Decree No. 124/2021/ND-CP amends and supplements several articles of Decree No. 115/2018/ND-CP dated September 4, 2018, of the Government on administrative penalties for violations related to food safety, and Decree No. 117/2020/ND-CP dated September 28, 2020, of the Government on administrative penalties in the field of health.

 DECREE

Amending and supplementing some articles of Decree No. 115/2018/NĐ-CP

dated September 4, 2018 of the Government on administrative penalties for violations related to food safety and Decree No. 117/2020/NĐ-CP

 dated September 28, 2020 of the Government on administrative penalties in the field of health

 dated September 28, 2020 of the Government on administrative penalties in the field of health

administrative in the field of health

Pursuant to the Law on Organization of the Government dated June 19, 2015; the Law Amending and Supplementing Certain Provisions 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 Administrative Violations dated June 20, 2012; the Law Amending and Supplementing Certain Provisions of the Law on Handling Administrative Violations dated November 13, 2020;

Pursuant to the Law on Prevention and Control of Viruses Causing Acquired Immunodeficiency Syndrome (AIDS) dated June 29, 2006; the Law Amending and Supplementing Some Articles of the Law on Prevention and Control of Viruses Causing Acquired Immunodeficiency Syndrome (AIDS) dated November 16, 2020;

At the proposal of the Minister of Health;

The Government promulgates this Decree amending and supplementing some articles of Decree No. 115/2018/NĐ-CP dated September 4, 2018 of the Government on administrative penalties for violations related to food safety and Decree No. 117/2020/NĐ-CP dated September 28, 2020 of the Government on administrative penalties in the field of health.

Article 1. Amending and supplementing some articles of Decree No. 115/2018/NĐ-CP dated September 4, 2018 of the Government on administrative penalties for violations related to food safety

1. Supplementing some clauses of Article 2 as follows:

a) Supplementing point m after point l of Clause 3 as follows:

“m) Compelling the return of documents and materials that have been altered or erased.”;

b) Add Clause 4 after Clause 3 as follows:

“4. The implementation of administrative penalty measures and remedial actions must ensure the following requirements:

a) In cases where the supplementary administrative penalty measure is suspension of operation for a period, the person authorized to issue the administrative violation decision shall be responsible for sending a notification letter to the competent state agency for coordination in monitoring, inspection, and reporting when the enforcement period ends;

b) In cases where the remedial action is compelling the return of documents and materials that have been altered or erased, the person issuing the administrative violation decision shall be responsible for sending a notification letter to the agency that issued or received them for recovery;

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

2. Amending and supplementing some clauses of Article 3 as follows:

a) Amend and supplement Clause 1 as follows:

“1. The maximum fine for food safety violations is 100,000,000 VND for individuals and 200,000,000 VND for organizations, except for the cases stipulated in Clauses 1 and 5 of Article 4; Clause 6 of Article 5; Clause 5 of Article 6; Clause 7 of Article 11; Clauses 1 and 9 of Article 22; Clause 6 of Article 26 of this Decree. For violations stipulated in Clause 1 of Article 4, Clause 1 of Article 22, and Clause 6 of Article 26 of this Decree, if applying the highest fine amount as prescribed in Clause 1 of Article 23 of the Law on Handling Administrative Violations is still lower than seven times the value of the non-compliant food, the maximum fine will be applied at seven times the value of the non-compliant food.”;

b) Amend and supplement Clause 2 as follows:

“2. The fines prescribed in Chapter II of this Decree apply to individuals, except for the provisions in Clauses 1 and 5 of Article 4; Clause 6 of Article 5; Clause 5 of Article 6; Clause 6 of Article 9; Clause 7 of Article 11; Article 18; Article 19; point a of Clause 3 of Article 20; Clause 1 of Article 21; Clauses 1 and 9 of Article 22; Article 24; Clause 6 of Article 26 of this Decree, which apply to organizations. For the same administrative violation, the fine for organizations is twice the fine for individuals.

For individuals violating the provisions in Clauses 1 and 5 of Article 4; Clause 6 of Article 5; Clause 5 of Article 6; Clause 6 of Article 9; Clause 7 of Article 11; Article 18; Article 19; point a of Clause 3 of Article 20; Clause 1 of Article 21; Clauses 1 and 9 of Article 22; Article 24; Clause 6 of Article 26 of this Decree, the fine will be reduced by half.”.

3. Amending and supplementing some clauses of Article 9 as follows:

a) Amend and supplement Clause 1 as follows:

“1. Imposing a fine from 1,000,000 VND to 3,000,000 VND for the act of using persons directly involved with food without wearing full personal protective equipment as required; not trimming nails; wearing watches, bracelets, necklaces; eating, smoking, spitting in areas producing food, food additives, food processing aids, packaging materials, containers in direct contact with food.”;

b) Amending and supplementing Point b Clause 2 as follows:

“b) Using waste collection tools without lids as required;”;

c) Supplementing point d after point c of Clause 2 as follows:

“d) Not maintaining hygiene in food retail premises.”;

d) Amending and supplementing point đ of Clause 3 as follows:

"đ) Using persons directly involved in the production and sale of food, food additives, food processing aids, packaging materials, containers in direct contact with food without a certificate of training in food safety knowledge;"

đ) Amending and supplementing point d of Clause 5 as follows:

“d) The head of the establishment producing, selling food, food additives, food processing aids, packaging materials, containers in direct contact with food does not have a certificate of training in food safety knowledge;"

e) Amending and supplementing point a of Clause 6 as follows:

“a) Imposing a fine from 7,000,000 VND to 10,000,000 VND for establishments that set up but do not fully comply with regulations or do not apply sufficiently in practice or are not suitable for the actual production and business activities of the establishment;"

g) Amending and supplementing points a and b of Clause 7 as follows:

“a) Using persons directly involved in the production and sale of food, food additives, food processing aids, packaging materials, containers in direct contact with food who are currently suffering from cholera, dysentery, typhoid fever, hepatitis A, E, infectious skin diseases, pulmonary tuberculosis, acute diarrhea;

b) Using water that does not meet technical standards or does not comply with hygiene regulations for production or cleaning equipment and utensils used in food production, food additives, food processing aids, packaging materials, containers in direct contact with food.”

4. Amending and supplementing point b of Clause 1 of Article 10 as follows:

“b) Transporting food, food additives, food processing aids, packaging materials, containers in direct contact with food together with other goods that pose a risk of contaminating food.”

5. Amending and supplementing point a of Clause 5 of Article 11 as follows:

“a) Imposing a fine from 3,000,000 VND to 5,000,000 VND for the act of directly adding impurities to aquatic products;"

6. Amending and supplementing some clauses of Article 15 as follows:

a) Supplementing point đ after point d of Clause 1 as follows:

"d) Failing to ensure cross-contamination prevention between raw food and processed food in kitchen layout."

b) Amending and supplementing Point d Clause 2 as follows:

"d) Sewers for wastewater discharge in the store and kitchen are blocked; not covered;"

c) Amend and supplement Point e Clause 2 as follows:

"e) Lack of equipment for collecting and storing waste in a sanitary manner;"

d) Amending and supplementing Clause 3 as follows:

"3. Imposing a fine of VND 5,000,000 to VND 7,000,000 for the act of using personnel directly involved in food preparation without a certificate confirming training on food safety knowledge."

d) Amend and supplement Point b Clause 4 as follows:

"b) The business owner does not have a certificate confirming training on food safety knowledge;"

e) Amend and supplement Clause 5 as follows:

"5. Imposing a fine of VND 10,000,000 to VND 15,000,000 for the act of using personnel directly involved in food preparation who are currently suffering from cholera, dysentery, typhoid, hepatitis A, E, infectious skin disease, pulmonary tuberculosis, acute diarrhea;"

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

"b) Personnel directly involved in food preparation who are currently suffering from cholera, dysentery, typhoid, hepatitis A, E, infectious skin disease, pulmonary tuberculosis, acute diarrhea;"

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

"1. Imposing a fine of VND 20,000,000 to VND 30,000,000 for the act of operating food service businesses without a Food Safety Certificate or with an expired Food Safety Certificate, except in cases where such certificates are not required;"

2. Imposing a fine of VND 30,000,000 to VND 40,000,000 for the act of producing or trading food without a Food Safety Certificate or with an expired Food Safety Certificate, except in cases where such certificates are not required;"

3. Imposing a fine of VND 40,000,000 to VND 60,000,000 for any of the following acts:

a) Producing health foods without a Good Manufacturing Practice (GMP) Certificate or with an expired GMP Certificate, except in cases of producing health foods on herbal medicine or traditional medicine production lines or other cases as prescribed by the Minister of Health;"

b) Trading or circulating domestically produced or imported health foods that have been issued a Declaration of Conformity with Food Safety Regulations or a Registration Notification before July 1, 2019 without obtaining a GMP Certificate or equivalent certification prior to production;"

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

a) Amend and supplement the opening part of Clause 2 as follows:

"2. Imposing a fine of VND 40,000,000 to VND 60,000,000 for any of the following acts in importing or exporting food, food additives, food processing aids, packaging materials, or containers that come into direct contact with food:"

"a) Deposits of microfinance organizations at credit institutions, branches of foreign banks, except deposits at credit institutions under special control according to Clause 9, Article 174 of the Law on Credit Institutions;"

"a) Altering or erasing the content of product self-declaration statements, product declaration statements, Registration Notification for Product Declaration Statements, Import Confirmation Notification, Food Safety Certificate (Certificate), Free Circulation Certificate, and other types of documents;"

c) Supplementing point d after point c of Clause 2 as follows:

"d) Exporting a batch of food products with incorrect quantities or specifications as registered for assessment and issuance of a Food Safety Certificate;"

d) Amend and supplement Point a Clause 5 as follows:

"a) Seizing the evidence of violation under Point c Clause 2 of this Article if such evidence still exists;"

d) Supplement Point e after Point d Clause 6 as follows:

"e) Compelling the return of altered or erased documents in violation of Point a Clause 2 of this Article;"

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

a) Amending and supplementing Point b Clause 1 as follows:

"b) Failing to publish on the Food Safety Information Data System or failing to submit one copy of the product self-declaration statement to the competent authority as required;"

b) Supplement Point e after Point d Clause 2 as follows:

"e) Not having a test result certificate in the self-declaration file within its validity period at the time of self-declaration;"

c) Amend and supplement point a of clause 3 as follows:

"a) Producing or importing products subject to self-declaration that do not comply with relevant technical standards or regulations of the competent authority or published standards;"

11. Amend and supplement Clause 1 Article 21 as follows:

"1. Imposing a fine of VND 30,000,000 to VND 40,000,000 for the act of producing or importing products subject to registration declaration that do not comply with relevant technical standards or regulations of the competent authority or published standards;"

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

a) Amend and supplement Clause 1 as follows:

"1. The amount of fines for violations related to trading or circulating products on the market shall be determined as follows:"

a) Imposing a fine of one to two times the total value of the non-compliant food products sold for trading or circulating non-compliant food products or food products that must be produced in facilities with a Food Safety Certificate or equivalent but are not produced according to regulations;"

b) Imposing a fine of two to three times the total value of the non-compliant food products sold for substituting, swapping, adding, or removing components or additives compared to the declared standards;"

c) Imposing a fine of three to five times the total value of the non-compliant food products sold for substituting, swapping, adding, or removing components or additives or having safety indicators that do not comply with relevant technical standards or regulations of the competent authority;"

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

"h) Personnel involved in production have not been trained or retrained on basic principles of Good Manufacturing Practices for health foods;

i) There is no job description for key personnel, responsible personnel, and groups of personnel of departments as prescribed;

k) There is no approved production process for each product;

l) Self-inspection activities to monitor implementation, application, and compliance with Good Manufacturing Practices for health food products are not conducted and maintained regularly, and necessary and timely corrective measures are not taken;

m) There is no contract or there is a contract but it is not clearly defined, consistent, and strictly controlled in terms of enforcement when producing and/or testing under contract;

n) Initial raw material samples and finished product samples are not retained as required, or if they are retained, the quantity and retention period do not meet the requirements.";

c) Add Clause 2a after Clause 2 as follows:

"2a. A fine of VND 15,000,000 to VND 20,000,000 shall be imposed on any of the violations regarding the production of health food products stipulated in Clause 2 of this Article in case of recidivism.";

d) Amend and supplement Point a Clause 5 as follows:

"a) Producing, importing, trading, circulating on the market food, food additives, food processing aids, utensils, packaging materials that come into direct contact with food which are inconsistent with the information about the product already published, except in cases provided for in Clause 1 of this Article;"

đ) Amend and supplement Point a of Clause 6 as follows:

"a) Importing, producing, processing, supplying, selling food causing food poisoning affecting the health of from one to four people without reaching the level of criminal prosecution;"

e) Amend and supplement Point a of Clause 8 as follows:

"a) Importing, producing, processing, supplying, selling food causing food poisoning affecting the health of five or more people without reaching the level of criminal prosecution;"

g) Amend and supplement Point a of Clause 10 as follows:

"a) Suspension of part or all of the production, processing, business, supply of food for one to three months for violations stipulated in Clauses 2a and 7 of this Article;"

h) Amend and supplement Point b of Clause 11 as follows:

"b) Compel the destruction of food for violations stipulated in Clauses 6, 7, 8, and 9 of this Article;"

i) Add Points đ and e after Point d of Clause 11 as follows:

"đ) Compel a change in the purpose of use or recycling or compel the destruction of food for violations stipulated in Clauses 1, 3, and 5 of this Article;

e) Compel the return of altered or erased documents for violations stipulated in Point c of Clause 4 of this Article."

13. Add Point c after Point b of Clause 6 of Article 24 as follows:

"c) Compel the return of altered or erased documents for violations stipulated in Point a of Clause 4 of this Article."

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

a) Amend and supplement the name of Article 26 as follows:

"Article 26. Violations of regulations on traceability, recall, and handling of food, food additives, food processing aids, utensils, packaging materials that come into direct contact with food that do not ensure safety;"

b) Amending and supplementing Point b Clause 2 as follows:

"b) Not establishing a traceability data system for food products or establishing one but not fully providing information; not conducting traceability of unsafe food products as prescribed;"

c) Amend and supplement Point d of Clause 2 as follows:

"d) Not reporting or reporting incomplete, inaccurate, or untimely information on traceability of food products as prescribed by law;"

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

a) Amending and supplementing Point b Clause 1 as follows:

"b) Confiscate goods and means of administrative violation with a value not exceeding VND 10,000,000 for individuals and VND 20,000,000 for organizations;"

b) Amend and supplement Point c of Clause 2 and Point c of Clause 3 as follows:

"c) Confiscate goods and means of administrative violation;"

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

a) Amending and supplementing Point b Clause 1 as follows:

"b) Confiscate goods and means of administrative violation with a value not exceeding VND 1,000,000 for individuals and VND 2,000,000 for organizations;"

b) Amend and supplement the opening paragraph of Clause 2 as follows:

"2. The Head of the Health Department's Inspectorate; the Head of the Agriculture and Rural Development Department's Inspectorate; the Head of the Industry and Trade Department's Inspectorate; the Head of the Culture, Sports and Tourism Department's Inspectorate; the Head of the Tourism Department's Inspectorate; the Head of the Culture, Information, Sports and Tourism Department's Inspectorate; the Head of the Information and Communications Department's Inspectorate; the Director of the Food Safety Office under the Health Department; the Director of the Animal Health Region's Inspection Office; the Director of the Animal Quarantine Region's Inspection Office under the Animal Health Service; the Director of the Plant Protection Region's Inspection Office under the Plant Protection Service; the Director of the Central Region's Quality Management Office for Forestry, Agricultural and Aquatic Products; the Director of the Southern Region's Quality Management Office for Forestry, Agricultural and Aquatic Products under the Quality Management Service for Forestry, Agricultural and Aquatic Products; the Director of the Crop Production and Plant Protection Office, Livestock, Animal Health, Aquaculture, Quality Management of Forestry, Agricultural and Aquatic Products, Water Resources, Dikes, Flood Control, Forestry, and Rural Development under the Agriculture and Rural Development Department have the authority:"

c) Amend and supplement Point c of Clause 2 as follows:

"c) Confiscate goods and means of administrative violation with a value not exceeding VND 100,000,000 for individuals and VND 200,000,000 for organizations;"

d) Amending and supplementing Clause 3 as follows:

"3. The Head of the specialized inspection team at the provincial level (including: Health Department; Agriculture and Rural Development Department; Industry and Trade Department; Culture, Sports and Tourism Department, Tourism Department, Culture, Information, Sports and Tourism Department; Information and Communications Department; Food Safety Office; Plant Production and Plant Protection Office; Livestock and Animal Health Office; Aquaculture Office; Quality Management Office for Forestry, Agricultural and Aquatic Products); The Head of the specialized inspection team of the General Administration, Bureau 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: General Fisheries Administration; Animal Health Service; Plant Protection Service; Crop Service; Livestock Service; Quality Management Service for Forestry, Agricultural and Aquatic Products; Processing and Market Development Service for Agricultural Products; Food Safety Service; Radio, Television and Electronic Information Service; Press Service; Publishing, Printing and Distribution Service) have the authority to impose penalties as prescribed in Clause 2 of this Article."

đ) Amend and supplement Point c Clause 4 as follows:

“c) Confiscate contraband items and means of transportation with a value not exceeding 140,000,000 VND for individuals and 280,000,000 VND for organizations;”

e) Amend and supplement the opening sentence of Clause 5 as follows:

“5. The Director of the Ministry of Health Inspectorate; the Director of the Ministry of Agriculture and Rural Development Inspectorate; the Director of the Ministry of Industry and Trade Inspectorate; the Director of the Ministry of Culture, Sports and Tourism Inspectorate; the Director of the Ministry of Information and Communications Inspectorate; the General Director of the Fisheries General Department; the Director of the Animal Health Department; the Director of the Plant Protection Department; the Director of the Crop Production Department; the Director of the Livestock Production Department; the Director of the Quality Control Department for Forestry, Agriculture and Aquatic Products; the Director of the Agricultural Product Processing and Market Development Department; the Director of the Food Safety Department; the Director of the Radio, Television and Electronic Information Department; the Director of the Press Department; the Director of the Publishing, Printing and Distribution Department have the following powers:”

g) Amend and supplement Point c Clause 5 as follows:

"c) Confiscate goods and means of administrative violation;"

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

a) Amend and supplement the opening part of Clause 2 as follows:

“2. The Station Chief, Team Leader of the persons specified in Clause 1 of this Article have the following powers:”

b) Amend and supplement the opening sentence of Clause 3 as follows:

“3. The Chief of Police at the commune level; the Chief of Police Station; the Chief of Border Gate Police Station; the Chief of Industrial Zone Police Station; the Chief of International Airport Border Gate Police Station; the Commander of Water Police Team have the following powers:”

c) Amend and supplement Point b Clause 3 as follows:

“b) Confiscate contraband items and means of transportation with a value not exceeding 5,000,000 VND for individuals and 10,000,000 VND for organizations;”

d) Amend and supplement the opening sentence of Clause 4 as follows:

“4. The Chief of Police at the district level; the Head of the Internal Political Security Department's functional units; the Head of the Functional Units under the Administrative Management Department for Social Order; the Head of the Traffic Police Department's functional units; the Head of the Cybersecurity and High-Tech Crime Prevention Department's functional units; the Provincial Police Department Heads including the Head of the Internal Political Security Department; the Head of the Economic Crime Investigation Department; the Head of the Traffic Police Department; the Head of the Road Traffic Police Department; the Head of the Waterway Police Department; the Head of the Environmental Crime Prevention Department; the Head of the Cybersecurity and High-Tech Crime Prevention Department; the Head of the Economic Security Department have the following powers:"

đ) Amend and supplement Point a Clause 4 as follows:

“a) Fine up to 20,000,000 VND for individuals and up to 40,000,000 VND for organizations;”

e) Amend and supplement Point c Clause 4 as follows:

“c) Confiscate contraband items and means of transportation with a value not exceeding 40,000,000 VND for individuals and 80,000,000 VND for organizations;"

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

“c) Confiscate contraband items and means of transportation;”

h) Amend and supplement the opening sentence of Clause 6 as follows:

“6. The Director of the Internal Political Security Department; the Director of the Economic Security Department; the Director of the Administrative Management Department for Social Order; the Director of the Social Order Crime Investigation Department; the Director of the Corruption, Economy and Smuggling Crime Investigation Department; the Director of the Traffic Police Department; the Director of the Environmental Crime Prevention Department; the Director of the Cybersecurity and High-Tech Crime Prevention Department; the Director of the Internal Security Department have the following powers:”

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

a) Supplement Clause 2a after Clause 2 as follows:

“2a. The Team Leader of the Special Task Force against Drugs and Crime under the Special Task Force against Drugs and Crime has the following powers:

a) Fine up to 10,000,000 VND for individuals and 20,000,000 VND for organizations;

b) Confiscate contraband items and means of transportation with a value not exceeding 20,000,000 VND for individuals and 40,000,000 VND for organizations;

c) Apply remedial measures prescribed in Point b Clause 3 Article 2 of this Decree.”

b) Amend and supplement the opening sentence of Clause 3 as follows:

“3. The Commander of Border Guard Post; the Commander of Border Guard Squadron; the Commander of Border Guard Command at Port have the following powers:”

c) Amend and supplement Points b and c Clause 3 as follows:

“b) Confiscate contraband items and means of transportation with a value not exceeding 50,000,000 VND for individuals and 100,000,000 VND for organizations;

c) Apply remedial measures prescribed in Points a, b, d, đ, e, i and l Clause 3 Article 2 of this Decree.”

d) Supplement Clause 3a after Clause 3 as follows:

“3a. The Commander of the Special Task Force against Drugs and Crime under the Anti-Drug and Crime Department of the Border Guard Command has the following powers:

a) Fine up to 50,000,000 VND for individuals and 100,000,000 VND for organizations;

b) Confiscate contraband items and means of transportation with a value not exceeding 100,000,000 VND for individuals and 200,000,000 VND for organizations;

c) Apply remedial measures prescribed in Points a, b, d, đ, e, i and l Clause 3 Article 2 of this Decree.”

đ) Amend and supplement the opening sentence of Clause 4 as follows:

“4. The Commander of the Border Guard Force at the provincial level; the Commander of the Border Guard Flotilla; the Director of the Anti-Drug and Crime Department of the Border Guard Command under the Border Guard Command Headquarters have the following powers:”

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

“c) Confiscate contraband items and means of transportation;

d) Apply remedial measures prescribed in Points a, b, d, đ, e, i and l Clause 3 Article 2 of this Decree.”

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

a) Amend and supplement Point b Clause 4 as follows:

“b) Confiscate contraband items and means of transportation with a value not exceeding 40,000,000 VND for individuals and 80,000,000 VND for organizations;”

b) Amend and supplement the opening clause of Clause 5 as follows:

“5. The Commander of the Coast Guard Flotilla; the Commander of the Reconnaissance Squadron, the Commander of the Special Task Force against Drug Crimes under the Coast Guard Command of Vietnam have the following powers:”

c) Amend and supplement Point b of Clause 5 as follows:

“b) Confiscate contraband items and means of transportation with a value not exceeding 60,000,000 VND for individuals and 120,000,000 VND for organizations;”

d) Amend and supplement the opening sentence of Clause 6 as follows:

“6. The Commander of the Coast Guard Region; the Director of the Operations and Law Department under the Coast Guard Command of Vietnam have the following powers:”

d) Add point a1 after point a of Clause 6 as follows:

“a1) Revoking the Food Safety Certificate, the Product Registration Acceptance Certificate for a period of time or suspending operations for a period of time;”

e) Amend and supplement point b of Clause 6 as follows:

“b) Confiscating contraband goods and means of administrative violation;”

g) Amend and supplement the opening sentence of Clause 7 as follows:

“7. The Commander of the Vietnam Coast Guard has the authority to:”

h) Amend and supplement point c of Clause 7 as follows:

“c) Confiscating contraband goods and means of administrative violation;”

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

a) Amend and supplement the opening part of Clause 2 as follows:

“2. The Head of Customs Sub-Department; the Head of Control Team under the Provincial, Inter-Provincial, or Central-City Customs Department; the Head of Post-Clearance Inspection Sub-Department have the authority to:”

b) Amend and supplement the opening sentence of Clause 3 as follows:

“3. The Head of Customs Sub-Department; the Head of Post-Clearance Inspection Sub-Department, the Head of Control Team under the Provincial, Inter-Provincial, or Central-City Customs Department; the Head of Criminal Investigation Team, the Head of Anti-Smuggling Control Team, the Head of Sea Control Squadron, and the Head of Anti-Fake Goods and Intellectual Property Protection Control Team under the Anti-Smuggling Investigation Department; the Head of Post-Clearance Inspection Sub-Department under the Post-Clearance Inspection Department have the authority to:”

c) Amend and supplement Points b and c Clause 3 as follows:

“b) Confiscate contraband items and means of transportation with a value not exceeding 50,000,000 VND for individuals and 100,000,000 VND for organizations;

c) Apply the remedial measures prescribed in points a, b, d, đ, e, h, k, l, and m of Clause 3, Article 2 of this Decree.”

d) Amend and supplement points c and d of Clause 4 as follows:

“c) Confiscate contraband items and means of transportation;

d) Applying the remedial measures prescribed in points a, b, d, đ, e, h, k, l, and m of Clause 3, Article 2 of this Decree.”

đ) Amend and supplement point c of Clause 5 as follows:

“c) Applying the remedial measures prescribed in points a, b, d, đ, e, h, k, l, and m of Clause 3, Article 2 of this Decree.”

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

a) Amend and supplement the opening part of Clause 2 as follows:

“2. The Head of Market Management Team; the Head of Business Affairs Department under the Market Management Affairs Bureau have the authority to:”

b) Amending and supplementing Point b Clause 2 as follows:

“b) Confiscating contraband goods and means of administrative violation with a value not exceeding VND 50,000,000 for individuals and VND 100,000,000 for organizations;”

c) Amend and supplement the opening sentence of Clause 3 as follows:

“3. The Head of Provincial Market Management Bureau; the Head of Market Management Affairs Bureau under the General Market Management Bureau have the authority to:”

d) Amend and supplement point b of Clause 3 as follows:

"b) Confiscating contraband goods and means of administrative violation;"

đ) Amend and supplement the opening sentence of Clause 4 as follows:

"4. The Director of the General Market Management Bureau has the authority:"

22. Amend and supplement Clause 4 and Clause 5 of Article 35 as follows:

“4. The authorized person to impose administrative penalties of the Border Guard specified in Article 31 of this Decree and the Coast Guard specified in Article 32 of this Decree have the authority to issue administrative violation records, impose administrative penalties, and apply remedial measures against administrative violations in the field of food safety related to activities of collecting, selling, supplying, and importing food as stipulated in Clause 3, Point b of Clause 4, and Clause 5 of Article 4; Articles 10 and 11; Clauses 1 and 4 of Article 19; Point a of Clause 4 of Article 20; Clause 2 of Article 21; Clause 1, Points b and c of Clause 6 of Article 22; Clause 6 of Article 26 of this Decree according to their assigned functions, tasks, and authorities.

5. The authorized person to impose administrative penalties of the customs agency specified in Article 33 of this Decree have the authority to issue administrative violation records, impose administrative penalties, and apply remedial measures against administrative violations in the field of food safety as stipulated in Article 19; Clauses 2, 3, and 4 of Article 20; Article 21; Points a and b of Clause 5, Clause 6, Clause 7, Clause 8, Clause 9 of Article 22; Clause 4 of Article 24 of this Decree if such violations are discovered within the territory under the management of customs agencies where the Government's Decree on administrative penalties in the field of customs does not provide regulations.”

Article 2. Amending and supplementing some articles of Decree No. 117/2020/NĐ-CP dated September 28, 2020 of the Government on administrative penalties in the field of health

1. Amending and supplementing Clause 4 of Article 1 as follows:

"4. When discovering violations as stipulated 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, đ, e, g and h Clause 2 Article 85; points d, đ, e, g, h and i Clause 2 Article 86 of this Decree or cases of recidivism for violations as stipulated 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, if based on the nature and degree of the violation it is deemed to have signs of criminal offenses according to the corresponding provisions in the Penal Code, the authority currently handling the case shall transfer the case file to the competent authority for criminal proceedings according to the provisions of Clauses 1, 2 and 4 Article 62 of the Law on Handling Administrative Violations. In case the competent authority for criminal proceedings decides not to initiate a criminal case according to the laws on criminal procedure, that authority shall return the case file to the authority which transferred the file according to Clause 3 Article 62 of the Law on Handling Administrative Violations to impose administrative penalties according to this Decree.”

2. Amending and supplementing Point đ Clause 2 of Article 2 as follows:

“đ) Public service units;”

3. Amending and supplementing some clauses of Article 3 as follows:

a) Amending and supplementing Point s Clause 3 as follows:

“s) Compelling the submission of the professional practice certificate; medical examination and treatment license; medical equipment import permit; pharmaceutical business qualification certificate; free circulation certificate for domestically produced medical equipment; drug registration certificate; cosmetic product declaration number; declaration receipt; drug registration certificate; free circulation certificate for medical equipment category C, D to the competent state authority.”

b) Add Clause 4 after Clause 3 as follows:

“4. The implementation of administrative penalty measures and remedial actions must ensure the following requirements:

a) In cases where the supplementary administrative penalty measure is suspension of operation for a period, the person authorized to issue the administrative violation decision shall be responsible for sending a notification letter to the competent state agency for coordination in monitoring, inspection, and reporting when the enforcement period ends;

b) In case the remedial measure is compelling the submission of licenses and certificates to the competent state authority, the authority imposing the administrative penalty shall be responsible for sending a notification letter to the authority issuing or receiving such licenses and certificates for their revocation.

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

4. Amending and supplementing Clause 6 of Article 4 as follows:

"6. The fine-imposing authority of the positions specified in Chapter III of this Decree is the authority to impose fines on individual administrative violations, and the authority to impose fines on organizations is twice the amount of fines imposed on individuals."

5. Amending and supplementing some clauses of Article 12 as follows:

a) Amend and supplement point a, Clause 1 as follows:

"a) Failing to implement personal protection measures for those participating in disease control and those at risk of contracting diseases as guided by health authorities, including: wearing masks, disinfection, maintaining social distance, health declaration, and other measures;"

b) Amend and supplement Point c Clause 2 as follows:

"c) Refusing to participate in disease control as decided by the authorized authority, except in cases stipulated at point m Clause 5 Article 38 and point b Clause 4 Article 39 of this Decree;"

c) Amending and supplementing Point a Clause 4 as follows:

"a) Failing to comply with inspection, supervision, and medical handling decisions when entering and leaving areas with group A diseases;"

d) Amending and supplementing Point b Clause 5 as follows:

"b) Failing to comply with decisions prohibiting gatherings in areas declared under emergency due to disease according to resolutions, decisions, directives, and other documents of the authorized authority;"

6. Amending and supplementing Point e Clause 3 of Article 20 as follows:

"e) Conducting HIV tests on individuals under 15 years old, persons without civil capacity, persons with difficulty in understanding and controlling their behavior, and persons with limited civil capacity without written consent from their parents or legal guardians, or representatives, except in cases of emergency as provided by laws on medical examination and treatment."

7. Amending and supplementing the opening paragraph of Article 32 as follows:

"A fine of VND 20,000,000 to VND 30,000,000 shall be imposed for any of the following acts:"

8. Amending and supplementing some clauses of Article 38 as follows:

a) Amending and supplementing Point a Clause 4 as follows:

"a) A practitioner registering to practice simultaneously at different healthcare facilities; a practitioner performing practice outside the registered time approved by the competent authority or practicing contrary to the dispatch and assignment of the competent authority as prescribed by law;"

b) Supplementing Point đ after Point d Clause 4 as follows:

"đ) A practitioner failing to register to practice medical examination and treatment as prescribed by law;"

c) Supplementing Point m after Point l Clause 5 as follows:

"m) A practitioner refusing to comply with mobilization decisions of state authorities during natural disasters, catastrophes, and dangerous epidemics;"

d) Amending and supplementing Point a Clause 8 as follows:

"a) Revoking the right to use the medical examination and treatment practice certificate for a period of one to three months for violations stipulated at Points b, c, d, đ, e, g, h, i, k, l, and m Clause 5 of this Article;"

9. Amending and supplementing some clauses of Article 39 as follows:

a) Supplement Clause 2a after Clause 2 as follows:

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

a) Charging more than the publicly displayed price for medical examination and treatment services;

b) Charging more than the cost covered by health insurance, except where the excess charge is due to additional services requested by patients or exceeds the scope of health insurance coverage.”

b) Amend and supplement Point a Clause 7 as follows:

"a) Revoking the right to use the business license for medical examination and treatment for a period of from two months to four months for the acts specified in point đ clause 2, point b clause 3, clause 4, point c clause 5, and points b, c, d, e clause 6 of this Article;"

10. Supplement point đ following point d clause 1 Article 40 as follows:

”đ) Failing to establish or establish medical examination and treatment records but not recording fully as prescribed by law."

11. Supplement Article 48a following Article 48 as follows:

"Article 48a. Violations of clinical pharmacy activities regulations of medical examination and treatment facilities

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

a) Failing to allocate sufficient number of personnel for clinical pharmacy work according to the prescribed timeline by law;

b) Failing to allocate personnel who meet the conditions stipulated by law for clinical pharmacy work.

2. Imposing a fine of VND 5,000,000 to VND 10,000,000 for the act of allocating personnel responsible for clinical pharmacy work without a practice certificate or during the period when such certificate has been revoked or suspended.

3. Imposing a fine of VND 10,000,000 to VND 20,000,000 for the act of failing to organize clinical pharmacy activities according to the prescribed timeline by law."

12. Amend and supplement point đ clause 2 Article 51 as follows:

"đ) Permitting production and business establishments to give samples or gifts related to breast milk substitutes in healthcare facilities;"

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

a) Amending and supplementing Point b Clause 1 as follows:

"b) Failing to notify the competent state agency of minor changes that require prior notification before drug circulation;"

b) Amend and supplement points c and d clause 3 as follows:

”c) Failing to register changes or supplements to the drug circulation registration with the competent state agency and obtain approval before circulating drugs or drug materials for major changes or minor changes requiring approval;

d) Producing and circulating drugs or drug materials that have changed compared to the approved drug registration dossier where such changes require circulation registration according to law;"

b) Documents handling illegal legal normative documents issued by the competent agency or person authorized to issue;

"6. In cases where there are two or more drugs or drug materials belonging to the same violation act as stipulated in clauses 1, 2, 3, 4 of this Article and discovered in one inspection or check, impose punishment for one act and apply aggravating circumstances."

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

a) Supplement point d following point c clause 1 as follows:

"d) Failing to store drug samples and drug material samples for testing according to the provisions of law;"

b) Amend and supplement points a, b, and c clause 2 as follows:

"a) Producing drugs or drug materials with minor changes compared to the approved drug registration dossier that require notification to the competent authority according to law but fail to notify, except as provided in point b clause 1 of this Decree;

b) Producing drugs or drug materials with minor changes compared to the approved drug registration dossier but not yet approved by the competent authority according to law, except as provided in point c clause 3 of this Decree;

c) Failing to retain finished product samples for at least twelve months after their expiration date or failing to retain raw material samples for at least twelve months after the expiration date of the products made from them;"

c) Amend and supplement Point d of Clause 3 as follows:

"đ) Producing drugs or drug materials with significant changes compared to the approved drug registration dossier but not yet approved according to law, except as provided in point c clause 3 of this Decree;"

d) Supplement point i following point h clause 4 as follows:

“i) Producing drugs from active pharmaceutical ingredients produced by manufacturing facilities without documentation proving compliance with good manufacturing practices for drug materials according to law or facilities not meeting good manufacturing practices for drug materials as notified by the competent authority.”

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

a) Amend and supplement Point a Clause 2 as follows:

"a) Buying, selling drug samples, testing samples, research samples, or samples for exhibitions or fairs; buying, selling imported drug materials for export production without complying with regulations;"

b) Amend and supplement Point b of Clause 3 as follows:

“b) Failing to submit periodic evaluation applications for maintaining good distribution practices for drugs according to law;”

c) Amend and supplement points d and đ clause 3 as follows:

“d) Failing to establish a mechanism for transferring information or transferring incomplete information about drug distribution and quality between manufacturers and customers, or failing to transfer information to relevant management agencies upon request;

đ) The competent authority concludes that the facility maintains good distribution practices for drugs and drug materials at level 3.”

d) Amend and supplement clause 9 as follows:

"9. Measures to remedy consequences:

Compelling the destruction of all drugs and drug materials for the acts specified in point b clause 4 and clause 6 of this Article."

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

a) Amending and supplementing point b Clause 2 as follows:

”b) Failing to establish a separate area for non-drug products or failing to display a sign indicating "this product is not a drug" in a separate area for non-drug products when also selling cosmetics, health foods, or medical devices according to law;"

b) Amend and supplement points đ and e clause 3 as follows:

“đ) Selling retail vaccines;

e) Failing to submit periodic evaluation applications for maintaining good retail pharmacy practices according to law;"

c) Amend and supplement points h and i clause 3 as follows:

"h) Failing to transfer information or transferring incomplete information about drug purchases and sales and quality between suppliers and customers as required by law, except for retail herbal medicine stores;

i) The competent authority concludes that the facility does not meet good retail pharmacy practices standards."

d) Supplement point g following point e clause 4 as follows:

“g) Selling prescription drugs without a prescription.”

đ) Amend and supplement point c clause 9 as follows:

"c) Order the complete destruction of all quantities of drugs and medicinal materials for the acts specified in Clause 6 of this Article."

e) Supplement Clause 10 following Clause 9 as follows:

"10. In cases where there are two or more drugs or drug ingredients violating the provisions at Point g, Clause 4 of this Article and discovered in one inspection or check, impose punishment for one act and apply aggravating circumstances."

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

a) Supplement Points c and d following Point b, Clause 1 as follows:

"c) Not conducting sample retention of finished drugs for at least 12 months after the expiration date of the drug;"

d) Not conducting sample retention of active ingredients used to produce drugs for at least 12 months after the expiration date of the finished product produced from such raw material."

b) Amend and supplement Point b of Clause 3 as follows:

"b) The competent authority concludes that the facility maintains compliance with good storage practice principles and standards at level 3;"

c) Supplement Point đ following Point d, Clause 5 as follows:

"đ) Importing drugs and drug ingredients from suppliers not included in the categories of suppliers permitted under the law;"

d) Amend and supplement Point đ of Clause 6 as follows:

"đ) Impose a fine of VND 15,000,000 to VND 20,000,000 on goods valued from VND 20,000,000 to less than VND 30,000,000;"

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

a) Amend and supplement point d of Clause 2 as follows:

"d) Retail pharmacies within healthcare facilities sell drugs at a retail mark-up higher than the maximum allowed by law;"

b) Supplement Clause 6 following Clause 5 as follows:

"6. In cases where there are two or more drugs or drug ingredients involved in the same violation under Clauses 1, 2, 3, and 4 of this Article and discovered in one inspection or check, impose punishment for one act and apply aggravating circumstances."

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

a) Amend and supplement Clause 2 as follows:

"2. Impose a fine of VND 20,000,000 to VND 30,000,000 on the act of circulating cosmetics before obtaining a registration number for cosmetic product notification from the competent state agency or after the registration number has expired without re-notification as required by law;"

b) Supplement Clause 6 following Clause 5 as follows:

"6. In cases where there are two or more cosmetics involved in the same violation under Clauses 1, 2, and 3 of this Article and discovered in one inspection or check, impose punishment for one act and apply aggravating circumstances."

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

a) Amending and supplementing Point a Clause 4 as follows:

"a) Order the recall and destruction of all cosmetic products for the acts specified in Clauses 1 and 2 of this Article. If the cosmetic product does not meet the packaging volume standard specified in Point d, Clause 1 of this Article, destruction shall not be ordered;"

b) Supplement clause 5 after clause 4 as follows:

"5. In cases where there are two or more cosmetics involved in the same violation under Clauses 1 and 2 of this Article and discovered in one inspection or check, impose punishment for one act and apply aggravating circumstances."

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

a) Supplement Point đ following Point d, Clause 2 as follows:

"đ) Selling cosmetics with Product Information File (PIF) but not in accordance with the provisions of the law;"

b) Amend and supplement Point b of Clause 3 as follows:

"b) Selling cosmetics without or failing to present the Product Information File (PIF) when requested by the competent authority;"

c) Supplement Clause 5 after Clause 4 as follows:

"5. In cases where there are two or more cosmetics involved in the same violation under Clauses 1, 2, and 3 of this Article and discovered in one inspection or check, impose punishment for one act and apply aggravating circumstances."

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

a) Amend and supplement Clause 1 as follows:

"1. Impose a fine of VND 5,000,000 to VND 10,000,000 on the act of the owner of the circulation number of medical devices not publicly announcing the classification results of medical devices issued according to the law;"

b) Amend and supplement Points d, đ, and e, Clause 2 as follows:

"d) Failure to report in writing to the customs authority where clearance was performed and the authority issuing the circulation number for medical devices that have been issued a circulation number and used a revoked classification result and completed customs clearance procedures but not yet sold;"

đ) The report to the customs authority does not specify the quantity of medical devices cleared for customs when medical devices have been issued a circulation number and used a revoked classification result and completed customs clearance procedures but not yet sold;"

e) The report to the authority issuing the circulation number does not clearly specify the quantity of medical devices cleared for customs and purchase-sale contracts (if any) when medical devices have been issued a circulation number and used a revoked classification result and completed customs clearance procedures but not yet sold;"

c) Amend and supplement Point b Clause 3 as follows:

"b) The owner of the circulation number does not stop the circulation of medical devices; does not take measures to recall medical devices with a circulation number whose filing documents used a revoked classification result and completed customs clearance procedures but not yet sold;"

d) Amend and supplement Point a Clause 5 as follows:

"a) Suspend operations for a period of one to three months for the act specified in Point a, Clause 2 of this Article;"

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

a) Amend and supplement Clause 1 as follows:

"1. Impose a fine of VND 5,000,000 to VND 10,000,000 on the act of not establishing a notification document with relevant documents regarding changes or not updating changed documents into the publicly disclosed filing on the Medical Device Management Portal as required by law when there is a change related to previous filings;"

b) Amending and supplementing Point b Clause 2 as follows:

"b) Producing medical devices without meeting the ISO 13485 quality management system standard;"

c) Amending and supplementing Point c Clause 3 as follows:

"c) Producing medical devices without completing the filing procedure for production conditions as required by law;"

d) Amending and supplementing Clause 4 as follows:

"4. Additional forms of punishment:"

Suspend operations for a period of from one to three months for the acts specified in Clause 1, Point b Clause 2 and Point a Clause 3 of this Article.

d) Amend and supplement Point a Clause 5 as follows:

"a) Order the return of the receipt for the submission of the application for registration of medical devices that meet the conditions as specified in Point a Clause 2 and Point a Clause 3 of this Article;"

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

a) Amend and supplement point a, Clause 1 as follows:

"a) Circulate medical devices on the market without complete labeling as required by law;"

b) Amend and supplement Point d of Clause 1 as follows:

"d) Fail to notify the competent state authority or update changed documents into the publicly disclosed registration dossier within the prescribed time when there are changes as stipulated by law during the circulation of medical devices;"

c) Amend and supplement Point g Clause 1 as follows:

"g) Circulate medical devices on the market where the production facility has not been granted a certificate of compliance with ISO 13485 quality management standards and has not been circulated in any country worldwide for imported medical devices;"

d) Amend and supplement Point a Clause 2 as follows:

"a) Fail to re-declare applicable standards for medical devices classified as types A and B as required by law;"

đ) Sửa đổi, bổ sung điểm g khoản 2 như sau:

"g) Fail to report to the Public Security Authority when discovering the loss of medical devices containing narcotics and precursors, raw materials for producing medical devices containing narcotics and precursors;"

e) Amend and supplement Point l Clause 2 as follows:

"l) Fail to maintain the validity of the circulation permit, authorization letter, and confirmation of warranty conditions during the validity period of the circulation permit as stipulated by law."

g) Amend and supplement Points b, c, d and đ Clause 3 as follows:

"b) Alter or erase the content of the receipt for the declaration of applicable standards for medical devices classified as types A and B;

c) Alter or erase the content of the registration certificate for medical devices classified as types C and D;

d) Documents in the declaration dossier for medical devices classified as types A and B do not comply with the legality requirements as stipulated by law;

đ) Documents in the application dossier for issuance or reissuance of the registration certificate for medical devices classified as types C and D do not comply with the legality requirements as stipulated by law.”

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

"a) Circulate medical devices classified as types A and B on the market without a receipt for the declaration of applicable standards or without an import permit;

b) Circulate medical devices classified as types C and D on the market without a registration certificate number or without an import permit;"

i) Amend and supplement Point a Clause 5 as follows:

"a) Confiscate the administrative violation evidence, which includes receipts, certificates, documents, and dossiers, for the acts specified in Points d and đ Clause 3 of this Article;"

k) Amend and supplement Point b Clause 6 as follows:

"b) Order the return of the receipt for the declaration of applicable standards for medical devices classified as types A and B or the circulation certificate for medical devices classified as types C and D for the acts specified in Points b, c, d and đ Clause 3 of this Article."

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

a) Amend and supplement Clause 1 as follows:

“1. Impose a fine of from VND 3,000,000 to VND 5,000,000 for the act of failing to establish a notification document regarding changes along with related documents or failing to update the changed documents into the publicly disclosed declaration dossier on the medical device management portal within the prescribed time when there are changes related to the previous declaration dossier.”

b) Amending and supplementing Point b Clause 2 as follows:

"b) Provide consultancy on medical devices before the Ministry of Health publicly discloses information and the declaration dossier of medical devices meeting the consulting technical conditions;"

26. Add Article 78a after Article 78 as follows:

"Article 78a. Violations concerning medical equipment price management regulations

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

a) Not publishing information on price declaration on the Ministry of Health's portal before the first circulation of medical equipment on the Vietnamese market;

b) Declaring prices without providing all required information components as stipulated by law;

c) Not updating declared prices of medical equipment when there are changes;

d) Not explaining the factors constituting the price when requested by competent authorities;

đ) Declaring prices of medical equipment when not being the owner of the medical equipment serial number or not being designated by the owner of the medical equipment serial number to declare prices;

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

a) Not declaring prices of medical equipment before circulation in Vietnam;

e) Trading medical equipment without declared prices or trading at prices higher than those declared on the Ministry of Health's electronic portal at the time of purchase or sale."

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

a) Amend and supplement Point c Clause 1 as follows:

“c) Confiscate the objects and means of administrative violations with a value not exceeding VND 6,000,000 for administrative violations related to population; VND 10,000,000 for administrative violations related to preventive healthcare, HIV/AIDS prevention and control, health insurance, medical examination and treatment, pharmaceuticals, cosmetics, and medical equipment;"

b) Amending and supplementing Point d Clause 2 as follows:

"d) Confiscate the objects and means of administrative violations;"

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

a) Amend and supplement Point c Clause 1 as follows:

“c) Confiscate the objects and means of administrative violations with a value not exceeding VND 600,000 for administrative violations related to population; VND 1,000,000 for administrative violations related to preventive healthcare and HIV/AIDS prevention and control, health insurance, medical examination and treatment, pharmaceuticals, cosmetics, and medical equipment;"

b) Amend and supplement the opening paragraph of Clause 2 as follows:

"2. The Chief Inspector of the Departments, the Heads of the Population and Family Planning Sub-Councils under the Department of Health, the Heads of specialized inspection teams at the provincial level, and the Heads of specialized inspection teams of authorized state agencies have the right:"

c) Amend and supplement Point d of Clause 2 as follows:

"d) Confiscate the objects and means of administrative violations with a value not exceeding VND 30,000,000 for administrative violations related to population; VND 50,000,000 for administrative violations related to preventive healthcare and HIV/AIDS prevention and control; VND 75,000,000 for administrative violations related to health insurance; VND 100,000,000 for administrative violations related to medical examination and treatment, pharmaceuticals, cosmetics, and medical equipment;"

d) Amend and supplement the beginning of Clause 3 as follows:

"3. The Chief Inspector of the Ministry; the Director of the General Bureau of Population and Family Planning; the Director of the Drug Administration; the Director of the Medical Examination and Treatment Management; the Director of the Environmental Health Management; the Director of the Preventive Healthcare Management have the right:"

đ) Amend and supplement Point d of Clause 4 as follows:

"d) Confiscate the objects and means of administrative violations with a value not exceeding VND 42,000,000 for administrative violations related to population; VND 70,000,000 for administrative violations related to preventive healthcare and HIV/AIDS prevention and control; VND 105,000,000 for administrative violations related to health insurance; VND 140,000,000 for administrative violations related to medical examination and treatment, pharmaceuticals, cosmetics, and medical equipment;"

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

a) Amend and supplement the opening part of Clause 2 as follows:

"2. The Head of Market Management Teams, the Heads of Business Departments under the Business Management Department have the right:"

b) Amend and supplement Point c Clause 2 as follows:

“c) Confiscate the objects and means of administrative violations with a value not exceeding VND 50,000,000 for administrative violations related to population, preventive healthcare, medical examination and treatment, pharmaceuticals, cosmetics, and medical equipment;"

c) Amend and supplement the opening sentence of Clause 3 as follows:

“3. The Head of Provincial Market Management Bureau; the Head of Market Management Affairs Bureau under the General Market Management Bureau have the authority to:”

d) Amend and supplement Point c of Clause 3 as follows:

"c) Confiscate goods and means of administrative violation;"

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

a) Amend and supplement the opening part of Clause 2 as follows:

"2. The Heads of Stations, Team Leaders of persons specified in Clause 1 of this Article have the right:"

b) Amend and supplement the opening sentence of Clause 3 as follows:

"3. The Heads of Public Security Villages; the Heads of Public Security Posts; the Heads of Public Security Stations at border gates, export processing zones; the Heads of Public Security Stations at international airport ports; the Waterway Commanders have the right:"

c) Amending and supplementing Point c Clause 3 as follows:

“c) Confiscate the objects and means of administrative violations with a value not exceeding VND 3,000,000 for administrative violations related to population and up to VND 5,000,000 for administrative violations related to preventive healthcare, HIV/AIDS prevention and control, health insurance, medical examination and treatment, pharmaceuticals, cosmetics, and medical equipment;"

d) Amend and supplement the opening sentence of Clause 4 as follows:

“4. The Heads of Public Security Districts; the Heads of Departments under the Political Security Investigation Bureau; the Heads of Departments under the Administrative Management Police Bureau; the Heads of Departments under the Traffic Police Bureau; the Heads of Provincial Public Security Departments, including: the Heads of Economic Security Departments; the Heads of Political Security Departments; the Heads of Administrative Management Police Departments; the Heads of Environmental Crime Prevention and Control Departments; the Heads of Traffic Police Departments; the Heads of Road Traffic Police Departments; the Heads of Road Traffic Police Departments; the Heads of Waterway Police Departments; the Heads of Corruption, Economic Crime, and Smuggling Investigation Departments; the Waterway Commanders have the right:"

đ) Amend and supplement Point d of Clause 4 as follows:

"d) Confiscate the objects and means of administrative violations with a value not exceeding VND 12,000,000 for administrative violations related to population; VND 20,000,000 for administrative violations related to preventive healthcare and HIV/AIDS prevention and control; VND 30,000,000 for administrative violations related to health insurance; VND 40,000,000 for administrative violations related to medical examination and treatment, pharmaceuticals, cosmetics, and medical equipment;"

e) Amend and supplement Point d of Clause 5 as follows:

"d) Confiscate the objects and means of administrative violations;"

g) Amend and supplement the beginning of Clause 6 as follows:

“6. The Directors of the Political Security Investigation Bureau; the Directors of the Administrative Management Police Bureau; the Directors of the Social Order Crime Investigation Bureau; the Directors of the Economic Security Bureau; the Directors of the Environmental Crime Prevention and Control Bureau; the Directors of the Traffic Police Bureau; the Directors of the Corruption, Economic Crime, and Smuggling Investigation Bureau have the right:"

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

a) Amend and supplement the opening part of Clause 2 as follows:

"2. The Head of the Customs Team, the Head of the Inspection Group under the Customs Branch; the Head of the Control Group under the Provincial, Interprovincial, or Central City Customs Bureau; the Head of the Post-Clearance Inspection Branch have the authority:"

b) Amend and supplement the opening sentence of Clause 3 as follows:

"3. The Head of the Customs Branch; the Head of the Post-Clearance Inspection Branch, the Head of the Control Group under the Provincial, Interprovincial, or Central City Customs Bureau; the Head of the Criminal Investigation Group, the Head of the Anti-Smuggling Control Group, the Head of the Maritime Control Squadron, and the Head of the Anti-Fake Goods and Intellectual Property Protection Control Group under the Anti-Smuggling Investigation Bureau; the Head of the Post-Clearance Inspection Branch under the Post-Clearance Inspection Bureau have the authority:"

c) Amending and supplementing Point c Clause 3 as follows:

"c) To confiscate contraband items and means of transportation with a value not exceeding 50,000,000 VND for administrative violations related to preventive healthcare, HIV/AIDS prevention, pharmaceuticals, cosmetics, and medical equipment;"

d) Amend and supplement point d of Clause 4 as follows:

"d) To confiscate contraband items and means of transportation;"

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

a) Supplement Clause 2a after Clause 2 as follows:

"2a. The Head of the Special Task Force against Drugs and Crime under the Special Task Force against Drugs and Crime has the authority:

a) To issue warnings;

b) To impose fines up to 3,000,000 VND for administrative violations related to population; up to 5,000,000 VND for administrative violations related to preventive healthcare and HIV/AIDS prevention; up to 10,000,000 VND for administrative violations related to medical examination and treatment, pharmaceuticals, cosmetics, and medical equipment;

c) To confiscate contraband items and means of transportation with a value not exceeding 6,000,000 VND for administrative violations related to population; 10,000,000 VND for administrative violations related to preventive healthcare and HIV/AIDS prevention; 20,000,000 VND for administrative violations related to medical examination and treatment, pharmaceuticals, cosmetics, and medical equipment;

d) To apply remedial measures prescribed at points c and đ of Clause 1, Article 28 of the Law on Handling Administrative Violations;"

b) Amend and supplement the opening sentence of Clause 3 as follows:

"3. The Commander of the Border Guard Post; the Commander of the Border Guard Squadron; the Chief of the Border Guard Command at the Port have the authority:"

c) Amend and supplement points c and d of Clause 3 as follows:

“c) To confiscate contraband items and means of transportation with a value not exceeding 12,000,000 VND for administrative violations related to population; 20,000,000 VND for administrative violations related to preventive healthcare and HIV/AIDS prevention; 40,000,000 VND for administrative violations related to medical examination and treatment, pharmaceuticals, cosmetics, and medical equipment;

d) To apply remedial measures prescribed at points c, d, and đ of Clause 1, Article 28 of the Law on Handling Administrative Violations and Clause 3, Article 3 of this Decree;"

d) Supplement Clause 3a after Clause 3 as follows:

"3a. The Head of the Special Task Force against Drugs and Crime under the Drug Prevention and Crime Suppression Department of the Border Guard Command has the authority:

a) To issue warnings;

b) To impose fines up to 15,000,000 VND for administrative violations related to population; up to 25,000,000 VND for administrative violations related to preventive healthcare and HIV/AIDS prevention; up to 50,000,000 VND for administrative violations related to medical examination and treatment, pharmaceuticals, cosmetics, and medical equipment;

c) To confiscate contraband items and means of transportation with a value not exceeding 30,000,000 VND for administrative violations related to population; 50,000,000 VND for administrative violations related to preventive healthcare and HIV/AIDS prevention; 100,000,000 VND for administrative violations related to medical examination and treatment, pharmaceuticals, cosmetics, and medical equipment;

d) To apply remedial measures prescribed at points c, d, đ, and i of Clause 1, Article 28 of the Law on Handling Administrative Violations and Clause 3, Article 3 of this Decree.”

đ) Amend and supplement the opening sentence of Clause 4 as follows:

“4. The Commander of the Border Guard Force at the provincial level, the Commander of the Border Guard Flotilla, the Director of the Drug Prevention and Crime Suppression Department of the Border Guard Command have the authority:"

e) Amend and supplement point đ of Clause 4 as follows:

“đ) To apply remedial measures prescribed at points c, d, đ, and i of Clause 1, Article 28 of the Law on Handling Administrative Violations and Clause 3, Article 3 of this Decree."

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

a) Amend and supplement Point c Clause 4 as follows:

“c) To confiscate contraband items and means of transportation with a value not exceeding 12,000,000 VND for administrative violations related to population; 20,000,000 VND for administrative violations related to preventive healthcare and HIV/AIDS prevention; 40,000,000 VND for administrative violations related to medical examination and treatment, pharmaceuticals, cosmetics, and medical equipment;"

b) Amend and supplement the opening clause of Clause 5 as follows:

“5. The Commander of the Coast Guard Flotilla, the Head of the Reconnaissance Unit, the Head of the Special Task Force against Drug Crimes under the Vietnam Coast Guard Command have the authority:"

"c) Amend and supplement Point c of Clause 5 as follows:"

“c) To confiscate contraband items and means of transportation with a value not exceeding 18,000,000 VND for administrative violations related to population; 30,000,000 VND for administrative violations related to preventive healthcare and HIV/AIDS prevention; 60,000,000 VND for administrative violations related to medical examination and treatment, pharmaceuticals, cosmetics, and medical equipment;"

d) Amend and supplement the opening sentence of Clause 6 as follows:

“6. The Commander of the Coast Guard Zone, the Director of the Operations and Legal Affairs Department under the Vietnam Coast Guard Command have the authority:"

đ) Supplement point b1 after point b of Clause 6 as follows:

“b1) To suspend the use of licenses and professional certificates for a limited period;"

e) Amend and supplement point c of Clause 6 as follows:

"c) Confiscate goods and means of administrative violation;"

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

a) Amend and supplement points c and d of Clause 3 as follows:

“c) To confiscate contraband items and means of transportation with a value not exceeding 50,000,000 VND for administrative violations related to preventive healthcare and HIV/AIDS prevention;

d) To apply remedial measures prescribed at point i of Clause 1, Article 28 of the Law on Handling Administrative Violations and Clause 3, Article 3 of this Decree.”

b) Amend and supplement points c and d of Clause 4 as follows:

“c) Confiscate contraband items and means of transportation;

d) To apply remedial measures prescribed at point i of Clause 1, Article 28 of the Law on Handling Administrative Violations and Clause 3, Article 3 of this Decree.”

c) Amend and supplement Point d Clause 5 as follows:

“d) To apply remedial measures prescribed at point i of Clause 1, Article 28 of the Law on Handling Administrative Violations and Clause 3, Article 3 of this Decree.”

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

a) Amending and supplementing Point b Clause 1 as follows:

"b) To impose fines up to 37,500,000 VND for administrative violations related to health insurance contributions;"

b) Amend and supplement Point d of Clause 1 as follows:

"d) Confiscate the objects, means of transport involved in administrative violations with a value not exceeding 75,000,000 VND for administrative violations related to health insurance contributions;"

c) Amend and supplement Point b Clause 2 as follows:

"b) Impose a fine up to 75,000,000 VND for administrative violations related to health insurance contributions;"

d) Amend and supplement point b of Clause 3 as follows:

"b) Impose a fine up to 52,500,000 VND for administrative violations related to health insurance contributions;"

d) Amend and supplement point d clause 3 as follows:

"d) Confiscate the objects, means of transport involved in administrative violations with a value not exceeding 105,000,000 VND for administrative violations related to health insurance contributions;"

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

a) Amending and supplementing Clause 5 as follows:

"5. The authorized authority to impose fines of the Customs Department has the authority to issue administrative violation reports, impose administrative penalties, and apply measures to mitigate consequences within its scope of management, functions, tasks, and powers assigned and according to the authority prescribed in Article 107 of this Decree for violations stipulated in Articles 7, 11, 12, 13, 14, 25, 26, 27, 29, 30, 31, 32, 33, 34, 35, 36, 37, 60, 64, 71, 76; Clause 1 and Clause 2 of Article 6; Point b Clause 1 of Article 54; Clause 6 and Clause 7 of Article 58; Clause 6 and Clause 7 of Article 59; Point b Clause 1, Clause 2 of Article 65; Points d and d Clause 2 of Article 72; Points a and b Clause 4 of Article 74 and Point c Clause 2 of Article 75 of this Decree."

b) Amend and supplement Clause 7 as follows:

"7. The authorized authority to impose fines of the Coast Guard has the authority to issue administrative violation reports, impose administrative penalties, and apply measures to mitigate consequences within its scope of management, functions, tasks, and powers assigned and according to the authority prescribed in Article 109 of this Decree for violations stipulated 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 of Article 8; Point b Clause 3 of Article 9; Points a and b Clause 3 of Article 16; Point g Clause 2, Clause 3 of Article 23; Clauses 1, 2, 3, Points a, b, c, g Clause 4, Point a Clause 5 of Article 29; Clauses 1, 3, 5, 6 and 7 of Article 38; Point b Clause 4 of Article 39; Clause 4 of Article 40; Point b Clause 1 of Article 45; Point b Clause 3 of Article 48; Point b Clause 1 of Article 52; Clause 1, Point b Clause 2, Points a and b Clause 3 of Article 64; Clause 2 of Article 68; Clause 1 of Article 74; Clause 2 of Article 78 and Points a and b Clause 1, Clause 2 of Article 95 of this Decree."

c) Amend and supplement Clause 11 as follows:

"11. The authorized authority to impose fines of the Inspection Department under the Ministry of Culture, Sports and Tourism has the authority to issue administrative violation reports, impose administrative penalties, and apply measures to mitigate consequences within its scope of management, functions, tasks, and powers assigned and according to the authority prescribed in Article 104 of this Decree for violations stipulated 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 of Article 12; Clause 2 of Article 14; Clauses 1, 2, 3, Points a, b, c, e, g Clause 4, Point a Clause 5 of Article 29 and Point b Clause 2 of Article 35 of this Decree."

Article 3. Replace and abolish some provisions of Decree No. 115/2018/NĐ-CP dated September 4, 2018 of the Government on administrative penalties for violations of food safety regulations and Decree No. 117/2020/NĐ-CP dated September 28, 2020 of the Government on administrative penalties for violations in the field of health care.

1. Replace the phrase "Recommend the competent state agency to recover" with the phrase "Compel to 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 Decree No. 117/2020/NĐ-CP dated September 28, 2020 of the Government on administrative penalties for violations in the field of health care.

2. Abolish the provision at point a clause 2 Article 9, point d clause 10 Article 22, point b clause 5 Article 24 of Decree No. 115/2018/NĐ-CP dated September 4, 2018 of the Government on administrative penalties for violations of food safety regulations.

3. Abolish the provision at 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 Decree No. 117/2020/NĐ-CP dated September 28, 2020 of the Government on administrative penalties for violations in the field of health care.

Article 4. Effective date

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

2. For administrative violations in the fields of health care and food safety that occurred before the effective date of this Decree but were discovered or are being examined and resolved thereafter, if this Decree does not provide for legal liability or provides for lighter legal liability for individuals and organizations committing such violations, then the provisions on administrative penalties set forth in this Decree shall be applied.

Article 5. Responsibilities for Implementation

Ministers, Heads of ministerial-level agencies, Heads of government agencies, Chairpersons of provincial People's Committees directly under the central government, and relevant organizations and individuals are responsible for implementing this Decree./.