| THE MINISTRY OF HEALTH | THE SOCIALIST REPUBLIC OF VIETNAM |
| No.: 01/VBHN-BYT | Hanoi, January 24, 2022 |
PRESCRIBING PENALTIES FOR ADMINISTRATIVE VIOLATIONS IN MEDICAL SECTOR
The Government’s Decree No. 117/2020/ND-CP dated September 28, 2020 prescribing penalties for administrative violations in medical sector, coming into force from November 15, 2021, is amended by:
The Government’s Decree No. 124/2021/ND-CP dated December 28, 2021 providing amendments to the Government’s Decree No. 115/2018/ND-CP dated September 04, 2018 prescribing penalties for administrative violations against regulations on food safety and the Government’s Decree No. 117/2020/ND-CP dated September 28, 2020 prescribing penalties for administrative violations in medical sector, coming into force from January 01, 2022.
Pursuant to the Law on Government Organization dated June 19, 2015; the Law on amendments to the Law on Government Organization and the Law on Organization of Local Governments dated November 22, 2019;
Pursuant to the Law on penalties for administrative violations dated June 20, 2012, and the Law on amendments to the Law on penalties for administrative violations dated November 13, 2020;
Pursuant to the Law on HIV/AIDS prevention and control dated June 29, 2006; the Law on amendments to the Law on HIV/AIDS prevention and control dated November 16, 2020;
Pursuant to the Law on donation, removal and transplantation of human tissues and organs, and body donation dated November 29, 2006;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Pursuant to the Law on health insurance dated November 14, 2008 and the Law on amendments to the Law on health insurance dated June 13, 2014;
Pursuant to the Law on medical examination and treatment dated November 23, 2009;
Pursuant to the Law on prevention and control of tobacco harms dated June 18, 2012;
Pursuant to the Law on pharmacy dated April 06, 2016;
Pursuant to the Law on prevention and control of harmful effects of alcoholic beverages dated June 14, 2019;
Pursuant to the Ordinance on population dated January 09, 2003 and the Ordinance on amendments to Article 10 of the Ordinance on population dated December 27, 2008;
At the request of the Minister of Health,
The Government promulgates a Decree prescribing penalties for administrative violations in medical sector. 1
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
1. This Decree deals with administrative violations, penalties, fines, remedial measures against each violation, the power to record violations, and the power of each title holder to impose penalties for administrative violations in medical sector.
2. Administrative violations in medical sector prescribed herein are acts performed by organizations and individuals that are wrongful or contravene regulations on state management of medical sector but do not constitute criminal offences, and are punishable by administrative penalties as prescribed by law, including:
a) Violations against regulations on preventive healthcare, and HIV/AIDS prevention and control;
b) Violations against regulations on medical examination and treatment;
c) Violations against regulations on pharmacy and cosmetics;
d) Violations against regulations on medical equipment;
dd) Violations against regulations on health insurance;
e) Violations against regulations on population.
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
4. 2 When detecting the violations in Point c Clause 3 Article 7, Point b Clause 6 Article 38, Points a, b Clause 7 Article 44, Clause 6 Article 48, Point a Clause 2 Article 52, Clause 3 Article 53, Point a Clause 1 Article 54, Point c Clause 4 Article 56, Point d Clause 5, Clause 7 Article 57, Clause 7 Article 58, Clause 7 Article 59, Point a Clause 4 Article 60, Point c Clause 5 Article 67, Clause 3 Article 68, Point b Clause 2 Article 70, Points a, b Clause 3 Article 73, Clause 4 Article 80, Points d, dd, e, g and h Clause 2 Article 85, Points d, dd, e, g, h and i Clause 2 Article 86 hereof or the repeating of the violations in Points a, b Clause 3 Article 7, Clause 9 Article 15, Clause 6 Article 40, Point a Clause 6 Article 44, Point b Clause 5 Article 67 and Clauses 2, 3 Article 80 hereof, the competent officials who are handling such cases shall, based on the nature and severity of the violation which denotes signs of crime according to corresponding regulations of the Criminal Code, transfer the case files to competent criminal proceeding agencies for initiating criminal prosecution in accordance with the provisions of Clauses 1, 2 and 4 Article 62 of the Law on penalties for administrative violations. If the relevant criminal proceeding agency decides not to institute criminal proceedings in accordance with the provisions of the Criminal Procedure Code, the case file shall be returned to the official who has transferred it to the criminal proceeding agency as prescribed in Clause 3 Article 62 of the Law on penalties for administrative violations for imposing administrative penalties in accordance with the provisions herein.
1. Vietnamese and foreign organizations and individuals (hereinafter referred to as “entities”) that commit administrative violations in medical sector, persons competent to make records of violations, those competent to impose penalties and other relevant entities.
2. Organizations that are the entities incurring penalties as prescribed herein include:
a) Economic organizations that are duly established under the Law on enterprises, including: Sole proprietorships, joint-stock companies, limited liability companies, partnerships and their affiliates (including branches and representative offices);
b) Co-operatives and cooperative unions that are duly established under the Law on co-operatives;
c) Organizations that are duly established under the Law on Investment or the Law on Commerce, including: Domestic and foreign investors (except individual investors) and foreign-invested economic organizations; representative offices and branches of foreign traders in Vietnam; representative offices of foreign trade promotion organizations in Vietnam;
d) Social organizations, socio-political organizations, socio-political-professional organizations, and socio-professional organizations;
dd) 3 Administrative units;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
g) Artels;
h) Other organizations as prescribed by law.
3. Household businesses, family businesses, domestic and foreign individual investors shall be liable to the same penalties as those imposed upon individuals for committing the administrative violations prescribed herein.
Article 3. Penalties and remedial measures
1. Primary penalties:
a) Warning;
b) Fines.
2. Depending on the nature and severity of each administrative violation, the violating entity may face one or some of the following additional penalties:
a) Suspension of the following licenses or practicing certificates for a fixed period of 01-24 months, including: certificate of eligibility for pharmacy business, license for medical operations, certificate of satisfaction of level-3 biosafety standards, certificate of eligibility to provide HIV testing, certificate of eligibility to produce cosmetics, license to trade in alcoholic beverages, license to operate tissue bank, pharmacy practice certificate and medical examination and treatment practice certificate;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
c) Suspension of operations for a fixed period of 01 - 24 months;
d) Deportation.
3. In addition to the primary and additional penalties, the violating entity may, depending on the nature and severity of each administrative violation, be liable to one or some of the remedial measures specified in Points c, d, dd, e, g, h and i Clause 1 Article 28 of the Law on penalties for administrative violations and the following remedial measures:
a) Enforced return of amounts of money collected against regulations of law. Any amounts of money which cannot be returned to payers shall be paid to state budget as prescribed by law;
b) Enforced implementation of cleaning, disinfection and sterilization measures and other measures for prevention and control of infectious diseases;
c) Enforced organization of medical isolation, implementation of coercive measures for medical isolation, health inspection and control;
d) Enforced implementation of measures for cleaning of clean water supply and distribution system;
dd) Enforced making of direct apologies to HIV patients and their families and correction of information published on means of mass media at the place where the HIV patient is living within 03 days as prescribed by law, unless the HIV patient rejects public apologies;
e) Enforced receipt and burial or cremation of HIV infected bodies or ashes;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
h) Enforced making of direct apologies to persons who are discriminated against, practitioners, and patients;
i) Enforced re-appointment to previous job positions;
k) Enforced provision of legitimate rights and benefits to HIV-infected employees;
l) Enforced cancellation of decisions to discipline or expel pupil or student for HIV infection;
m) Enforced payment of interests on different amounts due to false declarations or late payment of compulsory contributions; enforced making of payments due to evasion or commission of frauds in payment of compulsory contributions; enforced return of amounts of money which have been used against regulations;
n) Enforced payment of costs of medical services;
o) Enforced return of entire different amounts. Any payments which cannot be made to payers shall be paid to state budget in accordance with regulations of law;
p) Enforced reimbursement of amounts of money as compensation for damage suffered by health insurance purchasers (if any); enforced reimbursement of amounts of money as compensation for damage suffered by health facilities (if any). Any payments which cannot be made to payers shall be paid to state budget in accordance with regulations of law;
q) Enforced transfer of amounts of money involving in the violations to the dedicated account of the health insurance fund (if any);
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
s) 4 Enforced return of practice certificates, license for medical operations, license to import medical devices, certificate of eligibility for pharmacy business, certificate of marketing authorization for domestically manufactured medical devices, certificate of registration of drugs/medicinal materials, receipt number of cosmetic product declaration, acknowledgement of receipt of declaration dossier, certificate of registration of drugs/medicinal materials, certificate of registration of free sale of type C, D medical devices to competent regulatory authorities.
4. 5 The imposition of penalties and remedial measures must comply with the following provisions:
a) If the additional penalty that is fixed-period suspension of operations is imposed, the person having authority to impose administrative penalties shall send a written notice thereof to competent regulatory authorities for cooperating in monitoring, inspecting and reporting upon expiration of the time limit for execution of the penalty imposition decision;
b) If the remedial measure that is enforced submission of licenses/practicing certificates to competent regulatory authorities is imposed, the person having authority to impose administrative penalties shall send a written notice thereof to regulatory authorities issuing or receiving such licenses/practicing certificates;
c) Other requirements laid down in the Law on penalties for administrative violations.
1. The maximum fine imposed for a violation against regulations on population is VND 30.000.000 if committed by an individual or VND 60.000.000 if committed by an organization.
2. The maximum fine imposed for a violation against regulations on preventive medicine and HIV/AIDS prevention and control is VND 50.000.000 if committed by an individual or VND 100.000.000 if committed by an organization.
3. The maximum fine imposed for a violation against regulations on health insurance is VND 75.000.000 if committed by an individual or VND 150.000.000 if committed by an organization.
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
5. The fines prescribed in Chapter II hereof are imposed on violating individuals. The fine imposed on an organization is twice as much as that imposed on an individual for committing the same administrative violation.
6. 6 Fines imposed by the competent officials specified in Chapter III hereof are incurred by individuals. An official having the power to impose fines shall have the right to impose a fine twice as much as that imposed upon an individual upon an organization for committing the same administrative violation.
ADMINISTRATIVE VIOLATIONS, PENALTIES AND REMEDIAL MEASURES
Section 1. VIOLATIONS AGAINST REGULATIONS ON PREVENTIVE HEALTHCARE, AND HIV/AIDS PREVENTION AND CONTROL
1. The following fines shall be imposed for failing to organize information dissemination, education and communication activities in prevention and control of infectious diseases for employees at the request of competent authorities:
a) A fine ranging from VND 1.000.000 to VND 3.000.000 shall be imposed upon a violating establishment using less than 100 employees;
b) A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed upon a violating establishment using from 100 to under 300 employees;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
d) A fine ranging from VND 7.000.000 to VND 10.000.000 shall be imposed upon a violating establishment using from 500 to under 1.000 employees;
dd) A fine ranging from VND 10.000.000 to VND 15.000.000 shall be imposed upon a violating establishment using from 1.000 to under 1.500 employees;
e) A fine ranging from VND 15.000.000 to VND 20.000.000 shall be imposed upon a violating establishment using from 1.500 to under 2.500 employees;
g) A fine ranging from VND 20.000.000 to VND 25.000.000 shall be imposed upon a violating establishment using 2.500 employees or more.
2. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for failing to implement or improperly implementing regulations on broadcasting time or volume or capacity or location for publishing information on prevention and control of infectious diseases.
3. A fine ranging from VND 10.000.000 to VND 15.000.000 shall be imposed for commission of one of the following violations:
a) Failing to provide accurate and timely information on an epidemic upon declaration of epidemic or declaration of end of epidemic according to contents provided by competent health agencies;
b) Charging the provision of information, education and communication about prevention and control of infectious diseases on means of mass media, unless the payment is made under a contract signed for implementing a program/project or such activities are sponsored by domestic or foreign entities.
4. Remedial measures:
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
b) The entity committing the violation in Point b Clause 3 of this Article is compelled to return any amounts of money collected against regulations of law. The amounts of money which cannot be returned to payers shall be paid to state budget in accordance with regulations of law.
1. A warning or a fine ranging from VND 200.000 to VND 500.000 shall be imposed for failing to implement hygiene measures at residences, public areas, vehicles and domestic waste storage areas for preventing infectious diseases.
2. A fine ranging from VND 1.000.000 to VND 3.000.000 shall be imposed for failure to implement hygiene measures at residences, public areas, vehicles and domestic waste storage areas which causes or spreads of an infectious disease.
3. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for commission of one of the following violations:
a) Failing to provide adequate drink water and clean domestic water that meet quality standards in educational institutions as prescribed by law;
b) Failing to build or building sanitation works which do not meet hygiene requirements in educational institutions as prescribed by law;
c) Failing to provide adequate lighting in an educational institution as prescribed by law;
d) Failing to educate learners in hygiene measures for prevention of infectious diseases, including personal hygiene, hygiene in daily life, labour hygiene and environmental sanitation;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
4. A fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed for failing to implement measures for ensuring hygiene in manufacturing/business establishment, treatment of industrial waste and other hygiene measures as prescribed by law, and thus causing or spreading an infectious disease.
5. Remedial measure:
The entity committing the violation in Clause 2 or 4 of this Article is compelled to implement cleaning, disinfection and sterilization measures.
Article 7. Violations against regulations on infectious disease surveillance
1. A fine ranging from VND 500.000 to VND 1.000.000 shall be imposed for concealing, failing to report or delaying the reporting when detecting a person infected with an infectious disease as prescribed by law, except the case prescribed in Point a Clause 3 of this Article.
2. A fine ranging from VND 1.000.000 to VND 3.000.000 shall be imposed for commission of one of the following violations:
a) Failing to perform tests at the request of competent health agencies during the infectious disease surveillance;
b) Failing to submit reports or submitting reports which do not contain adequate information on infectious disease surveillance as prescribed by law;
c) Concealing, failing to report or delaying the reporting on personal infectious disease status, except the case prescribed in Point a Clause 3 of this Article.
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
a) Concealing, failing to report or delaying the reporting on personal status of infection from a group-A infectious disease or the infection from a group-A infectious disease of others;
b) Deliberately providing false reports or information on a group-A infectious disease;
c) Deliberately spreading pathogens causing group-A infectious diseases.
Article 8. Violations against regulations on laboratory biosafety
1. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for commission of one of the following violations:
a) Failing to meet one of requirements for biosafety level 1 laboratory after self-declaration of satisfaction of biosafety level 1 laboratory standards;
b) Failing to assess risks of biosafety incidents at testing laboratories;
c) Performing tests beyond the professional scope after declaration of satisfaction of biosafety level 1 or level 2 laboratory standards;
d) Failing to formulate and organize the implementation of regulations on internal biosafety inspection as prescribed by law;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
2. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for commission of one of the following violations:
a) Failing to meet one of requirements for biosafety level 2 laboratory after self-declaration of satisfaction of biosafety level 2 laboratory standards;
b) Failing to formulate a plan for prevention and handling of biosafety incidents or formulating a plan that does not contain adequate contents as prescribed by law;
c) Failing to disinfect or sterilize waste generated from testing activities before putting it into the waste collection system or temporary waste storage area of a biosafety level 2 laboratory.
3. A fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed for commission of one of the following violations:
a) Failing to mobilize or delaying the mobilization of human resources and equipment for handling a biosafety incident according to the plan for prevention and handling of biosafety incidents as prescribed by law;
b) Collecting, transporting, maintaining, storing, using, researching, exchanging and destroying pathological samples carrying pathogens of infectious diseases against regulations on management of infectious disease samples;
c) Failing to submit reports to the relevant Provincial Department of Health on serious biosafety incidents and measures taken against such incidents.
4. A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed for commission of one of the following violations:
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
b) Maintaining, storing, using, researching, exchanging and destroying samples of a group-A infectious disease without meeting edibility requirements;
c) Failing to disinfect or sterilize waste generated from testing activities before putting it into the waste collection system or temporary waste storage area of a biosafety level 3 laboratory.
5. A fine ranging from VND 30.000.000 to VND 40.000.000 shall be imposed for commission of one of the following violations:
a) Failing to organize annual drills of biosafety incident prevention and handling by a biosafety level 3 laboratory;
b) Performing tests before completing procedures for self-declaration of satisfaction of biosafety level 1 or level 2 laboratory standards, or before obtaining a certificate of satisfaction of biosafety level 3 laboratory standards, or when the certificate of satisfaction of biosafety level 3 laboratory standards has expired.
6. Additional penalties:
a) The operation of the biosafety laboratory shall be suspended for a fixed period of 01 – 03 months in case of commission of the violation in Point a or c Clause 1, Point a Clause 2 or Point b Clause 4 of this Article;
b) The operation of the biosafety level 1 or 2 laboratory shall be suspended for a fixed period of 03 – 06 months in case of commission of the violation in Point b Clause 5 of this Article;
c) The certificate of satisfaction of biosafety level 3 laboratory standards shall be suspended for a fixed period of 01 – 03 months in case of commission of the violation in Point a or c Clause 4 or Point b Clause 5 of this Article.
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
1. A warning or a fine ranging from VND 300.000 to VND 500.000 shall be imposed for commission of one of the following violations:
a) Failing to provide or obstructing children or pregnant women in using vaccines and biologicals compulsory for infectious diseases included in the expanded program on immunization;
b) Failing to provide counseling for vaccine recipients, parents, families or guardians of children receiving vaccines before vaccination; failing to provide counseling on benefits and risks related to vaccination;
c) Failing to give instructions to vaccine recipients or families of children getting vaccinated on how to monitor and treat side effects after vaccination;
d) Failing to submit reports or submitting inadequate reports on vaccination as prescribed by law.
2. A fine ranging from VND 1.000.000 to VND 3.000.000 shall be imposed for commission of one of the following violations:
a) Failing to use or obstructing the use of vaccines and biologicals for vaccine-preventable diseases for people susceptible to infectious diseases in epidemic zones or for people sent to epidemic zones at the request or according to guidelines of competent authorities;
b) Failing to issue and keep physical or electronic personal vaccination records of people vaccinated at the vaccination clinic;
c) Failing to compile the list of people vaccinated at the vaccination clinic;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
dd) Failing to prepare adequate relevant documents as requested to enable the provincial advisory council to verify the eligibility for compensation for a serious injury or death from vaccination;
e) Failing to retain and manage documents concerning vaccination and post-vaccination reactions as prescribed by law.
3. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for commission of one of the following violations:
a) Failing to provide pre-vaccination screening or insufficiently providing pre-vaccination screening for people getting vaccinated;
b) Failing to strictly comply with regulations on receipt, transport and storage of vaccines;
c) Failing to strictly comply with regulations of law and professional guidance on vaccine safety and vaccinee management;
d) Failing to immediately stop the vaccination session in case of a serious vaccine injury occurring after vaccination;
dd) Failing to record adequate information on serious vaccine injuries in accordance with regulations of the Minister of Health and submit a report to the Provincial Department of Health within 24 hours from the occurrence of the injury;
e) Failing to organize vaccination against epidemics at the request of competent authorities in case a health facility has registered with the provincial Department of Health for participation in the expanded immunization program;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
h) Selling vaccines and biologicals included in the expanded immunization program.
4. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for commission of one of the following violations:
a) Failing to follow indications for vaccines and ensure safety during vaccination;
b) Failing to give emergency treatment and find the causes of a serious injury after vaccination;
c) Failing to transfer the patient suffering from a serious injury after vaccination to the nearest health facility if the case is beyond the capacity of the vaccination clinic;
d) Failing to give emergency and medical treatment to the patient suffering from a serious injury after vaccination, and submit a report to the Provincial Department of Health within 24 hours from the time of receipt of the patient;
dd) Failing to meet one of requirements for a fixed vaccination clinic after having made a declaration of eligibility for vaccination.
5. A fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed for commission of one of the following violations:
a) Using vaccines and biologicals at a facility that fails to meet eligibility requirements;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
6. A fine ranging from VND 30.000.000 to VND 40.000.000 shall be imposed for using vaccines which are not granted certificate of registration, expired vaccines or poor quality vaccines.
7. Additional penalties:
a) All or part of operations of the violating entity shall be suspended for a fixed period of 01 – 03 months in case of commission of one of the violations in Point a, b, c and d Clause 3, Clause 4, Clause 5 and Clause 6 of this Article;
b) The medical examination and treatment practice certificate shall be suspended for a fixed period of 01 – 03 months in case of commission of the violation in Point a, b, c or d Clause 3 or Point a, b, c or d Clause 4 of this Article.
8. Remedial measures:
a) The entity committing the violation in Point g or h Clause 3 of this Article is compelled to return any amounts of money collected against regulations of law. Any payments which cannot be made to payers shall be paid to state budget in accordance with regulations of law;
b) Vaccines involving the violation in Clause 6 of this Article shall be destroyed.
1. A fine ranging from VND 1.000.000 to VND 3.000.000 shall be imposed for commission of one of the following violations:
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
b) Failing to register for health monitoring with the medical station of commune, ward or communal-level town where the person infected with a group-A infectious disease resides after he/she is discharged or completes treatment at a health facility;
c) Failing to provide counseling on measures for prevention and control of infectious diseases for patients and their families.
2. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for commission of one of the following violations:
a) Failing to provide information on persons infected with infectious diseases receiving medical services at the health facility to the preventive medicine agency of the same level;
b) Failing to monitor the health of doctors and healthcare workers who directly provide medical examination and treatment for persons infected with group-A infectious diseases;
c) Failing to implement measures for prevention and control of the spread of infectious diseases from infected persons;
d) Failing to clean, disinfect, sterilize and implement other measures for prevention and control of infectious diseases when detecting environment carrying pathogens causing group B or C infectious diseases, persons infected with, or suspected of infection with, group B or C infectious diseases, or persons carrying pathogens causing group B or C infectious diseases.
3. A fine ranging from VND 5.000.000 to VND 7.000.000 shall be imposed for failing to notify competent health agencies when detecting environment carrying pathogens causing group A infectious diseases, persons infected with, or suspected of infection with, group A infectious diseases, or persons carrying pathogens causing group A infectious diseases.
4. A fine ranging from VND 7.000.000 to VND 10.000.000 shall be imposed for failing to clean, disinfect, sterilize and implement other measures for prevention and control of infectious diseases when detecting environment carrying pathogens causing group A infectious diseases, persons infected with, or suspected of infection with, group A infectious diseases, or persons carrying pathogens causing group A infectious diseases.
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
The entity committing the violation in Point d Clause 2 or Clause 4 of this Article is compelled to implement cleaning, disinfection, sterilization and other measures for prevention and control of infectious diseases.
Article 11. Violations against regulations on medical isolation and coercive medical isolation
1. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for commission of one of the following violations:
a) Failing to organize or force medical isolation in case of compulsory medical isolation prescribed by law, except the case prescribed in Point a Clause 2 of this Article;
b) Refusing or evading medical isolation or coercive medical isolation measures implemented by competent authorities, except case prescribed in Point b Clause 2 of this Article;
c) Failing to compile the list and monitor health of persons in close contact with persons who are managed under isolation or coercive isolation as prescribed by law.
2. A fine ranging from VND 15.000.000 to VND 20.000.000 shall be imposed for commission of one of the following violations:
a) Failing to organize medical isolation of persons infected with group A infectious diseases;
b) Refusing or evading the implementation of a competent authority’s decision on medical isolation or coercive medical isolation of persons infected with group A infectious diseases, border health quarantine subjects infected with group A infectious diseases or at the request of a competent authority;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
3. Remedial measure:
Enforced organization of medical isolation or coercive medical isolation if one of the violations in Points a, b Clause 1 and Points a, b Clause 2 of this Article is committed.
Article 12. Violations against regulations on epidemic control measures
1. A fine ranging from VND 1.000.000 to VND 3.000.000 shall be imposed for commission of one of the following violations:
a) 7 Failing to adopt personal protective measures for persons participating in epidemic control and susceptible persons according to guidance of health agencies, including: wearing face masks, disinfection, distancing, medical declaration and other measures;
b) Failing to submit reports on infection cases to People’s Committee or local preventive medicine agency as prescribed by law.
2. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for commission of one of the following violations:
a) Concealing the status of infection with an infectious disease declared as an epidemic of oneself or another person;
b) Failing to implement or refusing to implement cleaning, disinfection and sterilization measures in an epidemic zone;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
d) Charging medical examination and treatment services rendered to persons infected with group A infectious diseases;
dd) Failing to implement decisions on compulsory destruction of animals, plants and other things which are vectors, except the cases prescribed in Point c Clause 4 and Point d Clause 5 of this Article.
3. A fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed for commission of one of the following violations:
a) Failing to implement decisions on temporary closure of public eating establishments that may cause the spread of epidemic in an epidemic zone;
b) Failing to implement decisions on prohibition of trading or use of foods which are vectors;
c) Failing to implement decisions on restrictions on public gatherings or temporary suspension of business and services at public places.
4. A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed for commission of one of the following violations:
a)9 Failing to implement decisions on inspection, surveillance and medical control when entering or leaving epidemic areas of a group-A infectious disease;
b) Transporting articles, animals, plants, foods and other goods that may cause the spread of epidemic out of an epidemic area of a group A infectious disease;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
5. A fine ranging from VND 30.000.000 to VND 40.000.000 shall be imposed for commission of one of the following violations:
a) Failing to comply with requests for health inspection and control of vehicles before they are moved out of an epidemic zone in the state of epidemic emergency;
b)10 Failing to implement decisions on no gathering of crowds in areas where epidemic state of emergency has been declared according to resolutions, decisions, directives and other documents issued by competent authorities;
c) Transporting unauthorized persons or vehicles to disease clusters in an area where the state of epidemic emergency is declared;
d) Failing to implement decisions on compulsory destruction of animals, foods, plants and other things that may cause the spread of disease to people in an area where the state of epidemic emergency is declared.
6. Remedial measures:
a) The entity committing the violation in Point b Clause 2 of this Article is compelled to implement cleaning, disinfection and sterilization measures;
b) The entity committing the violation in Point d Clause 2 of this Article is compelled to return any amounts of money collected against regulations of law. Any payments which cannot be made to payers shall be paid to state budget in accordance with regulations of law;
c) Animals, foods, plants and other things shall be destroyed in case of commission of the violation in Point dd Clause 2, Point b or c Clause 4 or Point d Clause 5 of this Article;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Article 13. Violations against regulations on border health quarantine
1. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for commission of one of the following violations:
a) Failing to submit a written report to the Ministry of Health on carving, re-carving, revocation, destruction, invalidation or loss of the health quarantine seal;
b) Failing to make a record of specimen health quarantine seals;
c) Failing to prepare and keep documents when carving or re-carving a health quarantine seal as prescribed;
d) Failing to immediately contact the border health quarantine unit in the checkpoint area if a passenger or aircrew member on board an aircraft or a ship displays signs or symptoms of an infectious disease before the aircraft takes off or lands or the ship arrives at the port;
dd) Deliberately embarking or disembarking, unloading or receiving goods when a ship anchors pending heath quarantine or is quarantined, unless the ship is in distress.
2. A fine ranging from VND 5.000.000 to VND 7.000.000 shall be imposed for commission of one of the following violations:
a) Failing to follow the health inspection and control carried out by the border health quarantine unit as prescribed by law, except the case prescribed in Clause 4 of this Article;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
c) Erasing, repairing or lending symbols, badges, cards or uniforms of health quarantine officers, or traditional flags of border health quarantine units for serving other purposes;
d) Failing to make health declaration or making untruthful declaration of border health quarantine as prescribed by law.
3. A fine ranging from VND 7.000.000 to VND 10.000.000 shall be imposed for commission of one of the following violations:
a) Transporting corpses, bones, body ashes, microorganism samples, biological products, tissues, body organs, blood or its components through the border without inspection by a health quarantine unit;
b) Importing samples of blood, serum, plasma, urine, fecal, body fluids or other human materials that contain or may contain infectious agents, microorganism species or samples containing microorganisms that may human diseases for reserve, diagnosis or medical examination without the import permit.
4. A fine ranging from VND 15.000.000 to VND 20.000.000 shall be imposed for failing to comply with medical isolation, coercive medical isolation and health control of people, vehicles, goods and other health quarantine subjects carrying pathogens causing any group-A infectious diseases.
5. Remedial measures:
a) The entity committing the violation in Point a Clause 2 of this Article is compelled to follow the health inspection and control;
b) The health control shall be carried out in case of commission of the violation in Point a Clause 3 of this Article. If requirements for prevention and control of infectious diseases are not met, the violating subjects/articles shall be transported out of the territory of the Socialist Republic of Vietnam or re-exported;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
d) Enforced organization/implementation of medical isolation, coercive medical isolation and health control of people, vehicles, goods and goods carrying pathogens causing any group-A infectious diseases in case of commission of the violation in Clause 4 of this Article.
Article 14. Violations against other regulations on preventive medicine
1. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for employing persons infected with infectious diseases to directly do the jobs that may cause the spread of such infectious diseases to others or to the public, unless they directly engage in production or trading of foods, food additives, food processing aids, food containers or primary packages of foods, or directly provide food and beverage services.
2. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for failing to comply with measures for prevention and control of infectious diseases at the request of competent authorities, except the cases prescribed in Articles 5 through 13 hereof.
3. A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed for taking advantage of epidemics for imposing irrational prices of drugs, medical devices, medicinal materials, and materials used in manufacturing of medical devices serving prevention and management of epidemics.
4. Additional penalties:
a) The certificate of eligibility for pharmacy business, pharmacy practice certificate, or operation of the violating entity shall be suspended for a fixed period of 06 – 12 months in case of commission of the violation in Clause 3 of this Article;
b) The certificate of eligibility for pharmacy business, pharmacy practice certificate, or operation of the violating entity shall be suspended for a fixed period of 12 – 24 months if the violation in Clause 3 of this Article involves goods worth more than VND 50.000.000 or re-committed.
5. Remedial measure:
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Article 15. Violations against regulations on domestic water quality
1. A fine ranging from VND 1.000.000 to VND 3.000.000 shall be imposed for failing to submit reports on water quality to competent authorities as prescribed.
2. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for supplying water with a design capacity of less than 1.000 m3/24 hours or serving fewer than 500 households in one of the following cases:
a) The testing of water quality parameters of each water sample is not performed by an accredited laboratory or certification body as prescribed by law;
b) Testing results of water quality parameters are not made publicly available as prescribed by law;
c) 01 – 05 parameters of each water sample are not tested.
3. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for supplying water with a design capacity of less than 1.000 m3/24 hours or serving fewer than 500 households in one of the following cases:
a) Domestic water supplied does not meet the requirements laid down in national technical regulations on domestic water quality;
b) 06 or more parameters of each water sample are not tested.
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
a) The testing of water quality parameters of each water sample is not performed by an accredited laboratory or certification body as prescribed by law;
b) Testing results of water quality parameters are not made publicly available as prescribed by law;
c) 01 – 05 parameters of each water sample are not tested.
5. A fine ranging from VND 15.000.000 to VND 20.000.000 shall be imposed for supplying water with a design capacity of 1.000 m3/24 hours or more or serving 500 households or more in one of the following cases:
a) Domestic water supplied does not meet the requirements laid down in national technical regulations on domestic water quality;
b) 06 or more parameters of each water sample are not tested.
6. A fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed for failing to take adequate samples as required for each testing by a water supplier that has a design capacity of less than 1.000 m3/24 hours or serves fewer than 500 households.
7. A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed for commission of one of the following violations:
a) Failing to perform periodic testing of water quality parameters by a water supplier that has a design capacity of less than 1.000 m3/24 hours or serves fewer than 500 households;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
8. A fine ranging from VND 30.000.000 to VND 40.000.000 shall be imposed for failing to perform periodic testing of water quality parameters by a water supplier that has a design capacity of 1.000 m3/24 hours or more or serves 500 households or more.
9. The fine shall be doubled but not exceed VND 50.000.000 if the water supplier committing one of the violations in Clauses 1 through 7 of this Article has two or more water production plants.
Article 16. Violations against regulations on burial and cremation
1. A warning or a fine ranging from VND 300.000 to VND 500.000 shall be imposed for failing to keep records of information on funerals taken place at a funeral home or crematorium.
2. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for failing to meet hygiene conditions by a funeral home or crematorium.
3. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for commission of one of the following violations:
a) Failing to implement or insufficiently implementing regulations on hygiene in lying in state, embalming, transporting, preserving corpses or remains of persons who have died from any group-A infectious diseases or some group-B infectious diseases included in the list of infectious diseases requiring medical isolation;
b) Failing to handle corpses of persons who have died from any group-A infectious diseases or some group-B infectious diseases included in the list of infectious diseases requiring medical isolation;
c) Failing to strictly comply with regulations on mass-grave burials.
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
5. A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed for using cremation technology that fails to meet waste treatment requirements as prescribed by law.
6. Remedial measure:
Enforced implementation of measures for treatment of environmental pollution caused by one of the violations in Clauses 2, 3, 4 and 5 of this Article.
Article 17. Violations against regulations on occupational health, diseases and accidents
1. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed upon a health facility for commission of one of the following violations:
a) Failing to consolidate results of screening examinations for occupation diseases or periodic examinations for workers having occupational diseases at the end of each examination as prescribed by law;
b) Failing to compile an occupational disease dossier for the worker who is diagnosed with an occupational disease;
c) Failing to submit reports on occupational disease cases or annual reports on occupational disease examination to competent authorities as prescribed by law;
d) Failing to submit annual reports on victims of occupational accidents receiving medical examination and treatment at the health facility to competent authorities as prescribed by law.
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
a) Failing to submit reports on medical units providing training in first aid and emergency aid or training for issuance of professional certificates/certifications of occupational health to competent authorities as prescribed by law;
b) Providing training in first aid and emergency aid with inadequate training duration or contents.
3. The following fines shall be imposed for violations against regulations on examination and treatment of occupational diseases:
a) A fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed for providing false results of occupational disease examination and treatment;
b) A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed for providing results of occupational disease examination and treatment without providing occupational disease examination and treatment as prescribed by law.
4. Additional penalty:
The medical examination and treatment practice certificate shall be suspended for a fixed period of 01 - 03 months in case of commission of the violation in Clause 3 of this Article.
Article 18. Violations against other regulations on health environment
A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for failing to build, or failing to meet hygiene conditions for, hygienic hand-washing and toilet areas in offices, medical facilities and other public establishments.
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
1. A warning or the following fines shall be imposed for failing to organize education and dissemination of information about HIV/AIDS prevention and control measures at the request of competent authorities:
a) A warning or fine ranging from 300.000 to VND 500.000 shall be imposed upon a violating establishment using less than 50 employees;
b) A fine ranging from 1.000.000 to VND 2.000.000 shall be imposed upon a violating establishment using from 50 to under 100 employees;
c) A fine ranging from 2.000.000 to VND 3.000.000 shall be imposed upon a violating establishment using from 100 to under 200 employees;
d) A fine ranging from 3.000.000 to VND 5.000.000 shall be imposed upon a violating establishment using from 200 to under 500 employees;
dd) A fine ranging from 5.000.000 to VND 10.000.000 shall be imposed upon a violating establishment using from 500 to under 1.000 employees;
e) A fine ranging from 10.000.000 to VND 15.000.000 shall be imposed upon a violating establishment using from 1.000 to under 1.500 employees;
g) A fine ranging from 15.000.000 to VND 20.000.000 shall be imposed upon a violating establishment using from 1.500 to under 2.000 employees;
h) A fine ranging from 20.000.000 to VND 25.000.000 shall be imposed upon a violating establishment using from 2.000 to under 2.500 employees;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
2. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for commission of one of the following violations:
a) Providing inaccurate information on the HIV/AIDS pandemic compared to data announced by competent authorities;
b) Failing to comply with the preferred time and duration for broadcasting of information and educational contents about HIV/AIDS prevention and control on radio and television stations and content ratio and column positions in printed newspapers, television newspapers and online newspapers.
3. A fine ranging from VND 10.000.000 to VND 15.000.000 shall be imposed for commission of one of the following violations:
b) Failing to give priority to time and duration for broadcasting of information and educational contents about HIV/AIDS prevention and control on radio and television stations and content ratio and column positions in printed newspapers, television newspapers and online newspapers.
b) Charging for the provision of information and education about HIV/AIDS prevention and control, unless payments are made under signed contracts for implementation of national HIV/AIDS prevention and control programs or such activities are sponsored by domestic and/or foreign entities;
c) Disclosing a patient’s HIV status to a third party without having the patient's consent, unless information is provided to serve HIV/AIDS epidemiological surveillance purposes and when giving HIV test results as prescribed by law.
4. A fine ranging from VND 15.000.000 to VND 20.000.000 shall be imposed for disclosing name, address and photo of a person infected with HIV without having his/her consent, unless information is provided to serve HIV/AIDS epidemiological surveillance purposes and when giving HIV test results as prescribed by law.
5. Remedial measures:
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
b) The entity committing the violation in Point b Clause 3 of this Article is compelled to return any amounts of money collected against regulations of law. Any payments which cannot be made to payers shall be paid to state budget in accordance with regulations of law;
c) The entity committing the violation in Point c Clause 3 or Clause 4 of this Article is compelled to make direct apologies to HIV patients/their families and correction of information on means of mass media at the place where the HIV patient is living within at least 03 consecutive days as prescribed by law, unless the HIV patient rejects public apologies.
Article 20. Violations against regulations on HIV testing and counseling
1. A fine ranging from VND 1.000.000 to VND 3.000.000 shall be imposed for commission of one of the following violations:
a) Hindering the access to counseling on HIV/AIDS prevention and control;
b) Failing to provide HIV/AIDS counseling when providing healthcare or treatment for HIV-infected women during pregnancy or breastfeeding or persons exposed to HIV;
c) Failing to comply with pre- and post-HIV test counseling procedures/contents;
d) Providing pre- and post-HIV test counseling before completing training course in HIV/AIDS counseling;
dd) Providing HIV/AIDS counseling at a counseling facility that fails to meet eligibility requirements set by law;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
g) Failing to retain or improperly retaining HIV test results, blood samples, blood packs, blood products and specimens for HIV testing;
h) Failing to dispose of or disposing of blood samples, blood packs, blood products and specimens used for HIV testing against regulations of law;
i) Contravening regulations on HIV/AIDS reporting.
2. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for commission of one of the following violations:
a) Failing to provide pre- and post-HIV test counseling;
b) Failing to notify positive HIV test results within the prescribed time limit;
c) Failing to comply with procedures for notification of positive HIV test results;
d) Transporting or delivering positive HIV test reports against regulations of law;
dd) Failing to report on discovered substandard biologicals and equipment used for HIV testing to competent authorities;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
g) Failing to notify relevant parties and take appropriate measures upon discovery of HIV testing which fails to meet quality standards;
h) Charging for HIV tests performed in case of solicitation for judicial expertise or according to a decision of the investigating authority, people’s procuracy or people’s court or HIV tests for pregnant women of which costs are covered by other funding sources.
3. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for commission of one of the following violations:
a) Confirming positive HIV test results without obtaining certificate of eligibility to perform HIV confirmatory tests from a competent authority;
b) Failing to comply with instructions of the Ministry of Health when conducting HIV tests;
c) Failing to satisfy one of the conditions for HIV testing after obtaining the certificate of eligibility to perform HIV tests;
d) Confirming positive HIV test results within the period of suspension of HIV confirmatory tests;
dd) Notifying positive HIV test results to entities other than the ones prescribed by law or disclosing positive HIV test results which must be kept confidential as prescribed by law;
e) 11 Performing HIV tests for persons aged under 15, incapacitated persons, persons with limited cognition, behavior control, and persons with limited legal capacity without obtaining written consent of their parents, lawful guardians or representatives, except emergency cases prescribed in the Law on medical examination and treatment.
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
a) Forcing persons who are not subjects of HIV/AIDS epidemiological surveillance and mandatory HIV testing to be tested for HIV;
b) Performing HIV testing without obtaining the certificate of eligibility to perform HIV tests;
c) Failing to perform testing for blood bags and blood products before use.
5. Additional penalties:
a) The certificate of eligibility to perform HIV tests shall be suspended for a fixed period of 01 – 03 months in case of commission of the violation in Point e Clause 2 or Point b Clause 3 of this Article;
b) The certificate of eligibility to perform HIV tests shall be suspended for a fixed period of 03 - 06 months in case of commission of the violation in Point c or d Clause 3 of this Article;
c) Operations of the violating entity shall be suspended for a fixed period of 03 - 06 months in case of commission of the violation in Point b Clause 4 of this Article.
6. Remedial measures:
a) The entity committing the violation in Point h Clause 2 of this Article is compelled to return any amounts of money collected against regulations of law. Any payments which cannot be made to payers shall be paid to state budget in accordance with regulations of law;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
1. A fine ranging from VND 1.000.000 to VND 3.000.000 shall be imposed for commission of one of the following violations:
a) Writing prescriptions of antiretroviral drugs for HIV patients, persons exposed to HIV or pre-exposure prophylaxis before completing training courses in HIV/AIDS treatment according to regulations of the Minister of Health;
b) Failing to comply with HIV/AIDS treatment procedures and regimen promulgated by the Minister of Health when writing prescriptions of antiretroviral drugs.
2. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for commission of one of the following violations:
a) Treating for HIV with antiretroviral drugs at a facility that fails to meet eligibility requirements set by law;
b) Failing to strictly comply with regulations on prioritized access to antiretroviral drugs;
c) Failing to organize management, care and counseling for HIV patients at rehabilitation centers as prescribed by law;
d) Failing to give instructions on post-exposure prophylaxis to persons exposed to HIV;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
3. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for commission of one of the following violations:
a) Failing to monitor and treat for HIV-infected pregnant women under management;
b) Failing to provide post-exposure prophylaxis to persons exposed to HIV;
c) Hindering a HIV patient from caring for another HIV patient or accessing HIV treatment and care services;
d) Failing to ensure medical care policies for HIV infected people at social protection centers;
dd) Charging for treatment of persons exposed to HIV, persons infected with HIV due to occupational accidents or risks of medical procedures, HIV-infected women during pregnancy and HIV-infected children aged under 6 for whom antiretroviral drugs are provided free of charge by the State.
e) Charging for HIV drugs which are provided free of charge.
4. A fine ranging from VND 10.000.000 to VND 15.000.000 shall be imposed for refusing to give antiretroviral therapy for qualified HIV-infected persons as prescribed by law.
5. Remedial measure:
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Article 22. Violations against regulations on harm reduction interventions for HIV prevention
1. A warning or a fine ranging from VND 200.000 to VND 500.000 shall be imposed upon community access specialists for the commission of one of the following violations:
a) Failing to carry community access specialist’s card when performing harm reduction intervention activities for HIV prevention;
b) Using an expired community access specialist’s card when performing harm reduction intervention activities for HIV prevention, unless such use of expired card is permitted by the issuing authority pending the issuance of a new card;
c) Altering, erasing or lending the community access specialist’s card to another person.
2. A fine ranging from VND 500.000 to VND 1.000.000 shall be imposed for commission of one of the following violations:
a) Failing to give a prior notification of harm reduction intervention activities for HIV prevention to the People’s Committee and police authority of commune where such activities are performed;
b) Failing to introduce and transfer copies of treatment documents of the HIV patient who is receiving antiretroviral therapy to a new treatment facility appropriate to his/her working and living conditions;
c) Failing to receive treatment documents, which are valid as prescribed by law, of the HIV patient who is receiving antiretroviral therapy transferred from another treatment facility;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
3. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for commission of one of the following violations:
a) Using a community access specialist’s card for wrong purposes, beyond scope of operations or against provisions of the program/project for harm reduction intervention for HIV prevention;
b) Failing to cooperate with local HIV/AIDS prevention and control agencies in performing harm reduction intervention measures for HIV prevention;
c) Failing to comply with procedures for selection of patients eligible for opioid replacement therapy.
4. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for commission of one of the following violations:
a) Failing to comply with professional guidelines for opioid replacement therapy as prescribed by law;
b) Failing to treat the patient who is receiving opioid replacement therapy transferred from another treatment facility;
c) An accommodation facility’s failure to provide condoms as prescribed by law.
5. A fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed for commission of one of the following violations:
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
b) Failing to submit the list of patients, their health status and compliance with opioid replacement therapy to competent authorities as prescribed by law;
c) Selling condoms, syringes with needles, drugs and biologicals which are provided free of charge as prescribed by law or which are subsidized at higher prices;
d) Providing opioid replacement therapy to ineligible persons;
dd) Forcing persons dependent on opioid to receive opioid replacement therapy in any form.
6. A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed for commission of one of the following violations:
a) Providing opioid replacement therapy at a facility that does not complete procedures for declaration of eligibility to provide opioid replacement therapy;
b) Failing to print the phrase “cung cấp miễn phí, không được bán” (“provided free of charge. Not for sale”) on packages or auxiliary labels of condoms and syringes with needles of the program/projects on harm reduction intervention for HIV prevention;
c) Providing opioid replacement therapy with using drugs which are not yet permitted for sale in Vietnam.
7. Additional penalties:
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
b) Operation of the violating entity shall be suspended for a fixed period of 01 – 03 months in case of commission of the violation in Point a Clause 5 or Point a or c Clause 6 of this Article;
c) The exhibit of the violation in Point b or c Clause 1 of this Article which is the community access specialist’s card shall be confiscated.
8. Remedial measures:
a) The violating entity is compelled to return any benefits illegally obtained from the commission of the violation in Point c Clause 5 or Point a Clause 6 of this Article;
b) The drugs involving the violation in Point c Clause 6 of this Article shall be destroyed.
Article 23. Violations against HIV anti-discrimination regulations
1. A fine ranging from VND 500.000 to VND 1.000.000 shall be imposed for commission of one of the following violations:
a) Requesting pupils, students, trainees or applicants for admission to undergo HIV tests or provide their HIV test reports;
b) Hindering pupils, students or trainees from participating in an educational institution’s activities/services because they themselves or their family members are living with HIV;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
d) Refusing to receive bodies of persons died from HIV/AIDS for burial or cremation.
2. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for commission of one of the following violations:
a) Requesting applicants for job to undergo HIV tests or present their HIV test reports, or refusing to employ them because they are infected with HIV, except some jobs for which applicants are required to undergo pre-employment HIV tests as prescribed by the Government;
b) Refusing admission of pupils, students or trainees who are infected with HIV;
c) Refusing admission of social protection beneficiaries to a social protection center because they are living with HIV;
d) Abandoning HIV-infected juvenile children or HIV-infected wards;
dd) Isolating, restricting or prohibiting HIV-infected pupils, students or trainees to/from a facility/institution’s activities and/or services;
e) Practicing discrimination in care and treatment of HIV patients;
g) Arranging jobs/works inappropriate to health status and qualification of HIV-infected workers.
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
a) Terminating signed employment contracts or public employee contracts or causing difficulties during employment because employees are infected with HIV;
b) Forcing employees who are still fit for their current job positions to transfer to other job positions because they are infected with HIV;
c) Refusing to accept pay raise/promotion claims or failing to ensure lawful rights and benefits of employees who are infected with HIV;
d) Discipline or expel pupils, students or trainees for HIV infection;
dd) Using images/media messages that discriminate against HIV-infected persons and/or their family members.
4. Remedial measures:
a) Enforced receipt and burial or cremation of HIV-infected bodies or remains in case of commission of the violation in Point d Clause 1 of this Article;
b) Enforced admission of HIV-infected persons in case of commission of the violation in Point b or c Clause 2 or Point a Clause 3 of this Article;
c) The violating entity is compelled to make direct apologies to persons who have been unfairly discriminated against in case of commission of the violation in Point e Clause 2 or Point dd Clause 3 of this Article;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
dd) Enforced provision of lawful rights and benefits to HIV-infected employees in case of commission of the violation in Point c Clause 3 of this Article;
e) The entity committing the violation in Point d Clause 3 of this Article is compelled to abrogate the decision to discipline or expel pupil, student or trainee for HIV infection;
g) Enforced removal of violating elements in case of commission of the violation in Point dd Clause 3 of this Article. If violating elements cannot be removed, medical products shall be destroyed.
Article 24. Violations against other regulations on HIV/AIDS prevention and control
1. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for hindering employees from participating in HIV/AIDS prevention and control activities.
2. A fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed for commission of one of the following violations:
a) Threatening to transmit HIV to others;
b) Taking advantage of HIV/AIDS prevention and control for profiteering.
3. Remedial measure:
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Article 25. Violations against regulations on non-smoking areas
1. A warning or a fine ranging from VND 200.000 to VND 500.000 shall be imposed for smoking in non-smoking areas. Acts of inflight smoking shall be penalized in accordance with regulations on penalties for administrative violations in civil aviation sector.
2. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for commission of one of the following violations:
a) Failing to display “non-smoking” words or signs at non-smoking areas as prescribed by law;
b) Failing to organize, instruct, inspect and expedite the implementation of smoking bans in areas under management.
3. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for commission of one of the following violations in designated smoking areas:
a) Failing to provide rooms and air ventilation systems separate from non-smoking areas;
b) Failing to provide containers of tobacco butts and ashes;
c) Failing to display signs at suitable and prominent positions;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Article 26. Violations against regulations on sale and supply of tobacco
1. A fine ranging from VND 1.000.000 to VND 3.000.000 shall be imposed for failing to display the notice stating “It is illegal to sell tobacco products to anyone under the age of 18” at points of sale of tobacco wholesale or retail dealers.
2. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for commission of one of the following violations:
a) Displaying more than one pack, carton or box of a tobacco brand at a tobacco retail agent or point of sale;
b) Selling or supplying tobacco products to persons aged under 18;
c) Selling or supplying tobacco products which are not labeled or whose packages do not indicate health warning as prescribed by law. If tobacco products which are not labeled or whose packages do not indicate health warning are illegally imported, the violation shall be penalized in accordance with regulations on penalties for administrative violations against regulations on commerce, production and trade in counterfeit and prohibited goods, and protection of consumer rights.
3. Additional penalty:
Business operations involving the violation in Clause 2 of this Article shall be suspended for a fixed period of 01 – 03 months.
4. Remedial measure:
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
1. A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed for commission of one of the following violations:
a) Failing to comply with the prescribed form, position, area and color of the health warning printed on tobacco packages;
b) Failing to change the health warning printed on tobacco packages for every 2 years as prescribed by law;
c) Failing to indicate the quantity of cigarettes on each cigarette pack or the weight on other tobacco products;
d) Using words or phrases that mislead readers or users into believing that tobacco only causes little harm, or cause them to misunderstand the harms of tobacco and tobacco smoke to human health.
2. A fine ranging from VND 30.000.000 to VND 40.000.000 shall be imposed for commission of one of the following violations:
a) Failing to print health warnings on packages of tobacco products manufactured or imported for sale in Vietnam;
b) Signing contracts for production of foreign-branded tobacco products for sale in Vietnam without obtaining a permit from a competent authority.
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Business operations involving the violation in Clause 2 of this Article shall be suspended for a fixed period of 03 – 06 months.
4. Remedial measures:
a) The entity committing the violation in Clause 1 or Point a Clause 2 of this Article is compelled to recall tobacco products and rectify or remove violating elements. If violating elements cannot be rectified, tobacco products shall be destroyed.
b) The violating entity is compelled to return any benefits illegally obtained from the commission of the violation in Point b Clause 2 of this Article.
Article 28. Violations against regulations on smoking cessation
A fine ranging from VND 1.000.000 to VND 2.000.000 shall be imposed for commission of one of the following violations:
1. Failing to have a separate place for providing direct counseling on smoking cessation as prescribed by law.
2. Failing to prepare media documents on smoking cessation and smoking cessation counseling.
3. Failing to equip telephones, internet or other means of communication to serve the provision of indirect smoking cessation counseling.
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Article 29. Violations against other regulations on prevention and control of tobacco harms
1. A warning or a fine ranging from VND 200.000 to VND 500.000 shall be imposed upon a person aged from 16 to under 18 for smoking.
2. A fine ranging from VND 500.000 to VND 1.000.000 shall be imposed for commission of one of the following violations:
a) Encouraging or forcing others to smoke;
b) Requesting persons aged under 18 to buy tobacco products.
3. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for commission of one of the following violations:
a) Using tobacco images on newspapers or publications for children;
b) Providing information without scientific grounds or inaccurate information on tobacco and its harms;
c) Failing to include contents about prevention and control of tobacco harms in annual operation plan or failing to include workplace smoking bans in internal regulations;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
4. A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed for commission of one of the following violations:
a) Using name, brand and symbols of tobacco products on other products/services;
b) Performing direct marketing of tobacco products to consumers in any forms;
c) Allowing the provision of direct-to-consumer tobacco marketing in facilities under their management;
d) Delaying payment of compulsory contributions as prescribed by law;
dd) Making false statements resulting in insufficient payment of compulsory contributions as prescribed by law;
e) Using funds derived from the Fund for prevention and control of tobacco harms against regulations of law;
g) Disseminating information or notices of sponsors by tobacco traders.
5. A fine ranging from VND 30.000.000 to VND 40.000.000 shall be imposed for commission of one of the following violations:
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
b) Evading or cheating on payment of compulsory contributions as prescribed by law.
6. Remedial measures:
a) The entity committing the violation in Point a, b or d Clause 3 or Point a Clause 4 of this Article is compelled to recall tobacco products and rectify or remove violating elements. If violating elements cannot be rectified, tobacco products shall be destroyed.
b) The entity committing the violation in Point d Clause 4 of this Article is compelled to pay interests on late payment of compulsory contributions;
c) The entity committing the violation in Point e Clause 4 of this Article is compelled to return any amounts of money used against regulations of law;
d) The entity committing the violation in Point dd Clause 4 or Point b Clause 5 of this Article is compelled to pay compulsory contributions and any interests arising from false declaration, evasion or cheating on payment of compulsory contributions.
1. A warning or a fine ranging from VND 200.000 to VND 500.000 shall be imposed upon a person aged from 16 to under 18 for consumption of alcoholic beverages.
2. A fine ranging from VND 500.000 to VND 1.000.000 shall be imposed for commission of one of the following violations:
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
b) Inciting, persuading and forcing others to consume alcoholic beverages.
3. A fine ranging from VND 1.000.000 to VND 3.000.000 shall be imposed for commission of one of the following violations:
a) Consuming alcoholic beverages before or during working or learning hours or break times;
b) Forcing others to consume alcoholic beverages.
Article 31. Violations against regulations on sale and supply of alcoholic beverages
1. A fine ranging from VND 1.000.000 to VND 3.000.000 shall be imposed for commission of one of the following violations:
a) Selling or supplying alcoholic beverages to persons aged under 18;
b) Failing to post a notice stating that “It’s is illegal to sell alcoholic beverages to anyone under the age of 18” at a prominent place in the establishment that sells alcoholic beverages.
2. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for commission of one of the following violations:
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
b) Establishing a new on-premise establishment within a radius of 100 m from the outer boundary of a health facility, kindergarten, nursery school, pre-school or general education school.
3. A fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed for failing to satisfy one of the conditions when selling alcoholic beverages through e-commerce.
4. Additional penalty:
The license to trade alcoholic beverages shall be suspended for a fixed period of 01 - 03 months in case of commission of the violation in Point b Clause 2 or Clause 3 of this Article.
Article 32. Violations against regulations on sales promotion of alcoholic beverages
12A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed for commission of one of the following violations:
1. Offering discounts on alcoholic beverages to persons aged under 18.
2. Running sales promotions of alcoholic beverages having at least 15% ABV.
3. Using alcoholic beverages having at least 15% ABV to run sales promotion in any form.
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Article 33. Violations against regulations on advertising of alcoholic beverages
1. A fine ranging from VND 15.000.000 to VND 20.000.000 shall be imposed for employing persons aged under 18 to directly engage in advertising of alcoholic beverages.
2. A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed for one of the following acts of advertising spirits having less than 15 ABV and beer products:
a) An advertisement contains information/images aimed at encouraging alcoholic beverage consumption, saying that alcoholic beverages may enable the maturity, success, friendliness and sex appeal, or being directed towards children, students, adolescents and pregnant women;
b) An advertisement uses objects, images, symbols, music, movie characters and brands of products intended for children, pupils and students, or uses images of persons aged under 18;
c) Alcoholic beverages are advertised in advertising events or through advertising facilities/products that are intended for persons aged under 18, pupils, students, adolescents and pregnant women;
d) Alcoholic beverages are advertised on vehicles;
dd) Alcoholic beverages are advertised on audio or visual newspapers before, during or after a children's program, or from 18:00 PM to 21:00 PM daily, unless permitted by law;
e) Alcoholic beverages are advertised through outdoor advertising facilities that violate regulations on sizes and placement distance from educational institutions, nursing care centers and recreational centers intended for persons aged under 18;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
h) Failing to run a filtering system or access control software to prevent persons aged under 18 from accessing and searching for information about alcoholic beverages when running advertisements on online newspapers, websites, electronic equipment, terminal devices and other telecommunications equipment.
3. A fine ranging from VND 30.000.000 to VND 40.000.000 shall be imposed for one of the following acts of advertising spirits having from 5.5 to less than 15% ABV and beer products having at least 5.5% ABV:
a) Advertisements are displayed in art performance or sports programs;
b) Advertisements are placed on outdoor advertising facilities, except for signboards of alcoholic beverage traders.
4. Additional penalty:
The advertising of alcoholic beverages shall be suspended for a fixed period of 01- 03 months in case of commission of the violation in Point h Clause 2 of this Article.
5. Remedial measure:
Advertisements shall be taken back and have their violating elements removed in case of commission of one of the violations in Clauses 1, 2 and 3 of this Article.
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
a) Failing to organize the implementation of measures for preventing and controlling harmful effects of alcoholic beverages;
b) Failing to organize the implementation of regulations on prohibition on consumption of alcoholic beverages during working hours and at workplaces;
c) Failing to warn or request persons who consume or sell alcoholic beverages at places where the consumption or sale of alcoholic beverages is not allowed under their management to stop their violations;
d) Failing to organize, instruct, inspect and expedite the implementation of regulations on prohibition on consumption and sale of alcoholic beverages at places under their management.
2. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed upon a head of transport company or vehicle owner for failing to implement measures for detecting and preventing vehicle operators from consuming alcoholic beverages before and while driving.
Article 35. Violations against regulations on responsibilities of alcoholic beverage traders
1. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for commission of one of the following violations:
a) Failing to provide adequate and accurate information on their business at the request of competent authorities;
b) Failing to remind or post a sign warning customers not to drive after drinking.
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
a) Employing persons aged under 18 to directly engage in trading of alcoholic beverages.
b) Providing inaccurate information or information without scientific grounds about alcoholic beverages.
3. Remedial measure:
The violating entity is compelled to remove violating elements on alcoholic beverage products (if any) and correct inaccurate information in case of commission of the violation in Point b Clause 2 of this Article.
1. A fine ranging from VND 500.000 to VND 1.000.000 shall be imposed for failing to educate, supervise and remind family members aged under 18 not to consume alcoholic beverages.
2. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for failing to ensure accuracy, objectivity and rationality when disseminating and providing information and education about prevention and control of harmful effects of alcoholic beverages.
3. A fine ranging from VND 10.000.000 to VND 15.000.000 shall be imposed for providing inaccurate or misleading information on affects of alcoholic beverages on health.
4. Remedial measure:
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Article 37. Violations against regulations on alcoholic beverage sponsorship
A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed for providing alcoholic beverages as part of the sponsorship.
Section 2. VIOLATIONS AGAINST REGULATIONS ON MEDICAL EXAMINATION AND TREATMENT
1. A warning or a fine ranging from VND 200.000 to VND 500.000 shall be imposed for commission of one of the following violations:
a) Failing to wear name badges;
b) Failing to wear personal protective equipment as prescribed by law.
2. A fine ranging from VND 500.000 to VND 1.000.000 shall be imposed for commission of one of the following violations:
a) Failing to conclude an internship contract with a new intern of the health facility or failing to use the prescribed form of internship contract;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
c) Assigning a practical instructor to instruct more than 05 interns at the same time.
3. A fine ranging from VND 1.000.000 to VND 3.000.000 shall be imposed for commission of one of the following violations:
a) Failing to report a competent person or failing to introduce the patient to another health facility when refusing to provide medical examination and treatment in case a disease is beyond the capacity or scope of professional activities of the medical practitioner;
b) Requesting patients to pay costs of medical services which are not publicly posted as prescribed by law;
c) Disclosing health status, information provided by the patient and medical record, unless they are disclosed with the patient’s consent or for sharing information/experience for improving quality of diagnosis, healthcare and treatment of the patient between practitioners who directly treat the patient or in other cases prescribed by law;
d) Issuing certificate of internship completion without using the form prescribed by law.
4. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for commission of one of the following violations:
a) 13 Registering for practicing at multiple health facilities for the same period of time; failing to comply with the practicing period approved by a competent authority or transfer or assignment orders of competent authorities as prescribed by law;
b) Failing to issue the certificate of internship completion after the intern has successfully completed his/her internship as prescribed by law;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
d) Assigning unqualified practical instructors to instruct interns;
dd) 14 Failing to apply for certificate of practicing in medical examination and treatment in accordance with regulations of law.
5. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for commission of one of the following violations:
a) Hindering patients who are placed on compulsory treatment orders to entering the health facility;
b) Requesting patients to use medical services or suggesting them for other health facilities in their own self-interest;
c) Taking advantage of the job to offend honor or dignity of, or bodily harm the patient;
d) A foreigner directly provides medical examination and treatment in Vietnamese but does not obtain a certificate of proficiency in Vietnamese issued by a medical training institution designated by the Minister of Health, or in a language other than Vietnamese without completing registration procedures;
dd) Prescribing in a language other than Vietnamese which is not yet registered or of which the translator is unqualified to translate it into Vietnamese;
e) Falsifying information on medical examination and treatment by erasing or altering medical records;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
h) Acting as the chief physician of two or more health facilities;
i) Acting as the head of two or more clinical departments of the same health facility, or acting as the head of department of another health facility within the same practicing period;
k) The chief physician of a health facility concurrently acts as the head of a department of that health facility which is not appropriate to the practicing scope specified in his/her practicing certificate;
l) The chief physician of a health facility does not authorize another during his/her absence from the health facility during its operation period;
m) 15 Failing to comply with human resource mobilization decisions issued by competent authorities in case of disasters or dangerous epidemics.
6. A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed for commission of one of the following violations:
a) Selling drugs to patients in any forms, except for the sale of traditional drugs as prescribed by law;
b) Offering, taking or brokering bribes in medical examination and treatment.
7. A fine ranging from VND 30.000.000 to VND 40.000.000 shall be imposed for commission of one of the following violations:
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
b) Providing medical examination and treatment while the practicing certificate is suspended or revoked;
c) Providing medical examination and treatment beyond the practicing scope specified in the practicing certificate, except emergency cases and provision of additional technical procedures which have been permitted as prescribed by law;
d) Using a rented or borrowed medical examination and treatment practicing certificate;
dd) Renting or lending a medical examination and treatment practicing certificate;
e) Failing to provide first aids, emergency treatment or medical treatment to patients in a timely manner;
g) Refusing to provide medical examination and treatment for patients, except cases of refusal prescribed by law.
8. Additional penalties:
a) 16 The medical examination and treatment practicing certificate shall be suspended for a fixed period of 01 – 03 months in case of commission of the violation in Point b, c, d, dd, e, g, h, i, k, l or m Clause 5 of this Article;
b) The medical examination and treatment practicing certificate shall be suspended for a fixed period of 03 - 06 months in case of commission of the violation in Clause 6 of this Article;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
d) The medical examination and treatment practicing certificate shall be suspended for a fixed period of 22 - 24 months in case of commission of the violation in Point b, c, d or dd Clause 7 of this Article;
dd) Foreigners who re-commit the violation in Clause 7 of this Article shall be deported.
9. Remedial measures:
a) The entity committing the violation in Point c Clause 5 of this Article is compelled to make direct apologies to patients;
b) The violating entity is compelled to return any benefits illegally obtained from the commission of the violation in Point b Clause 6 or Point a, b, c, d or dd Clause 7 of this Article;
c) 17 Enforced return of medical examination and treatment practicing certificate to the issuing authority in case of commission of the violation in Point d or Point dd Clause 7 of this Article.
1. A fine ranging from VND 1.000.000 to VND 3.000.000 shall be imposed for commission of one of the following violations:
a) Failing to hang a signboard or hanging a signboard which does not contain adequate primary information as prescribed by law;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
c) Using names of departments/wards of the health facility other than those specified in the application for license for medical operations which has been approved by a competent authority.
2. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for commission of one of the following violations:
a) Failing to report the replacement of the chief physician of the health facility to the licensing authority;
b) Failing to report replacement of practitioners to competent authorities as prescribed by law;
c)18 (abrogated);
d) (abrogated);
dd) Failing to satisfy one of eligibility requirements after obtaining the license for medical operations or send a written notification of satisfaction of eligibility requirements to a competent authority, except polyclinics and hospitals.
2a. 19 A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for commission of one of the following violations:
a) Charging medical examination and treatment services at prices higher than the ones posted;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
3. A fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed for commission of one of the following violations:
a) Deliberately providing mandatory treatment for persons who are ineligible for mandatory disease treatment;
b) A polyclinic fails to satisfy one of eligibility requirements after obtaining the license for medical operations.
4. A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed for commission of one of the following violations:
a) Employing a practitioner who does not possess any practicing certificate or whose practicing certificate has been revoked or suspended;
b) Failing to comply with personnel arrangement decisions issued by competent authorities in case of disasters or dangerous epidemics;
c) A hospital with fewer than 100 beds fails to satisfy one of eligibility requirements after obtaining the license for medical operations.
5. A fine ranging from VND 30.000.000 to VND 40.000.000 shall be imposed for commission of one of the following violations:
a) Using a rented or borrowed license for medical operations;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
c) A hospital with 100 to 500 beds fails to satisfy one of eligibility requirements after obtaining the license for medical operations.
6. A fine ranging from VND 40.000.000 to VND 50.000.000 shall be imposed for commission of one of the following violations:
a) Providing medical services without obtaining license for medical operations, or during the suspension period of the license for medical operations, or at a location which is not specified in the license for medical operations;
b) Providing medical services beyond the scope of the license for medical operations, except emergency cases;
c) Applying new medical procedures without obtaining permission from the Minister of Health or Director of the relevant Provincial Department of Health;
d) A hospital with more than 500 beds fails to satisfy one of eligibility requirements after obtaining the license for medical operations;
dd) Providing cosmetological services before sending written notification of satisfaction of eligibility requirements to competent authorities as prescribed by law;
e) Providing inpatient treatment without obtaining permission for inpatient treatment services, unless outpatients are kept for health monitoring as prescribed by law.
7. Additional penalties:
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
b) The license for medical operations shall be suspended for a fixed period of 12 - 24 months in case of commission of the violation in Point a or b Clause 5 of this Article;
c) Operations of the violating entity shall be suspended for a fixed period of 12 - 24 months in case of commission of the violation in Point a or dd Clause 6 of this Article;
d) The medical examination and treatment practicing certificate shall be suspended for a fixed period of 01 – 03 months in case of commission of the violation in Point a Clause 3 or Point c Clause 6 of this Article;
dd) The medical examination and treatment practicing certificate of the chief physician of the health facility shall be suspended for a fixed period of 01 – 03 months in case of commission of the violation in Point a Clause 4 or Point b or e Clause 6 of this Article.
8. Remedial measures:
a) The entity committing the violation in Point c or d Clause 2 of this Article is compelled to return any amounts of money collected against regulations of law. Any payments which cannot be made to payers shall be paid to state budget in accordance with regulations of law;
b) The violating entity is compelled to return any benefits illegally obtained from the commission of the violation in Point a or b Clause 5 of this Article;
c) 21 Enforced return of medical examination and treatment practicing certificate to the issuing authority in case of commission of the violation in Point a or Point b Clause 5 of this Article.
Article 40. Violations against regulations on technical and professional qualifications
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
a) Failing to prepare or preparing medical records which do not contain clear and adequate contents as those included in the medical record form prescribed by law;
b) Failing to issue or issuing an outpatient’s medical examination book which does not contain clear and adequate personal details of the patient, diagnosis, treatment indications, prescriptions and follow-up examination;
c) Failing to retain medical records as prescribed by law;
d) Failing to submit reports on medical operations as prescribed by law;
dd)22 Failing to prepare medical records or preparing medical records which fail to have adequate information as prescribed by law.
2. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for commission of one of the following violations:
a) Abandoning patients who do not have relatives;
b) Abandoning dead patients;
c) Failing to keep or organize watch at a health facility as prescribed;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
3. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for commission of one of the following violations:
a) Failing to organize medical consultations for diseases beyond capacity of a practitioner or a health facility;
b) Failing to hold medical consultations about a disease that does not respond well to treatment or becomes more severe.
4. A fine ranging from VND 10.000.000 to VND 15.000.000 shall be imposed for failing to transfer emergency patients to appropriate health facilities when their medical conditions are beyond the health facility’s capacity.
5. A fine ranging from VND 15.000.000 to VND 20.000.000 shall be imposed for commission of one of the following violations:
a) Performing surgeries, minor surgeries or other surgical interventions of class III or higher without obtaining the patient or his/her representative's written consent, unless the patient's life will be threatened if the surgery or surgical intervention is not performed;
b) Failing to equip sufficient and appropriate means of emergency transport; medical equipment/devices and essential medicines to provide timely emergency treatment to patients.
6. A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed for using drugs, substances or equipment for interventions in human body (surgeries, minor surgeries, interventions involving injection, pumping, ray emission, firing or other interventions) that change the color of skin, shape, weight and shortcomings of body parts (skin, nose, eyes, lips, face, belly, buttock and other parts) or providing services of doing tattoos or spraying or embroidering pictures on the surface of the skin with injection of anesthetics at a facility other than a hospital with cosmetological specialty, specialized cosmetological clinic, or a health facility with cosmetological specialty.
7. A fine ranging from VND 40.000.000 to VND 50.000.000 shall be imposed for committing a violation against regulations on technical and professional qualifications in medical examination and treatment that causes injuries to patients.
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
a) The medical examination and treatment practicing certificate shall be suspended for a fixed period of 01 – 03 months in case of commission of the violation in Point a or b Clause 1, Point c Clause 2, Clause 3 or Clause 4 of this Article;
b) The medical examination and treatment practicing certificate shall be suspended for a fixed period of 03 - 06 months in case of commission of the violation in Clause 5 or 7 of this Article;
c) The license for medical operations shall be suspended for a fixed period of 01 – 03 months in case of re-commission of one of the violations in Clauses 1, 2, 3, 4 and Point a Clause 5 of this Article, or commission of 03 or more of the said violations at the same time;
d) A part of operations (ward, department, center, unit or division committing the violation) or the license for medical operations of the violating entity (if the violation influences on all of its operations) shall be suspended for a fixed period of 03 - 06 months in case of commission of the violation in Point b Clause 5 or Clause 7 of this Article;
dd) Operations of the violating entity shall be suspended for a fixed period of 03 - 06 months in case of commission of the violation in Clause 6 of this Article.
9. Remedial measure:
The violating entity is compelled to pay entire costs of medical services in case of commission of the violation in Clause 3 or 7 of this Article.
1. A fine ranging from VND 1.000.000 to VND 2.000.000 shall be imposed for commission of one of the following violations:
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
b) Failing to check prescriptions, medication request forms, content, dosage, administration route, names and quality of drugs before dispensing drugs to patients;
c) Failing to compare prescriptions with information on concentration, content and quantity of drugs when receiving drugs and expiry dates specified in medication request forms and drug labels when dispensing drugs to patients;
d) Failing to check full names of patients, names of drugs, dosage forms, content, dosage, administration route and times to take drugs before administering drugs to patients;
dd) Failing to fully record times of dispensing drugs to patients;
e) Failing to track and record clinical response of patients as taking drugs in medical records; failing to punctually detect and report drug use-related complications to treating physicians when dispensing drugs to patients.
2. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for failing to monitor drug’s effectiveness and punctually handle drug use-related complications in patients receiving direct treatment from and using drugs as indicated by the physician.
3. A fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed for commission of one of the following violations:
a) Prescribing proprietary drugs which are expensive and unnecessary for treatment for personal interests;
b) Writing out prescriptions which are not conformable with medical diagnosis results and the severity of illness;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
d) Writing out prescriptions clinical guidelines on diagnosis and treatment or clinical guidelines on HIV/AIDS treatment and care promulgated or recognized by the Ministry of Health, clinical guidelines on diagnosis and treatment formulated by the health facility, package inserts accompanied with drugs licensed for sale or the National Pharmacopoeia of Vietnam.
4. A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed for using expired or substandard drugs or drugs which are not yet granted import license or certificate of drug registration, except drugs of which certificate of registration is not required as prescribed by law.
5. Additional penalty:
The medical examination and treatment practicing certificate shall be suspended for a fixed period of 01 – 03 months in case of commission of the violation in Point e Clause 1, Clause 2, Clause 3 or Clause 4 of this Article.
6. Remedial measure:
The violating entity is compelled to pay entire costs of medical services in case of commission of the violation in Clause 2 of this Article.
Article 42. Violations against regulations on in-vitro fertilization
1. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for failing to submit reports on the provision of IVF and surrogacy services to the Ministry of Health as prescribed by law.
2. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for failing to perform medical examination and testing of sperm and egg donors for infectious diseases, mental disorder or another health condition that makes them lose their awareness or control of their acts, and HIV infection.
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
a) Providing names, addresses or images of sperm donors or sperm or embryo recipients;
b) Using sperm or eggs of a donor for two or more recipients, except unsuccessful childbirth;
c) Failing to destroy or donate unused donor sperm or eggs to scientific research institutes in case of successful childbirth;
d) Failing to encode donor sperm and eggs, or failing to specify characteristics of donors, especially their race, of encoded donor sperm and eggs;
dd) Storing sperm, eggs or embryos at a health facility that is not allowed to perform IVF;
e) Failing to destroy sperm, eggs or embryos when receiving a notice and a lawful copy of the death certificate of the depositor from his/her family, unless the depositor's spouse makes a written request for continued storage and still pays storage and preservation charges;
g) Destroying sperm, eggs or embryos of a depositor who has died while his/her spouse has submitted a written request for continued storage and still pays storage and preservation charges;
h) Failing to destroy sperm or eggs at the request of the depositor who gets divorced;
i) Failing to destroy embryos at the written request of the couple after they gets divorced;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
l) Failing to adhere to the principle of anonymity of gamete donors when donating and receiving sperm/embryos; failing to encode information on depositors who donate their deposited sperm, eggs or embryos to the storage facility for further use for others, unless they are donated to scientific research purposes;
m) Accepting requests for storage of sperm, eggs or embryos in cases other than those prescribed by law.
4. A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed for commission of one of the following violations:
a) Donating sperm or eggs at two or more health facilities qualified to perform IVF as certified by the Ministry of Health;
b) Failing to comply with technical procedures or regulations on health standards of persons receiving IVF treatment, having pregnancy and giving birth adopted by the Minister of Health;
c) Providing IVF treatment for a person who is ineligible to receive sperm, egg or embryo as prescribed by law;
d) Using surplus embryos for perform IVF without valid donation contracts;
dd) Using surplus embryos donated under a donation contract for two or more other recipients, except unsuccessful childbirth;
e) Failing to destroy or donate surplus embryos to the health facility for scientific research purposes in case of successful childbirth;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
5. A fine ranging from VND 30.000.000 to VND 40.000.000 shall be imposed for commission of one of the following violations:
a) Performing IVF without obtaining certification of eligibility to perform IFV as prescribed by law;
b) Failing to satisfy one of eligibility requirements after obtaining certification of eligibility to perform IFV.
6. Additional penalties:
a) The provision of IVF treatment shall be suspended for a fixed period of 01 – 03 months in case of commission of 03 or more of the violations in Clauses 1, 2, 3 and Points c, d, dd, e, g Clause 4 of this Article;
b) The provision of IVF treatment shall be suspended for a fixed period of 06 – 12 months in case of commission of the violation in Point b Clause 4 or Clause 5 of this Article.
Article 43. Violations against regulations on altruistic surrogacy
1. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for commission of one of the following violations:
a) Providing health counseling for intended parents and surrogates by a person who is not a qualified obstetrician;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
c) Failing to possess a bachelor of laws degree or higher when providing legal counseling for intended parents and surrogates;
d) Failing to provide adequate counseling contents for the intended parents and surrogate.
2. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for commission of one of the following violations:
a) Failing to provide health, legal and psychological counseling for the intended parents, except cases where such counseling is not required as prescribed by law;
b) Failing to provide health, legal and psychological counseling for the surrogate, except cases where such counseling is not required as prescribed by law;
c) Failing to sign and specify full name, position, working place and counseling date on the written certification of counseling contents.
3. A fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed for providing name, age, address or images of the intended parents, surrogate or the child born through altruistic surrogacy.
4. A fine ranging from VND 30.000.000 to VND 40.000.000 shall be imposed for commission of one of the following violations:
a) Performing altruistic surrogacy technique without obtaining certification of eligibility to perform altruistic surrogacy technique;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
5. Additional penalties:
a) The provision of altruistic surrogacy service shall be suspended for a fixed period of 01 – 03 months in case of commission of 03 or more of the violations in Clauses 1, 2, 3 of this Article;
b) Operations involving the violation in Clause 4 of this Article shall be suspended for a fixed period of 06 – 12 months.
1. A fine ranging from VND 1.000.000 to VND 2.000.000 shall be imposed for commission of one of the following violations:
a) Failing to provide direct counseling on donation and removal of tissues and organs for the donor when receiving a notice from Vietnam National Coordinating Center for Human Organ Transplantation;
b) Failing to give instructions to complete the donation registration form when receiving a notice from Vietnam National Coordinating Center for Human Organ Transplantation;
c) Failing to perform health check for a living donor before removing a tissue or organ from his/her body;
d) Failing to submit the list of registered living donors to the Vietnam National Coordinating Center for Human Organ Transplantation;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
2. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for charging post-donation healthcare and periodic health check-ups provided for a living donor.
3. A fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed for failing to satisfy one of operating conditions after obtaining the license to operate tissue bank.
4. A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed for running a tissue bank without possessing a valid license.
5. A fine ranging from VND 30.000.000 to VND 40.000.000 shall be imposed for commission of one of the following violations:
a) Disclosing information or personal privacy of the donor and recipient, unless agreed in writing by the persons concerned or otherwise prescribed by law;
b) Removing a non-regenerable organ from a living body without obtaining a written approval from the advisory council for human organ transplantation of the health facility;
c) Storing human tissues and organs for commercial purposes.
6. A fine ranging from VND 60.000.000 to VND 80.000.000 shall be imposed for commission of one of the following violations:
a) Removing, transplanting or using human tissues and organs for commercial purposes, except trading or appropriation of human tissues and organs;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
7. A fine ranging from VND 80.000.000 to VND 100.000.000 shall be imposed for commission of one of the following violations:
a) Forcing others to donate their human tissues/organs or removing human tissues/organs from involuntary donors;
b) Removing human tissues/organs from living donors aged under 18;
c) Transplanting human tissues/organs removed from persons infected with diseases included in the list of diseases issued by a competent authority.
8. Additional penalties:
a) The license to operate tissue bank shall be suspended for a fixed period of 03 - 06 months in case of commission of the violation in Clause 3 or Point c Clause 5 of this Article;
b) Partial operations of the health entity involving the violation in Point c or dd Clause 1 or Point b Clause 5 of this Article shall be suspended for a fixed period of 01 – 03 months;
c) The license for medical operations shall be suspended for a fixed period of 03 - 06 months in case of commission of the violation in Clause 6 or 7 of this Article.
9. Remedial measures:
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
b) The violating entity is compelled to pay entire costs of medical services rendered to damaged person in case of commission of the violation in Clause 7 of this Article. The amounts of money which cannot be returned to payers shall be paid to state budget in accordance with regulations of law.
Article 45. Violations against regulations on sex reassignment
1. A fine ranging from VND 2.000.000 to VND 5.000.000 shall be imposed for commission of one of the following violations:
a) Disclosing information on sex reassignment of others;
b) Discriminating against a person whose sex is reassigned.
2. A fine ranging from VND 30.000.000 to VND 40.000.000 shall be imposed for performing sex reassignment without obtaining permission from the Minister of Health or Director of the relevant Provincial Department of Health.
3. Remedial measures:
a) The entity committing the violation in Point b Clause 1 of this Article is compelled to make direct apologies to persons who are discriminated against;
b) The violating entity is compelled to return any benefits illegally obtained from the commission of the violation in Clause 2 of this Article.
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
1. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for commission of one of the following violations:
a) Providing health check report without performing the actual examination as requested;
b) Failing to give health classification results according to the actual health conditions of the person undergoing heath check.
2. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for failing to satisfy one of eligibility requirements for health check facility.
3. A fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed for providing health check without announcing the eligibility to provide health check services.
4. Additional penalties:
a) The provision of health check services shall be suspended for a fixed period of 01 - 03 months in case of commission of the violation in Clause 2 of this Article;
b) The license for medical operations shall be suspended for a fixed period of 01 - 03 months in case of commission of the violation in Clause 3 of this Article.
Article 47. Violations against regulations on infection control in health facilities
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
a) Failing to provide counseling on infection control measures for patients and their relatives;
b) Failing to comply with regulations of law and of the health facility on infection control by persons working in the health facility, patients and other persons entering the health facility.
2. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for commission of one of the following violations:
a) Failing to implement or insufficiently implementing infection control measures at the health facility;
b) Failing to ensure material facilities, equipment, personal protective clothing and hygiene for persons working in the health facility, patients and other persons entering the health facility in conformity with infection control requirements in the health facility.
3. Additional penalties:
a) The medical examination and treatment practicing certificate shall be suspended for a fixed period of 01 - 03 months in case of commission of the violation in Point b Clause 1 of this Article;
b) The license for medical operations shall be suspended for a fixed period of 01 - 03 months in case of commission of the violation in Clause 2 of this Article.
Article 48. Violations against principles of medical examination and treatment
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
a) Failing to respect or cooperate with practitioners during the medical examination and treatment;
b) Failing to respect patient’s rights as prescribed by law;
c) Failing to comply with the practitioner’s indications for diagnosis and treatment, except prescribed cases of refusal to receive treatment.
2. A fine ranging from VND 500.000 to VND 1.000.000 shall be imposed for commission of one of the following violations:
a) Failing to provide truthful information on personal health condition or failing to cooperate with practitioners and health facility;
b) Failing to comply with the health facility’s internal regulations;
c) Failing to provide prioritized medical examination and treatment for emergency patients, children aged under 06, persons with severe disabilities, persons aged 80 or older, persons with meritorious services to the revolution and pregnant women.
3. A fine ranging from VND 1.000.000 to VND 3.000.000 shall be imposed for commission of one of the following violations:
a) Harming honor or dignity of practitioners during medical examination and treatment;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
c) Discriminating unfairly against patients.
4. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for commission of one of the following violations:
a) Failing to pay costs of medical services, except cases of exemption and reduction prescribed by law;
b) Failing to establish a specialized council to evaluate whether the unintended complication is resulted from a medical error in order to serve the settlement of a medical dispute.
5. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for failing to strictly comply with technical and professional regulations in medical examination and treatment, except the violation prescribed in another part of this Section.
6. A fine ranging from VND 30.000.000 to VND 40.000.000 shall be imposed for bodily harming or threatening the life of practitioners while they are providing medical examination and treatment.
7. Additional penalties:
a) The medical examination and treatment practicing certificate shall be suspended for a fixed period of 01 - 03 months in case of commission of the violation in Clause 5 of this Article;
b) A part of operations (ward, department, center, unit or division committing the violation) or the license for medical operations of the violating entity (if the violation influences on all of its operations) shall be suspended for a fixed period of 01 - 03 months in case of commission of the violation in Clause 5 of this Article.
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
a) The entity committing the violation in Point a Clause 1, Point a Clause 3 or Clause 6 of this Article is compelled to make direct apologies to practitioners;
b) The entity committing the violation in Point b Clause 1 or Point c Clause 3 of this Article is compelled to make direct apologies to patients.
Article 48a. Violations against regulations on clinical pharmacology of health facilities23
1. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for commission of one of the following violations:
a) Failing to assign sufficient clinical pharmacologists according to the roadmap prescribed by law;
b) Failing to assign qualified clinical pharmacologists as prescribed by law.
2. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for assigning clinical pharmacologists who do not possess pharmacy practicing certificate or whose pharmacy practicing certificate is suspended or who are suspended from pharmacy practicing.
3. A fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed for failing to organize clinical pharmacology activities according to the roadmap prescribed by law.
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
a) Guidelines for selection and use of appropriate nutritious products for infants;
b) Guidelines for cleaning and sterilization of infant feeding equipment;
c) Guidelines for cup feeding and spoon feeding;
d) Possible risks associated with the use of pacifiers, bottle feeding or complementary feeding for infant under 06 months of age;
dd) Possible risks of infection and contamination from bottle feeding and incorrect preparation and feeding of infant formulas;
e) Potential costs associated with formula feeding.
2. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for releasing documents providing information or educating about infant feeding without complying with regulations on one of the following contents:
a) Benefits and superiority of breastfeeding, affirming that breast milk is the best food for the health and all-sided growth of infants; antibacterial elements, especially antibodies, only included in breast milk, which help prevent and control diarrhea, respiratory infection and some other infectious diseases;
b) Instructions on exclusive breastfeeding for 06 months and then continued breastfeeding for 24 months or as long as mother and baby desire, and appropriate complementary feeding from 07 months;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
d) Negative effects of bottle feeding, use of pacifiers or complementary feeding for infant under 06 months of age;
dd) Instructions on preparation, storage, selection and use of complementary foods at home through simple ways to ensure safety and rational nutrition with available foods;
e) Instructions on diet for breastfeeding mothers.
3. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for releasing documents providing information or educating about infant feeding but containing one of the following contents:
a) Images, words or other communication forms to encourage the formula feeding or bottle feeding or discourage the breastfeeding;
b) Comparisons leading to the conclusion that the infant formula is as good as or better than breast milk;
c) Names or logos of infant formulas, feeding bottles or pacifiers.
4. A fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed for failing to prioritize the dissemination of information and education about breastfeeding benefits and infant feeding methods in programs on dissemination of information and education about maternal and child health protection and child nutrition improvement.
5. Remedial measure:
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Article 50. Violations against regulations on advertising of nutritious products for infants
1. A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed for failing to meet the following requirements when advertising for complementary foods for infants under 24 months of age:
a) The first part of an advertisement must contain the phrase "Sữa mẹ là thức ăn tốt nhất cho sức khỏe và sự phát triển toàn diện của trẻ nhỏ" “Breast milk is the best food for health and complete growth of infants”;
b) The advertisement must contain the phrase “Sản phẩm này là thức ăn bổ sung và được ăn thêm cùng với sữa mẹ dùng cho trẻ trên 06 tháng tuổi” (“This product is a complementary food and is combined with breast milk fed to infants after 06 months of age”).
2. A fine ranging from VND 40.000.000 to VND 50.000.000 shall be imposed for using foetus or infant images in advertisements for milk products for pregnant women.
3. Remedial measure:
Violating elements must be removed in case of commission of the violation in Clause 1 or Clause 2 of this Article.
Article 51. Violations against regulations on trading and use of nutritious products for infants
1. A fine ranging from VND 1.000.000 to VND 3.000.000 shall be imposed for commission of one of the following violations:
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
b) Informing pregnant women, nursing mothers or their family members that formula feeding is as good as or better than breastfeeding.
2. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for commission of one of the following violations:
a) Failing to provide accurate and scientific information on and correct usage of nutritious products for infants to physicians, healthcare workers and consumers;
b) Sending employees to directly or indirectly contact nursing mothers, pregnant women or their family members in or outside health facilities for advertising or encouraging the use of infant formulas;
c) Failing to disseminate information on and provide counseling on breastfeeding to pregnant women, nursing mothers, and their family members at antenatal care rooms, labor and delivery rooms, postpartum rooms, nutrition counseling rooms or at noticeable places where there are lots of pregnant women, nursing mothers, and their family members;
d) Receiving infant formulas, material benefits or utensils bearing names or logos of infant formulas which are given by infant formula producer or traders;
dd) 24 Allowing infant formula producers or traders to give sample products or gifts related to their infant formulas in health facilities;
e) Providing lists of names, ages, addresses and telephone numbers of nursing mothers and pregnant women to employees of infant formula producers or traders for contacting them at health facilities.
3. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for commission of one of the following violations:
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
b) Granting scholarships or providing funds for scientific research, training courses, conferences, seminars, music concerts, contests, stage performances, making of films or video clips, telephone counseling services or other forms in order to disseminate or introduce infant formulas, or promote the sale or use of infant formulas;
c) Allowing infant formula producers or traders to display or post up utensils or equipment bearing names or logos of their formula products, feeding bottles and pacifiers at health facilities;
d) Allowing employees of infant formula producers or traders to contact nursing mothers and pregnant women in any form.
4. A fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed for commission of one of the following violations:
a) Organizing display of infant formulas and/or complementary foods for infants under 06 months of age at health facilities; displaying names or logos of infant formulas on banners, posters and other advertising leaflets in supermarkets, retail stores and health facilities;
b) Applying sales promotion methods for infant formulas such as giving free samples, coupons, rewards, gifts, point accumulation for rewards, discount or any other forms;
c) Providing or supporting the provision of information and education about infant feeding so as to disseminate on, introduce or promote the sale or use of infant formulas.
Section 3. VIOLATIONS AGAINST REGULATIONS ON PHARMACY AND COSMETICS
Article 52. Violations against regulations on pharmacy practicing
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
a) The chief pharmacist of a drug retailer is absent throughout its operation, except for authorization cases prescribed by law;
b) Failing to comply with decisions issued by competent authorities in case of disasters or dangerous epidemics;
c) Failing to complete the training program and refresher program in pharmacy within 03 years from the issuance date of the pharmacy practicing certificate or the issuance date of the latest certificate of completion of training program and refresher program in pharmacy;
d) Replacing drugs in a prescription with other drugs that have the same active ingredients, usage, and dose without the buyer’s consent.
2. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for commission of one of the following violations:
a) Forging one of required documents in the application for the pharmacy practicing certificate;
b) Practicing pharmacy without obtaining the pharmacy practicing certificate or while the pharmacy practicing certificate at the job position requiring the pharmacy practicing certificate has been suspended;
c) Acting as the chief pharmacist of two or more pharmacy business establishments or at two or more pharmacy business locations;
d) Practicing pharmacy beyond the scope written on the pharmacy practicing certificate and technical and professional regulations;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
e) The organization that administers the examination for the pharmacy practicing certificate fails to meet eligibility requirements set by law;
g) Renting, lending or allowing others to use the pharmacy practicing certificate.
3. A fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed for using a rented or borrowed pharmacy practicing certificate.
4. Additional penalties:
a) The pharmacy practicing certificate shall be suspended for a fixed period of 01 - 03 months in case of commission of the violation in Point c or d Clause 2 of this Article;
b) The pharmacy practicing certificate and certificate of eligibility for pharmacy business shall be suspended for a fixed period of 06 - 09 months in case of commission of the violation in Point b Clause 1 of this Article.
5. Remedial measures:
a) The violating entity is compelled to return any benefits illegally obtained from the commission of the violation in Point g Clause 2, or Clause 3 of this Article;
b) 25 The violating entity is compelled to return the pharmacy practicing certificate to the issuing authority in case of commission of one of the violations in Points b, c Clause 1, Points a, g Clause 2 and Clause 3 of this Article.
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
1. A fine ranging from VND 1.000.000 to VND 3.000.000 shall be imposed for commission of one of the following violations:
a) A mobile drug retailer fails to meet eligibility requirements set by law;
b) A mobile drug retailer fails to send a written notification to the Department of Health of the province where the mobile retailer will operate.
2. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed upon a business establishment that has a drug cabinet for failing to meet one of eligibility requirements set by law;
3. A fine ranging from VND 10.000.000 to VND 15.000.000 shall be imposed for forging any of the required documents in the application for listing of business establishment that has a drug cabinet.
4. A fine ranging from VND 15.000.000 to VND 20.000.000 shall be imposed for separating or storing the following drugs/medicinal materials at specific areas, except the case prescribed in Point dd Clause 4 Article 59 hereof:
a) Substandard drugs/medicinal materials;
b) Drugs or medicinal materials subject to a recall notification of a competent authority;
c) Expired drugs or medicinal materials;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
5. Additional penalties:
a) Business operations involving the violation in Point a Clause 1 or Clause 2 of this Article shall be suspended for a fixed period of 01 – 03 months;
b) Business operations involving the violation in Clause 3 of this Article shall be suspended for a fixed period of 06 – 12 months.
6. Remedial measure:
All drugs and medicinal materials involving the violation in Clause 4 of this Article shall be destroyed, except those in Point a and b Clause 4 of this Article which are allowed by competent authorities to be re-exported or remedied as prescribed by law.
Article 54. Violations against regulations on certificate of eligibility for pharmacy business
1. A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed for commission of one of the following violations:
a) Forging or altering any documents or papers issued by competent authorities or relevant organizations/individuals included in the application for issuance of the certificate of eligibility for pharmacy business;
b) Using rented or borrowed certificate of eligibility for pharmacy business, or renting, lending or allowing others to use certificate of eligibility for pharmacy business.
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
b) The certificate of eligibility for pharmacy business shall be suspended for a fixed period of 24 months in case of commission of the violation in Clause 1 of this Article.
3. Remedial measures:
a) The violating entity is compelled to return any benefits illegally obtained from the commission of the violation in Point b Clause 1 of this Article;
b) 26 The violating entity is compelled to return certificate of eligibility for pharmacy business to the issuing authority in case of commission of the violation in Clause 1 of this Article.
1. A fine ranging from VND 1.000.000 to VND 3.000.000 shall be imposed for commission of one of the following violations:
a) Failing to report to the Ministry of Health or Provincial Department of Health or failing to fulfill the obligations in case of suspension of pharmacy business for 06 months or longer or shutdown;
b) Failing to notify or update the list of practitioners possessing pharmacy practicing certificates to the competent authority as prescribed by law;
c) Failing to submit periodic reports or ad hoc reports at the request of competent pharmacy authorities;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
2. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for commission of one of the following violations:
a) Failing to openly post pharmacy practicing certificates in cases where the pharmacy practicing certificate is required or the certificate of eligibility for pharmacy business in the premises;
b) Failing to pay compensation for entities that suffer damage caused by the drug/medicinal material retailer as prescribed by law.
3. A fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed for failing to pay compensation for entities that suffer damage caused by the establishment as prescribed by law, except the case prescribed in Point b Clause 2 of this Article.
4. The fine shall be 1.5 times or twice the fine imposed for the violation in Point c Clause 1 of this Article but not exceed VND 100.000.000 if the violation involves drugs or active ingredients on the List of banned substances in some fields and sectors, combined drugs that contain narcotic substances, psychotropic ingredients or precursors or radiopharmaceuticals, or involves narcotic drugs, psychotropic drugs, precursor drugs, medicinal materials that are narcotic substances or psychotropic ingredients or drug precursors respectively.
5. Additional penalty:
Business operations involving the violation in Point a Clause 1 of this Article shall be suspended for a fixed period of 01 – 03 months.
Article 56. Violations against regulations on registration of drugs and medicinal materials
1. A fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed for commission of one of the following violations:
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
b) 27 Failing to follow procedures for notifying competent authorities of minor variations which must be notified before placing drugs and medicinal materials on the market;
c) Failing to notify competent authorities of suspension of manufacture or supply of drugs or of the scarcity or threat of scarcity of drugs or medicinal materials.
2. A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed for commission of one of the following violations:
a) Failing to retain documents related to the drug/medicinal material registration or failing to provide information on the registered drug when there is information or evidence about the safety and efficacy of the drug during the effective period of its marketing authorization to competent authorities at their request;
b) Failing to publish information about the recalled drug or failing to organize the recall and receive the recalled drug as prescribed by law;
c) Failing to update standards on quality of drugs/medicinal materials as prescribed by law.
3. A fine ranging from VND 30.000.000 to VND 50.000.000 shall be imposed for commission of one of the following violations:
a) Failing to maintain the satisfaction of operating conditions during the effective period of the certificate of marketing authorization for drug/medicinal material;
b) Failing to implement the approved risk management plan included in the application for issuance or renewal of certificate of marketing authorization for vaccine;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
d) Manufacturing and placing on the market drugs/medicinal materials having changes compared to the approved application for registration which require following procedures for issuance of certificate of free sale as prescribed by law.
4. A fine ranging from VND 50.000.000 to VND 70.000.000 shall be imposed for commission of one of the following violations:
a) Failing to notify competent authorities of the case where the drug or medicinal material granted certificate of free sale in Vietnam is recalled in any country other than the manufacturing country or reference country issuing the Certificate of Pharmaceutical Product (CPP) included in the application for registration;
b) Failing to notify competent authorities of the case where the drug or medicinal material granted certificate of free sale in Vietnam is recalled in the manufacturing country or reference country issuing the Certificate of Pharmaceutical Product (CPP) included in the application for registration;
c) The application for registration of drug or medicinal material includes documents or information that is provided without research or production in reality, or fraudulent documents according to the conclusion given a competent authority.
5. Remedial measures:
a) Enforced recall of drug/medicinal material in case of commission of the violation in Point c Clause 4 of this Article;
b) 29 Enforced return of certificate of marketing authorization for drug/medicinal material to the issuing authority in case of commission of the violation in Point b or c Clause 4 of this Article.
6. 30 In case 02 or more drugs/medicinal materials are found during an inspection to involve one of the violations specified in Clauses 1, 2, 3, 4 of this Article, only penalties for that violation shall be imposed while taking the number of violating drugs/medicinal materials into account as aggravating factors.
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
1. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for commission of one of the following violations:
a) A vaccine manufacturer fails to report before making changes or repairing the manufacturing premises as prescribed by law;
b) Failing to cooperate or obstructing the quality inspection agency in taking samples of drugs or medicinal materials to serve quality inspection tasks;
c) Failing to submit report on recall of drug/medicinal material as prescribed by law;
d) 31 Failing to retain samples of drug/medicinal material when performing drug/medicinal material testing as prescribed by law.
2. A fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed for commission of one of the following violations:
a) 32 Failing to notify competent authorities when manufacturing drug/medicinal material to which there are minor variations compared to the approved application for registration which requires notification, except the case specified in Point b Clause 1 Article 56 of this Decree;
b) Manufacturing drug/medicinal material to which there are minor variations compared to the approved application for registration before obtaining approval for such variations from a competent authority as prescribed by law, except the case specified in Point c Clause 3 Article 56 of this Decree;
c) Failing to retain samples of finished drug products for a minimum period of 12 months after the expiry date of drug products; failing to retain samples of active ingredients for a minimum period of 12 months after the expiry date of finished drugs made of such ingredients;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
3. A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed for commission of one of the following violations:
a) Failing to comply with the drug/medicinal material manufacturing or testing procedures included in the approved application for registration;
b) Committing a third-degree violation regarding the quality of manufactured drugs;
c) Failing to perform testing for medicinal materials and primary packages before they are used in the manufacturing of drugs;
d) Failing to have drugs tested by a testing laboratory designated by a competent authority before the sale of drugs which must be tested as prescribed by law;
dd)33 Manufacturing drug/medicinal material to which there are major variations compared to the approved application for registration before obtaining approval for such variations as prescribed by law, except the case specified in Point c Clause 3 Article 56 of this Decree;
e) Manufacturing the drug while the certificate of marketing authorization has been expired, except cases permitted by law;
g) Using medicinal material/herbal ingredient which is not granted certificate of marketing authorization, is not included in the announced list of medicinal materials, or of which quality standards are not yet announced as prescribed by law.
4. A fine ranging from VND 30.000.000 to VND 40.000.000 shall be imposed for commission of one of the following violations:
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
b) Committing a second-degree violation regarding the quality of manufactured drugs;
c) Manufacturing drugs with using substandard primary packages;
d) Manufacturing the medicinal material which fails to meet quality standards;
dd) Replacing main/important manufacturing equipment that may significantly affect the manufacturing procedures or quality of drug/medicinal material without following procedures for issuance of certificate of eligibility for pharmacy business or submitting reports on such replacement as prescribed by law;
e) Changing auxiliary system or principles of designing/operating utility systems that may affect the manufacturing environment without following procedures for issuance of certificate of eligibility for pharmacy business or submitting reports on such changes as prescribed by law;
g) Failing to submit reports on GMP compliance as prescribed by law;
h) Failing to perform testing of drug/medicinal material before release as prescribed by law;
i) 34 Manufacturing drugs from active ingredients provided by manufacturers that do not have documents proving their compliance with GMP or that fail to meet GMP requirements as announced by competent authorities.
5. A fine ranging from VND 40.000.000 to VND 60.000.000 shall be imposed for commission of one of the following violations:
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
b) Manufacturing drug/medicinal material at a location other than the registered one by adopting the production line which has been certified by a competent authority to be conformable with GMP;
c) Failing to reporting changes in case of expansion of the existing factory or major repairs or changes in structure or floor plan of the premises or production line;
d) Forging or altering any documents, papers or certifications issued by competent authorities and other entities during the manufacturing of drug/medicinal material;
dd) Manufacturing drug/medicinal material beyond the scope specified in the certificate of eligibility for pharmacy business or scope of inspection of GMP compliance;
e) Only maintaining the GMP compliance at level 4.
6. A fine ranging from VND 60.000.000 to VND 80.000.000 shall be imposed for commission of one of the following violations:
a) Manufacturing and selling drug or medicinal material that is not granted certificate of marketing authorization in Vietnam, except drugs/medicinal materials which are not required to be registered as prescribed by law;
b) Manufacturing drugs using medicinal materials which are substandard, subject to a recall notice given by a competent authority, of unknown origin, or have been expired;
c) Manufacturing drug or medicinal material at a location other than the one specified in the approved application for registration, except the violation in Point b Clause 5 of this Article;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
dd) Manufacturing drug/medicinal material while business operation or the certificate of eligibility for pharmacy business is suspended;
e) Manufacturing products which are not drugs on the drug production line, except the manufacturing of health supplements on the herbal or traditional drug production line or other cases prescribed by the Minister of Health;
g) Manufacturing, processing or preparing a traditional drug containing an active ingredient which is not licensed by a competent authority as prescribed by law.
7. The fine shall be 1.5 times or twice the fine imposed for the violation in Point dd Clause 5 or Point c, d or dd Clause 6 of this Article but not exceed VND 100.000.000 if the violation involves drugs or active ingredients on the List of banned substances in some fields and sectors, combined drugs that contain narcotic substances, psychotropic ingredients or precursors or radiopharmaceuticals, or involves narcotic drugs, psychotropic drugs, precursor drugs, medicinal materials that are narcotic substances or psychotropic ingredients or drug precursors respectively.
8. Additional penalties:
a) Business operations involving the violation in Point c Clause 3 or Point h Clause 4 of this Article shall be suspended for a fixed period of 01 – 03 months;
b) The production line involving the violation in Point dd or e Clause 4 or Point a or c Clause 5 of this Article shall be suspended for a fixed period of 01 – 03 months;
c) Business operations involving the violation in Point b or dd Clause 5 or Point a or c Clause 6 of this Article shall be suspended for a fixed period of 03 – 06 months;
d) Operations shall be suspended until the violating entity submits required reports to the Ministry of Health but for a period not exceeding 24 months in case of commission of the violation in Point g Clause 4 of this Article;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
e) The certificate of eligibility for pharmacy business shall be suspended for a fixed period of 03 - 06 months in case of commission of the violation in Point d Clause 5 or Point b Clause 6 of this Article;
g) Operations of the pharmacy business establishment directly involving the violation in Point e Clause 5 of this Article shall be suspended for a fixed period of 03 – 06 months.
9. Remedial measures:
a) All drugs/medicinal materials shall be destroyed in case of commission of the violation in Point c Clause 3, Point b or c Clause 4, Point a or d Clause 5, Clause 6 or Clause 7 of this Article;
b) 35 Enforced revocation of certificate of eligibility for business pharmacy in case of commission of the violation in Point e Clause 5 of this Article; upon the end of the suspension period, if the violating entity fails to rectify deficiencies, its operations shall be suspended until it successfully completes rectification of such deficiencies;
c) Enforced return of certificate of eligibility for pharmacy business to the issuing authority in case of commission of the violation in Point d Clause 5 or Point e or g Clause 6 of this Article.
Article 58. Violations against regulations on wholesaling of drugs and medicinal materials
1. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for commission of one of the following violations:
a) Expanding the existing warehouse or repairing or having significant changes in structure or floor plan of the warehouse of a drug/medicinal material wholesaler without submitting a report on such changes, accompanied by relevant technical documents;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
c) Failing to submit reports on drug recall at the request of a competent authority;
d) Buying/selling drug in violation of quality regulations at level 3;
dd) Trading drugs that belong to a national target program, drugs as emergency aid and other drugs banned from selling;
e) Failing to retain all documents about each batch/shipment of drugs/ medicinal materials for a period prescribed by law.
2. A fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed for commission of one of the following violations:
a) 36 Trading drugs/medicinal materials which are samples used for registration, testing, scientific research, or display at a fair or exhibition; trading medicinal materials which are imported under license for manufacturing of exported drugs inconsistently with regulations;
b) Selling or buying drugs, medicinal materials, vaccines or biologicals against the business scope specified in the certificate of eligibility;
c) Trading drug in violation of quality regulations at level 2;
d) Failing to recall drugs/medicinal materials at the request of a competent authority.
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
a) Selling or buying drugs, medicinal materials, vaccines or biologicals to or from an establishment that does not hold a valid certificate of eligibility for pharmacy business, except non-commercial pharmacy business establishments;
b) 37 Failing to apply for periodic inspection of GDP (Good distribution practices) compliance as prescribed by law;
c) Failing to have equipment and computers connected to the Internet and use software to manage distribution activities;
d) 38 Failing to adopt mechanism for transmission of information or failing to transmit adequate information on distribution and quality of drugs between a manufacturer and its clients, or to relevant regulatory authorities at their request;
dd) Only maintaining the GDP compliance at level 3 according to the conclusion given by a competent authority.
4. A fine ranging from VND 30.000.000 to VND 40.000.000 shall be imposed for commission of one of the following violations:
a) Trading drug in violation of quality regulations at level 1;
b) Failing to meet quality standards as prescribed by competent authorities when trading in herbal ingredients which have been preliminarily processed;
c) Storing drugs/medicinal materials against the conditions written on the labels;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
dd) Making changes in the auxiliary system or principles of design or operation of utility systems that may affect storage requirements or conditions without submitting a report on such changes, accompanied by relevant technical documents as prescribed by law.
5. A fine ranging from VND 40.000.000 to VND 60.000.000 shall be imposed for buying or selling drugs/medicinal materials:
a) without a valid certificate of eligibility for pharmacy business;
b) at a location other than the one specified in the issued certificate of eligibility for pharmacy business; or
c) while business operation or the certificate of eligibility for pharmacy business is suspended.
6. The following fines shall be imposed for buying or selling drugs/medicinal materials which are subject to recall decisions issued by competent authorities, which have been expired, or which are not issued with the import license or certificate of marketing authorization, except drugs/medicinal materials which are not required to be registered as prescribed by law:
a) A fine ranging from VND 5.000.000 to VND 7.000.000 shall be imposed for the violation involving goods worth less than VND 5.000.000;
b) A fine ranging from VND 7.000.000 to VND 10.000.000 shall be imposed for the violation involving goods worth from VND 5.000.000 to under VND 10.000.000;
c) A fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed for the violation involving goods worth from VND 10.000.000 to under VND 20.000.000;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
dd) A fine ranging from VND 30.000.000 to VND 40.000.000 shall be imposed for the violation involving goods worth from VND 30.000.000 to under VND 40.000.000;
e) A fine ranging from VND 40.000.000 to VND 50.000.000 shall be imposed for the violation involving goods worth from VND 40.000.000 to under VND 50.000.000;
g) A fine ranging from VND 50.000.000 to VND 60.000.000 shall be imposed for the violation involving goods worth from VND 50.000.000 to under VND 60.000.000;
h) A fine ranging from VND 60.000.000 to VND 70.000.000 shall be imposed for the violation involving goods worth from VND 60.000.000 to under VND 70.000.000;
i) A fine ranging from VND 70.000.000 to VND 80.000.000 shall be imposed for the violation involving goods worth from VND 70.000.000 to under VND 80.000.000;
k) A fine ranging from VND 80.000.000 to VND 90.000.000 shall be imposed for the violation involving goods worth from VND 80.000.000 to under VND 100.000.000;
l) A fine ranging from VND 90.000.000 to VND 100.000.000 shall be imposed for the violation involving goods worth VND 100.000.000 or more.
7. The fine shall be 1.5 times or twice the fine imposed for the violation in Point e Clause 1, Point a or b Clause 2, Point a Clause 3, Point d Clause 4, Clause 5 or Clause 6 of this Article but not exceed VND 100.000.000 if the violation involves active ingredients or drugs banned in some fields and sectors, combined drugs that contain narcotic substances, psychotropic ingredients or precursors or radiopharmaceuticals, or involves narcotic drugs, psychotropic drugs, precursor drugs, medicinal materials that are narcotic substances or psychotropic ingredients or drug precursors respectively.
8. Additional penalties:
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
b) The pharmacy practicing certificate shall be suspended for a fixed period of 03 – 06 months in case of commission of the violation in Point a or c Clause 2, Clause 4, Point b Clause 5 or Clause 6 of this Article;
c) Operations of the violating entity shall be suspended for a fixed period of 06 - 09 months in case of commission of the violation in Point dd Clause 3, Point a or c Clause 5 or Clause 6 of this Article;
d) Operations shall be suspended until the violating entity submits required reports to the Ministry of Health but for a period not exceeding 24 months in case of commission of the violation in Point b Clause 3 of this Article.
9. 39 Remedial measure:
All drugs/medicinal materials must be destroyed in case of commission of any of the violations in Point b Clause 4 and Clause 6 of this Article.
Article 59. Violations against regulations on retailing of drugs and herbal ingredients
1. A fine ranging from VND 1.000.000 to VND 3.000.000 shall be imposed for commission of one of the following violations:
a) Failing to meet quality standards as prescribed by competent authorities when selling herbal ingredients which have been preliminarily processed;
b) A pharmacist who directly engages in the drug retailing fails to possess professional qualifications as prescribed by law;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
d) Buying/selling drug in violation of quality regulations at level 3;
dd) Failing to specify the drug name, content and expiry date when retailing drugs without secondary packages; failing to specify the dose and usage when selling drugs without a prescription;
e) Failing to retain all documents about each batch/shipment of drugs/ medicinal materials for a period prescribed by law;
g) Failing to cooperate or obstructing the quality inspection agency in taking samples of drugs or medicinal materials to serve quality inspection tasks.
2. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for commission of one of the following violations:
a) Relocating the drug retailer’s premises at the same business location or expanding the premises or making major repairs or changes in structure of the premises without submitting a report on such changes, accompanied by relevant technical documents as prescribed by law;
b)40 Failing to provide a separate area for displaying products other than drugs or failing to put a notice indicating that "sản phẩm này không phải là thuốc" (“This product is not a drug”) or displaying products which are not drugs in the same area with drugs in case cosmetics, functional foods and medical devices are sold together with drugs as prescribed by law;
c) Trading drug in violation of quality regulations at level 2.
3. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for commission of one of the following violations:
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
b) Failing to have a separate room for making extemporaneous preparations or failing to have a separate area for washing preparation devices if preparing drugs according to prescriptions;
c) Failing to have a storage facility which has been registered by the drug retailer, or storing drugs against the storage conditions specified in the drug labels or against GPP (Good pharmacy practices) requirements;
d) Storing or retailing drugs beyond the business scope specified in the certificate of eligibility for pharmacy business, drugs that belong to a national target program, drugs as emergency aid and other drugs banned from selling;
dd)41 Retailing vaccines;
e) Failing to apply for periodic inspection of GPP (Good pharmacy practices) compliance as prescribed by law;
g) Failing to have appropriate IT equipment, apply IT, make network connection or control origin, prices and sources of drugs bought and sold as prescribed by law, except herbal ingredient retailers;
h) 42 Failing to transmit information or transmitting inadequate information on the sale, purchase and quality of drugs between suppliers and customers upon a request made in accordance with regulations of law, except herbal ingredient retailers;
i) Only maintaining GPP compliance at level 3 according to the conclusion given by a competent authority.
4. A fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed for commission of one of the following violations:
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
b) Buying or selling drugs manufactured or prepared according to prescriptions for use within health facilities, except cases permitted by law;
c) Buying or selling modern drugs prepared according to prescriptions from other drugstores;
d) Buying or selling drugs on the list of drugs restricted from retailing without obtaining permission as prescribed by law;
dd) Failing to adopt isolation measures or put the following drugs/herbal ingredients at quarantine areas: substandard drugs/herbal ingredients; drugs/herbal ingredients subject to a recall notification of a competent authority; expired drugs/herbal ingredients; drugs/herbal ingredients of unknown origin;
e) Trading drug in violation of quality regulations at level 1;
g) 43 Selling prescription drugs without a prescription presented.
5. A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed for buying or selling drugs/herbal ingredients:
a) without a valid certificate of eligibility for pharmacy business;
b) at a location other than the one specified in the issued certificate of eligibility for pharmacy business; or
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
6. The following fines shall be imposed for buying or selling drugs/herbal ingredients which are subject to recall decisions issued by competent authorities, which have been expired, or which are not issued with the import license or certificate of registration, except drugs/medicinal materials which are not required to be registered as prescribed by law:
a) A fine ranging from VND 1.000.000 to VND 2.000.000 shall be imposed for the violation involving goods worth less than VND 1.000.000;
b) A fine ranging from VND 2.000.000 to VND 3.000.000 shall be imposed for the violation involving goods worth from VND 1.000.000 to under VND 2.000.000;
c) A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for the violation involving goods worth from VND 2.000.000 to under VND 5.000.000;
d) A fine ranging from VND 5.000.000 to VND 7.000.000 shall be imposed for the violation involving goods worth from VND 5.000.000 to under VND 10.000.000;
dd) A fine ranging from VND 7.000.000 to VND 10.000.000 shall be imposed for the violation involving goods worth from VND 10.000.000 to under VND 15.000.000;
e) A fine ranging from VND 10.000.000 to VND 15.000.000 shall be imposed for the violation involving goods worth from VND 15.000.000 to under VND 30.000.000;
g) A fine ranging from VND 15.000.000 to VND 20.000.000 shall be imposed for the violation involving goods worth from VND 30.000.000 to under VND 40.000.000;
h) A fine ranging from VND 20.000.000 to VND 25.000.000 shall be imposed for the violation involving goods worth from VND 40.000.000 to under VND 50.000.000;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
k) A fine ranging from VND 30.000.000 to VND 40.000.000 shall be imposed for the violation involving goods worth from VND 70.000.000 to under VND 100.000.000;
l) A fine ranging from VND 40.000.000 to VND 50.000.000 shall be imposed for the violation involving goods worth VND 100.000.000 or more.
7. The fine shall be 1.5 times or twice the fine imposed for the violation in Point c or e Clause 1, Point a Clause 2, Point d Clause 3, Clause 5 or Clause 6 of this Article but not exceed VND 100.000.000 if the violation involves drugs or active ingredients banned in some fields and sectors, combined drugs that contain narcotic substances, psychotropic ingredients or precursors or radiopharmaceuticals, or involves narcotic drugs, psychotropic drugs, precursor drugs, medicinal materials that are narcotic substances or psychotropic ingredients or drug precursors respectively.
8. Additional penalties:
a) The certificate of eligibility for pharmacy business shall be suspended for a fixed period of 01 - 02 months in case of re-commission of the violation in Point g or h Clause 3 of this Article;
b) The pharmacy practicing certificate and certificate of eligibility for pharmacy business shall be suspended for a fixed period of 01 - 03 months in case of commission of the violation in Point b, c or d Clause 4 of this Article;
c) The pharmacy practicing certificate shall be suspended for a fixed period of 03-06 months in case of commission of the violation in Point b Clause 5 or Clause 6 of this Article;
d) Operations of the violating entity shall be suspended for a fixed period of 01 - 03 months in case of commission of the violation in Point a Clause 2 of this Article;
dd) Operations of the violating entity shall be suspended for a fixed period of 06 - 09 months in case of commission of the violation in Point dd or i Clause 3 or Point c Clause 5 of this Article.
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
a) The violating entity is compelled to return any benefits illegally obtained from the commission of one of the violations in Clause 5 or 6 of this Article;
b) All substandard drugs/herbal ingredients shall be destroyed in case of commission of the violation in Point e Clause 4 of this Article;
c) 44 All drugs/herbal ingredients shall be destroyed in case of commission of the violation in Clause 6 of this Article.
10. 45 In case 02 or more drugs/medicinal materials are found during an inspection to involve the violation specified in Point g Clause 4 of this Article, only penalties for that violation shall be imposed while taking the number of violating drugs/medicinal materials into account as aggravating factors.
Article 60. Violations against regulations on import and export of drugs and medicinal materials
1. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for commission of one of the following violations:
a) Failing to submit reports on recall of drugs/medicinal materials at the request of a competent authority;
b) Failing to cooperate or obstructing the quality inspection agency in taking samples of drugs or medicinal materials to serve quality inspection tasks.
c)46 Failing to retain samples of finished drug products for a minimum period of 12 months after their expiry date;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
2. A fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed for commission of one of the following violations:
a) Failing to submit reports on GSP (Good storage practices) compliance as prescribed by law;
b) Failing to send a written notification to the Ministry of Health of the wholesaler that distributes drugs/medicinal materials imported into Vietnam by an entity that is entitled to import but not entitled to distribute drugs/ medicinal materials in Vietnam before starts to sell or stops selling drugs to that wholesaler;
c) Failing to retain documents concerning the drug/medicinal material shipment for a period prescribed by law;
d) Selling drugs that belong to a national target program, drugs as emergency aid and other drugs banned from selling;
dd) Exporting drugs/medicinal materials without possessing a certificate of eligibility for pharmacy business or while business operation or the certificate of eligibility for pharmacy business is suspended;
e) Exporting drugs/medicinal materials that are subject to a recall notification as prescribed by law;
g) Exporting drugs/medicinal materials beyond the scope specified in the certificate of eligibility for pharmacy business;
h) Exporting herbal ingredients included in the list of controlled rare and special herbs without obtaining permission from a competent authority.
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
a) Storing drugs/medicinal materials at a warehouse facility that fails to meet GSP requirements or at a location other than the one specified in the certificate of eligibility for pharmacy business, except cases of use of storage services;
b) 47 Only maintaining the GSP (Good storage practices) compliance at level 3 according to the conclusion given by a competent authority.
c) Importing drugs/medicinal materials with a quantity exceeding that written on the import license given by a competent authority;
d) Failing to re-export all drugs/medicinal materials imported under the import license for display at a medicinal, pharmaceutical or medical device exhibition or fair upon the end of the exhibition or fair;
dd) Exporting controlled drugs without the export license;
e) Importing drugs/medicinal materials whose shelf life contravenes regulations on remaining shelf life of drugs/medicinal materials when they arrive at Vietnam’s port without obtaining permission from the Minister of Health;
g) Failing to recall drugs/ medicinal materials at the request of a competent authority;
h) Importing drugs/medicinal materials beyond the scope specified in the certificate of eligibility for pharmacy business;
i) Expanding the existing warehouse, making major repairs or changes in structure or floor plan of the warehouse, or changing the auxiliary system or principle of design or operation of utility systems that may affect storage requirements or conditions without submitting a report on such changes, accompanied by relevant technical documents as prescribed by law.
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
a) Using fraudulent documents in the approved application for drug/medicinal material import license according to the conclusion given by the competent authority;
b) Importing drugs/medicinal materials manufactured at a location other than that specified in the approved application for the drug import license;
c) Submitting an application for import license containing information on the drug/medicinal material which is not based on research findings or the manufacturer’s actual production.
5. A fine ranging from VND 70.000.000 to VND 80.000.000 shall be imposed for commission of one of the following violations:
a) Importing drugs/medicinal materials without possessing a certificate of eligibility for pharmacy business or while business operation or the certificate of eligibility for pharmacy business is suspended;
b) Importing drugs/medicinal materials subject to a recall notification of a competent authority;
c) Importing drugs/medicinal materials without the import license or certificate of registration, except drugs/medicinal materials which are not required to be registered or do not require the import license;
d) Performing activities related to the distribution of drugs/medicinal materials in Vietnam by an entity is entitled to import but not entitled to distribute drugs/medicinal materials in Vietnam, except drugs and medicinal materials it manufactures in Vietnam.
dd) 48 Importing drugs/medicinal materials from suppliers that are not licensed to supply drugs/medicinal materials as prescribed by law.
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
a) A fine ranging from VND 1.000.000 to VND 3.000.000 shall be imposed for the violation involving goods worth less than VND 2.000.000;
b) A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for the violation involving goods worth from VND 2.000.000 to under VND 5.000.000;
c) A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for the violation involving goods worth from VND 5.000.000 to under VND 10.000.000;
d) A fine ranging from VND 10.000.000 to VND 15.000.000 shall be imposed for the violation involving goods worth from VND 10.000.000 to under VND 20.000.000;
dd) 49 A fine ranging from VND 15.000.000 to VND 20.000.000 shall be imposed for the violation involving goods worth from VND 20.000.000 to under VND 30.000.000;
e) A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed for the violation involving goods worth from VND 30.000.000 to under VND 40.000.000;
g) A fine ranging from VND 30.000.000 to VND 40.000.000 shall be imposed for the violation involving goods worth from VND 40.000.000 to under VND 50.000.000;
h) A fine ranging from VND 40.000.000 to VND 50.000.000 shall be imposed for the violation involving goods worth from VND 50.000.000 to under VND 60.000.000;
i) A fine ranging from VND 50.000.000 to VND 60.000.000 shall be imposed for the violation involving goods worth from VND 60.000.000 to under VND 80.000.000;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
l) A fine ranging from VND 70.000.000 to VND 80.000.000 shall be imposed for the violation involving goods worth VND 100.000.000 or more.
7. The fine shall be 1.5 times or twice the fine imposed for the violation in Point c, d, dd or g Clause 2, Point a, c, d or h Clause 3, or Point a or c Clause 5 of this Article but not exceed VND 100.000.000 if the violation involves drugs or active ingredients on the List of banned substances in some fields and sectors, combined drugs that contain narcotic substances, psychotropic ingredients or precursors or radiopharmaceuticals, or involves narcotic drugs, psychotropic drugs, precursor drugs, medicinal materials that are narcotic substances or psychotropic ingredients or drug precursors respectively.
8. Additional penalties:
a) The pharmacy practicing certificate of the chief pharmacist shall be suspended for a fixed period of 01 - 03 months in case of commission of the violation in Point b, c, dd, e or g Clause 2 of this Article;
b) The pharmacy practicing certificate of the chief pharmacist shall be suspended for a fixed period of 03 - 06 months in case of commission of the violation in Point a, c, d, dd, e, g or i Clause 3 of this Article;
c) The pharmacy practicing certificate of the chief pharmacist shall be suspended for a fixed period of 06 - 09 months in case of commission of the violation in Clause 5 of this Article;
d) The certificate of eligibility for pharmacy business shall be suspended for a fixed period of 18 - 24 months in case of commission of the violation in Point d Clause 5 of this Article;
dd) Business operations involving the violation in Point dd, e or g Clause 2 of this Article shall be suspended for a fixed period of 01 – 03 months;
e) Business operations involving the violation in Point b, c, dd or h Clause 3 or Point b Clause 4 of this Article shall be suspended for a fixed period of 03 – 06 months;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
h) Operations shall be suspended until the violating entity submits required reports to the Ministry of Health but for a period not exceeding 24 months in case of commission of the violation in Point d Clause 2 of this Article.
9. Remedial measures:
a) The violating entity is compelled to remove from the Socialist Republic of Vietnam or re-export drugs/medicinal materials involving the violation in Point d Clause 3 or Clause 4, 5, 6 or 7 of this Article. If these measures cannot be implemented, drugs/medicinal materials shall be destroyed;
b) The violating entity is compelled to return any benefits illegally obtained from the commission of the violation in Point d Clause 2 of this Article.
1. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for commission of one of the following violations:
a) Failing to submit a report on changes, accompanied by relevant technical documents, to the receiving authority when changing the location of the existing warehouse or opening a new warehouse at the same business location;
b) Failing to submit a report on changes, accompanied by relevant technical documents, to the receiving authority when expanding the existing warehouse, making major repairs or changes in structure or floor plan of the warehouse, or changing the auxiliary system or principle of design or operation of utility systems that may affect storage requirements or conditions;
c) Failing to send a written notification of GSP compliance to the receiving authority, failing to comply with the roadmap for GSP application and compliance by establishments that store and supply vaccines, drugs and medicinal materials by non-commercial pharmacy business establishments as prescribed by law;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
dd) Failing to retain all documents about each batch/shipment of drugs/ medicinal materials for a period prescribed by law.
2. A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed for commission of one of the following violations:
a) Providing drug/medicinal material storage services to ineligible entities;
b) Health facilities, vaccination clinics, vaccine storage facilities under the national expanded program on immunization of districts and provinces, facilities in charge of storage of drugs that belong to national health programs or people’s armed forces, vaccine storage facilities under the national expanded program on immunization at central level or regional level fail to submit written notifications of GSP compliance to receiving authorities before starting storage activities;
c) Failing to comply with storage conditions during the storage or transport of drugs/medicinal materials;
d) Providing drug/medicinal material storage services at an establishment that is not issued with the certificate of eligibility for pharmacy business with a scope appropriate to the drug/medicinal material storage service provider.
3. A fine ranging from VND 30.000.000 to VND 40.000.000 shall be imposed for providing drug/medicinal material storage services:
a) without a valid certificate of eligibility for pharmacy business;
b) at a location other than the one specified in the issued certificate of eligibility for pharmacy business; or
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
d) Failing to submit reports on GSP compliance as prescribed by law;
dd) Only maintaining GSP compliance at level 3.
4. The fine shall be 1.5 times or twice the fine imposed for the violation in Point a or dd Clause 1, Point a or d Clause 2, or Point a, b or c Clause 3 of this Article but not exceed VND 100.000.000 if the violation involves drugs or active ingredients on the List of banned substances in some fields and sectors, combined drugs that contain narcotic substances, psychotropic ingredients or precursors or radiopharmaceuticals, or involves narcotic drugs, psychotropic drugs, precursor drugs, medicinal materials that are narcotic substances or psychotropic ingredients or drug precursors respectively.
5. Additional penalties:
a) The pharmacy practicing certificate shall be suspended for a fixed period of 01 - 03 months in case of commission of the violation in Clause 2 of this Article;
b) Operations involving the violation in Clause 2 of this Article shall be suspended for a fixed period of 01 – 03 months;
c) Operations of the violating entity shall be suspended for a fixed period of 06 - 12 months in case of commission of the violation in Point a, b, c or dd Clause 3 of this Article.
6. Remedial measures:
a) All substandard drugs/medicinal materials shall be destroyed in case of commission of the violation in Point a Clause 1 or Point c Clause 2 of this Article;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
c) The violating entity is compelled to return any benefits illegally obtained from the commission of the violation in Point a, b or c Clause 3 of this Article.
Article 62. Violations against regulations on drug testing, clinical trial and bioequivalence study
1. A fine ranging from VND 10.000.000 to VND 15.000.000 shall be imposed for commission of one of the following violations:
a) Failing to submit a report on changes, accompanied by relevant technical documents, to the receiving authority when expanding the existing laboratory, making major repairs or changes in structure or floor plan of the laboratory, or changing the auxiliary system or principle of design or operation of utility systems that may affect the laboratory environment;
b) A drug testing service provider takes drug samples against regulations on drug sampling of the Ministry of Health.
2. A fine ranging from VND 15.000.000 to VND 20.000.000 shall be imposed for commission of one of the following violations:
a) Providing drug/medicinal material testing service, bioequivalence study service or clinical trial service against or beyond the scope specified in the certificate of eligibility for pharmacy business or the scope of inspection of GLP (Good laboratory practices) compliance or GCP (Good clinical practice) compliance of a non-commercial pharmacy business establishment;
b) Disclosing personal information of participants in the bioequivalence study without their consent;
c) Concealing information or failing to provide participants with adequate and truthful information on the bioequivalence study, its process and possible risks.
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
a) A non-commercial pharmacy business establishments provides bioequivalence study or clinical trial service without possessing a valid certificate of eligibility for pharmacy business or passing the inspection of GCP compliance;
b) Changing any documents included in the approved application or bioequivalence study outline;
c) Failing to submit reports on GLP compliance as prescribed by law;
d) Only maintaining the GLP compliance at level 3;
dd) Failing to submit a report on changes, accompanied by relevant technical documents, to the authority receiving the application for inspection of GLP compliance when changing the location of the existing laboratory or opening a new laboratory within the same business location.
4. A fine ranging from VND 30.000.000 to VND 40.000.000 shall be imposed for forging or falsifying drug testing/analysis results.
5. The fine shall be 1.5 times or twice the fine imposed for the violation in Point a Clause 2 or Point a or dd Clause 3 of this Article but not exceed VND 100.000.000 if the violation involves drugs or active ingredients on the List of banned substances in some fields and sectors, combined drugs that contain narcotic substances, psychotropic ingredients or precursors or radiopharmaceuticals, or involves narcotic drugs, psychotropic drugs, precursor drugs, medicinal materials that are narcotic substances or psychotropic ingredients or drug precursors respectively.
6. Additional penalties:
a) The certificate of eligibility for pharmacy business or operations of the violating non-commercial pharmacy business establishment shall be suspended for a fixed period of 01 – 03 months in case of commission of the violation in Clause 2, Point a, b or d Clause 3, or Clause 4 of this Article;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Article 63. Violations against regulations on clinical trial of drugs
1. A fine ranging from VND 15.000.000 to VND 20.000.000 shall be imposed for commission of one of the following violations:
a) Disclosing personal information of participants in the clinical trial without their consent;
b) Failing to submit reports on clinical trial procedures; failing to publish clinical trial results as prescribed by law;
c) Failing to comply with GCP requirements.
2. A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed for commission of one of the following violations:
a) Conducting clinical trial without obtaining the scientific and ethical assessment record of the clinical trial dossier from the National Biomedical Ethics Committee and a written approval from the Minister of Health;
b) Changing any documents included in the clinical trial dossier or clinical trial outline approved by the Minister of Health.
3. A fine ranging from VND 30.000.000 to VND 40.000.000 shall be imposed for commission of one of the following violations:
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
b) Forging others to participate in clinical trial.
4. The fine shall be twice as much as the fine imposed for the violation in Clause 2 or Clause 3 of this Article but not exceed VND 100.000.000 if the violation involves narcotic drugs, psychotropic drugs or precursor drugs.
5. Additional penalties:
a) The certificate of eligibility for pharmacy business or operations of the violating non-commercial pharmacy business establishment shall be suspended for a fixed period of 01 – 03 months in case of commission of the violation in Clause 1 or Clause 2 of this Article;
b) The certificate of eligibility for pharmacy business or operations of the violating non-commercial pharmacy business establishment shall be suspended for a fixed period of 03 – 06 months in case of commission of the violation in Clause 3 or Clause 4 of this Article.
Article 64. Violations against regulations on packages and labels of drugs and medicinal materials
1. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for commission of one of the following violations:
a) Importing, buying or trading drugs/medicinal materials whose commercial packages have been damaged, unless permitted by law;
b) Importing herbal ingredients whose secondary packages do not contain information on their origin.
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
a) Manufacturing or importing drugs/medicinal materials whose packages are not conformable with those described in the approved application, except the case prescribed in Point b Clause 3 of this Article;
b) An applicant for registration or a pharmacy business establishment erasures or alters information about manufacturing date or batch number of drugs/medicinal materials specified in their original labels;
c) Failing to update the drug-related information on labels and package inserts of drugs sold in Vietnam at the request of the Ministry of Health;
d) An importer, application for registration or domestic manufacturer sells/supplies drugs/medicinal materials whose labels or package inserts are not conformable with the approved contents or do not correctly reflect the drug.
3. A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed for commission of one of the following violations:
a) Changing or altering the expiry date on the drug label;
b) Packaging material or method does not ensure the quality of drugs/medicinal materials;
c) Failing to update information on contraindications and drug users as prescribed by law.
4. Additional penalty:
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
5. Remedial measure:
All substandard drugs/medicinal materials shall be recalled for reprocessing or destroyed in case of commission of the violation in Point b, c or d Clause 2 or Clause 3 of this Article.
Article 65. Violations against regulations on controlled drugs
1. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for commission of one of the following violations:
a) Storing, manufacturing, preparing, dispensing or using controlled drugs/medicinal materials at a non-commercial pharmacy business establishment against regulations of law;
b) Transporting or delivering controlled drugs against regulations of law;
c) Destroying controlled drugs against regulations of law;
2. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed upon a drug retailer, or a fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed upon a provider of drug/medicinal material storage service, clinical trial service, bioequivalence study service or testing service, or a fine ranging from VND 30.000.000 to VND 40.000.000 shall be imposed upon a drug/medicinal material manufacturer, exporter, importer or wholesaler for commission of one of the following violations:
a) Failing to meet personnel and facility requirements to prevent controlled drugs from loss as prescribed by law;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
3. Additional penalty:
Business operations involving the violation in Clause 2 of this Article shall be suspended for a fixed period of 01 – 03 months.
Article 66. Violations against regulations on management of drug prices
1. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for failing to submit an application for adjustment to information about a drug whose price has been declared or re-declared while the drug price is not adjusted.
2. A fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed for commission of one of the following violations:
a) Buying a drug for a retailer within the premises of a public health facility at a price higher than the successful bid for that drug bought at that health facility at the same time, except cases prescribed by law;
b) Buying a drug for a drug retailer within the premises of a public health facility at a price higher than the highest successful bid for that drug at provincial and central health facilities within the last 12 months, or the price of that drug bought through local or national centralized bidding or price negotiation within the term of the contract or the framework agreement on centralized procurement before the time of buying drug, except cases permitted by law;
c) A drug retailer within the premises of a public health facility buys a drug which is not on the list of drugs supplied by successful bidders of that health facility, or the lists of drugs supplied by successful bidders of provincial and central health facilities within the last 12 months, or the lists of drugs supplied by successful bidders at local or national centralized bidding or price negotiation before the time of buying drug, except cases permitted by law;
d)50 A drug retailer located within the premises of a health facility retails drugs with a retail margin higher than the maximum one prescribed by law.
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
a) A fine ranging from VND 1.000.000 to VND 3.000.000 shall be imposed for the violation involving the drug whose selling price is not exceeding VND 1.000 per smallest packaging unit;
b) A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for the violation involving the drug whose selling price is exceeding VND 1.000 but not exceeding VND 5.000 per smallest packaging unit;
c) A fine ranging from VND 5.000.000 to VND 7.000.000 shall be imposed for the violation involving the drug whose selling price is exceeding VND 5.000 but not exceeding VND 100.000 per smallest packaging unit;
d) A fine ranging from VND 7.000.000 to VND 10.000.000 shall be imposed for the violation involving the drug whose selling price is exceeding VND 100.000 but not exceeding VND 1.000.000 per smallest packaging unit;
dd) A fine ranging from VND 10.000.000 to VND 15.000.000 shall be imposed for the violation involving the drug whose selling price is exceeding VND 1.000.000 per smallest packaging unit.
4. A fine ranging from VND 30.000.000 to VND 50.000.000 shall be imposed for commission of one of the following violations:
a) Failing to declare or re-declare prices of drugs before they are sold on the market;
b) Failing to submit a report on refusal to adjust the drug price at the written request of a drug pricing authority;
c) Failing to report accurate drug pricing elements as prescribed by law.
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
The violating entity is compelled to return any different amounts in case of commission of the violation in Clause 2, Clause 3 or Point b Clause 4 of this Article. Any payments which cannot be made to payers shall be paid to state budget in accordance with regulations of law.
6. 51 In case 02 or more drugs/medicinal materials are found during an inspection to involve one of the violations specified in Clauses 1, 2, 3, 4 of this Article, only penalties for that violation shall be imposed while taking the number of violating drugs/medicinal materials into account as aggravating factors.
Article 67. Violations against regulations on drug information
1. A warning or a fine ranging from VND 200.000 to VND 500.000 shall be imposed for commission of one of the following violations:
a) Failing to wear the pharmaceutical sales representative’s card while introducing drugs;
b) Introducing drugs without obtaining the practitioner’s consent.
2. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for commission of one of the following violations:
a) Failing to submit the lists of sales representatives issued with the sales representative’s card or whose sales representative’s card is revoked to the Department of Health of the province where the sales representative operates;
b) The sales representative introduces products which are not drugs;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
3. A fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed for commission of one of the following violations when providing drug information to medical and pharmaceutical practitioners:
a) Providing information which is not yet certified by a competent authority or which is different from the one certified by a competent authority;
b) Providing drug information certified by a competent authority but the certificate of drug information has been expired;
c) Comparing and affirming that its drug is better than that of others without providing any scientific documents approved by competent authorities;
d) The sales representative contacts patients, accesses their medical records or prescriptions, discuss or request for information related to patients;
dd) Failing to send a written notification of the time and location of the pharmaceutical conference which is held for providing drug information, accompanied by the copy of certificate of drug information, to the Department of Health of the province where that conference is held.
4. A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed for commission of one of the following violations:
a) Failing to report and update competent authorities on information about quality, safety and efficacy of drugs produced, registered, sold, prepared or processed;
b) A sales representative performs activities related to the sale and purchase of drugs with medical practitioners.
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
a) Providing information, advertising, marketing, counseling, labeling, giving instructions that foods, cosmetics and other non-medicinal products can be used for prevention, treatment, diagnosis, alleviation of diseases or regulating human physiological functions, except for medical devices;
b) Using material or financial benefits to affect medicinal practitioners or drug users to make them to give more prescriptions or purchase more drugs;
c) Altering or forging legal documents issued by competent authorities in the application for certification of drug information or drug advertisement;
d) Using a certificate not recognized by the Ministry of Health or using material benefits, reputation of an organization or individual, symbols, images, positions, mails, letters of thanks to provide information about or advertise drugs;
dd) Using results of clinical trial or pre-clinical trial, testing results, results of bioequivalence study that are not recognized by the Ministry of Health to provide information about or advertise drugs;
e) Failing to apply for certification of drug information upon the occurrence of changes which requires certification.
6. Additional penalties:
a) Operations of the violating entity shall be suspended for a fixed period of 03 – 06 months in case of commission of the violation in Point a Clause 5 of this Article 03 times or more during a year;
b) The exhibits of the violation in Point b Clause 5 of this Article, which are material or financial benefits, shall be confiscated.
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
The entity committing the violation in Point a, b or c Clause 3 or Point a, d, dd or e Clause 5 of this Article is compelled to recall goods and remove violating elements. If violating elements cannot be removed, products shall be destroyed.
Article 68. Violations against regulations on cosmetic product notification
1. A fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed for commission of one of the following violations:
a) Failing to accurately complete items on the notification of cosmetic product;
b) Failing to obtain a written approval from a competent authority as prescribed by law when changing the contents which have been notified and issued with a notification number.
2. 52 A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed for placing a cosmetic product on the market before obtaining an acknowledgment of notification of that cosmetic product (i.e. notification number) from a competent authority or placing a cosmetic product on the market after its notification number has been expired without following procedures for re-notification as prescribed by law.
3. A fine ranging from VND 30.000.000 to VND 40.000.000 shall be imposed for forging documents, using a counterfeit seal, or forging signature/seal of a competent authority of Vietnam, foreign competent authority, manufacturer or owner of the cosmetic product in the application for notification of cosmetic product.
4. Additional penalty:
Cosmetics business shall be suspended for a fixed period of 03 – 06 months in case of commission of the violation in Clause 2 or 3 of this Article.
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
a) Cosmetic products involving in the violation in Clause 2 or 3 of this Article shall be recalled and destroyed;
b) 53 Enforced return of the notification number to the issuing authority in case of commission of the violation in Point a Clause 1 or Clause 3 of this Article.
654. In case 02 or more cosmetic products are found during an inspection to involve one of the violations specified in Clauses 1, 2, 3 of this Article, only penalties for that violation shall be imposed while taking the number of violating cosmetic products into account as aggravating factors.
A fine ranging from VND 30.000.000 to VND 40.000.000 shall be imposed for organizing a conference, meeting or event for introducing a cosmetic product:
1. Without sending a prior notification to a competent authority as prescribed by law; or
2. whose contents are different from those notified to the competent authority.
Article 70. Violations against regulations on cosmetic manufacturing
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
a) Failing to adopt the quality management system according to the ASEAN Guidelines for Cosmetic Good Manufacturing Practice (CGMP-ASEAN);
b) Manufacturing a cosmetic product whose formulation is not conformable with that indicated in the application for notification of cosmetic product;
c) Manufacturing cosmetic products with expired or substandard raw materials;
d) Manufacturing cosmetic products that fail to meet quality standards;
dd) Carrying out manufacturing activities at a location other than the one specified in the certificate of eligibility for cosmetic manufacturing;
e) Carrying out manufacturing activities beyond the scope specified in the certificate of eligibility for cosmetic manufacturing;
g) Manufacturing cosmetic products that contain substances which are prohibited from use in cosmetic products or whose concentration exceeds the maximum authorized concentration prescribed by law.
2. A fine ranging from VND 40.000.000 to VND 50.000.000 shall be imposed for commission of one of the following violations:
a) Manufacturing cosmetic products without possessing a valid certificate of eligibility for cosmetic manufacturing;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
c) Failing to satisfy one of eligibility requirements after obtaining certificate of eligibility for cosmetic manufacturing.
3. Additional penalties:
a) The cosmetic manufacturing shall be suspended until obtaining an approval for operations to be added to the certificate of eligibility for cosmetic manufacturing as prescribed by law but for a period not exceeding 24 months in case of commission of the violation in Point dd or e Clause 1 of this Article;
b) The cosmetic manufacturing shall be suspended until obtaining a certificate of eligibility for cosmetic manufacturing as prescribed by law but for a period not exceeding 24 months in case of commission of the violation in Point a Clause 2 of this Article;
c) The certificate of eligibility for cosmetic manufacturing shall be suspended for a fixed period of 01 - 03 months in case of commission of the violation in Point a or g Clause 1 of this Article;
d) The certificate of eligibility for cosmetic manufacturing shall be suspended for a fixed period of 03 - 06 months in case of commission of the violation in Point b Clause 2 of this Article.
4. Remedial measures:
a)55 All cosmetic products involving in the violation specified in Clause 1 or Clause 2 of this Article shall be recalled and destroyed. The cosmetic products which fail to meet packaging weight or volume standards as specified in Point d Clause 1 of this Article shall not be subject to disposal;
b)56 Enforced return of the notification number to the issuing authority in case of commission of the violation in Point a, b, c, dd or e Clause 1 or Point b or c Clause 2 of this Article.
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Article 71. Violations against regulations on cosmetics trading in the field of cosmetics business
1. A fine ranging from VND 5.000.000 to VND 10.000.000, if the shipment is assessed at less than VND 20.000.000 according to their selling prices, or a fine ranging from VND 10.000.000 to VND 20.000.000, if the shipment is assessed at VND 20.000.000 or more according to their selling prices, shall be imposed for an entity other than the one responsible for placing cosmetic products in the market for commission of one of the following violations:
a) Trading in cosmetic products whose packages have been damaged;
b) Trading in expired cosmetic products;
c) Trading in cosmetic products subject to a recall notification of a competent authority.
2. A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed upon the entity responsible for placing the cosmetic product in the market for commission of one of the following violations:
a) Trading in the cosmetic product that is substandard or unsafe for use;
b) Trading in cosmetic products whose packages have been damaged;
c) Trading in expired cosmetic products;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
dd) 58 Trading cosmetic product whose Product Information File (PIF) fails to have adequate information as prescribed by law.
3. A fine ranging from VND 30.000.000 to VND 40.000.000 shall be imposed upon the entity responsible for placing the cosmetic product in the market for commission of one of the following violations:
a) Trading in the cosmetic product that contains substances which are prohibited from use in cosmetic products or whose concentration exceeds the maximum authorized concentration prescribed by law;
b)59 Trading cosmetic products without PIF or failing to present PIF of cosmetic products within the prescribed time limit to serve inspection requirements upon request of a competent authority;
c) Trading in the cosmetic product whose formulation is not conformable with that specified in the approved application for notification of cosmetic product;
d) Failing to recall cosmetic products at the request of a competent authority.
4. Remedial measures:
a) Cosmetic products involving in the violation in Clause 1, Clause 2, or Point a, b or c Clause 3 of this Article shall be recalled and destroyed;
b) 60 Enforced return of the notification number to the issuing authority in case of commission of the violation in Clause 3 of this Article.
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Section 4. VIOLATIONS AGAINST REGULATIONS ON MEDICAL DEVICES
Article 72. Violations against regulations on classification of medical devices
1. 62 A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed upon a registration number holder for failing to publish Medical device classification results in accordance with regulations of law.
2. A fine ranging from VND 10.000.000 to VND 15.000.000 shall be imposed for commission of one of the following violations:
a) Failing to comply with the rules of risk-based classification of medical devices;
b) 63 (abrogated);
c) 64 (abrogated);
d) 65 Failing to send reports to the customs authority that has granted customs clearance and the authority that has issued the registration number in case the medical device has been issued with the registration number using the cancelled classification result and has been granted the customs clearance but are not yet sold to customers;
dd) Failing to specify the quantity of medical device granted customs clearance in the report sent to the customs authority that has granted customs clearance in case the medical device has been issued with the registration number using the cancelled classification result and has been granted the customs clearance but are not yet sold to customers;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
g) 66 (abrogated);
h) 67 (abrogated).
3. A fine ranging from VND 15.000.000 to VND 20.000.000 shall be imposed for commission of one of the following violations:
a) Classifying the medical device or issuing the medical device classification result during the operation suspension period;
b) 68 The registration number holder fails to stop placing on the market or fails to organize the recall of the medical device which has been granted the registration number using the classification result that has been cancelled and has been granted customs clearance but are not yet sold to customers.
4. 69 (abrogated).
5. Additional penalties:
a) 70 Operation of the violating entity shall be suspended for a fixed period of 01 - 03 months in case of commission of the violation in Point a Clause 2 of this Article;
b) Operation of the violating entity shall be suspended for a fixed period of 03 - 06 months in case of commission of the violation in Point b Clause 3 of this Article;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
6. Remedial measures:
a) 71 (abrogated);
a)72 Enforced return of the acknowledgement of receipt of application for declaration of eligibility for medical device classification in case of commission of the violation in Point b Clause 2 or Point a Clause 3 of this Article.
Article 73. Violations against regulations on medical device manufacturing
1. 73 A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for failing to prepare notice of changes which must be accompanied by supporting documents for such changes or failing to update such documents to the application for declaration of eligibility for manufacture of medical devices published on the Portal on management of medical devices within the prescribed time limit upon occurrence of any changes in the published application for declaration of eligibility as prescribed by law.
2. A fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed for commission of one of the following violations:
a) Failing to ensure the legitimacy of documents included in the application for declaration of eligibility for medical device manufacturing;
b) 74 Failing to meet ISO 13485 quality control standards when manufacturing medical devices.
3. A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed for commission of one of the following violations:
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
b) 75 (abrogated);
c) 76 Manufacturing medical devices before completing procedures for declaration of eligibility for manufacture of medical devices in accordance with regulations of law.
4. 77 Additional penalty:
Operation of the violating entity shall be suspended for a fixed period of 01 - 03 months in case of commission of the violation in Clause 1, Point b Clause 2 or Point a Clause 3 of this Article.
5. Remedial measures:
a) 78 Enforced submission of certification of declaration of eligibility for manufacture of medical devices in case of commission of the violation in Point a Clause 2 or Point b Clause 3 of this Article;
b) Medical devices involving in the violation in Clause 3 of this Article shall be recalled and destroyed or re-processed.
Article 74. Violations against regulations on registration of medical devices
1. A fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed for commission of one of the following violations:
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
b) 80 (abrogated);
c) Marketing a medical device without providing instructions for use in Vietnamese;
d) Marketing a medical device without providing information on the warranty center, warranty conditions and period, except single-use medical devices which must be disposed after use as prescribed by their owners or medical devices for which no warranty is provided as proved by specific documents;
dd) 81 Failing to notify competent authorities or failing to update documents about changes to the application for registration number published on the Portal on management of medical devices within the prescribed time limit upon occurrence of changes during the placement of the medical device;
e) Failing to send a written notification to competent authorities and traders/users of the medical advice batch that has an adverse event posing a serious threat to public health or causing death of a user;
g) 82 Placing on the market a medical device which is imported from the manufacturer that fails to obtain a certificate of conformity with ISO 13485 quality control standards and which is not yet sold in any other country on the world;
h) Placing on the market a medical device which is not conformable with national technical regulations or applicable standards announced by the manufacturer.
2. A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed for commission of one of the following violations:
a) 83 Failing to follow procedures for declaration of standards applied to Class A medical device;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
c) Failing to retain adequate documents for after-sale management of medical devices as prescribed by law;
d) Failing to complete the recall of the entire batch of defective medical device within the time limit decided by a competent authority;
dd) Failing to establish a warranty center for medical devices as prescribed by law;
e) Failing to prepare and retain documents for monitoring medical devices as prescribed by law;
g) 84 Failing to submit reports to police authorities on loss of medical devices or raw materials for manufacture of medical devices that contain narcotic substances and precursors;
h) Failing to provide information or providing inadequate or inaccurate information about the product on the label and instruction manual of the medical device as prescribed by law;
i) Failing to issue warnings or issuing late, inadequate or inaccurate warnings about risks to users’ health and the environment, and instructions for sellers and users on how to minimize the risks; failing to provide information about requirements for transport, storage and use of the medical devices;
k) Failing to stop placing on the market or failing to inform relevant parties; failing to take corrective or remedial actions or recall defective medical devices as prescribed by law;
l) 85 Failing to maintain the validity of certificate of free sale, authorization letter or certificate of eligibility to provide warranty services during the effective period of the registration number as prescribed by law.
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
a) Failing to stop placing the medical device on the market in case of a determination that it has a defect which will be harmful to users’ health;
b) 86 Altering or erasing the acknowledgement of declaration of applied standards for Class-A or Class-B medical device;
c) Altering or erasing the certificate of registration of Class-C or Class-D medical device;
d) Failing to ensure the legitimacy of documents included in the application for declaration of applied standards for Class-A or Class-B medical devices;
dd) Failing to ensure the legitimacy of documents included in the application for issuance or re-issuance of certificate of registration of Class-C or Class-D medical device.
4. A fine ranging from VND 40.000.000 to VND 50.000.000 shall be imposed for commission of one of the following violations:
a) 87 Placing Class-A or Class-B medical devices on the market before obtaining the acknowledgement of the application for declaration of applied standards or the import license;
b) Placing Class-C or Class-D medical devices on the market before obtaining the number of certificate of registration or the import license;
c) Placing on the market a medical device which fails to meet the registered quality;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
dd) Failing to stop placing on the market the medical device associated with an adverse event that poses a serious threat to public health or has caused death of a user;
e) Continuing placing the medical device issued with the registration number for 24 months after the medical device owner declares the termination of manufacturing of that medical device or is declared bankrupt or dissolved, but the holder of the registration number in Vietnam provides no commitment to provide warranty/maintenance and spare parts for replacing or serving the use of that medical device for 08 years, unless the registration number holder is a Vietnam-based representative office of the foreign medical device owner;
g) Continuing placing the medical device issued with the registration number for a period exceeding 24 months after the medical device owner declares the termination of manufacturing of that medical device or is declared bankrupt or dissolved.
5. Additional penalties:
a) 88 The exhibits, including the acknowledgment of receipt, certificate and documents, shall be confiscated in case of commission of the violation in Point b, c, d or dd Clause 3 of this Article;
b) Operation of the violating entity shall be suspended for a fixed period of 01 - 03 months in case of commission of the violation in Clause 2, Point a Clause 3 or Clause 4 of this Article.
6. Remedial measures:
a) Medical devices involving in the violation in Point g or h Clause 1 of this Article shall be recalled and destroyed or re-processed;
b) 89 Enforced submission of the acknowledgment of application for declaration of applied standards for Class-A or Class-B medical devices or certificate of registration of Class-C or Class-D medical devices in case of commission of the violation in Point b, c, d or dd Clause 3 of this Article.
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
1. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for commission of one of the following violations:
a) Failing to adopt internal control measures for maintaining quality of medical devices according to requirements of the registration number holder;
b) Failing to provide or providing users with inadequate or late instructions for use of the medical device, and conditions for ensuring safety, storage, calibration, inspection and maintenance of the medical device;
c) Failing to inform or inadequately or lately informing users of the defective medical device;
d) Failing to keep documents for monitoring medical devices, tracing origin and recalling medical devices as prescribed by law;
dd) Failing to inform or lately informing the registration number holder and competent authorities of cases of defective medical device.
2. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for commission of one of the following violations:
a) Failing to repeat procedures for declaration of eligibility for trading in medical devices upon the occurrence of any changes in the submitted application for declaration of eligibility as prescribed by law;
b) 90 (abrogated);
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
d) 91 (abrogated).
3. A fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed for commission of one of the following violations:
a) Failing to satisfy one of eligibility requirements for trading in Class B, C and D medical devices;
b) Trading in Class B, C or D medical devices without completing procedures for declaration of eligibility for trading in medical devices as prescribed by law;
c) Failing to ensure the legitimacy of documents included in the application for declaration of eligibility for trading in Class B, C or D medical devices;
d) Failing to ensure the legitimacy of documents included in the application for issuance of certificate of free sale of domestically manufactured medical devices.
4. Additional penalty:
Operation of the violating entity shall be suspended for a fixed period of 01 - 03 months in case of commission of the violation in Point a or d Clause 1, Point a Clause 2 or Point a, c or d Clause 3 of this Article.
5. Remedial measures:
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
b) Enforced return of certificate of free sale of domestically manufactured medical devices to the issuing authority in case of commission of the violation in Point d Clause 3 of this Article.
Article 76. Violations against regulations on import of medical devices
1. A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed for commission of one of the following violations:
a) Failing to ensure the legitimacy of documents included in the application for the license to import medical devices;
b) Exporting or importing medical devices without satisfying eligibility requirements set by law.
2. A fine ranging from VND 30.000.000 to VND 40.000.000 shall be imposed for importing medical devices without a valid registration number or the import license as prescribed by law.
3. Additional penalty:
Operation of the violating entity shall be suspended for a fixed period of 01 - 03 months in case of commission of the violation in Clause 1 or Clause 2 of this Article.
4. Remedial measures:
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
b) 93 Enforced return of the license to import medical devices in case of commission of the violation in Clause 1 of this Article.
Article 77. Violations against regulations on medical device consulting
1. 94 A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for failing to prepare notice of changes which must be accompanied by supporting documents for such changes or failing to update such documents to the application for declaration of eligibility to provide medical device technical consulting published on the Portal on management of medical devices within the prescribed time limit upon occurrence of any changes in the published application for declaration of eligibility as prescribed by law.
2. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for commission of one of the following violations:
a) Failing to ensure the legitimacy of documents included in the application for declaration of eligibility to provide medical device technical consulting;
b) 95 Providing medical device technical consulting before the Ministry of Health publishes relevant information and application for declaration of eligibility to provide medical device technical consulting;
c) Providing consulting services beyond the scope specified in the application for declaration of eligibility to provide medical device technical consulting.
3. Additional penalty:
Operation of the violating entity shall be suspended for a fixed period of 01 - 03 months in case of commission of the violation in Clause 1 or Clause 2 of this Article.
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
96Enforced return of the acknowledgement of receipt of application for declaration of eligibility to provide medical device technical consulting in case of commission of the violation in Point a Clause 2 of this Article.
Article 78. Violations against regulations on information about medical devices
1. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for commission of one of the following violations:
a) Failing to provide information about levels of risks that patients are subjected to from Class C and D medical devices;
b) Failing to make information about levels of risks and use of medical devices publicly available;
c) Failing to disseminate information about levels of risks and use of medical devices in health facilities.
2. 97 (abrogated)
Article 78a. 98 Violations against regulations on management of medical device prices
1. A fine ranging from VND 10.000.000 to VND 15.000.000 shall be imposed for commission of one of the following violations:
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
b) Making declaration of medical device prices which does not have adequate information as prescribed by law;
c) Failing to update the declared prices of medical devices whenever they are changed;
d) Failing to explain elements constituting the medical device price at the request of regulatory authorities;
dd) Making declaration of medical device prices by an entity that is not the registration number holder or distributor appointed by the registration number holder to make declaration of medical device prices.
2. A fine ranging from VND 15.000.000 to VND 20.000.000 shall be imposed for commission of one of the following violations:
a) Failing to declare prices of medical devices before they are placed on the market in Vietnam;
e) Trading medical devices before their prices are declared or at prices higher than those published on the Ministry of Health’s Portal at the time of trading.
1. A fine ranging from VND 500.000 to VND 1.000.000 shall be imposed for failing to submit reports on defective medical devices and other information at the request of competent authorities.
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
a) Failing to prepare, manage and retain adequate documents on medical devices; failing to punctually and sufficiently record medical devices in kind and in cash in accordance with regulations of the laws on accounting and statistics and relevant laws;
b) Using and operating medical devices against instructions given by their owners.
3. A fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed for failing to carry out periodic maintenance, inspection and calibration of medical devices according to instructions given by their owners or as prescribed by law.
4. A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed for using medical devices without the certificate of registration or import license, or expired or substandard medical devices.
Section 5. VIOLATIONS AGAINST REGULATIONS ON HEALTH INSURANCE
Article 80. Violations against regulations on health insurance contributions
1. A warning or a fine ranging from VND 300.000 to VND 500.000 shall be imposed upon a person who is required to participate in health insurance for failing to make health insurance contributions.
2. The following fines shall be imposed upon an employer for failing to pay or insufficiently or lately paying health insurance contributions for his/her employees who are subjected to compulsory health insurance, or evading payment of health insurance contributions:
a) A fine ranging from VND 1.000.000 to VND 3.000.000 shall be imposed for the violation involving less than 10 employees;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
c) A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for the violation involving from 50 to less than 100 employees;
d) A fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed for the violation involving from 100 to less than 500 employees;
dd) A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed for the violation involving from 500 to less than 1.000 employees;
e) A fine ranging from VND 30.000.000 to VND 40.000.000 shall be imposed for the violation involving from 1.000 employees or more.
3. The following fines shall be imposed for failing to pay sufficient amounts payable of health insurance contributions:
a) A fine ranging from VND 1.000.000 to VND 2.000.000 shall be imposed if the arrears are less than VND 5.000.000;
b) A fine ranging from VND 2.000.000 to VND 3.000.000 shall be imposed if the damage is assessed at from VND 5.000.000 to less than VND 10.000.000;
c) A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed if the damage caused by the violation is assessed at from VND 10.000.000 to less than VND 20.000.000;
d) A fine ranging from VND 5.000.000 to VND 7.000.000 shall be imposed if the arrears are from VND 20.000.000 to less than VND 40.000.000;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
e) A fine ranging from VND 10.000.000 to VND 15.000.000 shall be imposed if the arrears are from VND 60.000.000 to less than VND 80.000.000;
g) A fine ranging from VND 15.000.000 to VND 20.000.000 shall be imposed if the arrears are from VND 80.000.000 to less than VND 120.000.000;
h) A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed if the arrears are from VND 120.000.000 to less than VND 160.000.000;
i) A fine ranging from VND 30.000.000 to VND 40.000.000 shall be imposed if the arrears are VND 160.000.000 or more.
4. A fine ranging from VND 10.000.000 to VND 15.000.000 shall be imposed for illegally obtaining health insurance payout.
5. Remedial measures:
a) The violating entity is compelled to make compensations for any damage incurred by health insurance policyholders in commission of the violation in Clause 2, 3 or 4 of this Article. Any payments which cannot be made to payers shall be paid to state budget in accordance with regulations of law;
b) Any benefits illegally obtained from the violation in Clause 2, 3 or 4 of this Article shall be paid to the dedicated account of the health insurance fund.
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
a) A fine ranging from VND 1.000.000 to VND 2.000.000 per heath insurance card shall be imposed for the violation which does not cause damage to the health insurance fund;
b) A fine ranging from VND 2.000.000 to VND 3.000.000 per health insurance card shall be imposed if health insurance cards have been used resulting in damage to the health insurance fund.
2. The following fines shall be imposed for participating in health insurance at an agency or organization against regulations of law:
a) The fine ranging from VND 1.000.000 to VND 2.000.000 shall be imposed for each person holding the health insurance card which is not used;
b) The fine ranging from VND 2.000.000 to VND 3.000.000 shall be imposed for each person holding the health insurance card which has been used.
3. Additional penalty:
The exhibits, which are health insurance cards, used for committing the violation in Clause 1 or Clause 2 of this Article shall be confiscated.
4. Remedial measure:
The violating entity is compelled to return medical costs to the account of the health insurance fund in case of commission of the violation in Point b Clause 1 or Point b Clause 2 of this Article.
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
The following fines shall be imposed for certifying incorrect amounts of health insurance contributions:
1. A fine ranging from VND 1.000.000 to VND 2.000.000 shall be imposed if the certified amount is less than VND 10.000.000.
2. A fine ranging from VND 2.000.000 to VND 3.000.000 shall be imposed if the incorrectly certified amount is from VND 10.000.000 to less than VND 20.000.000.
3. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed if the incorrectly certified amount is from VND 20.000.000 to less than VND 40.000.000.
4. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed if the incorrectly certified amount is from VND 40.000.000 to less than VND 60.000.000.
5. A fine ranging from VND 10.000.000 to VND 15.000.000 shall be imposed if the incorrectly certified amount is from VND 60.000.000 to less than VND 80.000.000.
6. A fine ranging from VND 15.000.000 to VND 20.000.000 shall be imposed if the incorrectly certified amount is from VND 80.000.000 to less than VND 100.000.000.
7. A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed if the incorrectly certified amount is from VND 100.000.000 to less than VND 120.000.000.
8. A fine ranging from VND 30.000.000 to VND 40.000.000 shall be imposed if the incorrectly certified amount is from VND 120.000.000 to less than VND 150.000.000.
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
1. A fine ranging from VND 500.000 to VND 1.000.000 shall be imposed for commission of one of the following violations:
a) Preparing and transferring the list of policyholders issued with health insurance card after the prescribed deadline but the violation does not harm legitimate rights and benefits of policyholders;
b) Preparing and transferring the list of policyholders issued with health insurance card which does not contain all of eligible policyholders under management but the violation does not harm legitimate rights and benefits of policyholders.
2. The following fines shall be imposed for preparing and transferring the list of policyholders issued with health insurance card after the prescribed deadline and the violation has caused harm to legitimate rights and benefits of policyholders:
a) A fine ranging from VND 1.000.000 to VND 2.000.000 shall be imposed if the list is submitted within 10 working days after the prescribed deadline;
b) A fine ranging from VND 2.000.000 to VND 3.000.000 shall be imposed if the list is submitted 10 working days or more after the prescribed deadline.
3. The following fines shall be imposed for preparing and transferring the list of policyholders issued with health insurance card which does not contain all of eligible policyholders under management and the violation has caused harm to legitimate rights and benefits of policyholders:
a) A fine ranging from VND 1.000.000 to VND 3.000.000 shall be imposed if the list lacks less than 50 persons eligible to participate in health insurance;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
c) A fine ranging from VND 5.000.000 to VND 7.000.000 shall be imposed if the list lacks from 100 to less than 500 persons eligible to participate in health insurance;
d) A fine ranging from VND 7.000.000 to VND 10.000.000 shall be imposed if the list lacks from 500 to less than 1.000 persons eligible to participate in health insurance;
dd) A fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed if the list lacks 1.000 or more persons eligible to participate in health insurance.
4. Remedial measure:
The violating entity is compelled to make compensations for any damage incurred by health insurance policyholders in commission of the violation in Clause 2 or 3 of this Article. The amounts of money which cannot be returned to payers shall be paid to state budget in accordance with regulations of law.
Article 84. Violations against regulations on use of health insurance cards
1. The following fines shall be imposed for lending the health insurance card to another or using a borrowed health insurance card:
a) A fine ranging from VND 1.000.000 to VND 2.000.000 shall be imposed of the violation does not cause damage to the health insurance fund;
b) A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed of the violation has caused damage to the health insurance fund.
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
The violating entity is compelled to pay compensation to the health insurance fund in case of commission of the violation in Point b Clause 1 of this Article.
1. A fine ranging from VND 200.000 to VND 500.000 shall be imposed for preparing a medical record or writing out a prescription without a patient or for a wrong patient if the violation involves an amount of less than VND 1.000.000.
2. The following fines shall be imposed for preparing medical records or writing out prescriptions without patients or for wrong patients:
a) A fine ranging from VND 500.000 to VND 1.000.000 shall be imposed if the violation involves an amount of from VND 1.000.000 to less than VND 2.000.000;
b) A fine ranging from VND 1.000.000 to VND 2.000.000 shall be imposed if the violation involves an amount of from VND 2.000.000 to less than VND 5.000.000;
c) A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed if the violation involves an amount of from VND 5.000.000 to less than VND 10.000.000;
d) A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed if the violation involves an amount of from VND 10.000.000 to less than VND 15.000.000;
dd) A fine ranging from VND 10.000.000 to VND 15.000.000 shall be imposed if the violation involves an amount of from VND 15.000.000 to less than VND 25.000.000;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
g) A fine ranging from VND 20.000.000 to VND 25.000.000 shall be imposed if the violation involves an amount of from VND 50.000.000 to less than VND 80.000.000;
h) A fine ranging from VND 25.000.000 to VND 30.000.000 shall be imposed if the violation involves an amount of VND 80.000.000 or more.
3. Remedial measure:
The violating entity is compelled to transfer the amounts of money involving in the violation in Clause 1 or Clause 2 of this Article to the dedicated account of the health insurance fund.
1. A fine ranging from VND 500.000 to VND 1.000.000 shall be imposed for commission of one of the following violations which cause damage assessed at less than VND 1.000.000 to the health insurance fund:
a) Falsely increasing the quantity or types of drugs, chemicals, medical supplies, technical services, hospital bed days and other costs that are actually not used by patients;
b) Failing to provide adequate drugs, chemicals, medical supplies and technical services when providing covered medical services.
2. The following fines shall be imposed for falsely increasing the quantity or types of drugs, chemicals, medical supplies, technical services, hospital bed days and other costs that are actually not used by patients:
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
b) A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed if the violation involves an amount of from VND 3.000.000 to less than VND 5.000.000;
c) A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed if the violation involves an amount of from VND 5.000.000 to less than VND 10.000.000;
d) A fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed if the violation involves an amount of from VND 10.000.000 to less than VND 20.000.000;
dd) A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed if the violation involves an amount of from VND 20.000.000 to less than VND 30.000.000;
e) A fine ranging from VND 30.000.000 to VND 40.000.000 shall be imposed if the violation involves an amount of from VND 30.000.000 to less than VND 40.000.000;
g) A fine ranging from VND 40.000.000 to VND 50.000.000 shall be imposed if the violation involves an amount of from VND 40.000.000 to less than VND 50.000.000;
h) A fine ranging from VND 50.000.000 to VND 60.000.000 shall be imposed if the arrears are from VND 50.000.000 to less than VND 60.000.000;
i) A fine ranging from VND 60.000.000 to VND 70.000.000 shall be imposed if the violation involves an amount of VND 60.000.000 or more.
3. The following fines shall be imposed for failing to prescribe and provide adequate drugs, chemicals, medical supplies and technical services when providing covered medical services:
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
b) A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed if the violation involves an amount of from VND 10.000.000 to less than VND 20.000.000;
c) A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed if the violation involves an amount of from VND 20.000.000 to less than VND 40.000.000;
d) A fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed if the violation involves an amount of from VND 40.000.000 to less than VND 80.000.000;
dd) A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed if the violation involves an amount of from VND 80.000.000 to less than VND 120.000.000;
e) A fine ranging from VND 30.000.000 to VND 40.000.000 shall be imposed if the violation involves an amount of from VND 120.000.000 to less than VND 160.000.000;
g) A fine ranging from VND 40.000.000 to VND 50.000.000 shall be imposed if the violation involves an amount of VND 160.000.000 or more.
4. Remedial measures:
a) The violating entity is compelled to transfer the amounts of money involving in the violation in Clause 1 or Clause 2 of this Article to the dedicated account of the health insurance fund;
b) The violating entity is compelled to make compensations for any damage incurred by health insurance policyholders in commission of the violation in Clause 1, 2 or 3 of this Article. The amounts of money which cannot be returned to payers shall be paid to state budget in accordance with regulations of law.
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
1. A warning or a fine ranging from VND 300.000 to VND 500.000 shall be imposed for committing a violation against regulations on rights and benefits of health insurance policyholders which involves an amount of less than VND 1.000.000.
2. The following fines shall be imposed for committing a violation against regulations on rights and benefits of health insurance policyholders:
a) A fine ranging from VND 1.000.000 to VND 2.000.000 shall be imposed if the damage is assessed at from VND 1.000.000 to less than VND 5.000.000;
b) A fine ranging from VND 2.000.000 to VND 3.000.000 shall be imposed if the damage is assessed at from VND 5.000.000 to less than VND 10.000.000;
c) A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed if the damage is assessed at from VND 10.000.000 to less than VND 15.000.000;
d) A fine ranging from VND 5.000.000 to VND 7.000.000 shall be imposed if the violation involves an amount of from VND 15.000.000 to less than VND 20.000.000;
dd) A fine ranging from VND 7.000.000 to VND 10.000.000 shall be imposed if the violation involves an amount of from VND 20.000.000 to less than VND 40.000.000;
e) A fine ranging from VND 10.000.000 to VND 15.000.000 shall be imposed if the violation involves an amount of VND 40.000.000 or more.
3. Remedial measures:
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
b) The violating entity is compelled to transfer the amounts of money involving in the violation in Clause 1 or Clause 2 of this Article to the dedicated account of the health insurance fund.
Article 88. Violations against regulations on reimbursement of costs of covered medical services
1. A warning or a fine ranging from VND 300.000 to VND 500.000 shall be imposed for setting incorrect prices or writing incorrect types, units and names of technical services upon reimbursement of costs of covered medical services if the violation involves an amount of less than VND 1.000.000.
2. The following fines shall be imposed for setting incorrect prices or writing incorrect types, units and names of technical services upon reimbursement of costs of covered medical services:
a) A fine ranging from VND 1.000.000 to VND 2.000.000 shall be imposed if the damage is assessed at from VND 1.000.000 to less than VND 5.000.000;
b) A fine ranging from VND 2.000.000 to VND 3.000.000 shall be imposed if the damage is assessed at from VND 5.000.000 to less than VND 10.000.000;
c) A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed if the damage caused by the violation is assessed at from VND 10.000.000 to less than VND 20.000.000;
d) A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed if the damage caused by the violation is assessed at from VND 20.000.000 to less than VND 40.000.000;
dd) A fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed if the damage caused by the violation is assessed at from VND 40.000.000 to less than VND 80.000.000;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
g) A fine ranging from VND 40.000.000 to VND 50.000.000 shall be imposed if the damage caused by the violation is assessed at VND 120.000.000 or more.
3. Remedial measures:
a) The violating entity is compelled to transfer the amounts of money involving in the violation in Clause 1 or Clause 2 of this Article to the dedicated account of the health insurance fund;
b) The violating entity is compelled to make compensations for any damage incurred by health insurance policyholders in commission of the violation in Clause 1 or 2 of this Article. The amounts of money which cannot be returned to payers shall be paid to state budget in accordance with regulations of law.
Article 89. Violations against regulations on contracts for provision of covered medical services
1. A fine ranging from VND 1.000.000 to VND 3.000.000 shall be imposed for commission of one of the following violations which do not cause damage to rights and benefits of health insurance policyholders, heath facilities and the health insurance fund:
a) Unilaterally terminating a contract for provision of covered medical services against regulations of law;
b) Entering into a contract for provision of covered medical services whose contents are contrary to regulations of law;
c) Entering into a contract for provision of covered medical services beyond the power prescribed by law.
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
a) A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed if the damage is assessed at less than VND 50.000.000;
b) A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed if the damage is assessed at from VND 50.000.000 to less than VND 100.000.000;
c) A fine ranging from VND 10.000.000 to VND 15.000.000 shall be imposed if the damage is assessed at from VND 100.000.000 to less than VND 500.000.000;
d) A fine ranging from VND 15.000.000 to VND 20.000.000 shall be imposed if the damage is assessed at from VND 500.000.000 to less than VND 1.000.000.000;
dd) A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed if the damage is assessed at from VND 1.000.000.000 to less than VND 5.000.000.000;
e) A fine ranging from VND 30.000.000 to VND 40.000.000 shall be imposed if the damage is assessed at VND 5.000.000.000 or more.
3. The following fines shall be imposed for entering into a contract for provision of covered medical services whose contents are contrary to regulations of law or beyond the power prescribed by law resulting in damage caused to rights and benefits of health insurance policyholders, heath facilities and health insurance fund:
a) A fine ranging from VND 1.000.000 to VND 5.000.000 shall be imposed if the damage is assessed at less than VND 50.000.000;
b) A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed if the damage is assessed at from VND 50.000.000 to less than VND 100.000.000;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
d) A fine ranging from VND 15.000.000 to VND 20.000.000 shall be imposed if the damage is assessed at from VND 500.000.000 to less than VND 1.000.000.000;
dd) A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed if the damage is assessed at from VND 1.000.000.000 to less than VND 5.000.000.000;
e) A fine ranging from VND 30.000.000 to VND 40.000.000 shall be imposed if the damage is assessed at VND 5.000.000.000 or more.
4. Remedial measures:
a) The violating entity is compelled to transfer the amounts of money involving in the violation in Clause 2 or Clause 3 of this Article to the dedicated account of the health insurance fund;
b) The violating entity is compelled to make compensations for any damage incurred by health insurance policyholders in commission of the violation in Clause 2 or 3 of this Article. Any payments which cannot be made to payers shall be paid to state budget in accordance with regulations of law;
c) The violating entity is compelled to make compensations for any damage incurred by the health facility in case of commission of the violation in Clause 3 of this Article. The amounts of money which cannot be returned to payers shall be paid to state budget in accordance with regulations of law.
1. A warning or a fine ranging from VND 200.000 to VND 500.000 shall be imposed for determining health insurance benefits inconsistently with information on the health insurance card if the damage is assessed at less than VND 1.000.000.
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
a) A fine ranging from VND 1.000.000 to VND 2.000.000 shall be imposed if the damage is assessed at from VND 1.000.000 to less than VND 5.000.000;
b) A fine ranging from VND 2.000.000 to VND 3.000.000 shall be imposed if the damage is assessed at from VND 5.000.000 to less than VND 10.000.000;
c) A fine ranging from VND 3.000.000 to VND 4.000.000 shall be imposed if the damage is assessed at from VND 10.000.000 to less than VND 15.000.000;
d) A fine ranging from VND 4.000.000 to VND 5.000.000 shall be imposed if the damage is assessed at from VND 15.000.000 to less than VND 20.000.000;
dd) A fine ranging from VND 5.000.000 to VND 6.000.000 shall be imposed if the damage is assessed at from VND 20.000.000 to less than VND 40.000.000;
e) A fine ranging from VND 6.000.000 to VND 7.000.000 shall be imposed if the damage is assessed at VND 40.000.000 or more.
3. Remedial measures:
a) The violating entity is compelled to make compensations for any damage incurred by health insurance policyholders in commission of the violation in Clause 1 or 2 of this Article. Any payments which cannot be made to payers shall be paid to state budget in accordance with regulations of law;
b) The violating entity is compelled to make compensations for any damage incurred by the health facility in case of commission of the violation in Clause 1 or 2 of this Article. Any payments which cannot be made to payers shall be paid to state budget in accordance with regulations of law;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
1. A warning or a fine ranging from VND 200.000 to VND 500.000 shall be imposed for submitting reports on implementation of health insurance policies after the prescribed deadline or with no data or incorrect data to competent authorities but the violation does not yet adversely affect management, implementation and formulation of health insurance policies.
2. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for submitting reports on implementation of health insurance policies after the prescribed deadline or with no data or incorrect data to competent authorities resulting in adverse effects on management, implementation and formulation of health insurance policies.
1. A warning or a fine ranging from VND 200.000 to VND 500.000 shall be imposed for failing to provide or incorrectly or lately providing information about health insurance policyholders but the violation does not yet cause damage to the health insurance fund.
2. The following fines shall be imposed for failing to provide or incorrectly or lately providing information about health insurance policyholders resulting in damage caused to the health insurance fund:
a) A fine ranging from VND 1.000.000 to VND 3.000.000 shall be imposed if the damage is assessed at less than VND 50.000.000;
b) A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed if the damage is assessed at from VND 50.000.000 to less than VND 100.000.000;
c) A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed if the damage is assessed at from VND 100.000.000 to less than VND 200.000.000;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
1. A warning or a fine ranging from VND 200.000 to VND 500.000 shall be imposed for failing to provide or providing inadequate or incorrect information for provision of health insurance benefits to patients at health facilities or direct reimbursement of medical costs to policyholders but the violation does not yet cause damage to policyholders.
2. A fine ranging from VND 1.000.000 to VND 3.000.000 shall be imposed for failing to provide or providing inadequate or incorrect information for provision of health insurance benefits to patients at health facilities or direct reimbursement of medical costs to policyholders resulting in damage caused to policyholders.
3. Remedial measure:
The violating entity is compelled to make compensations for damage incurred by health insurance policyholders in case of commission of the violation in Clause 2 of this Article. The amounts of money which cannot be returned to payers shall be paid to state budget in accordance with regulations of law.
Article 94. Late submission of statements of costs of covered medical services
1. A fine ranging from VND 500.000 to VND 1.000.000 shall be imposed for submitting statements of costs of covered medical services less than 05 working days late after the prescribed deadline.
2. The following fines shall be imposed for late submission of statements of costs of covered medical services:
a) A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed if the statement is submitted from 05 to less than 20 working days late after the prescribed deadline;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Article 95. Violations against other regulations on health insurance
1. A fine ranging from VND 500.000 to VND 1.000.000 shall be imposed for commission of one of the following violations:
a) Causing difficulties in or obstructing the provision of covered medical services but the violation does not yet cause damage to policyholders and health facilities;
b) Taking advantage of prescription or using drugs, chemicals, medical supplies, technical services and other medical services in excess of essential levels according to regulations on medical techniques and qualifications resulting in damage assessed at less than VND 1.000.000 caused to policyholders, health insurance fund and health facilities.
2. The following fines shall be imposed for causing difficulties in or obstructing the provision of covered medical services resulting in damage to policyholders and health facilities:
a) A fine ranging from VND 1.000.000 to VND 2.000.000 shall be imposed if the damage is assessed at from VND 1.000.000 to less than VND 5.000.000;
b) A fine ranging from VND 2.000.000 to VND 3.000.000 shall be imposed if the damage is assessed at from VND 5.000.000 to less than VND 10.000.000;
c) A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed if the damage is assessed at from VND 10.000.000 to less than VND 15.000.000;
d) A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed if the damage is assessed at from VND 15.000.000 to less than VND 20.000.000;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
e) A fine ranging from VND 15.000.000 to VND 20.000.000 shall be imposed if the damage is assessed at VND 40.000.000 or more.
3. The following fines shall be imposed for misusing covered medical services, including prescribing and using drugs, chemicals, medical supplies, technical services and other medical services in excess of the maximum norms or essential levels according to regulations on medical techniques and qualifications resulting in damage to policyholders, health facilities and health insurance fund:
a) A fine ranging from VND 1.000.000 to VND 2.000.000 shall be imposed if the damage is assessed at from VND 1.000.000 to less than VND 5.000.000;
b) A fine ranging from VND 2.000.000 to VND 3.000.000 shall be imposed if the damage is assessed at from VND 5.000.000 to less than VND 10.000.000;
c) A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed if the damage caused by the violation is assessed at from VND 10.000.000 to less than VND 20.000.000;
d) A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed if the damage caused by the violation is assessed at from VND 20.000.000 to less than VND 40.000.000;
dd) A fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed if the damage is assessed at from VND 40.000.000 to less than VND 60.000.000;
e) A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed if the damage is assessed at from VND 60.000.000 to less than VND 80.000.000;
g) A fine ranging from VND 30.000.000 to VND 40.000.000 shall be imposed if the damage is assessed at VND 80.000.000 or more.
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
a) Failing to register the specimen seal and signature of the practitioner licensed to sign certificates of incapacity and of the person authorized to sign and append the seal of the health facility on certificates with the competent social agency;
b) Failing to make connection for data sharing and prepare electronic documents in medical examination and treatment according to regulations on electronic transactions in health insurance sector.
5. Remedial measures:
a) The violating entity is compelled to make compensations for any damage incurred by the health facility in case of commission of the violation in Point b Clause 1, Clause 2 or Clause 3 of this Article. Any payments which cannot be made to payers shall be paid to state budget in accordance with regulations of law;
b) The violating entity is compelled to make compensations for any damage incurred by health insurance policyholders in commission of the violation in Point b Clause 1, Clause 2 or Clause 3 of this Article. Any payments which cannot be made to payers shall be paid to state budget in accordance with regulations of law;
c) The violating entity is compelled to transfer the amounts of money involving in the violation in Point b Clause 1 or Clause 3 of this Article to the dedicated account of the health insurance fund.
Section 6. VIOLATIONS AGAINST REGULATIONS ON POPULATION
1. A warning or a fine ranging from VND 200.000 to VND 500.000 shall be imposed for obstructing the dissemination and provision of information and counseling on population, reproductive health and family planning.
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
a) Disseminating or providing information that is contrary to the Communist Party’s guidelines and policies, State law or elegant traditional heritages, or adversely affects the performance of population tasks and social life;
b) Disseminating information that is false or inaccurate or adversely affects the performance of population tasks, social life or other sectors;
c) Taking advantage of propagation activities and dissemination of information on population, reproductive health and family planning for disseminating documents/objects or performing other acts contrary to traditional customs and habits, and social ethics.
3. Additional penalty:
The exhibits, including documents and objects containing violating information, of the violation in Clause 2 of this Article shall be confiscated.
4. Remedial measures:
a) The exhibits used for committing the violation in Clause 2 of this Article shall be destroyed;
b) The violating entity is compelled to correct any information that is contrary to the Communist Party’s guidelines and policies, and State law on population in case of commission of the violation in Clause 2 of this Article.
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
a) Disseminating information on sex selection methods;
b) Providing counseling on sex selection methods.
2. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for commission of one of the following violations:
a) Selling, leasing, delivering or publishing on the internet publications or articles containing information on sex selection methods;
b) Publishing or broadcasting information on sex selection methods.
3. A fine ranging from VND 10.000.000 to VND 15.000.000 shall be imposed for translating, producing, printing, releasing, duplicating or photocopying publications or articles containing information on sex selection methods.
4. Additional penalty:
The exhibits, including publications, articles and documents used for propagation and information dissemination activities, of the violation in Clause 1, 2 or 3 of this Article shall be confiscated.
5. Remedial measure:
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Article 98. Violations against regulations on fetal sex diagnosis and determination
1. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for determining fetal sex by means of fortune-telling.
2. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for checking the pulse, giving ultrasound scan or performing tests for pregnant women for diagnosing and revealing/providing information on fetal sex, unless otherwise prescribed by law.
3. Additional penalty:
The license for medical operations and/or practicing certificate shall be suspended for a fixed period of 01 - 03 months in case of commission of the violation in Clause 2 of this Article.
Article 99. Violations against regulations on sex selection
1. A fine ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for threatening to use violence or mentally intimidating others to adopt sex selection methods.
2. A fine ranging from VND 10.000.000 to VND 15.000.000 shall be imposed for using violence to force others to adopt sex selection methods.
3. A fine ranging from VND 15.000.000 to VND 20.000.000 shall be imposed for commission of one of the following violations:
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
b) Providing tools, drugs and supplies for selecting fetal sex;
c) Doing research on sex selection methods, unless otherwise prescribed by law.
4. Additional penalties:
a) Operations of the violating entity shall be suspended for a fixed period of 01 - 03 months in case of commission of the violation in Clause 3 of this Article;
b) The medical examination and treatment practicing certificate shall be suspended for a fixed period of 01 - 03 months in case of commission of the violation in Clause 3 of this Article.
5. Remedial measure:
Tools, drugs and supplies involving in the violation in Point b Clause 3 of this Article shall be destroyed.
Article 100. Sex-selective abortion
1. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for voluntarily deciding to have an abortion because of the predicted sex of the infant.
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
3. A fine ranging from VND 7.000.000 to VND 10.000.000 shall be imposed for threatening to use violence or mentally intimidating a pregnant woman into an abortion because of the predicted sex of the infant.
4. A fine ranging from VND 10.000.000 to VND 12.000.000 shall be imposed for using violence to force a pregnant woman to have an abortion because of the predicted sex of the infant.
5. A fine ranging from VND 12.000.000 to VND 15.000.000 shall be imposed for commission of one of the following violations:
a) Providing chemicals and drugs for aborting the pregnancy in the knowledge that the abortion is sex-selective;
b) Prescribing for or instructing the use of chemicals and drugs or other measures for aborting the pregnancy in the knowledge that the abortion is sex-selective.
6. A fine ranging from VND 15.000.000 to VND 20.000.000 shall be imposed for performing an abortion in the knowledge that the abortion is sex-selective.
7. Additional penalties:
a) The license for medical operations and/or practicing certificate shall be suspended for a fixed period of 03 - 06 months in case of commission of the violation in Clause 5 of this Article;
b) The license for medical operations and/or practicing certificate shall be suspended for a fixed period of 06 - 12 months in case of commission of the violation in Clause 6 of this Article;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Article 101. Violations against regulations on forced birth control
a) Failing to provide free of charge contraceptive instruments for individuals who are eligible as prescribed by law and have registered for free-of-charge receipt of contraceptive instruments;
b) Having or performing words or acts that offend the honor or dignity of persons using birth control methods or persons who only give birth to boys or girls.
2. A fine ranging from VND 1.000.000 to VND 2.000.000 shall be imposed for threatening to use violence or mentally intimidating others into using contraceptive methods.
3. A fine ranging from VND 3.000.000 to VND 5.000.000 shall be imposed for commission of one of the following violations:
a) Threatening to use violence or mentally intimidating others into not using or stopping using contraceptive methods;
b) Threatening to use violence or mentally intimidating a woman who has only given birth to boys or girls into conceiving or giving birth.
4. A fine ranging from VND 5.000.000 to VND 7.000.000 shall be imposed for using violence to force others to use contraceptive methods.
5. A fine ranging from VND 7.000.000 to VND 10.000.000 shall be imposed for commission of one of the following violations:
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
b) Using violence to force others not to use or to stop using contraceptive methods;
c) Using violence to force a woman who has only given birth to boys or girls into conceiving or giving birth.
6. A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed for performing sterilization procedure for a person without his/her consent.
7. Additional penalty:
The license for medical operations and/or medical examination and treatment practicing certificate shall be suspended for a fixed period of 01 - 03 months in case of commission of the violation in Clause 6 of this Article.
8. Remedial measure:
Intrauterine devices/implanted contraceptives shall be removed in case of commission of the violation in Point a Clause 5 of this Article.
Article 102. Violations against regulations on sale of contraceptives
1. A fine ranging from VND 1.000.000 to VND 3.000.000 shall be imposed for selling contraceptives which must be provided free of charge as prescribed by competent authorities.
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
3. Additional penalty:
The exhibits that are contraceptives in the violation in Clause 1 of this Article shall be confiscated.
4. Remedial measure:
The entity committing the violation in Clause 1 or Clause 2 of this Article is compelled to return any amounts of money collected against regulations of law. The amounts of money which cannot be returned to payers shall be paid to state budget in accordance with regulations of law.
POWER TO IMPOSE PENALTIES FOR ADMINISTRATIVE VIOLATIONS IN MEDICAL SECTOR
Article 103. Power to impose penalties of Chairpersons of People’s Committees
1. Chairpersons of communal-level People’s Committees shall have the power to:
a) Issue warning;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
c) 99 Confiscate the exhibits and instrumentalities worth up to VND 6.000.000 for the administrative violations against regulations on population, or up to VND 10.000.000 for the administrative violations against regulations on preventive medicine, HIV/AIDS prevention and control, health insurance, medical examination and treatment, pharmacy, cosmetics and medical devices;
d) Enforce the remedial measures mentioned in Points c and dd Clause 1 Article 28 of the Law on actions against administrative violations.
2. Chairpersons of District-level People’s Committees shall have the power to:
a) Issue warning;
b) Impose a fine up to VND 15.000.000 for the administrative violations against regulations on population, up to VND 25.000.000 for the administrative violations against regulations on preventive medicine, HIV/AIDS prevention and control, up to VND 37.500.000 for the administrative violations against regulations on health insurance, or up to VND 50.000.000 for the administrative violations against regulations on medical examination and treatment, pharmacy, cosmetics and medical devices;
c) Suspend licenses/practicing certificates or operations for a fixed period;
d) 100 Confiscate the exhibits and instrumentalities used for committing administrative violations;
dd) Enforce the remedial measures mentioned in Points c, dd, e, h and i Clause 1 Article 28 of the Law on penalties for administrative violations and in Clause 3 Article 3 hereof.
3. Chairpersons of Provincial-level People’s Committees shall have the power to:
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
b) Impose a fine up to VND 30.000.000 for the administrative violations against regulations on population, up to VND 50.000.000 for the administrative violations against regulations on preventive medicine, HIV/AIDS prevention and control, up to VND 75.000.000 for the administrative violations against regulations on health insurance, or up to VND 100.000.000 for the administrative violations against regulations on medical examination and treatment, pharmacy, cosmetics and medical devices;
c) Suspend licenses/practicing certificates or operations for a fixed period;
d) &fA100; Confiscate the exhibits and instrumentalities used for committing administrative violations;
dd) Enforce the remedial measures mentioned in Points c, d, dd, e, g, h and i Clause 1 Article 28 of the Law on penalties for administrative violations and in Clause 3 Article 3 hereof.
Article 104. Power to impose penalties of inspectors
1. On-duty inspectors and persons assigned to carry out specialized inspections shall have the power to:
a) Issue warning;
b) Impose a fine up to VND 300.000 for the administrative violations against regulations on population, or up to VND 500.000 for the administrative violations against regulations on preventive medicine, HIV/AIDS prevention and control, health insurance, medical examination and treatment, pharmacy, cosmetics and medical devices;
c)101 Confiscate the exhibits and instrumentalities worth up to VND 600.000 for the administrative violations against regulations on population, or up to VND 1.000.000 for the administrative violations against regulations on preventive medicine, HIV/AIDS prevention and control, health insurance, medical examination and treatment, pharmacy, cosmetics and medical devices;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
2. 102 Chief Inspectors of provincial departments, Directors of Population and Family Planning Sub-departments affiliated to provincial Departments of Health, heads of provincial-level specialized inspection teams, and heads of specialized inspection teams established by competent authorities assigned to perform specialized inspection functions shall have the power to:
a) Issue warning;
b) Impose a fine up to VND 15.000.000 for the administrative violations against regulations on population, up to VND 25.000.000 for the administrative violations against regulations on preventive medicine, HIV/AIDS prevention and control, up to VND 37.500.000 for the administrative violations against regulations on health insurance, or up to VND 50.000.000 for the administrative violations against regulations on medical examination and treatment, pharmacy, cosmetics and medical devices;
c) Suspend licenses/practicing certificates or operations for a fixed period;
d)103 Confiscate the exhibits and instrumentalities worth up to VND 30.000.000 for the administrative violations against regulations on population, or up to VND 50.000.000 for the administrative violations against regulations on preventive medicine, HIV/AIDS prevention and control, or up to VND 75.000.000 for the administrative violations against regulations on health insurance, or up to VND 100.000.000 for the administrative violations against regulations on medical examination and treatment, pharmacy, cosmetics and medical devices;
dd) Enforce the remedial measures mentioned in Points c, d, dd, e, g, h and i Clause 1 Article 28 of the Law on penalties for administrative violations and in Clause 3 Article 3 hereof.
3. 104 Chief Inspectors of Ministries, Director General of General Department of Population and Family Planning, Director General of Drug Administration of Vietnam, Director General of Vietnam Administration of Medical Services, Director General of Health Environment Management Agency, and Director General of General Department of Preventive Medicine shall have the power to:
a) Issue warning;
b) Impose a fine up to VND 30.000.000 for the administrative violations against regulations on population, up to VND 50.000.000 for the administrative violations against regulations on preventive medicine, HIV/AIDS prevention and control, up to VND 75.000.000 for the administrative violations against regulations on health insurance, or up to VND 100.000.000 for the administrative violations against regulations on medical examination and treatment, pharmacy, cosmetics and medical devices;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
d) Confiscate the exhibits and instrumentalities used for committing administrative violations;
dd) Enforce the remedial measures mentioned in Points c, d, dd, e, g, h and i Clause 1 Article 28 of the Law on penalties for administrative violations and in Clause 3 Article 3 hereof.
4. Heads of specialized inspection teams established by Ministries shall have the power to:
a) Issue warning;
b) Impose a fine up to VND 21.000.000 for the administrative violations against regulations on population, up to VND 35.000.000 for the administrative violations against regulations on preventive medicine, and HIV/AIDS prevention and control, up to VND 52.500.000 for the administrative violations against regulations on health insurance, or up to VND 70.000.000 for the administrative violations against regulations on medical examination and treatment, pharmacy, cosmetics and medical devices;
c) Suspend licenses/practicing certificates or operations for a fixed period;
d) 105 Confiscate the exhibits and instrumentalities worth up to VND 42.000.000 for the administrative violations against regulations on population, or up to VND 70.000.000 for the administrative violations against regulations on preventive medicine, HIV/AIDS prevention and control, or up to VND 105.000.000 for the administrative violations against regulations on health insurance, or up to VND 140.000.000 for the administrative violations against regulations on medical examination and treatment, pharmacy, cosmetics and medical devices;
dd) Enforce the remedial measures mentioned in Points c, d, dd, e, g, h and i Clause 1 Article 28 of the Law on penalties for administrative violations and in Clause 3 Article 3 hereof.
Article 105. Power to impose penalties of market surveillance forces
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
a) Issue warning;
b) Impose a fine up to VND 500.000 for the administrative violations against regulations on population, preventive medicine, medical examination and treatment, pharmacy, cosmetics and medical devices.
2. 106 Leaders of Market Surveillance Teams and Heads of Professional Divisions under the control of the Departments of Market Surveillance Operations shall have the power to:
a) Issue warning;
b) Impose a fine up to VND 25.000.000 for the administrative violations against regulations on population, preventive medicine, medical examination and treatment, pharmacy, cosmetics and medical devices;
c) 107 Confiscate the exhibits and instrumentalities worth up to VND 50.000.000 for the administrative violations against regulations on population, preventive medicine, medical examination and treatment, pharmacy, cosmetics and medical devices;
d) Enforce the remedial measures mentioned in Point dd, e, h and i Clause 1 Article 28 of the Law on penalties for administrative violations and those mentioned in Clause 3 Article 3 hereof.
3. 108 Directors of Provincial-level Market Surveillance Departments and Directors of Market Surveillance Operations Departments affiliated to Vietnam Directorate of Market Surveillance shall have the power to:
a) Issue warning;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
c) 109 Confiscate the exhibits and instrumentalities for committing administrative violations;
d) Suspend licenses/practicing certificates or suspend operations for fixed periods;
dd) Enforce the remedial measures mentioned in Points c, d, dd, e, g, h and i Clause 1 Article 28 of the Law on penalties for administrative violations and in Clause 3 Article 3 hereof.
4. Director General of Vietnam Directorate of Market Surveillance shall have the power to:
a) Issue warning;
b) Impose a fine up to VND 30.000.000 for the administrative violations against regulations on population, or up to VND 50.000.000 for the administrative violations against regulations on preventive medicine, or up to VND 100.000.000 for the administrative violations against regulations on medical examination and treatment, pharmacy, cosmetics and medical devices;
c) Confiscate the exhibits and instrumentalities for committing administrative violations;
d) Suspend licenses/practicing certificates or suspend operations for fixed periods;
dd) Enforce the remedial measures mentioned in Points c, d, dd, e, g, h and i Clause 1 Article 28 of the Law on penalties for administrative violations and in Clause 3 Article 3 hereof.
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
1. On-duty soldiers of people’s police forces shall have the power to:
a) Issue warning;
b) Impose a fine up to VND 300.000 for the administrative violations against regulations on population, or up to VND 500.000 for the administrative violations against regulations on preventive medicine, HIV/AIDS prevention and control, medical examination and treatment, pharmacy, cosmetics and medical devices;
2. 110 Heads of stations and leaders of the soldiers mentioned in Clause 1 of this Article shall have the power to:
a) Issue warning;
b) Impose a fine up to VND 900.000 for the administrative violations against regulations on population, or up to VND 1.500.000 for the administrative violations against regulations on preventive medicine, HIV/AIDS prevention and control, health insurance, medical examination and treatment, pharmacy, cosmetics and medical devices.
3. 111 Communal-level police chiefs, heads of public security stations, heads of public security stations at border gates and export processing zones, heads of public security stations at international airports, and captains of squadrons shall have the power to:
a) Issue warning;
b) Impose a fine up to VND 1.500.000 for the administrative violations against regulations on population, or up to VND 2.500.000 for the administrative violations against regulations on preventive medicine, HIV/AIDS prevention and control, health insurance, medical examination and treatment, pharmacy, cosmetics and medical devices;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
d) Enforce the remedial measures mentioned in Points c and dd Clause 1 Article 28 of the Law on actions against administrative violations.
4. 113 Heads of district-level police agencies, heads of professional divisions of the following authorities, including the Internal Political Security Department, the Police Department for Administration of Social Order, the Traffic Police Department, and the Department of Cybersecurity, Hi-Tech Crime Prevention and Control, and heads of provincial-level police departments, including: Economic Security Departments, Internal Political Security Divisions, Police Departments for Social Order Administration, Police Divisions for Prevention and Control of Environmental Crimes, Traffic Police Divisions, Road and Railway Traffic Police Divisions, Road Traffic Police Divisions, Waterway Police Divisions, Investigation Police Divisions for Corruption, Economic and Smuggling Crimes, and Captains of Squadrons shall have the power to:
a) Issue warning;
b) Impose a fine up to VND 6.000.000 for the administrative violations against regulations on population, up to VND 10.000.000 for the administrative violations against regulations on preventive medicine, and HIV/AIDS prevention and control, up to VND 15.000.000 for the administrative violations against regulations on health insurance, or up to VND 20.000.000 for the administrative violations against regulations on medical examination and treatment, pharmacy, cosmetics and medical devices;
c) Suspend licenses/practicing certificates or operations for a fixed period;
d) 114 Confiscate the exhibits and instrumentalities worth up to VND 12.000.000 for the administrative violations against regulations on population, or up to VND 20.000.000 for the administrative violations against regulations on preventive medicine, HIV/AIDS prevention and control, or up to VND 30.000.000 for the administrative violations against regulations on health insurance, or up to VND 40.000.000 for the administrative violations against regulations on medical examination and treatment, pharmacy, cosmetics and medical devices;
dd) Enforce the remedial measures mentioned in Points c and dd Clause 1 Article 28 of the Law on penalties for administrative violations and in Clause 3 Article 3 hereof.
5. Directors of Provincial-level Police Departments shall have the power to:
a) Issue warning;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
c) Suspend licenses/practicing certificates or operations for a fixed period;
d) 115 Confiscate the exhibits and instrumentalities used for committing administrative violations;
dd) Enforce the remedial measures mentioned in Points c, dd and i Clause 1 Article 28 of the Law on penalties for administrative violations and in Clause 3 Article 3 herein.
e) Impose the deportation penalty in accordance with current regulations on imposition of deportation penalty under administrative procedures.
6. 116 Directors of Internal Political Security Department, Police Department for Administrative Management of Social Order, Police Department for Social Order Crimes, Economic Security Department, Police Department for Prevention and Control of Environmental Crimes, Traffic Police Department, and Investigation Police Department for Corruption, Economic and Smuggling Crimes shall have the power to:
a) Issue warning;
b) Impose a fine up to VND 30.000.000 for the administrative violations against regulations on population, up to VND 50.000.000 for the administrative violations against regulations on preventive medicine, and HIV/AIDS prevention and control, up to VND 75.000.000 for the administrative violations against regulations on health insurance, or up to VND 100.000.000 for the administrative violations against regulations on medical examination and treatment, pharmacy, cosmetics and medical devices;
c) Suspend licenses/practicing certificates or operations for a fixed period;
d) Confiscate the exhibits and instrumentalities used for committing administrative violations;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Article 107. Power to impose penalties of customs agencies
1. Customs officials on duty shall have the power to:
a) Issue warning;
b) Impose a fine up to VND 500.000 for the administrative violations against regulations on preventive medicine, HIV/AIDS prevention and control, pharmacy, cosmetics and medical devices.
2. 117 Team Leaders, Group Leaders of Customs Sub-departments; Leaders of Groups in Control Teams affiliated to provincial, inter-provincial or municipal Customs Departments; Leaders of Teams in Post-clearance Inspection Sub-departments, shall have the power to:
a) Issue warning;
b) Impose a fine up to VND 5.000.000 for the administrative violations against regulations on preventive medicine, HIV/AIDS prevention and control, pharmacy, cosmetics and medical devices.
3. 118 Directors of Customs Sub-departments; Directors of Post-clearance Inspection Sub-departments; Leaders of Control Teams of provincial, inter-provincial or municipal Customs Departments; Leaders of Criminal Investigation Teams; Leaders of Smuggling Control Teams; Captains of Maritime Control Flotillas and Leaders of Anti-smuggling, Counterfeit Product Control and Intellectual Property Teams affiliated to the Smuggling Investigation and Prevention Department; Directors of Post-clearance Inspection Sub-departments affiliated to the Post-clearance Inspection Department shall have the power to:
a) Issue warning;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
c) 119 Confiscate the exhibits and instrumentalities worth up to VND 50.000.000 for the administrative violations against regulations on preventive medicine, HIV/AIDS prevention and control, pharmacy, cosmetics and medical devices;
d) Enforce the remedial measures mentioned in Points d, dd and i Clause 1 Article 28 of the Law on penalties for administrative violations and in Clause 3 Article 3 hereof.
4. Directors of Anti-smuggling and Investigation Department and Post-clearance Audit Department affiliated to General Department of Customs, and Directors of Customs Departments of provinces shall have the power to:
a) Issue warning;
b) Impose a fine up to VND 50.000.000 for the administrative violations against regulations on preventive medicine, pharmacy, cosmetics and medical devices;
c) Suspend licenses/practicing certificates or operations for a fixed period;
d) 120 Confiscate the exhibits and instrumentalities used for committing administrative violations;
dd) Enforce the remedial measures mentioned in Points d, dd and i Clause 1 Article 28 of the Law on penalties for administrative violations and in Clause 3 Article 3 hereof.
5. Director General of General Department of Customs shall have the power to:
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
b) Impose a fine up to VND 50.000.000 for the administrative violations against regulations on preventive medicine, or up to VND 100.000.000 for the administrative violations against regulations on pharmacy, cosmetics and medical devices;
c) 121 (abrogated);
d) Confiscate the exhibits and instrumentalities used for committing administrative violations;
dd) Enforce the remedial measures mentioned in Points d, dd and i Clause 1 Article 28 of the Law on penalties for administrative violations and in Clause 3 Article 3 hereof.
Article 108. Power to impose penalties of border guard forces
1. On-duty soldiers of border guard forces shall have the power to:
a) Issue warning;
b) Impose a fine up to VND 300.000 for the administrative violations against regulations on population, or up to VND 500.000 for the administrative violations against regulations on preventive medicine, HIV/AIDS prevention and control, medical examination and treatment, pharmacy, cosmetics and medical devices.
2. Heads of border guard stations and leaders of soldiers of border guard forces shall have the power to:
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
b) Impose a fine up to VND 1.500.000 for the administrative violations against regulations on population, or up to VND 2.500.000 for the administrative violations against regulations on preventive medicine, HIV/AIDS prevention and control, medical examination and treatment, pharmacy, cosmetics and medical devices.
2a. 122 Leaders of Task Force Teams for drug and crime prevention and control which are put under the control of Task Force Commissions for drug and crime prevention and control shall have the power to:
a) Issue warning;
b) Impose a fine up to VND 3.000.000 for the administrative violations against regulations on population, or up to VND 5.000.000 for the administrative violations against regulations on preventive medicine, and HIV/AIDS prevention and control, or up to VND 10.000.000 for the administrative violations against regulations on medical examination and treatment, pharmacy, cosmetics and medical devices;
c) Confiscate the exhibits and instrumentalities worth up to VND 6.000.000 for the administrative violations against regulations on population, or up to VND 10.000.000 for the administrative violations against regulations on preventive medicine, HIV/AIDS prevention and control, or up to VND 20.000.000 for the administrative violations against regulations on medical examination and treatment, pharmacy, cosmetics and medical devices;
d) Enforce the remedial measures mentioned in Points c and dd Clause 1 Article 28 of the Law on actions against administrative violations.
3. 123 Heads of Border Guard Posts, Captains of Naval Border Guard Flotillas and Commanders of Border Guard Commands at port border gates shall have the power to:
a) Issue warning;
b) Impose a fine up to VND 6.000.000 for the administrative violations against regulations on population, or up to VND 10.000.000 for the administrative violations against regulations on preventive medicine, and HIV/AIDS prevention and control, or up to VND 20.000.000 for the administrative violations against regulations on medical examination and treatment, pharmacy, cosmetics and medical devices;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
d) Enforce the remedial measures mentioned in Points c, d and dd Clause 1 Article 28 of the Law on penalties for administrative violations and in Clause 3 Article 3 hereof.
3a. 125 Leaders of Task Force Teams for drug and crime prevention and control affiliated to the Department of Drug and Crime Prevention and Control under the control of the Command of Border Guards shall have the power to:
a) Issue warning;
b) Impose a fine up to VND 15.000.000 for the administrative violations against regulations on population, or up to VND 25.000.000 for the administrative violations against regulations on preventive medicine, and HIV/AIDS prevention and control, or up to VND 50.000.000 for the administrative violations against regulations on medical examination and treatment, pharmacy, cosmetics and medical devices;
c) Confiscate the exhibits and instrumentalities worth up to VND 30.000.000 for the administrative violations against regulations on population, or up to VND 50.000.000 for the administrative violations against regulations on preventive medicine, HIV/AIDS prevention and control, or up to VND 100.000.000 for the administrative violations against regulations on medical examination and treatment, pharmacy, cosmetics and medical devices;
d) Enforce the remedial measures mentioned in Points c, d, dd and i Clause 1 Article 28 of the Law on penalties for administrative violations and in Clause 3 Article 3 hereof.
4. 126 Commanders of Provincial-level Border Guard Forces, Captains of Naval Border Guard Squadrons, and Director of the Department of Drug and Crime Prevention and Control affiliated to the Command of Border Guards shall have the power to:
a) Issue warning;
b) Impose a fine up to VND 30.000.000 for the administrative violations against regulations on population, or up to VND 50.000.000 for the administrative violations against regulations on preventive medicine, and HIV/AIDS prevention and control, or up to VND 100.000.000 for the administrative violations against regulations on medical examination and treatment, pharmacy, cosmetics and medical devices;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
d) Confiscate the exhibits and instrumentalities used for committing administrative violations;
dd) 127 Enforce the remedial measures mentioned in Points c, d, dd and i Clause 1 Article 28 of the Law on penalties for administrative violations and in Clause 3 Article 3 of this Decree.
Article 109. Power to impose penalties of Vietnam marine police forces
1. On-duty coast guard officers shall have the power to:
a) Issue warning;
b) Impose a fine up to VND 600.000 for the administrative violations against regulations on population, or up to VND 1.500.000 for the administrative violations against regulations on preventive medicine, HIV/AIDS prevention and control, medical examination and treatment, pharmacy, cosmetics and medical devices.
2. Coastguard team leaders shall have the power to:
a) Issue warning;
b) Impose a fine up to VND 1.500.000 for the administrative violations against regulations on population, or up to VND 2.500.000 for the administrative violations against regulations on preventive medicine, and HIV/AIDS prevention and control, or up to VND 5.000.000 for the administrative violations against regulations on medical examination and treatment, pharmacy, cosmetics and medical devices.
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
a) Issue warning;
b) Impose a fine up to VND 3.000.000 for the administrative violations against regulations on population, or up to VND 5.000.000 for the administrative violations against regulations on preventive medicine, and HIV/AIDS prevention and control, or up to VND 10.000.000 for the administrative violations against regulations on medical examination and treatment, pharmacy, cosmetics and medical devices;
c) Enforce the remedial measures mentioned in Points c and dd Clause 1 Article 28 of the Law on penalties for administrative violations.
4. Commanders of coastguard platoons shall have the power to:
a) Issue warning;
b) Impose a fine up to VND 6.000.000 for the administrative violations against regulations on population, or up to VND 10.000.000 for the administrative violations against regulations on preventive medicine, and HIV/AIDS prevention and control, or up to VND 20.000.000 for the administrative violations against regulations on medical examination and treatment, pharmacy, cosmetics and medical devices;
c) 128 Confiscate the exhibits and instrumentalities worth up to VND 12.000.000 for the administrative violations against regulations on population, or up to VND 20.000.000 for the administrative violations against regulations on preventive medicine, HIV/AIDS prevention and control, or up to VND 40.000.000 for the administrative violations against regulations on medical examination and treatment, pharmacy, cosmetics and medical devices;
d) Enforce the remedial measures mentioned in Points c, d and dd Clause 1 Article 28 of the Law on penalties for administrative violations and in Clause 3 Article 3 hereof.
5. 129 Captains of Naval Border Guard Squadrons; Heads of Reconnaissance Commissions; Heads of Task Force Commissions for Drug Crime Prevention and Control under the control of the Command of Coast Guard of Vietnam shall have the power to:
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
b) Impose a fine up to VND 9.000.000 for the administrative violations against regulations on population, or up to VND 15.000.000 for the administrative violations against regulations on preventive medicine, and HIV/AIDS prevention and control, or up to VND 30.000.000 for the administrative violations against regulations on medical examination and treatment, pharmacy, cosmetics and medical devices;
c) 130 Confiscate the exhibits and instrumentalities worth up to VND 18.000.000 for the administrative violations against regulations on population, or up to VND 30.000.000 for the administrative violations against regulations on preventive medicine, HIV/AIDS prevention and control, or up to VND 60.000.000 for the administrative violations against regulations on medical examination and treatment, pharmacy, cosmetics and medical devices;
d) Enforce the remedial measures mentioned in Points c, d and dd Clause 1 Article 28 of the Law on penalties for administrative violations and in Clause 3 Article 3 hereof.
6. 131 Regional Commands of Coast Guard and Director of the Department of Operations and Legislation under the control of the Command of Coast Guard of Vietnam shall have the power to:
a) Issue warning;
b) Impose a fine up to VND 15.000.000 for the administrative violations against regulations on population, or up to VND 25.000.000 for the administrative violations against regulations on preventive medicine, and HIV/AIDS prevention and control, or up to VND 50.000.000 for the administrative violations against regulations on medical examination and treatment, pharmacy, cosmetics and medical devices;
b1) 132 Suspend licenses/practicing certificates for a fixed period;
c) 133 Confiscate the exhibits and instrumentalities for committing administrative violations;
d) Enforce the remedial measures mentioned in Points c, d and dd Clause 1 Article 28 of the Law on penalties for administrative violations and in Clause 3 Article 3 hereof.
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
a) Issue warning;
b) Impose a fine up to VND 30.000.000 for the administrative violations against regulations on population, or up to VND 50.000.000 for the administrative violations against regulations on preventive medicine, and HIV/AIDS prevention and control, or up to VND 100.000.000 for the administrative violations against regulations on medical examination and treatment, pharmacy, cosmetics and medical devices;
c) Suspend licenses/practicing certificates or operations for a fixed period;
d) Confiscate the exhibits and instrumentalities used for committing administrative violations;
dd) Enforce the remedial measures mentioned in Points c, d and dd Clause 1 Article 28 of the Law on penalties for administrative violations and in Clause 3 Article 3 hereof.
Article 110. Power to impose fines of tax authorities
1. Tax officials on duty shall have the power to:
a) Issue warning;
b) Impose a fine up to VND 500.000 for the administrative violations against regulations on preventive medicine, and HIV/AIDS prevention and control.
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
a) Issue warning;
b) Impose a fine up to VND 2.500.000 for the administrative violations against regulations on preventive medicine, and HIV/AIDS prevention and control.
3. Directors of Sub-departments of taxation shall have the power to:
a) Issue warning;
b) Impose a fine up to VND 25.000.000 for the administrative violations against regulations on preventive medicine, and HIV/AIDS prevention and control;
c)134 Confiscate the exhibits and instrumentalities worth up to VND 50.000.000 for the administrative violations against regulations on preventive medicine, HIV/AIDS prevention and control;
d) Enforce the remedial measures mentioned in Point i Clause 1 Article 28 of the Law on penalties for administrative violations and in Clause 3 Article 3 of this Decree.
4. Directors of Departments of taxation shall have the power to:
a) Issue warning;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
c) 135 Confiscate the exhibits and instrumentalities for committing administrative violations;
d) Enforce the remedial measures mentioned in Point i Clause 1 Article 28 of the Law on penalties for administrative violations and in Clause 3 Article 3 of this Decree.
5. Director General of General Department of Taxation shall have the power to:
a) Issue warning;
b) Impose a fine up to VND 50.000.000 for the administrative violations against regulations on preventive medicine, and HIV/AIDS prevention and control;
c) Confiscate the exhibits and instrumentalities for committing administrative violations;
d) 136 Enforce the remedial measures mentioned in Point i Clause 1 Article 28 of the Law on penalties for administrative violations and in Clause 3 Article 3 of this Decree.
Article 111. Power to impose penalties of social security authorities
1. Directors of provincial-level social insurance authorities shall have the power to:
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
b) 137 Impose a fine up to VND 37.500.000 for administrative violations against regulations on health insurance contributions;
c) 138 (abrogated);
d) 139 Confiscate the exhibits and instrumentalities worth up to VND 75.000.000 for the administrative violations against regulations on health insurance contributions;
dd) Enforce the remedial measures mentioned in Points c, d, dd, e, g, h and i Clause 1 Article 28 of the Law on penalties for administrative violations and in Clause 3 Article 3 hereof.
2. The General Director of Vietnam Social Security shall have the power to:
a) Issue warning;
b) 140 Impose a fine up to VND 75.000.000 for administrative violations against regulations on health insurance contributions;
c) 141 (abrogated);
d) Confiscate the exhibits and instrumentalities used for committing administrative violations;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
3. Heads of specialized inspection teams established by the General Director of Vietnam Social Security shall have the power to:
a) Issue warning;
b) 142 Impose a fine up to VND 52.500.000 for administrative violations against regulations on health insurance contributions;
c) 143 (abrogated);
d) 144 Confiscate the exhibits and instrumentalities worth up to VND 105.000.000 for the administrative violations against regulations on health insurance contributions;
dd) Enforce the remedial measures mentioned in Points c, d, dd, e, g, h and i Clause 1 Article 28 of the Law on penalties for administrative violations and in Clause 3 Article 3 hereof.
Article 112. Division of power to impose penalties
1. Chairpersons of people’s committees of all levels have the power to make records of, impose penalties, and enforce remedial measures against the administrative violations in Chapter II hereof within their competence prescribed in Article 103 hereof and within the ambit of their assigned functions, duties and powers.
2. Health inspectors competent to impose penalties and persons assigned to perform specialized health inspections shall have the power to make records of, impose penalties, and enforce remedial measures against the administrative violations in Chapter II hereof within their competence prescribed in Article 104 hereof, the administrative violations in medical sector within the competence of holders of equivalent titles prescribed in other Decrees prescribing penalties for administrative violations, and within the ambit of their assigned functions, duties and powers.
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
4. Officers competent to impose penalties of people’s public security forces shall have the power to make records of, impose penalties, and enforce remedial measures against the administrative violations in Articles 7, 10, 11, 12, 13, 14, 15, 16, 18, 19, 22, 24, 25, 26, 27, 29, 30, 31, 32, 33, 34, 35, 36, 37, 54, 65, 66, 67, 69, 71, 76, 96, 97, 98, 99, 100, 101, 102; Point a Clause 3 Article 5; Clause 1, 2, 4 Article 6; Point a Clause 1, Point a Clause 2, Point h Clause 3 Article 9; Point a, c Clause 5, Point b Clause 6, Clause 7 Article 38; Point a Clause 7 Article 44; Point a Clause 1 Article 45; Point a Clause 1, Point b Clause 2 Article 48; Point a, g Clause 2 Article 52; Clause 3 Article 53; Clause 4 Article 55; Point c Clause 4 Article 56; Point d Clause 5, Clause 7 Article 57; Clause 7 Article 58; Clause 4, 5, 6, 7 Article 59; Point d, dd, e, g Clause 2, Point dd Clause 3, Clause 4, 5, 6, 7 Article 60; Clause 4 Article 61; Clause 5 Article 62; Clause 4 Article 63; Clause 1, 2, Point a, b Clause 3 Article 64; Clause 2, 3 Article 68; Point b Clause 2 Article 70; Point a Clause 2, Point a, b Clause 3 Article 73; Point g Clause 2, Clause 3 Article 74 and Point b, c, d Clause 2, Point c, d Clause 3 Article 75 hereof within the ambit of their assigned functions, duties and powers, and their competence prescribed in Article 106 hereof.
5. 145 Officers competent to impose penalties of customs authorities shall have the power to make records of, impose penalties, and enforce remedial measures against the administrative violations in Articles 7, 11, 12, 13, 14, 25, 26, 27, 29, 30, 31, 32, 33, 34, 35, 36, 37, 60, 64, 71, 76; Clauses 1, 2 Article 6; Point b Clause 1 Article 54; Clauses 6, 7 Article 58; Clauses 6, 7 Article 59; Point b Clause 1, Clause 2 Article 65, Points c and d Clause 2 Article 72, Points a, b Clause 4 Article 74 and Point c Clause 2 Article 75 of this Decree within the ambit of their assigned functions, duties and powers, and their competence prescribed in Article 107 of this Decree.
6. Officers competent to impose penalties of border guard forces shall have the power to make records of, impose penalties, and enforce remedial measures against the administrative violations in Article 5, 6, 7, 10, 11, 12, 13, 14, 19, 22, 24, 25, 26, 27, 30, 31, 32, 33, 34, 35, 36, 37, 60, 65, 76, 96, 97, 101, 102; Point b Clause 3 Article 8; Point b Clause 3 Article 9; Points a, b Clause 3 Article 16; Point g Clause 2, Point dd Clause 3 Article 23; Clause 1, 2, 3, Points a, b, c, g Clause 4, Point a Clause 5 Article 29; Point b Clause 4 Article 39; Point b Clause 3 Article 48; Point b Clause 1 Article 52 and Clause 1, Point b Clause 2, Point a, b Clause 3 Article 64 hereof within the ambit of their assigned functions, duties and powers, and their competence prescribed in Article 108 hereof.
7. 146 Officers competent to impose penalties of coast guard forces shall have the power to make records of, impose penalties, and enforce remedial measures against the administrative violations in Articles 5, 6, 7, 10, 11, 12, 13, 14, 17, 19, 22, 24, 25, 26, 27, 30, 31, 32, 33, 34, 35, 36, 37, 60, 65, 71, 76, 80, 83, 96, 97, 102; Point b Clause 3 Article 8; Point b Clause 3 Article 9; Point a, b Clause 3 Article 16; Point g Clause 2, Clause 3 Article 23; Clauses 1, 2, 3, Points a, b, c, g Clause 4, Point a Clause 5 Article 29; Clauses 1, 3, 5, 6, 7 Article 38; Point b Clause 4 Article 39; Clause 4 Article 40; Point b Clause 1 Article 45; Point b Clause 3 Article 48; Point b Clause 1 Article 52; Clause 1, Point b Clause 2, Points a, b Clause 3 Article 64; Clause 2 Article 68, Clause 1 Article 74, Clause 2 Article 78, and Point a Clause 1, Clause 2 Article 95 of this Decree within the ambit of their assigned functions, duties and powers, and their competence prescribed in Article 109 of this Decree.
8. Officers competent to impose penalties of tax authorities shall have the power to make records of, impose penalties, and enforce remedial measures against the administrative violations in Points d, dd, e Clause 4 and Point b Clause 5 Article 29 hereof within the ambit of their assigned functions, duties and powers, and their competence prescribed in Article 110 hereof.
9. Officers competent to impose penalties of social security authorities shall have the power to make records of, impose penalties, and enforce remedial measures against the administrative violations in Section 5 hereof within the ambit of their assigned functions, duties and powers, and their competence prescribed in Article 111 hereof.
10. Inspectors in the field of information and communications competent to impose penalties shall have the power to make records of, impose penalties, and enforce remedial measures against the administrative violations in Article 5, 19, 25, 26, 30, 32, 33, 34, 36, 37, 49, 50, 51, 67, 69, 78, 96, 97; Clause 2 Article 14; Clause 1, 2, 3, Point a, b, c, e, g Clause 4, Point a Clause 5 Article 29; Clause 3 Article 31 and Point b Clause 2 Article 35 hereof within the ambit of their assigned functions, duties and powers, and their competence prescribed in Article 104 hereof.
11. 147 Inspectors in the fields of culture, sports and tourism competent to impose penalties shall have the power to make records of, impose penalties, and enforce remedial measures against the administrative violations in Articles 5, 19, 25, 26, 30, 31, 32, 33, 34, 36, 37, 49, 50, 51, 67, 69, 78, 96, 97; Points b and c Clause 3 Article 12; Clause 2 Article 14; Clauses 1, 2, 3, Points a, b, c, e, g Clause 4, Point a Clause 5 Article 29 and Point b Clause 2 Article 35 of this Decree within the ambit of their assigned functions, duties and powers, and their competence prescribed in Article 104 of this Decree.
12. Inspectors in the field of education, transport, agriculture and rural development, science and technology competent to impose penalties shall have the power to make records of, impose penalties, and enforce remedial measures against the administrative violations in Articles 5, 6, 18, 19, 23, 25, 26, 30, 31, 32, 33, 34, 36, 37; Clause 2 Article 14 and Clauses 1, 2, 3, Points a, b, c, e Clause 4, Point a Clause 5 Article 29 hereof within the ambit of their assigned functions, duties and powers, and their competence prescribed in Article 104 hereof.
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Article 113. Power to record administrative violations
Persons that have the power to make records of administrative violations in medical sector include:
1. The persons having the power to impose administrative penalties prescribed this Decree shall have the power to record administrative violations within the ambit of their assigned functions, tasks and power.
2. Officials and public employees of health agencies and social security agencies, officials, public employees and persons of people’s army or people’s security forces, and officials, public employees working at the agencies specified in Article 112 hereof shall have the power to record administrative violations discovered when they are on duty and within the ambit of their assigned functions, tasks and power.
Article 114. Violation detection facilities and techniques
1. Authorities and persons competent to impose penalties are entitled to use technical and operational facilities and equipment for detecting the administrative violations prescribed in Articles 25, 30, 31, 32, 33, 34, 35, 36, 37 hereof.
2. Management, use and list of violation detection facilities and equipment shall comply with regulations of laws in force.
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
1. This Decree comes into force from November 15, 2020.
2. The following provisions come into force from the date of promulgation of this document, including:
a) Articles 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 47, 115, 116, 117 Point b Clause 1, Point b Clause 4 Article 52 and Point a, b Clause 2, Points b, dd Clause 3, Point b Clause 4 Article 57 hereof;
b) Articles 1, 2, 3, 4, 103, 104, 105, 106, 107, 108, 109, 110, 111, 112, 113 and 114 are applied to impose penalties for the administrative violations prescribed in Point a of this Clause.
3. The entire Government’s Decree No. 176/2013/ND-CP dated November 14, 2013 shall be null and void from November 15, 2020.
4. Articles 5, 6, 7, 8, 9, 10, 11, 12, and 13 of the Government’s Decree No. 176/2013/ND-CP dated November 14, 2013 shall be null and void from the date of promulgation of this document.
If this Decree does not contain legal liability or impose a less serious legal liability on an administrative violation in medical sector which is committed before the date of entry into force of this Decree but is detected afterwards or is under consideration, regulations hereof shall apply.
Article 117. Responsibility for guidance and implementation
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
2. Ministers, heads of ministerial-level agencies, heads of the Government’s affiliates, Chairpersons of people’s committees at all levels, and relevant authorities, organizations and individuals shall implement this Decree./.
PP. MINISTER
DEPUTY MINISTER
Tran Van Thuan
1 The Government’s Decree No. 124/2021/ND-CP dated December 28, 2021 providing amendments to the Government’s Decree No. 115/2018/ND-CP dated September 04, 2018 prescribing penalties for administrative violations against regulations on food safety and the Government’s Decree No. 117/2020/ND-CP dated September 28, 2020 prescribing penalties for administrative violations in medical sector (hereinafter referred to as “Decree No. 124/2021/ND-CP”) is pursuant to:
“The Law on Government Organization dated June 19, 2015; the Law on amendments to the Law on Government Organization and the Law on Organization of Local Governments dated November 22, 2019;
The Law on penalties for administrative violations dated June 20, 2012, and the Law on amendments to the Law on penalties for administrative violations dated November 13, 2020;
The Law on HIV/AIDS prevention and control dated June 29, 2006; the Law on amendments to the Law on HIV/AIDS prevention and control dated November 16, 2020;
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
2 This Clause is amended by Clause 1 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
3 This Point is amended by Clause 2 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
4 This Point is amended by Point a Clause 3 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
5 This Point is amended by Point b Clause 3 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
6 This Clause is amended by Clause 4 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
7 This Point is amended by Point a Clause 5 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
8 This Point is amended by Point b Clause 5 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
9 This Point is amended by Point c Clause 5 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
10 This Point is amended by Point d Clause 5 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
12 This content is amended by Clause 7 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
13 This Point is amended by Point a Clause 8 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
14 This Point is amended by Point b Clause 8 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
15 This Point is amended by Point c Clause 8 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
16 This Point is amended by Point d Clause 8 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
17 This Point is amended by Clause 1 Article 3 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
18 These Points are abrogated by Clause 3 Article 3 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
19 This Clause is amended by Point a Clause 9 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
20 This Point is amended by Point b Clause 9 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
22 This Point is added by Clause 10 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
23 This Point is added by Clause 11 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
24 This Point is amended by Clause 12 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
25 This Point is amended by Clause 1 Article 3 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
26 This Point is amended by Clause 1 Article 3 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
27 This Point is amended by Point a Clause 13 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
28 These Points are amended by Point b Clause 13 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
29 This Point is amended by Clause 1 Article 3 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
30 This Clause is added by Point c Clause 13 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
32 These Points are amended by Point b Clause 14 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
33 This Point is amended by Point c Clause 14 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
34 This Point is amended by Point d Clause 14 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
35 These Points are amended by Clause 1 Article 3 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
36 This Point is amended by Point a Clause 15 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
37 This Point is amended by Point b Clause 15 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
38 These Points are amended by Point c Clause 15 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
39 This Clause is amended by Point d Clause 15 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
40 This Point is amended by Point a Clause 16 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
42 These Points are amended by Point c Clause 16 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
43 This Point is amended by Point d Clause 16 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
44 This Point is amended by Point a Clause 16 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
45 This Clause is added by Point e Clause 16 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
46 These Points are amended by Point a Clause 17 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
47 This Point is amended by Point b Clause 17 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
48 This Point is amended by Point c Clause 17 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
49 This Point is amended by Point d Clause 17 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
50 This Point is amended by Point a Clause 18 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
52 This Clause is amended by Point a Clause 19 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
53 This Point is amended by Clause 1 Article 3 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
54 This Clause is amended by Point b Clause 19 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
55 This Point is amended by Point a Clause 20 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
56 This Point is amended by Clause 1 Article 3 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
57 This Clause is added by Point b Clause 20 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
58 This Point is amended by Point a Clause 21 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
59 This Point is amended by Point b Clause 21 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
60 This Point is amended by Clause 1 Article 3 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
62 This Clause is amended by Point a Clause 22 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
63 This Point is abrogated by Clause 3 Article 3 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
64 This Point is abrogated by Clause 3 Article 3 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
65 These Points are amended by Point a Clause 22 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
66 This Point is abrogated by Clause 3 Article 3 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
67 This Point is abrogated by Clause 3 Article 3 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
68 This Point is amended by Point b Clause 22 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
69 This Clause is abrogated by Clause 3 Article 3 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
70 This Point is amended by Point c Clause 22 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
72 This Point is amended by Clause 1 Article 3 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
73 This Clause is amended by Point a Clause 23 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
74 This Point is amended by Point b Clause 23 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
75 This Point is abrogated by Clause 3 Article 3 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
76 This Point is amended by Point c Clause 23 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
77 This Clause is amended by Point d Clause 23 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
78 This Point is amended by Point dd Clause 23 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
79 This Point is amended by Point a Clause 24 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
80 This Point is abrogated by Clause 3 Article 3 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
82 This Point is amended by Point c Clause 24 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
83 This Point is amended by Point d Clause 24 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
84 This Point is amended by Point dd Clause 24 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
85 This Point is amended by Point e Clause 24 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
86 These Points are amended by Point g Clause 24 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
87 These Points are amended by Point h Clause 24 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
88 This Point is amended by Point i Clause 24 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
89 This Point is amended by Point k Clause 24 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
90 This Point is abrogated by Clause 3 Article 3 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
92 These Points are amended by Clause 1 Article 3 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
93 This Point is amended by Clause 1 Article 3 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
94 This Clause is amended by Point a Clause 25 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
95 This Point is amended by Point b Clause 25 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
96 This content is amended by Clause 1 Article 3 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
97 This Clause is abrogated by Clause 3 Article 3 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
98 This Point is added by Clause 26 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
99 This Point is amended by Point a Clause 27 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
100 This Point is amended by Point b Clause 27 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
102 This Point is amended by Point b Clause 28 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
103 This Point is amended by Point c Clause 28 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
104 This Point is amended by Point d Clause 28 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
105 This Point is amended by Point dd Clause 28 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
106 This Clause is amended by Point a Clause 29 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
107 This Point is amended by Point b Clause 29 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
108 This Clause is amended by Point c Clause 29 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
109 This Point is amended by Point d Clause 29 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
110 This Clause is amended by Point a Clause 30 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
112 This Point is amended by Point c Clause 30 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
113 This Clause is amended by Point d Clause 30 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
114 This Point is amended by Point dd Clause 30 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
115 This Point is amended by Point e Clause 30 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
116 This Clause is amended by Point g Clause 30 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
117 This Clause is amended by Point a Clause 31 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
118 This Clause is amended by Point b Clause 31 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
119 This Point is amended by Point c Clause 31 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
120 This Point is amended by Point d Clause 31 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
122 This Clause is amended by Point a Clause 32 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
123 This Clause is amended by Point b Clause 32 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
124 These Points are amended by Point c Clause 32 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
125 This Clause is amended by Point d Clause 32 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
126 This Clause is amended by Point dd Clause 32 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
127 This Point is amended by Point e Clause 32 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
128 This Point is amended by Point a Clause 33 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
129 This Clause is amended by Point b Clause 33 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
130 This Point is amended by Point c Clause 33 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
132 This Point is amended by Point dd Clause 33 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
133 This Point is amended by Point e Clause 33 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
134 These Points are amended by Point a Clause 34 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
135 These Points are amended by Point b Clause 34 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
136 This Point is amended by Point c Clause 34 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
137 This Point is amended by Point a Clause 35 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
138 This Point is abrogated by Clause 3 Article 3 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
139 This Point is amended by Point b Clause 35 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
140 This Point is amended by Point c Clause 35 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
142 This Point is amended by Point d Clause 35 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
143 This Point is abrogated by Clause 3 Article 3 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
144 This Point is amended by Point dd Clause 35 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
145 This Clause is amended by Point a Clause 36 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
146 This Clause is amended by Point b Clause 36 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
147 This Clause is amended by Point c Clause 36 Article 2 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022.
148 Articles 4, 5 of the Decree No. 124/2021/ND-CP, coming into force from January 01, 2022, stipulate as follows:
“Article 4. Effect
1. This Decree comes into force from January 01, 2022.
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Article 5. Responsibility for implementation
Ministers, heads of ministerial agencies, heads of Governmental agencies, Chairpersons of people’s committees of central-affiliated cities and provinces, and relevant organizations and individuals shall implement this Decree.”
File gốc của Integrated document No. 01/VBHN-BYT dated January 24, 2022 Decree on Prescribing penalties for administrative violations in medical sector đang được cập nhật.
Integrated document No. 01/VBHN-BYT dated January 24, 2022 Decree on Prescribing penalties for administrative violations in medical sector
Tóm tắt
| Cơ quan ban hành | Bộ Y tế |
| Số hiệu | 01/VBHN-BYT |
| Loại văn bản | Văn bản hợp nhất |
| Người ký | Trần Văn Thuấn |
| Ngày ban hành | 2022-01-24 |
| Ngày hiệu lực | 2022-01-24 |
| Lĩnh vực | Vi phạm hành chính |
| Tình trạng | Còn hiệu lực |