What documents are included in application for approval for contents of advertisements for health care services in Vietnam?
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What documents are included in application for approval for contents of advertisements for health care services in Vietnam?
Pursuant to Article 19 of Circular 09/2015/TT-BYT regulating application for approval for contents of advertisements for health care services:
Application for approval for contents of advertisements for health care services
1. Documents stipulated in Article 13 hereof.
2. The permit for advertising of healthcare services granted by the Minister of Health or the Director of the Department of Health to healthcare establishments, and the professional practices approved by the Minister of Health or the Director of the Department of Health.
3. The Certificate of healthcare practicing held by the medical practitioner licensed to advertise their services. This will apply if the law stipulates that the practice certificate is compulsory.
Thus, the application for approval for contents of advertisements for health care services includes the following documents:
- Application form for approval for advertisement contents;
- The Certificate of Business Registration of an enterprise or the license for representative office establishment of a foreign dealer;
- Contents of applications for approval for advertisements:
+ If these are advertised on audio and video news, the applicant is required to prepare 01 recording of proposed advertisement content written in VCDs, CDs or in the form of soft copies together with 03 copies of proposed advertising scripts in which contents, proposed advertisement instruments, pictorial (applicable to video news), oral and music contents, must be clearly described;
+ If these are advertised on the advertising means distinct from audio and video news, the applicant is obliged to prepare 03 copies of mockups of proposed advertisement contents printed in color in combination with soft copies recording the proposed advertisement contents;
+ If these are advertised through conferences, seminars or events: In addition to materials stipulated in this point, the applicant is required to submit the followings: the valid sample of advertisement contents used in the program approved by competent authorities (applicable to advertisements of which contents have been approved), agenda in which the presentation title and time (dd/mm/yy), venue (specific address); presentation contents, materials and handouts; name tags including academic ranks and professional qualifications of presenters.
+ Sample labels of these products or those approved by competent healthcare authorities, applicable to the case in which the law stipulates that product labels must be approved by competent healthcare authorities.
- If the authorized applicant is filing the application for approval for advertisement contents, the following documents must be shown:
+ Legal authorization letter;
+ The Certificate of business registration or the license for representative office establishment of a foreign dealer held by the authorized applicant.
- Materials used for reference, demonstration and verification of information provided in the advertisement content:
+ English materials must be translated into Vietnamese, enclosing the original English ones. Translated materials in Vietnamese must be sealed by the applicant for approval for advertisement contents;
+ Materials in foreign languages other than English must be translated into Vietnamese, enclosing the original copies of these materials. Materials translated into Vietnamese must be notarized in accordance with legal regulations.
- The permit for advertising of healthcare services granted by the Minister of Health or the Director of the Department of Health to healthcare establishments, and the professional practices approved by the Minister of Health or the Director of the Department of Health.
- The Certificate of healthcare practicing held by the medical practitioner licensed to advertise their services. This will apply if the law stipulates that the practice certificate is compulsory
What documents are included in application for approval for contents of advertisements for health care services in Vietnam? (Image from the Internet)
What are conditions for medical examination and treatment service advertising content to be certified in Vietnam?
Pursuant to Article 11 of Circular 09/2015/TT-BYT regulating requirements for approval for contents of advertisements for health care services:
Requirements for approval for contents of advertisements for health care services
1. All advertisement requirements stipulated in Point e Clause 4 Article 20 of the Law on Advertising must be met as follows:
a) The license for medical operations, applicable to healthcare establishments;
b) The certificate of medical practice, applicable to those required to achieve the practicing certificate by laws before being allowed to practise medical services.
2. Advertisement contents must conform to regulations laid down in Article 9 of the Decree No. 181/2013/NĐ-CP.
3. All necessary documents must be submitted as stipulated in Article 19 hereof.
4. Applicants for approval for advertisement contents are those who sign their names on the licence for medical operations, or those who have the legal standing to be authorized in writing by the legal holder of the license for medical operations.
Thus, contents of advertisements for health care services is approved in Vietnam when the following conditions are met:
(1) Have a certificate of eligibility to practice issued by the health sector according to the provisions of law. As follows:
- License for medical operations, applicable to healthcare establishments;
- Certificate of medical practice, applicable to those required to achieve the practicing certificate by laws before being allowed to practise medical services.
(2) Advertisement contents must comply with the following regulations:
- The contents of advertisements for medical services must be conformable with the license to provide medical services of the medical facility or the practising certificate of the medical practitioner.
- An advertisement for medical services must contain:
+ Name of the licensed medical facility;
+ The scope of operation written in the operating license or practising certificate issued by a competent authority.
(3) There is sufficient application for approval for contents of advertisements for health care services.
(4) Applicants for approval for advertisement contents are those who sign their names on the licence for medical operations, or those who have the legal standing to be authorized in writing by the legal holder of the license for medical operations.
When does the certificate of approval for advertisement contents expire in Vietnam?
Pursuant to Clause 6, Article 23 of Circular 09/2015/TT-BYT stipulating circumstances under which the validity of the certificate of approval for advertisement contents for healthcare services is terminated:
a) Healthcare establishments are subject to revocation of the permit for operations, their operations are suspended;
b) Healthcare establishments have been deprived of the ownership of the permit for operations in accordance with legal regulations on penalties for administrative violations;
c) Healthcare establishments have been reissued the permit for operations due to change to their scope of professional operations in relation to healthcare services allowed to be advertised.
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