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REQUIREMENTS OF NEW PHARMA REGISTRATION DOSSIER IN VIETNAM

According to Circular 32/TT-BYT dated Nov. 12, 2018

NoREQUIREMENTSGENERICInstruction for signing and stampWho will sign/stamp
(Notes: In case having form 8B/TT, Chief of rep office in VN can sign on all reg. documents. Stamp of rep office will be used to replace for stamp of applicant. In case the authorized person signs on the application who is not the chief representative of office in Vietnam, the authorization letter Form 8B must be sealed and signed by the chief representative office in Vietnam.)
PART 1: ADMINISTRATIVE DOSSIER AND INFORMATION OF PRODUCTS1 original copy & 02 copies of application form 6/TT
1Cover page (Form 3/TT)1 copyNo required
2Brief of product – Form 4/TT1 copyStamp at right corner at the top of page.Applicant will stamp
3List of content (Form 5/TT)1 copy
4Application for registration – Form 6/TT1 original copy of eachSign and stampDirector of applicant will sign and put the stamp of applicant
5Letter of Authorization – Form 08/TT
* Form 8A/TT: Authorization for applicant
* Form 8B/TT: Authorization for signing on registration dossier (only required if director of applicant wants to authorize for Chief of rep office in Vietnam to sign reg. dossier) (In case the authorized person signs on the application who is not the chief representative of the office, the authorization letter must be signed and sealed by the chief representative office in Vietnam)
– 1 original/notarized copy with legalization at Vietnam embassy
– 1original/ copy with applicant’s RO stamp
Sign and stamp– 8A: The product license holder (mentioned in CPP) sign and stamp and legalize by Vietnamese Embassy
– 8B: Director of applicant and Chief of rep office in Vietnam will sign and stamp
6– Vietnam company: Certificate for satisfying business condition in medicine: (at least one of 04 scopes: manufacture, wholesale, export, import)
– Foreign company:
+ Pharmaceutical Business License (at least one of 04 scopes: manufacture, wholesale, export, import)
+ License of Rep. office in Vietnam
– 01 copy with applicant stamp

+ 01 original/notarized copy with legalization at Vietnam embassy
+ 01 notarized copy

– Certificate for satisfying business condition in medicine: applicant will stamp: Put stamp at right corner at the top of first page and put a boundary stamp on all pages (Applicant is Vietnam company)
7CPP according to WHO-format
In case CPP doesn’t mention that Manufacturer meets GMP-WHO, GMP-WHO certificate is required. If there are many manufacturers take part in the manufacturing process of finished product, GMP-WHO certificates of all manufacturers are required.
CPP need to have: from 01/01/2022 with information:
– Drug formulation: It is required to fully state the composition, concentration/content of each pharmaceutical substance, excipients. For soft capsules, hard capsules must have more information about the composition of the capsule shell.
– Specification DP, DS, DS manufacturer’s name and address
– All manufacturers and role of each
– Attachments need to certify by authority to issue CPP
–  In case the drug is not licensed for marketing in the manufacturing country or is licensed but not is actually marketed in the manufacturing country: provide another CPP certifying that the drug is licensed for marketing and is marketed in one of the member of Strignet regulatory authorities
1 original/notarized copy with legalization at Vietnam embassyNo required
8Drug label intended circulation in Vietnam
– Original set of designed label (under guideline of Circular 01/2018/TT-BYT)
3 sets of original copiesPut stamp on a part of label (box, blister/bottle label,…)Applicant will stamp
9Product information (in Vietnamese or in both Vietnamese and English)
– Package insert
3 original copiesPI: Put stamp at right corner at the top of first page and put a boundary stamp on all pagesApplicant will stamp
10Drug label and package insert circulate in manufacturer’s country or country issue CPP
If PI is not in English, need translate to Vietnamese
1 original copyPut stamp on a part of label (box, blister/bottle label,…)
PI: Put stamp at right corner at the top of first page and put a boundary stamp on all pages
Applicant will stamp
11Summary of product characteristics – Form 9/TT (in Vietnamese)1 original copyPut stamp at right corner at the top of first page and put a boundary stamp on all pagesApplicant will stamp
12Legal documents of manufacturer of drug substance, excipients, capsule shell, herbal pharmaceutical materials, semi-finished herbal pharmaceutical materials justify adapt with GMP (one of below):
from 01 Sep 2019: required for drug substance
from 01 Jan 2021: required for excipients, capsule shell, herbal pharmaceutical materials, semi-finished herbal pharmaceutical materials.
– GMP certificate
– Manufacturing license that justify GMP
– CPP for DS mention GMP
– CEP
1 original/notarized copy with legalization at Vietnam embassyNANA
13Protection certificates, contracts on transfer of industrial property rights, documents certifying the origin of materials (GACP, CEP, domestic herbal sources, imported herbal sources, …) and other relevant documents (If any).
For legal document in electronic version: link to website of issued authority (English website) + Commitment of applicant is responsible for the legality of this document.
+ 1 copy with legalized by Vietnamese Embassy (for legal document issued by Competent Authority), and 01 notarized copy for othersNo required
PART 2: QUALITY DOSSIER1 original copy +
2 copies of Specification of finished product + Method of analysis (P5.1+P5.2)
 
ATable of Content
BQuality Overall SummaryStamp on the first page which contains information (the first page is not devided page which only contains the sentense “Quality Overall Summary”)Applicant will stamp
 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 and Process Controls
 2.3 Control of materials
 2.4. Control of Critical Steps and Immediates
 2.5. Process Validation and/or Evaluation
 2.6. Manufacturing Process Development
 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
 4.5. Justification of Specifications
 S.5. Reference Standards or Materials
 S.6. Container Closure System
 S.7. Stability
 P. DRUG PRODUCT
 P.1. Description and Composition:
– Formula for smallest unit

– Description of packing material and packaging materials
 P.2. Pharmaceutical Development
 2.1. Information on Development Studies
 2.2. Components of the Drug Product
 2.3. Finished Product
 2.4. Manufacturing Process Development
 2.5. Container Closure System
 2.6. Microbiological Antributes
 2.7. Compatibility
 P.3. Manufacture
 3.1. Batch Formula
 3.2. Manufacturing Process and  Process Control
Flow Chart of Manufacturing and Packaging Process
List of Equipment used in Manufacturing and Packaging Process
 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
 P.5. Control of Finished Product
 5.1. SpecificationSign and stamp by DP manufacturer
 5.2. Analytical proceduresSign and stamp by DP manufacturer
 5.3. Validation of Analytical Procedures
 5.4. Batch Analysis
 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
(follow the requirements according to Circular 08/2010/TT-BYT dated Apr. 26, 2010)
CBody of Data
 S. DRUG SUBSTANCE
 S.1. General InformationStamp on the first page which contains informationApplicant will stamp
 1.1. Nomenclature
 1.2. Structure
 1.3. General Properties
 S.2. Manufacture
 2.1. Manufacturer (s)
 2.2. Description of Manufacturing Process and Process Controls
 2.3 Control of materials
 2.4. Control of Critical Steps and Immediates
 2.5. Process Validation and/or Evaluation
 2.6. Manufacturing Process Development
 S.3. Characterization
 3.1. Elucidation of Structure and other characteristics
 3.2. Impurities
 S.4. Control of Drug Substance
 4.1. SpecificationStamp and signManufacturer will sign and stamp, original
 4.2. Analytical ProceduresStamp and signManufacturer will sign and stamp, original
 4.3. Validation of Analytical Procedures
 4.4. Batch Analysis
 4.5. Justification of Specifications
 S.5. Reference Standards or Materials
 S.6. Container Closure System:
 S.7. Stability:
– Long term condition

– Accelerate condition
Stamp and signManufacturer of DS will sign and stamp, original (accept photocopy from original with stamp by applicant)
 P. DRUG PRODUCT
 P.1. Description and Composition:
– Formula for smallest unit: name and quantity of all active and inactive ingredients

– Description of packing material and packaging materials
Stamp on the first page which contains informationApplicant will stamp
 P.2. Pharmaceutical Development
 2.1. Information on Development Studies
 2.2. Components of the Drug Product
 2.3. Finished Product
 2.4. Manufacturing Process Development
 2.5. Container Closure System
 2.6. Microbiological Antributes
 2.7. Compatibility
 P.3. Manufacture
 3.1. Batch Formula
 List of Equipment used in Manufacturing and Packaging Process
 3.2. Manufacturing Process and  Process Control
 Flow Chart of Manufacturing and Packaging Process
 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
 P.5. Control of Finished Product
 5.1. SpecificationStamp and signManufacturer will sign and stamp, original (accept photocopy from original with stamp by applicant)
 5.2. Analytical proceduresStamp and signManufacturer will sign and stamp, original (accept photocopy from original with stamp by applicant)
 5.3. Validation of Analytical Procedures
 5.4. Batch Analysis
Summary of protocol of 3 consecutive lots
 5.5. Characterisation of Impurities
 5.6. Justification of Specifications
 P.6. Reference Standards or Materials
 P.7. Container Closure System
 P.8. Stability
– Long term condition at Zone 4B
– Accelerate condition
Stamp and signManufacturer will sign and stamp, original (accept photocopy from original with stamp by applicant)
 P.9. Product Interchangeability Equivalence evidence
(follow the requirements according to Circular 08/2010/TT-BYT dated Apr. 26, 2010)
(including 01 set of Brief product form 4/TT)
DCertificate of analysis issued by manufacturer
– for finished product
– for drug substance
– for excipient which has non- compendial specification
– Batch release certificate of 3 consecutive lots with legalization



COA for drug substance and excipient: signature and stamp of manufacturerManufacturer will sign and stamp, original
 Certificate of analysis for finished product issued by National Institute for Control of Vaccine and Biological in Vietnam (NICVB)
EReference documentsStamp on the first page which contains informationApplicant will stamp
PART 3: PRE-CLINICAL DOSSIERNAStamp on the first pageApplicant will stamp
 Brief of product – Form 4/TTStamp on the first pageApplicant will stamp
ATable of Content
BNonclinical Over View
1. General Aspect
2. Content and Structural Format
CNonclinical Summary (Written and Tabulated)
1. Nonclinical Written Summaries
Introduction
General Presentation Issues
2. Content of nonclinical written Summaries
2.1. Pharmacology
Primary Pharmacodynamics
Secondary Pharmacodynamics
Safety Pharmacology
Pharmacodynamics Drug Interactions
2.2. Pharmacokinetics
Absorption
Distribution
Metabolism
Excretion
Pharmacokinetics Drug Interaction (non-clinical)
2.3. Toxicology
Single Dose Toxicity
Repeat Dose Toxicity
Genotoxicity
Carcinogenicity
Reproductive and Developmental Toxicity
 – Fertility and Early Embryonic Development
 – Embryo-fetal Development
 – Prenatal and Postnatal Development
Local Tolerance
Other Toxicity Studies (if available)
3. Content of Nonclinical Tabulated Summaries
(Pharmacology, pharmacokinetics, toxicology)
DNonclinical Study Report (As requested)
1. Table of Content
2. Pharmacology
Primary Pharmacodynamics
Secondary Pharmacodynamics
Safety Pharmacology
Pharmacodynamics Drug Interactions
3. Pharmacokinetics
Analytical Methods and Validation Reports
Absorption
Distribution
Metabolism
Excretion
Pharmacokinetics Drug Interaction (non-clinical)
Other Pharmacokinetics Studies
4. Toxicology
Single Dose Toxicity
Repeat Dose Toxicity
Genotoxicity
– In vitro Report
– In vivo Report
Carcinogenicity
– Long Term Studies
– Short or Medium Term Studies
– Other Studies
Reproductive and developmental toxicity
– Fertility and early embryonic development
– Embryo-fetal development
– Prenatal and Postnatal development
– Studies in which the offspring are dosed and/or
further evaluated
Local tolerance
Other Toxicity Studies, if available
– Antigenicity
– Immunotoxicity
– Dependence
– Metabolites
– Impurities
– Other
EList of key Literature References
PART 4: CLINICAL DOSSIERNAStamp on the first pageApplicant will stamp
ATable of contents
BClinical Overview
 Product Development Rationale
 Overview of Biopharmaceutics
 Overview of Clinical pharmacology
 Overview of Efficacy
 Overview of Safety
 Benefits and Risks Conclusion
CClinical Summary
 Summary of Biophamaceutic Studies and Associated analytical Methods
 Summary of Clinical phamacology studies
 Summary of Clinical Efficacy
 Summary of Clinical Safety
 Synopses of individual study
DTabular Listing of All Clinical Studies
EClinical Study Reports
 Report of Biopharmaceutic Studies
 Repoort of Studies Pertinent to Pharmacokinetics Using Human Biomaterials
 Report of Human Pharmcokinetic (PK) Studies
 Report of Human Ppharmcodinamic (PD) Studies
 Report of Efficacy and Safety Studies
 Report of Post-Marketing Experience
 Case Report Forms and Individual Patient Listings
FList of Key Literature References
PART 5: GMP ASSESSMENT DOSSIER
Applicable object:
– Foreign manufacturer for the first time who having drugs registered for circulation in Vietnam;

– Drug manufacturing line has not yet been evaluated by the Ministry of Health;
– Drug raw materials are pharmaceutical substances registered for the first time in Vietnam;
– Foreign manufacturer for the first time who having herbal materials registered for circulation in Vietnam.
‘- In case that the manufacturer belongs ICH, Australia and is inspected by one of following HA: FDA (USA)/ EMA (Euro)/ TGA (Australia)/ PMDA (Japan)/ Health Canada (Canada): required 1 & 2
– Other cases: required all (1-> 5)
1 original copyStamp on the first pageApplicant will stamp
 Brief of product – Form 4/TT1 copyStamp on the first pageApplicant will stamp
1GMP certificate / or GMP inspection report / or Manufacturing license1 original/notarized copy with legalization at Vietnam embassy
2Site master file conforming to the guidelines of European Union (EU) or the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) or the World Health Organization (WHO).1 copy with manufacturer’s stampManufacturer will stamp
3List of GMP inspections for last 3 years1 copy with manufacturer’s stampManufacturer will stamp
4Last GMP inspection report which has as inspection scope the registered drugs or dosage forms of the registered drugs1 original/notarized copy with legalization at Vietnam embassy
5Periodic quality review report for sterile drug product1 copy with manufacturer’s stampManufacturer will stamp

Note:

1.      For ASEAN member countries, the studies report of  part 3, part 4 may not be required for NCE, BIOTECH, and other MaV. if the Original Products are already registered and approved for market authorisation in Reference Countries. Therefore, submission of Study reports will be required upon request from Authority.

2.      Symbol:

√    :Necessary

∗  Where applicable, i.e change of route of administration due to change on formulation

3.      Dossier should be presented in A4, with letter font as Times New Roman, size 12.

4.      Enclosed forms