View Procedure
| Procedure Name | Granting permission to export finished addictive drugs, psychotropic substances, precursor substances without registration numbers in combined forms |
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| Description |
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Category
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License
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Responsible agency
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Drugs Administration Bureau – Ministry of Health
Address:
Phone:
Email:
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Base on legal documents
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- Law on Pharmacy No. 105/2016/QH13
- Circular 19/2014/TT-BYT Management of addictive drugs, psychotropic drugs, and drug precursors
- Circular No. 45/2011/TT-BYT amending and supplementing a number of articles in documents regulating pharmaceutical and cosmetic industries.
- Circular No. 47/2010/TT-BYT dated December 29, 2010 of the Ministry of Health guiding the export, import of drugs/medicines and packaging in direct contact with drugs/medicines
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Processing time
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- Within 15 working days from the date of reception of adequate and valid dossier
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Fee
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0 VND
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Required documents
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Serial
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Title
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Comment
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1
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Export order (Form 13a) |
01 original copy |
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2
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Written permission for import of the competent authority of the importing country; |
01 original copy |
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3
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Commitment of conforming the export contract and not circulating products not yet granted registration numbers for circulation by the Ministry of Health. |
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Requirements and conditions in following administrative procedures
| Enterprises having certificates of eligibility for drug/medicine trading and drug/medicine warehouses obtaining standard "Good Storage Practice" (GSP) are eligible to import directly and receive entrusting to import finished drugs, addictive ingredients, psychotropic substances and precursor substances with registration numbers for circulation (Clause 1 Article 3 - Circular No. 47/2010/TT-BYT dated December 29, 2010 of the Ministry of Health guiding the export, import of drugs/medicines and packaging in direct contact with drugs/medicines and Clause 2, Article 1 of Circular No.11/2010/TT-BYT dated April 29, 2010 guiding activities related to psychotropic substances and precursor substances) |
Process steps:
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Step 1
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The applicant shall submit a dossier of Application to the Drug Administration of Vietnam - Ministry of Health
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Step 2
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The Drug Administration of Vietnam shall receive and examine the dossier.
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Step 3
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The Administration shall inform the applicant of the results.
In case of refusal, the Administration shall reply in writing and clearly state relevant reasons
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Process map:
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| Category | Procedure |
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This procedure apply to theses Measures.
