View Procedure
| Procedure Name | Granting permission to import drugs/medicines in service of national target health programs |
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| Description |
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Category
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License/Permit
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Responsible Agency
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Drug Administration of Vietnam - Ministry of Health
Address:
Phone:
Email:
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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 15 working days from the date of reception of adequate and valid dossier
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Fee
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VND 0
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Required documents:
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No
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Type of documents
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Note
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1
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Import order (Form 9);
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01 original copy
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Conditions:
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Finished drugs imported into Vietnam with expiry date of more than 24 months, the remaining expiry date must be at least 18 months from the date of arrival in Vietnam. For drugs with a use duration of 24 months or less, the remaining use duration must be at least 12 months, counting from the date of arrival at a Vietnamese port.
Raw materials for making medicines imported into Vietnam, except for pharmaceutical materials, must have remaining expiry date of more than 36 months from the date of arrival in Vietnam. For raw materials with expiry date of equal to or less than 36 months, the arrival date of the Vietnam's ports is not exceeded 06 months from date of manufacture.
Drugs/medicines of the national health target program must be entrusted through the enterprises with direct importing function of medicines. On the drug/medicine’s label must bear the phase "program medicine, not for sale".
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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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The following form/s are used in this procedure
This procedure applies to the following measures
