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THE GOVERNMENT
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SOCIALIST
REPUBLIC OF VIET NAM
Independence - Freedom - Happiness-
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No. 46-CP
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Hanoi , August 06,
1996
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DECREE
ON SANCTIONS AGAINST ADMINISTRATIVE VIOLATIONS IN THE FIELD
OF STATE MANAGEMENT OVER PUBLIC HEALTH
THE GOVERNMENT
Pursuant to the Law on Organization of the
Government of September 30, 1992;
Pursuant to the Law on the Protection of the People’s Health of June 30, 1989;
Pursuant to the Ordinance on the Handling of Administrative Violations of July
6, 1995;
At the proposal of the Minister of Health,
DECREES:
Chapter I
ADMINISTRATIVE
VIOLATIONS IN THE FIELD OF PUBLIC HEALTH, FORMS AND LEVELS OF SANCTION
Section A - ADMINISTRATIVE
VIOLATIONS OF THE HYGIENE REGULATIONS; FORMS AND LEVELS OF SANCTION
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1. Warning or a fine of 20,000 to 50,000 VND for
one of the following acts:
a) Persons whose work is directly related to the
processing, production of food products, foodstuffs, drinks of various kinds,
liquors and smoking stuffs, but who fail to observe the regulations on personal
hygiene or contract infectious diseases or skin diseases or have no training
certificates in food hygiene and safety.
b) Failing to cover or pack cooked foods,
instant food and drinks.
2. A fine of 200,000 to 800,000 VND for one of
the following acts:
a) Failing to observe the regulations on ambient
and tool hygiene at the places of production, processing, preservation, trading
and transport of food products, foodstuffs, beverages and liquors.
b) Using materials, food additives and water not
up to hygiene standard, for the production of food products, foodstuffs,
beverages, liquors and smoking stuffs.
c) Establishments producing and trading in food
products, foodstuffs, beverages, liquors and smoking stuffs having no
certificates of food safety and hygiene or failing to renew their already
expired certificates.
d) Producing and/or trading in food products,
foodstuffs, beverages, liquors and smoking stuffs, which must be packed but are
not labeled or improperly labeled.
e) Producing and/or trading in food products,
foodstuffs, beverages, liquors and smoking stuffs without registration of food
safety and hygiene.
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g) Trading in expired foodstuffs, beverages,
liquors and smoking stuffs or failing to ensure hygiene standards.
3. A fine of 1,000,000 to 3,000,000 VND for one
of the following acts:
a) Using chemical sugar (sweetener), coloring
matters and other additives in the production and processing of foods,
foodstuffs, beverages, liquors and smoking stuffs outside the list issued by
the Ministry of Health.
b) Transporting for the purpose of consuming or
trading meats of poultry and cattle affected by infectious diseases.
c) Manufacturing dining tools, containers for
food products, foodstuffs, drinks, liquors and smoking stuffs from new
materials and additives without certificates of quality control issued by the
competent health agency.
d) Producing and processing food products,
foodstuffs, drinks, liquors and smoking stuffs not up to hygiene standards.
e) Wholesaling on the market farm products with
a residue of pesticide or chemical fertilizer exceeding the allowed limits.
4. Destruction of objects mentioned in Points f
and g, Clause 2 and Points a, b, d and e, Clause 3 of this Article.
Article 2.- Violations
of the regulations on water hygiene:
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2. A fine of 500,000 to 2,000,000 VND for failure
to observe the regulations on examining and controlling the quality of water
supplied by water plants/enterprises.
3. A fine of 2,000,000 to 8,000,000 VND for one
of the following acts:
a) Discharging waste by State agencies,
organizations, production or business establishments, causing the pollution of
water sources used by the people in their daily life.
b) Failing to ensure hygiene standards by water
plants/enterprises.
4. Forcible application of measures to overcome
consequences of the violations mentioned in Clause 1 and Point a, Clause 3 of
this Article.
Article 3.- Violations
of the regulations on labor sanitation:
1. A fine of 500,000 to 2,000,000 VND for one of
the following acts:
a) Failing to organize health checks before
recruitment, failing to organize periodical health checks and medical checks
for employees to detect occupational diseases or failing to give medical
treatment to employees suffering from occupational diseases.
b) Failing to prepare dossiers on sanitation of
enterprises, health check records, occupational disease dossiers and annual or
periodical registrations of labor sanitation control.
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d) Failing to take disinfecting and poison
neutralizing measures at places where noxious and infectious elements are
present.
2. A fine of 1,000,000 to 4,000,000 VND for one
of the acts:
a) Failing to take measures and install
equipment for disposal of poisonous steam and gases, dust, noxious waste water,
industrial discharge and other hazardous factors exceeding the allowed limits.
b) Failing to observe the regulation on labor
sanitation with regard to temperature, humidity, lighting, noise, vibration,
dust, steam, noxious gases and other hazardous factors.
3. A fine of 5,000,000 to 20,000,000 VND for one
of the following acts:
a) Using radioactive or X-ray emitting
substances without storing them at separate places or without observing the
regulations on radiation safety or without disposing radioactive waste in
accordance with prescriptions.
b) Failing to observe the labor sanitation
regulations on radiation and magnetic electricity.
4. Suspension and forcible application of
measures to overcome the consequences of the violations mentioned in Clauses 2
and 3 of this Article.
Article 4.- Violations
of the regulations on hygiene in construction:
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2. Forcible application of measures to overcome
the consequences of the violations mentioned in Clause 1 of this Article.
Article 5.- Violations
of other hygiene regulations:
1. A fine of 50,000 to 200,000 VND shall be
imposed on individuals for violating the regulations on the prevention and
fight against epidemics and diseases.
2. A fine of 200,000 to 500,000 VND shall be
imposed on violations of the regulations on ambient hygiene in offices,
hospitals, schools, kindergartens and other public places.
3. A fine of 500,000 to 2,000,000 VND shall be
imposed on agencies or organizations for violating the regulations on the
prevention and fight against epidemics and diseases.
4. A fine of 2,000,000 to 5,000,000 VND shall be
imposed on acts of manufacturing and trading in teaching aids and children�s
toys which badly effect the health of pupils and children or manufacturing and
trading in children�s toys banned from
manufacture and trade.
5. Forcible destruction of objects mentioned in
Clause 4 of this Article.
Article 6.- Violations
of the regulations on trading in and use of substitutes for breast milk:
1. A fine of 500,000 to 2,000,000 VND for one of
the following acts:
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b) Conducting false information and/or
advertisements on the use of substitutes for breast milk.
c) Presenting mothers who have sufficient breast
milk after childbirth or members of their family with samples of goods, aimed
at encouraging the use of such products as substitutes for breast milk.
d) Giving presents or donations in any form to
medical personnel working in hospitals, maternity homes or other medical
establishments in order to advertise the substitutes for breast milk.
2. A fine of 5,000,000 to 20,000,000 VND shall
be imposed on violations of the regulations on quality and labels of substitutes
for breast milk.
3. All substitutes for breast milk that fail to
meet the quality standard shall be destroyed.
Article 7.- Violations
of the regulations on border epidemiological control:
1. A fine of 1,000,000 to 3,000,000 VND for one
of the following acts:
a) Failing to take anti-rat measures on maritime
transport means when they anchor at ports.
b) Using rat-free certificates or certificates
of exemption from rat killing at variance with prescriptions.
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d) Modifying without authorization or forging
epidemiological control certificates.
e) Exporting or importing waste matters, used
articles, used transport means without declaring at the epidemiological control
agency, without subjecting them to medical treatment or without epidemiological
control certificates issued by the epidemiological control agency.
f) Entry transport means failing to give signals
asking for an epidemiological check.
2. A fine of 3,000,000 to 9,000,000 VND for one
of the following acts:
a) Concealing the actual situation of
epidemiological hygiene which must be checked, or wiping out evidences of
epidemics.
b) Transporting human corpses, remains, and
other special objects such as microbes, biological items, tissues, organs or
parts of human body, blood and blood constituents across the border without
being checked and granted certificates by the epidemiological control agency.
3. A fine of 10,000,000 to 30,000,000 VND for
one of the following acts:
a) Failing to make the prescribed
epidemiological control declarations by the transport means owners at the
epidemiological control agency in order to conduct the epidemiological control
before their entry or exit.
b) Refusing to submit to epidemiological control
or to implement the requirements of epidemiological control officials by
persons who are subject to epidemiological control.
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Section B - ADMINISTRATIVE
VIOLATIONS OF THE REGULATIONS ON DISEASE EXAMINATION AND TREATMENT; FORMS AND
LEVELS OF SANCTION
Article 8.- Violations
of the regulations on the use of certificates of qualification and conditions
for establishing disease examination and treatment establishments (hereafter
referred to as certificates of qualification and conditions for practice):
1. A fine of 200,000 to 1,000,000 VND for one of
the following acts:
a) Medical establishments having addresses other
than defined in the certificates of qualification for practice or having no
signboard as prescribed.
b) Failing to ensure the necessary technical
conditions and equipment as prescribed.
c) Failing to open statistical books, or to keep
books of medication prescriptions and lists of poisons and psychotropic drugs.
2. A fine of 3,000,000 to 12,000,000 VND for one
of the following acts:
a) Conducting medical practice beyond one’s
professional capability or not in conformity with the area of practice defined
in the certificate of qualification and conditions for practice.
b) Allowing another person to use diplomas of medical
doctor, the certificates of medical practice or the certificate of
qualification and conditions for practice.
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4. Suspension of acts mentioned in Clause 3 and
forfeiture of the right to use the certificate of qualification and conditions
for practice with regard to violations prescribed in Clause 2 of this Article.
Article 9.- Violations
of the regulations on medical profession:
1. A fine of 500,000 to 2,000,000 VND for one of
the following acts:
a) Giving medication prescriptions which are not
appropriate to the disease but which have not yet caused serious consequences
to the health and life of the patient.
b) Failing to observe the regulations on
sterilization and bacteria-killing in the course of acupuncture, injection,
pricking, surgery and other methods used for medical examination and treatment.
2. A fine of 2,000,000 to 8,000,000 VND for one
of the following acts:
a) Failing to observe the regulations on medical
technical profession.
b) Giving medication prescriptions and selling
drugs besides the quantity prescribed for emergency (except for medical
examination and treatment by methods of traditional national medicine).
c) Using medical instruments of poor quality for
medical examination and treatment.
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4. Forfeiture of the right to use the
certificate of qualification and conditions for practice for violations mentioned
in Clause 3 of this Article.
Article 10.- Violations
of other regulations on medical examination and treatment:
1. A fine of 200,000 to 1,000,000 VND for one of
the following acts:
a) Failing to take part in the medical
activities for primary health care and popularization of measures of health
protection, disease prevention and treatment among the population at the
request of the local health authorities.
b) Failing to observe the regime of periodical
reports to the health agencies directly managing the professional and technical
operations of the establishments.
c) Failing to report to the local health
authorities when discovering persons having contracted sexually transmitted
diseases including AIDS or addicted to drugs.
d) Failing to take measures for controlling as
prescribed persons having contracted serious infectious diseases.
2. A fine of 500,000 to 3,000,000 VND for acts
of failing to report to the State health agencies when discovering infectious
diseases that must be quarantined, strange diseases or collective contamination
in order to promptly solve the consequences.
3. A fine of 3,000,000 to 10,000,000 VND for one
of the following acts:
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b) Failing to comply with the mobilization order
of the competent health agency when natural calamities or epidemics break out.
Article 11.- Violations
of the regulations on qualification and conditions for massage service:
1. A fine of 50,000 to 200,000 VND for one of
the following acts:
a) Having no signboard at the massage room.
b) Failing to dress and wear name cards as
required.
2. A fine of 200,000 to 500,000 VND for one of
the following acts:
a) Massage beds not up to the required standards.
b) Failing to install emergency buzzers.
c) Failing to ensure lighting and hygienic
standards required for massage rooms.
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3. A fine of 500,000 to 2,000,000 VND for one of
the following acts:
a) Having no emergency medicine chest as
prescribed.
b) Failing to meet the requirements on exit
and/or entry doors of massage rooms.
c) Failing to observe the regulations on
professional technique of massage practitioners.
d) Practicing massage not at the prescribed
place.
4. Forms of additional sanction and other
measures:
a) Forcible application of measures to overcome
the consequences of acts prescribed in Clauses 1, 2 and Points a, b, Clause 3
of this Article.
b) Forfeiture of the right to use the
certificate of professional massage service for violations defined in Point c,
Clause 3 of this Article.
Article 12.- Violations
of the regulations on medical insurance:
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2. A fine of 500,000 to 2,000,000 VND for one of
the following acts:
a) Abusing position and powers to use medical
the insurance card for personal interests.
b) Employers failing to buy or cheating in
making dossiers for buying compulsory medical insurance cards for their
employees.
3. A fine of 5,000,000 to 20,000,000 VND for
acts of cheating in making vouchers and paying for expenditures not in
accordance with regulations, thus causing losses to the medical insurance fund,
but not seriously enough to be examined for penal liability.
Article 13.- Violations
of the regulations on HIV/AIDS prevention and fight:
1. Warning or a fine of 50,000 to 200,000 VND
for one of the following acts:
a) A HIV/AIDS infected person failing to declare
the infection in the medical control form when entering Vietnam.
b) Failing to immediately inform his/her spouse
of his/her HIV/AIDS infection when it is detected.
2. A fine of 200,000 to 800,000 VND for one of
the following acts:
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b) Violations of the regulations on keeping
secret the names, ages, addresses and photographs of those who are infected
with HIV/AIDS but not yet causing serious consequences.
c) Broadcasting on the mass media the names,
ages, addresses or photographs of HIV/AIDS infected persons without their
consent or their relatives’ consent after their death.
d) Refusing to provide HIV/AIDS infected persons
with medical examination and treatment.
e) HIV/AIDS-infected persons deliberately doing
jobs that they are not allowed to do.
f) An employer failing to transfer HIV/AIDS
infected persons to other jobs from jobs that they are not allowed to do.
3. A fine of 500,000 to 2,000,000 VND for
violations of the regulations on blood transfusion, sterilization,
bacteria-killing and other regulations on professional treatment of HIV/AIDS
infection.
Section C - ADMINISTRATIVE
VIOLATION OF THE REGULATIONS ON PHARMACY; FORMS AND LEVELS OF SANCTION
Article 14.- Violations
of the regulations on criteria and conditions for pharmaceutical practice:
1. A fine of 500,000 to 2,000,000 VND for one of
the following acts:
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b) Allowing another person to use the
certificate of qualification and conditions for pharmaceutical practice and
other professional diplomas or certificates.
c) Drug sellers not qualified for the job as
prescribed by the Ministry of Health.
d) Material and technical bases equipped for the
manufacture and sale of pharmaceuticals not conforming to the regulations of
the Ministry of Health.
e) Drugstore owners are absent when their
drugstores are open.
f) Wholesale-dealing in drugs by drugstores.
2. Forfeiture of the right to use the
certificate of qualification and conditions for pharmaceutical practice shall
be applied to violations mentioned in Point b, Clause 1 of this Article.
Article 15.- Violations
of the regulations on drug manufacture:
1. A fine of 3,000,000 to 10,000,000 VND for one
of the following acts:
a) Manufacturing drugs without certificates of
qualification and conditions for pharmaceutical practice.
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2. A fine of 5,000,000 to 15,000,000 VND for one
of the following acts:
a) Manufacturing drugs through improper
processes or without monitoring records.
b) Manufacturing drugs not according to approved
formulas.
c) Manufacturing drugs without a registration
number issued by the competent health agency.
d) Manufacturing eastern medicines from
materials of low quality.
3. A fine of 20,000,000 to 50,000,000 VND for
one of the following acts:
a) Manufacturing drugs of low quality (not up to
the quality standards).
b) Manufacturing western medicines from
materials not yet subject to examination.
4. Forfeiture of the right to use certificates
of qualification and conditions for pharmaceutical practice shall be applied to
violations mentioned in Clause 3 of this Article.
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Article 16.- Violations
of the regulations on preservation of drugs and materials for the production of
drugs:
A fine of 1,000,000 to 4,000,000 VND for one of
the following acts:
a) Failing to satisfy technical requirements for
preservation to ensure the quality of drugs and materials for drug production.
b) Failing to keep technical records and books
on the quantities of drugs and materials received and issued for drug
production in accordance with regulations.
Article 17.- Violations
of the regulations on trading, export and import of drugs and materials for
drug production:
1. A fine of 500,000 to 2,000,000 VND for one of
the following acts:
a) Selling the wrong drugs but not yet causing
serious consequences.
b) Selling without a doctor’s prescription or
not according to prescriptions drugs that require a doctor�s
prescription.
2. A fine of 2,000,000 to 5,000,000 VND for one
of the following acts:
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b) Trading in drugs of unidentified sources of
production or with original containers no longer intact.
c) Trading in drugs which are not included in
the list of drugs allowed for circulation by the Ministry of Health, or drugs
having no registration number.
3. A fine of 5,000,000 to 20,000,000 VND for one
of the following acts:
a) Trading drugs of low quality (not up to the
quality standards) or drugs the usage date of which has expired.
b) Importing drugs or materials for drug
production with their containers no longer intact.
4. A fine of 20,000,000 to 60,000,000 VND for
one of the following acts:
a) Exporting and/or importing drugs or materials
for drug production, which are not included in the list prescribed by the
Ministry of Health.
b) Importing for drug production drugs or
materials, which have already been declared banned from circulation on the
market by the producing country.
5. Forcible destruction of drugs for violations
mentioned in Point b, Clause 4 of this Article.
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7. Forfeiture of the right to use certificates
of qualification and conditions for pharmaceutical practice shall be applied on
violations mentioned in Points a and b, Clause 4 of this Article if such
violations involve aggravating factors.
Article 18.- Violations
of the regulations on poisons, addictive drugs, psychotropic drugs, radioactive
drugs:
1. A fine of 2,000,000 to 8,000,000 VND shall be
imposed on acts of writing prescribing and using poisons, addictive drugs,
psychotropic drugs, radioactive drugs not in conformity with regulations issued
by the Ministry of Health but not yet causing serious consequences.
2. A fine of 5,000,000 to 20,000,000 VND shall
be imposed on acts of manufacturing, preparing, preserving and trading in
poisons, addictive drugs, psychotropic drugs or radioactive drugs not in
conformity with regulations issued by the Ministry of Health.
3. Forfeiture of the right to use certificates
of qualification and conditions for pharmaceutical practice shall be applied to
violations mentioned Clauses 1 and 2 of this Article.
4. With regard to violations of the regulations
on manufacturing and/or trading in poisons, addictive drugs, psychotropic
drugs, if there exist all factors for establishing crime, the dossiers,
material evidences and means of violation shall be transferred to the
investigation agency for examination of penal liability.
Article 19.- Violations
of the regulations on information, advertisement and labels of drugs:
1. A fine of 2,000,000 to 8,000,000 VND shall be
imposed on one of the following acts:
a) Conducting information and advertisement
untrue to the properties and effect of the drug.
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c) Using drugs label not ratified by the
competent health agency or printing drug label not identical to the approved
pattern.
d) Imitating labels of registered drugs being
circulated on the market.
e) Failing to print drug labels in Vietnamese
for domestically produced drugs, or failing to print the name and address of
the producer.
f) Failing to print the expiry date of the drug.
2. Seizure of imitated drug labels and/or drugs
with imitated labels shall be applied to violations mentioned in Points c, d
and e, Clause 1 of this Article;
3. Forfeiture of the right to use the
certificates of qualification and conditions for pharmaceutical practice shall
be applied to violations mentioned in Points a and b, Clause 1 of this Article
if such violations involve aggravating factors.
Article 20.- Acts of
manufacturing and trading in fake drugs:
When detecting acts of manufacturing and trading
in fake drugs, the person with competence to handle the case shall have to make
a record, temporarily seize the material evidences and means used for the
violation, the certificate of qualification and conditions for pharmaceutical
practice, establishment licenses and business licenses, and then transfer the
dossiers and material evidences and means used for the violation to
investigation agency of the examination for penal liability in accordance with
provisions of law.
Article 21.- Violations
of the regulations on cosmetics:
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a) Trading in and manufacturing cosmetics
without certificates of qualification and conditions for business issued by the
competent health agency.
b) Material base equipped not in accordance with
regulations issued by the Ministry of Health.
c) Imitating or failing to register cosmetics
labels.
d) Using cosmetics labels not approved by the
competent health agency or printing labels not identical to the approved ones.
e) Failing to specify on the cosmetics labels
the date of manufacture or the expiry date and other information about the
cosmetics: components, instructions for use and preservation in accordance with
regulations issued by the Ministry of Health.
2. A fine of 2,000,000 to 5,000,000 VND shall be
imposed on acts of manufacturing and trading in soaps, toothpaste, talc and
other personal items, that are not up to the hygiene standards.
3. A fine of 2,000,000 to 8,000,000 VND for one
of the following acts:
a) Manufacturing cosmetics without registration
number issued by the competent health agency.
b) Manufacturing cosmetics from materials not
yet examined.
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d) Failing to satisfy the technical requirements
to ensure the quality safety of cosmetics.
e) Trading in cosmetics of unidentified
production sources not up to the quality standards, beyond the expiry date or
cosmetics which have been declared banned from circulation on the market by the
producing country.
4. A fine of 5,000,000 to 15,000,000 VND for one
of the following acts:
a) Manufacturing cosmetics which are below the
quality standards.
b) Importing cosmetics or materials for
cosmetics production which have been declared banned from circulation on the
market by the producing country.
c) Importing and trading in cosmetics with
containers no longer intact.
5. Forcible destruction of cosmetics shall be
imposed on violations mentioned in Points b, c, d and e, Clauses 2 and 3 and
Points a and b, Clause 4 of this Article.
Chapter II
COMPETENCE TO IMPOSE
SANCTIONS AGAINST ADMINISTRATIVE VIOLATIONS
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1. An Inspector for hygiene, medical examination
and treatment and pharmaceutical practice, while performing his/her duty within
his/her jurisdiction, shall have the competence to issue warnings, impose fines
up to 200,000 VND, seize the material evidences and means used for violation
valued at up to 500,000 VND, and apply other measures provided for in Points a,
b and d, Clause 3, Article 11 of the Ordinance on the Handling of
Administrative Violations, except for forcible compensation for damage.
2. The Chief Inspector of the provincial Health
Service can impose fines of up to 10,000,000 VND, forfeit the right to use
certificates of qualification and conditions for practice according to his/her
competence; issue decisions to stop the violation and request the competent
agency to forfeit the right to use the permits for establishing an enterprise
or company, the certificate of registration for under-prescribed capital
business, and apply other measures provided for in Clauses 2 and 3, Article 11
of the Ordinance on the Handling of Administrative Violations.
3. The Chief Inspector of the Ministry of Health
can impose fines up to 20,000,000 VND, forfeit the right to use certificates of
qualification and conditions for practice according to his/her competence; issue
decisions to stop the violation and request the competent agency to forfeit the
right to use the permit for establishing an enterprise or company the
certificate of registration for under-prescribed capital business and apply
supplementary forms of sanction and other measures provided for in Clauses 2
and 3, Article 11 of the Ordinance on the Handling of Administrative Violations.
Article 23.-
Sanctioning competence of the President of the People�s Committee at all levels:
1. The President of the People’s Committee of
commune, ward or district town can impose warnings, fines of up to 200,000 VND,
seize the material evidences and means used for violations valued at up to
500,000 VND, order compensations of up to 500,000 VND for damage caused by the
administrative violation, suspend the acts causing the pollution of the living
environment, the spread of epidemics and diseases and destroy matters harmful
to human health.
2. The President of People’s Committee of
district, precinct, township or provincial city can impose warnings or fines of
up to 10,000,000 VND, decide the application of supplementary forms of sanction
and other measures provided for in Clauses 2 and 3, Article 11 of the Ordinance
on the Handling of Administrative Violations; except for the forfeiture of the
right to use permits issued by the higher State agencies in which case the
President of the People�s Committee at
district level shall issue a decision to stop the violation and propose the
competent State agency to revoke the permit.
3. The President of the People’s Committee of
the province or city directly under the Central Government can impose warnings
or fines of up to 100,000,000 VND, apply supplementary forms of sanction and
other measures provided for in Clauses 2 and 3, Article 11 of the Ordinance on
the Handling of Administrative Violations; except for the forfeiture of the
right to use permits issued by the higher State agencies in which case the
President of the People’s Committee at provincial level shall issue a decision
to stop the violation and propose the competent State agency to revoke the
permit.
Article 24.- The
sanctioning competence of other agencies:
1. In addition to persons defined in Articles 22
and 23 of this Decree, those persons who have competence to impose sanctions
according to the Ordinance of the Handling of Administrative Violations, when
discovering an administrative violation defined in this Decree that fall within
their respective jurisdiction and geographical area, can impose sanctions but
must observe the provisions of Articles 46, 47 and 48 of the Ordinance on the
Handling of Administrative Violations.
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Chapter III
PROCEDURES, PRINCIPLES
AND MEASURES FOR IMPOSING SANCTIONS
Article 25.- Warnings:
1. Warnings shall be served to individuals
and/or organizations that have committed for the first time minor
administrative violations which involve extenuating factors.
2. The decision on warnings shall be made in
writing; when deemed necessary, the agency with sanctioning competence shall
notify the administration of the locality or agency or organization where the
violator resides or works.
Article 26.- Procedures
and measures to impose fines:
1. Upon detection of an administrative
violation, the person with sanctioning competence shall promptly make a record,
except for cases requiring only simple procedures. The content of and
procedures for making a record shall conform with Article 47 of the Ordinance
on the Handling of Administrative Violations.
2. Within 15 days from the date of making the
record, the person with sanctioning competence shall issue a decision on
sanction clearly stating the provisions and name of the legal document which
have been violated, the level of liability and the form of sanction to be
imposed in accordance with Article 48 of the Ordinance on the Handling of
Administrative Violations.
The Ministry of Health shall uniformly set the
model form of record, the model form of sanctioning decision for each field of
medical management.
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3. Individuals and organizations that commit
administrative violations in the field of State management over medicine and
are fined shall have to pay fines at the places defined in the sanctioning
decisions and shall be given fining receipts. The persons who issue decisions
shall not be entitled to collect the fines on the spot.
4. Within 5 days from the date of receiving the
sanctioning decision, the sanctioned individual or organization that
deliberately disobey the decision shall be forced to comply with the
sanctioning decision in accordance with Article 55 of the Ordinance on the
Handling of Administrative Violations.
The agency, organizations or lawful
representative of the sanctioned shall have to strictly comply with the
coercive measures taken by the agency that has issued the sanctioning decision.
Article 27.- Forfeiture
of the right to use permit and revocation of permit:
1. The right to use permit for establishing an
enterprise, the certificate of qualification and conditions for practice and
the business license granted by the State competent agencies to individuals or
organizations to conduct business activities may be forfeited of if the
violations of the regulations is directly related to the use of the permit or
license.
2. The Chief State Inspector of the medical
service (inspection on hygiene, medical examination and treatment,
pharmaceutical practice) can forfeit the right to use certificates of
qualification and conditions for practice and propose to the agency with
competence to issue permits for establishment, certificates of registration of
business the following:
a) Where the violator is allowed to continue
his/her professional practice, his/her right to use the certificate of
qualification and conditions for practice shall be forfeited for a given period
of time.
b) In serious cases where the violator is not
allowed to continue his/her professional practice, his/her right to use the
certificate of qualification and conditions for practice shall be indefinitely
forfeited.
c) To propose to the agency with competence to
grant the permit of establishment and business licenses to withdraw such
permits and licenses in the following cases:
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- The contents of permits and licenses are
contrary to the provisions of law.
Article 28.- Procedures
for the application of other administrative measures:
1. State agencies and persons having sanctioning
competence to impose sanctions stipulated in Articles 22, 23 and 24 of this
Decree shall have to base themselves on the provisions of law and the extent of
the actual damage caused by such administrative violations when issuing
decisions on application of other administrative measures.
2. Where material objects which may have harmful
effects on human health must be destroyed immediately, when enforcing the
destruction, records must be made signed by the sanctioned person, the person
who has issued the sanctioning decisions and witnesses. Where objects which may
have harmful effects on human health must be destroyed but not necessarily
right away such objects must be sealed and a council for the destruction shall
be set up.
Article 29.- Principles
of applying the forms of sanction:
1. In addition to the main forms of sanction:
warning and fine, supplementary forms of sanction and other administrative
measures may be applied in accordance with Article 11 of the Ordinance on the
Handling of Administrative Violations.
2. The main forms of administrative sanction can
be applied separately, the supplementary forms of sanction and other administrative
measures cannot be applied separately but together with the main form(s) of
sanction.
3. When a fine is imposed, the specific amount
of the fine against an administrative violation shall be the average amount in
the fine bracket prescribed for such violation; if the violation involves
extenuating factors, the amount of fine may be reduced but not lower than the
minimum in the fine bracket; if the violation involves aggravating factors, the
in fine may be increased but not more than the maximum amount of the fine
bracket.
4. The sanctioned organization must comply with
the sanctioning decision, and at the same time identify the faults of its
members who directly committed the administrative violation while performing
their assigned duties for examination of discipline liability and the payment
of compensation for damage in accordance with the provisions of law.
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COMMENDATION AND HANDLING OF VIOLATIONS, COMPLAINTS AND
DENUNCIATIONS
Article 30.-
Commendation:
Organizations and individuals that have merits
in supplying information, detecting, preventing, handling administrative
violations in the field of medicine shall be commended in accordance with the
common regime of commendation and reward of the State.
Article 31.- Handling
of violations:
If an organization or individual with
sanctioning competence commits violations they shall be disciplined or examined
for penal liability; depending on the nature and extent of their violations, if
damage is caused to other organizations and individuals, compensations must be
paid.
Article 32.-
Re-examination of sanctioning decisions in case of complaints:
1. The Chief Inspector of the provincial Health
Service shall review the sanctioning decision issued by the medical inspector
of the provincial service when the sanctioned organization and individual file
their complaints.
2. The Chief Inspector of the Ministry of Health
shall review the sanctioning decision issued by the chief medical inspector of
the provincial health services or the medical inspectors of the ministerial
level when the sanctioned organization and individual file their complaints.
Article 33.- Procedures
for handling complaints and denunciations:
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2. Within 15 days from the date of receiving
complaints, the person(s) that issued the sanctioning decision(s) shall have to
decide and answer in writing to the complainants.
If the complainant disagrees with the decision
of settlement, he/she can lodge a complaint to the immediate superior of the
person that issued the sanctioning decision within 3 days from the date of
receiving the settlement decisions.
Within 20 days from the date of receiving the
complaint, the head of the immediate higher agency of the person that issued
the sanctioning decision shall have to decide and answer in writing to the
complainant.
Complaints against the settlement of complaints
by the Presidents of the province or city directly under the Central Government
must be sent by the Chief Inspector of the Ministry of Health to the Minister
of Health.
Within 30 days from the date of receiving such a
complaint, the Minister of Health shall have to examine, conclude and answer in
writing to the complainant. Within 7 days from the date of receiving the
answer, the person who has issued the decision on settling the complaint shall
have to comply with the decision of the Minister of Health.
In case the President of the People�s
Committee of the province or city directly under the Central Government
disagrees with the settlement of the Minister of Health, he/she shall have the
right to lodge a complaint to the General State Inspector. Within 45 days from
the date of receiving the complaint the General State Inspector shall have to
consider and issue a decision on the complaint. The decision of the General
State Inspector shall be final.
3. The complaint about sanctions against
administrative violations shall not cause the suspension of the implementation
of the sanctioning decisions.
4. Where the person in charge of settling
complaints issue a decision to change the form, level and measure of sanction,
or annul the previous sanctioning decision, he/she may also decide the
compensation or direct repayment for damage (if any) in accordance with the
provisions of law.
If the complainants disagrees with the decisions
on compensation or repayment, he/she can request the Court to settle the complaint
through the procedure of civil proceedings.
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IMPLEMENTATION PROVISIONS
Article 34.- Scope of
application:
This Decree shall apply to all individuals and
organizations, including the foreign individuals and organizations and
foreign-invested enterprises in Vietnam.
Article 35.- Legal
effect:
This Decree takes effect from the date of its
signing and replaces Decree No.341-HDBT of September 22, 1992 of the Council of
Ministers (now the Government) promulgating the Regulation on the Handling of
Administrative Violations in the Field of Medicine.
Article 36.-
Responsibility for guiding the implementation of this Decree:
1. The Minister of Health shall have to guide
the implementation of this Decree.
2. The Minister of Finance and the Minister of
Health shall have to guide and manage the use of fines against administrative
violations in the field of State management over medicine.
Article 37.- The Ministers, the Heads of the
ministerial-level agencies, the Heads of the agencies attached to the Government,
the Presidents of the People’s Committees of the provinces and cities
directly under the Central Government shall have to implement this Decree.
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ON BEHALF OF
THE GOVERNMENT
THE PRIME MINISTER
Vo Van Kiet