Guidelines for health claims certification in advertising for food and food additives of the Ministry of Health of Vietnam

Guidelines for health claims certification in advertising for food and food additives of  the Ministry of Health of Vietnam

This page  provides for the conditions, competence, dossiers and procedures for health claims certification in advertising for food and food additives of  the Ministry of Health of Vietnam, including:

a/ Functional food;
b/ Food fortified with micronutrients;
c/ Natural mineral water;
d/ Bottled drinking water;
dd/ Food additives and food processing aids.

This page applies to entities and individuals involved in the health claims certification in advertising for food and food additives of  the Ministry of Health of Vietnam in the teritory of Vietnam.

I.Appraisal charge and fee for grant or re-grant of written health claims certification in advertising for food and food additives of  the Ministry of Health of Vietnam.

1.The applicant shall pay an appraisal charge and a fee for grant or re-grant of written  health claims certification in advertising for food and food additives to the local authority for  health claims certification in advertising for food and food additives as prescribed by law.

2. An advertisement design to be regarded as a dossier of  application file for  health claims certification in advertising that is liable to appraisal charge and certification fee.

The following shall be regarded as a dossier of application file for  health claims certification in advertising for food and food additives:
- An adve1tisement design for a product, goods or service for a single target user;
- An advertisement design for a product, goods or service for a single target user used for different forms of advertising (e.g., leaflet, poster, book, newspaper).
- An advertisement design for two or more products of food and food additives having
the same uses and target users.

The following shall not be regarded as a dossier of application file for  health claims certification in advertising for food and food additives:
+ Different advertisement designs for a product, goods or service for a single target user. In this case, each adve1tisement design shall be regarded as a dossier;
+An advertisement design showing different products, goods or services for a single target user. In this case, each goods, product or service shall be regarded as a dossier.
+ An advertisement design for two or more products of food and food additives having different uses and target users. In this case, each product shall be regarded as a dossier.

II.Conditions, competence, dossiers and procedures for health claims certification in advertising for food and food additives  of the Ministry of  Health of Vietnam.

2.1 General conditions for health claims certification in advertising:

1. Advertising contents must comply with the law on advertising and do not fall in the prohibited cases prescribed in A1ticle 8 of the Law on Advertising.

2. Voices, texts and images in an advertisement must be short, common and compliant with Article 18 of the Law on Advertising. The smallest font size used in an advertisement must be readable under nomal conditions and must not be smaller than the proportion corresponding to VnTime or Times New Roman font size 12 on A4 paper.

2.2 Conditions for  health claims certification in advertising for food and food additives of the Ministry of  Health of Vietnam

1. Food and food additives are accompanied by written certifications of conformity with food safety regulations (for products for which no national technical regulations are available) or receipts of regulation confo1mity announcements issued by a competent state agency.

2. Advertising contents must comply with Article 5 of Decree No. 181/2013/ND-CP and the following provisions:

a/ For contents other than the announced ones, there must be lawful and scientific documents as proof and sources of reference materials cited in advertising layouts and scripts; for products with special usage and preservation instructions, such shall be specified in their advertisements;

b/ For advertisements on billboards, signboards, posters or product shelves, or with texts appearing at the foot of the television screen, on other articles, or on aerial, underwater or mobile objects, not all the information on usage, effects and preservation shall be presented, but the advertising contents must comply with the contents announced to be conformable with technical regulations or with food safety regulations;

c/ Not to advertise food in the form of pieces of writing of physicians, pharmacists or health workers that describe the food as having treatment effects;

d/ Not to use images, uniforms, names or mails of health establishments, physicians, pharmacists or health workers, or thank-you letters of patients to adve1iise food.

3.Having a complete dossier specified in Clause 2.4 below.

4. The applicant for health claims certification in advertising for food and food additives is the unit named in the receipt of regulation conformity announcement or the written certification of conformity with food safety regulations (for products for which no national technical regulations are available) or a
unit with legal person status authorized in writing by the unit named in such receipt or written certification.

III. Competent local authority to issue written health claims certification in advertising for food and food additives of the Ministry of Health  of Vietnam.

1. Organizations under the Ministry of Health of Vietnam  have competence to issue written health claims certification in advertising for food and food additives as follows:
- The Food Safety Administration, for functional food, food fo1tified with micronutrients. 

2. Food Safety and Hygiene Branches under provincial-level Health Departments have competence to:
a/ Issue written health claims certification in advertising for natural mineral water, bottled drinking water, food additives and food processing aids;
b/ Issue written health claims certification in advertising in case of advertising at conferences, workshops or events held in geographical areas under their management to introduce food and food additives;

VI Dossier of application file for health claims certification in advertising for food and food additives:

1. A dossier shall be made in one set.

2. A dossier must comprise:

a/ A written application file for health claims certification in advertising for food and food additives as specified in Appendix No.01 to Circular 09;

b/ The enterprise”s business registration certificate or the foreign trader”s representative office establishment license;

c/Health claims in advertising for certification:
- For radio or television advertisements, there must be one audio or visual disc or electronic file to-be-advertised contents enclosed with 3 scripts of the advertisement, clearly describing the contents and medium of advertising, images (for television advertisements), texts and music;
- For advertisements in media other than radio or television, there must be 3 color advertising layouts enclosed with an electronic file of advertising contents;
- For advertisements at conferences, workshops or events, in addition to the materials specified at this Point, there must also be a valid advertisement design approved by a competent agency and used in the agenda (in case the advertisement design has been approved), the agenda specifying the contents of reports, time (date) and venue (address) of the the conference/ workshop/event; contents of the reports to be presented at the conference/workshop/event and documents to be distributed to participants; list of names, academic titles and professional qualifications of speakers (speakers must possess diplomas and professional qualifications relevant to to-be-advertised products, goods or services. For advertising of food, food additives and food processing aids, speakers must possess medicine and pharmacy diploma or a university or higher degree in a relevant discipline).

d/ Label designs or approved label designs in case approval by a competent health agency is required by law.

3. Other documents:

a/ In case the applicant for  health claims certification in advertising for food and food additives is an authorized unit, the following papers are required:
- The valid paper of authorization;
- The authorized unit”s business registration certificate or the license for establishment of the foreign trader”s representative office.

b/ Reference documents proving or certifying information in the advertising contents:
- Documents in English shall be translated into Vietnamese and enclosed with the English originals. The Vietnamese translations shall be appended with the seal of the applicant;
- Documents in a foreign language other than English shall be translated into Vietnamese and enclosed with the original documents in that language. The Vietnamese translations shall be notarized in accordance with law.

c/ The papers in the dossier shall be clearly printed and a1rnnged in the order specified in Circular 09, and must have a cover and a list of papers; different parts of the dossier shall be separated with color sheets;

d/ The papers in the dossier must remain valid and may be certified copies or copies appended with the seal of the applicant. These papers must each have the applicant”s seal, and every two adjoining pages shall be appended with such seal;

dd/ An advertisement design shall be presented on an A4-size paper; a large-size outdoor advertisement design shall be presented on an A3-size paper or a paper of another size, with a scale showing its actual size.

4. Requirements on dossiers submitted to agencies providing level-4 online public services:

Dossiers shall be converted into electronic files (single file) and must comply with the guidance of agencies providing level-4 online public services.

5. The regulation conformity announcement receipt or the written certification of conformity with food safety regulations (for products for which no technical regulations are available) issued by a competent state agency.

6. A sheet of detailed  information on the products, ce1tified by a competent state agency.

7. Valid documents proving the features and uses of and info1mation on the products, in case the advertising contents mention the products” features, uses and information not stated  in the sheet of detailed  information.

V. Procedures for issuance of written health claims certification in advertising for food and food additives

1. The applicant for health claims certification in advertising for food and food additives shall submit a dossier to a competent agency defined in Clause 2.3 above (below referred to as dossier-receiving agency).

2. For an invalid dossier, within 5 working days from the date of receipt based on the dossier-receiving agency”s mark of incoming official letters, this agency shall notify such to the applicant for completion of the dossier. The time limit for the applicant to complete the dossier is 90 days after receiving the written notice from the dossier-receiving agency. Past this time limit, the dossier will become invalid.

3. Within 10 working days from the date of receipt of a complete and valid dossier based on the dossier-receiving agency”s mark of incoming official letters, the competent state agency shall issue a written certification of advertising contents, made according to the fo1m provided in Appendix No. 03 to Circular 09. In case of refusal, it shall issue a written reply clearly stating the reason.

4. The dossier-receiving agency shall publicize on its portal the list of products, goods and services under its management for which written certifications of advertising contents have been issued and of which written certifications of advertising contents have expired.

5. Advertising at conferences, workshops or events:

a/ At least 2 working days before advertising, the entity or individual that has food and food additives for which a competent agency of the Ministry of Health of Vietnam  has issued the written health claims certification in advertising for food and food additives at conferences, workshops or other events shall notify in writing the form, time and place of advertising, enclosed with copies of such written certification and approved advertisement design or advertising script to the provincial-level Health Department of the locality where advertising will be conducted, for inspection or examination when necessary;

b/ If the venue and time of the conference, workshop or event are changed as compared to the written health claims certification in advertising for food and food additives, the entity or individual having products, goods services advertised shall notify such change to the provincial-level Health Department
of the locality where the conference, workshop or event will be held at least 2 working days before advertising is conducted.

6. Procedures for registration of health claims certification in advertising shall be carried out again in the following cases:

a/ The applicant for health claims certification in advertising modifies or supplements the dossier in contravention of the dossier-receiving agency”s notice for dossier completion;

b/ The applicant for health claims certification in advertising fails to modify or supplement the dossier within the time limit specified in Clause 2 of this Article.

7. The dossier-receiving agency shall not receive dossiers of application filet for health claims certification in advertising from a unit that has committed a violation of the law on advertising until the unit has completely served the sanctioning decision issued by a competent agency or person.

VI Cases of expiration of a written  health claims certification in advertising for food, food additives:

a/ The receipt of the regulation conformity announcement or the written certification of conformity with food safety regulations expires;

b/ The enterprise”s food safety and hygiene eligibility certificate is revoked;

c/ The components or uses of the products or goods are changed;

d/ The products or goods are banned from sale or are recalled.

dd/ Other cases stipulated by laws.

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