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Procedure NameLicensing for export of controlled drugs for emergency aid or humanitarian aid.
Description

Category      

Permission

Responsible Agency

MOH

Legal basis of the Procedure                

Law 105/2016/QH13

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

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

The original copy or certified true copy of the written approval for use of drugs for emergency aid or humanitarian aid issued by a competent authority of the importing country;

4

The unexpired license issued by a competent authority of the importing country for import of narcotic drugs, psychotropic drugs, drug precursors or combined drugs that contain narcotic active ingredients, psychotropic active ingredients or precursors;

If any of the documents mentioned in Points 3 and 4 of this Clause is written in a language other than Vietnamese or English language, a notarized Vietnamese or English translation shall be included. The documents shall be consularly legalized in accordance with regulations of law on consular legalization, except for the cases in which consular legalization is exempted by law.

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 controlled drugs  is licensed for sale in Vietnam  that  is exported as emergency aid or humanitarian aid.

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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