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Procedure Name | Licensing for export herbal ingredients on the list of controlled herbs |
Description |
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 59)
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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
Item
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Required document
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1
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03 original copies of the purchase order according to Form No. 06 in Appendix III Decree 54/2017/NĐ-CP
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2
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A copy of the Certificate of eligibility for pharmacy business which is authenticated or bears the exporter’s seal. If a copy bearing the exporter’s seal is submitted, the original copy shall be produced for comparison when the application is submitted
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3
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A copy of the confirmation of herb origin issued by the People’s Committee of the commune which is authenticated or bears the exporter’s seal. If a copy bearing the exporter’s seal is submitted, the original copy shall be produced for comparison when the application is submitted
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4
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A copy of the herbal ingredient purchase order which is authenticated or bears the exporter’s seal. If a copy bearing the exporter’s seal is submitted, the original copy shall be produced for comparison when the application is submitted
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5
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In case of export for non-commercial purposes, the documents specified in Points 3 and 4 of this Clause are not required
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Process Steps
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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Step 5
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Within 20 (twenty) days from the granting date, the Ministry of Health shall have to disclose information related to herbal medicines already licensed for export on the list of species and types of precious and rare materia medica, Endemism must be controlled on the Portal of the unit.
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Conditions:
The export of a herbal ingredient on the List of controlled rare and special herbs shall only be licensed if it is naturally obtained and is not on the list of herbs banned from export published by the Minister of Health. In case of export for non-commercial purposes, regulations of law on biodiversity shall apply.
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Category | Procedure |
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This procedure apply to theses Measures.