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Procedure Name | Granting permission to import drugs/medicines meeting urgent needs for prevention and treatment of epidemic diseases, recovery from natural disasters and calamities |
Description |
Category
|
License/Permit
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Responsible Agency
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Drug Administration of Vietnam - Ministry of Health
Address:
Phone:
Email:
|
Legal base of the Procedure
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- Law on Pharmacy No. 105/2016/QH13
- Decree 102/2016/ND-CP on Drug business requirements
- Decision 151/2007/QD-TTg dated September 12, 2007, promulgating the Regulation on the Import of Drugs without Registration Numbers in Vietnam
- Circular 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 5 working days from the date of reception of adequate and valid dossier
|
Fee
|
VND 0
|
Required documents:
No
|
Type of documents
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Note
|
1
|
Import order (Form 8);
|
01 original copy
|
Conditions:
1
|
Conditions and scope of organizations and individuals participating in export and import of drags/medicines, packaging in direct contact with drugs/medicines:
Enterprises having certificates of eligibility for drug/medicine trading and drug/medicine warehouses obtaining standard "Good Storage Practice" (GSP) are imported directly and received entrusting to import finished drugs, addictive ingredients, psychotropic substances and precursor substances with registration numbers for circulation in accordance with the business scope stated in the certificate of eligibility for drug/medicine trading and GSP certificate;
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Process Steps
Step 1
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The applicant shall submit a dossier of Application to the Drug Administration of Vietnam - Ministry of Health
|
Step 2
|
The Drug Administration of Vietnam shall receive and examine the dossier.
|
Step 3
|
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 |
The following form/s are used in this procedure
This procedure applies to the following measures