View Procedure
| Procedure Name | Granting permission to the import order of rare drugs/medicines to be distributed to chains of pharmacies meeting the standard GPP |
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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: 183A Giang Vo – Ba Dinh - Hanoi
Phone: +844 3736 6483
Email: cqldvn@moh.gov.vn
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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 37/2008/QD-BYT issuing the list of rare drugs/medicines
- Circular 45/2011/TT-BYT amending and supplementing a number of articles in documents regulating pharmaceutical and cosmetic industries.
- 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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Process time
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- Within 7 working days from the date of reception of adequate and valid dossier
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Fee
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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 6a)
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03 original copy
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2
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Written statement of reasons for delay in providing records of imported medicines, original testing sheet of the drug/medicine lot and commitment on ensuring the quality of imported drugs/medicines (in case of failure to provide these materials).
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01 original copy
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Requirements and conditions:
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1
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Dare drugs, specific drugs or drugs of special preparation forms to meet treatment needs
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2
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Enterprises having certificates of eligibility for drug/medicine trading and drug/medicine warehouses obtaining the standard "Good Storage Practice" (GSP) are eligible to import directly and receive entrusting to import rare drugs/medicines for the treatment needs of specific hospitals in special cases in accordance with the business scope stated in the Certificate of eligibility for drug/medicine trading and GSP certificate
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3
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Enterprises organizing chains of pharmacies obtaining the standard "good pharmacy practice" GPP in need of importing drugs/medicines in the list of rare drugs and medicines imported for the treatment needs of specific hospitals in special cases to sell at the pharmacies obtaining GPP in the system: They must submit a written statement of reasons for delay in providing records of imported medicines, original testing sheet of the drug/medicine lot and commitment on ensuring the quality of imported drugs/medicines.
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4
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Enterprises having already received the written announcement of "The Enterprise organizing a chain of pharmacies obtaining the standard "good pharmacy practice" GPP" certified by the Drug Administration of Vietnam
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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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This procedure apply to theses Measures.
