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Administrative dossier:
1. Cover page - Form 1/GC
2. Table of contents
3. Application for registration - Form 4a/GC or Form 4b/GC
4. A Power of attorney (if any) - Form 3a/GC or Form 3b/GC
5. A Certificate of eligibility for drug/medicine trading applying to Vietnamese drug-trading establishment (certified photocopy)
6. CPP certificate - Form 01/ACTD applying to foreign drugs.
7. Where having no CPP, it can be replaced by FSC.
8. A GMP certificate of the foreign drug manufacturer if the FSC or CPP certification does not certify the GMP requirements. In case there are many manufacturers involving in the drug/medicine manufacturing process, the applicant shall submit the GMP certificates of all applicants involving in the finished drug/medicine manufacturing process.
9. Drug/medicine labeling: These drug labels shall be attached to A4 paper, borne the stamp of the applicant - 03 sets
10. Drug/medicine information: Instruction or information sheet for patient or Summary of product characteristics as prescribed for each type of corresponding drug with the affixed seal of the registration establishment - 03 sets
11. Drug/medicine sample:
12. Summary of Product (Form 7b/GC)
13. Certificates, protection titles and transfer contracts for ownership of industrial property objects.
14. Other legal documents (if any).
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