for the acts specified at Point b, Clause 1 of this Article;

b) Deprivation of the right to use the medical examination and treatment operation license for a definite time of between 01 month and 03 months, for the acts of violation specified in Clauses 2 of this Article.

Article 48. Violation of regulations on principles for medical practice

1. A fine from VND 200,000 to VND 500,000 shall be imposed for any of the following violations:

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

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

c) Failing to comply with professional methods and techniques applied by practitioners for medical examination and treatment, except for cases where the right to refuse treatment is exercised.

2. A fine from VND 500,000 to VND 1,000,000 shall be imposed for any of the following violations:

a) Failing to truthfully provide information related to one’s health condition or failing to fully cooperate with practitioners and medical examination and treatment establishments;

b) Failing to comply with, or failing to request relatives or visitors to comply with, the internal rules of medical examination and treatment establishments and the law on medical examination and treatment;

c) Failing to give priority in medical examination and treatment to emergency patients, under-6 children, pregnant women, persons with extremely severe disabilities, persons with severe disabilities, persons aged full 75 years or older, and persons with meritorious services to the revolution, in accordance with the characteristics of medical examination and treatment establishments.

3. A fine from VND 1,000,000 to VND 3,000,000 shall be imposed for any of the following violations:

a) Infringing upon the honor and dignity of practitioners while they are conducting medical examination and treatment;

b) Failing to comply with code of conduct of practitioners in accordance with law;

c) Stigmatizing or discriminating against patients.

4. A fine from VND 3,000,000 to VND 5,000,000 shall be imposed for any of the following violations:

a) Failing to pay medical examination and treatment expenses when using medical examination and treatment services, except cases of exemption or reduction under law;

b) Failing to set up a professional council in accordance with law to determine whether or not professional and technical mistakes are made, for cases where there is a request for settlement of a dispute over medical examination and treatment upon occurrence of an incident to a patient.

5. A fine from VND 5,000,000 to VND 10,000,000 shall be imposed for the act of failing to observe professional and technical regulations in medical examination and treatment, except cases of non-compliance with professional and technical regulations prescribed in other articles of this Section.

6. A fine from VND 30,000,000 to VND 40,000,000 shall be imposed for the act of causing harm to the health of, or threatening the life of, practitioners while they are conducting medical examination and treatment, where such acts are not yet subject to criminal prosecution.

7. Additional sanctions:

a) Deprivation of the right to use the license or medical practice certificate for a definite time of between 01 month and 03 months, for the acts specified in Clause 5 of this Article;

b) Suspension from operation of part of the establishment (with respect to violating departments, divisions, centers, units or sections) or deprivation of the right to use the medical examination and treatment operation license of the establishment (with respect to violations affecting the entire operation of the medical examination and treatment establishment) for a definite period of between 01 month and 03 months, for the act specified in Clause 5 of this Article.

8. Remedial measures:

a) Forcible direct apology to practitioners for the acts of violation specified at Point a, Clause 1; Point a, Clause 3 and Clause 6 of this Article;

b) Forcible direct apology to patients for the acts of violation specified at Point b, Clause 1 and Point c, Clause 3 of this Article.

Article 49. Violation of regulations on clinical pharmacy activities of medical examination and treatment establishments

1. A fine from VND 3,000,000 to VND 5,000,000 shall be imposed for any of the following violations:

a) Failing to arrange enough persons to implement clinical pharmacy activities according to the roadmap prescribed by law;

b) Failing to arrange persons fully meeting conditions prescribed by law to implement clinical pharmacy activities.

2. A fine from VND 5,000,000 to VND 10,000,000 shall be imposed for the act of arranging for a person, who does not possess a pharmacy practice license or pharmacy practice certificate or who is during the period of revocation of the pharmacy practice certificate or suspension from pharmacy practice, to be in charge of clinical pharmacy activities.

3. A fine from VND 10,000,000 to VND 20,000,000 shall be imposed for the act of failing to organize clinical pharmacy activities according to the roadmap prescribed by law.

Article 50. Violation of regulations on information, education and communication regarding infant feeding, use of nutritious products for infants and the benefits of breastfeeding

1. A fine from VND 1,000,000 to VND 3,000,000 shall be imposed for the act of issuing information, education and communication documents on the use of nutritious products for infants in contravention of regulations, for one of the following contents:

a) Providing instructions on how to select and use the nutritious products for infants;

b) Providing instructions on how to clean and sanitize infant feeding items;

c) Providing instructions on how to feed infants with hygienic cups and spoons;

d) Giving warnings about possible harms to infant’s health caused by pacifiers, bottle-feeding or complementary feeding when they are under 6 months;

dd) Providing information on possible infections caused by bottle-feeding and improper preparation of and feeding with breast-milk substitutes;

e) Giving cautions about high costs of infant feeding with breast-milk substitutes.

2. A fine from VND 3,000,000 to VND 5,000,000 shall be imposed for the act of issuing information, education and communication documents on nurturing infants in contravention of regulations, for one of the following contents:

a) Stating benefits and superiority of breastfeeding, affirming that breast milk is the best food for health and all-sided growth of infants; anti-infective elements, especially antibodies, existing only in breast milk, which help infants prevent diarrhea, respiratory infections and some other infectious diseases;

b) Providing instructions on exclusive breastfeeding for the first 06 months of infants and continued breastfeeding until children reach 24 months of age or beyond, and instructions on proper and rational feeding of infants with complementary foods when they reach 07 months of age;

c) Stating disadvantages of feeding infants with breast milk substitutes instead of breast milk, such as failure to provide infants with immunity contained in breast milk, financial and time costs, possible infection due to improper preparation and other disadvantages prescribed by law;

d) Stating adverse impacts of bottle-feeding, use of pacifiers and complementary foods on infants aged under 06 months;

dd) Providing instructions on simple preparation, storage, selection and use of complementary foods at home for infants, ensuring safety and rational nutrition with available foods;

e) Providing instructions on rational nutrition for mothers to maintain their breast milk.

3. A fine from VND 5,000,000 to VND 10,000,000 shall be imposed for the act of issuing information, education and communication documents on nurturing infants that contain one of the following contents:

a) Images, words or other forms to encourage the use of breast-milk substitutes or bottle-feeding or discourage breastfeeding;

b) Comparison of breast milk substitutes as equivalent to or better than breast milk;

c) Names or logos of breast-milk substitutes, feeding bottles and pacifiers.

4. A fine from VND 10,000,000 to VND 20,000,000 shall be imposed for the act of failing to prioritize information, education and communication about benefits of breastfeeding and infant nurturing methods in programs on information, education and communication about mother and child health protection and infant nutrition improvement.

5. Remedial measures:

Forcible revocation of communication documents, for the acts of violation specified in Clauses 1, 2 and 3 of this Article.

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

1. A fine from VND 1,000,000 to VND 3,000,000 shall be imposed for any of the following violations:

a) Guiding the use of breast-milk substitutes for under-6-month infants, except the case prescribed by doctors;

b) Informing pregnant women, nursing mothers or members of their families that breast-milk substitutes are as good as or better than breast milk.

2. A fine from VND 3,000,000 to VND 5,000,000 shall be imposed for any of the following violations:

a) Failing to provide accurate and scientific information on, and proper usage of, nutritious products for infants to physicians, medical staffs and consumers in accordance with law;

b) Sending employees to directly or indirectly contact mothers, pregnant women or members of their families at or outside medical establishments in order to advertise, disseminate and encourage the use of breast-milk substitutes;

c) Failing to disseminate or provide counseling about breastfeeding to pregnant women, nursing mothers and members of their families at antenatal clinics, delivery waiting rooms, postnatal rooms, nutrition counseling rooms or easy-to-notice places or places where concentrate pregnant women, nursing mothers and members of their families in accordance with law;

d) Receiving breast-milk substitutes; material benefits; utensils bearing names or logos of breast-milk substitutes which are given by production and business establishments;

dd) Permitting production and business establishments to give sample products or gifts related to breast-milk substitutes in medical establishments;

e) Providing lists of names, ages, addresses and telephone numbers of nursing mothers and pregnant women to employees of production and business establishments or permit them to meet pregnant women and nursing mothers at medical establishments.

3. A fine from VND 5,000,000 to VND 10,000,000 shall be imposed for any of the following violations:

a) Selling, or permitting the sale of, breast-milk substitutes at medical establishments, except hospital drugstores;

b) Granting scholarships, providing funds for scientific research, training courses, conferences, workshops, courses, music concerts, contests, stage performances, making of films or video clips, telephone counseling services or other forms in order to disseminate or introduce, promote the sales or use of breast-milk substitutes;

c) Permitting establishments producing or trading in breast-milk substitutes to display or post up any utensils or equipment bearing names or logos of breast-milk substitutes, feeding bottles and pacifiers at medical establishments;

d) Permitting employees of establishments producing or trading in breast-milk substitutes to approach nursing mothers and pregnant mothers in any forms.

4. A fine from VND 10,000,000 to VND 20,000,000 shall be imposed for any of the following violations:

a) Displaying breast-milk substitutes or complementary foods for under-6-month infants at medical establishments; displaying names or logos of breast-milk substitutes on banners, posters and other leaflets in supermarkets, retail stores and medical establishments;

b) Applying sales promotion measures for breast-milk substitutes such as giving free samples, coupons, rewards, gifts, bonus point accumulation, discount or any other forms;

c) Providing or supporting the provision of information, education and communications about infant nurturing in order to disseminate, introduce and promote the trading and use of breast-milk substitutes.

Section 3

ADMINISTRATIVE VIOLATIONS ON PHARMACY AND COSMETICS

Article 52. Violation of regulations on pharmacy practice

1. A fine from VND 3,000,000 to VND 5,000,000 shall be imposed for any of the following violations:

a) A drug retailer’s person in charge of professional pharmacy activities is absent during the operation of such pharmaceutical establishment, except for cases of authorization upon being absent as prescribed by law;

b) Failing to comply with the decision of competent state agencies in cases of dangerous epidemics, natural disasters or catastrophes;

c) Failing to complete the program of training and updating professional knowledge about pharmacy within a period of 03 years from the date of being granted pharmacy practice certificates or from the date of obtaining the most recent certificates of completing the program of training and updating professional knowledge about pharmacy;

d) Replacing a drug prescribed in the prescription with another drug that has the same active ingredients, administration and dosage without consent of the buyer.

2. A fine from VND 5,000,000 to VND 10,000,000 shall be imposed for any of the following violations:

a) Forging one of the documents in dossiers of application for pharmacy practice certificates without being subject to criminal prosecution;

b) Practicing pharmacy without pharmacy practice certificates or practicing pharmacy during the period of being deprived of the right to use pharmacy practice certificates at the position where pharmacy practice certificates are required in accordance with law;

c) Being in charge of professional pharmacy activities at two or more pharmaceutical business locations of the same establishment, except for the person in charge of professional pharmacy activities of an establishment organizing a pharmacy chain as prescribed by law; being in charge of professional pharmacy activities at two or more pharmaceutical business establishments or two or more forms of pharmaceutical business of the same establishment;

d) Practicing pharmacy beyond the scope of professional activities stated in the pharmacy practice certificate and contrary to professional and technical regulations;

dd) Establishment providing training and updating of professional pharmaceutical knowledge fails to satisfy the conditions prescribed by law;

e) Establishment organizing examinations for issuance of pharmacy practice certificates fails to satisfy the conditions prescribed by law;

g) Leasing, lending or letting another person use pharmacy practice certificates in order to practice pharmacy;

h) Issuing a certificate of duration of pharmaceutical practice contrary to the truth.

3. A fine from VND 10,000,000 to VND 20,000,000 shall be imposed for the act of leasing or borrowing a pharmacy practice certificate for pharmacy practice.

4. Additional sanctions:

a) Deprivation of the right to use pharmacy practice certificates for a period of between 01 month and 03 months, for the acts specified at Points c and, Clause 2 of this Article;

b) Deprivation of the right to use pharmacy practice certificates and certificate of eligibility for pharmaceutical business for a period of between 06 months and 09 months, for the acts specified at Point b, Clause 1 of this Article.

5. Remedial measures:

Forcible refund of illicit profits earned through the commission of violations specified at Point g, Clause 2 and Clause 3 of this Article (if any).

Article 53. Violation of regulations on pharmaceutical business establishments and conditions for pharmaceutical business

1. A fine from VND 1,000,000 to VND 3,000,000 shall be imposed for any of the following violations:

a) Mobile drug retailers fail to satisfy conditions as prescribed by law;

b) Mobile drug retailers fail to send a written notification to local Departments of Health before organizing the mobile drug retail at such localities.

2. A fine from VND 3,000,000 to VND 5,000,000 shall be imposed for the act of failing to satisfy one of the regulations applicable to business establishments that have a drug shelf as prescribed by law.

3. A fine from VND 10,000,000 to VND 15,000,000 shall be imposed for the act of forging papers in the dossier for declaration of a business establishment organizing drug shelves without being subject to criminal prosecution.

4. A fine from VND 15,000,000 to VND 20,000,000 shall be imposed for the act of failing to take isolation measures or keeping the following drugs or drug materials in isolated areas, except for the cases specified at Point dd, Clause 4 Article 59 of this Decree:

a) Those failing to satisfy quality standards;

b) Those subject to recall under notifications of competent state agencies;

c) Those having expired;

d) Those of unknown origin.

5. Additional sanctions:

a) Suspension of business activities related to the violations for a period of between 01 month and 03 months, for acts specified at Point a, Clause 1 and Clause 2 of this Article;

b) Suspension of business activities related to violations for a period of between 06 months and 12 months, for acts specified in Clause 3 of this Article.

6. Remedial measures:

Forcible destruction of all drugs or drug materials for violations specified in Clause 4 of this Article, except for cases where drugs or drug materials specified at Points a and b, Clause 4 of this Article are permitted by competent state agencies for re-export or remedy in accordance with law.

Article 54. Violation of regulations on certificates of eligibility for pharmaceutical business

1. A fine from VND 20,000,000 to VND 30,000,000 shall be imposed for any of the following violations:

a) Forging or modifying dossiers, papers, documents or certificates of competent agencies or organizations, and of other organizations and individuals in the dossiers of application for certificates of eligibility for pharmaceutical business without being subject to criminal prosecution;

b) Renting, borrowing, leasing, lending or letting other individuals or organizations use a certificate of eligibility for pharmaceutical business in order to conduct activities of pharmacy business.

2. Additional sanctions:

Deprivation of the right to use certificates of eligibility for pharmaceutical business for a period of between 22 months and 24 months, for violations specified at Point d, Clause 1 of this Article.

3. Remedial measures:

Forcible refund of illicit profits earned through the commission of violations specified at Point b, Clause 1 of this Article (if any).

Article 55. Violation of regulations on rights and responsibilities of pharmaceutical business establishments

1. A fine from VND 1,000,000 to VND 3,000,000 shall be imposed for any of the following violations:

a) Failing to report to the Ministry of Health or the Departments of Health or failing to fulfill obligations as prescribed by law in case of suspension of operations for 06 months or more or termination of operations;

b) Failing to report or update the list of persons who have a pharmacy practice certificate and are practicing at the establishment to competent state agencies as prescribed by law;

c) Failing to make periodic reports, ad-hoc reports, and reports at the request of competent state agencies in charge of pharmacy as prescribed by law.

2. A fine from VND 5,000,000 to VND 10,000,000 shall be imposed for any of the following violations:

a) Failing to publicly display pharmacy practice certificates for cases that require pharmacy practice certificates or certificates of eligibility for pharmaceutical business at the establishment;

b) Failing to pay compensations to organizations or individuals for damage caused by the retailer of drugs or medicinal materials as prescribed by law.

3. A fine from VND 10,000,000 to VND 20,000,000 shall be imposed for acts of failing to pay compensations to organizations or individuals for damage caused by the establishment’s faults in accordance with law, except for the cases specified at Point b, Clause 2 of this Article.

4. A fine equal to 1.5 times the prescribed fine level shall be imposed for violations relating to drugs and pharmaceutical materials on the list of substances prohibited from use in a number of sectors and fields, combination drugs containing habit-forming pharmaceutical ingredients, combination drugs containing psychotropic pharmaceutical ingredients, combination drugs containing pre-substances or radioactive drugs, or a fine equal to 2 times the prescribed fine level shall be imposed for violations relating to habit-forming drugs, psychotropic drugs, pre-substance drugs, or materials that are habit-forming pharmaceutical ingredients, psychotropic pharmaceutical ingredients, or pre-substances used for drug production, but not exceeding VND 100,000,000 for violations specified at Point c, Clause 1 of this Article.

5. Additional sanctions:

Suspension of business activities related to acts of violation for a period of between 01 month and 03 months, for violations specified at Point a, Clause 1 of this Article.

Article 56. Violation of regulations on registration of drugs or drug materials

1. A fine from VND 10,000,000 to VND 20,000,000 shall be imposed for any of the following violations:

a) Failing to report or provide information related to drug registration in Vietnam in accordance with regulations on responsibilities of drug registration establishments and drug manufacturers or at the request of competent state agencies, except for cases where a written explanation approved by competent state agencies is provided;

b) Failing to carry out the procedures for notifying competent state agencies of minor changes subject to notification before the circulation of drugs or drug materials;

c) Failing to notify competent state agencies in case of discontinuation of manufacture, discontinuation of supply of drugs, or risks and shortages of drugs and drug materials, or in case where contract-manufactured drugs cease manufacture, or pre-technology transfer drugs cease manufacture;

d) Failing to notify competent state agencies in case of discontinuation of manufacture, discontinuation of supply of drugs, or risks and shortages of drugs and drug materials, or in case where contract-manufactured drugs cease manufacture, or pre-technology transfer drugs cease manufacture.

2. A fine from VND 20,000,000 to VND 30,000,000 shall be imposed for any of the following violations:

a) Failing to fully preserve the registration dossiers of drugs or failing to provide information about registered drugs when there is information or evidence related to the safety and efficacy of such drugs during circulation at the request of competent state management agencies;

b) Failing to disclose information about the recalled drugs, organize the recall or receive the recalled drugs as prescribed by law;

c) Failing to update quality standards of drugs or drug materials as prescribed by law.

3. A fine from VND 30,000,000 to VND 50,000,000 shall be imposed for any of the following violations:

a) Failing to maintain operating conditions of the registered establishment within the validity duration of the marketing authorization of drugs or drug materials;

b) Failing to follow the approved risk management plan in the dossier of application for issuance of the marketing authorization for new pharmacochemical drugs, vaccines and biologicals (except probiotic biologicals);

c) Failing to carry out the procedures for registration of changing or supplementing the marketing authorization before the circulation of drugs or drug materials for major changes or minor changes that require approval;

d) Manufacturing or circulating drugs or drug materials with changes compared to the approved drug registration dossier that requires the procedures for granting the marketing authorization in accordance with law;

dd) Failing to make changes and supplements corresponding to the changes and supplements of contract-manufactured drugs for processed drugs satisfying the provisions of law, where the contract-manufactured drugs currently manufactured and circulated in the host country have changes and supplements relating to drug formulation; manufacturing process; quality standards of ingredients; quality standards of finished drugs; or trade names approved by competent management agencies of the host country;

e) Failing to make changes and supplements corresponding to the changes and supplements of pre-technology transfer drugs. For technology transfer drugs satisfying the provisions of law, where the pre-technology transfer drugs currently manufactured and circulated in the host country have changes and supplements relating to drug formulation; manufacturing process; quality standards of ingredients; quality standards of finished drugs; or trade names approved by competent management agencies of the host country;

g) Failing to report within the prescribed time limit the revocation of the manufacturing license of a foreign manufacturer or its failure to satisfy Good Manufacturing Practices in accordance with the law;

h) Failing to report within the prescribed time limit the recall of drugs and drug materials or revocation of the marketing authorization in accordance with law.

4. A fine from VND 50,000,000 to VND 70,000,000 shall be imposed for any of the following violations:

a) Failing to send a notification to competent agencies in case where drugs or drug materials obtaining a marketing authorization in Vietnam are recalled in any country in the world other than the manufacturing country or reference country that has issued the certificate of pharmaceutical product (CPP) submitted in the drug registration dossier;

b) Failing to send a notification to competent agencies in case where drugs or drug materials obtaining a marketing authorization in Vietnam are recalled in the manufacturing country or reference country that has issued the certificate of pharmaceutical product (CPP) submitted in the drug registration dossier;

c) Failing to notify competent agencies where there is a decision to revoke the marketing authorization of contract-manufactured drugs in any country in the world (during the validity period of the marketing authorization of the processed drugs);

d) Failing to notify in writing competent agencies where there is a decision to revoke the marketing authorization of pre-technology transfer drugs in any country in the world (during the validity period of the marketing authorization of the technology transfer drugs);

dd) Documents and information in the dossier for registration of drugs and drug materials are not based on actual research or production of the manufacturer, or such documents are concluded by competent agencies to be forged documents, without being subject to criminal prosecution;

e) Documents in the dossier for application for assessment of compliance with Good Manufacturing Practices of overseas manufacturers of drugs and drug materials are concluded by competent agencies to be forged documents without being subject to criminal prosecution.

5. Remedial measures:

Forcible recall of drugs or drug materials, for violations specified at Points dd and e, Clause 4 of this Article.

Article 57. Violation of regulations on production of drugs or drug materials

1. A fine from VND 5,000,000 to VND 10,000,000 shall be imposed for any of the following violations:

a) Vaccine-manufacturing establishments fail to make reports before changing or repairing the manufacturing establishments in accordance with law;

b) Failing to cooperate with or obstructing quality control agencies to take samples of drugs or drug materials in order to inspect their quality;

c) Failing to report on the recall of drugs or drug materials in accordance with law;

d) Failing to preserve samples of drugs, drug materials during testing drugs or drug materials as prescribed by law.

2. A fine from VND 10,000,000 to VND 20,000,000 shall be imposed for any of the following violations:

a) Manufacturing drugs and drug materials with minor changes compared to the approved drug registration dossier in cases where notification to competent agencies is required in accordance with the law but failing to make such notification, except for the case specified at Point b, Clause 1, Article 56 of this Decree;

b) Manufacturing drugs or drug materials with minor changes compared to the approved drug registration dossier but the content of such changes has not been approved by competent agencies in accordance with law, except for the cases specified at Point c, Clause 3, Article 56 of this Decree;

c) Failing to preserve samples of finished drugs for at least 12 months after the expiry of the shelf life of drugs; failing to preserve samples of materials that are active ingredients used for drug production for at least 12 months after the expiry of the shelf life of finished products from such materials;

d) Failing to preserve or preserving inadequately dossiers of manufacture of drugs or drug materials as prescribed by law.

3. A fine from VND 20,000,000 to VND 30,000,000 shall be imposed for any of the following violations:

a) Failing to follow the manufacturing process or testing process of drugs or drug materials in the approved drug registration dossiers as prescribed by law;

b) Manufacturing and circulating drugs with a level-3 violation as prescribed by law;

c) Failing to test drug materials and packaging directly contacting drugs before use in drug manufacture;

d) Failing to test drugs by drug testing establishments designated by competent agencies before the circulation of drugs subject to testing in accordance with law;

dd) Manufacturing drugs or drug materials with major changes compared to the approved drug registration dossier but the content of such changes has not been approved in accordance with law, except for the cases specified at Point c, Clause 3, Article 56 of this Decree;

e) Manufacturing and circulating drugs when the marketing authorization has expired, unless otherwise permitted by law;

g) Using drug materials or medicinal materials for drug manufacture, which have not been granted the marketing authorization or have not been announced in the list of drug materials or have not been announced quality standards as prescribed by law;

c) Failing to comply with regulations on preservation of drugs or drug materials during the course of storage at establishments manufacturing drugs or drug materials.

4. A fine from VND 30,000,000 to VND 40,000,000 shall be imposed for any of the following violations:

a) Failing to recall drugs or drug materials at the request of competent agencies or upon self-detection by the establishment in case where recall is required as prescribed by law;

b) Manufacturing and circulating drugs with a level-3 violation as prescribed by law;

c) Manufacturing drugs using packaging directly contacting drugs that fails to satisfy quality standards in accordance with law;

d) Manufacturing and circulating drug materials that fail to satisfy quality standards prescribed by law;

dd) Changing major or important production equipment that affects the manufacturing process and quality of drugs or drug materials without following the procedure of application for certificates of eligibility for pharmaceutical business or without making reports about such changes in accordance with law;

e) Changing the auxiliary system or changing the principles of designing and operating the utility system that affect the manufacturing environment but the establishment manufacturing drugs or drug materials fails to follow the procedure of application for certificates of eligibility for pharmaceutical business or fails to make reports about such changes in accordance with law;

g) Failing to report on the satisfaction of the requirements of good manufacturing practices for drugs or drug materials in accordance with law;

h) Failing to inspect quality of drugs or drug materials before release in accordance with law;

i) Manufacturing drugs from pharmaceutical ingredients manufactured by establishments that do not have documents proving the satisfaction of good manufacturing practices of drug materials as prescribed by law, or establishments that fail to meet requirements for good manufacturing practices of drug materials as announced by the competent agencies;

k) Manufacturing and circulating drugs using drug materials that have not yet been tested by drug manufacturers in accordance with the law.

5. A fine from VND 40,000,000 to VND 60,000,000 shall be imposed for any of the following violations:

a) Manufacturing and circulating drugs violating level-1 quality standards in accordance with law;

b) Manufacturing drugs or drug materials at a wrong place but the production line has been assessed by competent agencies to satisfy good manufacturing practices of drugs or drug materials;

c) Failing to make reports on changes in cases where a factory is expanded on the basis of existing factory structure or the structure, design of workshop, and production line is repaired or changed substantially;

d) Forging or modifying dossiers, papers, documents and certificates of competent organizations and agencies, and organizations and individuals in the manufacture of drugs or drug materials without being subject to criminal prosecution;

dd) Manufacturing drugs or drug materials beyond the scope stated in certificates of eligibility for pharmaceutical business or beyond the scope of assessment of good manufacturing practices for drugs or drug materials as prescribed by law;

e) Only maintaining the satisfaction of principles and standards of good manufacturing practices for drugs or drug materials at level 4.

6. A fine from VND 60,000,000 to VND 80,000,000 shall be imposed for any of the following violations:

a) Manufacturing and circulating in Vietnam drugs or drug materials that have not yet obtained a marketing authorization, except for the cases in which such drugs or drug materials are not required to be registered before being circulated in accordance with law;

b) Manufacturing drugs from drug materials that fail to meet quality standards or drug materials that have been recalled under notifications of competent state agencies or drug materials that have unknown origin or have expired;

c) Manufacturing drugs or drug materials at a place other than that registered in the approved drug registration dossier, except for the acts specified at Point b, Clause 5 of this Article;

d) Manufacturing drugs or drug materials at an establishment that has not obtained a certificate of eligibility for pharmaceutical business or has not been assessed for satisfaction of good manufacturing practices of drugs or drug materials as prescribed by law;

dd) Manufacturing drugs or drug materials during the period of suspension of operation or deprivation of the right to use certificates of eligibility for pharmaceutical business;

e) Manufacturing products other than drugs by a drug production line, except for the manufacture of dietary supplements by a production line of herbal medicines, traditional medicines or otherwise as prescribed by the Minister of Health;

g) Producing, processing, and preparing traditional medicines containing active ingredients without the permission of competent state agencies as prescribed by law.

7. A fine equal to 1.5 times the prescribed fine shall be imposed for violations related to combination drugs containing habit-forming pharmaceutical ingredients, combination drugs containing psychotropic pharmaceutical ingredients, combination drugs containing pre-substances, or radioactive drugs, or a fine equal to 2 times the prescribed fine shall be imposed for violations related to habit-forming drugs, psychotropic drugs, pre-substance drugs or materials that are habit-forming pharmaceutical ingredients, psychotropic pharmaceutical ingredients, or pre-substances used for drug manufacture, but not exceeding VND 100,000,000, and corresponding additional sanctions specified in Clause 8 of this Article and remedial measures specified in Clause 9 of this Article shall apply to the acts specified at Point dd, Clause 5 and Points c, d and dd, Clause 6 of this Article.

8. Additional sanctions:

a) Suspension of business activities related to violations for a period of between 01 month and 03 months, for the acts specified at Point c, Clause 3, and Point h, Clause 4, of this Article;

b) Suspension of operation of production lines related to the violations for a period of between 01 month and 03 months, for the acts specified at Points dd and e, Clause 4 and Points a and c, Clause 5 of this Article;

c) Suspension of business activities related to the violations for a period of between 03 months and 06 months, for the acts specified at Points b and dd, Clause 5 and Points a and c, Clause 6 of this Article;

d) Deprivation of the right to use certificates of eligibility for pharmaceutical business for a period of between 09 months and 12 months, for the acts specified at Points e and g, Clause 6 of this Article;

dd) Deprivation of the right to use certificates of eligibility for pharmaceutical business for a period of between 03 months and 06 months, for the acts specified at Point d, Clause 5 and Point b, Clause 6 of this Article;

e) Suspension of operation of pharmacy business establishments directly related to violations for a period of between 03 months and 06 months, for the acts specified at Point e, Clause 5 of this Article.

9. Remedial measures:

a) Forcible destruction of all drugs or drug materials, for the acts specified at Point c, Clause 3, Points b and c, Clause 4, Point a, Clause 5, and Clause 6 of this Article;

Article 58. Violation of regulations on wholesale of drugs or drug materials

1. A fine from VND 5,000,000 to VND 10,000,000 shall be imposed for any of the following violations:

a) Expanding a storehouse for preservation on the basis of existing storehouse structure or repairing or changing its structure and design but wholesalers of drugs or drug materials fail to make reports about changes together with technical documents corresponding to such changes in accordance with law;

b) Failing to cooperate with or obstructing quality control agencies to take samples of drugs or drug materials in order to inspect their quality;

c) Failing to make reports about the drug recall at the request of competent state agencies;

d) Purchasing and selling drugs with a level-3 violation of regulations on quality as prescribed by law after recall notices have been issued;

dd) Purchasing and selling drugs belonging to the national target program, aid drugs and other drugs that are not allowed to be sold in accordance with law;

e) Failing to keep documents related to batches of drugs or drug materials during the retention period prescribed by law.

2. A fine from VND 10,000,000 to VND 20,000,000 shall be imposed for any of the following violations:

a) Purchasing and selling drugs or drug materials as samples for registration, testing, scientific research, or display at exhibitions or fairs; purchasing or selling drug materials permitted for import for manufacturing drugs for exports contrary to regulations;

b) Selling drugs, drug materials, vaccines, or medical bio-products to establishments beyond the scope of business specified in certificates of eligibility for pharmaceutical business or purchasing drugs, drug materials, vaccines or medical bio-products of establishments beyond the scope of business specified in certificates of eligibility for pharmaceutical business;

c) Purchasing and selling drugs with a level-2 violation of regulations on quality as prescribed by law after recall notices have been issued;

d) Failing to recall drugs or drug materials at the request of competent agencies.

3. A fine from VND 20,000,000 to VND 30,000,000 shall be imposed for any of the following violations:

a) Selling drugs, drug materials, vaccines or medical bio-products to establishments that do not obtain a certificate of eligibility for pharmaceutical business or purchasing drugs, drug materials, vaccines or medical bio-products from establishments that do not obtain a certificate of eligibility for pharmaceutical business, except for the cases in which establishments conducting pharmaceutical activities not subject to issuance of certificates of eligibility for pharmaceutical business;

b) Failing to submit dossiers requesting periodic assessment of maintenance of compliance with good distribution practices for drugs as prescribed by law;

c) Failing to have equipment and computers connected to the Internet and failing to manage distribution activities using computer software;

d) Failing to establish mechanisms for transmission of information, or transmitting insufficient information on drug distribution and drug quality between manufacturers and customers and transmission of information to relevant management agencies upon request;

dd) The competent agencies conclude that the establishment maintains the satisfaction of principles and standards for good practices in distributing drugs or drug materials at level 3.

4. A fine from VND 30,000,000 to VND 40,000,000 shall be imposed for any of the following violations:

a) Purchasing and selling drugs with a level-1 violation of regulations on quality as prescribed by law after recall notices have been issued;

b) Purchasing and selling preprocessed medicinal materials that fail to satisfy quality standards as prescribed by competent state agencies;

c) Storing drugs and drug materials not in accordance with the conditions stated on labels; not at the business locations stated in the certificate of eligibility for pharmaceutical business, except where storage services for drugs and drug materials are used;

d) Changing locations of storage warehouses or adding new warehouses at the same business location where wholesalers of drugs and drug materials fail to report such changes together with technical documents corresponding to such changes in accordance with law;

dd) Changing the auxiliary system or changing the principles of designing and operating the utility system that affects the preservation requirements and conditions but wholesalers of drugs or drug materials fail to make reports on changes enclosed together with technical documents corresponding to such changes as prescribed by law.

5. A fine from VND 40,000,000 to VND 60,000,000 shall be imposed for any of the following acts of purchasing or selling drugs and drug materials:

a) Without a certificate of eligibility for pharmaceutical business, except where establishments conducting pharmaceutical activities are not subject to issuance of certificates of eligibility for pharmaceutical business;

b) Beyond the scope stated in the granted certificate of eligibility for pharmaceutical business;

c) At locations inconsistent with those stated in the granted certificate of eligibility for pharmaceutical business, except for purchase and sale activities conducted through e-commerce methods;

d) During the period of suspension of operation or during the period of deprivation of the right to use the certificate of eligibility for pharmaceutical business.

6. With regard to the acts of purchasing or selling drugs or drug materials subject to recall under notification by competent state agencies; of unknown origin; expired; without import permits, except for drugs and drug materials not required to obtain import permits before circulation as prescribed by law; or without marketing authorizations, except for drugs and drug materials not required to be registered before circulation, a fine shall be imposed according to one of the following levels:

a) A fine from VND 5,000,000 to VND 7,000,000 shall be imposed on goods valued at less than VND 5,000,000;

b) A fine from VND 7,000,000 to VND 10,000,000 shall be imposed on goods valued at between VND 5,000,000 and less than VND 10,000,000;

c) A fine from VND 10,000,000 to VND 20,000,000 shall be imposed on goods valued at between VND 10,000,000 and less than VND 20,000,000;

d) A fine from VND 20,000,000 to VND 30,000,000 shall be imposed on goods valued at between VND 20,000,000 and less than VND 30,000,000;

dd) A fine from VND 30,000,000 to VND 40,000,000 shall be imposed on goods valued at between VND 30,000,000 and less than VND 40,000,000;

e) A fine from VND 40,000,000 to VND 50,000,000 shall be imposed on goods valued at between VND 40,000,000 and less than VND 50,000,000;

g) A fine from VND 50,000,000 to VND 60,000,000 shall be imposed on goods valued at between VND 50,000,000 and less than VND 60,000,000;

h) A fine from VND 60,000,000 to VND 70,000,000 shall be imposed on goods valued at between VND 60,000,000 and less than VND 70,000,000;

i) A fine from VND 70,000,000 to VND 80,000,000 shall be imposed on goods valued at between VND 70,000,000 and less than VND 80,000,000;

k) A fine from VND 80,000,000 to VND 90,000,000 shall be imposed on goods valued at between VND 80,000,000 and less than VND 100,000,000;

l) A fine from VND 90,000,000 to VND 100,000,000 shall be imposed on goods valued at VND 100,000,000 or more.

7. A fine equal to 1.5 times the prescribed fine shall be imposed for violations related to pharmaceutical ingredients and drugs prohibited from use in certain industries and sectors, combination drugs containing habit-forming active ingredients or psychotropic pharmaceutical ingredients, combination drugs containing pre-substances, or radioactive drugs, or a fine equal to 2 times the prescribed fine shall be imposed for violations related to habit-forming drugs, psychotropic drugs, pre-substance drugs or materials that are habit-forming pharmaceutical ingredients, psychotropic pharmaceutical ingredients, or pre-substances used for drug manufacture, but not exceeding VND 100,000,000, and corresponding additional sanctions specified in Clause 8 of this Article and remedial measures specified in Clause 9 of this Article shall apply to any of the acts specified at Point e, Clause 1 and Points a and b, Clause 2, Point a, Clause 3, Point d, Clause 4, and Clauses 5 and 6 of this Article.

8. Additional sanctions:

a) Deprivation of the right to use certificates of eligibility for pharmaceutical business for a period of between 01 month and 02 months, for the acts specified at Points c and d, Clause 3 of this Article in cases of recidivism;

b) Deprivation of the right to use pharmacy practice certificates for a period of between 03 months and 06 months, for the acts specified at Points a, c, Clause 2, Clause 4, Point b, Clause 5 and Clause 6 of this Article;

c) Suspension of the operation of the establishment for a period of between 06 months and 09 months, for the acts specified at Point dd, Clause 3, Points a, c, Clause 5 and Clause 6 of this Article;

d) Suspension of operation for a period of between 03 months and 06 months, for the acts specified at Point b, Clause 3 of this Article.

9. Remedial measures:

Forcible destruction of all drugs or drug materials for the acts specified at Point b, Clause 4 and Clause 6 of this Article.

Article 59. Violation of regulations on retail of drugs or medicinal materials

1. A fine from VND 1,000,000 to VND 3,000,000 shall be imposed for any of the following acts of violation:

a) Selling preprocessed medicinal materials that fail to satisfy quality standards as prescribed by competent agencies;

b) The persons directly participating in retail of drugs do not have a professional degree as prescribed by law provisions;

c) Failing to keep a log of, or failing to use computers for management of the import, export, preservation, tracking of lot number, expiry date, origin of drugs and other relevant information as prescribed by law provisions;

d) Buying and selling drugs with a level-3 quality violation as prescribed by law provisions after a notice on recall of drugs is issued;

dd) Failing to clearly write down drugs’ name, strength, and expiry date for the user in cases of retailing drugs without a secondary package; and also failing to clearly write down drugs’ dose, number of times and route of administration in cases of retailing drugs without a prescription;

e) Failing to archive the documents, papers related to each lot of drugs and drug materials for a period specified by law regulations;

g) Failing to cooperate with or obstructing quality control agencies to take samples of drugs or drug materials in order to examine their quality.

2. A fine from VND 3,000,000 to VND 5,000,000 shall be imposed for any of the following acts of violation:

a) Changing the location of a drug retailer at the same place of business or expanding a drug retailer, or repairing and changing substantially the structure of a drug retailer without making reports about changes enclosed with technical documents corresponding to such changes in accordance with law provisions;

b) Failing to have separate areas for products other than drugs or failing to arrange signboards in separate areas stating “this product is not a drug” or placing products other than drugs together with drugs in cases of trading in cosmetics, functional foods, and medical equipment in accordance with law provisions;

c) Buying and selling drugs with a level-2 quality violation as prescribed by law provision after a notice on recall of drugs is issued;

d) Failing to install IT equipment connected to the Internet and manage drug purchase and sale activities using application software; or failing to control over the origin, price, and source of drugs purchased and sold or failing to ensure traceability of drugs; or failing to ensure full extraction of all such information data at the request of a management agency; or failing to fully connect and update data with the pharmaceutical information system as guided by the Ministry of Health.

3. A fine from VND 5,000,000 to VND 10,000,000 shall be imposed for any of the following acts of violation:

a) Failing to recall drugs and medicinal materials at the request of competent agencies;

b) Failing to arrange separate rooms for preparation or failing to arrange places to wash preparation tools in cases where drug retailers prepare prescription drugs;

c) Failing to have storehouses for preservation in cases where drug retailers have registered storehouses for preservation or fail to preserve drugs according to the conditions on the label or fail to comply with regulations on good practice of drug retailers;

d) Storing and retailing drugs outside of the scope of business specified in certificates of eligibility for pharmaceutical business; drugs under national target programs; donated drugs and other drugs not permitted for sale as prescribed by law provisions;

dd) Retailing vaccines;

e) Failing to submit a dossier of request for periodic assessment of the satisfaction of good practices of drug retailers in accordance with law provisions;

g) Having no equipment, failing to apply information technology, failing to implement network connection, failing to control the origin and price of drugs bought and sold as prescribed by law provisions, except for retailers of medicinal materials;

h) Failing to transfer information, or transferring incomplete information, on the purchase and sale of drugs and drug quality with their suppliers to customers upon request in accordance with law provisions, except for retailers of medicinal materials;

i) Being concluded by competent authorities as not yet satisfying the principles and standards of good practices for drug retailers;

k) Drugstores in a drugstore chain receiving drugs from an establishment other than the drugstore chain-organizing establishment;

l) Operating at a location inconsistent with the location stated in the granted certificate of eligibility for pharmaceutical business, except for activities of buying and selling by e-commerce methods;

m) Retailing drugs by e-commerce methods without provide online counselling and instructions on drug use to drug buyers; failing to publish adequate information about the certificate of eligibility for pharmaceutical business, pharmacy practice certificates of persons in charge of professional pharmacy activities of establishments, and information about approved drugs.

4. A fine from VND 10,000,000 to VND 20,000,000 shall be imposed for any of the following acts of violation:

a) Buying and selling drugs put for clinical trial;

b) Buying and selling drugs manufactured or prepared according to prescriptions for use at medical examination and treatment establishments to use outside such establishments, except for cases being permitted for purchase as prescribed by law provisions;

c) Buying and selling pharmacochemical drugs prepared according to prescriptions of another drugstore;

d) Buying and selling drugs on the list of drugs restricted from retail without obtaining the permission as prescribed by law provisions;

dd) Failing to take isolation measures or to keep any of the following drugs and medicinal materials in isolated areas, including drugs and medicinal materials that fail to meet quality standards, or drugs and medicinal materials that have been recalled under notification by competent state agencies, or drugs and medicinal materials that have expired or have unknown origin;

e) Buying and selling drugs with a level-3 quality violation as prescribed by law provisions after a notice on recall of drugs is issued;

g) Selling prescription drugs without prescriptions;

h) Drugstore chain-organizing establishments or drugstores in a drugstore chain rotating their persons in charge of professional pharmacy activities among drugstores attached to the drugstore chain without sending a written notice to competent agencies; drugstore chain-organizing establishments failing to notify or update to competent agencies the list of drugstores in the drugstore chain;

i) Conducting business by e-commerce methods in respect of drugs and drug materials under special control, or retailing drugs on the list of drugs restricted from retail, or retailing prescription drugs, except for the case of medical isolation upon the occurrence of a group-A infectious disease which is declared as an epidemic in accordance with the law provisions;

k) Trading in drugs and drug materials by e-commerce methods through means other than e-commerce trading exchanges, e-commerce applications, or websites with the function of online order placement;

l) Failing to send a written notice to competent agencies before conducting business in drugs or drug materials by e-commerce methods.

5. A fine from VND 20,000,000 to VND 30,000,000 shall be imposed for any of the following acts of buying and selling drugs or medicinal materials:

a) Failing to possess a certificate of eligibility for pharmaceutical business, except for the cases where establishments engaged in pharmaceutical activities not subject to grant of a certificate of eligibility for pharmaceutical business; operating beyond the business scope stated in the granted certificate of eligibility for pharmaceutical business;

b) Being in the period of suspension or deprivation of the right to use certificates of eligibility for pharmaceutical business;

c) Drugstores in a drugstore chain operating during the period in which the drugstore chain-organizing establishment has terminated its operation or suspended its operation for 06 months or more.

6. With regard to acts of buying and selling drugs or medicinal materials that have been recalled under notification by competent state agencies; of unclear origin; or that have expired or that have obtained no import license, except for the cases where drugs or medicinal materials are not required to obtain import licences prior to circulation in accordance with law provisions; or having no marketing authorization, except for cases where drugs or medicinal materials are not required to be registered before being circulated, a fine shall be imposed according to one of the following levels:

a) A fine ranged from VND 1,000,000 to VND 2,000,000 shall be imposed on goods valued at less than VND 1,000,000;

b) A fine ranged from VND 2,000,000 to VND 3,000,000 shall be imposed on goods valued at VND 1,000,000 and less than VND 2,000,000;

c) A fine ranged from VND 3,000,000 to VND 5,000,000 shall be imposed on goods valued at between VND 2,000,000 and less than VND 5,000,000;

d) A fine ranged from VND 5,000,000 to VND 7,000,000 shall be imposed on goods valued at between VND 5,000,000 and less than VND 10,000,000;

dd) A fine ranged from VND 7,000,000 to VND 10,000,000 shall be imposed on goods valued at between VND 10,000,000 and less than VND 15,000,000;

e) A fine ranged from VND 10,000,000 to VND 15,000,000 shall be imposed on goods valued at between VND 15,000,000 and less than VND 30,000,000;

g) A fine ranged from VND 15,000,000 to VND 20,000,000 shall be imposed on goods valued at between VND 30,000,000 and less than VND 40,000,000;

h) A fine ranged from VND 20,000,000 to VND 25,000,000 shall be imposed on goods valued between VND 40,000,000 and less than VND 50,000,000;

i) A fine ranged from VND 25,000,000 to VND 30,000,000 shall be imposed on goods valued at between VND 50,000,000 and less than VND 70,000,000;

k) A fine ranged from VND 30,000,000 to VND 40,000,000 shall be imposed on goods valued at between VND 70,000,000 and less than VND 100,000,000;

l) A fine ranged from VND 40,000,000 to VND 50,000,000 shall be imposed on goods valued at VND 100,000,000 or more.

7. A fine equal to 1.5 times shall be imposed for acts of violation related to drugs or pharmaceutical ingredients on the list of substances banned from use in a number of sectors and fields, combination drugs containing habit-forming pharmaceutical ingredients, combination drugs containing psychotropic pharmaceutical ingredients, combination drugs containing pre-substances or radioactive drugs, or a fine equal to 02 times shall be imposed for acts of violation related to habit-forming drugs, psychotropic drugs, pre-substance drugs, or materials that are habit-forming pharmaceutical ingredients, psychotropic pharmaceutical ingredients, or pre-substances, but not exceeding VND 100,000,000, and the additional sanction forms specified in Clause 8 of this Article and the remedial measures specified in Clause 9 of this Article shall apply correspondingly, for any of acts of violation specified at Points c and e Clause 1, Point a Clause 2, Point d Clause 3, and Clause 5 and Clause 6 of this Article.

8. Additional sanctions:

a) Deprivation of the right to use certificates of eligibility for pharmaceutical business for a definite time of between 01 month and 02 months, for the acts of violation specified at Points g and h, Clause 3 of this Article in cases of recidivism;

b) Deprivation of the right to use pharmacy practice certificates or certificates of eligibility for pharmaceutical business for a definite time of between 01 month and 03 months, for the acts of violation specified at Points b, c and d, Clause 4 of this Article;

c) Deprivation of the right to use pharmacy practice certificates for a definite time of between 03 months and 06 months, for the acts of violation specified at Point c Clause 5 and Clause 6 of this Article;

d) Suspension of operation of establishments for a definite time of between 01 month and 03 months, for the acts of violation specified at Point a, Clause 2 of this Article;

dd) Suspension of operation of establishments for a definite time of between 06 months and 09 months, for the acts of violation specified at Points dd and i Clause 3 and Point b Clause 5 of this Article;

e) Suspension of operation of drugstore chain-organizing establishments for a definite time of between 01 month and 03 months, when at least 02 drugstores in the drugstore chain commit the act of violation specified at Point e Clause 4 of this Article for the same drug;

9. Remedial measures:

a) Forcible refund of illicit profits earned through the commission of violations specified in Clause 5 and Clause 6 of this Article;

b) Forcible destruction of all drugs or medicinal materials of inferior quality, for the acts of violation specified at Point e, Clause 4 of this Article;

c) Forcible destruction of all drugs or medicinal materials, for the acts of violation specified at Point c, Clause 5 and Clause 6 of this Article.

Article 60. Violation of regulations on export and import of drugs or drug materials

1. A fine from VND 5,000,000 to VND 10,000,000 shall be imposed for any of the following acts of violation:

a) Failing to make reports on the recall of drugs or drug materials at the request of competent agencies;

b) Failing to cooperate with or obstructing quality control agencies to take samples of drugs or drug materials in order to inspect their quality;

c) Failing to retain samples of finished drugs, for imported drugs for which sample retention is required under regulations, for at least 12 months after the expiry date of the drugs;

d) Failing to retain samples, at the importing establishment, of materials being active ingredients used for drug manufacture, for materials for which sample retention is required under regulations, for at least 12 months after the expiry date of the finished drugs manufactured from such materials;

dd) Failing to report on the voluntary recall of drugs or drug materials in accordance with law provisions.

2. A fine from VND 10,000,000 to VND 20,000,000 shall be imposed for any of the following acts of violation:

a) Failing to make reports on the satisfaction of requirements on good storage practices of drugs or drug materials (hereinafter referred to as GSP) in accordance with law provisions;

b) Failing to keep documents related to each lot of imported drugs or drug materials for a specified period as prescribed by law provisions;

c) Exporting drugs or drug materials without a certificate of eligibility for pharmaceutical business in accordance with law provisions, or during the period of suspension of operation, or during the period of deprivation of the right to use the certificate of eligibility for pharmaceutical business, or exporting drugs or drug materials not consistent with the information stated in the export license or document permitting export, except for the case where the actual export quantity is smaller than the quantity licensed for export;

d) Exporting drugs or drug materials that have been recalled under notification as prescribed by law provisions;

dd) Exporting drugs or drug materials that are inconsistent with the scope stated in certificates of eligibility for pharmaceutical business;

e) Exporting medicinal materials on the list of precious, rare and endemic medicinal material species and varieties under control without permission of competent state management agencies.

3. A fine from VND 40,000,000 to VND 50,000,000 shall be imposed for any of the following acts of violation:

a) Preserving drugs or drug materials in storehouses for preservation that have not been assessed as dissatisfaction of GSP requirements or at locations that are inconsistent with the business location in granted certificates of eligibility for pharmaceutical business, except for the use of services of preserving drugs or drug materials;

b) Being concluded by competent agencies as maintaining the satisfaction of principles and standards of good storage practices for drugs and drug materials at level 3;

c) Importing drugs or drug materials in excess of the quantity stated in the import license approved by competent agencies, or having one of the following information inconsistent with the import license: packing specifications, exporting establishment, supplying establishment, or shelf life;

d) Failing to re-export all drugs or drug materials that are licensed to be imported for display at medical, pharmaceutical or medical equipment exhibitions or fairs after such exhibitions or fairs have been completed;

dd) Exporting drugs or drug materials under special control without export licenses;

e) Importing drugs or drug materials whose expiry dates are inconsistent with regulations on the remaining expiry date upon arrival at Vietnam's ports without the permission of a competent agency;

g) Failing to recall drugs or drug materials at the request of competent agencies;

h) Importing drugs or drug materials that are inconsistent with the scope of certificates of eligibility for pharmaceutical business;

i) Expanding storehouses for preservation on the basis of existing storehouse structure or repairing and changing substantially their structure and design or changing the backend system or changing the principles of design and operation of the utility system that affects the preservation requirements and conditions without making reports on changes enclosed together with technical documents corresponding to such changes as prescribed by law provisions.

4. A fine from VND 50,000,000 to VND 70,000,000 shall be imposed for any of the following acts of violation:

a) Documents in the approved dossiers of application for a license to import drugs or drug materials are concluded by competent agencies as fake documents, but not being subject to penal liability examination;

b) Importing drugs or drug materials that are manufactured at the places other than that in the approved dossiers of application for drug import license;

c) Information on drugs or drug materials in the dossiers of application for a license to import is not based on research or actual production of manufacturers.

5. A fine from VND 70,000,000 to VND 80,000,000 shall be imposed for any of the following acts of violation:

a) Importing drugs or drug materials without a certificate of eligibility for pharmaceutical business as prescribed by law provisions or during the period of operation suspension or during the period of deprivation of the right to use certificates of eligibility for pharmaceutical business;

b) Importing drugs or drug materials that have been recalled under notifications by competent state agencies;

c) Importing drugs or drug materials without marketing authorization, except for cases where drugs or drug materials are not required to be registered prior to circulation, or importing drugs or drug materials without import license, except for cases where drugs or drug materials are not required to obtain import license prior to circulation in accordance with law provisions, or importing drugs or drug materials with one of the following pieces of information inconsistent with the import license: active ingredient, concentration/strength, preparation form, or manufacturing establishment;

d) Foreign-invested pharmaceutical business establishments conducting activities directly related to distribution of drugs or drug materials prohibited by the law on pharmacy;

dd) Importing drugs or drug materials from establishments supplying drugs or drug materials other than those permitted to supply them in accordance with law provisions;

e) Continuing to supply or import drugs into Vietnam after the foreign manufacturing establishment has had its manufacturing license revoked or fails to satisfy good manufacturing practices for drugs.

6. A fine shall be imposed on acts of importing expired drugs or drug materials according to one of the following levels:

a) A fine ranged from VND 1,000,000 to VND 3,000,000 shall be imposed on goods valued at less than VND 2,000,000;

b) A fine ranged from VND 3,000,000 to VND 5,000,000 shall be imposed on goods valued at between VND 2,000,000 and less than VND 5,000,000;

c) A fine ranged from VND 5,000,000 to VND 10,000,000 shall be imposed on goods valued at between VND 5,000,000 and less than VND 10,000,000;

d) A fine ranged from VND 10,000,000 to VND 15,000,000 shall be imposed on goods valued at between VND 10,000,000 and less than VND 20,000,000;

dd) A fine ranged from VND 15,000,000 to VND 20,000,000 shall be imposed on goods valued at between VND 20,000,000 and less than VND 30,000,000;

e) A fine ranged from VND 20,000,000 to VND 30,000,000 shall be imposed on goods valued at between VND 30,000,000 and less than VND 40,000,000;

g) A fine ranged from VND 30,000,000 to VND 40,000,000 shall be imposed on goods valued at between VND 40,000,000 and less than VND 50,000,000;

h) A fine ranged from VND 40,000,000 to VND 50,000,000 shall be imposed on goods valued between VND 50,000,000 and less than VND 60,000,000;

i) A fine ranged from VND 50,000,000 to VND 60,000,000 shall be imposed on goods valued at between VND 60,000,000 and less than VND 80,000,000;

k) A fine ranged from VND 60,000,000 to VND 70,000,000 shall be imposed on goods valued at between VND 80,000,000 and less than VND 100,000,000;

l) A fine ranged from VND 70,000,000 to VND 80,000,000 shall be imposed on goods valued at VND 100,000,000 or more.

7. A fine equal to 1.5 times shall be imposed for acts of violation related to drugs or pharmaceutical ingredients on the list of substances banned from use in a number of sectors and fields, combination drugs containing habit-forming pharmaceutical ingredients, combination drugs containing psychotropic pharmaceutical ingredients, combination drugs containing pre-substances or radioactive drugs, or a fine equal to 02 times shall be imposed for acts of violation related to habit-forming drugs, psychotropic drugs, pre-substance drugs, or materials that are habit-forming pharmaceutical ingredients, psychotropic pharmaceutical ingredients, or pre-substances, but not exceeding VND 100,000,000, and the additional sanction forms specified in Clause 8 of this Article and the remedial measures specified in Clause 9 of this Article shall apply correspondingly, for any of acts of violation specified at Points c, d, dd and g Clause 2, Points a, c, d and h Clause 3, and Points a and c Clause 5 of this Article.

8. Additional sanctions:

a) Deprivation of the right to use pharmacy practice certificates of the persons in charge of professional pharmacy activities for a definite time of between 01 month and 03 months, for the acts of violation specified at Points b, c, d, dd and e, Clause 2 of this Article;

b) Deprivation of the right to use pharmacy practice certificates of the persons in charge of professional pharmacy activities for a definite time of between 03 months and 06 months, for the acts of violation specified at a, c, d, dd, e, g and i, Clause 3 of this Article;

c) Deprivation of the right to use pharmacy practice certificates of the persons in charge of professional pharmacy activities for a definite time of between 06 months and 09 months, for the acts of violation specified in Clause 5 of this Article;

d) Deprivation of the right to use certificates of eligibility for pharmaceutical business for a definite time of between 18 months and 24 months, for the acts of violation specified at Point d, Clause 5 of this Article;

dd) Suspension of business activities related to the acts of violation for a definite time of between 01 month and 03 months, for the acts of violation specified at Point dd and Point e Clause 2 of this Article;

e) Suspension of business activities related to the violations for a definite time of between 03 months and 06 months, for the acts of violation specified at Points b, c, dd, h, Clause 3 and Point b, Clause 4 of this Article;

g) Suspension of import of drugs or drug materials for a definite time of between 06 months and 09 months, for the acts of violation specified at Points a, b and c, Clause 5 of this Article.

9. Remedial measures:

Forcible bringing out of the territory of the Socialist Republic of Vietnam or forcible re-export of drugs or drug materials due to the commission of violations specified at Points c, d, e and h Clause 3, and Clauses 4, 5 and 6 of this Article. In cases where this measure is not applicable, drugs or drug materials must be destructed.

Article 61. Violation of regulations on preservation of drugs or drug materials, applicable to establishments providing the services of preserving drugs or drug materials and establishments engaged in pharmacy activities for non-commercial purposes

1. A fine from VND 5,000,000 to VND 10,000,000 shall be imposed for any of the following acts of violation:

a) Failing to make reports on changes enclosed together with technical documents corresponding to such changes to receiving agencies in cases where establishments of preservation change the location of storehouses at the same place of business or adding storehouses at a new location at the same place of business;

b) Failing to make reports on changes enclosed together with technical documents corresponding to such changes to receiving agencies in cases where establishments of preservation expand storehouses on the basis of existing storehouse structure or repair and change substantially their structure and design or change the backend system or the principles of design and operation of the utility system that affect the preservation requirements and conditions;

c) Failing to send written notifications of the satisfaction of GSP requirements to receiving agencies, failing to comply with the roadmap for implementation or to comply with GSP requirements applicable to establishments engaged in preservation, storage and supply of vaccines, drugs or drug materials, for establishments engaged in pharmaceutical activities for non-commercial purposes as prescribed by law provisions;

d) Failing to cooperate with or obstructing quality control agencies to take samples of drugs or drug materials in order to examine their quality;

dd) Failing to keep documents related to each lot of drugs or drug materials for a specified period in accordance with law provisions.

2. A fine from VND 20,000,000 to VND 30,000,000 shall be imposed for any of the following acts of violation:

a) Providing the services of preserving drugs or drug materials to entities against law provisions;

b) Medical examination and treatment establishments, vaccination establishments, commune-level establishments assigned to manage vaccination, focal establishments of preserving drugs of the national health programs, and of the people’s armed forces, and establishments of preserving vaccines under the national expanded vaccination program at the central, regional or provincial level fail to send written notifications of the satisfaction of GSP requirements to receiving agencies as prescribed by provisions before implementing activities of preserving drugs or drug materials;

c) Failing to comply with regulations on preservation of drugs or drug materials during the course of preservation or transportation of drugs or drug materials;

d) Providing the services of preserving drugs or drug materials at establishments that have not obtained a certificate of eligibility for pharmaceutical business with an appropriate scope for establishments providing the services of preserving drugs or drug materials.

3. A fine from VND 30,000,000 to VND 40,000,000 shall be imposed for any of the acts of providing the services of preserving drugs or drug materials in the following cases:

a) Failing to possess certificates of eligibility for pharmaceutical business;

b) Failing to comply with regulations on the location specified on granted certificates of eligibility for pharmaceutical business;

c) Being in the period of suspension or deprivation of the right to use certificates of eligibility for pharmaceutical business;

d) Failing to make reports on the satisfaction of requirements on good practices of GSP as prescribed by law provisions;

dd) Only maintaining the principles and standards of good practices of GSP requirements at level 3.

4. A fine equal to 1.5 times shall be imposed for the acts of violation related to drugs or pharmaceutical materials on the list of substances banned from use in a number of sectors and fields, combination drugs containing habit-forming pharmaceutical ingredients, combination drugs containing psychotropic pharmaceutical ingredients, combination drugs containing pre-substances or radioactive drugs, or a fine equal to 02 times shall be imposed for the acts of violation related to habit-forming drugs, psychotropic drugs, pre-substance drugs, or materials that are habit-forming pharmaceutical ingredients, psychotropic pharmaceutical ingredients, or pre-substances, but not exceeding VND 100,000,000, and the additional sanction forms specified in Clause 5 of this Article shall apply correspondingly, for any of acts of violation specified at Points a and dd Clause 1, Points a and d Clause 2, and Points a, b and c Clause 3 of this Article.

5. Additional sanctions:

a) Deprivation of the right to use pharmacy practice certificates for a definite time of between 01 month and 03 months, for the acts of violation specified in Clause 2 of this Article;

b) Suspension of operation of establishments related to the acts of violation for a definite time of between 01 month and 03 months, for the acts of violation specified in Clause 2 of this Article;

c) Suspension of operation of establishments for a definite time of between 06 months and 12 months, for the acts of violation specified at Points a, b, c and dd, Clause 3 of this Article.

6. Remedial measures:

a) Forcible destruction of all drugs or drug materials of inferior quality, for the acts of violation specified at Point c Clause 2 of this Article;

b) Forcible destruction of all drugs or drug materials, for the acts of violation specified at Point a, Clause 3 of this Article;

c) Forcible refund of profits earned through the commission of the acts of violation specified at Points a, b and c, Clause 3 of this Article.

Article 62. Violation of regulations on testing, clinical trial, or bioequivalence trial of drugs

1. A fine from VND 10,000,000 to VND 15,000,000 shall be imposed for any of the following acts of violation:

a) Failing to make reports on changes enclosed together with technical documents corresponding to such changes to receiving agencies in cases where testing establishments expand laboratories on the basis of the structure of laboratories that have been repaired or changed substantially the structure and design or have been changed the backend system or have been changed the principles of design and operation of the utility system, affecting the testing environment;

b) Taking drug samples against the Ministry of Health’s regulations on drug sampling, applicable to establishments providing the services of drug testing.

2. A fine from VND 15,000,000 to VND 20,000,000 shall be imposed for any of the following acts of violation:

a) Providing the services of testing drugs or drug materials, the services of bioequivalence trial, or the services of clinical trial in contravention of the scope or beyond the scope stated in certificates of eligibility for pharmaceutical business or the scope of assessing the satisfaction of requirements on good laboratory practices of drugs or drug materials (hereinafter referred to as GLP) as well as good practices of clinical trials of establishments involved in pharmaceutical activities for non-commercial purposes;

b) Providing personal information about participants in bioequivalence trials of drugs without their consent;

c) Concealing information or failing to provide sufficient and truthful information to participants in drug trials about bioequivalence study of drugs, the trial process and possible risks.

3. A fine from VND 20,000,000 to VND 30,000,000 shall be imposed for any of the following acts of violation:

a) Providing the services of bioequivalence trials or clinical trials of drugs when establishments have not obtained a certificate of eligibility for pharmaceutical business or when establishments have not been assessed for the eligibility for good clinical practice, applicable to establishments operating for non-commercial purposes;

b) Changing the content of approved research dossiers and protocols related to bioequivalence trials of drugs;

c) Failing to make reports on the satisfaction of GLP requirements as prescribed by law provisions;

d) Only maintaining the satisfaction of GLP requirements at level 3;

dd) Failing to send reports on changes enclosed together with technical documents corresponding to such changes to agencies receiving dossiers of the GLP satisfaction in cases where testing establishments change the location of laboratories at the same place of business or add laboratories at a new location at the same place of business.

4. A fine from VND 30,000,000 to VND 40,000,000 shall be imposed for acts of forging or falsifying testing or analytical results of drug samples tested or analyzed.

5. A fine equal to 1.5 times shall be imposed for the acts of violation related to drugs or pharmaceutical ingredients on the list of substances banned from use in a number of sectors and fields, combination drugs containing habit-forming pharmaceutical ingredients, combination drugs containing psychotropic pharmaceutical ingredients, combination drugs containing pre-substances or radioactive drugs, or a fine equal to 02 times shall be imposed for the acts of violation related to habit-forming drugs, psychotropic drugs, pre-substance drugs, or materials that are habit-forming pharmaceutical ingredients, psychotropic pharmaceutical ingredients, or pre-substances, but not exceeding VND 100,000,000, and the additional sanction forms specified in Clause 6 of this Article shall apply correspondingly, for any of acts of violation specified at Point a Clause 2 and Points a and dd Clause 3 of this Article.

6. Additional sanctions:

a) Deprivation of the right to use certificates of eligibility for pharmaceutical business for a definite time of between 01 month and 03 months, for the acts of violation specified in Clause 2, Points a, b and d Clause 3, and Clause 4 of this Article, except for the case specified at Point b of this Clause;

b) Suspension of operation, applicable to establishments operating for non-commercial purposes for a definite time of between 01 month and 03 months, for the acts of violation specified in Clause 2, Points a, b and d Clause 3, and Clause 4 of this Article;

c) Suspension of operation for a definite time of between 22 months and 24 months for an establishment committing violations specified at Point c, Clause 3 of this Article.

Article 63. Violation of regulations on clinical trials of drugs

1. A fine from VND 15,000,000 to VND 20,000,000 shall be imposed for any of the following acts of violation:

a) Providing personal information of participants in clinical trials of drugs without their consent;

b) Failing to make reports on the implementation process or failing to publish results of drug clinical trials in accordance with law provisions;

c) Failing to comply with regulations on good practices of drug clinical trials.

2. A fine from VND 20,000,000 to VND 30,000,000 shall be imposed for any of the following acts of violation:

a) Conducting clinical trials of drugs without being assessed in terms of scientific and ethical issues by the National Council of Ethics in Biomedical Research and being approved in writing by the Minister of Health;

b) Changing the content of research dossiers and protocols approved by the Minister of Health.

3. A fine from VND 30,000,000 to VND 40,000,000 shall be imposed for any of the following acts of violation:

a) Using drugs put for clinical trials for other purposes;

b) Forcing a person to participate in drug trial research.

4. A fine equal to 02 times shall be imposed for the acts of violation related to habit-forming drugs, psychotropic drugs or pre-substance drugs, but not exceeding VND 100,000,000 and the additional sanction forms specified in Clause 5 of this Article shall apply correspondingly, for the acts of violation specified in Clauses 2 and 3 of this Article.

5. Additional sanctions:

a) Deprivation of the right to use certificates of eligibility for pharmaceutical business or suspension of operation, applicable to establishments operating for non-commercial purposes for a definite time of between 01 month and 03 months, for the acts of violation specified in Clauses 1 and 2 of this Article;

b) Deprivation of the right to use certificates of eligibility for pharmaceutical business or suspension of operation, for establishments that operate for non-commercial purposes for a definite time of between 03 months and 06 months, for the acts of violation specified in Clauses 3 and 4 of this Article.

Article 64. Violation of regulations on packages, labels of drugs and drug materials

1. A fine from VND 5,000,000 to VND 10,000,000 shall be imposed for any of the following acts of violation:

a) Importing, buying or wholesaling drugs or drug materials without the manufacturer's intact commercial package, except for cases being permitted in accordance with law provisions;

b) Importing medicinal materials without the origin being written down on secondary packages.

2. A fine from VND 10,000,000 to VND 20,000,000 shall be imposed for any of the following acts of violation:

a) An establishment manufactures or imports drugs or drug materials with packages against the approved dossier, except for cases specified at Point b, Clause 3 of this Article;

b) Registration establishments or pharmacy business establishments falsify and modify information on the manufacture date, manufacture lot number of drugs or drug materials written on the original label;

c) Failing to update drug information on the label or package insert of drugs circulated in Vietnam at the request of the Ministry of Health;

d) Importing establishments, registration establishments, domestic manufacture establishments circulate drugs or drug materials whose labels or package inserts are inconsistent with the approved contents or fails to reflect the correct information of drugs regarding the contents not subject to approval.

3. A fine from VND 20,000,000 to VND 30,000,000 shall be imposed for any of the following acts of violation:

a) Changing or modifying the shelf life of a drug on the label;

b) Packaging materials or forms fail to satisfy the requirements for ensuring the quality of drugs or drug materials;

c) Failing to update drug information related to contraindications or narrowing down of drug users as prescribed by law provisions.

4. Additional sanctions:

Suspension of business activities related to the acts of violation for a definite time of between 01 month and 03 months, for acts of violation specified at Point b, Clause 2 and Clause 3 of this Article.

5. Remedial measures:

Forcible recall to remediation or destruction of all drugs or drug materials of inferior quality, for the acts of violation specified at Points b, c, d, Clause 2 and Clause 3 of this Article.

Article 65. Violation of regulations on drugs subject to special control

1. A fine from VND 5,000,000 to VND 10,000,000 shall be imposed for any of the following acts of violation:

a) Preserving, manufacturing, preparing, dispensing, and using drugs or drug materials under special control at an establishment involved in pharmacy activities for non-commercial purposes in contravention of law provisions;

b) Transporting, delivering, or receiving drugs under special control in contravention of law provisions;

c) Destroying drugs subject to special control in contravention of law provisions.

2. A fine from VND 5,000,000 to VND 10,000,000 shall be imposed for a retailer or a fine from VND 10,000,000 to VND 20,000,000 shall be imposed for an establishment providing the service of preserving drugs or drug materials, clinical trial, bioequivalence trial of drug or drug testing, or a fine from VND 30,000,000 to VND 40,000,000 shall be imposed for an establishment manufacturing, exporting, importing, or wholesaling drugs or drug materials that commits any of the following acts of violation:

a) Failing to have sufficient conditions of physical and technical foundations and personnel to prevent loss of drugs under special control as prescribed by law provisions;

b) Supplying or receiving materials that are habit-forming pharmaceutical ingredients, psychotropic pharmaceutical ingredients, or pre-substances used as drugs without an order approved by competent state agencies; supplying or receiving habit-forming drugs, psychotropic drugs, or pre-substance drugs without approval by competent state agencies in accordance with law provisions.

3. Additional sanctions:

Suspension of business activities related to the acts of violation for a definite time of between 01 month and 03 months, for the acts of violation specified in Clause 2 of this Article.

Article 66. Violation of regulations on management of drug prices

1. A fine from VND 10,000,000 to VND 20,000,000 shall be imposed for a drug retailer on the premise of a medical examination and treatment establishment that sells drugs with a retail surplus higher than the maximum rate of retail surplus in accordance with law provisions.

2. With regard to acts of wholesaling prescription drugs while their projected wholesale prices have not yet declared by manufacturers, establishments ordering the drug processing or establishments importing the drugs or while the selling price of such drugs is higher than the declared or re-declared projected price in accordance with law provisions, except for cases specified at Point a, Clause 3 of this Article, a fine shall be imposed according to one of the following levels:

a) A fine ranged from VND 1,000,000 to VND 3,000,000 shall be imposed on drugs whose selling price calculated on the smallest packaging unit is less than or equal to VND 1,000;

b) A fine ranged from VND 3,000,000 to VND 5,000,000 shall be imposed for drugs whose selling price calculated on the smallest packaging unit is from over VND 1,000 to VND 5,000;

c) A fine ranged from VND 5,000,000 to VND 7,000,000 shall be imposed for drugs whose selling price calculated on the smallest packaging unit is from over VND 5,000 to VND 100,000;

d) A fine ranged from VND 7,000,000 to VND 10,000,000 shall be imposed for drugs whose selling price calculated on the smallest packaging unit is from over VND 100,000 to VND 1,000,000;

dd) A fine ranged from VND 10,000,000 to VND 15,000,000 shall be imposed for drugs whose selling price calculated on the smallest packaging unit is over VND 1,000,000.

3. A fine from VND 30,000,000 to VND 50,000,000 shall be imposed for any of the following acts of violation:

a) Failing to declare projected drug wholesale prices for prescription drugs before wholesaling the first lot of drugs to the market, or failing to re-declare projected drug wholesale prices when changing the projected drug wholesale prices that have been declared or re-declared previously posted on the portal of the Ministry of Health;

b) Failing to report or provide explanations according to written recommendations or requests of state management agencies in charge of drug prices.

4. Remedial measures:

a) Forcible refund of the full amount of difference, for the acts of violation specified in Clause 1 and Clause 2 of this Article. In cases of failing to refund to customers, the amount of difference shall be remitted into the state budget in accordance with law provisions.

b) Forcible submission of dossiers of application for declaration or re-declaration of drug prices, for the act of violation specified at Point a Clause 3 of this Article;

c) Forcible reporting according to the written recommendations, for the act of violation specified at Point b Clause 3 of this Article.

Article 67. Violation of regulations on drug information

1. A fine from VND 200,000 to VND 500,000 shall be imposed for any of the following acts of violation:

a) The pharmaceutical sales representative (hereinafter referred to as drug representative) do not wear a drug representative’s card while working;

b) Introducing drugs without the consent of medicine practitioners.

2. A fine from VND 5,000,000 to VND 10,000,000 shall be imposed for any of the following acts of violation:

a) Failing to send the list of persons who are granted or revoked a drug representative’s card of a pharmacy business establishment to the provicial-level Department of Health where the drug representative carries out drug introduction activities;

b) Drug representatives introduce products other than drugs;

c) Drug representatives introduce drugs that are not assigned by pharmacy business establishments.

3. A fine from VND 15,000,000 to VND 30,000,000 shall be imposed for acts of giving drug information to medicine or pharmacy practitioners that fall into any of the following acts of violation:

a) Drug information contents containing information not included in the materials as prescribed by law provisions;

b) Drug information contents not fully containing information as prescribed by law provisions;

c) Drug information contents not satisfying the requirements as prescribed by law provisions;

d) Comparing and introducing their own drugs better than those of other establishments without being proved by the scientific documents approved by competent agencies;

dd) Drug representatives approach patients, medical records, prescriptions, discusses or requests of information related to the patients;

e) Failing to send a written notice to the specialized health agency under the provincial-level People’s Committee of the locality where the drug information provision is held in the form of a drug introduction seminar, regarding the seminar agenda, reports used at the seminar, seminar participants, and the time and location of the drug introduction seminar.

4. A fine from VND 20,000,000 to VND 30,000,000 shall be imposed for any of the following acts of violation:

a) Failing to make reports and provide updates on information to competent agencies on the quality, safety and efficacy of drugs manufactured, registered, circulated, prepared or processed by their establishments;

b) Drug representatives perform activities related to drug purchase, sale and consignment with medicine practitioners.

5. A fine from VND 30,000,000 to VND 40,000,000 shall be imposed for any of the following acts of violation:

a) Providing information, marketing, consulting, labeling, instructing for the use of foods, cosmetics and other products other than drugs that are used to prevent and treat diseases, diagnose and alleviate diseases, and adjust the physiological functions of the human body, causing consumers to misunderstand those products as drugs, except for medical equipment;

b) Using material or financial benefits to influence physicians and drug users in order to promote drug prescription and use;

c) Modifying or forging legal papers of competent state agencies in the dossiers of application for certification of drug information or upon drug information provision but not being subject to penal liability examination;

d) Using certificates not yet recognized by the Ministry of Health, using material benefits, taking advantage of names of organizations and individuals, types of symbols, images, status, prestige, letters, letters of thanks in order to provide information about drugs;

dd) Using results of clinical research, preclinical research, testing, or bioequivalence testing that have not yet recognized by the Ministry of Health in order to provide information about drugs.

6. Additional sanctions:

a) Suspension of operation of establishments for a definite time of between 03 months and 06 months, for the acts of violation specified at Point a, Clause 5 of this Article, in cases of violations committed 03 times per year or more;

b) Confiscation of material evidences of administrative violations that are part of material and financial benefits, for the acts of violation specified at Point b, Clause 5 of this Article.

7. Remedial measures:

Forcible recall and removal of infringing elements, for the acts of violation specified at Points a, b and c Clause 3, and Points a, d and dd Clause 5 of this Article. In cases of failing to remove the infringing elements, the product is forced to be destroyed.

Article 68. Violation of regulations on cosmetic product declaration

1. A fine from VND 10,000,000 to VND 20,000,000 shall be imposed for any of the following acts of violation:

a) Failing to declare truthful contents in the cosmetic product declaration forms;

b) Changing the announced contents and being granted the receipt number of cosmetic product declaration forms without being approved in writing by competent agencies in accordance with law provisions.

2. A fine from ND 20,000,000 to VND 30,000,000 shall be imposed for acts of putting cosmetic products into circulation without being granted the receipt number of cosmetic product declaration forms orfor the act of putting cosmetic products into circulation by organizations or individuals responsible for bringing the products to the market after the receipt number of cosmetic product declaration forms has expired.

3. A fine from VND 30,000,000 to VND 40,000,000 shall be imposed for the acts of forging documents, using fake seals or forging signatures or seals of Vietnamese or foreign functional agencies or manufacturers, product owners in the cosmetic product notification dossiers that are not subject to penal liability examination.

4. Additional sanctions:

Suspension of cosmetic business operation of organizations or individuals responsible for bringing the products to the market for a definite time of between 06 months and 09 months from the date of issuance of the decision of competent agencies, for the act specified in Clause 2 of this Article.

5. Remedial measures:

a) Forcible recall and destruction of cosmetic products related to violations, for the acts of violation specified in Clause 2 and Clause 3 of this Article;

b) Forcible return of the receipt number of cosmetic product declaration forms for the acts of violation specified at Point a Clause 1 and Clause 3 of this Article.

Article 69. Violation of regulations on cosmetic manufacture

1. A fine from VND 30,000,000 to VND 40,000,000 shall be imposed for any of the following acts of violation:

a) Failing to apply a quality management system according to the principles and standards of “cosmetic good manufacturing practice” (CGMP-ASEAN);

b) Manufacturing cosmetics according to formulas that are inconsistent with the formulas included in the cosmetic product notification dossiers;

c) Using expired ingredients, failing to meet quality standards in the production of cosmetics;

d) Manufacturing cosmetics that fail to meet quality standards;

dd) Manufacturing at the wrong place indicated on certificates of eligibility for cosmetic manufacturing;

e) Failing to manufacture in accordance with the scope inscribed on certificates of eligibility for cosmetic manufacturing;

g) Manufacturing cosmetics containing substances banned from use in cosmetics or in excess of the permitted limits for substances that limit the concentration or strength of use in accordance with law provisions.

2. A fine from VND 40,000,000 to VND 50,000,000 shall be imposed for any of the following acts of violation:

a) Manufacturing cosmetics without a certificate of eligibility for cosmetic manufacturing;

b) Forging documents in the dossier of application for grant, re-grant or adjustment of a certificate of eligibility for cosmetic manufacturing, but not being subject to penal liability examination;

c) Failing to satisfy one of the conditions after being granted a certificate of eligibility for cosmetic manufacturing as prescribed by law provisions.

d) Manufacturing cosmetics during the period of suspension of operation or during the period of deprivation of the right to use the certificate of eligibility for cosmetic manufacturing.

3. Additional sanctions:

a) Suspension of cosmetic manufacture operation of the establishments for a definite time of between 09 months and 12 months from the date of issuance of the decision of competent agencies, for the act specified at Point e Clause 1 of this Article;

b) Suspension of cosmetic manufacture operation for a definite time of between 12 months and 18 months from the date of issuance of the decision of competent agencies, for the act specified at Point a Clause 2 of this Article;

c) Deprivation of the right to use certificates of eligibility for cosmetic manufacturing for a definite time of between 01 month and 03 months, for the acts of violation specified at Points a, d and g, Clause 1 of this Article;

d) Deprivation of the right to use certificates of eligibility for cosmetic manufacturing for a definite time of between 03 months and 06 months, for the acts of violation specified at Point b, Clause 2 of this Article.

4. Remedial measures:

a) Forcible recall and destruction of the entire quantity of cosmetic products, for the acts of violation specified in Clause 1 and Clause 2 of this Article. In case cosmetic products fail to meet the standards on packaged weight or volume specified at Point d Clause 1 of this Article, the forcible destruction shall not be required;

b) Forcible return of the receipt number of cosmetic product declaration forms, for the acts of violation specified at Points a, b, c, dd and e Clause 1, and Points b, c and d Clause 2 of this Article.

Article 70. Violation of regulations on buying and selling cosmetics in the cosmetic business

1. A fine from VND 5,000,000 to VND 10,000,000 shall be imposed for cases where a lot of infringing goods is valued at less than VND 20,000,000 or a fine from VND 10,000,000 to VND 20,000,000 shall be imposed for cases where a lot of infringing goods is valued at VND 20,000,000 or more, calculated according to the selling prices of organizations and individuals who are not responsible for bringing the products to the market when they commit any of the following acts of violation:

a) Trading in cosmetics without manufacturers’ intact packages;

b) Trading in cosmetics that have expired or passed the time limit as recommended by manufacturers;

c) Trading in cosmetics that have been included in the recall notification by competent state agencies due to violations of law provisions;

2. A fine from VND 20,000,000 to VND 30,000,000 shall be imposed on organizations or individuals responsible for bringing products to the market that commit any of the following acts of violation:

a) Trading in cosmetics that fail to satisfy quality standards or to ensure safety for users;

b) Trading in cosmetics without manufacturers' intact packages;

c) Trading in cosmetics that have expired or passed the time limit as recommended by manufacturers;

d) Trading in cosmetics that have been included in the recall notification by competent state agencies due to violations of law provisions;

dd) Trading in cosmetics with the product information files (PIF) incomplete as prescribed by law provisions;

e) Trading in cosmetics having labels stating features or uses inconsistent with the notification dossier, inconsistent with the nature of the product, or not being features of cosmetic products.

3. A fine from VND 30,000,000 to VND 40,000,000 shall be imposed on organizations or individuals responsible for bringing products to the market that commit any of the following acts of violation:

a) Trading in cosmetics with ingredients banned from use in cosmetics or in excess of the permitted limits for substances with prescribed concentration and strength limits in accordance with law provisions;

b) Trading in cosmetics without having, or failing to present, the product information files (PIF) within the time limit prescribed by law provisions upon request of inspection by competent agencies;

c) Trading in cosmetics with formulas that are inconsistent with the approved notification dossiers;

d) Failing to recall cosmetics at the request of competent state agencies.

4. Remedial measures:

a) Forcible recall and destruction of cosmetic products for the acts of violation specified in Clauses 1, 2 and Points a, b, c, Clause 3 of this Article;

b) Forcible return of the receipt number of cosmetic product declaration forms for the acts of violation specified in Clause 3 of this Article.

Section 4

ACTS OF ADMINISTRATIVE VIOLATION ON MEDICAL EQUIPMENT

Article 71. Violation of regulations on classification of medical equipment

1. A fine from VND 5,000,000 to VND 10,000,000 shall be imposed for the act of the holder of the marketing authorization number of medical equipment failing to conduct classification or declare the result of classification of medical equipment on the portal of the Ministry of Health in accordance with law provisions.

2. A fine from VND 50,000,000 to VND 75,000,000 shall be imposed for any of the following acts of violation:

a) Failing to send a written report to the agency receiving the dossier of application for grant of a marketing authorization number in order to stop the procedure for grant of the marketing authorization number in case where the classification results have been recalled;

b) Failing to stop customs clearance procedures and failing to send a written report to the border-gate Customs office where customs clearance is expected to be carried out in order to stop customs clearance procedures, and to the agency that granted the marketing authorization number for revocation of the marketing authorization number, in case where the classification results have been revoked but customs clearance procedures have not yet been carried out;

c) Failing to send a written report to the Customs agency where customs clearance procedures have been carried out (which must clearly state the quantity of medical equipment already cleared from customs procedures, and that import procedures for subsequent shipments must not carried out until the medical equipment is granted a new marketing authorization number according to the adjusted classification result) in case where the classification results have been revoked and customs clearance procedures have been carried out but the medical equipment has not yet been sold to users;

d) Failing to send a written report to the agency that granted the marketing authorization number (clearly stating the quantity of cleared medical equipment and sale and purchase contracts (if any)) in case where the classification results have been revoked and customs clearance procedures have been carried out but the equipment has not yet been sold to users;

dd) Failing to send a written report to the agency that granted the marketing authorization number (clearly stating the quantity of medical equipment sold to medical establishments) in case where the classification results have been revoked and the medical equipment has been sold to medical establishments;

e) Failing to send a written report to medical establishments currently using such medical equipment in case where the classification results have been revoked and the medical equipment has been sold to medical establishments;

g) Failing to complete the dossier on circulation of medical equipment at medical establishments after a new marketing authorization number is granted, in case where the classification results have been revoked and the medical equipment has been sold to medical establishments (in case the medical equipment with a granted marketing authorization number uses a classification results incorrect regarding the classification level but not potentially affecting the health of patients: medical establishments may continue to use such medical equipment);

h) Failing to implement remedial measures to ensure the normal operation of medical establishments in case where the classification results have been revoked and the medical equipment has been sold to medical establishments (in case the medical equipment with a granted marketing authorization number uses a classification results incorrect regarding the classification level that potentially affect the health of patients: medical establishments may not continue to use such medical equipment).

3. A fine from VND 80,000,000 to VND 100,000,000 shall be imposed for any of the following acts of violation:

a) Medical equipment classification is not based on the rules of risk level classification;

b) Failing to stop circulating medical equipment and fail to take measures to recall medical equipment with such marketing authorization number (in cases where the dossier of application for such marketing authorization number uses the classification results being revoked) and customs clearance procedures have been carried out but the equipment has not yet been sold to users.

4. Additional sanctions:

a) Suspension of operation related to the acts of violation for a definite time of between 01 month and 03 months, for the acts of violation specified at Points a, b, c, d, dd and e Clause 2 of this Article;

b) Suspension of operation related to the acts of violation for a definite time of between 03 months and 06 months, for the acts of violation specified at Point g and Point h Clause 2 of this Article.

Article 72. Violation of regulations on medical equipment manufacture

1. A fine from VND 5,000,000 to VND 10,000,000 shall be imposed for the act of failing to make a written notice of changes enclosed with documents related to such changes, or failing to update documents evidencing such changes in the declaration dossier already publicized on the portal on medical equipment management within 03 working days from the occurrence of one of the changes related to the previous declaration dossier in accordance with law provisions.

2. A fine from VND 10,000,000 to VND 20,000,000 shall be imposed for any of the following acts of violation:

a) The dossier of application for declaration of eligibility for medical equipment manufacture has incomplete dossier components or fails to ensure the legality as prescribed law provisions;

b) Manufacturing medical equipment without a quality control system satisfying ISO 13485.

3. A fine from VND 20,000,000 to VND 30,000,000 shall be imposed for any of the following acts of violation:

a) Failing to have a system for monitoring the dispatching, warehousing, inventory and use of narcotic substances and precursors as well as the medical equipment and raw materials containing narcotic substances and precursors, for establishments manufacturing medical equipment containing narcotic substances and precursors;

b) Failing to store medical equipment and raw materials containing narcotic substances and precursors in a separate area in the same warehouse or in a separate warehouse, for establishments manufacturing medical equipment containing narcotic substances and precursors;

c) Medical equipment manufacturing establishments having not yet submitted the declaration dossier to the provincial-level Department of Health of the locality where the manufacturing location is situated upon manufacture of medical equipment;

d) Failing to retain papers and documents in the submitted dossier of application for declaration of eligibility for medical equipment manufacture.

4. Additional sanctions:

Suspension of operation for a definite time of between 01 month and 03 months for the acts of violation prescribed at Point b Clause 2 and Clause 3 of this Article.

5. Remedial measures:

Forcible recall, destruction or recycling of medical equipment, for the acts of violation specified in Clause 3 of this Article.

Article 73. Violation of regulations on circulation of medical equipment

1. A fine from VND 20,000,000 to VND 40,000,000 shall be imposed for any of the following acts of violation:

a) Placing a medical equipment on the market without a label with adequate information in accordance with the current law provisions on labeling of goods;

b) Placing a medical equipment on the market without an instruction for use of the medical equipment in Vietnamese;

c) Placing medical equipment on the market without information about establishments, conditions and duration of warranty, except for disposable medical equipment as prescribed by the owner of such medical equipment or cases documents proving that there is no warranty are presented;

d) During the placement of the medical equipment on the market, failing to send a written notice of changes, enclosed with documents related to such changes, and update them to its dossier of application for declaration of applicable standards published on the portal on medical equipment management within 05 working days;

dd) During the placement of the medical equipment on the market, failing to send a written notice of changes, enclosed with documents related to such changes, and update them to its dossier of application for registration published on the portal on medical equipment management within 10 working days;

e) Failing to send their commitment to the Ministry of Health through the portal on medical equipment management within 60 days from the date on which the owner of medical equipment or marketing authorization number holder declares termination of manufacturing or goes bankrupt or is dissolved.

g) Manufacturer placing medical equipment on the market without making declaration of eligibility for manufacture of medical equipment, for medical equipment manufactured domestically;

h) Placing imported medical equipment on the market in case the manufacturer has not obtained a certificate of satisfaction of quality management standards ISO 13485 and such imported medical equipment has not been permitted for circulation in any country in the world;

i) Placing medical equipment on the market that fails to comply with national technical regulations or standards announced by the manufacturers.

2. A fine from VND 40,000,000 to VND 60,000,000 shall be imposed for any of the following acts of violation:

a) Failing to carry out the declaration of applicable standards for Type-A or Type-B medical equipment according to law provisions in cases where there are changes in the medical equipment owner, the type of the medical equipment, its category, intended purposes or indications for use, or additional information about the manufacturer or product code is provided;

b) Failing to establish, organize or manage the traceability of medical equipment on the market as prescribed by law provisions;

c) Failing to keep the sufficient dossiers of post-sale medical equipment management as prescribed by law provisions;

d) The organization declaring applicable standards or applying for registration number of a medical equipment not establishing and maintaining a warranty center in Vietnam or not signing a contract with a qualified warranty center, unless otherwise such medical equipment is single-use medical equipment as defined by its product owner or there are documents proving that it is not under warranty;

dd) The product owner not establishing and maintaining a warranty center in Vietnam or not signing a contract with a qualified warranty center, unless otherwise such medical equipment is single-use medical equipment as defined by its product owner or there are documents proving that it is not under warranty, in case the organization declaring applicable standards or applying for registration number of a medical equipment is the permanent representative office in Vietnam of a foreign trader that is the product owner or authorized by the product owner;

e) The warranty center failing to possess a certificate of eligibility for providing warranty services granted by the product owner;

g) Failing to prepare and maintain dossiers on the management of medical equipment and failing to carry out the tracing of origin of medical equipment in accordance with regulations;

h) Failing to report to Public Security agencies upon the loss of medical equipment containing narcotic substances and precursors or raw materials for manufacture of medical equipment that contain narcotic substances and precursors;

i) Failing to have information or failing to have information in a sufficient and accurate manner about products on the labels or in the documents accompanying the medical equipment as prescribed by law provisions;

k) Failing to provide warnings or failing to provide warnings in an timely, complete and accurate manner about the risk of adversely affecting the health of users, the environment, and preventive measures for sellers and consumers; failing to provide information about the requirements on transportation, storage, preservation or usage of medical equipment;

l) Failing to stop circulating or to notify related parties or to take measures to deal with, fix or recall defective medical equipment as prescribed by law provisions;

m) Failing to maintain the validity of market authorization for imported medical equipment, power of attorney, or certificate of eligibility for warranty while the marketing authorization number remains valid as prescribed by law provisions.

3. A fine from VND 60,000,000 to VND 80,000,000 shall be imposed for any of the following acts of violation:

a) Failing to comply with regulations applicable to cases where medical equipment is subject to a warning issued by a competent agency of Vietnam or international competent agency regarding a potential risk that poses a serious threat to public health or may cause death of users;

b) Documents in the dossier of application for declaration of applicable standards of Class A and Class B medical equipment fail to ensure their legality as prescribed by law provisions, but not being subject to penal liability examination;

c) Dossier of application for declaration or dossier of application for marketing authorization of a marketing authorization number holder fails to comply with law provisions;

d) Components in the dossier of application for registration of medical equipment are concluded by a competent agency as not complying with law provisions, but not being subject to penal liability examination;

dd) Failing to comply with law provisions or decisions on inspection and examination of competent state agencies.

4. A fine from VND 80,000,000 to VND 100,000,000 shall be imposed for any of the following acts of violation:

a) Placing medical equipment on the market without a marketing authorization number, registration number, certificate of registration of medical equipment, import license as prescribed by regulations on management of medical equipment, or, in cases where medical equipment is not on the list requiring to obtain the import license (except for insecticidal and germicidal chemicals and preparations for medical and household use which are used solely for disinfection of medical equipment), without classification results as Class C or D medical equipment as announced on the Portal of the Ministry of Health;

b) Placing medical equipment on the market that fails to satisfy the quality requirements registered for circulation;

c) Failing to comply with regulations applicable to cases where medical equipment incidents have occurred affecting the health of users in accordance with law provisions;

d) Medical equipment granted with a marketing authorization number remains in circulation for 24 months from the date when the owner of such medical equipment declares the discontinuation of production or bankruptcy or dissolution but the holder of marketing authorization number in Vietnam has no commitment to be responsible for the warranty, maintenance as well as provision of materials to replace or serve the use of medical equipment for a period of 08 years, except for cases where the holder of marketing authorization number is a representative office of permanent residence in Vietnam of a foreign trader in which that trader is the owner of medical equipment;

dd) Medical equipment granted with a marketing authorization number remains in circulation for 24 months from the date when the owner of such medical equipment declares the discontinuation of production or bankruptcy or dissolution;

e) Failing to carry out recall of all medical equipment currently circulated on the market in cases where the Ministry of Health has issued a written document on refusal to permit continued circulation of such medical equipment on the market, except for medical equipment already sold to medical establishments or users;

g) Failing to pay compensation for damage in accordance with law provisions in case medical equipment is defective;

h) Failing to retain papers and documents in the submitted dossier of application for declaration of applied standards of Class A or Class B medical equipment, or in the submitted dossier of application for registration of Class C or Class D medical equipment.

5. Additional sanctions:

a) Confiscation of material evidences of administrative violations being documents and dossiers, for the acts specified at Point d Clause 3 of this Article;

b) Suspension of operation related to the act of violation for a definite time of between 01 month and 03 months, for the acts specified in Clause 2, Point a Clause 3, and Clause 4 of this Article.

6. Remedial measures:

Forcible recall, destruction or recycling of medical equipment, for the acts of violation specified at Points h and i Clause 1 of this Article.

Article 74. Violation of regulations on the sale of medical equipment

1. A fine from VND 3,000,000 to VND 5,000,000 shall be imposed for any of the following acts of violation:

a) Failing to implement internal control measures to maintain the quality of medical equipment as prescribed by the holder of the marketing authorization number;

b) Failing to provide, or providing in an insufficient, and untimely manner – information on instructions on the use of medical equipment; conditions for ensuring the safety, preservation, calibration, inspection and maintenance of medical equipment to users;

c) Failing to inform, or informing users of defective medical equipment in an insufficient, and untimely manner;

d) Failing to maintain tracking records of medical equipment, failing to check for traceability and recall medical equipment as prescribed by law provisions;

dd) Failing to inform, or informing holders of the marketing authorization number and competent state agencies of cases of defective medical equipment in an untimely manner;

e) Failing to comply with law provisions and decisions on inspection and examination of competent state agencies.

2. A fine from VND 5,000,000 to VND 10,000,000 shall be imposed for any of the following acts of violation:

a) Failing to report, failing to report in accordance with the defined form, or failing to report within the prescribed time limit to competent state agencies on the sale and purchase, import, export, or transfer of medical equipment which contains narcotic substances and precursors, or medical equipment which is made of materials containing narcotic substances and precursors;

b) Failing to make a written notice of changes enclosed with documents related to such changes, or failing to update documents evidencing such changes in the declaration dossier already publicized on the portal on medical equipment management within 03 working days from the occurrence of one of the changes related to the previous declaration dossier in accordance with law provisions.

3. A fine from VND 10,000,000 to VND 20,000,000 shall be imposed for any of the following acts of violation:

a) Failing to have at least 01 technical staff holding a college degree or higher in engineering, medicine, pharmacy, chemistry, biology, or medical equipment engineering, or failing to have at least 01 technical staff holding a college degree or higher in a discipline appropriate to the class of medical equipment traded by the establishment;

b) Failing to have warehouses and means of transport that satisfy the minimum conditions as prescribed by law provisions;

c) Medical equipment trading establishments having not yet submitted the declaration dossier to the provincial-level Department of Health of the locality where the trading location is situated upon trading in medical equipment;

d) The dossier of declaration of eligibility for trading in medical equipment has incomplete dossier components or fails to ensure its legality as prescribed law provisions;

4. A fine from VND 20,000,000 to VND 30,000,000 shall be imposed for any of the following acts of violation:

a) Failing to have a person in charge of professional activities holding a university degree in medical equipment, medicine, pharmacy, pharmaceutical chemistry, or biology, for establishments trading in medical equipment containing narcotic substances and precursors;

b) Failing to have a warehouse that satisfies the requirements prescribed by law provisions, for establishments trading in medical equipment containing narcotic substances and precursors;

c) Failing to have a system for monitoring and management of the export, import, and inventory of medical equipment containing narcotic substances and precursors;

d) Failing to retain papers and documents in the submitted dossier of application for declaration of eligibility for trading in medical equipment of classes B, C and D.

5. Additional sanctions:

Suspension of operation related to the act of violation for a definite time of between 01 month and 03 months, for the acts specified at Points a and d Clause 1, Points a, b and d Clause 3, and Clause 4 of this Article.

Article 75. Violation of regulations on the import of medical equipment

1. A fine from VND 20,000,000 to VND 30,000,000 shall be imposed for any of the following acts of violation:

a) The dossier of application for import license fails to ensure legality in accordance with law provisions;

b) An organization or individual wishing to import the medical equipment that has been granted a marketing authorization number but does not satisfy the conditions prescribed by law provisions;

c) The dossier of application for certificate of free sale for medical equipment fails to ensure legality in accordance with law provisions;

d) Failing to retain papers and documents in the submitted dossier of application for declaration of eligibility for trading in medical equipment of classes B, C and D.

2. Additional sanctions:

Suspension of business activities related to the acts of violation for a definite time of between 01 month and 03 months, for the acts of violation specified in Clause 1 of this Article.

Article 76. Violations of regulations on declaration for raw materials for manufacture of medical equipment and substances for external quality assessment that contain narcotic substances and precursors

1. A fine from VND 10,000,000 to VND 20,000,000 shall be imposed for the act that components of the application dossier for declaration for raw materials for manufacture of medical equipment and substances for external quality assessment that contain narcotic substances and precursors is incomplete or the dossier fails to ensure legality in accordance with law provisions.

2. A fine from VND 20,000,000 to VND 30,000,000 shall be imposed for any of the following acts of violation:

a) Establishments importing raw materials for manufacture of medical equipment and substances for external quality assessment that contain narcotic substances and precursors having not yet uploaded their application dossiers for declaration on the portal on medical equipment management in provinces and centrally run cities;

b) Importing or exporting establishments failing to reapply for the declaration of concentration/strength of narcotic substances and precursors whenever there are any changes to their declaration dossiers;

c) Failing to retain papers and documents in the submitted dossier of application for declaration of eligibility for trading in medical equipment of classes B, C and D.

3. Additional sanctions:

Suspension of operation related to the acts of violation for a definite time of between 01 month and 03 months, for the acts of violation specified at Clause 1 and Clause 2 of this Article.

Article 77. Violations of regulations on conditions for provision of medical equipment technical consulting

1. A fine from VND 3,000,000 to VND 5,000,000 shall be imposed for any of the following acts of violation:

a) Not having a university degree or higher in engineering, medicine, or pharmacy;

b) Not having at least 05 years’ experience of working in medical equipment techniques at medical establishments;

c) Not yet having been examined and recognized by a training institution as having sufficient capability to provide medical equipment technical consulting in accordance with the training program issued by the Ministry of Health.

2. A fine from VND 5,000,000 to VND 10,000,000 shall be imposed for the act that the application dossier for declaration of eligibility to provide medical equipment technical consulting fails to ensure the legality in accordance with law provisions.

3. Additional sanctions:

Suspension of operation related to the acts of violation for a definite time of between 01 month and 03 months, for the acts of violation specified at Clause 1 and Clause 2 of this Article.

Article 78. Violation of regulations on information of medical equipment

A fine from VND 3,000,000 to VND 5,000,000 shall be imposed for any of the following acts of violation:

1. Medical staff failing to inform patients of the risk of using Class C or Class D medical equipment;

2. Holders of marketing authorization numbers or trading establishments failing to publish information on the risk and the use of medical equipment.

3. Medical establishments failing to disseminate information on the risk and the use of medical equipment within such medical establishments.

Article 79. Violation of regulations on the management and use of medical equipment at medical establishments

1. A fine from VND 500,000 to VND 1,000,000 shall be imposed for the act of failing to report cases of defective medical equipment and other information at the request of competent state agencies.

2. A fine from VND 3,000,000 to VND 5,000,000 shall be imposed for any of the following acts of violation:

a) Failing to establish, manage, or maintain sufficient records of medical equipment; failing to promptly and adequately conduct accounting of medical equipment in terms of their quantity and value in accordance with current law provisions on accounting, statistics and other relevant law provisions;

b) Failing to use and operate medical equipment in accordance with instructions provided by the owner of such medical equipment or law provisions.

3. A fine from VND 10,000,000 to VND 20,000,000 shall be imposed for the act of using medical equipment without marketing authorization numbers, import licenses, or beyond their expiry dates.

Article 80. Violations by inspectors and medical equipment inspection organizations

1. A fine from VND 5,000,000 to VND 10,000,000 shall be imposed for the act of conducting inspection of safety and technical function of medical equipment without possessing a certificate of continuous training on inspection and safety and technical function for such medical equipment.

2. A fine from VND 10,000,000 to VND 20,000,000 shall be imposed for the act of failing to send written notices of results of inspection that do not meet safety and technical function requirements for medical equipment to the Ministry of Health.

3. A fine from VND 30,000,000 to VND 40,000,000 shall be imposed for any of the following acts of violation:

a) Conducting inspection beyond the scope of the certificate of registration of medical equipment inspection services granted by competent agencies;

b) Failing to comply with the order and procedures for inspection that have been announced or the inspection processes issued by competent agencies;

c) Failing to maintain the registered conditions for inspection activities in accordance with regulations.

4. A fine from VND 70,000,000 to VND 100,000,000 shall be imposed for any of the following acts of violation:

a) Providing services of inspection of safety and technical function of medical equipment without possessing a certificate of registration for inspection activities of medical equipment by competent agencies;

b) Issuing certificates of inspection of safety and technical function for medical equipment without conducting inspection.

5. Additional sanctions:

a) Suspension of inspection activities of medical equipment inspectors for a definite time of between 01 month and 03 months, for the acts of violation specified in Clause 1 and Point b Clause 3 of this Article;

b) Suspension of operation of medical equipment inspection organization for a definite time of between 01 month and 03 months, for the acts of violation specified in Clause 3 and Clause 4 of this Article.

6. Remedial measures:

a) Forcible revocation of medical equipment inspection certificates, for the act specified at Point b Clause 4 of this Article;

b) Forcible refund of illicit profits earned through the commission of acts of violation specified in Clause 3 and Clause 4 of this Article.

Section 5

ACTS OF ADMINISTRATIVE VIOLATION ON HEALTH INSURANCE

Article 81. Violation of regulations on the late-payment of health insurance premiums

1. For employers failing to make lists, or making incomplete lists of persons participating in health insurance within 60 days from the expiry of the time limit specified at Point b Clause 1 Article 17 of the Law on Health Insurance; failing to make lists, or making incomplete lists of persons participating in health insurance, but falling into cases not regarded as evasion of payment as prescribed by law provisions, a fine shall be imposed according to one of the following levels:

a) A fine ranged from VND 1,000,000 to VND 2,000,000 shall be imposed for the violation involving under 10 laborers;

b) A fine ranged from VND 2,000,000 to VND 4,000,000 shall be imposed for the violation involving from 10 to under 50 laborers;

c) A fine ranged from VND 4,000,000 to VND 7,000,000 shall be imposed for the violation involving from 50 to under 100 laborers;

d) A fine ranged from VND 7,000,000 to VND 15,000,000 shall be imposed for the violation involving from 100 to under 500 laborers;

dd) A fine ranged from VND 15,000,000 to VND 25,000,000 shall be imposed for the violation involving from 500 to under 1.000 laborers;

e) A fine ranged from VND 25,000,000 to VND 35,000,000 shall be imposed for the violation involving 1.000 laborers or more.

2. For employers failing to pay or to fully pay the payable health insurance premium amount after the health insurance premium payment deadline specified in Clause 8, Article 15 of the Law on Health Insurance, except for the case specified at Clause c Article 48b of the Law on Health Insurance, or failing to pay or to fully pay the payable health insurance premium amount but not regarded as evasion of payment as prescribed by law provisions, a fine shall be imposed according to one of the following levels:

a) A fine ranged from VND 500,000 to VND 1,000,000 shall be imposed for the violation valued below VND 5,000,000;

b) A fine ranged from VND 1,000,000 to VND 2,000,000 shall be imposed for the violation valued from VND 5,000,000 to below VND 10,000,000;

c) A fine ranged from VND 2,000,000 to VND 3,000,000 shall be imposed for the violation valued from VND 10,000,000 to below VND 20,000,000;

d) A fine ranged from VND 3,000,000 to VND 5,000,000 shall be imposed for the violation valued from VND 20,000,000 to below VND 40,000,000;

dd) A fine ranged from VND 5,000,000 to VND 7,000,000 shall be imposed for the violation valued from VND 40,000,000 to below VND 60,000,000;

e) A fine ranged from VND 7,000,000 to VND 15,000,000 shall be imposed for the violation valued from VND 60,000,000 to below VND 80,000,000;

g) A fine ranged from VND 15,000,000 to VND 20,000,000 shall be imposed for the violation valued from VND 80,000,000 to below VND 120,000,000;

h) A fine ranged from VND 20,000,000 to VND 25,000,000 shall be imposed for the violation valued from VND 120,000,000 to below VND 160,000,000;

i) A fine ranged from VND 25,000,000 to VND 35,000,000 shall be imposed for the violation valued at VND 160,000,000 or more.

3. Remedial measures:

a) Forcible refund of the amount of money that a health insurance participant lost (if any) for the acts of violation prescribed in Clause 1 and Clause 2 of this Article. In cases where it is impossible to refund such amount of money to the insured, it shall be remitted into the State budget in accordance with law provisions;

b) Forcible refund of illicit profits earned into the receipt account of health insurance fund, for the acts of violation prescribed in Clause 1 and Clause 2 of this Article;

c) Forcible full payment of the delayed amounts of health insurance premiums, corresponding to the period of non-payment in accordance with law provisions, for the acts of violation specified in Clause 1 and Clause 2 of this Article;

d) Forcible payment of a money amount equal to 0.03% of the delayed amount of health insurance premiums for every day of delayed payment, corresponding to the period of non-payment in accordance with law provisions, for the acts of violation specified in Clause 1 and Clause 2 of this Article.

Article 82. Violation of regulations on evasion of health insurance premium payment which is not serious enough for penal liability examination

1. A fine from VND 300,000 to VND 500,000 shall be imposed for the act of failing to pay health insurance premiums of subjects obliged to participate in the health insurance.

2. For employers failing to make lists, or making incomplete lists of persons participating in health insurance within 60 days from the expiry of the time limit specified at Point b Clause 1 Article 17 of the Law on Health Insurance, except for the cases not regarded as evasion of payment, a fine shall be imposed according to one of the following levels:

a) A fine ranged from VND 2,000,000 to VND 4,000,000 shall be imposed for the violation involving under 10 laborers;

b) A fine ranged from VND 4,000,000 to VND 7,000,000 shall be imposed for the violation involving from 10 to under 50 laborers;

c) A fine ranged from VND 7,000,000 to VND 20,000,000 shall be imposed for the violation involving from 50 to under 100 laborers;

d) A fine ranged from VND 20,000,000 to VND 30,000,000 shall be imposed for the violation involving from 100 to under 500 laborers;

dd) A fine ranged from VND 30,000,000 to VND 50,000,000 shall be imposed for the violation involving from 500 to under 1.000 laborers;

e) A fine ranged from VND 50,000,000 to VND 70,000,000 shall be imposed for the violation involving 1.000 laborers or more.

3. For the acts of registering a salary for use as a basis for health insurance premium payment that is lower than the salary level specified in Article 14 of the Law on Health Insurance, or failing to pay or to fully pay the registered amount of health insurance premiums after 60 days from the health insurance premium payment deadline specified in Clause 8, Article 15 of the Law on Health Insurance, though having been urged by a competent agency under except for the cases not regarded as evasion of payment, a fine shall be imposed according to one of the following levels:

a) A fine ranged from VND 1,000,000 to VND 2,000,000 shall be imposed for the violation valued below VND 5,000,000;

b) A fine ranged from VND 2,000,000 to VND 3,000,000 shall be imposed for the violation valued from VND 5,000,000 to below VND 10,000,000;

c) A fine ranged from VND 3,000,000 to VND 5,000,000 shall be imposed for the violation valued from VND 10,000,000 to below VND 20,000,000;

d) A fine ranged from VND 5,000,000 to VND 7,000,000 shall be imposed for the violation valued from VND 20,000,000 to below VND 40,000,000;

dd) A fine ranged from VND 7,000,000 to VND 15,000,000 shall be imposed for the violation valued from VND 40,000,000 to below VND 60,000,000;

e) A fine ranged from VND 15,000,000 to VND 20,000,000 shall be imposed for the violation valued from VND 60,000,000 to below VND 80,000,000;

g) A fine ranged from VND 20,000,000 to VND 25,000,000 shall be imposed for the violation valued from VND 80,000,000 to below VND 120,000,000;

h) A fine ranged from VND 25,000,000 to VND 35,000,000 shall be imposed for the violation valued from VND 120,000,000 to below VND 160,000,000;

i) A fine ranged from VND 35,000,000 to VND 45,000,000 shall be imposed for the violation valued at VND 160,000,000 or more.

4. Remedial measures:

a) Forcible full payment of the evaded amounts of health insurance premiums specified in Clauses 1, 2 and 3 of this Article into the health insurance fund;

b) Forcible refund of the amount of money that a health insurance participant lost (if any) for the acts of violation prescribed in Clause 2 and Clause 3 of this Article. In cases where it is impossible to refund such amount of money to the insured, it shall be remitted into the State budget in accordance with law provisions;

c) Forcible refund of illicit profits earned into the receipt account of health insurance fund for the acts of violation prescribed in Clause 2 and Clause 3 of this Article;

d) Forcible payment of a money amount equal to 0.03% of the evaded amounts of health insurance premiums for every day of delayed payment, corresponding to the period of payment evasion in accordance with the Law on Health Insurance, for the acts of violation specified in Clause 2 and Clause 3 of this Article.

Article 83. Violation of regulations on bringing people not under the management responsibility of organizations into the list of health insurance participants

1. For the act of failing to include people into the list of health insurance participants in accordance with law provisions, a fine shall be imposed according to one of the following levels:

a) A fine ranged from VND 1,000,000 to VND 2,000,000 for each health insurance card, for cases where there are violations not causing loss to the health insurance fund;

b) A fine ranged from VND 2,000,000 to VND 3,000,000 for each health insurance card, for cases of having used health insurance in medical examination and treatment and causing loss to the health insurance fund.

2. For the act of failing to participate in health insurance at agencies or organizations in accordance with law provisions, a fine shall be imposed according to one of the following levels:

a) A fine ranged from VND 1,000,000 to VND 2,000,000 for each person who owns a health insurance card but has yet to use the health insurance card in medical examination and treatment covered by health insurance;

b) A fine ranged from VND 2,000,000 to VND 3,000,000 for each person who owns a health insurance card and has already used the health insurance card in medical examination and treatment covered by health insurance.

3. Additional sanctions

Confiscation of health insurance cards as material evidences used in administrative violations for the acts of violation prescribed in Clause 1 and Clause 2 of this Article.

4. Remedial measures:

Forcible refund of illicit amount of money into the receipt account of health insurance fund (if any) for the acts of violation prescribed at Point b, Clause 1 and Point b, Clause 2 of this Article.

Article 84. Violation of regulations on using health insurance cards in medical examination and treatment

1. For the act of lending health insurance card to another or using another’s health insurance card in medical examination and treatment, a fine shall be imposed according to one of the following levels:

a) A fine ranged from VND 1,000,000 to VND 2,000,000 for cases of violations not causing any damage to the health insurance fund;

b) A fine ranged from VND 3,000,000 to VND 5,000,000, for the act of using health insurance cards to appropriate health insurance money of under VND 10,000,000 or causing damage to the health insurance fund of under VND 20,000,000.

2. Remedial measures:

Forcible refund of the violated amount of money into the receipt account of health insurance fund (if any) for acts of violation prescribed at Point b, Clause 1 of this Article.

Article 85. Violation of regulations on making medical records for or giving prescriptions to fictitious patients, inflating the quantity of actually used drugs, medical consumables or technical services or the amount of actually arisen inpatient bed costs and other costs or declaring drugs, medical consumables, technical services, inpatient bed costs and other costs not used or arisen in reality in order to appropriate health insurance money, which is not serious enough for penal liability examination

1. A fine ranged from VND 200,000 to VND 500,000 shall be imposed for the violations valued below VND 1,000,000.

2. A fine ranged from VND 500,000 to VND 1,000,000 shall be imposed for the violations valued from VND 1,000,000 to below VND 2,000,000.

3. A fine ranged from VND 1,000,000 to VND 2,000,000 shall be imposed for the violations valued from VND 2,000,000 to below VND 5,000,000.

4. A fine ranged from VND 3,000,000 to VND 5,000,000 shall be imposed for the violations valued from VND 5,000,000 to below VND 10,000,000.

5. Remedial measures:

Forcible refund of the violated amount of money into the receipt account of health insurance fund (if any) for the acts of violation prescribed in Clauses 1, 2, 3 and 4 of this Article.

Article 86. Violation of regulations on making medical records for or giving prescriptions to fictitious patients, inflating the quantity of actually used drugs, medical consumables or technical services or the amount of actually arisen inpatient bed costs and other costs or declaring drugs, medical consumables, technical services, inpatient bed costs and other costs not used or arisen in reality and causing loss to the health insurance fund, which is not serious enough for penal liability examination

1. A fine ranged from VND 200,000 to VND 500,000 shall be imposed for the violations valued below VND 1,000,000.

2. A fine ranged from VND 500,000 to VND 1,000,000 shall be imposed for the violations valued from VND 1,000,000 to below VND 2,000,000.

3. A fine ranged from VND 1,000,000 to VND 2,000,000 shall be imposed for the violations valued from VND 2,000,000 to below VND 5,000,000.

4. A fine ranged from VND 3,000,000 to VND 5,000,000 shall be imposed for the violations valued from VND 5,000,000 to below VND 10,000,000.

5. A fine ranged from VND 5,000,000 to VND 10,000,000 shall be imposed for the violations valued from VND 10,000,000 to below VND 15,000,000;

6. A fine ranged from VND 10,000,000 to VND 20,000,000 shall be imposed for the violations valued from VND 15,000,000 to below VND 20,000,000.

7. Remedial measures:

a) Forcible refund of the violated amount of money into the receipt account of health insurance fund (if any) for acts of violation prescribed in Clauses 1, 2, 3, 4, 5 and 6 of this Article;

b) Forcible refund of the amount of money that a health insurance participant lost (if any) for the acts of violation prescribed in Clauses 1, 2, 3, 4, 5 and 6 of this Article. In cases where it is impossible to refund such amount of money, it shall be remitted into the State budget in accordance with law provisions.

Article 87. Violation of regulations on the scope of benefits of health insurance participants

1. A fine from VND 300,000 to VND 500,000 shall be imposed for the act of violation on the scope of benefits of health insurance participants, for violations valued below VND 1,000,000.

2. For the act of violation on the scope of benefits of health insurance participants, a fine shall be imposed according to one of the following levels:

a) A fine ranged from VND 1,000,000 to VND 2,000,000 shall be imposed for the violation valued from VND 1,000,000 to below VND 5,000,000;

b) A fine ranged from VND 2,000,000 to VND 3,000,000 shall be imposed for the violation valued from VND 5,000,000 to below VND 10,000,000;

c) A fine ranged from VND 3,000,000 to VND 5,000,000 shall be imposed for the violation valued from VND 10,000,000 to below VND 15,000,000;

d) A fine ranged from VND 5,000,000 to VND 7,000,000 shall be imposed for the violation valued from VND 15,000,000 to below VND 20,000,000;

dd) A fine ranged from VND 7,000,000 to VND 10,000,000 shall be imposed for the violation valued from VND 20,000,000 to below VND 40,000,000;

e) A fine ranged from VND 10,000,000 to VND 15,000,000 shall be imposed for the violation valued at VND 40,000,000 or more.

3. Remedial measures:

a) Forcible refund of the amount of money that a health insurance participant lost (if any) for the acts of violation prescribed in Clause 1 and Clause 2 of this Article. In cases where it is impossible to refund such amount of money, it shall be remitted into the State budget in accordance with law provisions;

b) Forcible refund of illicit amount of money into the receipt account of health insurance fund (if any) for the acts of violation prescribed at Clause 1 and Clause 2 of this Article.

Article 88. Violation of regulations on payment of expenses in medical examination and treatment covered by health insurance, causing loss to the health insurance fund

1. A fine from VND 300,000 to VND 500,000 shall be imposed for the acts of applying false prices, applying prices not yet prescribed or approved, recording incorrect types, strength, methods of use, units, or names of technical services in payment of expenses of medical examination and treatment covered by health insurance, or expenses already paid from other sources, for the violations valued below 1,000,000.

2. For the acts of applying false prices, applying prices not yet prescribed or approved, recording incorrect types, strength, methods of use, units, or names of technical services in payment of expenses of medical examination and treatment covered by health insurance, or expenses already paid from other sources, a fine shall be imposed according to one of the following levels:

a) A fine ranged from VND 1,000,000 to VND 2,000,000 shall be imposed for the violation valued from VND 1,000,000 to below VND 5,000,000;

b) A fine ranged from VND 2,000,000 to VND 3,000,000 shall be imposed for the violation valued from VND 5,000,000 to below VND 10,000,000;

c) A fine ranged from VND 3,000,000 to VND 5,000,000 shall be imposed for the violation valued from VND 10,000,000 to below VND 20,000,000;

d) A fine ranged from VND 5,000,000 to VND 10,000,000 shall be imposed for the violation valued from VND 20,000,000 to below VND 40,000,000;

dd) A fine ranged from VND 10,000,000 to VND 20,000,000 shall be imposed for the violation valued from VND 40,000,000 to below VND 80,000,000;

e) A fine ranged from VND 20,000,000 to VND 40,000,000 shall be imposed for the violation valued from VND 80,000,000 to below VND 120,000,000;

g) A fine ranged from VND 40,000,000 to VND 50,000,000 shall be imposed for the violation valued at VND 120,000,000 or more.

3. Remedial measures:

a) Forcible refund of illicit amount of money into the receipt account of health insurance fund (if any) for the acts of violation prescribed at Clause 1 and Clause 2 of this Article.

b) Forcible refund of the amount of money that a health insurance participant lost (if any) for the acts of violation prescribed in Clause 1 and Clause 2 of this Article. In cases where it is impossible to refund such amount of money, it shall be remitted into the State budget in accordance with law provisions.

Article 89. Violation of regulations on contracts of medical examination and treatment covered by health insurance

1. A fine from VND 1,000,000 to VND 3,000,000 shall be imposed for any of the following acts of violation which cause no harm to the interest of health insurance participants, of medical examination and treatment establishments and of the health insurance fund:

a) Unilaterally terminating a contract of medical examination and treatment covered by health insurance in contravention of law provisions;

b) Signing a contract of medical examination and treatment covered by health insurance that contains contents in contravention of law provisions;

c) Failing to sign a contract of medical examination and treatment covered by health insurance within the right competence as prescribed by law provisions;

d) Carrying out procedures for signing contracts for medical examination and treatment covered by health insurance not in accordance with the law on health insurance.

2. For the acts of unilaterally terminating a contract of medical examination and treatment covered by health insurance which causes damage to the interests of health insurance participants, of medical examination and treatment establishments or of the health insurance fund, a fine shall be imposed according to one of the following levels:

a) A fine ranged from VND 3,000,000 to VND 5,000,000 shall be imposed for the violation valued below VND 50,000,000;

b) A fine ranged from VND 5,000,000 to VND 10,000,000 shall be imposed for the violation valued from VND 50,000,000 to below VND 100,000,000;

c) A fine ranged from VND 10,000,000 to VND 15,000,000 shall be imposed for the violation valued from VND 100,000,000 to below VND 500,000,000;

d) A fine ranged from VND 15,000,000 to VND 20,000,000 shall be imposed for the violation valued from VND 500,000,000 to below VND 1,000,000,000;

dd) A fine ranged from VND 20,000,000 to VND 30,000,000 shall be imposed for the violation valued from VND 1,000,000,000 to below VND 5,000,000,000;

e) A fine ranged from VND 30,000,000 to VND 40,000,000 shall be imposed for the violation valued at VND 5,000,000,000 or more.

3. For the acts of signing a contract of medical examination and treatment covered by health insurance that contain contents in contravention of law provisions or failing to sign a contract of medical examination and treatment covered by health insurance within the right competence, which causes damage to the interests of health insurance participants, of medical examination and treatment establishments and of the health insurance fund, a fine shall be imposed according to one of the following levels:

a) A fine ranged from VND 1,000,000 to VND 5,000,000 shall be imposed for the violation valued below VND 50,000,000;

b) A fine ranged from VND 5,000,000 to VND 10,000,000 shall be imposed for the violation valued from VND 50,000,000 to below VND 100,000,000;

c) A fine ranged from VND 10,000,000 to VND 15,000,000 shall be imposed for the violation valued from VND 100,000,000 to below VND 500,000,000;

d) A fine ranged from VND 15,000,000 to VND 20,000,000 shall be imposed for the violation valued from VND 500,000,000 to below VND 1,000,000,000;

dd) A fine ranged from VND 20,000,000 to VND 30,000,000 shall be imposed for the violation valued from VND 1,000,000,000 to below VND 5,000,000,000;

e) A fine ranged from VND 30,000,000 to VND 40,000,000 shall be imposed for the violation valued at VND 5,000,000,000 or more.

4. A fine from VND 1,000,000 to VND 3,000,000 shall be imposed for any of the following acts of violation:

a) Failing to provide medical examination and treatment establishments with information on the medical examination and treatment history of health insurance participants;

b) Failing to make advance payment or failing to finalize expenses for medical examination and treatment covered by health insurance within the prescribed time limit and in the prescribed amount and advance payment rate in accordance with the law on health insurance.

5. Remedial measures:

a) Forcible refund of the violated amount of money into the receipt account of health insurance fund (if any) for the acts of violation prescribed in Clauses 1, 2, 3 and 4 of this Article;

b) Forcible refund of the amount of money that a health insurance participant lost (if any) for the acts of violation prescribed in Clause 2 and Clause 3 of this Article. In cases where it is impossible to refund such amount of money, it shall be remitted into the State budget in accordance with law provisions;

c) Forcible refund of the amount of money that a medical examination and treatment establishment lost (if any) for the acts of violation prescribed in Clause 3 of this Article. In cases where it is impossible to refund such amount of money, it shall be remitted into the State budget in accordance with law provisions.

Article 90. Violation of regulations on failing to determine the benefits in medical examination and treatment covered by health insurance in accordance with information given in health insurance cards

1. A fine from VND 200,000 to VND 500,000 for the act of failing to determine the benefits in medical examination and treatment covered by health insurance in accordance with information given in health insurance cards, for the violations valued below VND 1,000,000.

2. For the acts of failing to determine the benefits in medical examination and treatment covered by health insurance in accordance with information given in health insurance cards, a fine shall be imposed according to one of the following levels:

a) A fine ranged from VND 1,000,000 to VND 2,000,000 shall be imposed for the violation valued from VND 1,000,000 to below VND 5,000,000;

b) A fine ranged from VND 2,000,000 to VND 3,000,000 shall be imposed for the violation valued from VND 5,000,000 to below VND 10,000,000;

c) A fine ranged from VND 3,000,000 to VND 4,000,000 shall be imposed for the violation valued from VND 10,000,000 to below VND 15,000,000;

d) A fine ranged from VND 4,000,000 to VND 5,000,000 shall be imposed for the violation valued from VND 15,000,000 to below VND 20,000,000;

dd) A fine ranged from VND 5,000,000 to VND 6,000,000 shall be imposed for the violation valued from VND 20,000,000 to below VND 40,000,000;

e) A fine ranged from VND 6,000,000 to VND 7,000,000 shall be imposed for the violation valued at VND 40,000,000 or more.

3. Remedial measures:

a) Forcible refund of the amount of money that a health insurance participant lost (if any) for the acts of violation prescribed in Clause 1 and Clause 2 of this Article. In cases where it is impossible to refund such amount of money, it shall be remitted into the State budget in accordance with law provisions;

b) Forcible refund of the amount of money that a medical examination and treatment establishment lost (if any) for the acts of violation prescribed in Clause 1 and Clause 2 of this Article. In cases where it is impossible to refund such amount of money, it shall be remitted into the State budget in accordance with law provisions;

c) Forcible refund of the violated amount of money into the receipt account of health insurance fund (if any), for the acts of violation causing loss to the health insurance fund as prescribed in Clause 1 and Clause 2 of this Article.

Article 91. Violation of regulations on reporting the implementation of health insurance duties with competent state agencies

1. A fine from VND 200,000 to VND 500,000 shall be imposed for the act of failing to report the implementation of health insurance duties within the prescribed duration, failing to provide statistics, providing incorrect statistics with competent state agencies which does not cause negative impacts on the management, implementation and development of health insurance policies.

2. A fine from VND 5,000,000 to VND 10,000,000 shall be imposed for the act of failing to report the implementation of health insurance duties within the prescribed duration, failing to provide statistics, providing incorrect statistics with competent state agencies which causes negative impacts on the management, implementation and development of health insurance policies.

3. Remedial measures:

Forcible refund of the violated amount of money into the receipt account of health insurance fund (if any) for the acts of violation causing loss to the health insurance fund as prescribed in Clause 1 and Clause 2 of this Article.

Article 92. Violation of regulations on providing information on health insurance participants

1. A fine from VND 200,000 to VND 500,000 for the act of failing to provide information, providing untruthful information, or failing to provide information on health insurance participants timely but causing no loss to the fund for medical examination and treatment covered by health insurance.

2. For the act of failing to provide information, providing false information, or failing to provide information on health insurance participants timely which causes loss to the fund for medical examination and treatment covered by health insurance, a fine shall be imposed according to one of the following levels:

a) A fine ranged from VND 1,000,000 to VND 3,000,000 shall be imposed for the violation valued below VND 50,000,000;

b) A fine ranged from VND 3,000,000 to VND 5,000,000 shall be imposed for the violation valued from VND 50,000,000 to below VND 100,000,000;

c) A fine ranged from VND 5,000,000 to VND 10,000,000 shall be imposed for the violation valued from VND 100,000,000 to below VND 200,000,000;

d) A fine ranged from VND 10,000,000 to VND 20,000,000 shall be imposed for the violation valued at VND 200,000,000 or more.

3. Remedial measures:

Forcible refund of the violated amount of money into the receipt account of health insurance fund (if any) for the acts of violation causing loss to the health insurance fund as prescribed in Clause 1 and Clause 2 of this Article.

Article 93. Violation of regulations on providing, providing information inadequately, providing untruthful information in the settlement of patient’s interests at medical examination and treatment establishments or in direct payment for health insurance participants

1. A fine from VND 200,000 to VND 500,000 shall be imposed for the act of failing to provide information, providing information inadequately, providing untruthful information in the settlement of patient’s interests at medical examination and treatment establishments or in direct payment for health insurance participants which causes no damage to the interest of health insurance participants.

2. A fine from VND 1,000,000 to VND 3,000,000 shall be imposed for the act of failing to provide information, providing information inadequately, providing untruthful information in the settlement of patient’s interests at medical examination and treatment establishments or in direct payment for health insurance participants which causes damage to the interest of health insurance participants.

3. Remedial measures:

Forcible refund of the amount of money that a health insurance participant lost (if any) for the acts of violation prescribed in Clause 2 of this Article. In cases where it is impossible to refund such amount of money, it shall be remitted into the State budget in accordance with law provisions.

Article 94. Violation of regulations on sending settlement reports of expenses for medical examination and treatment covered by health insurance later than the prescribed time

1. A fine from VND 500,000 to VND 1,000,000 shall be imposed for the act of sending settlement reports of expenses for medical examination and treatment covered by health insurance later than the prescribed time below 05 working days.

2. For the act of sending settlement reports of expenses for medical examination and treatment covered by health insurance later than the prescribed time, a fine shall be imposed according to one of the following levels:

a) A fine ranged from VND 3,000,000 to VND 5,000,000 shall be imposed for the cases where reports are sent late from 05 working days to less than 20 days;

b) A fine ranged from VND 5,000,000 to VND 7,000,000 shall be imposed for the cases where reports are sent late 20 days or more.

Article 95. Other violations in health insurance

1. A fine from VND 500,000 to VND 1,000,000 shall be imposed for any of the following acts of violation:

a) Causing difficulties or hindering the medical examination and treatment covered by health insurance which causes no harm to the interests of health insurance participants, of health insurance-covered medical examination and treatment establishments;

b) Abusing the prescription and use of medicines, chemicals, medical equipment, technical services and other medical services that are superfluous compared to law provisions on medical expertise, causing damage to patients with health insurance cards, the health insurance fund and medical examination and treatment establishment, for the acts of violation valued below VND 1,000,000;

c) Using an account for access to the hospital management software system assigned to another person, or lending the account to another person, for medical examination, ordering paraclinical tests, surgeries or procedures, or prescribing drugs for patients.

2. For the acts of causing difficulties or hindering the medical examination and treatment covered by health insurance which causes damage to the interest of health insurance participants, of health insurance-covered medical examination and treatment establishments, a fine shall be imposed according to one of the following levels:

a) A fine ranged from VND 1,000,000 to VND 2,000,000 shall be imposed for the violation valued from VND 1,000,000 to below VND 5,000,000;

b) A fine ranged from VND 2,000,000 to VND 3,000,000 shall be imposed for the violation valued from VND 5,000,000 to below VND 10,000,000;

c) A fine ranged from VND 3,000,000 to VND 5,000,000 shall be imposed for the violation valued from VND 10,000,000 to below VND 15,000,000;

d) A fine ranged from VND 5,000,000 to VND 10,000,000 shall be imposed for the violation valued from VND 15,000,000 to below VND 20,000,000;

dd) A fine ranged from VND 10,000,000 to VND 15,000,000 shall be imposed for the violation valued from VND 20,000,000 to below VND 40,000,000;

e) A fine ranged from VND 15,000,000 to VND 20,000,000 shall be imposed for the violation valued at VND 40,000,000 or more.

3. For the act of abusing medical services in medical examination and treatment covered by health insurance, including: prescribing and using medicines, chemicals, medical supplies, technical services and other medical services that are beyond the maximum level, or that are superfluous compared to law provisions on medical expertise, causing damage to the interest of health insurance participants, medical examination and treatment establishments and of the health insurance fund, a fine shall be imposed according to one of the following levels:

a) A fine ranged from VND 1,000,000 to VND 2,000,000 shall be imposed for the violation valued from VND 1,000,000 to below VND 5,000,000;

b) A fine ranged from VND 2,000,000 to VND 3,000,000 shall be imposed for the violation valued from VND 5,000,000 to below VND 10,000,000;

c) A fine ranged from VND 3,000,000 to VND 5,000,000 shall be imposed for the violation valued from VND 10,000,000 to below VND 20,000,000;

d) A fine ranged from VND 5,000,000 to VND 10,000,000 shall be imposed for the violation valued from VND 20,000,000 to below VND 40,000,000;

dd) A fine ranged from VND 10,000,000 to VND 20,000,000 shall be imposed for the violation valued from VND 40,000,000 to below VND 60,000,000;

e) A fine ranged from VND 20,000,000 to VND 30,000,000 shall be imposed for the violation valued from VND 60,000,000 to below VND 80,000,000;

g) A fine ranged from VND 30,000,000 to VND 40,000,000 shall be imposed for the violation valued at VND 80,000,000 or more.

4. A fine from VND 1,000,000 to VND 3,000,000 shall be imposed for any of the following acts of violation:

a) Failing to register with social insurance agencies the seal sample, the signature specimen of practitioners who are authorized to sign the certificates of physical incapacity, or of the authorized persons to sign and seal on behalf of the medical examination and treatment establishment on such certificates;

b) Failing to connect, inter-connect data, form electronic documents on medical examination and treatment as prescribed by law provisions on electronic transactions in the field of health insurance.

5. For the act of organizing the registration for initial health insurance-covered medical examination and treatment, or the change in the place of registration for initial health insurance-covered medical examination and treatment for health insurance participants, not in accordance with the quantity allocated by competent agencies to medical examination and treatment establishments in accordance with law provisions, a fine shall be imposed according to one of the following levels:

a) A fine ranged from VND 1,000,000 to VND 3,000,000 shall be imposed, for the case of exceeding under 10% of the allocated number of health insurance cards;

b) A fine ranged from VND 3,000,000 to VND 5,000,000 shall be imposed, for the case of exceeding 10% or more of the allocated number of health insurance cards.

6. A fine from VND 1,000,000 to VND 3,000,000 shall be imposed for the act of organizing the registration for initial health insurance-covered medical examination and treatment, or the change in the place of registration for initial health insurance-covered medical examination and treatment for health insurance participants, not in accordance with the subjects allocated by competent agencies to medical examination and treatment establishments in accordance with law provisions.

7. A fine from VND 1,000,000 to VND 3,000,000 shall be imposed for the act of giving notice to medical examination and treatment establishments of results of assessment of electronic data, and of results of assessment and finalization amounts of expenses for medical examination and treatment covered by health insurance, later than prescribed by law provisions.

8. Remedial measures:

a) Forcible refund of the amount of money that a medical examination and treatment establishment lost (if any) for the acts of violation prescribed at Point b Clause 1, Clause 2 and Clause 3 of this Article. In cases where it is impossible to refund such amount of money, it shall be remitted into the State budget in accordance with law provisions;

b) Forcible refund of the amount of money that a health insurance participant lost (if any) for the acts of violation prescribed at Point b Clause 1, Clause 2 and Clause 3 of this Article. In cases where it is impossible to refund such amount of money, it shall be remitted into the State budget in accordance with law provisions;

c) Forcible refund of the violated amount of money into the receipt account of health insurance fund (if any) for the acts of violation causing loss to the health insurance fund as prescribed at Point b Clause 1, and Clause 3 of this Article.

Section 6

ACTS OF ADMINISTRATIVE VIOLATIONS ON POPULATION

Article 96. Violation of regulations on spreading and disseminating information, providing consultation on population, reproductive health, and birth control

1. A fine from VND 200,000 to VND 500,000 shall be imposed for the act of hindering the persuasion, spread and dissemination of information or consultation on population, reproductive health and birth control.

2. A fine from VND 3,000,000 to VND 5,000,000 shall be imposed for any of the following acts of violation:

a) Spreading and disseminating information in contravention of the direction and policies of the Party and in contravention of the State’s law provisions, against fine traditions of the country, causing negative impacts on the population work and people’s lives;

b) Spreading and disseminating information on population which is untruthful and misleading, causing negative impacts on the implementation of population work and on people’s lives as well as on other fields;

c) Taking advantage of the dissemination and spread of information on population, reproductive health and birth control to disseminate documents and materials, or to commit acts which are against the fine traditions and morality.

3. Additional sanctions:

Confiscation of material evidences of administrative violations which are documents or items containing information, for the acts of violation prescribed in Clause 2 of this Article.

4. Remedial measures:

Forcible correction of information which is in contravention of the direction and policies of the Party and against the State’s law provisions on population, for the acts of violation prescribed in Clause 2 of this Article, in accordance with law provisions.

Article 97. Violation of regulations on dissemination, spread or consultation on methods of selection of gender for the unborn babies

1. A fine from VND 5,000,000 to VND 7,000,000 shall be imposed for any of the following acts of violation:

a) Spreading, disseminating or and distributing information about methods of selection of gender for the unborn babies;

b) Consultation on methods of selection of gender for the unborn babies.

2. A fine from VND 7,000,000 to VND 15,000,000 shall be imposed for any of the following acts of violation:

a) Selling, renting, distributing, and posting on the Internet, social platforms, applications publications and articles with contents on methods of selection of gender for the unborn babies; or using communication products such as audio or images containing contents on methods of selection of gender for the unborn babies;

b) Posting and distributing information about methods of selection of gender for the unborn babies.

3. A fine from VND 15,000,000 to VND 20,000,000 shall be imposed for the act of translating, publishing, producing, printing, distributing, duplicating, copying publications or articles with contents on methods of selection of gender for the unborn babies.

4. Additional sanctions:

Confiscation of material evidences of administrative violations which are publications, articles, documents, information and propaganda for the acts of violation prescribed in Clause 1, Clause 2 and Clause 3 of this Article.

5. Remedial measures:

Forcible removal of infringing elements for the acts of violation prescribed at Point a Clause 1, and Point b Clause 2 of this Article. In cases where it is impossible to remove such elements, the forcible destruction of the product containing such infringing elements shall be applied.

Article 98. Violation of regulations on diagnosis and determination of gender for the unborn babies

1. A fine from VND 5,000,000 to VND 7,000,000 shall be imposed for the act of using divination for determination of gender for the unborn babies.

2. A fine from VND 7,000,000 to VND 15,000,000 shall be imposed for the act of checking pulse, or using diagnostic imaging techniques or applying testing on pregnant women to diagnose, disclose and provide information on gender for the unborn babies, unless otherwise prescribed by the law provisions.

3. Additional sanctions:

Deprivation of the right to use the license for medical examination and treatment, and the medical practice certificate, license for a definite time of between 01 month and 03 months for acts of violation prescribed in Clause 2 of this Article.

Article 99. Violation of regulations on selection of gender for the unborn babies

1. A fine from VND 7,000,000 to VND 15,000,000 shall be imposed for the act of threatening to use force or using mental intimidation to force others to apply methods of selection of gender for the unborn babies.

2. A fine from VND 15,000,000 to VND 20,000,000 shall be imposed for the act of using violence to force others to apply methods of selection of gender for the unborn babies.

3. A fine from VND 20,000,000 to VND 25,000,000 shall be imposed for any of the following acts of violation:

a) Prescribing or instructing the use of drugs, functional foods and all kinds of preparations in any form affecting the process of conception for selection of gender for the unborn babies;

b) Supplying tools, drugs, supplies, functional foods and all kinds of preparations in any form affecting the process of conception for selection of gender for the unborn babies;

c) Studying methods of selection of gender for the unborn babies, unless otherwise prescribed by the law provisions.

4. Additional sanctions:

a) Suspension of operation of the establisment for a definite time of between 01 month and 03 months for the acts of violation prescribed in Clause 3 of this Article;

b) Deprivation of the right to use the the medical practice certificate or license for a definite time of between 01 month and 03 months, for the acts of violation prescribed in Clause 3 of this Article.

5. Remedial measures:

Forcible destruction of tools, drugs, supplies used to commit the acts of violation prescribed at Point b Clause 3 of this Article.

Article 100. The act of abortion due to sex selection

1. A fine from VND 5,000,000 to VND 7,000,000 shall be imposed for the act of abortion due to sex selection of pregnant women without being forced to remove the fetus.

2. A fine from VND 7,000,000 to VND 10,000,000 shall be imposed for the act of seducing and enticing a pregnant woman to remove the fetus for the reason of sex selection.

3. A fine from VND 10,000,000 to VND 15,000,000 shall be imposed for the act of threatening by force, or using mental intimidation to force a pregnant woman to remove the fetus for the reason of sex selection.

4. A fine from VND 15,000,000 to VND 20,000,000 shall be imposed for the act of use violence to force a pregnant woman to remove the fetus for the reason of sex selection.

5. A fine from VND 20,000,000 to VND 25,000,000 shall be imposed for any of the following acts of violation:

a) Providing chemicals and drugs for the removal of the fetus while knowing clearly that the pregnant woman wants to remove the fetus due to sex selection;

b) Providing indications or instructions on the use of chemicals, medicines or other measures to remove the fetus while knowing clearly that the pregnant woman wants to remove the fetus due to sex selection.

6. A fine from VND 25,000,000 to VND 30,000,000 shall be imposed for the act of removing the fetus while knowing clearly that the pregnant woman wants to remove the fetus due to sex selection.

7. Additional sanctions:

a) Deprivation of the right to use the license for medical examination and treatment, the medical practice certificate or license for a definite time of between 03 months and 06 months for the acts of violation prescribed in Clause 5 of this Article;

b) Deprivation of the right to use the license for medical examination and treatment, and the medical practice certificate or license for a definite time of between 06 months and 12 months for the acts of violation prescribed in Clause 6 of this Article;

c) Deprivation of the right to use the certificate of eligibility for pharmaceutical business or suspension of operation for non-commercial pharmaceutical establishments for a definite time of between 01 month and 03 months for the acts of violation prescribed at Point a Clause 5 of this Article.

Article 101. Violation of regulations on implementation of birth control

1. A fine from VND 200,000 to VND 500,000 shall be imposed for any of the following acts of violation:

a) Failing to provide free contraceptive means to people who are entitled to in accordance with law provisions and have a need for free contraceptive means;

b) Having words or actions that offend the honor and dignity of contraceptive users, or the people giving birth to only boys or giving birth to only girls.

2. A fine from VND 1,000,000 to VND 2,000,000 shall be imposed for the act of threatening to use force, using mental intimidation to force others to use contraceptive measures.

3. A fine from VND 3,000,000 to VND 5,000,000 shall be imposed for any of the following acts of violation:

a) Threatening to use force, using mental intimidation to force others not to use contraceptive measures or stop using contraceptive measures;

b) Threatening to use force, using mental intimidation to force others to be pregnant; or to give birth to another child while they have given birth to only boys, or only girls.

4. A fine from VND 5,000,000 to VND 7,000,000 shall be imposed for the act of using force to force others to use contraceptive measures.

5. A fine from VND 7,000,000 to VND 10,000,000 shall be imposed for any of the following acts of violation:

a) Placing intrauterine devices, injecting contraceptives, and transplanting contraceptives drugs without the consent of users;

b) Using force to force others not to use contraceptive measures or to stop using contraceptive measures;

c) Using force to force others to be pregnant; to have another child when they have given birth to only boys or only girls.

6. A fine from VND 20,000,000 to VND 30,000,000 for the act of performing sterilization techniques without the consent of the sterilized person.

7. Additional sanctions:

Deprivation of the right to use the license for medical examination and treatment, the medical practice certificate or license for a definite time of between 01 month and 03 months, for the acts of violation prescribed in Clause 6 of this Article.

8. Remedial measures:

Forcible removal of uterine devices or contraceptive implants, for the acts of violation prescribed at Point a, Clause 5 of this Article.

Article 102. Violation of regulations on selling contraceptive means

1. A fine from VND 1,000,000 to VND 3,000,000 shall be imposed for the act of selling contraceptive means which have been prescribed by the competent state agencies to be provided free-of-charge.

2. A fine from VND 3,000,000 to VND 5,000,000 shall be imposed for the act of selling contraceptive means as social marketing products at a higher price than the price prescribed by the competent state agencies.

3. Additional sanctions:

Confiscation of material evidences of administrative violations which are contraceptive means for the acts of violation prescribed in Clause 1 of this Article.

4. Remedial measures:

Forcible refund of the money amount collected in contravention of law provisions, for the acts of violation specified in Clause 1 and Clause 2 of this Article. In cases where it is impossible to refund such amount of money, it shall be remitted into the State budget in accordance with law provisions.

Chapter III

COMPETENCE TO IMPOSE SANCTIONING OF ADMINISTRATIVE VIOLATIONS IN HEALTH

Article 103. Santioning competence of chairpersons of People’s Committees

1. Chairpersons of People’s Committees of communes, wards and special zones (hereinafter referred to as commune level) shall have the power to:

a) Impose a caution;

b) Impose a fine of up to VND 15,000,000 for acts of administrative violation in population; fines of up to VND 25,000,000 for acts of administrative violation in preventive healthcare, and HIV/AIDS prevention and control; fines of up to VND 37,500,000 for acts of administrative violation in health insurance; fines of up to VND 50,000,000 for acts of administrative violation in medical examination and treatment, pharmacy, cosmetics and medical equipment;

c) Deprive of the right to use licenses or practice certificates for a definite term or suspend operation for a definite time;

d) Confiscate material evidences or means of administrative violations;

dd) Apply remedial measures specified in Clause 3, Article 3 of this Decree.

2. Chairpersons of People’s Committees of provinces and cities (hereinafter referred to as provincial level) shall have the power to:

a) Impose a caution;

b) Impose a fine of up to VND 30,000,000 for acts of administrative violation in population; up to VND 50,000,000 for acts of administrative violation in preventive healthcare, and HIV/AIDS prevention and control; up to VND 75,000,000 for acts of administrative violation in health insurance; up to VND 100,000,000 for acts of administrative violation in medical examination and treatment, pharmacy, cosmetics and medical equipment;

c) Deprive of the right to use licenses or practice certificates for a definite term or suspend operation for a definite time;

d) Confiscate material evidences or means of administrative violations;

dd) Apply remedial measures specified in Clause 3, Article 3 of this Decree.

Article 104. Competence of heads of agencies performing state management tasks

1. Heads of Sub-Departments in charge of population and children under provincial-level Departments of Health; Heads of Regional Sub-Departments of Animal Husbandry and Animal Health under the Department of Animal Husbandry and Animal Health; Directors of Regional Radio Frequency Centers, shall have the power to:

a) Impose a caution;

b) Imposing a fine of up to VND 15,000,000 for acts of administrative violation in population; VND 25,000,000 for acts of administrative violation in preventive healthcare, and HIV/AIDS prevention and control; VND 37,500,000 for acts of administrative violation in health insurance; VND 100,000,000 for acts of administrative violation in medical examination and treatment, pharmacy, cosmetics and medical equipment;

c) Deprive of the right to use licenses or practice certificates for a definite term or suspend operation for a definite time;

d) Confiscate material evidences or means of administrative violations;

dd) Apply remedial measures specified in Clause 3, Article 3 of this Decree.

2. Directors of provincial-level Departments shall have the power to:

a) Impose a caution;

b) Imposing a fine of up to VND 24,000,000 for acts of administrative violation in population; VND 40,000,000 for acts of administrative violation in preventive healthcare, and HIV/AIDS prevention and control; VND 60,000,000 for acts of administrative violation in health insurance; VND 80,000,000 for acts of administrative violation in medical examination and treatment, pharmacy, cosmetics and medical equipment;

c) Deprive of the right to use licenses or practice certificates for a definite term or suspend operation for a definite time;

d) Confiscate material evidences or means of administrative violations;

dd) Apply remedial measures specified in Clause 3, Article 3 of this Decree.

3. Directors or General Directors of the Drug Administration of Vietnam; the Department of Medical Service Administration; the Vietnam Administration of Disease Prevention; the Vietnam Population Authority; the Department for Roads of Vietnam; the Vietnam Maritime and Waterway Administration; the Civil Aviation Authority of Vietnam; the Vietnam Railway Authority; the Vietnam Register; the Plant Production and Protection Department; the Department of Animal Husbandry and Animal Health; the Department of Hydraulic Works Management and Construction; the Vietnam Disaster and Dyke Management Authority; the National Authority for Agro-Forestry-Fishery Quality, Processing and Market Development; the Department of Land Administration; the Department of Water Resources Management; the Department of Geology and Minerals of Vietnam; the Vietnam Environment Agency; the Vietnam Meteorological and Hydrological Agency; the Nature and Biodiversity Conservation Agency; the Vietnam Agency for Radiation and Nuclear Safety; the Intellectual Property Office of Vietnam; the Authority of Radio Frequency Management; the Vietnam Telecommunications Authority; the Chairperson of the Commission for the Standards, Metrology and Quality of Vietnam; the Department of Vocational Education and Continuing Education; the Authority of Press; the Authority of Broadcasting and Electronic Information; the Authority of Publishing, Printing and Distribution; heads of organizations under the ministries assigned to perform the inspection task within the scope of the ministries’ state management shall have the power to:

a) Impose a caution;

b) Impose a fine of up to VND 30,000,000 for acts of administrative violation in population; up to VND 50,000,000 for acts of administrative violation in preventive healthcare, and HIV/AIDS prevention and control; up to VND 75,000,000 for acts of administrative violation in health insurance; up to VND 100,000,000 for acts of administrative violation in medical examination and treatment, pharmacy, cosmetics and medical equipment;

c) Deprive of the right to use licenses or practice certificates for a definite term or suspend operation for a definite time;

d) Confiscate material evidences or means of administrative violations;

dd) Apply remedial measures specified in Clause 3, Article 3 of this Decree.

4. Heads of inspection teams established by heads of organizations under ministries specified in Clause 3 of this Article shall have the sanctioning competence specified in Clause 2 of this Article.

Heads of inspection teams established by the Ministers of: Health; Science and Technology; Culture, Sports and Tourism; Education and Training, Construction; Agriculture and Environment shall have the sanctioning competence specified in Clause 3 of this Article.

Article 105. Sanctioning competence of the Market Surveillance Force

1. Market controllers who are on duty shall have the power to:

a) Impose a caution;

b) Impose a fine of up to VND 3,000,000 for acts of administrative violation on population; up to VND 5,000,000 for acts of administrative violation on preventive healthcare, and HIV/AIDS prevention and control; up to VND 10,000,000 for acts of administrative violation on medical examination and treatment, pharmacy, cosmetics and medical equipment;

c) Confiscate material evidences or means of administrative violations valued up to VND 6,000,000 for acts of administrative violation on population; VND 10,000,000 for acts of administrative violation on preventive healthcare, and HIV/AIDS prevention and control; VND 20,000,000 for acts of administrative violation on medical examination and treatment, pharmacy, cosmetics and medical equipment.

2. Heads of market surveillance teams of Market Surveillance Branches under provincial-level Departments of Industry and Trade shall have the power to:

a) Impose a caution;

b) Impose a fine of up to VND 9,000,000 for acts of administrative violation on population; up to VND 15,000,000 for acts of administrative violation on preventive healthcare, and HIV/AIDS prevention and control; up to VND 30,000,000 for acts of administrative violation on medical examination and treatment, pharmacy, cosmetics and medical equipment;

c) Confiscate material evidences or means of administrative violations valued up to VND 18,000,000 for acts of administrative violation on population; VND 30,000,000 for acts of administrative violation on preventive healthcare, and HIV/AIDS prevention and control; VND 60,000,000 for acts of administrative violation on medical examination and treatment, pharmacy, cosmetics and medical equipment;

d) Apply the remedial measures specified in Clause 3, Article 3 of this Decree.

3. Directors of Market Surveillance Branches, and heads of market surveillance divisions under the Agency for Domestic Market Surveillance and Development shall have the power to:

a) Impose a caution;

b) Impose a fine of up to VND 15,000,000 for acts of administrative violation on population; up to VND 25,000,000 for acts of administrative violation on preventive healthcare, and HIV/AIDS prevention and control; up to VND 50,000,000 for acts of administrative violation on medical examination and treatment, pharmacy, cosmetics and medical equipment;

c) Confiscate material evidences or means of administrative violations;

d) Deprive of the right to use licenses or practice certificates for a definite term or suspend operation for a definite time;

dd) Apply the remedial measures specified in Clause 3, Article 3 of this Decree.

4. The Director of the Agency for Domestic Market Surveillance and Development shall have the power to:

a) Impose a caution;

b) Impose a fine of up to VND 30,000,000 for acts of administrative violation on population; up to VND 50,000,000 for acts of administrative violation on preventive healthcare; up to VND 100,000,000 for acts of administrative violation on medical examination and treatment, pharmacy, cosmetics and medical equipment;

c) Confiscate material evidences or means of administrative violations;

d) Deprive of the right to use licenses or practice certificates for a definite term or suspend operation for a definite time;

dd) Apply the remedial measures specified in Clause 3, Article 3 of this Decree.

Article 106. Sanctioning competence of the Public Security Force

1. Policemen who are on duty shall have the power to:

a) Impose a caution;

b) Impose a fine of up to VND 3,000,000 for acts of administrative violation on population; up to VND 5,000,000 for acts of administrative violation on preventive healthcare, and HIV/AIDS prevention and control; up to VND 10,000,000 for acts of administrative violation on medical examination and treatment, pharmacy, cosmetics and medical equipment;

c) Confiscate material evidences or means of administrative violations valued up to VND 6,000,000 for acts of administrative violation on population; VND 10,000,000 for acts of administrative violation on preventive healthcare, and HIV/AIDS prevention and control; VND 20,000,000 for acts of administrative violation on medical examination and treatment, pharmacy, cosmetics and medical equipment.

2. Heads of company-level mobile police units shall have the power to:

a) Impose a caution;

b) Impose a fine of up to VND 6,000,000 for acts of administrative violation on population; up to VND 10,000,000 for acts of administrative violation on preventive healthcare, and HIV/AIDS prevention and control; up to VND 20,000,000 for acts of administrative violation on medical examination and treatment, pharmacy, cosmetics and medical equipment;

c) Confiscate material evidences or means of administrative violations valued up to VND 12,000,000 for acts of administrative violation on population; VND 20,000,000 for acts of administrative violation on preventive healthcare, and HIV/AIDS prevention and control; VND 40,000,000 for acts of administrative violation on medical examination and treatment, pharmacy, cosmetics and medical equipment;

d) Applying the remedial measures prescribed at Point c, dd and e Clause 1 Article 28 of the Law on Handlings of Administrative Violations.

3. Chiefs of police stations, heads of battalion-level mobile police units, heads of marine squads, station chiefs and team heads shall have the power to:

a) Impose a caution;

b) Impose a fine of up to VND 9,000,000 for acts of administrative violation in population; up to VND 15,000,000 for acts of administrative violation in preventive healthcare, and HIV/AIDS prevention and control; up to VND 22,500,000 for acts of administrative violation in health insurance; up to VND 30,000,000 for acts of administrative violation in medical examination and treatment, pharmacy, cosmetics and medical equipment;

c) Deprive of the right to use licenses or practice certificates for a definite term or suspend operation for a definite time;

d) Confiscate material evidences or means of administrative violations valued up to VND 18,000,000 for acts of administrative violation on population; VND 30,000,000 for acts of administrative violation on preventive healthcare, and HIV/AIDS prevention and control; up to VND 45,000,000 for acts of administrative violation in health insurance; up to VND 60,000,000 for acts of administrative violation on medical examination and treatment, pharmacy, cosmetics and medical equipment;

dd) Applying the remedial measures prescribed at Point c, dd and e Clause 1 Article 28 of the Law on Handlings of Administrative Violations.

4. Chiefs of commune-level police offices shall have the power to:

a) Impose a caution;

b) Impose a fine of up to VND 15,000,000 for acts of administrative violation in population; up to VND 25,000,000 for acts of administrative violation in preventive healthcare, and HIV/AIDS prevention and control; up to VND 37,500,000 for acts of administrative violation in health insurance; up to VND 50,000,000 for acts of administrative violation in medical examination and treatment, pharmacy, cosmetics and medical equipment;

c) Deprive of the right to use licenses or practice certificates for a definite term or suspend operation for a definite time;

d) Confiscate material evidences or means of administrative violations;

dd) Apply the remedial measures specified in Clause 3, Article 3 of this Decree.

5. Heads of border-gate police offices of international airports; heads of professional divisions of the Internal Political Security Department, including: Head of the Health and Education Security Division; Head of the Culture, Sports and Social Labor Security Division; heads of the professional divisions of the Police Department for Administrative Management of Social Order, including: heads of Divisions for Guidance and Management of Sectors and Trades Subject to Conditional Business Investment Related to Security and Order and Seals; Heads of professional divisions under the Traffic Police Department, including: Head of the Division for Guidance on Communications, Investigation, and Handling of Traffic Accidents; Head of the Division for Guidance on Patrol and Control of Road and Railway Traffic; Head of the Division for Guidance on Patrol, Control, and Crime Prevention on Inland Waterways, Commanders of Waterway Police Squadrons; Heads of divisions under provincial-level Police Departments: Heads of the Internal Political Security Divisions, Heads of the Police Divisions for Administrative Management of Social Order; Heads of the Traffic Police Divisions; Heads of the Economic Security Divisions; Heads of regiment-level Mobile Police units; Heads of the Mobile Police Divisions; Heads of the Police Divisions for Investigation of Corruption, Economic, Smuggling, and Environmental Crimes; Chiefs of the Offices of the provincial-level Investigation Police Agencies shall have the power to:

a) Impose a caution;

b) Impose a fine of up to VND 24,000,000 for acts of administrative violation in population; VND 40,000,000 for acts of administrative violation in preventive healthcare, and HIV/AIDS prevention and control; VND 60,000,000 for acts of administrative violation in health insurance; VND 80,000,000 for acts of administrative violation in medical examination and treatment, pharmacy, cosmetics and medical equipment;

c) Deprive of the right to use licenses or practice certificates for a definite term or suspend operation for a definite time;

d) Confiscate material evidences or means of administrative violations;

dd) Apply the remedial measures specified in Clause 3, Article 3 of this Decree.

6. Directors of provincial-level Public Departments shall have the power to:

a) Impose a caution;

b) Impose a fine of up to VND 30,000,000 for acts of administrative violation in population; up to VND 50,000,000 for acts of administrative violation in preventive healthcare, and HIV/AIDS prevention and control; up to VND 75,000,000 for acts of administrative violation in health insurance; up to VND 100,000,000 for acts of administrative violation in medical examination and treatment, pharmacy, cosmetics and medical equipment;

c) Deprive of the right to use licenses or practice certificates for a definite term or suspend operation for a definite time;

d) Confiscate material evidences or means of administrative violations;

dd) Apply the remedial measures specified in Clause 3, Article 3 of this Decree.

7. The Director of the Internal Political Security Department; Director of the Economic Security Department; Director of the Police Department for Administrative Management of Social Order; Director of the Police Department for Investigation of Corruption, Economic and Smuggling Crimes; Director of the Traffic Police Department; Director of the Environmental Crime Prevention and Combat Police Department; Commander of the Mobile Police Department; Chief of the Office of the Investigation Police Agency under the Ministry of Public Security shall have the power to:

a) Impose a caution;

b) Impose a fine of up to VND 30,000,000 for acts of administrative violation on population; up to VND 50,000,000 for acts of administrative violation on preventive healthcare and HIV/AIDS prevention and control; up to VND 75,000,000 for acts of administrative violation on health insurance; up to VND 100,000,000 for acts of administrative violation on medical examination and treatment, pharmacy, cosmetics and medical equipment;

c) Deprive of the right to use licenses or practice certificates for a definite term or suspend operation for a definite time;

d) Confiscate material evidences or means of administrative violations;

dd) Apply the remedial measures specified in Clause 3, Article 3 of this Decree.

Article 107. Competence to sanction administrative violations of Customs agencies

1. Customs officers who are on duty shall have the power to:

a) Impose a caution;

b) Impose a fine of up to VND 2,500,000 for acts of administrative violation on preventive healthcare and HIV/AIDS prevention and control; up to VND 5,000,000 for acts of administrative violation on pharmacy, cosmetics and medical equipment;

c) Confiscate material evidences or means of administrative violations valued up to VND 5,000,000 for acts of administrative violation on preventive healthcare, and HIV/AIDS prevention and control; VND 10,000,000 for acts of administrative violation on pharmacy, cosmetics and medical equipment.

2. Heads of border-gate customs offices/outside-of-border gate customs offices, heads of post-customs clearance inspection and review teams, heads of customs clearance teams, heads of customs control teams of regional Customs Branches, heads of anti-smuggling control teams of Anti-Smuggling Investigation Branches; and heads of regional post-customs clearance inspection teams of Post-Customs Clearance Inspection Branches shall have the power to:

a) Impose a caution;

b) Impose a fine of up to VND 15,000,000 for acts of administrative violation on preventive healthcare and HIV/AIDS prevention and control; up to VND 30,000,000 for acts of administrative violation on pharmacy, cosmetics and medical equipment;

c) Confiscate material evidences or means of administrative violations valued up to VND 30,000,000 for acts of administrative violation on preventive healthcare, and HIV/AIDS prevention and control; VND 60,000,000 for acts of administrative violation on pharmacy, cosmetics and medical equipment;

d) Apply the remedial measures specified in Clause 3, Article 3 of this Decree.

3. Directors of Anti-Smuggling Investigation Branches, directors of Post-Customs Clearance Inspection Branches and directors of regional Customs Branches shall have the power to:

a) Impose a caution;

b) Impose a fine of up to VND 25,000,000 for acts of administrative violation on preventive healthcare and HIV/AIDS prevention and control; up to VND 50,000,000 for acts of administrative violation on pharmacy, cosmetics and medical equipment;

c) Confiscate material evidences or means of administrative violations;

d) Deprive of the right to use licenses or practice certificates for a definite term or suspend operation for a definite time;

dd) Apply the remedial measures specified in Clause 3, Article 3 of this Decree.

4. The Director General of the Department of Vietnam Customs shall have the power to:

a) Impose a caution;

b) Impose a fine of up to VND 50,000,000 for acts of administrative violation on preventive healthcare and HIV/AIDS prevention and control; up to VND 100,000,000 for acts of administrative violation on pharmacy, cosmetics and medical equipment;

c) Confiscate material evidences or means of administrative violations;

d) Deprive of the right to use licenses or practice certificates for a definite term or suspend operation for a definite time;

dd) Apply the remedial measures specified in Clause 3, Article 3 of this Decree.

Article 108. Competence to sanction administrative violations of the Border Guards

1. Border-guard soldiers who are on duty shall have the power to:

a) Impose a caution;

b) Impose a fine of up to VND 1,500,000 for acts of administrative violation on population; up to VND 2,500,000 for acts of administrative violation on preventive healthcare, and HIV/AIDS prevention and control; up to VND 5,000,000 for acts of administrative violation on medical examination and treatment, pharmacy, cosmetics and medical equipment;

c) Confiscate material evidences or means of administrative violations valued up to VND 3,000,000 for acts of administrative violation on population; VND 5,000,000 for acts of administrative violation on preventive healthcare, and HIV/AIDS prevention and control; VND 10,000,000 for acts of administrative violation on medical examination and treatment, pharmacy, cosmetics and medical equipment.

2. Station chiefs or team commanders of border-guard soldiers shall have the power to:

a) Impose a caution;

b) Impose a fine of up to VND 3,000,000 for acts of administrative violation on population; up to VND 5,000,000 for acts of administrative violation on preventive healthcare, and HIV/AIDS prevention and control; up to VND 10,000,000 for acts of administrative violation on medical examination and treatment, pharmacy, cosmetics and medical equipment;

c) Confiscate material evidences or means of administrative violations valued up to VND 6,000,000 for acts of administrative violation on population; VND 10,000,000 for acts of administrative violation on preventive healthcare, and HIV/AIDS prevention and control; VND 20,000,000 for acts of administrative violation on medical examination and treatment, pharmacy, cosmetics and medical equipment;

d) Applying the remedial measures prescribed at Point c, dd and e Clause 1 Article 28 of the Law on Handlings of Administrative Violations.

3. Heads of drug and crime prevention and combat task force teams under drug and crime prevention and combat task force regiments shall have the power to:

a) Impose a caution;

b) Impose a fine of up to VND 4,500,000 for acts of administrative violation on population; up to VND 7,500,000 for acts of administrative violation on preventive healthcare, and HIV/AIDS prevention and control; up to VND 15,000,000 for acts of administrative violation on medical examination and treatment, pharmacy, cosmetics and medical equipment;

c) Confiscate material evidences or means of administrative violations valued up to VND 9,000,000 for acts of administrative violation on population; VND 15,000,000 for acts of administrative violation on preventive healthcare, and HIV/AIDS prevention and control; VND 30,000,000 for acts of administrative violation on medical examination and treatment, pharmacy, cosmetics and medical equipment;

d) Applying the remedial measures prescribed at Point c, dd and e Clause 1 Article 28 of the Law on Handlings of Administrative Violations.

4. Chiefs of border-guard stations, heads of border-guard flotillas, and commanders of commanding boards of port border-gate guards at ports shall have the power to:

a) Caution;

b) Impose a fine of up to VND 9,000,000 for acts of administrative violation on population; up to VND 15,000,000 for acts of administrative violation on preventive healthcare, and HIV/AIDS prevention and control; up to VND 30,000,000 for acts of administrative violation on medical examination and treatment, pharmacy, cosmetics and medical equipment;

c) Confiscate material evidences or means of administrative violations valued up to VND 18,000,000 for acts of administrative violation on population; VND 30,000,000 for acts of administrative violation on preventive healthcare, and HIV/AIDS prevention and control; VND 60,000,000 for acts of administrative violation on medical examination and treatment, pharmacy, cosmetics and medical equipment;

d) Apply the remedial measures specified in Clause 3, Article 3 of this Decree.

5. Heads of drug and crime prevention and combat task force regiments of Drug and Crime Prevention and Combat Department under the Border Guard High Command shall have the power to:

a) Impose a caution;

b) Impose a fine of up to VND 15,000,000 for acts of administrative violation on population; up to VND 25,000,000 for acts of administrative violation on preventive healthcare, and HIV/AIDS prevention and control; up to VND 50,000,000 for acts of administrative violation on medical examination and treatment, pharmacy, cosmetics and medical equipment;

c) Deprive of the right to use licenses or practice certificates for a definite term or suspend operation for a definite time;

d) Confiscate material evidences or means of administrative violations;

dd) Apply the remedial measures specified in Clause 3, Article 3 of this Decree.

6. The Commander of Border Guard Command; chiefs of border-guard fleets and the Director of the Drug and Crime Prevention and Combat Department under the Border-Guard High Command shall have the power to:

a) Impose a caution;

b) Impose a fine of up to VND 30,000,000 for acts of administrative violation on population; up to VND 50,000,000 for acts of administrative violation on preventive healthcare, and HIV/AIDS prevention and control; up to VND 100,000,000 for acts of administrative violation on medical examination and treatment, pharmacy, cosmetics and medical equipment;

c) Deprive of the right to use licenses or practice certificates for a definite term or suspend operation for a definite time;

d) Confiscate material evidences or means of administrative violations;

dd) Apply the remedial measures specified in Clause 3, Article 3 of this Decree.

Article 109. Competence to of the Vietnam Coast Guard force

1. Coast Guard officers on official duty shall have the power to:

a) Impose a caution;

b) Impose a fine of up to VND 1,500,000 for acts of administrative violation on population; up to VND 2,500,000 for acts of administrative violation on preventive healthcare, and HIV/AIDS prevention and control; up to VND 5,000,000 for acts of administrative violation on medical examination and treatment, pharmacy, cosmetics and medical equipment;

c) Confiscate material evidences or means of administrative violations valued up to VND 3,000,000 for acts of administrative violation on population; VND 5,000,000 for acts of administrative violation on preventive healthcare, and HIV/AIDS prevention and control; VND 10,000,000 for acts of administrative violation on medical examination and treatment, pharmacy, cosmetics and medical equipment.

2. Heads of Coast Guard professional teams shall have the power to:

a) Impose a caution;

b) Impose a fine of up to VND 3,000,000 for acts of administrative violation on population; up to VND 5,000,000 for acts of administrative violation on preventive healthcare, and HIV/AIDS prevention and control; up to VND 10,000,000 for acts of administrative violation on medical examination and treatment, pharmacy, cosmetics and medical equipment;

c) Confiscate material evidences or means of administrative violations valued up to VND 6,000,000 for acts of administrative violation on population; VND 10,000,000 for acts of administrative violation on preventive healthcare, and HIV/AIDS prevention and control; VND 20,000,000 for acts of administrative violation on medical examination and treatment, pharmacy, cosmetics and medical equipment.

3. Heads of professional operation squads of the Coast Guard and Heads of Coast Guard stations shall have the power to:

a) Impose a caution;

b) Impose a fine of up to VND 6,000,000 for acts of administrative violation on population; up to VND 10,000,000 for acts of administrative violation on preventive healthcare, and HIV/AIDS prevention and control; up to VND 20,000,000 for acts of administrative violation on medical examination and treatment, pharmacy, cosmetics and medical equipment;

c) Confiscate material evidences or means of administrative violations valued up to VND 12,000,000 for acts of administrative violation on population; VND 20,000,000 for acts of administrative violation on preventive healthcare, and HIV/AIDS prevention and control; VND 40,000,000 for acts of administrative violation on medical examination and treatment, pharmacy, cosmetics and medical equipment;

d) Applying the remedial measures prescribed at Point c, dd and e Clause 1 Article 28 of the Law on Handling of Administrative Violations.

4. Captains of Coast Guard flotillas shall have the power to:

a) Impose a caution;

b) Impose a fine of up to VND 9,000,000 for acts of administrative violation on population; up to VND 15,000,000 for acts of administrative violation on preventive healthcare, and HIV/AIDS prevention and control; up to VND 30,000,000 for acts of administrative violation on medical examination and treatment, pharmacy, cosmetics and medical equipment;

c) Confiscate material evidences or means of administrative violations valued up to VND 18,000,000 for acts of administrative violation on population; VND 30,000,000 for acts of administrative violation on preventive healthcare, and HIV/AIDS prevention and control; VND 60,000,000 for acts of administrative violation on medical examination and treatment, pharmacy, cosmetics and medical equipment;

d) Applying remedial measures prescribed at Points c, d, dd, e and i Clause 1 Article 28 of the Law on Handling of Administrative Violations and Point b Clause 3 Article 3 of this Decree.

5. Chiefs of coast guard fleets; heads of reconnaissance teams, and heads of drug-related crime prevention and combat task force regiments of the Vietnam Coast Guard shall have the power to:

a) Impose a caution;

b) Impose a fine of up to VND 15,000,000 for acts of administrative violation on population; up to VND 25,000,000 for acts of administrative violation on preventive healthcare, and HIV/AIDS prevention and control; up to VND 50,000,000 for acts of administrative violation on medical examination and treatment, pharmacy, cosmetics and medical equipment;

c) Deprive of the right to use licenses or practice certificates for a definite term or suspend operation for a definite time;

d) Confiscate material evidences or means of administrative violations;

dd) Applying remedial measures prescribed at Points c, d, dd, e and i Clause 1 Article 28 of the Law on Handling of Administrative Violations, and Points c, d and dd Clause 1 Article 28 of the Law on Handling of Administrative Violations, and Point b Clause 3 Article 3 of this Decree.

6. Coast Guard regional commanders, and the Director of the Professional and Legal Department of the Vietnam Coast Guard shall have the power to:

a) Impose a caution;

b) Impose a fine of up to VND 24,000,000 for acts of administrative violation on population; up to VND 40,000,000 for acts of administrative violation on preventive healthcare, and HIV/AIDS prevention and control; up to VND 80,000,000 for acts of administrative violation on medical examination and treatment, pharmacy, cosmetics and medical equipment;

c) Deprive of the right to use licenses or practice certificates for a definite time;

d) Confiscate material evidences or means of administrative violations;

dd) Apply the remedial measures specified in Clause 3, Article 3 of this Decree.

7. The Vietnam Coast Guard Commander shall have the power to:

a) Impose a caution;

b) Impose a fine of up to VND 30,000,000 for acts of administrative violation on population; up to VND 50,000,000 for acts of administrative violation on preventive healthcare, and HIV/AIDS prevention and control; up to VND 100,000,000 for acts of administrative violation on medical examination and treatment, pharmacy, cosmetics and medical equipment;

c) Deprive of the right to use licenses or practice certificates for a definite term or suspend operation for a definite time;

d) Confiscate material evidences or means of administrative violations;

dd) Apply the remedial measures specified in Clause 3, Article 3 of this Decree.

Article 110. Competence of tax offices

1. Tax officers who are on duty shall have the power to:

a) Impose a caution;

b) Impose a fine of up to VND 3,000,000 for acts of administrative violation on preventive healthcare, and HIV/AIDS prevention and control;

c) Confiscate material evidences or means of administrative violations valued up to VND 6,000,000 for acts of administrative violation on preventive healthcare, and HIV/AIDS prevention and control.

2. Managers of commune - level Tax Offices shall have the power to:

a) Impose a caution;

b) Impose a fine of up to VND 15,000,000 for acts of administrative violation on preventive healthcare, and HIV/AIDS prevention and control;

c) Confiscate material evidences or means of administrative violations valued up to VND 30,000,000 for acts of administrative violation on preventive healthcare, and HIV/AIDS prevention and control;

d) Applying remedial measures prescribed at Points e and i Clause 1 Article 28 of the Law on Handling of Administrative Violations and Point b Clause 3 Article 3 of this Decree.

3. Managers of Sub-Departments, Manager of Tax Offices of provinces and cities shall have the power to:

a) Impose a caution;

b) Impose a fine of up to VND 24,000,000 for acts of administrative violation on preventive healthcare, and HIV/AIDS prevention and control;

c) Confiscate material evidences or means of administrative violations;

d) Apply the remedial measures specified in Clause 3, Article 3 of this Decree.

4. The Director General of Department of Taxation shall have the power to:

a) Impose a caution;

b) Impose a fine of up to VND 50,000,000 for acts of administrative violation on preventive healthcare, and HIV/AIDS prevention and control;

c) Confiscate material evidences or means of administrative violations;

d) Apply the remedial measures specified in Clause 3, Article 3 of this Decree.

Article 111. Sanctioning competence of Social security agencies

1. Directors of provincial-level Social Security Offices shall have the power to:

a) Impose a fine of up to VND 37,500,000 for acts of administrative violation on health insurance premium payment;

b) Confiscate material evidences or means of administrative violations valued up to VND 75,000,000 for acts of administrative violation on payment of health insurance premiums;

c) Apply the remedial measures defined in Clause 3 Article 3 of this Decree.

2. The Director General of the Vietnam Social Security shall have the power to:

a) Impose a fine of up to VND 75,000,000 for acts of administrative violation on payment of health insurance premiums and the acts specified in Articles 83, 84, 85 and 86 of this Decree;

b) Confiscate material evidences or means of administrative violations;

c) Apply the remedial measures defined in Clause 3 Article 3 of this Decree.

Article 112. Determination of the competence to impose sanctions of administrative violations of positions competent to impose sanctions of administrative violations in health

1. Chairpersons of People’s Committees at all levels shall be competent in making records of administrative violations, imposing administrative sanctions, and applying remedial measures for the acts of administrative violation prescribed in Chapter II of this Decree in accordance with the competence prescribed in Article 103 of this Decree and their assigned functions, tasks and powers.

2. Heads of agencies performing state management in the health may make records of administrative violations, imposing sanctions of administrative violation, and applying remedial measures for the acts of administrative violation prescribed in Chapter II of this Decree in accordance with the competence prescribed in Article 104 of this Decree and acts of administrative violation related to health, in accordance with the competence of equivalent positions prescribed in other Decrees on santioning of administrative violations, and in accordance with the assigned functions, tasks and powers.

3. Competent persons of the Market Surveillance agencies may make records of administrative violations, impose sanctions of administrative violation, and apply remedial measures within their scope of management, functions, tasks, and powers as assigned and in accordance with their competence specified in Article 105 of this Decree, for the acts of violation specified at Clause 4 Article 6; Point g Clause 3 Article 9; Clause 3 and Clause 4 Article 12; Clause 2 and Clause 3 Article 24; Article 25; Clause 2 Article 26; Article 27; Points a and b Clause 3; Points a, b, c and g Clause 4, Point a Clause 5 Article 29; Articles 31, 32, 33 and 35; Clause 2 and Clause 3 Article 36; Articles 37 and 51; Points a and d Clause 1, Points a, b and g Clause 2, Clause 3 Article 52; Articles 53 and 54; Point a Clause 2 Article 55; Articles 56, 57, 58, 59 and 60; Points d and dd Clause 1, Points a, c and d Clause 2; Points a, b and c Clause 3, Clause 4 Article 61; Point a Clause 2, Point a Clause 3, Clauses 4 and 5 Article 62; Articles 64, 65, 66,67,68, 69 and 70; Points e, g and h Clause 2, Point b Clause 3 Article 71; Articles 72, 73, 74, 75, 76 and 78; Point a Clause 2, Clause 3 Article 97; and Article 102 of this Decree.

4. Competent persons of the People’s Public Security agencies may make records of administrative violations, impose sanctions of administrative violation, and apply remedial measures within their scope of management, functions, tasks, and powers as assigned and in accordance with their competence specified in Article 106 of this Decree, for the acts of violation specified in Articles 7, 10, 11, 12, 13, 14, 15, 16, 18, 21, 23, 24, 25, 26,28, 30, 31, 32, 33, 34, 35, 36, 37, 54, 65, 66, 67, 68, 70, 75, 96, 97, 98, 99, 100 and 101; Point a Clause 3 Article 5; Clauses 1, 2 and 4 Article 6;

Point a Clause 1, Point a Clause 2, Point g Clause 3 Article 9; Points a and c Clause 5, Clause 6 and 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; Points a and g Clause 2 Article 52; Clause 3 Article 53; Clause 4 Article 55; Points dd and e Clause 4 Article 56; Point d Clause 5, Clause 7 Article 57; Clause 7 Article 58; Clauses 4, 5, 6, 7 and 8 Article 59; Points c, d, dd and e Clause 2,

Point dd Clause 3, Clauses 4, 5, 6 and 7 Article 60; Clause 4 Article 61; Clause 5 Article 62; Clause 4 Article 63; Clauses 1 and 2, Points a and b Clause 3 Article 64; Clauses 2 and 3 Article 68; Point b Clause 2 Article 69; Point a Clause 2, Points a and b Clause 3 Article 72; Point e Clause 2, Clause 3 Article 73; and Point b Clause 2, Point d Clause 3 Article 74 of this Decree.

5. Competent persons of the Customs agencies may make records of administrative violations, impose sanctions of administrative violation, and apply remedial measures within their scope of management, functions, tasks, and powers as assigned and in accordance with their competence specified in Article 107 of this Decree, for the acts of violation specified in Articles 7, 11, 12, 13, 14, 25, 26,27, 28, 30, 31, 32, 33, 34, 35, 36, 37, 60, 64, 70 and 75; Clauses 1 and 2 Article 6; Point b Clause 1 Article 54; Clauses 6 and 7 Article 58; Clauses 7 and 8 Article 59; Point b Clause 1, Clause 2 Article 65; Points d and dd Clause 2 Article 71; Point a Clause 4 Article 73; and Point b Clause 2 Article 74 of this Decree.

6. Competent persons of the Border Guard force may make records of administrative violations, impose sanctions of administrative violation, and apply remedial measures within their scope of management, functions, tasks, and powers as assigned and in accordance with their competence specified in Article 108 of this Decree, for the acts of violation specified in Articles 5, 6, 7, 10, 11, 12, 13, 14, 19, 22, 24, 25, 26, 27, 30, 31,32, 33, 34, 35, 36, 37, 60, 65, 75, 95, 96, 100 and 101; Point b Clause 3 Article 8; Point b Clause 3 Article 9; Points a and b Clause 2 Article 16; Point g Clause 2, Point dd Clause 3 Article 22; Clauses 1, 2 and 3, Points a, b, c and g Clause 4, Point a Clause 5 Article 29; Point b Clause 4, Point b Clause 5 Article 39; Point b Clause 3 Article 48; Point b Clause 3 Article 50; Point b Clause 1 Article 52; and Clause 1, Point b Clause 2, Points a and b Clause 3 Article 64 of this Decree.

7. Competent persons of the Coast Guard force may make records of administrative violations, impose sanctions of administrative violation, and apply remedial measures within their scope of management, functions, tasks, and powers as assigned and in accordance with their competence specified in Article 109 of this Decree, for the acts of violation specified 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, 70, 75, 79, 80, 95, 96 and 101; Point b Clause 3 Article 8; Point b Clause 3 Article 9; Points a and b Clause 2 Article 16; Point g Clause 2, Clause 3 Article 22; Clauses 1, 2 and 3, Points a, b, c and g Clause 4, Point a Clause 5 Article 29; Clauses 1, 3, 5, 6 and 7 Article 38; Point b Clause 4 Article 39; Clause 4 Article 40; Point b Clause 1 Article 45; Point b Clause 3 Article 50; Point b Clause 1 Article 52; Clause 1, Point b Clause 2, Points a and b Clause 3 Article 64; Clause 2 Article 68; Clause 1 Article 73; Clause 2 Article 78; and Point a Clause 1, Clause 2 Article 95 of this Decree.

8. Competent persons of the tax agencies may make records of administrative violations, impose sanctions of administrative violation, and apply remedial measures within their scope of management, functions, tasks, and powers as assigned and in accordance with their competence specified in Article 110 of this Decree, for the acts of violation specified at Points d, dd and e Clause 4 and Point b Clause 5 Article 29 of this Decree.

9. Competent persons of the social insurance agencies may make records of administrative violations, impose sanctions of administrative violation, and apply remedial measures within their scope of management, functions, tasks, and powers as assigned and in accordance with their competence specified in Article 111 of this Decree, for the acts of violations of regulations on payment of health insurance premiums and the acts specified in Articles 83, 84, 85 and 86 of this Decree.

10. Competent persons of agencies performing state management in the field of science and technology may make records of administrative violations, impose sanctions of administrative violation, and apply remedial measures within their scope of management, functions, tasks, and powers as assigned and in accordance with their competence specified in Article 104 of this Decree, for the acts of violation specified in Articles 5, 6, 18, 19, 23,25, 26, 30, 32, 33, 34, 36, 37,49, 50, 51, 67, 77, 95 and 96; Clause 2 Article 14; Clauses 1, 2 and 3, Points a, b, c, e and g Clause 4, Point a Clause 5 Article 29; Clause 3 Article 31 and Point b Clause 2 Article 35 of this Decree.

11. Competent persons of agencies performing state management in the field of of culture, sports and tourism may make records of administrative violations, impose sanctions of administrative violation, and apply remedial measures within their scope of management, functions, tasks, and powers as assigned and in accordance with their competence specified in Article 104 of this Decree, for the acts of violation specified in Articles 5, 19, 25, 26, 30, 31, 32, 33, 34, 36, 37, 49, 50, 51, 67, 77, 95 and 96; Points b and c Clause 3 Article 12; Clause 2 Article 14; Clauses 1, 2 and 3, Points a, b, c, e and g Clause 4, Point a Clause 5 Article 29; and Point b Clause 2 Article 35 of this Decree.

12. Competent persons of agencies performing state management in the fields of education and construction may make records of administrative violations, impose sanctions of administrative violation, and apply remedial measures within their scope of management, functions, tasks, and powers as assigned and in accordance with their competence specified in Article 104 of this Decree, for the acts of violation specified in Articles 5, 6, 18, 19, 23, 25, 26, 30, 31, 32, 33, 34, 36 and 37; Clause 2 Article 14; and Clauses 1, 2 and 3, Points a, b, c and e Clause 4, Point a Clause 5 Article 29 of this Decree.

13. Competent persons of agencies performing state management in the fields of of agriculture and environment may make records of administrative violations, impose sanctions of administrative violation, and apply remedial measures within their scope of management, functions, tasks, and powers as assigned and in accordance with their competence specified in Article 104 of this Decree, for the acts of violation specified in Articles 5, 6, 7, 10, 12, 15, 16, 18, 19, 23, 25, 26, 30, 31, 32, 33, 34, 36 and 37; Clause 2 Article 14; and Clauses 1, 2 and 3, Points a, b, c and e Clause 4 and Point a Clause 5 Article 29 of this Decree.

Article 113. Competence to make written records of administrative violations

1. Persons competent to impose sanctions of administrative sanction as specified in Articles 103, 104, 105, 106, 107, 108, 109, 110 and 111 of this Decree shall have the power to make records of administrative violations within the scope of performance of official duties and tasks in accordance with their assigned functions, tasks, and powers.

2. Civil servants and public employees of the health and social insurance sectors, public servants, public employees, people of the People's Army Force, the People's Public Security Force and public servants and employees in the agencies defined in Article 112 of this Decree who are on duties and tasks in accordance with their assigned functions, duties and powers.

Article 114. The use of technical operational means and devices in detecting acts of violation

1. Agencies and persons competent to impose sanctions of administrative violations shall be allowed to use technical operational means and devices to detect the acts of violation defined in Articles 24, 26, 30, 31, 32, 33, 34, 35, 36 and 37 of this Decree.

2. The management, use and list of technical operational means and devices to detect acts of violation shall be performed in accordance with law provisions.

Chapter IV

IMPLEMENTATION PROVISIONS

Article 115. Effect

1. This Decree takes effect on May 15, 2026.

2. From the effective date of this Decree, the following regulations cease to be effective:

a) Decree No. 117/2020/ND-CP dated September 28, 2020 of the Government, on sanctioning of administrative violations in health sector;

b) Article 2 and Clause 1 Article 3 of Decree No. 124/2021/ND-CP dated December 28, 2021 of the Government, on amending and supplementing a number of articles of the Government’s Decree No. 115/2018/ND-CP dated September 04, 2018, on sanctioning of administrative violations in food safety and the Government’s Decree No. 117/2020/ND-CP dated September 28, 2020, on sanctioning of administrative violations in health sector

c) Article 2 of Decree No. 371/2025/ND-CP dated December 31, 2025 of the Government, on amending and supplementing a number of articles of the Government's Decree No. 77/2013/ND-CP dated July 17, 2013, detailing the Law on Prevention and Control of Tobacco Harms regarding measures for prevention and control of tobacco harms, and the Government’s Decree No. 117/2020/ND-CP dated September 28, 2020, on sanctioning of administrative violations in health sector.

Article 116. Transitional provision

1. For acts of administrative violations in the field of health occurring and terminating before the effective date of this Decree but detected or being considered and settled after the date on which this Decree takes effect, the Government's Decree on sanctioning of administrative violations and related legal documents which is effective at the time of committing acts of violation shall apply for handling.

2. For acts of administrative violation in the field of health that occurred before the effective date of this Decree but are still ongoing after this Decree has taken effect, this Decree shall prevail for handling.

3. For decisions on sanctioning of administrative violations that have been issued or have been fully executed before the effective date of this Decree, if the sanctioned individuals or organizations still lodge complaints, the Law on Handling of Administrative Violations, the Government’s Decrees on sanctioning of administrative violations, and relevant legal normative documents effective at the time of issuance of the decisions on sanctioning of administrative violations shall apply for handling.

Article 117. Guidance and implementation responsibilities

1. The Minister of Health shall be responsible for providing guidance and organizing the implementation of this Decree.

2. Ministers, heads of ministerial-level agencies, heads of government-attached agencies, chairpersons of People’s Committees at all levels, and related agencies, organizations and individuals shall implement this Decree.