Decision 1613/QD-BYT 2024 amend Decisions on administrative procedures concerning nutrition

3- Administrative procedure

Registration of advertisement contents of dietary supplements

Order of implementation

Step 1:

The owner of the advertised product shall submit a dossier for registration of certification of advertisement content to the Vietnam Food Administration (Ministry of Health).

Step 2:

Within 10 working days from the date of receiving a complete and valid dossier, the dossier-receiving agency shall examine it and issue a reply, made using Form No. 11, Appendix I to the Decree No. 15/2018/ND-CP.  The time limit shall be counted from the date of receipt of a complete dossier in the online public service system.

Step 3:

If rejecting the advertisement content or requesting modification and supplementation of the advertisement content, the dossier-receiving agency shall issue a notice clearly stating the reason and legal basis for its request. The dossier-receiving agency may request modification and supplementation only once.

Within 10 working days after receiving the modified and supplemented dossier, the dossier-receiving agency shall appraise it and issue a written reply. If the dossier is not modified and supplemented after 90 working days from the date a written request is made, it will become invalid.

Implementation methods

- Submit directly;

- Online;

- Send via public postal service

Components of a dossier and quantity:

A. Components of a dossier:

1. A written registration of certification of advertisement content, made using Form No. 10, Appendix I to the Government’s Decree No. 15/2018/ND-CP dated February 02, 2018, on detailing the implementation of a number of articles of the Law on Food Safety;

2. The receipt of the registration of the product declaration and the product declaration certified by a competent agency or valid receipt of the declaration of regulation conformity/ certificate of declaration of conformity with food safety regulations (a copy certified by the registrant);

3. A product label specimen (certified by the registrant);

4. An audio or video disc that contains the advertisement script and contents, for radio or television advertisements; or the advertisement layout (certified by the registrant), for advertisements in other media;

5. Scientific documents proving the uses or effects of the product other than those written in the product declaration (copies certified by the registrant);

Documents in the dossier must be in Vietnamese; for documents in a foreign language, their notarized Vietnamese translations are required.

6. Documents proving that the advertisement contain an individual’s pictures, words or scripts;

7. In case of advertising using the words “best”, “only”, “the best”, “number one” or words with similar meaning, documents proving advertisement contents using the words “best”, “only”, “the best”, “number one” or words with similar meaning as defined in Clause 1 Article 2 of the Circular No. 10/2013/TT-BVHTTDL are required.

B. Quantity: 01 dossier

Time limit of settlement

10 working days

Administrative procedure-complying subjects

Registering organizations or individuals

Administrative procedure-implementing agencies

The Vietnam Food Administration

Results of administrative procedure performance

Certificates of advertisement contents (Form No. 11 of Appendix I to the Decree No. 15/2018/ND-CP)

Charge and fee

Charge: VND 1,100,000/time/product 

Fee: N/A

(According to Circular No. 67/2021/TT-BTC prescribing charges related to food safety and the collection, remittance, management and use thereof)

Form

Written registration of certification of advertisement content (Form No. 10 of Appendix I to the Decree No. 15/2018/ND-CP)

Requirements or conditions concerning to administrative procedure

1/ According to law regulations on advertising:

 - Receipt of the registration of the product declaration granted by a competent state agency.

- For advertisements that contain other people’s pictures, words or scripts, documents proving their consent or permission by law are required.

- In case of advertisements using the words “best”, “only”, “the best”, “number one” or words with similar meaning, lawful proving documents defined in Article 2 of the Circular No. 10/2013/TT-BVHTTDL dated December 06, 2013, on detailing and guiding the implementation of a number of articles of the Law on Advertising and the Government’s Decree No. 181/2013/ND-CP dated November 14, 2013, on detailing the implementation of a number of articles of the Law on Advertising are required.

- For advertisements using logos, brands, trademarks, and information about invention protection, documents, protection titles, certificates, etc. proving the advertisement contents are required in accordance with laws on intellectual property.

Required contents in advertisements (Decree No. 181/2013/ND-CP):

- Name of the food;

- Primary effect and side effects (if any);

- Name and address of the organization or person responsible for the food;

Contents banned in advertisements:

- Prohibited acts in advertising specified in Article 8 of the Law No. 16/2012/QH13 on Advertising;

- Advertising of a functional food misleads that such product is a drug;

2/ According to Article 27 of the Government’s Decree No. 15/2018/ND-CP dated February 2, 2018, on detailing the implementation of a number of articles of the Law on Food Safety:

- Before advertising, the advertisement contents of the dietary supplements must be registered.

- The receipt of the registration of the product declaration, the product declaration and the product label certified by a competent agency must be provided.

- The advertisement contents must match the effects of the product stated in the product declaration.

It is prohibited to use images, equipment, uniforms, names and documents of health facilities, medical physicians, pharmacists, health workers, patients’ letters of thanks and articles written by medical physicians, pharmacists or health workers to advertise foods.

- It is required to have the recommendation“Thực phẩm này không phải là thuốc và không có tác dụng thay thế thuốc chữa bệnh” (This product is not a medicine and cannot replace medical treatment), which shall be written clearly and printed in a color contrasting with the background color;

- The above-mentioned recommendation shall be read aloud in radio or television advertisements;

- The above-mentioned recommendation is not required to be read aloud if the duration of a radio or television advertisement is shorter than 15 seconds, but shall be shown during the advertisement.

- An audio or video disc that contains the advertisement script and contents, for radio or television advertisements;

- The advertisement layout (certified by the registrant), for advertisements in other media;

- Scientific documents proving the uses or effects of the product other than those written in the product declaration (copies certified by the registrant);

- Documents in the dossier must be in Vietnamese; for documents in a foreign language, their notarized Vietnamese translations are required.

Legal grounds of the administrative procedure

1. Law No. 55/2010/QH12 on Food Safety dated June 17, 2010 of the National Assembly.

2. Law No. 16/2012/QH13 on Advertising dated June 21, 2012 of the National Assembly.

3. Decree No. 15/2018/ND-CP dated February 02, 2018 of the Government, on detailing the implementation of a number of articles of the Law on Food Safety.

4. Decree No. 181/2013/ND-CP dated November 14, 2013 on detailing the implementation of a number of articles of the Law on Advertising.

5. Circular No. 09/2015/TT-BYT dated May 25, 2015, prescribing the certification of advertisement contents applied to special products, goods and services under the Ministry of Health’s management.

6. Circular No. 10/2013/TT-BVHTTDL dated December 06, 2013, on detailing and guiding the implementation of a number of articles of the Law on Advertising and the Government’s Decree No. 181/2013/ND-CP on detailing the implementation of a number of articles of the Law on Advertising;

7. Circular No. 67/2021/TT-BTC dated August 05, 2021 prescribing charges related to food safety and the collection, remittance, management and use thereof.

4- Administrative procedure

Registration of advertisement contents of food for special medical purposes, food for special dietary uses, foods for young children up to 36 months of age

Order of implementation

Step 1:

The owner of the advertised product shall submit a dossier for registration of certification of advertisement content to the functional agency assigned by the People's Committee.

Step 2:

Within 10 working days from the date of receiving a complete and valid dossier, the dossier-receiving agency shall examine it and issue a reply, made using Form No. 11, Appendix I to the Decree No. 15/2018/ND-CP. This time limit shall be counted from the date of the incoming mail stamp appended by the dossier-receiving agency (if the dossier is sent by post) or the date of receipt of a complete dossier in the online public service system.

Step 3:

If rejecting the advertisement content or requesting modification and supplementation of the advertisement content, the dossier-receiving agency shall issue a notice clearly stating the reason and legal basis for its request. The dossier-receiving agency may request modification and supplementation only once.

Within 10 working days after receiving the modified and supplemented dossier, the dossier-receiving agency shall appraise it and issue a written reply. If the dossier is not modified and supplemented after 90 working days from the date a written request is made, it will become invalid.

Implementation methods

- Submit directly;

- Online;

- Send via public postal service.

Components of a dossier and quantity:

A. Components of a dossier:

1. A written registration of certification of advertisement content, made using Form No. 10, Appendix I to the Government’s Decree No. 15/2018/ND-CP dated February 02, 2018, on detailing the implementation of a number of articles of the Law on Food Safety;

2. The receipt of the registration of the product declaration and the product declaration certified by a competent agency or valid receipt of the declaration of regulation conformity/ certificate of declaration of conformity with food safety regulations (a copy certified by the registrant);

3. A product label specimen (certified by the registrant);

4. An audio or video disc that contains the advertisement script and contents, for radio or television advertisements; or the advertisement layout (certified by the registrant), for advertisements in other media;

5. Scientific documents proving the uses or effects of the product other than those written in the product declaration (copies certified by the registrant); Documents in the dossier must be in Vietnamese; for documents in a foreign language, their notarized Vietnamese translations are required.

6. Documents proving that the advertisement contain an individual’s pictures, words or scripts;

7. In case of advertising using the words “best”, “only”, “the best”, “number one” or words with similar meaning, documents proving advertisement contents using the words “best”, “only”, “the best”, “number one” or words with similar meaning as defined in Clause 1 Article 2 of the Circular No. 10/2013/TT-BVHTTDL are required.

B. Quantity: 01 dossier

Time limit of settlement

10 working days

Administrative procedure-complying subjects

Registering organizations or individuals

Administrative procedure-implementing agencies

Functional agencies assigned by the People's Committees

Results of administrative procedure performance

Certificates of advertisement contents

Charge and fee

Charge: VND 1,100,000/time/product 

Fee: N/A;

(According to Circular No. 67/2021/TT-BTC prescribing charges related to food safety and the collection, remittance, management and use thereof)

Form

Form No. 10 of Appendix I: Written registration of certification of advertisement content

Requirements or conditions concerning to administrative procedure

1/ According to law regulations on advertising:

- Receipt of the registration of the product declaration granted by a competent state agency.

- For advertisements that contain other people’s pictures, words or scripts, documents proving their consent or permission by law are required.

- In case of advertisements using the words “best”, “only”, “the best”, “number one” or words with similar meaning, lawful proving documents defined in Article 2 of the Circular No. 10/2013/TT-BVHTTDL dated December 06, 2013, on detailing and guiding the implementation of a number of articles of the Law on Advertising and the Government’s Decree No. 181/2013/ND-CP dated November 14, 2013, on detailing the implementation of a number of articles of the Law on Advertising are required.

- For advertisements using logos, brands, trademarks, and information about invention protection, documents, protection titles, certificates, etc. proving the advertisement contents are required in accordance with laws on intellectual property.

Required contents in advertisements (Decree No. 181/2013/ND-CP):

- Name of the food;

- Primary effect and side effects (if any);

- Name and address of the organization or person responsible for the food;

Contents banned in advertisements:

- Prohibited acts in advertising specified in Article 8 of the Law No. 16/2012/QH13 on Advertising;

- Advertising of a functional food misleads that such product is a drug;

2/ According to Article 27 of the Government’s Decree No. 15/2018/ND-CP dated February 2, 2018, on detailing the implementation of a number of articles of the Law on Food Safety

- Not being products banned from advertising specified in Article 7 of the Law on Advertising

- The owner of the advertised product shall register the advertisement contents with the agency that issued the receipt of the registration of the product declaration under current regulations.

- The receipt of the registration of the product declaration, the product declaration and the product label certified by a competent agency must be provided.

- The advertisement contents must match the effects of the product stated in the product declaration.

It is prohibited to use images, equipment, uniforms, names and documents of health facilities, medical physicians, pharmacists, health workers, patients’ letters of thanks and articles written by medical physicians, pharmacists or health workers to advertise foods.

- An audio or video disc that contains the advertisement script and contents, for radio or television advertisements;

- The advertisement layout (certified by the registrant), for advertisements in other media;

- Scientific documents proving the uses or effects of the product other than those written in the product declaration (copies certified by the registrant);

- Documents in the dossier must be in Vietnamese; for documents in a foreign language, their notarized Vietnamese translations are required.

3/ According to the Government’s Decree No. 100/2014/ND-CP on the trading in and use of nutritious products for infants, feeding bottles and teats:

- to strictly prohibit the advertising of breast milk substitutes for under-24 month infants; complementary foods for under-6 month infants;

- to strictly prohibit the advertising of feeding bottles and teats in any forms; the use of fetus or infant images in advertisements for milk for pregnant women.

- The following contents are banned:

+ Images, words or other communications forms to encourage the use of breast milk substitutes or bottle feeding or discourage breast feeding;

+ Comparisons leading to the conclusion that breast milk substitutes are as good as or better than breast milk;

+ Names or logos of breast milk substitutes.

- The advertising of complementary foods for under-24 month infants must satisfy the following requirements:

+ The first part of the advertisement must have the phrase: “Breast milk is the best food for health and all-sided growth of infants”;

+ Advertisement contents must clearly state “This product is a complementary food and may be used as a supplement to breast milk for infants over 6 months”; and comply with Articles 4 and 5 of the Decree No. 100/2014/ND-CP and the laws on advertising and food safety.

Legal grounds of the administrative procedure

1. Law No. 55/2010/QH12 on Food Safety dated June 17, 2010 of the National Assembly.

2. Law No. 16/2012/QH13 on Advertising dated June 21, 2012 of the National Assembly.

3. Decree No. 15/2018/ND-CP dated February 02, 2018 of the Government, on detailing the implementation of a number of articles of the Law on Food Safety.

4. Decree No. 181/2013/ND-CP dated November 14, 2013, on detailing the implementation of a number of articles of the Law on Advertising.

5. Circular No. 09/2015/TT-BYT dated May 25, 2015, prescribing the certification of advertisement contents applied to special products, goods and services under the Ministry of Health’s management.

6. Circular No. 10/2013/TT-BVHTTDL dated December 06, 2013, on detailing and guiding the implementation of a number of articles of the Law on Advertising and the Government’s Decree No. 181/2013/ND-CP, on detailing the implementation of a number of articles of the Law on Advertising;

7. Decree No. 100/2014/ND-CP dated November 06, 2014 of the Government, on the trading in and use of nutritious products for infants, feeding bottles and teats.

8. Circular No. 67/2021/TT-BTC prescribing charges related to food safety and the collection, remittance, management and use thereof.

3- Procedure

Registration of advertisement contents of food for special medical purposes, food for special dietary uses, foods for young children up to 36 months of age (in case the organization/individual submits a dossier for registration of product declarations to the Ministry of Health under Clause 1 Article 27 of Decree No. 15/2018/ND-CP)

Order of implementation

Step 1:

The owner of the advertised product shall submit a dossier for registration of certification of advertisement content to the functional agency assigned by the People's Committee.

Step 2:

Within 10 working days from the date of receiving a complete and valid dossier, the dossier-receiving agency shall examine it and issue a reply, made using Form No. 11, Appendix I to the Decree No. 15/2018/ND-CP. This time limit shall be counted from the date of the incoming mail stamp appended by the dossier-receiving agency (if the dossier is sent by post) or the date of receipt of a complete dossier in the online public service system.

Step 3:

If rejecting the advertisement content or requesting modification and supplementation of the advertisement content, the dossier-receiving agency shall issue a notice clearly stating the reason and legal basis for its request. The dossier-receiving agency may request modification and supplementation only once.

Within 10 working days after receiving the modified and supplemented dossier, the dossier-receiving agency shall appraise it and issue a written reply. If the dossier is not modified and supplemented after 90 working days from the date a written request is made, it will become invalid.

Implementation methods

- Submit directly;

- Online;

- Send via public postal service.

Components of a dossier and quantity:

A. Components of a dossier:

1. A written registration of certification of advertisement content, made using Form No. 10, Appendix I to the Government’s Decree No. 15/2018/ND-CP dated February 02, 2018, on detailing the implementation of a number of articles of the Law on Food Safety;

2. The receipt of the registration of the product declaration and the product declaration certified by a competent agency or valid receipt of the declaration of regulation conformity/ certificate of declaration of conformity with food safety regulations (a copy certified by the registrant);

3. A product label specimen (certified by the registrant);

4. An audio or video disc that contains the advertisement script and contents, for radio or television advertisements; or the advertisement layout (certified by the registrant), for advertisements in other media;

5. Scientific documents proving the uses or effects of the product other than those written in the product declaration (copies certified by the registrant); Documents in the dossier must be in Vietnamese; for documents in a foreign language, their notarized Vietnamese translations are required.

6. Documents proving that the advertisement contain an individual’s pictures, words or scripts;

7.  In case of advertising using the words “best”, “only”, “the best”, “number one” or words with similar meaning, documents proving advertisement contents using the words “best”, “only”, “the best”, “number one” or words with similar meaning as defined in Clause 1 Article 2 of the Circular No. 10/2013/TT-BVHTTDL are required.

B. Quantity: 01

Time limit of settlement

10 working days

Administrative procedure-complying subjects

Registering organizations or individuals

Administrative procedure-implementing agencies

The Vietnam Food Administration

Results of administrative procedure performance

Certificates of advertisement contents

Charge and fee

Charge: VND 1,100,000/time/product 

Fee: N/A;

(According to Circular No. 67/2021/TT-BTC prescribing charges related to food safety and the collection, remittance, management and use thereof)

Form

Form No. 10 of Appendix I: Written registration of certification of advertisement content

Requirements or conditions concerning to administrative procedure

1/ According to law regulations on advertising:

- Receipt of the registration of the product declaration granted by a competent state agency.

- For advertisements that contain other people’s pictures, words or scripts, documents proving their consent or permission by law are required.

- In case of advertising using the words “best”, “only”, “the best”, “number one” or words with similar meaning, lawful proving documents defined in Article 2 of the Circular No. 10/2013/TT-BVHTTDL dated December 06, 2013, on detailing and guiding the implementation of a number of articles of the Law on Advertising and the Government’s Decree No. 181/2013/ND-CP dated November 14, 2013, on detailing the implementation of a number of articles of the Law on Advertising are required.

- For advertisements using logos, brands, trademarks, and information about invention protection, documents, protection titles, certificates, etc. proving the advertisement contents are required in accordance with laws on intellectual property.

Required contents in advertisements (Decree No. 181/2013/ND-CP):

- Name of the food;

- Primary effect and side effects (if any);

- Name and address of the organization or person responsible for the food;

Contents banned in advertisements:

- Prohibited acts in advertising specified in Article 8 of the Law No. 16/2012/QH13 on Advertising;

- Advertising of a functional food misleads that such product is a drug;

2/ According to Article 27 of the Government’s Decree No. 15/2018/ND-CP dated February 2, 2018, on detailing the implementation of a number of articles of the Law on Food Safety;

- Not being products banned from advertising specified in Article 7 of the Law on Advertising

- The owner of the advertised product shall register the advertisement contents with the agency that issued the receipt of the registration of the product declaration under current regulations.

- The receipt of the registration of the product declaration, the product declaration and the product label certified by a competent agency must be provided

- The advertisement contents must match the effects of the product stated in the product declaration.

It is prohibited to use images, equipment, uniforms, names and documents of health facilities, medical physicians, pharmacists, health workers, patients’ letters of thanks and articles written by medical physicians, pharmacists or health workers to advertise foods.

- An audio or video disc that contains the advertisement script and contents, for radio or television advertisements;

- The advertisement layout (certified by the registrant), for advertisements in other media;

- Scientific documents proving the uses or effects of the product other than those written in the product declaration (copies certified by the registrant);

- Documents in the dossier must be in Vietnamese; for documents in a foreign language, their notarized Vietnamese translations are required.

3/ According to the Government’s Decree No. 100/2014/ND-CP on the trading in and use of nutritious products for infants, feeding bottles and teats:

- to strictly prohibit the advertising of breast milk substitutes for under-24 month infants; complementary foods for under-6 month infants;

- to strictly prohibit the advertising of feeding bottles and teats in any forms; the use of fetus or infant images in advertisements for milk for pregnant women.

- The following contents are banned:

+ Images, words or other communications forms to encourage the use of breast milk substitutes or bottle feeding or discourage breast feeding;

+ Comparisons leading to the conclusion that breast milk substitutes are as good as or better than breast milk;

+ Names or logos of breast milk substitutes.

- The advertising of complementary foods for under-24 month infants must satisfy the following requirements:

+ The first part of the advertisement must have the phrase: “Breast milk is the best food for health and all-sided growth of infants”;

+ Advertisement contents must clearly state “This product is a complementary food and may be used as a supplement to breast milk for infants over 6 months”; and comply with Articles 4 and 5 of the Decree No. 100/2014/ND-CP and the laws on advertising and food safety.

Legal grounds of the administrative procedure

1. Law No. 55/2010/QH12 on Food Safety dated June 17, 2010 of the National Assembly.

2. Law No. 16/2012/QH13 on Advertising dated June 21, 2012 of the National Assembly.

3. Decree No. 15/2018/ND-CP dated February 02, 2018 of the Government, on detailing the implementation of a number of articles of the Law on Food Safety.

4. Decree No. 181/2013/ND-CP dated November 14, 2013 on detailing the implementation of a number of articles of the Law on Advertising.

5. Circular No. 09/2015/TT-BYT dated May 25, 2015, prescribing the certification of advertisement contents applied to special products, goods and services under the Ministry of Health’s management.

6. Circular No. 10/2013/TT-BVHTTDL dated December 06, 2013, on detailing and guiding the implementation of a number of articles of the Law on Advertising and the Government’s Decree No. 181/2013/ND-CP on detailing the implementation of a number of articles of the Law on Advertising;

7. Decree No. 100/2014/ND-CP dated November 06, 2014 of the Government, on the trading in and use of nutritious products for infants, feeding bottles and teats.

8. Circular No. 67/2021/TT-BTC prescribing charges related to food safety and the collection, remittance, management and use thereof.