Nghị định 117/2020/NĐ-CP quy định xử phạt vi phạm hành chính trong lĩnh vực y tế mới nhất
THE
GOVERNMENT
———
THE
SOCIALIST REPUBLIC OF VIETNAM
Independence – Freedom – Happiness
—————
No.:
117/2020/ND-CP
Hanoi,
September 28, 2020
DECREE
PRESCRIBING PENALTIES FOR ADMINISTRATIVE VIOLATIONS IN
MEDICAL SECTOR
Pursuant to the Law on Organization of the
Government dated June 19, 2015;
Pursuant to the Law on penalties for
administrative violations dated June 20, 2012;
Pursuant to the Law on HIV/AIDS prevention
and control dated June 29, 2006;
Pursuant to the Law on donation, removal and
transplantation of human tissues and organs, and body donation dated November
29, 2006;
Pursuant to the Law on prevention and control
of infectious diseases dated November 21, 2007;
Pursuant to the Law on health insurance dated
November 14, 2008 and the Law on amendments to the Law on health insurance
dated June 13, 2014;
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Pursuant to the Law on prevention and control
of tobacco harms dated June 18, 2012;
Pursuant to the Law on pharmacy dated April
06, 2016;
Pursuant to the Law on prevention and control
of harmful effects of alcoholic beverages dated June 14, 2019;
Pursuant to the Ordinance on population dated
January 09, 2003 and the Ordinance on amendments to Article 10 of the Ordinance
on population dated December 27, 2008;
At the request of the Minister of Health;
The Government promulgates a Decree
prescribing penalties for administrative violations in medical sector.
Chapter I
GENERAL PROVISIONS
Article 1. Scope
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2. Administrative violations in medical sector
prescribed herein are wrongful acts committed by organizations and individuals
that contravene regulations on state management of medical sector but do not
constitute criminal offences and are punishable by administrative penalties,
including:
a) Violations against regulations on preventive
healthcare, and HIV/AIDS prevention and control;
b) Violations against regulations on medical
examination and treatment;
c) Violations against regulations on pharmacy
and cosmetics;
d) Violations against regulations on medical
devices;
dd) Violations against regulations on health
insurance;
e) Violations against regulations on population.
3. Other administrative violations in medical
sector which are not prescribed herein shall be penalized in accordance with
the Decrees in which they are mentioned.
4. When detecting the violations in Point c
Clause 3 Article 7, Point e Clause 5, Point b Clause 6 Article 38, Points a, b
Clause 7 Article 44, Clause 6 Article 48, Point a Clause 2 Article 52, Clause 3
Article 53, Point a Clause 1 Article 54, Point c Clause 4 Article 56, Point d
Clause 5, Clause 7 Article 57, Clause 7 Article 58, Clause 7 Article 59, Point
a Clause 4 Article 60, Point c Clause 5 Article 67, Clause 3 Article 68, Point
b Clause 2 Article 70, Points a, b Clause 3 Article 73, Clause 4 Article 80,
Points d, dd, e, g, h Clause 2 Article 85, Points d, dd, e, g, h, i Clause 2
Article 86 or the repeating of the violations in Points a, b Clause, 3 Article
7, Clause 9 Article 15, Clause 6 Article 40, Point a Clause 6 Article 44, Point
b Clause 5 Article 67 and Clauses 2, 3 Article 80 hereof, the competent persons
who are handling such cases shall transfer the case files to competent criminal
proceedings agencies for initiating criminal prosecution in accordance with the
provisions in Clauses 1, 2 and 4 Article 62 of the Law on penalties for
administrative violations. If the relevant criminal proceedings agency decides
not to institute criminal proceedings in accordance with the provisions of the
Criminal Procedure Code, the case file shall be returned to the person
competent to impose penalties who has transferred it to the criminal
proceedings agency as prescribed in Clause 3 Article 62 of the Law on penalties
for administrative violations for imposing administrative penalties in
accordance with the provisions hereof.
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1. Vietnamese and foreign organizations and
individuals (hereinafter referred to as “entities”) that commit administrative
violations in the medical sector, persons competent to make records of
violations, those competent to impose penalties and other relevant entities.
2. Organizations that are the entities incurring
penalties as prescribed herein include:
a) Economic organizations that are duly
established under the Law on enterprises, including: Sole proprietorships,
joint-stock companies, limited liability companies, partnerships and their
affiliates (including branches and representative offices);
b) Co-operatives and cooperative unions that are
duly established under the Law on co-operatives;
c) Organizations that are duly established under
the Law on investment or the Law on commerce, including: Domestic and foreign
investors (except individual investors) and foreign-invested economic
organizations; representative offices and branches of foreign traders in
Vietnam; representative offices of foreign trade promotion organizations in
Vietnam;
d) Social organizations, socio-political
organizations, socio-political-professional organizations, and
socio-professional organizations;
dd) Public service providers, people’s armed
forces and agencies of the Communist Party of Vietnam;
e) Regulatory authorities committing the
violations which are not related to their assigned management tasks;
g) Artels;
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3. Household businesses, family businesses,
domestic and foreign individual investors shall be liable to the same penalties
as those imposed upon individuals for committing the administrative violations
prescribed herein.
Article 3. Penalties and
remedial measures
1. Primary penalties:
a) Warning;
b) Fines.
2. Depending on the nature and severity of each
administrative violation, the violating entity may face one or some of the
following additional penalties:
a) Suspension of the following licenses or
practicing certificates for a fixed period of 01-24 months, including:
certificate of eligibility for pharmacy business, license for medical
operations, certificate of satisfaction of level-3 biosafety standards,
certificate of eligibility to provide HIV testing, certificate of eligibility
to produce cosmetics, license to trade in alcoholic beverages, license to
operate tissue bank, pharmacy practicing certificate and medical examination
and treatment practicing certificate;
b) Confiscation of exhibits and
instrumentalities used for committing administrative violations in medical
sector;
c) Suspension of operations for a fixed period
of 01 – 24 months;
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(028) 3930 3279
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3. In addition to the primary and additional
penalties, the violating entity may, depending on the nature and severity of
each administrative violation, be liable to one or some of the remedial
measures specified in Points c, d, dd, e, g, h and i Clause 1 Article 28 of the
Law on penalties for administrative violations and the following remedial
measures:
a) Enforced return of amounts of money collected
against regulations of law. Any amounts of money which cannot be returned to
payers shall be paid to state budget as prescribed by law;
b) Enforced implementation of cleaning,
disinfection and sterilization measures and other measures for prevention and
control of infectious diseases;
c) Enforced organization of medical isolation,
implementation of coercive measures for medical isolation, health inspection
and control;
d) Enforced implementation of measures for
cleaning of clean water supply and distribution system;
dd) Enforced making of direct apologies to HIV-positive
persons and their families and correction of information published on means of
mass media at the place where the HIV patient is living within 03 days as
prescribed by law, unless the HIV patient rejects public apologies;
e) Enforced receipt and burial or cremation of
corpses or remains of HIV infected persons;
g) Enforced receipt of HIV-positive persons;
h) Enforced making of direct apologies to
persons who are discriminated against, practitioners, and patients;
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(028) 3930 3279
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0906 22 99 66
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k) Enforced provision of legitimate rights and
benefits to HIV-infected employees;
l) Enforced cancellation of decisions to
discipline or expel pupil or student for HIV infection;
m) Enforced payment of interests on different
amounts due to false declarations or late payment of compulsory contributions;
enforced making of payments due to evasion or commission of frauds in payment
of compulsory contributions; enforced return of amounts of money which have been
used against regulations;
n) Enforced payment of all costs of medical
services;
o) Enforced return of entire different amounts.
Any payments which cannot be made to payers shall be paid to state budget in
accordance with regulations of law;
p) Enforced reimbursement of amounts of money as
compensation for damage suffered by health insurance purchasers (if any);
enforced reimbursement of amounts of money as compensation for damage suffered
by health facilities (if any). Any payments which cannot be made to payers
shall be paid to state budget in accordance with regulations of law;
q) Enforced transfer of amounts of money
involving in the violations to the dedicated account of the health insurance
fund (if any);
r) Enforced removal of intrauterine devices and
contraceptive implants;
s) Enforced revocation of practicing
certificates, license for medical operations, license to import medical devices
and medical face masks, certificate of eligibility for pharmacy business,
certificate of free sale of domestically manufactured medical devices,
certificate of registration of drugs/pharmaceutical starting materials, receipt
number of cosmetic product declaration, acknowledgement of receipt of
declaration dossier, certificate of registration of drugs/pharmaceutical
starting materials, certificate of registration of type B, C, D medical
devices.
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(028) 3930 3279
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0906 22 99 66
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1. The maximum fine imposed for a violation
against regulations on population is VND 30.000.000 if committed by an
individual or VND 60.000.000 if committed by an organization.
2. The maximum fine imposed for a violation
against regulations on preventive medicine and HIV/AIDS prevention and control
is VND 50.000.000 if committed by an individual or VND 100.000.000 if committed
by an organization.
3. The maximum fine imposed for a violation
against regulations on health insurance is VND 75.000.000 if committed by an
individual or VND 150.000.000 if committed by an organization.
4. The maximum fine imposed for a violation
against regulations on medical examination and treatment, pharmacy, cosmetics
or medical devices is VND 100.000.000 if committed by an individual or VND
200.000.000 if committed by an organization.
5. The fines prescribed in Chapter II hereof are
imposed on violating individuals. The fine imposed on an organization is twice
as much as that imposed on an individual for the same administrative violation.
6. Fines imposed by the competent officials
prescribed in Chapter VIII hereof are incurred by violating individuals; a
competent official who has the power to impose fines shall have the right to
impose a fine twice as much as that imposed upon an individual upon a violating
organization for the same administrative violation.
Chapter II
ADMINISTRATIVE
VIOLATIONS, PENALTIES AND REMEDIAL MEASURES
Section 1. VIOLATIONS AGAINST
REGULATIONS ON PREVENTIVE HEALTHCARE, AND HIV/AIDS PREVENTION AND CONTROL
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1. The following fines shall be imposed for
failing to organize dissemination of information and education about prevention
and control of infectious diseases for employees at the request of competent
authorities:
a) A fine ranging from 1.000.000 to VND
3.000.000 shall be imposed upon a violating establishment using less than 100
employees;
b) A fine ranging from 3.000.000 to VND
5.000.000 shall be imposed upon a violating establishment using from 100 to
under 300 employees;
c) A fine ranging from 5.000.000 to VND
7.000.000 shall be imposed upon a violating establishment using from 300 to
under 500 employees;
d) A fine ranging from 7.000.000 to VND
10.000.000 shall be imposed upon a violating establishment using from 500 to
under 1.000 employees;
dd) A fine ranging from 10.000.000 to VND
15.000.000 shall be imposed upon a violating establishment using from 1.000 to
under 1.500 employees;
e) A fine ranging from 15.000.000 to VND
20.000.000 shall be imposed upon a violating establishment using from 1.500 to
under 2.500 employees;
g) A fine ranging from 20.000.000 to VND
25.000.000 shall be imposed upon a violating establishment using 2.500
employees or more.
2. A fine ranging from VND 3.000.000 to VND
5.000.000 shall be imposed for failing to implement or improperly implementing
regulations on broadcasting time or volume or capacity or location for
publishing information on prevention and control of infectious diseases.
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(028) 3930 3279
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0906 22 99 66
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a) Failing to provide accurate and timely
information on an epidemic upon declaration of epidemic or declaration of end
of epidemic according to contents provided by competent health agencies;
b) Charging for the provision of information and
education about prevention and control of infectious diseases on means of mass
media, unless payments are made under signed contracts for implementation of
programs/projects or such activities are sponsored by domestic and/or foreign
entities.
4. Remedial measures:
a) The entity committing the violation in Point
a Clause 3 of this Article is compelled to correct false information via means
of mass media at the place where the false information has been published
within at least 03 consecutive days as prescribed by law;
b) The entity committing the violation in Point
b Clause 3 of this Article is compelled to return any amounts of money
collected against regulations of law. The amounts of money which cannot be
returned to payers shall be paid to state budget in accordance with regulations
of law.
Article 6. Violations
against regulations on sanitation and hygiene for prevention of infectious
diseases
1. A warning or a fine ranging from VND 200.000
to VND 500.000 shall be imposed for failing to implement hygiene measures at
residences, public areas, vehicles and domestic waste storage areas for
preventing infectious diseases.
2. A fine ranging from VND 1.000.000 to VND
3.000.000 shall be imposed for failing to implement hygiene measures at
residences, public areas, vehicles and domestic waste storage areas and thus
causing or spreading an infectious disease.
3. A fine ranging from VND 3.000.000 to VND
5.000.000 shall be imposed for commission of one of the following violations:
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b) Failing to build or building sanitation works
which do not meet hygiene requirements in an educational institution as
prescribed by law;
c) Failing to provide adequate lighting in an
educational institution as prescribed by law;
d) Failing to educate learners in hygiene
measures for prevention of infectious diseases, including personal hygiene,
hygiene in daily life, labour hygiene and environmental sanitation;
dd) Failing to disseminate information on
hygiene and sanitation for disease prevention or failing to inspect and
supervise environmental sanitation activities; failing to implement measures
for prevention and control of infectious diseases in educational institutions.
4. A fine ranging from VND 10.000.000 to VND
20.000.000 shall be imposed for failing to implement measures for ensuring hygiene
in manufacturing/business establishment, treatment of industrial waste and
other hygiene measures as prescribed by law, and thus causing or spreading an
infectious disease.
5. Remedial measure:
The entity committing the violation in Clause 2
or 4 of this Article is compelled to implement cleaning, disinfection and
sterilization measures.
Article 7. Violations
against regulations on infectious disease surveillance
1. A fine ranging from VND 500.000 to VND
1.000.000 shall be imposed for concealing, failing to report or delaying the
reporting when detecting a person infected with an infectious disease as
prescribed by law, except the case prescribed in Point a Clause 3 of this
Article.
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(028) 3930 3279
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0906 22 99 66
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a) Failing to perform tests at the request of
competent health agencies during the infectious disease surveillance;
b) Failing to submit reports or submitting
reports which do not contain adequate information on infectious disease
surveillance as prescribed by law;
c) Concealing, failing to report or delaying the
reporting on the infection with an infectious disease of oneself, except the
case prescribed in Point a Clause 3 of this Article.
3. A fine ranging from VND 10.000.000 to VND
20.000.000 shall be imposed for commission of one of the following violations:
a) Concealing, failing to report or delaying the
reporting on the status of infection with a group-A infectious disease of
oneself or another person;
b) Deliberately providing false reports or
information on a group-A infectious disease;
c) Deliberately spreading pathogens causing
group-A infectious diseases.
Article 8. Violations
against regulations on laboratory biosafety
1. A fine ranging from VND 3.000.000 to VND
5.000.000 shall be imposed for commission of one of the following violations:
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(028) 3930 3279
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0906 22 99 66
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b) Failing to assess risks of biosafety
incidents at testing laboratories;
c) Performing tests beyond the professional
scope after declaration of satisfaction of biosafety level 1 or level 2
laboratory standards;
d) Failing to formulate and organize the
implementation of regulations on internal biosafety inspection as prescribed by
law;
dd) Failing to make and keep records of handled
less serious biosafety incidents at the testing laboratory.
2. A fine ranging from VND 5.000.000 to VND
10.000.000 shall be imposed for commission of one of the following violations:
a) Failing to meet one of requirements for
biosafety level 2 laboratory after self-declaration of satisfaction of
biosafety level 2 laboratory standards;
b) Failing to formulate a plan for prevention
and handling of biosafety incidents or formulating a plan that does not contain
adequate contents as prescribed by law;
c) Failing to disinfect or sterilize waste
generated from testing activities before putting it into the waste collection
system or temporary waste storage area of a biosafety level 2 laboratory.
3. A fine ranging from VND 10,000,000 to VND
20,000,000 shall be imposed for commission of one of the following violations:
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(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
b) Collecting, transporting, maintaining,
storing, using, researching, exchanging and destroying pathological samples
carrying infectious agents against regulations on management of infectious
disease samples;
c) Failing to submit reports to the relevant
Provincial Department of Health on serious biosafety incidents and measures
taken against such incidents.
4. A fine ranging from VND 20.000.000 to VND
30.000.000 shall be imposed for commission of one of the following violations:
a) Failing to meet one of requirements for
biosafety level 3 laboratory after obtaining the certificate of satisfaction of
biosafety level 3 laboratory standards;
b) Maintaining, storing, using, researching,
exchanging and destroying samples of a group-A infectious disease without
meeting edibility requirements;
c) Failing to disinfect or sterilize waste generated
from testing activities before putting it into the waste collection system or
temporary waste storage area of a biosafety level 3 laboratory.
5. A fine ranging from VND 30.000.000 to VND
40.000.000 shall be imposed for commission of one of the following violations:
a) Failing to organize annual drills of
biosafety incident prevention and handling by a biosafety level 3 laboratory;
b) Performing tests before completing procedures
for self-declaration of satisfaction of biosafety level 1 or level 2 laboratory
standards, or before obtaining a certificate of satisfaction of biosafety level
3 laboratory standards, or when the certificate of satisfaction of biosafety
level 3 laboratory standards has expired.
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Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
a) The operation of the biosafety laboratory
shall be suspended for a fixed period of 01 – 03 months in case of commission
of the violation in Point a or c Clause 1, Point a Clause 2 or Point b Clause 4
of this Article;
b) The operation of the biosafety level 1 or 2
laboratory shall be suspended for a fixed period of 03 – 06 months in case of
commission of the violation in Point b Clause 5 of this Article;
c) The certificate of satisfaction of biosafety
level 3 laboratory standards shall be suspended for a fixed period of 01 – 03
months in case of commission of the violation in Point a or c Clause 4 or Point
b Clause 5 of this Article.
Article 9. Violations
against regulations on use of vaccines and biologicals
1. A warning or a fine ranging from VND 300.000
to VND 500.000 shall be imposed for commission of one of the following
violations:
a) Failing to provide or obstructing children or
pregnant women in using vaccines and biologicals compulsory for infectious
diseases included in an expanded immunization program;
b) Failing to provide counseling for vaccine
recipients, parents, families or guardians of children getting vaccinated
before vaccination; failing to provide counseling on benefits and risks related
to vaccination;
c) Failing to give instructions to vaccinees or
families of children getting vaccinated on how to monitor and treat vaccine
reactions;
d) Failing to submit reports or submitting
inadequate reports on vaccination as prescribed by law.
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
a) Failing to use or obstructing the use of
vaccines and biologicals for vaccine-preventable diseases for people
susceptible to infectious diseases in epidemic zones or for people sent to
epidemic zones at the request or according to guidelines of competent
authorities;
b) Failing to issue and keep physical or
electronic personal vaccination records of people vaccinated at the vaccination
clinic;
c) Failing to compile the list of people
vaccinated at the vaccination clinic;
d) Failing to monitor vaccinees for at least 30
minutes after vaccination and instruct them or their facilities to monitor
vaccine reactions for at least 24 hours later;
dd) Failing to prepare adequate relevant
documents as requested to enable the provincial advisory council to verify the
eligibility for compensation for a serious injury or death from vaccination;
e) Failing to retain and manage documents
concerning vaccination and post-vaccination reactions as prescribed by law.
3. A fine ranging from VND 3.000.000 to VND
5.000.000 shall be imposed for commission of one of the following violations:
a) Failing to provide pre-vaccination screening
or insufficiently providing pre-vaccination screening for people getting
vaccinated;
b) Failing to strictly comply with regulations
on receipt, transport and storage of vaccines;
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Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
d) Failing to immediately stop the vaccination
session in case of a serious injury occurring after vaccination;
dd) Failing to record adequate information on
serious injuries in accordance with regulations of the Minister of Health and
submit a report to the Provincial Department of Health within 24 hours from the
occurrence of the injury;
e) Failing to organize vaccination against
epidemics at the request of competent authorities by a health facility that has
registered with the provincial Department of Health for participation in the
expanded immunization program;
g) Including costs covered by state budget in
vaccination prices under expanded immunization programs and vaccinations
against epidemics;
h) Selling vaccines and biologicals included in
an expanded immunization program.
4. A fine ranging from VND 5.000.000 to VND
10.000.000 shall be imposed for commission of one of the following violations:
a) Failing to follow prescriptions and ensure
safety during vaccination;
b) Failing to give emergency treatment and find
the causes of a serious injury after vaccination;
c) Failing to give the patient suffering from a
serious injury after vaccination to the nearest health facility if the case is
beyond the capacity of the vaccination clinic;
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
dd) Failing to meet one of requirements for a
fixed vaccination clinic after having made a declaration of eligibility for
vaccination.
5. A fine ranging from VND 10,000,000 to VND
20,000,000 shall be imposed for commission of one of the following violations:
a) Using vaccines and biologicals at a facility
that fails to meet eligibility requirements;
b) Giving vaccinations before completing
procedures for declaration of eligibility for vaccination.
6. A fine ranging from VND 30.000.000 to VND
40.000.000 shall be imposed for using vaccines which are not granted
certificate of registration, expired vaccines or substandard vaccines.
7. Additional penalties:
a) All or part of operations of the violating
entity shall be suspended for a fixed period of 01 – 03 months in case of
commission of one of the violations in Point a, b, c and d Clause 3, Clause 4,
Clause 5 and Clause 6 of this Article;
b) The medical examination and treatment
practicing certificate shall be suspended for a fixed period of 01 – 03 months
in case of commission of the violation in Point a, b, c or d Clause 3 or Point
a, b, c or d Clause 4 of this Article.
8. Remedial measures:
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
b) Vaccines involving the violation in Clause 6
of this Article shall be destroyed.
Article 10. Violations against
prevention of transmission of infectious diseases in health facilities
1. A fine ranging from VND 1.000.000 to VND
3.000.000 shall be imposed for commission of one of the following violations:
a) Failing to report or untruthfully reporting
personal infectious disease development to doctors and healthcare workers;
b) Failing to register for health monitoring
with the medical station of commune, ward or communal-level town where the
person infected with a group-A infectious disease resides after he is
discharged or completes treatment at a health facility;
c) Failing to provide counseling on measures for
prevention and control of infectious diseases for patients and their families.
2. A fine ranging from VND 3.000.000 to VND
5.000.000 shall be imposed for commission of one of the following violations:
a) Failing to provide information on persons
infected with infectious diseases receiving medical services at the health
facility to the preventive medicine agency of the same level;
b) Failing to monitor the health of doctors and
healthcare workers who directly provide medical examination and treatment for
persons infected with group-A infectious diseases;
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
d) Failing to clean, disinfect, sterilize and
implement other measures for prevention and control of infectious diseases when
detecting environment carrying pathogens causing group B or C infectious
diseases, persons infected with, or suspected of infection with, group B or C
infectious diseases, or persons carrying pathogens causing group B or C
infectious diseases.
3. A fine ranging from VND 5.000.000 to VND
7.000.000 shall be imposed for failing to notify competent health agencies when
detecting environment carrying pathogens causing group A infectious diseases,
persons infected with, or suspected of infection with, group A infectious
diseases, or persons carrying pathogens causing group A infectious diseases.
4. A fine ranging from VND 7.000.000 to VND
10.000.000 shall be imposed for failing to clean, disinfect, sterilize and
implement other measures for prevention and control of infectious diseases when
detecting environment carrying pathogens causing group A infectious diseases, persons
infected with, or suspected of infection with, group A infectious diseases, or
persons carrying pathogens causing group A infectious diseases.
5. Remedial measure:
The entity committing the violation in Point d
Clause 2 or Clause 4 of this Article is compelled to implement cleaning,
disinfection, sterilization and other measures for prevention and control of
infectious diseases.
Article 11. Violations
against regulations on medical isolation and coercive medical isolation
1. A fine ranging from VND 5.000.000 to VND
10.000.000 shall be imposed for commission of one of the following violations:
a) Failing to organize or force medical
isolation in case of compulsory medical isolation prescribed by law, except the
case prescribed in Point a Clause 2 of this Article;
b) Refusing or evading medical isolation or
coercive medical isolation measures implemented by competent authorities,
except case prescribed in Point b Clause 2 of this Article;
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Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
2. A fine ranging from VND 15.000.000 to VND
20.000.000 shall be imposed for commission of one of the following violations:
a) Failing to organize medical isolation of
persons infected with group A infectious diseases;
b) Refusing or evading the implementation of a
competent authority’s decision on medical isolation or coercive medical
isolation of persons infected with group A infectious diseases, border health
quarantine subjects infected with group A infectious diseases or at the request
of a competent authority;
c) Organizing medical isolation or coercive
medical isolation at an unqualified location.
3. Remedial measure:
Enforced organization of medical isolation or
coercive medical isolation if one of the violations in Points a, b Clause 1 and
Points a, b Clause 2 of this Article is committed.
Article 12. Violations
against regulations on epidemic management measures
1. A fine ranging from VND 1.000.000 to VND
3.000.000 shall be imposed for commission of one of the following violations:
a) Failing to adopt personal protective measures
by persons participating in epidemic management and susceptible persons
according to guidance of health agencies;
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
2. A fine ranging from VND 5.000.000 to VND
10.000.000 shall be imposed for commission of one of the following violations:
a) Concealing the status of infection with an
infectious disease declared as an epidemic of oneself or another person;
b) Failing to implement or refusing to implement
cleaning, disinfection and sterilization measures in an epidemic zone;
c) Failing to participate in epidemic management
activities according to a mobilization decision issued by the steering
committee for epidemic management;
d) Charging for the provision of medical
examination and treatment services to persons infected with group A infectious
diseases;
dd) Failing to implement decisions on compulsory
destruction of animals, plants and other things which are regarded as vectors,
except the cases prescribed in Point c Clause 4 and Point d Clause 5 of this
Article.
3. A fine ranging from VND 10,000,000 to VND
20,000,000 shall be imposed for commission of one of the following violations:
a) Failing to implement decisions on temporary
closure of public eating establishments that may cause the spread of epidemic
in an epidemic zone;
b) Failing to implement decisions on prohibition
of trading or use of foods which are regarded as vectors;
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
4. A fine ranging from VND 20.000.000 to VND
30.000.000 shall be imposed for commission of one of the following violations:
a) Failing to implement decisions on health
inspection, surveillance and control before entering or leaving epidemic areas
of a group A infectious disease;
b) Transporting articles, animals, plants, foods
and other goods that may cause the spread of epidemic out of an epidemic area
of a group A infectious disease;
c) Failing to implement decisions on compulsory
destruction of animals, foods, plants and other things which are regarded as
vectors of group A infectious diseases.
5. A fine ranging from VND 30.000.000 to VND
40.000.000 shall be imposed for commission of one of the following violations:
a) Failing to comply with requests for health
inspection and control of vehicles before they are moved out of an epidemic
zone in the state of epidemic emergency;
b) Failing to implement a decision on
prohibition of gatherings in an area where the state of epidemic emergency is
declared;
c) Transporting unauthorized persons or vehicles
to disease clusters in an area where the state of epidemic emergency is
declared;
d) Failing to implement decisions on compulsory
destruction of animals, foods, plants and other things that may cause the
spread of disease to people in an area where the state of epidemic emergency is
declared.
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
a) The entity committing the violation in Point
b Clause 2 of this Article is compelled to implement cleaning, disinfection and
sterilization measures;
b) The entity committing the violation in Point
d Clause 2 of this Article is compelled to return any amounts of money
collected against regulations of law. Any payments which cannot be made to
payers shall be paid to state budget in accordance with regulations of law;
c) Animals, foods, plants and other things shall
be destroyed in case of commission of the violation in Point dd Clause 2, Point
b or c Clause 4 or Point d Clause 5 of this Article;
d) The health control of vehicles shall be
carried out in case of commission of the violation in Point a Clause 5 of this
Article.
Article 13. Violations
against regulations on border health quarantine
1. A fine ranging from VND 3.000.000 to VND
5.000.000 shall be imposed for commission of one of the following violations:
a) Failing to submit a written report to the
Ministry of Health on carving, re-carving, revocation, destruction,
invalidation or loss of the health quarantine seal;
b) Failing to make a record of specimen health quarantine
seals;
c) Failing to prepare and keep documents when
carving or re-carving a health quarantine seal as prescribed;
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Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
dd) Deliberately embarking or disembarking,
unloading or receiving goods when a ship anchors pending heath quarantine or is
quarantined, unless the ship is in distress.
2. A fine ranging from VND 5.000.000 to VND
7.000.000 shall be imposed for commission of one of the following violations:
a) Failing to follow the health inspection and
control carried out by the border health quarantine unit as prescribed by law,
except the case prescribed in Clause 4 of this Article;
b) Failing to strictly comply with regulations
on quarantine signs for incoming ships;
c) Erasing, repairing or lending symbols,
badges, cards or uniforms of health quarantine officers, or traditional flags
of border health quarantine units for serving other purposes;
d) Failing to make health declaration or making
untruthful declaration of border health quarantine as prescribed by law.
3. A fine ranging from VND 7.000.000 to VND
10.000.000 shall be imposed for commission of one of the following violations:
a) Transporting corpses, remains, body ashes,
microorganism samples, biological products, tissues, body organs, blood or its
components through the border without inspection by a health quarantine unit;
b) Importing samples of blood, serum, plasma,
urine, fecal, body fluids or other human materials that contain or may contain
infectious agents, microorganism species or samples containing microorganisms
that may human diseases for reserve, diagnosis or medical examination without
the import permit.
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
5. Remedial measures:
a) The entity committing the violation in Point
a Clause 2 of this Article is compelled to follow the health inspection and
control;
b) The health control shall be carried out in
case of commission of the violation in Point a Clause 3 of this Article. If
requirements for prevention and control of infectious diseases are not met, the
violating subjects/articles shall be removed from the territory of the
Socialist Republic of Vietnam or re-exported;
c) The violating entity is compelled to remove
from the territory of the Socialist Republic of Vietnam or re-export the
subjects/articles involving the violation in Point b Clause 3 of this Article;
d) Enforced organization/implementation of
medical isolation, coercive medical isolation and health control of people,
vehicles, goods and goods carrying pathogens causing any group-A infectious
diseases in case of commission of the violation in Clause 4 of this Article.
Article 14. Violations
against other regulations on preventive medicine
1. A fine ranging from VND 3.000.000 to VND
5.000.000 shall be imposed for employing persons infected with infectious
diseases to directly do the jobs that may cause the spread of such infectious
diseases to others or to the public, unless they directly engage in production
or trading of foods, food additives, food processing aids, food containers or
primary packages of foods, or directly provide food and beverage services.
2. A fine ranging from VND 5.000.000 to VND
10.000.000 shall be imposed for failing to comply with measures for prevention
and control of infectious diseases at the request of competent authorities,
except the cases prescribed in Article 5 through 13 hereof.
3. A fine ranging from VND 20.000.000 to VND
30.000.000 shall be imposed for taking advantage of epidemics for imposing
irrational prices of drugs, medical devices, pharmaceutical starting materials,
and materials used in manufacturing of medical devices serving prevention and
management of epidemics.
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Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
a) The certificate of eligibility for pharmacy
business, pharmacy practicing certificate, or operation of the violating entity
shall be suspended for a fixed period of 06 – 12 months in case of commission
of the violation in Clause 3 of this Article;
b) The certificate of eligibility for pharmacy
business, pharmacy practicing certificate, or operation of the violating entity
shall be suspended for a fixed period of 12 – 24 months if the violation in
Clause 3 of this Article involves goods worth more than VND 50.000.000 or
re-committed.
5. Remedial measure:
The violating entity is compelled to return any
different amounts to buyers or sellers in case of commission of the violation
in Clause 3 of this Article. Any payments which cannot be made to payers shall
be paid to state budget in accordance with regulations of law.
Article 15. Violations
against regulations on domestic water quality
1. A fine ranging from VND 1.000.000 to VND
3.000.000 shall be imposed for failing to submit reports on water quality to
competent authorities as prescribed.
2. A fine ranging from VND 3.000.000 to VND
5.000.000 shall be imposed for supplying water with a design capacity of less
than 1.000 m3/24 hours or serving fewer than 500 households in one
of the following cases:
a) The testing of water quality parameters of
each water sample is not performed by an accredited laboratory or certification
body as prescribed by law;
b) Testing results of water quality parameters
are not made publicly available as prescribed by law;
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Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
3. A fine ranging from VND 5.000.000 to VND
10.000.000 shall be imposed for supplying water with a design capacity of less
than 1.000 m3/24 hours or serving fewer than 500 households in one
of the following cases:
a) Domestic water supplied does not meet the
requirements laid down in national technical regulations on domestic water
quality;
b) 06 or more parameters of each water sample
are not tested.
4. A fine ranging from VND 10.000.000 to VND
15.000.000 shall be imposed for supplying water with a design capacity of 1.000
m3/24 hours or more or serving 500 households or more in one of the
following cases:
a) The testing of water quality parameters of
each water sample is not performed by an accredited laboratory or certification
body as prescribed by law;
b) Testing results of water quality parameters
are not made publicly available as prescribed by law;
c) 01 – 05 parameters of each water sample are
not tested.
5. A fine ranging from VND 15.000.000 to VND
20.000.000 shall be imposed for supplying water with a design capacity of 1.000
m3/24 hours or more or serving 500 households or more in one of the
following cases:
a) Domestic water supplied does not meet the
requirements laid down in national technical regulations on domestic water
quality;
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Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
6. A fine ranging from VND 10.000.000 to VND
20.000.000 shall be imposed for failing to take adequate samples as required
for each testing by a water supplier that has a design capacity of less than
1.000 m3/24 hours or serves fewer than 500 households.
7. A fine ranging from VND 20.000.000 to VND
30.000.000 shall be imposed for commission of one of the following violations:
a) Failing to perform periodic testing of water
quality parameters by a water supplier that has a design capacity of less than
1.000 m3/24 hours or serves fewer than 500 households;
b) Failing to take adequate samples as required
for each testing by a water supplier that has a design capacity of 1.000 m3/24
hours or more or serves 500 households or more.
8. A fine ranging from VND 30.000.000 to VND
40.000.000 shall be imposed for failing to perform periodic testing of water
quality parameters by a water supplier that has a design capacity of 1.000 m3/24
hours or more or serves 500 households or more.
9. The fine shall be doubled but not exceed VND
50.000.000 if the water supplier committing one of the violations in Clause 1
through 7 of this Article has two or more water production plants.
Article 16. Violations
against regulations on burial and cremation
1. A warning or a fine ranging from VND 300.000
to VND 500.000 shall be imposed for failing to keep records of information on
funerals taken place at a funeral home or crematorium.
2. A fine ranging from VND 3.000.000 to VND
5.000.000 shall be imposed for failing to meet hygiene conditions by a funeral
home or crematorium.
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Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
a) Failing to implement or insufficiently
implementing regulations on hygiene in lying in state, embalming, transporting,
preserving corpses or remains of persons who have died from any group-A
infectious diseases or some group-B infectious diseases included in the list of
infectious diseases requiring medical isolation;
b) Failing to handle corpses of persons who have
died from any group-A infectious diseases or some group-B infectious diseases
included in the list of infectious diseases requiring medical isolation;
c) Failing to strictly comply with regulations
on mass-grave burials.
4. A fine ranging from VND 10.000.000 to VND
20.000.000 shall be imposed for failing to strictly comply with regulations on
safe handling of corpses, remains and surroundings when moving corpses and
remains from a relocated cemetery before appropriate time for reinterment.
5. A fine ranging from VND 20.000.000 to VND
30.000.000 shall be imposed for using cremation technology that fails to meet
waste treatment requirements as prescribed by law.
6. Remedial measure:
Enforced implementation of measures for
treatment of environmental pollution caused by one of the violations in Clauses
2, 3, 4 and 5 of this Article.
Article 17. Violations
against regulations on occupational health, diseases and accidents
1. A fine ranging from VND 3.000.000 to VND
5.000.000 shall be imposed upon a health facility for commission of one of the
following violations:
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
b) Failing to compile an occupational disease
dossier for the worker who is diagnosed with an occupational disease;
c) Failing to submit reports on occupational
disease cases or annual reports on occupational disease examination to
competent authorities as prescribed by law;
d) Failing to submit annual reports on victims
of occupational accidents receiving medical examination and treatment at the
health facility to competent authorities as prescribed by law.
2. A fine ranging from VND 5.000.000 to VND
10.000.000 shall be imposed upon a health facility for commission of one of the
following violations:
a) Failing to submit reports on medical units
providing training in first aid and emergency aid or training for issuance of
professional certificates/certifications of occupational health to competent
authorities as prescribed by law;
b) Providing training in first aid and emergency
aid with inadequate training duration or contents.
3. The following fines shall be imposed for
violations against regulations on examination and treatment of occupational
diseases:
a) A fine ranging from VND 10.000.000 to VND
20.000.000 shall be imposed for providing false results of occupational disease
examination and treatment;
b) A fine ranging from VND 20.000.000 to VND
30.000.000 shall be imposed for providing results of occupational disease
examination and treatment without providing occupational disease examination
and treatment as prescribed by law.
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
The medical examination and treatment practicing
certificate shall be suspended for a fixed period of 01 – 03 months in case of
commission of the violation in Clause 3 of this Article.
Article 18. Violations
against other regulations on health environment
A fine ranging from VND 3.000.000 to VND
5.000.000 shall be imposed for failing to build, or failing to meet hygiene
conditions for, hygienic handwashing and toilet areas in offices, medical
facilities and other public establishments.
Article 19. Violations
against regulations on dissemination of information and education about
HIV/AIDS prevention and control
1. A warning or the following fines shall be
imposed for failing to organize education and dissemination of information
about HIV/AIDS prevention and control measures at the request of competent
authorities:
a) A warning or fine ranging from 300.000 to VND
500.000 shall be imposed upon a violating establishment using less than 50
employees;
b) A fine ranging from 1.000.000 to VND 2.000.000
shall be imposed upon a violating establishment using from 50 to under 100
employees;
c) A fine ranging from 2.000.000 to VND
3.000.000 shall be imposed upon a violating establishment using from 100 to
under 200 employees;
d) A fine ranging from 3.000.000 to VND
5.000.000 shall be imposed upon a violating establishment using from 200 to
under 500 employees;
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
e) A fine ranging from 10.000.000 to VND
15.000.000 shall be imposed upon a violating establishment using from 1.000 to
under 1.500 employees;
g) A fine ranging from 15.000.000 to VND
20.000.000 shall be imposed upon a violating establishment using from 1.500 to
under 2.000 employees;
h) A fine ranging from 20.000.000 to VND
25.000.000 shall be imposed upon a violating establishment using from 2.000 to
under 2.500 employees;
i) A fine ranging from 25.000.000 to VND
30.000.000 shall be imposed upon a violating establishment using 2.500
employees or more.
2. A fine ranging from VND 5.000.000 to VND
10.000.000 shall be imposed for commission of one of the following violations:
a) Providing inaccurate information on the
HIV/AIDS pandemic compared to the data announced by competent authorities;
b) Failing to follow the preferred time and
duration for broadcasting of information and educational contents about
HIV/AIDS prevention and control on radio and television stations and content
ratio and column positions in printed newspapers, television newspapers and
online newspapers.
3. A fine ranging from VND 10.000.000 to VND
15.000.000 shall be imposed for commission of one of the following violations:
b) Failing to give priority to time and duration
for broadcasting of information and educational contents about HIV/AIDS
prevention and control on radio and television stations and content ratio and
column positions in printed newspapers, television newspapers and online
newspapers;
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
c) Disclosing a patient’s HIV status to a third
party without having the patient’s consent, unless information is provided to
serve HIV/AIDS epidemiological surveillance purposes and when giving HIV test
results as prescribed by law.
4. A fine ranging from VND 15.000.000 to VND
20.000.000 shall be imposed for disclosing name, address and photo of a person
infected with HIV without having his/her consent, unless information is
provided to serve HIV/AIDS epidemiological surveillance purposes and when
giving HIV test results as prescribed by law.
5. Remedial measures:
a) The entity committing the violation in Point
a Clause 2 of this Article is compelled to correct inaccurate information via
means of mass media at the place where the inaccurate information has been published
within at least 03 consecutive days as prescribed by law;
b) The entity committing the violation in Point
b Clause 3 of this Article is compelled to return any amounts of money
collected against regulations of law. Any payments which cannot be made to
payers shall be paid to state budget in accordance with regulations of law;
c) The entity committing the violation in Point
c Clause 3 or Clause 4 of this Article is compelled to make direct apologies to
HIV patients/their families and correction of information on means of mass
media at the place where the HIV patient is living within at least 03
consecutive days as prescribed by law, unless the HIV patient rejects public
apologies.
Article 20. Violations
against regulations on HIV testing and counseling
1. A fine ranging from VND 1.000.000 to VND
3.000.000 shall be imposed for commission of one of the following violations:
a) Hindering the access to counseling on
HIV/AIDS prevention and control;
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
c) Failing to comply with pre- and post-HIV test
counseling procedures/contents;
d) Providing pre- and post-HIV test counseling
before completing training course in HIV/AIDS counseling;
dd) Providing HIV/AIDS counseling at a
counseling facility that fails to meet eligibility requirements set by law;
e) Failing to provide or providing the list of
HIV-infected persons for HIV/AIDS surveillance against regulations of law;
g) Failing to retain or improperly retaining HIV
test results, blood samples, blood bags, blood products and specimens used for
HIV testing;
h) Failing to dispose of or disposing of blood
samples, blood bags, blood products and specimens used for HIV testing against
regulations of law;
i) Contravening regulations on HIV/AIDS
reporting.
2. A fine ranging from VND 3.000.000 to VND
5.000.000 shall be imposed for commission of one of the following violations:
a) Failing to provide pre- and post-HIV test
counseling;
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
c) Failing to comply with procedures for
notification of positive HIV test results;
d) Transporting or delivering positive HIV test
reports against regulations of law;
dd) Failing to report on discovered substandard
biologicals and equipment used for HIV testing to competent authorities;
e) Failing to strictly comply with the Ministry
of Health’s regulations on sterilization, antisepsis and waste treatment when
performing surgical, injection or acupuncture procedures for HIV prevention and
control;
g) Failing to notify relevant parties and take
appropriate measures upon discovery of unconformable HIV testing;
h) Charging for HIV tests performed in case of
solicitation for judicial expertise or according to a decision of the
investigating authority, people’s procuracy or people’s court or HIV tests for
pregnant women of which costs are covered by other funding sources.
3. A fine ranging from VND 5.000.000 to VND
10.000.000 shall be imposed for commission of one of the following violations:
a) Confirming positive HIV test results without
obtaining certificate of eligibility to perform HIV confirmatory tests from a
competent authority;
b) Failing to comply with instructions of the
Ministry of Health when conducting HIV tests;
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
d) Confirming positive HIV test results within
the period of suspension of HIV confirmatory tests;
dd) Notifying positive HIV test results to
entities other than the ones prescribed by law or disclosing positive HIV test
results which must be kept confidential as prescribed by law;
e) Performing HIV tests for persons aged under
16 or incapacitated persons without obtaining written consent of their parents
or legal guardians, except emergency cases prescribed in the Law on medical
examination and treatment.
4. A fine ranging from VND 10.000.000 to VND
20.000.000 shall be imposed for commission of one of the following violations:
a) Forcing persons who are not subjects of
HIV/AIDS epidemiological surveillance and mandatory HIV testing to be tested
for HIV;
b) Performing HIV testing without obtaining the
certificate of eligibility to perform HIV tests;
c) Failing to perform testing for blood bags and
blood products before use.
5. Additional penalties:
a) The certificate of eligibility to perform HIV
tests shall be suspended for a fixed period of 01 – 03 months in case of
commission of the violation in Point e Clause 2 or Point b Clause 3 of this
Article;
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
c) Operations of the violating entity shall be
suspended for a fixed period of 03 – 06 months in case of commission of the
violation in Point b Clause 4 of this Article.
6. Remedial measures:
a) The entity committing the violation in Point
h Clause 2 of this Article is compelled to return any amounts of money
collected against regulations of law. Any payments which cannot be made to
payers shall be paid to state budget in accordance with regulations of law;
b) The violating entity is compelled to return
any benefits illegally obtaining from the violation in Point b Clause 4 of this
Article.
Article 21. Violations
against regulations on treatment and care of HIV patients, pre-exposure and
post-exposure prophylaxis of HIV
1. A fine ranging from VND 1.000.000 to VND
3.000.000 shall be imposed for commission of one of the following violations:
a) Writing prescriptions of antiretroviral drugs
for HIV patients, persons exposed to HIV or pre-exposure prophylaxis before
completing training courses in HIV/AIDS treatment according to regulations of
the Minister of Health;
b) Failing to comply with HIV/AIDS treatment
procedures and regimen promulgated by the Minister of Health when writing
prescriptions of antiretroviral drugs.
2. A fine ranging from VND 3.000.000 to VND
5.000.000 shall be imposed for commission of one of the following violations:
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
b) Failing to strictly comply with regulations
on prioritized access to antiretroviral drugs;
c) Failing to organize management, care and
counseling for HIV patients at rehabilitation centers as prescribed by law;
d) Failing to give instructions on post-exposure
prophylaxis to persons exposed to HIV;
dd) Failing to monitor, provide treatment and
implement other measures for reducing mother-to-child transmission of HIV for
pregnant women having HIV.
3. A fine ranging from VND 5.000.000 to VND
10.000.000 shall be imposed for commission of one of the following violations:
a) Failing to monitor and treat for HIV-infected
pregnant women under management;
b) Failing to provide post-exposure prophylaxis
to persons exposed to HIV;
c) Hindering a HIV patient from caring for
another HIV patient or accessing HIV treatment and care services;
d) Failing to ensure medical care policies for
HIV infected people at social protection centers;
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
e) Charging for HIV drugs which are provided
free of charge.
4. A fine ranging from VND 10.000.000 to VND
15.000.000 shall be imposed for refusing to give antiretroviral therapy for
qualified HIV-infected persons as prescribed by law.
5. Remedial measure:
The entity committing the violation in Point dd
or e Clause 3 of this Article is compelled to return any amounts of money
collected against regulations of law. The amounts of money which cannot be
returned to payers shall be paid to state budget in accordance with regulations
of law.
Article 22. Violations
against regulations on harm reduction interventions for HIV prevention
1. A warning or a fine ranging from VND 200.000
to VND 500.000 shall be imposed upon community access specialists for the
commission of one of the following violations:
a) Failing to carry community access
specialist’s card when performing harm reduction intervention activities for
HIV prevention;
b) Using an expired community access
specialist’s card when performing harm reduction intervention activities for
HIV prevention, unless such use of expired card is permitted by the issuing
authority pending the issuance of a new card;
c) Altering, erasing or lending the community
access specialist’s card to another person.
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
a) Failing to give a prior notification of harm
reduction intervention activities for HIV prevention to the People’s Committee
and police authority of commune where such activities are performed;
b) Failing to introduce and transfer copies of
treatment documents of the HIV patient who is receiving antiretroviral therapy
to a new treatment facility appropriate to his/her working and living
conditions;
c) Failing to receive treatment documents, which
are valid as prescribed by law, of the HIV patient who is receiving
antiretroviral therapy transferred from another treatment facility;
d) Terminating opioid replacement therapy,
unless it is terminated as prescribed by law.
3. A fine ranging from VND 3.000.000 to VND
5.000.000 shall be imposed for commission of one of the following violations:
a) Using a community access specialist’s card
for wrong purposes, beyond scope of operations or against provisions of the
program/project for harm reduction intervention for HIV prevention;
b) Failing to cooperate with local HIV/AIDS
prevention and control agencies in performing harm reduction intervention
measures for HIV prevention;
c) Failing to comply with procedures for
selection of patients eligible for opioid replacement therapy.
4. A fine ranging from VND 5.000.000 to VND
10.000.000 shall be imposed for commission of one of the following violations:
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
b) Failing to treat for the patient who is
receiving opioid replacement therapy transferred from another treatment
facility;
c) Failing to provide condoms by an
accommodation facility as prescribed by law.
5. A fine ranging from VND 10.000.000 to VND
20.000.000 shall be imposed for commission of one of the following violations:
a) Failing to satisfy one of eligibility
requirements after completing procedures for declaration of eligibility to
provide opioid replacement therapy;
b) Failing to submit the list of patients, their
health status and compliance with opioid replacement therapy to competent
authorities as prescribed by law;
c) Selling condoms, syringes with needles, drugs
and biologicals which are provided free of charge as prescribed by law or which
are subsidized at higher prices;
d) Providing opioid replacement therapy to
ineligible persons;
dd) Forcing persons dependent on opioid to
receive opioid replacement therapy in any form.
6. A fine ranging from VND 20.000.000 to VND
30.000.000 shall be imposed for commission of one of the following violations:
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
b) Failing to print the phrase “cung cấp miễn
phí, không được bán” (“provided free of charge. Not for sale”) on packages or
auxiliary labels of condoms and syringes with needles of the program/projects
on harm reduction intervention for HIV prevention;
c) Providing opioid replacement therapy with
using drugs which are not yet permitted for sale in Vietnam.
7. Additional penalties:
a) The medical examination and treatment practicing
certificate shall be suspended for a fixed period of 01 – 03 months in case of
commission of the violation in Point a or b Clause 4 or Point d or dd Clause 5
of this Article;
b) Operation of the violating entity shall be
suspended for a fixed period of 01 – 03 months in case of commission of the
violation in Point a Clause 5 or Point a or c Clause 6 of this Article;
c) The exhibit of the violation in Point b or c
Clause 1 of this Article which is the community access specialist’s card shall
be confiscated.
8. Remedial measures:
a) The violating entity is compelled to return
any benefits illegally obtained from the commission of the violation in Point c
Clause 5 or Point a Clause 6 of this Article;
b) The drugs involving the violation in Point c
Clause 6 of this Article shall be destroyed.
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
1. A fine ranging from VND 500.000 to VND
1.000.000 shall be imposed for commission of one of the following violations:
a) Requesting pupils, students, trainees or
applicants for admission to undergo HIV tests or provide their HIV test
reports;
b) Hindering pupils, students or trainees from
participating in an educational institution’s activities/services because they
themselves or their family members are living with HIV;
c) Obstructing the admission of social
protection beneficiaries to a social protection center because they are living
with HIV;
d) Refusing to receive bodies of persons died
from HIV/AIDS for burial or cremation.
2. A fine ranging from VND 5.000.000 to VND
10.000.000 shall be imposed for commission of one of the following violations:
a) Requesting applicants for job to undergo HIV
tests or present their HIV test reports, or refusing to employ them because
they are infected with HIV, except some jobs for which applicants are required
to undergo pre-employment HIV tests as prescribed by the Government;
b) Refusing admission of pupils, students or
trainees who are infected with HIV;
c) Refusing admission of social protection
beneficiaries to a social protection center because they are living with HIV;
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
dd) Isolating, restricting or prohibiting
HIV-infected pupils, students or trainees to/from a facility/institution’s
activities and/or services;
e) Practicing discrimination in care and
treatment of HIV patients;
g) Arranging jobs/works inappropriate to health
status and qualification of HIV-infected workers.
3. A fine ranging from VND 10,000,000 to VND
20,000,000 shall be imposed for commission of one of the following violations:
a) Terminating signed employment contracts or
public employee contracts or causing difficulties to employees during
employment because they are infected with HIV;
b) Forcing employees who are still fit for their
current job positions to transfer to other job positions because they are
infected with HIV;
c) Refusing to accept pay raise/promotion claims
or failing to ensure lawful rights and benefits of employees who are infected
with HIV;
d) Discipline or expel pupils, students or
trainees for HIV infection;
dd) Using images/media messages that
discriminate against HIV-infected persons and/or their family members.
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
a) Enforced receipt and burial or cremation of
HIV-infected bodies or remains in case of commission of the violation in Point
d Clause 1 of this Article;
b) Enforced admission of HIV-infected persons in
case of commission of the violation in Point b or c Clause 2 or Point a Clause
3 of this Article;
c) The violating entity is compelled to make
direct apologies to persons who have been unfairly discriminated against in
case of commission of the violation in Point e Clause 2 or Point dd Clause 3 of
this Article;
d) The entity committing the violation in Point
b Clause 3 of this Article is compelled to re-assign employees to their
previous job positions;
dd) Enforced provision of lawful rights and
benefits to HIV-infected employees in case of commission of the violation in
Point c Clause 3 of this Article;
e) The entity committing the violation in Point
d Clause 3 of this Article is compelled to abrogate the decision to discipline
or expel pupil, student or trainee for HIV infection;
g) Enforced removal of violating elements in case
of commission of the violation in Point dd Clause 3 of this Article. If
violating elements cannot be removed, medical products shall be destroyed.
Article 24. Violations
against other regulations on HIV/AIDS prevention and control
1. A fine ranging from VND 3.000.000 to VND
5.000.000 shall be imposed for hindering employees from participating in
HIV/AIDS prevention and control activities.
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Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
a) Threatening to transmit HIV to others;
b) Taking advantage of HIV/AIDS prevention and
control for profiteering.
3. Remedial measure:
The violating entity is compelled to return any
benefits illegally obtained from the commission of the violation in Point b
Clause 2 of this Article.
Article 25. Violations
against regulations on non-smoking areas
1. A warning or a fine ranging from VND 200.000
to VND 500.000 shall be imposed for smoking in non-smoking areas. Acts of
in-light smoking shall be penalized in accordance with regulations on penalties
for administrative violations in civil aviation sector.
2. A fine ranging from VND 3.000.000 to VND
5.000.000 shall be imposed for commission of one of the following violations:
a) Failing to display “non-smoking” words or
signs at non-smoking areas as prescribed by law;
b) Failing to organize, instruct, inspect and
expedite the implementation of smoking bans in areas under management.
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Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
a) Failing to provide rooms and air ventilation
systems separate from non-smoking areas;
b) Failing to provide containers of tobacco
butts and ashes;
c) Failing to display signs at suitable and
prominent positions;
d) Failing to provide firefighting equipment.
Article 26. Violations
against regulations on sale and supply of tobacco
1. A fine ranging from VND 1.000.000 to VND 3.000.000
shall be imposed for failing to display the notice stating “It is illegal to
sell tobacco products to anyone under the age of 18” at points of sale of a
tobacco wholesale or retail dealer.
2. A fine ranging from VND 3.000.000 to VND
5.000.000 shall be imposed for commission of one of the following violations:
a) Displaying more than one pack, carton or box
of a tobacco brand at a tobacco retail agent or point of sale;
b) Selling or supplying tobacco products to
persons aged under 18;
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Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
3. Additional penalty:
Business operations involving the violation in
Clause 2 of this Article shall be suspended for a fixed period of 01 – 03
months.
4. Remedial measure:
The entity committing the violation in Point c
Clause 2 of this Article is compelled to recall and remove violating elements
of tobacco products which are not labeled or whose packages do not indicate
health warning. If violating elements cannot be removed, tobacco products shall
be destroyed.
Article 27. Violations
against regulations on labeling and printing of health warnings on tobacco
packages
1. A fine ranging from VND 20.000.000 to VND
30.000.000 shall be imposed for commission of one of the following violations:
a) Failing to comply with the prescribed form,
position, area and color of the health warning printed on tobacco packages;
b) Failing to change the health warning printed
on tobacco packages for every 2 years as prescribed by law;
c) Failing to indicate the quantity of
cigarettes on each cigarette pack or the weight on other tobacco products;
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Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
2. A fine ranging from VND 30.000.000 to VND
40.000.000 shall be imposed for commission of one of the following violations:
a) Failing to print health warnings on packages
of tobacco products manufactured or imported for sale in Vietnam;
b) Signing contracts for production of
foreign-branded for sale in Vietnam without obtaining a permit from a competent
authority.
3. Additional penalty:
Business operations involving the violation in
Clause 2 of this Article shall be suspended for a fixed period of 03 – 06
months.
4. Remedial measures:
a) The entity committing the violation in Clause
1 or Point a Clause 2 of this Article is compelled to recall tobacco products
and rectify or remove violating elements. If violating elements cannot be
rectified, tobacco products shall be destroyed.
b) The violating entity is compelled to return
any benefits illegally obtained from the commission of the violation in Point b
Clause 2 of this Article.
Article 28. Violations
against regulations on smoking cessation
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Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
1. Failing to have a separate place for
providing direct smoking cessation counseling as prescribed by law.
2. Failing to prepare media documents on smoking
cessation and smoking cessation counseling.
3. Failing to equip telephones, internet or
other means of communication to serve the provision of indirect smoking
cessation counseling.
4. Failing to give a written notification before
providing smoking cessation or smoking cessation counseling services to the Department
of Health of province where such services are provided.
Article 29. Violations
against other regulations on prevention and control of tobacco harms
1. A warning or a fine ranging from VND 200.000
to VND 500.000 shall be imposed upon a person aged from 16 to under 18 for
tobacco use.
2. A fine ranging from VND 500.000 to VND
1.000.000 shall be imposed for commission of one of the following violations:
a) Encouraging or forcing others to use tobacco;
b) Requesting persons aged under 18 to buy tobacco
products.
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Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
a) Using tobacco images on newspapers or
publications for children;
b) Providing information without scientific
grounds or inaccurate information on tobacco and its harms;
c) Failing to include contents about prevention
and control of tobacco harms in annual operation plan or failing to include
workplace smoking bans in internal regulations;
d) Failing to impose restriction on tobacco use
in theatrical and cinematographic works as prescribed by law.
4. A fine ranging from VND 20.000.000 to VND
30.000.000 shall be imposed for commission of one of the following violations:
a) Using name, brand and symbols of tobacco
products on other products/services;
b) Performing direct marketing of tobacco
products to consumers in any forms;
c) Allowing the provision of direct-to-consumer
tobacco marketing at facilities under management;
d) Delaying payment of compulsory contributions
as prescribed by law;
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Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
e) Using funds provided by the Fund for
prevention and control of tobacco harms against regulations of law;
g) Disseminating information or notices of
sponsoring by tobacco traders.
5. A fine ranging from VND 30.000.000 to VND
40.000.000 shall be imposed for commission of one of the following violations:
a) Sponsoring in any form, unless permitted by
law;
b) Evading or cheating on payment of compulsory
contributions as prescribed by law.
6. Remedial measures:
a) The entity committing the violation in Point
a, b or d Clause 3 or Point a Clause 4 of this Article is compelled to recall
tobacco products and rectify or remove violating elements. If violating
elements cannot be rectified, tobacco products shall be destroyed.
b) The entity committing the violation in Point
d Clause 4 of this Article is compelled to pay interests on late payment of
compulsory contributions;
c) The entity committing the violation in Point
e Clause 4 of this Article is compelled to return any amounts of money used
against regulations of law;
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Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
Article 30. Violations
against regulations on consumption of alcoholic beverages and places where
alcoholic beverage consumption is not allowed
1. A warning or a fine ranging from VND 200.000
to VND 500.000 shall be imposed upon a person aged from 16 to under 18 for
consumption of alcoholic beverages.
2. A fine ranging from VND 500.000 to VND
1.000.000 shall be imposed for commission of one of the following violations:
a) Consuming alcoholic beverages at places where
the alcoholic beverage consumption is not allowed;
b) Inciting or persuading others to consume
alcoholic beverages.
3. A fine ranging from VND 1.000.000 to VND
3.000.000 shall be imposed for commission of one of the following violations:
a) Consuming alcoholic beverages before or
during working or learning hours or break times;
b) Forcing others to consume alcoholic
beverages.
Article 31. Violations
against regulations on sale and supply of alcoholic beverages
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Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
a) Selling or supplying alcoholic beverages to
persons aged under 18;
b) Failing to post a notice stating that “It’s
is illegal to sell alcoholic beverages to anyone under the age of 18” at a
prominent place in the establishment that sells alcoholic beverages.
2. A fine ranging from VND 5.000.000 to VND
10.000.000 shall be imposed for commission of one of the following violations:
a) Selling alcoholic beverages at places where
the sale of alcoholic beverage is not allowed;
b) Establishing a new on-premise establishment
within a radius of 100 m from the outer boundary of a health facility,
kindergarten, nursery school, pre-school or general education school.
3. A fine ranging from VND 10.000.000 to VND
20.000.000 shall be imposed for failing to satisfy one of the eligibility
requirements when selling alcoholic beverages through e-commerce.
4. Additional penalty:
The license to trade alcoholic beverages shall
be suspended for a fixed period of 01 – 03 months in case of commission of the
violation in Point b Clause 2 or Clause 3 of this Article.
Article 32. Violations
against regulations on sales promotion of alcoholic beverages
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Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
1. Offering discounts on alcoholic beverages to
persons aged under 18.
2. Running sales promotions of alcoholic
beverages having at least 15% ABV.
3. Using alcoholic beverages having at least 15%
ABV to run sales promotion in any form.
4. Failing to comply with regulations on sales
promotion when running sales promotions of alcoholic beverages having less than
15% ABV.
Article 33. Violations
against regulations on advertising of alcoholic beverages
1. A fine ranging from VND 15.000.000 to VND
20.000.000 shall be imposed for employing persons aged under 18 to directly
engage in advertising of alcoholic beverages.
2. A fine ranging from VND 20.000.000 to VND
30.000.000 shall be imposed for one of the following acts of advertising
spirits having less than 15% ABV and beer products:
a) An advertisement contains information/images
aimed at encouraging alcoholic beverage consumption, saying that alcoholic
beverages may enable the maturity, success, friendliness and sex appeal, or
being directed towards children, students, adolescents and pregnant women;
b) An advertisement uses objects, images,
symbols, music, movie characters and brands of products intended for children,
pupils and students, or uses images of persons aged under 18;
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Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
d) Alcoholic beverages are advertised on
vehicles;
dd) Alcoholic beverages are advertised on audio
or visual newspapers before, during or after a children’s program, or from
18:00 PM to 21:00 PM daily, unless permitted by law;
e) Alcoholic beverages are advertised through
outdoor advertising facilities that violate regulations on sizes and placement distance
from educational institutions, nursing care centers and recreational centers
intended for persons aged under 18;
g) An advertisement does not contain warnings
against harmful effects of alcoholic beverages as prescribed by law;
h) Failing to run a filtering system or access
control software to prevent persons aged under 18 from accessing and searching
for information about alcoholic beverages when running advertisements on online
newspapers, websites, electronic equipment, terminal devices and other
telecommunications equipment.
3. A fine ranging from VND 30.000.000 to VND
40.000.000 shall be imposed for one of the following acts of advertising
spirits having from 5.5 to less than 15% ABV and beer products having at least
5.5% ABV:
a) Advertisements are displayed in art
performance or sports programs;
b) Advertisements are placed on outdoor
advertising facilities, except for signboards of alcoholic beverage traders.
4. Additional penalty:
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Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
5. Remedial measure:
Advertisements shall be taken back and have
their violating elements removed in case of commission of one of the violations
in Clauses 1, 2 and 3 of this Article.
Article 34. Violations
against regulations on responsibilities of heads of agencies/organizations for
prevention and control of harmful effects of alcoholic beverages
1. A fine ranging from VND 3.000.000 to VND
5.000.000 shall be imposed for commission of one of the following violations:
a) Failing to organize the implementation of
measures for preventing and controlling harmful effects of alcoholic beverages;
b) Failing to organize the implementation of
regulations on prohibition on consumption of alcoholic beverages during working
hours and at workplaces;
c) Failing to warn or request persons who
consume or sell alcoholic beverages at places where the consumption or sale of
alcoholic beverages is not allowed under their management to stop their
violations;
d) Failing to organize, instruct, inspect and
expedite the implementation of regulations on prohibition on consumption and
sale of alcoholic beverages at places under their management.
2. A fine ranging from VND 5.000.000 to VND
10.000.000 shall be imposed upon a head of transport company or vehicle owner
for failing to implement measures for detecting and preventing vehicle
operators from consuming alcoholic beverages before and while driving.
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Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
1. A fine ranging from VND 3.000.000 to VND
5.000.000 shall be imposed for commission of one of the following violations:
a) Failing to provide adequate and accurate
information on their business at the request of competent authorities;
b) Failing to remind or post a sign warning
customers not to drive after drinking.
2. A fine ranging from VND 10.000.000 to VND
15.000.000 shall be imposed for commission of one of the following violations:
a) Employing persons aged under 18 to directly
engage in trading of alcoholic beverages.
b) Providing inaccurate information or
information without scientific grounds about alcoholic beverages.
3. Remedial measure:
The violating entity is compelled to remove
violating elements on alcoholic beverage products (if any) and correct
inaccurate information in case of commission of the violation in Point b Clause
2 of this Article.
Article 36. Violations
against regulations on dissemination of information and education about
prevention and control of harmful effects of alcohol beverages
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Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
2. A fine ranging from VND 3.000.000 to VND
5.000.000 shall be imposed for failing to ensure accuracy, objectivity and
rationality when disseminating and providing information and education about
prevention and control of harmful effects of alcoholic beverages.
3. A fine ranging from VND 10.000.000 to VND
15.000.000 shall be imposed for providing inaccurate or misleading information
on affects of alcoholic beverages on health.
4. Remedial measure:
The violating entity is compelled to rectify or
remove inaccurate information in case of commission of the violation in Clause
2 or 3 of this Article.
Article 37. Violations
against regulations on alcoholic beverage sponsorship
A fine ranging from VND 20.000.000 to VND
30.000.000 shall be imposed for providing alcoholic beverages as part of the
sponsorship.
Section 2. VIOLATIONS AGAINST
REGULATIONS ON MEDICAL EXAMINATION AND TREATMENT
Article 38. Violations
against regulations on practicing and use of practicing certificates by medical
practitioners
1. A warning or a fine ranging from VND 200.000
to VND 500.000 shall be imposed for commission of one of the following
violations:
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Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
b) Failing to wear personal protective equipment
as prescribed by law.
2. A fine ranging from VND 500.000 to VND
1.000.000 shall be imposed for commission of one of the following violations:
a) Failing to conclude an internship contract
with a new intern of the health facility or failing to use the prescribed form
of internship contract;
b) Failing to issue a decision to assign
practical instructor or failing to use the prescribed form of decision to
assign practical instructor;
c) Assigning a practical instructor to instruct
more than 05 interns at the same time.
3. A fine ranging from VND 1.000.000 to VND
3.000.000 shall be imposed for commission of one of the following violations:
a) Failing to report a competent person or
failing to introduce the patient to another health facility when refusing to
provide medical examination and treatment in case a disease is beyond the
capacity or practicing scope of the medical practitioner;
b) Requesting patients to pay costs of medical
services which are not publicly posted as prescribed by law;
c) Disclosing health status, information provided
by the patient and medical record, unless they are disclosed with the patient’s
consent or for sharing information/experience for improving quality of
diagnosis, healthcare and treatment of the patient between practitioners who
directly treat the patient or in other cases prescribed by law;
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Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
4. A fine ranging from VND 3.000.000 to VND
5.000.000 shall be imposed for commission of one of the following violations:
a) Registering for practicing at multiple health
facilities for the same period of time; working overtime exceeding the maximum
period of overtime work prescribed in the Labor Code; failing to comply with
the practicing period approved by a competent authority;
b) Failing to issue the certificate of
internship completion after the intern has successfully completed his/her
internship as prescribed by law;
c) Issuing a certificate of internship
completion that contains inaccurate or untruthful contents or that is not
suitable for qualifications of the intern;
d) Assigning unqualified practical instructors
to instruct interns.
5. A fine ranging from VND 5.000.000 to VND
10.000.000 shall be imposed for commission of one of the following violations:
a) Preventing patients who are eligible for
mandatory treatment from entering the health facility;
b) Requesting patients to use medical services
or suggesting them for other health facilities for personal interests;
c) Taking advantage of the job to offend honor
or dignity of, or bodily harm the patient;
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Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
dd) Prescribing in a language other than
Vietnamese which is not yet registered or of which the translator is
unqualified to translate it into Vietnamese;
e) Falsifying information on medical examination
and treatment by erasing or altering medical records;
g) Using superstitious forms when providing
medical examination and treatment;
h) Acting as the chief physician of two or more
health facilities;
i) Acting as the head of two or more clinical
departments of the same health facility or of multiple health facilities;
k) The chief physician of a health facility
concurrently acts as the head of a department of that health facility which is
not appropriate to the practicing scope specified in his/her practicing
certificate;
l) The chief physician of a health facility does
not authorize another during his/her absence from the health facility during
its operation period.
6. A fine ranging from VND 20.000.000 to VND
30.000.000 shall be imposed for commission of one of the following violations:
a) Selling drugs to patients in any forms,
except for the sale of traditional drugs as prescribed by law;
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
7. A fine ranging from VND 30.000.000 to VND
40.000.000 shall be imposed for commission of one of the following violations:
a) Providing medical examination and treatment
without obtaining a practicing certificate;
b) Providing medical examination and treatment
while the practicing certificate is suspended or revoked;
c) Providing medical examination and treatment
beyond the practicing scope specified in the practicing certificate, except
emergency cases and provision of additional medical procedures which have been
permitted as prescribed by law;
d) Using a rented or borrowed medical
examination and treatment practicing certificate;
dd) Renting or lending a medical examination and
treatment practicing certificate;
e) Failing to provide first aids, emergency
treatment or medical treatment to patients in a timely manner;
g) Refusing to provide medical examination and
treatment for patients, except cases of refusal prescribed by law.
8. Additional penalties:
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
b) The medical examination and treatment
practicing certificate shall be suspended for a fixed period of 03 – 06 months
in case of commission of the violation in Clause 6 of this Article;
c) The medical examination and treatment
practicing certificate shall be suspended for a fixed period of 06 – 09 months
in case of commission of the violation in Point e or g Clause 7 of this
Article;
d) The medical examination and treatment
practicing certificate shall be suspended for a fixed period of 22 – 24 months
in case of commission of the violation in Point b, c, d or dd Clause 7 of this
Article;
dd) Foreigners who re-commit the violation in
Clause 7 of this Article shall be deported.
9. Remedial measures:
a) The entity committing the violation in Point
c Clause 5 of this Article is compelled to make direct apologies to patients;
b) The violating entity is compelled to return
any benefits illegally obtained from the commission of the violation in Point b
Clause 6 or Point a, b, c, d or dd Clause 7 of this Article;
c) Enforced revocation of medical examination
and treatment practicing certificate in case of commission of the violation in
Point d or dd Clause 7 of this Article.
Article 39. Violations
against regulations on eligibility requirements and use of license for medical
operations
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
a) Failing to hang a signboard or hanging a
signboard which does not contain adequate primary information as prescribed by
law;
b) Failing to post or insufficiently posting
prices of medical services;
c) Using names of departments/wards of the
health facility other than those specified in the application for license for
medical operations which has been approved by a competent authority.
2. A fine ranging from VND 3.000.000 to VND
5.000.000 shall be imposed for commission of one of the following violations:
a) Failing to report the replacement of the
chief physician of the health facility to the licensing authority;
b) Failing to report replacement of
practitioners to competent authorities as prescribed by law;
c) Charging medical services at prices higher
than the ones posted;
d) Charging covered medical services at prices
higher than those reimbursed by the health insurance fund, except differences
due to use of services provided upon request or beyond the coverage scope of
health insurance fund;
dd) Failing to satisfy one of eligibility
requirements after obtaining the license for medical operations or send a written
notification of satisfaction of eligibility requirements to a competent
authority, except polyclinics and hospitals.
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
a) Deliberately providing mandatory treatment
for persons who are ineligible for mandatory disease treatment;
b) A polyclinic fails to satisfy one of
eligibility requirements after obtaining the license for medical operations.
4. A fine ranging from VND 20.000.000 to VND
30.000.000 shall be imposed for commission of one of the following violations:
a) Employing a practitioner who does not possess
any practicing certificate or whose practicing certificate has been revoked or
suspended;
b) Failing to comply with personnel arrangement
decisions issued by competent authorities in case of disasters or dangerous
epidemics;
c) A hospital with fewer than 100 beds fails to
satisfy one of eligibility requirements after obtaining the license for medical
operations.
5. A fine ranging from VND 30.000.000 to VND
40.000.000 shall be imposed for commission of one of the following violations:
a) Using a rented or borrowed license for
medical operations;
b) Renting or lending a license for medical
operations;
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
6. A fine ranging from VND 40.000.000 to VND
50.000.000 shall be imposed for commission of one of the following violations:
a) Providing medical services without obtaining
license for medical operations, or during the suspension period of the license
for medical operations, or at a location which is not specified in the license
for medical operations;
b) Providing medical services beyond the scope
of the license for medical operations, except emergency cases;
c) Applying new medical procedures without
obtaining permission from the Minister of Health or Director of the relevant
Provincial Department of Health;
d) A hospital with more than 500 beds fails to
satisfy one of eligibility requirements after obtaining the license for medical
operations;
dd) Providing cosmetological services before
sending written notification of satisfaction of eligibility requirements to
competent authorities as prescribed by law;
e) Providing inpatient treatment without
obtaining permission for inpatient treatment services, unless outpatients are
kept for health monitoring as prescribed by law.
7. Additional penalties:
a) The license for medical operations shall be
suspended for a fixed period of 02 – 04 months in case of commission of the
violation in Point dd Clause 2, Point b Clause 3, Point a or c Clause 4, Point
c Clause 5 or Point b, c, d or e Clause 6 of this Article;
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
c) Operations of the violating entity shall be
suspended for a fixed period of 12 – 24 months in case of commission of the
violation in Point a or dd Clause 6 of this Article;
d) The medical examination and treatment
practicing certificate shall be suspended for a fixed period of 01 – 03 months
in case of commission of the violation in Point a Clause 3 or Point c Clause 6
of this Article;
dd) The medical examination and treatment
practicing certificate of the chief physician of the health facility shall be
suspended for a fixed period of 01 – 03 months in case of commission of the
violation in Point a Clause 4 or Point b or e Clause 6 of this Article.
8. Remedial measures:
a) The entity committing the violation in Point
c or d Clause 2 of this Article is compelled to return any amounts of money
collected against regulations of law. Any payments which cannot be made to
payers shall be paid to state budget in accordance with regulations of law;
b) The violating entity is compelled to return
any benefits illegally obtained from the commission of the violation in Point a
or b Clause 5 of this Article;
c) Enforced revocation of the license for
medical operations in case of commission of the violation in Point a or b
Clause 5 of this Article.
Article 40. Violations
against regulations on technical and professional qualifications
1. A fine ranging from VND 1.000.000 to VND
3.000.000 shall be imposed for commission of one of the following violations:
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
b) Failing to issue or issuing an outpatient’s
medical examination book which does not contain clear and adequate personal
details of the patient, diagnosis, treatment indications, prescriptions and
follow-up examination;
c) Failing to retain medical records as prescribed
by law;
d) Failing to submit reports on medical
operations as prescribed by law.
2. A fine ranging from VND 3.000.000 to VND
5.000.000 shall be imposed for commission of one of the following violations:
a) Abandoning patients who do not have relatives;
b) Abandoning dead patients;
c) Failing to keep or organize watch at a health
facility as prescribed;
d) Failing to organize medical nutrition therapy
or failing to give diet indications for patients or failing to provide
nutrition counseling for patients as prescribed by law.
3. A fine ranging from VND 5.000.000 to VND
10.000.000 shall be imposed for commission of one of the following violations:
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
b) Failing to hold medical consultations about a
disease that does not respond well to treatment or becomes more severe.
4. A fine ranging from VND 10.000.000 to VND
15.000.000 shall be imposed for failing to transfer emergency patients to
appropriate health facilities when their medical conditions are beyond the
health facility’s capacity.
5. A fine ranging from VND 15.000.000 to VND
20.000.000 shall be imposed for commission of one of the following violations:
a) Performing surgeries, minor surgeries or
other surgical interventions of class III or higher without obtaining the
patient or his/her representative’s written consent, unless the patient’s life
will be threatened if the surgery or surgical intervention is not performed;
b) Failing to equip sufficient and appropriate
means of emergency transport; medical equipment/devices and essential medicines
to provide timely emergency treatment to patients.
6. A fine ranging from VND 20.000.000 to VND
30.000.000 shall be imposed for using drugs, substances or equipment for
interventions in human body (surgeries, minor surgeries, interventions
involving injection, pumping, ray emission, firing or other interventions) that
change the color of skin, shape, weight and shortcomings of body parts (skin,
nose, eyes, lips, face, belly, buttock and other parts) or providing services
of doing tattoos or spraying or embroidering pictures on the surface of the
skin with injection of anesthetics at a facility other than a hospital with
cosmetological specialty, specialized cosmetological clinic, or a health
facility with cosmetological specialty.
7. A fine ranging from VND 40.000.000 to VND
50.000.000 shall be imposed for committing a violation against regulations on
technical and professional qualifications in medical examination and treatment
that causes harms or injuries to patients.
8. Additional penalties:
a) The medical examination and treatment
practicing certificate shall be suspended for a fixed period of 01 – 03 months
in case of commission of the violation in Point a or b Clause 1, Point c Clause
2, Clause 3 or Clause 4 of this Article;
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
c) The license for medical operations shall be
suspended for a fixed period of 01 – 03 months in case of re-commission of one
of the violations in Clauses 1, 2, 3, 4 and Point a Clause 5 of this Article,
or commission of 03 or more of the said violations at the same time;
d) A part of operations (ward, department,
center, unit or division committing the violation) or the license for medical
operations of the violating entity (if the violation influences on all of its
operations) shall be suspended for a fixed period of 03 – 06 months in case of
commission of the violation in Point b Clause 5 or Clause 7 of this Article;
dd) Operations of the violating entity shall be
suspended for a fixed period of 03 – 06 months in case of commission of the
violation in Clause 6 of this Article.
9. Remedial measure:
The violating entity is compelled to pay entire
costs of medical services in case of commission of the violation in Clause 3 or
7 of this Article.
Article 41. Violations
against regulations on use of drugs by health facilities providing inpatient
treatment and for outpatients who are kept at health facilities for health
monitoring
1. A fine ranging from VND 1.000.000 to VND
2.000.000 shall be imposed for commission of one of the following violations:
a) Failing to clearly and adequately write names
of drugs, their quantity, content, dosage, administration route and period of
using drugs in prescriptions or medical records as prescribed by law;
b) Failing to check prescriptions, medication
request forms, content, dosage, administration route, names and quality of
drugs before dispensing drugs to patients;
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
d) Failing to check full names of patients,
names of drugs, dosage forms, content, dosage, administration route and times
to take drugs before administering drugs to patients;
dd) Failing to fully record times of dispensing
drugs to patients;
e) Failing to track and record clinical
happening of patients after taking drugs in medical records; failing to
punctually detect and report drug use-related complications to treating
physicians when dispensing drugs to patients.
2. A fine ranging from VND 5.000.000 to VND
10.000.000 shall be imposed for failing to monitor drug’s effectiveness and
punctually handle drug use-related complications in patients receiving direct
treatment from and using drugs as indicated by the physician.
3. A fine ranging from VND 10.000.000 to VND
20.000.000 shall be imposed for commission of one of the following violations:
a) Prescribing proprietary drugs which are
expensive and unnecessary for treatment for personal interests;
b) Writing out prescriptions which are not
conformable with medical diagnosis results and the severity of illness;
c) Writing out prescriptions for products for
which the prescription is not allowed;
d) Writing out prescriptions clinical guidelines
on diagnosis and treatment or clinical guidelines on HIV/AIDS treatment and
care promulgated or recognized by the Ministry of Health, clinical guidelines
on diagnosis and treatment formulated by the health facility, package inserts
accompanied with drugs licensed for sale or the National Pharmacopoeia of
Vietnam.
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
5. Additional penalty:
The medical examination and treatment practicing
certificate shall be suspended for a fixed period of 01 – 03 months in case of
commission of the violation in Point e Clause 1, Clause 2, Clause 3 or Clause 4
of this Article.
6. Remedial measure:
The violating entity is compelled to pay entire
costs of medical services in case of commission of the violation in Clause 2 of
this Article.
Article 42. Violations
against regulations on in-vitro fertilization (IVF)
1. A fine ranging from VND 3.000.000 to VND
5.000.000 shall be imposed for failing to submit reports on the provision of
IVF and surrogacy services to the Ministry of Health as prescribed by law.
2. A fine ranging from VND 5.000.000 to VND
10.000.000 shall be imposed for failing to perform medical examination and
testing of sperm and egg donors for infectious diseases, mental disorder or
another health condition that makes them lose their awareness or control of
their acts, and HIV infection.
3. A fine ranging from VND 10.000.000 to VND
20.000.000 shall be imposed for commission of one of the following violations:
a) Providing names, addresses or images of sperm
donors or sperm or embryo recipients;
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
c) Failing to destroy or donate unused donor
sperm or eggs to scientific research institutes in case of successful
childbirth;
d) Failing to encode donor sperm and eggs, or
failing to specify characteristics of donors, especially their race, of encoded
donor sperm and eggs;
dd) Storing sperm, eggs or embryos at a health
facility that is not allowed to perform IVF;
e) Failing to destroy sperm, eggs or embryos
when receiving a notice and a lawful copy of the death certificate of the
depositor from his/her family, unless the depositor’s spouse makes a written
request for continued storage and still pays storage and preservation charges;
g) Destroying sperm, eggs or embryos of a
depositor who has died while his/her spouse has submitted a written request for
continued storage and still pays storage and preservation charges;
h) Failing to destroy sperm or eggs at the
request of the depositor who gets divorced;
i) Failing to destroy embryos at the written
request of the couple after they gets divorced;
k) Destroying embryos of a depositor who gets
divorced but has submitted a written request for continued storage and still
pays storage and preservation charges;
l) Failing to adhere to the principle of
anonymity of gamete donors when donating and receiving sperm/embryos; failing
to encode information on depositors who donate their deposited sperm, eggs or
embryos to the storage facility for further use for others, unless they are
donated to scientific research purposes;
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
4. A fine ranging from VND 20.000.000 to VND
30.000.000 shall be imposed for commission of one of the following violations:
a) Donating sperm or eggs at two or more health
facilities qualified to perform IVF as certified by the Ministry of Health;
b) Failing to comply with technical procedures
or regulations on health standards of persons receiving IVF treatment, having
pregnancy and giving birth adopted by the Minister of Health;
c) Providing IVF treatment for a person who is
ineligible to receive sperm, egg or embryo as prescribed by law;
d) Using surplus embryos for perform IVF without
valid donation contracts;
dd) Using surplus embryos donated under a
donation contract for two or more other recipients, except unsuccessful
childbirth;
e) Failing to destroy or donate surplus embryos
to the health facility for scientific research purposes in case of successful
childbirth;
g) Using surplus embryos donated under donation
contracts without the approval of the head of the health facility.
5. A fine ranging from VND 30.000.000 to VND
40.000.000 shall be imposed for commission of one of the following violations:
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
b) Failing to satisfy one of eligibility
requirements after obtaining certification of eligibility to perform IFV.
6. Additional penalties:
a) The provision of IVF treatment shall be
suspended for a fixed period of 01 – 03 months in case of commission of 03 or
more of the violations in Clauses 1, 2, 3 and Points c, d, dd, e, g Clause 4 of
this Article;
b) The provision of IVF treatment shall be
suspended for a fixed period of 06 – 12 months in case of commission of the
violation in Point b Clause 4 or Clause 5 of this Article.
Article 43. Violations
against regulations on altruistic surrogacy
1. A fine ranging from VND 3.000.000 to VND
5.000.000 shall be imposed for commission of one of the following violations:
a) Providing health counseling for the intended
parents and surrogate by a person who is not a qualified obstetrician;
b) Failing to possess a bachelor’s degree in
psychology or higher when providing psychological counseling for the intended
parents and surrogate;
c) Failing to possess a bachelor of laws degree
or higher when providing legal counseling for the intended parents and
surrogate;
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
2. A fine ranging from VND 5.000.000 to VND
10.000.000 shall be imposed for commission of one of the following violations:
a) Failing to provide health, legal and
psychological counseling for the intended parents, except cases where such
counseling is not required as prescribed by law;
b) Failing to provide health, legal and
psychological counseling for the surrogate, except cases where such counseling
is not required as prescribed by law;
c) Failing to sign and specify full name,
position, working place and counseling date on the written certification of
counseling contents.
3. A fine ranging from VND 10.000.000 to VND
20.000.000 shall be imposed for providing name, age, address or images of the
intended parents, surrogate or the child born through altruistic surrogacy.
4. A fine ranging from VND 30.000.000 to VND
40.000.000 shall be imposed for commission of one of the following violations:
a) Performing altruistic surrogacy technique
without obtaining certification of eligibility to perform altruistic surrogacy
technique;
b) Failing to satisfy one of eligibility
requirements after obtaining certification of eligibility to perform altruistic
surrogacy technique.
5. Additional penalties:
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…
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
b) Operations involving the violation in Clause
4 of this Article shall be suspended for a fixed period of 06 – 12 months.
Article 44. Violations
against regulations on donation, removal and transplantation of human tissues
and organs, and body donation
1. A fine ranging from VND 1.000.000 to VND
2.000.000 shall be imposed for commission of one of the following violations:
a) Failing to provide direct counseling on
donation and removal of tissues and organs for the donor when receiving a
notice from Vietnam National Coordinating Center for Human Organ
Transplantation;
b) Failing to give instructions to complete the
donation registration form when receiving a notice from Vietnam National
Coordinating Center for Human Organ Transplantation;
c) Failing to perform health check for a living
donor before removing a tissue or organ from his/her body;
d) Failing to submit the list of registered
living donors to the Vietnam National Coordinating Center for Human Organ
Transplantation;
dd) Failing to provide health and social
psychological counseling for the living donor or failing to check biological
parameters of the living donor before removing a tissue or organ from his/her
body.
2. A fine ranging from VND 5.000.000 to VND
10.000.000 shall be imposed for charging post-donation healthcare and periodic
health check-ups provided for a living donor.
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
4. A fine ranging from VND 20.000.000 to VND
30.000.000 shall be imposed for running a tissue bank without possessing a
valid license.
5. A fine ranging from VND 30.000.000 to VND
40.000.000 shall be imposed for commission of one of the following violations:
a) Disclosing information or personal privacy of
the donor and recipient, unless agreed in writing by the persons concerned or
otherwise prescribed by law;
b) Removing a non-regenerable organ from a
living body without obtaining a written approval from the advisory council for
human organ transplantation of the health facility;
c) Storing human tissues and organs for
commercial purposes.
6. A fine ranging from VND 60.000.000 to VND
80.000.000 shall be imposed for commission of one of the following violations:
a) Removing, transplanting or using human
tissues and organs for commercial purposes, except trading or appropriation of
human tissues and organs;
b) Removing or transplanting human
tissues/organs at a facility that fails to meet eligibility requirements set by
law.
7. A fine ranging from VND 80.000.000 to VND
100.000.000 shall be imposed for commission of one of the following violations:
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
b) Removing human tissues/organs from living
donors aged under 18;
c) Transplanting human tissues/organs removed
from persons infected with diseases included in the list of diseases issued by
a competent authority.
8. Additional penalties:
a) The license to operate tissue bank shall be
suspended for a fixed period of 03 – 06 months in case of commission of the
violation in Clause 3 or Point c Clause 5 of this Article;
b) Partial operations of the health entity
involving the violation in Point c or dd Clause 1 or Point b Clause 5 of this
Article shall be suspended for a fixed period of 01 – 03 months;
c) The license for medical operations shall be
suspended for a fixed period of 03 – 06 months in case of commission of the
violation in Clause 6 or 7 of this Article.
9. Remedial measures:
a) The entity committing the violation in Clause
2 of this Article is compelled to return any amounts of money collected against
regulations of law. Any payments which cannot be made to payers shall be paid
to state budget in accordance with regulations of law;
b) The violating entity is compelled to pay
entire costs of medical services provided for damaged person in case of
commission of the violation in Clause 7 of this Article. The amounts of money
which cannot be returned to payers shall be paid to state budget in accordance
with regulations of law.
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
1. A fine ranging from VND 2.000.000 to VND
5.000.000 shall be imposed for commission of one of the following violations:
a) Disclosing information on sex reassignment of
others;
b) Discriminating against a person whose sex is
reassigned.
2. A fine ranging from VND 30.000.000 to VND
40.000.000 shall be imposed for performing sex reassignment without obtaining
permission from the Minister of Health or Director of the relevant Provincial
Department of Health.
3. Remedial measures:
a) The entity committing the violation in Point
b Clause 1 of this Article is compelled to make direct apologies to persons who
are discriminated against;
b) The violating entity is compelled to return
any benefits illegally obtained from the commission of the violation in Clause
2 of this Article.
Article 46. Violations
against regulations on health examination
1. A fine ranging from VND 3.000.000 to VND
5.000.000 shall be imposed for commission of one of the following violations:
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
b) Classifying health unconformable with the
health condition of the person undergoing heath check.
2. A fine ranging from VND 5.000.000 to VND
10.000.000 shall be imposed for failing to satisfy one of eligibility
requirements for health check facility.
3. A fine ranging from VND 10.000.000 to VND
20.000.000 shall be imposed for providing health check without announcing the
eligibility to provide health check service.
4. Additional penalties:
a) The provision of health check service shall
be suspended for a fixed period of 01 – 03 months in case of commission of the
violation in Clause 2 of this Article;
b) The license for medical operations shall be
suspended for a fixed period of 01 – 03 months in case of commission of the
violation in Clause 3 of this Article.
Article 47. Violations
against regulations on infection control in health facilities
1. A fine ranging from VND 500.000 to VND
1.000.000 shall be imposed for commission of one of the following violations:
a) Failing to provide counseling on infection
control measures for patients and their relatives;
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
2. A fine ranging from VND 5.000.000 to VND
10.000.000 shall be imposed for commission of one of the following violations:
a) Failing to implement or insufficiently
implementing infection control measures at the health facility;
b) Failing to ensure material facilities,
equipment, personal protective clothing and hygiene for persons working in the
health facility, patients and other persons entering the health facility in
conformity with infection control requirements in the health facility.
3. Additional penalties:
a) The medical examination and treatment
practicing certificate shall be suspended for a fixed period of 01 – 03 months
in case of commission of the violation in Point b Clause 1 of this Article;
b) The license for medical operations shall be
suspended for a fixed period of 01 – 03 months in case of commission of the
violation in Clause 2 of this Article.
Article 48. Violations
against principles of medical examination and treatment practicing
1. A warning or a fine ranging from VND 200.000
to VND 500.000 shall be imposed for commission of one of the following
violations:
a) Failing to respect or cooperate with
practitioners during the medical examination and treatment;
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Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
c) Failing to comply with the practitioner’s
indications for diagnosis and treatment, except prescribed cases of refusal to
receive treatment.
2. A fine ranging from VND 500.000 to VND
1.000.000 shall be imposed for commission of one of the following violations:
a) Failing to provide truthful information on
personal health condition or failing to cooperate with practitioners and health
facility;
b) Failing to comply with the health facility’s
internal regulations;
c) Failing to provide prioritized medical
examination and treatment for emergency patients, children aged under 06,
persons with severe disabilities, persons aged 80 or older, persons with
meritorious services to the revolution and pregnant women.
3. A fine ranging from VND 1.000.000 to VND
3.000.000 shall be imposed for commission of one of the following violations:
a) Harming honor or dignity of practitioners
during medical examination and treatment;
b) Failing to strictly comply with code of
conduct for health practitioners as prescribed by law;
c) Discriminating unfairly against patients.
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Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
a) Failing to pay costs of medical services,
except cases of exemption and reduction prescribed by law;
b) Failing to establish a specialized council to
evaluate whether the unintended complication is resulted from a medical error
in case of settlement of a medical dispute.
5. A fine ranging from VND 5.000.000 to VND 10.000.000
shall be imposed for failing to strictly comply with technical and professional
regulations in medical examination and treatment, except the violation
prescribed in another part of this Section.
6. A fine ranging from VND 30.000.000 to VND
40.000.000 shall be imposed for bodily harming or threatening the life of
practitioners while they are providing medical examination and treatment.
7. Additional penalties:
a) The medical examination and treatment
practicing certificate shall be suspended for a fixed period of 01 – 03 months
in case of commission of the violation in Clause 5 of this Article;
b) A part of operations (ward, department,
center, unit or division committing the violation) or the license for medical
operations of the violating entity (if the violation influences on all of its
operations) shall be suspended for a fixed period of 01 – 03 months in case of
commission of the violation in Clause 5 of this Article.
8. Remedial measures:
a) The entity committing the violation in Point
a Clause 1, Point a Clause 3 or Clause 6 of this Article is compelled to make
direct apologies to practitioners;
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
Article 49. Violations
against regulations on dissemination of information and education about infant
feeding, nutritious products for infants and breastfeeding benefits
1. A fine ranging from VND 1.000.000 to VND
3.000.000 shall be imposed for releasing documents providing information or
educating about use of nutritious products for infants without complying with
regulations on one of the following contents:
a) Guidelines for selection and use of
appropriate nutritious products for infants;
b) Guidelines for cleaning and sterilization of
infant feeding equipment;
c) Guidelines for cup feeding and spoon feeding;
d) Possible risks associated with the use of
pacifiers, bottle feeding or complementary feeding for infant under 06 months
of age;
dd) Possible risks of infection and
contamination from bottle feeding and incorrect preparation and feeding of
infant formulas;
e) Potential costs associated with formula
feeding.
2. A fine ranging from VND 3.000.000 to VND
5.000.000 shall be imposed for releasing documents providing information or
educating about infant feeding without complying with regulations on one of the
following contents:
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
b) Instructions on exclusive breastfeeding for
06 months and then continued breastfeeding for 24 months or as long as mother
and baby desire, and appropriate complementary feeding from 07 months;
c) Disadvantages of formula feeding, including:
The infant formula does not have immunity factors as those in breast milk,
formula feeding takes time and money, incorrect preparation may pose a
potential risk of infection to infants, and other disadvantages as prescribed
by law;
d) Negative effects of bottle feeding, use of
pacifiers or complementary feeding for infant under 06 months of age;
dd) Instructions on preparation, storage,
selection and use of complementary foods at home through simple ways to ensure
safety and rational nutrition with available foods;
e) Instructions on diet for breastfeeding
mothers.
3. A fine ranging from VND 5.000.000 to VND
10.000.000 shall be imposed for releasing documents providing information or
educating about infant feeding but containing one of the following contents:
a) Images, words or other communication forms to
encourage the formula feeding or bottle feeding or discourage the
breastfeeding;
b) Comparisons leading to the conclusion that
the infant formula is as good as or better than breast milk;
c) Names or logos of infant formulas, feeding
bottles or pacifiers.
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
5. Remedial measure:
Communication documents shall be recollected in
case of commission of the violation in Clause 1, 2 or 3 of this Article.
Article 50. Violations
against regulations on advertising for nutritious products for infants
1. A fine ranging from VND 20.000.000 to VND
30.000.000 shall be imposed for failing to meet the following requirements when
advertising for complementary foods for infants under 24 months of age:
a) The first part of an advertisement must
contain the phrase “Sữa mẹ là thức ăn tốt nhất cho sức khỏe và sự phát triển
toàn diện của trẻ nhỏ” “Breast milk is the best food for health and
complete growth of infants”;
b) The advertisement must contain the phrase “Sản
phẩm này là thức ăn bổ sung và được ăn thêm cùng với sữa mẹ dùng cho trẻ trên
06 tháng tuổi” (“This product is a complementary food and is combined with
breast milk fed to infants after 06 months of age”).
2. A fine ranging from VND 40.000.000 to VND 50.000.000
shall be imposed for using foetus or infant images in advertisements for milk
products for pregnant women.
3. Remedial measure:
Violating elements must be removed in case of
commission of the violation in Clause 1 or Clause 2 of this Article.
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
1. A fine ranging from VND 1.000.000 to VND
3.000.000 shall be imposed for commission of one of the following violations:
a) Giving instructions on formula feeding for
infants under 06 months of age, except cases prescribed by doctors;
b) Informing pregnant women, nursing mothers or
their family members that formula feeding is as good as or better than
breastfeeding.
2. A fine ranging from VND 3.000.000 to VND 5.000.000
shall be imposed for commission of one of the following violations:
a) Failing to provide accurate and scientific
information on and correct usage of nutritious products for infants to
physicians, healthcare workers and consumers;
b) Sending employees to directly or indirectly
contact nursing mothers, pregnant women or their family members in or outside
health facilities for advertising or encouraging the use of infant formulas;
c) Failing to disseminate information on and
provide counseling on breastfeeding to pregnant women, nursing mothers, and
their family members at antenatal care rooms, labor and delivery rooms,
postpartum rooms, nutrition counseling rooms or at noticeable places where
there are lots of pregnant women, nursing mothers, and their family members;
d) Receiving infant formulas, material benefits
or utensils bearing names or logos of infant formulas which are given by infant
formula producers or traders;
dd) Allowing infant formula producers or traders
to give sample products or gifts related to their infant formulas;
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
3. A fine ranging from VND 5.000.000 to VND
10.000.000 shall be imposed for commission of one of the following violations:
a) Selling or allowing the sale of infant
formulas at health facilities, except hospital drugstores;
b) Granting scholarships or providing funds for
scientific research, training courses, conferences, seminars, music concerts,
contests, stage performances, making of films or video clips, telephone
counseling services or other forms in order to disseminate or introduce infant
formulas, or promote the sale or use of infant formulas;
c) Allowing infant formula producers or traders
to display or post up utensils or equipment bearing names or logos of their
formula products, feeding bottles and pacifiers at health facilities;
d) Allowing employees of infant formula
producers or traders to contact nursing mothers and pregnant women in any form.
4. A fine ranging from VND 10.000.000 to VND
20.000.000 shall be imposed for commission of one of the following violations:
a) Organizing display of infant formulas and/or
complementary foods for infants under 06 months of age at health facilities;
displaying names or logos of infant formulas on banners, posters and other
advertising leaflets in supermarkets, retail stores and health facilities;
b) Applying sales promotion methods for infant
formulas such as giving free samples, coupons, rewards, gifts, point
accumulation for rewards, discount or any other forms;
c) Providing or supporting the provision of
information and education about infant feeding so as to disseminate on,
introduce or promote the sale or use of infant formulas.
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
Article 52. Violations
against regulations on pharmacy practicing
1. A fine ranging from VND 3.000.000 to VND
5.000.000 shall be imposed for commission of one of the following violations:
a) The chief pharmacist of a drug retailer is
absent throughout its operation, except for authorization cases prescribed by
law;
b) Failing to comply with decisions issued by
competent authorities in case of disasters or dangerous epidemics;
c) Failing to complete the training program and
refresher program in pharmacy within 03 years from the issuance date of the
pharmacy practicing certificate or the issuance date of the latest certificate
of completion of training program and refresher program in pharmacy;
d) Replacing drugs in a prescription with other
drugs that have the same active ingredients, usage, and dose without the
buyer’s consent.
2. A fine ranging from VND 5.000.000 to VND
10.000.000 shall be imposed for commission of one of the following violations:
a) Forging one of required documents in the
application for the pharmacy practicing certificate;
b) Practicing pharmacy without obtaining the
pharmacy practicing certificate or while the pharmacy practicing certificate at
the job position requiring the pharmacy practicing certificate has been
suspended;
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
d) Practicing pharmacy beyond the scope written
on the pharmacy practicing certificate and technical and professional
regulations;
dd) The institution providing training and
refresher programs in pharmacy fails to meet eligibility requirements set by
law;
e) The organization that administers the
examination for the pharmacy practicing certificate fails to meet eligibility
requirements set by law;
g) Renting, lending or allowing others to use
the pharmacy practicing certificate.
3. A fine ranging from VND 10.000.000 to VND
20.000.000 shall be imposed for using a rented or borrowed pharmacy practicing
certificate.
4. Additional penalties:
a) The pharmacy practicing certificate shall be
suspended for a fixed period of 01 – 03 months in case of commission of the
violation in Point c or d Clause 2 of this Article;
b) The pharmacy practicing certificate and
certificate of eligibility for pharmacy business shall be suspended for a fixed
period of 06 – 09 months in case of commission of the violation in Point b
Clause 1 of this Article.
5. Remedial measures:
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Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
b) Enforced revocation of pharmacy practicing
certificate in case of commission of the violation in Point b or c Clause 1,
Point a or g Clause 2, or Clause 3 of this Article.
Article 53. Violations
against regulations on pharmacy business establishments and eligibility
requirements to run pharmacy business
1. A fine ranging from VND 1.000.000 to VND
3.000.000 shall be imposed for commission of one of the following violations:
a) A mobile drug retailer fails to meet
eligibility requirements set by law;
b) A mobile drug retailer fails to send a
written notification to the Department of Health of the province where the
mobile retailer will operate.
2. A fine ranging from VND 3.000.000 to VND
5.000.000 shall be imposed upon a business establishment that has a drug
cabinet for failing to meet one of eligibility requirements set by law;
3. A fine ranging from VND 10.000.000 to VND
15.000.000 shall be imposed for forging any of the required documents in the
application for listing of business establishment that has a drug cabinet.
4. A fine ranging from VND 15.000.000 to VND
20.000.000 shall be imposed for failing to adopt isolation measures or put the
following drugs/pharmaceutical starting materials at quarantine areas, except
the case prescribed in Point dd Clause 4 Article 59 hereof:
a) Substandard drugs or pharmaceutical starting
materials;
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Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
c) Expired drugs or pharmaceutical starting
materials;
d) Drugs or pharmaceutical starting materials of
unknown origin.
5. Additional penalties:
a) Business operations involving the violation
in Point a Clause 1 or Clause 2 of this Article shall be suspended for a fixed
period of 01 – 03 months;
b) Business operations involving the violation
in Clause 3 of this Article shall be suspended for a fixed period of 06 – 12
months.
6. Remedial measure:
All drugs and pharmaceutical starting materials
involving the violation in Clause 4 of this Article shall be destroyed, except
those in Point a and b Clause 4 of this Article which are allowed by competent
authorities to be re-exported or remedied as prescribed by law.
Article 54. Violations
against regulations on certificate of eligibility for pharmacy business
1. A fine ranging from VND 20.000.000 to VND 30.000.000
shall be imposed for commission of one of the following violations:
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
b) Using rented or borrowed certificate of
eligibility for pharmacy business, or renting, lending or allowing others to
use certificate of eligibility for pharmacy business.
2. Additional penalty:
b) The certificate of eligibility for pharmacy
business shall be suspended for a fixed period of 24 months in case of
commission of the violation in Clause 1 of this Article.
3. Remedial measures:
a) The violating entity is compelled to return
any benefits illegally obtained from the commission of the violation in Point b
Clause 1 of this Article;
b) Enforced revocation of certificate of
eligibility for pharmacy business in case of commission of the violation in
Clause 1 of this Article.
Article 55. Violations against
regulations on rights and responsibilities of pharmacy business establishments
1. A fine ranging from VND 1.000.000 to VND
3.000.000 shall be imposed for commission of one of the following violations:
a) Failing to report to the Ministry of Health
or Provincial Department of Health or failing to fulfill the obligations in
case of suspension of pharmacy business for 06 months or longer or shutdown;
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
c) Failing to submit periodic reports or ad hoc
reports at the request of competent pharmacy authorities;
d) Failing to post wholesale and retail prices
in Vietnamese dong, or posting them in an insufficient, improper and ambiguous
manner that misleads customers at places where drugs are sold.
2. A fine ranging from VND 5.000.000 to VND
10.000.000 shall be imposed for commission of one of the following violations:
a) Failing to openly post pharmacy practicing
certificates in cases where the pharmacy practicing certificate is required or
the certificate of eligibility for pharmacy business in the premises;
b) Failing to pay compensation for entities that
suffer damage caused by the drug/pharmaceutical starting material retailer as
prescribed by law.
3. A fine ranging from VND 10.000.000 to VND
20.000.000 shall be imposed for failing to pay compensation for entities that
suffer damage caused by the establishment as prescribed by law, except the case
prescribed in Point b Clause 2 of this Article.
4. The fine shall be 1.5 times or twice as much
as the fine imposed for the violation in Point c Clause 1 of this Article but
not exceed VND 100.000.000 if the violation involves drugs or active ingredients
on the List of banned substances in some fields and sectors, combined drugs
that contain narcotic substances, psychotropic ingredients or precursors or
radiopharmaceuticals, or involves narcotic drugs, psychotropic drugs, precursor
drugs, pharmaceutical starting materials that are narcotic substances or
psychotropic ingredients or drug precursors respectively.
5. Additional penalty:
Business operations involving the violation in
Point a Clause 1 of this Article shall be suspended for a fixed period of 01 –
03 months.
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
1. A fine ranging from VND 10.000.000 to VND
20.000.000 shall be imposed for commission of one of the following violations:
a) Failing to report or provide information on
registration of drugs in Vietnam according to regulations on obligations of
applicants for drug registration and of drug manufacturers or at the request of
competent authorities, unless a written representation is provided and accepted
by competent authorities;
b) Failing to follow procedures for adjustment
of certificate of registration before the sale of drugs/pharmaceutical starting
materials in case of minor variations only requiring notification;
c) Failing to notify competent authorities of
suspension of manufacture or supply of drugs or of the scarcity or threat of
scarcity of drugs or pharmaceutical starting materials.
2. A fine ranging from VND 20.000.000 to VND
30.000.000 shall be imposed for commission of one of the following violations:
a) Failing to retain documents related to the
drug/medicinal ingredient registration or failing to provide information on the
registered drug when there is information or evidence about the safety and
efficacy of the drug during the effective period of its marketing authorization
to competent authorities at their request;
b) Failing to publish information about the
recalled drug or failing to organize the recall and receive the recalled drug
as prescribed by law;
c) Failing to update standards on quality of
drugs/pharmaceutical starting materials as prescribed by law.
3. A fine ranging from VND 30.000.000 to VND
50.000.000 shall be imposed for committing one of the following violations:
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
b) Failing to implement the approved risk
management plan included in the application for issuance or renewal of
certificate of registration of vaccine;
c) Failing to follow procedures for adjustment
of certificate of registration before the sale of drugs/pharmaceutical starting
materials in case of major/minor variations requiring approval;
d) Manufacturing or selling drug/pharmaceutical
starting material in case there are changes compared to the approved
application for registration which require following procedures for issuance of
certificate of registration .
4. A fine ranging from VND 50.000.000 to VND
70.000.000 shall be imposed for commission of one of the following violations:
a) Failing to notify competent authorities of
the case where the drug/pharmaceutical starting material granted certificate of
registration in Vietnam is recalled in any country other than the manufacturing
country or reference country issuing the Certificate of Pharmaceutical Product
(CPP) included in the application for registration;
b) Failing to notify competent authorities of
the case where the drug/pharmaceutical starting material granted certificate of
registration in Vietnam is recalled in the manufacturing country or reference
country issuing the Certificate of Pharmaceutical Product (CPP) included in the
application for registration;
c) The application for registration of
drug/pharmaceutical starting material includes documents or information that
are/is not based on research findings or manufacturer’s actual production, or
fraudulent documents according to the conclusion given a competent authority.
5. Remedial measures:
a) Enforced recall of drug/pharmaceutical
starting material in case of commission of the violation in Point c Clause 4 of
this Article;
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
Article 57. Violations
against regulations on manufacturing of drugs and pharmaceutical starting
materials
1. A fine ranging from VND 5.000.000 to VND
10.000.000 shall be imposed for commission of one of the following violations:
a) A vaccine manufacturer fails to report before
making changes or repairing the manufacturing premises as prescribed by law;
b) Failing to cooperate or obstructing quality
inspection agency in taking samples of drugs or pharmaceutical starting materials
to serve quality inspection tasks;
c) Failing to submit report on recall of
drug/pharmaceutical starting material as prescribed by law.
2. A fine ranging from VND 10.000.000 to VND
20.000.000 shall be imposed for commission of one of the following violations:
a) Failing to send a notification to competent
authorities when manufacturing drug/pharmaceutical starting material in case
there are minor variations compared to the approved application for
registration which requires notification;
b) Failing to obtain an approval from a
competent authority when manufacturing drug/pharmaceutical starting material in
case there are minor variations compared to the approved application for
registration which requires an approval from a competent authority;
c) Failing to retain samples of
drug/pharmaceutical starting material when performing drug/pharmaceutical
starting material testing as prescribed by law;
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
3. A fine ranging from VND 20.000.000 to VND
30.000.000 shall be imposed for commission of one of the following violations:
a) Failing to comply with the
drug/pharmaceutical starting material manufacturing or testing process included
in the approved application for registration;
b) Manufacturing drug in violation of quality
regulations at level 3;
c) Failing to perform testing for pharmaceutical
starting materials and primary packages before they are used in the manufacturing
of drugs;
d) Failing to have drugs tested by a testing
laboratory designated by a competent authority before the sale of drugs which
must be tested as prescribed by law;
dd) Failing to obtain an approval when
manufacturing drug/pharmaceutical starting material in case there are major
variations compared to the approved application for registration;
e) Manufacturing the drug while the certificate
of registration has been expired, unless permitted by law;
g) Using pharmaceutical starting material/herbal
ingredient which is not granted certificate of registration, is not included in
the announced list of pharmaceutical starting materials, or of which quality
standards are not yet announced as prescribed by law.
4. A fine ranging from VND 30.000.000 to VND
40.000.000 shall be imposed for commission of one of the following violations:
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
b) Manufacturing drug in violation of quality
regulations at level 2;
c) Manufacturing drugs with using substandard
primary packages;
d) Manufacturing the pharmaceutical starting
material which fails to meet quality standards;
dd) Making changes in the main/important
manufacturing equipment that may significantly affect the manufacturing process
or quality of drug/pharmaceutical starting material without following
procedures for issuance of certificate of eligibility for pharmacy business or
reporting such changes as prescribed by law;
e) Making changes in auxiliary system or
principles of design or operation of utility systems that may affect the
manufacturing environment without following procedures for issuance of
certificate of eligibility for pharmacy business or reporting such changes as
prescribed by law;
g) Failing to submit reports on GMP (Good
manufacturing practices) compliance as prescribed by law;
h) Failing to perform testing of
drug/pharmaceutical starting material before release as prescribed by law.
5. A fine ranging from VND 40.000.000 to VND
60.000.000 shall be imposed for commission of one of the following violations:
a) Manufacturing drug in violation of quality
regulations at level 1;
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
c) Failing to reporting changes in case of
expansion of the existing factory or major repairs or changes in structure or
floor plan of the premises or production line;
d) Forging or altering any documents, papers or
certifications issued by competent authorities and other entities during the
manufacturing of drug/pharmaceutical starting material;
dd) Manufacturing drug/pharmaceutical starting
material beyond the scope specified in the certificate of eligibility for
pharmacy business or scope of inspection of GMP compliance;
e) Only maintaining the GMP compliance at level
4.
6. A fine ranging from VND 60.000.000 to VND
80.000.000 shall be imposed for commission of one of the following violations:
a) Manufacturing and selling drug/pharmaceutical
starting material that is not granted certificate of registration in Vietnam,
except drugs/pharmaceutical starting materials which are not required to be
registered as prescribed by law;
b) Manufacturing drugs using pharmaceutical
starting materials which are substandard, subject to a recall notice given by a
competent authority, of unknown origin, or have been expired;
c) Manufacturing drug/pharmaceutical starting
material at a location other than the one specified in the approved application
for registration, except the violation in Point b Clause 5 of this Article;
d) Manufacturing drug/pharmaceutical starting
material at an establishment that is not issued with the certificate of
eligibility for pharmacy business or does not pass the inspection of GMP
compliance as prescribed by law;
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
e) Manufacturing products which are not drugs on
the production line, except the manufacturing of health supplements on the
herbal or traditional drug production line or other cases prescribed by the
Minister of Health;
g) Manufacturing, processing or preparing a
traditional drug containing an active ingredient which is not licensed by a
competent authority as prescribed by law.
7. The fine shall be 1.5 times or twice as much
as the fine imposed for the violation in Point dd Clause 5 or Point c, d or dd
Clause 6 of this Article but not exceed VND 100.000.000 if the violation
involves drugs or active ingredients on the List of banned substances in some
fields and sectors, combined drugs that contain narcotic substances,
psychotropic ingredients or precursors or radiopharmaceuticals, or involves
narcotic drugs, psychotropic drugs, precursor drugs, medicinal ingredients that
are narcotic substances or psychotropic ingredients or drug precursors
respectively.
8. Additional penalties:
a) Business operations involving the violation
in Point c Clause 3 or Point h Clause 4 of this Article shall be suspended for
a fixed period of 01 – 03 months;
b) The production line involving the violation
in Point dd or e Clause 4 or Point a or c Clause 5 of this Article shall be
suspended for a fixed period of 01 – 03 months;
c) Business operations involving the violation
in Point b or dd Clause 5 or Point a or c Clause 6 of this Article shall be
suspended for a fixed period of 03 – 06 months;
d) Operations shall be suspended until the
violating entity submits required reports to the Ministry of Health but for a
period not exceeding 24 months in case of commission of the violation in Point
g Clause 4 of this Article;
dd) The certificate of eligibility for pharmacy
business shall be suspended for a fixed period of 09 – 12 months in case of
commission of the violation in Point e or g Clause 6 of this Article;
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
g) Operations of the pharmacy business
establishment directly involving the violation in Point e Clause 5 of this
Article shall be suspended for a fixed period of 03 – 06 months.
9. Remedial measures:
a) All drugs/pharmaceutical starting materials
shall be destroyed in case of commission of the violation in Point c Clause 3,
Point b or c Clause 4, Point a or d Clause 5, Clause 6 or Clause 7 of this
Article;
b) Enforced revocation of certificate of
eligibility for business pharmacy in case of commission of the violation in
Point e Clause 5 of this Article; upon the end of the suspension period, if the
violating entity fails to rectify deficiencies, its operations shall be
suspended until it successfully completes rectification of such deficiencies;
c) Enforced revocation of certificate of eligibility
for pharmacy business in case of commission of the violation in Point d Clause
5 or Point e or g Clause 6 of this Article.
Article 58. Violations
against regulations on wholesaling of drugs and pharmaceutical starting
materials
1. A fine ranging from VND 5.000.000 to VND
10.000.000 shall be imposed for commission of one of the following violations:
a) Expanding the existing warehouse or repairing
or having significant changes in structure or floor plan of the warehouse of a
drug/pharmaceutical starting material wholesaler without submitting a report on
such changes, accompanied by relevant technical documents;
b) Failing to cooperate or obstructing the
quality inspection agency in taking samples of drugs or pharmaceutical starting
materials to serve quality inspection tasks;
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
d) Trading drug in violation of quality
regulations at level 3;
dd) Trading drugs that belong to a national
target program, drugs as emergency aid and other drugs banned from selling;
e) Failing to retain all documents about each
batch/shipment of drugs/ pharmaceutical starting materials for a period
prescribed by law.
2. A fine ranging from VND 10.000.000 to VND
20.000.000 shall be imposed for commission of one of the following violations:
a) Trading drugs/pharmaceutical starting
materials as samples for registration, testing, scientific research, or display
at a fair or exhibition;
b) Selling or buying drugs, pharmaceutical
starting materials, vaccines or biologicals to or from an establishment beyond
its business scope specified in the certificate of eligibility for pharmacy
business;
c) Trading drug in violation of quality
regulations at level 2;
d) Failing to recall drugs/pharmaceutical
starting materials at the request of a competent authority.
3. A fine ranging from VND 20.000.000 to VND
30.000.000 shall be imposed for commission of one of the following violations:
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
b) Failing to submit reports on GDP (Good distribution
practices) compliance as prescribed by law;
c) Failing to have equipment and computers
connected to the Internet and use software to manage distribution activities;
d) Failing to adopt mechanism for transmission
of information on distribution and quality of drugs between a manufacturer and
its clients, and transmission of information to relevant regulatory authorities
at their request;
dd) Only maintaining the GDP compliance at level
3.
4. A fine ranging from VND 30.000.000 to VND
40.000.000 shall be imposed for commission of one of the following violations:
a) Trading drug in violation of quality
regulations at level 1;
b) Failing to meet quality standards as
prescribed by competent authorities when trading in herbal ingredients which
have been preliminarily processed;
c) Storing drugs/pharmaceutical starting
materials against the conditions written on the labels;
d) Changing the location of the existing
warehouse or opening a new warehouse at the same business location of the
drug/pharmaceutical starting material wholesaler without submitting a report on
such changes, accompanied by relevant technical documents as prescribed by law;
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
5. A fine ranging from VND 40.000.000 to VND
60.000.000 shall be imposed for buying or selling drugs/pharmaceutical starting
materials:
a) without a valid certificate of eligibility
for pharmacy business;
b) at a location other than the one specified in
the issued certificate of eligibility for pharmacy business; or
c) while business operation or the certificate
of eligibility for pharmacy business is suspended.
6. The following fines shall be imposed for
buying or selling drugs/pharmaceutical starting materials which are subject to
recall decisions issued by competent authorities, which have been expired, or
which are not issued with the import license or certificate of registration,
except drugs/pharmaceutical starting materials which are not required to be
registered as prescribed by law:
a) A fine ranging from VND 5.000.000 to VND
7.000.000 shall be imposed for the violation involving goods worth less than
VND 5.000.000;
b) A fine ranging from VND 7.000.000 to VND
10.000.000 shall be imposed for the violation involving goods worth from VND
5.000.000 to under VND 10.000.000;
c) A fine ranging from VND 10.000.000 to VND
20.000.000 shall be imposed for the violation involving goods worth from VND
10.000.000 to under VND 20.000.000;
d) A fine ranging from VND 20.000.000 to VND
30.000.000 shall be imposed for the violation involving goods worth from VND
20.000.000 to under VND 30.000.000;
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
e) A fine ranging from VND 40.000.000 to VND
50.000.000 shall be imposed for the violation involving goods worth from VND
40.000.000 to under VND 50.000.000;
g) A fine ranging from VND 50.000.000 to VND
60.000.000 shall be imposed for the violation involving goods worth from VND
50.000.000 to under VND 60.000.000;
h) A fine ranging from VND 60.000.000 to VND
70.000.000 shall be imposed for the violation involving goods worth from VND
60.000.000 to under VND 70.000.000;
i) A fine ranging from VND 70.000.000 to VND
80.000.000 shall be imposed for the violation involving goods worth from VND
70.000.000 to under VND 80.000.000;
k) A fine ranging from VND 80.000.000 to VND
90.000.000 shall be imposed for the violation involving goods worth from VND
80.000.000 to under VND 100.000.000;
l) A fine ranging from VND 90.000.000 to VND
100.000.000 shall be imposed for the violation involving goods worth VND
100.000.000 or more.
7. The fine shall be 1.5 times or twice as much
as the fine imposed for the violation in Point e Clause 1, Point a or b Clause
2, Point a Clause 3, Point d Clause 4, Clause 5 or Clause 6 of this Article but
not exceed VND 100.000.000 if the violation involves active ingredients or
drugs banned in some fields and sectors, combined drugs that contain narcotic
substances, psychotropic ingredients or precursors or radiopharmaceuticals, or
involves narcotic drugs, psychotropic drugs, precursor drugs, pharmaceutical
starting materials that are narcotic substances or psychotropic ingredients or
drug precursors respectively.
8. Additional penalties:
a) The certificate of eligibility for pharmacy
business shall be suspended for a fixed period of 01 – 02 months in case of
re-commission of the violation in Point c or d Clause 3 of this Article;
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
c) Operations of the violating entity shall be
suspended for a fixed period of 06 – 09 months in case of commission of the
violation in Point dd Clause 3, Point a or c Clause 5 or Clause 6 of this
Article;
d) Operations shall be suspended until the
violating entity submits required reports to the Ministry of Health but for a
period not exceeding 24 months in case of commission of the violation in Point
b Clause 3 of this Article.
9. Remedial measure:
All drugs/pharmaceutical starting materials
shall be destroyed in case of commission of the violation in Point a or b
Clause 5 or Clause 6 of this Article.
Article 59. Violations
against regulations on retailing of drugs and herbal ingredients
1. A fine ranging from VND 1.000.000 VND
3.000.000 shall be imposed for commission of one of the following violations:
a) Failing to meet quality standards as
prescribed by competent authorities when selling herbal ingredients which have
been preliminarily processed;
b) A pharmacist who directly engages in the drug
retailing fails to possess a professional qualifications as prescribed by law;
c) Failing to use records or computers for managing
the warehousing, dispatching, inventory, batch number, expiry date, origin of
drugs and other relevant information as prescribed by law;
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
dd) Failing to specify the drug name, content
and expiry date when retailing drugs without secondary packages; failing to
specify the dose and usage when selling drugs without a prescription;
e) Failing to retain all documents about each
batch/shipment of drugs/ pharmaceutical starting materials for a period
prescribed by law;
g) Failing to cooperate or obstructing the
quality inspection agency in taking samples of drugs or pharmaceutical starting
materials to serve quality inspection tasks.
2. A fine ranging from VND 3.000.000 to VND
5.000.000 shall be imposed for commission of one of the following violations:
a) Relocating the drug retailer’s premises at
the same business location or expanding the premises or making major repairs or
changes in structure of the premises without submitting a report on such
changes, accompanied by relevant technical documents as prescribed by law;
b) Failing to provide a separate area for
displaying products other than drugs or failing to put a notice indicating that
“sản phẩm này không phải là thuốc” (“This is not a drug”) at the
separate area for cosmetics, functional foods and medical devices as prescribed
by law;
c) Trading drug in violation of quality
regulations at level 2.
3. A fine ranging from VND 5.000.000 to VND
10.000.000 shall be imposed for commission of one of the following violations:
a) Failing to recall drugs/herbal ingredients at
the request of a competent authority;
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
c) Failing to have a storage facility which has
been registered by the drug retailer, or storing drugs against the storage
conditions specified in the drug labels or against GPP (Good pharmacy
practices) requirements;
d) Storing or retailing drugs beyond the
business scope specified in the certificate of eligibility for pharmacy
business, drugs that belong to a national target program, drugs as emergency
aid and other drugs banned from selling;
dd) Selling vaccines or selling prescription
drugs without a prescription presented;
e) Failing to submit reports on GPP compliance
as prescribed by law;
g) Failing to have appropriate IT equipment,
apply IT, make network connection or control origin, prices and sources of
drugs bought and sold as prescribed by law, except herbal ingredient retailers;
h) Failing to transmit information about the
drug purchase and sale, and drug quality between suppliers and customers;
failing to transmit information to relevant regulatory authorities at their
request, except herbal ingredient retailers;
i) Only maintaining GPP compliance at level 3.
4. A fine ranging from VND 10.000.000 to VND
20.000.000 shall be imposed for commission of one of the following violations:
a) Buying or selling drugs for clinical trial;
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
c) Buying or selling modern drugs prepared
according to prescriptions from other drugstores;
d) Buying or selling drugs on the list of drugs
restricted from retailing without obtaining permission as prescribed by law;
dd) Failing to adopt isolation measures or put
the following drugs/herbal ingredients at quarantine areas: substandard
drugs/herbal ingredients; drugs/herbal ingredients subject to a recall
notification of a competent authority; expired drugs/herbal ingredients;
drugs/herbal ingredients of unknown origin;
e) Trading drug in violation of quality regulations
at level 1.
5. A fine ranging from VND 20.000.000 to VND
30.000.000 shall be imposed for buying or selling drugs/herbal ingredients:
a) without a valid certificate of eligibility
for pharmacy business;
b) at a location other than the one specified in
the issued certificate of eligibility for pharmacy business; or
c) while business operation or the certificate
of eligibility for pharmacy business is suspended.
6. The following fines shall be imposed for
buying or selling drugs/herbal ingredients which are subject to recall
decisions issued by competent authorities, which have been expired, or which
are not issued with the import license or certificate of registration, except
drugs/pharmaceutical starting materials which are not required to be registered
as prescribed by law:
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
b) A fine ranging from VND 2.000.000 to VND
3.000.000 shall be imposed for the violation involving goods worth from VND
1.000.000 to under VND 2.000.000;
c) A fine ranging from VND 3.000.000 to VND
5.000.000 shall be imposed for the violation involving goods worth from VND
2.000.000 to under VND 5.000.000;
d) A fine ranging from VND 5.000.000 to VND
7.000.000 shall be imposed for the violation involving goods worth from VND
5.000.000 to under VND 10.000.000;
dd) A fine ranging from VND 7.000.000 to VND
10.000.000 shall be imposed for the violation involving goods worth from VND
10.000.000 to under VND 15.000.000;
e) A fine ranging from VND 10.000.000 to VND
15.000.000 shall be imposed for the violation involving goods worth from VND
15.000.000 to under VND 30.000.000;
g) A fine ranging from VND 15.000.000 to VND
20.000.000 shall be imposed for the violation involving goods worth from VND
30.000.000 to under VND 40.000.000;
h) A fine ranging from VND 20.000.000 to VND
25.000.000 shall be imposed for the violation involving goods worth from VND
40.000.000 to under VND 50.000.000;
i) A fine ranging from VND 25.000.000 to VND
30.000.000 shall be imposed for the violation involving goods worth from VND
50.000.000 to under VND 70.000.000;
k) A fine ranging from VND 30.000.000 to VND
40.000.000 shall be imposed for the violation involving goods worth from VND
70.000.000 to under VND 100.000.000;
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
7. The fine shall be 1.5 times or twice as much
as the fine imposed for the violation in Point c or e Clause 1, Point a Clause
2, Point d Clause 3, Clause 5 or Clause 6 of this Article but not exceed VND
100.000.000 if the violation involves drugs or active ingredients banned in
some fields and sectors, combined drugs that contain narcotic substances,
psychotropic ingredients or precursors or radiopharmaceuticals, or involves
narcotic drugs, psychotropic drugs, precursor drugs, pharmaceutical starting
materials that are narcotic substances or psychotropic ingredients or drug
precursors respectively.
8. Additional penalties:
a) The certificate of eligibility for pharmacy
business shall be suspended for a fixed period of 01 – 02 months in case of
re-commission of the violation in Point g or h Clause 3 of this Article;
b) The pharmacy practicing certificate and
certificate of eligibility for pharmacy business shall be suspended for a fixed
period of 01 – 03 months in case of commission of the violation in Point b, c
or d Clause 4 of this Article;
c) The pharmacy practicing certificate shall be
suspended for a fixed period of 03 – 06 months in case of commission of the
violation in Point b Clause 5 or Clause 6 of this Article;
d) Operations of the violating entity shall be
suspended for a fixed period of 01 – 03 months in case of commission of the
violation in Point a Clause 2 of this Article;
dd) Operations of the violating entity shall be
suspended for a fixed period of 06 – 09 months in case of commission of the
violation in Point dd or i Clause 3 or Point c Clause 5 of this Article.
9. Remedial measures:
a) The violating entity is compelled to return
any benefits illegally obtained from the commission of one of the violations in
Clause 5 or 6 of this Article;
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
c) All drugs/herbal ingredients shall be
destroyed in case of commission of the violation in Point a Clause 5 or Clause
6 of this Article.
Article 60. Violations
against regulations on import and export of drugs and medicinal ingredients
1. A fine ranging from VND 5.000.000 to VND
10.000.000 shall be imposed for commission of one of the following violations:
a) Failing to submit reports on recall of
drugs/pharmaceutical starting materials at the request of a competent
authority;
b) Failing to cooperate or obstructing the
quality inspection agency in taking samples of drugs or pharmaceutical starting
materials to serve quality inspection tasks.
2. A fine ranging from VND 10.000.000 to VND
20.000.000 shall be imposed for commission of one of the following violations:
a) Failing to submit reports on GSP (Good
storage practices) compliance as prescribed by law;
b) Failing to send a written notification to the
Ministry of Health of the wholesaler that distributes drugs/pharmaceutical
starting materials imported into Vietnam by an entity that is entitled to
import but not entitled to distribute drugs/pharmaceutical starting materials
in Vietnam before starts to sell or stops selling drugs to that wholesaler;
c) Failing to retain documents concerning the
drug/pharmaceutical starting material shipment for a period prescribed by law;
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
dd) Exporting drugs/pharmaceutical starting
materials without possessing a certificate of eligibility for pharmacy business
or while business operation or the certificate of eligibility for pharmacy
business is suspended;
e) Exporting drugs/pharmaceutical starting
materials that are subject to a recall notification as prescribed by law;
g) Exporting drugs/pharmaceutical starting
materials beyond the scope specified in the certificate of eligibility for
pharmacy business;
h) Exporting herbal ingredients included in the
list of controlled rare and special herbs without obtaining permission from a
competent authority.
3. A fine ranging from VND 40.000.000 to VND
50.000.000 shall be imposed for commission of one of the following violations:
a) Storing drugs/pharmaceutical starting
materials at a warehouse facility that fails to meet GSP requirements or at a
location other than the one specified in the certificate of eligibility for
pharmacy business, except cases of use of storage services;
b) Only maintaining GSP compliance at level 3;
c) Importing drugs/pharmaceutical starting
materials with a quantity exceeding that written on the import license given by
a competent authority;
d) Failing to re-export all drugs/pharmaceutical
starting materials imported under the import license for display at a
medicinal, pharmaceutical or medical device exhibition or fair upon the end of
the exhibition or fair;
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
e) Importing drugs/pharmaceutical starting
materials whose shelf life contravenes regulations on remaining shelf life of
drugs/pharmaceutical starting materials when they arrive at Vietnam’s port
without obtaining permission from the Minister of Health;
g) Failing to recall drugs/pharmaceutical
starting materials at the request of a competent authority;
h) Importing drugs/pharmaceutical starting
materials beyond the scope specified in the certificate of eligibility for
pharmacy business;
i) Expanding the existing warehouse, making
major repairs or changes in structure or floor plan of the warehouse, or
changing the auxiliary system or principle of design or operation of utility
systems that may affect storage requirements or conditions without submitting a
report on such changes, accompanied by relevant technical documents as
prescribed by law.
4. A fine ranging from VND 50.000.000 to VND
70.000.000 shall be imposed for commission of one of the following violations:
a) Using fraudulent documents in the approved
application for drug/pharmaceutical starting material import license according
to the conclusion given by the competent authority;
b) Importing drugs/pharmaceutical starting
materials manufactured at a location other than that specified in the approved
application for the drug import license;
c) Submitting an application for import license
containing information on the drug/pharmaceutical starting material which is
not based on research findings or the manufacturer’s actual production.
5. A fine ranging from VND 70.000.000 to VND
80.000.000 shall be imposed for commission of one of the following violations:
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
b) Importing drugs/pharmaceutical starting
materials subject to a recall notification of a competent authority;
c) Importing drugs/pharmaceutical starting
materials without the import license or certificate of registration, except
drugs/pharmaceutical starting materials which are not required to be registered
or do not require the import license;
d) Performing activities related to the
distribution of drugs/pharmaceutical starting materials in Vietnam by an entity
is entitled to import but not entitled to distribute drugs/pharmaceutical
starting materials in Vietnam, except drugs and pharmaceutical starting
materials it manufactures in Vietnam.
6. The following fines shall be imposed for
importing drugs/pharmaceutical starting materials which have been expired:
a) A fine ranging from VND 1.000.000 to VND
3.000.000 shall be imposed for the violation involving goods worth less than
VND 2.000.000;
b) A fine ranging from VND 3.000.000 to VND
5.000.000 shall be imposed for the violation involving goods worth from VND
2.000.000 to under VND 5.000.000;
c) A fine ranging from VND 5.000.000 to VND
10.000.000 shall be imposed for the violation involving goods worth from VND
5.000.000 to under VND 10.000.000;
d) A fine ranging from VND 10.000.000 to VND
15.000.000 shall be imposed for the violation involving goods worth from VND
10.000.000 to under VND 20.000.000;
dd) A fine ranging from VND 15.000.000 to VND
20.000.000 shall be imposed for the violation involving goods worth from VND
20.000.000 to under VND 130.000.000;
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
g) A fine ranging from VND 30.000.000 to VND
40.000.000 shall be imposed for the violation involving goods worth from VND
40.000.000 to under VND 50.000.000;
h) A fine ranging from VND 40.000.000 to VND
50.000.000 shall be imposed for the violation involving goods worth from VND
50.000.000 to under VND 60.000.000;
i) A fine ranging from VND 50.000.000 to VND
60.000.000 shall be imposed for the violation involving goods worth from VND
60.000.000 to under VND 80.000.000;
k) A fine ranging from VND 60.000.000 to VND
70.000.000 shall be imposed for the violation involving goods worth from VND
80.000.000 to under VND 100.000.000;
l) A fine ranging from VND 70.000.000 to VND
80.000.000 shall be imposed for the violation involving goods worth VND
100.000.000 or more.
7. The fine shall be 1.5 times or twice as much
as the fine imposed for the violation in Point c, d, dd or g Clause 2, Point a,
c, d or h Clause 3, or Point a or c Clause 5 of this Article but not exceed VND
100.000.000 if the violation involves drugs or active ingredients on the List
of banned substances in some fields and sectors, combined drugs that contain
narcotic substances, psychotropic ingredients or precursors or radiopharmaceuticals,
or involves narcotic drugs, psychotropic drugs, precursor drugs, medicinal
ingredients that are narcotic substances or psychotropic ingredients or drug
precursors respectively.
8. Additional penalties:
a) The pharmacy practicing certificate of the
chief pharmacist shall be suspended for a fixed period of 01 – 03 months in
case of commission of the violation in Point b, c, dd, e or g Clause 2 of this
Article;
b) The pharmacy practicing certificate of the
chief pharmacist shall be suspended for a fixed period of 03 – 06 months in
case of commission of the violation in Point a, c, d, dd, e, g or i Clause 3 of
this Article;
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
d) The certificate of eligibility for pharmacy
business shall be suspended for a fixed period of 18 – 24 months in case of
commission of the violation in Point d Clause 5 of this Article;
dd) Business operations involving the violation
in Point dd, e or g Clause 2 of this Article shall be suspended for a fixed
period of 01 – 03 months;
e) Business operations involving the violation
in Point b, c, dd or h Clause 3 or Point b Clause 4 of this Article shall be
suspended for a fixed period of 03 – 06 months;
g) The import of drugs/pharmaceutical starting
materials shall be suspended for a fixed period of 06 – 09 months in case of
commission of the violation in Point a, b or c Clause 5 of this Article;
h) Operations shall be suspended until the
violating entity submits required reports to the Ministry of Health but for a
period not exceeding 24 months in case of commission of the violation in Point
d Clause 2 of this Article.
9. Remedial measures:
a) The violating entity is compelled to remove
from the Socialist Republic of Vietnam or re-export drugs/pharmaceutical
starting materials involving the violation in Point d Clause 3 or Clause 4, 5,
6 or 7 of this Article. If these measures cannot be implemented,
drugs/pharmaceutical starting materials shall be destroyed;
b) The violating entity is compelled to return
any benefits illegally obtained from the commission of the violation in Point d
Clause 2 of this Article.
Article 61. Violations
against regulations on storage of drugs and pharmaceutical starting materials
by drug/pharmaceutical starting material storage service providers and
non-commercial pharmacy business establishments
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
a) Failing to submit a report on changes,
accompanied by relevant technical documents, to the receiving authority when
changing the location of the existing warehouse or opening a new warehouse at
the same business location;
b) Failing to submit a report on changes,
accompanied by relevant technical documents, to the receiving authority when
expanding the existing warehouse, making major repairs or changes in structure
or floor plan of the warehouse, or changing the auxiliary system or principle
of design or operation of utility systems that may affect storage requirements
or conditions;
c) Failing to send a written notification of GSP
compliance to the receiving authority, failing to comply with the roadmap for
GSP application and compliance by establishments that store and supply
vaccines, drugs and pharmaceutical starting materials by non-commercial
pharmacy business establishments as prescribed by law;
d) Failing to cooperate or obstructing the
quality inspection agency in taking samples of drugs or pharmaceutical starting
materials to serve quality inspection tasks;
dd) Failing to retain all documents about each
batch/shipment of drugs/ pharmaceutical starting materials for a period
prescribed by law.
2. A fine ranging from VND 20.000.000 to VND
30.000.000 shall be imposed for commission of one of the following violations:
a) Providing drug/pharmaceutical starting
material storage services to ineligible entities;
b) Health facilities, vaccination clinics,
vaccine storage facilities under the national expanded program on immunization
of districts and provinces, facilities in charge of storage of drugs that
belong to national health programs or people’s armed forces, vaccine storage
facilities under the national expanded program on immunization at central level
or regional level fail to submit written notifications of GSP compliance to
receiving authorities before starting storage activities;
c) Failing to comply with storage conditions
during the storage or transport of drugs/pharmaceutical starting materials;
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
3. A fine ranging from VND 30.000.000 to VND
40.000.000 shall be imposed for providing drug/pharmaceutical starting material
storage services:
a) without a valid certificate of eligibility
for pharmacy business;
b) at a location other than the one specified in
the issued certificate of eligibility for pharmacy business; or
c) while business operation or the certificate
of eligibility for pharmacy business is suspended;
d) Failing to submit reports on GSP compliance
as prescribed by law;
dd) Only maintaining GSP compliance at level 3.
4. The fine shall be 1.5 times or twice as much
as the fine imposed for the violation in Point a or dd Clause 1, Point a or d
Clause 2, or Point a, b or c Clause 3 of this Article but not exceed VND
100.000.000 if the violation involves drugs or active ingredients on the List
of banned substances in some fields and sectors, combined drugs that contain
narcotic substances, psychotropic ingredients or precursors or
radiopharmaceuticals, or involves narcotic drugs, psychotropic drugs, precursor
drugs, medicinal ingredients that are narcotic substances or psychotropic
ingredients or drug precursors respectively.
5. Additional penalties:
a) The pharmacy practicing certificate shall be
suspended for a fixed period of 01 – 03 months in case of commission of the
violation in Clause 2 of this Article;
…
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TVPL
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
c) Operations of the violating entity shall be
suspended for a fixed period of 06 – 12 months in case of commission of the
violation in Point a, b, c or dd Clause 3 of this Article.
6. Remedial measures:
a) All substandard drugs/pharmaceutical starting
materials shall be destroyed in case of commission of the violation in Point a
Clause 1 or Point c Clause 2 of this Article;
b) All drugs/pharmaceutical starting materials
shall be destroyed in case of commission of the violation in Point a Clause 3
of this Article;
c) The violating entity is compelled to return
any benefits illegally obtained from the commission of the violation in Point
a, b or c Clause 3 of this Article.
Article 62. Violations
against regulations on drug testing, clinical trial and bioequivalence study
1. A fine ranging from VND 10.000.000 to VND
15.000.000 shall be imposed for commission of one of the following violations:
a) Failing to submit a report on changes,
accompanied by relevant technical documents, to the receiving authority when
expanding the existing laboratory, making major repairs or changes in structure
or floor plan of the laboratory, or changing the auxiliary system or principle
of design or operation of utility systems that may affect the laboratory environment;
b) A drug testing service provider takes drug
samples against regulations on drug sampling of the Ministry of Health.
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Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
a) Providing drug/pharmaceutical starting
material testing service, bioequivalence study service or clinical trial
service against or beyond the scope specified in the certificate of eligibility
for pharmacy business or the scope of inspection of GLP (Good laboratory
practices) compliance or GCP (Good clinical practice) compliance of a
non-commercial pharmacy business establishment;
b) Disclosing personal information of
participants in the bioequivalence study without their consent;
c) Concealing information or failing to provide
participants with adequate and truthful information on the bioequivalence
study, its procedures and possible risks.
3. A fine ranging from VND 20.000.000 to VND
30.000.000 shall be imposed for commission of one of the following violations:
a) A non-commercial pharmacy business
establishments provides bioequivalence study or clinical trial service without
possessing a valid certificate of eligibility for pharmacy business or passing
the inspection of GCP compliance;
b) Changing any documents included in the
approved bioequivalence study dossier or bioequivalence study outline;
c) Failing to submit reports on GLP compliance
as prescribed by law;
d) Only maintaining the GLP compliance at level
3;
dd) Failing to submit a report on changes,
accompanied by relevant technical documents, to the authority receiving the
application for inspection of GLP compliance when changing the location of the
existing laboratory or opening a new laboratory within the same business
location.
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
5. The fine shall be 1.5 times or twice as much
as the fine imposed for the violation in Point a Clause 2 or Point a or dd
Clause 3 of this Article but not exceed VND 100.000.000 if the violation
involves drugs or active ingredients on the List of banned substances in some
fields and sectors, combined drugs that contain narcotic substances,
psychotropic ingredients or precursors or radiopharmaceuticals, or involves
narcotic drugs, psychotropic drugs, precursor drugs, medicinal ingredients that
are narcotic substances or psychotropic ingredients or drug precursors
respectively.
6. Additional penalties:
a) The certificate of eligibility for pharmacy
business or operations of the violating non-commercial pharmacy business
establishment shall be suspended for a fixed period of 01 – 03 months in case
of commission of the violation in Clause 2, Point a, b or d Clause 3, or Clause
4 of this Article;
b) Operations shall be suspended until the
violating entity submits required reports to the Ministry of Health but for a
period not exceeding 24 months in case of commission of the violation in Point
c Clause 3 of this Article.
Article 63. Violations
against regulations on clinical trial of drugs
1. A fine ranging from VND 15.000.000 to VND
20.000.000 shall be imposed for commission of one of the following violations:
a) Disclosing personal information of
participants in the clinical trial without their consent;
b) Failing to submit reports on clinical trial
procedures; failing to publish clinical trial results as prescribed by law;
c) Failing to comply with GCP requirements.
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
a) Conducting clinical trial without obtaining
the scientific and ethical assessment record of the clinical trial dossier from
the National Biomedical Ethics Committee and a written approval from the
Minister of Health;
b) Changing any documents included in the
clinical trial dossier or clinical trial outline approved by the Minister of
Health.
3. A fine ranging from VND 30.000.000 to VND
40.000.000 shall be imposed for commission of one of the following violations:
a) Using drugs undergoing clinical trial for
other purposes;
b) Forging others to participate in clinical
trial.
4. The fine shall be twice as much as the fine
imposed for the violation in Clause 2 or Clause 3 of this Article but not exceed
VND 100.000.000 if the violation involves narcotic drugs, psychotropic drugs or
precursor drugs.
5. Additional penalties:
a) The certificate of eligibility for pharmacy
business or operations of the violating non-commercial pharmacy business
establishment shall be suspended for a fixed period of 01 – 03 months in case
of commission of the violation in Clause 1 or Clause 2 of this Article;
b) The certificate of eligibility for pharmacy
business or operations of the violating non-commercial pharmacy business
establishment shall be suspended for a fixed period of 03 – 06 months in case
of commission of the violation in Clause 3 or Clause 4 of this Article.
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
1. A fine ranging from VND 5.000.000 to VND
10.000.000 shall be imposed for commission of one of the following violations:
a) Importing, buying or trading
drugs/pharmaceutical starting materials whose commercial packages have been
damaged, unless permitted by law;
b) Importing herbal ingredients whose secondary
packages do not contain information on their origin.
2. A fine ranging from VND 10.000.000 to VND
20.000.000 shall be imposed for commission of one of the following violations:
a) Manufacturing or importing
drugs/pharmaceutical starting materials whose packages are not conformable with
those described in the approved application, except the case prescribed in
Point b Clause 3 of this Article;
b) An applicant for registration or a pharmacy
business establishment erasures or alters information about manufacturing date
or batch number of drugs/pharmaceutical starting materials specified in their
original labels;
c) Failing to update the drug-related
information on labels and package inserts of drugs sold in Vietnam at the
request of the Ministry of Health;
d) An importer, application for registration or
domestic manufacturer sells/supplies drugs/pharmaceutical starting materials
whose labels or package inserts are not conformable with the approved contents
or do not correctly reflect the drug.
3. A fine ranging from VND 20.000.000 to VND
30.000.000 shall be imposed for commission of one of the following violations:
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Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
b) Packaging material or method does not ensure
the quality of drugs/pharmaceutical starting materials;
c) Failing to update information on
contraindications and drug users as prescribed by law.
4. Additional penalty:
Business operations involving the violation in
Point b Clause 2 or Clause 3 of this Article shall be suspended for a fixed
period of 01 – 03 months.
5. Remedial measure:
All substandard drugs/pharmaceutical starting
materials shall be recalled for reprocessing or destroyed in case of commission
of the violation in Point b, c or d Clause 2 or Clause 3 of this Article.
Article 65. Violations
against regulations on controlled drugs
1. A fine ranging from VND 5.000.000 to VND
10.000.000 shall be imposed for commission of one of the following violations:
a) Storing, manufacturing, preparing, dispensing
or using controlled drugs/pharmaceutical starting materials at a non-commercial
pharmacy business establishment against regulations of law;
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
c) Destroying controlled drugs against
regulations of law.
2. A fine ranging from VND 5.000.000 to VND
10.000.000 shall be imposed upon a drug retailer, or a fine ranging from VND
10.000.000 to VND 20.000.000 shall be imposed upon a provider of drug/pharmaceutical
starting material storage service, clinical trial service, bioequivalence study
service or testing service, or a fine ranging from VND 30.000.000 to VND
40.000.000 shall be imposed upon a drug/pharmaceutical starting material
manufacturer, exporter, importer or wholesaler for commission of one of the
following violations:
a) Failing to meet personnel and facility
requirements to prevent controlled drugs from loss as prescribed by law;
b) Buying or selling materials that are narcotic
substances, psychotropic ingredients or drug precursors without the order forms
approved by competent authorities; buying or selling narcotic drugs,
psychotropic drugs and precursor drugs without the order forms approved by
competent authorities or bidding results or bidding plans approved by competent
persons.
3. Additional penalty:
Business operations involving the
violation in Clause 2 of this Article shall be suspended for a fixed period of
01 – 03 months.
Article 66. Violations
against regulations on management of drug prices
1. A fine ranging from VND 5.000.000 to VND
10.000.000 shall be imposed for failing to submit an application
for adjustment to information about a drug whose price has been declared
or re-declared while the drug price is not adjusted.
2. A fine ranging from VND 10.000.000 to VND
20.000.000 shall be imposed for commission of one of the following violations:
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
b) Buying a drug for a drug retailer within the
premises of a public health facility at a price higher than the highest
successful bid for that drug at provincial and central health facilities within
the last 12 months, or the price of that drug bought through local or national
centralized bidding or price negotiation within the term of the contract or the
framework agreement on centralized procurement before the time of buying drug, except
cases permitted by law;
c) A drug retailer within the premises of a
public health facility buys a drug which is not on the list of drugs supplied
by successful bidders of that health facility, or the lists of drugs supplied
by successful bidders of provincial and central health facilities within the
last 12 months, or the lists of drugs supplied by successful bidders at local
or national centralized bidding or price negotiation before the time of buying
drug, except cases permitted by law;
d) A drug retailer within the premises of a
public health facility retails drugs with a retail margin higher than the
maximum one prescribed by law.
3. The following fines shall be imposed for
wholesaling drugs whose prices are not yet declared by the manufacturer, outsourcing
entity or importer, or are higher than declared or re-declared prices which are
still valid as prescribed by law, except the case prescribed in Point a Clause
4 of this Article:
a) A fine ranging from VND 1.000.000 to VND
3.000.000 shall be imposed for the violation involving the drug whose selling
price is not exceeding VND 1.000 per smallest packaging unit;
b) A fine ranging from VND 3.000.000 to VND
5.000.000 shall be imposed for the violation involving the drug whose selling
price is exceeding VND 1.000 but not exceeding VND 5.000 per smallest packaging
unit;
c) A fine ranging from VND 5.000.000 to VND
7.000.000 shall be imposed for the violation involving the drug whose selling
price is exceeding VND 5.000 but not exceeding VND 100.000 per smallest
packaging unit;
d) A fine ranging from VND 7.000.000 to VND
10.000.000 shall be imposed for the violation involving the drug whose selling
price is exceeding VND 100.000 but not exceeding VND 1.000.000 per smallest
packaging unit;
dd) A fine ranging from VND 10.000.000 to VND
15.000.000 shall be imposed for the violation involving the drug whose selling
price is exceeding VND 1.000.000 per smallest packaging unit.
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
a) Failing to declare or re-declare prices of
drugs before they are sold on the market;
b) Failing to submit a report on refusal to
adjust the drug price at the written request of a drug pricing authority;
c) Failing to report accurate drug pricing
elements as prescribed by law.
5. Remedial measure:
The violating entity is compelled to return any
different amounts in case of commission of the violation in Clause 2, Clause 3
or Point b Clause 4 of this Article. Any payments which cannot be made to
payers shall be paid to state budget in accordance with regulations of law.
Article 67. Violations
against regulations on drug information
1. A warning or a fine ranging from VND 200.000
to VND 500.000 shall be imposed for commission of one of the following
violations:
a) Failing to wear the pharmaceutical sales
representative’s card while introducing drugs;
b) Introducing drugs without obtaining the
practitioner’s consent.
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
a) Failing to submit the lists of sales
representatives issued with the sales representative’s card or whose sales
representative’s card is revoked to the Department of Health of the province
where the sales representative operates;
b) The sales representative introduces products
which are not drugs;
c) The sales representative introduces a drug
other than the one designated by the pharmacy business establishment.
3. A fine ranging from VND 10.000.000 to VND
20.000.000 shall be imposed for commission of one of the following violations
when providing drug information to medical and pharmaceutical practitioners:
a) Providing information which is not yet
certified by a competent authority or which is different from the one certified
by a competent authority;
b) Providing drug information certified by a
competent authority but the certification of drug information has been expired;
c) Comparing and affirming that its drug is
better than that of others without providing any scientific documents approved
by competent authorities;
d) The sales representative contacts patients,
accesses their medical records or prescriptions, discuss or request for
information related to patients;
dd) Failing to send a written notification of
the time and location of the pharmaceutical conference which is held for
providing drug information, accompanied by the copy of certification of drug
information, to the Department of Health of the province where that conference
is held.
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
a) Failing to report and update competent
authorities on information about quality, safety and efficacy of drugs produced,
registered, sold, prepared or processed;
b) A sales representative performs activities
related to the sale and purchase of drugs with medical practitioners.
5. A fine ranging from VND 30.000.000 to VND
40.000.000 shall be imposed for commission of one of the following violations:
a) Providing information, advertising,
marketing, counseling, labeling, giving instructions that foods, cosmetics and
other non-medicinal products can be used for prevention, treatment, diagnosis,
alleviation of diseases or regulating human physiological functions, except for
medical devices;
b) Using material or financial benefits to
affect medicinal practitioners or drug users to make them to give more
prescriptions or purchase more drugs;
c) Altering or forging legal documents issued by
competent authorities in the application for certification of drug information
or drug advertisement;
d) Using a certificate not recognized by the
Ministry of Health or using material benefits, reputation of an organization or
individual, symbols, images, positions, mails, letters of thanks to provide
information about or advertise drugs;
dd) Using results of clinical trial or
pre-clinical trial, testing results, results of bioequivalence study that are
not recognized by the Ministry of Health to provide information about or
advertise drugs;
e) Failing to apply for certification of drug
information upon the occurrence of changes which requires certification.
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
a) Operations of the violating entity shall be
suspended for a fixed period of 03 – 06 months in case of commission of the
violation in Point a Clause 5 of this Article 03 times or more during a year;
b) The exhibits of the violation in Point b
Clause 5 of this Article, which are material or financial benefits, shall be
confiscated.
7. Remedial measure:
The entity committing the violation in Point a,
b or c Clause 3 or Point a, d, dd or e Clause 5 of this Article is compelled to
recall goods and remove violating elements. If violating elements cannot be
removed, products shall be destroyed.
Article 68. Violations
against regulations on cosmetic product notification
1. A fine ranging from VND 10.000.000 to VND
20.000.000 shall be imposed for commission of one of the following violations:
a) Failing to accurately complete items on the
notification of cosmetic product;
b) Failing to obtain a written approval from a
competent authority as prescribed by law when changing the contents which have
been notified and issued with a number of acknowledgment of the notification of
cosmetic product (hereinafter referred to as “notification number”).
2. A fine ranging from VND 20.000.000 to VND
30.000.000 shall be imposed for marketing a cosmetic product which is not
issued by a competent authority with a notification number or whose
notification number has been expired.
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Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
4. Additional penalty:
Cosmetics business shall be suspended for a
fixed period of 03 – 06 months in case of commission of the violation in Clause
2 or 3 of this Article.
5. Remedial measures:
a) Cosmetic products involving in the violation
in Clause 2 or 3 of this Article shall be recalled and destroyed;
b) Enforced revocation of notification number in
case of commission of the violation in Point a Clause 1 or Clause 3 of this
Article.
Article 69. Violations
against regulations on cosmetics advertising in conferences, meetings and
events
A fine ranging from VND 30.000.000 to VND
40.000.000 shall be imposed for organizing a conference, meeting or event for
introducing a cosmetic product:
1. without sending a prior notification to a
competent authority as prescribed by law; or
2. whose contents are different from those
notified to the competent authority.
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Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
1. A fine ranging from VND 30.000.000 to VND
40.000.000 shall be imposed for commission of one of the following violations:
a) Failing to adopt the quality management
system according to the ASEAN Guidelines for Cosmetic Good
Manufacturing Practice (CGMP-ASEAN);
b) Manufacturing a cosmetic product whose
formulation is not conformable with that indicated in the application for
notification of cosmetic product;
c) Manufacturing cosmetic products with expired
or substandard raw materials;
d) Manufacturing cosmetic products that fail to
meet quality standards;
dd) Carrying out manufacturing activities at a
location other than the one specified in the certificate of eligibility for
cosmetic manufacturing;
e) Carrying out manufacturing activities beyond
the scope specified in the certificate of eligibility for cosmetic
manufacturing;
g) Manufacturing cosmetic products that contain
substances which are prohibited from use in cosmetic products or whose concentration
exceeds the maximum authorized concentration prescribed by law.
2. A fine ranging from VND 40.000.000 to VND
50.000.000 shall be imposed for commission of one of the following violations:
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
b) Forging documents included in the application
for issuance, re-issuance or modification of certificate of eligibility for
cosmetic manufacturing;
c) Failing to satisfy one of eligibility
requirements after obtaining certificate of eligibility for cosmetic
manufacturing.
3. Additional penalties:
a) The cosmetic manufacturing shall be suspended
until obtaining an approval for operations to be added to the certificate of
eligibility for cosmetic manufacturing as prescribed by law but for a period
not exceeding 24 months in case of commission of the violation in Point dd or e
Clause 1 of this Article;
b) The cosmetic manufacturing shall be suspended
until obtaining a certificate of eligibility for cosmetic manufacturing as
prescribed by law but for a period not exceeding 24 months in case of
commission of the violation in Point a Clause 2 of this Article;
c) The certificate of eligibility for cosmetic
manufacturing shall be suspended for a fixed period of 01 – 03 months in case
of commission of the violation in Point a or g Clause 1 of this Article;
d) The certificate of eligibility for cosmetic
manufacturing shall be suspended for a fixed period of 03 – 06 months in case
of commission of the violation in Point b Clause 2 of this Article.
4. Remedial measures:
a) All cosmetic products involving in the
violation in Clause 1 or 2 of this Article shall be recalled and destroyed,
except those failing to meet packaging weight or volume standards prescribed in
Point d Clause 1 of this Article;
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
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;
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Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
3. A fine ranging from VND 30.000.000 to VND
40.000.000 shall be imposed upon the entity responsible for placing the cosmetic
product in the market for commission of one of the following violations:
a) Trading in the cosmetic product that contains
substances which are prohibited from use in cosmetic products or whose
concentration exceeds the maximum authorized concentration prescribed by law;
b) Trading in the cosmetic product which does
not have the Product Information File (PIF) or whose PIF is inadequate or is
not presented at the request of a competent authority;
c) Trading in the cosmetic product whose
formulation is not conformable with that specified in the approved application
for notification of cosmetic product;
d) Failing to recall cosmetic products at the
request of a competent authority.
4. Remedial measures:
a) Cosmetic products involving in the violation
in Clause 1, Clause 2, or Point a, b or c Clause 3 of this Article shall be
recalled and destroyed;
b) Enforced revocation of notification number in
case of commission of the violation in Clause 3 of this Article.
Section 4. VIOLATIONS AGAINST
REGULATIONS ON MEDICAL DEVICES
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Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
1. A fine ranging from VND 5.000.000 to VND
10.000.000 shall be imposed for commission of one of the following violations:
a) Failing to ensure the legitimacy of documents
included in the application for issuance or modification of the medical device
classification practicing certificate;
b) Failing to publish the issued medical device
classification result;
c) The medical device classification result is
signed by a person other than the one named in the acknowledgment of receipt of
application for declaration of eligibility for medical device classification or
the legal representative;
d) Failing to notify a competent authority of
replacement of the person performing medical device classification in case the
replacement has the same practicing scope with the replaced one.
2. A fine ranging from VND 10.000.000 to VND
15.000.000 shall be imposed for commission of one of the following violations:
a) Failing to comply with the rules of
risk-based classification of medical devices;
b) Failing to ensure the legitimacy of documents
included in the application for declaration of eligibility for medical device
classification;
c) Performing the classification of medical
devices beyond the scope of the medical device classification practicing
certificate;
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
dd) Failing to specify the quantity of medical
device granted customs clearance in the report sent to the customs authority
that has granted customs clearance in case the medical device has been issued
with the registration number that is based on the classification result subject
to a recall notification given by the Ministry of Health and has granted the
customs clearance but are not sold to customers;
e) Failing to specify the quantity of medical
device granted customs clearance and sales contracts (if any) in the report
sent to the authority that has issued the registration number in case the
medical device has been issued with the registration number that is based on
the classification result subject to a recall notification given by the Ministry
of Health and has granted the customs clearance but are not sold to customers;
g) Issuing a wrong classification result which
reduces the risk level of the classified medical device;
h) Failing to repeat the procedures for
declaration of eligibility for medical device classification upon the
occurrence of change of the person performing medical device classification
whose practicing scope is not yet specified in the previous application for
declaration of eligibility for medical device classification.
3. A fine ranging from VND 15.000.000 to VND
20.000.000 shall be imposed for commission of one of the following violations:
a) Classifying the medical device or issuing the
medical device classification result during the operation suspension period;
b) The registration number holder fails to
suspend the sale of medical device, or fails to organize the recall of the
medical device which has been issued with the registration number based on the
classification result subject to a recall notification given by the Ministry of
Health and has granted the customs clearance but are not sold to customers.
4. A fine ranging from VND 20.000.000 to VND
30.000.000 shall be imposed for commission of one of the following violations:
a) Performing medical device classification
without completing procedures for declaration of eligibility for medical device
classification or while the acknowledgment of receipt of application for
declaration of eligibility for medical device classification has been revoked;
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Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
5. Additional penalties:
a) Operation of the violating entity shall be
suspended for a fixed period of 01 – 03 months in case of commission of the
violation in Point b Clause 1 or Point a, c, g or h Clause 2 of this Article;
b) Operation of the violating entity shall be
suspended for a fixed period of 03 – 06 months in case of commission of the
violation in Point b Clause 3 of this Article;
c) Operation of the violating entity shall be
suspended for a fixed period of 06 – 09 months in case of commission of the
violation in Point b Clause 4 of this Article.
6. Remedial measures:
a) Enforced revocation of medical device
classification practicing certificate in case of commission of the violation in
Point a Clause 1 of this Article;
b) Enforced revocation of the acknowledgment of
receipt of application for declaration of eligibility for medical device
classification in case of commission of the violation in Point b Clause 2 or
Point a Clause 3 of this Article.
Article 73. Violations
against regulations on medical device manufacturing
1. A fine ranging from VND 5.000.000 to VND
10.000.000 shall be imposed for failing to repeat the procedures for
declaration of eligibility for medical device manufacturing upon the occurrence
of changes in the submitted application for declaration.
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
a) Failing to ensure the legitimacy of documents
included in the application for declaration of eligibility for medical device
manufacturing;
b) Failing to satisfy one of eligibility requirements
after having successfully completed procedures for declaration of eligibility
for medical device manufacturing.
3. A fine ranging from VND 20.000.000 to VND
30.000.000 shall be imposed for commission of one of the following violations:
a) Manufacturing medical devices that contain
narcotic substances and precursors at a facility that fails to meet eligibility
requirements set by law;
b) Manufacturing medical devices that contain
narcotic substances and precursors from raw materials, which are narcotic
substances and precursors, imported without the import license;
c) Manufacturing medical devices before
obtaining the acknowledgment of receipt of application for declaration of
eligibility for medical device manufacturing as prescribed by law.
4. Additional penalty:
Operation of the violating entity shall be
suspended for a fixed period of 01 – 03 months in case of commission of the
violation in Clause 1, Point b Clause 2 or Point a or b Clause 3 of this
Article.
5. Remedial measures:
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Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
b) Medical devices involving in the violation in
Clause 3 of this Article shall be recalled and destroyed or re-processed.
Article 74. Violations
against regulations on registration of medical devices
1. A fine ranging from VND 10.000.000 to VND
20.000.000 shall be imposed for commission of one of the following violations:
a) Placing on the market a medical device which
is not yet labeled or whose secondary label does not contain adequate
information required by law;
b) Placing on the market a medical device which
is not accompanied by technical documents serving the repair and maintenance,
except single-use medical devices which must be disposed after use as
prescribed by their owners;
c) Placing on the market a medical device
without providing instructions for use in Vietnamese;
d) Placing on the market a medical device
without providing information on the warranty center, warranty conditions and
period, except single-use medical devices which must be disposed after use
as prescribed by their owners or medical devices for which no warranty is
provided as proved by specific documents;
dd) Failing to notify a competent authority of
changes that occur during the sale of a medical device;
e) Failing to send a written notification to
competent authorities and traders/users of the medical advice batch that has an
adverse event posing a serious threat to public health or causing death of a
user;
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Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
h) Placing on the market a medical device which
is not conformable with national technical regulations or applied standards
declared by the manufacturer.
2. A fine ranging from VND 20.000.000 to VND
30.000.000 shall be imposed for commission of one of the following violations:
a) Failing to follow procedures for declaration
of standards applied to Class A medical device;
b) Failing to establish, organize and manage the
tracing of origin of medical devices placed on the market as prescribed by law;
c) Failing to retain adequate documents for
after-sale management of medical devices as prescribed by law;
d) Failing to complete the recall of the entire
batch of defective medical device within the time limit decided by a competent
authority;
dd) Failing to establish a warranty center for
medical devices as prescribed by law;
e) Failing to prepare and retain documents for
monitoring medical devices as prescribed by law;
g) Failing to inform relevant Provincial
Departments of Health and police authorities of any confusion or loss of
medical devices containing narcotic substances and precursors or raw materials
for production thereof.
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
i) Failing to issue warnings or issuing late,
inadequate or inaccurate warnings about risks to users’ health and the
environment, and instructions for sellers and users on how to minimize the
risks; failing to provide information about requirements for transport, storage
and use of the medical devices;
k) Failing to stop placing on the market or
failing to inform relevant parties; failing to take corrective or remedial
actions or recall defective medical devices as prescribed by law;
l) Failing to maintain the validity of the
certificate of free sale, power of attorney or certificate of warranty
qualification during the effective period of the registration number as
prescribed by law.
3. A fine ranging from VND 30.000.000 to VND
40.000.000 shall be imposed for commission of one of the following violations:
a) Failing to stop placing the medical device on
the market in case of a determination that it has a defect which will be
harmful to users’ health;
b) Altering or erasing the acknowledgement of
receipt of declaration of standards applied to Class A medical device;
c) Altering or erasing the certificate of
registration of Class B, C or D medical devices;
d) Failing to ensure the legitimacy of documents
included in the application for declaration of standards applied to Class A
medical devices;
dd) Failing to ensure the legitimacy of
documents included in the application for issuance, re-issuance or renewal of
certificate of registration of Class B, C or D medical devices.
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
a) Placing Class A medical devices on the market
without obtaining the acknowledgement of receipt of the application for
declaration of applied standards or the import license;
b) Placing Class B, C or D medical devices on
the market without obtaining the number of certificate of registration or the import
license;
c) Placing on the market a medical device which
fails to meet the registered quality;
d) The warranty center fails to meet
qualification requirements as specified in the certificate of warranty
qualification provided by the medical device owner;
dd) Failing to stop placing on the market the
medical device associated with an adverse event that poses a serious threat to
public health or has caused death of a user;
e) Continuing placing the medical device issued
with the registration number for 24 months after the medical device owner
declares the termination of manufacturing of that medical device or is declared
bankrupt or dissolved, but the holder of the registration number in Vietnam
provides no commitment to provide warranty/maintenance and spare parts for
replacing or serving the use of that medical device for 08 years, unless the
registration number holder is a Vietnam-based representative office of the
foreign medical device owner;
g) Continuing placing the medical device issued
with the registration number for a period exceeding 24 months after the medical
device owner declares the termination of manufacturing of that medical device
or is declared bankrupt or dissolved.
5. Additional penalties:
a) The exhibits, including the acknowledgment of
receipt, certificate and documents, shall be confiscated in case of commission
of the violation in Point b, c, d or dd Clause 3 of this Article;
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Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
6. Remedial measures:
a) Medical devices involving in the violation in
Point g or h Clause 1 of this Article shall be recalled and destroyed or
re-processed;
b) Enforced revocation of the acknowledgment of
receipt of the application for declaration of standards applied to Class A
medical devices or certificate of registration of Class B, C or D medical
devices in case of commission of the violation in Point b, c, d or dd Clause 3
of this Article.
Article 75. Violations
against regulations on trading in medical devices
1. A fine ranging from VND 3.000.000 to VND
5.000.000 shall be imposed for commission of one of the following violations:
a) Failing to adopt internal control measures
for maintaining quality of medical devices according to requirements of the
registration number holder;
b) Failing to provide or providing users with
inadequate or late instructions for use of the medical device, and conditions
for ensuring safety, storage, calibration, inspection and maintenance of the
medical device;
c) Failing to inform or inadequately or lately
informing users of the defective medical device;
d) Failing to keep documents for monitoring
medical devices, tracing origin and recalling medical devices as prescribed by
law;
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Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
2. A fine ranging from VND 5.000.000 to VND
10.000.000 shall be imposed for commission of one of the following violations:
a) Failing to repeat procedures for declaration
of eligibility for trading in medical devices upon the occurrence of changes in
the submitted application for declaration of eligibility as prescribed by law;
b) Failing to report or submitting reports of
incorrect form or after the prescribed deadline to the relevant provincial
Department of Health on any confusion or loss of medical devices containing
narcotic substances and precursors or raw materials for production thereof;
c) Failing to report or submitting reports of
incorrect form or after the prescribed deadline to competent authorities on the
sale, export, import and transfer of medical devices containing narcotic
substances and precursors, or raw materials for production thereof;
d) Failing to report or submitting a report of
incorrect form or after the prescribed deadline on receipt, delivery, inventory
and use of medical devices containing narcotic substances and precursors and
raw materials for production thereof.
3. A fine ranging from VND 10.000.000 to VND
20.000.000 shall be imposed for commission of one of the following violations:
a) Failing to satisfy one of eligibility
requirements for trading in Class B, C and D medical devices;
b) Trading in Class B, C or D medical devices
without completing procedures for declaration of eligibility for trading in
medical devices as prescribed by law;
c) Failing to ensure the legitimacy of documents
included in the application for declaration of eligibility for trading in Class
B, C or D medical devices;
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Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
4. Additional penalty:
Operation of the violating entity shall be
suspended for a fixed period of 01 – 03 months in case of commission of the
violation in Point a or d Clause 1, Point a Clause 2 or Point a, c or d Clause
3 of this Article.
5. Remedial measures:
a) Enforced revocation of the acknowledgment of
receipt of application for declaration of eligibility for trading in Class B, C
or D medical devices in case of commission of the violation in Point c Clause 3
of this Article;
b) Enforced revocation of certificate of free
sale of domestically manufactured medical devices in case of commission of the
violation in Point d Clause 3 of this Article.
Article 76. Violations
against regulations on import of medical devices
1. A fine ranging from VND 20.000.000 to VND
30.000.000 shall be imposed for commission of one of the following violations:
a) Failing to ensure the legitimacy of documents
included in the application for the license to import medical devices;
b) Exporting or importing medical devices
without satisfying eligibility requirements set by law.
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
3. Additional penalty:
Operation of the violating entity shall be
suspended for a fixed period of 01 – 03 months in case of commission of the
violation in Clause 1 or Clause 2 of this Article.
4. Remedial measures:
a) The violating entity is compelled to remove
from the territory of the Socialist Republic of Vietnam or re-export medical
devices involving the violation in Clause 2 of this Article. If these measures
cannot be implemented, medical violations shall be destroyed;
b) Enforced revocation of the license to import
medical devices in case of commission of the violation in Clause 1 of this
Article.
Article 77. Violations
against regulations on counseling on medical devices
1. A fine ranging from VND 3.000.000 to VND
5.000.000 shall be imposed for failing to repeat the procedures for declaration
of eligibility to provide technical counseling on medical devices upon the
occurrence of changes in the submitted application for declaration of
eligibility.
2. A fine ranging from VND 5.000.000 to VND
10.000.000 shall be imposed for commission of one of the following violations:
a) Failing to ensure the legitimacy of documents
included in the application for declaration of eligibility to provide technical
counseling on medical devices;
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
c) Providing counseling services beyond the
scope specified in the application for declaration of eligibility to provide
technical counseling on medical devices.
3. Additional penalty:
Operation of the violating entity shall be
suspended for a fixed period of 01 – 03 months in case of commission of the
violation in Clause 1 or Clause 2 of this Article.
4. Remedial measure:
Enforced revocation of the acknowledgment of
receipt of application for declaration of eligibility to provide technical
counseling on medical devices in case of commission of the violation in Point a
Clause 2 of this Article.
Article 78. Violations
against regulations on information about medical devices
1. A fine ranging from VND 3.000.000 to VND
5.000.000 shall be imposed for commission of one of the following violations:
a) Failing to provide information about levels
of risks that patients are subjected to from Class C and D medical devices;
b) Failing to make information about levels of
risks and use of medical devices publicly available;
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Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
2. A fine ranging from VND 5.000.000 to VND
10.000.000 shall be imposed for failing to keep the original label and stick a
secondary label containing compulsory information in Vietnamese on the imported
medical device whose label does not contain or insufficiently contains
information required by law.
Article 79. Violations
against regulations on management and use of medical devices in health
facilities
1. A fine ranging from VND 500.000 to VND
1.000.000 shall be imposed for failing to submit reports on defective medical
devices and other information at the request of competent authorities.
2. A fine ranging from VND 3.000.000 to VND
5.000.000 shall be imposed for commission of one of the following violations:
a) Failing to prepare, manage and retain
adequate documents on medical devices; failing to punctually and sufficiently
record medical devices in kind and in cash in accordance with regulations of
the laws on accounting and statistics and relevant laws;
b) Using and operating medical devices against
instructions given by their owners.
3. A fine ranging from VND 10.000.000 to VND
20.000.000 shall be imposed for failing to carry out periodic maintenance,
inspection and calibration of medical devices according to instructions given
by their owners or as prescribed by law.
4. A fine ranging from VND 20.000.000 to VND
30.000.000 shall be imposed for using medical devices without the certificate
of registration or import license, or expired or substandard medical devices.
Section 5. VIOLATIONS AGAINST
REGULATIONS ON HEALTH INSURANCE
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Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
1. A warning or a fine ranging from VND 300.000
to VND 500.000 shall be imposed upon a compulsory health insurance policyholder
for failing to make health insurance contributions.
2. The following fines shall be imposed upon an
employer for failing to pay, insufficiently or lately paying health insurance
contributions for his/her employees who are subjected to compulsory health
insurance, or evading payment of health insurance contributions:
a) A fine ranging from VND 1.000.000 to VND
3.000.000 shall be imposed for the violation involving less than 10 employees;
b) A fine ranging from VND 3.000.000 to VND
5.000.000 shall be imposed for the violation involving from 10 to less than 50
employees;
c) A fine ranging from VND 5.000.000 to VND
10.000.000 shall be imposed for the violation involving from 50 to less than
100 employees;
d) A fine ranging from VND 10.000.000 to VND
20.000.000 shall be imposed for the violation involving from 100 to less than
500 employees;
dd) A fine ranging from VND 20.000.000 to VND
30.000.000 shall be imposed for the violation involving from 500 to less than
1.000 employees;
e) A fine ranging from VND 30.000.000 to VND
40.000.000 shall be imposed for the violation involving from 1.000 employees or
more.
3. The following fines shall be imposed for
failing to pay sufficient amounts payable of health insurance contributions:
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TVPL
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
b) A fine ranging from VND 2.000.000 to VND
3.000.000 shall be imposed if the arrears are from VND 5.000.000 to less than
VND 10.000.000;
c) A fine ranging from VND 3.000.000 to VND
5.000.000 shall be imposed if the arrears are from VND 10.000.000 to less than
VND 20.000.000;
d) A fine ranging from VND 5.000.000 to VND
7.000.000 shall be imposed if the arrears are from VND 20.000.000 to less than
VND 40.000.000;
dd) A fine ranging from VND 7.000.000 to VND
10.000.000 shall be imposed if the arrears are from VND 40.000.000 to less than
VND 60.000.000;
e) A fine ranging from VND 10.000.000 to VND
15.000.000 shall be imposed if the arrears are from VND 60.000.000 to less than
VND 80.000.000;
g) A fine ranging from VND 15.000.000 to VND
20.000.000 shall be imposed if the arrears are from VND 80.000.000 to less than
VND 120.000.000;
h) A fine ranging from VND 20.000.000 to VND
30.000.000 shall be imposed if the arrears are from VND 120.000.000 to less
than VND 160.000.000;
i) A fine ranging from VND 30.000.000 to VND
40.000.000 shall be imposed if the arrears are VND 160.000.000 or more.
4) A fine ranging from VND 10.000.000 to VND
15.000.000 shall be imposed for illegally obtaining health insurance payout.
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TVPL
Pro
để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
a) The violating entity is compelled to make
compensations for any damage incurred by health insurance policyholders in case
of commission of the violation in Clause 2, 3 or 4 of this Article. Any
payments which cannot be made to payers shall be paid to state budget in
accordance with regulations of law;
b) Any benefits illegally obtained from the
violation in Clause 2, 3 or 4 of this Article shall be paid to account of the
health insurance fund.
Article 81. Inclusion of
external persons in the list of policyholders
1. The following fines shall be imposed for
including external persons in the list of policyholders against regulations of
law:
a) A fine ranging from VND 1.000.000 to VND
2.000.000 per heath insurance card shall be imposed for the violation which
does not cause damage to the health insurance fund;
b) A fine ranging from VND 2.000.000 to VND
3.000.000 per health insurance card shall be imposed if health insurance cards
have been used resulting in damage to the health insurance fund.
2. The following fines shall be imposed for
participating in health insurance at an agency or organization against
regulations of law:
a) The fine ranging from VND 1.000.000 to VND
2.000.000 shall be imposed for each person holding the health insurance card
which is not used;
b) The fine ranging from VND 2.000.000 to VND
3.000.000 shall be imposed for each person holding the health insurance card
which has been used.
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TVPL
Pro
để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
The exhibits, which are health insurance cards,
used for committing the violation in Clause 1 or Clause 2 of this Article shall
be confiscated.
4. Remedial measure:
The violating entity is compelled to transfer
the amounts of money involving in the violation in Point b Clause 1 or Point b
Clause 2 of this Article to the dedicated account of the health insurance fund.
Article 82. Certification
of incorrect amounts of health insurance contributions
The following fines shall be imposed for
certifying incorrect amounts of health insurance contributions:
1. A fine ranging from VND 1.000.000 to VND 2.000.000
shall be imposed if the incorrectly certified amount is less than VND
10.000.000.
2. A fine ranging from VND 2.000.000 to VND
3.000.000 shall be imposed if the incorrectly certified amount is from VND
10.000.000 to less than VND 20.000.000.
3. A fine ranging from VND 3.000.000 to VND
5.000.000 shall be imposed if the incorrectly certified amount is from VND
20.000.000 to less than VND 40.000.000.
4. A fine ranging from VND 5.000.000 to VND
10.000.000 shall be imposed if the incorrectly certified amount is from VND
40.000.000 to less than VND 60.000.000.
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TVPL
Pro
để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
6. A fine ranging from VND 15.000.000 to VND
20.000.000 shall be imposed if the incorrectly certified amount is from VND
80.000.000 to less than VND 100.000.000.
7. A fine ranging from VND 20.000.000 to VND
30.000.000 shall be imposed if the incorrectly certified amount is from VND
100.000.000 to less than VND 120.000.000.
8. A fine ranging from VND 30.000.000 to VND
40.000.000 shall be imposed if the incorrectly certified amount is from VND
120.000.000 to less than VND 150.000.000.
9. A fine ranging from VND 40.000.000 to VND
50.000.000 shall be imposed if the incorrectly certified amount is VND
150.000.000 or more.
Article 83. Violations
against regulations on preparation and transfer of list of policyholders issued
with health insurance card
1. A fine ranging from VND 500.000 to VND
1.000.000 shall be imposed for commission of one of the following violations:
a) Preparing and transferring the list of
policyholders issued with health insurance card after the prescribed deadline
but the violation does not harm legitimate rights and benefits of
policyholders;
b) Preparing and transferring the list of
policyholders issued with health insurance card which does not contain all of
persons eligible to participate in health insurance under management but the
violation does not harm their rights and benefits.
2. The following fines shall be imposed for
preparing and transferring the list of policyholders issued with health
insurance card after the prescribed deadline and the violation has caused harm
to legitimate rights and benefits of policyholders:
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TVPL
Pro
để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
b) A fine ranging from VND 2.000.000 to VND
3.000.000 shall be imposed if the list is submitted 10 working days or more
late after the prescribed deadline.
3. The following fines shall be imposed for
preparing and transferring the list of policyholders issued with health
insurance card which does not contain all of persons eligible to participate in
health insurance under management and the violation has caused harm to their
rights and benefits:
a) A fine ranging from VND 1.000.000 to VND
3.000.000 shall be imposed if the list lacks less than 50 persons eligible to
participate in health insurance;
b) A fine ranging from VND 3.000.000 to VND
5.000.000 shall be imposed if the list lacks from 50 to less than 100 persons
eligible to participate in health insurance;
c) A fine ranging from VND 5.000.000 to VND
7.000.000 shall be imposed if the list lacks from 100 to less than 500 persons
eligible to participate in health insurance;
d) A fine ranging from VND 7.000.000 to VND
10.000.000 shall be imposed if the list lacks from 500 to less than 1.000
persons eligible to participate in health insurance;
dd) A fine ranging from VND 10.000.000 to VND
20.000.000 shall be imposed if the list lacks 1.000 or more persons eligible to
participate in health insurance.
4. Remedial measure:
The violating entity is compelled to make
compensations for any damage incurred by health insurance policyholders in case
of commission of the violation in Clause 2 or 3 of this Article. The amounts of
money which cannot be returned to payers shall be paid to state budget in
accordance with regulations of law.
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TVPL
Pro
để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
1. The following fines shall be imposed for
lending the health insurance card to another or using a borrowed health insurance
card for using medical services:
a) A fine ranging from VND 1.000.000 to VND
2.000.000 shall be imposed of the violation does not cause damage to the health
insurance fund;
b) A fine ranging from VND 3.000.000 to VND
5.000.000 shall be imposed of the violation has caused damage to the health
insurance fund.
2. Remedial measure:
The violating entity is compelled to transfer
the amounts of money involving in the violation in Point b Clause 1 of this
Article to the dedicated account of the health insurance fund.
Article 85. Violations
against regulations on preparation of medical records and prescription for
drugs covered by health insurance fund
1. A fine ranging from VND 200.000 to VND
500.000 shall be imposed for preparing medical records or writing out prescriptions
without patients or for wrong patients if the damage caused by the violation is
assessed at less than VND 1.000.000.
2. The following fines shall be imposed for
preparing medical records or writing out prescriptions without patients or for
wrong patients:
a) A fine ranging from VND 500.000 to VND
1.000.000 shall be imposed if the damage caused by the violation is assessed at
from VND 1.000.000 to less than VND 2.000.000;
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TVPL
Pro
để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
c) A fine ranging from VND 3.000.000 to VND
5.000.000 shall be imposed if the damage caused by the violation is assessed at
from VND 5.000.000 to less than VND 10.000.000;
d) A fine ranging from VND 5.000.000 to VND
10.000.000 shall be imposed if the damage caused by the violation is assessed
at from VND 10.000.000 to less than VND 15.000.000;
dd) A fine ranging from VND 10.000.000 to VND
15.000.000 shall be imposed if the damage caused by the violation is assessed
at from VND 15.000.000 to less than VND 25.000.000;
e) A fine ranging from VND 15.000.000 to VND
20.000.000 shall be imposed if the damage caused by the violation is assessed
at from VND 25.000.000 to less than VND 50.000.000;
g) A fine ranging from VND 20.000.000 to VND
25.000.000 shall be imposed if the damage caused by the violation is assessed
at from VND 50.000.000 to less than VND 80.000.000;
h) A fine ranging from VND 25.000.000 to VND
30.000.000 shall be imposed if the damage caused by the violation is assessed
at VND 80.000.000 or more.
3. Remedial measure:
The violating entity is compelled to transfer
the amounts of money involving in the violation in Clause 1 or Clause 2 of this
Article to the dedicated account of the health insurance fund.
Article 86. Violations
against regulations on management of drugs, chemicals, medical supplies,
technical services, costs of hospital bed days and other costs
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TVPL
Pro
để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
a) Falsely increasing the quantity or types of
drugs, chemicals, medical supplies, technical services, hospital bed days and
other costs that are actually not used by patients;
b) Failing to provide adequate drugs, chemicals,
medical supplies and technical services when providing covered medical
services.
2. The following fines shall be imposed for falsely
increasing the quantity or types of drugs, chemicals, medical supplies,
technical services, hospital bed days and other costs that are actually not
used by patients:
a) A fine ranging from VND 1.000.000 to VND
3.000.000 shall be imposed if the damage caused by the violation is assessed at
from VND 1.000.000 to less than VND 3.000.000;
b) A fine ranging from VND 3.000.000 to VND
5.000.000 shall be imposed if the damage caused by the violation is assessed at
from VND 3.000.000 to less than VND 5.000.000;
c) A fine ranging from VND 5.000.000 to VND
10.000.000 shall be imposed if the damage caused by the violation is assessed
at from VND 5.000.000 to less than VND 10.000.000;
d) A fine ranging from VND 10.000.000 to VND
20.000.000 shall be imposed if the damage caused by the violation is assessed
at from VND 10.000.000 to less than VND 20.000.000;
dd) A fine ranging from VND 20.000.000 to VND
30.000.000 shall be imposed if the damage caused by the violation is assessed
at from VND 20.000.000 to less than VND 30.000.000;
e) A fine ranging from VND 30.000.000 to VND
40.000.000 shall be imposed if the damage caused by the violation is assessed
at from VND 30.000.000 to less than VND 40.000.000;
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TVPL
Pro
để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
h) A fine ranging from VND 50.000.000 to VND
60.000.000 shall be imposed if the damage caused by the violation is assessed
at from VND 50.000.000 to less than VND 60.000.000;
i) A fine ranging from VND 60.000.000 to VND
70.000.000 shall be imposed if the damage caused by the violation is assessed
at VND 60.000.000 or more.
3. The following fines shall be imposed for
failing to prescribe and provide adequate drugs, chemicals, medical supplies
and technical services when providing covered medical services:
a) A fine ranging from VND 1.000.000 to VND
3.000.000 shall be imposed if the damage caused by the violation is assessed at
from VND 1.000.000 to less than VND 10.000.000;
b) A fine ranging from VND 3.000.000 to VND
5.000.000 shall be imposed if the damage caused by the violation is assessed at
from VND 10.000.000 to less than VND 20.000.000;
c) A fine ranging from VND 5.000.000 to VND
10.000.000 shall be imposed if the damage caused by the violation is assessed
at from VND 20.000.000 to less than VND 40.000.000;
d) A fine ranging from VND 10.000.000 to VND
20.000.000 shall be imposed if the damage caused by the violation is assessed
at from VND 40.000.000 to less than VND 80.000.000;
dd) A fine ranging from VND 20.000.000 to VND
30.000.000 shall be imposed if the damage caused by the violation is assessed
at from VND 80.000.000 to less than VND 120.000.000;
e) A fine ranging from VND 30.000.000 to VND
40.000.000 shall be imposed if the damage caused by the violation is assessed
at from VND 120.000.000 to less than VND 160.000.000;
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TVPL
Pro
để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
4. Remedial measures:
a) The violating entity is compelled to transfer
the amounts of money involving in the violation in Clause 1 or Clause 2 of this
Article to the dedicated account of the health insurance fund;
b) The violating entity is compelled to make
compensations for any damage incurred by health insurance policyholders in case
of commission of the violation in Clause 1, 2 or 3 of this Article. The amounts
of money which cannot be returned to payers shall be paid to state budget in
accordance with regulations of law.
Article 87. Violations
against regulations on rights and benefits of health insurance policyholders
1. A warning or a fine ranging from VND 300.000
to VND 500.000 shall be imposed for committing a violation against regulations
on rights and benefits of health insurance policyholders which involves an
amount of less than VND 1.000.000.
2. The following fines shall be imposed for
committing a violation against regulations on rights and benefits of health
insurance policyholders:
a) A fine ranging from VND 1.000.000 to VND
2.000.000 shall be imposed if the damage caused by the violation is assessed at
from VND 1.000.000 to less than VND 5.000.000;
b) A fine ranging from VND 2.000.000 to VND
3.000.000 shall be imposed if the damage caused by the violation is assessed at
from VND 5.000.000 to less than VND 10.000.000;
c) A fine ranging from VND 3.000.000 to VND
5.000.000 shall be imposed if the damage caused by the violation is assessed at
from VND 10.000.000 to less than VND 15.000.000;
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TVPL
Pro
để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
dd) A fine ranging from VND 7.000.000 to VND
10.000.000 shall be imposed if the damage caused by the violation is assessed
at from VND 20.000.000 to less than VND 40.000.000;
e) A fine ranging from VND 10.000.000 to VND
15.000.000 shall be imposed if the damage caused by the violation is assessed
at VND 40.000.000 or more.
3. Remedial measures:
a) The violating entity is compelled to make
compensations for any damage incurred by health insurance policyholders in case
of commission of the violation in Clause 1 or 2 of this Article. Any payments
which cannot be made to payers shall be paid to state budget in accordance with
regulations of law;
b) The violating entity is compelled to transfer
the amounts of money involving in the violation in Clause 1 or Clause 2 of this
Article to the dedicated account of the health insurance fund.
Article 88. Violations
against regulations on reimbursement of costs of covered medical services
1. A warning or a fine ranging from VND 300.000
to VND 500.000 shall be imposed for setting incorrect prices or writing
incorrect types, units and names of technical services upon reimbursement of
costs of covered medical services if the damage caused by the violation is
assessed at less than VND 1.000.000.
2. The following fines shall be imposed for
setting incorrect prices or writing incorrect types, units and names of
technical services upon reimbursement of costs of covered medical services:
a) A fine ranging from VND 1.000.000 to VND
2.000.000 shall be imposed if the damage caused by the violation is assessed at
from VND 1.000.000 to less than VND 5.000.000;
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TVPL
Pro
để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
c) A fine ranging from VND 3.000.000 to VND
5.000.000 shall be imposed if the damage caused by the violation is assessed at
from VND 10.000.000 to less than VND 20.000.000;
d) A fine ranging from VND 5.000.000 to VND
10.000.000 shall be imposed if the damage caused by the violation is assessed
at from VND 20.000.000 to less than VND 40.000.000;
dd) A fine ranging from VND 10.000.000 to VND
20.000.000 shall be imposed if the damage caused by the violation is assessed
at from VND 40.000.000 to less than VND 80.000.000;
e) A fine ranging from VND 20.000.000 to VND
40.000.000 shall be imposed if the damage caused by the violation is assessed
at from VND 80.000.000 to less than VND 120.000.000;
g) A fine ranging from VND 40.000.000 to VND
50.000.000 shall be imposed if the damage caused by the violation is assessed
at VND 120.000.000 or more.
3. Remedial measures:
a) The violating entity is compelled to transfer
the amounts of money involving in the violation in Clause 1 or Clause 2 of this
Article to the dedicated account of the health insurance fund;
b) The violating entity is compelled to make
compensations for any damage incurred by health insurance policyholders in case
of commission of the violation in Clause 1 or 2 of this Article. The amounts of
money which cannot be returned to payers shall be paid to state budget in
accordance with regulations of law.
Article 89. Violations
against regulations on contracts for provision of covered medical services
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TVPL
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
a) Unilaterally terminating a contract for
provision of covered medical services against regulations of law;
b) Entering into a contract for provision of
covered medical services whose contents are contrary to regulations of law;
c) Entering into a contract for provision of
covered medical services beyond the power prescribed by law.
2. The following fines shall be imposed for
unilaterally terminating a contract for provision of covered medical services
resulting in damage caused to rights and benefits of health insurance
policyholders, heath facilities or heath insurance fund:
a) A fine ranging from VND 3.000.000 to VND
5.000.000 shall be imposed if the damage is assessed at less than VND
50.000.000;
b) A fine ranging from VND 5.000.000 to VND
10.000.000 shall be imposed if the damage is assessed at from VND 50.000.000 to
less than VND 100.000.000;
c) A fine ranging from VND 10.000.000 to VND
15.000.000 shall be imposed if the damage is assessed at from VND 100.000.000
to less than VND 500.000.000;
d) A fine ranging from VND 15.000.000 to VND
20.000.000 shall be imposed if the damage is assessed at from VND 500.000.000
to less than VND 1.000.000.000;
dd) A fine ranging from VND 20.000.000 to VND
30.000.000 shall be imposed if the damage is assessed at from VND 1.000.000.000
to less than VND 5.000.000.000;
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
3. The following fines shall be imposed for
entering into a contract for provision of covered medical services whose
contents are contrary to regulations of law or beyond the power prescribed by
law resulting in damage caused to rights and benefits of health insurance
policyholders, heath facilities and health insurance fund:
a) A fine ranging from VND 1.000.000 to VND
5.000.000 shall be imposed if the damage is assessed at less than VND
50.000.000;
b) A fine ranging from VND 5.000.000 to VND
10.000.000 shall be imposed if the damage is assessed at from VND 50.000.000 to
less than VND 100.000.000;
c) A fine ranging from VND 10.000.000 to VND
15.000.000 shall be imposed if the damage is assessed at from VND 100.000.000
to less than VND 500.000.000;
d) A fine ranging from VND 15.000.000 to VND
20.000.000 shall be imposed if the damage is assessed at from VND 500.000.000
to less than VND 1.000.000.000;
dd) A fine ranging from VND 20.000.000 to VND
30.000.000 shall be imposed if the damage is assessed at from VND 1.000.000.000
to less than VND 5.000.000.000;
e) A fine ranging from VND 30.000.000 to VND
40.000.000 shall be imposed if the damage is assessed at VND 5.000.000.000 or
more.
4. Remedial measures:
a) The violating entity is compelled to transfer
the amounts of money involving in the violation in Clause 2 or Clause 3 of this
Article to the dedicated account of the health insurance fund;
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
c) The violating entity is compelled to make
compensations for any damage incurred by the health facility in case of
commission of the violation in Clause 3 of this Article. The amounts of money
which cannot be returned to payers shall be paid to state budget in accordance
with regulations of law.
Article 90. Determination
of health insurance benefits inconsistently with information on health
insurance cards
1. A warning or a fine ranging from VND 200.000
to VND 500.000 shall be imposed for determining health insurance benefits
inconsistently with information on the health insurance card if the damage is
assessed at less than VND 1.000.000.
2. The following fines shall be imposed for
determining health insurance benefits inconsistently with information on the
health insurance card:
a) A fine ranging from VND 1.000.000 to VND
2.000.000 shall be imposed if the damage is assessed at from VND 1.000.000 to
less than VND 5.000.000;
b) A fine ranging from VND 2.000.000 to VND
3.000.000 shall be imposed if the damage is assessed at from VND 5.000.000 to
less than VND 10.000.000;
c) A fine ranging from VND 3.000.000 to VND
4.000.000 shall be imposed if the damage is assessed at from VND 10.000.000 to
less than VND 15.000.000;
d) A fine ranging from VND 4.000.000 to VND
5.000.000 shall be imposed if the damage is assessed at from VND 15.000.000 to
less than VND 20.000.000;
dd) A fine ranging from VND 5.000.000 to VND
6.000.000 shall be imposed if the damage is assessed at from VND 20.000.000 to
less than VND 40.000.000;
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
3. Remedial measures:
a) The violating entity is compelled to make
compensations for any damage incurred by health insurance policyholders in
commission of the violation in Clause 1 or 2 of this Article. Any payments
which cannot be made to payers shall be paid to state budget in accordance with
regulations of law;
b) The violating entity is compelled to make
compensations for any damage incurred by the health facility in case of
commission of the violation in Clause 1 or 2 of this Article. Any payments
which cannot be made to payers shall be paid to state budget in accordance with
regulations of law;
c) The violating entity is compelled to transfer
the amounts of money involving in the violation in Clause 1 or Clause 2 of this
Article to the dedicated account of the health insurance fund.
Article 91. Violations
against regulations on reporting on implementation of health insurance policies
to competent authorities
1. A warning or a fine ranging from VND 200.000
to VND 500.000 shall be imposed for submitting reports on implementation of
health insurance policies after the prescribed deadline or with no data or
incorrect data to competent authorities but the violation does not yet
adversely affect management, implementation and formulation of health insurance
policies.
2. A fine ranging from VND 5.000.000 to VND
10.000.000 shall be imposed for submitting reports on implementation of health
insurance policies after the prescribed deadline or with no data or incorrect
data to competent authorities resulting in adverse effects on management,
implementation and formulation of health insurance policies.
Article 92. Violations
against regulations on provision of information about health insurance
policyholders
1. A warning or a fine ranging from VND 200.000
to VND 500.000 shall be imposed for failing to provide or incorrectly or lately
providing information about health insurance policyholders but the violation
does not yet cause damage to the health insurance fund.
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
a) A fine ranging from VND 1.000.000 to VND
3.000.000 shall be imposed if the damage is assessed at less than VND
50.000.000;
b) A fine ranging from VND 3.000.000 to VND
5.000.000 shall be imposed if the damage is assessed at from VND 50.000.000 to
less than VND 100.000.000;
c) A fine ranging from VND 5.000.000 to VND
10.000.000 shall be imposed if the damage is assessed at from VND 100.000.000
to less than VND 200.000.000;
d) A fine ranging from VND 10.000.000 to VND
20.000.000 shall be imposed if the damage is assessed at VND 200.000.000 or
more.
Article 93. Violations
against regulations on provision of information for provision of health
insurance benefits to patients at health facilities or direct reimbursement of
medical costs to policyholders
1. A warning or a fine ranging from VND 200.000
to VND 500.000 shall be imposed for failing to provide or providing inadequate
or incorrect information for provision of health insurance benefits to patients
at health facilities or direct reimbursement of medical costs to policyholders
but the violation does not yet cause damage to policyholders.
2. A fine ranging from VND 1.000.000 to VND
3.000.000 shall be imposed for failing to provide or providing inadequate or
incorrect information for provision of health insurance benefits to patients at
health facilities or direct reimbursement of medical costs to policyholders
resulting in damage caused to policyholders.
3. Remedial measure:
The violating entity is compelled to make
compensations for damage incurred by health insurance policyholders in case of
commission of the violation in Clause 2 of this Article. The amounts of money
which cannot be returned to payers shall be paid to state budget in accordance
with regulations of law.
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
1. A fine ranging from VND 500.000 to VND
1.000.000 shall be imposed for submitting statements of costs of covered
medical services less than 05 working days late after the prescribed deadline.
2. The following fines shall be imposed for late
submission of statements of costs of covered medical services:
a) A fine ranging from VND 3.000.000 to VND
5.000.000 shall be imposed if the statement is submitted from 05 to less than
20 working days late after the prescribed deadline;
b) A fine ranging from VND 5.000.000 to VND 7.000.000
shall be imposed if the statement is submitted 20 working days or more late
after the prescribed deadline.
Article 95. Violations
against other regulations on health insurance
1. A fine ranging from VND 500.000 to VND
1.000.000 shall be imposed for commission of one of the following violations:
a) Causing difficulties in or obstructing the
provision of covered medical services but the violation does not yet cause
damage to policyholders and health facilities;
b) Taking advantage of prescription or using
drugs, chemicals, medical supplies, technical services and other medical
services in excess of essential levels according to regulations on medical
techniques and qualifications resulting in damage assessed at less than VND
1.000.000 caused to policyholders, health insurance fund and health facilities.
2. The following fines shall be imposed for
causing difficulties in or obstructing the provision of covered medical
services resulting in damage to policyholders and health facilities;
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
b) A fine ranging from VND 2.000.000 to VND
3.000.000 shall be imposed if the damage is assessed at from VND 5.000.000 to
less than VND 10.000.000;
c) A fine ranging from VND 3.000.000 to VND
5.000.000 shall be imposed if the damage is assessed at from VND 10.000.000 to
less than VND 15.000.000;
d) A fine ranging from VND 5.000.000 to VND
10.000.000 shall be imposed if the damage is assessed at from VND 15.000.000 to
less than VND 20.000.000;
dd) A fine ranging from VND 10.000.000 to VND
15.000.000 shall be imposed if the damage is assessed at from VND 20.000.000 to
less than VND 40.000.000;
e) A fine ranging from VND 15.000.000 to VND
20.000.000 shall be imposed if the damage is assessed at VND 40.000.000 or
more.
3. The following fines shall be imposed for
misusing covered medical services, including prescribing and using drugs,
chemicals, medical supplies, technical services and other medical services in
excess of the maximum norms or essential levels according to regulations on
medical techniques and qualifications resulting in damage to policyholders,
health facilities and health insurance fund:
a) A fine ranging from VND 1.000.000 to VND
2.000.000 shall be imposed if the damage is assessed at from VND 1.000.000 to
less than VND 5.000.000;
b) A fine ranging from VND 2.000.000 to VND
3.000.000 shall be imposed if the damage is assessed at from VND 5.000.000 to
less than VND 10.000.000;
c) A fine ranging from VND 3.000.000 to VND
5.000.000 shall be imposed if the damage caused by the violation is assessed at
from VND 10.000.000 to less than VND 20.000.000;
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
dd) A fine ranging from VND 10.000.000 to VND
20.000.000 shall be imposed if the damage is assessed at from VND 40.000.000 to
less than VND 60.000.000;
e) A fine ranging from VND 20.000.000 to VND
30.000.000 shall be imposed if the damage is assessed at from VND 60.000.000 to
less than VND 80.000.000;
g) A fine ranging from VND 30.000.000 to VND
40.000.000 shall be imposed if the damage is assessed at VND 80.000.000 or
more.
4. A fine ranging from VND 1.000.000 to VND
3.000.000 shall be imposed for commission of one of the following violations:
a) Failing to register the specimen seal and
signature of the practitioner licensed to sign certificates of incapacity and
of the person authorized to sign and append the seal of the health facility on
certificates with the competent social agency;
b) Failing to make connection for data sharing
and prepare electronic documents in medical examination and treatment according
to regulations on electronic transactions in health insurance sector.
5. Remedial measures:
a) The violating entity is compelled to make
compensations for any damage incurred by the health facility in case of
commission of the violation in Point b Clause 1, Clause 2 or Clause 3 of this
Article. Any payments which cannot be made to payers shall be paid to state
budget in accordance with regulations of law;
b) The violating entity is compelled to make
compensations for any damage incurred by health insurance policyholders in
commission of the violation in Point b Clause 1, Clause 2 or Clause 3 of this
Article. Any payments which cannot be made to payers shall be paid to state
budget in accordance with regulations of law;
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
Section 6. VIOLATIONS AGAINST
REGULATIONS ON POPULATION
Article 96. Violations
against regulations on dissemination of information and counseling on
population, reproductive health and birth control
1. A warning or a fine ranging from VND 200.000
to VND 500.000 shall be imposed for obstructing the dissemination and provision
of information and counseling on population, reproductive health and birth
control.
2. A fine ranging from VND 3.000.000 to VND
5.000.000 shall be imposed for commission of one of the following violations:
a) Disseminating or providing information that
is contrary to the Communist Party’s guidelines and policies, State law or
elegant traditional heritages, or adversely affects the performance of
population tasks and social life;
b) Disseminating information that is false or
inaccurate or adversely affects the performance of population tasks, social
life or other sectors;
c) Taking advantage of propagation activities
and dissemination of information on population, reproductive health and birth
control for disseminating documents/objects or performing other acts contrary
to traditional customs and habits, and social ethics.
3. Additional penalty:
The exhibits, including documents and objects
containing violating information, of the violation in Clause 2 of this Article
shall be confiscated.
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Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
a) The exhibits used for committing the
violation in Clause 2 of this Article shall be destroyed;
b) The violating entity is compelled to correct
any information that is contrary to the Communist Party’s guidelines and
policies, and State law on population in case of commission of the violation in
Clause 2 of this Article.
Article 97. Violations
against regulations on dissemination of information and counseling on sex
selection methods
1. A fine ranging from VND 3.000.000 to VND
5.000.000 shall be imposed for commission of one of the following violations:
a) Disseminating information on sex selection
methods;
b) Providing counseling on sex selection
methods.
2. A fine ranging from VND 5.000.000 to VND
10.000.000 shall be imposed for commission of one of the following violations:
a) Selling, leasing, delivering or publishing on
the internet publications or articles containing information on sex selection
methods;
b) Publishing or broadcasting information on sex
selection methods.
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
4. Additional penalty:
The exhibits, including publications, articles
and documents used for propagation and information dissemination activities, of
the violation in Clause 1, 2 or 3 of this Article shall be confiscated.
5. Remedial measure:
Violating elements must be removed in case of
commission of the violation in Point a Clause 1 or Point b Clause 2 of this
Article. If violating elements cannot be removed, products shall be destroyed.
Article 98. Violations
against regulations on fetal sex diagnosis and determination
1. A fine ranging from VND 3.000.000 to VND
5.000.000 shall be imposed for determining fetal sex by means of
fortune-telling.
2. A fine ranging from VND 5.000.000 to VND
10.000.000 shall be imposed for checking the pulse, giving ultrasound scan or
performing tests for pregnant women for diagnosing and revealing/providing
information on fetal sex, unless otherwise prescribed by law.
3. Additional penalty:
The license for medical operations and/or
practicing certificate shall be suspended for a fixed period of 01 – 03 months
in case of commission of the violation in Clause 2 of this Article.
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
1. A fine ranging from VND 5.000.000 to VND
10.000.000 shall be imposed for threatening to use violence or mentally
intimidating a person into adopting sex selection methods.
2. A fine ranging from VND 10.000.000 to VND
15.000.000 shall be imposed for using violence to force a person to adopt sex
selection methods.
3. A fine ranging from VND 15.000.000 to VND
20.000.000 shall be imposed for commission of one of the following violations:
a) Prescribing or instructing a person to use
drugs for selecting fetal sex;
b) Providing tools, drugs and supplies for
selecting fetal sex;
c) Doing research on sex selection methods,
unless otherwise prescribed by law.
4. Additional penalties:
a) Operations of the violating entity shall be
suspended for a fixed period of 01 – 03 months in case of commission of the
violation in Clause 3 of this Article;
b) The medical examination and treatment
practicing certificate shall be suspended for a fixed period of 01 – 03 months
in case of commission of the violation in Clause 3 of this Article.
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
Tools, drugs and supplies involving in the
violation in Point b Clause 3 of this Article shall be destroyed.
Article 100. Sex-selective
abortion
1. A fine ranging from VND 3.000.000 to VND
5.000.000 shall be imposed for voluntarily deciding to have an abortion because
of the predicted sex of the infant.
2. A fine ranging from VND 5.000.000 to VND 7.000.000
shall be imposed for persuading or inciting a pregnant woman to have an
abortion because of the predicted sex of the infant.
3. A fine ranging from VND 7.000.000 to VND
10.000.000 shall be imposed for threatening to use violence or mentally
intimidating a pregnant woman into an abortion because of the predicted sex of
the infant.
4. A fine ranging from VND 10.000.000 to VND
12.000.000 shall be imposed for using violence to force a pregnant woman to
have an abortion because of the predicted sex of the infant.
5. A fine ranging from VND 12.000.000 to VND
15.000.000 shall be imposed for commission of one of the following violations:
a) Providing chemicals and drugs for aborting
the pregnancy in the knowledge that the abortion is sex-selective;
b) Prescribing for or instructing the use of
chemicals and drugs or other measures for aborting the pregnancy in the
knowledge that the abortion is sex-selective.
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
7. Additional penalties:
a) The license for medical operations and/or
practicing certificate shall be suspended for a fixed period of 03 – 06 months
in case of commission of the violation in Clause 5 of this Article;
b) The license for medical operations and/or
practicing certificate shall be suspended for a fixed period of 06 – 12 months
in case of commission of the violation in Clause 6 of this Article;
c) The certificate of eligibility for pharmacy
business or operations of the violating non-commercial pharmacy business
establishment shall be suspended for a fixed period of 01 – 03 months in case
of commission of the violation in Point a Clause 5 of this Article.
Article 101. Violations
against regulations on forced birth control
1. A warning or a fine ranging from VND 200.000
to VND 500.000 shall be imposed for commission of one of the following
violations:
a) Failing to provide free of charge
contraceptives for individuals who are eligible as prescribed by law and have
registered for free-of-charge receipt of contraceptives;
b) Having or performing words or acts that
offend the honor or dignity of persons adopting contraceptive methods or
persons who only give birth to boys or girls.
2. A fine ranging from VND 1.000.000 to VND
2.000.000 shall be imposed for threatening to use violence or mentally
intimidating others into using contraceptive methods.
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
a) Threatening to use violence or mentally
intimidating others into not using or stopping using contraceptive methods;
b) Threatening to use violence or mentally intimidating
a woman who has only given birth to boys or girls into conceiving or giving
birth.
4. A fine ranging from VND 5.000.000 to VND
7.000.000 shall be imposed for using violence to force others to use
contraceptive methods.
5. A fine ranging from VND 7.000.000 to VND
10.000.000 shall be imposed for commission of one of the following violations:
a) Inserting intrauterine devices, injecting or
implanting contraceptive without the user’s consent;
b) Using violence to force others not to use or
to stop using contraceptive methods;
c) Using violence to force a woman who has only
given birth to boys or girls into conceiving or giving birth.
6. A fine ranging from VND 20.000.000 to VND
30.000.000 shall be imposed for performing sterilization procedure for a person
without his/her consent.
7. Additional penalty:
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
8. Remedial measure:
Intrauterine devices/implanted contraceptives
shall be removed in case of commission of the violation in Point a Clause 5 of
this Article.
Article 102. Violations
against regulations on sale of contraceptives
1. A fine ranging from VND 1.000.000 to VND
3.000.000 shall be imposed for selling contraceptives which must be provided
free of charge as prescribed by competent authorities.
2. A fine ranging from VND 3.000.000 to VND
5.000.000 shall be imposed for selling contraceptives at prices higher than
those fixed by competent authorities.
3. Additional penalty:
The exhibits that are contraceptives in the
violation in Clause 1 of this Article shall be confiscated.
4. Remedial measure:
The entity committing the violation in Clause 1
or Clause 2 of this Article is compelled to return any amounts of money
collected against regulations of law. The amounts of money which cannot be
returned to payers shall be paid to state budget in accordance with regulations
of law.
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
POWER TO IMPOSE
PENALTIES FOR ADMINISTRATIVE VIOLATIONS IN MEDICAL SECTOR
Article 103. Power to
impose penalties of Chairpersons of People’s Committees
1. Chairpersons of communal-level People’s
Committees shall have the power to:
a) Issue warning;
b) Impose a fine up to VND 3.000.000 for the
administrative violations against regulations on population, or up to VND
5.000.000 for the administrative violations against regulations on preventive
medicine, HIV/AIDS prevention and control, health insurance, medical
examination and treatment, pharmacy, cosmetics and medical devices;
c) Confiscate the exhibits and instrumentalities
which have been used for committing administrative violations but are worth
less than the corresponding fine in each sector specified in Point b of this
Clause;
d) Enforce the remedial measures mentioned in
Points c and dd Clause 1 Article 28 of the Law on actions against
administrative violations.
2. Chairpersons of district-level People’s
Committees shall have the power to:
a) Issue warning;
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
c) Suspend licenses/practicing certificates or
operations for a fixed period;
d) Confiscate the exhibits and instrumentalities
which have been used for committing administrative violations but are worth
less than the corresponding fine in each sector specified in Point b of this
Clause;
dd) Enforce the remedial measures mentioned in
Points c, dd, e, h and i Clause 1 Article 28 of the Law on penalties for
administrative violations and in Clause 3 Article 3 hereof.
3. Chairpersons of provincial-level People’s
Committees shall have the power to:
a) Issue warning;
b) Impose a fine up to VND 30.000.000 for the
administrative violations against regulations on population, up to VND
50.000.000 for the administrative violations against regulations on preventive
medicine, HIV/AIDS prevention and control, up to VND 75.000.000 for the
administrative violations against regulations on health insurance, or up to VND
100.000.000 for the administrative violations against regulations on medical
examination and treatment, pharmacy, cosmetics and medical devices;
c) Suspend licenses/practicing certificates or
operations for a fixed period;
d) Confiscate the exhibits and instrumentalities
used for committing administrative violations;
dd) Enforce the remedial measures mentioned in
Points c, d, dd, e, g, h and i Clause 1 Article 28 of the Law on penalties for
administrative violations and in Clause 3 Article 3 hereof.
…
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
1. On-duty inspectors and persons assigned to
carry out specialized inspections shall have the power to:
a) Issue warning;
b) Impose a fine up to VND 300.000 for the
administrative violations against regulations on population, or up to VND
500.000 for the administrative violations against regulations on preventive
medicine, HIV/AIDS prevention and control, health insurance, medical
examination and treatment, pharmacy, cosmetics and medical devices;
c) Confiscate the exhibits and instrumentalities
which have been used for committing administrative violations but are worth
less than the corresponding fine in each sector specified in Point b of this
Clause;
d) Enforce the remedial measures mentioned in
Points c and dd Clause 1 Article 28 of the Law on actions against
administrative violations.
2. Chief Inspectors of provincial departments,
Directors of Branches for Population and Family Planning affiliated to
provincial Departments of Health, Directors of Branches of Vietnam Food
Administration, heads of provincial-level specialized inspection teams, and
heads of specialized inspection teams established by competent authorities
assigned to perform specialized inspection functions shall have the power to:
a) Issue warning;
b) Impose a fine up to VND 15.000.000 for the
administrative violations against regulations on population, up to VND
25.000.000 for the administrative violations against regulations on preventive
medicine, HIV/AIDS prevention and control, up to VND 37.500.000 for the
administrative violations against regulations on health insurance, or up to VND
50.000.000 for the administrative violations against regulations on medical
examination and treatment, pharmacy, cosmetics and medical devices;
c) Suspend licenses/practicing certificates or operations
for a fixed period;
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
dd) Enforce the remedial measures mentioned in
Points c, d, dd, e, g, h and i Clause 1 Article 28 of the Law on penalties for
administrative violations and in Clause 3 Article 3 hereof.
3. Chief Inspectors of Ministries, Director
General of General Office for Population and Family Planning, Director General
of Drug Administration of Vietnam, Director General of Vietnam Administration
of Medical Services, Director General of Health Environment Management Agency,
Director General of General Department of Preventive Medicine, and holders of
equivalent titles assigned by the Government to perform specialized inspection
tasks shall have the power to:
a) Issue warning;
b) Impose a fine up to VND 30.000.000 for the
administrative violations against regulations on population, up to VND
50.000.000 for the administrative violations against regulations on preventive
medicine, HIV/AIDS prevention and control, up to VND 75.000.000 for the
administrative violations against regulations on health insurance, or up to VND
100.000.000 for the administrative violations against regulations on medical
examination and treatment, pharmacy, cosmetics and medical devices;
c) Suspend licenses/practicing certificates or
operations for a fixed period;
d) Confiscate the exhibits and instrumentalities
used for committing administrative violations;
dd) Enforce the remedial measures mentioned in
Points c, d, dd, e, g, h and i Clause 1 Article 28 of the Law on penalties for
administrative violations and in Clause 3 Article 3 hereof.
4. Heads of specialized inspection teams
established by Ministries shall have the power to:
a) Issue warning;
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
c) Suspend licenses/practicing certificates or
operations for a fixed period;
d) Confiscate the exhibits and instrumentalities
which have been used for committing administrative violations but are worth
less than the fine specified in Point b of this Clause;
dd) Enforce the remedial measures mentioned in
Points c, d, dd, e, g, h and i Clause 1 Article 28 of the Law on penalties for
administrative violations and in Clause 3 Article 3 hereof.
Article 105. Power to
impose penalties of market surveillance forces
1. Market controllers on duty shall have the
power to:
a) Issue warning;
b) Impose a fine up to VND 500.000 for the
administrative violations against regulations on population, preventive
medicine, medical examination and treatment, pharmacy, cosmetics and medical
devices.
2. Leaders of market surveillance teams shall
have the power to:
a) Issue warning;
…
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
c) Confiscate the exhibits and instrumentalities
which have been used for committing administrative violations but are worth
less than the fine specified in Point b of this Clause;
d) Enforce the remedial measures mentioned in
Point dd, e, h and i Clause 1 Article 28 of the Law on penalties for
administrative violations and those mentioned in Clause 3 Article 3 hereof.
3. Directors of Provincial Market Surveillance
Departments and Director of Market Surveillance Operations Department
affiliated to Vietnam Directorate of Market Surveillance shall have the power
to:
a) Issue warning;
b) Impose a fine up to VND 30.000.000 for the
administrative violations against regulations on population, or up to VND
50.000.000 for the administrative violations against regulations on preventive
medicine, medical examination and treatment, pharmacy, cosmetics and medical
devices;
c) Confiscate the exhibits and instrumentalities
which have been used for committing administrative violations but are worth
less than the fine specified in Point b of this Clause;
d) Suspend licenses/practicing certificates or
suspend operations for fixed periods;
dd) Enforce the remedial measures mentioned in
Points c, d, dd, e, g, h and i Clause 1 Article 28 of the Law on penalties for
administrative violations and in Clause 3 Article 3 hereof.
4. Director General of Vietnam Directorate of
Market Surveillance shall have the power to:
…
…
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
b) Impose a fine up to VND 30.000.000 for the
administrative violations against regulations on population, or up to VND
50.000.000 for the administrative violations against regulations on preventive
medicine, or up to VND 100.000.000 for the administrative violations against
regulations on medical examination and treatment, pharmacy, cosmetics and
medical devices;
c) Confiscate the exhibits and instrumentalities
used for committing administrative violations;
d) Suspend licenses/practicing certificates or
suspend operations for fixed periods;
dd) Enforce the remedial measures mentioned in
Points c, d, dd, e, g, h and i Clause 1 Article 28 of the Law on penalties for
administrative violations and in Clause 3 Article 3 hereof.
Article 106. Power to
impose penalties of people’s public security forces
1. On-duty soldiers of people’s police forces
shall have the power to:
a) Issue warning;
b) Impose a fine up to VND 300.000 for the
administrative violations against regulations on population, or up to VND
500.000 for the administrative violations against regulations on preventive
medicine, HIV/AIDS prevention and control, medical examination and treatment,
pharmacy, cosmetics and medical devices.
2. Heads of police stations and leaders of the
soldiers mentioned in Clause 1 of this Article shall have the power to:
…
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
b) Impose a fine up to VND 900.000 for the
administrative violations against regulations on population, or up to VND
1.500.000 for the administrative violations against regulations on preventive
medicine, HIV/AIDS prevention and control, health insurance, medical
examination and treatment, pharmacy, cosmetics and medical devices.
3. Heads of communal police authorities and
heads of police stations at checkpoints and export processing zones shall have
the power to:
a) Issue warning;
b) Impose a fine up to VND 1.500.000 for the
administrative violations against regulations on population, or up to VND
2.500.000 for the administrative violations against regulations on preventive
medicine, HIV/AIDS prevention and control, health insurance, medical
examination and treatment, pharmacy, cosmetics and medical devices;
c) Confiscate the exhibits and instrumentalities
which have been used for committing administrative violations but are worth
less than the fine specified in Point b of this Clause;
d) Enforce the remedial measures mentioned in
Points c and dd Clause 1 Article 28 of the Law on actions against administrative
violations.
4. Heads of District-level police forces, heads
of operations divisions affiliated to the Police Department for Administrative
Management of Social Order, heads of operations divisions affiliated to the
Traffic Police Department, and heads of provincial-level police agencies,
including: Heads of economic security departments, heads of police departments
for administrative management of social order, heads of environment crime
prevention and fighting police departments, heads of traffic police
departments, heads of railway and road traffic police departments, heads of
waterway traffic police departments, and heads of police departments for
investigation into corruption, economy and smuggling-related crimes, shall have
the power to:
a) Issue warning;
b) Impose a fine up to VND 6.000.000 for the
administrative violations against regulations on population, up to VND
10.000.000 for the administrative violations against regulations on preventive
medicine, and HIV/AIDS prevention and control, up to VND 15.000.000 for the
administrative violations against regulations on health insurance, or up to VND
20.000.000 for the administrative violations against regulations on medical
examination and treatment, pharmacy, cosmetics and medical devices;
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
d) Confiscate the exhibits and instrumentalities
which have been used for committing administrative violations but are worth
less than the fine specified in Point b of this Clause;
dd) Enforce the remedial measures mentioned in
Points c and dd Clause 1 Article 28 of the Law on penalties for administrative
violations and in Clause 3 Article 3 hereof.
5. Directors of provincial-level Public Security
Departments shall have the power to:
a) Issue warning;
b) Impose a fine up to VND 15.000.000 for the
administrative violations against regulations on population, up to VND
25.000.000 for the administrative violations against regulations on preventive
medicine, and HIV/AIDS prevention and control, up to VND 35.000.000 for the
administrative violations against regulations on health insurance, or up to VND
50.000.000 for the administrative violations against regulations on medical
examination and treatment, pharmacy, cosmetics and medical devices;
c) Suspend licenses/practicing certificates or
operations for a fixed period;
d) Confiscate the exhibits and instrumentalities
which have been used for committing administrative violations but are worth
less than the fine specified in Point b of this Clause;
dd) Enforce the remedial measures mentioned in
Points c, dd and i Clause 1 Article 28 of the Law on penalties for
administrative violations and in Clause 3 Article 3 hereof.
e) Impose the deportation penalty in accordance
with current regulations on imposition of deportation penalty under
administrative procedures.
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
a) Issue warning;
b) Impose a fine up to VND 30.000.000 for the
administrative violations against regulations on population, up to VND
50.000.000 for the administrative violations against regulations on preventive
medicine, and HIV/AIDS prevention and control, up to VND 75.000.000 for the
administrative violations against regulations on health insurance, or up to VND
100.000.000 for the administrative violations against regulations on medical
examination and treatment, pharmacy, cosmetics and medical devices;
c) Suspend licenses/practicing certificates or
operations for a fixed period;
d) Confiscate the exhibits and instrumentalities
used for committing administrative violations;
dd) Enforce the remedial measures mentioned in
Points c, dd and i Clause 1 Article 28 of the Law on penalties for
administrative violations and in Clause 3 Article 3 herein.
Article 107. Power to
impose penalties of customs agencies
1. Customs officials on duty shall have the
power to:
a) Issue warning;
b) Impose a fine up to VND 500.000 for the
administrative violations against regulations on preventive medicine, HIV/AIDS
prevention and control, pharmacy, cosmetics and medical devices.
…
…
…
TVPL
Pro
để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
a) Issue warning;
b) Impose a fine up to VND 5.000.000 for the
administrative violations against regulations on preventive medicine, HIV/AIDS
prevention and control, pharmacy, cosmetics and medical devices.
3. Directors of Customs Branches, Directors of
Post-clearance Audit Branches, leaders of customs control teams affiliated to
Customs Departments of provinces, leaders of anti-smuggling control teams,
commanders of marine control squads and leaders of intellectual property
protection and control teams affiliated to Anti-smuggling and Investigation
Department of General Department of Customs shall have the power to:
a) Issue warning;
b) Impose a fine up to VND 25.000.000 for the
administrative violations against regulations on preventive medicine, HIV/AIDS
prevention and control, pharmacy, cosmetics and medical devices;
b) Confiscate the exhibits and instrumentalities
which have been used for committing administrative violations but are worth
less than the fine specified in Point b of this Clause;
c) Enforce the remedial measures mentioned in
Points d, dd and i Clause 1 Article 28 of the Law on penalties for
administrative violations and in Clause 3 Article 3 hereof.
4. Directors of Anti-smuggling and Investigation
Department and Post-clearance Audit Department affiliated to General Department
of Customs, and Directors of Customs Departments of provinces shall have the
power to:
a) Issue warning;
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
c) Suspend licenses/practicing certificates or
operations for a fixed period;
d) Confiscate the exhibits and instrumentalities
which have been used for committing administrative violation but are worth less
than the fine specified in Point b of this Clause;
dd) Enforce the remedial measures mentioned in
Points d, dd and i Clause 1 Article 28 of the Law on penalties for
administrative violations and in Clause 3 Article 3 hereof.
5. Director General of General Department of
Customs shall have the power to:
a) Issue warning;
b) Impose a fine up to VND 50.000.000 for the
administrative violations against regulations on preventive medicine, or up to
VND 100.000.000 for the administrative violations against regulations on
pharmacy, cosmetics and medical devices;
c) Suspend licenses/practicing certificates or
operations for a fixed period;
d) Confiscate the exhibits and instrumentalities
used for committing administrative violations;
dd) Enforce the remedial measures mentioned in
Points d, dd and i Clause 1 Article 28 of the Law on penalties for
administrative violations and in Clause 3 Article 3 hereof.
…
…
…
TVPL
Pro
để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
1. On-duty soldiers of border guard forces shall
have the power to:
a) Issue warning;
b) Impose a fine up to VND 300.000 for the
administrative violations against regulations on population, or up to VND
500.000 for the administrative violations against regulations on preventive
medicine, HIV/AIDS prevention and control, medical examination and treatment,
pharmacy, cosmetics and medical devices.
2. Heads of border guard stations and leaders of
soldiers of border guard forces shall have the power to:
a) Issue warning;
b) Impose a fine up to VND 1.500.000 for the
administrative violations against regulations on population, or up to VND
2.500.000 for the administrative violations against regulations on preventive
medicine, HIV/AIDS prevention and control, medical examination and treatment,
pharmacy, cosmetics and medical devices.
3. Heads of border-guard posts, commanders of
border-guard flotillas and commanders of port border guards shall have the
power to:
a) Issue warning;
b) Impose a fine up to VND 6.000.000 for the
administrative violations against regulations on population, or up to VND
10.000.000 for the administrative violations against regulations on preventive
medicine, and HIV/AIDS prevention and control, or up to VND 20.000.000 for the
administrative violations against regulations on medical examination and
treatment, pharmacy, cosmetics and medical devices;
…
…
…
TVPL
Pro
để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
d) Enforce the remedial measures mentioned in
Points c and dd Clause 1 Article 28 of the Law on penalties for administrative
violations and in Clause 3 Article 3 hereof.
4. Commanders of provincial-level border guard
forces and commanders of border guard fleets affiliated to the Border Guard
High Command shall have the power to:
a) Issue warning;
b) Impose a fine up to VND 30.000.000 for the
administrative violations against regulations on population, or up to VND
50.000.000 for the administrative violations against regulations on preventive
medicine, and HIV/AIDS prevention and control, or up to VND 100.000.000 for the
administrative violations against regulations on medical examination and
treatment, pharmacy, cosmetics and medical devices;
c) Suspend licenses/practicing certificates or
operations for a fixed period;
d) Confiscate the exhibits and instrumentalities
used for committing administrative violations;
dd) Enforce the remedial measures mentioned in
Points c, dd and i Clause 1 Article 28 of the Law on penalties for
administrative violations and in Clause 3 Article 3 hereof.
Article 109. Power to
impose penalties of Vietnam marine police forces
1. Coast guard officers on duty shall have the
power to:
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
b) Impose a fine up to VND 600.000 for the
administrative violations against regulations on population, or up to VND
1.500.000 for the administrative violations against regulations on preventive
medicine, HIV/AIDS prevention and control, medical examination and treatment,
pharmacy, cosmetics and medical devices.
2. Coastguard team leaders shall have the power
to:
a) Issue warning;
b) Impose a fine up to VND 1.500.000 for the
administrative violations against regulations on population, or up to VND
2.500.000 for the administrative violations against regulations on preventive
medicine, and HIV/AIDS prevention and control, or up to VND 5.000.000 for the
administrative violations against regulations on medical examination and
treatment, pharmacy, cosmetics and medical devices.
3. Coastguard squad leaders and captains of
coastguard stations shall have the power to:
a) Issue warning;
b) Impose a fine up to VND 3.000.000 for the
administrative violations against regulations on population, or up to VND
5.000.000 for the administrative violations against regulations on preventive
medicine, and HIV/AIDS prevention and control, or up to VND 10.000.000 for the
administrative violations against regulations on medical examination and
treatment, pharmacy, cosmetics and medical devices;
c) Enforce the remedial measures mentioned in
Points c and dd Clause 1 Article 28 of the Law on penalties for administrative
violations.
4. Commanders of coastguard platoons shall have
the power to:
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Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
b) Impose a fine up to VND 6.000.000 for the
administrative violations against regulations on population, or up to VND
10.000.000 for the administrative violations against regulations on preventive
medicine, and HIV/AIDS prevention and control, or up to VND 20.000.000 for the
administrative violations against regulations on medical examination and
treatment, pharmacy, cosmetics and medical devices;
c) Confiscate the exhibits and instrumentalities
which have been used for committing administrative violations but are worth
less than the fine specified in Point b of this Clause;
d) Enforce the remedial measures mentioned in
Points c, d and dd Clause 1 Article 28 of the Law on penalties for
administrative violations and in Clause 3 Article 3 hereof.
5. Commanders in chief of coastguard squadrons
shall have the power to:
a) Issue warning;
b) Impose a fine up to VND 9.000.000 for the
administrative violations against regulations on population, or up to VND
15.000.000 for the administrative violations against regulations on preventive
medicine, and HIV/AIDS prevention and control, or up to VND 30.000.000 for the
administrative violations against regulations on medical examination and
treatment, pharmacy, cosmetics and medical devices;
c) Confiscate the exhibits and instrumentalities
which have been used for committing administrative violations but are worth
less than the fine specified in Point b of this Clause;
d) Enforce the remedial measures mentioned in
Points c, d and dd Clause 1 Article 28 of the Law on penalties for
administrative violations and in Clause 3 Article 3 hereof.
6. Commanders of Regional Coast Guards shall
have the power to:
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Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
b) Impose a fine up to VND 15.000.000 for the
administrative violations against regulations on population, or up to VND
25.000.000 for the administrative violations against regulations on preventive
medicine, and HIV/AIDS prevention and control, or up to VND 50.000.000 for the
administrative violations against regulations on medical examination and
treatment, pharmacy, cosmetics and medical devices;
c) Confiscate the exhibits and instrumentalities
which have been used for committing administrative violations but are worth
less than the fine specified in Point b of this Clause;
d) Enforce the remedial measures mentioned in
Points c, d and dd Clause 1 Article 28 of the Law on penalties for
administrative violations and in Clause 3 Article 3 hereof.
7. Commander of Vietnam Coast Guard shall have
the power to:
a) Issue warning;
b) Impose a fine up to VND 30.000.000 for the
administrative violations against regulations on population, or up to VND
50.000.000 for the administrative violations against regulations on preventive
medicine, and HIV/AIDS prevention and control, or up to VND 100.000.000 for the
administrative violations against regulations on medical examination and
treatment, pharmacy, cosmetics and medical devices;
c) Suspend licenses/practicing certificates or
operations for a fixed period;
d) Confiscate the exhibits and instrumentalities
used for committing administrative violations;
dd) Enforce the remedial measures mentioned in
Points c, d and dd Clause 1 Article 28 of the Law on penalties for
administrative violations and in Clause 3 Article 3 hereof.
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
1. Tax officials on duty shall have the power
to:
a) Issue warning;
b) Impose a fine up to VND 500.000 for the
administrative violations against regulations on preventive medicine, and
HIV/AIDS prevention and control.
2. Tax team leaders shall have the power to:
a) Issue warning;
b) Impose a fine up to VND 2.500.000 for the
administrative violations against regulations on preventive medicine, and
HIV/AIDS prevention and control.
3. Directors of Sub-departments of taxation
shall have the power to:
a) Issue warning;
b) Impose a fine up to VND 25.000.000 for the
administrative violations against regulations on preventive medicine, and
HIV/AIDS prevention and control;
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
d) Enforce the remedial measures mentioned in
Points i and k Clause 1 Article 28 of the Law on penalties for administrative
violations and in Clause 3 Article 3 hereof.
4. Directors of Departments of taxation shall
have the power to:
a) Issue warning;
b) Impose a fine up to VND 50.000.000 for the
administrative violations against regulations on preventive medicine, and
HIV/AIDS prevention and control;
c) Confiscate the exhibits and instrumentalities
which have been used for committing administrative violations but are worth
less than the fine specified in Point b of this Clause;
d) Enforce the remedial measures mentioned in
Points i and k Clause 1 Article 28 of the Law on penalties for administrative
violations and in Clause 3 Article 3 hereof.
5. Director General of General Department of
Taxation shall have the power to:
a) Issue warning;
b) Impose a fine up to VND 50.000.000 for the
administrative violations against regulations on preventive medicine, and
HIV/AIDS prevention and control;
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
d) Enforce the remedial measures mentioned in
Points i and k Clause 1 Article 28 of the Law on penalties for administrative
violations and in Clause 3 Article 3 hereof.
Article 111. Power to
impose penalties of social security authorities
1. Directors of provincial-level social security
authorities shall have the power to:
a) Issue warning;
b) Impose a fine up to VND 37.500.000 for the
administrative violations against regulations on health insurance;
c) Suspend licenses/practicing certificates or
operations for a fixed period;
d) Confiscate the exhibits and instrumentalities
which have been used for committing administrative violations but are worth
less than the fine specified in Point b of this Clause;
dd) Enforce the remedial measures mentioned in
Points c, d, dd, e, g, h and i Clause 1 Article 28 of the Law on penalties for
administrative violations and in Clause 3 Article 3 hereof.
2. General Director of Vietnam Social Security
shall have the power to:
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
b) Impose a fine up to VND 75.000.000 for the
administrative violations against regulations on health insurance;
c) Suspend licenses/practicing certificates or
operations for a fixed period;
d) Confiscate the exhibits and instrumentalities
used for committing administrative violations;
dd) Enforce the remedial measures mentioned in
Points c, d, dd, e, g, h and i Clause 1 Article 28 of the Law on penalties for
administrative violations and in Clause 3 Article 3 hereof.
3. Heads of specialized inspection teams
established by General Director of Vietnam Social Security shall have the power
to:
a) Issue warning;
b) Impose a fine up to VND 52.500.000 for the
administrative violations against regulations on health insurance;
c) Suspend licenses/practicing certificates or
operations for a fixed period;
d) Confiscate the exhibits and instrumentalities
which have been used for committing administrative violations but are worth
less than the fine specified in Point b of this Clause;
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
Article 112. Division of
power to impose penalties
1. Chairpersons of people’s committees of all
levels shall have the power to make records of, impose penalties, and enforce
remedial measures against the administrative violations in Chapter II hereof
within their competence prescribed in Article 103 hereof and within the ambit
of their assigned functions, duties and powers.
2. Health inspectors competent to impose
penalties and persons assigned to perform specialized health inspections shall
have the power to make records of, impose penalties, and enforce remedial
measures against the administrative violations in Chapter II hereof within
their competence prescribed in Article 104 hereof, the administrative
violations in medical sector within the competence of holders of equivalent
titles prescribed in other Decrees prescribing penalties for administrative
violations, and within the ambit of their assigned functions, duties and
powers.
3. Officers competent to impose penalties of
market surveillance forces shall have the power to make records of, impose
penalties, and enforce remedial measures against the administrative violations
in Articles 14, 25, 26, 27, 29, 30, 31, 32, 33, 34, 35, 36, 37, 49, 50, 51, 52,
53, 54, 55, 57, 58, 59, 60, 64, 65, 66, 67, 69, 70, 71, 72, 73, 74, 75, 76, 77,
78, 102, Clause 4 Article 6, Point h Clause 3 Article 9, Clause 3, 4 Article
12, Point dd Clause 1, Point a, d Clause 2, Point a, b, c Clause 3, Clause 4
Article 61, Clause 2 Article 68 and Point a Clause 2 Article 97 within the
ambit of their assigned functions, duties and powers, and their competence
prescribed in Article 105 hereof.
4. Officers competent to impose penalties of
people’s public security forces shall have the power to make records of, impose
penalties, and enforce remedial measures against the administrative violations
in Articles 7, 10, 11, 12, 13, 14, 15, 16, 18, 19, 22, 24, 25, 26, 27, 29, 30,
31, 32, 33, 34, 35, 36, 37, 54, 65, 66, 67, 69, 70, 76, 96, 97, 98, 99,
100, 101, 102; Point a Clause 3 Article 5; Clause 1, 2, 4 Article 6; Point a
Clause 1, Point a Clause 2, Point h Clause 3 Article 9; Point a, c Clause 5,
Point b Clause 6, Clause 7 Article 38; Point a Clause 7 Article 44; Point a
Clause 1 Article 45; Point a Clause 1, Point b Clause 2 Article 48; Point a, g
Clause 2 Article 52; Clause 3 Article 53; Clause 4 Article 55; Point c Clause 4
Article 56; Point d Clause 5, Clause 7 Article 57; Clause 7 Article 58; Clause
4, 5, 6, 7 Article 59; Point d, dd, e, g Clause 2, Point dd Clause 3, Clause 4,
5, 6, 7 Article 60; Clause 4 Article 61; Clause 5 Article 62; Clause 4 Article
63; Clause 1, 2, Point a, b Clause 3 Article 64; Clause 2, 3 Article 68; Point
b Clause 2 Article 70; Point a Clause 2, Point a, b Clause 3 Article 73; Point
g Clause 2, Clause 3 Article 74 and Point b, c, d Clause 2, Point c, d Clause 3
Article 75 hereof within the ambit of their assigned functions, duties and
powers, and their competence prescribed in Article 106 hereof.
5. Officers competent to impose penalties of
customs authorities shall have the power to make records of, impose penalties,
and enforce remedial measures against the administrative violations in Articles
7, 11, 12, 13, 14, 25, 26, 27, 29, 30, 31, 32, 33, 34, 35, 36, 37, 60, 64, 71,
76; Clause 1, 2 Article 6; Point b Clause 1 Article 54; Clause 6, 7 Article 58;
Clause 6, 7 Article 59; Point b Clause 1, Clause 2 Article 65 and Point c
Clause 2 Article 75 hereof within the ambit of their assigned functions, duties
and powers, and their competence prescribed in Article 107 hereof.
6. Officers competent to impose penalties of
border guard forces shall have the power to make records of, impose penalties,
and enforce remedial measures against the administrative violations in Article
5, 6, 7, 10, 11, 12, 13, 14, 19, 22, 24, 25, 26, 27, 30, 31, 32, 33, 34, 35,
36, 37, 60, 65, 76, 96, 97, 101, 102; Point b Clause 3 Article 8; Point b
Clause 3 Article 9; Point a, b Clause 3 Article 16; Point g Clause 2, Point dd
Clause 3 Article 23; Clause 1, 2, 3, Point a, b, c, g Clause 4, Point a Clause
5 Article 29; Point b Clause 4 Article 39; Point b Clause 3 Article 48; Point b
Clause 1 Article 52 and Clause 1, Point b Clause 2, Point a, b Clause 3 Article
64 hereof within the ambit of their assigned functions, duties and powers, and
their competence prescribed in Article 108 hereof.
7. Officers competent to impose penalties of
coast guard forces shall have the power to make records of, impose penalties,
and enforce remedial measures against the administrative violations in Articles
5, 6, 7, 10, 11, 12, 13, 14, 17, 19, 22, 24, 25, 26, 27, 30, 31, 32, 33, 34,
35, 36, 37, 60, 65, 71, 76, 80, 83, 96, 97, 101, 102; Point b Clause 3 Article
8; Point b Clause 3 Article 9; Point a, b Clause 3 Article 16; Point g Clause
2, Clause 3 Article 23; Clause 1, 2, 3, Point a, b, c, g Clause 4, Point a
Clause 5 Article 29; Clause 1, 3, 5, 6, 7 Article 38; Point b Clause 4 Article
39; Clause 4 Article 40; Point b Clause 1 Article 45; Point b Clause 3 Article
48; Point b Clause 1 Article 52; Clause 1, Point b Clause 2, Point a, b Clause
3 Article 64; Clause 1 Article 74 and Point a Clause 1, Clause 2 Article 95
hereof within the ambit of their assigned functions, duties and powers, and
their competence prescribed in Article 109 hereof.
8. Officers competent to impose penalties of tax
authorities shall have the power to make records of, impose penalties, and
enforce remedial measures against the administrative violations in Points d,
dd, e Clause 4 and Point b Clause 5 Article 29 hereof within the ambit of their
assigned functions, duties and powers, and their competence prescribed in
Article 110 hereof.
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Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
10. Inspectors in the field of information and
communications competent to impose penalties shall have the power to make
records of, impose penalties, and enforce remedial measures against the
administrative violations in Article 5, 19, 25, 26, 30, 32, 33, 34, 36, 37, 49,
50, 51, 67, 69, 78, 96, 97; Clause 2 Article 14; Clause 1, 2, 3, Point a, b, c,
e, g Clause 4, Point a Clause 5 Article 29; Clause 3 Article 31 and Point b Clause
2 Article 35 hereof within the ambit of their assigned functions, duties and
powers, and their competence prescribed in Article 104 hereof.
11. Inspectors in the field of culture, sports
and tourism competent to impose penalties shall have the power to make records
of, impose penalties, and enforce remedial measures against the administrative
violations in Article 5, 19, 25, 26, 30, 32, 33, 34, 36, 37, 49, 50, 51, 67,
69, 78, 96, 97; Clause 2 Article 14; Clause 1, 2, 3, Point a, b, c, e, g Clause
4, Point a Clause 5 Article 29 and Point b Clause 2 Article 35 hereof within
the ambit of their assigned functions, duties and powers, and their competence
prescribed in Article 104 hereof.
12. Inspectors in the field of education,
transport, agriculture and rural development, science and technology competent
to impose penalties shall have the power to make records of, impose penalties,
and enforce remedial measures against the administrative violations in Articles
5, 6, 18, 19, 23, 25, 26, 30, 31, 32, 33, 34, 36, 37; Clause 2 Article 14 and
Clauses 1, 2, 3, Points a, b, c, e Clause 4, Point a Clause 5 Article 29 hereof
within the ambit of their assigned functions, duties and powers, and their
competence prescribed in Article 104 hereof.
13. Inspectors in the field of natural resources
and environment competent to impose penalties shall have the power to make
records of, impose penalties, and enforce remedial measures against the
administrative violations in Articles 5, 6, 7, 10, 12, 15, 16, 18, 19, 23, 25,
26, 30, 31, 32, 33, 34, 36, 37, Point a Clause 5 Article 29 hereof within the
ambit of their assigned functions, duties and powers, and their competence
prescribed in Article 104 hereof.
Article 113. Power to
record administrative violations
Persons that have the power to make records of
administrative violations in medical sector include:
1. The persons having the power to impose
administrative penalties prescribed this Decree shall have the power to record
administrative violations within the ambit of their assigned functions, tasks
and power.
2. Officials and public employees of health
agencies and social security agencies, officials, public employees and persons
of people’s army or people’s security forces, and officials, public employees
working at the agencies specified in Article 112 hereof shall have the power to
record administrative violations detected when they are on duty and within the
ambit of their assigned functions, tasks and power.
Article 114. Violation
detection facilities and equipment
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Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
2. Management, use and list of violation
detection facilities and equipment shall comply with regulations of laws in
force.
Chapter IV
IMPLEMENTATION
Article 115. Effect
1. This Decree comes into force from November
15, 2020.
2. The following provisions come into force from
the date of promulgation of this document, including:
a) Articles 5, 6, 7, 8, 9, 10, 11, 12, 13, 14,
47, 115, 116, 117 Point b Clause 1, Point b Clause 4 Article 52 and Point a, b
Clause 2, Point b, dd Clause 3, Point b Clause 4 Article 57 hereof;
b) Articles 1, 2, 3, 4, 103, 104, 105, 106, 107,
108, 109, 110, 111, 112, 113 and 114 are applied to impose penalties for the
administrative violations prescribed in Point a of this Clause.
3. The entire Government’s Decree No.
176/2013/ND-CP dated November 14, 2013 shall be null and void from November 15,
2020.
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Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
Article 116. Transition
If this Decree does not contain legal liability
or impose a less serious legal liability on an administrative violation in
medical sector which is committed before the date of entry into force of this
Decree but is detected afterwards or is under consideration, regulations hereof
shall apply.
Article 117.
Responsibility for guidance and implementation
1. The Minister of Health shall instruct and
organize the implementation of this Decree.
2. Ministers, heads of ministerial agencies,
heads of Governmental agencies, Chairpersons of people’s committees at all
levels, and relevant authorities, organizations and individuals shall implement
this Decree./.
ON BEHALF OF
THE GOVERNMENT
THE PRIME MINISTER
Nguyen Xuan Phuc
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để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ: ĐT:
(028) 3930 3279
DĐ:
0906 22 99 66
Bạn phải đăng nhập hoặc đăng ký Thành Viênđể sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.Mọi chi tiết xin liên hệ:
![Toni Kroos là ai? [ sự thật về tiểu sử đầy đủ Toni Kroos ]](https://evbn.org/wp-content/uploads/New-Project-6635-1671934592.jpg)
