MINISTRY
OF CULTURE AND INFORMATION MINISTRY OF HEALTH
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SOCIALIST
REPUBLIC OF VIET NAM
Independence - Freedom – Happiness
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No:
01/2004/TTLT-BVHTT-BYT
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Ha
Noi, January 12, 2004
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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.
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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.
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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;
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- 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;
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+ 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;
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- 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:
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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);
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- 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;
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- 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;
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- 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;
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- 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.
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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.
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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.
Le Ngoc
Trong
(Signed)
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