Circular 1/2004/ttlt/bvhtt-Byt: Guidance On Advertising Activities In The Health Sector

Original Language Title: Thông tư liên tịch 01/2004/TTLT/BVHTT-BYT: Hướng dẫn về hoạt động quảng cáo trong lĩnh vực y tế

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Circulars advertising activity in the health sector based advertising Ordinance No. 39/2001/PL UBTVQH-November 16, 2001;
Pursuant to Decree No. 24/2003/ND-CP of August 13, 2003 detailing the Government's enforcement of the Ordinance on advertising;
Pursuant to circular No. 43/2003/TT-BVHTT on 16/7/2003 of the Ministry of culture-information guide the implementation of Decree No. 24/2003/ND-CP dated 13/3/2003 detailing the Government's enforcement of the Ordinance on advertising;
Contact President Ministry of culture and information and the Ministry of health guidelines on advertising activities in the health sector are as follows: i. GENERAL PROVISIONS 1. This circular applies to organizations, individuals, organizations, Vietnam foreign individuals (hereinafter referred to as the organization or individual) active promotion in the health sector in Vietnam.
2. This circular regulates advertising conditions; records, registration of advertising; inspected, checked and processed in breach of the advertising activities in the health sector include: a) examination and treatment (including treatment, healing with traditional medicine, cosmetic surgery and rehabilitation);
b) Drugs for people;
c) cosmetics directly affects to human health;
d) vaccines, medical products;
medical equipment);
e) food;
g) chemical preparations for destroying insects, bactericide used in household and medical fields.
3. Organizations and individuals active in the field of medical ads must comply with the provisions of Ordinance No. 39/2001 ad/PL UBTVQH-16/11/2001 (hereinafter referred to as the Ordinance of advertising), Decree No. 24/2003/ND-CP dated 13/3/2003 detailing the Government's enforcement of the Ordinance (hereinafter referred to as the Decree No. 24/2003/ND-CP); Circular No. 43/2003/TT-BVHTT on 16/7/2003 of the Ministry of culture-information guide the implementation of Decree No. 24/2003/ND-CP (hereinafter referred to as the circular No. 43/2003/TT-BVHTT) and the provisions of this circular.
4. The medical facility, physician, medical staff are not to the Organization, active personal ads using the image, its nominal to advertising in the medical field.
II. ADVERTISING ACTIVITIES 1. The advertising content.
a) the advertising content of examinations and treatment to ensure the information and the following conditions:-accurate, honest, clear, authoritative scientific base, fit the ability qualifications and scope of practice were the Department of health or the Department of health;
-Name, address, telephone number (if any) of the organizations or individuals performing services;
-If the advertising content of examinations, cure has ad content about drugs, vaccines, biological medical products, medical equipment, this content must comply with the rules on advertising conditions about drugs, vaccines, biological medical products, medical equipment.
b) drug ad content for people to ensure the information and the following conditions:-the name of the drug, especially drug name (by the manufacturer), the active ingredient or the original name (the name gerenic);
-How to use, assign, contraindications, the special recommendations and things to avoid, note when using drugs;
-The name and address of the manufacturer, the drug business;
-The lyrics said "read carefully the user manual before use";
-Other necessary conditions pursuant to the Department of health.
c) cosmetic advertising content directly to human health must ensure that information and the following conditions:-the name (by the manufacturer);
-Effect (outlined the effects of cosmetics) and things to note when using cosmetic;
-The name and address of the manufacturer of cosmetics;
-Other necessary conditions pursuant to the Department of health.
d) the advertising content of vaccines, medical products to ensure the information and conditions: + name of the vaccine, medical products;
+ How to use, dosage, contraindications, side effects, and the case should note when using vaccines, medical products;
+ Name, address of the manufacturer, the vaccine business, medical products;
+ The lyrics said "used with the guidance of a medical officer";
+ The other necessary conditions pursuant to the Department of health.
DD) the advertising content of medical equipment to ensure the information and the following conditions:-the name of the medical device, which production, the registration number (if a medical device is manufactured in the country) or import licence number (if it is an imported medical devices);
-Features, effects and how to use;
-Name, address, business facilities, medical equipment, warranty, maintenance and repair of medical equipment.
e) the advertising content of foods, food additives have to ensure the information and the following conditions:-that the quality, hygiene and safety for the user as announced or signed up to the quality of food hygiene and safety;
-Work;
-Instructions for use and maintenance (for the food need to have the instructions for use and maintenance);
-The name and address of the manufacturer, the food business, food additives;
-With regard to the promotion of breast milk substitutes made according to the law about business and the use of alternative products to breast milk.
g) the advertising content of chemical insecticides, preparations used in sterilizing medical and household sectors to ensure the information and the following conditions:-the names of chemicals, insecticides, preparations used in sterilizing medical and household sectors; the number of registered products in circulation;
-The name and address of the manufacturer, the chemical business, preparations for destroying insects, bactericide used in household and medical field;
-The composition, the effect;

-Instructions for use and maintenance;
-Handling first aid emergency, when poisoned.
2. Behavioral advertising in the medical field were forbidden: a consultation ad), healing beyond professional level and scope of practice;
b) advertises the treatments not yet allowed the Ministry of health;
c) advertising of drugs, vaccines, biological medical products, medical equipment, chemicals, preparations for destroying insects, bactericide used in household and medical sector has not yet been allowed to circulate in Vietnam; poison ad, smoking addictive, psychotropic drugs, drugs are prescribed, the drug has been administered State Agency on health recommended not to be used or to be used, but must be supervised by a physician;
d) food advertising, food additives are not yet published or not yet registered quality safety and hygiene; food additives, poor quality, does not guarantee safety and hygiene; false advertising with content already published or registered; food advertising works as a drug;
ad) chemicals, insecticides product prohibits the use in household and medical field;
e) tobacco advertising in any form prescribed in resolution No. 12/2000/NQ-CP dated 14 August 2000 by the Government on national policies on the prevention of the harmful effects of tobacco during the period 2000-2010.
III. Records, REGISTRATION, PROFILE and ADVERTISING PERMIT PROCEDURE DONE ADS for ADS on the AD MEDIA MUST ASK PERMISSION i.e. advertising paperwork.
a) Ad registration record examinations, cure, medical equipment, food, chemicals, insecticides, preparations used in sterilizing medical and household sector includes:-advertising registration (form Appendix 1);
-Patient establishments, private healing, medical facility, healing with traditional medicine, private enterprises private medical equipment must have a legal copy of the certificate of eligibility to practice by the Ministry of health or the Department of health;
-For food must announce the standard must have a copy of the standard legal basis and receiving paper record published quality standards of hygiene and food safety of the competent medical authorities;
-For food must register the safety quality must have a copy of the registration certificate of the legal quality of safety and hygiene;
-For medical equipment must have documents to verify the content of the ads (if the document is in a foreign language must be translated into Vietnamese) includes the technical documentation issued by the manufacturer was the governing body of the medical equipment producer country to accept or the clinical facility , the Research Institute of Vietnam Ministry of health authorized testing acceptance;
-The authorization of the owner of a published standard of quality of product advertising (for the units authorized to carry ads);
-Product advertising in television tape recorders; audio tapes, audio discs, floppy disks, or other materials, ad makét.
b) registration documents for drug ads include:-the advertising registration (form Appendix 2);
-The form and content of advertising of drugs for people. If advertising on tv, radio stations must submit videotapes, video discs; audio tapes, audio discs. If newspaper advertising in print, electronic, they must send the ad makét;
-The document verifying the advertising content;
-The case of organizations, individual product ads suggested smoking the company's possessing the registration number issued by the Ministry of health drug levels must have written authorization or written consent to allow advertising of that company;
-Leaflet drug use has been approved by the Ministry of health;
-The reference (if any).
c) registration profile cosmetic ad that directly affect human health, including:-the advertising registration (form Appendix 2);
-The form and content of advertising. If advertising on tv, radio stations must submit videotapes, video discs; audio tapes, audio discs. If newspaper advertising in print, electronic, they must send the ad makét;
-The document verifying the advertising content.
d) registered profile advertising medical products, vaccines are:-the advertising registration (form Appendix 1);
-Forms of advertising content, vaccines, biological medical. If advertising on tv, radio stations must submit videotapes, video discs; audio tapes, audio discs. If newspaper advertising in print, electronic, they must send the ad makét;
-Legal copies of the registration certificates issued for vaccines, products intended to advertise because the Ministry of health;
-The document verifying the advertising content.
DD) the whole of the documents contained in the profile as specified at points a, b, c, d of this paragraph is marked borders of establishment units.
2. procedure for considering registration profile ads.
Organizations and individuals before making the ad must submit registration documents to the Ministry of health or the Department of health, the central cities (hereinafter referred to as the Department of health).
a) Ministry of health authorize the receiving unit, addressed promotional registration records are as follows:-the Service receiving treatment, addressing the registration profile ad about the doctor, healing of the base doctor, cure has invested abroad and the base doctor, cure has direct alien examination treatment by the method of modern medicine;

-Service of traditional medicine reception, resolving paperwork ad about the doctor, healing with traditional medicine for the medical facility, healing with traditional medicine to foreign investment and the base doctor, healing with traditional medicine have direct alien examination , healing;
-Service equipment and medical works reception, resolving application advertising for medical devices establishments medical equipment business invested abroad, medical equipment;
-The Department of preventive medicine and HIV/AIDS receive, resolve registration profile ads about vaccines, medical products, chemical substances, preparations for destroying insects, bactericide used in household and medical field;
Vietnam Pharmaceutical Management Bureau-reception, resolve registration profile ads about smoking for people;
-The food safety Bureau to receive, resolve registration documents about food advertising for foods, food additives by receiving quality, quality registration level of hygiene and food safety.
b) the Department of health to receive, resolve registration documents as follows: advertising-advertise on examination and treatment (including treatment, healing with traditional medicine, cosmetic surgery, rehabilitation) of the base doctor, healing is based on the exclusion of the cases under the jurisdiction of the Service and Service of traditional medicine-the Health Ministry under the provisions at the point of a category 2 part III of this circular.
-Advertising of medical devices of the production base, sales of medical devices based on the area except under the authority of the Service equipment and Health-Ministry of health as defined in point a category 2 part III of this circular.
-Advertising on food, food additives of the production base, the food business based on the area except under the authority of the Bureau of food safety and hygiene-Health Ministry as defined in point a category 2 part III of this circular.
-Advertisement of cosmetic directly affects to human health of the production base of business, cosmetics based on the area.
3. The order of consideration of the registration ad.
a) after receiving the registration profile advertising, the agency receiving the records sent to the unit, the registered individual receiving paper advertising profile (form Appendix 3). After 10 working days from the date indicated on the receipt Paper records, if the receiving agency records without written request modification, then additional units, individuals register ad is right according to the advertising content was registered.
b) where the receiving agency records See record registration of advertising is not yet valid, then notify the individual unit sign advertising to supplement or complete records.
c) where the receiving agency profile request in writing amendments and supplements shall in writing are outlined specifically added the document, modify the content.
d) upon receipt of a written request to amend, Supplement, units, individuals register ad must modify, Supplement according to the content outlined in writing and sent to the receiver records the advertising content has been modified and supplemented. After receiving the revised profile, additions, receiver records sent to the unit, the registered individual receiving Paper advertising profile (form Appendix 3). After 10 working days from the date indicated on the receipt Paper records, if the Agency receives text none profile require modification, Supplement, the individual units are advertised as the content was modified.
DD) unit case, registered personal ads with additional amendments but not right with the content in the text requires amendment, addition of the receiver, the receiver records the profile will inform the unit, individuals register ad is not being advertised by the registered content.
4. Records, permit procedures make ads for ads in the health sector on the advertising media must ask permission.
Applying for license for ads with ads in the health sector on the advertising media must ask permission to follow the provisions in circular No. 43/2003/TT-BVHTT.
5. The unit register the ad must file charges, registration fees prescribed in the current ad.
IV. ENFORCEMENT of TERMS i. inspections, checking and handling of violations.
a) inspection, check the medical inspector and Inspector culture-information in the function, the tasks are responsible for independently or in coordination with other organizations examined, inspected about ads in the health sector, and processed the offense under the provisions of the law.
b) handle violation of: the Organization, the individual has violated the provisions of this circular, depending on the level of violation will be disciplined, sanctioning administrative violations, criminal prejudice, if damage to compensation under the provisions of the law.
2. Implementation.
a) Ministry of culture information in the scope of functions, the mission is responsible for coordinated with the Ministry of Health implemented the function of State management of advertising in the medical field.
b) the Ministry of health has the responsibility to guide the Directorate, Service functions, the Department of health made the reception profile and granting registration to receive advertising.
3. The effect of the circular.

This circular effect after 15 days from the date The report. The regulations of the Ministry of health and Ministry of culture-information on advertising in medical field as opposed to this circular are repealed.
The Ministry of health is responsible for the study to amend, supplement information regulation for drug advertising, cosmetic direct influence to human health attached to decision No. 2557/2002/QD-BYT on 4/7/2002 of the Minister of health and circular No. 12/2002/TT-BYT on 23/8/2002 of the Ministry of health guide vaccine business ads medical products, in accordance with the provisions of the Ordinance on advertisement, Decree No. 24/2003/ND-CP, circular No. 43/2003/TT-BVHTT and instructions of circular.

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