View Procedure
| Procedure Name | Licensing for import of controlled drugs having the certificate of drug registration in Vietnam |
|---|
| Description |
Required documents
|
Item
|
Required document
|
|
1
|
01 original copy of the purchase order according to Form No. 33 or 34 in Appendix III Decree 54/2017/NĐ-CP
|
|
2
|
A report on sale of the drug according to Form No. 18 in Appendix III enclosed herewith, except for toxic drugs
|
|
3
|
A copy (authenticated or bearing the importer’s seal) of the importer’s license to perform radiological works in case of import of radiopharmaceuticals. If a copy bearing the importer’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 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 import license.
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
|
Conditions:
The specimens of the import license and permission for import are provided in Form No. 28, 29, 30, 40, 44 in Appendix III enclosed herewith.
|
|---|
| Category | Procedure |
|---|
The following form/s are used in this procedure
This procedure applies to the following measures
| Name | Measure Type | Agency | Description | Comments | Legal Document | Validity To | Measure Class |
| No results found. |
