Decree 124/2021/ND-CP sanctioning administrative violations on food safety, violations in health sector

DECREE

Amending and supplementing a number of articles of the Government’s Decree No. 115/2018/ND-CP dated September 04, 2018, on penalties for administrative violations against regulations on food safety and the Government’s Decree No. 117/2020/ND-CP dated September 28, 2020, on sanctioning of administrative violations in health sector

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Pursuant to the Law on Organization of the Government dated June 19, 2015, and the Law Amending and Supplementing a Number of Articles of the Law on Organization of the Government and the Law on Organization of Local Administration dated November 22, 2019;

Pursuant to the Law on Handling of Administrative Violations dated June 20, 2012, and the Law Amending and Supplementing a Number of Articles of the Law on Handling of Administrative Violations dated November 13, 2020;

Pursuant to the Law on HIV/AIDS Prevention and Control dated June 29, 2006, Law Amending and Supplementing a Number of Articles of the Law on Prevention and Control of Human Immunodeficiency Virus and Acquired Immunodeficiency Syndrome (HIV/AIDS) dated November 16, 20202;

At the proposal of the Minister of Health;

The Government hereby promulgates the Decree amending and supplementing a number of articles of the Government’s Decree No. 115/2018/ND-CP dated September 04, 2018, on penalties for administrative violations against regulations on food safety and the Government’s Decree No. 117/2020/ND-CP dated September 28, 2020, on sanctioning of administrative violations in health sector.

Article 1. Amending and supplementing a number of articles of the Government’s Decree 115/2018/ND-CP dated September 04, 2018, on penalties for administrative violations against regulations on food safety

1. To add a number of clauses of Article 2 as follows:

a) To add Point m after Point l Clause 3 as follows:

“m) Forcible return of modified or erased papers, documents.”;

b) To add Clause 4 after Clause 3 as follows:

“4. The execution of sanctioning forms and remedial measures must meet the following requirements:

a) In case of applying the additional sanction which is suspension from operation for e definite term, the person competent to issue decisions to sanction administrative violations shall be responsible for sending the written notice to the competent State agency for coordination in monitoring, inspection and summarization of reports upon the expiry of the decisions to sanction administrative violations;

b) In case of applying the remedial measure which is forcible return of modified, erased papers and documents, the person competent to issue decisions to sanction administrative violations shall be responsible for sending the written notice to the State agency competent to grant or receive to revoke such papers and documents;

c) Other requirements according to the provisions of law on handling of administrative violations.”.

2. To amend and supplement some clauses of Article 3 as follows:

a) To amend and supplement Clause 1 as follows:

“1. The maximum fines applied to individuals and organizations committing violations related to food safety are VND 100,000,000 and VND 200,000,000, respectively, except for the cases specified in Clauses 1 and 5 Article 4; Clause 6 Article 5; Clause 5 Article 6; Clause 7 Article 11; Clauses 1 and 9 Article 22; Clause 6 Article 26 of this Decree. For acts of violation specified in Clause 1 Article 4, Clause 1 Article 22 and Clause 6 Article 26 of this Decree, if the maximum fine specified in Clause 1 Article 23 of the Law on Handling of Administrative Violations which is applied is 7 times less than the violated food value, then the maximum fine to be applied shall be 7 times as much as the violated food value.”.

b) To amend and supplement Clause 2 as follow:

“2. Fines specified in Chapter II of this Decree are applied to 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 of this Decree which are applied to organizations. For the same administrative violation, the fine to be imposed on an institutional violator is twice as heavy as that to be imposed on an individual violator.

For individuals committing violations 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 of this Decree, the fine to be applied shall be 1/2 of the fine imposed to organizations.”.

3. To amend and supplement some clauses of Article 9 as follows:

a) To amend and supplement Clause 1 as follows:

“1. A fine ranging from VND 1,000,000 to VND 3,000,000 shall be imposed for the act of employing persons who work in direct contact with food but do not wear labor protection equipment as prescribed, or do not have their nails cut, or wear watches, bracelets or bangles, or eat, drink, smoke or spit in the production areas of food, food additives, food processing aids, primary packages and containers of food.”;

b) To amend and supplement Point b Clause 2 as follows:

“b) Solid waste containers are not covered according to regulations;”;

c) To add Point d after Point d Clause 2 as follows:

“Failing to maintain and ensure hygiene for areas for trading processed food.”;

d) To amend and supplement Point dd Clause 3 as follows:

“dd) Employing persons directly engaged in production and trading of food, food additives, food processing aids, primary packages and containers of food who do not possess a certificate of training in knowledge about food safety;”;

dd) To amend and supplement Point d Clause 5 as follows:

“d) Owners of facilities producing and trading in food, food additives, food processing aids, primary packages and containers of food fail to possess a certificate of training in knowledge about food safety;”;

e) To amend and supplement Point a Clause 6 as follows:

“a) A fine ranging from VND 7,000,000 to VND 10,000,000 shall be imposed on the facility that fails to fully establish a food safety management system according to regulations, or fails to fully apply a food safety management system in its production and trading activities, or fails to apply a food safety management system suitable to its production and trading activities;”;

g) To amend and supplement Points a and b Clause 7 as follows:

“a) Employing persons directly engaged in production and trading of food, food additives, food processing aids, primary packages and containers of food who are suffering cholera, dysentery, typhoid, hepatitis A, E, infectious dermatitis, pulmonary tuberculosis, acute diarrhea;

b) Using water that fails to meet technical regulations or using unqualified water according to corresponding laws to serve the food production, or clean equipment and devices serving the production of foods, food additives, food processing aids, primary packages and containers of food.”.

4. To amend and supplement Point b Clause 1 Article 10 as follows:

“b) Transporting food, food additives, food processing aids, primary packages and containers of food with other commodities that may contaminate food.”.

5. To amend and supplement Point a Clause 5 Article 11 as follows:

“a) A fine from VND 3,000,000 to VND 5,000,000 shall be imposed for the acts of directly adding impurities to aquatic animals;”.

6. To amend and supplement some clauses of Article 15 as follows:

a) To add Point dd after Point d Clause 1 as follows:

“Failing to prevent cross-contamination between processed food and unprocessed food in arranging the kitchen.”;

b) To amend and supplement Point d Clause 2 as follows:

“d) Sewers in the areas of shops and kitchens are stagnant, without any cover;”;

c) To amend and supplement Point e Clause 2 as follows:

“e) Failing to have hygienic devices for collecting and containing garbage and waste;”;

d) To amend and supplement Clause 3 as follows:

“3. A fine ranging from VND 5,000,000 to VND 7,000,000 shall be imposed for the act of employing persons directly engaged in processing of food who fail to have certificates of training in knowledge about food safety.”;

dd) To amend and supplement Point b Clause 4 as follows:

“b) Facility owners fail to have certificates of training in knowledge about food safety;”;

To amend and supplement Clause 5 as follows:

“5. A fine ranging from VND 10,000,000 to VND 15,000,000 shall be imposed for the act of employing persons directly engaged in processing of food who are suffering cholera, dysentery, typhoid, hepatitis A, E, infectious dermatitis, pulmonary tuberculosis, acute diarrhea.”.

7. To amend and supplement Point b Clause 2 Article 16 as follows:

“b) Persons directly engaged in processing of food are suffering cholera, dysentery, typhoid, hepatitis A, E, infectious dermatitis, pulmonary tuberculosis, acute diarrhea;”.

8. To amend and supplement Clauses 1, 2 and 3 Article 18 as follows:

“1. A fine ranging from VND 20,000,000 to VND 30,000,000 shall be imposed for the act of providing catering services without a certificate of food safety eligibility, or providing catering services with an expired certificate of food safety eligibility, except for the cases of exemption from the grant of certificates of food safety eligibility.

2. A fine ranging from VND 30,000,000 to VND 40,000,000 shall be imposed for the act of conducting food production and trading activities without a certificate of food safety eligibility, or conducting food production and trading activities with an expired certificate of food safety eligibility, except for the cases of exemption from the grant of certificates of food safety eligibility.

3. A fine ranging from VND 40,000,000 to VND 60,000,000 shall be imposed for any of the following acts of violation:

a) Producing dietary supplements but failing to obtain the
certificate of good manufacturing practices (GMP certificate), or obtain an expired GMP certificate, except for the cases of manufacturing dietary supplements on the line for production of drugs from medicinal materials, traditional drugs or other cases as prescribed by the Minister of Health;

b) Trading and circulating in the market of domestically produced or imported dietary supplements that have been issued with a certificate of declaration of conformity with the food safety regulations or a certificate of registered product declaration before July 01, 2019, without additional GMP certificate or equivalent certification before production.”.

9. To amend and supplement some clauses of Article 19 as follows:

a) To amend and supplement the first paragraph of Clause 2 as follows:

“2. A fine ranging from VND 40,000,000 to VND 60,000,000 shall be imposed for one of the following acts in importing or exporting food, food additives, food processing aids, primary packages and containers of food:”;

b) To amend and supplement Point a Clause 2 as follows:

“a) Altering or falsifying the contents of the self-declaration form, the declaration form, the certificate of registered product declaration, the notice of satisfactory inspection results of imported foods, the certificate of food safety, certificate of free sale or other documents;”;

c) To add Point d after Point c Clause 2 as follows:

“d) Exporting a consignment of food that is not in accordance with the volume and product specifications as registered for appraisal and grant of a certificate of food safety.”;

d) To amend and supplement Point a Clause 5 as follows:

“a) Confiscation of material evidences, for the acts of violation specified at Point c Clause 2 of this Article, in case such violation material evidences have not been sold yet;”;

dd) To add Point e after Point dd Clause 6 as follows:

“ c) Forcible return of erased, corrected papers and documents, for the acts of violation prescribed at Point a Clause 2 of this Article.”.

10. To amend and supplement some clauses of Article 20 as follows:

a) To amend and supplement Point b Clause 1 as follows:

“b) Failing to publish on the food safety database or failing to submit a copy of the self-declaration form to the competent state agency as prescribed;”;

b) To add Point e after Point dd Clause 2 as follows:

“e) Failing to include test reports in the valid self-declaration dossiers at the time of self-declaration as prescribed.”;

c) To amend and supplement Point a Clause 3 as follows:

“a) Producing or importing products subject to self-declaration of products that do not conform to relevant technical regulations or regulations of competent agencies or announced standards;”.

11. To amend and supplement Clause 1 Article 21 as follows:

“1. A fine ranging from VND 30,000,000 to VND 40,000,000 shall be imposed for the act of producing or importing products subject to declaration registration that do not conform to relevant technical regulations or regulations of competent agencies or announced standards.”.

12. To amend and supplement some clauses of Article 22 as follows:

a) To amend and supplement Clause 1 as follows:

“1. The fine levels imposed for the acts of violation in terms of trading and circulating on the market of food products are prescribed as follows:

a) A fine equal to 01 to 02 times the total value of the infringing food products that have been consumed, for the acts of trading and circulating on the market of food products that do not conform to the announced standards; food products that must be produced at a facility that has a certificate of food safety eligibility or an equivalent certificate but fail to do so;

b) A fine equal to 02 to 03 times the total value of the infringing food products that have been consumed, for the acts of substituting, swapping, adding or subtracting ingredients or additives compared to the announced standards;

c) A fine equal to 03 to 05 times the total value of the infringing food products that have been consumed for acts of replacing, swapping, adding or subtracting ingredients or additives or having safety criteria that are not in accordance with relevant technical regulations or regulations of competent agencies.”;

b) To add Points h, i, k, l, m and n after Point g Clause 2 as follows:

“h) Employees involved in the production are not trained or retrained about basic principles of good manufacturing practices for dietary supplements;

i) Failing to have job descriptions for key employees, persons in charge and groups of employees of different departments as prescribed;

k) Failing to have an approved production process for each product;

l) Failing to regularly conduct and maintain the self-inspection for supervision of the implementation, application of, and compliance with the good manufacturing practices for dietary supplements and take necessary and timely remedial measures;

m) Failing to sign a contract, or failing to sign a contract with clear, consistent regulations on determination and failing to strictly control the contract performance in case of production and/or test in accordance with the contract;

n) Failing to store original material and finished product samples as prescribed, or failing to store sufficient quantity of samples for a prescribed period.”;

c) To add Clause 2a after Clause 2 as follows:

"2a. A fine ranging from VND 15,000,000 to VND 20,000,000 shall be imposed on any of the acts of violation against regulations on manufacturing dietary supplements as prescribed in Clause 2 of this Article, in case of recidivism.”;

d) To amend and supplement Point a Clause 5 as follows:

“a) Producing, importing, selling or circulating on the market of foods, food additives, food processing aids, primary packages and containers of food which are unconformable with the declared product information, except for the cases prescribed in Clause 1 of this Article;”;

dd) To amend and supplement Point a Clause 6 as follows:

“a) Importing, producing, processing, supplying or selling food causing food poisoning and affecting the health of 01 to 04 persons, but are not serious enough for penal liability examination;”;

e) To amend and supplement Point a Clause 8 as follows:

“a) Importing, producing, processing, supplying or selling food causing food poisoning and affecting the health of 05 persons or more, but are not serious enough for penal liability examination;”;

g) To amend and supplement Point a Clause 10 as follows:

“a) Suspension of a part or entire operation of production, processing, trading or provision of food from 01 month to 03 months, for the acts of violation specified in Clauses 2a and 7 of this Article;”;

h) To amend and supplement Point b Clause 11 as follows:

“b) Forcible destruction of food, for the acts of violations specified in Clauses 6, 7, 8 and 9 of this Article;”;

i) To add Points dd and e after Point d Clause 11 as follows:

“dd) Forcible change of use purpose, or recycle or forcible destruction of food, for the acts of violation specified in Clauses 1, 3 and 5 of this Article;

e) Forcible return of erased, corrected papers and documents, for the acts of violation prescribed at Point c Clause 4 of this Article.”.

13. To add Point c after Point b Clause 6 Article 24 as follows:

“c) Forcible return of erased, corrected papers and documents, for the acts of violation prescribed at Point a Clause 4 of this Article.”.

14. To amend and supplement some clauses of Article 26 as follows:

a) To amend and supplement the title of Article 26 as follows:

“Article 26. “Violations against regulations on tracing of origins, recalling and disposing of unsafe food, food additives, food processing aids, primary packages and containers of food”;

b) To amend and supplement Point b Clause 2 as follows:

“b) Failing to establish a data system for tracing the origins of food products, or failing to establish a data system for tracing the origins of food products with sufficient information; failing to trace the origins of unsafe food products as prescribed;”;

c) To amend and supplement Point d Clause 2 as follows:

“d) Failing to report, or failing to sufficiently, accurately and timely report information on tracing the food product origin as prescribed by law;”.

15. To amend and supplement some clauses of Article 28 as follows:

a) To amend and supplement Point b Clause 1 as follows:

“b) Confiscate material evidences and means used in administrative violations with a value of not exceeding VND 10,000,000, for individuals, or VND 20,000,000, for organizations;”;

b) To amend and supplement Point c Clause 2 and Point c Clause 3 as follows:

“c) Confiscation of material evidences and means used in administrative violations;”;

16. To amend and supplement some clauses of Article 29 as follows:

a) To amend and supplement Point b Clause 1 as follows:

“b) Confiscate material evidences and means used in administrative violations with a value of not exceeding VND 1,000,000, for individuals, or VND 2,000,000, for organizations;”;

b) To amend and supplement the first paragraph of Clause 2 as follows:

“2. Chief inspectors of provincial-level Departments of Health, provincial-level Departments of Agriculture and Rural Development; provincial-level Departments of Industry and Trade, provincial-level Departments of Culture and Sports, provincial-level Departments of Tourism, provincial-level Departments of Culture, Sports and Tourism; provincial-level Departments of Information and Communications; Directors of Sub-Departments of Food Hygiene and Safety under provincial-level Departments of Health; Directors of regional Animal Health Sub-Departments, regional Animal Quarantine Sub-Departments under the Departments of Animal Health; Directors of regional Plant Protection Sub-Departments under Plant Protection Departments; Directors of Agro-Forestry-Fisheries Quality Assurance Sub-Departments in Central and Southern Vietnam under Agro-Forestry-Fisheries Quality Assurance Departments; Directors of Sub-departments of cultivation and plant protection, livestock production, animal health, fisheries, agro-forestry-fisheries quality assurance, irrigation, dikes, natural disaster prevention and control, forestry, and rural development under provincial-level Departments of Agriculture and Rural Development may:”;

c) To amend and supplement Point c Clause 2 as follows:

“c) Confiscate material evidences and means used in administrative violations with a value of not exceeding VND 100,000,000, for individuals, or VND 200,000,000, for organizations;”;

d) To amend and supplement Clause 3 as follows:

“3. Heads of specialized inspection teams of provincial-level departments (including provincial-level Department of Health; provincial-level Department of Agriculture and Rural Development; provincial-level of Industry and Trade; provincial-level Department of Culture, Information, Sports and Tourism, provincial-level Department of Tourism, provincial-level Department of Culture, Sports and Tourism; provincial-level Department of Information and Communications; Sub-Department of Food Hygiene and Safety; Sub-Department of Cultivation and Plant Protection; Sub-Department of Livestock Production and Animal Health; Fisheries Sub-department; Agro-Forestry-Fisheries Quality Assurance Sub-Department); heads of specialized inspection teams of General Departments and Departments under the Ministry of Health, Ministry of Agriculture and Rural Development, Ministry of Industry and Trade, Ministry of Culture, Sports and Tourism, Ministry of Information and Communications (including Directorate of Fisheries, Department of Animal Health; Department of Plant Protection, Department of Crop Production; Department of Livestock Production; Agro-Forestry-Fisheries Quality Assurance Department; Agro Processing and Market Development Authority; Vietnam Food Administration; Authority of Broadcasting and Electronic Information; Authority of Press, Authority of Publication, Printing and Distribution) have the competence to sanction in accordance with Clause 2 of this Article.”;

dd) To amend and supplement Point c Clause 4 as follows:

“c) Confiscate material evidences and means used in administrative violations with a value of not exceeding VND 140,000,000, for individuals, or VND 280,000,000, for organizations;”;

e) To amend and supplement the first paragraph of Clause 5 as follows:

“5. Chief inspectors of the Ministry of Health, Ministry of Agriculture and Rural Development, Ministry of Industry and Trade, Ministry of Culture, Sports and Tourism, and Ministry of Information and Communication; Director General of the Directorate of Fisheries; Directors of the Department of Animal Health, Department of Plant Protection, Department of Crop Production, Department of Livestock Production, Agro-Forestry-Fisheries Quality Assurance Department, Agro Processing and Market Development Authority, Vietnam Food Administration, Authority of Broadcasting and Electronic Information, Authority of Press, and Authority of Publication, Printing and Distribution may:”;

g) To amend and supplement Point c Clause 5 as follows:

“c) Confiscate material evidences and means used in administrative violations;”;

17. To amend and supplement some clauses of Article 30 as follows:

a) To amend and supplement the first paragraph of Clause 2 as follows:

“2. Heads of stations or team leaders of those mentioned in Clause 1 of this Article may:”;

b) To amend and supplement the first paragraph of Clause 3 as follows:

“3. Chiefs of commune-level police offices; chiefs of police offices; chiefs of police stations at border gates or export processing zones; heads of border-gate police offices of international airports; captains of ship fleets may:”;

c) To amend and supplement Point c Clause 3 as follows:

“b) Confiscate material evidences and means used in administrative violations with a value of not exceeding VND 5,000,000, for individuals, or VND 10,000,000, for organizations;”;

e) To amend and supplement the first paragraph of Clause 4 as follows:

“4. Chiefs of district-level police offices, heads of the professional sections of the Internal Political Security Department, heads of the professional sections of the Police Department for Administrative Management of Social Order, heads of the professional sections of the Traffic Police Department, heads of the professional sections of the Department of Cyber ​​Security and Hi-tech Crime Prevention; chiefs of provincial-level Police Departments, including heads of internal political security sections, heads of police offices for corruption, smuggling and economic crimes; heads of traffic police offices; heads of road and railway traffic police offices; heads of road traffic police offices; heads of waterway police offices; heads of police sections for prevention and combat of environment-related crimes; heads of police offices for cybersecurity and hi-tech crime prevention and combat and heads of economic security offices may:”:

dd) To amend and supplement Point a Clause 4 as follows:

“a) Impose a fine of up to VND 20,000,000 on an individual, or a fine of up to VND 40,000,000 on an organization;”;

e) To amend and supplement Point c Clause 4 as follows:

“c) Confiscate material evidences and means used in administrative violations with a value of not exceeding VND 40,000,000, for individuals, or VND 80,000,000, for organizations;”;

g) To amend and supplement Point c Clause 5 and Point c Clause 6 as follows:

“c) Confiscate material evidences and means used in administrative violations;”;

h) To amend and supplement the first paragraph of Clause 6 as follows:

“6. Director of the Internal Political Security Department; Director of the Department of Economic Security; Director of the Police Department for Administrative Management of Social Order; Director of the Police Department of Social Order-related Crime Investigation; Director of the Police Department of Corruption, Smuggling and Economic Crime Investigation; Director of the Traffic Police Department; Director of the Police Department for Prevention and Combat of Environment-Related Crimes, the Department of Cybersecurity and Hi-tech Crimes; and Director of the Department of Homeland Security may:”.

18. To amend and supplement some clauses of Article 31 as follows:

a) To add Clause 2a after Clause 2 as follows:

“2a. Captains of the Crime and Drug Prevention and Control Teams under the Crime and Drug Prevention and Control Task Forces may:

a) Impose a fine of up to VND 10,000,000 on an individual, or a fine of up to VND 20,000,000 on an organization;

b) Confiscate material evidences and means used in administrative violations with a value of not exceeding VND 20,000,000, for individuals, or VND 40,000,000, for organizations;

c) Take remedial measures specified at Point b Clause 3 Article 2 of this Decree.”;

b) To amend and supplement the first paragraph of Clause 3 as follows:

“3. Chiefs of border-guard stations, captains of border-guard flotillas and commanders of port border-gate guard command posts may:”;

c) To amend and supplement Points b and c Clause 3 as follows:

“b) Confiscate material evidences and means used in administrative violations with a value of not exceeding VND 50,000,000, for individuals, or VND 100,000,000, for organizations;

d) Take remedial measures specified at Points a, b, dd, e, i and l Clause 3 Article 2 of this Decree.”;

d) To add Clause 3a after Clause 3 as follows:

“3a. Captains of the Crime and Drug Prevention and Control Task Forces affiliated to the Crime and Drug Prevention and Control Department under the Border-Guard Command may:

a) Impose a fine of up to VND 50,000,000 on an individual, or a fine of up to VND 100,000,000 on an organization;

b) Confiscate material evidences and means used in administrative violations with a value of not exceeding VND 100,000,000, for individuals, or VND 200,000,000, for organizations;

c) Take remedial measures specified at Points a, b, d, dd, e, i and l Clause 3 Article 2 of this Decree.”;

dd) To amend and supplement the first paragraph of Clause 4 as follows:

“4. Provincial-level border-guard commanders; captains of border-guard ship fleets; Directors of the Crime and Drug Prevention and Control Departments under the Border-Guard Command may:”;

e) To amend and supplement Points c and d Clause 4 as follows:

“c) Confiscate material evidences and means used in administrative violations;

c) Take remedial measures specified at Points a, b, d, dd, e, i and l Clause 3 Article 2 of this Decree.”.

19. To amend and supplement some clauses of Article 32 as follows:

a) To amend and supplement Point b Clause 4 as follows:

“b) Confiscate material evidences and means used in administrative violations with a value of not exceeding VND 40,000,000, for individuals, or VND 80,000,000, for organizations;”;

b) To amend and supplement the first paragraph of Clause 5 as follows:

“5. Captains of marine police ship fleets; Captains of the Scout Forces and the Special Task Forces for Drugs and Crime Prevention and Control under the Vietnam Marine Police Command Post may:”;

c) To amend and supplement Point b Clause 5 as follows:

“b) Confiscate material evidences and means used in administrative violations with a value of not exceeding VND 60,000,000, for individuals, or VND 120,000,000, for organizations;”;

e) To amend and supplement the first paragraph of Clause 6 as follows:

“6. Commanders of regional Marine Police Command Posts and the Director of the Operation and Law Department under the Vietnam Marine Police Command Post may:”;

dd) To add Point a1 after Point a Clause 6 as follows:

“a1) Deprive the right to use the certificate of food safety eligibility or the certificate of registered product declaration for a definite time, or suspend operations for a definite time;”;

e) To amend and supplement Point b Clause 6 as follows:

“b) Confiscate material evidences and means used in administrative violations;”;

g) To amend and supplement the first paragraph of Clause 7 as follows:

“7. Commander of Vietnam Marine Police may:”;

h) To amend and supplement Point c Clause 7 as follows:

“c) Confiscate material evidences and means used in administrative violations;”.

20. To amend and supplement some clauses of Article 33 as follows:

a) To amend and supplement the first paragraph of Clause 2 as follows:

“2. Leaders or heads of teams under the Customs Branches; heads of control teams of provincial, inter-provincial or municipal Customs Departments; heads of teams under Post-Customs Clearance Inspection Branches may:”;

b) To amend and supplement the first paragraph of Clause 3 as follows:

“3. Heads of Customs Branches; heads of Post-Customs Clearance Inspection Branches, heads of control teams of provincial, inter-provincial or municipal Customs Departments; heads of criminal investigation teams, heads of anti-smuggling control teams, captains of marine control flotillas, and heads of anti-smuggling control and protection of intellectual property right teams of the Anti-Smuggling Investigation Department; heads of Post-Customs Clearance Inspection Branches under the Post-Customs Clearance Inspection Department may:”;

c) To amend and supplement Points b and c Clause 3 as follows:

“b) Confiscate material evidences and means used in administrative violations with a value of not exceeding VND 50,000,000, for individuals, or VND 100,000,000, for organizations;

c) Take remedial measures specified at Points a, b, d, dd, e, h, k, l and m Clause 3 Article 2 of this Decree.”;

d) To amend and supplement Points c and d Clause 4 as follows:

“c) Confiscate material evidences and means used in administrative violations;

d) Take remedial measures specified at Points a, b, d, dd, e, h, k, l and m Clause 3 Article 2 of this Decree.”;

dd) To amend and supplement Point c Clause 5 as follows:

“c) Take remedial measures specified at Points a, b, d, dd, e, h, k, l and m Clause 3 Article 2 of this Decree.”.

21. To amend and supplement some clauses of Article 34 as follows:

a) To amend and supplement the first paragraph of Clause 2 as follows:

“2. Heads of market management teams, heads of the professional sections of the Department of Market Surveillance may:”;

b) To amend and supplement Point b Clause 2 as follows:

“b) Confiscate material evidences and means used in administrative violations with a value of not exceeding VND 50,000,000, for individuals, or VND 100,000,000, for organizations;”;

c) To amend and supplement the first paragraph of Clause 3 as follows:

“3. Director of the provincial-level Market Surveillance Department, Director of the Market Management Department under the Directorate of Market Surveillance may:”;

d) To amend and supplement Point b Clause 3 as follows:

“b) Confiscate material evidences and means used in administrative violations;”;

dd) To amend and supplement the first paragraph of Clause 4 as follows:

“4. The General Director of the Directorate of Market Surveillance may:”.

22. To amend and supplement Clauses 4 and 5 Article 35 as follows:

“4. Persons competent to sanction of the border-guards specified in Article 31 of this Decree and marine police specified in Article 32 of this Decree shall have the competence to make written records of administrative violations, sanction administrative violations and take remedial measures for the administrative violations in the field of food safety, relating to the collection, sale, provision and import of food as prescribed in Clause 3, Point b Clause 4 and Clause 5 Article 4; Articles 10 and 11; Clauses 1 and 4 Article 19; Point b Clause 4 Article 20; Clause 2 Article 21; Clause 1, Points b and c Clause 6 Article 22; Clause 6 Article 26 of this Decree according to their assigned functions, tasks and powers.

5. Persons competent to sanction of the customs offices specified in Article 33 of this Decree shall have the competence to make written records of administrative violations, sanction administrative violations and take remedial measures for the administrative violations in the field of food safety as prescribed in Article 19; Clauses 2, 3 and 4 Article 20; Article 21; Points a and b Clause 5, Clause 6, Clause 7, Clause 8, Clause 9 Article 22; Clause 4 Article 24 of this Decree, if detecting these violations in the localities under their management, which have not yet been prescribed in the Government's Decrees on sanctioning administrative violations in the field of customs.”.

Article 2. Amending and supplementing a number of articles of the Government’s Decree 117/2020/ND-CP dated September 28, 2020, on sanctioning of administrative violations in health sector

1. To amend and supplement Clause 4 Article 1 as follows:

“4. Upon detecting acts of violations specified at Point c Clause 3 Article 7; Point b Clause 6 Article 38; Points a and 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 and 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 or cases of recidivism, for the acts of violations specified at Points a and 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 and 3 Article 80 of this Decree, the competent person accepting the case shall, based on the nature and level of the violation, transfer the dossier of the violation to a body competent to conduct the criminal proceedings in accordance with Clauses 1, 2 and 4, Article 62 of the Law on Handling of Administrative Violations, if it shows signs of crime. In cases where the body competent to conduct the proceedings decide not to institute such criminal cases in accordance with the law on criminal procedure code, they shall return the violation case dossiers to the persons with sanctioning competence that have sent such dossiers in accordance with Clause 3 Article 62 of the Law on Handling of Administrative Violations to sanction administrative violations as prescribed in this Decree.”.

2. To amend and supplement Point dd Clause 2 Article 2 as follows:

“dd) Non-business units;”.

3. To amend and supplement some clauses of Article 3 as follows:

a) To amend and supplement Point s Clause 3 as follows:

“s) Forcible revocation (to the competent State agency) of the practice certificate; license for medical examination and treatment; medical equipment import permit; certificate of eligibility for pharmaceutical business; certificate of free sale for domestically manufactured medical equipment; certificate of registration for marketing authorization of drugs or drug materials; the cosmetic product proclamation receipt number; receipt of declaration dossier; certificate of registration for marketing authorization of drugs or drug materials; certificate of free sale for medical equipment of categories C, D.”;

b) To add Clause 4 after Clause 3 as follows:

“4. The execution of sanctioning forms and remedial measures must meet the following requirements:

a) In case of applying the additional sanction which is suspension from operation for a definite term, the person competent to issue decisions to sanction administrative violations shall be responsible for sending the written notice to the competent State agency for coordination in monitoring, inspection and summarization of reports upon the expiry of the decisions to sanction administrative violations;

b) In case of applying the remedial measure which is forcible return of licenses, practice certificates, the person competent to sanction administrative violations shall be responsible for sending the written notice to the State agency competent to grant or receive to revoke such licenses and practice certificates;

c) Other requirements according to the law on handling of administrative violations.”.

4. To amend and supplement Clause 6 Article 4 as follows:

“6. The competence to impose fines of titles specified in Chapter III of this Decree is the competence to impose fines to an administrative violation committed by an individual; the competence to impose fines on an organization is twice as much as the competence to fine an individual.”.

5. To amend and supplement some clauses of Article 12 as follows:

a) To amend and supplement Point a Clause 1 as follows:

“a) Failing to take personal protection measures, for persons participating in anti-epidemic activities and persons at risk of contracting an epidemic disease according to instructions of health agencies, including wearing face masks, disinfecting, keeping a safe distance, making health declaration and other measures;”;

c) To amend and supplement Point c Clause 2 as follows:

“c) Failing to participate in the epidemic prevention under the mobilization decision of the competent person, except for the cases specified at Point m Clause 5 Article 38 and Point b Clause 4 Article 39 of this Decree;”;

c) To amend and supplement Point a Clause 4 as follows:

“a) Failing to comply with decisions on medical inspection, surveillance and control when leaving or entering group-A epidemic zones;”;

d) To amend and supplement Point b Clause 5 as follows:

“b) Failing to comply with the decision on prohibiting mass gatherings in the area already declared a state of emergency in case of epidemic according to resolutions, decisions, directives and other documents issued by competent agencies;”.

6. To amend and supplement Point e Clause 3 Article 20 as follows:

“e) Testing for HIV for a person under 15 years old, person who loses his/her civil act capacity, person who has difficulty in perceiving and controlling his/her acts, or person who has a limited civil act capacity without his/her parent or legal guardian’s written consent, excepts for the emergency cases according to the law on medical examination and treatment.”.

7. To amend and supplement the first paragraph of Article 32 as follows:

“A fine ranging from VND 20,000,000 to VND 30,000,000 shall be imposed for any of the following acts of violation:”

8. To amend and supplement some clauses of Article 38 as follows:

a) To amend and supplement Point a Clause 4 as follows:

“a) A medical practitioner registers to work in the same period of time at multiple medical examination and treatment establishments; a medical practitioner works in the period of time other than the working time approved by a competent agency, or fails to practice according to the mobilization or assignment of the competent agency or person as prescribed by law;”;

b) To add Point dd after Point d Clause 4 as follows:

“dd) The medical practitioner fails to register for medical practice in accordance with law provisions.”;

c) To add Point m after Point l Clause 5 as follows:

“m) The medical practitioner fails to observe mobilization decisions of competent state agencies upon occurrence of natural disasters, catastrophes or dangerous epidemics.”;

d) To amend and supplement Point a Clause 8 as follows:

“a) Deprivation of the right to use the medical practice certificate from 01 month to 03 months, for the acts of violations specified at Points b, c, d, dd, e, g, h, i, k, l and m Clause 5 of this Article;”.

9. To amend and supplement some clauses of Article 39 as follows:

a) To add Clause 2a after Clause 2 as follows:

“2a. A fine ranging from VND 5,000,000 to VND 10,000,000 shall be imposed for any of the following acts of violation:

a) Collecting charges for medical examination and treatment services higher than the listed ones;

b) Collecting medical examination and treatment expenses higher than the ones covered by the health insurance fund, except for the differences due to the use of on-demand services, or beyond the payment scope of the health insurance.”;

b) To amend and supplement Point a Clause 7 as follows:

“a) Deprivation of the right to use the license for medical examination and treatment from 02 months to 04 months, for the acts of violations specified at Point dd Clause 2, Point b Clause 3, Clause 4, Point c Clause 5 and Points b, c, d and e Clause 6 of this Article;”.

10. To add Point dd after Point d Clause 1 Article 40 as follows:

“dd) Failing to make the medical record, or failing to include sufficient information in the medical record in accordance with law provisions.”.

11. To add Article 48a after Article 48 as follows:

“Article 48a. Violations of regulations on clinical pharmacy activities of medical examination and treatment establishments

1. A fine ranging from VND 3,000,000 to VND 5,000,000 shall be imposed for any of the following acts of violation:

a) Failing to arrange enough persons to implement clinical pharmacy activities according to the roadmap prescribed by law;

b) Failing to arrange persons fully meeting conditions prescribed by law to implement clinical pharmacy activities.

2. A fine ranging from VND 5,000,000 to VND 10,000,000 shall be imposed for the act of arranging for a person, who does not possess a pharmacy practice certificate or in the duration subject to revocation of the practice certificate or suspension from pharmacy practice, to be in charge of clinical pharmacy activities.

3. A fine ranging from VND 10,000,000 to VND 20,000,000 shall be imposed for the act of failing to implement clinical pharmacy activities according to the roadmap prescribed by law.”.

12. To amend and supplement PHoint dd Clause 2 Article 51 as follows:

“dd) Permitting production and business establishments to give sample products or gifts related to breast-milk substitutes in medical establishments;”.

13. To amend and supplement some clauses of Article 56 as follows:

a) To amend and supplement Point b Clause 1 as follows:

“b) Failing to carry out the procedures for notifying competent State agencies of minor changes subject to notification before the circulation of drugs or drug materials;”;

b) To amend and supplement Points c and d Clause 3 as follows:

“c) Failing to carry out the procedures for registration of changing or supplementing certificates of registration for marketing authorization before the circulation of drugs or drug materials for major changes or minor changes that require approval;

d) Manufacturing or circulating drugs or drug materials with changes compared to the approved drug registration dossier that requires the procedures for granting certificates of registration for marketing authorization in accordance with law.”;

c) To add Clause 6 after Clause 5 as follows:

“6. In case there are 2 or more drugs or drug materials involved in the same act of violation specified in Clauses 1, 2, 3, 4 of this Article, that are detected in the same inspection or examination, then only one act shall be fined, and aggravating circumstance shall be applied.”.

14. To amend and supplement some clauses of Article 57 as follows:

a) To add Point d after Point c Clause 1 as follows:

“d) Failing to preserve the drug or drug material samples when testing drugs and drug materials in accordance with law provisions.”;

b) To amend and supplement Points a, b and c Clause 2 as follows:

“a) Manufacturing drugs or drug materials with minor changes compared to the approved drug registration dossier in the cases that must be notified to competent agencies but no notification of such changes is made in accordance with law, except for the cases specified at Point b Clause 1 Article 56 of this Decree;

b) Manufacturing drugs or drug materials with minor changes compared to the approved drug registration dossier but the content of such changes has not been approved by competent agencies in accordance with law, except for the cases specified at Point c Clause 3 Article 56 of this Decree;

c) Failing to preserve samples of finished drugs for at least 12 months after the expiry of the shelf life of drugs; failing to preserve samples of materials that are active ingredients used for drug production for at least 12 months after the expiry of the shelf life of finished products from such materials;”;

c) To amend and supplement Point dd Clause 3 as follows:

“dd) Manufacturing drugs or drug materials with major changes compared to the approved drug registration dossier but the content of such changes has not been approved in accordance with law, except for the cases specified at Point c Clause 3 Article 56 of this Decree;”;

d) To add Point i after Point h Clause 4 as follows:

“i) Manufacturing drugs from pharmaceutical ingredients manufactured by production establishments that do not have documents proving the satisfaction of good manufacturing practices of drug materials as prescribed by law, or establishments that fail to meet requirements for good manufacturing practices of drug materials as announced by the competent agencies.”.

15. To amend and supplement some clauses of Article 58 as follows:

a) To amend and supplement Point a Clause 2 as follows:

“a) Buying and selling drugs or drug materials as samples for registration, testing, scientific research, or display at exhibitions or fairs; buying or selling drug materials permitted for import for manufacturing drugs for exports contrary to regulations;”;

b) To amend and supplement Point b Clause 3 as follows:

“b) Failing to make dossier of request for regular evaluation of the satisfaction of requirements on good practices of drug distribution as prescribed by law;”;

c) To amend and supplement Points d and dd Clause 3 as follows:

“d) Failing to develop mechanism for the transfer of information about drug distribution and drug quality between manufacturers and customers and the transfer of information to relevant management agencies upon request, or failing to transfer sufficient information hereof;

dd) The competent agencies conclude that the establishment maintains the satisfaction of principles and standards for good practices in distributing drugs or drug materials at level 3.”;

d) To amend and supplement Clause 9 as follows:

“9. Remedial measures:

Forcible destruction of all drugs or drug materials for the acts of violation specified at Point b Clause 4 and Clause 6 of this Article.”.

16. To amend and supplement some clauses of Article 59 as follows:

a) To amend and supplement Point b Clause 2 as follows:

“b) Failing to have separate areas for products other than drugs or failing to arrange signboards in separate areas stating “this product is not a drug”, or storing products other than drugs in the same place as drugs in cases of trading in cosmetics, functional foods, and medical equipment in accordance with law;”;

b) To amend and supplement Points dd and e Clause 3 as follows:

“dd) Retailing vaccines;

“e) Failing to make dossier of request for regular evaluation of the satisfaction of requirements on good practices of drug retailing establishments as prescribed by law;”;

c) To amend and supplement Points h and i Clause 3 as follows:

“h) Failing to transfer information or failing to transfer sufficient information about drug sale and purchase or drug quality between suppliers and customers upon request as prescribed by law, except for retailers of medicinal materials;

i) The competent agencies conclude that the establishment fails to satisfy the principles and standards for good practices of drug retailing establishments.”;

d) To add Point g after Point e Clause 4 as follows:

“g) Selling prescription drugs without prescriptions.”;

dd) To amend and supplement Point c Clause 9 as follows:

“c) Forcible destruction of all drugs or medicinal materials, for the acts of violation specified in Clause 6 of this Article.”;

e) To add Clause 10 after Clause 9 as follows:

“10. In case there are 2 or more drugs or drug materials involved in the violations specified at Point g Clause 4 of this Article, that are detected in the same inspection or examination, then only one act shall be fined, and aggravating circumstance shall be applied.”.

17. To amend and supplement some clauses of Article 60 as follows:

a) To add Points c and d after Point b Clause 1 as follows:

“c) Failing to store samples of finished drugs at least 12 months after the expiry of the shelf life of drugs;

d) Failing to store samples of materials being active ingredients used for manufacturing drugs at least 12 months after the expiry of the shelf life of finished products manufactured from such materials.”;

b) To amend and supplement Point b Clause 3 as follows:

“b) The competent agencies conclude that the establishment maintains the satisfaction of principles and standards for good practices of storage of drugs or drug materials at level 3;”;

c) To add Point dd after Point d Clause 5 as follows:

“dd) Importing drugs and drug materials from establishments supplying drugs and drug materials other than those permitted to supply as prescribed by law.”;

d) To amend and supplement Point dd Clause 6 as follows:

“dd) A fine ranging from VND 15,000,000 to VND 20,000,000 shall be imposed if the good value ranges from VND 20,000,000 to less than VND 30,000,000;”.

18. To amend and supplement some clauses of Article 66 as follows:

a) To amend and supplement Point d Clause 2 as follows:

“d) A drug retailer on the premise of a medical examination and treatment establishment sells drugs with a retail surplus higher than the maximum rate of retail surplus in accordance with law.”;

b) To add Clause 6 after Clause 5 as follows:

“6. In case there are 2 or more drugs or drug materials involved in the same act of violation specified in Clauses 1, 2, 3, 4 of this Article, that are detected in the same inspection or examination, then only one act shall be fined, and aggravating circumstance shall be applied.”.

19. To amend and supplement some clauses of Article 68 as follows:

a) To amend and supplement Clause 2 as follow:

“2. A fine ranging from VND 20,000,000 to VND 30,000,000 shall be imposed for the act of putting cosmetic products into circulation without being granted the cosmetic product proclamation receipt number by the competent State agency, or the act of putting cosmetic products into circulation after the expiry date of the cosmetic product proclamation receipt number without re-proclamation in accordance with law provisions.”;

b) To add Clause 6 after Clause 5 as follows:

“6. In case there are 2 or more cosmetic products involved in the same act of violation specified in Clauses 1, 2, 3 of this Article, that are detected in the same inspection or examination, then only one act shall be fined, and aggravating circumstance shall be applied.”.

20. To amend and supplement some clauses of Article 70 as follows:

a) To amend and supplement Point a Clause 4 as follows:

“a) Forcible recall and destruction of all cosmetic products, for the acts of violation specified in Clauses 1 and 2 of this Article. Forcible destruction shall not be applied in cases where the cosmetic products fail to meet the standards of weight and packing volume specified at Point d Clause 1 of this Article;”;

b) To add Clause 5 after Clause 4 as follows:

“5. In case there are 2 or more cosmetic products involved in the same act of violation specified in Clauses 1, 2 of this Article, that are detected in the same inspection or examination, then only one act shall be fined, and aggravating circumstance shall be applied.”.

21. To amend and supplement some clauses of Article 71 as follows:

a) To add Point dd after Point d Clause 2 as follows:

“dd) Trading in cosmetics without sufficient product information files (PIF) in accordance with law provisions.”;

b) To amend and supplement Point b Clause 3 as follows:

“b) Trading in cosmetics without product information files (PIF) or without presenting product information files (PIF) within the prescribed period upon request by competent agencies;”;

c) To add Clause 5 after Clause 4 as follows:

“5. In case there are 2 or more cosmetic products involved in the same act of violation specified in Clauses 1, 2, 3 of this Article, that are detected in the same inspection or examination, then only one act shall be fined, and aggravating circumstance shall be applied.”.

22. To amend and supplement some clauses of Article 72 as follows:

a) To amend and supplement Clause 1 as follows:

“1. A fine ranging from VND 5,000,000 to VND 10,000,000 shall be imposed on the holder of medical equipment circulation number who fails to publicize the result of classification of medical equipment issued in accordance with law provisions.”;

b) To amend and supplement Points d, dd and e Clause 2 as follows:

“d) Failing to send written reports to the customs agencies where the customs clearance has been carried out and the agencies that have issued circulation numbers in cases where medical equipment being granted with a circulation number uses the classification results that have been recalled and cleared but have not yet been sold to users;

dd) Written reports sent to the customs agencies where the customs clearance has been carried out fail to clearly state the quantity of cleared medical equipment in cases where medical equipment being granted with a circulation number uses the classification results that have been recalled and cleared but have not yet been sold to users;

e) Written reports sent to the agencies that have granted circulation numbers fail to clearly state the quantity of cleared medical equipment and purchase contracts (if any) in cases where medical equipment being granted with a circulation number uses the classification results that have been recalled and cleared but have not yet been sold to users;”;

c) To amend and supplement Point b Clause 3 as follows:

b) Holders of circulation numbers fail to stop circulating medical equipment or fail to take measures to recall medical equipment with circulation numbers of which the dossier uses the classification results that have been recalled and the medical equipment has been cleared but not yet been sold to users.”;

d) To amend and supplement Point a Clause 5 as follows:

“a) Suspension of operation from 01 month to 03 months, for the acts of violation specified at Point a Clause 2 of this Article;”.

23. To amend and supplement some clauses of Article 73 as follows:

a) To amend and supplement Clause 1 as follows:

“1. A fine ranging from VND 5,000,000 to VND 10,000,000 shall be imposed for the acts of failing to issue a written notice of changes, enclosed with relevant documents, or failing to update documents related to the changes in the declaration dossier posted on the medical equipment management portal according to the prescribed time limit if there are changes related to the previous declaration dossiers in accordance with law.”;

b) To amend and supplement Point b Clause 2 as follows:

“b) Manufacturing medical equipment when failing to satisfy the standard for quality control system ISO 13485.”;

c) To amend and supplement Point c Clause 3 as follows:

“c) Manufacturing medical equipment without carrying out procedures for declaration of satisfaction of conditions for manufacturing medical equipment as prescribed by law”;

d) To amend and supplement Clause 4 as follows:

“4. Additional sanctions:

Suspension of operation from 01 month to 03 months, for the acts of violation specified in Clause 1, Point b Clause 2 and Point a Clause 3 of this Article.”;

dd) To amend and supplement Point a Clause 5 as follows:

“a) Forcible return of receipt of declaration dossier of eligibility for medical equipment manufacture, for the acts of violation specified at Point a Clause 2 and Point a Clause 3 of this Article;”.

24. To amend and supplement some clauses of Article 74 as follows:

a) To amend and supplement Point a Clause 1 as follows:

“a) Circulating medical equipment on the market without labels with sufficient information as prescribed by law;”;

b) To amend and supplement Point dd Clause 1 as follows:

“dd) Failing to notify competent state agencies, or failing to update documents with changes in the dossier of registration for circulation already posted on the medical equipment management portal within the prescribed period when there are changes as prescribed by law during the circulation of medical equipment;”;

c) To amend and supplement Point g Clause 1 as follows:

“g) Circulating medical equipment on the market when manufacturers have not obtained a certificate of satisfaction of quality management standard ISO 13485 and have not been permitted for circulation in any country in the world, for imported medical equipment;”;

d) To amend and supplement Point a Clause 2 as follows:

“a) Failing to re-publish the standards applicable to type-A or type-B medical equipment as prescribed by law;”;

dd) To amend and supplement Point g Clause 2 as follows:

g) Failing to make reports to the police office when detecting loss of medical equipment containing narcotic substances and precursors or materials for manufacturing medical equipment containing narcotic substances and precursors;”;

e) To amend and supplement Point l Clause 2 as follows:

“l) Failing to maintain the validity of a circulation certificate, power of attorney, or certificate of eligibility for warranty while the circulation number remains valid as prescribed by law.”;

g) To amend and supplement Points b, c, d and dd Clause 3 as follows:

“b) Modifying, erasing or falsifying a receipt for declaration of standards applicable to type-A or type-B medical equipment;

c) Modifying, erasing or falsifying a certificate of circulation registration of medical equipment of type C or D;

d) Documents in the dossier for declaration of standards applicable to type-A or type-B medical equipment fail to ensure the legality as prescribed by law;

dd) Documents in the dossier of request for granting, re-granting or extending a circulation registration certificate of medical equipment of type C or D fail to ensure the legality as prescribed by law.”;

h) To amend and supplement Points a and b Clause 4 as follows:

“a) Circulating medical equipment of type A or B on the market without the receipt of dossier of declaration for applicable standards or without import permits;

b) Circulating medical equipment of type C or D on the market without numbers of circulation registration certificates or without import permits;”;

i) To amend and supplement Point a Clause 5 as follows:

“a) Confiscation of material evidences being receipts, certificates, documents and dossiers, for the acts of violation specified at Points d and dd Clause 3 of this Article;”;

k) To amend and supplement Point b Clause 6 as follows:

“b) Forcible return of receipts of declaration for standards applicable to type-A or type-B medical equipment or certificate of free sale for medical equipment of type C or D, for acts of violation specified at Points b, c, d and dd Clause 3 of this Article.”.

25. To amend and supplement some clauses of Article 77 as follows:

a) To amend and supplement Clause 1 as follow:

“1. A fine ranging from VND 3,000,000 to VND 5,000,000 shall be imposed for the act of failing to issue a written notice of changes, enclosed with relevant documents, or failing to update documents in the declaration dossier posted on the medical equipment management portal within the prescribed period when there are changes related to the previously dossier.”;

b) To amend and supplement Point b Clause 2 as follows:

“b) Conducting consultation of medical equipment without having information and dossier of declaration of eligibility for providing consultancy relating to medical equipment technique disclosed by the Ministry of Health;”.

26. To add Article 78a after Article 78 as follows:

“Article 78a. Violations of regulation on management of medical equipment costs

1. A fine ranging from VND 10,000,000 to VND 15,000,000 shall be imposed for any of the following acts of violation:

a) Failing to publish information on price declaration on the portal of the Ministry of Health before the first medical equipment is circulated on the Vietnamese market;

b) Failing to declare prices with sufficient information components as prescribed by law;

c) Failing to update the declared price of medical equipment when there is a change;

d) Failing to explain price constituents at the request of a competent agency;

dd) Declaring the price of medical equipment when not being the holder of medical equipment circulation number or the distributor designated by the holder of medical equipment circulation number to declare the price.

2. A fine ranging from VND 15,000,000 to VND 20,000,000 shall be imposed for any of the following acts of violation:

a) Failing to declare the price of medical equipment before circulating them in Vietnam;

e) Buying and selling medical equipment without the declared prices or the buying and selling prices are higher than the prices declared on the portal of the Ministry of Health at the time of buying and selling.”.

27. To amend and supplement some clauses of Article 103 as follows:

a) To amend and supplement Point c Clause 1 as follows:

“c) Confiscate material evidences and means used in administrative violations of a value not exceeding VND 6,000,000 for the acts of administrative violation on population; VND 10,000,000 for the acts of administrative violation on preventive healthcare, HIV/AIDS prevention and control, health insurance, medical examination and treatment, pharmacy, cosmetics and medical equipment;”;

b) To amend and supplement Point d Clause 2 as follows:

“d) Confiscate administrative violation material evidences and means;”.

28. To amend and supplement some clauses of Article 104 as follows:

a) To amend and supplement Point c Clause 1 as follows:

“c) Confiscate material evidences and means used in administrative violations of a value not exceeding VND 600,000 for the acts of administrative violation on population; VND 1,000,000 for the acts of administrative violation on preventive healthcare, HIV/AIDS prevention and control, health insurance, medical examination and treatment, pharmacy, cosmetics and medical equipment;”;

b) To amend and supplement the first paragraph of Clause 2 as follows:

“2. Chief inspectors of provincial-level Departments, Directors of Sub-Departments of Population and Family Planning under the provincial-level Department of Health, heads of specialized inspection teams of provincial-level departments and heads of specialized inspection teams of competent state agencies assigned to perform the specialized inspection function may:”;

c) To amend and supplement Point d Clause 2 as follows:

“d) Confiscate material evidences and means used in administrative violations of a value not exceeding VND 30,000,000 for the acts of administrative violation on population; VND 50,000,000 for the acts of administrative violation on preventive healthcare, HIV/AIDS prevention and control; VND 75,000,000 for the acts of administrative violation on health insurance; VND 100,000,000 for the acts of administrative violation on medical examination and treatment, pharmacy, cosmetics and medical equipment;”;

d) To amend and supplement the first paragraph of Clause 3 as follows:

“3. Chief inspectors of the Ministry; Director General of the General Office for Population and Family Planning; Director of the Drug Administration of Vietnam; Director of the Department of Medical Service Administration, Director of the Health Environment Management Agency and Director of the General Department of Preventive Medicine may:”;

dd) To amend and supplement Point d Clause 4 as follows:

“d) Confiscate material evidences and means used in administrative violations of a value not exceeding VND 42,000,000 for the acts of administrative violation on population; VND 70,000,000 for the acts of administrative violation on preventive healthcare, HIV/AIDS prevention and control; VND 105,000,000 for the acts of administrative violation on health insurance; VND 140,000,000 for the acts of administrative violation on medical examination and treatment, pharmacy, cosmetics and medical equipment;”.

29. To amend and supplement some clauses of Article 105 as follows:

a) To amend and supplement the first paragraph of Clause 2 as follows:

“2. Heads of market management teams, Heads of the professional sections of the Directorate of Market Surveillance may:”;

c) To amend and supplement Point c Clause 2 as follows:

“c) Confiscate material evidences and means used in administrative violations of a value not exceeding VND 50,000,000 for the acts of administrative violation on population, preventive healthcare, medical examination and treatment, pharmacy, cosmetics and medical equipment;”;

c) To amend and supplement the first paragraph of Clause 3 as follows:

“3. Director of the provincial-level Market Management Department, Director of the Market Surveillance Department under the Directorate of Market Surveillance may:”;

d) To amend and supplement Point c Clause 3 as follows:

“c) Confiscate material evidences and means used in administrative violations;”.

30. To amend and supplement some clauses of Article 106 as follows:

a) To amend and supplement the first paragraph of Clause 2 as follows:

“2. Heads of stations or team leaders of those mentioned in Clause 1 of this Article may:”;

b) To amend and supplement the first paragraph of Clause 3 as follows:

“3. Chiefs of commune-level police offices; chiefs of police stations, chiefs of police offices of border gates or export processing zones, chiefs of the international airport border gate police, captains of ship fleets may:”;

c) To amend and supplement Point c Clause 3 as follows:

“c) Confiscate material evidences and means used in administrative violations of a value not exceeding VND 3,000,000 for the acts of administrative violation on population; VND 5,000,000 for the acts of administrative violation on preventive healthcare, HIV/AIDS prevention and control, health insurance, medical examination and treatment, pharmacy, cosmetics and medical equipment;”;

d) To amend and supplement the first paragraph of Clause 4 as follows:

“4. Chiefs of district-level police offices, heads of the professional sections of the Internal Political Security Department, heads of the professional sections of the Police Department for Administrative Management of Social Order, heads of the professional sections of the Traffic Police Department and chiefs of provincial-level Police Departments, including heads of combat and heads of economic security offices, heads of internal political security sections, heads of police sections for administrative management of social order, heads of police sections for prevention and combat of environment-related crimes; heads of traffic police offices; heads of road and railway traffic police offices; heads of road traffic police offices; heads of waterway police offices; heads of police offices for corruption, smuggling and economic crimes; captains of crews may:”;

dd) To amend and supplement Point d Clause 4 as follows:

“d) Confiscate material evidences and means used in administrative violations of a value not exceeding VND 12,000,000 for the acts of administrative violation on population; VND 20,000,000 for the acts of administrative violation on preventive healthcare, HIV/AIDS prevention and control; VND 30,000,000 for the acts of administrative violation on health insurance; VND 40,000,000 for the acts of administrative violation on medical examination and treatment, pharmacy, cosmetics and medical equipment;”;

e) To amend and supplement Point d Clause 5 as follows:

“d) Confiscate administrative violation material evidences and means;”;

g) To amend and supplement the first paragraph of Clause 6 as follows:

“6. Director of the Internal Political Security Department; Director of the Police Department for Administrative Management of Social Order; Director of the Police Department of Social Order-related Crime Investigation; Director of the Department of Economic Security; Director of the Police Department for Prevention and Combat of Environment-Related Crimes; Director of the Traffic Police Department; Director of the Police Department of Corruption, Smuggling and Economic Crime Investigation may:”.

31. To amend and supplement some clauses of Article 107 as follows:

a) To amend and supplement the first paragraph of Clause 2 as follows:

“2. Leaders or heads of teams under the Customs Branches; heads of control teams of provincial, inter-provincial or municipal Customs Departments; heads of teams under Post-Customs Clearance Inspection Branches may:”;

b) To amend and supplement the first paragraph of Clause 3 as follows:

“3. Heads of Customs Branches; heads of Post-Customs Clearance Inspection Branches, heads of control teams of provincial, inter-provincial or municipal Customs Departments; heads of criminal investigation teams, heads of anti-smuggling control teams, captains of marine control flotillas, and heads of anti-smuggling control and protection of intellectual property right teams of the Anti-Smuggling Investigation Department; heads of Post-Customs Clearance Inspection Branches under the Post-Customs Clearance Inspection Department may:”;

c) To amend and supplement Point c Clause 3 as follows:

“c) Confiscate material evidences and means used in administrative violations of a value not exceeding VND 50,000,000 for the acts of administrative violation on preventive healthcare, HIV/AIDS prevention and control, pharmacy, cosmetics and medical equipment;”;

d) To amend and supplement Point d Clause 4 as follows:

“d) Confiscate material evidences and means used in administrative violations;”.

32. To amend and supplement some clauses of Article 108 as follows:

a) To add Clause 2a after Clause 2 as follows:

“2a. Captains of the Crime and Drug Prevention and Control Teams under the Crime and Drug Prevention and Control Task Forces may:

a) Impose warnings;

b) Impose a fine of up to VND 3,000,000 for the acts of administrative violation on population; up to VND 5,000,000 for the acts of administrative violation on preventive healthcare, HIV/AIDS prevention and control; up to VND 10,000,000 for the acts of administrative violation on medical examination and treatment, pharmacy, cosmetics and medical equipment;

c) Confiscate material evidences and means used in administrative violations of a value not exceeding VND 6,000,000 for the acts of administrative violation on population; VND 10,000,000 for the acts of administrative violation on preventive healthcare, HIV/AIDS prevention and control; 20,000,000 for the acts of administrative violation on medical examination and treatment, pharmacy, cosmetics and medical equipment;

d) Take the remedial measures specified at Points c and dd Clause 1 Article 28 of the Law on Handling of Administrative Violations.”;

b) To amend and supplement the first paragraph of Clause 3 as follows:

“3. Chiefs of border-guard stations, captains of border-guard flotillas and commanders of border-gate guards at ports may:”;

c) To amend and supplement Points c and d Clause 3 as follows:

“c) Confiscate material evidences and means used in administrative violations of a value not exceeding VND 12,000,000 for the acts of administrative violation on population; VND 20,000,000 for the acts of administrative violation on preventive healthcare, HIV/AIDS prevention and control; VND 40,000,000 for the acts of administrative violation on medical examination and treatment, pharmacy, cosmetics and medical equipment;

d) Apply the remedial measures specified at Points c, d and dd Clause 1 Article 28 of the Law on Handling of Administrative Violations and Clause 3 Article 3 of this Decree.”;

d) To add Clause 3a after Clause 3 as follows:

“3a. Captains of the Special Task Force on Drugs and Crime of the Department of Drugs and Crime under the Border-Guard Command may:

a) Impose warnings;

b) Impose a fine of up to VND 15,000,000 for the acts of administrative violation on population; up to VND 25,000,000 for the acts of administrative violation on preventive healthcare, HIV/AIDS prevention and control; up to VND 50,000,000 for the acts of administrative violation on medical examination and treatment, pharmacy, cosmetics and medical equipment;

c) Confiscate material evidences and means used in administrative violations of a value not exceeding VND 30,000,000 for the acts of administrative violation on population; VND 50,000,000 for the acts of administrative violation on preventive healthcare, HIV/AIDS prevention and control; VND 100,000,000 for the acts of administrative violation on medical examination and treatment, pharmacy, cosmetics and medical equipment;

d) Apply the remedial measures specified at Points c, d, dd and i Clause 1 Article 28 of the Law on Handling of Administrative Violations and Clause 3 Article 3 of this Decree.”;

dd) To amend and supplement the first paragraph of Clause 4 as follows:

“4. Provincial-level border-guard commanders, captains of border-guard ship fleets the Director of the Department of Drugs and Crime under the Border-Guard Command Post may:”;

e) To amend and supplement Point dd Clause 4 as follows:

“dd) Apply the remedial measures specified at Points c, d, dd and i Clause 1 Article 28 of the Law on Handling of Administrative Violations and Clause 3 Article 3 of this Decree.”.

33. To amend and supplement some clauses of Article 109 as follows:

a) To amend and supplement Point c Clause 4 as follows:

“c) Confiscate material evidences and means used in administrative violations of a value not exceeding VND 12,000,000 for acts of administrative violation on population; VND 20,000,000 for the acts of administrative violation on preventive healthcare, HIV/AIDS prevention and control; VND 40,000,000 for the acts of administrative violation on medical examination and treatment, pharmacy, cosmetics and medical equipment;”;

b) To amend and supplement the opening of Clause 5 as follows:

“5. Captains of marine police ship fleets, Captains of the Scout Force and the Special Task Force on Drugs and Crime under the Marine Police Command Post may:”;

c) To amend and supplement Point c Clause 5 as follows:

”c) Confiscate material evidences and means used in administrative violations of a value not exceeding VND 18,000,000 for the acts of administrative violation on population; VND 30,000,000 for acts of administrative violation on preventive healthcare, HIV/AIDS prevention and control; VND 60,000,000 for the acts of administrative violation on medical examination and treatment, pharmacy, cosmetics and medical equipment;”;

d) To amend and supplement the first paragraph of Clause 6 as follows:

“6. Commanders of marine police zones and the Director of the Operation and Law Department under the Vietnam Marine Police Command Post may:”;

dd) To add Point b1 after Point b Clause 6 as follows:

"b1) Deprive the right to use licenses or practice certificates for a definite time;”;

e) To amend and supplement Point c Clause 6 as follows:

“c) Confiscate material evidences and means used in administrative violations;”.

34. To amend and supplement some clauses of Article 110 as follows:

a) To amend and supplement Points c and d Clause 3 as follows:

“c) Confiscate material evidences and means used in administrative violations of a value not exceeding VND 50,000,000 for the acts of administrative violation on preventive healthcare, HIV/AIDS prevention and control;

d) Apply the remedial measures specified at Point i Clause 1 Article 28 of the Law on Handling of Administrative Violations and Clause 3 Article 3 of this Decree.”;

b) To amend and supplement Points c and d Clause 4 as follows:

“c) Confiscate material evidences and means used in administrative violations;

d) Apply the remedial measures specified at Point i Clause 1 Article 28 of the Law on Handling of Administrative Violations and Clause 3 Article 3 of this Decree.”;

c) To amend and supplement Point d Clause 5 as follows:

“d) Apply the remedial measures specified at Point i Clause 1 Article 28 of the Law on Handling of Administrative Violations and Clause 3 Article 3 of this Decree.”.

35. To amend and supplement some clauses of Article 111 as follows:

a) To amend and supplement Point b Clause 1 as follows:

“b) Impose a fine of up to VND 37,500,000, for the acts of administrative violation on health insurance contribution;”;

b) To amend and supplement Point d Clause 1 as follows:

"d) Confiscate material evidences and means used in administrative violations of a value not exceeding VND 75,000,000 for the acts of administrative violation on health insurance contribution;”;

c) To amend and supplement Point b Clause 2 as follows:

“b) Impose a fine of up to VND 75,000,000 for the acts of administrative violation on health insurance contribution;”;

d) To amend and supplement Point b Clause 3 as follows:

“b) Impose a fine of up to VND 52,500,000 for the acts of administrative violation on health insurance contribution;”.

dd) To amend and supplement Point d Clause 3 as follows:

“d) Confiscate material evidences and means used in administrative violations of a value not exceeding VND 105,000,000 for the acts of administrative violation on health insurance contribution;”.

36. To amend and supplement some clauses of Article 112 as follows:

a) To amend and supplement Clause 5 as follows:

“5. Persons competent to sanction of the customs offices shall have the competence to make written records of administrative violations, sanction administrative violations and take remedial measures according to the scope of management, assigned functions, tasks and powers and according to the competence specified in Article 107 of this Decree for the administrative violations specified 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 and 2 Article 6; Point b Clause 1 Article 54; Clauses 6 and 7 Article 58; Clauses 6 and 7 Article 59; Point b Clause 1, Clause 2 Article 65; Points d and dd Clause 2 Article 72; Points a, b Clause 4 Article 74 and Point c Clause 2 Article 75 of this Decree.”;

b) To amend and supplement Clause 7 as follows:

“7. Persons competent to sanction of marine police shall have the competence to make written records of administrative violations, sanction administrative violations and take remedial measures according to the scope of management, assigned functions, tasks and powers and according to the competence specified in Article 107 of this Decree for the administrative violations specified 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; Points a and 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 and 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 and 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.”;

c) To amend and supplement Clause 11 as follows:

“11. Persons competent to sanction of inspectors of Culture, Information, Sports and Tourism sectors shall have the competence to make written records of administrative violations, sanction administrative violations and take remedial measures according to the scope of management, assigned functions, tasks and powers and according to the competence specified in Article 104 of this Decree for the administrative violations specified 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.”.

Article 3. Replacing and annulling a number of provisions of the Government’s Decree No. 115/2018/ND-CP dated September 04, 2018, on penalties for administrative violations against regulations on food safety and the Government’s Decree No. 117/2020/ND-CP dated September 28, 2020, on sanctioning of administrative violations in health sector

1. To replace the phrase “proposing a competent state agency to revoke” with the phrase “forcible return” at 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, on sanctioning of administrative violations in health sector.

2. To annul the provisions at 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, on penalties for administrative violations against regulations on food safety.

3. To annul the provisions at Points c and 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, on sanctioning of administrative violations in health sector.

Article 4. Effect

1. This Decree takes effect from January 01, 2022.

2. For administrative violations in the field of health and food safety occurring before the effective date of this Decree and then discovered or being considered and handled, the provisions on sanctioning prescribed in this Decree shall apply if this Decree does not stipulate liability or prescribe lighter liability for violators.

Article 5. Implementation responsibility

Ministers, heads of ministerial-level agencies, heads of government-attached agencies, chairpersons of People’s Committees of provinces and centrally-run cities, and related organizations and individuals shall be responsible for the implementation of this Decree.