View Procedure
| Procedure Name | Granting permission to import raw materials for addictive drugs/medicines |
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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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Import order (Form 12d);
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01 original copy
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2
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Inventory report of finished addictive drugs (or psychotropic substances, precursor substances) (Form 3)
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01 original copy
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3
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Quality standards (for raw materials not subject to the quality standards of the Pharmacopeia)
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01 original copy (if any)
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Conditions:
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Central Pharmaceutical Company 1, Central Pharmaceutical Company 2, Central Pharmaceutical Company 3, SAFACO, YTECO, HAPHARCO are responsible for the supply of addictive ingredients and finished addictive drugs to the sellers and users nationwide.
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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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