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Procedure Name

Licensing for export of a radiopharmaceutical, toxic drug, toxic medicinal ingredient, drug or active ingredient on the list of drugs and active ingredients banned from certain fields for the purpose of clinical trial, bioequivalence study...

Description

Category	Permission
Responsible Agency	MOH
Legal basis of the Procedure	Law 105/2016/QH13 Decree 54/2017/NĐ-CP (article 62 point 4)
Processing time	within 10 working days from the day on which the application is received
Fee

Required documents

Item	Required document
1	01 original copy of the purchase order according to Form No. 04 or Form No. 05 in Appendix III Decree 54/2017/NĐ-CP
2	The original copy of the confirmation of the importer that the drug is used for the purpose of clinical trial, bioequivalence study, bioavailability assessment, testing, scientific research or as specimens for registration in the importing country and the quantity thereof. If this document is written in a language other than Vietnamese or English language, a notarized Vietnamese or English translation shall be included

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 radiopharmaceutical, toxic drug, toxic medicinal ingredient, drug or active ingredient on the list of drugs and active ingredients banned from certain fields shall only be licensed when one of the following requirements is satisfied:

It is manufactured in Vietnam, whether or not granted the certificate of drug registration in Vietnam; or
It is manufactured overseas and has been granted a certificate of drug registration in Vietnam

Title	Description	Created Date	Updated Date	Issued By
Form 4 Appendix III Decree 54/2017/NĐ-CP	Form 4 Appendix III Decree 54/2017/NĐ-CP	08-05-2018	08-05-2018	Ministry of Health
Form 5 Appendix III Decree 54/2017/NĐ-CP	Form 5 Appendix III Decree 54/2017/NĐ-CP	08-05-2018	08-05-2018	Ministry of Health