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| Procedure Name | State quality inspection of imported veterinary drugs |
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| Description |
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Category
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Certificate
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Responsible Agency
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Department of Animal Health - Ministry of Agriculture and Rural Development
Address: No. 15/78 Giai Phong Rd, Phuong Mai, Dong Da, Hanoi
Phone: 04.36290447
Email: Quanlythuoc@dah.gov.vn
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Legal base of the Procedure
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- Law on Product and Goods Quality No. 05/2007/QH12
- Circular 13/2016/TT-BNNPTNT dated June 2, 2016 of the Ministry of Agriculture and Rural Development on veterinary drug management
- Circular 285/2016/TT-BTC on the collection, remittance, management and amount of veterinary fees and charges
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Processing time
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- 05 working days for raw materials for veterinary drugs medicines, chemicals, biological preparations after taking samples for quality inspection
- 14 working days for vaccines and antibodies subject to inspection of sterility, purity or safety criteria after taking samples for quality inspection
- 60 working days for vaccines and antibodies subject to inspection of effectiveness criteria after taking samples for quality inspection
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Fee
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- According to Annex 6 enclosed with Circular No. 04/2012/TT-BTC
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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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Written registration for quality inspection of the imported veterinary drugs
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Annex XXXVII Circular No. 13/2016/TT-BNNPTNT (2 copies)
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2
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Contract, Packing list, Invoice, Bill of Lading
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Copy certified by the Enterprise
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3
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Written permission to import of raw materials for veterinary drugs, vaccines or microorganisms for veterinary medicines issued by the Department of Animal Health or Certificate of Free Sale of the veterinary medicines in the form of vaccines or microorganisms
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Original or Copy certified by the Enterprise
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4
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Certificate of Analyst (CoA) of the manufacturer
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Original or Copy certified by the Enterprise
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5
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Sample labels of the veterinary drugs and extra-labels if the main ones fail to specify the required contents
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Original or Copy certified by the Enterprise
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Process Steps
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Step 1
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The Enterprise shall submit a dossier of registration for quality inspection to the Department of Animal Health
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Step 2
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The Department shall certify the Registration for quality inspection for settlement of procedures for customs clearance or request for completion if the dossier is not sufficient.
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Step 3
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If testing samples are not required, the Enterprise shall follow procedures for customs clearance at the border gate.
If testing samples are not required, the Enterprise shall transport the commodity to the inspection location specified in the Registration Form
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Step 4
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Within 2 days, the Department shall examine the dossier, conduct external inspection and take samples for quality inspection
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Step 5
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Issue a Notice of Testing Results if the prescribed requirements for customs clearance are met
Within 05 days, if the unsatisfactory results are not subject to any objections or complaints by the Enterprise, the inspection agency may request competent agencies for prescribed steps of treatment
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Process Map:
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| Category | Procedure |
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This procedure apply to theses Measures.
