View Procedure
| Procedure Name | Granting permission to import vaccines and medical biological products as special treatment demand |
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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 No. 151/2007/QD-TTg dated September 12, 2007, promulgating the Regulation on the Import of Drugs without Registration Numbers in Vietnam
- 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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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 7a)
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01 original copy
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2
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Reserves of vaccines, medical biological products of the establishments of vaccination, testing establishments (Form 7b);
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3
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The supplier’ commitment on quality assurance of vaccines and medical biological products provided to Vietnam (Form 7c);
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01 original copy
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4
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Certificate of Free Sale (FSC)
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01 original copy (if available)
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5
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"Good Manufacturing Practice" (GMP) certificate or CPP
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01 original copy (if available)
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Conditions:
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1
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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;
- Enterprises trading medical equipment and enterprises having certificates of eligibility for medicine trading are imported directly and received entrusting to import medical biological products for In Vitro diagnosis;
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2
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The Ministry of Health shall grant the import permit if one of the following conditions are met:
- Vaccines, medical biological products without registration numbers, when imported into Vietnam they must have a remaining expiry date of at least by 2/3 of expiry date from the date of arrival in Vietnam;
- Vaccines, medical biological products with valid circulation registration numbers in Vietnam, when imported into Vietnam, they must have a remaining expiry date of at least by 1/2 of expiry date from the date of arrival in Vietnam;
- Biological products used in In Vitro diagnosis with expiry date of equal to or less than 12 months when imported into Vietnam, they must have a remaining expiry date of at least by 3 months from the date of arrival in Vietnam;
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3
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The attached documents (if any) include: Certificate of production facilities obtaining GMP standards or certificate of production facilities obtaining standard of quality management system (ISO) issued by the competent agencies (for In vitro diagnostic medical biological products), permits for the circulation of vaccines and medical biological products, permits for the circulation in some other countries where such vaccines and medical biological products are registered circulation. In special cases, the companies have not provided enough materials or vaccines, medical bio-products not meeting the provisions in points b, c, and d, clause 2 of Article 4 of this Circular but they are necessary for needs of use, the Drug Administration Department of Vietnam - Ministry of Health shall consider and decide.
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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
