Category      

Permission

Responsible Agency

MOH

Legal basis of the Procedure                

Law 105/2016/QH13

Decree 54/2017/NĐ-CP  (Article 68, point 1 - b,c)

Processing time

15 days

Fee

Item

Required document

1

03 copies of the purchase order according to Form No. 15, 16 or 17 in Appendix III Decree 54/2017/NĐ-CP

2

Documents proving the quality, safety and efficacy of the vaccine

3

The original copy of the document written by head of the health facility which contains the reason for import of the drug, the quantity of patients that need to use it and quantity of drug needed, commitment to take responsibility for the use of the drug. The document shall be enclosed with the minutes of meeting of the drug and treatment council regarding the need for drug import (original copy or copy bearing the seal of the health facility). If such a council does not exist, the minutes of meeting are not required

4

The list of drugs to be imported according to Form No. 10, 20 or 21 in Appendix III  Decree 54/2017/NĐ-CP

5

A report on the quantity, efficacy (except vaccines) and safety of drugs used according to Form No. 22 in Appendix III Decree 54/2017/NĐ-CP

6

The original copy of the foreign exporter and manufacturer’s commitment to quality, safety and efficacy of the vaccine or biological supplied to the Vietnamese importer according to Form No. 23 in Appendix III  Decree 54/2017/NĐ-CP

7

A copy bearing the importer’s seal of the authorization letter or the seller’s license or certificate of partnership. The content of such document is specified in Clause 15dd Article 91 Decree 54/2017/NĐ-CP

Step 1

The applicant shall submit an application to the Ministry of Health directly or by post

Step 2

After receiving the application, the Ministry of Health shall give the applicant form No. 01 in Appendix I Decree 54/2017/NĐ-CP

Step 3

If the application is satisfactory, the Ministry of Health shall issue the import license within 15 working days from the day on which the application is received;

If the application is not satisfactory, the Ministry of Health shall request the applicant in writing to complete it within 15 working days from the day on which it is received;

Step 4

After receiving the supplemented application, the Ministry of Health shall give the applicant form No. 01 in Appendix I enclosed herewith. If the application is still unsatisfactory, the Ministry of Health shall request the applicant to complete it in accordance with Point d this Article. If the supplemented application is satisfactory, the Ministry of Health shall issue the import license.

Within 06 months from the day on which additional documents are requested in writing by the Ministry of Health, the applicant shall submit additional documents as requested. If the applicant fails to satisfy such request by the aforementioned deadline or the application is not satisfactory within 12 months from the first time it is submitted, the application will be rejected

Step 5

Within 10 (ten) working days as from the date of licensing the import of drugs, the Ministry of Health shall have to publish such information on the electronic portal of the unit, including information on importers, manufacturers, serial numbers quantity, name of drug and number of import permit, number of circulation registration certificate for each active substance.