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| Procedure Name | Licensing for import of active ingredients, herbal ingredients, semi-finished drugs and semi-finished herbal ingredients for manufacture of drugs for export |
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| Description |
Required documents
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Item
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Required document
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1
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03 original copy of the purchase order according to Form No. 36 or 41 in Appendix III Decree 54/2017/NĐ-CP
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2
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A copy of the document about the quality standards and medicinal ingredient testing method of the manufacturer which bears the importer’s seal. If this document is written in a language other than Vietnamese or English language, a notarized Vietnamese or English translation shall be included
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3
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A commitment to use the medicinal ingredients for intended purposes and export drugs derived from such ingredients
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Process Steps
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Step 1
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The applicant shall submit an application to the Ministry of Health directly or by post
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Step 2
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After receiving the application, the Ministry of Health shall give the applicant form No. 01 in Appendix I Decree 54/2017/NĐ-CP
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Step 3
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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;
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Step 4
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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
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Conditions:
The specimens of the import license and permission to import medicinal ingredients are provided in Form No. 44 or Form No. 45 in Appendix III Decree 54/2017/NĐ-CP
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| Category | Procedure |
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