Thông tư 08/2013/TT-BYT

CIRCULAR

ON THE ADVERTISEMENTS FOR THE FOODS UNDER THE MANAGEMENT OF THE MINISTRY OF HEALTH

Pursuant to the Law on Advertising No. 16/2012/QH13 dated June 21^st 2012;

Pursuant to the Law of Food safety No. 55/2010/QH12 dated June 17^th 2010 and the Government's Decree No. 38/2012/ND-CP dated April 25^th 2012, detailing the implementation of a number of articles of the Law of Food safety;

Pursuant to the Government's Decree No. 63/2012/ND-CP dated August 31^st 2012 defining the functions, tasks, powers and organizational structure of the Ministry of Health;

At the request of the construction of Vietnam Food Administration;

The Minister of Health issues a Circular on the advertisements for the foods under the management of the Ministry of Health.

Chapter I

GENERAL REGULATIONS

Article 1. Scope of regulation

1. This Circular deals with the conditions, authority, documentation, and procedure for certifying the contents of advertisements for the foods under the management of the Ministry of Health.

2. This Circular is applicable to the organizations and individuals related to the advertisements for the foods under the management of the Ministry of Health in Vietnam.

Article 2. The advertisements for the following foods must be registered:

1. Functional foods;

2. Micronutrient-fortified foods;

3. Mineral water;

4. Bottled water;

5. Food additives, food processing aids;

6. The food packing materials during food preparation, production, and trade;

Article 3. Prohibited acts when advertising foods

1. Advertising foods without the written advertisement content certification issued by a competent health agency.

2. Advertising foods being counterfeits or goods of inferior quality.

3. Advertising foods that act as medicines.

4. Advertising foods inconsistently with the contents of the Declaration of conformity with the regulations on food safety, or exaggerate the effects of foods.

5. Advertising foods in the form of articles written by doctors, pharmacists, medical workers, claiming that such foods can treat diseases.

6. Use the images, reputation, and documents from health agencies, medical workers, and gratitude letters written by patients to advertise foods.

7. Other prohibited acts prescribed in the laws on advertising.

Chapter II

CONDITIONS, AUTHORITY, DOCUMENTATION, AND PROCEDURE FOR CERTIFYING THE CONTENTS OF FOOD ADVERTISEMENTS

Article 4. Requirement of food advertisement contents

1. The advertisement contents on the mass media, fliers, posters, and billboards must be consistent with the affects of the products; other contents than that announced must be proved by scientific documents. The following information must be accurate:

a) The product name;

b) The product origin, names of the producer and importer;

c) Effects of the product (if any);

d) The warnings when using the product (if any);

dd) The instruction on how to use and preserve (if the product has special uses and methods of preservation);

e) The advertisements for functional foods must read or say “This product is not medicines and do not substitute medicines”. The font is Times New Roman, font size 14. The dialog must be audible in normal conditions.

2. The advertisements on signboards, billboards, shelves, on other items, in the air, underwater, on moving objects do not necessarily contain all information about the products (uses, effects, preservation), but they must be consistent with the content of the Declaration of conformity to food safety regulations.

Article 5. Authority to issue certifications of food advertisement contents, applications for holding seminars on food introduction

1. Vietnam Food Administration is appointed by the Ministry of Health to issue advertisement content certifications to functional foods and micronutrient-fortified foods.

2. Food Safety And Hygiene Offices shall issue advertisement content certifications to bottled water, mineral water, food additives, food processing aids, and food packing materials during the production, processing, and trade of food under the appointment of the Ministry of Health; certify the application for holding seminars to introduce foods under the management of the health agencies; certify the food advertisement contents under the management of other Ministries and sectors if the advertisements claim health effects;

Article 6. Application for the advertisement content certification

Before advertising foods, 01 dossier of application for advertising must be sent to a competent State agency.

The application includes:

1. The written application for the food advertisement content certification (according to Annex 01 enclosed with this Circular);

2. The Certificate of Business registration of the enterprise, or the License to establish representative office of the foreign trader (a copy sealed the applicant);

3. The Certificate of Declaration of conformity with food safety regulations (applicable to the products without technical standards) or the Notice of reception of the Declaration of conformity issued by a competent State agency (a copy sealed by the applicant);

4. A product information sheet certified by a competent agency (a copy sealed by the applicant);

5. The food advertisements:

a) 01 description of the advertisement contents in a computer disc enclosed with 02 scripts (sealed by the applicant), applicable to advertisement on radio, television, and movies.

b) 02 maquettes of the advertisement contents (sealed by the applicant) enclosed with a soft copy of the application for advertising on newspapers, fliers, posters, billboards, or on other items, on online news, websites of enterprises, websites of advertising companies, on the internet.

6. Reference materials and scientific documents proving the advertisement contents in case the advertisement contents are not provided in the product information sheet, certified by a competent agency. The documents in foreign languages must be translated into Vietnamese.

All documents must be sealed by the applicant.

7. The label design approved by a competent health agency (a copy sealed by the applicant).

Article 7. Procedure for issuing advertisement content certifications

1. Within 10 working days from the date on which the complete and valid dossier is received, the competent State agency must issue the advertisement content certification as prescribed (according to Annex 02 enclosed with this Circular); the refusal to issue the advertisement content certification must be notified and explained in writing by the competent State agency.

2. If the applicant fails to amend or supplement the dossier without explanation within 03 months from the day on which the request for amendment or supplementation is made by the competent agency, the applicant is considered to cancel the advertisement.

Article 8. Seminars on food introduction

1. The foods licensed to be sold in Vietnam, or not being licensed to be sold in Vietnam but already licensed to be sold in the home country, may be introduced in Vietnam at seminars. In particular:

a) The Vietnamese organizations and individuals having appropriate Certificates of Business registration may hold seminars on food introduction.

b) Foreign organizations and individuals wishing to holds seminars to introduce foods that have not been licensed to be sold in Vietnam but have been licensed to be sold in their home country must cooperate with a Vietnamese organization or individual that has an appropriate Certificate of Business registration in holding the seminars.

2. The speakers at the seminars must be expert in health, pharmacy, nutrition, or have at least bachelor’s degrees in relevant disciplines, and take responsibility before law for the accuracy of their speech at the seminars.

3. The food introduction materials at the seminars must comply with the laws on advertising and other relevant laws.

4. Before holding the seminar, an application for the seminar content certification must be sent to a competent State agency, and the seminar is only held after the certification is issued by the competent State agency.

5. The introduction and advertisements for the sponsors’ products must comply with the regulations on advertising of this Circular and other relevant laws.

Article 9. Documentation and procedure for certifying the application for holding seminars on food introduction

1. The application for holding a seminar on food introduction includes:

a) The agenda of the seminar on food introduction (according to Annex 03 enclosed with this Circular);

b) The copy of the Certificate of Business registration of the enterprise, or the License to establish representative office (a copy sealed by the seminar organizer);

c) The Certificate of Standard or the Notice of reception of the Declaration of conformity, certified by a Health agency. The foods that have not been licensed or be sold in Vietnam must have the Certificate of Free sale in the home country (a copy sealed by the seminar organizer);

d) The copy of the product information sheet certified by a competent agency (a copy sealed by the seminar organizer);

dd) The design of the product label (sealed by the seminar organizer);

e) 02 maquettes or scripts or brochures, certified and sealed by the seminar organizer (enclosed with soft copies) at the seminar;

g) The list of speakers (together with information about their qualifications or titles).

h) The reference materials and scientific documents proving the advertisement contents in case the advertisement contents are not provided in the product information sheet certified by competent agencies. The documents in foreign languages must be translated into Vietnamese. All documents must be sealed by the seminar organizer.

2. Procedure for certifying the contents of advertisements for foods at seminars on food introduction.

Before holding the seminar, the organizer must send an application to the local Food Safety And Hygiene Office.

Within 10 working days from the date on which the complete and valid dossier is received, the competent State agency must issue the certification of the application for holding the seminar on food introduction (according to Annex 04 enclosed with this Circular); the refusal to issue the certification must be notified and explained in writing.

Article 10. Numbering food advertisement content certifications

1. The advertisement content certifications issued by the Ministry of Health (Vietnam Food Administration) shall be numbered as follows: ordinal number/year of issue/ XNQC- ATTP (for instance: 123/2008/XNQC-ATTP).

2. The advertisement content certifications issued by Food Safety And Hygiene Offices shall be numbered similarly to that issued by Vietnam Food Administration, followed by abbreviated names of provinces after “YT” (upper case). The abbreviated names of central-affiliated cities and provinces are provided in Annex 05 enclosed with this Circular. For instance: 123/2013/XNQC-YTHN.

Article 11. Validity of food advertisement content certifications

A food advertisement content certification shall be invalidated in the following cases:

1. The Notice of reception of the Declaration of conformity or the Certificate of Declaration of conformity with the food safety regulations expires.

2. The Certificate of fulfillment of food safety and hygiene conditions is revoked.

3. The composition or uses of the product is changed.

Chapter III

IMPLEMENTATION

Article 12. Effect

This Circular takes effect on April 26^th 2013.

Article 13. Transitional regulations

The applicants for food advertisements that have been issued with the Note of reception of application for advertising foods or additives before this Circular takes effect may continue the advertisements until the advertising documents are no longer valid.

Article 14. Implementation organization

The Director of Vietnam Food Administration, Directors of Services of Health central-affiliated cities and provinces are responsible for the implementation of this Circular.

Local units are recommended to report the difficulties arising during the course of implementation to the Ministry of Health (Vietnam Food Administration) for consideration and settlement./.