KENFOX IP & Law Office > REQUIREMENTS OF NEW PHARMA REGISTRATION DOSSIER IN VIETNAM

REQUIREMENTS OF NEW PHARMA REGISTRATION DOSSIER IN VIETNAM

For generic drugs, the drug manufacturers need to prepare the drug dossier in according to ACTD form which includes administrative part and quality part. For your reference, KENFOX provide checklist for new drug registration with highlighted Generic column. 

Notes:

  • symbol “√” means “required to provide”
  • symbol “X” means “not required to provide”

 

No.RequirementsQuantityGeneric
PART 1: ADMINISTRATIVE DOSSIER AND INFORMATION OF PRODUCTS
1Cover page (Form 1/TT)1 copy
2List of content1 copy
3Application for registration (Form 6A)2 original copies
4Letter of Authorization – Form 5/TT (if any)2 original copies
5Representative Office License in Vietnam1 notarized copy
6The manufacturing license in the origin country1 notarized legalization copyX
7CPP according to WHO-format1 notarized legalization copy
8Drug label:- Original set of designed label- Original label that is being circulated in the country of origin5 original sets2 original sets
9Product information (in Vietnamese) – Summary of product characteristics – Form2/ACTD (for new pharmaco-chemical drugs) – Package insert2 original copies 6 original copies 
10Under-license or processing agreement or contract regarding drugs manufactured under-license (if any)1 copy
11Certificates of trademark (acceptance letter of trademark), protection licence, contract of transfering industrial property right (if any)1 notarized copy
12Other legal documents (if any)1 copy
13Brief information of product (Form 4B)1 copy
14Overall information of the manufacturer1 original copy
PART 2: QUALITY DOSSIER
ATable of Content 
BQuality Overall Summary 
 S. DRUG SUBSTANCE  
 S.1. General Information 
 S.2. Manufacture 
 S.3. Characterization 
 S.4. Control of Drug Substance 
 S.5. Reference Standards or Materials 
 S.6. Container Closure System 
 S.7. Stability 
 P. DRUG PRODUCT 
 P.1. Description and Composition 
 P.2. Pharmaceutical Development 
 P.3. Manufacture 
 P.4. Control of excipients 
 P.5. Control of Finished Product 
 P.6. Reference Standards or Materials 
 P.7. Container Closure System 
 P.8. Stability 
 P.9. Product Interchangeability Equivalence evidence (comply  requirements under Circular 08/2010/TT-BYT)
CBody of Data  
 S. DRUG SUBSTANCE 
 S.1. General Information 
 1.1. Nomenclature 
 1.2. Structure 
 1.3. General Properties 
 S.2. Manufacture  
 2.1. Manufacturer (s) 
 2.2. Description of Manufacturing Process andProcess Controls X
 2.3 Control of materials X
 2.4. Control of Critical Steps and Immediates X
 2.5. Process Validation and/or Evaluation X
 2.6. Manufacturing Process Development X
 S.3. Characterization  
 3.1. Elucidation of Structure and other characteristics 
 3.2. Impurities 
 S.4. Control of Drug Substance  
 4.1. Specification 
 4.2. Analytical Procedures 
 4.3. Validation of Analytical Procedures 
 4.4. Batch Analysis X
 4.5. Justification of Specifications X
 S.5. Reference Standards or Materials 
 S.6. Container Closure System X
 S.7. Stability 
 P. DRUG PRODUCT  
 P.1. Description and Composition 
 P.2. Pharmaceutical Development X
 2.1. Information on Development Studies X
 2.2. Components of the Drug Product 
 2.3. Finished Product 
 2.4. Manufacturing Process Development X
 2.5. Container Closure System 
 2.6. Microbiological Antributes 
 2.7. Compatibility 
 P.3. Manufacture  
 Formula for the Smallest Unit: name and quantity of all active and inactive ingredients  
 3.1. Batch Formula 
 List of Equipment used in Manufacturing andPackaging Process 
 Flow Chart of Manufacturing and Packaging Process 
 3.2. Manufacturing Process and  Process Control 
 3.3. Control of Critical Steps and Intermediates 
 3.4. Process Validation and/or Evaluation 
 P.4. Control of excipients  
 4.1. Specification 
 4.2. Analytical Procedures 
 4.3. Excipient of Human or Animal Origin 
 4.4. Novel excipients X
 P.5. Control of Finished Product  
 5.1. Specification 
 5.2. Analytical procedures 
 5.3. Validation of Analytical Procedures 
 5.4. Batch Analysis X
 5.5. Characterisation of Impurities 
 5.6. Justification of Specifications 
 P.6. Reference Standards or Materials 
 P.7. Container Closure System 
 P.8. Stability 
 P.9. Product Interchangeability Equivalence evidence (comply  requirements under Circular 08/2010/TT-BYT)
DCertificate of analysis:    – for finished product    – for excipient which has non- compendial specification  
EReference documents X
FMaster file of manufacturer (Form 4/TT)In case a product undergoes many manufacturing stages, the master file should be the general one including all manufacturers involving in the production prior to marketing of the product   
GBioequivalent and Bio Availability report under Circular 08/2010/TT-BYT 
HBrief of product  in Vietnamese – Form 7B