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Procedure NameLicensing for export of controlled drugs that has been granted an import license to serve humanitarian medical services and is not completely used
Description

Category      

Permission

Responsible Agency

MOH

Legal basis of the Procedure                

Law 105/2016/QH13

Decree 54/2017/NĐ-CP  (Article 60 point 1c)

Processing time

within 10 working days from the day on which the application is received

Fee

Required documents

Item

Required document

1

The exporter’s written request for issuance of the export license written in either Vietnamese or English language;

2

03 original copies of the purchase order according to Form No. 01 or Form No. 04 in Appendix III  Decree 54/2017/NĐ-CP

3

A report on quantity of drugs used for humanitarian medical services according to Form No. 08 in Appendix III Decree 54/2017/NĐ-CP

Process Steps

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 export license within 10 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 07 working days from the day on which the application is received;

Step 4

After receiving the supplemented application, the Ministry of Health shall give the applicant form No. 01 in Appendix I Decree 54/2017/NĐ-CP. If the application is still unsatisfactory, the Ministry of Health shall request the applicant to complete. If the supplemented application is satisfactory, the Ministry of Health shall issue the export license in accordance with Clause 63 Decree 54/2017/NĐ-CP

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, it will be rejected

 Conditions:

The drug has been granted an import license to serve humanitarian medical services and is not completely used.

CategoryProcedure

The following form/s are used in this procedure
TitleDescriptionCreated DateUpdated DateIssued By
Form 4 Appendix III Decree 54/2017/NĐ-CP08-05-201808-05-2018Ministry of HealthThis is Dowload File
Form 1 Appendix III Decree 54/2017/NĐ-CP08-05-201808-05-2018Ministry of HealthThis is Dowload File
This procedure applies to the following measures
NameMeasure TypeAgencyDescriptionCommentsLegal DocumentValidity ToMeasure Class
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