The Minister of Health issued Decision 1613/QD-BYT dated June 11, 2024, which amends the procedures for registration of advertisement contents for dietary products for children up to 36 months in Vietnam.
Procedures for registration of advertisement contents for dietary products for children up to 36 months in Vietnam (Internet image)
The procedures for registration of advertisement contents for medical foods, food for special dietary uses, and dietary products for children up to 36 months in Vietnam, according to Decision 1613/QD-BYT in 2024, are as follows:
* Implementation
** Step 1:
The owner of the advertised product submits the registration application for confirmation of advertising contents to the designated competent authority by the People's Committee.
** Step 2:
Within a period of 10 working days from the date of receiving a complete and valid application, the receiving agency is responsible for examining the application and providing results according to Form 11 Appendix I issued with Decree 15/2018/ND-CP. This period is calculated from the date of stamping by the receiving agency if the application is sent by post or from the date the complete application is received on the online public service system.
Form No. 11 |
** Step 3:
In case of disagreement with the advertising content of the organization, individual, or a request for amendment or supplementation, the receiving agency must provide a written document stating the reasons and legal basis for the request. The receiving agency can only request amendment or supplementation once.
Within a period of 10 working days from the date of receiving the amended or supplemented application, the receiving agency shall assess the application and provide a written response. If the organization or individual does not make the required amendments or supplements within 90 working days from the date of the request, the application will no longer be valid.
* Submission methods
- Directly;
- Online;
- Through public postal service.
* Composition and quantity of documents
- Composition:
+ Application for confirmation of advertising contents according to Form 10 Appendix I issued with Decree 15/2018/ND-CP.
Form No. 10 |
+ Receipt of registration for product announcement and the confirmed product announcement or the receipt of a compliant product announcement or the certificate confirming compliance with food safety regulations (authenticated copy by the organization or individual);
+ Product label sample (authenticated copy by the organization or individual);
+ For advertisements in newspapers or magazines, an expected advertising script and the expected advertising content must be recorded on a video disc and an audio disc. For advertisements on other media, an expected advertising script (content sample) must be provided (authenticated copy by the organization or individual);
+ For advertising content beyond the product's functions and features stated in the product announcement, scientific documents proving the claims must be provided (authenticated copy by the organization or individual);
All documents in the registration application for confirmation of advertising contents must be in Vietnamese. In case there are documents in a foreign language, they must be translated into Vietnamese and notarized.
+ Documents proving the use of personal images, speech, or written words in advertising;
+ In case the advertisement uses words such as “nhất”, “duy nhất”, “tốt nhất”, “số một” (“the first rank”, “the unique”, “the best”, “number one”) or similar meanings, additional documents proving the legitimacy of the advertising information must be provided according to Clause 1, Article 2 of Circular 10/2013/TT-BVHTTDL.
- Quantity: 01 set
* Processing time: 10 working days
* Subjects of administrative procedures: Organizations, individuals
* In-charge authority: Competent authority designated by the People's Committee
* Results: certificate of advertisement contents:
* Fees and charges
- Fee: 1,100,000 VND per product per registration
- No additional fees
(According to Circular 67/2021/TT-BTC)
* Requirements, conditions for administrative procedures
** According to advertising regulations:
- Having a receipt of registration for product announcement issued by the competent state authority.
- Advertising that utilizes personal images, speech, or written words must have documents proving the consent of the individual or legal permission.
- Advertising that uses words such as “nhất”, “duy nhất”, “tốt nhất”, “số một” (“the first rank”, “the unique”, “the best”, “number one”) or similar meanings must have legally valid documents proving the claims according to Article 2 of Circular 10/2013/TT-BVHTTDL and Decree 181/2013/ND-CP.
- Advertising that uses logos, trademarks, brand names, or information regarding exclusive patent protection must have documents, certificates, or protections proving the advertising information in accordance with intellectual property laws.
Mandatory content in advertising (Decree 181/2013/ND-CP):
- Name of food;
- Primary and secondary effects (if any);
- Name and address of the entity in charge of launching the product;
Content not allowed in advertising:
- Not violating the prohibited acts in advertising prescribed in Article 8 of the Law on Advertising 2012;
- Do not advertise functional foods in a way that cause people to confuse them with medicines.
** According to the provisions of Article 27 of Decree 15/2018/ND-CP
- Not being a product prohibited from advertising prescribed in Article 7 of the Law on Advertising 2012.
- The owner of the advertised product shall register the advertisement content to the authority that issued the certificate of product registration.
- The product applying for registration of advertisement contents must have a certificate of product registration, product declaration, product label confirmed by the competent authority.
- The advertisement content must be consistent with the effects of the product specified in the product declaration.
Do not use images, equipment, uniforms, documents of health facilities, physicians, pharmacists, health workers, patients’ appreciation letter, articles written by health facilities, physicians or pharmacists to advertise foods.
- For audio or video advertisement, a disc that contains the advertisement script;
- For other types of advertisement, a maquette (certified by the applicant);
- The uses or effects other than those written in the product declaration must be proven by scientific documents (copies certified by the applicant);
- The documents must be written in Vietnamese language; documents in other languages must be translated into Vietnamese language and notarized.
** According to the provisions of Decree 100/2014/ND-CP:
- 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 content is prohibited
+ 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, feeding bottles and teats.
- 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”;
- Advertising 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 Decree 100/2014/ND-CP and the laws on advertising and food safety.
More details can be found in Decision 1613/QD-BYT, which comes into force from June 11, 2024.
Vo Tan Dai
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