THE GOVERNMENT ___________ No. 117/2020/ND-CP | THE SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness ________________________ Hanoi, September 28, 2020 |
DECREE
On sanctioning of administrative violations in health sector
___________
Pursuant to the Law on Government Organization dated June 19, 2015;
Pursuant to the Law on Handling of Administrative Violations dated June 20, 2012;
Pursuant to the Law on HIV/AIDS prevention and control dated June 29, 2006;
Pursuant to the Law on Donation, Removal and Transplantation of Human Tissues and Organs and Donation and Recovery of Cadavers dated November 29, 2006;
Pursuant to the Law on Prevention and Control of Infectious Diseases dated November 21, 2007;
Pursuant to the Law on Health Insurance dated November 14, 2008 and the Law on Amending and Supplementing a Number of Articles of the Law on Health Insurance dated June 13, 2014;
Pursuant to the Law on Medical Examination and Treatment dated November 23, 2009;
Pursuant to the Law on Prevention and Control of Tobacco Harms dated June 18, 2012;
Pursuant to the Law on Pharmacy dated April 06, 2016;
Pursuant to the Law on Prevention and Control of Harms of Liquor and Beer Abuse dated June 14, 2019;
Pursuant to the Population Ordinance dated January 09, 2003 and the Ordinance on Amending Article 10 of the Population Ordinance dated December 27, 2008;
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) Violations of regulations on preventive medicine and HIV/AIDS prevention and control;
b) Violations of regulations on medical examination and treatment;
c) Violations of regulations on pharmacy and cosmetics;
d) Violations of regulations on medical equipment;
dd) Violations of regulations on health insurance;
e) Violations 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.
4. Upon detecting acts of violations specified at Point c, Clause 3, Article 7; Point e, Clause 5, and Point b, Clause 6, Article 38; Points a and b, Clause 7, Article 44; Clause 6, Article 48; Point a, Clause2, Article52; Clause 3, Article 53; Point a, Clause 1, Article 54; Point c, Clause 4, Article 56; Point d, Clause 5, and Clause 7, Article 57; Clause 7, Article 58; Clause 7, Article 59; Point a, Clause 4, Article 60; Point c, Clause 5, Article 67; Clause 3, Article 68; Point b, Clause 2, Article 70; Points a and b, Clause 3, Article 73; Clause 4, Article 80; Points d, dd, e, g and h, Clause 2, Article 85; Points d, dd, e, g, h and i, Clause 2, Article 86 or cases of recidivism, for the acts of violations specified at Points a and b, Clause 3, Article 7; Clause 9, Article 15; Clause 6, Article 40; Point a, Clause 6, Article 44; Point b, Clause 5, Article 67, and Clauses 2 and 3, Article 80 of this Decree, the competent person accepting the case must transfer the dossier of the violation to a body competent to conduct the criminal proceedings for penal liability examination in accordance with Clauses 1, 2 and 4, Article 62 of the Law on Handling of Administrative Violations. In case the body conducting the criminal proceedings decide not to prosecute a criminal case under the law on criminal procedure, such body conducting the criminal proceedings shall return dossiers to the person competent to sanction who has transferred such dossiers in accordance with Clause 3, Article 62 of the Law on Handling of Administrative Violations sanctioning administrative violations according to this Decree.
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: Private enterprises, join stock companies, limited liability companies, partnerships 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-politico-professional organizations, and socio-professional organizations;
dd) Public non-business units, people s armed units and Communist Party of Vietnam;
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. Depending on the nature and severity of violations, individuals or organizations committing administrative violations may also be subject to one or some of the following additional sanctions:
a) Deprivation of the right to use licenses, practice certificates for a definite term of between 01 month and 24 months for: certificate of eligibility for pharmaceutical business; license for medical examination and treatment; class-III biosafety standard conformity certificate; certificate of eligibility to run HIV tests; certificate of eligibility for cosmetic production; liquor or beer business license; tissue bank license; pharmacy practice certificate; and medical practice certificate;
b) Confiscation of material evidences and means used in administrative violations in health sector;
c) Suspension of operation for a definite time of between 01 and 24 months;
d) Expulsion.
3. In addition to principal sanctions and additional sanctions, depending on the nature and severity of violations, individuals or organizations committing administrative violations in health sector may also be subject to one or some of the 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 and the following remedial measures:
a) Forcible refund of money amounts collected in contravention of law provisions, in case of failing to refund them to payers, such amounts shall be remitted into the state budget in accordance with law provisions;
b) Forcible application of measures for cleaning, disinfecting, decontaminating and other infectious diseases prevention and control measures;
c) Forcible implementation of medical isolation, enforcement of medical isolation, medical examination and treatment;
d) Forcible implementation of measures for cleaning water supply and transmission systems;
dd) Forcible direct apology of the HIV-infected person and his/her family members and correction of information publicly available on mass media where the HIV-infected person lives continuously for 03 consecutive days as prescribed by law, unless the HIV-infected person does not agree with public apology;
e) Forcible reception and burial, cremation of corpses and bones of HIV-infected people;
g) Forcible admission of HIV-infected people;
h) Forcible direct apology of the discriminated person, practitioners, and patients;
i) Forcible transfer of the position;
k) Forcible performance of legitimate rights and interests of HIV-infected workers;
l) Forcible cancellation of a decision on disciplining or expelling a pupil or student or learner because he or she is positive with HIV;
m) Forcible refund of the interest amount for the difference due to incorrect declaration or late payment of the compulsory contribution; Forcible refund of the amount due to evasion or fraud of the compulsory contribution; Forcible refund of the amount due to improper use;
n) Forcible payment of medical examination and treatment costs;
o) Forcible refund of the difference amount, in case of failing to refund them to customers, such amounts shall be remitted into the state budget in accordance with law provisions;
p) Forcible refund of the damaged amount for the health insurance participant (if any); Forcible refund of the damaged amount for the medical examination and treatment establishments (if any). Such amount shall be transferred to state budget in accordance with law provisions if the recipients are not identifiable;
q) Forcible refund of the violated amount to the health insurance fund s collection account (if any);
r) Forcible removal of intrauterine devices or implanted contraceptives;
s) Proposing a competent state agency to revoke the practice certificate; license for medical examination and treatment; medical equipment import permit; certificate of eligibility for pharmaceutical business; certificate of free sale for domestically manufactured medical equipment; certificate of registration for marketing authorization of drugs or drug materials; the cosmetic product proclamation receipt number; receipt of declaration dossier; certificate ofmarketing authorizationfor medical equipment of categories B, C, D.
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 VIII 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
ACTS OF ADMINISTRATIVE VIOLATIONS, SANCTIONING FORMS AND REMEDIAL MEASURES
Section 1
ACTS OF ADMINISTRATIVE VIOLATIONS IN PREVENTIVE MEDICINE AND HIV/AIDS PREVENTION AND CONTROL
Article 5. Violations 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 if the establishment employs less than 100 workers;
b) A fine from VND 3,000,000 to VND 5,000,000 shall be imposed if the establishment employs from 100 to less than 300 workers;
c) A fine from VND 5,000,000 to VND 7,000,000 shall be imposed if the establishment employs from 300 to less than 500 workers;
d) A fine from VND 7,000,000 to VND 10,000,000 shall be imposed if the establishment 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 if the establishment 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 if the establishment 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 if the establishment 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 improperly performance of law regulations on broadcasting time or duration, or the capacity or location of posting information about infectious disease prevention and control.
3. A fine from VND 10,000,000 to VND 15,000,000 shall be imposed for any of the following acts of violations:
a) Providing inaccurate or untimely information on the infectious disease after the announcement of epidemic or announcement of epidemic termination according to the content provided by a competent health agency;
b) Making charges for information, education and communication on prevention and control of infectious diseases on the mass media, unless there is a separate contract with the program, project or sponsored by a domestic or foreign organization or individual.
4. Remedial measures:
a) Forcible correction of untruthful information on mass media in the area previously reported for 03 consecutive days as prescribed by law, for the acts of violation specified at Point a, Clause 3 of this Article;
b) Forcible refund of the money amount collected in contravention of law provisions, for the acts of violations specified at Point b, Clause 3 of this Article. Such amount shall be transferred to state budget in accordance with law provisions if the recipients are not identifiable.
Article 6. Violations of regulations on sanitation for prevention and control of infectious diseases
1. A warning or 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 acts of violations:
a) Failing to provide sufficient quality drinking water and clean water used for domestic purposes in the educational institution as prescribed by law;
b) Not having or having sanitary facilities but failing to meet the sanitary requirements in the educational institution as prescribed by law;
c) Failing to provide enough lighting in educational institutions as prescribed by law;
d) Failing to educate learners about sanitation for prevention and control of infectious diseases, including personal hygiene, hygiene in daily life, labor and environmental sanitation;
dd) Failing to propagate about disease prevention hygiene or failing to inspect and supervise environmental sanitation; failing to measures to prevent and control 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 take measures to ensure hygiene in places of production, business, industrial waste disposal and other hygiene measures as prescribed by law, causing or spreading 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. Violations 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 report or failing to report in time when detecting another person suffering from an infectious disease as prescribed by 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 acts of violations:
a) Failing to perform test at the request of a competent health agency during infectious disease surveillance;
b) Failing to report or reporting inadequately on infectious disease surveillance as prescribed by law;
c) Concealing, failing to report or failing to report in time the current state of infectious disease 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 acts of violations:
a) Concealing, failing to report or failing to report in time the current state of group A infectious diseases of oneself or of other people;
b) Deliberately giving false information about group A infectious diseases;
c) Deliberately spreading agents of 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 acts of violations:
a) Failing to meet one of the requirements for level I biosafety establishments after the announcement of meeting biosafety standards of level I;
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 acts of violations:
a) Failing to meet one of the requirements for biosafety level II establishments after the announcement of meeting biosafety standards of level II;
b) Failing to make a prevention plan, biosafety incident handling plan or an incomplete plan 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 establishments.
3. A fine from VND 10,000,000 to VND 20,000,000 shall be imposed for any of the following acts of violations:
a) Failing to mobilize or failing to properly mobilize human resources and equipment to handle biosafety incidents according to the plan of biosafety incident prevention and settlement 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 acts of 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 group A infectious specimens when the conditions are not satisfied;
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 establishments.
5. A fine from VND 30,000,000 to VND 40,000,000 shall be imposed for any of the following acts of violations:
a) Failure to organize an annual biosafety incident prevention and remedy for level III biosafety establishments;
b) Conducting test without carrying out procedures for self-declaration of biosafety standards of level I, level II or without a level-III biosafety standard conformity certificate or with an invalid level-III biosafety standard conformity certificate.
6. Additional sanctions:
a) Suspension of operation for a definite time of between 01 and 03 months, for a biosafety establishment 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 03 and 06 months, for a level I or level II biosafety establishment that commits acts of violations specified at Point b, Clause 5 of this Article;
Deprivation of the right to use the biosafety standard conformity certificate from 01 month to 03 months, for the acts of violations specified at Points a and c, Clause 4, and Point b, Clause 5 of this Article.
Article 9. Violations of regulations on using vaccines and medical biological products
1. A warning or a fine from VND 300,000 to VND 500,000 shall be imposed for any of the following acts of violations:
a) Failing to implement or prevent children and pregnant women from using compulsory vaccines and medical biological products for infectious diseases under the expanded program on immunization;
b) Failing to advise the immunized person, parent or family, or guardians of the children before being immunized; failing to advice on potential benefits and risks of vaccination;
c) Failing to guide the immunized person or the immunized child’s family on how to monitor and manage the response after vaccination;
d) Failing to report or reporting inadequately on immunization 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 acts of violations:
a) Failing to use or obstructing the use of vaccines and medical biological products for diseases with vaccines and medical biological products for the risk of contracting infectious diseases in epidemic zones or for the case of traveling to epidemic zones upon requests and instructions of competent agencies;
b) Failing to grant and record into the personal immunization books or electronic immunization books for those who come to vaccinate at the vaccination establishment;
c) Failing to make the list of immunized persons at the immunization establishment;
d) Failing to monitor the immunized person at least 30 minutes after the immunization and guide the immunized person’s family or the immunized person to continue monitoring at least 24 hours after the immunization;
dd) Failing to prepare sufficient dossiers and related documents upon requests to serve the provincial professional advisory council in determining compensation cases in case of serious complications that seriously affect the immunized person’s health or lead to his/her death;
e) Failing to keep and manage documents and dossiers related to the immunization and response after immunization 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 acts of violations:
a) Failing to carry out a screening or carry out inadequate screening for immunized persons;
b) Failing to comply with the law on receiving, transporting and preserving vaccines;
c) Failing to comply with the law, and provide professional guidance on safe immunization and management of immunized persons;
d) Failing to suspend the immunization session which is in progress if there is any serious complications after being immunized;
dd) Failing to fully list information related to serious complications according to the Minister of Health’s regulations and report to the Department of Health within 24 hours from the time of complications;
e) Failing to organize the immunization to prevent epidemics at the competent state competent agencies’ requests, for medical examination and treatment establishments that already registered with the Department of Health to carry out the immunization under the Expanded Program on Immunization;
g) Including costs guaranteed by the State in the cost of vaccination services in the Expanded Program on Immunization and immunization to prevent epidemics;
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 acts of violations:
a) Failing to immunize as directed, failing to ensure safety during the immunization;
b) Failing to provide first aid, diagnose causes of serious complications after the immunization;
c) Failing to transfer persons suffering from serious complications after the immunization to the nearest medical examination and treatment establishment, in case of beyond the capacity;
d) Failing to provide first aid, treatment for persons suffering from serious complications after the immunization, and report the Department of Health within 24 hours from the time of receiving such persons;
dd) Failing to ensure one of the requirements for fixed immunization establishments after the announcement of being eligible for immunization.
5. A fine from VND 10,000,000 to VND 20,000,000 shall be imposed for any of the following acts of violations:
a) Using vaccines and medical biological products at an unsatisfactory establishment as prescribed by law;
b) Provide immunization service without the announcement of being eligible for immunization.
6. A fine from VND 30,000,000 to VND 40,000,000 shall be imposed for the acts of using vaccines without registration numbers, or using expired vaccines or using low quality vaccines.
7. Additional sanctions:
a) Suspension of the whole or a part of establishment operation for a definite time of between 01 and 03 months, for the acts of violations specified at Points a, b, c and d, Clause 3, Clause 4, Clause 5 and Clause 6 of this Article;
b) Deprivation of the right to use the medical practice certificate from 01 month to 03 months, for the acts of violations specified at Points a, b, c and d, Clause 3, and Points a, b, c and d, Clause 4 of this Article.
8. Remedial measures:
a) Forcible refund of the money amount collected in contravention of law provisions, for the acts of violations specified at Point g and h, Clause 3 of this Article. Such amount shall be transferred to state budget in accordance with law provisions if the recipients are not identifiable;
b) Forcible destruction of vaccines, for the acts of violations specified in Clause 6 of this Article.
Article 10. Violations 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 acts of 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 give patients and their families coming to the medical examination and treatment establishment advices on measures of prevention and treatment of infectious diseases.
2. A fine from VND 3,000,000 to VND 5,000,000 shall be imposed for any of the following acts of violations:
b) Failing to notify the preventive medicine agencies of the same level of information related to the sufferers of infectious diseases being examined and treated;
b) Failing to monitor the health of the medical practitioners and health workers directly involved in examining and treating persons suffering from group A infectious diseases in the medical examination and treatment establishment;
c) Failing to take transmission prevention and control measures for persons suffering from infectious diseases;
d) Failing to clean, disinfect, decontaminate and take other transmission prevention and control measures upon detecting environment with agents of 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 persons carrying agents of group B and group C infectious diseases.
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 of violations specified at Point d, Clause 2 and Clause 4 of this Article.
Article 11. Violations of regulations on medical isolation and enforcement of medical isolation
1. A fine from VND 5,000,000 to VND 10,000,000 shall be imposed for any of the following acts of violations:
a) Failing to organize the medical isolation and enforcement of 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 and enforcement of 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 and enforcement of 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 acts of violations:
a) Failing to organize the medical isolation for persons suffering from group A infectious diseases;
b) Refusing or avoiding to take medical isolation and enforcement of medical isolation decided by competent state agencies, for persons suffering from group A infectious diseases, persons who are subject to border health quarantine and suffer from group A infectious diseases or at request of the competent state agency;
c) Carrying out medical isolation or enforcement of medical isolation at unsatisfactory places as prescribed by law.
3. Remedial measures:
Forcible implementation of medical isolation or enforcement of medical isolation, for the acts of violations specified at Points a and b, Clause 1 and Points a and b, Clause 2 of this Article.
Article 12. Violations of regulations on epidemic prevention
1. A fine from VND 1,000,000 to VND 3,000,000 shall be imposed for any of the following acts of violations:
a) Failing to take personal protection measures, for persons participating in anti-epidemic activities and persons at risk of contracting an epidemic disease according to instructions of health agencies;
b) Failing to report to the local People’s Committee and 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 acts of violations:
a) Concealing the infection of oneself or of other people after the epidemic is announced;
b) Failing to carry out or refusing to carry out cleaning, disinfection, and decontaminating in the epidemic zone;
c) Failing to participate in anti-epidemic activities at requests of anti-epidemic steering committees;
d) Collecting charges for medical examination and treatment of group A infectious diseases;
dd) Failing to implement the decision on forcible destruction of animals, plants and other articles that are 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 acts of violations:
a) Failing to apply the measure of suspension of operation of public food and drink establishments likely to transmit the epidemic disease in epidemic zones;
b) Failing to impose a ban on trading in and consumption of foods which have been identified to be vectors;
c) Failing to take measures of prohibiting mass gatherings or suspending business activities and services in public places.
4. A fine from VND 20,000,000 to VND 30,000,000 shall be imposed for any of the following acts of violations:
a) Failing to comply with decisions on medical inspection, surveillance and control before 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 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 acts of violations:
a) Failing to comply with the request for medical inspection and control of the vehicles before leaving the epidemic zone that is in a state of emergency;
b) Failing to comply with the decision on prohibiting mass gatherings in the area already declared a state of emergency in case of epidemic;
c) Taking unauthorized people or vehicles to the epidemic foci where a state of emergency over the epidemic is 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 of violations specified at Point b, Clause 2 of this Article;
b) Forcible refund of the money amount collected in contravention of law provisions, for the acts of violations specified at Point d, Clause 2 of this Article. Such amount shall be transferred to state budget in accordance with law provisions if the recipients are not identifiable;
c) Forcible destruction of animals, food, plants and other articles, for the acts of violations specified at Point dd, Clause 2; Points b and c, Clause 4 and Point d, Clause 5 of this Article;
c) Forcible implementation of medical control for transport vehicles, for the acts of violations specified at Point a, Clause 5 of this Article.
Article 13. Violations 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 acts of violations:
a) Failing to report in writing the carving, re-carving, revoking, canceling or loss of the health quarantine seals to the Ministry of Health;
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 unit 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 embarking or disembarking any persons, loading or unloading or receiving goods while the vessel is waiting for health quarantine or under health quarantine, unless the vessel is having an accident.
2. A fine from VND 5,000,000 to VND 7,000,000 shall be imposed for any of the following acts of violations:
a) Failing to abide by medical inspection and control of border health quarantine units as prescribed by law, except for the cases specified in Clause 4 of this Article;
b) Failing to comply with regulations on health quarantine signal for vessels upon arriving at the port;
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 acts of violations:
b) Transporting corpses, bones, body ash, bio-products, bacteria, tissues, human body organs, blood and constituents of blood through the border gate without the heath quarantine units’ inspection;
c) Importing blood samples, serum, plasma, urine, fecal, body fluids and other human materials containing or likely containing agents of infectious diseases for human, microorganism species and samples containing microorganism that may cause human diseases for preventive purposes, study, diagnosis and treatment without 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, enforcement of medical isolation or medical control 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 control, for the acts of violations specified at Point a, Clause 2 of this Article;
b) Forcible application of medical control, for the acts of violations 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 violations specified at Point b, Clause 3 of this Article;
c) Forcible implementation of medical isolation, enforcement of medical isolation or medical control 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 of from VND 3,000,000 to VND 5,000,000 VND shall be imposed for the acts of employing persons suffering from infectious diseases to directly do the jobs that threaten to spread infectious diseases for others or in the community, except for those directly involved in producing or trading foods, food additives, food processing aids, food containers and primary packages of foods and providing food and drink services.
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.
3. A fine from VND 20,000,000 to VND 30,000,000 shall be imposed for the acts of making use of epidemic to fix an unreasonable selling or purchasing prices for drugs, medical equipment drug materials and materials used in medical equipment manufacturing in service of epidemic prevention and control.
4. Additional sanctions:
a) Deprivation of the right to use certificates of eligibility for pharmaceutical business, pharmacy practice certificates; suspension of operation of establishments not eligibility for pharmaceutical business from 06 months to 12 months, for the acts of violations specified in Clause 3 of this Article;
b) Deprivation of the right to use certificates of eligibility for pharmaceutical business, pharmacy practice certificates; suspension of operation of establishments not eligibility for pharmaceutical business from 12 months to 24 months, for the acts of violations specified in Clause 3 of this Article, in case infringing goods valued at over VND 50,000,000 or in case of recidivism.
5. Remedial measures:
Forcible return of the difference amount to the purchasers or sellers, for the acts of violations specified in Clause 3 of this Article. In case of failing to transfer to customers, such amount shall be remitted to the state budget as prescribed by law.
Article 15. Violations of regulations on domestic water quality
1. A fine of from VND 1,000,000 to VND 3,000,000 shall be imposed for the acts of failing to report competent agencies about water quality as prescribed by law.
2. A fine from VND 3,000,000 to VND 5,000,000 shall be imposed for the acts of supplying water with a design capacity of less than 1,000 m3/day or the scale of water supply to less than 500 households in any of the following cases:
a) The testing of water quality parameters for each water sample to be tested is not conducted at a laboratory or certification organization in accordance with the law;
b) Failing to publicize the result of testing water quality parameter as prescribed by law for each testing time;
c) Testing missing from 01 to 05 parameters of each water sample to be tested as prescribed by law.
3. A fine from VND 5,000,000 to VND 10,000,000 shall be imposed for the acts of supplying water with a design capacity of under 1,000 m3/day or the scale of water supply to less than 500 households in any of the following cases:
a) Providing domestic water which does not meet technical regulations on domestic water quality;
b) Testing missing at least 06 parameters of each water sample to be tested as prescribed by law.
4. A fine from VND 10,000,000 to VND 15,000,000 shall be imposed for the acts of providing water with a design capacity of 1,000 m3/day or more or the scale of water supply to 500 households or more in any of the following cases:
a) The testing of water quality parameters for each water sample to be tested is not conducted at a laboratory or certification organization in accordance with the law;
b) Failing to publicize the result of testing water quality parameter, for each testing time, for each testing time as prescribed by law;
c) Testing missing from 01 to 05 parameters of each water sample to be tested as prescribed by law.
5. A fine from VND 15,000,000 to VND 20,000,000 shall be imposed for the acts of providing water with a design capacity of 1,000 m3/day or more or the scale of water supply to 500 households or more in any of the following cases:
a) Providing domestic water which does not meet technical regulations on domestic water quality;
b) Testing missing at least 06 parameters of each water sample to be tested as prescribed by law.
6. A fine from VND 10,000,000 to VND 20,000,000 shall be imposed on water supplier with a design capacity of less than 1,000 m3/day or the scale of water supply to less than 500 households for the acts of missing the quantity of testing samples, for each testing time as prescribed by law.
7. A fine from VND 20,000,000 to VND 30,000,000 shall be imposed for any of the following acts of violations:
a) Failing to periodically test water quality parameters, for each testing time in accordance with regulations of the water supplier which has a design capacity of less than 1,000 m3/day or the scale of water supply to less than 500 households;
b) Missing the quantity of testing samples, for each testing time according to regulations of water supplier which has a design capacity of 1,000 m3/day or more, or the scale of water supply to 500 households or more.
8. A fine from VND 30,000,000 to VND 40,000,000 shall be imposed for the acts of failing to periodically test water quality parameters, for each testing time in accordance with regulations of the water supplier which has a design capacity of 1,000 m3/day or more, or the scale of water supply to 500 households or more.
9. A fine doubling but not exceeding VND 50,000,000 shall be imposed for any of the acts of violations specified in Clauses 1, 2, 3, 4, 5, 6 and 7 of this Article if the water supplier has two violating production establishments or more.
Article 16. Violations of regulations on burial and cremation
1. A warning or a fine from VND 300,000 to VND 500,000 shall be imposed for the acts of failing to have records of information related to the performance of funerals at funeral halls or crematoria.
3. A fine from VND 5,000,000 to VND 10,000,000 shall be imposed for any of the following acts of violations:
a) Failing to implement or implement insufficiently law regulations of hygiene when handling, shrouding, transporting, embalming corpses and bones of the dead due to group A infectious diseases and some of group B infectious diseases in the list of infectious diseases that require isolation;
b) Failing to handle corpses of the dead due to group A infectious diseases and some of group B infectious diseases in the list of infectious diseases that require isolation;
c) Failing to comply with law regulations on mass burial.
4. A fine from VND 10,000,000 to 20,000,000 shall be imposed for the acts of failing to comply with regulations on handling corpses, bones, and the surrounding environment when moving a corpse or bone before the appropriate time for exhumation, in case of cemetery clearance.
5. A fine from VND 20,000,000 to VND 30,000,000 shall be imposed for the acts of applying technology for the cremation which does not meet requirements of waste disposal as prescribed by law.
6. Remedial measures:
Forcible implementation of measures to remedy environmental pollution, for the acts of violations specified in Clauses 2, 3, 4 and 5 of this Article.
Article 17. Violations 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 of occupational diseases;
c) Failing to report cases of occupational diseases or failing to report the annually occupational disease examination status to competent state agencies in accordance with law provisions;
d) Failing to report cases of occupational accident who are examined and treated annually at medical examination and treatment establishments to competent state agencies in accordance with law provisions.
2. A fine from VND 5,000,000 to VND 10,000,000 shall be imposed for medical examination and treatment establishments committing any of the following violations:
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 in accordance with law provisions;
b) Providing training in first aid and emergency care with an improper time and contents as prescribed by law.
3. A fine shall be imposed for the acts of violations in term of occupational disease examination and treatment according to one of the following levels:
a) A fine from VND 10,000,000 to VND 20,000,000 shall be imposed for the acts of providing incorrect occupational disease 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 disease examination and treatment result without conducting any occupational disease examination and treatment as prescribed by law.
4. Additional sanctions:
Deprivation of the right to use medical practice certificates from 01 month to 03 months, for the acts of violations specified in Clause 3 of this Article.
Article 18. Other violations of regulations on health environment
A fine from VND 3,000,000 to VND 5,000,000 shall be imposed for the acts of failing to build or failing to ensure hygiene for hand washing facilities, hygienic toilet areas in health agencies, health facilities and other public health facilities.
Article 19. Violations 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 warning or a fine from VND 300,000 to VND 500,000 shall be imposed on the establishment that employs 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 acts of violations:
A) Providing incorrect information about the HIV/AIDS epidemic situation in comparison with data announced by the competent state agency during the information, education and communication about HIV/AIDS prevention and control;
b) Failing to comply with the prior time and length of radio and television programs and the content, length and position of news and articles in printed, visual and electronic press on information, education and communication on HIV/AIDS control and prevention 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 acts of violations:
b) Failing to give priority to the time and length of radio and television programs and the content, length and position of news and articles in printed, visual and electronic press on information, education and communication on HIV/AIDS control and prevention as prescribed by law;
b) Making charges for the information, education and communication on HIV/AIDS prevention and control, unless a contract is signed with the national HIV/AIDS prevention and control program, or such information, education and communication is sponsored by a domestic or foreign organization or individual;
c) Revealing that a person is infected with HIV without his/her consent, unless such information is provided to serve the HIV/AIDS epidemiological surveillance or when giving 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 the his/her consent, unless such information is provided to serve the HIV/AIDS epidemiological surveillance or when a HIV test result is given as prescribed by law.
5. Remedial measures:
a) Forcible correction of untruthful information on mass media in the area previously reported for 03 consecutive days as prescribed by law, for the acts of violations specified at Point a, Clause 2 of this Article;
b) Forcible refund of the money amount collected in contravention of law provisions, for the acts of violations specified at Point b, Clause 3 of this Article. Such amount shall be transferred to state budget in accordance with law provisions if the recipients are not identifiable;
c) Forcible direct apology of the HIV-infected person and his/her family members and correction of information publicly available on mass media where the HIV-infected person lives continuously for 03 consecutive days as prescribed by law, for the acts of violations 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 20. Violations 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 acts of violations:
a) Obstructing the right to access HIV/AIDS prevention and control counseling services of others;
b) Failing to provide counseling on HIV/AIDS prevention and control while providing care or treatment for pregnant or breastfeeding women suffering from HIV or HIV-exposed persons;
c) Failing to follow the counseling procedures and contents before and after the HIV testing;
d) Providing counseling before after HIV testing without being trained about 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 report or report the list of HIV-infected persons under the HIV/AIDS surveillance contrary to law regulations;
g) Failing to store or failing to comply with law regulations on storing testing results, blood samples, blood bags, blood products and HIV-infected pathological materials;
h) Failing to dispose or failing to comply with law regulations on disposing blood samples, blood bags, blood products and HIV-infected pathological materials;
i) Violating law regulations on HIV/AIDS reporting.
2. A fine from VND 3,000,000 to VND 5,000,000 shall be imposed for any of the following acts of violations:
a) Failing to provide counseling before and after the HIV testing;
b) Failing to inform the HIV positive test result on time as prescribed by law;
c) Failing to comply with the prescribed order when informing the HIV positive test result;
d) Failing to comply with law regulations when delivering and receiving the slip of HIV positive test result;
dd) Failing to report the competent agency upon detecting unqualified bio-products and equipment used for HIV testing;
e) Failing to comply with the Ministry of Health’s regulations on disinfection, sterilization and waste disposal when performing operations, injection and acupuncture so as to prevent HIV transmission;
g) Failing to notify relevant parties and take measures to handle and remedy upon detecting the unqualified HIV test;
h) Collecting money from the people required to test in the case that there is an official request for judicial appraisal or a decision of an investigative body, a people’s procuracy or a people’s court, or pregnant women that voluntarily test for HIV when the testing cost is covered by another source.
3. A fine from VND 5,000,000 to VND 10,000,000 shall be imposed for any of the following acts of 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 run HIV tests;
d) Confirming HIV positive test result when being suspended from operation of confirming HIV positive test result;
dd) Notifying HIV positive test result for subjects other than those specified by law; revealing HIV positive test result that requires to be kept confidential;
e) Testing for HIV for a person under 16 year old or person who loses his/her civil act capacity without his/her parent or legal guardian’s written consent, excepts for the emergency cases according to the law on medical examination and treatment.
4. A fine from VND 10,000,000 to VND 20,000,000 shall be imposed for any of the following acts of violations:
a) Forcible HIV testing of people not subject to HIV/AIDS epidemiological surveillance or those who are not required to test for HIV as prescribed by law;
b) Testing for HIV without a certificate of eligibility to run HIV tests;
c) Failing to test blood bags and blood preparations before putting them into use.
5. Additional sanctions:
a) Deprivation of the right to use a certificate of eligibility to run HIV tests from 01 month to 03 months, for the acts of violations specified at Point e, Clause 2 and Point b, Clause 3 of this Article;
b) Deprivation of the right to use a certificate of eligibility to run HIV tests from 03 months to 06 months, for the acts of violations specified at Points c and d, Clause 3 of this Article;
c) 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 the money amount collected in contravention of law provisions, for the acts of violations specified at Point h, Clause 2 of this Article. Such amount shall be transferred to state budget in accordance with law provisions if the recipients are not identifiable;
b) Forcible refund of illicit profits, for the acts of violations specified at Point b, Clause 4 of this Article.
Article 21. Violations of regulations on treating and caring for HIV-infected people, providing prophylactic and exposure treatment
1. A fine from VND 1,000,000 to VND 3,000,000 shall be imposed for any of the following acts of 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 acts of violations:
a) Treating with anti-retroviral drugs at an unsatisfactory facility as prescribed by law;
b) Failing to comply with the laws on priority of access to anti-retroviral drugs;
c) Failing to organize the management, care and counseling for HIV-infected persons at compulsory drug rehabilitation centers in accordance with law provisions;
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 acts of violations:
a) Failing to monitor and provide treatment for HIV-infected women during pregnancy under the management;
b) Failing to take 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 provide adequate healthcare for HIV-infected persons at social relief establishments;
dd) Collecting treatment costs from HIV-exposed persons, people who infected with HIV due to occupational accidents, people who have been infected with HIV due to risks of medical technique, HIV-infected pregnant women and HIV-infected under-six children who are provided anti-retroviral drugs free-of-charge by the State;
e) Collecting charges of HIV/AIDS medicines that are provided and distributed free of charge.
4. A fine from VND 10,000,000 to VND 15,000,000 shall be imposed for the acts of refusing to treat with antiretroviral drugs for HIV-infected persons who are eligible for treatment in accordance with law provisions.
5. Remedial measures:
Forcible refund of the money amount collected in contravention of law provisions, for the acts of violations specified at Points dd and e, Clause 3 of this Article. Such amount shall be transferred to state budget in accordance with law provisions if the recipients are not identifiable.
Article 22. Violations of regulations on harm reduction intervention to prevent HIV transmission
1. A warning or a fine from VND 200,000 to VND 500,000 shall be imposed on any communicator that commits one of the following violations:
a) Failing to wear the community outreach worker’s card while practicing harm reduction intervention activities to prevent HIV transmission;
b) Using an expired community outreach worker’s card while practicing harm reduction intervention activities to prevent HIV transmission, unless otherwise permitted by agency issuing such card during the waiting time for a new card;
c) Erasing, editing or lending the community outreach worker’s card.
2. A fine from VND 500,000 to VND 1,000,000 shall be imposed for any of the following acts of violations:
a) Failing to report harm reduction intervention activities in HIV transmission prevention to the People s Committee of the commune and the police station at the same level where the community outreach worker is implemented;
b) 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 convenient to him/her;
c) Failing to receive valid medical records of the patients being treated with antiretroviral drugs sent by another establishment;
d) 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 acts of violations:
a) Using the community outreach worker’s 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 selecting opioid-addicted person to be treated.
4. A fine from VND 5,000,000 to VND 10,000,000 shall be imposed for any of the following acts of violations:
a) Failing to comply with specialized instructions as prescribed by law when providing treatment of opioid addiction with opioid substitution;
b) Failing to provide treatment for patients being treated with anti-retroviral drugs sent by other establishments;
e) Accommodation establishments failing to provide condoms in accordance with law provisions.
5. A fine from VND 10,000,000 to VND 20,000,000 shall be imposed for any of the following acts of violations:
a) Failing to ensure any of conditions after the announcement of eligible to provide treatment of opioid addiction;
b) Failing to report the list of treated people, the situation of treatment and treatment observance of persons participating the treatment of opioid addiction to competent agencies in accordance with law provisions;
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 subsidized condoms, syringes and injection needles, drugs and bio-products at higher prices;
d) Providing treatment of opioid addiction for a person who does not meet requirements for treatment as prescribed by law;
dd) Forcing 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 acts of violations:
a) Providing treatment of opioid addiction at establishment which has not announced 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, drugs and bio-products 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 to legally circulate in Vietnam.
7. Additional sanctions:
a) Deprivation of the right to use the medical practice certificate from 01 month to 03 months, for the acts of violations specified at Points a and b, Clause 4, and Points d and dd, Clause 5 of this Article;
b) Suspension of operation for a definite time of between 01 month to 03 months, for the acts of violations specified at Point a, Clause 5 and Points a and c, Clause 6 of this Article;
c) Confiscation of material evidences used in administrative violations, which are community outreach workers’ cards, for the acts of violations specified at Points b and c, Clause 1 of this Article.
8. Remedial measures:
a) Forcible refund of illicit profits earned through the commission of violations specified at Point c, Clause 5 and Point a, Clause 6 of this Article;
b) Forcible destruction of drugs, for the acts of violations specified at Point c, Clause 6 of this Article.
Article 23. Violations of regulations on fighting stigmatization 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 acts of violations:
a) Requesting a pupil, student, leaner or a candidate to have HIV tested or produce an HIV test result;
b) Obstructing a pupil, student or learner from participating in the activities or services provided by an educational institution on the ground that such pupil, student or learner or a member of his/her family is infected with HIV;
c) Obstructing the admission of a social protection beneficiary to a social relief establishment on the ground that such person is infected with HIV;
d) Refusing to bury or cremate the people that die of HIV/AIDS.
2. A fine from VND 5,000,000 to VND 10,000,000 shall be imposed for any of the following acts of violations:
a) Requesting a candidate to have HIV tested or produce an HIV test result; refusing to employ a candidate on the ground that such person is infected with HIV, except for some jobs require HIV testing before recruitment according to the Government s regulations;
b) Refusing to admit a pupil, student or learner on the ground that such person is infected with HIV;
c) Refusing to admit a social protection beneficiary to a social relief establishment on the ground that such person is infected with HIV;
d) Parents abandoning their HIV-infected minor children; guardians abandoning their HIV-infected wards;
dd) Separating, limiting or forbidding a pupil, student or learner from participating in the establishment’s activities or services on the ground that such person is infected with HIV;
e) Discriminating while providing healthcare and treatment for HIV-infected persons;
g) Arranging jobs that are not suitable to the health and professional qualification 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 acts of violations:
a) Terminating the labor or job contract of a worker or cause difficulties to this person in his/her work on the ground that such person is infected with HIV;
b) Forcing a physically fit worker to change the job he/she has been doing on the ground that such person is infected with HIV;
c) Refusing to give a salary raise to or to promote a worker, or fail to ensure his/her legitimate rights or benefits on the ground that such person is infected with HIV;
b) Disciplining or expelling a pupil, student or learner on the ground that such person is infected with HIV;
c) Using pictures or messages that stigmatize or discriminate against HIV-infected persons and their families for propagation.
4. Remedial measures:
a) Forcible receipt, burial or cremation of corpses and bones of HIV-infected persons, for the acts of violations specified at Point d, Clause 1 of this Article;
b) Forcible admission of HIV-infected persons, for the acts of violations specified at Points b and c, Clause 2 and Point a, Clause 3 of this Article;
c) Forcible direct apology of the discriminated persons, for the acts of violations specified at Point e, Clause 2 and Point dd, Clause 3 of this Article;
d) Forcible re-appointment of the previous titles, for the acts of violations 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 violations specified at Point c, Clause of this Article;
e) Forcible cancellation of a decision on disciplining or expelling a pupil, student or learner on the ground that such person is infected with HIV, for the acts of violations specified at Point d, Clause 3 of this Article;
g) Forcible removal of infringing elements, for the acts of violations specified at Point dd, Clause 3 of this Article. Forcible destruction of communication products, in case where the infringing elements cannot be removed.
Article 24. 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 acts of violations:
a) Threatening to transmit HIV to another person;
b) Taking advantage of HIV/AIDS prevention and control activities to make personal profits.
3. Remedial measures:
Forcible refund of illicit profits earned through the commission of violations specified at Point b, Clause 2 of this Article.
Article 25. Violations of regulations on no-smoking areas
1. A warning or 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 the air plane 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 acts of violations:
a) Failing to put signs with text or symbol of “No smoking” signs at smoking prohibited areas in accordance with law provisions;
b) Failing to organize the implementation, guide, inspect and urge other people to comply properly with regulations on smoking ban at the places under the management.
3. A fine from VND 5,000,000 to VND 10,000,000 shall be imposed for any of the following acts of violations in separate smoking areas:
a) Failing to have rooms and ventilation system separating from the no-smoking area;
b) Failing to provide tools to contain cigarette ends, ashes;
c) Failing to put up the signs at suitable and noticeable positions;
d) Failing to equip fire safety equipment.
Article 26. Violations of regulations on selling and supplying cigarettes
1. A fine from VND 1,000,000 and VND 3,000,000 shall be imposed for the acts of failing to hang notice boards of not selling cigarettes to persons under 18 years old at points of sale of cigarette wholesale and retail agents.
2. A fine from VND 3,000,000 to VND 5,000,000 shall be imposed for any of the following acts of violations:
a) Displaying more than one pack, one carton or box of one cigarette brand at a cigarette retail agent or store;
b) Selling or supplying cigarettes to persons under 18 years old;
c) Selling or supplying cigarettes without labels or health warnings printed on the package as prescribed by law. In case of selling cigarettes without labels or health warnings printed on the package, that are smuggled or fake cigarettes, sanctions shall be imposed in accordance with the law on fake goods, banned goods production, and trading, and protecting the consumers’ interests.
3. Additional sanctions:
Suspension of business operation relating to violations for a definite time from 01 month to 03 months, for the acts of violations specified in Clause 2 of this Article.
4. Remedial measures:
Forcible of withdrawal and removal of infringing elements with cigarettes without labels or health warnings printed on the package, for the acts of violations specified at Point b Clause 2 of this Article. Forcible destruction shall be applied, if infringing elements cannot be removed.
Article 27. Violations of regulations on labeling or printing health warnings on the cigarette packages
1. A fine from VND 20,000,000 to VND 30,000,000 shall be imposed for any of the following acts of violations:
a) The design, position, area, and color of the health warnings is not conformable with law;
b) Failing to change the health warnings on the cigarette packages every two years in accordance with law provisions;
b) Failing to specify the number of cigarettes in the pack or the weight of other forms of tobacco;
c) Using words and phrases that mislead users into believing that cigarettes only causes little harms, or cause users to misunderstand the harms of cigarette and its smoke to human health.
2. A fine from VND 30,000,000 to VND 40,000,000 shall be imposed for any of the following acts of violations:
a) Failing to print health warnings on tobacco packages in accordance with law provisions for tobaccos produced and imported to consume in Vietnam;
b) Signing contracts, producing foreign brands of tobacco for domestic consumption without permission of competent state agencies.
3. Additional sanctions:
Suspension of business operation related to violations for a definite time of between 03 month and 06 months, for the acts of violations specified in Clause 2 of this Article.
4. Remedial measures:
a) Forcible recall of products and remedy, removal of infringing elements, for the acts of violations 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. Violations of regulations on tobacco use cessation
A fine from VND 1,000,000 to VND 2,000,000 shall be imposed for any of the following acts of violations:
1. Failing to arrange a separate area for direct tobacco use cessation counseling in accordance with law provisions.
2. Failing to have communication materials on tobacco use cessation and tobacco use cessation counseling.
3. Failing to have telephones, Internet and other means of communication for indirect tobacco use cessation counseling.
4. Failing to notify in writing to the Department of Health of locality where such establishment operates before providing tobacco use cessation or tobacco use cessation counseling.
Article 29. Violations of other regulations on prevention and control of tobacco harms
1. A warning or a fine from VND 200,000 to VND 500,000 shall be imposed on persons aged between full 16 years and under 18 years, for the acts of using tobacco.
2. A fine from VND 500,000 to VND 1,000,000 shall be imposed for any of the following acts of violations:
a) Encouraging, persuading, and coercing other people 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 acts of violations:
a) Using pictures of tobacco in the press, publications dedicated for children;
b) Providing incorrect and unscientific information on tobacco and its harms;
c) Failing to include the content of prevention and control of tobacco harms in annual operating plan; failing to include the regulation of no-smoking in workplaces in the internal rules;
d) Failing to prohibit the abuse of tobacco use in the movie and dramas work in accordance with 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 violations:
a) Using tobacco products’ names, brands, or symbols on other products or services;
b) Advertising tobacco directly to consumers in any form;
c) Letting other organizations or individuals to directly market tobacco to consumers in establishments under the management and administration;
d) Making the compulsory contribution behind schedule as prescribed by law;
dd) Incorrectly declaring that leads to insufficient contribution as prescribed by law;
e) Using the Fund for Prevention and control of tobacco harms in contravention of the law;
g) Enterprises and mass media that provide information and notify the sponsorship by individuals or organizations trading tobacco.
5. A fine from VND 30,000,000 to VND 40,000,000 shall be imposed for any of the following acts of violations:
a) Sponsoring in any form, unless otherwise permitted by the law;
b) Evading or cheating when making compulsory contributions as prescribed by law.
6. Remedial measures:
a) Forcible recall of products to remedy or remove infringing elements, for the acts of violations 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 the interest amount for the difference due to late payment of the compulsory contribution, for the acts of violations specified at Point d, Clause 4 of this Article;
c) Forcible refund of the amount due to improper use, for the acts of violations 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 violations specified at Point dd, Clause 4 and Point b, Clause 5 of this Article.
Article 30. Violations of regulations on liquor and beer drinking, and places where liquor and beer drinking is prohibited
1. A warning or a fine from VND 200,000 to VND 500,000 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 acts of violations:
a) Drinking liquor or beers at places where liquor and beer drinking is prohibited as prescribed by law;
b) Inciting, luring or encouraging other persons 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 acts of violations:
a) Drinking liquor or beer before or during working and studying hours and breaks;
b) Forcing other persons to drink liquor or beer.
Article 31. Violations of regulations on liquor and beer selling and supplying
1. A fine from VND 1,000,000 to VND 3,000,000 shall be imposed for any of the following acts of 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 acts of 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 the acts of selling liquor or beer via e-commerce platforms without meeting any of the prescribed conditions.
4. Additional sanctions:
Deprivation of the right to use a liquor or beer business license for a definite time from 01 month to 03 months, for the acts of violations specified at Point b, Clause 2 and Clause 3 of this Article.
Article 32. Violations of regulations on liquor and beer sale promotion
A fine from VND 10,000,000 to VND 20,000,000 shall be imposed for any of the following acts of violations:
1. Offering promotional items being liquor or beer to under-18 persons.
2. Offering sales promotion in the trading of liquor and beer with an alcoholic strength of 15% or higher.
3. Using liquor and beer with an alcoholic strength of 15% or higher for sale promotion in any form.
4. Failing to comply with the law on sale promotion when offering sales promotion for liquor or beer with an alcoholic strength of under 15%.
Article 33. Violations of regulations on liquor and beer sale advertisement
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 advertisement.
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 alcoholic strength of under 15% and advertising beer as follows:
a) Having liquor and beer drinking inspiration information or images; information about positive effects of liquor and beer on maturity, success, friendliness and gender appeal; advertising information targeting children, pupils, students, adolescents and pregnant women;
b) Using objects, images, symbols, soundtracks and characters in films and product labels for children, pupils and students; use of under-18 persons’ images in liquor and beer advertisements;
c) Advertising in events, advertising media and products for under-18 persons, pupils, students, adolescents and pregnant women;
d) Advertising on transport vehicles;
dd) Advertising on radio and television before, during and after children’s programs; from 18:00 to 21:00 every day, unless otherwise prescribed by law;
e) Advertising on outdoor advertising media that violates the regulations on size of media and their distance from boundaries of education institutions, nurturing establishments, entertainment and recreational facilities exclusively for under-18 persons as prescribed by law;
g) Advertisements without warnings about harms of liquor and beer abuse as prescribed by law;
h) Advertising on newswires, websites, electronic equipment, terminal devices and other telecommunications devices which do not have a screening technology system or software to control subscribers’ age so as to prevent under-18 persons to access, subscribe or seek liquor and beer information.
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 alcoholic strength of between 5.5% to under 15% and beer with an alcoholic strength of 5.5% or higher as follows:
a) Advertising in cultural, stage, cinematographic and sports programs and activities;
b) Advertising on outdoor advertising media, excluding signboards of liquor and beer trading establishments.
4. Additional sanctions:
Suspension of operation of liquor and beer advertisement for a definite time from 01 month to 03 months, for the acts of violations specified at Point h, Clause 2 of this Article.
5. Remedial measures:
a) Forcible recall or removal of advertisements to remove infringing elements, for the acts of violations specified in Clauses 1, 2 and 3 of this Article.
Article 34. Violations of regulations on responsibilities of heads of organizations and agencies in prevention and control of harms of liquor and beer abuse
1. A fine from VND 3,000,000 to VND 5,000,000 shall be imposed for any of the following acts of violations:
a) Failing to organize the application of measures to prevent and control harms of liquor and beer abuse in their organizations and agencies;
b) Failing to organize the observance of the regulations on prohibition of liquor and beer use during working hours and at workplaces of their agencies and organizations;
c) Failing to make warnings about and request stoppage of the acts of drinking or selling liquor and beer at places where liquor and beer drinking is prohibited, within the ambit of the management and administration;
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. Violations 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 acts of violations:
a) Provide 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 acts of violations:
a) Employing under-18 persons to directly take part in liquor and beer trading activities;
b) Providing in accurate and irrational information about liquor and beer products.
3. Remedial measures:
Forcible removal of infringing elements on products (if any) and correction of incorrect information, for the acts of violations specified at Point b, Clause 2 of this Article.
Article 36. Violations of regulations on information, education and communications about the prevention and control of harms of liquor and beer abuse
1. A fine from VND 500,000 to VND 1,000,000 shall be imposed for the acts of failing to educate, supervise and warn under-18 family members about no liquor and beer drinking.
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 abuse 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 about health effects of liquor and beer.
4. Remedial measures:
Forcible correction and removal of untruthful information, for the acts of violations specified in Clauses 2 and 3 of this Article.
Article 37. Violations 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 of liquor or beer products.
Section 2
ACTS OF ADMINISTRATIVE VIOLATIONS IN MEDICAL EXAMINATION AND TREATMENT
Article 38. Violation of regulations on medical practice, and use of practice certificates, of medical practitioners
1. A warning or a fine from VND 200,000 to VND 500,000 shall be imposed for any of the following acts of violations:
a) Failing to wear name tags;
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 acts of violations:
a) Failing to sign a practice contract with the intern at the medical examination and treatment establishment or signing a practice contract that is not made according to the form prescribed by law;
b) Failing to issue a decision on assignment of practice instructors or issuing a decision on assignment of practice instructors that is not made according to the form prescribed by law;
c) Assigning a practice instructor to provide instruction for more than 05 interns at a time.
3. A fine from VND 1,000,000 to VND 3,000,000 shall be imposed for any of the following acts of violations:
a) Refusing to provide medical examination and treatment when the examination and treatment of a disease go beyond practitioners’ professional capacity or are outside the scope of their professional operation but failing to report to a competent person or failing to introduce patients to other medical examination and treatment establishments for handling;
b) Requesting patients to pay expenses for medical examination and treatment that have not yet posted up in accordance with law;
c) Disclosing the health status of patients, information provided by patients and case history dossiers, except the cases agreed by patients or for exchange of information and experience between practitioners directly treating the patients to improve the quality of diagnosis, care and treatment of patients or in other cases provided by law;
d) Granting a written certification of the practice duration that is not made according to the form prescribed by law.
4. A fine from VND 3,000,000 to VND 5,000,000 shall be imposed for any of the following acts of violations:
a) A medical practitioner registers to work in the same period of time at multiple medical examination and treatment establishments; the total amount of overtime work exceeds the one as prescribed in the Labor Code; a medical practitioner works in the period of time other than the working time approved by a competent agency;
b) Failing to grant a written certification of the practice duration to a intern after the intern completes the practice duration prescribed by law;
c) Granting a written certification of the practice duration with incorrect content, untruth or not being in conformity with professional diploma of the person registering practice;
d) Assigning a practice instructor that does not fully satisfy conditions prescribed by law.
5. A fine from VND 5,000,000 to VND 10,000,000 shall be imposed for any of the following acts of violations:
a) Obstructing patients in need of compulsory treatment in admitting to medical examination and treatment establishments;
b) Instructing the use of medical examination and treatment services for patients, or recommending them to move to another medical examination and treatment establishment, for self-seeking interests;
c) Abusing the profession to harm the honor, dignity and body of patients;
d) A foreigner uses Vietnamese without being tested and recognized to be proficient in Vietnamese by a medical training institution under an assignment by the Minister of Health, or uses another language not registered to use, for directly practicing medical examination and treatment;
dd) Giving an instruction on treatment and a prescription written in a language other than Vietnamese, but that language has not yet registered to use or the translator’s qualification for translation into Vietnamese has not recognized;
e) Erasing and modifying case history dossiers to falsify 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;
i) Working as a person taking charge of two or more clinical departments of the same medical examination and treatment establishment or simultaneously working as a person taking charge of departments of multiple medical examination and treatment establishments in the same period of practice time;
k) A medical practitioner being the person responsible for professional and technical operations of a medical examination and treatment establishment concurrently takes charge of a department of such establishment but that is not in accordance with the scope of professional activity stated in the granted practice certificate;
l) A medical practitioner being the person responsible for professional and technical operations of the medical examination and treatment establishment is not present at the establishment in the registered operating hours of such establishment and doesn t authorize any person to take this responsibility in accordance with law.
6. A fine from VND 20,000,000 to VND 30,000,000 shall be imposed for any of the following acts of violations:
a) Selling drugs to patients in any forms, except the cases of selling drugs of traditional medicine in accordance with law;
b) Giving or taking bribes or acting as bribe brokers in medical examination and treatment.
7. A fine from VND 30,000,000 to VND 40,000,000 shall be imposed for any of the following acts of violations:
a) Practicing medical examination and treatment without possessing a medical practice certificate;
b) Providing medical examination and treatment during the time subject to revocation of the practice certificate or during the time subject to suspension from medical examination and treatment practice;
c) Providing medical examination and treatment outside the scope of professional operation under a medical practice certificate, except cases of emergency or of implementation of additional professional techniques that have been permitted in accordance with law;
d) Hiring or borrowing medical practice certificates to implement professional practice;
dd) Leasing or lending medical practice certificates;
e) Failing to provide timely first aid, emergency aid and medical treatment for patients;
g) Refusing to provide medical examination and treatment for patients, except cases eligible for refusal of medical examination and treatment in accordance with law.
8. Additional sanctions:
a) Deprivation of the right to use a medical practice certificate for a definite time of between 01 month and 03 months, for the acts of violations specified at Points b, c, d, dd, e, g, h, i, k and l, Clause 5 of this Article;
b) Deprivation of the right to use a medical practice certificate for a definite time of between 03 months and 06 months, for the acts of violations specified in Clause 6 of this Article;
c) Deprivation of the right to use a medical practice certificate for a definite time of between 06 months and 09 months, for the acts of violations specified at Points e and g, Clause 7 of this Article;
d) Deprivation of the right to use a medical practice certificate for a definite time of between 22 months and 24 months, for the acts of violations specified at Points b, c, d and dd, Clause 7 of this Article;
dd) The sanction of expulsion that shall be imposed on a foreigner committing recidivism of acts of violations specified in Clause 7 of this Article.
9. Remedial measures:
a) Forcible direct apology to patients for the act of violations specified at Point c, Clause 5 of this Article;
b) Forcible refund of illicit profits earned through the commission of acts of violations specified at Point b, Clause 6 and Points a, b, c, d, dd, Clause 7 of this Article (if any);
c) Making recommendation to a competent state agency on revocation of a medical practice certificate, for acts of violations specified at Points d and dd, Clause 7 of this Article.
Article 39. Violation of regulations on conditions for operation and use of license for 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 acts of violations:
a) Operating without any signboard or having signboards which don’t contain enough basic details in accordance with law;
b) Failing to posting up or posting up insufficiently charges for their medical examination and treatment services;
c) Failing to write on room signs names of departments, rooms at a medical examination and treatment establishment at variance with the dossier of license for medical examination and treatment granted by a competent agency.
2. A fine from VND 3,000,000 to VND 5,000,000 shall be imposed for any of the following acts of violations:
a) Failing to report on replacement of the person responsible for professional and technical operations of a medical examination and treatment establishment to the agency granting the license for medical examination and treatment;
b) Failing to report on change in practitioners to the competent agency in accordance with law;
c) Collecting higher charges for medical examination and treatment services than the posted-up charges;
d) Collecting an amount being greater than medical examination and treatment expenses covered by the health insurance, except the difference due to the use of services as required or due to the excess of the coverage of the health insurance;
dd) Failing to satisfy one of the conditions, after having been granted a license for medical examination and treatment for medical examination and treatment establishments, or after having notified to a competent agency for other health service establishments, except for general clinics and hospitals.
3. A fine from VND 10,000,000 to VND 20,000,000 shall be imposed for any of the following acts of violations:
a) Intentionally providing treatment for those not in need of compulsory treatment;
b) Failing to satisfy one of the conditions, after having been granted a license for medical examination and treatment for general clinics.
4. A fine from VND 20,000,000 to VND 30,000,000 shall be imposed for any of the following acts of violations:
a) Using a medical practitioner not possessing medical practice certificate or being subject to revocation of the medical practice certificate, to suspension from medical examination and treatment practice;
b) Failing to observe mobilization decisions of competent state agencies upon occurrence of natural disasters, catastrophes or dangerous epidemics;
c) Failing to satisfy one of the conditions, after having been granted a license for medical examination and treatment 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 acts of violations:
a) Hiring or borrowing licenses for medical examination and treatment;
b) Leasing or lending licenses for medical examination and treatment;
c) Failing to satisfy one of the conditions, after having been granted a license for medical examination and treatment 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 acts of violations:
a) Providing medical examination and treatment services without license for medical examination and treatment or during the time subject to revocation of operation or at a location not stated in the license for medical examination and treatment;
b) Providing medical examination and treatment services outside the scope of professional operation under the license for medical examination and treatment, except cases 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 a Health Department;
d) Failing to satisfy one of the conditions, after having been granted a license for medical examination and treatment for hospitals with the scale of more than 500 patient beds;
dd) Providing cosmetological service at a cosmetological service establishment without written notice of satisfaction of all conditions for cosmetological service provision to a competent state agency in accordance with law;
e) Providing inpatient treatment at a medical examination and treatment establishment that is not permitted to provide inpatient treatment, except in cases where outpatients are in need of staying for supervision in accordance with law.
7. Additional sanctions:
a) Deprivation of the right to use a license for medical examination and treatment for a definite time of between 02 months and 04 months, for the acts of violations specified at Point dd Clause 2; Point b, Clause 3; Points a and c, Clause 4; Point c, Clause 5 and Points b, c, d and e, Clause 6 of this Article;
b) Deprivation of the right to use a license for medical examination and treatment for a definite time of between 12 months and 24 months, for the acts of violations specified at Points a and b, Clause 5 of this Article;
c) Suspension of an establishment s operation for a definite time of between 12 months and 24 months, for the acts of violations specified at Points a and dd, Clause 6 of this Article;
d) Deprivation of the right to use a medical practice certificate for a definite time of between 01 month and 03 months, for the acts of violations specified at Point a, Clause 3 and Point c, Clause 6 of this Article;
dd) Deprivation of the right to use a medical practice certificate of the person responsible for professional operations of an establishment for a definite time of between 01 month and 03 months, for the acts of violations specified at Point a, Clause 4 and Points b and e, Clause 6 of this Article.
8. Remedial measures:
a) Forcible refund of an amount collected at variance with law, for the acts of violations specified at Points c and d, Clause 2 of this Article. If the amount can’t be refunded to the payer, it shall be remitted to the state budget in accordance with law;
b) Forcible refund of illicit profits earned through the commission of violations specified at Points a and b, Clause 5 of this Article (if any);
c) Making recommendation to a competent state agency on revocation of a license for medical examination and treatment, for acts of violations specified at Points a and b, Clause 5 of this Article.
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 acts of violations:
a) Failing to make dossiers, medical records or making dossiers, medical records that have not enough clear contents in all items of case history dossiers according to the form prescribed by law;
b) Failing to record on a medical report book, or granting a patient receiving an outpatient treatment a medical report book that doesn’t specify clearly and fully personal information of the patient, diagnosis, treatment instructions, prescription in accordance with regulations and time for reexamination;
c) Failing to preserve dossiers, medical records in accordance with law;
d) 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 acts of violations:
a) Failing to handle an abandoned patient in accordance with law;
b) Failing to handle a dead patient in accordance with law;
c) Failing to be on standby, to organize on-standby medical examination and treatment in accordance with law;
d) Failing to organize nutrition in treatment, to give an instruction for nutrition regime to patients or to give a nutritional advise to patients in accordance with law.
3. A fine from VND 5,000,000 to VND 10,000,000 shall be imposed for any of the following acts of violations:
a) Failing to hold a consultation when the disease status of a patient goes beyond the professional capacity of practitioners or a medical examination and treatment establishment;
b) Failing to hold a consultation when treatment of a disease experiences worse developments or no progress.
4. A fine from VND 10,000,000 to VND 15,000,000 shall be imposed for the act of failing to transfer a patient to an appropriate medical examination and treatment establishment when the disease status of the patient goes beyond the professional capacity of an establishment.
5. A fine from VND 15,000,000 to VND 20,000,000 shall be imposed for any of the following acts of violations:
a) Conducting a surgery, operation or another surgical intervention of type III or higher without written consent of a patient or his/her representative, unless it is impossible to consult a patient or his/her representative and the patient’s life is directly threatened without surgery or surgical intervention;
b) Failing to ensure sufficient means of transport for first-aid suited to the form of medical examination and treatment; medical equipment and devices and essential drugs to promptly give first aid to patients.
6. A fine from VND 20,000,000 to VND 30,000,000 shall be imposed for any of the following acts of violations: conducting an intervention of drugs, substances or equipment in human body (surgery, operation, intervention involving injection, pumping, ray emission, burning or other types of invasive intervention) that changes the color of skin, shape, weight and defects of human body (skin, nose, eyes, lips, face, breast, belly, buttock and other parts), any of services of doing tattoos or spraying or embroidering pictures on the skin, using anesthetics in injection form at an establishment not being a hospital with a cosmetological department or a cosmetological clinic or at a medical examination and treatment establishment with the scope of professional activity in cosmetological specialty.
7. A fine from VND 40,000,000 to VND 50,000,000 shall be imposed for the act of violating professional and technical regulations for medical examination and treatment causing an incident to a patient.
8. Additional sanctions:
a) Deprivation of the right to use a medical practice certificate for a definite time of between 01 month and 03 months, for the acts of violations specified at Points a and b, Clause 1; Point c, Clause 2 and in Clauses 3 and 4 of this Article;
b) Deprivation of the right to use a medical practice certificate for a definite time of between 03 months and 06 months, for the acts of violations specified in Clauses 5 and 7 of this Article;
c) Deprivation of the right to use a license for medical examination and treatment for a definite time of between 01 month and 03 months, for an establishment committing recidivism any of, or simultaneously committing 03 or more, acts of violations specified in Clauses 1, 2, 3, 4 and at Point a, Clause 5 of this Article;
d) Suspension of operation for a part of an establishment (for departments, rooms, centers, units, sections committing acts of violations) or deprivation of the right to use a license for medical examination and treatment (if acts of violations affect the entire operation of an establishment), for a definite time of between 03 months and 06 months, for acts of violations specified at Point b, Clause 5 and in Clause 7 of this Article;
dd) Suspension of an establishment s operation for a definite time of between 03 months and 06 months, for the acts of violations specified in Clause 6 of this Article.
9. Remedial measures:
Forcible payment of the entire medical examination and treatment expenses, for the acts of violations prescribed in Clauses 3 and 7 of this Article;
Article 41. Violation of regulations on use of drugs at medical examination and treatment establishments with inpatient treatment and in the staying duration of outpatients for supervision
1. A fine from VND 1,000,000 to VND 2,000,000 shall be imposed for any of the following acts of violations:
a) Failing to fully and clearly write in the prescription or case history names of drugs, their quantity, contents, dosage, routes of administration and use times when making a prescription in accordance with law;
b) Failing to check the prescription, drug receipt slip, contents, dosage, methods of administration, names and quality of drugs when distributing drugs to patients;
c) Failing to compare the prescription with information on concentrations, contents and quantities of drugs when receiving drugs and expiry dates of drugs indicated in drug receipt slips and on drug labels when distributing drugs to patients;
d) Failing to check the patient’s full name and the names, forms, contents, dosage, methods of administration and use times of drugs before letting the patient use drugs;
dd) Failing to fully record times of distributing drugs to the patient;
e) Failing to monitor and record clinical developments of the patient after using drugs in the case history dossier; failing to promptly detect and report incidents to the practitioner directly providing treatment when distributing drugs to patients.
2. A fine from VND 5,000,000 to VND 10,000,000 shall be imposed for a practitioner’s acts of failing to monitor effects and failing to promptly handle incidents caused by the drug use of a patient directly provided with treatment and instruction on drug use by such practitioner.
3. A fine from VND 10,000,000 to VND 20,000,000 shall be imposed for any of the following acts of violations:
a) Prescribing expensive brand-name drugs for self-seeking interests;
b) Making a prescription which does not accord with diagnosis and severity of a disease;
c) Prescribing products that are not allowed in a prescription in accordance with law;
d) Making a prescription which does not accord with guidelines for diagnosis and treatment of HIV/AIDS or guidelines for HIV/AIDS treatment and care issued or recognized by the Ministry of Health; instructions for diagnosis and treatment of medical examination and treatment establishments, instructions for use of drugs accompanying drugs that are permitted for circulation, and national pharmacopoeia of Vietnam.
4. A fine from VND 20,000,000 to VND 30,000,000 shall be imposed for the act of using a drug which has expired or fails to meet quality or has not been granted an import permit or a certificate of registration for circulation of drugs, unless a certificate of registration for circulation of drugs is not required in accordance with law.
5. Additional sanctions:
Deprivation of the right to use a medical practice certificate for a definite time of between 01 month and 03 months, for the acts of violations specified at Point e, Clause 1 and in Clauses 2, 3, 4 of this Article.
6. Remedial measures:
Forcible payment of the entire medical examination and treatment expenses, for the acts of violations 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 act of failing to report on in vitro fertilization and gestational surrogacy to the Ministry of Health in accordance with law.
2. A fine from VND 5,000,000 to VND 10,000,000 shall be imposed for the act of failing to examine and test to make sure that a sperm or an egg donor suffers no hereditary disease which can affect subsequent generations; suffers no mental or another disease which deprives him/her of the capacity to perceive and control his/her acts; and does not contract HIV.
3. A fine from VND 10,000,000 to VND 20,000,000 shall be imposed for any of the following acts of violations:
a) Providing name, age, address or image of a sperm donor, a sperm or embryo recipient;
b) Using sperm or eggs of a donor for two persons or more, except the cases where the childbirth fails;
c) Failing to destroy or to donate all unused sperm or eggs to scientific research institutions, in case the childbirth is successful;
d) Failing to encode sperm, embryos of a donor or encoding sperm, embryos of a donor without specifying characteristics of such donor, particularly his/her race;
dd) Storing sperm, eggs, embryos at a medical examination and treatment establishment ineligible to perform in vitro fertilization;
e) An establishment storing sperm, eggs or embryos of a depositor fails to destroy them when receiving a notice together with a lawful copy of the death certificate of such depositor from his/her family, unless the spouse of that person makes a written request for storage and still pays the storage and preservation charges;
g) Destroying sperm, eggs or embryos of a dead depositor although his/her spouse makes a written request for storage and still pays the storage and preservation charges;
h) Failing to destroy sperm, eggs of a depositor in case that person gets divorced and requests to destroy them;
i) Failing to destroy embryos of a depositor in case that person gets divorced and both that person and his/her spouse make a written consent to the request for destruction of their embryos;
k) Destroying embryos of a depositor in case that person gets divorced but makes a written request for storage and still pays the storage and preservation charges;
l) Failing to ensure the principle of anonymity of donors and recipients when conducting the donation and receipt of sperm or embryos; failing to encode information about a depositor of sperm, eggs or embryos who wishes to donate them to the storing establishment for use for others, except the cases of donation for scientific research;
m) Receiving cases of depositing sperm, eggs and embryos other than the one as prescribed in law.
4. A fine from VND 20,000,000 to VND 30,000,000 shall be imposed for any of the following acts of violations:
a) Donating sperm or eggs at more than one medical examination and treatment establishment recognized by the Ministry of Health as qualified to perform in vitro fertilization;
b) Failing to comply with technical processes, regulations on health standards for persons eligible for in vitro fertilization, pregnancy and childbirth that are promulgated by the Minister of Health, when performing in vitro fertilization technique;
c) Performing in vitro fertilization for a sperm or an egg or embryo recipient who is ineligible for the receipt in accordance with law;
d) Using surplus embryos to perform in vitro fertilization without donation contract;
dd) Using surplus embryos donated under contracts for more than one person, unless the childbirth is unsuccessful;
e) Failing to destroy or to donate all unused embryos to medical examination and treatment establishments for scientific research, in case the childbirth is successful;
g) Using surplus embryos donated under contracts without consent of the head of a medical examination and treatment establishment.
5. A fine from VND 30,000,000 to VND 40,000,000 shall be imposed for any of the following acts of violations:
a) A medical examination and treatment establishment performs in vitro fertilization technique when it has not been recognized in accordance with law;
b) Failing to ensure one of the conditions after being recognized to be a medical examination and treatment establishment permitted to perform in vitro fertilization.
6. Additional sanctions:
a) Suspension of operation of in vitro fertilization for a definite time of between 01 month and 03 months, for an establishment simultaneously committing 03 or more acts of violations prescribed in Clauses 1, 2, 3 and at Points c, d, dd, e, g, Clause 4 of this Article;
b) Suspension of operation of in vitro fertilization for a definite time of between 06 months and 12 months, for the acts of violations specified at Point b, Clause 4 and in Clause 5 of this Article.
Article 43. Violation of regulations on conditions for altruistic gestational surrogacy
1. A fine from VND 3,000,000 to VND 5,000,000 shall be imposed for any of the following acts of violations:
a) A health counselor of a gestational surrogacy-requesting couple or a gestational surrogate is not an obstetrics doctor;
b) A psychological counselor of a gestational surrogacy-requesting couple or a gestational surrogate doesn’t hold a bachelor or higher degree in psychology;
c) A legal counselor of a gestational surrogacy-requesting couple or a gestational surrogate doesn’t hold a bachelor or higher degree in law;
d) Failing to counsel a gestational surrogacy-requesting couple or a gestational surrogate all the contents specified by law.
2. A fine from VND 5,000,000 to VND 10,000,000 shall be imposed for any of the following acts of violations:
a) Not providing health, legal and psychological counseling for a gestational surrogacy-requesting couple, except in cases where the counseling is not required in accordance with law;
b) Not providing health, legal and psychological counseling for a gestational surrogate, except in cases where the counseling is not required in accordance with law;
c) A counselor fails to sign and clearly write his/her full name, title, working address and date of counseling on the written certification of counseling contents.
3. A fine from VND 10,000,000 to VND 20,000,000 shall be imposed for the act of providing name(s), age(s), an address or an image of a gestational surrogacy-requesting couple, a gestational surrogate or a child born through altruistic gestational surrogacy.
4. A fine from VND 30,000,000 to VND 40,000,000 shall be imposed for any of the following acts of violations:
a) Performing altruistic gestational surrogacy at a medical examination and treatment establishment that has not been recognized;
b) Failing to ensure one of the conditions after being recognized to be a medical examination and treatment establishment permitted to perform altruistic gestational surrogacy.
5. Additional sanctions:
a) Suspension of operation of altruistic gestational surrogacy for a definite time of between 01 month and 03 months, for an establishment simultaneously committing 03 or more acts of violations prescribed in Clauses 1, 2 and 3 of this Article;
b) Suspension of operation related to the act of violations for a definite time of between 06 months and 12 months, for the acts of violations specified in Clause 4 of this Article.
Article 44. Violation of regulations on donation, removal and transplantation of human tissues and organs and donation and acceptance of cadavers
1. A fine from VND 1,000,000 to VND 2,000,000 shall be imposed for any of the following acts of violations:
a) A health establishment fails to directly meet the donor to give counseling on 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 of the donor before removing tissues or organs from a living donor;
d) Failing to report the list of registered living donors of tissues or organs to the National Coordination Center for Organ Transplantation;
dd) Failing to give counseling on health and social psychology to the donor or failing to examine biological parameters of the donor before removing tissues or organs from a living donor.
2. A fine from VND 5,000,000 to VND 10,000,000 shall be imposed for the act of collecting a payment for health care and rehabilitation right after their tissues are removed or regular health checks for a donor from whom organs have been removed.
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.
4. A fine from VND 20,000,000 to VND 30,000,000 shall be imposed for the act of operation of a tissue bank without license for tissue bank.
5. A fine from VND 30,000,000 to VND 40,000,000 shall be imposed for any of the following acts of violations:
a) Disclosing information and secrets about donors and transplant recipients unless otherwise agreed upon by the parties with a written consent or provided for by law;
b) Removal of non-regenerable organs from living donors without written opinion of a Counseling Council on Human Organ Removal and Transplantation of a 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 acts of 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 establishment ineligible for implementation 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 acts of violations:
a) Forcing other person to give away his/her tissues and organs or removing tissues and organs from a person who refuses to donate his/her tissues and organs;
b) Removing tissues and organs from a living person aged under 18 years;
c) Transplanting tissues or organs of a person infected with any of diseases on the list prescribed by the competent agency.
8. Additional sanctions:
a) Deprivation of the right to use a license for tissue bank for a definite time of between 03 months and 06 months, for the acts of violations specified in Clause 3 and at Point c, Clause 5 of this Article;
b) Suspension of a part of the operation of a medical examination and treatment establishment related to the act of violations for a definite time of between 01 month and 03 months, for the acts of violations specified at Point c, dd, Clause 1 and Point b, Clause 5 of this Article;
c) Deprivation of the right to use a license for medical examination and treatment for a definite time of between 03 months and 06 months, for the acts of violations specified in Clauses 6 and 7 of this Article.
9. Remedial measures:
a) Forcible refund of an amount collected at variance with law, for the act of violations specified in Clause 2 of this Article. If the amount can’t be refunded to the payer, it shall be remitted to the state budget in accordance with law;
b) Forcible payment of the entire expenses for medical examination and treatment for a damaged individual, for the act of violations prescribed in Clause 7 of this Article. If the amount can’t be refunded to the payer, it shall be remitted to the state budget.
Article 45. Violation of regulations on re-determination of gender
1. A fine from VND 2,000,000 to VND 5,000,000 shall be imposed for any of the following acts of violations:
a) Disclosing information about re-determination of gender of other persons;
b) Making a discrimination against a person whose gender has been redetermined.
2. A fine from VND 30,000,000 to VND 40,000,000 shall be imposed for the act of re-determination of gender without permission of the Minister of Health or the Director of a Department of Health.
3. Remedial measures:
a) Forcible direct apology to a person experiencing a discrimination, for the act of violations 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 medical check-ups
1. A fine from VND 3,000,000 to VND 5,000,000 shall be imposed for any of the following acts of violations:
a) Providing a health certificate without performing medical check-up with full contents as required;
b) A health classification is not in conformity with health status of the person requesting medical check-up.
2. A fine from VND 5,000,000 to VND 10,000,000 shall be imposed for the act of failing to satisfy one of the conditions for establishments performing medical check-ups.
3. A fine from VND 10,000,000 to VND 20,000,000 shall be imposed for the act of performing medical check-ups without an announcement of medical check-up performance.
4. Additional sanctions:
a) Suspension of an establishment s operation of performing medical check-ups for a definite time of between 01 month and 03 months, for the act of violations specified in Clause 2 of this Article;
b) Deprivation of the right to use a license for medical examination and treatment for a definite time of between 01 month and 03 months, for the act of violations specified in Clause 3 of this Article.
Article 47. Violation of regulations on control of bacterial contamination 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 acts of violations:
a) Failing to counsel patients and their relatives on measures to control bacterial contamination;
b) Failing to comply with law on control of bacterial contamination and regulation on control of bacterial contamination of a medical examination and treatment establishment, for those working at the establishment, patients and visitors of the establishment.
2. A fine from VND 5,000,000 to VND 10,000,000 shall be imposed for any of the following acts of violations:
a) Failing to perform one of measures or to fully perform measures to control bacterial contamination at medical examination and treatment establishments;
b) Failing to guarantee physical foundations, equipment, protective clothing, personal hygiene conditions for those working at the establishment, patients and visitors of the establishment in conformity with requirements on bacterial contamination control at medical examination and treatment establishments.
3. Additional sanctions:
a) Deprivation of the right to use a medical practice certificate for a definite time of between 01 month and 03 months, for the act of violation specified at Point b, Clause 1 of this Article;
b) Deprivation of the right to use a license for medical examination and treatment for a definite time of between 01 month and 03 months, for the acts of violations specified in Clauses 2 of this Article.
Article 48. Violation of regulations on principles for medical practice
1. A warning or a fine from VND 200,000 to VND 500,000 shall be imposed for any of the following acts of violations:
a) Failing to respect or to cooperate with practitioners when getting a medical examination or treatment;
b) Failing to respect patient’s rights as prescribed by law;
c) Failing to follow practitioners’ instructions on diagnosis and treatment, except in cases where patients have rights to refusal of medical treatment.
2. A fine from VND 500,000 to VND 1,000,000 shall be imposed for any of the following acts of violations:
a) Failing to truthfully provide information related to their health status, failing to fully cooperate with practitioners and medical examination and treatment establishments;
b) Failing to comply with regulations of the medical examination and treatment establishment;
c) Failing to prioritize medical examination and treatment for cases of emergency, under-6 children, sufferers of serious disabilities, people aged full 80 or older; people with meritorious services to the revolution; or pregnant women.
3. A fine from VND 1,000,000 to VND 3,000,000 shall be imposed for any of the following acts of violations:
a) Harming the honor, dignity of practitioners when receiving a medical examination and treatment;
b) Failing to comply with code of conduct of practitioners in accordance with law;
c) Elimination of stigma and discrimination against patients.
4. A fine from VND 3,000,000 to VND 5,000,000 shall be imposed for any of the following acts of 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 and clauses of this Section.
6. A fine from VND 30,000,000 to VND 40,000,000 shall be imposed for the act of harming the health or threatening life of practitioners when receiving a medical examination and treatment.
7. Additional sanctions:
a) Deprivation of the right to use a medical practice certificate for a definite time of between 01 month and 03 months, for the act of violations specified in Clause 5 of this Article;
b) Suspension of operation for a part of an establishment (for departments, rooms, centers, units, sections committing the act of violations) or deprivation of the right to use a license for medical examination and treatment (if the act of violations affects the entire operation of a medical examination and treatment establishment), for a definite time of between 01 month and 03 months, for the act of violations specified in Clause 5 of this Article.
8. Remedial measures:
a) Forcible direct apology to practitioners for the acts of violations 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 violations specified at Point b, Clause 1 and Point c, Clause 3 of this Article.
Article 49. Violation of regulations on information, education and communications of infant feeding, the 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 communications 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 cautions 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 communications 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; antibacterial elements, especially antibodies, only present in breast milk, which help infants prevent and control 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 providing infants with no immunological elements which can be found only in breast milk, requiring more money and time, possible child infection in case of improper preparation, and other disadvantages in accordance with 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 communications documents on nurturing infants that contain one of the following contents:
a) Images, words or other communications forms to encourage the use of breast-milk substitutes or bottle-feeding or discourage breastfeeding;
b) Comparisons leading to the conclusion that breast-milk substitutes are as good as 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 communications about benefits of breastfeeding and on infant nurturing methods in programs on information, education and communications about mother and child health protection and infant nutrition improvement.
5. Remedial measures:
Forcible revocation of communications documents, for the acts of violations specified in Clauses 1, 2 and 3 of this Article.
Article 50. Violation of regulations on advertising of nutritious products for infants
1. A fine from VND 20,000,000 to VND 30,000,000 shall be imposed for the act of advertising complementary foods for under-24-month infants that fails to satisfy the following requirements:
a) The first part of the advertisement must have the phrase: “Breast milk is the best food for health and all-sided growth of infants”;
b) Advertising contents must clearly state “This product is a complementary food and may be used as a supplement to breast milk for infants over 06 months”.
2. A fine from VND 40,000,000 to VND 50,000,000 shall be imposed for the act of using fetus or infant images in advertisements for milk for pregnant women.
3. Remedial measures:
Forcible removal of infringing elements, for the acts of violations specified in Clauses 1 and 2 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 acts of 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 acts of 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 to provide counseling about breastfeeding to pregnant women, nursing mothers and members of their families at antenatal clinics, labor and delivery clinics, postpartum rooms, nutrition counseling clinics 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;
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 acts of 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 products, 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 meet or contact 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 acts of 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, point accumulation for rewards, 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
ACTS OF ADMINISTRATIVE VIOLATIONS ONPHARMACY 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 acts of violations:
a) A drug retailer’s person in charge of expertise is absent during the operation of such pharmaceutical establishment, except for cases of authorization upon being absent as prescribed by law provisions;
b) Failing to comply with the decision of competent state agencies in cases of severe epidemics, natural disasters or calamities;
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 latest date of obtaining certificates of completing the program of training and updating professional knowledge about pharmacy;
d) Replacing a drug prescribed 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 acts of violations:
a) Forging a number of documents in dossiers of application for pharmacy practice certificates;
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 provisions;
c) Taking the professional responsibility for two or more pharmaceutical business establishments or at two or more pharmaceutical business locations;
d) Practicing pharmacy in contravention of the scope of professional activities inscribed in pharmacy practice certificates and technical regulations;
dd) Institutions for training and updating professional knowledge about pharmacy fail to satisfy conditions as prescribed by law provisions;
e) Institutions for organizing the examination for granting pharmacy practice certificates fail to satisfy conditions as prescribed by law provisions;
g) Leasing, lending or letting another person use pharmacy practice certificates in order to practice pharmacy.
3. A fine from VND 10,000,000 to VND 20,000,000 shall be imposed on acts of renting or borrowing pharmacy practice certificates in order to practice pharmacy.
4. Additional sanctions:
a) Deprivation of the right to use pharmacy practice certificates for a period of between 01 month and 03 months, for acts of violations specified at Points c and d, 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 acts of violations specified at Point b, Clause 1 of this Article.
5. Remedial measures:
a) 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);
b) Proposing competent state agencies for recall of pharmaceutical practice certificates, for acts of violations specified at Points b and c, Clause 1, Points a and g, Clause 2 and Clause 3 of this Article.
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 acts of violations:
a) Mobile drug retailers fail to satisfy conditions as prescribed by law provisions;
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 acts of failing to satisfy one of the regulations applicable to business establishments that have a drug shelf as prescribed by law provisions;
3. A fine from VND 10,000,000 to VND 15,000,000 shall be imposed for acts of forging papers in the dossier of announcing business establishments that have a drug shelf.
4. A fine from VND 15,000,000 to VND 20,000,000 shall be imposed for acts 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) Failing to satisfy quality standards;
b) Being recalled under notifications of competent state agencies;
c) Being expired;
d) Having unknown origin.
5. Additional sanctions:
a) Suspension of business activities related to acts of violations for a period of between 01 month and 03 months, for acts of violations specified at Point a, Clause 1 and Clause 2 of this Article;
b) Suspension of business activities related to acts of violations for a period of between 06 months and 12 months, for acts of violations specified in Clause 3 of this Article.
6. Remedial measures:
Forcible destruction of all drugs or drug materials for acts of 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 approved by competent state agencies to re-export or remedy in accordance with law provisions.
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 acts of 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;
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 24 months, for acts of violations specified in Clause 1 of this Article.
3. Remedial measures:
a) Forcible refund of illicit profits earned through the commission of violations specified at Point b, Clause 1 of this Article (if any);
b) Proposing competent state agencies for recall of certificates of eligibility for pharmaceutical business for acts of violations specified in Clause 1 of this Article.
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 acts of violations:
a) Failing to report to the Ministry of Health or the Departments of Health or failing to fulfill obligations as prescribed by law provisions in cases where the operation is suspended for a period of 06 months or more, or the operation terminates;
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 provisions;
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 provisions;
d) Failing to display wholesale and retail prices in Vietnam dong, or failing to display in a sufficient and clear manner and in accordance with regulations, causing confusion for customers at the pharmaceutical business establishment’s transaction places or places of drug sale.
2. A fine from VND 5,000,000 to VND 10,000,000 shall be imposed for any of the following acts of 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 provisions.
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 timesshall be imposed for acts of violations 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, ora fine equal to 2 timesshall be imposed for acts of 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, but not exceeding VND 100,000,000 for acts of violations specified at Point c, Clause 1 of this Article.
5. Additional sanctions:
Suspension of business activities related to acts of violations for a period of between 01 month and 03 months, for acts of 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 and VND 20,000,000 shall be imposed for any of the following acts of 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 registration of changing or supplementing certificates of registration for marketing authorization of drugs or drug materials before the circulation of drugs or drug materials for minor changes that only require notification;
c) Failing to send a notification to competent state agencies in the event of stopping manufacture or supply of drugs, or in the case of being at risks and shortage of drug materials.
2. A fine from VND 20,000,000 to VND 30,000,000 shall be imposed for any of the following acts of 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 provisions;
c) Failing to update quality standards of drugs or drug materials as prescribed by law provisions.
3. A fine from VND 30,000,000 to VND 50,000,000 shall be imposed for any of the following acts of violations:
a) Failing to maintain operating conditions of the registered establishment within the validity duration of certificates of registration for marketing authorization of drugs or drug materials;
b) Failing to follow the approved risk management plan in dossiers of application for granting or extending certificates of registration for marketing authorization of vaccines;
c) Failing to carry out the procedures for registration of changing or supplementing certificates of registration for marketing authorization before the circulation of drugs or drug materials for major changes or minor changes that require approval prior to implementation;
d) Manufacturing or circulating drugs or drug materials with changes compared to the approved drug registration dossier that requires the procedures for granting certificates of registration for 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 acts of violations:
a) Failing to send a notification to competent agencies in cases 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 dossier of application for drugs;
b) Failing to send a notification to competent agencies in cases where drugs or drug materials obtaining a certificate of registration in Vietnam are recalled in the manufacturing country or reference country that has issued the certificate of pharmaceutical product (CPP) submitted in the dossier of application for drugs;
c) Documents and information in the dossier of registration for drugs or drug materials are not based on research or actual production of manufacturers or have been approved, concluded by competent agencies as fake documents.
5. Remedial measures:
a) Forcible recall of drugs or drug materials, for acts of violations specified at Point c, Clause 4 of this Article;
b) Proposing competent state agencies for recall of certificates of registration for marketing authorization of drugs or drug materials, for acts of violations specified at Points b and c, 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 acts of 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 from taking samples of drugs or drug materials to examine their quality;
c) Failing to report on the recall of drugs or drug materials in accordance with law.
2. A fine from VND 10,000,000 to VND 20,000,000 shall be imposed for any of the following acts of violations:
a) Manufacturing drugs or drug materials with minor changes compared to the approved drug registration dossier in the cases that must be notified to competent agencies but no notification of such changes is made in accordance with law;
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, for the cases requiring approval by competent agencies;
c) Failing to preserve samples of drugs, drug materials during drug testing or drug materials as prescribed by law provisions;
d) Failing to preserve or preserving inadequately dossiers of manufacture of drugs or drug materials as prescribed by law provisions.
3. A fine from VND 20,000,000 to VND 30,000,000 shall be imposed for any of the following acts of 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 provisions;
b) Manufacturing drugs with a level-3 violation of regulations on quality as prescribed by law provisions;
c) Failing to test drug materials and primary packages of drugs before they are put into production;
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;
e) Manufacturing drugs when marketing authorization has expired, unless otherwise permitted by law provisions;
g) Using drug materials or medicinal materials for drug manufacture, which have not been granted marketing authorization or have not been announced in the list of drug materials or has not been announced quality standards as prescribed by law provisions.
4. A fine from VND 30,000,000 to VND 40,000,000 shall be imposed for any of the following acts of violations:
a) Failing to recall drugs or drug materials at the request of competent agencies or upon the establishment’s discovery related to cases where drugs are required to be recalled as prescribed by law;
b) Manufacturing drugs with a level-2 violation of regulations on quality as prescribed by law provisions;
c) Manufacturing drugs using primary packages of drugs that fail to satisfy quality standards as prescribed by law provisions;
d) Manufacturing drug materials that fail to satisfy quality standards prescribed by law provisions;
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 backend system or changing the principles of designing and operating the utility system that affect the manufacturing environment but the establishment of 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 delivery in accordance with law.
5. A fine from VND 40,000,000 to VND 60,000,000 shall be imposed for any of the following acts of violations:
a) Manufacturing drugs with a level-1 violation of regulations on quality as prescribed by law provisions;
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;
dd) Manufacturing drugs or drug materials against the scope specified in certificates of eligibility for pharmaceutical business or against the scope of assessment of good manufacturing practices for drugs or drug materials as prescribed by law provisions;
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 acts of 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 provisions;
dd) Manufacturing drugs or drug materials during a 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 provisions.
7. A fine equal to 1.5 times shall be imposed for acts of violations related to combination drugs containing habit-forming pharmaceutical ingredients, psychotropic active ingredients, combination drugs containing psychotropic pharmaceutical ingredients, combination drugs containing pre-substances, or radioactive drugs, or a fine equal to 2 times shall be imposed for acts of 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, but not exceeding VND 100,000,000 for acts of violations specified at Point dd, Clause 5, and Point c, d, and dd, Clause 6 of this Article.
8. Additional sanctions:
a) Suspension of business activities related to acts of violations for a period of between 01 month and 03 months, for acts of violations 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 acts of violations 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 acts of violations specified at Points b and dd, Clause 5 and Points a and c, Clause 6 of this Article;
d) Suspension of operation until establishments make reports to the Ministry of Health within 24 months for acts of violations specified at Point g, Clause 4 of this Article;
dd) Deprivation of the right to use certificates of eligibility for pharmaceutical business for a period of between 09 months and 12 months, for acts of violations specified at Points e and g, Clause 6 of this Article;
e) Deprivation of the right to use certificates of eligibility for pharmaceutical business for a period of between 03 months and 06 months, for acts of violations specified at Point d, Clause 5 and Point b, Clause 6 of this Article;
g) Suspension of operation of pharmacy business establishments directly related to violations for a period of between 03 months and 06 months, for acts of violations specified at Point e, Clause 5 of this Article.
9. Remedial measures:
a) Forcible destruction of all drugs or drug materials, for acts of violations specified at Point c, Clause 3, Points b and c, Clause 4, Points a and d, Clause 5, and Clauses 6 and 7 of this Article;
b) Proposing competent state agencies for recall of certificates of eligibility for pharmaceutical business for acts of violations specified at Point e, Clause 5 of this Article in cases where the suspension duration expires but the establishments have not performed any rectification or correction, such establishments may not be allowed to operate until carrying out the satisfactory rectification or correction;
c) Proposing competent state agencies for recall of certificates of eligibility for pharmaceutical business for acts of violations specified at Point d, Clause 5, and Points e and g, 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 acts of 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) Buying and selling drugs with a level-3 violation of regulations on quality as prescribed by law provisions;
dd) Buying and selling drugs belonging to the national target program, aid drugs and other drugs that are not allowed to be sold in accordance with regulations of law;
e) Failing to keep documents related to each lot of drugs or drug materials during the specified period in accordance with law.
2. A fine from VND 10,000,000 to VND 20,000,000 shall be imposed for any of the following acts of violations:
a) Buying and selling drugs or drug materials as samples for registration, testing, scientific research, or display at exhibitions or fairs;
b) Selling drugs, drug materials, vaccines, or medical bio-products to establishments that do not comply with the scope of business specified in certificates of eligibility for pharmaceutical business or buying drugs, drug materials, vaccines or medical bio-products of establishments that do not comply with the scope of business specified in certificates of eligibility for pharmaceutical business;
c) Buying and selling drugs with a level-2 violation of regulations on quality as prescribed by law provisions;
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 acts of 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 buying 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 operate non-commercial pharmaceutical business;
b) Failing to make reports about the satisfaction of requirements on good practices of drug distribution as prescribed by law provisions;
c) Failing to have internet-connected equipment or computers, and to manage distribution activities by computer software;
d) Failing to develop mechanism for the transfer of information about drug distribution and drug quality between manufacturers and customers and the transfer of information to relevant management agencies upon request;
dd) Only maintaining the satisfaction of principles and standards of 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 acts of violations:
a) Buying and selling drugs with a level-1 violation of regulations on quality as prescribed by law provisions;
b) Buying and selling preprocessed medicinal materials that fail to satisfy quality standards as prescribed by competent state agencies;
c) Preserving drugs or drug materials against the conditions on the label;
d) Changing the location of storehouses for preservation or adding new storehouses at the same place of business but wholesalers of drugs or drug materials fail to make reports about changes enclosed together with technical documents corresponding to such changes as prescribed by law provisions;
dd) Changing the backend 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 provisions.
5. A fine from VND 40,000,000 to VND 60,000,000 shall be imposed for any of the following acts of buying and selling drugs or drug materials:
a) Failing to have 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.
6. With regard to acts of buying or selling drugs or drug materials that have been recalled under notification by competent state agencies or have expired or have obtained no import permit or certificate of registration for marketing authorization, except for the cases in which drugs or drug 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 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 shall be imposed for acts of violations related to pharmaceutical substances, drugs 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, ora fine equal to 02 timesshall be imposed for acts of 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, but not exceeding VND 100,000,000 for any of acts of violations specified at Point e, Clause 1, Points a, b, Clause 2, Point a, Clause 3, and Point d, Clause 4, 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 period of between 01 month and 02 months, for acts of violations 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 acts of violations 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 establishments for a period of between 06 months and 09 months, for acts of violations specified at Point dd, Clause 3, Points a, c, Clause 5 and Clause 6 of this Article;
d) Suspension of operation until establishments send reports to the Ministry of Health within 24 months, for acts of violations specified at Point b, Clause 3 of this Article.
9. Remedial measures:
Forcible destruction of all drugs or drug materials for acts of violations specified at Points a and b, Clause 5 and 6 of this Article.
Article 59. Violation of regulations on retail of drugs or drug materials
1. A fine from VND 1,000,000 to VND 3,000,000 shall be imposed for any of the following acts of violations:
a) Selling preprocessed medicinal materials that fail to satisfy quality standards as prescribed by competent agencies;
b) The persons directly participating in drug retail 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 violation of regulations on quality as prescribed by law provisions;
dd) Failing to clearly write down drugs’ name, content, 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 administration in cases of retailing drugs without a prescription;
e) Failing to keep the documents related to each lot of drugs and drug materials for a specified period in accordance with law;
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 violations:
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 together with technical documents corresponding to such changes in accordance with law;
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” in cases of trading in cosmetics, functional foods, and medical equipment in accordance with law;
c) Buying and selling drugs with a level-2 violation of regulations on quality as prescribed by law provisions.
3. A fine from VND 5,000,000 to VND 10,000,000 shall be imposed for any of the following acts of violations:
a) Failing to recall drugs and medicinal materials at the request of competent agencies;
b) Failing to have separate rooms for preparation or to have 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) Selling vaccines or selling prescription drugs without prescriptions;
e) Failing to make reports about the satisfaction of good practices at drug retailers in accordance with law;
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 perform the transfer of information about drug sale and purchase or drug quality between suppliers and customers; failing to perform the transfer of information to relevant management agencies upon request as prescribed by law provisions, except for retailers of medicinal materials;
i) Only maintaining the principles and standards of good practices of drug retailers at level 3.
4. A fine from VND 10,000,000 to VND 20,000,000 shall be imposed for any of the following acts of violations:
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 pharmaceutical drugs prepared according to prescriptions of another drugstore;
d) Buying and selling drugs on the list of drugs restricted from retail without 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-1 violation of regulations on quality as prescribed by law provisions.
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 have 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.
6. With regard to acts of buying and selling drugs or medicinal materials that have been recalled under notification by competent state agencies or that have expired or that have obtained no import license or certificates of registration for marketing authorization, except for cases where drugs or medicinal materials are not required to be registered before being circulated, a fine shall be imposes according to one of the following levels:
a) A fine 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 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 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 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 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 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 from VND 15,000,000 to VND 20,000,000 shall be imposed on goods values at between VND 30,000,000 and less than VND 40,000,000;
h) A fine from VND 20,000,000 to VND 25,000,000 shall be imposed on goods valued at between VND 40,000,000 and less than VND 50,000,000;
i) A fine 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 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 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 violations related to drugs orpharmaceutical substances 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, ora fine equal to 02 timesshall be imposed for acts of 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, but not exceeding VND 100,000,000 for any of acts of violations 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 period of between 01 month and 02 months, for acts of violations 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 period of between 01 month and 03 months, for acts of violations specified at Points b, c and d, Clause 4 of this Article;
c) Deprivation of the right to use pharmacy practice certificates for a period of between 03 months and 06 months, for acts of violations specified at Point b, Clause 5 and Clause 6 of this Article;
d) Suspension of operation of establishments for a period of between 01 month and 03 months, for acts of violations specified at Point a, Clause 2 of this Article;
dd) Suspension of operation of establishments for a period of between 06 months and 09 months, for acts of violations specified at Points dd, i, Clause 3 and Point c, Clause 5 of this Article.
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 acts of violations specified at Point e, Clause 4 of this Article;
c) Forcible destruction of all drugs or medicinal materials, for acts of violations specified at Point a, 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 violations:
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.
2. A fine from VND 10,000,000 to VND 20,000,000 shall be imposed for any of the following acts of violations:
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;
b) Failing to send written notifications to the Ministry of Health of wholesale establishments that distribute drugs or drug materials imported into Vietnam by establishments having the right to import but not exercising the right to distribute drugs or drug materials in Vietnam before selling drugs or stopping selling drugs to such establishments;
c) Failing to keep documents related to each lot of imported drugs or drug materials for a specified period as prescribed by law provisions;
d) Selling drugs under national target programs, donated drugs and other drugs not being permitted for sale as prescribed by law provisions;
dd) Exporting drugs or drug materials without certificates 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;
e) Exporting drugs or drug materials that have been recalled under notification as prescribed by law provisions;
g) Exporting drugs or drug materials that are inconsistent with the scope stated in certificates of eligibility for pharmaceutical business;
h) Exporting medicinal materials on the list of precious, rare and endemic medicinal material species and varieties subject to 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 violations:
a) Preserving drugs or drug materials in storehouses for preservation that have not been assessed to satisfy GSP requirements or at locations that are inconsistent with the pharmacy business location in granted certificates of eligibility for pharmaceutical business, except for the use of services of preserving drugs or drug materials;
b) Only maintaining the principles and standards of good practices of GSP at level 3;
c) Importing drugs drug materials in excess of the quantity specified in import licenses approved by competent agencies;
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 subject to 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 the Minister of Health;
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 violations:
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;
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 fora license to importis 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 violations:
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 an import permit or a certificate of registration for marketing authorization, except for cases where drugs or drug materials are not subject to import registration or license before being circulated;
d) Carrying out activities directly related to the distribution of drugs or drug materials in Vietnam in cases where establishments have the right to import but not exercising the right to distribute drugs or drug materials in Vietnam, except for drugs or drug materials manufactured by establishments in Vietnam.
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 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 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 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 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 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 130,000,000;
e) A fine 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 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 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 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 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 from VND 70,000,000 and 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 violations related to drugs orpharmaceutical substances 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 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, but not exceeding VND 100,000,000, for acts of violations specified at Points c, d, dd, g, Clause 2, and Points a, c, d, 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 responsible for professional expertise for a period of between 01 month and 03 months, for acts of violations specified at Points b, c, dd, e and g, Clause 2 of this Article;
b) Deprivation of the right to use pharmacy practice certificates of the persons responsible for professional expertise for a period of between 03 months and 06 months, for acts of violations specified at Points 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 responsible for professional expertise for a period of between 06 months and 09 months, for acts of violations specified in Clause 5 of this Article;
d) Deprivation of the right to use certificates of eligibility for pharmaceutical business for a period of between 18 months and 24 months, for acts of violations specified at Point d, Clause 5 of this Article;
dd) Suspension of business activities related to acts of violations for a period of between 01 month and 03 months, for acts of violations specified at Points dd, e and g, Clause 2 of this Article;
e) Suspension of business activities related to the violations for a period of between 03 months and 06 months, for acts of violations 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 period of between 06 months and 09 months, for acts of violations specified at Points a, b and c, Clause 5 of this Article;
h) Suspension of operation until establishments send a report to the Ministry of Health within 24 months, for acts of violations specified at Point d, Clause 2 of this Article.
9. Remedial measures:
a) 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 Point d, Clause 3 and Clauses 4, 5, 6, 7 of this Article. In cases where this measure is not applicable, drugs or drug materials must be destructed;
b) Forcible refund of profits earned through the commission of violations specified at Point d, Clause 2 of this Article.
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 violations:
a) Failing to make reports on changes enclosed together with technical documents corresponding to such changes toreceiving agenciesin cases where establishments of preservation change the location of storehouses at the same place of business or adding storehouses to 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.
2. A fine from VND 20,000,000 to VND 30,000,000 shall be imposed for any of the following acts of violations:
a) Providing the services of preserving drugs or drug materials to entities against law provisions;
b) Medical examination and treatment establishments, vaccination establishments, vaccine preservation establishments in the national expanded immunization program at district and provincial levels, and focal establishments of preserving drugs under national health programs and of the people’s armed forces, and establishments of preserving vaccines under the national expanded vaccination program at the central or regional level fail to send written notifications of the satisfaction of GSP requirements to receiving agencies as prescribed by law 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 following acts of providing the services of preserving drugs or drug materials:
a) Failing to have 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;
e) 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 acts of violations 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, ora fine equal to 02 timesshall be imposed for acts of 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, but not exceeding VND 100,000,000 for acts of violations specified at Points a, dd, Clause 1, Points a, d, Clause 2 and Points a , b, c, Clause 3 of this Article.
5. Additional sanctions:
a) Deprivation of the right to use pharmacy practice certificates for a period of between 01 month and 03 months, for acts of violations specified in Clause 2 of this Article;
b) Suspension of operation of establishments related to acts of violations for a period of between 01 month and 03 months, for acts of violations specified in Clause 2 of this Article;
c) Suspension of operation of establishments for a period of between 06 months and 12 months, for acts of violations 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 acts of violations specified at Point a, Clause 1 and Point c, Clause 2 of this Article;
b) Forcible destruction of all drugs or drug materials, for acts of violations specified at Point a, Clause 3 of this Article;
c) Forcible refund of profits earned through the commission of violations 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 violations:
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 violations:
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 violations:
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 practices of clinical trials, 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 to 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 acts of violations 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, ora fine equal to 02 timesshall be imposed for acts of 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, but not exceeding VND 100,000,000 for acts of violations 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 or suspension of operation, applicable to establishments operating for non-commercial purposes for a period of between 01 month and 03 months, for acts of violations specified in Clause 2, Points a, b and d, Clause 3 and Clause 4 of this Article;
b) Suspension of operation until establishments send a report to the Ministry of Health within 24 months, for acts of 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 violations:
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;
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 violations:
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 violations:
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 timesshall be imposed for acts of violations related to habit-forming drugs, psychotropic drugs or pre-substance drugs, but not exceeding VND 100,000,000 for acts of violations 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 period of between 01 month and 03 months, for acts of violations 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 of establishments that operate for non-commercial purposes for a period of between 03 months and 06 months, for acts of violations 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 violations:
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;
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 violations:
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 or medicinal 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 violations:
a) Changing or modifying the shelf life of a drug on the label;
b) Packaging materials or forms fail to ensure 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 acts of violations for a period of between 01 month and 03 months, for acts of violations specified at Point b, Clause 2 and Clause 3 of this Article.
5. Remedial measures:
Forcible recall to repair or destruction of all drugs or drug materials of inferior quality, for acts of violations 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 violations:
a) Preserving, manufacturing, preparing, dispensing, and using drugs or drug materials subject to special control at an establishment involved in pharmacy activities for non-commercial purposes in contravention of law;
b) Transporting, delivering, or receiving drugs subject to special control in contravention of law;
c) Destroying drugs subject to special control in contravention of law.
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 services of drug or drug material preservation, 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 violations:
a) Failing to have sufficient conditions of physical and technical foundations and personnel to prevent loss of drugs subject to special control as prescribed by law provisions;
b) Buying or selling materials that are habit-forming pharmaceutical ingredients, psychotropic pharmaceutical ingredients, or pre-substances without orders approved by competent state agencies; buying or selling habit-forming drugs, psychotropic drugs and pre-substance drugs without orders approved by competent state agencies or without winning results or without bidding plans approved by authorized persons.
3. Additional sanctions:
Suspension of business activities related to acts of violations for a period of between 01 month and 03 months, for acts of violations specified in Clause 2 of this Article.
Article 66. Violation of regulations on management of drug prices
1. A fine from VND 5,000,000 to VND 10,000,000 shall be imposed for acts of failing to submit a written request for supplementing and changing the information of declared drugs or re-declaring drug prices in cases where there are changes compared to published information but drug prices do not change.
2. A fine from VND 10,000,000 to VND 20,000,000 shall be imposed for any of the following acts of violations:
a) Purchasing drugs for a drug retailer within the premise of a public medical examination and treatment establishment at a price higher than the bid-winning price of such drugs at the same medical examination and treatment establishment at the same time, except for cases being permitted for purchase in accordance with law;
b) Purchasing drugs for a drug retailer within the premise of a publicmedical examination and treatment establishmentat a price higher than the highest bid-winning price of such drugs that have won a bid at provincial and central health establishments within 12 months; have won a bid for local and national concentrated procurement; or have been negotiated about prices within the term of contracts or about the procurement framework up to the time of drug purchase,except for cases being permitted for purchase in accordance with law;
c) Purchasing drugs for a drug retailer within the premise of a public medical examination and treatment establishment while such drugs are not included in the list of drugs that have won a bid at provincial and central health establishments within 12 months or have won a bid for local and national concentrated procurement or have been negotiated about prices within the term of contracts or about the procurement framework up to the time of drug purchase,except for cases being permitted for purchase in accordance with law;
d) A drug retailer on the premise of a public medical examination and treatment establishment sells drugs with a retail surplus higher than the maximum rate of retail surplus in accordance with law.
3. With regard to acts of wholesaling drugs while the drugs have not been 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 price which is in effect in accordance with law, except for cases specified at Point a, Clause 4 of this Article, a fine shall be imposed according to one of the following levels:
a) A fine 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 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 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 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 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.
4. A fine from VND 30,000,000 to VND 50,000,000 shall be imposed for any of the following acts of violations:
a) Failing to declare drug prices or re-declare drug prices in cases of changes in drug prices declared before being circulated on the market;
b)Failing to make reports at the written request of state management agencies on drug prices for dossiers of drug price declaration and re-declaration in cases of making no adjustment for prices;
c) Failing to make accurate reports on the factors forming drug prices as prescribed by law provisions.
5. Remedial measures:
Forcible refund of the full amount of difference, for acts of violations specified in Clauses 2 and 3, and Point b, Clause 4 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.
Article 67. Violation of regulations on drug information
1. A warning or a fine from VND 200,000 to VND 500,000 shall be imposed for any of the following acts of violations:
a)The pharmaceutical sales representative (hereinafter referred to as drug rep) do not wear a drug rep’s card while working;
b) Introducing drugs without the consent of medical practitioners.
2. A fine from VND 5,000,000 to VND 10,000,000 shall be imposed for any of the following acts of violations:
a) Failing to send the list of persons who are granted or recalled a drug rep’s card of a pharmacy business establishment to the Department of Health where the drug rep carries out drug introduction activities;
b) Drug reps introduce products other than drugs;
c) Drug reps introduce drugs that are not assigned by pharmacy business establishments.
3. A fine from VND 10,000,000 to VND 20,000,000 shall be imposed for acts of giving drug information to medical or pharmaceutical practitioners that fall into any of the following acts of violations:
a) Drug information is carried out without being certified by competent state agencies or in contradiction with the contents certified by competent state agencies;
b) Drug information is carried out according to the information contents that have been granted a certificate of information contents by competent agencies but the certificate has expired;
c) Comparing and introducing their own drugs better than those of other establishments without being proved by the scientific documents approved by competent agencies;
d) Drug reps approach patients, medical records, prescriptions, discusses or requests of information related to the patients;
dd) Failing to send written notifications to the Department of Health of localities where the drug information is held in the form of a drug introduction workshop, enclosed together with a copy of the approved certificate of drug information contents before implementation.
4. A fine from VND 20,000,000 to VND 30,000,000 shall be imposed for any of the following acts of violations:
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 reps perform activities related to drug purchase, sale and consignment with health examination and treatment practitioners.
5. A fine from VND 30,000,000 to VND 40,000,000 shall be imposed for any of the following acts of violations:
a) Providing information, advertising, 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 certificates of drug information and advertisement contents;
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 or advertise 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 or advertise drugs;
e) Failing to carry out procedures for granting certification in case of requiring certification due to changing contents drug information.
6. Additional sanctions:
a) Suspension of operation of establishments for a period of between 03 months and 06 months, for acts of violations 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 acts of violations specified at Point b, Clause 5 of this Article.
7. Remedial measures:
Forcible recall and removal of infringing elements, for acts of violations specified at Points a, b, c, Clause 3 and Points a, d, dd, e, 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 violations:
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.
2. A fine from VND 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 or the receipt number of cosmetic product declaration forms that have expired.
3. A fine from VND 30,000,000 to VND 40,000,000 shall be imposed for 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 declaration dossiers.
4. Additional sanctions:
Suspension of trading in cosmetic products for a period of between 03 months and 06 months, for acts of violations specified in Clauses 2 and 3 of this Article.
5. Remedial measures:
a) Forcible recall and destruction of cosmetic products related to violations, for acts of violations specified in Clauses 2 and 3 of this Article;
b) Proposing competent state agencies for recall of the cosmetic product proclamation receipt number, for acts of violations specified at Point a, Clause 1 and Clause 3 of this Article.
Article 69. Violation of regulations on advertising cosmetics through the form of seminars, conferences, events
A fine from VND 30,000,000 to VND 40,000,000 shall be imposed for any of the following acts of organizing seminars, conferences, or cosmetic introduction events:
1. Failing to notify competent agencies prior to the organization as prescribed by law provisions.
2. Failing to comply with the contents notified to competent agencies as prescribed by law provisions.
Article 70. 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 violations:
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 proclamation 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 production;
e) Failing to manufacture in accordance with the scope inscribed on certificates of eligibility for cosmetic production;
g) Manufacturing cosmetics containing substances banned from use in cosmetics or in excess of the permitted limits for substances that limit the concentration or content of use in accordance with law.
2. A fine from VND 40,000,000 to VND 50,000,000 shall be imposed for any of the following acts of violations:
a) Manufacturing cosmetics without a certificate of eligibility for cosmetic production;
b) Forging documents in the application dossier for granting, re-granting or adjusting a certificate of eligibility for cosmetic manufacture;
c) Failing to satisfy one of the conditions after being granted a certificate of eligibility for cosmetic manufacture as prescribed by law provisions.
3. Additional sanctions:
a) Suspension of cosmetic manufacture until establishments are granted the additional scope of operation in certificates of eligibility for cosmetic manufacture in accordance with law within 24 months, for acts of violations specified at the Points dd and e, Clause 1 of this Article;
b) Suspension of cosmetic manufacture until certificates of eligibility for cosmetic manufacture are issued in accordance with law within 24 months, for acts of violations specified at Point a, Clause 2 of this Article;
c) Deprivation of the right to use certificates of eligibility for cosmetic manufacture for a period of between 01 month and 03 months, for acts of violations specified at Points a and g, Clause 1 of this Article;
d) Deprivation of the right to use certificates of eligibility for cosmetic manufacture for a period of between 03 months and 06 months, for acts of violations specified at Point b, Clause 2 of this Article.
4. Remedial measures:
a) Forcible recall and destruction of all cosmetic products for acts of violations specified in Clauses 1 and 2 of this Article, except for cases where cosmetic products fail to meet the standards of weight and packing volume specified at Point d, Clause 1 of this Article;
b) Proposing competent state agencies for recall of the cosmetic product declaration receipt number, for acts of violations specified at Points a, b, c, dd, e, Clause 1 and Points b, c, Clause 2 of this Article.
Article 71. 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 violations:
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 recalled 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 for organizations or individuals responsible for bringing products to the market that commit any of the following acts of violations:
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 recalled by competent state agencies due to violations of law provisions.
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 violations:
a) Trading in cosmetics with ingredients banned from use in cosmetics or in excess of the permitted limits for substances with prescribed concentration and content limits in accordance with law;
b) Trading in cosmetics without product information files (PIF) or with product information files (PIF) but such files are not in a sufficient manner as prescribed by law provisions or without presenting product information files (PIF) upon request by competent agencies;
c) Trading in cosmetics with formulas that are inconsistent with the approved proclamation 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 acts of violations specified in Clauses 1, 2 and Points a, b, c, Clause 3 of this Article;
b) Proposing competent state agencies for recall of the receipt number of cosmetic product declaration forms for acts of violations specified in Clause 3 of this Article.
Section 4
ACTS OF ADMINISTRATIVE VIOLATIONS ON MEDICAL EQUIPMENT
Article 72. 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 any of the following acts of violations:
a) Documents in the application for granting or modifying practice certificates of medical equipment classification fail to ensure the legality as prescribed by law provisions;
b) Medical equipment-classifying establishments fail to publish the issued results of medical equipment classification;
c) The results of medical equipment classification are signed by a person not named in the receipt of declaration of eligibility for classification or other than the legal representative;
d) Failing to notify competent agencies of modification of information about the change of medical equipment classifiers in cases where the substitutes have the same practice scope as the replaced persons.
2. A fine from VND 10,000,000 to VND 15,000,000 shall be imposed for any of the following acts of violations:
a) Medical equipment classification is not based on the rules of risk level classification;
b) Documents in the application for declaration of eligibility for medical equipment classification fail to ensure the legality as prescribed by law provisions;
c) Medical equipment classification is inconsistent with the scope inscribed in practice certificates of medical equipment classification;
d) Failing to send written reports to the customs agencies where the customs clearance has been carried out and the agencies that have issued circulation numbers in cases where medical equipment being issued with a circulation number uses the classification results being recalled under written notification by the Ministry of Health and have been cleared but not yet being sold to users;
dd) Written reports to the customs agencies where the customs clearance has been carried out fail to clearly state the quantity of cleared medical equipment in cases where medical equipment being issued with a circulation number uses the classification results being recalled under written notification by the Ministry of Health and have been cleared but not yet being sold to users;
e) Written reports to the agencies that have issued circulation numbers fail to clearly state the quantity of cleared medical equipment and purchase contracts (if any) in cases where medical equipment being issued with a circulation number uses the classification results being recalled under written notification by the Ministry of Health and have been cleared but not yet being sold to users;
g) Issuing incorrect classification results, causing the reduction of medical equipment’s risk levels;
h) Failing to re-perform the procedures for declaration of eligibility for medical equipment classification when there are changes in the classifiers whose practice scope is not included in the previous dossiers of declaration of eligibility for medical equipment classification.
3. A fine from VND 15,000,000 to VND 20,000,000 shall be imposed for any of the following acts of violations:
a) Medical equipment classification or issuance of medical equipment classification results is carried out during the time of suspension of operation;
b) Holders of circulation numbers fail to stop circulating medical equipment or fail to take measures to recall medical equipment with such circulation numbers in cases where the application for such circulation numbers uses the classification results being recalled under written notification by the Ministry of Health and the medical equipment has been cleared but not yet being sold to users.
4. A fine from VND 20,000,000 to VND 30,000,000 shall be imposed for any of the following acts of violations:
a) Medical equipment classification is carried out when establishments have not announced the eligibility for medical equipment classification or have their receipt of eligibility for medical equipment classification recalled;
b) Medical equipment classification is carried out when establishments fail to satisfy the conditions of medical equipment-classifying establishments after announcing the eligibility for medical equipment classification as prescribed by law provisions.
5. Additional sanctions:
a) Suspension of operation for a period of between 01 month and 03 months, for acts of violations specified at Point b, Clause 1, and Points a, c, g, h, Clause 2 of this Article;
b) Suspension of operation for a period of between 03 months and 06 months, for acts of violations specified at Point b, Clause 3 of this Article;
c) Suspension of operation for a period of between 06 months and 09 months, for acts of violations specified at Point b, Clause 4 of this Article.
6. Remedial measures:
a) Proposing competent state agencies for recall of practice certificates of medical equipment classification, for acts of violations specified at Point a, Clause 1 of this Article;
b) Proposing competent state agencies for recall of dossier receipts of declaration of eligibility for medical equipment classification, for acts of violations specified at Point b, Clause 2 and Point a, Clause 3 of this Article.
Article 73. Violation of regulations on medical equipment manufacture
1. A fine from VND 5,000,000 to VND 10,000,000 shall be imposed for acts of failing to re-perform the procedures for declaration of eligibility for medical equipment manufacture in cases where there are changes related to the previous declaration dossiers in accordance with law.
2. A fine from VND 10,000,000 to VND 20,000,000 shall be imposed for any of the following acts of violations:
a) Documents in the dossier for declaration of eligibility for medical equipment manufacture fail to ensure the legality as prescribed law provisions;
b) Medical equipment manufacture is carried out when establishments fail to satisfy one of the conditions as prescribed after the declaration of eligibility for medical equipment manufacture.
3. A fine from VND 20,000,000 to VND 30,000,000 shall be imposed for any of the following acts of violations:
a) Manufacturing medical equipment containing narcotic substances and pre-substances at an establishment that fails to meet the conditions as prescribed by law provisions;
b) Manufacturing medical equipment containing narcotic substances and pre-substances from materials that are narcotic substances and pre-substances being imported without import permits;
c) Manufacturing medical equipment without the dossier receipt of declaration of eligibility for medical equipment manufacture granted by competent state agencies as prescribed by law provisions.
4. Additional sanctions:
Suspension of operation for a period of between 01 month and 03 months, for acts of violations specified in Clause 1, Point b Clause 2, and Points a and b Clause 3 of this Article.
5. Remedial measures:
a) Proposing competent state agencies for recall of the dossier receipt of declaration of eligibility for medical equipment classification, for acts of violations specified at Point a, Clause 2 and Points a and b, Clause 3 of this Article;
b) Forcible recall, destruction or recycling of medical equipment, for acts of violations specified in Clause 3 of this Article.
Article 74. Violation of regulations on registration of marketing authorization of medical equipment
1. A fine from VND 10,000,000 to VND 20,000,000 shall be imposed for any of the following acts of violations:
a) Circulating medical equipment on the market without labels or sub-labels with sufficient information as prescribed by law provisions;
b) Circulating medical equipment on the market without technical documents serving the repair or maintenance of medical equipment, except for disposable medical equipment as prescribed by the owner of such medical equipment;
c) Circulating medical equipment on the market without instructions for use of the medical equipment in Vietnamese;
d) Circulating 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 having documents proving that there is no warranty;
dd) Failing to notify competent state agencies of changes in accordance with law during the circulation of medical equipment;
e) Failing to send written notification to competent state agencies and establishments buying, selling or using the lot of medical equipment that has experienced an incident seriously threatening the public health or causing death to the users;
g) Circulating medical equipment on the market when manufacturers have not obtained a certificate of satisfaction of quality management standards and have not been permitted for circulation in any country in the world for imported medical equipment;
h) Circulating medical equipment on the market that fails to comply with national technical regulations or standards announced by the manufacturers.
2. A fine from VND 20,000,000 to VND 30,000,000 shall be imposed for any of the following acts of violations:
a) Failing to re-publish the standards applicable to type A medical equipment as prescribed by law provisions;
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) Failing to recall the entire lot of defective medical equipment within a time limit decided by competent state agencies;
dd) Failing to have medical equipment warranty establishments as prescribed by law provisions;
e) Failing to formulate or keep medical equipment monitoring documents as prescribed by law provisions;
g) Failing to make reports to Departments of Health and police agencies in cases of detecting mistakes or loss of medical equipment containing narcotic substances and pre-substances or materials for manufacturing medical equipment containing narcotic substances and pre-substances;
h) 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;
i) 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;
k) 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;
l) Failing to maintain the validity of a marketing authorization, power of attorney, or certificate of eligibility for warranty while the circulation number remains valid as prescribed by law provisions.
3. A fine from VND 30,000,000 to VND 40,000,000 shall be imposed for any of the following acts of violations:
a) Failing to stop circulating medical equipment in cases where the medical equipment has been determined to have a fault affecting the health of users;
b) Modifying, erasing or falsifying a receipt for declaration of standards applicable to type A medical equipment;
c) Modifying, erasing or falsifying a certificate of marketing authorization of medical equipment of types B, C or D;
d) Documents in the application for declaration of standards applicable to type A medical equipment fail to ensure the legality as prescribed by law provisions;
dd) Documents in the application for granting, re-granting or extending a marketing authorization of medical equipment of types B, C, and D fail to ensure the legality as prescribed by law provisions.
4. A fine from VND 40,000,000 to VND 50,000,000 shall be imposed for any of the following acts of violations:
a) Circulating medical equipment of type A on the market without dossier receipts of declaration for applicable standards or without import permits;
b) Circulating medical equipment of types B, C or D on the market without numbers of certificates of registration for marketing authorization or without import permits;
c) Circulating medical equipment on the market that fails to satisfy the quality requirements registered for circulation;
d) Warranty establishments are incapable of providing warranty for medical equipment according to certificates of eligibility of the owners of such medical equipment;
dd) Failing to stop circulating medical equipment related to an incident that seriously threatens the public health or causes death to the users;
e) Medical equipment granted with a circulation 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 circulation 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 circulation number is a representative office of permanent residence in Vietnam of a foreign trader in which that trader is the owner of medical equipment;
g) Medical equipment granted with a circulation 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.
5. Additional sanctions:
a) Confiscation of material evidences related to administrative violations that are receipts, certificates, documents and dossiers, for acts of violations specified at Points b, c, d and dd, Clause 3 of this Article;
b) Suspension of operation for a period of between 01 month and 03 months, for acts of violations specified in Clause 2, Point a Clause 3, and Clause 4 of this Article.
6. Remedial measures:
a) Forcible recall, destruction or recycling of medical equipment, for acts of violations specified at Points g and h, Clause 1 of this Article;
b) Proposing competent state agencies for recall of dossier receipts of declaration for standards applicable to type A medical equipment or certificate of marketing authorization for medical equipment of categories B, C, D, for acts of violations specified at Points b, c, d and dd, Clause 3 of this Article.
Article 75. 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 violations:
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 usersof defective medical equipmentin an insufficient, and untimely manner;
d)Failing to maintain tracking records ofmedical equipment, failing to check for traceability and recall medical equipment as prescribed by law provisions;
dd)Failing to inform, or informingholders of the marketing authorization numberand competent state agencies of cases ofdefective medical equipmentin an untimely manner.
2. A fine from VND 5,000,000 to VND 10,000,000 shall be imposed for any of the following acts of violations:
a)Failing to re-perform the procedure for announcing the sale and purchase conditions when there are changes related to the previously announced dossier in accordance with law provisions;
b)Failing to report, failing to report in accordance with the given sample, or failing to report within the time duration as prescribed by the law – to the Department of Health when detecting mistakes or loss ofmedical equipment which contains narcotics and precursors, or medical equipment which is made of materials containing narcotics and precursors;
c)Failing to report, failing to report in accordance with the given sample, or failing to report within the prescribed time duration- to competent state agencies on the sale and purchase, import, export, or transfer of medical equipment which contains narcotics and precursors, or medical equipment which is made of materials containing narcotics and precursors;
d)Failing to report, failing to report in accordance with the given sample, or failing to report within the time duration as prescribed by the law – on the export, import, inventory, and use of medical equipment containing narcotics and precursors, ormedical equipment which is made of materials containing narcotics and precursors;
3. A fine from VND 10,000,000 to VND 20,000,000 shall be imposed for any of the following acts of violations:
a)Failing to satisfy one of the following conditions for trading establishments ofmedical equipmentof categories B, C, D;
b) Trading medical equipmentof categoriesB, C, D while failing to conduct procedure for the announcement of trading eligibility in accordance with law provisions;
c) Documents in the dossier for the announcement of trading eligibility for medical equipmentof categoriesB, C, D fails to ensure the legality in accordance with law provisions;
d) Documents in the dossier requesting the issuance of thecertificate of free sale for domestically manufactured medical equipment fails toensure the legality in accordance with law provisions.
4. Additional sanctions:
Suspension of operation for a definite time of between 01 month and 03 months for acts of violation prescribed at Point a and Point d , Clause 1, Point a , Clause 2, Points a, c, d , Clause 3 of this Article.
5. Remedial measures:
a) Proposing competent state agencies to revoke the receipt of dossier for the announcement of trading eligibility for medical equipment of categories B, C, D – for acts of violations prescribed at Point c , Clause 3 of this Article;
b) Proposing competent state agencies to revoke thecertificate of free sale for domestically manufactured medical equipment -for acts of violations prescribed at Point d, Clause 3 of this Article.
Article76. Violation of regulations onthe 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 violations:
a) Documents in the dossier requestingmedical equipment import permit fails toensure the legality in accordance with law provisions;
b) Conducting the export or import of medical equipment while failing to satisfy conditions as prescribed by the law;
2. A fine from VND 30,000,000 to VND 40,000,000 shall be imposed for the act of importing medical equipment when having no marketing authorization number or import permit as prescribed by the law.
3. Additional sanctions:
Suspension of operation for a definite time of between 01 month and 03 months for acts of violation prescribed in Clause 1 and Clause 2 of this Article.
4. Remedial measures:
a)Forcible bringing out of the territory of the Socialist Republic of Vietnam or forcible re-export – for acts of violations prescribed in Clause 2 of this Article. In cases of not applying this measure, the forcible destruction shall be implemented;
b) Proposing competent state agencies to revoke the medical equipment import permit for acts of violation prescribed in Clause 1 of this Article.
Article 77. Violation of regulations on consulting services of medical equipment
1. A fine from VND 3,000,000 to VND 5,000,000 shall be imposed for the act of failing to re-perform the procedure for the announcement of eligibility for technical consultation of medical equipment when there are changes related to the previously published dossier.
2. A fine from VND 5,000,000 to VND 10,000,000 shall be imposed for any of the following acts of violations:
a) Documents in the dossier for the announcement of eligibility for technical consultation of medical equipmentfails toensure the legality in accordance with law provisions;
b) Conducting consultation of medical equipment without being granted any receipt of the dossier for the announcement of eligibility.
c) Failing to conduct consultation of medical equipment within the scope of technical consultation of medical equipment prescribed in the dossier for the announcement of eligibility for technical consultation of medical equipment
3. Additional sanctions:
Suspension of operation for a definite time of between 01 month and 03 months for acts of violation prescribed in Clause 1 and Clause 2 of this Article.
4. Remedial measures:
Proposing competent state agencies to revoke the receipt of the dossier for the announcement of eligibility for technical consultation of medical equipment – for acts of violation prescribed at Point a, Clause 2 of this Article.
Article 78. Violation of regulations on information 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 violations:
a) Failing to inform patients of the risk of using medical equipment of categories C, D;
b) Failing to publish information on the risk and the use of medical equipment;
c) Failing to disseminate information on the risk and the use of medical equipment within a medical establishment;
2. A fine from VND 5,000,000 to VND 10,000,000 shall be imposed for the act of importing to Vietnam medical equipment whose label fails to address, or address contents as prescribed by the law in an insufficient manner and which fails to have an additional label showing required contents in Vietnamese and keeps the original label of the product.
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 3,000,000 to VND 5,000,000 shall be imposed for any of the following acts of violations:
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 number 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.
3. A fine from 10,000,000 to VND 20,000,000 shall be imposed for the act of failing to conduct periodical maintenance, testing or calibration in accordance with instructions provided by the owner of such medical equipment or in accordance with law provisions.
4. A fine from 20,000,000 to VND 30,000,000 shall be imposed for the act of using medical equipment without any certificate of registration for marketing authorization, or import permit or using expired and unqualified medical equipment.
Section 5
ACTS OF ADMINISTRATIVE VIOLATIONS ON HEALTH INSURANCE
Article 80. Violation of regulations on the payment of health insurance premiums
1. Imposing warnings or imposing a fine from VND 300,000 to VND 500,000 for the act of not paying health insurance premiums of subjects obliged to participate in the health insurance program.
2. Imposing fines for the act of employer not paying health insurance premiums for all laborers obliged to participate in the health insurance program, paying not enough health insurance premiums for all laborers obliged to participate in the health insurance program, delaying payment of health insurance premiums, avoiding payment of health insurance premiums, the level of fine shall be:
a) From VND 1,000,000 to VND 3,000,000 when the violation involves under 10 laborers;
b) From VND 3,000,000 to VND 5,000,000 when the violation involves from 10 to under 50 laborers;
c) From VND 5,000,000 to VND 10,000,000 when the violation involves from 50 to under 100 laborers;
d) From VND 10,000,000 to VND 20,000,000 when the violation involves from 100 to under 500 laborers;
dd) From VND 20,000,000 to VND 30,000,000 when the violation involves from 500 to under 1.000 laborers;
e) From VND 30,000,000 to VND 40,000,000 when the violation involves more than 1.000 laborers.
3. Imposing fines for the act of paying health insurance premiums in insufficient amount, the level of fine shall be:
a) From VND 1,000,000 to VND 3,000,000 when the unpaid amount is below VND 5,000,000;
b) From VND 2,000,000 to VND 3,000,000 when the unpaid amount is from VND 5,000,000 to below VND 10,000,000;
c) From VND 3,000,000 to VND 5,000,000 when the unpaid amount is from VND 10,000,000 to below VND 20,000,000;
d) From VND 5,000,000 to VND 7,000,000 when the unpaid amount is from VND 20,000,000 to below VND 40,000,000;
dd) From VND 7,000,000 to VND 10,000,000 when the unpaid amount is from VND 40,000,000 to below VND 60,000,000;
e) From VND 10,000,000 to VND 15,000,000 when the unpaid amount is from VND 60,000,000 to below VND 80,000,000;
g) From VND 15,000,000 to VND 20,000,000 when the unpaid amount is from VND 80,000,000 to below VND 120,000,000;
h) From VND 20,000,000 to VND 30,000,000 when the unpaid amount is from VND 120,000,000 to below VND 160,000,000;
i) From VND 30,000,000 to VND 40,000,000 when the unpaid amount is VND 160,000,000 or more.
4) A fine from 10,000,000 to VND 15,000,000 shall be imposed for the act of appropriation of health insurance premiums.
5. Remedial measures:
a)Forcible refund of the amount of money that a health insurance participant lost(if any)for acts of violation prescribed in Clause 2, Clause 3 and Clause 4 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)Forciblerefund of illicit profits earned into the receiptaccountof health insurance fundfor acts of violation prescribed in Clause 2, Clause 3 and Clause 4 of this Article.
Article 81. Violation of regulations on bringing people not under the management responsibility of organizations into the list of health insurance participants
1. Imposing fines for the act of failing to bring people into the list of health insurance participants in accordance with law provisions, the level of fine shall be:
a) 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) From VND2,000,000to 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. Imposing fines for the act of failing to participate in the health insurance program at agencies or organizations in accordance with law provisions, the level of fine shall be:
a) 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) 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 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 ofhealth insurance fund (if any) foracts of violation prescribed at Point b, Clause 1 and Point b, Clause 2 of this Article.
Article 82. Violation of regulations on confirming improper payment level of health insurance participants
Imposing fines for the act of confirming improper payment level of health insurance participants, the fine level shall be:
1. From VND 1,000,000 to VND 2,000,000 for violations valued at under VND 10,000,000.
2. From VND 2,000,000 to VND 3,000,000 for violations valued from VND 10,000,000 to below VND 20,000,000.
3. From VND 3,000,000 to VND 5,000,000 for violations valued from VND 20,000,000 to below VND 40,000,000.
4. From VND 5,000,000 to VND 10,000,000 for violations valued from VND 40,000,000 to below VND 60,000,000.
5. From VND 10,000,000 to VND 15,000,000 for violations valued from VND 60,000,000 to below VND 80,000,000.
6. From VND 15,000,000 to VND 20,000,000 for violations valued from VND 80,000,000 to below VND 100,000,000.
7. From VND 20,000,000 to VND 30,000,000 for violations valued from VND 100,000,000 to below VND 120,000,000.
8. From VND 30,000,000 to VND 40,000,000 for violations valued from VND 120,000,000 to below VND 150,000,000.
9. From VND 40,000,000 to VND 50,000,000 for violations valued at 150,000,000 or more.
Article 83. Violation of regulations on establishing and transferring the issuing list of health insurance cards
1. A fine from VND 500,000 to VND 1,000,000 shall be imposed for any of the following acts of violations:
a) Failing to establish and transfer an issuing list of health insurance cards for health insurance participants under their management within the prescribed time duration but not causing any damage to the interest of such health insurance participants;
b) Failing to establish and transfer an issuing list of health insurance cards for health insurance participants under their management which include enough number of participants as prescribed by the law, but not causing any damage to the interest of such health insurance participants.
2. Imposing fines for the act of failing to establish and transfer an issuing list of health insurance cards for health insurance participants under their management within the prescribed time duration, causing damage to the interest of such health insurance participants, the fine level shall be:
a) From VND 1,000,000 to VND 2,000,000 for cases of being late for less than 10 working days as prescribed by the law;
b) From VND 2,000,000 to VND 3,000,000 for cases of being late for 10 working days or more as prescribed by the law.
3. Imposing fines for the act of failing to establish and transfer an issuing list of health insurance cards for health insurance participants under their management which include enough number of participants as prescribed by the law, causing damage to the interest of such health insurance participants, the fine level shall be:
a) From VND 1,000,000 to VND 3,000,000 for cases where the list lacks under 50 people;
b) From VND3,000,000to VND 5,000,000 for cases where the list lacks from 50 people to under 100 people;
c) From VND 5,000,000 to VND 7,000,000 for cases where the list lacks from 100 people to under 500 people;
d) From VND 7,000,000 to VND 10,000,000 for cases where the list lacks from 500 people to under 1,000 people;
dd) From VND 10,000,000 to VND 20,000,000 for cases where the list lacks 1,000 people or more;
4. Remedial measures:
Forcible refund of the amount of money that a health insurance participant lost(if any)for acts of violation prescribed in Clause 2, 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;
Article 84. Violation of regulations on using health insurance cards in medical examination and treatment
1. Imposing fine for the act of lending health insurance card to another or using another’s health insurance card in medical examination and treatment, the fine level shall be:
a) From VND 1,000,000 to VND 2,000,000 for cases of violations not causing any damage to the health insurance fund;
b) From VND 3,000,000 to VND 5,000,000 for cases of violations causing damage to the health insurance fund.
2. Remedial measures:
Forcible refund of the violatedamount of moneyinto the receipt accountof health insurance fund (if any) for acts of violation prescribed at Point b, Clause 1 of this Article.
Article 85. Violation of regulations on establishing health records and prescribing drugs covered by health insurance
1. A fine from VND 200,000 to VND 500,000 shall be imposed for the act of establishing health records or prescribing drugs that are in fact not available or not right for patients – for violations valued below VND 1,000,000.
2. Imposing fines for the act of establishing health records or prescribing drugs which are in fact not available or not right for patients, the fine level shall be:
a) From VND500,000to VND 1,000,000 for violations valued from VND 1,000,000 to below VND 2,000,000;
b) From VND 1,000,000 to VND 2,000,000 for violations valued from VND 2,000,000 to below VND 5,000,000;
c) From VND 3,000,000 to VND 5,000,000 for violations valued from VND 5,000,000 to below VND 10,000,000;
d) From VND 5,000,000 to VND 10,000,000 for violations valued from VND 10,000,000 to below VND 15,000,000;
dd) From VND 10,000,000 to VND 15,000,000 for violations valued from VND 15,000,000 to below VND 25,000,000;
e) From VND 15,000,000 to VND 20,000,000 for violations valued from VND 25,000,000 to below VND 50,000,000;
g) From VND 20,000,000 to VND 25,000,000 for violations valued from VND 50,000,000 to below VND 80,000,000;
h) From VND 25,000,000 to VND 30,000,000 for violations valued at VND 80,000,000 or more.
3. Remedial measures:
Forciblerefund of the violated amount of money into the receiptaccountof health insurance fund(if any)for acts of violation prescribed in Clause 1 and Clause 2 of this Article.
Article 86. Violation of regulations on the management of medicine, chemicals, medical supplies, technical services, hospital stay expenses and other expenses in medical examination and treatment covered by 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 which causes damage valued under VND 1,000,000 to the health insurance fund:
a) Prescribing anincrease in thequantityof, or adding medicine, chemicals, medical supplies, technical services, hospital stay expenses and other expenses which are in fact unnecessary for patients;
b) Providing medicine, chemicals, medical supplies, technical inadequately in medical examination and treatment covered by health insurance.
2. Imposing fines for the act of prescribing anincrease in thequantityof, or adding medicine, chemicals, medical supplies, technical services, hospital stay expenses and other expenses which are in fact unnecessary for patients, the fine level shall be:
a) From VND1,000,000to VND 3,000,000 for violations valued from VND1,000,000to below VND 3,000,000;
b) From VND3,000,000to VND 5,000,000 for violations valued from VND3,000,000to below VND 5,000,000;
c) From VND5,000,000to VND 10,000,000 for violations valued from VND3,000,000to below VND 10,000,000;
d) From VND10,000,000to VND 20,000,000 for violations valued from VND10,000,000to below VND 20,000,000;
dd) From VND20,000,000to VND 30,000,000 for violations valued from VND20,000,000to below VND 30,000,000;
e) From VND30,000,000to VND 40,000,000 for violations valued from VND30,000,000to below VND 40,000,000;
g) From VND40,000,000to VND 50,000,000 for violations valued from VND40,000,000to below VND 50,000,000;
h) From VND50,000,000to VND 60,000,000 for violations valued from VND50,000,000to below VND 60,000,000;
i) From VND60,000,000to VND 70,000,000 for violations valued at VND60,000,000 or more.
3. Imposing fines for the act of prescribing drugs, providing medicine, chemicals, medical supplies, technical inadequately in medical examination and treatment covered by health insurance, the fine level shall be:
a) From VND1,000,000to VND 3,000,000 for violations valued from VND1,000,000to below VND 10,000,000;
b) From VND3,000,000to VND 5,000,000 for violations valued from VND10,000,000to below VND 20,000,000;
c) From VND5,000,000to VND 10,000,000 for violations valued from VND20,000,000to below VND 40,000,000;
d) From VND10,000,000to VND 20,000,000 for violations valued from VND40,000,000to below VND 80,000,000;
dd) From VND20,000,000to VND 30,000,000 for violations valued from VND80,000,000to below VND 120,000,000;
e) From VND30,000,000to VND 40,000,000 for violations valued from VND120,000,000to below VND 160,000,000;
g) From VND40,000,000to VND 50,000,000 for violations valued at VND160,000,000or more;
4. Remedial measures:
a)Forciblerefund of the violated amount of money into the receiptaccountof health insurance fund(if any)for acts of violation prescribed in 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 acts of violation prescribed in Clause 1, 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.
Article 87. Violation of regulations on the scope of benefits entitled to health insurance participants
1. Imposing warnings or a fine from VND 300,000 to VND 500,000 for the act of violation on the scope of benefits entitled to health insurance participants - for violations valued below VND 1,000,000.
2. Imposing fines for the act of violation on the scope of benefits entitled to health insurance participants, the fine level shall be:
a) From VND1,000,000to VND 2,000,000 for violations valued from VND1,000,000to below VND 5,000,000;
b) From VND2,000,000to VND 3,000,000 for violations valued from VND5,000,000to below VND 10,000,000;
c) From VND3,000,000to VND 5,000,000 for violations valued from VND10,000,000to below VND 15,000,000;
d) From VND5,000,000to VND 7,000,000 for violations valued from VND15,000,000to below VND 20,000,000;
dd) From VND7,000,000to VND 10,000,000 for violations valued from VND20,000,000to below VND 40,000,000;
e) From VND10,000,000to VND 15,000,000 for violations valued at VND40,000,000or more;
3. Remedial measures:
a)Forcible refund of the amount of money that a health insurance participant lost(if any)for acts of violation prescribed in Clause 1, 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) Forciblerefund of the violated amount of money into the receiptaccountof health insurance fund (if any)for acts of violation prescribed in Clause 1 and Clause 2 of this Article.
Article 88. Violation of regulations on paymentof expenses inmedical examination and treatment coveredbyhealth insurance
1. Imposingwarnings ora fine from VND 300,000 to VND 500,000 for the act of applying false prices, recording incorrect types, units, or names of technical services in the payment of expenses of medical examination and treatment covered by health insurance - for violations valued below 1,000,000.
2. Imposing fines for the act of applying false prices, recording incorrect types, units, or names of technical services in the payment of expenses of medical examination and treatment covered by health insurance, the fine level shall be:
a) From VND1,000,000to VND 2,000,000 for violations valued from VND1,000,000to below VND 5,000,000;
b) From VND2,000,000to VND 3,000,000 for violations valued from VND5,000,000to below VND 10,000,000;
c) From VND3,000,000to VND 5,000,000 for violations valued from VND10,000,000to below VND 20,000,000;
d) From VND5,000,000to VND 10,000,000 for violations valued from VND20,000,000to below VND 40,000,000;
dd) From VND10,000,000to VND 20,000,000 for violations valued from VND40,000,000to below VND 80,000,000;
e) From VND20,000,000to VND 40,000,000 for violations valued from VND80,000,000to below VND 120,000,000;
g) From VND40,000,000to VND 50,000,000 for violations valued at VND120,000,000 or more.
3. Remedial measures:
a)Forciblerefund of the violated amount of money into the receiptaccountof health insurance fund (if any)for acts of violation prescribed in 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 acts of violation prescribed in Clause 1, 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.
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 which cause no harm to the interest of health insurance participants, of medical examination and treatment establishments and health insurance fund:
a) Unilaterally terminating a contract of medical examination and treatment covered by health insurance against law provisions;
b) Signing a contract of medical examination and treatment covered by health insurance that contains contents against 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;
2. Imposing fines for the act ofunilaterally terminating a contract of medical examination and treatment covered by health insurance which causes damage to the interests ofhealth insurance participants, of medical examination and treatment establishments or of the health insurance fund, the fine level shall be:
a) From VND3,000,000to VND 5,000,000 for violations valued below VND 50,000,000;
b) From VND5,000,000to VND 10,000,000 for violations valued from VND 50,000,000 to below VND 100,000,000;
c) From VND10,000,000to VND 15,000,000 for violations valued from VND 100,000,000 to below VND 500,000,000;
d) From VND 15,000,000to VND 20,000,000 for violations valued from VND 500,000,000 to below VND 1,000,000,000;
dd) From VND20,000,000to VND 30,000,000 for violations valued from VND 1,000,000,000 to below VND 5,000,000,000;
e) From VND30,000,000to VND 40,000,000 for violations valued at VND 5,000,000,000 or more;
3. Imposing fines for the act ofsigning a contract of medical examination and treatment covered by health insurance that contain contents against 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 ofhealth insurance participants, of medical examination and treatment establishments or of the health insurance fund, the fine level shall be:
a) From VND1,000,000to VND 5,000,000 for violations valued below VND 50,000,000;
b) From VND5,000,000to VND 10,000,000 for violations valued from VND 50,000,000 to below VND 100,000,000;
c) From VND10,000,000to VND 15,000,000 for violations valued from VND 100,000,000 to below VND 500,000,000;
d) From VND 15,000,000to VND 20,000,000 for violations valued from VND 500,000,000 to below VND 1,000,000,000;
dd) From VND20,000,000to VND 30,000,000 for violations valued from VND 1,000,000,000 to below VND 5,000,000,000;
e) From VND30,000,000to VND 40,000,000 for violations valued at VND 5,000,000,000 or more;
4. Remedial measures:
a)Forciblerefund of the violated amount of money into the receiptaccountof health insurance fund (if any)for acts of violation prescribed in Clause 2 and Clause 3 of this Article.
b) Forcible refund of the amount of money that a health insurance participant lost(if any)for acts of violation prescribed in Clause 2andClause 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 the amount of money that amedical examination and treatment establishment lost (if any) for actsof violation prescribed in 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.
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. Imposingwarnings ora 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 violations valued below VND 1,000,000.
2. Imposing fines 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, the fine level shall be:
a) From VND1,000,000to VND 2,000,000 for violations valued from VND 1,000,000 to below VND 5,000,000;
b) From VND2,000,000to VND 3,000,000 for violations valued from VND 5,000,000 to below VND 10,000,000;
c) From VND3,000,000to VND 4,000,000 for violations valued from VND 10,000,000 to below VND 15,000,000;
d) From VND4,000,000to VND 5,000,000 for violations valued from VND 15,000,000 to below VND 20,000,000;
dd) From VND5,000,000to VND 6,000,000 for violations valued from VND 20,000,000 to below VND 40,000,000;
e) From VND6,000,000to VND 7,000,000 for violations 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 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 the amount of money that amedical examination and treatment establishment lost (if any) for actsof 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.
c) Forciblerefund of the violated amount of money into the receiptaccountof health insurance fund (if any)for acts of violation prescribed in Clause 1 and Clause 2 of this Article.
Article 91. Violation of regulations on reporting the implementation of the health insurance program with competent state agencies
1. Imposing warnings or a fine from VND 200,000 to VND 500,000 for the act of failing to report the implementation of health insurance program within the prescribed time duration, failing to provide statistics, providing incorrect statistics with competent state agencies, butcausing no 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 program within the prescribed time duration, failing to provide statistics, providing incorrect statistics with competent state agencies – which causesnegative impacts on the management, implementation and development of health insurance policies.
Article 92. Violation of regulations on providing information on health insurance participants
1. Imposing warnings or a fine from VND 200,000 to VND 500,000 for the act of failing to provide, provide untruthful information, or failing to provide information on health insurance participants timely butcausingno loss to the fund for medical examination and treatment covered by health insurance.
2. Imposing fines for the act of failing to provide, provide 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, the fine level shall be:
a) From VND1,000,000to VND 3,000,000 for violations valued below VND 50,000,000;
b) From VND3,000,000to VND 5,000,000 for violations valued from VND 50,000,000 to below VND 100,000,000;
c) From VND5,000,000to VND 10,000,000 for violations valued from VND 100,000,000 to below VND 200,000,000;
d) From VND10,000,000to VND 20,000,000 for violations valued at VND 200,000,000 or more.
Article 93. Violation of regulations on providing, providing information inadequately, providinguntruthful information in the settlement of patient’s interests at medical examination and treatment establishments or in direct payment for health insurance participants
1. Imposing warnings or a fine from 200,000 to VND 500,000 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 but causing 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 acts of violation prescribed in 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.
Article 94. Violation of regulations on sending settlement reports of medical examination and treatment expenses covered by health insurance later than the prescribed time
1. A fine from VND 500,000 to VND 1,000,000 shall be prescribed for the act of sending settlement reports of medical examination and treatment expenses covered by health insurance later than the prescribed timebelow05 working days.
2. Imposing fines for the act of sending settlement reports of medical examination and treatment expenses covered by health insurance later than the prescribed time, the fine level shall be:
a) From VND3,000,000to VND 5,000,000 for cases where reports are sent late from 05 to less than 20 working days.
b) From VND5,000,000to VND 7,000,000 for cases where reports are sent late 20 working 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 violations:
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 establishments where medical examination and treatment is covered by health insurance;
b) Abusing the prescription and use of medicines, chemicals, medical supplies, 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 violations valued below VND 1,000,000.
2. Imposing fines for the acts ofcausing difficulties or hindering the medical examination and treatment covered by health insurance which causes damage to the interest of health insurance participants, of establishments where medical examination and treatment is covered by health insurance, the fine level shall be:
a) From VND1,000,000to VND 2,000,000 for violations valued from VND 1,000,000 to below VND 5,000,000;
b) From VND2,000,000to VND 3,000,000 for violations valued from VND 5,000,000 to below VND 10,000,000;
c) From VND3,000,000to VND 5,000,000 for violations valued from VND 10,000,000 to below VND 15,000,000;
d) From VND5,000,000to VND 10,000,000 for violations valued from VND 15,000,000 to below VND 20,000,000;
dd) From VND10,000,000to VND 15,000,000 for violations valued from VND 20,000,000 to below VND 40,000,000;
e) From VND15,000,000to VND 20,000,000 for violations valued at VND 40,000,000 or more;
3. Imposing fines 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 theinterest of health insurance participants, medical examination and treatment establishments and of the health insurance fund, the fine level shall be:
a) From VND1,000,000to VND 2,000,000 for violations valued from VND 1,000,000 to below VND 5,000,000;
b) From VND2,000,000to VND 3,000,000 for violations valued from VND 5,000,000 to below VND 10,000,000;
c) From VND3,000,000to VND 5,000,000 for violations valued from VND 10,000,000 to below VND 20,000,000;
d) From VND5,000,000to VND 10,000,000 for violations valued from VND 20,000,000 to below VND 40,000,000;
dd) From VND10,000,000to VND 20,000,000 for violations valued from VND 40,000,000 to below VND 60,000,000;
e) From VND20,000,000to VND 30,000,000 for violations valued from VND 60,000,000 to below VND 80,000,000;
g) From VND30,000,000to VND 40,000,000 for violations 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 violations:
a) Failing to register with social insurance agencies the seal sample, the signature specimen of practitioners who are authorized to sign the certificate 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. Remedial measures:
a)Forcible refund of the amount of money that amedical examination and treatment establishment lost (if any) for actsof 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 to the insured, 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 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 to the insured, it shall be remitted into the State budget in accordance with law provisions.
c) Forciblerefund of the violated amount of money into the receiptaccountof health insurance fund (if any)for acts of violation 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. Imposing warnings or a fine from VND 200,000 to VND 500,000 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 violations:
a) Spreading and disseminating information against the direction and policies of the Party and against 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 acts of violation prescribed in Clause 2 of this Article.
4. Remedial measures:
a) Forcible destruction of material evidences used to commit acts of violation prescribed in Clause 2 of this Article;
b)Forcible correction ofinformation which is against the direction and policies of the Party and against the State’s law provisions on population – for 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 sex selection
1. A fine from VND 3,000,000 to VND 5,000,000 shall be imposed for any of the following acts of violations:
a) Dissemination and spread of methods of sex selection;
b) Consultation on methods of sex selection.
2. A fine from VND 5,000,000 to VND 10,000,000 shall be imposed for any of the following acts of violations:
a) Selling, renting, distributing, and posting on the Internet publications and articles with contents on methods of sex selection;
b) Posting and distributing information about methods of sex selection.
3. A fine from VND 10,000,000 to VND 15,000,000 shall be imposed for the act of translating, publishing, producing, printing, distributing, duplicating, copying publications or articles with contents on methods of sex selection.
4. Additional sanctions:
Confiscation of material evidences used in administrative violations which are publications, articles, documents, information and propaganda for the acts prescribed in Clause 1, Clause 2 and Clause 3 of this Article.
5. Remedial measures:
Forcible removal of infringing elements for 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 prenatal diagnosis and gender determination
1. A fine from VND 3,000,000 to VND 5,000,000 shall be imposed for the act of using divination for prenatal gender determination.
2. A fine from VND 5,000,000 to VND 10,000,000 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 the prenatal gender, unless otherwise prescribed by the law.
3. Additional sanctions:
Deprivation of the right to use the license for medical examination and treatment, and the medical practice certificatefor 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 sex selection
1. A fine from VND 5,000,000 to VND 10,000,000 shall be imposed for the act of threatening to use force or using mental intimidation to force others to apply methods of sex selection.
2. A fine from VND 10,000,000 to VND 15,000,000 shall be imposed for the act of using violence to force others to apply methods of sex selection.
3. A fine from VND 15,000,000 to VND 20,000,000 shall be imposed for any of the following acts of violations:
a)Providingindicationsor instructions to use medicine forsex selection;
b) Providing tools, medicines and medicalsuppliesforsex selection
c)Studying methodsof sex selection, unless otherwise prescribed by the law.
4. Additional sanctions:
a) Suspension ofoperation for a definite time of between 01 month and 03 months for acts of violation prescribed in Clause 3 of this Article;
b) Deprivation of the right to use the medical examination and treatment practice certificatefor a definite time of between 01 month and 03 months for acts of violation prescribed in Clause 3 of this Article;
5. Remedial measures:
Forcible destruction of tools, medicines, and medical supplies used to commit 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 3,000,000 to VND 5,000,000 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 5,000,000 to VND 7,000,000 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 7,000,000 to VND 10,000,000 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 10,000,000 to VND 12,000,000 shall be imposed for the act of resorting to force to force a pregnant woman to remove the fetus for the reason of sex selection.
5. A fine from VND 12,000,000 to VND 15,000,000 shall be imposed for any of the following acts of violations:
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) Providingindicationsor 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 15,000,000 to VND 20,000,000 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, and the medical practice certificatefor a definite time of between 03 months and 06 months for 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 certificatefor a definite time of between 06 months and 12 months for acts of violation prescribed in Clause 6 of this Article.
c) Deprivation of the right to use thecertificate of eligibility for pharmaceutical business or suspension of operation for non-commercial pharmaceutical establishmentsfor a definite time of between 01month and03months for acts of violation prescribedat Point a,Clause5of this Article.
Article 101. Violation of regulations on forced implementation of birth control
1. Imposing warnings or a fine from VND 200,000 to VND 500,000 for any of the following acts of violations:
a) Failing to provide free contraceptive means to people who are entitled to in accordance with law provisions and register 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 sons 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 violations:
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 sons, 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 or using mental intimidation 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 violations:
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 20,000000 to VND 30,000,000for 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, and the medical practice certificatefor a definite time of between 01 month and 03 months for acts of violation prescribed in Clause 6 of this Article.
8. Remedial measures:
Forcible removal of uterine devices or contraceptive implants - for violations 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 competent agencies to be provided free-of-charge.
2. A fine from 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 agency
3. Additional sanctions:
Confiscation of material evidences used in in administrative violations which are contraceptive means for acts of violation prescribed in Clause 1 of this Article.
4. Remedial measures:
Forcible refund of money collected against law provisions, for acts prescribed in Clauses 1 and Clause 2 of this Article. In cases where it is impossible to refund, it shall be remitted into the State budget in accordance with law provisions.
Chapter III
COMPETENCE TO IMPOSE FINES FOR ADMINISTRATIVE VIOLATIONS IN HEALTHCARE
Article 103. Competence to impose fines of Chairpersons of People’s Committees
1. Chairpersons of Commune-level People’s Committees shall have the following powers:
a) Imposing warnings;
b) Imposingfinesof 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,HIV/AIDS prevention and control, healthinsurance, medical examination and treatment, pharmacy, cosmetics and medical equipment;
c) Confiscating material evidences and means whose value does not exceed the fine level prescribed for each field as prescribed at Point b of this Clause;
d) Implementing remedial measures prescribed at Point c and Point dd, Clause 1, Article 28 of the Law on Handlings of Administrative Violations.
2. Chairpersons of District-level People’s Committees shall have the following powers:
a) Imposing warnings;
b) Imposingfinesof 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,HIV/AIDS prevention and control;up to VND 37,500,000 for acts of administrative violation on health insurance; up to VND 50,000,000 for acts of administrative violation onmedical examination and treatment, pharmacy, cosmetics and medical equipment;
c) Depriving of the right to use the license for medical examination and treatment, and the medical practice certificate for a definite time, or suspension of operation for a definite time;
d) Confiscating material evidences and means whose value does not exceed the fine level prescribed for each field as prescribed at Point b, this Clause;
dd) Applying remedial measures prescribed at Point c, dd, e, h and i, Clause 1, Article 28 of the Law on Handlings of Administrative Violations and Clause 3, Article 3 of this Decree.
3. Chairpersons of Provincial-level People’s Committees shall have the following powers:
a) Imposing warnings;
b) Imposingfinesof 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,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 onmedical examination and treatment, pharmacy, cosmetics and medical equipment;
c) Depriving of the right to use the license for medical examination and treatment, and the medical practice certificate for a definite time, or suspension of operation for a definite time;
d) Confiscating material evidences and means;
dd) Applying remedial measures prescribed at Point c, d, dd, e, g, h and i Clause 1, Article 8 of the Law on Handlings of Administrative Violations and Clause 3, Article 3 of this Decree.
Article 104. Competencetoimposefines ofInspectors
1.Inspectors and persons assigned to conduct specialized inspection taskswhile being on duty shall have the following powers:
a) Imposing warnings;
b) Imposingfinesof up to VND 300,000 for acts of administrative violation on population; up to VND 500,000 for acts of administrative violation on preventive healthcare,HIV/AIDS prevention and control, healthinsurance, medical examination and treatment, pharmacy, cosmetics and medical equipment;
c) Confiscating material evidences and means whose value does not exceed the fine level prescribed for each field as prescribed at Point b of this Clause;
d) Applying remedial measures prescribed at Point c and Point dd, Clause 1, Article 28 of the Law on Handlings of Administrative Violations.
2.Chief Inspectors of Department-level Inspection agencies, Directors of the Sub-departments of Family planning under the Departments of Health,Directors of the Sub-department of Food Safety and Hygiene under the Departments of Health, Heads of Department-level specialized inspection teams, Heads of specialized inspection teams of competent state agencies assigned to perform the specialized inspectionshall have the following powers:
a) Imposing warnings;
b) Imposingfinesof 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,HIV/AIDS prevention and control;up to VND 37,500,000 for acts of administrative violation on health insurance; up to VND 50,000,000 for acts of administrative violation onmedical examination and treatment, pharmacy, cosmetics and medical equipment;
c) Depriving of the right to use the license for medical examination and treatment, and the medical practice certificate for a definite time, or suspension of operation for a definite time;
d) Confiscating material evidences and means whose value does not exceed the fine level for each field as prescribed at Point b of this Clause;
dd) Applying remedial measures as prescribed at Points c, d, dd, e, g,h andi, Clause 1, Article 28 of the Law on Handlings of Administrative Violations and Clause 3, Article 3 of this Decree.
3.Chief Inspectors of Ministerial-level Inspection agencies, the Director of the General Departments of Family planning, theDirector of the General Department of Pharmacy management, the Director of the Department of Medical examination and treatment, the Director of the Department of Environmental management of health, the Director of the Department of Preventive healthcare and equivalent positions assigned by the Government to perform the specialized inspectionshall have the following powers:
a) Imposing warnings;
b) Imposingfinesof 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,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 onmedical examination and treatment, pharmacy, cosmetics and medical equipment;
c) Depriving of the right to use the license for medical examination and treatment, and the medical practice certificate for a definite time, or suspension of operation for a definite time;
d) Confiscating material evidences and means;
dd) Applying remedial measures as prescribed at Points c, d, dd, e, g,hand i, Clause 1, Article 28 of the Law on Handlings of Administrative Violations and Clause 3, Article 3 of this Decree.
4.Heads of ministerial-level specialized inspection teams shall have the following powers:
a) Imposing warnings;
b) Imposingfinesof up to VND 21,000,000 for acts of administrative violation on population; up to VND 35,000,000 for acts of administrative violation on preventive healthcare, andHIV/AIDS prevention and control;up to VND 52,500,000 for acts of administrative violation on health insurance; up to VND 70,000,000 for acts of administrative violation onmedical examination and treatment, pharmacy, cosmetics and medical equipment;
c) Depriving of the right to use the license for medical examination and treatment, and the medical practice certificate for a definite time, or suspension of operation for a definite time;
d) Confiscating material evidences and means whose value does not exceed the fine level prescribed at Point b of this Clause;
dd) Applying remedial measures prescribed at Points c, d, dd, e, g,hand i, Clause 1, Article 28 of the Law on Handlings of Administrative Violations and Clause 3, Article 3 of this Decree.
Article 105. Competencetoimposefines ofthe MarketSurveillanceagencies
1.Marketsurveillanceofficers who areon dutyshall have the followingpowers:
a) Imposing warnings;
b) Imposingfinesof up to VND 500,000 for acts of administrative violation on population, preventive healthcare, medical examination and treatment, pharmacy, cosmetics and medical equipment;
2.Team leadersof MarketSurveillanceteamsshall have the followingpowers:
a) Imposing warnings;
b) Imposingfinesof up to VND 25,000,000 for acts of administrative violation on population, preventive healthcare, medical examination and treatment, pharmacy, cosmetics and medical equipment;
c) Confiscating material evidences and means whose value does not exceed the fine level prescribed at Point b, this Clause;
d) Applying remedial measures prescribed at Points dd, e, g,hand i, Clause 1, Article 28 of the Law on Handlings of Administrative Violations and Clause 3, Article 3 of this Decree.
3.Directors of the provincial-level Market Surveillance Sub-departments and the Director of the Market Surveillance Operations Department under the General Department of Market Surveillance shall have the following powers:
a) Imposing warnings;
b) Imposingfinesof 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, medical examination and treatment, pharmacy, cosmetics and medical equipment;
c) Confiscating material evidences and means whose value does not exceed the fine level prescribed at Point b of this Clause;
d) Depriving of the right to use the license for medical examination and treatment, and the medical practice certificate for a definite time, or suspension of operation for a definite time;
dd) Applying remedial measures prescribed at Points c, d, dd, e, g,hand i, Clause 1, Article 28 of the Law on Handlings of Administrative Violations and Clause 3, Article 3 of this Decree.
4.TheGeneral Directorofthe GeneralDepartmentofMarket Surveillance shall havethe followingpowers:
a) Imposing warnings;
b) Imposingfinesof 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) Confiscating material evidences and means;
d) Depriving of the right to use the license for medical examination and treatment, and the medical practice certificate for a definite time, or suspension of operation for a definite time;
dd) Applying remedial measures prescribed at Points c, d, dd, e, g,hand i, Clause 1, Article 28 of the Law on Handlings of Administrative Violations and Clause 3, Article 3 of this Decree.
Article 106. Competence to impose fines ofthe People’sPublic Security forces
1.People’s Public Security officers who are on duty shall have the following powers:
a) Imposing warnings;
b) Imposingfinesof up to VND 300,000 for acts of administrative violation on population; up to VND 500,000 for acts of administrative violation on preventive healthcare,HIV/AIDS prevention and control,medical examination and treatment, pharmacy, cosmetics and medical equipment;
2.Heads of stationsor team leaders of the persons defined in Clause 1 of this Article shall have the following powers:
a) Imposing warnings;
b) Imposingfinesof up to VND 900,000 for acts of administrative violation on population; up to VND 1,500,000 for acts of administrative violation on preventive healthcare,HIV/AIDS prevention and control,health insurance, medical examination and treatment, pharmacy, cosmetics and medical equipment;
3.Heads of Commune-level Police Stations, Heads of Police Stations, Heads of Police stations at border gates and export processing zones shall have the following powers:
a) Imposing warnings;
b) Imposingfinesof 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,HIV/AIDS prevention and control,health insurance, medical examination and treatment, pharmacy, cosmetics and medical equipment;
c) Confiscating material evidences and means used to commit administrative violations whose value does not exceed the fine level prescribed at Point b of this Clause;
d) Applying remedial measures prescribed at Point c and Point dd, Clause 1, Article 28 of the Law on Handlings of Administrative Violations.
4.Headsof District-level Police Sub-departments; Heads of the professional divisions under the Police force of Social Order Administrative Management, Heads of the professional divisions under the Department of Traffic Police; Heads of Divisions under Provincial Police Departments including Heads of Divisions of Economic Security, Heads of Police Divisions of Social Order Administrative Management, Heads of the Police Divisions of Environmental Crimes, Heads of Divisions of Road and Railway Traffic Police, Heads of Divisions of Waterway Police, Heads of Police Divisions of Corruption, Smuggling, and Economic Crime Investigationshall have the following powers:
a) Imposing warnings;
b) Imposingfinesof 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 andHIV/AIDS prevention and control; up to VND 15,000,000for acts of administrative violation on health insurance; up to VND 20,000,000 for acts of administrative violation on medical examination and treatment, pharmacy, cosmetics and medical equipment;
c) Depriving of the right to use the license for medical examination and treatment, and the medical practice certificate for a definite time, or suspension of operation for a definite time;
d) Confiscating material evidences and means whose value does not exceed the fine level prescribed at Point b of this Clause;
dd) Applying remedial measures prescribed at Point c and Point dd, Clause 1, Article 28 of the Law on Handlings of Administrative Violations and Clause 3, Article 3 of this Decree.
5.Directors of Provincial Police Departments shall have the following powers:
a) Imposing warnings;
b) Imposingfinesof 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 andHIV/AIDS prevention and control; up to VND 35,000,000for acts of administrative violation on health insurance; up to VND 50,000,000 for acts of administrative violation on medical examination and treatment, pharmacy, cosmetics and medical equipment;
c) Depriving of the right to use the license for medical examination and treatment, and the medical practice certificate for a definite time, or suspension of operation for a definite time;
d) Confiscating material evidences and means whose value does not exceed the fine level prescribed at Point b of this Clause;
dd) Applying remedial measures prescribed at Points c, Point dd and Point i , Clause 1, Article 28 of the Law on Handlings of Administrative Violations and Clause 3, Article 3 of this Decree.
e) Applying expulsion in accordance with the current law on provisions on expulsion by administrative procedures.
6.The Director of the Police Department of Social Order Administrative Management; the Director of the Department of Economic Security; the Director of the Police Department of Environmental Crimes, the Director of the Traffic Police Department; the Director of the Police Department of Corruption, Smuggling and Economic Crime Investigation shall have the following powers:
a) Imposing warnings;
b) Imposingfinesof 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 andHIV/AIDS prevention and control; up to VND 75,000,000for 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) Depriving of the right to use the license for medical examination and treatment, and the medical practice certificate for a definite time, or suspension of operation for a definite time;
d) Confiscating material evidences and means;
dd) Applying remedial measures prescribed at Point c, Point dd and Point i, Clause 1, Article 28 of the Law on Handlings of Administrative Violations and Clause 3, Article 3 of this Decree.
Article 107. Competence to impose finesfor administrative violationsoftheCustoms agencies
1.Customs officers who are on duty shall have the following powers:
a) Imposing warnings;
b) Imposingfinesof up to VND 500,000 for acts of administrative violation on preventive healthcare,HIV/AIDS prevention and control,pharmacy, cosmetics and medical equipment;
2.Team leaders under Customs Sub-departments, team leaders under Post-Customs Clearance Inspection Sub-departments shall have the following powers:
a) Imposing warnings;
b) Imposingfinesof up to VND 5,000,000 for acts of administrative violation on preventive healthcare,HIV/AIDS prevention and control,pharmacy, cosmetics and medical equipment;
3.Directors of Customs Sub-departments, Directors of Post-Customs Clearance Inspection Sub-departments, Team leaders of Control Teams under provincial, inter-provincial and municipal Customs Departments, Team leaders of Anti-Smuggling Control Teams, HeadsofCustoms Marine Enforcement Fleets and Team leaders of the Intellectual Property Protection and Control Teams under the Department for Anti-Smuggling and Investigation of the General Department of Customs shall have the following powers:
a) Imposing warnings;
b) Imposingfinesof up to VND 25,000,000 for acts of administrative violation on preventive healthcare,HIV/AIDS prevention and control,pharmacy, cosmetics and medical equipment;
c) Confiscating material evidences and means whose value does not exceed the fine level prescribed at Point b of this Clause;
d) Applying remedial measures prescribed at Points d, dd and i, Clause 1, Article 28 of the Law on Handlings of Administrative Violations and Clause 3, Article 3 of this Decree.
4.The Director of the Department for Anti-Smuggling Investigation, the Director of the Department for Post-Customs Clearance Inspection under the General Department of Customs, and Directors of provincial, inter-provincial and municipal Customs Departments shall have the following powers:
a) Imposing warnings;
b) Imposingfinesof up to VND 50,000,000 for acts of administrative violation on preventive healthcare, pharmacy, cosmetics and medical equipment;
c) Depriving of the right to use the license for medical examination and treatment, and the medical practice certificate for a definite time, or suspension of operation for a definite time;
d)Confiscating material evidences and means whose value does not exceed the fine level prescribed at Point b of this Clause;
dd) Applying remedial measures prescribed at Points d, dd and i, Clause 1, Article 28 of the Law on Handlings of Administrative Violations and Clause 3, Article 3 of this Decree.
5.The General Director of the General Department of Customs shall have the following powers:
a) Imposing warnings;
b) Imposingfinesof 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 pharmacy, cosmetics and medical equipment;
c) Depriving of the right to use the license for medical examination and treatment, and the medical practice certificate for a definite time, or suspension of operation for a definite time;
d)Confiscating material evidences and means;
dd) Applying remedial measures prescribed at Points d, dd and i, Clause 1, Article 28 of the Law on Handlings of Administrative Violations and Clause 3, Article 3 of this Decree.
Article 108. Competence to impose finesfor administrative violationsoftheBorder Guard force
1.Border Guard soldiers who are on duty shall have the following powers:
a) Imposing warnings;
b) Imposingfinesof up to VND 300,000 for acts of administrative violation on preventive healthcare; up to VND 500,000 for acts of administrative violation on preventive healthcare, HIV/AIDS prevention and control, medical examination and treatment, pharmacy, cosmetics and medical equipment;
2.Heads of station or team leaders of the persons defined in Clause 1 of this Article shall have the following powers:
a) Imposing warnings;
b) Imposingfinesof up to VND 1,500,000 for acts of administrative violation on preventive healthcare; up to VND 2,500,000 for acts of administrative violation on preventive healthcare, HIV/AIDS prevention and control, medical examination and treatment, pharmacy, cosmetics and medical equipment;
3.Heads of Border guard stations, Captains of Border Guard Flotillas, Commanders of Port Border Gates shall have the following powers:
a) Imposing warnings;
b) Imposingfinesof up to VND 6,000,000 for acts of administrative violation on preventive healthcare; 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) Confiscating material evidences and means whose value does not exceed the fine level prescribed at Point b of this Clause;
d) Applying remedial measures prescribed at Points c, and dd, Clause 1, Article 28 of the Law on Handlings of Administrative Violations and Clause 3, Article 3 of this Decree.
4.Commanders of provincial-level Border Guard Commands, Commanders of Border Guard Squadrons under the Border Guard High Command shall have the following powers:
a) Imposing warnings;
b) Imposingfinesof up to VND 30,000,000 for acts of administrative violation on preventive healthcare; 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) Depriving of the right to use the license for medical examination and treatment, and the medical practice certificate for a definite time, or suspension of operation for a definite time;
d) Confiscating material evidences and means;
dd) Applying remedial measures prescribed at Points c, dd and i, Clause 1, Article 28 of the Law on Handlings of Administrative Violations and Clause 3, Article 3 of this Decree.
Article 109. Competence to impose fines for administrative violations oftheVietnam Coast Guard force
1.Soldiersof the Coast Guard who are on duty shall have the following powers:
a) Imposing warnings;
b) Imposingfinesof up to VND 600,000 for acts of administrative violation on population; up to VND 1,500,000 for acts of administrative violation on preventive healthcare, HIV/AIDS prevention and control, medical examination and treatment, pharmacy, cosmetics and medical equipment.
2.Team leaders of Coast Guard Operational Teams shall have the following powers:
a) Imposing warnings;
b) Imposingfinesof 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
3.Leaders of Coast Guard Operational Groups, and Headsof Coast GuardStations shall have the following powers:
a) Imposing warnings;
b) Imposingfinesof 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) Applying remedial measures prescribed at Point c and Point dd, Clause 1, Article 28 of the Law on Handlings of Administrative Violations.
4.Captains of Coast Guard Flotillas shall have the following powers:
a) Imposing warnings;
b) Imposingfinesof 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) Confiscating material evidences and means whose value does not exceed the fine level prescribed at Point b of this Clause;
d) Applying remedial measures prescribed at Points c, d, and dd, Clause 1, Article 28 of the Law on Handlings of Administrative Violations and Clause 3, Article 3 of this Decree.
5.Commanders of Coast Guard Squadrons shall have the following powers:
a) Imposing warnings;
b) Imposingfinesof 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) Confiscating material evidences and means whose value does not exceed the fine level prescribed at Point b of this Clause;
d) Applying remedial measures prescribed at Points c, d, and dd, Clause 1, Article 28 of the Law on Handlings of Administrative Violations and Clause 3, Article 3 of this Decree.
6.Commanders of the Regional Coast Guard shall have the following powers:
a) Imposing warnings;
b) Imposingfinesof 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) Confiscating material evidences and means whose value does not exceed the fine level prescribed at Point b of this Clause;
d) Applying remedial measures prescribed at Points c, d, and dd, Clause 1, Article 28 of the Law on Handlings of Administrative Violations and Clause 3, Article 3 of this Decree.
7.The Commander of the Vietnam Coast Guard shall have the following powers:
a) Imposing warnings;
b) Imposingfinesof 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) Depriving of the right to use the license for medical examination and treatment, and the medical practice certificate for a definite time, or suspension of operation for a definite time;
d) Confiscating material evidences and means;
dd) Applying remedial measures prescribed at Points c, d, and dd, Clause 1, Article 28 of the Law on Handlings of Administrative Violations and Clause 3, Article 3 of this Decree.
Article 110. Competence of Taxation agencies
1. Taxation officers who are on duty shall have the following powers:
a) Imposing warnings;
b) Imposingfinesof up to VND 500,000 for acts of administrative violation on preventive healthcare, and HIV/AIDS prevention and control.
2. Heads of Taxation teams shall have the following powers:
a) Imposing warnings;
b) Imposingfinesof up to VND 2,500,000 for acts of administrative violation on preventive healthcare, and HIV/AIDS prevention and control.
3. Directors of Sub-departments of Taxation shall have the following powers:
a) Imposing warnings;
b) Imposingfinesof up to VND 25,000,000 for acts of administrative violation on preventive healthcare, and HIV/AIDS prevention and control;
c) Confiscating material evidences and means whose value does not exceed the fine level prescribed at Point b of this Clause;
d) Applying remedial measures prescribed at Point i and Point k , Clause 1, Article 28 of the Law on Handlings of Administrative Violations and Clause 3, Article 3 of this Decree.
4. Directors of Departments of Taxation shall have the following powers:
a) Imposing warnings;
b) Imposingfinesof up to VND 50,000,000 for acts of administrative violation on preventive healthcare, and HIV/AIDS prevention and control;
c) Confiscating material evidences and means whose value does not exceed the fine level prescribed at Point b of this Clause;
d) Applying remedial measures prescribed at Point i and Point k , Clause 1, Article 28 of the Law on Handlings of Administrative Violations and Clause 3, Article 3 of this Decree.
5. The General Director of the General Department of Taxation shall have the following powers:
a) Imposing warnings;
b) Imposingfinesof up to VND 50,000,000 for acts of administrative violation on preventive healthcare, and HIV/AIDS prevention and control;
c) Confiscation of material evidences and means;
d) Applying remedial measures prescribed at Point i and Point k, Clause 1, Article 28 of the Law on Handlings of Administrative Violations and Clause 3, Article 3 of this Decree.
Article 111. Competence to impose fines of Social security agencies
1. Directors of provincial-level Social Security agencies shall have the following powers:
a) Imposing warnings;
b) Imposingfinesof up to VND 37,500,000 for acts of administrative violation on health insurance;
c) Depriving of the right to use the license for medical examination and treatment, and the medical practice certificate for a definite time, or suspension of operation for a definite time;
d) Confiscating material evidences and means whose value does not exceed the fine level prescribed at Point b of this Clause;
dd) Applying remedial measures prescribed at Points c, d, dd, e, g, h and i, Clause 1, Article 28 of the Law on Handlings of Administrative Violations and Clause 3, Article 3 of this Decree.
2. The General Director of the Vietnam Social Security shall have the following powers:
a) Imposing warnings;
b) Imposingfinesof up to VND 75,000,000 for acts of administrative violation on health insurance;
c) Depriving of the right to use the license for medical examination and treatment, and the medical practice certificate for a definite time, or suspension of operation for a definite time;
d) Confiscating material evidences and means;
dd) Applying remedial measures prescribed at Points c, d, dd, e, g, h and i, Clause 1, Article 28 of the Law on Handlings of Administrative Violations and Clause 3, Article 3 of this Decree.
3. Heads of specialized inspection teams established by the General Director of the Vietnam Social Security shall have the following powers:
a) Imposing warnings;
b) Imposingfinesof up to VND 52,500,000 for acts of administrative violation on health insurance;
c) Depriving of the right to use the license for medical examination and treatment, and the medical practice certificate for a definite time, or suspension of operation for a definite time;
d) Confiscating material evidences and means whose value does not exceed the fine level prescribed at Point b of this Clause;
dd) Applying remedial measures prescribed at Points c, d, dd, e, g, h and i, Clause 1, Article 28 of the Law on Handlings of Administrative Violations and Clause 3, Article 3 of this Decree.
Article 112. Determination of the Competence to impose fines for administrative violations of positions competent to impose fines for administrative violations in healthcare
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 acts of administrative violations prescribed in Chapter II of this Decree in accordance with the Competence prescribed in Article 103 of this Decree and the assigned functions, tasks and powers.
2. Competent persons of Healthcare Inspection agency, persons assigned to perform specialized inspection in healthcare shall be competent in making records of administrative violations, imposing administrative sanctions, and applying remedial measures for acts of administrative violations prescribed in Chapter II of this Decree in accordance with the competence prescribed in Article 104 of this Decree and acts of administrative violations related to healthcare, in accordance with the Competence of equivalent positions prescribed in other Decrees on imposing fines for administrative violations, and in accordance with the assigned functions, tasks and powers.
3. Competent persons of Market Surveillance agencies shall be competent in making records of administrative violations, imposing administrative sanctions, and applying remedial measures in accordance with their scope of management and their assigned functions, tasks and powers, as well as in accordance with the Competence prescribed in Article 105 of this Decree – for acts of violations defined in Articles 14, 25, 26, 27, 29, 30, 31, 32, 33, 34, 35, 36, 37, 49, 50, 51, 52, 53, 54, 55, 57, 58, 59, 60, 64, 65, 66, 67, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 102; in Clause 4 of Article 6; at Point h, Clause 3 of Article 9; Clause 3 and Clause 4 of Article 12; Point dd, Clause 1; Point a and Point d, Clause 2; Points a, b, c, Clause 3 and Clause 4 of Article 61; Clause 2, Article 69 and Point a, Clause 2, Article 97 of this Decree.
4. Competent persons of the People’s Public Security force shall be competent in making records of administrative violations, imposing administrative sanctions, and applying remedial measures in accordance with their scope of management and their assigned functions, tasks and powers, as well as in accordance with the Competence prescribed in Article 106 of this Decree– for acts of violations defined in Articles7, 10, 11, 12, 13, 14, 15, 16, 18, 19, 22, 24, 25, 26, 27, 29, 30, 31, 32,33,34, 35, 36, 37, 54, 65, 66, 67, 69, 70, 76, 96, 97, 98, 99, 100, 101, 102; Point a, Clause 3 of Article 5; Clauses 1, 2 and 4 of Article 6; Point a, Clause 1, Point a, Clause 2, Point h, Clause 3 of Article 9; Point a and Point c, Clause 5, Point b, Clause 6, Clause 7 of Article 38; Point a , Clause 7 of Article 44; Point a, Clause 1 of Article 45; Point a, Clause 1, Point b, Clause 2 of Article 48; Point a and Point g, Clause 2 of Article 52; Clause 3 of Article 53; Clause 4 of Article 55; Point c, Clause 4 of Article 56; Point d, Clause 5, Clause 7 of Article 57; Clause 7 of Article 58; Clauses 4, 5, 6, 7 of Article 59; Points d, dd, e, g, Clause 2, Point dd, Clause 3, Clauses 4, 5, 6, 7 of Article 60; Clause 4 of Article 61; Clause 5 of Article 62; Clause 4 of Article 63; Clause 1, Clause 2, Point a and Point b, Clause 3 of Article 64; Clause 2 and Clause 3 of Article 68; Point b, Clause 2 of Article 70; Point a, Clause 2, Point a and Point b, Clause 3 of Article 73; Point g, Clause 2, Clause 3 of Article 74; Points b, c, d, Clause 2, Point c and Point d, Clause 3 of Article 75 of this Decree.
5. Competent persons of the Customs agencies shall be competent in making records of administrative violations, imposing administrative sanctions, and applying remedial measures in accordance with their scope of management and their assigned functions, tasks and powers, as well as in accordance with the Competence prescribed in Article 107 of this Decree – for acts of violations defined in Articles 7, 11, 12, 13, 14, 25, 26, 27, 29, 30, 31, 32, 33, 34, 35, 36, 37, 60, 64, 71, 76; Clause 1 and Clause 2 of Article 6; Point b, Clause 1 of Article 54; Clause 6 and Clause 7 of Article 58; Clause 6 and Clause 7 of Article 59; Point b, Clause 1, Clause 2 of Article 65; Point c, Clause 2 of Article 75 of this Decree.
6. Competent persons of the Border Guard force shall be competent in making records of administrative violations, imposing administrative sanctions, and applying remedial measures in accordance with their scope of management and their assigned functions, tasks and powers, as well as in accordance with the Competence prescribed in Article 108 of this Decree – for acts of violations defined 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, 76, 96, 97, 101, 102; Point b , Clause 3 of Article 8; Point b , Clause 3 of Article 9; Point a and Point b, Clause 3 of Article 16; Point g, Clause 2, Point dd, Clause 3 of Article 23; Clauses 1, 2, 3, Points a, b, c, g , Clause 4, Point a, Clause 5 of Article 29; Point b , Clause 4 of Article 39; Point b, Clause 3 of Article 48; Point b, Clause 1 of Article 52 and Clause 1, Point b Clause 2, Points a, b Clause 3 of Article 64 of this Decree.
7. Competent persons of theVietnam Coast Guardforce shall be competent in making records of administrative violations, imposing administrative sanctions, and applying remedial measures in accordance with their scope of management and their assigned functions, tasks and powers, as well as in accordance with the Competence prescribed in Article 109of this Decree– for acts of violations defined in Articles5, 6, 7, 10, 11, 12, 13, 14, 17, 19, 22, 24, 25, 26, 27, 30, 31, 32, 33, 34, 35, 36, 37, 60, 65, 71, 76, 80, 83, 96, 97, 101, 102; Point b, Clause 3 of Article 8; Point b, Clause 3 of Article 9; Point a and Point b, Clause 3 of Article 16; Point g, Clause 2, Clause 3 of Article 23; Clauses 1, 2, 3, Points a, b, c, g, Clause 4, Point a, Clause 5 of Article 29; Clauses 1, 3, 5, 6, 7 of Article 38; Point b, Clause 4 of Article 39; Clause 4 of Article 40; Point b, Clause 1 of Article 45; Point b, Clause 3 of Article 48; Point b, Clause 1 of Article 52; Clause 1, Point b, Clause 2, Point a and Point b, Clause 3 of Article 64; Clause 1 of Article 74 and Point a, Clause 1, Clause 2 of Article 95 of this Decree.
8. Competent persons of theTaxation agenciesshall be competent in making records of administrative violations, imposing administrative sanctions, and applying remedial measures in accordance with their scope of management and their assigned functions, tasks and powers, as well as in accordance with the Competence prescribed in Article 110 of this Decree – for acts of violations defined at Points d, dd, e, Clause 4 and Point b, Clause 5 of Article 29 of this Decree.
9. Competent persons of theSocial security agenciesshall be competent in making records of administrative violations, imposing administrative sanctions, and applying remedial measures in accordance with their scope of management and their assigned functions, tasks and powers, as well as in accordance with the Competence prescribed in Article 111 of this Decree – for acts of violations defined in Section 5 of this Decree.
10. Competent persons of Inspection ofInformation and Communicationshall be competent in making records of administrative violations, imposing administrative sanctions, and applying remedial measures in accordance with their scope of management and their assigned functions, tasks and powers, as well as in accordance with the Competence prescribed in Article 104 of this Decree – for acts of violations defined in Articles 5, 19, 25, 26, 30, 32, 33, 34, 36, 37, 49, 50, 51, 67, 69, 78, 96, 97; Clause 2 of Article 14; Clauses 1, 2, 3, Points a, b, c, e, g, Clause 4, Point a, Clause 5 of Article 29; Clause 3 of Article 31 and Point b, Clause 2 of Article 35 of this Decree.
11. Competent persons of Inspection ofCulture – Sports - Tourismshall be competent in making records of administrative violations, imposing administrative sanctions, and applying remedial measures in accordance with their scope of management and their assigned functions, tasks and powers, as well as in accordance with the Competence prescribed in Article 104 of this Decree – for acts of violations defined in Articles 5, 19, 25, 26, 30, 32, 33, 34, 36, 37, 49, 50, 51, 67, 69, 78, 96, 97; Clause 2 of Article 14; Clauses 1, 2, 3, Points a, b, c, e, g, Clause 4, Point a, Clause 5 of Article 29 and Point b, Clause 2 of Article 35 of this Decree.
12. Competent persons in Inspection of education, transportation, agriculture and rural development, science and technology shall be competent in making records of administrative violations, imposing administrative sanctions, and applying remedial measures in accordance with their scope of management and their assigned functions, tasks and powers, as well as in accordance with the Competence prescribed in Article 104 of this Decree – for acts of violations defined in Articles 5, 6, 18, 19, 23, 25, 26, 30, 31, 32, 33, 34, 36, 37; Clause 2 of Article 14 and Clauses 1, 2, 3, Points a, b, c, e, Clause 4, Point a, Clause 5 of Article 29 of this Decree.
13. Competent persons in Inspection of environment and natural resources shall be competent in making records of administrative violations, imposing administrative sanctions, and applying remedial measures in accordance with their scope of management and their assigned functions, tasks and powers, as well as in accordance with the Competence prescribed in Article 104 of this Decree – for acts of violations defined in Articles 5, 6, 7, 10, 12, 15, 16, 18, 19, 23, 25, 26, 30, 31, 32, 33, 34, 36, 37 and Point a, Clause 5 of Article 29 of this Decree.
Article 113. Competence to make records of administrative violations
Persons competent to make records of administrative violations in healthcare shall include:
1. Persons competent to impose fines who are specified in this Decree 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 performing public 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 violations
1. Agencies and persons competent to impose fines for administrative violations shall be allowed to use technical operational means and devicesto detect acts of violations defined in Articles 25, 30, 31, 32, 33, 34, 35, 36, 37 of this Decree.
2. The management, use and listing of technical operational means and devicesto 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 November 15, 2020.
2. The following regulations take effect from the date of signing and promulgation:
a) Articles 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 47, 115, 116, 117, Point b, Clause 1, Point b, Clause 4 ofArticle 52 and Points a and b, Clause 2, Points b and dd, Clause 3, Point b, Clause 4 of Article 57 of this Decree;
b) Articles 1, 2, 3, 4, 103, 104, 105, 106, 107, 108, 109, 110, 111, 112, 113 and 114 shall be applied in imposing fines for administrative violations prescribed at Point a of this Clause.
3. The Government’s Decree No. 176/2013/ND-CP, dated November 14, 2013, on imposing fines for administrative violations in healthcare shall terminate its effect from November 15, 2020.
4. Articles 5, 6, 7, 8, 9, 10, 11, 12, and 13 of the Government’s Decree No. 176/2013/ND-CP, dated November 14, 2013, on imposing fines for administrative violations in healthcare shall terminate its effect from the signing date of this Decree.
Article 116. Transitional provisions
For acts of administrative violations in the healthcarewhich are committedbeforethe date on which this Decree takes effect,and are later uncovered, or which are being considered and settled – whereas this Decree does not prescribe the legal liability or prescribe lighter legal liability, provisions of this Decree shall prevail.
Article 117. Guidance and implementation responsibilities
1.The Minister of Health shall be responsible for providing guidelines and organizing the implementation of this Decree.
2. Ministers, Heads of Ministerial-level agencies, Heads of Governmental agencies, Chairpersons of People’s Committees at all levels, relevant organizations and individuals shall be responsible for implementing this Decree./.
For the Government
The Prime Minister
Nguyen Xuan Phuc
Vietnamese
Decree 117/2020/NĐ-CP DOC (Word)
Decree 117/2020/NĐ-CP PDF (Original)
