THE GOVERNMENT
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|
THE SOCIALIST
REPUBLIC OF VIETNAM
Independence – Freedom – Happiness
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No.: 124/2021/ND-CP
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Hanoi, December 28, 2021
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DECREE
AMENDMENTS TO GOVERNMENT’S DECREE NO. 115/2018/ND-CP DATED
SEPTEMBER 04, 2018 PRESCRIBING PENALTIES FOR ADMINISTRATIVE VIOLATIONS AGAINST
REGULATIONS ON FOOD SAFETY AND GOVERNMENT’S
DECREE NO.117/2020/ND-CP DATED SEPTEMBER 28, 2020 PRESCRIBING PENALTIES
FOR ADMINISTRATIVE VIOLATIONS IN MEDICAL SECTOR
Pursuant to the
Law on Government Organization dated June 19, 2015; the Law on amendments to
the Law on Government Organization and the Law on Organization of Local
Governments dated November 22, 2019;
Pursuant to the Law on penalties for
administrative violations dated June 20, 2012
and the Law on amendments to the Law on penalties for administrative
violations dated November 13, 2020;
Pursuant to the Law on HIV/AIDS prevention and
control dated June 29, 2006; the Law on
amendments to the Law on HIV/AIDS prevention and control dated November
16, 2020;
At the request of
the Minister of Health;
The Government
promulgates a Decree providing amendments to the Government’s Decree No.
115/2018/ND-CP dated September 04, 2018 prescribing penalties for
administrative violations against regulations on food safety and the
Government’s Decree No.117/2020/ND-CP dated September 28, 2020 prescribing
penalties for administrative violations in medical sector.
Article
1. Amendments to Government’s Decree No. 115/2018/ND-CP dated
September 04, 2018
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a) Point m is added
following Point l Clause 3 as follows:
“m) Enforced
submission of altered or erased documents.”;
b) Clause 4 is added
following Clause 3 as follows:
“4. The imposition of
penalties and remedial measures must comply with the following provisions:
a) If the additional
penalty that is fixed-period suspension of operations is imposed, the person
having authority to impose administrative penalties shall send a written notice
thereof to competent regulatory authorities for cooperating in monitoring,
inspecting and reporting upon expiration of the time limit for execution of the
penalty imposition decision;
b) If the remedial
measure that is enforced submission of altered and/or erased documents is
imposed, the person issuing penalty imposition decision shall send a written
notice thereof to regulatory authorities issuing or receiving such documents
for revocation;
c) Other
requirements laid down in the Law on penalties for administrative violations.”.
2. Some Clauses of
Article 3 are amended as follows:
a) Clause 1 is
amended as follows:
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b) Clause 2 is
amended as follows:
“2. The fines
specified in Chapter II hereof shall be imposed on individuals, except the
fines specified in Clauses 1 and 5 Article 4, Clause 6 Article 5, Clause 5
Article 6, Clause 6 Article 9, Clause 7 Article 11, Article 18, Article 19,
Point a Clause 3 Article 20, Clause 1 Article 21, Clauses 1 and 9 Article 22,
Article 24, and Clause 6 Article 26 hereof which shall be imposed on
organizations. The fine imposed upon an organization is twice as much as the
fine imposed upon an individual for committing the same violation.
The fine imposed
upon an individual for committing the violation in Clause 1 or 5 Article 4,
Clause 6 Article 5, Clause 5 Article 6, Clause 6 Article 9, Clause 7 Article
11, Article 18, Article 19, Point a Clause 3 Article 20, Clause 1 Article 21,
Clause 1 or 9 Article 22, Article 24, or Clause 6 Article 26 hereof shall be
reduced by half.”.
3. Some Clauses of
Article 9 are amended as follows:
a) Clause 1 is
amended as follows:
“1. A fine ranging
from VND 1,000,000 to VND 3,000,000 shall be imposed for using persons who work
in direct contact with foods but do not wear adequate personal protective
equipment as prescribed, do not have their nails trimmed, wear watches,
bracelets or bangles, eat, drink, smoke or spit in the production areas of
foods, food additives, food processing aids, food containers and/or primary
packages.”;
b) Point b Clause 2
is amended as follows:
“b) Solid waste
containers are not covered as prescribed;”;
c) Point d is added
following Point c Clause 2 as follows:
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d) Point dd Clause 3
is amended as follows:
“dd) Hiring persons
who fail to have certificates of completion of training in food safety to
directly participate in the production/trading of foods, food additives, food
processing aids, food containers and/or primary packages;”;
dd) Point dd Clause
5 is amended as follows:
“d) The owner of the
establishment producing/trading in foods, food
additives, food processing aids, food containers and/or primary packages fails
to possess certificate of completion of training in food safety;”;
e) Point a Clause 6
is amended as follows:
“a) A fine ranging
from VND 7,000,000 to VND 10,000,000 shall be imposed for establishing systems
which fail to meet requirements set forth in law or applying such systems
inadequately or in a manner that is not conformable with food production and
trading;”;
g) Point a and Point
b Clause 7 are amended as follows:
“a) Hiring
persons who are suffering from diseases such as cholera, dysentery, typhoid,
hepatitis A or E, eczema, pulmonary tuberculosis or acute diarrhea to directly
take part in the production and/or trading of foods, food additives, food
processing aids, food containers and/or primary packages;
b) Using water that
fails to meet requirements set forth in relevant technical regulations or
unqualified water to serve the production, or clean equipment and devices
serving the production of foods, food additives, food processing aids, food
containers and/or primary packages.”.
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“b) Transporting
foods, food additives, food processing aids, food containers and primary
packages with other commodities that pose risk of food contamination.”.
5. Point a Clause 5 Article
11 is amended as follows:
“a) A fine ranging
from VND 3,000,000 to VND 5,000,000 shall be imposed for directly injecting
impurities into aquatic animals;”.
6. Some Clauses of
Article 15 are amended as follows:
a) Point dd is added
following Point d Clause 1 as follows:
“dd) Failing to
adopt measures for preventing cross-contamination between unprocessed foods and
processed foods in kitchen arrangements.”;
b) Point d Clause 2
is amended as follows:
“d) Wastewater is
stagnant in the food store or kitchen area; the sewage system is not closely
and carefully covered;”;
c) Point e Clause 2
is amended as follows:
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d) Clause 3 is
amended as follows:
“3. A fine ranging
from VND 5,000,000 to VND 7,000,000 shall be imposed for hiring persons who
fail to have certificates of completion of training in food safety to directly
process foods.”;
dd) Point b Clause 4
is amended as follows:
“b) The business
owner fails to possess certificate of completion of training in food safety;”;
e) Clause 5 is
amended as follows:
“5. A fine
ranging from VND 10,000,000 to VND 15,000,000 shall be imposed for hiring
persons who are suffering from diseases such as cholera, dysentery, typhoid,
hepatitis A or E, eczema, pulmonary tuberculosis or acute diarrhea to directly
process foods.”.
7. Point b Clause 2
Article 16 is amended as follows:
“b) The person
who directly processes foods is suffering from diseases such as cholera,
dysentery, typhoid, hepatitis A or E, eczema, pulmonary tuberculosis or acute
diarrhea;”.
8. Clauses 1, 2 and
3 Article 18 are amended as follows:
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2. A fine ranging
from VND 30,000,000 to VND 40,000,000 shall be imposed for failing to obtain a
certificate of food safety or using an expired certificate of food safety when
producing and/or trading foods, except cases where certificate of food safety
is exempted.
3. 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) Failing to obtain
Good Manufacturing Practice (GMP) certificate or using an expired GMP
certificate when producing dietary supplements, except cases where dietary
supplements are produced on the herbal drug or traditional drug production
lines or other cases as prescribed by the Minister of Health;
b) Trading or
placing on the market domestically manufactured or imported dietary supplements
granted Certificate of Declaration of conformity with the food safety
regulations or certificate of registered product declaration before July 01,
2019 without obtaining GMP certificate or another document of equivalent
validity before manufacturing.”.
9. Some Clauses of
Article 19 are amended as follows:
a) The first
paragraph of Clause 2 is amended as follows:
“2. A fine ranging
from VND 40,000,000 to VND 60,000,000 shall be imposed for committing one of
the following violations in the course of importing or exporting foods, food
additives, food processing aids, food containers and primary packages:”;
b) Point a Clause 2
is amended as follows:
“a) Altering or
falsifying the contents of the self-declaration form, product declaration form,
certificate of registered product declaration, notice of satisfactory
inspection results of imported foods, certificate of food safety, certificate
of free sale (CFS) and other documents;”;
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“d) Exporting a food
shipment whose quantity and product specifications do not match with those specified
in the application for certificate of food safety.”;
d) Point a Clause 5
is amended as follows:
“a) The exhibits of
violation prescribed in Point c Clause 2 of this Article shall be confiscated
if they are not yet destroyed;”;
dd) Point e is added
following Point dd Clause 6 as follows:
“e) Enforced
submission of altered and/or erased documents if the violation prescribed in
Point a Clause 2 of this Article is committed.”.
10. Some Clauses of
Article 20 are amended as follows:
a) Point b Clause 1
is amended as follows:
“b) Failing to
publish the self-declaration form on the food safety data system or failing to
submit a copy of the self-declaration form to the competent authority as
prescribed;”;
b) Point e is added
following Point dd Clause 2 as follows:
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c) Point a Clause 3
is amended as follows:
“a) Producing or
importing products which are subject to self-declaration inconsistently with
corresponding technical regulations or regulations adopted by competent
authorities or declared standards;".
11. Clause 1 Article
21 is amended as follows:
“1. A fine ranging
from VND 30,000,000 to VND 40,000,000 shall be imposed for producing or
importing products which are subject to mandatory registration of the
product declaration inconsistently with
corresponding technical regulations or regulations adopted by competent
authorities or declared standards.”.
12. Some Clauses of
Article 22 are amended as follows:
a) Clause 1 is
amended as follows:
“1. The following
fines shall be imposed for on trading or placing on the market food products
against regulations:
a) A fine equal to
01 - 02 times the value of the sold food products shall be imposed for trading
or placing on the market food products which are not conformable with declared
standards or food products which must be manufactured by establishments
possessing certificate of food safety or other documents of equivalent validity
but are manufactured by establishments that do not have such documents;
b) A fine equal to
02 - 03 times the value of the sold food products for replacing, swapping,
adding or cutting down ingredients or additives compared with those specified
in declared standards;
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b) Points h, i, k,
l, m and n are added following Point g Clause 2 as follows:
“h) Personnel
participating in production are not trained or re-trained in basic GMP rules
for production of dietary supplements;
i) Failing to have
the job description of key personnel, responsible personnel and personnel of
departments as prescribed;
k) Failing to have
approved production process of each product;
l) Failing to carry
out and maintain internal inspections to monitor the application and compliance
with GMP rules for production of dietary supplements and take necessary and
timely remedial actions;
m) Failing to
conclude contract or concluding a contract which does not clearly and
consistently determine and is not strictly performed in case of production
and/or testing under contract;
n) Failing to retain
samples of raw materials and finished products as prescribed or failing to
retain adequate number of samples for prescribed retention period.”;
c) Clause 2a is
added following Clause 2 as follows:
“2a. A fine ranging
from VND 15,000,000 to VND 20,000,000 shall be imposed if one of the violations
specified in Clause 2 of this Article is re-committed.”;
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“a) Producing, importing,
trading or placing on the market foods, food additives, food processing aids,
food containers and/or primary packages which are unconformable with the
declared product information, except the cases specified in Clause 1 of this
Article;”;
dd) Point a Clause 6
is amended as follows:
“a) Importing,
producing, processing, supplying or selling foods that cause food poisoning and
harm the health of 01 - 04 persons if not liable to criminal prosecution;”;
e) Point a Clause 8
is amended as follows:
“a) Importing,
producing, processing, supplying or selling foods that cause food poisoning and
harm the health of 05 persons or more if not liable to criminal prosecution;”;
g) Point a Clause 10
is amended as follows:
“a) The food
production/ processing/ trading/ supply shall be partially or entirely
suspended for a fixed period of 01 – 03 months if the violation prescribed in
Clause 2a or Clause 7 of this Article is committed;”;
h) Point b Clause 11
is amended as follows:
“b) Enforced
destruction of foods if any of the violations prescribed in Clauses 6, 7, 8 and
9 of this Article is committed;”;
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“dd) Enforced
repurposing or recycling or destruction of foods if any of the violations prescribed
in Clauses 1, 3 and 5 of this Article is committed;
e) Enforced
submission of altered and/or erased documents if the violation prescribed in
Point c Clause 4 of this Article is committed.”.
13. Point c is added
following Point b Clause 6 Article 24 as follows:
“c) Enforced
submission of altered and/or erased documents if the violation prescribed in
Point a Clause 4 of this Article is committed.”.
14. Some Clauses of
Article 26 are amended as follows:
a) Heading of Clause
26 is amended as follows:
“Article 26.
Violations against regulations on tracing of origin, recall and disposal of
disqualified foods, food additives, food processing aids, food containers
and/or primary packages”;
b) Point b Clause 2
is amended as follows:
“b) Failing to
establish a food traceability system or establishing a food traceability system
which does not contain adequate information; failing to trace the origin of
disqualified foods as prescribed;”;
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“d) Failing to provide
or inadequately, inaccurately or lately providing information serving the
traceability of foods as prescribed by law;”.
15. Some Clauses of
Article 28 are amended as follows:
a) Point b Clause 1
is amended as follows:
“b) Confiscate the
exhibits and instrumentalities for committing administrative violations worth
up to VND 10,000,000 if the violation is committed by an individual or VND
20,000,000 if the violation is committed by an organization;”;
b) Point c Clause 2
and Point c Clause 3 are amended as follows:
“c) Confiscate the
exhibits and instrumentalities for committing administrative violations;”.
16. Some Clauses of
Article 29 are amended as follows:
a) Point b Clause 1
is amended as follows:
“b) Confiscate the exhibits
and instrumentalities for committing administrative violations worth up to VND
1,000,000 if the violation is committed by an individual or VND 2,000,000 if
the violation is committed by an organization;”;
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"2. Chief
Inspectors of Provincial Departments of Health, Provincial Departments of
Agriculture and Rural Development, Provincial Departments of Industry and
Trade, Provincial Departments of Culture and Sports, Provincial Departments of
Tourism, Provincial Departments of Culture, Information, Sports and Tourism,
Provincial Departments of Information and Communications, Directors of Branches
of Vietnam Food Administration affiliated to Provincial
Departments of Health, Directors of Regional Animal Health Offices and Regional
Animal Quarantine Sub-departments affiliated to Department of Animal Health,
Directors of Regional Plant Quarantine Sub-departments affiliated to Plant Protection Department, Directors of Central
Region Authority and Southern Region Authority of the National
Agro-Forestry-Fisheries Quality Assurance Department (NAFIQAD), Directors of
Sub-Departments for crop production and plant protection, livestock, animal
health, fishery, quality control of agricultural, forestry and fishery
products, irrigation, flood control system,
natural disaster prevention and control, forestry, and rural development
affiliated to Provincial Departments of Agriculture and Rural Development shall
have the power to:”;
c) Point c Clause 2
is amended as follows:
“c) Confiscate the
exhibits and instrumentalities for committing administrative violations worth
up to VND 100,000,000 if the violation is committed by an individual or VND
200,000,000 if the violation is committed by an organization;”;
d) Clause 3 is
amended as follows:
“3. Heads
of specialized inspection teams established by provincial-level authorities
(including Provincial Departments of Health, Provincial Departments of
Agriculture and Rural Development, Provincial Departments of Industry and
Trade, Provincial Departments of Culture, Sports and Tourism, Provincial
Departments of Tourism, Provincial Departments of Culture, Information, Sports
and Tourism, Provincial Departments of Information and Communications, Branches
of Vietnam Food Administration, Provincial Departments of Crop Production and
Plant Protection, Animal Husbandry and Veterinary Sub-departments, Fisheries
Sub-departments, NAFIQAD's branches), heads of specialized inspection teams
established by Directorates or Departments affiliated to the Ministry of
Health, the Ministry of Agriculture and Rural Development, the Ministry of
Industry and Trade, the Ministry of Culture, Sports and Tourism, and the
Ministry of Information and Communications (including Directorate of Fisheries,
Department of Animal Health, Plant Protection
Department, Department of Crop Production, Department of Livestock Production, National
Agro-Forestry-Fisheries Quality Assurance Department (NAFIQAD), Agro Processing
and Market Development Authority, Vietnam Food Administration, Authority of Broadcasting and Electronic Information, Authority
of Press, Agency of Publication, Print and Release) shall have the power to
impose penalties as prescribed in Clause 2 of this Article.”;
dd) Point c Clause 4
is amended as follows:
“c) Confiscate the
exhibits and instrumentalities for committing administrative violations worth
up to VND 140,000,000 if the violation is committed by an individual or VND
280,000,000 if the violation is committed by an organization;”;
e) The first
paragraph of Clause 5 is amended as follows:
“5. Chief
Inspectors of the Ministry of Health, the Ministry of Agriculture and Rural
Development, the Ministry of Industry and Trade, the Ministry of Culture,
Sports and Tourism, and the Ministry of Information and Communications,
Directors of Directorate of Fisheries, the Department of Animal Health, the
Plant Protection Department, the Department of Crop Production, the Department
of Livestock Production, the National Agro-Forestry-Fisheries Quality Assurance
Department (NAFIQAD), the Agro Processing and Market Development Authority, the
Vietnam Food Administration, the Authority of Broadcasting and Electronic
Information, the Authority of Press, and Agency of Publication, Print and
Release shall have the power to:”;
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“c) Confiscate the
exhibits and instrumentalities for committing administrative violations;”.
17. Some Clauses of
Article 30 are amended as follows:
a) The first
paragraph of Clause 2 is amended as follows:
“2. Heads of
stations and leaders of the soldiers mentioned in Clause 1 of this Article
shall have the power to:”;
b) The first
paragraph of Clause 3 is amended as follows:
“3. Communal-level
police chiefs, heads of public security stations, heads of public security
stations at border gates and export processing zones, heads of public security
stations at international airports, and captains of squadrons shall have the
power to:”;
c) Point b Clause 3
is amended as follows:
“b) Confiscate the
exhibits and instrumentalities for committing administrative violations worth
up to VND 5,000,000 if the violation is committed by an individual or VND
10,000,000 if the violation is committed by an organization;”;
d) The first
paragraph of Clause 4 is amended as follows:
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dd) Point a Clause 4
is amended as follows:
“a) Impose fines of
up to VND 20,000,000 upon individuals and up to VND 40,000,000 upon
organizations;”;
e) Point c Clause 4
is amended as follows:
“c) Confiscate the
exhibits and instrumentalities for committing administrative violations worth
up to VND 40,000,000 if the violation is committed by an individual or VND
80,000,000 if the violation is committed by an organization;”;
g) Point c Clause 5
and Point c Clause 6 are amended as follows:
“c) Confiscate the
exhibits and instrumentalities for committing administrative violations;”;
h) The first
paragraph of Clause 6 is amended as follows:
“6. Directors of Internal
Political Security Department, Economic Security Department, Police Department
for Administrative Management of Social Order, Police Department for Social
Order Crimes, Investigation Police Department for Corruption, Economic and
Smuggling Crimes, Traffic Police Department, Police Department for Prevention
and Control of Environmental Crimes, Cybersecurity, Hi-tech Crimes Prevention
and Control Department, and Internal Security Department shall have the power
to:”.
18. Some Clauses of
Article 31 are amended as follows:
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“2a. Leaders of Task
Force Teams for drug and crime prevention and control which are put under the
control of Task Force Commissions for drug and crime prevention and control
shall have the power to:
a) Impose fines of
up to VND 10,000,000 upon individuals and up to VND 20,000,000 upon
organizations;
b) Confiscate the
exhibits and instrumentalities for committing administrative violations worth up
to VND 20,000,000 if the violation is committed by an individual or VND
40,000,000 if the violation is committed by an organization;
c) Impose the
remedial measures mentioned in Point b Clause 3 Article 2 hereof.”;
b) The first
paragraph of Clause 3 is amended as follows:
“3. Heads of Border
Guard Posts, Captains of Naval Border Guard Flotillas and Commanders of Border
Guard Commands at port border gates shall have the power to:”;
c) Points b and c
Clause 3 are amended as follows:
“b) Confiscate the
exhibits and instrumentalities for committing administrative violations worth
up to VND 50,000,000 if the violation is committed by an individual or VND
100,000,000 if the violation is committed by an organization;
c) Enforce the
remedial measures mentioned in Points a, b, dd, e, i and l Clause 3 Article 2
of this Decree.”;
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“3a. Leaders of Task
Force Teams for drug and crime prevention and control affiliated to the
Department of Drug and Crime Prevention and Control under the control of the
Command of Border Guards shall have the power to:
a) Impose fines of
up to VND 50,000,000 upon individuals and up to VND 100,000,000 upon
organizations;
b) Confiscate the
exhibits and instrumentalities for committing administrative violations worth
up to VND 100,000,000 if the violation is committed by an individual or VND
200,000,000 if the violation is committed by an organization;
c) Enforce the
remedial measures mentioned in Points a, b, d, dd, e, i and l Clause 3 Article
2 of this Decree.”;
dd) The first
paragraph of Clause 4 is amended as follows:
“4. Commanders of
Provincial-level Border Guard Forces, Captains of Naval Border Guard Squadrons,
and Director of the Department of Drug and Crime Prevention and Control affiliated
to the Command of Border Guards shall have the power to:”;
e) Point c and Point
d Clause 4 are amended as follows:
“c) Confiscate the
exhibits and instrumentalities for committing administrative violations;
d) Enforce the
remedial measures mentioned in Points a, b, d, dd, e, i and l Clause 3 Article
2 of this Decree.”.
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a) Point b Clause 4
is amended as follows:
“b) Confiscate the
exhibits and instrumentalities for committing administrative violations worth
up to VND 40,000,000 if the violation is committed by an individual or VND
80,000,000 if the violation is committed by an organization;”;
b) The first
paragraph of Clause 5 is amended as follows:
“5. Captains of
Naval Border Guard Squadrons; Heads of Reconnaissance Commissions; Heads of
Task Force Commissions for Drug Crime Prevention and Control under the control
of the Command of Coast Guard of Vietnam shall have the power to:”;
c) Point b Clause 5
is amended as follows:
“b) Confiscate the
exhibits and instrumentalities for committing administrative violations worth
up to VND 60,000,000 if the violation is committed by an individual or VND
120,000,000 if the violation is committed by an organization;”;
d) The first paragraph
of Clause 6 is amended as follows:
“6. Regional
Commands of Coast Guard and Director of the Department of Operations and
Legislation under the control of the Command of Coast Guard of Vietnam shall
have the power to:”;
dd) Point a1 is
added following Point a Clause 6 as follows:
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e) Point b Clause 6
is amended as follows:
“b) Confiscate the
exhibits and instrumentalities for committing administrative violations;”;
g) The first
paragraph of Clause 7 is amended as follows:
“7. Commander of
Vietnam Coast Guard shall have the power to:”;
h) Point c Clause 7
is amended as follows:
“c) Confiscate the exhibits
and instrumentalities for committing administrative violations;”.
20. Some Clauses of
Article 33 are amended as follows:
a) The first
paragraph of Clause 2 is amended as follows:
“2. Team Leaders,
Group Leaders of Customs Sub-departments; Leaders of Groups in Control Teams
affiliated to provincial, inter-provincial or municipal Customs Departments;
Leaders of Teams in Post-clearance Inspection Sub-departments, shall have
the power to:”;
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“3. Directors of
Customs Sub-departments; Directors of Post-clearance Inspection
Sub-departments; Leaders of Control Teams of provincial, inter-provincial or
municipal Customs Departments; Leaders of Criminal Investigation Teams; Leaders
of Smuggling Control Teams; Captains of Maritime Control Flotillas and Leaders
of Anti-smuggling, Counterfeit Product Control and Intellectual Property Teams
affiliated to the Smuggling Investigation and Prevention Department; Directors
of Post-clearance Inspection Sub-departments affiliated to the Post-clearance
Inspection Department shall have the power to:”;
c) Points b and c
Clause 3 are amended as follows:
“b) Confiscate the
exhibits and instrumentalities for committing administrative violations worth
up to VND 50,000,000 if the violation is committed by an individual or VND
100,000,000 if the violation is committed by an organization;
c) Enforce the
remedial measures mentioned in Points a, b, d, dd, e, h, k, l and m Clause 3
Article 2 of this Decree.”;
d) Point c and Point
d Clause 4 are amended as follows:
“c) Confiscate the
exhibits and instrumentalities for committing administrative violations;
d) Enforce the
remedial measures mentioned in Points a, b, d, dd, e, h, k, l and m Clause 3
Article 2 of this Decree.”;
dd) Point c Clause 5
is amended as follows:
“c) Enforce the
remedial measures mentioned in Points a, b, d, dd, e, h, k, l and m Clause 3
Article 2 of this Decree.”.
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a) The first paragraph
of Clause 2 is amended as follows:
“2. Leaders of
Market Surveillance Teams and Heads of Professional Divisions under the control
of the Departments of Market Surveillance Operations shall have the power
to:”;
b) Point b Clause 2
is amended as follows:
“b) Confiscate the
exhibits and instrumentalities for committing administrative violations worth
up to VND 50,000,000 if the violation is committed by an individual or VND
100,000,000 if the violation is committed by an organization;”;
c) The first paragraph
of Clause 3 is amended as follows:
“3. Directors of
Provincial-level Market Surveillance Departments and Directors of Market
Surveillance Operations Departments affiliated to Vietnam Directorate of Market
Surveillance shall have the power to:”;
d) Point b Clause 3
is amended as follows:
“b) Confiscate the
exhibits and instrumentalities for committing administrative violations;”;
dd) The first
paragraph of Clause 4 is amended as follows:
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22. Clause 4 and f
Clause 5 Article 35 are amended as follows:
“4. Persons having
the power to impose penalties of Border Guard Forces prescribed in Article 31
hereof and of Coast Guard Forces prescribed in Article 32 hereof shall have the
power to make records of administrative violations, impose penalties and
remedial measures against administrative violations against regulations on food
safety regarding collection, selling, supply and import of foods prescribed in
Clause 3, Point b Clause 4 and Clause 5 Article 4, Articles 10, 11, Clauses 1,
4 Article 19, Point a Clause 4 Article 20, Clause 2 Article 21, Clause 1,
Points b, c Clause 6 Article 22, Clause 6 Article 26 hereof within the ambit of
their assigned duties, functions and powers.
5. Persons having
the power to impose penalties of customs agencies prescribed in Article 33
hereof shall have the power to make records of administrative violations,
impose penalties and remedial measures against food safety violations which are
prescribed in Article 19, Clauses 2, 3, 4 Article 20, Article 21, Points a, b
Clause 5, Clause 6, Clause 7, Clause 8, Clause 9 Article 22, Clause 4 Article
24 hereof, and detected in the areas under their management but are not
governed by the Government’s Decree on administrative penalties for customs
offences.”.
Article
2. Amendments to Government’s Decree No. 117/2020/ND-CP dated September 28,
2020
1. Clause 4 Article
1 is amended as follows:
"4. When
detecting the violations in Point c Clause 3 Article 7, Point b Clause 6
Article 38, Points a, b Clause 7 Article 44, Clause 6 Article 48, Point a
Clause 2 Article 52, Clause 3 Article 53, Point a Clause 1 Article 54, Point c
Clause 4 Article 56, Point d Clause 5, Clause 7 Article 57, Clause 7 Article
58, Clause 7 Article 59, Point a Clause 4 Article 60, Point c Clause 5 Article
67, Clause 3 Article 68, Point b Clause 2 Article 70, Points a, b Clause 3
Article 73, Clause 4 Article 80, Points d, dd, e, g and h Clause 2 Article 85,
Points d, dd, e, g, h and i Clause 2 Article 86 hereof or the repeating of the
violations in Points a, b Clause 3 Article 7, Clause 9 Article 15, Clause 6
Article 40, Point a Clause 6 Article 44, Point b Clause 5 Article 67 and
Clauses 2, 3 Article 80 hereof, the competent officials who are handling such
cases shall, based on the nature and severity of the violation which denotes
signs of crime according to corresponding regulations of the Criminal Code,
transfer the case files to competent criminal proceeding agencies for initiating
criminal prosecution in accordance with the provisions of Clauses 1, 2 and 4
Article 62 of the Law on penalties for administrative violations. If the
relevant criminal proceeding agency decides not to institute criminal
proceedings in accordance with the provisions of the Criminal Procedure Code,
the case file shall be returned to the official who has transferred it to the
criminal 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 herein.”.
2. Point dd Clause 2
Article 2 is amended as follows:
“dd) Administrative
units;”.
3. Some Clauses of
Article 3 are amended as follows:
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s) Enforced return
of practice certificates, license for medical operations, license to import
medical devices, certificate of eligibility for pharmacy business, certificate
of free sale of domestically manufactured medical devices, certificate of
registration of drugs/medicinal ingredients, receipt number of cosmetic product
declaration, acknowledgement of receipt of declaration dossier, certificate of
registration of drugs/medicinal ingredients, certificate of registration of
free sale of type C, D medical devices to competent regulatory authorities.”;
b) Clause 4 is added
following Clause 3 as follows:
“4. The imposition
of penalties and remedial measures must comply with the following provisions:
a) If the additional
penalty that is fixed-period suspension of operations is imposed, the person
having authority to impose administrative penalties shall send a written notice
thereof to competent regulatory authorities for cooperating in monitoring,
inspecting and reporting upon expiration of the time limit for execution of the
penalty imposition decision;
b) If the remedial
measure that is enforced submission of licenses/practicing certificates to
competent regulatory authorities is imposed, the person having authority to
impose administrative penalties shall send a written notice thereof to
regulatory authorities issuing or receiving such licenses/practicing
certificates;
c) Other
requirements laid down in the Law on penalties for administrative violations.”.
4. Clause 6 Article
4 is amended as follows:
"6. Fines imposed
by the competent officials specified in Chapter III hereof are incurred by
individuals. An official having the power to impose fines shall have the right
to impose a fine twice as much as that imposed upon an individual upon an
organization for committing the same administrative violation.”.
5. Some Clauses of
Article 12 are amended as follows:
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“a) Failing to adopt
personal protective measures for persons participating in epidemic control and
susceptible persons according to guidance of health agencies, including:
wearing face masks, disinfection, distancing, medical declaration and other
measures;”;
b) Point c Clause 2
is amended as follows:
“c) Failing to participate
in epidemic management activities according to mobilization decisions issued by
competent officials, except for the cases specified in Point m Clause 5 Article
38 and Point b Clause 4 Article 39 of this Decree;”;
c) Point a Clause 4
is amended as follows:
“a) Failing to implement
decisions on inspection, surveillance and medical control when entering or
leaving epidemic areas of a group-A infectious disease;
d) Point b Clause 5
is amended as follows:
“b) Failing to
implement decisions on no gathering of crowds in areas where epidemic state of
emergency has been declared according to resolutions, decisions, directives and
other documents issued by competent authorities;".
6. Point e Clause 3
Article 20 is amended as follows:
“e) Performing HIV
tests for persons aged under 15, incapacitated persons, persons with limited
cognition, behavior control, and persons with limited legal capacity without
obtaining written consent of their parents, lawful guardians or
representatives, except emergency cases prescribed in the Law on medical
examination and treatment.”.
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“A fine ranging from
VND 20.000.000 to VND 30.000.000 shall be imposed for commission of one of the
following violations:”
8. Some Clauses of
Article 38 are amended as follows:
a) Point a Clause 4
is amended as follows:
“a) Registering
for practicing at multiple health facilities for the same period of time;
failing to comply with the practicing period approved by a competent authority
or transfer or assignment orders of competent authorities as prescribed by
law;”;
b) Point dd is added
following Point d Clause 4 as follows:
“dd) Failing to
apply for medical examination and treatment practicing certificate in
accordance with regulations of law.";
c) Point m is added following
Point l Clause 5 as follows:
“m) Failing to
comply with human resource mobilization decisions issued by competent
authorities in case of disasters or dangerous epidemics.”;
d) Point a Clause 8
is amended as follows:
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9. Some Clauses of
Article 39 are amended as follows:
a) Clause 2a is
added following Clause 2 as follows:
"2a. A fine
ranging from VND 5.000.000 to VND 10.000.000 shall be imposed for commission of
one of the following violations:
a) Charging medical
services at prices higher than the ones posted;
b) 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.”;
b) Point a Clause 7
is amended as follows:
“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,
Clause 4, Point c Clause 5 or Point b, c, d or e Clause 6 of this Article;”.
10. Point dd is
added following Point d Clause 1 Article 40 as follows:
“dd) Failing to
prepare medical records or preparing medical records which fail to have
adequate information as prescribed by law.”.
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“Article 48a.
Violations against regulations on clinical pharmacology of health facilities
1. A fine ranging
from VND 3.000.000 to VND 5.000.000 shall be imposed for commission of one of
the following violations:
a) Failing to assign
sufficient clinical pharmacologists according to the roadmap prescribed by law;
b) Failing to assign
qualified clinical pharmacologists as prescribed by law.
2. A fine ranging
from VND 5.000.000 to VND 10.000.000 shall be imposed for assigning clinical pharmacologists
who do not possess pharmacy practicing certificate or whose pharmacy practicing
certificate is suspended or who are suspended from pharmacy practicing.
3. A fine ranging
from VND 10.000.000 to VND 20.000.000 shall be imposed for failing to organize
clinical pharmacology activities according to the roadmap prescribed by law.”.
12. Point dd Clause
2 Article 51 is amended as follows:
“dd) Allowing infant
formula producers or traders to give sample products or gifts related to their
infant formulas in health facilities;”.
13. Some Clauses of
Article 56 are amended as follows:
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“b) Failing to
follow procedures for notifying competent authorities of minor variations which
must be notified before placing drugs/medicinal ingredients on the
market;”;
b) Point c and Point
d Clause 3 are amended as follows:
“c) Failing to
follow procedures for modification of certificate of free sale with a competent
authority and obtain an approval for such modification before placing
drugs/medicinal ingredients in respect of major/minor variations requiring
approval;
d) Manufacturing and
placing on the market drugs/medicinal ingredients to which there are variations
compared to the approved application for registration which require following
procedures for issuance of certificate of free sale as prescribed by law.”;
c) Clause 6 is added
following Clause 5 as follows:
"6. In case 02
or more drugs/medicinal ingredients are found during an inspection to involve
one of the violations specified in Clauses 1, 2, 3, 4 of this Article, only
penalties for that violation shall be imposed while taking the number of
violating drugs/medicinal ingredients into account as aggravating factors.”.
14. Some Clauses of
Article 57 are amended as follows:
a) Point d is added
following Point c Clause 1 as follows:
“d) Failing to
retain samples of drug/medicinal ingredient when performing drug/medicinal
ingredient testing as prescribed by law.”;
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“a) Failing to
notify competent authorities when manufacturing drug/medicinal ingredient to
which there are minor variations compared to the approved application for
registration which requires notification, except the case specified in Point b
Clause 1 Article 56 of this Decree;
b) Manufacturing
drug/medicinal ingredient to which there are minor variations compared to the
approved application for registration before obtaining approval for such
variations from a competent authority as prescribed by law, except the case
specified in Point c Clause 3 Article 56 of this Decree;
c) Failing to
retain samples of finished drug products for a minimum period of 12 months
after the expiry date of drug products; failing to retain samples of active
ingredients for a minimum period of 12 months after the expiry date of finished
drugs made of such ingredients;”;
c) Point dd Clause 3
is amended as follows:
“dd) Manufacturing
drug/medicinal ingredient to which there are major variations compared to the
approved application for registration before obtaining approval for such
variations as prescribed by law, except the case specified in Point c Clause 3
Article 56 of this Decree;”;
d) Point i is added
following Point h Clause 4 as follows:
“i) Manufacturing
drugs from active ingredients provided by manufacturers that do not have
documents proving their compliance with GMP or that fail to meet GMP
requirements as announced by competent authorities.”.
15. Some Clauses of
Article 58 are amended as follows:
a) Point a Clause 2
is amended as follows:
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b) Point b Clause 3
is amended as follows:
“b) Failing to apply
for periodic inspection of GDP (Good distribution practices) compliance as
prescribed by law;”;
c) Point d and Point
dd Clause 3 are amended as follows:
“d) Failing to adopt
mechanism for transmission of information or failing to transmit adequate
information on distribution and quality of drugs between a manufacturer and its
customers, or to relevant regulatory authorities at their request;
dd) Only maintaining
the GDP compliance at level 3 according to the conclusion given by a competent
authority.”;
d) Clause 9 is
amended as follows:
"9. Remedial
measures:
All drugs/medicinal
ingredients must be destroyed in case of commission of any of the violations in
Point b Clause 4 and Clause 6 of this Article.”.
16. Some Clauses of
Article 59 are amended as follows:
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“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 product is not a drug”) or displaying products which are not drugs in
the same area with drugs in case cosmetics, functional foods and medical
devices are sold together with drugs as prescribed by law;”;
b) Point dd and
Point e Clause 3 are amended as follows:
“dd) Retailing
vaccines;
e) Failing to apply
for periodic inspection of GPP (Good pharmacy practices) compliance as
prescribed by law;”;
c) Point h and Point
I Clause 3 are amended as follows:
“h) Failing to
transmit information or transmitting inadequate information on the sale,
purchase and quality of drugs between suppliers and customers upon a request
made in accordance with regulations of law, except herbal ingredient retailers;
i) Only maintaining
GPP compliance at level 3 according to the
conclusion given by a competent authority.”;
d) Point g is added
following Point e Clause 4 as follows:
“g) Selling
prescription drugs without a prescription presented.”;
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“c) All drugs/herbal
ingredients shall be destroyed in case of commission of the violation in Clause
6 of this Article.”;
e) Clause 10 is
added following Clause 9 as follows:
"10. In case 02
or more drugs/medicinal ingredients are found during an inspection to involve
the violation specified in Point g Clause 4 of this Article, only penalties for
that violation shall be imposed while taking the number of violating
drugs/medicinal ingredients into account as aggravating factors.”.
17. Some Clauses of
Article 60 are amended as follows:
a) Point c and Point
d are added following Point b Clause 1 as follows:
“c) Failing to
retain samples of finished drug products for a minimum period of 12 months
after their expiry date;
d) Failing to retain
samples of active ingredients for a minimum period of 12 months after
the expiry date of finished drugs made of such ingredients.”;
b) Point b Clause 3
is amended as follows:
“b) Only maintaining
the GSP (Good storage practices) compliance
at level 3 according to the conclusion given by a competent authority.”;
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“dd) Importing
drugs/medicinal ingredients from suppliers that are not licensed to supply
drugs/medicinal ingredients as prescribed by law.”;
d) Point dd Clause 6
is amended as follows:
“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 30.000.000;”.
18. Some Clauses of
Article 66 are amended as follows:
a) Point d Clause 2
is amended as follows:
“d) A drug retailer
located within the premises of a health facility retails drugs with a retail
margin higher than the maximum one prescribed by law.”;
b) Clause 6 is added
following Clause 5 as follows:
"6. In case 02
or more drugs/medicinal ingredients are found during an inspection to involve
one of the violations specified in Clauses 1, 2, 3, 4 of this Article, only
penalties for that violation shall be imposed while taking the number of
violating drugs/medicinal ingredients into account as aggravating factors.”.
19. Some Clauses of
Article 68 are amended as follows:
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“2. A fine ranging
from VND 20.000.000 to VND 30.000.000 shall be imposed for placing a cosmetic
product on the market before obtaining an acknowledgment of notification
of that cosmetic product (i.e. notification number) from a competent authority
or placing a cosmetic product on the market
after its notification number has been expired without following procedures for
re-notification as prescribed by law.”;
b) Clause 6 is added
following Clause 5 as follows:
"6. In case 02
or more cosmetic products are found during an inspection to involve one of the
violations specified in Clauses 1, 2, 3, 4 of this Article, only penalties for
that violation shall be imposed while taking the number of violating cosmetic
products into account as aggravating factors.”.
20. Some Clauses of
Article 70 are amended as follows:
a) Point a Clause 4
is amended as follows:
“a) All cosmetic
products involving in the violation specified in Clause 1 or Clause 2 of this
Article shall be recalled and destroyed. The cosmetic products which fail to
meet packaging weight or volume standards as specified in Point d Clause 1 of
this Article shall not be subject to disposal;”;
b) Clause 5 is added
following Clause 4 as follows:
"5. In case 02
or more cosmetic products are found during an inspection to involve one of the
violations specified in Clauses 1, 2, 3, 4 of this Article, only penalties for that
violation shall be imposed while taking the number of violating cosmetic
products into account as aggravating factors.”.
21. Some Clauses of
Article 71 are amended as follows:
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“dd) Trading cosmetic
product whose Product Information File (PIF) fails to have adequate
information as prescribed by law.”;
b) Point b Clause 3
is amended as follows:
“b) Trading cosmetic
products without PIF or failing to present PIF of cosmetic products within the
prescribed time limit to serve inspection requirements upon request of a
competent authority;”;
c) Clause 5 is added
following Clause 4 as follows:
"5. In case 02
or more cosmetic products are found during an inspection to involve one of the
violations specified in Clauses 1, 2, 3 of this Article, only penalties for
that violation shall be imposed while taking the number of violating cosmetic
products into account as aggravating factors.”.
22. Some Clauses of
Article 72 are amended as follows:
a) Clause 1 is amended
as follows:
“1. A fine ranging
from VND 5.000.000 to VND 10.000.000 shall be imposed upon a registration
number holder for failing to publish Medical device classification results in
accordance with regulations of law.”;
b) Point d, Point dd
and Point e Clause 2 are amended as follows:
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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
registration number of the medical device has been issued using the
classification result which has been cancelled and the medical device has been
granted customs clearance but are not yet 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 registration number of the medical device has
been issued using the classification result which has been cancelled and the
medical device has been granted customs clearance but are not yet sold to
customers;”;
c) Point b Clause 3
is amended as follows:
“b) The registration
number holder fails to stop placing on the market or fails to organize the
recall of the medical device which has been granted the registration
number using the classification result that has been cancelled and has been
granted customs clearance but are not yet sold
to customers.”;
d) Point a Clause 5
is amended as follows:
“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 a Clause 2 of this Article;”.
23. Some Clauses of
Article 73 are amended as follows:
a) Clause 1 is
amended as follows:
“1. A fine ranging
from VND 5.000.000 to VND 10.000.000 shall be imposed for failing to prepare
notice of changes which must be accompanied by supporting documents for such
changes or failing to update such documents to the application for declaration
of eligibility for manufacture of medical devices published on the
Portal on management of medical devices within the prescribed time limit upon
occurrence of any changes in the published application
for declaration of eligibility as prescribed by law.”;
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“b) Failing to meet
ISO 13485 quality control standards when manufacturing medical devices.”;
c) Point c Clause 3
is amended as follows:
“c) Manufacturing medical
devices before completing procedures for declaration of eligibility for
manufacture of medical devices in accordance
with regulations of law.”;
d) Clause 4 is
amended as follows:
"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
Clause 3 of this Article.”;
dd) Point a Clause 5
is amended as follows:
“a) Enforced
submission of the acknowledgement of declaration of eligibility for
manufacture of medical devices in case of commission of the violation in Point
a Clause 2 or Point b Clause 3 of this Article;”.
24. Some Clauses of
Article 74 are amended as follows:
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“a) Placing on the
market the medical device whose label does not have adequate information as
prescribed by law;”;
b) Point dd Clause 1
is amended as follows:
“dd) Failing to
notify competent authorities or failing to update documents about changes to
the application for registration number published on the Portal on
management of medical devices within the prescribed time limit upon occurrence
of changes during the placement of the medical device on the market;”;
c) Point g Clause 1
is amended as follows:
“g) Placing on the
market a medical device which is imported from the manufacturer that fails to
obtain a certificate of conformity with ISO 13485 quality control standards and
which is not yet sold in any other country on the world;
d) Point a Clause 2
is amended as follows:
“a) Failing to
re-apply for declaration of applied standards for Class-A or Class-B medical
device in accordance with regulations of law;”;
dd) Point g Clause 2
is amended as follows:
“g) Failing to submit
reports to police authorities on loss of medical devices or raw materials for
manufacture of medical devices that contain narcotic substances and
precursors;”;
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“l) Failing to maintain
the validity of certificate of free sale, authorization letter or certificate
of eligibility to provide warranty services
during the effective period of the registration number as prescribed by law.”;
g) Point b, c, d and
dd Clause 3 are amended as follows:
“b) Altering or
erasing the acknowledgement of declaration of applied standards for Class-A or
Class-B medical device;
c) Altering or
erasing the certificate of registration of Class-C or Class-D medical device;
d) Failing to ensure
the legitimacy of documents included in the application for declaration of
applied standards for Class-A or Class-B medical devices;
dd) Failing to
ensure the legitimacy of documents included in the application for issuance or
re-issuance of certificate of registration of Class-C or Class-D medical
device.”;
h) Point a and Point
b Clause 4 are amended as follows:
“a) Placing Class-A
or Class-B medical devices on the market before obtaining the acknowledgement
of the application for declaration of applied standards or the import license;
b) Placing Class-C
or Class-D medical devices on the market before obtaining the number of
certificate of registration or the import license;”;
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“a) The exhibits,
including the acknowledgment of application, certificate and documents, shall
be confiscated in case of commission of the violation in Point d or dd Clause 3
of this Article;”;
k) Point b Clause 6
is amended as follows:
“b) Enforced
submission of the acknowledgment of application for declaration of applied
standards for Class-A or Class-B medical devices or certificate of registration
of Class-C or Class-D medical devices in case of commission of the violation in
Point b, c, d or dd Clause 3 of this Article.”.
25. Some Clauses of
Article 77 are amended as follows:
a) Clause 1 is
amended as follows:
“1. A fine ranging
from VND 3.000.000 to VND 5.000.000 shall be imposed for failing to prepare
notice of changes which must be accompanied by supporting documents for such
changes or failing to update such documents to the application for declaration
of eligibility to provide medical device technical consulting published on the Portal on management of medical
devices within the prescribed time limit upon occurrence of any changes in the
published application for declaration of eligibility as prescribed by law.”;
b) Point b Clause 2
is amended as follows:
“b) Providing medical
device technical consulting before the Ministry of Health publishes relevant
information and application for declaration of eligibility to provide medical
device technical consulting;”.
26. Article 78a is
added following Article 78 as follows:
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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
publish information about declaration of medical device prices on the Ministry of Health’s portal before such medical
devices are placed on the market of Vietnam for the first time;
b) Making
declaration of medical device prices which does not have adequate information
as prescribed by law;
c) Failing to update
the declared prices of medical devices whenever they are changed;
d) Failing to explain
elements constituting the medical device price at the request of regulatory
authorities;
dd) Making
declaration of medical device prices by an entity that is not the registration
number holder or distributor appointed by the registration number holder to
make declaration of medical device prices.
2. A fine ranging
from VND 15.000.000 to VND 20.000.000 shall be imposed for commission of one of
the following violations:
a) Failing to
declare prices of medical devices before they are placed on the market
in Vietnam;
e) Trading medical
devices before their prices are declared or at prices higher than those
published on the Ministry of Health’s Portal at the time of trading.”.
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a) Point a Clause 1 is
amended as follows:
“c) Confiscate
the exhibits and instrumentalities worth up to VND
6.000.000 for the administrative violations against regulations on population,
or up to VND 10.000.000 for the administrative violations against regulations
on preventive medicine, HIV/AIDS prevention and control, health insurance,
medical examination and treatment, pharmacy, cosmetics and medical devices;”;
b) Point d Clause 2
is amended as follows:
“d) Confiscate the
exhibits and instrumentalities used for committing administrative violations;
28. Some Clauses of
Article 104 are amended as follows:
a) Point a Clause 1
is amended as follows:
“c) Confiscate the
exhibits and instrumentalities worth up to VND 600.000 for the administrative
violations against regulations on population, or up to VND 1.000.000 for the
administrative violations against regulations on preventive medicine, HIV/AIDS
prevention and control, health insurance, medical examination and treatment,
pharmacy, cosmetics and medical devices;”;
b) The first paragraph
of Clause 2 is amended as follows:
"2. Chief
Inspectors of provincial departments, Directors of Population and Family
Planning Sub-departments affiliated to provincial Departments of Health, heads
of provincial-level specialized inspection teams, and heads of specialized
inspection teams established by competent authorities assigned to perform
specialized inspection functions shall have the power to:”;
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“d) Confiscate the
exhibits and instrumentalities worth up to VND 30.000.000 for the
administrative violations against regulations on population, or up to VND
50.000.000 for the administrative violations against regulations on preventive
medicine, HIV/AIDS prevention and control, or up to VND 75.000.000 for the
administrative violations against regulations on health insurance, or up to VND
100.000.000 for the administrative violations against regulations on medical
examination and treatment, pharmacy, cosmetics and medical devices;”;
d) The first
paragraph of Clause 3 is amended as follows:
"3. Chief
Inspectors of Ministries, Director General of General Department of Population
and Family Planning, Director General of Drug Administration of Vietnam, Director
General of Vietnam Administration of Medical Services, Director General of
Health Environment Management Agency, and Director General of General
Department of Preventive Medicine shall have the power to:”;
dd) Point d Clause 4
is amended as follows:
“d) Confiscate the
exhibits and instrumentalities worth up to VND 42.000.000 for the
administrative violations against regulations on population, or up to VND
70.000.000 for the administrative violations against regulations on preventive
medicine, HIV/AIDS prevention and control, or up to VND 105.000.000 for the
administrative violations against regulations on health insurance, or up to VND
140.000.000 for the administrative violations against regulations on medical
examination and treatment, pharmacy, cosmetics and medical devices;”.
29. Some Clauses of
Article 105 are amended as follows:
a) The first
paragraph of Clause 2 is amended as follows:
“2. Leaders of
Market Surveillance Teams and Heads of Professional Divisions under the control
of the Departments of Market Surveillance Operations shall have the power
to:”;
b) Point b Clause 2
is amended as follows:
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c) The first
paragraph of Clause 3 is amended as follows:
“3. Directors of
Provincial-level Market Surveillance Departments and Directors of Market
Surveillance Operations Departments affiliated to Vietnam Directorate of Market
Surveillance shall have the power to:”;
d) Point c Clause 3
is amended as follows:
“c) Confiscate the
exhibits and instrumentalities for committing administrative violations;”.
30. Some Clauses of
Article 106 are amended as follows:
a) The first
paragraph of Clause 2 is amended as follows:
“2. Heads of
stations and leaders of the soldiers mentioned in Clause 1 of this Article
shall have the power to:”;
b) The first paragraph
of Clause 3 is amended as follows:
“3. Communal-level
police chiefs, heads of public security stations, heads of public security
stations at border gates and export processing zones, heads of public security
stations at international airports, and captains of squadrons shall have the
power to:”;
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“c) Confiscate the
exhibits and instrumentalities worth 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;”;
d) The first
paragraph of Clause 4 is amended as follows:
“4. Heads of
district-level police agencies, heads of professional divisions of the
following authorities, including the Internal Political Security Department,
the Police Department for Administration of Social Order, the Traffic Police
Department, and the Department of Cybersecurity, Hi-Tech Crime Prevention and
Control, and heads of provincial-level police departments, including: Economic
Security Departments, Internal Political Security Divisions, Police Departments
for Social Order Administration, Police Divisions for Prevention and
Control of Environmental Crimes, Traffic Police Divisions, Road and Railway
Traffic Police Divisions, Road Traffic Police Divisions, Waterway Police
Divisions, Investigation Police Divisions for Corruption, Economic and
Smuggling Crimes, and Captains of Squadrons shall have the power to:”;
dd) Point d Clause 4
is amended as follows:
“d) Confiscate the
exhibits and instrumentalities worth up to VND 12.000.000 for the
administrative violations against regulations on population, or up to VND
20.000.000 for the administrative violations against regulations on preventive
medicine, HIV/AIDS prevention and control, or up to VND 30.000.000 for the
administrative violations against regulations on health insurance, or up to VND
40.000.000 for the administrative violations against regulations on medical
examination and treatment, pharmacy, cosmetics and medical devices;”;
e) Point d Clause 5
is amended as follows:
“d) Confiscate the
exhibits and instrumentalities used for committing administrative violations;”;
g) The first
paragraph of Clause 6 is amended as follows:
“6. Directors of
Internal Political Security Department, Police Department for Administrative
Management of Social Order, Police Department for Social Order Crimes, Economic
Security Department, Police Department for Prevention and Control of
Environmental Crimes, Traffic Police Department, and Investigation Police
Department for Corruption, Economic and Smuggling Crimes shall have the power
to:”.
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a) The first
paragraph of Clause 2 is amended as follows:
“2. Team Leaders,
Group Leaders of Customs Sub-departments; Leaders of Groups in Control Teams
affiliated to provincial, inter-provincial or municipal Customs Departments;
Leaders of Teams in Post-clearance Inspection Sub-departments, shall have
the power to:”;
b) The first
paragraph of Clause 3 is amended as follows:
“3. Directors of
Customs Sub-departments; Directors of Post-clearance Inspection Sub-departments;
Leaders of Control Teams of provincial, inter-provincial or municipal Customs
Departments; Leaders of Criminal Investigation Teams; Leaders of Smuggling
Control Teams; Captains of Maritime Control Flotillas and Leaders of
Anti-smuggling, Counterfeit Product Control and Intellectual Property Teams
affiliated to the Smuggling Investigation and Prevention Department; Directors
of Post-clearance Inspection Sub-departments affiliated to the Post-clearance
Inspection Department shall have the power to:”;
c) Point c Clause 3
is amended as follows:
“c) Confiscate the
exhibits and instrumentalities worth up to VND 50.000.000 for the
administrative violations against regulations on preventive medicine, HIV/AIDS
prevention and control, pharmacy, cosmetics and medical devices;”;
d) Point d Clause 4
is amended as follows:
“d) Confiscate the
exhibits and instrumentalities used for committing administrative violations;
32. Some Clauses of
Article 108 are amended as follows:
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"2a. Leaders of
Task Force Teams for drug and crime prevention and control which are put under
the control of Task Force Commissions for drug and crime prevention and control
shall have the power to:
a) Issue warning;
b) Impose a fine up
to VND 3.000.000 for the administrative violations against regulations on
population, or up to VND 5.000.000 for the administrative violations against
regulations on preventive medicine, and HIV/AIDS prevention and control, or up
to VND 10.000.000 for the administrative violations against regulations on
medical examination and treatment, pharmacy, cosmetics and medical devices;
c) Confiscate the
exhibits and instrumentalities worth up to VND 6.000.000 for the administrative
violations against regulations on population, or up to VND 10.000.000 for the
administrative violations against regulations on preventive medicine, HIV/AIDS
prevention and control, or up to VND 20.000.000 for the administrative
violations against regulations on medical examination and treatment, pharmacy,
cosmetics and medical devices;
d) Enforce the
remedial measures mentioned in Points c and dd Clause 1 Article 28 of the Law
on penalties for administrative violations.”;
b) The first
paragraph of Clause 3 is amended as follows:
“3. Heads of Border
Guard Posts, Captains of Naval Border Guard Flotillas and Commanders of Border
Guard Commands at port border gates shall have the power to:”;
c) Points c and d
Clause 3 are amended as follows:
“c) Confiscate the
exhibits and instrumentalities worth up to VND 12.000.000 for the
administrative violations against regulations on population, or up to VND
20.000.000 for the administrative violations against regulations on preventive
medicine, HIV/AIDS prevention and control, or up to VND 40.000.000 for the
administrative violations against regulations on medical examination and
treatment, pharmacy, cosmetics and medical devices;
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d) Clause 3a is
added following Clause 3 as follows:
"3a. Leaders of
Task Force Teams for drug and crime prevention and control affiliated to the Department
of Drug and Crime Prevention and Control under the control of the Command of
Border Guards shall have the power to:
a) Issue warning;
b) Impose a fine up
to VND 15.000.000 for the administrative violations against regulations on
population, or up to VND 25.000.000 for the administrative violations against
regulations on preventive medicine, and HIV/AIDS prevention and control, or up
to VND 50.000.000 for the administrative violations against regulations on
medical examination and treatment, pharmacy, cosmetics and medical devices;
c) Confiscate the
exhibits and instrumentalities worth up to VND 30.000.000 for the
administrative violations against regulations on population, or up to VND
50.000.000 for the administrative violations against regulations on preventive
medicine, HIV/AIDS prevention and control, or up to VND 100.000.000 for the
administrative violations against regulations on medical examination and
treatment, pharmacy, cosmetics and medical devices;
d) Enforce the
remedial measures mentioned in Points c, d, dd and i Clause 1 Article 28 of the
Law on penalties for administrative violations and in Clause 3 Article 3 of
this Decree.”;
dd) The first
paragraph of Clause 4 is amended as follows:
“4. Commanders of
Provincial-level Border Guard Forces, Captains of Naval Border Guard Squadrons,
and Director of the Department of Drug and Crime Prevention and Control
affiliated to the Command of Border Guards shall have the power to:”;
e) Point dd Clause 4
is amended as follows:
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33. Some Clauses of
Article 109 are amended as follows:
a) Point c Clause 4
is amended as follows:
“c) Confiscate the
exhibits and instrumentalities worth up to VND 12.000.000 for the
administrative violations against regulations on population, or up to VND
20.000.000 for the administrative violations against regulations on preventive
medicine, HIV/AIDS prevention and control, or up to VND 40.000.000 for the
administrative violations against regulations on medical examination and
treatment, pharmacy, cosmetics and medical devices;”;
b) The first
paragraph of Clause 5 is amended as follows:
“5. Captains of
Naval Border Guard Squadrons; Heads of Reconnaissance Commissions; Heads of
Task Force Commissions for Drug Crime Prevention and Control under the control
of the Command of Coast Guard of Vietnam shall have the power to:”;
c) Point c Clause 5
is amended as follows:
“c) Confiscate the
exhibits and instrumentalities worth up to VND 18.000.000 for the
administrative violations against regulations on population, or up to VND
30.000.000 for the administrative violations against regulations on preventive
medicine, HIV/AIDS prevention and control, or up to VND 60.000.000 for the
administrative violations against regulations on medical examination and
treatment, pharmacy, cosmetics and medical devices;”;
d) The first
paragraph of Clause 6 is amended as follows:
“6. Regional
Commands of Coast Guard and Director of the Department of Operations and
Legislation under the control of the Command of Coast Guard of Vietnam shall
have the power to:”;
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“b1) Suspend
licenses/practicing certificates for a fixed period;”;
e) Point c Clause 6
is amended as follows:
“c) Confiscate the
exhibits and instrumentalities for committing administrative violations;”.
34. Some Clauses of
Article 110 are amended as follows:
a) Point c and Point
d Clause 3 are amended as follows:
“c) Confiscate the
exhibits and instrumentalities worth up to VND 50.000.000 for the
administrative violations against regulations on preventive medicine, HIV/AIDS
prevention and control;
d) Enforce the
remedial measures mentioned in Point i Clause 1 Article 28 of the Law on
penalties for administrative violations and in Clause 3 Article 3 of this
Decree.”;
b) Point c and Point
d Clause 4 are amended as follows:
“c) Confiscate the
exhibits and instrumentalities for committing administrative violations;
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c) Point d Clause 5
is amended as follows:
“d) Enforce the
remedial measures mentioned in Point i Clause 1 Article 28 of the Law on
penalties for administrative violations and in Clause 3 Article 3 of this
Decree.”.
35. Some Clauses of
Article 111 are amended as follows:
a) Point b Clause 1
is amended as follows:
“b) Impose a fine up
to VND 37.500.000 for administrative violations against regulations on health
insurance contributions;”;
b) Point d Clause 1
is amended as follows:
“d) Confiscate the
exhibits and instrumentalities worth up to VND 75.000.000 for the
administrative violations against regulations on health insurance
contributions;”;
c) Point b Clause 2
is amended as follows:
“b) Impose a fine up
to VND 75.000.000 for administrative violations against regulations on health
insurance contributions;”;
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“b) Impose a fine up
to VND 52.500.000 for administrative violations against regulations on health
insurance contributions;”.
dd) Point d Clause 3
is amended as follows:
“d) Confiscate the
exhibits and instrumentalities worth up to VND 105.000.000 for the
administrative violations against regulations on health insurance
contributions;”;
36. Some Clauses of
Article 112 are amended as follows:
a) Clause 5 is
amended as follows:
“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; Clauses 1, 2 Article 6; Point b
Clause 1 Article 54; Clauses 6, 7 Article 58; Clauses 6, 7 Article 59; Point b
Clause 1, Clause 2 Article 65, Points c and d Clause 2 Article 72, Points a, b
Clause 4 Article 74 and Point c Clause 2 Article 75 of this Decree within the
ambit of their assigned functions, duties and powers, and their competence
prescribed in Article 107 of this Decree.”;
b) Clause 7 is
amended as follows:
“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,
102; Point b Clause 3 Article 8; Point b Clause 3 Article 9; Point a, b Clause
3 Article 16; Point g Clause 2, Clause 3 Article 23; Clauses 1, 2, 3, Points a,
b, c, g Clause 4, Point a Clause 5 Article 29; Clauses 1, 3, 5, 6, 7 Article
38; Point b Clause 4 Article 39; Clause 4 Article 40; Point b Clause 1 Article
45; Point b Clause 3 Article 48; Point b Clause 1 Article 52; Clause 1, Point b
Clause 2, Points a, b Clause 3 Article 64; Clause 2 Article 68, Clause 1
Article 74, Clause 2 Article 78, and Point a Clause 1, Clause 2 Article 95 of
this Decree within the ambit of their assigned functions, duties and powers,
and their competence prescribed in Article 109 of this Decree.”;
c) Clause 11 is
amended as follows:
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Article
3. Replacement and abrogation of some regulations of Government’s Decree No.
115/2018/ND-CP dated September 04, 2018 and Government’s Decree
No.117/2020/ND-CP dated September 28, 2020
1. The phrase “Kiến
nghị cơ quan nhà nước có thẩm quyền thu hồi” (“Enforced revocation by competent
authorities”) shall be replaced with the phrase “Buộc nộp lại” (“Enforced
submission”) in Point c Clause 9 Article 38; Point c Clause 8 Article 39; Point
b Clause 5 Article 52; Point b Clause 3 Article 54; Point b Clause 5 Article
56; Points b and c Clause 9 Article 57; Point b Clause 5 Article 68; Point b
Clause 4 Article 70; Point b Clause 4 Article 71; Point b Clause 6 Article 72;
Points a and b Clause 5 Article 75; Point b Clause 4 Article 76; Clause 4
Article 77 of the Government’s Decree No.117/2020/ND-CP dated September
28, 2020.
2. Point a Clause 2
Article 9, Point d Clause 10 Article 22, Point b Clause 5 Article 24 of the
Government’s Decree No. 115/2018/ND-CP dated September 04, 2018 are abrogated.
3. Points c, d
Clause 2 Article 39; Points b, c, g, h Clause 2, Clause 4, Point a Clause 6
Article 72; Point b Clause 3 Article 73; Point b Clause 1 Article 74; Points b
and d Clause 2 Article 75; Clause 2 Article 78; Point c Clause 5 Article 107;
Point c Clause 1, Point c Clause 2 and Point c Clause 3 Article 111 of the
Government’s Decree No.117/2020/ND-CP dated September 28, 2020 are abrogated.
Article
4. Effect
1. This Decree comes
into force as from January 01, 2022.
2. Regulations
herein shall apply to the administrative violations in medical or food safety
sector which have been committed before the effective date of this Decree but
have been detected afterwards or put under consideration if this Decree does
not provide for legal liability or impose less serious legal liability.
Article
5. Responsibility for implementation
Ministers, heads of
ministerial agencies, heads of Governmental agencies, Chairpersons of people’s
committees of central-affiliated cities and provinces, and relevant
organizations and individuals shall implement this Decree.
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ON BEHALF OF THE GOVERNMENT
PP. THE PRIME MINISTER
DEPUTY PRIME MINISTER
Vu Duc Dam