Joint Circular No. 01/2004/TTLT/BVHTT-BYT guiding advertising activities in the healthcare sector

CIRCULAR

Guidelines on advertising activities in the healthcare sector

Based on the Advertising Ordinance No. 39/2001/PL-UBTVQH dated November 16, 2001;

Pursuant to Decree No. 24/2003/NĐ-CP dated March 13, 2003 of the Government detailing the implementation of the Advertising Ordinance;

Based on Circular No. 43/2003/TT-BVHTT dated July 16, 2003 of the Ministry of Culture, Sports and Tourism guiding the implementation of Decree No. 24/2003/NĐ-CP dated March 13, 2003 of the Government detailing the implementation of the Advertising Ordinance;

The Ministry of Culture, Sports and Tourism and the Ministry of Health jointly issue guidelines on advertising activities in the healthcare sector as follows:

I. GENERAL PROVISIONS

1. These joint circulars apply to organizations and individuals in Vietnam, foreign organizations and individuals (hereinafter referred to collectively as organizations and individuals) engaging in advertising activities in the healthcare sector in Vietnam.

2. These joint circulars stipulate conditions for advertising; procedures for registering advertisements; inspection, supervision, and handling of violations related to advertising activities in the healthcare sector including:

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

b) Medicines for humans;

c) Cosmetics directly affecting human health;

d) Vaccines, medical products;

đ) Medical equipment;

e) Food;

g) Chemical insecticides and bactericides used in household and healthcare settings.

3. Organizations and individuals engaged in advertising activities in the healthcare sector must comply with the provisions of the Advertising Ordinance No. 39/2001/PL-UBTVQH dated November 16, 2001 (hereinafter referred to as the Advertising Ordinance), Decree No. 24/2003/NĐ-CP dated March 13, 2003 of the Government detailing the implementation of the Advertising Ordinance (hereinafter referred to as Decree No. 24/2003/NĐ-CP); Circular No. 43/2003/TT-BVHTT dated July 16, 2003 of the Ministry of Culture, Sports and Tourism guiding the implementation of Decree No. 24/2003/NĐ-CP (hereinafter referred to as Circular No. 43/2003/TT-BVHTT) and the provisions of these joint circulars.

4. Healthcare facilities, doctors, healthcare staff shall not allow organizations and individuals engaged in advertising activities to use their images or names for advertising in the healthcare sector.

II. ADVERTISING ACTIVITIES

1. Content of advertising.

a) The content of advertising about medical examination and treatment must ensure the following information and conditions:

- Accurate, truthful, clear, based on credible scientific grounds, consistent with the professional qualifications and scope of practice permitted by the Ministry of Health or the Department of Health;

- Name, address, telephone number (if available) of the organization or individual providing the medical examination and treatment service;

- If the advertising content about medical examination and treatment includes advertising about medicines, vaccines, medical products, medical equipment, such content must comply with the regulations on conditions for advertising about medicines, vaccines, medical products, medical equipment.

b) The content of advertising about medicines for humans must ensure the following information and conditions:

- Name of the medicine, brand name (set by the manufacturer), active ingredient or generic name;

- Usage instructions, indications, contraindications, special warnings, and precautions when using the medicine;

- Name, address of the medicine manufacturer or distributor;

- Warning "Read the usage instructions carefully before use";

- Other necessary conditions as prescribed by the Ministry of Health.

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

- Name of the cosmetic (set by the manufacturer);

- Effects (mentioning the main effects of the cosmetic) and precautions when using the cosmetic;

- Name, address of the cosmetic manufacturer;

- Other necessary conditions as prescribed by the Ministry of Health.

d) The content of advertising about vaccines and medical products must ensure the following information and conditions:

+ Name of the vaccine, medical product;

+ Usage instructions, dosage, indications, contraindications, side effects, and precautions when using the vaccine, medical product;

+ Name, address of the vaccine, medical product manufacturer or distributor;

+ Warning "Use under the guidance of healthcare personnel";

+ Other necessary conditions as prescribed by the Ministry of Health.

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

- Name of the medical equipment, place of manufacture, registration number for circulation (if domestically produced) or import permit number (if imported);

- Features, functions, and usage instructions;

- Name, address of the medical equipment manufacturer or distributor, warranty, maintenance, repair services for medical equipment.

e) The content of advertising about food and food additives must ensure the following information and conditions:

- Quality and safety for human consumption as declared or registered;

- Effects;

- Usage and storage instructions (for food, usage and storage instructions must be provided);

- Name, address of the food or food additive manufacturer or distributor;

- For advertising substitute milk products, follow the laws governing the sale and use of substitute milk products.

g) The content of advertising about chemical insecticides and bactericides used in household and healthcare settings must ensure the following information and conditions:

- Name of the chemical, insecticide, bactericide used in household and healthcare settings; registration number for circulation of the product;

- Name, address of the chemical, insecticide, bactericide manufacturer or distributor used in household and healthcare settings;

- Composition, function;

- Usage and storage instructions;

- First aid and emergency treatment for poisoning.

2. Prohibited advertising behaviors in the healthcare sector:

a) Advertising medical examination and treatment beyond professional qualifications and scope of practice;

b) Advertising unapproved disease treatment methods;

c) Advertising medicines, vaccines, medical products, medical equipment, chemical insecticides, and bactericides used in household and healthcare settings that have not been approved for circulation in Vietnam; advertising controlled substances, narcotics, psychotropic drugs, prescription-only drugs, or drugs recommended by health authorities not to be used or to be used only under medical supervision.

d) Advertising food and food additives that have not been announced or registered for quality and safety; substandard food and food additives that do not meet hygiene and safety requirements; advertising that is inconsistent with the content already announced or registered; advertising food with effects similar to those of drugs;

đ) Advertising chemicals and insecticides prohibited for use in household and medical fields;

e) Advertising tobacco products in any form as prescribed in Resolution No. 12/2000/NQ-CP dated August 14, 2000 of the Government on National Policy on Prevention and Control of Harmful Effects of Tobacco for the period 2000-2010.

III. DOCUMENTS AND PROCEDURES FOR REGISTRATION OF ADVERTISEMENTS AND APPLICATIONS FOR PERMITS TO CONDUCT ADVERTISEMENTS ON MEDIA REQUIRING PERMITS
DOCUMENTS AND PROCEDURES FOR REGISTRATION OF ADVERTISEMENTS AND APPLICATIONS FOR PERMITS TO CONDUCT ADVERTISEMENTS ON MEDIA REQUIRING PERMITS
III. DOCUMENTS AND PROCEDURES FOR REGISTRATION OF ADVERTISEMENTS AND APPLICATIONS FOR PERMITS TO CONDUCT ADVERTISEMENTS ON MEDIA REQUIRING PERMITS

I. Documents for registration of advertisements.

a) Documents for registration of advertisements for medical examination and treatment, medical equipment, food, chemicals, insecticides, and disinfectants used in household and medical fields include:

- Advertisement registration form (according to Appendix 1);

- For private medical examination and treatment facilities, private traditional medicine examination and treatment facilities, and private medical equipment manufacturing enterprises, a certified copy of the certificate of qualification issued by the Ministry of Health or the Department of Health is required;

- For food that must be announced according to standards, a certified copy of the standard and the receipt of the application for announcement of food quality and safety standards from the competent health authority is required;

- For food that must be registered for quality and safety, a certified copy of the certificate of registration for quality and safety is required;

- For medical equipment, verification documents for the advertisement content (if in a foreign language, it must be translated into Vietnamese) including technical documents issued by the manufacturer and accepted by the medical equipment management authority of the producing country or clinical bases and research institutes authorized by the Vietnamese Ministry of Health to conduct trials;

- Authorization letter from the entity owning the product's quality announcement (for entities authorized to conduct the advertisement);

- Advertised products recorded on video tapes, CDs; audio tapes, audio CDs, floppy disks, or other materials, advertisement designs.

b) Documents for registration of advertisements for human-use medicines include:

- Advertisement registration form (according to Appendix 2);

- Form and content of the advertisement for human-use medicines. If the advertisement is on television or radio, video tapes, CDs; audio tapes, audio CDs must be sent. If the advertisement is in print media or online, advertisement designs must be sent;

- Verification documents for the advertisement content;

- In cases where organizations or individuals request to advertise human-use medicines of companies holding registration certificates for circulation issued by the Ministry of Health, authorization letters or consent letters for advertising from such companies are required;

- The drug usage guide approved by the Ministry of Health;

- Reference materials (if available).

c) Documents for registration of advertisements for cosmetics directly affecting human health include:

- Advertisement registration form (according to Appendix 2);

- Form and content of the advertisement for cosmetics. If the advertisement is on television or radio, video tapes, CDs; audio tapes, audio CDs must be sent. If the advertisement is in print media or online, advertisement designs must be sent;

- Verification documents for the advertisement content.

d) Documents for registration of advertisements for vaccines and medical supplies include:

- Advertisement registration form (according to Appendix 1);

- Form and content of the advertisement for vaccines and medical supplies. If the advertisement is on television or radio, video tapes, CDs; audio tapes, audio CDs must be sent. If the advertisement is in print media or online, advertisement designs must be sent;

- A certified copy of the registration certificate for circulation of the vaccine or medical supply intended to be advertised, issued by the Ministry of Health;

- Verification documents for the advertisement content.

đ) All documents in the file as stipulated in points a, b, c, and d of this clause must bear the stamp of the entity preparing the file.

2. Procedures for reviewing advertisement registration dossiers.

Organizations and individuals must submit the advertisement registration documents to the Ministry of Health or the Department of Health of the provincial or centrally-administered city (hereinafter referred to as the Department of Health) before conducting the advertisement.

a) The Ministry of Health delegates the following units to receive and process advertisement registration documents:

- The Treatment Department receives and processes registration documents for advertisements related to medical examination and treatment for medical facilities with foreign investment capital and medical facilities with foreign nationals directly examining and treating patients using modern medical methods;

- The Traditional Medicine Department receives and processes registration documents for advertisements related to medical examination and treatment using traditional medicine for traditional medicine facilities with foreign investment capital and traditional medicine facilities with foreign nationals directly examining and treating patients;

- The Medical Equipment and Construction Department receives and processes registration documents for advertisements related to medical equipment for medical equipment business facilities with foreign investment capital and imported medical equipment;

- The Preventive Health and HIV/AIDS Control Department receives and processes registration documents for advertisements related to vaccines, medical supplies, chemicals, insecticides, and disinfectants used in household and medical fields;

- The Vietnam Drug Administration receives and processes registration documents for advertisements related to human-use medicines;

- The Food Safety and Hygiene Department receives and processes registration documents for advertisements related to food for types of food and food additives received for quality announcement and quality and safety registration by the Department.

b) The Department of Health receives and processes registration documents as follows:

- Advertisements about medical examination and treatment (including traditional medicine, aesthetic surgery, and rehabilitation) for medical facilities located within its jurisdiction, except for cases under the authority of the Treatment Department and the Traditional Medicine Department of the Ministry of Health as stipulated in point a, Section 2, Part III of this Circular.

- Advertisements for medical equipment for medical equipment production and trading facilities located within its jurisdiction, except for cases under the authority of the Medical Equipment and Construction Department of the Ministry of Health as stipulated in point a, Section 2, Part III of this Circular.

- Advertising for food and food additives from food production and business establishments with headquarters within the jurisdiction, except for cases under the authority of the Food Safety Agency - Ministry of Health as provided for in point a, Section 2, Part III of this Joint Circular.

- Advertising for cosmetics that directly affect human health from cosmetic production and business establishments with headquarters within the jurisdiction.

3. Procedure for examining advertising registration.

a) After receiving a valid advertising registration application, the agency receiving the application shall issue to the entity or individual applying for advertising a receipt for the application (according to Form Appendix 3). Within ten working days from the date recorded on the Receipt for Application, if the agency receiving the application does not issue a document requesting amendments or supplements, the entity or individual applying for advertising has the right to advertise according to the content registered.

b) In case the agency receiving the application finds the advertising registration application incomplete, it shall notify the entity or individual applying for advertising to supplement or complete the application.

c) In case the agency receiving the application issues a document requesting amendments or supplements, such document must specify in detail which additional documents are required and what contents need to be amended.

d) Upon receiving a document requesting amendments or supplements, the entity or individual applying for advertising must amend or supplement according to the contents specified in that document and submit the amended or supplemented advertising content back to the agency receiving the application. After receiving the amended or supplemented application, the agency receiving the application shall issue to the entity or individual applying for advertising a Receipt for Application (according to Form Appendix 3). Within ten working days from the date recorded on the Receipt for Application, if the agency receiving the application does not issue a document requesting amendments or supplements, the entity or individual may advertise according to the amended content.

đ) In case the entity or individual applying for advertising amends or supplements but does not comply with the contents specified in the document requesting amendments or supplements issued by the agency receiving the application, the agency receiving the application will notify the entity or individual applying for advertising that they cannot advertise according to the registered content.

4. Documents and procedures for obtaining a permit to implement advertising for advertising in the field of healthcare on advertising media must be applied for.

The procedure for obtaining a permit to implement advertising for advertising in the field of healthcare on advertising media must be carried out in accordance with the provisions of Circular No. 43/2003/TT-BVHTT.

5. Entities applying for advertising must pay registration fees and charges in accordance with current regulations.

IV. IMPLEMENTATION PROVISIONS

I. Inspection, supervision, and handling of violations.

a) Inspection and supervision

The Health Inspectorate and the Culture and Information Inspectorate, within their respective functions and duties, have the responsibility to independently or jointly organize inspections and supervisions regarding advertising in the field of healthcare and handle violations according to the provisions of the law.

b) Handling of violations:

Organizations and individuals who violate the provisions of this Joint Circular, depending on the degree of violation, will be subject to disciplinary action, administrative penalties, criminal prosecution, and if damage is caused, they must compensate for the damage according to the provisions of the law.

2. Implementation.

a) The Ministry of Culture, Sports and Tourism, within its functions and duties, is responsible for leading and coordinating with the Ministry of Health to perform state management functions over advertising in the field of healthcare.

b) The Ministry of Health is responsible for guiding relevant agencies, departments, and provincial health bureaus to carry out the reception of applications and issuance of Receipts for Advertising Registration.

3. Effectiveness of the Circular.

This Joint Circular takes effect fifteen days after its publication in the Official Gazette. Previous regulations of the Ministry of Health and the Ministry of Culture, Sports and Tourism concerning advertising in the field of healthcare that conflict with this Joint Circular are hereby abolished.

The Ministry of Health is responsible for researching and amending the Rules on Advertising Information for Medicines for Human Use and Cosmetics Directly Affecting Human Health issued together with Decision No. 2557/2002/QĐ-BYT dated July 4, 2002, of the Minister of Health, and Circular No. 12/2002/TT-BYT dated August 23, 2002, of the Ministry of Health, guiding advertising for vaccine and medical product sales, to be consistent with the provisions of the Advertising Law, Decree No. 24/2003/NĐ-CP, Circular No. 43/2003/TT-BVHTT, and the guidance of this Joint Circular./.