REQUIREMENTS OF NEW PHARMA REGISTRATION DOSSIER IN VIETNAM

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

REQUIREMENTS

GENERIC

Instruction for signing and stamp

Who 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 PRODUCTS

1 original copy & 02 copies of application form 6/TT

Cover page (Form 3/TT)

1 copy

No required

Brief of product – Form 4/TT

1 copy

Stamp at right corner at the top of page.

Applicant will stamp

List of content (Form 5/TT)

1 copy

Application for registration – Form 6/TT

1 original copy of each

Sign and stamp

Director of applicant will sign and put the stamp of applicant

Letter 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

– 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)

CPP 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 embassy

No required

Drug label intended circulation in Vietnam
– Original set of designed label (under guideline of Circular 01/2018/TT-BYT)

3 sets of original copies

Put stamp on a part of label (box, blister/bottle label,…)

Applicant will stamp

Product information (in Vietnamese or in both Vietnamese and English)
– Package insert

3 original copies

PI: Put stamp at right corner at the top of first page and put a boundary stamp on all pages

Applicant will stamp

Drug 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 copy

Put 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

Summary of product characteristics – Form 9/TT (in Vietnamese)

1 original copy

Put stamp at right corner at the top of first page and put a boundary stamp on all pages

Applicant will stamp

Legal 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 embassy

Protection 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 others

No required

PART 2: QUALITY DOSSIER

1 original copy +
2 copies of Specification of finished product + Method of analysis (P5.1+P5.2)

Table of Content

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Quality Overall Summary

√

Stamp 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

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1.2. Structure

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1.3. General Properties

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S.2. Manufacture

2.1. Manufacturer (s)

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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

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3.2. Impurities

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S.4. Control of Drug Substance

4.1. Specification

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4.2. Analytical Procedures

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4.3. Validation of Analytical Procedures

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4.4. Batch Analysis

4.5. Justification of Specifications

S.5. Reference Standards or Materials

√

S.6. Container Closure System

S.7. Stability

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P. DRUG PRODUCT

P.1. Description and Composition:
– Formula for smallest unit
– Description of packing material and packaging materials

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P.2. Pharmaceutical Development

2.1. Information on Development Studies

2.2. Components of the Drug Product

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2.3. Finished Product

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2.4. Manufacturing Process Development

2.5. Container Closure System

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2.6. Microbiological Antributes

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2.7. Compatibility

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P.3. Manufacture

3.1. Batch Formula

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3.2. Manufacturing Process and Process Control
Flow Chart of Manufacturing and Packaging Process
List of Equipment used in Manufacturing and Packaging Process

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3.3. Control of Critical Steps and Intermediates

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3.4. Process Validation and/or Evaluation

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P.4. Control of excipients

4.1. Specification

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4.2. Analytical Procedures

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4.3. Excipient of Human or Animal Origin

√

4.4. Novel excipients

P.5. Control of Finished Product

5.1. Specification

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Sign and stamp by DP manufacturer

5.2. Analytical procedures

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Sign and stamp by DP manufacturer

5.3. Validation of Analytical Procedures

√

5.4. Batch Analysis

5.5. Characterisation of Impurities

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5.6. Justification of Specifications

√

P.6. Reference Standards or Materials

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P.7. Container Closure System

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P.8. Stability

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P.9. Product Interchangeability Equivalence evidence

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(follow the requirements according to Circular 08/2010/TT-BYT dated Apr. 26, 2010)

Body of Data

S. DRUG SUBSTANCE

S.1. General Information

Stamp on the first page which contains information

Applicant will stamp

1.1. Nomenclature

√

1.2. Structure

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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

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3.2. Impurities

√

S.4. Control of Drug Substance

4.1. Specification

√

Stamp and sign

Manufacturer will sign and stamp, original

4.2. Analytical Procedures

√

Stamp and sign

Manufacturer 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

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S.6. Container Closure System:

S.7. Stability:
– Long term condition
– Accelerate condition

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Stamp and sign

Manufacturer 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 information

Applicant 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

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4.3. Excipient of Human or Animal Origin

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4.4. Novel excipients

P.5. Control of Finished Product

5.1. Specification

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Stamp and sign

Manufacturer will sign and stamp, original (accept photocopy from original with stamp by applicant)

5.2. Analytical procedures

√

Stamp and sign

Manufacturer will sign and stamp, original (accept photocopy from original with stamp by applicant)

5.3. Validation of Analytical Procedures

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5.4. Batch Analysis
Summary of protocol of 3 consecutive lots

5.5. Characterisation of Impurities

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5.6. Justification of Specifications

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P.6. Reference Standards or Materials

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P.7. Container Closure System

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P.8. Stability
– Long term condition at Zone 4B
– Accelerate condition

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Stamp and sign

Manufacturer 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)

Certificate 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

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√
√
–

COA for drug substance and excipient: signature and stamp of manufacturer

Manufacturer will sign and stamp, original

Certificate of analysis for finished product issued by National Institute for Control of Vaccine and Biological in Vietnam (NICVB)

–

Reference documents

Stamp on the first page which contains information

Applicant will stamp

PART 3: PRE-CLINICAL DOSSIER

Stamp on the first page

Applicant will stamp

Brief of product – Form 4/TT

Stamp on the first page

Applicant will stamp

Table of Content

Nonclinical Over View

1. General Aspect

2. Content and Structural Format

Nonclinical 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)

Nonclinical 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

List of key Literature References

PART 4: CLINICAL DOSSIER

Stamp on the first page

Applicant will stamp

Table of contents

Clinical Overview

Product Development Rationale

Overview of Biopharmaceutics

Overview of Clinical pharmacology

Overview of Efficacy

Overview of Safety

Benefits and Risks Conclusion

Clinical 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

Tabular Listing of All Clinical Studies

Clinical 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

List 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 copy

Stamp on the first page

Applicant will stamp

Brief of product – Form 4/TT

1 copy

Stamp on the first page

Applicant will stamp

GMP certificate / or GMP inspection report / or Manufacturing license

√

1 original/notarized copy with legalization at Vietnam embassy

Site 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 stamp

Manufacturer will stamp

List of GMP inspections for last 3 years

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1 copy with manufacturer’s stamp

Manufacturer will stamp

Last GMP inspection report which has as inspection scope the registered drugs or dosage forms of the registered drugs

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1 original/notarized copy with legalization at Vietnam embassy

Periodic quality review report for sterile drug product

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1 copy with manufacturer’s stamp

Manufacturer 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