Health claims certification in advertising for medical examination and treatment services in Vietnam

Health claims certification in advertising for medical examination and treatment services in Vietnam

This page  provides for the conditions, competence, dossiers and procedures for health claims certification in advertising for medical examination and treatment services of  the Ministry of Health of Vietnam.

This page applies to entities and individuals involved in the health claims certification in advertising for  medical examination and treatment services of  the Ministry of Health of Vietnam in the teritory of Vietnam.

I. Appraisal charge and fee for grant or re-grant of written health claims certification in advertising for medical examination and treatment services of  the Ministry of Health of Vietnam.

1.The applicant shall pay an appraisal charge and a fee for grant or re-grant of written  health claims certification in advertising for medical examination and treatment services to the local authority for  health claims certification in advertising for medical examination and treatment services as prescribed by law.

2. An advertisement design to be regarded as a dossier of  application file for  health claims certification in advertising that is liable to appraisal charge and certification fee.
The following shall be regarded as a dossier of application file for  health claims certification in advertising for medical examination and treatment services:
- An adve1tisement design for a product, goods or service for a single target user;
- An advertisement design for a product, goods or service for a single target user used for different forms of advertising (e.g., leaflet, poster, book, newspaper).

II.Conditions, competence, dossiers and procedures for health claims certification in advertising for medical examination and treatment services in Vietnam.

2.1 General conditions for health claims certification in advertising:

1. Advertising contents must comply with the law on advertising and do not fall in the prohibited cases prescribed in A1ticle 8 of the Law on Advertising.

2. Voices, texts and images in an advertisement must be short, common and compliant with Article 18 of the Law on Advertising. The smallest font size used in an advertisement must be readable under normal conditions and must not be smaller than the proportion corresponding to VnTime or Times New Roman font size 12 on A4 paper.

2.2 Conditions for  health claims certification in advertising for medical examination and treatment services in Vietnam.

1.The services must fully satisfy the advertising conditions specified at Point c, Clause 4, Article 20 of the Law on Advertising, specifically as follows:
a/ Having a medical examination and treatment license, for health establishments;
b/ Having a medical examination and treatment practice certificate, for practitioners
required by the law on medical examination and treatment to possess a practice certificate.

2. Advertising contents must comply with A1ticle 9 of Decree No. 181/2013/ND-CP.

3. Adve1tising contents shall be accompanied by a complete dossier specified in Article
19 of this Circular.

4. The requester for certification of advertising contents is the unit named in the medical
examination and treatment license or a unit with legal person status authorized in writing by the unit named in such license.

III. Competent local authority to issue written health claims certification in advertising for medical examination and treatment services of the Ministry of Health  in Vietnam.

a/ The Medical Examination and Treatment Management Department under the Ministry of Health of Vietnam, for medical
examination and treatment services using modern medical methods provided by health
establishments having operation licenses granted and lists of technical professional operations approved by the Minister of Health;
b/ The Traditional Medicine and Pharmacy Management Department under the Ministry of Health of Vietnam, for medical
examination and treatment services using traditional medical methods provided by health
establishments having operation licenses granted and lists of technical professional operations approved by the Minister of Health;

IV Dossier of application file for health claims certification in advertising for medical examination and treatment services:

1. A dossier shall be made in one set.

2. A dossier must comprise:
a/ A written application file for health claims certification in advertising for medical examination and treatment services as specified in Appendix No.01 to Circular 09;
b/ The enterprise”s business registration certificate or the foreign trader”s representative office establishment license;
c/Health claims in advertising for certification:
- For radio or television advertisements, there must be one audio or visual disc or electronic file to-be-advertised contents enclosed with 3 scripts of the advertisement, clearly describing
the contents and medium of advertising, images (for television advertisements), texts and music;
- For advertisements in media other than radio or television, there must be 3 color
advertising layouts enclosed with an electronic file of advertising contents;
- For advertisements at conferences, workshops or events, in addition to the materials specified at this Point, there must also be a valid advertisement design approved by a competent agency and used in the agenda (in case the advertisement design has been approved), the agenda specifying the contents of reports, time (date) and venue (address) of the the conference/ workshop/event; contents of the reports to be presented at the conference/workshop/event and
documents to be distributed to participants; list of names, academic titles and professional qualifications of speakers (speakers must possess diplomas and professional qualifications
relevant to to-be-advertised products, goods or services. 
d/ Label designs or approved label designs in case approval by a competent health agency is required by law.

3. Other documents:
a/ In case the applicant for  health claims certification in advertising for medical examination and treatment services is an authorized unit, the
following papers are required:
- The valid paper of authorization;
- The authorized unit”s business registration certificate or the license for establishment of the foreign trader”s representative office.
b/ Reference documents proving or certifying information in the advertising contents:
- Documents in English shall be translated into Vietnamese and enclosed with the English originals. The Vietnamese translations shall be appended with the seal of the applicant;
- Documents in a foreign language other than English shall be translated into Vietnamese and enclosed with the original documents in that language. The Vietnamese translations shall
be notarized in accordance with law.
c/ The papers in the dossier shall be clearly printed and arranged in the order specified in Circular 09, and must have a cover and a list of papers; different pa1ts of the dossier shall be separated with color sheets;
d/ The papers in the dossier must remain valid and may be certified copies or copies
appended with the seal of the applicant. These papers must each have the applicant”s seal, and
every two adjoining pages shall be appended with such seal;
dd/ An advertisement design shall be presented on an A4-size paper; a large-size outdoor advertisement design shall be presented on an A3-size paper or a paper of another size, with a scale showing its actual size.

4. Requirements on dossiers submitted to agencies providing level-4 online public services:

Dossiers shall be converted into electronic files (single file) and must comply with the
guidance of agencies providing level-4 online public services.

5. The medical examination and treatment license of the service provider, granted by
the Minister of Health or the director of the provincial-level Health Department, and the list
of technical professional operations approved by the Minister of Health or the director of the
provincial-level Health Department.

6. The medical examination and treatment practice certificate of the service provider, in
case such certificate is required by law.

V. Procedures for issuance of written health claims certification in advertising for medical examination and treatment services in Vietnam

1. The applicant for health claims certification in advertising for medical examination and treatment services shall submit a dossier to a

competent agency defined in Clause 2.3 above (below referred to as dossier-receiving agency).

2. For an invalid dossier, within 5 working days from the date of receipt based on the
dossier-receiving agency”s mark of incoming official letters, this agency shall notify such to the applicant for completion of the dossier. The time limit for the applicant to complete the dossier
is 90 days after receiving the written notice from the dossier-receiving agency. Past this time limit, the dossier will become invalid.

3. Within 10 working days from the date of receipt of a complete and valid dossier based on the dossier-receiving agency”s mark of incoming official letters, the competent state agency shall issue a written certification of advertising contents, made according to the fo1m provided in Appendix No. 03 to Circular 09. In case of refusal, it shall issue a written reply clearly stating the reason.

4. The dossier-receiving agency shall publicize on its portal the list of products, goods and services under its management for which written certifications of advertising contents have been issued and of which written certifications of advertising contents have expired.

5. Advertising at conferences, workshops or events:
a/ At least 2 working days before advertising, the entity or individual that has food and food additives for which a competent agency of the Ministry of Health of Vietnam  has issued the written health claims certification in advertising for food and food additives at conferences, workshops or other events shall notify in writing the form, time and place
of advertising, enclosed with copies of such written certification and approved advertisement design or advertising script to the provincial-level Health Department of the locality where advertising will be conducted, for inspection or examination when necessary;
b/ If the venue and time of the conference, workshop or event are changed as compared to the written health claims certification in advertising for food and food additives, the entity or individual having products, goods services advertised shall notify such change to the provincial-level Health Department
of the locality where the conference, workshop or event will be held at least 2 working days before advertising is conducted.

6. Procedures for registration of health claims certification in advertising shall be carried out again in the following cases:
a/ The applicant for health claims certification in advertising modifies or supplements the dossier in contravention of the dossier-receiving agency”s notice for dossier completion;
b/ The applicant for health claims certification in advertising fails to modify or supplement the dossier within the time limit specified in Clause 2 of this Article.
7. The dossier-receiving agency shall not receive dossiers of application filet for health claims certification in advertising from a unit that has committed a violation of the law on advertising until the unit has completely served the sanctioning decision issued by a competent agency or person.

VI Cases of expiration of a written  health claims certification in advertising for medical examination and treatment services in Vietnam:

a/ The health establishment”s operation license is revoked or it is suspended from operation;
b/ The health establishment”s right to use its operation license is deprived under the law
on handling of administrative violations;
c/ The health establishment is re-granted the operation license as a result of a change in
the scope of professional operations related to the advertised medical examination and treatment services.
d/ The products or goods are banned from sale or are recalled.

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