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VIETNAM |
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|
Authority |
Drug administration of Vietnam MOH |
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website |
www.moh.gov.vn/ |
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if any |
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|
REQUIREMENT FOR PRODUCT REGISTRATION |
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|
S.No. |
INDEX |
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1. |
Application form for registration of foreign drugs |
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2. |
Summary of product characteristics |
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3. |
Certificate of Pharmaceutical Product (For imported drug product) |
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4. |
GMP Certificate |
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5. |
Labeling sample |
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6. |
Quality Specifications and Analytical methods |
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7. |
Certificate of Analysis |
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8. |
Manufacturing Process with flow chart |
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9. |
Study reports on: |
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|
Shelf life (Stability) |
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Experimental pharmacology |
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Toxicology |
|
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Clinical Pharmacology |
|
|
Pharmacokinetics and bio-availability |
|
10 |
Other documents |
Toc for vietnam, toc formate for product registration
