View Procedure
| Procedure Name | Granting Free Sale Certificate (FSC) or Certificate of Pharmaceutical Product (CPP) for drugs/medicines domestically manufactured for export |
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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 5 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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An written application for a FSC or CPP (Form 14);
(Where the importing country requires the establishment to hand in a FSC or CPP in the form prescribed by that country, the Drug Administration of Vietnam - Ministry of Health may consider to grant FSC based on the form of application).
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01 original copy
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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
