What are procedures for issuance of the Certification of Drug Advertisement Contents in 2024 in Vietnam?

What is the compulsory information of the drug advertisement contents in Vietnam?

Pursuant to Clause 2 Article 125 of the Decree 54/2017/ND-CP, the drug advertisement contents have the following compulsory information:

- Drug name;

- Active ingredients or herbal materials in the approved package insert. Names of herbal materials must be written in Vietnamese language. Names of untranslatable foreign herbal materials may be written in Latin language;

- Indications;

- Uses;

- Dosage;

- Contraindications and warnings for special users (pregnant women, breast-feeding women, children, old people, people having chronic diseases);

- Cautions and what to avoid when using the drug;

- Side effects and adverse effects;

- Name and address of the manufacturer;

- The text “Đọc kỹ hướng dẫn sử dụng trước khi dùng" (“Read the instructions carefully before use”);

- The text “Số Giấy xác nhận nội dung quảng cáo thuốc của Bộ Y tế: .../XNQC..., ngày ... tháng ... năm...;” (“Number and date of the certification of drug advertisement contents issued by the Ministry of Health: …”) at the end of the first page;

- Pages of a multi-page document must be numbered. The first page must specify the number of pages and contain the table of content;

- Reference documents and extracts therefrom are specified.

The extracts must be accurate without addition or removal of information which leads to misunderstanding of the safety and efficacy of the drug.

What are procedures for issuance of the Certification of Drug Advertisement Contents in 2024 in Vietnam? - image from internet

What documents are included in the application for the certification of drug advertisement contents in Vietnam?

Pursuant to Article 121 of the Decree 54/2017/ND-CP (amended by Clause 64 Article 4; Clause 62 Article 5 of the Decree 155/2018/ND-CP), the application for the certification of drug advertisement contents in Vietnam includes following documents:

1. An application for the certification of drug advertisement contents, except for advertisements in the form of conferences, conventions or events, consists of:

- Request for the certification of drug advertisement contents;

- The drug advertisement contents;

- Specimens of the label and package insert approved by the Ministry of Health;

- Reference documents about the drug advertisement contents to be certified (if any);

- The license for establishment of a representative office in Vietnam if the applicant is a foreign establishment; or the Certificate of Eligibility for Pharmacy Business if the applicant is a Vietnamese pharmacy business establishment.

The Certificate of Eligibility for Pharmacy Business is not required if the applicant is a Vietnamese pharmacy business establishment.

- In case the applicant for the confirmation of drug advertisement contents is authorized by the applicant for drug registration, the authorization document.

- The expected agenda of the conference, convention or event.

2. An application for the certification of contents of drug advertisement other than cases in [1], consists of:

- Request for the certification of drug advertisement contents;

- The drug advertisement contents;

- The audio or video track of the advertisement on audio or video news and other means of audio and video advertisements defined by advertising laws;

- Specimens of the label and package insert approved by the Ministry of Health;

- Reference documents about the drug advertisement contents to be certified (if any);

- The license for establishment of a representative office in Vietnam if the applicant is a foreign establishment; or the Certificate of Eligibility for Pharmacy Business if the applicant is a Vietnamese pharmacy business establishment.

The Certificate of Eligibility for Pharmacy Business is not required if the applicant is a Vietnamese pharmacy business establishment.

- In case the applicant for the confirmation of drug advertisement contents is authorized by the applicant for drug registration, the authorization document;

What are procedures for issuance of the Certification of Drug Advertisement Contents in 2024 in Vietnam?

Pursuant to Article 127 of the Decree 54/2017/ND-CP (amended by Clause 64 Article 5 of the Decree 155/2018/ND-CP) stipulating procedures for issuance of the Certification of Drug Advertisement Contents:

Procedures for issuance of the Certification of Drug Advertisement Contents

1. The applicant for the Certification of Drug Advertisement Contents shall submit an application to the Ministry of Health.

2. Procedures for issuance of the Certification of Drug Advertisement Contents are the same as the procedures in Article 113 hereof.

As regulated above, procedures for issuance of the Certification of Drug Advertisement Contents are as follows:

Step 1: The applicant shall submit the application for the certification of drug information to the Ministry of Health.

Step 2: Within a period of 10 days from the date of receiving the complete application, the receiving agency shall issue a Certificate of Confirmation. In case the Certification of Drug Advertisement Contents is not granted, the receiving agency must respond in writing and clearly state the reasons for not granting it.

Step 3: In the event of a request for amendment or supplementation of the application, within a period of 10 days from the date of receiving the complete application, the receiving agency shall submit a written request to the facility for amendment or supplementation and carry out the following:

- The written request for amendment or supplementation must specify the specific and detailed documents and content that need to be amended or supplemented.

- Within a period of 10 days from the date of receiving the amended or supplemented application as requested, the receiving agency shall either issue the Certification of Drug Advertisement Contents or respond in writing and state the reasons for not granting it.

- Within a period of 90 days from the date the receiving agency issues a written notification for amendment or supplementation, the facility must submit the amended or supplemented application as requested. If the deadline is exceeded, the submitted application will no longer be valid.

Best regards!