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| Procedure Name | Licensing for export of a narcotic drug, psychotropic drug, precursor, narcotic active ingredient, psychotropic active ingredient, drug precursor or combined drug that contain narcotic active ingredients, psychotropic active ingredients... |
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| Description |
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Category
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Permission
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Responsible Agency
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MOH
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Legal basis of the Procedure
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Law 105/2016/QH13
Decree 54/2017/NĐ-CP (Article 62 point 2)
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Processing time
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within 10 working days from the day on which the application is received
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Fee
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Required documents
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Item
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Required document
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1
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01 original copy of the purchase order according to Form No. 01 or Form No. 02 in Appendix III Decree 54/2017/NĐ-CP
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2
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An original copy of the unexpired license to import drugs/medicinal ingredients issued by a competent authority of the importing country. If the import license is written in a language other than Vietnamese or English language, a notarized Vietnamese or English translation shall be included. The import license 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
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3
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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;
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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 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;
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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 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
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Conditions:
The export of a narcotic drug, psychotropic drug, precursor, narcotic active ingredient, psychotropic active ingredient, drug precursor or combined drug that contain narcotic active ingredients, psychotropic active ingredients or precursors shall only be licensed when one of the following requirements is satisfied:
- a) It is manufactured in Vietnam and granted an import license by a competent authority of the importing country regardless of availability of the certificate of drug registration in Vietnam;
- b) It is manufactured overseas, granted a certificate of drug registration in Vietnam and granted an import license by a competent authority of the importing country
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| Category | Procedure |
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This procedure apply to theses Measures.
