Nghị định 124/2021/ND-CP

Nội dung toàn văn Decree 124/2021/ND-CP amendments Decree 115/2018/ND-CP

THE GOVERNMENT -------	THE SOCIALIST REPUBLIC OF VIETNAM Independence – Freedom – Happiness ---------------------
No.: 124/2021/ND-CP	Hanoi, December 28, 2021

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

1. Some Clauses are added to Article 2 as follows:

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:

“1. The maximum fine imposed for an administrative violation against regulations on food safety shall be VND 100,000,000 if it is committed by an individual or VND 200,000,000 if it is committed by an organization, except the cases prescribed in Clause 1 and Clause 5 Article 4, Clause 6 Article 5, Clause 5 Article 6, Clause 7 Article 11, Clauses 1 and 9 Article 22, and Clause 6 Article 26 hereof. With regard to the violations prescribed in Clause 1 Article 4, Clause 1 Article 22 and Clause 6 Article 26 of this Decree, if the highest fine is imposed according to Clause 1 Article 23 of the Law on penalties against administrative violations but is still lower than 07 times the value of violating food products, the maximum fine imposed shall be equal to 07 times the value of violating food products.”;

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:

“d) Failing to ensure hygiene conditions at processed foods trading areas.”;

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.”.

4. Point b Clause 1 Article 10 is amended as follows:

“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:

“e) Failing to have devices and tools for collecting and containing garbage and waste as prescribed;”;

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:

“1. A fine ranging from VND 20,000,000 to VND 30,000,000 shall be imposed for failing to obtain a certificate of food safety or using an expired certificate of food safety when running food and drink business, except cases where certificate of food safety is exempted.

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;”;

c) Point d is added following Point c Clause 2 as follows:

“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:

“e) Failing to include a valid test report in the self-declaration dossier at the date of self-declaration as prescribed.”;

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;

c) A fine equal to 03 - 05 times the value of the sold food products for replacing, swapping, adding or cutting down ingredients or additives or having any safety indicators found unconformable with corresponding technical regulations or regulations adopted by competent authorities.”;

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.”;

d) Point a Clause 5 is amended as follows:

“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;”;

i) Point dd and Point e are added following Point d Clause 11 as follows:

“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;”;

c) Point d Clause 2 is amended as follows:

“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;”;

b) The first paragraph of Clause 2 is amended as follows:

"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:”;

g) Point c Clause 5 is amended as follows:

“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:

“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: Internal Political Security Divisions, Investigation Police Divisions for Corruption, Economic and Smuggling Crimes, Traffic Police Divisions, Road and Railway Traffic Police Divisions, Road Traffic Police Divisions, Waterway Police Divisions, Police Divisions for Prevention and Control of Environmental Crimes, Cybersecurity, Hi-Tech Crime Prevention and Control Divisions, and Economic Security Divisions, shall have the power to:”;

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:

a) Clause 2a is added following Clause 2 as follows:

“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.”;

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) 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.”.

19. Some Clauses of Article 32 are amended as follows:

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:

“a1) Suspend the certificate of food safety or certificate of registered product declaration for a fixed period, or suspend operations for a fixed period;”;

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:”;

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) Points b and c Clause 3 are 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.”;

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.”.

21. Some Clauses of Article 34 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:

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:

"4. Director General of Vietnam Directorate of Market Surveillance shall have the power to:”.

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:

a) Point s Clause 3 is amended as follows:

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:

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:

a) Point a Clause 1 is amended as follows:

“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.”.

7. The first paragraph of Clause 32 is amended as follows:

“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:

“a) The medical examination and treatment practicing certificate shall be suspended for a fixed period of 01 – 03 months in case of commission of any of the violations in Point b, c, d, dd, e, g, h, i, k, l and m Clause 5 of this Article;”.

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.”.

11. Article 48a is added following Article 48:

“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:

a) Point b Clause 1 is amended as follows:

“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.”;

b) Points a, b, c Clause 2 are amended as follows:

“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:

“a) Trading drugs/medicinal ingredients which are samples used for registration, testing, scientific research, or display at a fair or exhibition; trading medicinal ingredients which are imported under license for manufacturing of exported drugs inconsistently with regulations;”;

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:

a) Point b Clause 2 is amended as follows:

“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.”;

dd) Point c Clause 9 is amended as follows:

“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.”;

c) Point dd is added following Point d Clause 5 as follows:

“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:

19. Some Clauses of Article 68 are amended as follows:

a) Clause 2 is amended as follows:

“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:

a) Point dd is added following Point d Clause 2 as follows:

“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:

“d) Failing to send reports to the customs authority that has granted customs clearance and the authority that has issued the registration number in case the 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;

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.”;

b) Point b Clause 2 is amended as follows:

“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:

a) Point a Clause 1 is amended as follows:

“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;”;

e) Point l Clause 2 is amended as follows:

“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;”;

i) Point a Clause 5 is amended as follows:

“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:

“Article 78a. Violations against regulations on management of medical device prices

1. A fine ranging from VND 10.000.000 to VND 15.000.000 shall be imposed for commission of one of the following violations:

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.”.

27. Some Clauses of Article 103 are amended as follows:

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:”;

c) Point d Clause 2 is amended as follows:

“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:

“c) Confiscate the exhibits and instrumentalities worth up to VND 50.000.000 for the administrative violations against regulations on population, preventive medicine, medical examination and treatment, pharmacy, cosmetics and medical devices;”;

c) The first paragraph of Clause 3 is amended as follows:

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:

c) Point c Clause 3 is amended as follows:

“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:”.

31. Some Clauses of Article 107 are amended as follows:

a) The first paragraph of Clause 2 is amended as follows:

b) The first paragraph of Clause 3 is amended as follows:

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:

a) Clause 2a is added following Clause 2 as follows:

"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;

d) Enforce the remedial measures mentioned in Points c, d and dd Clause 1 Article 28 of the Law on penalties for administrative violations and in Clause 3 Article 3 hereof.”;

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:

e) Point dd Clause 4 is amended as follows:

“dd) 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.”.

33. Some Clauses of Article 109 are amended as follows:

a) Point c Clause 4 is amended as follows:

b) The first paragraph of Clause 5 is amended as follows:

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:”;

dd) Point b1 is added following Point b Clause 6 as follows:

“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;

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.”;

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;”;

d) Point b Clause 3 is amended as follows:

“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:

“11. Inspectors in the fields of culture, sports and tourism competent to impose penalties shall have the power to make records of, impose penalties, and enforce remedial measures against the administrative violations in Articles 5, 19, 25, 26, 30, 31, 32, 33, 34, 36, 37, 49, 50, 51, 67, 69, 78, 96, 97; Points b and c Clause 3 Article 12; Clause 2 Article 14; Clauses 1, 2, 3, Points a, b, c, e, g Clause 4, Point a Clause 5 Article 29 and Point b Clause 2 Article 35 of this Decree within the ambit of their assigned functions, duties and powers, and their competence prescribed in Article 104 of this Decree.”.

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.

ON BEHALF OF THE GOVERNMENT
PP. THE PRIME MINISTER
DEPUTY PRIME MINISTER

Vu Duc Dam

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This translation is made by THƯ VIỆN PHÁP LUẬT and for reference purposes only. Its copyright is owned by THƯ VIỆN PHÁP LUẬT and protected under Clause 2, Article 14 of the Law on Intellectual Property.Your comments are always welcomed

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Thuộc tính Văn bản pháp luật 124/2021/ND-CP
Loại văn bản	Nghị định
Số hiệu	124/2021/ND-CP
Cơ quan ban hành	Chính phủ
Người ký	Vũ Đức Đam
Ngày ban hành	28/12/2021
Ngày hiệu lực	01/01/2022
Ngày công báo	...
Số công báo
Lĩnh vực	Thể thao - Y tế, Vi phạm hành chính
Tình trạng hiệu lực	Còn hiệu lực
Cập nhật	2 năm trước
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Lược đồ Decree 124/2021/ND-CP amendments Decree 115/2018/ND-CP

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Decree 124/2021/ND-CP amendments Decree 115/2018/ND-CP
Loại văn bản	Nghị định
Số hiệu	124/2021/ND-CP
Cơ quan ban hành	Chính phủ
Người ký	Vũ Đức Đam
Ngày ban hành	28/12/2021
Ngày hiệu lực	01/01/2022
Ngày công báo	...
Số công báo
Lĩnh vực	Thể thao - Y tế, Vi phạm hành chính
Tình trạng hiệu lực	Còn hiệu lực
Cập nhật	2 năm trước

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28/12/2021
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Lịch sử hiệu lực Decree 124/2021/ND-CP amendments Decree 115/2018/ND-CP