Thông tư 08/2013/TT-BYT về quảng cáo thực phẩm thuộc phạm vi quản lý của Bộ Y tế

 THE MINISTRY OF FINANCE

Circular No.08/2013/TT-BYT dated March 13, 2013 of the Ministry of Health guiding on food advertisement under management scope of the Ministry of Health

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

Pursuant to the Law No. 55/2010/QH12 dated June 17, 2012 of the National Assembly on food safety and the Decree No. 38/2012/ND-CP dated April 25, 2012 of the Governmentdetailing the implementation of articles of the Law on food safety;

Pursuant to the Decree No. 63/2012/ND-CPdated August 31, 2012 of the Government defining the functions, tasks, powers and organizational structure of the Ministry of Health;

At the proposal of the Head of Food Safety Department;

The Ministry of Health issues the Circular guiding on food advertisement in the management scope of the Ministry of Health,

Chapter I

GENERAL PROVISIONS

Article 1.  Regulation scope

1. This Circular take regulations on conditions, authorities, dossiers, and procedures for certifying the contents of food advertisements under the management scope of the Ministry of Health.

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

Article 2.  Types of food must register advertisement’s contents as follows:

1. Functional foods;

2. Micronutrient-fortified foods;

3. Mineral water;

4. Bottled water;

5. Food additives, food processing aids;

6. Materials for packing food in preparation, production, and trade;

Article 3. Prohibited acts in food advertisement

1. Food advertisement without the confirmation certificate of advertisement contents issued by authorized health agencies.

2. Advertisements for foods that are counterfeits or low quality goods.

3. Advertisements for foods as medicines.

4. Food advertisements is not suitable with public contents or conformed with regulations on food safety or the advertisement exceeds food’s effects.

5. Food advertisements under article forms that are written by doctors, pharmacists, medical workers describing the effects of foods in disease treatment.

6. Use images, reputation, letters from health agencies, medical officers and thanks letter from patients with the purpose for food advertisement.

7. Other prohibited actions prescribed by laws on advertising.

Chapter II

CONDITIONS, AUTHORITIES, DOSSIERS, AND PROCEDURES FOR CERTIFYING FOOD ADVERTISEMENT’S CONTENT

Article 4. Requirements for food advertisement’s contents

1. The advertisement’s contents on the mass media, leaflets, posters, and billboards must be consistent with food’s public affects; it is compulsory to have scientific documents for proving beside public contents, the information must satisfy the accuracy as follows:

a) Product’s name;

b) Origin of product, names of producer and importer;

c) Product’s effects (if any);

d) Using warnings (if any);

dd) User guide, preservation instruction (products that have special usage and preservation).

e) It is compulsory to notice in words or sound  “This product is not medicine and cannot replace medicine in disease treatment” in functional products, this notice in words must be in Time New Roman 14, the notice in sound must be audible in normal conditions.

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

Article 5. Authority to issue confirmation certificates for food advertisement’s contents, applications for holding seminars, workshops on food introduction

1. The Ministry of Health appoints Food Safety Department to issue confirmation certificates to functional foods andmicronutrient-fortified foods.

2. Food Safety And Hygiene Offices shall issue confirmation certificate for advertisement’s content directly under the management of health agencies as follows: 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 dossier for confirmation certificate of advertisement’s contents

Organizations and individual shall send an application dossier for advertisement to authorized state agencies.

The application dossier includes:

1. The written application for confirmation certificate of food advertisement’s contents (prescribed in Appendix 01);

2. Business Registration Certificate or Permit to establish representative office for foreign businessmen (sealed copy of organization or individual applying for advertisement’s content).

3. The Certificate of conformity declaration with food safety regulations (applicable to the products without technical standards) or the reception notice of the conformity declaration issued by a authorized state agency (sealed copy of organization or individual applying for advertisement’s content);

4. Detailed information shall be confirmed by authorized agency (sealed copy of organization or individual applying for advertisement’s content);

5. Products of food advertisements:

a) 01 description of the advertisement’s contents in a computer disc enclosed with 02 scripts (sealed copy of organization or individual applying for advertisement’s content), applicable to advertisement on radio, television, and movies.

b) 02 Marquette of the advertisement’s contents (sealed copy of organization or individual applying for advertisement’s content) 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’s contents in case the advertisement’s contents are not provided in the product’s information, certified by a authorized agency. Documents in foreign languages must be translated into Vietnamese.

All documents must be sealed by organization or individual applying for advertisement’s content.

7. The label design approved by a authorized health agencies (sealed copy of organization or individual applying for advertisement’s content).

Article 7. Procedure for certify food advertisement’s contents

1. Within 10 working days from the date on which the complete and valid dossier is received, the authorized state agency must issue confirmation certificate of advertisement’s contents (in accordance with Appendix 02); the refusal to issue confirmation certificate of advertisement’s contents must be notified and explained in writing by the authorized state agency.

2. If the applicant fails to amend or supplement the dossier without explanation within 03 months from the date that authorized agencies send the request for amendment or supplementation, the applicant shall be cancelled 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 organizations in Vietnam or individual that has an valid Business Registration Certificate 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 certificate of seminar’s content must be sent to an authorized state agency, and the seminar is only held after the certificate issued by the authorized state agency.

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

Article 9. Dossier 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 (in accordance with Appendix 3);

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

c) The Certificate of Standard or the Notice of reception of the conformity declaration 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 sealed copy by the seminar organizer);

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

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

e) 02 Marquette or scripts or brochures, certified and sealed by the seminar organizer (attached soft copies) at the seminar;

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

h) The reference materials and scientific documents proving the advertisement’s contents in case the advertisement’s contents are not provided in the product information sheet certified by authorized 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 (in accordance with Appendix 04); the refusal to issue the certification must be notified and explained in writing.

Article 10. Numbering confirmation certificate of food advertisement

1. Confirmation certificate of food advertisement issued by the Ministry of Health (Vietnam Food Safety Department) shall be numbered as follows: ordinal number/year of issue/ XNQC- ATTP (for instance: 123/2008/XNQC-ATTP).

2. Confirmation certificate of food advertisement issued by Food Safety and Hygiene Offices shall be numbered similarly to that issued by Vietnam Food Safety Department, followed by abbreviated names of provinces after “YT” (upper case). The abbreviated names of central-affiliated cities and provinces are provided in Appendix 05. For example: 123/2013/XNQC-YTHN.

Article 11. Validity of confirmation certificate of food advertisement

A confirmation certificate of food advertisementshall be invalidated in the following cases:

1. The reception notice of conformity declaration or the Certificate of conformity declaration with the food safety regulations expires.

2. The Certificate 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, 2013.

Article 13. Transitional regulations

The applicants for food advertisements that have been issued with the reception note 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 Safety Department, Directors of Health Departments of provinces and municipal cities shall implement this Circular.

Any arising difficulties or problems in the course of implementation, local units are recommended to submit to the Ministry of Health (Vietnam Food Safety Department) for consideration and settlement./.

The Minister of Health
Nguyen Thi Kim Tien

* All appendices are not attached here