Procedures for issuance of certificates of drug information contents in the form of drug introduction seminars

The establishment is named in the dossier of request for certification of drug information content

1. Drug registration establishments in Vietnam;
2. Representative offices in Vietnam of foreign establishments that register drugs in Vietnam and are authorized by such establishments;
3. Vietnamese pharmaceutical business establishments authorized by drug registration establishments in Vietnam;
4. Vietnam's drug importers are only allowed to provide drug information in the form of drug introduction seminars for drugs that do not have a circulation registration certificate by the importer itself.

In case of issuance of a certificate of drug information content

1. Contents of information on drugs proposed for issuance of certificates for the first time;
2. The content of drug information has been granted a certificate but there is a change in the basis for drug registration, drug name, ingredients, concentration or content, dosage form, indications, contraindications, dosage, method of use and use of drugs on special subjects, information related to drug warnings and safety.

Drug information content

1. Have full drug information as prescribed; must not contain information and images not directly related to drugs or drug use and similar information and images that are not allowed to be used in drug advertising content in Article 126 of Decree 54/2017/ND-CP;
2. The contents of drug information must be clearly annotated with supporting documents and must clearly indicate the part of information cited in the supporting documents. The quotation must ensure accurate communication of information, not deduce or add or remove information in a way that misleads about the safety and efficacy of drugs;
3. The content of drug information must be expressed in Vietnamese, except for cases where the information cannot be translated into Vietnamese or is translated into Vietnamese without meaning;
4. The font size in the drug information content must be clear and easy to read, but must not be smaller than the font size 12 of the VnTime or Times New Roman font on A4 paper size.
5. The drug information content must have the words "Drug information document" at the top of all pages. For documents consisting of many pages, the page must be numbered, on the first page, the detailed information about the product must be clearly stated on which page (specify the page number) and clearly printed: Number of the Certificate of Drug Information Content of the Ministry of Health.../XNTT/..., date ... month... year...

1

Receiving agency

Departments of Health of provinces and centrally-run cities.

2

Components of the dossier

01 set of dossier includes[3]:

1. 01 original: An application for certification of drug information content in the form of introduction to the workshop according to Form No. 02, Appendix VI of Decree No. 54/2017/ND-CP;
2. 02 originals of drug information;
3. 01 copy: Sample of the label and the current drug instruction sheet approved by the Ministry of Health;
4. 01 original: Reference documents related to the content of drug information requested for certification (if any) (A stamped copy of the establishment requesting certification of drug information contents, for documents issued by the Ministry of Health or certified copies for documents not issued by the Ministry of Health);
5. License to establish a representative office of a foreign company in Vietnam for a foreign establishment in the name of a foreign establishment requesting certification of drug information content (Certified copy) or Certificate of eligibility for pharmacy business in the name of a Vietnamese pharmaceutical business establishment requesting certification of drug information content (A copy affixed with the seal of the establishments requesting certification of drug information content); Exemption from submission of the Certificate of eligibility for pharmacy business issued by the Ministry of Health for Vietnamese pharmaceutical business establishments in the name of requesting certification of drug information contents;

1. Power of attorney of the drug registration establishment to the establishment named on the dossier of request for certification of drug information content in case of authorization (Original or certified copy);
2. Drug introduction seminar program;

4

Fees

Fee for appraisal and certification of drug information: 1,600,000 VND[4].

5

Result

1. Certificate of drug information content in the form of a drug introduction seminar; or
2. The written reply clearly states the reason for not granting the license.