CHECKLIST FOR REGISTRATION OF NEW MODERN DRUGS, VACCINES, BIOLOGICALS updated July 06, 2017 ISSUED BY DRUG ADMINISTRATION OF VIETNAM

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New Checklist for drug registration in Vietnam

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CHECKLIST FOR REGISTRATION OF NEW MODERN DRUGS, VACCINES, BIOLOGICALS updated July 06, 2017 ISSUED BY DRUG ADMINISTRATION OF VIETNAM

	Content	Note
I	01 SET
1	Administration dossier
1.1	Cover Page Form 07/TT
1.2	Table of content
1.3	Application registration Form 6A/TT
1.4	Authorization letter for Registration ( if any) Form 05/TT
1.5	A Certificate of eligibility for drug trading of Vietnamese Registrars
1.6	– Drug manufacturing, trading license granted by the foreign competent agencies and License for representative office establishment in Vietnam of foreign registars
	– Or License conducting operation in medicine, medicinal material field in Vietnam of foreign registrars
1.7	CPP
1.8	Drug label (artwork design, package insert): 03 set
1.9	Summary of Product Characteristics pertaining to new modern drugs, vaccines, antibody-containing sera and biologicals
1.10	A franchise agreement on drug manufacturing. Outsourcing agreement on drug manufacturing (if any)
1.11	Certificates, protection titles and transfer contracts for ownership of industrial property objects (if any).
1.12	Actual drug label of original country or reference country for imported drugs
1.13	Manufacturing condition evaluating dossier
1.13.1	– GMP
	– or Good manufacturing practice inspection report
	– or the manufacturing license granted by the competent agency
1.13.2	Site master file on the manufacturing facility conforming to the guidelines of EU or PIC/S or WHO
1.13.3	Quality Manual of Manufacturer
1.13.4	List of Good manufacturing practice inspection performed by the pharmaceutical regulatory authority of the establishment’s home country
1.13.5	List of the drugs along with dosage forms, drug raw materials that have been supplied or are intended to be supplied to VN
1.13.6	Batch release process for drugs, drug raw materials intended to be registered for marketing in VN
1.13.7	Reports on periodic quality reviews with regard to the registered drugs, drug raw materials being of sterilized form
1.14	Other legal documents (if any)
2	Quality Documents
2.1	Table of content
2.2	Quality overall summary
2.3	Body of data
2.3.1	Drug substances
	2.3.1.1. General information( S1)

	2.3.1.2. Manufacture (S 2)
	2.3.1.3. Characterization (S 3)
	2.3.1.4. Control of drug substance (S 4)
	2.3.1.5. Reference standards or materials (S 5)
	2.3.1.6. Container closure system (S 6)
	2.3.1.7. Stability (S 7)
2.3.2	Drug product
	2.3.2.1. Description and Composition of the Drug product (P 1)
	2.3.2.2. Pharmaceutical development (P 2)
	2.3.2.3. Manufacture (P 3)
	2.3.2.4. Control of excipients P 4)
	2.3.2.5. Control of Finished product (P 5)
	2.3.2.6. Reference Standards or materials (P 6)
	23.2.1. Container closure system (P 7)
	2.3.2.8. Stability (P 8)
	2.3.2.9. Product Interchangeability Equivalence evidence (if any) (P 9)
2.4	Certificate of analysis (CoA)
2.5	Site Master file of Manufacturer Form 10/TT
2.6	Report BA/BE (if any)
3	Nonclinical document ( new modern drugs, vaccines, antibody-containing sera, or biologicals)
3.1	Table of contents
3.2	Nonclinical overview
3.3	Clinical Summary
3.4	Nonclinical Study Reports
3.5	References
4	Clinical Document ( new modern drugs, vaccines, antibody-containing sera, or biologicals)
4.1	Table of Contents
4.2	Clinical overview
4.3	Clinical Summary
4.4	Tabular Listing of All Clinical Studies
4.5	Clinical Study Reports
4.6	References
5	Summary of Product Form 4A
II.	02 SET COPY including
1	Application registration
2	Specification and Analytical procedures
III.	01 SET FULL COPY OF THE ORIGINAL REGISTRATION DOSSIER FOR VACCINES, ANTIBODY-CONTAINING SERE, OR BIOLOGICALS
IV.	INVOICE FROM THE DAV’S ACCOUNTING DEPARTMENT