View Procedure

Category      

Permission

Responsible Agency

MOH

Legal basis of the Procedure                

Law 105/2016/QH13

Decree 54/2017/NĐ-CP  (Aritcle 86)

Processing time

15 working days

Fee

Item

Required document

1

 03 original copy of the purchase order according to Form No. 43 in Appendix III  Decree 54/2017/NĐ-CP

2

 A copy of the document about the quality standards and method for testing excipients, capsule shells or primary packages of drugs of the manufacturer which bears the importer’s seal. If this document is written in a language other than Vietnamese or English language, a notarized Vietnamese or English translation shall be included.

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 written permission to import 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 written permission to;

 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