Legal basis

• Advertisement Law
• Law on Pharmacy 2005
• Circular 03/2013/TT-BTC – Regulations on fees for appraisal of conditional commercial business; assessment of standards and conditions for medical and pharmaceutical practice; fees for licensing import and export of medical equipment and pharmaceutical products; issue medical practice certificates; grant operation licenses to medical examination and treatment establishments.
• Decree 181/2013/ND-CP – detailing the implementation of some articles of the Law on Advertising
• Circular 09/2015/TT-BYT – Regulations on certification of advertising content for special products, goods, and services under the management of the Ministry of Health

Conditions

Pursuant to Article 4 of Circular No. 09/2015/TT-BYT:

“1. The advertisement content must conform to legal regulations on advertising and none of prohibited acts stipulated in Article 8 of the Law on Advertising is committed.

2. Voices, wording, and pictures used in an advertisement must be concise, common, and conform to regulations laid down in Article 18 of the Law on Advertising. The smallest size of the font used in an advertisement content must be large enough to be read in a normal condition and is not smaller than the size proportional to the size of Vntime font or the 12-point size of Times New Roman font printed on the A4-size paper.”

Article 6 of Circular No. 09/2015/TT-BYT: Conditions for certifying cosmetic advertising content

“1. Cosmetic products must conform to advertisement requirements stipulated in Point b Clause 4 Article 20 of the Law on Advertising.

2. Cosmetic advertisement contents must conform to regulations laid down in Article 4 of the Decree No. 181/2013/NĐ-CP and the following:

a) Do not use images, costumes, names, emails, and articles of other organizations, healthcare establishments, doctors, pharmacists, or medical staff;

b) Features and effects of a cosmetic product must accord with its nature, classification as well as those that have been already made known to the public following legal regulations.

3. All necessary documents must be submitted as stipulated in Article 15 hereof.

4. The applicant for approval for advertisement contents is the organization that signs its name on the product notification, or the representative office of that organization, or the organization with its legal standing authorized in writing by that organization.”

The procedures

Step 1: The organization requesting certification of advertising content submits a dossier to the Department of Health.

Step 2: In case the application is not valid, within 05 working days from the date of receipt of the application, according to the stamp of receipt of the incoming official dispatch, the application-receiving agency shall send a written request. modified and supplemented units. The time limit for the requesting organization for certification of advertising content to amend and supplement the dossier as requested is up to 90 days from the date of receipt of the notification of amendment and supplementation from the application-receiving agency. profile. Past this time limit, the application for certification of advertising content will be invalidated.

Step 3. Within 10 working days from the date of receipt of complete and valid dossiers according to the stamp of receipt of incoming dispatches from the receiving agencies, the competent state agencies shall issue certificates of advertisement contents. In case of refusal to issue a certificate of advertisement contents, the competent state agency must reply in writing and clearly state the reasons for not granting it.

Step 4. For advertising through seminars, conferences, and events:

a) At least 02 working days before conducting the advertisement, organizations, and individuals have special products, goods, and services under the management of the Ministry of Health which have been approved by the competent agencies of the Ministry of Health. The health authority that issues a certificate of advertisement content for a seminar, conference, or event organization must have written notice of the form, time, and place of advertisement enclosed with a copy of the written certification of content. advertisements, advertising samples, or advertising scripts that have been approved for the Department of Health where the advertisement is held for inspection and examination in case of necessity;

b) In case there is a change in the location and time of the seminar, conference, or event compared to the content written on the certificate of advertisement content, the organization or individual having the product or goods, advertising services must notify the local Department of Health.

The dossiers

• A written request for certification of advertising content as prescribed in Appendix 01 issued together with Circular 09/2015/TT-BYT;
• The business registration certificate of the enterprise or the license to establish a representative office of the foreign trader;
• If advertising on audio or video newspapers, there must be 01 record of the expected advertising content in the picture disc, audio disc, and floppy file, together with 03 expected advertising scenarios, which clearly describe the content of the advertisement. , media to be advertised, the image part (for photojournalism), the lyrics, the music part;
• If advertising through a seminar, conference, or event: In addition to the documents specified at this point, the following documents must be included: the advertising template used in the program approved by the competent authority, and valid (in case the advertisement template has been approved), the program must clearly state the name of the report content, time (day/month/year), venue (specific address); content of reports and presentation materials, distributed to attendees; List of names, scientific titles, professional qualifications of the reporter
• In case the unit requesting certification of advertising contents is an authorized unit, the following documents must be present:
  • A valid power of attorney;
  • Certificate of business registration or License for establishment of a representative office of a foreign trader of an authorized unit.
• References, proofs, authentication information in the advertising content.
• The cosmetic product announcement sheet has been issued by a competent state agency.
• Sample advertising content is presented on A4 paper size. The large-format outdoor advertising form can be presented on A3 or other paper sizes and clearly state the size to actual size ratio.

The competent authority

Health service Dept.

If you need more detailed advice and answers as well as how to access this service, please contact directly our Lawyer Nhat Nam via hotline: 0912.35.65.75, 0912.35.53.53 or call the toll free legal consultation hotline 1900.6575 or send a service request via email: lienheluathongbang@gmail.com

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