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Procedure NameLicensing for export radiopharmaceuticals, drugs or active ingredients on the list of drugs and active ingredients banned from certain fields, toxic drugs or toxic medicinal ingredients
Description

Category      

Permission

Responsible Agency

MOH

Legal basis of the Procedure                

Law 105/2016/QH13

Decree 54/2017/NĐ-CP  (Article 58)

Processing time

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

Fee

Required documents

Item

Required document

1

 03 original copy of the purchase order according to Form No. 04 or Form No. 05 in Appendix III  Decree 54/ 2017/NĐ-CP

2

A report on the quantity and origins or drugs/medicinal ingredients to Form No. 03 in Appendix III Decree 54/ 2017/NĐ-CP, except for toxic drugs, toxic medicinal ingredients and radiopharmaceuticals;

3

A copy (authenticated or bearing the exporter’s seal) of the exporter’s license to perform radiological works in case of export of radiopharmaceuticals. If a copy bearing the exporter’s seal is submitted, the original copy shall be produced for comparison when the application is submitted

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 export of a drug or medicinal ingredient shall only be licensed when one of the following requirements is satisfied:

  • The drug or ingredient is manufactured in Vietnam, whether or not granted the certificate of drug registration in Vietnam; or
  • The drug or ingredient is manufactured overseas and has been granted a certificate of drug registration in Vietnam.
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 5 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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