View Procedure
| Procedure Name | Granting permission to import vaccines and medical biological products under assistance and/or humanitarian aid 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
- 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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A written request for import of the establishment receiving assistance/humanitarian aid
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01 original copy
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2
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b) List of drugs/medicines of assistance/humanitarian aid (Form 10)
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01 original copy
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3
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Documents issued by the competent authority permitting the establishment to receive drugs/medicines of assistance/ humanitarian aid
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01 original copy
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4
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A certificate of the competent authority of the home country for permitting the circulation or export of vaccines and medical biological products;
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01 original copy
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5
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Certificate of production establishment obtaining GMP standard;
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01 original copy
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6
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Testing paper of obtaining the quality standard of vaccines, medical bio-products of the national accreditation agency or other competent authorities of the home country for lots of imported goods (certified true copy of the importer);
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01 original copy
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Conditions:
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Drug/medicine of assistance/humanitarian aid with expiry date of more than or equal to 24 months, the remaining expiry date of medicine must have a minimum period of 12 months from the date of arrival in Vietnam. Where drug/medicine with expiry date of less than 24 months, the remaining expiry date from the date of arrival in Vietnam is at least equal to 1/3 of drug/medicine’ expiry date;
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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
