Joint circular No. 01/2004/TTLT-BVHTT-BYT of January 12, 2004, guiding on advertising activities in the health sector

JOINT CIRCULAR

GUIDING ON ADVERTISING ACTIVITIES IN THE HEALTH SECTOR 

Pursuant to Ordinance on Advertisement No.39/2001/PL-UBTVQH10 of November 16, 2001;

Pursuant to Government’s Decree No.24/2003/ND-CP dated March 13th, 2003 detailing the implementation of the Ordinance on Advertisement;

Pursuant to the Culture and Information Ministry s Circular No.43/2003/TT-BVHTT dated July 16, 2003, guiding the implementation of Government’s Decree No.24/2003/ND-CP dated March 13th, 2003 detailing the implementation of the Ordinance on Advertisement;

The Ministry of Culture and Information, and the Ministry of Health guides on advertising activities in the health sector as follows:

I. GENERAL PROVISIONS

1. This Joint Circular shall apply to Vietnamese organizations and individuals as well as foreign organizations and individuals (hereinafter referred to as organizations, individuals) engaged in advertising activities in the health sector in Vietnam.

2. This Joint Circular stipulates advertising conditions; dossiers, procedures for registration of advertising; inspection, examination and handling of violations of advertising activities in the health sector including:

a) Medical examination and treatment (including examination and treatment by traditional medicine, aesthetic surgery and rehabilitation);

b) Medicines for human use;

c) Cosmetics directly affecting human health;

d) Vaccines, medical biological products;

đ) Medical equipment;

e) Food;

g) Chemical insecticides, disinfectants for domestic and healthcare use.

3. The Organizations and individuals engaging in advertising activities in the health sector must comply with the provisions of Ordinance on Advertisement No.39/2001/PL-UBTVQH10 of November 16, 2001 (hereinafter referred to as the Ordinance on Advertisement), Decree No.24/2003/ND-CP dated March 13th, 2003 of the Government detailing the implementation of the Ordinance on Advertisement (hereinafter referred to as Decree No.24/2003/ND-CP); Circular No.43/2003/TT-BVHTT dated July 16, 2003 of the Ministry of Culture and Information, guiding the implementation of Government’s decree No. 24/2003/ND-CP (hereinafter referred to as Circular No.43/2003/TT-BVHTT) and the provisions of this joint Circular.

4. The health facilities, physicians, healthcare staffs are not allowed to let the organizations and individuals engaging in advertising activities use their images, their names for advertising in the health sector.

II. ADVERTISING ACTIVITIES

1. The contents of advertisement.

a) The content of advertisements of examination and treatment must ensure the following information and conditions:

- Accuracy, truthfulness, clearness, accurate scientific basis, consistent with the with the professional qualifications, businessline scope which are permited by the Ministry of Health or the Health Department;

- Name, address, telephone number (if any) of the organizations or individuals performing services of medical examination and treatment;

- If the contents of advertisements on medical examination and treatment related to drugs, vaccines and medical biological products, medical equipment, these contents are subject to the provisions on conditions of advertising on drugs, vaccines and medical biological products, medical equipment.

b) The content of advertisements of medicines for human use must ensure the following information and conditions:

- Medicine’s name, proprietary medicine’s name (set by the manufacturer), the name of the active ingredient, or generic name;

- Usage, indications, contraindications, special warnings, avoidings, treatment notes;

- Name and address of medicine manufacturers, traders;

- Note: "Read the manual before using";

- The other necessary conditions as stipulated by the Ministry of Health.

c) The content of cosmetics advertisements directly affecting human health must ensure the following information and conditions:

- Cosmetic name (set by the manufacturers);

- The effects (main cosmetic effects) and the notes when using cosmetics;

- Name and address of the cosmetic’s manufacturers;

- The other necessary conditions as stipulated by the Ministry of Health.

d) The contents of advertisements of vaccines and medical biological products must ensure the following information and conditions:

+ Name of vaccines and medical biological products;

+ Usage, dosage, indications, contraindications, side effects, and the cases to be considered when using vaccines, medical biological products;

+ Name and address of the manufacturers, the traders of vaccines and medical biological products;

+ Advice "Use with medical staff’s guidance";

+ The other necessary conditions as stipulated by the Ministry of Health.

đ) The content of advertisements of medical equipment must ensure the following information and conditions:

- Name of medical equipment, the production place, circulation registration numbers (if medical equipment manufacturered domestically) or import permit numbers (for imported medical equipment);

- Features, effects and usage;

- Name and address of the manufacturers and traders of medical equipment, warranty, maintenance, and repair of medical equipment.

e) The contents of advertisement of food, food additives must ensure the following information and conditions:

- Truthful quality, hygiene, and safety for users as announced or registered quality of food hygiene and safety;

- Effects;

- Guidance of usage and preservation (for food which requires the usage manual and preservation);

- Name and address of manufacturers, traders of food, food additives;

- For the breast milk substitutes, the advertisements must comply with laws on trading and using of breastmilk substitutes.

g) The contents of advertisement of chemical insecticides, disinfectants used in domestic appliances and health must ensure the following information and conditions:

- Chemical name, chemical insecticides, disinfectants for domestic appliances and health; registration number for circulating products;

- Name and address of manufacturers, traders of chemicals, insecticides, disinfectants for domestic use and health;

- Composition and effect;

- Guidance of usage and preservation;

- Treatment of first aid, emergency treatment when being poisonned.

2. The prohibited advertisements in health sector are:

a) Medical examination and treatment advertisements beyond the professional qualifications or the scope of practice;

b) Advertisements of the remedies which have not been yet allowed by the Ministry of Health;

c) Advertisements for medicines, vaccines and medical biological products, medical equipment, chemicals, insecticides, disinfectants for domestic use and medical use which are not permitted for circulation in Vietnam; Advertisements of toxic medicines, narcotics, psychotropic medicines, prescription medicines, medicines which are not permitted, by state management agencies, for use or used but must be supervised by physicians.

d) Advertisements of food, food additives which have not been published yet or registered on quality, hygiene and safety; food and food additives which are poor quality, not guaranteeing safety; false advertising of published or registered content; advertisements of food which its effect is likely a type of medecine;

đ) Advertisements of chemicals, insecticides which are banned in domestic appliances and health sector;

e) Advertisements of tobacco in any form as stipulated in the Resolution No.12/2000/NQ-CP dated August 14, 2000 by the Government on National policy on prevention and combat of the harmful effects of tobacco during the period of 2000 - 2010.

III. DOSSIERS, PROCEDURES FOR REGISTRATION OF ADVERTISING AND DOSSIERS, PROCEDURES FOR PERMITS TO PERFORM ADVERTISEMENT ON THE MUST-BE-PERMITED MEANS OF ADVERTISEMENT

1. Advertisement registration dossier.

a) Advertisement registration dossier of medical examination, medical treatment, medical equipment, food, chemical insecticides, disinfectants for domestic use and medical use, including:

- Written Registration for advertisement (as the form of Appendix 1);

- For private facilities of medical examination, medical treatment; private facilities of traditional medical examination, medical treatment; private medical equipment manufacturing companies: It is necessary to have a valid copy of certificate of sufficient practice conditions issued by the Ministry of Health or the Department of Health;

- For the must-have-standard food, it is necessary to have a valid copy of the facility’s standards and receipt of document for publishing quality standards of food hygiene and safety of the competent health agency;

- For the must-have-hygiene-and-safety quality registration food, it is necessary to have a valid copy of certificate of quality registration of hygiene and safety;

- For medical equipment, it is necessary to have documents to verify the contents of advertisements (if documents are in foreign language, they must be translated into Vietnamese) including technical documentation, issued by the manufacturers, accepted by medical equipment management agency of producing countries or by clinical facilities, research institutes that are authorized by Vietnam Ministry of Health;

- Written authorization of the owner of the publication of quality standards of advertised products (for units authorized for performing advertisement);

- Advertised products recorded in video tapes, video discs, audio tapes, audio discs, floppy disks, or other materials, advertisement layout.

b) Advertisement registration dossier for human medicine includes:

- Advertisement Registration Form (as prescribed in Appendix 2);

- The form and contents of advertisement of medicines for human use: If advertised on television or radio, videotapes, video discs, audio tapes, audio discs must be included. If advertised on the print press or E-press, the advertisement layout must be included;

- Documents verifying the content of advertising;

- If the organizations or individuals request for the advertisement of medecine products of the company owning the circulation registration of medicines, issued by the Ministry of Health, must have written authorization or written approval for the company s advertising;

- Written usage instructions approved by the Ministry of Health;

- The reference (if any).

c) Advertisement registration dossier for cosmetic directly impacting on human health includes:

- Advertisement Registration Form (as prescribed in Appendix 2);

- The form and content of advertisement of cosmetic: If advertised on television or radio, videotapes, video discs, audio tapes, audio discs must be included. If advertised on the print press or E-press, the advertisement layout must be included;

- Documents verifying the contents of advertisements.

d) Advertisement registration dossier for vaccines, medical biological products, includes:

- Advertisement Registration form (as prescribed in Appendix 1);

- The form and content of advertising vaccines, medical biologicals products. If advertised on television or radio, videotapes, video discs, audio tapes, audio discs must be included. If advertised on print press or E-press, the advertisement layout must be included;

- A valid copy of certificate of registration for distribution of vaccines and medical biological products which are intended to advertise, issued the Ministry of Health;

- Documents verifying the contents of advertisements.

đ) All documents in the dossiers as prescribed at points a, b, c, d of this clause shall be sealed joint pages stamp by the applicant.

2. Procedures for consideration of advertisement registration dossiers.

Before organizations and individuals perform the advertising, they shall submit advertisement registration dossiers to the Ministry of Health or to the Health Departments of provinces or cities under central authority (hereinafter referred to as the Health Departments).

a) Ministry of Health authorises the units receiving and settling registration dossiers for advertisements as follows:

- The Department of Therapy shall receive, settle the advertisement registration dossiers of medical examination, medical treatment units, which have foreign-invested capital and the medical examination, medical treatment units which have foreigners directly examining, making treatment with modern medicine methods;

- The Department of Traditional Medicine shall receive and settle the advertisement registration dossiers on medical examination, treatment by traditional medicine of the medical examination, treatment units by traditional medicine with foreign-invested capital and of the one which have foreigners directly examining, treating;

- The Department of Equipment and Medical Works shall receive and settle the advertisement registration dossiers for the medical equipment of the traders with foreign-invested capital, or imported medical equipment;

- The Department of Preventive Health and HIV/AIDS shall receive and settle the advertisement registration dossiers of vaccines, medical biological products, chemicals, insecticides, disinfectants for domestic use and medical use;

- The Vietnam Drug Administration shall receive and settle the advertisement registration dossiers of medecines for human use;

- The Department of Hygiene and Safety of Food shall receive and settle the advertisement registration dossiers of food, food additives which are received by this agency for publishing quality, granting registration of food hygiene and safety quality.

b) The Health Department shall receive and settle advertisement registration dossiers as follows:

- Advertisements on medical examination, treatment (including examination and treatment by traditional medicine, cosmestic surgery, rehabilitation) of the medical examination and treatment facilities based on the area, excepting for the cases under the jurisdiction of the Department of Therapy and the Department of Traditional Medicine - Ministry of Health under the provisions of point a, item 2, Part III of this Joint Circular.

- Advertisements on the medical equipment of the facilities manufacturing, trading medical equipment based in the area, excepting for the cases under the jurisdiction of the Department of Equipment and medical works – Ministry of Health under the provisions of point a, item 2, Part III of this Joint Circular.

- Advertisements on food, food additives of the facilities manufacturing, trading food based in the area, excepting for the cases under the jurisdiction of the The Department of Hygiene and Safety of Food – the Health Ministry under the provisions of point a, item 2, Part III of this joint Circular.

- Advertisements on cosmetics directly affecting human health of the manufacturers, traders based in the area.

3. The order for consideration of advertisement registration.

a) After receiving of valid advertisement registration dossier, the receiving agency sent the receipt to the registered units or individuals (as prescribed form in Appendix 3). After 10 working days from the date stated in the receipt of the dossier, if the receiving agency makes no written requests for amendment and supplement, the units or individuals shall have the right to advertise upon the contents already registered.

b) In cases the receiving agency sees that the advertisement registration dossier is invalid, the agency informs to the registered units or individuals to supplement or complete the dosiers.

c) In cases the receiving agencies having written request for amendment and supplement, the written request must state clearly the must-be-supplemented documents, must-be-amended contents.

d) Upon receiving the written request for amendment, supplement, the units, or individuals of advertisement registration shall amend or supplement in accordance with the contents of the written request and sent it to the receiving agency. After receiving the amended and supplemented doccuments, the receiving agency of the dossier sends to registered units or individuals the receipt (as prescribed form in Appendix 3). After 10 working days from the date stated on the receipt of the dossier, if the receiving agency make no written request for amendment and supplement, the units or individuals shall have the right to advertise upn the contents already revised.

đ) In cases the units or individuals registering advertisement amend and supplement but not complying with the contents of the written request for amendment and supplement of the agencies receiving the dossiers, the receiving agencies will inform the registered units or individuals not to advertise the registerd contents.

4. Dossiers and procedures for requesting for permit of performing advertisement in the health sector on the advertising Medias required permission.

The application for permit of advertising in the health sector on the advertising Medias required permission is followed the provisions of Circular No.43/2003/TT-BVHTT.

5. The advertisement registration units must pay fee, charge for registration of advertisement according to the curent regulations.

IV. IMPLEMENTING PROVISIONS

1. Inspection, examination and handling of violations.

a) Inspection, examination

Within assigned Inspectors of Health and Culture – Information’s functions and duties shall be independently responsible for or coordinating with each other to organize the inspection, examination of advertisements in the health sector and handle the violations according to law regulations.

b) Handling of violations:

Organizations and individuals violating the provisions of this Joint Circular, depending on the seriousness of their violations, shall be disciplined, administrative penaltised, prosecuted penal liability; if causing damages, they shall pay the compensation as prescribed by law regulations.

2. Organization of implementation.

a) Within the Ministry of Culture and Information’s functions and duties shall preside over and coordinate with the Ministry of Health to perform the function of State management over advertisement in the health sector.

b) Ministry of Health is responsible for guiding the Derectorates, function Departments, the Health Departments in receiving dossiers and granting advertisement registration certificate.

3. Effect of the Circular.

This Joint Circular takes effect 15 days after its publication in the Official Gazette. The previous provisions of the Health Ministry and the Ministry of Culture - Information on advertisement in the health sector contrary to this Circular are now all annulled.

Ministry of Health is responsible for research to modify and supplement the Regulation of Information advertising medecines for human use and cosmetics directly affecting human health, issued together with Decision No.2557/2002/QD-BYT dated 04/7/2002 of the Minister of Health and Circular 12/2002/TT-BYT dated 23/8/2002 of the Ministry of Health, guiding advertisement of vaccines and medical biological products as appropriated with the provisions of the Advertisement Ordinance, Decree No.24/2003/ND-CP, Circular No.43/2003/TT- BVHTT and te guidances of this Circular.