– Decree No. 181/2013/ND-CP issued on November 14, 2013: Detailed regulations for the implementation of some provisions of the Advertising Law.
– Advertising Law (No. 47/VBHN-VPQH)
– Circular No. 09/2015/TT-BYT issued on May 25, 2015: Regulations on the confirmation of advertising content for products, goods, and services, especially those under the management of the Ministry of Health.
– Decree No. 54/2017/ND-CP issued on May 8, 2017: Detailed regulations and measures for the implementation of the Pharmacy Law.
– The advertised medicine belongs to the list of non-prescription drugs.
– The medicine is not subject to restrictions or requires supervision by a doctor as advised by the competent state authority.
– The medicine has a valid registration for circulation in Vietnam, and the drug usage instructions have been approved by the Ministry of Health.
– The application must include complete documentation as per regulations.
– The business entity must have a registered circulation of the drug in Vietnam, or the representative office of a foreign trader is authorized to register the drug in Vietnam, or a Vietnamese business with a pharmaceutical business registration code is authorized to distribute the product.
– Request form for confirming the advertising content of the medicine.
– Design template for the medicine advertising content; recorded audio and video content of the advertising on radio, television, electronic devices, advertising screens, and other advertising media with sound and moving images as per legal regulations.
– Current label and instructions for using the medicine approved by the Ministry of Health.
– Business registration certificate/operation certificate of the representative office of a foreign trader in Vietnam.
– Drug circulation registration certificate.
– Logo and trademark certificate (if these images are on the product label).
– Commitment certificate for using personal images (if personal images are on the product label).
– Letter of Authorization from the registered drug facility to the entity named in the advertising content confirmation application in case of authorization
a) Circulation license in Vietnam;
b) Approved drug usage instructions by the Ministry of Health;
c) Specialized information about the medicine recorded in the National Pharmacopoeia or in drug documents recognized by the authorized agency of the manufacturing country.
a) Name of the medicine as per the issued registration for circulation in Vietnam;
b) Active ingredient(s) of the medicine:
Drugs use international nomenclature.
Medicines with herbal origins use names in Vietnamese; if the herbal name is not available in Vietnam, use the original name of the country of origin along with the Latin name.
c) Indications of the medicine;
d) Contraindications or warnings for special groups such as pregnant women, breastfeeding mothers, elderly individuals, children, and those with chronic illnesses;
e) Name and address of the organization or individual responsible for bringing the product to the market;
f) Warning “Read the instructions carefully before use.”
a) Images of sick individuals;
b) Diagrams illustrating the effects of the medicine that have not been researched or evaluated;
c) Images or names of doctors to promote the medicine.
Procedure for applying drug product advertising license in Vietnam
a) Indications for treating tuberculosis, leprosy;
b) Indications for treating sexually transmitted diseases;
c) Indications for treating chronic insomnia;
d) Indications with sexual arousal characteristics;
e) Indications for treating cancer, tumors;
f) Indications for treating diabetes or similar metabolic disorders.
Step 1: The facility requesting confirmation of drug information submits the application to the competent authority.
Step 2: Within 15 working days (from the date of receiving the complete dossier), the receiving agency issues the Confirmation Certificate.
In case of a need for amendment or supplementation of the dossier, the receiving agency sends a written request for amendment, supplementation as follows:
a) The request for amendment or supplementation must specify and detail the documents and content that need to be amended or supplemented.
b) Within 15 days, starting from the date of receiving the requested amendments or supplements from the business, the receiving agency issues the Confirmation Certificate or provides a written response stating the reasons for not issuing the certificate.
(Within 90 days, starting from the date of receiving a written notice of amendment or supplementation, the facility must submit the amended dossier. If beyond this period, the submitted dossier is no longer valid).
The Ministry of Health issues, reissues the confirmation certificate, and adjusts the advertising content that has been granted the confirmation certificate.
For consultation on MEDGATE’s registration and import-export services, please contact us at the hotline 098.546.1894 or send a message via our fan page for immediate assistance.
Please leave complete and accurate information, Medgate will contact you immediately within 24 hours for free consultation and answer your questions.
Tiếng Việt