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THE MINISTRY OF
HEALTH OF VIET NAM
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THE SOCIALIST REPUBLIC OF VIET NAM
Independence-Freedom-Happiness
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No. 32/2026/TT-BYT
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Hanoi, July 29, 2026
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CIRCULAR
PRESCRIBING MARKETING AUTHORIZATION OF
DRUGS AND MEDICINAL MATERIALS
Pursuant to the Law on
Pharmacy No. 105/2016/QH13, as amended by Law No. 44/2024/QH15;
Pursuant to the
Government’s Decree No. 163/2025/ND-CP elaborating, and providing measures for
the implementation of, the Law on Pharmacy;
Pursuant to the
Government’s Decree No. 42/2025/ND-CP defining functions, tasks, powers and
organizational structure of the Ministry of Health (MOH);
At the request of the
Director of the Drug Administration of Vietnam (DAV);
The Minister of Health
of Viet Nam promulgates a Circular prescribing the marketing authorization of
drugs and medicinal materials.
Chapter
I
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Article 1. Scope
1. This Circular
elaborates and provides guidelines for implementation of some Articles of the
Law on Pharmacy No. 105/2016/QH13, as amended by Law No. 44/2024/QH15
(hereinafter referred to as “the Law on Pharmacy”), including:
a) Regulations on clinical
data supporting the safety and efficacy of drugs in the application for marketing
authorization; criteria for determining cases eligible for exemption from
clinical trials or certain phases thereof in Viet Nam; and drugs subject to the
requirement to undergo Phase IV clinical trials as prescribed in clause 4
Article 89 of the Pharmacy Law;
fb) Documentation requirements and procedures for granting,
renewing, approving variations to, and revoking marketing authorizations for
chemical drugs, vaccines, biologicals, herbal drugs, and medicinal materials
for human use in Viet Nam in clause 9 Article 56 and clause 2 Article 58 of the
Pharmacy Law;
c) Principles and criteria
for classification of over-the-counter (OTC) drugs in clause 27 Article 2 of
the Pharmacy Law;
d) Regulations on
post-authorization safety and efficacy reporting for the purpose of conducting
pharmacovigilance activities as prescribed in clause 2 Article 78 of the
Pharmacy Law;
dd) Regulations on the
organization and operation of the Advisory Council for the grant of marketing
authorizations for drugs and medicinal materials (hereinafter referred to as
“the Council”), validating units, and validators.
2. This Circular does not
apply to traditional drugs and herbal materials.
Article
2. Definitions
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1. ASEAN common
technical dossier (ACTD) means the standardized format of common technical
dossier for the registration of drugs adopted by the Association of
Southeast Asian Nations (ASEAN).
2. ICH-CTD means
the Common Technical Document (CTD) developed by the International Conference
for Harmonization (ICH) of Technical Requirements for Registration of
Pharmaceuticals for Human Use.
3. Major variations
(MaV) means variations that have a significant and/or direct impact on the
quality, safety, or efficacy of a drug, as specified in Appendix II to this
Circular.
4. Minor variations
(MiV) means variations that have no or minimal impact on the quality,
safety, and efficacy of a drug, as specified in Appendix II to this Circular.
5. Applicant means
the establishment whose name is stated in the application for the grant,
renewal, or approval of variations to the marketing authorization of a drug or
medicinal material.
6. Drug manufacturer means
an establishment that carries out one or more manufacturing steps, or the
entire manufacturing process, or batch release of a drug.
7. Medicinal material
manufacturer means an establishment that manufactures medicinal materials
for use in the manufacture of finished drugs or performs batch release of
medicinal materials.
8. Certificate of
Pharmaceutical Product (CPP) means a certificate issued under the World
Health Organization (WHO) Certification Scheme on the quality of Pharmaceutical
Products moving in International Commerce.
9. The European
Medicines Agency (EMA) and Stringent Regulatory Authorities (SRAs) are the
following authorities:
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b) Stringent Regulatory
Authorities (SRAs) classified by WHO as being on the list of SRAs, including:
- ICH Members as of
October 23, 2015, including: the U.S. Food and Drug Administration (US-FDA);
drug regulatory authorities of the European Union; the United Kingdom’s
Medicines and Healthcare products Regulatory Agency (MHRA); and Japan’s
Pharmaceuticals and Medical Devices Agency (PMDA);
- ICH Observers as of
October 23, 2015, including: the drug regulatory authority of the European Free
Trade Association (EFTA), represented by Swissmedic; and Health Canada;
- Members associated with
ICH Members through association or mutual recognition agreements before October
23, 2015, including: Australia, Iceland, Liechtenstein and Norway.
10. Product license
holder/marketing authorization holder means the establishment that holds
the marketing authorization for the drug stated in the Certificate of Pharmaceutical
Product (CPP) issued in the WHO-recommended format.
11. Drug processing means
the manufacture of a drug under a processing contract in accordance with law,
pursuant to which the processing establishment performs one or more, or all,
stages of the drug manufacturing process in Viet Nam at the request of the
ordering establishment and receives a processing fee.
12. Technology transfer
in drug manufacturing means the transfer of ownership of, or the right
to use, drug manufacturing technology as prescribed in Clause 1 Article 4 of
the Law on Technology Transfer No. 07/2017/QH14, as amended by Law No.
115/2025/QH15 (hereinafter referred to as the “Law on Technology Transfer”),
from an establishment having the right to transfer such technology to an
establishment receiving the technology for application to one or more, or all,
stages of the drug manufacturing process in Viet Nam under a contract between
the parties in accordance with law.
13. Ordering
establishment means the party that provides all or part of the ingredients,
materials, manufacturing process, and technical documentation demonstrating the
quality, safety, and efficacy of the drug to the processing establishment for
the processing of the drug under a processing contract between the parties.
14. Processing
establishment means the party that uses all or part of the ingredients,
materials, manufacturing process, and technical documentation provided by the
ordering establishment to perform one or more, or all, stages of the drug
manufacturing process at the request of the ordering establishment and receives
a processing fee under the processing contract between the parties.
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16. Transferee
establishment means the party that receives the ownership of, or the right
to use, drug manufacturing technology from the transferor establishment under a
contract between the parties for application to one or more, or all, stages of
the drug manufacturing process.
17. Drug ordered for processing
means a drug that has been granted a marketing authorization in Viet Nam or
a product license in at least one country in the world and is subject to the
processing of one or more, or all, stages of its manufacturing process by the
processing establishment at the request of the ordering establishment under a
processing contract between the parties.
18. Processed drug means
a drug of which one or more, or all, stages of the manufacturing process are
performed by the processing establishment for the ordering establishment under
a processing contract between the parties.
19. Drug prior to
technology transfer means a drug that has been granted a marketing
authorization in Viet Nam or a product license in at least one country and for
which the ownership of, or the right to use, the drug manufacturing technology
is transferred by the transferor establishment to the transferee establishment
for application to one or more, or all, stages of the drug manufacturing
process.
20. Drug manufactured
using transferred technology means a drug for which one or more, or all,
stages of the manufacturing process are carried out by the transferee
establishment using the technology transferred by the transferor establishment
under a contract between the parties, as prescribed in Clause 1 Article 4 of
the Law on Technology Transfer.
Article
3. Responsibilities of applicants
Each applicant shall:
1. Assume full responsibility before the law for the accuracy, legality, and
truthfulness of all documents included in its marketing authorization
application (MAA) for drugs and medicinal materials, except in the cases
specified in Clause 1 Article 4 of this Circular; Coordinate with domestic and
foreign authorities and manufacturers in responding to requests from the Drug
Administration of Vietnam (DAV) for verification of the authenticity of legal
documents included in its MAA.
2. Ensure the quality,
safety, and efficacy of the drugs/medicinal materials as declared in its MAA.
3. Notify DAV in writing
within 15 days from the date of a decision to revoke the marketing
authorization or a decision to recall the drug/medicinal material in any
country in the world, if the drug/medicinal material has been granted a
marketing authorization in Viet Nam that remains valid, and specify the reason
for such revocation or recall, except in cases of voluntary withdrawal of the
marketing authorization that is unrelated to the quality, safety, or efficacy
of the drug in countries other than the CPP-issuing country specified in the
CPP submitted in the MAA in Viet Nam.
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5. Coordinate with the
drug manufacturer, importer, and distributor in monitoring, supervising,
collecting, compiling, and evaluating information, and reporting cases of
post-vaccination reactions and adverse drug reactions to the National Centre of
Drug Information and Adverse Drug Reaction Monitoring (National DI & ADR
Centre) in accordance with Clause 5 Article 77 of the Pharmacy Law, the
National Pharmacovigilance Guidelines issued by the Ministry of Health (MOH),
and relevant regulations.
6. Take responsibility for
matters relating to the intellectual property rights of drugs/medicinal
materials registered for marketing in Viet Nam, in accordance with the Law on
intellectual property.
7. Implement the risk
management plan approved as part of the MAA for a new chemical drug, vaccine,
or biological (except probiotic biological products).
8. An applicant for a
processed drug shall fulfill the responsibilities set forth in clauses 1, 2, 3,
4, 5, 6, 7 and 10 of this Article, and the following:
a) Notify DAV in writing
within 30 days from the date on which a competent authority approves variations
to the formulation, manufacturing process, quality specifications of materials,
or quality specifications of the finished drug of the drug ordered for
processing during its marketing, in case the processed drug meets the
requirements specified in Clause 1 Article 9 of this Circular;
b) Notify DAV in writing
within 15 days from the date on which a decision to revoke the marketing
authorization of the drug ordered for processing is issued in any country in
the world (during the validity period of the marketing authorization of the
processed drug), except in cases of voluntary withdrawal of the marketing authorization
that is unrelated to the quality, safety, or efficacy of the drug in countries
other than the CPP-issuing country specified in the CPP submitted for the drug
ordered for processing;
c) Notify DAV within 30
days from the date on which the manufacture of the drug ordered for processing
is discontinued;
d) For a processed drug
that meets the requirements specified in Clause 1 Article 9 of this Circular,
when the drug ordered for processing is being manufactured or marketed in Viet
Nam or in the country concerned and there are variations to its formulation,
manufacturing process, quality specifications of materials, quality
specifications of the finished drug, or trade name, the applicant shall, within
03 months from the date on which such variations are approved by DAV or the
competent authority of the country concerned, submit an application for
approval of variations corresponding to the variations to the drug ordered for
processing.
9. An applicant for a drug
manufactured using transferred technology shall fulfill the responsibilities
specified in Clauses 1, 2, 3, 4, 5, 6, 7, and 10 of this Article, and the
following:
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b) Notify DAV in writing
within 15 days from the date on which a decision to revoke the marketing
authorization of the drug prior to technology transfer is issued in any country
in the world (during the validity period of the marketing authorization of the
drug manufactured using transferred technology), except in cases of voluntary
withdrawal of the marketing authorization that is unrelated to the quality,
safety, or efficacy of the drug in countries other than the CPP-issuing country
specified in the CPP submitted for the drug prior to technology transfer;
c) Notify DAV in writing
within 30 days from the date on which the manufacture of the drug prior to
technology transfer is discontinued;
d) For a drug manufactured
using transferred technology that meets the requirements specified in Clause 1
Article 9 of this Circular, when the drug prior to technology transfer is being
manufactured or marketed in Viet Nam or in the country concerned and there are
variations to its formulation, manufacturing process, quality specifications of
materials, quality specifications of the finished drug, or trade name, the
applicant shall, within 03 months from the date on which such variations are
approved by DAV or the competent authority of the country concerned, submit an
application for approval of variations corresponding to the variations to the
drug prior to technology transfer.
10. Fulfill other
responsibilities as prescribed in relevant laws.
Article
4. Responsibilities of drug/medicinal material manufacturers
1. Assume full
responsibility before the law for the accuracy, legality, and truthfulness of
all documents related to the drug/medicinal material provided by the
manufacturer to the applicant for the purpose of obtaining marketing
authorization in Viet Nam.
2. Closely coordinate with
the applicant in fulfilling the responsibility specified in Clause 3 Article 3
of this Circular.
3. Coordinate with the
applicant in fulfilling requests from competent authorities for inspection and evaluation
of the manufacturer.
4. If the manufacturer has
its manufacturing license revoked or fails to comply with GMP (Good
Manufacturing Practices) requirements for drugs/medicinal materials as notified
by a competent authority of the country concerned, the manufacturer shall
notify DAV in writing within 15 days from the date of such notification.
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6. Implement the risk
management plan approved as part of the MAA for a new chemical drug, vaccine,
or biological (except probiotic biological products).
7. A manufacturer that is a
processing establishment shall fulfill the responsibilities specified in
Clauses 1, 2, 3, 4, 5, 6, and 9 of this Article, and the following:
a) Fulfill the obligations
prescribed in Article 182 of the Law on Commerce No. 36/2005/QH11 and Article
35 of the Government’s Decree No. 292/2026/ND-CP elaborating certain Articles
and providing measures for implementation of the Law on Foreign Trade
Management;
d) For a processed drug
that meets the requirements specified in Clause 1 Article 9 of this Circular,
when the drug ordered for processing is being manufactured or marketed in Viet
Nam or in the country concerned and there are variations to its formulation,
manufacturing process, quality specifications of materials, quality
specifications of the finished drug, or trade name, the manufacturer shall,
within 03 months from the date on which such variations are approved by DAV or
the competent authority of the country concerned, coordinate with the applicant
for the processed drug to submit an application for approval of variations
corresponding to the variations to the drug ordered for processing.
8. A manufacturer that is
a transferee establishment shall fulfill the responsibilities specified in
Clauses 1, 2, 3, 4, 5, 6, and 9 of this Article, and the following:
a) Fulfill the obligations
prescribed in Article 26 of the Law on Technology Transfer;
d) For a drug manufactured
using transferred technology that meets the requirements specified in Clause 1
Article 9 of this Circular, when the drug prior to technology transfer is being
manufactured or marketed in Viet Nam or in the country concerned and there are
variations to its formulation, manufacturing process, quality specifications of
materials, quality specifications of the finished drug, or trade name, the manufacturer
shall, within 03 months from the date on which such variations are approved by
DAV or the competent authority of the country concerned, coordinate with the
applicant to submit an application for approval of variations corresponding to
the variations to the drug prior to technology transfer;
c) Carry out the
procedures for registration of the technology transfer as prescribed in Article
31 of the Law on Technology Transfer and Article 20 of the Government’s Decree
No. 101/2026/ND-CP elaborating certain Articles and providing measures for
implementation of the Law on Technology Transfer.
9. Fulfill other
responsibilities as prescribed in relevant laws.
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1. Fulfill the obligations
of the ordering establishment as prescribed in Article 181 of the Law on
Commerce No. 36/2005/QH11 and Article 34 of the Government’s Decree No.
292/2026/ND-CP.
2. Provide the processing
establishment with:
a) Part or all of the
materials and technical documents, including the manufacturing process, quality
specifications, and test methods for starting materials, semi-finished
products, finished products, and auxiliary materials for the processing
stage(s) to be performed;
b) Other documents related
to the marketing authorization of the processed drug and drug processing.
3. Assume responsibility
for the accuracy, legality, and truthfulness of the technical documents
provided to the processing establishment, which shall be consistent with the
registration dossier of the drug ordered for processing approved by the
competent authority.
4. Coordinate with the
applicant for the processed drug to fulfill the responsibilities specified in
Clause 8 Article 3 of this Circular.
5. Fulfill other
responsibilities as prescribed in relevant laws.
Article
6. Responsibilities of transferor establishments
1. Fulfill the obligations
of the transferor establishment as prescribed in Clause 2 Article 25 of the Law
on Technology Transfer.
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a) Technical documents,
including the manufacturing process, quality specifications, and test methods
for starting materials, semi-finished products, finished products, and
auxiliary materials of the stage(s) covered by the technology transfer;
b) Other documents related
to the marketing authorization of the drug manufactured using transferred
technology and the technology transfer for drug manufacturing.
3. Assume responsibility
for the accuracy, legality, and truthfulness of the technical documents
provided to the transferee establishment, which shall be consistent with the
registration dossier for the drug prior to technology transfer approved by the
competent authority.
4. Coordinate with the
applicant for the drug manufactured using transferred technology to fulfill the
responsibilities specified in Clause 9 Article 3 of this Circular.
5. Fulfill other
responsibilities as prescribed in relevant laws.
Article
7. Drug processing contract
In addition to the
contents prescribed in Article 31 of the Decree No. 292/2026/ND-CP, a drug
processing contract must also include the following:
1. Agreements on the
supply of materials. The provision by the ordering establishment to the
processing establishment of technical documents, including the manufacturing
process, quality specifications, and test methods for starting materials,
semi-finished products, finished drugs, and auxiliary materials, and other
documents related to the processing of the drug.
2. Rights and
responsibilities of the ordering establishment, processing establishment, and
applicant (if any), with respect to:
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b) Retention of records
relating to the manufacture, quality control, distribution, and marketing of
the drug; retention of drug samples; and handling of matters relating to
quality, complaints, and recall of the drug from the market.
3. Responsibilities of the
ordering establishment, processing establishment, and Applicant (if any) with
respect to intellectual property matters related to the processed drug.
4. Procedures for
inspection or supervision of the manufacturer.
5. Cases of termination of
the agreement and responsibilities for breach of the agreement.
Article
8. Technology transfer contract
In addition to the
contents prescribed in Article 23 of the Law on Technology Transfer, a
technology transfer contract for drug manufacturing must include the following:
1. Agreements on the
provision by the transferor establishment to the transferee establishment of
technical documents, including the manufacturing process, quality
specifications, and test methods for starting materials, semi-finished
products, finished drugs, and auxiliary materials, and other documents related
to the technology transfer for drug manufacturing.
2. Responsibilities of the
transferor establishment, transferee establishment, and applicant with respect
to intellectual property matters related to the drug manufactured using
transferred technology.
3. Cases of termination of
the agreement and responsibilities for breach of the agreement.
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A processed drug or drug
manufactured using transferred technology shall be classified as:
1. A processed drug or
drug manufactured using transferred technology having the same trade name,
formulation, quality specifications of materials, and quality specifications of
the finished drug as, and a manufacturing process similar to that of, the drug
ordered for processing or the drug prior to technology transfer, respectively.
If a processed drug or a
drug manufactured using transferred technology has a change in any of the
above-mentioned criteria (except for a change in the trade name) or any other
change related to the quality of the drug, the applicant shall provide a
comparative tabulated summary (Form 01/TT in Appendix IX to this Circular) and
the technical documents corresponding to each change in accordance with the
guidelines in Appendix II to this Circular, to demonstrate quality equivalence
to the drug ordered for processing or the drug prior to technology transfer,
respectively.
2. Other processed drug or
drug manufactured using transferred technology that does not fall under the
case specified in Clause 1 of this Article.
Article
10. Reporting on safety and efficacy monitoring and evaluation
1. Each Applicant shall
submit reports on the monitoring and evaluation of the safety and efficacy of
the drug during marketing as follows:
a) Periodic reports for
new drugs, vaccines, and biologicals (except probiotic biological products),
using Form 2A/TT in Appendix IX to this Circular;
b) Individual case safety
reports (ICSRs) of all adverse events (including adverse drug reactions,
medication errors, suspected counterfeit or substandard drugs, and lack of or
inadequate therapeutic efficacy) occurring in Viet Nam and related to the drug,
using Form 2B/TT in Appendix IX to this Circular.
2. Reporting frequency and
time limits:
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From the date on which the
marketing authorization is granted, the applicant shall submit periodic reports
every 6 months during the first 2 years; from the third year to the fifth year,
the applicant shall submit periodic reports annually;
b) For ICSRs as prescribed
in Point b Clause 1 of this Article:
The applicant shall submit
ICSRs within the time limits specified in the National Pharmacovigilance
Guidelines and other relevant regulations issued by MOH.
3. Methods of submission
and recipients of reports:
The applicant shall comply
with the National Pharmacovigilance Guidelines and other relevant regulations
issued by MOH.
4. Processing and
evaluation of reports, and provision of information to state regulatory
authorities and Specialized Councils of MOH for the purpose of managing the
marketing authorization of drugs:
Such activities shall be
carried out in accordance with the National Pharmacovigilance Guidelines and
other relevant regulations issued by MOH.
Article
11. Language and format of documents; number of required sets and submission
methods; cases where multiple drugs/medicinal materials may be submitted in a
single MAA; and validation methods
1. Language of the
documents included in an MAA for drug/medicinal material:
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2. Format of documents:
The documents included in
an MAA for drug/medicinal material must be prepared in accordance with the ACTD
or ICH-CTD guidelines and the provisions of this Circular.
3. Number of required sets
and submission methods for an MAA for drug/medicinal material:
a) One (01) complete set
of documents shall be submitted for each administrative procedure prescribed in
this Circular;
b) Where the MAA is
submitted directly or through the public postal service, the applicant shall
submit one (01) complete set of documents to DAV in accordance with Article 15
of the Government’s Decree No. 118/2025/ND-CP, as amended by Decree No.
367/2025/ND-CP;
c) Where the MAA is
submitted via the MOH’s Online Public Service Portal, the applicant shall
submit one (01) complete set of documents in accordance with the Government’s
Decree No. 45/2020/ND-CP, as amended by Decree No. 68/2024/ND-CP, Decree No.
69/2024/ND-CP, and Decree No. 118/2025/ND-CP.
4. Multiple drugs may be
submitted in a single MAA if they meet all of the following criteria:
a) They have the same drug
name, drug substance(s) or herbal material(s), and dosage form;
b) They have the same
manufacturer, or the same manufacturer with different packaging facilities or
batch-release facilities;
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5. MAA validation methods:
a) An MAA for
drug/medicinal material shall be reviewed by the respective subcommittees for
legal affairs, quality standards, pharmaceutics, pharmacology, clinical
matters, and bioequivalence, based on the parts of the application submitted
for the grant, renewal, or approval of variations to the marketing
authorization for drug/medicinal material;
b) The validation of the
legal affairs, quality standards, pharmaceutics, pharmacology, clinical, and
bioequivalence contents shall ensure that all contents are adequately covered
in accordance with the ACTD or ICH-CTD guidelines and the provisions of this
Circular, including the documents subject to validation and the corresponding
requirements to be satisfied for each validation content as prescribed in this
Circular;
c) Validation of an MAA in
the case specified in Clause 10 Article 26 of this Circular is subject to the
following provisions:
- Validation shall be
conducted to verify the consistency between the technical documents in the MAA
submitted in Viet Nam and the technical documents of the drug for which
marketing authorization has been granted by the drug regulatory authority
specified in Clause 9 Article 2 of this Circular, based on the documents
specified in Clause 10 Article 26 of this Circular.
- The administrative part
of the MAA and the parts of the technical documents for which differences have
been reported between the MAA submitted in Viet Nam and the technical documents
of the drug approved by the drug regulatory authority specified in Clause 9
Article 2 of this Circular shall be validated independently.
d) When considering the
grant of a marketing authorization for a new drug indicated for the prevention
and treatment of a Group A infectious disease for which an epidemic has been
declared in accordance with the Law on prevention and control of infectious
diseases, DAV shall not validate the technical documents or assess compliance
with GMP requirements on the basis of recognition of the licensing results of
one of the drug regulatory authorities specified in Clause 9 Article 2 of this
Circular.
Article
12. Validity, symbols of marketing authorizations for drugs/medicinal
materials, and deadline for application submission
1. The validity of a
marketing authorization for a drug/medicinal material is 05 years from the date
on which it is granted or renewed, except for the cases specified in Clauses 2
and 3 of this Article.
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a) New drugs, vaccines,
and biologicals (except probiotic biological products) granted a marketing
authorization in Viet Nam for the first time;
b) Drugs having the same
drug substance, concentration, strength, or dosage form as a new drug for which
a 05-year marketing authorization has not been granted;
c) Drugs specified in
Points a and b of this Clause that are not actually placed on the market during
the validity period of their marketing authorization;
d) Drugs not falling under
Points a, b, or c of this Clause but for which the Council requires continued
monitoring of safety and efficacy.
3. Where the validity
period of a marketing authorization for a drug/medicinal material has expired
and DAV has received an application for renewal of such marketing authorization
in accordance with applicable regulations, such marketing authorization may
continue to be used until it is renewed or until DAV issues a written
notification of non-renewal or suspension of the marketing authorization on the
grounds that the drug/medicinal material is found to pose a potential safety
risk to users or the legal documents are suspected of being forged.
4. Each MAA for a
drug/medicinal material shall be granted a marketing authorization bearing a
registration number in the format specified in Appendix V to this Circular.
The registration number is
intended for the retrieval, compilation, and statistical analysis of data on
the drug/medicinal material that has been granted marketing authorizations in
Viet Nam, and shall be publicly disclosed on the MOH’s web portal and the DAV’s
website. The classification and management of controlled drugs/medicinal
materials shall comply with relevant legal documents.
5. An application for
renewal of a marketing authorization for a drug/medicinal material must be
submitted before its expiration date. DAV shall not accept an application for renewal
of the marketing authorization which is submitted after it has expired, and the
applicant shall be required to submit an application for the grant of a new
marketing authorization.
6. An MAA for a drug
subject to validation by reference to available validation results shall be
submitted to DAV within 05 years from the date on which the drug was first
approved by a drug regulatory authority specified in Clause 9 Article 2 of this
Circular, as stated in the validation report.
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1. Criteria for
classification of original brand-name drugs and reference biologicals:
a) A drug granted a
marketing authorization that meets all of the following criteria shall be classified
as an original brand-name drug:
- It is the first drug
granted the marketing authorization on the basis of sufficient quality, safety,
and efficacy data.
- Its clinical data meets
the requirements laid down in Article 18 of this Circular;
b) A drug granted a
marketing authorization that meets all of the following criteria shall be
classified as a reference biological:
- It is a drug granted a
marketing authorization in Viet Nam on the basis of sufficient quality, safety,
and efficacy data.
- Its clinical data meets
the requirements laid down in Article 18 of this Circular, based on the
development of a biological product from the outset rather than development as
a biosimilar.
2. Where a drug classified
as an original brand-name drug or reference biological undergoes a change in
its manufacturer or manufacturing site and is granted a new marketing
authorization, it shall continue to be classified as an original brand-name
drug or reference biological if its trade name, formulation, quality
specifications for raw materials, and quality specifications for the finished
drug product remain unchanged, and its manufacturing process before the change
is similar to that after the change.
Where there are changes in
any of the criteria mentioned in this Clause (except changes in the trade name)
or other changes relating to the quality of the drug manufactured by the new
manufacturer or at the new manufacturing site, such changes must be approved by
the drug regulatory authority that granted the marketing authorization for the
drug, or the applicant must provide the comparative tabulated summary of such
changes (Form 01/TT in Appendix IX to this Circular) and relevant technical
documents corresponding to each change according to the guidelines in Appendix
II to this Circular, in order to demonstrate the quality equivalence between
the drug manufactured by the new manufacturer or at the new manufacturing site
and the original brand-name drug or reference biological.
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3. A drug ordered for
processing or drug prior to technology transfer that has been classified as an
original brand-name drug or reference biological, or that has not been so
classified but has clinical data meeting the requirements specified in Point a
or b, Clause 1 of this Article, and that is processed or manufactured using
transferred technology in Viet Nam, shall be classified as an original
brand-name drug or reference biological if it meets the criteria specified in
Clause 2 of this Article and Point d Clause 2 Article 38 of this Circular.
4. Cases in which drugs
are subject to classification as original brand-name drugs or reference
biologicals:
a) A drug for which
classification as an original brand-name drug or reference biological is
requested upon submission of an MAA:
The applicant shall submit
a request for classification of the drug as an original brand-name drug or
reference biological when submitting the MAA for the drug. The MAA which is
validated and approved for grant of a marketing authorization must meet the
criteria set out in Clause 1, 2 or 3 of this Article;
b) A drug that has been
granted a marketing authorization for which classification as an original
brand-name drug or reference biological is requested:
The applicant shall submit
an application for approval of variations to the marketing authorization to
request classification of a drug that has been granted a marketing
authorization as an original brand-name drug or reference biological, in
accordance with Appendix II to this Circular. The application for approval of
variations to the marketing authorization that is validated and approved must
meet the criteria set out in Clauses 1, 2, or 3 of this Article.
5. A drug which has been
classified as an original brand-name drug or reference biological shall
continue to be classified as original brand-name drug or reference biological
when its marketing authorization is considered for renewal or for approval of
variations to the marketing authorization. The applicant shall not be required
to submit an application for classification of the drug as an original
brand-name drug or reference biological.
Article
14. Criteria for classification of drugs with demonstrated bioequivalence
A drug granted a marketing
authorization in Viet Nam shall be classified as a drug with demonstrated
bioequivalence if its bioequivalence study report meets the requirements
specified in the Minister of Health’s Circular No. 07/2022/TT-BYT.
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1. Principles for
classification of OTC drugs:
a) Ensure the safety for
drug users;
b) Ensure timely access to
drugs for the public;
c) Be consistent with the
actual use and supply of drugs in Viet Nam;
d) Be harmonized with the
principles and regulations on the classification OTC drugs in countries in the
region and around the world.
2. Criteria for
determination of OTC drugs:
A drug shall be classified
as an OTC drug if it meets all of the following criteria:
a) It must be demonstrated
to be safe and effective in preventing, alleviating, or treating diseases; have
a wide safety margin to ensure the safety of users; have low toxicity; not
produce toxic degradation products during storage or after entering the human
body; not cause reproductive toxicity, genotoxicity, or carcinogenicity; not
cause adverse effects requiring supervision or monitoring by a physician or
healthcare professional when the drug is self-administered in accordance with
the package leaflet; and not interact with commonly used drugs or foods in a
manner that may lead to serious adverse reactions;
b) It is indicated for
short-term treatment of diseases that patients can self-treat without requiring
a prescription or monitoring by a healthcare professional;
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d) It must have a simple
dosage form and route of administration that allow users to self-administer the
drug without technical assistance or instructions from a physician or
healthcare professional; and must not require special conditions for storage or
handling before or after use;
dd) It does not contain
any herbal material included in the List of Toxic herbal materials promulgated
by the MOH.
3. Methods for
classification of OTC drugs:
a) Generic drugs shall be classified as OTC
drugs according to the classification of the original brand-name drug granted a
marketing authorization in Viet Nam;
b) Where no original brand-name drug has
been granted a marketing authorization in Viet Nam, a drug shall be classified
as an OTC drug according to the classification of a drug having the same active
ingredient(s), herbal material(s), strength, concentration, and dosage form as a drug
granted a marketing authorization and marketed in a country whose drug
regulatory authority is one of those specified in Clause 9 Article 2 of this
Circular;
c) A drug shall be classified as an OTC
drug according to the classification of a drug having the same active
ingredient(s), herbal material(s), strength, concentration, and dosage form that has been
granted a marketing authorization in Viet Nam, provided that it meets the
principles and criteria specified in Clauses 1 and 2 of this Article;
d) Classification of OTC
drugs in other cases shall be subject to opinions given by the Council on the
basis of the principles and criteria set out in Clauses 1 and 2 of this Article.
Article
16. Protection of test data in MAAs
The protection of test
data contained in MAAs shall be carried out in accordance with Clauses 1, 2,
and 3 of Article 128 of the Law on Intellectual Property No. 50/2005/QH11, as
amended by Law No. 36/2009/QH12, Law No. 42/2019/QH14, Law No. 07/2022/QH15,
Law No. 93/2025/QH15, and Law No. 131/2025/QH15 (hereinafter referred to as the
“Intellectual Property Law”).
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1. The authenticity of a
CPP included in an application for grant, renewal, or approval of variations to a marketing
authorization shall be verified in the following cases:
a) The CPP contains erased
or altered information;
b) The manufacturer or
applicant has incurred administrative penalties imposed by a competent
authority of Viet Nam for the violations in Point d and h Clause 2 Article 98
of the Decree No. 163/2025/ND-CP. Verification of the authenticity of the CPP
shall apply for a period of 03 years from the date of the administrative
penalty decision;
c) The manufacturer has,
for the first time, a drug registered for marketing authorization in Viet Nam,
including cases where the establishment participates in only one or several
stages of the manufacturing process;
d) The CPP is an
electronic document issued by a competent authority of another country but
cannot be retrieved from the website or database provided by the applicant
during validation of the application;
dd) Other cases in which
the Council requires verification of authenticity. <0}
2. The authenticity of
legal documents in MAAs shall be also verified in the following cases:
a) In the case of a
foreign applicant whose drug/medicinal material is registered for marketing in
Viet Nam for the first time, DAV shall verify the authenticity of the license
to manufacture and trade in drugs issued in the applicant’s home country;
b) Legal documents of the
applicant or manufacturer issued by a competent authority of a foreign country
do not meet the requirements specified in Point b Clause 1 Article 22 of this
Circular.
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a) A written document sent
to DAV, containing the full name and address of the submitting agency,
organization, or individual, together with relevant supporting documents;
b) Information obtained
from the mass media.
4. The authenticity of
CPPs and legal documents submitted in MAAs shall be verified by the following
means:
a) Verification of the
authenticity of legal documents relating to consular legalization: DAV shall
cooperate with the Consular Department of the Ministry of Foreign Affairs of
Viet Nam or Vietnamese diplomatic missions abroad competent to perform consular
legalization to verify the authority and information relating to the consular
legalization of foreign legal documents for use in Viet Nam in the cases
specified in Point c Clause 1 and Point a Clause 2 of this Article, except
where the legal documents are exempt from consular legalization in accordance
with Point c Clause 1 Article 22 of this Circular;
b) Verification of the
authenticity of the contents of legal documents:
DAV shall cooperate with
the authorities that issue or grant the relevant legal documents to verify the
information stated in such documents in the cases specified in Points a, b, d and
dd Clause 1 and Point b Clause 2 of this Article;
c) Verification of the
authenticity of legal documents shall be conducted concurrently with the
validation of the MAA or upon receipt of information as prescribed in Clause 3
of this Article;
d) A written request for
verification of the authenticity of legal documents shall be sent
simultaneously to the applicant.
5. Regarding an MAA
containing the legal documents subject to verification of authenticity as
prescribed in Clauses 1 and 2 of this Article, the drug/medicinal material
shall only be granted a marketing authorization when the verification results
are deemed satisfactory by the competent authority specified in Clause 4 of
this Article.
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Chapter
II
REQUIREMENTS
FOR CLINICAL DATA TO ENSURE SAFETY AND EFFICACY, CRITERIA FOR EXEMPTION FROM
CLINICAL TRIALS OR CERTAIN PHASES THEREOF, AND DRUGS REQUIRED TO UNDERGO PHASE
4 CLINICAL TRIALS IN VIET NAM
Article
18. Clinical data requirements to ensure safety and efficacy
1. Any drug for which an
MAA is submitted must have sufficient clinical data to demonstrate its safety
and efficacy.
2. Sufficient clinical
data means data from studies that have been conducted, reported, and assessed
in accordance with guidelines issued by MOH or other organizations recognized
by Viet Nam, including ICH, WHO, EMA, and other international organizations of
which Viet Nam is a member, and guidelines issued by drug regulatory
authorities as prescribed in Clause 9 Article 2 of this Circular.
Article
19. Criteria for exemption from clinical trials in Viet Nam
A drug is exempt from
clinical trials in the following cases:
1. It is a generic drug
that meets any of the following criteria:
a) It has bioequivalence
data demonstrating compliance with the requirements specified in Circular No.
07/2022/TT-BYT;
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2. It is a new drug
(except for vaccines) that meets all of the following criteria:
a) It has been granted
marketing authorization in at least one country in the world;
b) It has sufficient
clinical data as prescribed in Article 18 of this Circular;
c) Its clinical study data
contain sufficient information to analyze and interpret the effects of ethnic
factors of Asian populations on the safety and efficacy of the drug in
accordance with the ICH-E5 guidelines.
3. It is an herbal drug
that was granted marketing authorization before January 01, 2017.
Article
20. Criteria for exemption from certain phases of clinical trials in Viet Nam
1. The Minister of Health
may, based on the advisory opinions of the Council, decide to grant an
exemption from certain phases of clinical trials in Viet Nam for new drugs and
vaccines in the following cases:
a) The drug or vaccine is
intended to meet urgent needs for national defense and security, epidemic
prevention and control, or response to the consequences of natural disasters or
catastrophes, where no other alternative drug is available on the market; or is
intended for the treatment of rare diseases or life-threatening diseases;
b) The drug or vaccine has
been granted marketing authorization by at least one of the drug regulatory
authorities prescribed in Clause 9 Article 2 of this Circular based on a
reduced clinical data package in accordance with the requirements of that
authority.
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a) It has been granted
marketing authorization in at least one country in the world;
b) It has clinical data
that are either insufficient as prescribed in Article 18 of this Circular, or
sufficient as prescribed in Article 18 of this Circular but without an adequate
assessment of ethnic factors that may affect the safety and efficacy of the
drug.
Article
21. Criteria for drugs required to undergo phase 4 clinical trials
A drug that has been
granted marketing authorization but requires further evaluation of its safety
and efficacy based on the advisory opinions of the Council shall undergo a
Phase 4 clinical trial.
Chapter
III
MARKETING
AUTHORIZATION APPLICATIONS FOR DRUGS/MEDICINAL MATERIALS
Section
1. GENERAL PROVISIONS ON DOCUMENTS IN MARKETING AUTHORIZATION APPLICATIONS FOR
DRUGS/MEDICINAL MATERIALS
Article
22. General provisions on administrative documents
1. The documents specified
in Clauses 3, 4, 5, 6 and 7 of Article 26 of this Circular (hereinafter
referred to as “legal documents”) included in an MAA must satisfy the following
requirements:
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b) A legal document must
bear the signature, full name of the signatory, date of issuance, and seal of
the competent authority of the issuing country, except where, under the
regulations of the issuing country, a legal document is valid without
containing all of such information;
c) A legal document issued
by a competent foreign authority must undergo consular legalization in
accordance with regulations of law on consular legalization, except in the
following cases where consular legalization is not required:
- Documents exempt from
consular legalization as prescribed in Clauses 1, 2 and 3 of Article 9 of the
Government’s Decree No. 111/2011/ND-CP, as amended by Decree No. 196/2025/ND-CP.
- Cases where DAV is able
to independently verify the authenticity of the document, including a legal
document provided directly in writing or via the MOH’s email by the competent
authority of the issuing country; or a legal document published by the
competent authority of the issuing country or a competent regional authority on
its website or in an English-language database.
The applicant or
manufacturer shall submit the results of its own search, bearing its
confirmation seal, together with a document providing information on the link
to the search results;
d) A legal document that
specifies a validity period must remain valid at the time of receipt of the
MAA, as recorded in the MAA receipt note. Where a CPP does not specify a
validity period, its validity period shall be deemed to be 24 months from the
date of issuance.
2. For CPPs:
a) The CPP must contain
all information required by the WHO template published on WHO's website
(https://www.who.int);
b) CPP must be issued by
the competent authority of the manufacturing country, or by the authority
competent to issue CPPs in a country whose drug regulatory authority is one of
those prescribed in Clause 9 Article 2 of this Circular, certifying that the
drug is licensed and actually marketed in that country;
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d) Where the CPP does not
satisfy the requirements specified in Points a and b of this Clause, the
Minister of Health may, based on the advisory opinions of the Council, decide
to accept an alternative where the drug has been granted marketing
authorization by the competent authority of at least one country in the world
and falls into one of the following cases:
- It is a drug, vaccine or
biological intended to meet the needs of national defense and security,
epidemic prevention and control, response to the consequences of natural
disasters or catastrophes, or implementation of a State health program;
- It is a vaccine used in
the national expanded immunization program where no other vaccine is available
on the market that can serve as an alternative in terms of quantity, quality,
safety, efficacy, or cost of use;
- Other special cases
covered by a written mutual recognition agreement or arrangement between
competent authorities regarding the requirements for the manufacture and
marketing of drugs, vaccines and biologicals;
dd) The information stated
on the CPP must be consistent with the relevant information in the MAA. Where
the information stated on the CPP is inconsistent with the administrative
documents included in the MAA, the applicant shall provide an explanatory
report and relevant supporting documents.
3. For the application
form and other administrative documents:
a) The application form
and other relevant documents in the administrative section of the MAA must bear
the signature and seal of the authorized signatory. Digital signatures are
accepted but signature stamps are not permitted;
b) The above-mentioned
documents must be signed by a person holding one of the following positions:
- Chairperson of the Board
of Members or the Board of Directors; General Director; Chief Executive
Officer; or Director of the applicant or manufacturer;
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- A person directly
authorized to sign by any of the persons specified in the first or second
sub-point of this Point.
4. For letters of
authorization:
a) A letter of authorization
appointing an applicant must be an original and contain all of the following
information:
- Name and address of the
product license holder/marketing authorization holder or the authorizing
manufacturer.
- Name and address of the
authorized applicant.
- Name of the drug,
concentration/strength of the drug substance, and dosage form.
- Scope of authorization.
Where the authorization
covers multiple drugs, the letter of authorization must be accompanied by a
list of the drugs containing all information specified in the third sub-point
of this Point;
b) A letter of
authorization authorizing a person to sign documents included in an MAA must be
an original and contain all of the following information:
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- Name and title of the
authorizing person and the authorized person.
- Name of the drug,
concentration/strength of the drug substance, and dosage form.
- Scope of authorization.
- Validity period of the
letter of authorization.
Where the authorization
covers multiple drugs, the letter of authorization must be accompanied by a
list of the drugs containing all information specified in the third sub-point
of this Point;
c) Number of letters of
authorization in an MAA:
- Where the applicant is
not the manufacturer, the product license holder/marketing authorization
holder, ordering establishment, or transferor establishment, each MAA must be
accompanied by a letter of authorization appointing the applicant.
- Where the position of
the person signing the documents included in the MAA is not one of the
positions specified in Point b Clause 3 of this Article, each MAA must be
accompanied by a letter of authorization authorizing that person to sign the
documents included in the MAA.
5. An applicant must have
one of the following legal documents:
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b) A foreign applicant
must have a license to manufacture or trade in drugs issued by a competent
foreign regulatory authority, covering one of the following business scopes:
manufacture, wholesaling, importation, or exportation of drugs/medicinal
materials, and a license for establishment of a representative office in Viet
Nam.
Where the name or address
of the applicant stated in the license for establishment of a representative
office in Viet Nam differs from that stated in the legal documents of the
applicant issued by the competent foreign authority, documentary evidence of
such difference must be provided.
Where the applicant is
also the manufacturer stated on the CPP, the legal documents specified in this
Clause are not required.
Where a country does not
issue licenses for the manufacture, wholesaling, exportation, or importation of
drugs/medicinal materials, the applicant must provide a license for
establishment or a business registration certificate covering at least one of
the following business scopes: manufacture, wholesaling, exportation, or
importation of drugs/medicinal materials, together with a certificate issued by
a competent authority certifying that the applicant meets the applicable
conditions and is operating in the pharmaceutical sector, or one of the
following certificates of Good Practices:
Certificate of Good Manufacturing Practices (GMP) compliance, Certificate of
Good Distribution Practices (GDP) compliance, Certificate of Good Supply
Practices compliance, or Certificate of Good Storage Practices (GSP) compliance.
For an applicant for
medicinal materials, where the country concerned does not issue pharmaceutical
business licenses to establishments engaged in the business of medicinal
materials, licenses issued in accordance with the laws of that country shall be
accepted, provided that they specify one of the following business scopes:
manufacture, wholesaling, exportation, or importation of medicinal materials.
6. The certificate
confirming that the medicinal material is permitted to be manufactured or
marketed in the manufacturing country must contain all of the following
information: the name of the medicinal material; the name and address of the
manufacturer; the manufacturing country; and the signature, seal, and full name
of the signatory.
7. Documents demonstrating
that a manufacturer of drug substances, excipients, capsule shells, or herbal
materials (for the manufacture of herbal drugs) complies with GMP guideline for
medicinal materials may be one of the following:
a) A Certificate of GMP
compliance;
b) A manufacturing license
containing a certification that the manufacturer complies with GMP guideline;
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d) Other legal documents issued
by a competent authority containing, at a minimum, the following information:
the name and address of the manufacturer; confirmation that the manufacturer
complies with GMP guideline; and the name of the drug substance, herbal
material, excipient, or capsule shell;
dd) For excipients in an
MAA: Where the documents specified in any of Points a, b or d of this Clause
cannot be provided, the manufacturer of the finished drug product or
semi-finished product shall conduct a self-assessment of the excipient
manufacturer's compliance with GMP guideline in accordance with the Circular
No. 28/2025/TT-BYT of the Minister of Health, make a self-declaration in the
MAA of the GMP principles and standards with which the excipient manufacturer
complies (using Form No. 05/TT in Appendix IX to this Circular), and undertake
legal responsibility for such declaration;
e) For herbal materials in
an MAA:
Where the documents
specified in any of Points a, b or d of this Clause cannot be provided, a
certificate of compliance with Good Agricultural and Collection Practice (GACP)
for herbal materials shall be provided.
8. Mock-ups of the labels
of drugs/medicinal materials and the package leaflets intended for use in Viet
Nam shall comply with the provisions of the Circular No. 01/2018/TT-BYT of the
Minister of Health, as amended by the Circular No. 23/2023/TT-BYT, and the
following specific provisions:
a) The mock-ups of the
labels and package leaflets intended for use in Viet Nam shall bear the
confirmation seal of the representative office in Viet Nam, the applicant, or
the manufacturer;
b) The outer packaging of
drugs/medicinal materials shall bear a barcode, QR code, DataMatrix code, or
other form of coding as prescribed by relevant laws, printed on the outer
packaging by the manufacturers, for the purposes of managing, identifying, and
tracing the origin of drugs/medicinal materials placed on the market, in
accordance with the roadmap prescribed in Point h Clause 1 Article 55 of this
Circular;
c) The outer packaging
label of a drug/semi-finished drug product shall state, in full, the name and
strength, mass, or concentration of each drug substance and herbal material
contained in the formulation of the drug/semi-finished drug product, per
smallest dose unit or smallest pack size;
d) For dosage forms or
packaging for which an in-use stability study after opening is required in
accordance with the ACTD or ICH-CTD guidelines, the package leaflet shall
include information on the shelf life and storage conditions after opening;
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Article
23. General provisions on quality documents
1. Specifications, test
methods, certificates of analysis, and stability study data (applicable to both
the drug substance and finished drug product sections of the MAA) shall be
original documents bearing the seal of the manufacturer. Where more than one
manufacturer is involved in the manufacture of the finished drug product, the
seal of the establishment responsible for quality control of the drug or batch
release shall be accepted.
Where the manufacturer
does not use a seal but uses a digital signature instead, the applicant shall
affix its seal to certify the document and shall be legally responsible for its
accuracy, legality, and truthfulness.
Where the quality
documents for the drug substance section of the MAA for a finished drug product
are provided in the form of electronic documents without bearing the seal of
the drug substance manufacturer, the seal of the finished drug product
manufacturer or the applicant shall be accepted. The establishment whose seal
is affixed to such documents shall be legally responsible for their accuracy,
legality, and truthfulness.
2. The certificate of
analysis (CoA) for a drug/medicinal material must meet the following
requirements:
a) The CoA shall be in
Vietnamese or English. Where the CoA is not in Vietnamese or English, a
notarized translation into Vietnamese or English shall be provided;
b) Where two or more
establishments are involved in the manufacture of a drug, the batch of the drug
or medicinal material shall have a CoA issued by the manufacturer, the final
packaging establishment, or the establishment responsible for batch release;
c) The CoA shall include
the following information:
- The name and address of
the manufacturer, the CoA number, the name and signature of the person
responsible, and the date of issuance of the CoA. Where the CoA bears an
electronic signature, such signature shall comply with the applicable laws on
electronic transactions. Where the CoA does not bear the signature of the
person responsible, a CoA bearing the seal of the manufacturer shall be
accepted. The applicant shall bear full legal responsibility for the accuracy
and validity of the CoA.
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3. Requirements applicable to a CoA or
results of experimental validation of a specification or test method conducted at a state
laboratory for medicinal products and pharmaceutical ingredients at the request
of a regulatory authority:
The CoA and the results of
such experimental validation shall be certified by a state laboratory for drugs
and medicinal materials that complies with GLP requirements.
Article
24. Provisions on clinical documents required for assurance of the drug safety
and efficacy in MAAs
1. For a new chemical
drug, vaccine or biological:
a) Full clinical data must
be provided to demonstrate the safety and efficacy of the drug, vaccine, or
biological, and must comply with the following requirements:
- The clinical studies on
the drug and data included in the clinical documents must comply with ICH
guidelines, MOH’s guidelines, or guidelines of other organizations recognized
by Viet Nam, including guidelines issued by international organizations of
which Viet Nam is a member and guidelines issued by drug regulatory authorities
as prescribed in Clause 9 of Article 2 of this Circular.
- The clinical data,
except for a biosimilar to a reference biological that has been granted a
marketing authorization in Viet Nam, must contain sufficient information to
permit analysis and justification in accordance with the ICH-E5 guidelines.
- A drug containing a new
combination of drug substances must be supported by full clinical data in
accordance with the WHO, US FDA, or EMA guidelines on the clinical development
of fixed-dose combination medicinal products, as specified in Appendix I to
this Circular;
b) A vaccine that has full
clinical data demonstrating its safety and efficacy as prescribed in Point a of
this Clause but has not been licensed or placed on the market by any drug
regulatory authority prescribed in Clause 9 Article 2 of this Circular must
have clinical data on the assessment of safety and immunogenicity in the target
population in Viet Nam prior to being granted a marketing authorization;
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d) For a biological, where the manufacturer
is changed, including a change in the manufacturing site, documentation must be
provided to demonstrate the comparability in quality between the biological
manufactured at the former manufacturing site and the biological manufactured
at the new manufacturing site, in accordance with the guidelines of US FDA,
ICH, WHO, or EMA, the guidelines of international organizations of which Viet
Nam is a member, or the guidelines of any drug regulatory authority prescribed
in Clause 9 Article 2 of this Circular.
2. For a new chemical drug
that is not an original brand-name drug, clinical documents must be provided
that meets one of the following requirements:
a) Clinical data that meet
the requirements laid down in Point a Clause 1 of this Article;
b) Clinical data for a
similar drug with the same drug substance, concentration, strength, dosage
form, and route of administration that has been granted a marketing
authorization by one of the drug regulatory authorities prescribed in Clause 9
Article 2 of this Circular, the use of which has been authorized by the owner
of the clinical data. The clinical data for
the similar drug must meet the requirements laid down in Point a Clause 1 of
this Article;
c) Clinical data compiled
from studies reported in the medical literature, meaning scientific
publications in the field of medicine, including clinical study and clinical
trial reports, scientific articles, medical journals, pharmaceutical journals,
and specialized textbooks in the fields of medicine and pharmacy (hereinafter
referred to as “medical literature”); and bioequivalence study data comparing
the drug with a similar drug having the same drug substance, concentration,
strength, dosage form, and route of administration, which has been granted a
marketing authorization by one of the drug regulatory authorities prescribed in
Clause 9 Article 2 of this Circular and meets the MOH’s requirements for
reference drugs used in bioequivalence studies.
3. For a new herbal drug;
an oral drug containing an herbal material in combination with a drug substance
that is an essential oil or a pure substance extracted from an essential oil,
including substances obtained by synthesis or semi-synthesis; or a drug
containing a pure active ingredient extracted from an herbal material:
Clinical data or data
cited from documents must be provided in accordance with one of the following
requirements:
a) The clinical studies of the drug and the
data in the clinical documents must meet the requirements of Article 18 of this
Circular or comply with the MOH’s Guidance on Non-clinical and Clinical Studies
of Herbal Drugs set out in Appendix III to this Circular, or with guidelines
issued by other organizations recognized by Viet Nam, including the WHO
Research Guidelines for Evaluating the Safety and Efficacy of Herbal Medicines,
or with guidelines issued by the drug regulatory authorities prescribed in
Clause 9 Article 2 of this Circular;
b) Monographs on
drugs/medicinal materials contained in the pharmacopoeias or drug formularies
of Viet Nam or other countries in the world;
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d) Reports evaluating the
safety and efficacy of national-, ministerial-, or provincial-level science and
technology projects that have been formally accepted upon completion.
4. A chemical drug that
has the same drug substance, strength, concentration, route of administration,
and dosage form as a drug that has been granted a marketing authorization by
one of the drug regulatory authorities prescribed in Clause 9 Article 2 of this
Circular, but has a different indication, dosage regimen, bioavailability, or
pharmacokinetic profile from a drug with the same drug substance that has
already been granted a marketing authorization in Viet Nam, must have clinical
data meeting one of the following requirements:
a) Clinical data that meet
the requirements laid down in Point a Clause 1 of this Article;
b) Clinical data compiled from studies
published in the medical literature, accompanied by the package leaflet or
Summary of Product Characteristics (SmPC) of a drug with the same drug
substance, strength, concentration, route of administration, and dosage form
that has been granted a marketing authorization by one of the drug regulatory
authorities prescribed in Clause 9 Article 2 of this Circular;
c) Clinical data developed in accordance
with the guidelines on the clinical development of drugs with novel
improvements over the original brand-name drug, as specified in Appendix I to this
Circular.
5. Submission of safety
and efficacy documents in MAAs for the following drugs is exempted:
a) Generic drugs;
b) A chemical drug with
the same drug substance, strength, concentration, route of administration, and
dosage form as a drug that has been granted a marketing authorization by one of
the drug regulatory authorities prescribed in Clause 9 Article 2 of this
Circular (including a case where the marketing of such drug has been
discontinued for reasons unrelated to its quality, safety, or efficacy), and
that does not fall under the case specified in Clause 4 of this Article;
c) A probiotic biological product with the
same origin, bacterial strain, concentration, strength, indication, and dosage
regimen as a biological that has been granted a marketing authorization by one
of the drug regulatory authorities prescribed in Clause 9 Article 2 of this
Circular;
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dd) An external-use drug
containing an essential oil or a pure substance extracted from an essential oil
as the drug substance (including substances obtained by synthesis or
semi-synthesis), with the same drug substance, strength, concentration, and
dosage form as a drug that has been granted a marketing authorization in Viet
Nam for at least 10 years or that has been granted a marketing authorization
and placed on the market in at least one other country in the world for at
least 10 years;
e) An oral drug containing an herbal
material in combination
with an essential oil or a pure substance extracted from an essential oil as
the drug substance (including substances obtained by synthesis or
semi-synthesis), or a drug containing a pure active ingredient extracted from a
herbal material,
with the same drug substance, medicinal herb, strength, concentration, dosage
form, and indication as a drug that has been granted a marketing authorization
in Viet Nam;
g) A herbal drug with the
same herbal materials, strength, concentration, mass of herbal materials,
dosage form, indication, and route of administration as a drug that has been
granted a marketing authorization by one of the drug regulatory authorities
prescribed in Clause 9 Article 2 of this Circular, or as a drug that has been
granted a marketing authorization in Viet Nam (including where such marketing
authorization has expired);
h) A new drug, other than
a vaccine, manufactured in Viet Nam for the prevention or treatment of a group
A infectious disease for which an epidemic has been declared in accordance with
the Law on disease prevention, and having the same drug substance, dosage form,
route of administration, and indication as a drug that has been granted a
marketing authorization, an emergency use authorization, or a conditional
marketing authorization or conditional use authorization by one of the drug
regulatory authorities prescribed in Clause 9 Article 2 of this Circular.
6. MAAs for any drugs
other than those specified in clauses 1, 2, 3, 4 and 5 of this Article must be
supported by clinical data to ensure the safety and efficacy of the drug in
accordance with the guidelines of ICH, WHO, US FDA, EMA, the MOH’s guidelines,
or guidelines of other organizations recognized by Viet Nam.
7. Where a clinical study
has been conducted before the regulations or guidelines on drug development
research referred to in Point a Clause 1 and Point a Clause 3 of this Article
area adopted, the data from such study may be accepted.
Section
2. STRUCTURE AND COMPOSITION OF MARKETING AUTHORIZATION APPLICATIONS FOR
DRUGS/MEDICINAL MATERIALS
Article
25. Structure of MAAs for drugs/medicinal materials
1. An MAA shall be
prepared according to ACTD or ICH-CTD, and
shall comply with the provisions of this Circular.
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a) An MAA for a chemical drug, vaccine, or
biological prepared in accordance with the ACTD shall be structured as follows:
- Part I: Administrative
Document.
- Part II: Technical
Document (comprising quality document; non-clinical document; and clinical
document);
b) An MAA for a chemical
drug, vaccine, or biological prepared in accordance with the ICH-CTD shall be
structured as follows:
- Module I: Administrative
Document.
- Module II: Technical
Document (comprising the quality, non-clinical, and clinical overviews and
summaries; the quality document; non-clinical document; and clinical document).
3. Structure of MAAs for
herbal drugs; oral drugs containing an herbal material in combination with an
essential oil or a pure substance extracted from an essential oil as the drug
substance (including substances obtained by synthesis or semi-synthesis), or
drugs containing a pure active ingredient extracted from a herbal material:
a) For a new herbal drug; an oral drug containing
a herbal material in
combination with an essential oil or a pure substance extracted from an
essential oil as the drug substance (including substances obtained by synthesis
or semi-synthesis), or a drug containing a pure active ingredient extracted
from a herbal material:
- Part I: Administrative
Document.
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b) For an herbal drug that is not a new drug:
- Part I: Administrative
Document.
- Part II: Technical Document (comprising the
quality document prepared in accordance with the guidelines in Appendix III to
this Circular).
4. Structure of MAAs for
medicinal materials:
a) Part I: Administrative
Document;
b) Part II: Technical
Document (comprising the quality document prepared in accordance with the
guidelines in Appendix IV to this Circular).
Article
26. Administrative Document
1. An application form,
which is made using Form 4A/TT, Form 4B/TT, or Form 4C/TT in Appendix IX to
this Circular.
2. Letters of
authorization in an MAA:
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b) A letter of
authorization to sign documents in MAA (if any).
3. CPP (for an imported
drug).
For the cases prescribed
in the first and second sub-points of Point a Clause 2 Article 45 of this
Circular, the applicant shall submit an explanatory report stating why the CPP
could not be provided in the MAA at the time of initial MAA submission.
4. License to manufacture
or trade drugs in the country concerned; license for establishment of a
representative office in Viet Nam (for a foreign applicant).
5. Certificate of
eligibility for pharmaceutical business (for a Vietnamese applicant).
6. Legal documents of the
manufacturer of the drug substance, excipient, capsule shell, or herbal
material, as prescribed in Clause 7 Article 22 of this Circular.
7. The certificate
confirming that the medicinal material is permitted to be manufactured or
marketed in the manufacturing country (for an MAA for a medicinal material
manufactured overseas).
8. Mock-up of the label
and package leaflet for drugs and medicinal materials:
a) For the drug or
medicinal material intended to be placed on the market in Viet Nam;
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9. The SmPC or package
leaflet approved in the CPP-issuing country, for a new drug, vaccine, or
biological, or for a drug for which validation by reference to available
validation results is requested.
10. For an MAA requesting
the application of validation by reference to available validation results, or
an MAA is for a drug manufactured in a country whose drug regulatory authority
is not one of those specified in Clause 9 Article 2 of this Circular, where
only a CPP issued by the competent authority responsible for issuing CPPs in a
country whose drug regulatory authority is one of those specified in Clause 9
Article 2 of this Circular and certifying that the drug is licensed and
actually placed on the market in that country is submitted, the following
additional documents must be provided:
a) The validation report
of the drug regulatory authority issuing the CPP, as specified in Clause 9
Article 2 of this Circular, which must meet the requirements of Article 30 of
this Circular;
b) A comparative tabulated
summary demonstrating the consistency between the MAA for the drug in Viet Nam
and the information on the drug licensed in the country concerned, prepared
using Form 09/TT in Appendix IX to this Circular.
Article
27. Quality Document
1. Quality documents are
prepared according to the guidelines in Part II of ACTD or the guidelines in Module
2 and Module 3 of ICH-CTD, and relevant guidelines.
For a biosimilar, complete
documents and data demonstrating its quality similarity to the reference
biological shall be provided in accordance with the relevant guidelines of WHO,
US-FDA, or EMA.
2. The drug substance
documents may be replaced by the following documents:
a) A Certificate of
Suitability to the European Pharmacopoeia (CEP), as prescribed in Clause 3 of
this Article;
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c) Where the CEP does not
specify a retest period for the drug substance, stability study data for the
drug substance shall be submitted.
3. Requirements for CEPs in the Quality
Document:
a) The CEP included in the
submitted MAA must be valid at the time of receipt of the MAA, be issued by the
European Directorate for the Quality of Medicines & HealthCare (EDQM), and
include all annexes/documents attached to the CEP.
For a CEP issued before
September 01, 2023, the CEP must bear the seal of the finished drug
manufacturer or the applicant. The establishment whose seal is affixed to the
CEP shall be legally responsible for the accuracy, legality, and truthfulness
of the CEP. The CEP must state in full the name of the applicant or the
manufacturer authorized to use the CEP in the authorization section of the CEP.
For a CEP issued on or
after September 01, 2023, the CEP included in the submitted MAA must be an
electronic copy bearing a valid electronic signature, issued by the EDQM, and
accompanied by a letter of authorization from the CEP holder authorizing the
applicant or the manufacturer to use the CEP;
b) The applicant must
submit a document providing the results of its own search for the CEP in the
database published by the EDQM, including the search link and bearing the
applicant’s confirmation. The document providing such results must include the
following information:
- The name of the
material, information on the CEP holder, number, issuance date, and validity
status of the CEP, and the number of the applicable European Pharmacopoeia
monograph.
- The date by which
renewal is required or the expiry date, if applicable.
4. Where the manufacturer
uses a medicinal material that has been granted a marketing authorization in
Viet Nam and uses it in accordance with the approved information on the name of
the medicinal material, the manufacturer, quality specifications, and source of
the medicinal material:
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b) The applicant must
submit:
- One (01) CoA for the
medicinal material, issued by the finished drug manufacturer, covering all
quality specifications at levels equal to or more stringent than those
specified in the standard announced by the medicinal material manufacturer.
Where the finished drug manufacturer does not have the capacity to test the
medicinal material for all quality specifications, it must provide an analysis
report for the quality specifications not tested by the finished drug
manufacturer, issued by a state testing authority or a drug and medicinal
material testing service establishment that has been granted a certificate of
eligibility for pharmaceutical business;
- One (01) CoA for the
medicinal material, issued by the medicinal material manufacturer.
5. For vaccines, antisera,
and human blood and plasma derivatives, documents shall be submitted according
to Clause 1 of this Article and include the following:
a) A batch release certificate
issued by the competent authority of the CPP-issuing country as prescribed or
by one of the drug regulatory authorities prescribed in Clause 9 Article 2 of
this Circular;
b) A CoA, quality
specifications and test method confirmed by the National Institute for Control
of Vaccines and Biologicals (NICVB) or a state drug testing establishment in
charge of testing, evaluating and monitoring vaccines and medical biologicals
as assigned by MOH.
6. For orphan drugs, drugs
intended to meet needs for national defense and security, epidemic prevention
and control, or response to the consequences of natural disasters or
catastrophes, and drugs for special treatment needs:
a) Orphan drugs for the
treatment of rare diseases: <0}
Available stability study
data obtained according to the guidelines of ASEAN or ICH shall be accepted;
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Stability study data
available at the date of MAA submission shall be accepted for consideration of
the drug’s shelf life, based on the opinions given by the Council, where the
period covered by the drug’s stability study data does not yet meet the minimum
study duration required under ASEAN guidelines.
After the marketing
authorization has been granted, the applicant shall continue to submit
stability study data for the finished drug to the DAV until the period covered
by the stability study actually meets the minimum study duration required under
ASEAN guidelines. The applicant shall submit the data as a variation to the
marketing authorization, as prescribed in Appendix II to this Circular, for
consideration and updating of the drug’s shelf life in accordance with
regulations.
Where the stability study
results for the drug fail to comply with the study protocol included in the
MAA, the applicant shall immediately report the matter to DAV for submission to
the Council for consideration of the drug’s shelf life.
Based on opinions given by
the Council, DAV shall consider and decide the shelf life of the drug,
including the shelf life applicable to batches of the drug that have already
been manufactured, based on the actual stability study data;
c) Drugs for special
treatment needs:
Available stability study
data generated in accordance with ASEAN or ICH guidelines shall be accepted, as
decided by the Minister of Health based on the opinion of the Council, where
the applicant demonstrates that the drug cannot be stored under Climatic Zone
IVb conditions in accordance with ASEAN guidelines.
7. For the cases specified
in Clause 2 Article 13 of this Circular:
The applicant must submit
a comparative tabulated summary (using Form 01/TT in Appendix IX to this
Circular) comparing the drug before and after the change, and the technical
documents corresponding to each change, in accordance with the guidance in
Appendix II to this Circular.
8. For an MAA for a drug
ordered for processing or a drug manufactured using transferred technology that
meets the requirements of Clause 1 Article 9 of this Circular:
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b) Where the drug ordered
for processing or the drug prior to technology transfer does not yet have
Climatic Zone IVb stability data, Climatic Zone IVb stability study data for
the drug for which marketing authorization is sought are required, in
accordance with ASEAN guidelines on drug stability studies;
c) For vaccines and
biologicals, the stability data requirements shall follow the WHO, EMA, and
US-FDA guidelines applicable to a change of manufacturer;
d) After the marketing
authorization has been granted, the manufacturer shall continue to conduct stability
studies of the finished drug in accordance with the study protocol included in
the submitted MAA. Where the drug fails to meet the stability study
requirements, the applicant shall report such failure to DAV and propose
appropriate measures to address it.
9. For an MAA for a drug
that has already been granted a marketing authorization upon a change of its
manufacturer as prescribed in Point b Clause 2 Article 55 of the Pharmacy Law,
where the MAA includes documents evidencing approval of the change of
manufacturer by the competent authority of the country concerned and a
comparative tabulated summary (using Form 01/TT in Appendix IX to this
Circular):
a) A minimum of 06 months
of stability study data, including long-term and accelerated stability data, is
required for the drug for which marketing authorization is sought, in
accordance with ASEAN guidelines applicable to variations;
b) For vaccines and
biologicals, the stability data requirements shall follow the WHO, EMA, and
US-FDA guidelines applicable to a change of manufacturer;
c) After the marketing
authorization has been granted, the manufacturer shall continue to conduct
stability studies of the finished drug in accordance with the study protocol
included in the submitted MAA. Where the drug fails to meet the stability study
requirements, the applicant shall report such failure to DAV and propose
appropriate measures to address it.
Article
28. Non-clinical Document
Non-clinical documents are
prepared in accordance with the guidelines in Part III of the ACTD or Module 2
and Module 4 of the ICH-CTD, and relevant guidelines or the guidelines in
Appendix III to this Circular.
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Clinical documents are
prepared in accordance with the guidelines in Part IV of the ACTD or Module 2
and Module 5 of the ICH-CTD, and relevant guidelines or the guidelines in
Appendix III enclosed herewith.
Article
30. Documents on validation results of drug regulatory authorities specified in
Clause 9 Article 2 of the Circular in case where an MAA is validated by
reference to available validation results
1. The document used as
reference must be an official validation report issued by a drug regulatory
authority specified in Clause 9 Article 2 of this Circular, setting out in
detail the assessment and validation process regarding the quality, safety, and
efficacy of the drug, as well as the scientific and legal basis for granting
the marketing authorization for the drug in the country concerned.
2. The validation report
used as reference must be the final report used by the drug regulatory
authority to grant the marketing authorization for the product, together with
all validation report(s) and document(s) approving variations to the product
following the grant of marketing authorization.
3. A validation report
used as reference for valuation of an MAA shall include, at a minimum, the
following information:
a) Administrative
information, including:
- Information on the drug.
- A list of all approved
pack sizes and packaging specifications.
- The pharmacological
group.
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b) Quality information,
including:
- An assessment of
the composition and manufacturing process.
- An assessment of
quality control.
- An assessment of
stability, including conclusions on the product quality;
c) Safety and efficacy information,
including:
- A summary assessment of the key
non-clinical data.
- A summary assessment of the key clinical
data.
- A benefit-risk assessment.
- The basis for the
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Section
3. SPECIFIC PROVISIONS ON MARKETING AUTHORIZATION APPLICATIONS FOR
DRUGS/MEDICINAL MATERIALS
Article
31. MAAs for drugs specified in clauses 1, 2 and 6 Article 24 of this Circular
1. Administrative Document:
The documents specified in
Article 26 of this Circular.
2. Quality Document:
The documents specified in
Article 27 of this Circular.
3. Non-clinical Document:
The documents specified in
Clauses 1, 2, 6 and 7 of Article 24 of this Circular and prepared in accordance
with Article 28 of this Circular.
4. Clinical Document:
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5. A risk management plan,
for a new chemical drug, vaccine or biological (except probiotic biological
products) (using Form
03/TT in Appendix IX to this Circular).
Article
32. MAAs for generic drugs and drugs specified in Points b, c, d and h Clause 5
Article 24 of this Circular
1. Administrative Document:
The documents specified in
Article 26 of this Circular.
2. Quality Document:
a) The documents specified
in Article 27 of this Circular;
b) Documentary evidence of
demonstrated bioequivalence for a drug containing a drug substance or having a dosage
form for which bioequivalence study data are required to be reported upon
submission of an MAA.
Article
33. MAAs for drugs specified in Clause 4 Article 24 of this Circular
1. Administrative Document:
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2. Quality Document:
a) The documents specified
in Article 27 of this Circular;
b) Documentary evidence of
demonstrated bioequivalence for a drug containing a drug substance or having a
dosage form for which bioequivalence study data are required to be reported
upon submission of an MAA.
3. Clinical Document:
The documents specified in
Clause 4 Article 24 of this Circular and prepared in accordance with Article 29
of this Circular.
4. The package leaflet or
SmPC of the drug with the same drug substance, strength, concentration, route
of administration, and dosage form that has been granted a marketing
authorization by one of the drug regulatory authorities specified in Clause 9
Article 2 of this Circular, where clinical data compiled from studies published
in the medical literature are submitted.
5. Additional safety and
efficacy data shall be provided where necessary, based on the advisory opinion
of the Council.
Article
34. MAAs for drugs specified in Points dd and e Clause 5 Article 24 of this
Circular
1. Administrative Document:
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2. Quality Document:
The documents specified in
Appendix III to this Circular.
Article
35. MAAs for drugs specified in Clause 3 Article 24 of this Circular
1. Administrative Document:
The documents specified in
Article 26 of this Circular.
2. Quality Document:
The documents prepared
according to the guidelines in Appendix III to this Circular.
3. Clinical data or data
cited from documents as prescribed in Clause 3 Article 24 of this Circular.
Article
36. MAAs for drugs specified in Point g Clause 5 Article 24 of this Circular
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The documents specified in
Article 26 of this Circular.
2. Quality Document:
The documents prepared
according to the guidelines in Appendix III to this Circular.
Article
37. MAAs for medicinal materials
1. Administrative Document:
The documents specified in
Article 26 of this Circular.
2. Quality Document:
The documents specified in
Appendix IV to this Circular.
Section
4. SPECIFIC PROVISIONS ON MARKETING AUTHORIZATION APPLICATIONS FOR PROCESSED
DRUGS AND DRUGS MANUFACTURED USING TRANSFERRED TECHNOLOGY IN VIET NAM
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1. Administrative Document:
a) The administrative
documents for the
processed drug or the drug manufactured using transferred technology, as
specified in Article 26 of this Circular. The legal documents of the manufacturer
of the drug substance, excipient, capsule shell, or herbal material are not
required where drug processing or technology transfer is limited to the
packaging stage;
b) Other documents
concerning the drug processing or technology transfer, including:
- The drug processing
contract or technology transfer contract. Where the ordering establishment or
the processing establishment is not the applicant, the processing contract must
bear the signatures of the legal representatives of the ordering establishment,
the applicant, and the processing establishment.
- The technology transfer registration
certificate as prescribed in Article 31 of the Law on Technology Transfer, for
an MAA for a drug manufactured using transferred technology;
c) The CPP for the drug ordered for
processing or the drug prior to technology transfer, where the drug ordered for
processing or the drug prior to technology transfer is an imported drug that
has not been granted a marketing authorization in Viet Nam or whose marketing
authorization in Viet Nam has expired at the time of MAA submission.
2. Quality Document:
a) The quality documents
for the processed drug/the drug manufactured using transferred technology and
the drug ordered for processing/the drug prior to technology transfer, as
specified in Articles 31, 32, 33, 34, and 35 of this Circular;
b) The comparative
tabulated summary (Form 01/TT in Appendix IX to this Circular), comparing the drug ordered for
processing with the processed drug, or the drug prior to technology transfer
with the drug manufactured using transferred technology, and the technical
documents corresponding to each change, in accordance with the guidelines in
Appendix II to this Circular.
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d) An MAA for a processed
drug or a drug manufactured using transferred technology for which
classification as an original brand-name drug or as a drug with demonstrated
bioequivalence is requested must also include the following quality documents:
- The bioequivalence study report for the
processed drug or the drug manufactured using transferred technology.
The may replace the bioequivalence study report
for the processed drug or the drug manufactured using transferred technology
with a dissolution equivalence study report comparing the processed drug with
the drug ordered for processing, or the drug manufactured using transferred
technology with the drug prior to technology transfer, provided that the
processed drug and the drug ordered for processing, or the drug manufactured
using transferred technology and the drug prior to technology transfer, have
the same formulation, manufacturing process, material quality specifications,
and finished-product quality specifications, in accordance with US-FDA SUPAC,
ICH, WHO, and EMA guidelines, guidelines of international organizations of
which Viet Nam is a member, or guidelines of the drug regulatory authorities
specified in Clause 9 Article 2 of this Circular.
Where any of the above-mentioned items are changed at a level that
does not require submission of a bioequivalence study report, the applicant
must submit the supporting documents corresponding to each change in accordance
with US-FDA SUPAC, ICH, WHO, and EMA guidelines,
guidelines of
international organizations of which Viet Nam is a member, or guidelines of the drug
regulatory authorities specified in Clause 9 Article 2 of this Circular.
- The bioequivalence study report for the
drug ordered for processing or the drug prior to technology transfer, where the
drug ordered for processing or the drug prior to technology transfer has not
been classified as a drug with demonstrated bioequivalence in Viet Nam and the
processed drug or the drug manufactured using transferred technology is
proposed for classification as a drug with demonstrated bioequivalence.
3. Non-clinical Document
and Clinical Document:
a) For a processed drug or
a drug manufactured using transferred technology:
The non-clinical documents
specified in Clause 3 Article 31 of this Circular and the clinical documents
specified in Clause 4 Article 31 of this Circular shall be submitted where the
processed drug or the drug manufactured using transferred technology is a new
chemical drug, vaccine, or biological.
Non-clinical and clinical
documents are not required in the following cases:
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- The drug ordered for
processing or the drug prior to technology transfer is a biological whose
marketing authorization in Viet Nam remains valid at the time of MAA
submission, or for which the non-clinical documents specified in Clause 3
Article 31 of this Circular and the clinical documents specified in Clause 4
Article 31 of this Circular have already been submitted, and there are
sufficient documents demonstrating quality comparability between the processed
drug and the drug ordered for processing, or between the drug manufactured
using transferred technology and the drug prior to technology transfer.
- The drug ordered for
processing or the drug prior to technology transfer is a vaccine whose
marketing authorization in Viet Nam remains valid at the time of MAA submission
and for which documents demonstrating quality comparability between the
processed drug and the drug ordered for processing, or between the drug
manufactured using transferred technology and the drug prior to technology
transfer, have been submitted;
b) For the drug ordered
for processing or the drug prior to technology transfer:
The non-clinical documents
specified in Clause 3 Article 31 of this Circular and the clinical documents specified
in Clause 4 Article 31 of this Circular shall be submitted where the processed
drug or the drug manufactured using transferred technology is a new chemical
drug, vaccine, or biological, or where classification of the processed drug or
the drug manufactured using transferred technology as an original brand-name
drug or reference biological is requested, and the drug ordered for processing
or the drug prior to technology transfer has not been classified as an original
brand-name drug or reference biological, as applicable.
4. A risk management plan,
for a new chemical drug, vaccine or biological (except probiotic biological
products) (using Form 03/TT in Appendix IX to this Circular).
Article
39. MAA for a processed drug or a drug manufactured using transferred
technology that is an herbal drug
1. Administrative Document:
a) The administrative
documents for the processed drug or the drug manufactured using transferred
technology, as prescribed in Article 26 of this Circular. The legal documents
of the manufacturers of herbal materials, excipients, or capsule shells are not
required where the processing or technology transfer is limited to the
packaging stage;
b) Other documents
concerning the drug processing or technology transfer, including:
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- The technology transfer
registration certificate as prescribed in Article 31 of the Law on Technology
Transfer, for an MAA for a drug manufactured using transferred technology;
c) The CPP for the drug
ordered for processing or the drug prior to technology transfer, where the drug
ordered for processing or the drug prior to technology transfer is an imported
drug that has not been granted a marketing authorization in Viet Nam or whose
marketing authorization in Viet Nam has expired at the time of MAA submission.
2. Quality Document:
a) The quality documents
for the processed drug/the drug manufactured using transferred technology and
the drug ordered for processing/the drug prior to technology transfer, as
prescribed in Articles 35 and 36 of this Circular;
b) The comparative
tabulated summary (Form 01/TT in Appendix IX to this Circular), comparing the
drug ordered for processing with the processed drug, or the drug prior to
technology transfer with the drug manufactured using transferred technology,
and the technical documents corresponding to each change, in accordance with
the guidelines in Appendix II to this Circular.
3. Clinical Document:
a) For a processed drug or
a drug manufactured using transferred technology:
The clinical documents
specified in Clause 3 Article 35 of this Circular shall be submitted where the
processed drug or the drug manufactured using transferred technology is a new
drug.
Clinical documents are not
required where the drug ordered for processing or the drug prior to technology
transfer is an herbal drug whose
marketing authorization in Viet Nam remains valid at the time of MAA
submission, or for which the clinical documents specified in Clause 3 Article
35 of this Circular have already been submitted;
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- The clinical documents
specified in Clause 3 Article 35 of this Circular shall be submitted where the
processed drug or the drug manufactured using transferred technology is a new
drug.
- The clinical documents
specified in Article 18 of this Circular shall be submitted where
classification of the processed drug or the drug manufactured using transferred
technology as an original brand-name drug or reference biological is requested,
and the drug ordered for processing or the drug prior to technology transfer
has not been classified as an original brand-name drug or reference biological,
as applicable.
Article
40. MAA for a drug processed involving transfer of drug manufacturing
technology from ordering establishment to processing establishment
1. The MAA includes the
documents prescribed in Article 38 or 39 of this Circular.
2. The applicant shall
concurrently submit:
a) The drug processing
contract and the technology transfer contract;
b) The technology transfer
registration certificate as prescribed in Article 31 of the Law on Technology
Transfer.
Section
5. SPECIFIC PROVISIONS ON APPLICATIONS FOR RENEWAL OF, OR APPROVAL OF
VARIATIONS TO, MARKETING AUTHORIZATION FOR DRUG/MEDICINAL MATERIAL
Article
41. Application for renewal of marketing authorization for drug/medicinal
material
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2. An unexpired CPP, for
an imported drug.
3. A report on the safety
and efficacy of the drug during the period it has been placed on the market,
using Form 2C/TT in Appendix IX to this Circular.
Article
42. Application for approval of variations to marketing authorization for
drug/medicinal material
1. An application form for
approval of variations to the marketing authorization for the drug/medicinal
material (using Form 4C/TT in Appendix IX to this Circular), and a letter of
authorization to sign documents in the MAA (if any).
2. The documents corresponding to the major
variations (MaV) or minor variations (MiV) prescribed in Appendix II to this
Circular.
3. For variations relating
to the drug formulation, manufacturing process, quality specifications for
starting materials, quality specifications for the finished drug, or the trade
name of a processed drug or a drug manufactured using transferred technology
that has been announced as meeting the criteria set out in Clause 1 Article 9
of this Circular, the applicant for the processed drug or the drug manufactured
using transferred technology shall provide evidence that the corresponding
variation to the drug ordered for processing or the drug prior to technology
transfer, as manufactured and marketed in the country concerned, has been
approved by a competent regulatory authority.
Chapter
IV
AUTHORITY
AND PROCEDURES FOR GRANTING, RENEWING, AND APPROVING VARIATIONS TO MARKETING
AUTHORIZATIONS FOR DRUGS/MEDICINAL MATERIALS
Article
43. Authority to grant, renew, and approve variations to marketing
authorizations for drugs/medicinal materials
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a) Granting a marketing
authorization for a drug/medicinal material;
b) Renewing a marketing
authorization for a drug/medicinal material based on the application validation
and the Council’s advisory opinion, in the following cases:
- A drug prescribed in
Clause 2 of Article 12 of this Circular.
- A drug/medicinal
material that has been subject to a mandatory recall decision or a voluntary
recall for failure to meet quality specifications during the period it has been
placed on the market since the most recent grant or renewal of the marketing
authorization.
- A drug for which the
report in Form 2C/TT in Appendix IX to this Circular indicates a new adverse
event, a known adverse event occurring at a higher frequency than that stated
in the approved package leaflet, or a known adverse event requiring further
assessment;
c) Approving variations to
a marketing authorization for a drug in accordance with Appendix II to this
Circular, in the following cases:
Classification as a
prescription or OTC drug; variations to the indication, dosage, route of
administration, or intended patient population; and classification as an
original brand-name drug, a reference biological, or a drug with demonstrated
bioequivalence.
2. The DAV shall renew, or
approve variations to, a marketing authorization for a drug/medicinal material
based on the application validation without requiring the application
validation and advisory opinions of the Council in the following cases:
a) Renewing a marketing
authorization for a drug/medicinal material not falling under Point b Clause 1
of this Article;
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3. The DAV shall publish,
on the MOH’s web portal and the DAV’s website, the variations to marketing
authorizations for drugs/medicinal materials that do not require application
validation, for minor variations (MiV) requiring notification only.
Article
44. Submission of supplementary documents, updated documents during validation,
cases in which a variation application is not required, and periods for
applying existing information before approval or announcement of variations
1. Within 06 months from
the date of the DAV’s written notice, the applicant shall submit the requested
supplementary documents. After this period, if the applicant fails to submit
the supplementary documents as requested, the submitted application shall no
longer be valid.
The period from the date
of the DAV’s written notice to the date on which the applicant submits the
supplementary documents shall not be counted toward the time limit prescribed
in Clause 6 Article 56 of the Pharmacy Law.
2. Number of rounds of
supplementary document submission for an application for grant, renewal, or
approval of variations to a marketing authorization for a drug/medicinal material:
a) For an application for
grant, renewal, or approval of variations to a marketing authorization for a
drug/medicinal material, the applicant may submit supplementary documents no
more than twice.
Where, following the
second submission of supplementary documents, the application still does not
meet the requirements based on the validators’ assessment, the DAV shall refer
the case to the Council for consideration of refusing to grant or renew the
marketing authorization, or refusing to approve the variations, for a drug
falling under Clause 1 Article 43 of this Circular; or shall issue a written
notice of refusal to renew the marketing authorization or approve the
variations thereto, for a drug falling under Clause 2 Article 43 of this
Circular.
Where, following the
second submission of supplementary documents, the application does not meet the
requirements based on the validators’ assessment due to new issues arising
beyond the requirements previously communicated, the DAV shall refer the case
to the Council for consideration of allowing the applicant one additional
submission of supplementary documents to address the validators’ comments, for
a drug falling under Clause 1 Article 43 of this Circular; or shall issue a
written notice allowing one additional submission of supplementary documents,
for a drug falling under Clause 2 Article 43 of this Circular;
b) Supplementary documents
submitted at the Council’s request shall not count toward the number of
permitted submissions of supplementary documents prescribed in Point a of this
Clause.
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a) Documents updating
safety and efficacy information in the drug’s package leaflet, for an
application for grant of, or approval of variations to, a marketing
authorization for a drug;
b) Documents updating
administrative information on the name and address of the applicant and the
person signing documents in the MAA, provided that the applicant remains
unchanged, for an application for grant of, or approval of variations to, a
marketing authorization for a drug;
c) Documents updating
administrative information on the manufacturer’s name and address format,
provided that the manufacturer and manufacturing site remain unchanged, for an
application for grant of, or approval of variations to, a marketing
authorization for a drug;
d) Documents updating
information on the actual marketing status of the drug in Viet Nam, for an
application for renewal of a marketing authorization for a drug.
4. For an application for
renewal of a marketing authorization for a drug/medicinal material as
prescribed in Article 41 of this Circular, the applicant may change only the
name of the drug in the renewal application and shall clearly state the change
in the application form for renewal of the marketing authorization for the
drug/medicinal material.
5. The applicant and the
drug manufacturer shall be responsible for updating the label and package
leaflet without being required to submit an application for approval of
variations or notify the DAV, in the following cases:
a) A change to the
position or information of the importer of the drug/medicinal material stated
on the label or package leaflet;
b) Labeling the
drug/medicinal material and preparing the package leaflet in accordance with
Clause 2 Article 35 of Circular No. 01/2018/TT-BYT;
c) Making changes to the
contents of the label or package leaflet pursuant to an official letter issued
by the DAV based on the Council’s advisory opinion;
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dd) Other items:
- Correction of spelling
errors on the label or package leaflet.
- Changes to the layout of
sections in the package leaflet without changing the approved contents, in
accordance with the requirements applicable to the package leaflet.
- Changes to or addition
of information on quality specifications on the label or package leaflet in
accordance with the application approved by the DAV.
- Removal of non-mandatory
information from the label or package leaflet.
6. The applicant and the
manufacturer shall apply a newly approved variation no later than 12 months
from the date on which the DAV issues the approval letter. For a minor
variation (MiV) requiring only notification, the variation shall take effect
immediately upon receipt of the notification or no later than 12 months from
the date on which the DAV publishes the variation.
During the 12-month period
from the date on which the DAV issues the approval letter or publishes the
variation, the variation shall apply as follows:
a) An imported
drug/medicinal material may continue to be imported and marketed, up to its
expiry date, with the information applicable before the variation was approved
or published, provided that the drug/medicinal material was handed over at the
port of departure in the exporting country before the date on which the new
variation is required to apply;
b) A drug/medicinal
material manufactured in Viet Nam may continue to be marketed, up to its expiry
date, with the information applicable before the variation was approved or
published, provided that the drug/medicinal material was manufactured before
the date on which the new variation is required to apply.
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During the 12-month period
from the date on which the marketing authorization is renewed, the use of the
drug’s name shall be governed as follows:
a) An imported
drug/medicinal material may continue to be imported and marketed, up to its
expiry date, under the name used before renewal of the marketing authorization,
provided that the drug/medicinal material was handed over at the port of
departure in the exporting country before the date on which the new name
approved upon renewal of the marketing authorization is required to be used;
b) A drug/medicinal
material manufactured in Viet Nam may continue to be marketed, up to its expiry
date, under the name used before renewal of the marketing authorization,
provided that the drug/medicinal material was manufactured before the date on
which the new name approved upon renewal of the marketing authorization is
required to be used.
Article
45. Procedures for granting marketing authorization for drug/medicinal material
1. Method of MAA
submission:
The applicant shall submit
the MAA in accordance with Article 15 of Decree No. 118/2025/ND-CP.
2. Receipt and time limits
for processing of the MAA:
a) Receipt of the MAA:
Upon receipt of a complete
MAA, the DAV shall issue the applicant an MAA receipt as prescribed.
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- The CPP, for a new drug.
- The CPP, for the case
prescribed in Point d Clause 2 Article 22 of this Circular.
- The documents prescribed
in Point b Clause 5 Article 27 of this Circular.
No later than the second
submission of supplementary documents prescribed in Point a Clause 2 Article 44
of this Circular, the applicant shall submit the documents referred to in this
Point for consideration of the grant of the marketing authorization;
b) Time limits for
processing an MAA from the date of its receipt:
- An MAA for a drug: not
exceeding 12 months.
- An MAA for a drug
validated by reference to available validation results: not exceeding 09 months.
- An MAA for a processed
drug or a drug manufactured using transferred technology, where the drug
ordered for processing or the drug prior to technology transfer has a valid
marketing authorization in Viet Nam at the time of MAA submission, or an MAA
for a processed drug involving the transfer of drug manufacturing technology
from the ordering establishment to the processing establishment, where the drug
ordered for processing has a valid marketing authorization in Viet Nam at the
time of MAA submission: not exceeding 03 months.
- An MAA for a processed
drug or a drug manufactured using transferred technology, where the drug
ordered for processing or the drug prior to technology transfer does not have a
marketing authorization in Viet Nam or has an expired marketing authorization
at the time of MAA submission, or an MAA for a processed drug involving the
transfer of drug manufacturing technology from the ordering establishment to
the processing establishment, where the drug ordered for processing does not
have a marketing authorization in Viet Nam or has an expired marketing
authorization at the time of MAA submission: not exceeding 09 months.
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- An MAA for a drug
eligible for administrative-procedure priority as prescribed in Clause 5
Article 7 of the Pharmacy Law: not exceeding 06 months.
- An MAA for a medicinal
material: not exceeding 06 months.
3. Organization of MAA
validation:
a) From the date of
receipt of the MAA, the DAV shall review, classify, and forward the MAA to the
validators or validating units within the following time limits:
- An MAA for a drug: 10
days, for both the initial submission and any supplementary submission.
- An MAA for a drug
validated by reference to available validation results: 10 days, for both the
initial submission and any supplementary submission.
- An MAA for a processed
drug or a drug manufactured using transferred technology, where the drug
ordered for processing or the drug prior to technology transfer has a valid
marketing authorization in Viet Nam at the time of MAA submission, or an MAA
for a processed drug involving the transfer of drug manufacturing technology
from the ordering establishment to the processing establishment, where the drug
ordered for processing has a valid marketing authorization in Viet Nam at the
time of MAA submission: 03 working days, for both the initial submission and
any supplementary submission.
- An MAA for a processed
drug or a drug manufactured using transferred technology, where the drug
ordered for processing or the drug prior to technology transfer does not have a
marketing authorization in Viet Nam or has an expired marketing authorization
at the time of MAA submission, or an MAA for a processed drug involving the
transfer of drug manufacturing technology from the ordering establishment to
the processing establishment, where the drug ordered for processing does not
have a marketing authorization in Viet Nam or has an expired marketing
authorization at the time of MAA submission: 10 days, for both the initial
submission and any supplementary submission.
- An MAA for a new drug
indicated for the prevention or treatment of a Group A infectious disease for
which an epidemic has been declared in accordance with the Law on disease
prevention: 01 working day, for both the initial submission and any
supplementary submission.
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- An MAA for a medicinal
material: 03 working days, for both the initial submission and any
supplementary submission.
b) From the date of
receipt of the MAA from the DAV, the validators and validating units shall
conduct the validation, complete the validation record, and submit it to the
DAV within the following time limits:
- An MAA for a drug: 07
months for the initial submission and 02 months for a supplementary submission.
- An MAA for a drug validated
by reference to available validation results: 04 months for the initial
submission and 02 months for a supplementary submission.
- An MAA for a processed
drug or a drug manufactured using transferred technology, where the drug
ordered for processing or the drug prior to technology transfer has a valid
marketing authorization in Viet Nam at the time of MAA submission, or an MAA
for a processed drug involving the transfer of drug manufacturing technology
from the ordering establishment to the processing establishment, where the drug
ordered for processing has a valid marketing authorization in Viet Nam at the
time of MAA submission: 01 month for both the initial submission and any
supplementary submission.
- An MAA for a processed
drug or a drug manufactured using transferred technology, where the drug
ordered for processing or the drug prior to technology transfer does not have a
marketing authorization in Viet Nam or has an expired marketing authorization
at the time of MAA submission, or an MAA for a processed drug involving the
transfer of drug manufacturing technology from the ordering establishment to
the processing establishment, where the drug ordered for processing does not
have a marketing authorization in Viet Nam or has an expired marketing authorization
at the time of MAA submission: 04 months for the initial submission and 01
month for a supplementary submission.
- An MAA for a new drug
indicated for the prevention or treatment of a Group A infectious disease for
which an epidemic has been declared in accordance with the Law on disease
prevention: 03 working day, for both the initial submission and any
supplementary submission.
- An MAA for a drug
eligible for administrative-procedure priority as prescribed in Clause 5 Article
7 of the Pharmacy Law: 04 months for the initial submission and 01 month for a
supplementary submission.
- An MAA for a medicinal
material: 04 months for the initial submission and 01 month for a supplementary
submission.
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Upon receipt of the
validation record, the DAV shall, based on the consolidated report on
validation opinions of the validators and validating units and the regulations
in force, issue a written request to the applicant for additional documents if
the MAA has not yet met the requirements, or refer the MAA to the Council if
the validation result indicates that the MAA meets the requirements, fails to
meet the requirements, or requires the Council’s opinion, together with the
DAV’s proposal to grant, refuse, or seek the Council’s opinion on marketing
authorization, within the following time limits:
a) An MAA for a drug: 02
months for the initial submission and 01 month for a supplementary submission;
b) An MAA for a drug
validated by reference to available validation results: 02 months for the
initial submission and 01 month for a supplementary submission;
c) An MAA for a processed
drug or a drug manufactured using transferred technology, where the drug
ordered for processing or the drug prior to technology transfer has a valid
marketing authorization in Viet Nam at the time of MAA submission, or an MAA
for a processed drug involving the transfer of drug manufacturing technology
from the ordering establishment to the processing establishment, where the drug
ordered for processing has a valid marketing authorization in Viet Nam at the
time of MAA submission: 15 days for both the initial submission and any
supplementary submission;
d) An MAA for a processed
drug or a drug manufactured using transferred technology, where the drug
ordered for processing or the drug prior to technology transfer does not have a
marketing authorization in Viet Nam or has an expired marketing authorization
at the time of MAA submission, or an MAA for a processed drug involving the
transfer of drug manufacturing technology from the ordering establishment to
the processing establishment, where the drug ordered for processing does not
have a marketing authorization in Viet Nam or has an expired marketing
authorization at the time of MAA submission: 02 months for the initial
submission and 01 month for a supplementary submission;
dd) An MAA for a new drug
indicated for the prevention or treatment of a Group A infectious disease for
which an epidemic has been declared in accordance with the Law on disease
prevention: 01 working day, for both the initial submission and any
supplementary submission;
e) An MAA for a drug
eligible for administrative-procedure priority as prescribed in Clause 5
Article 7 of the Pharmacy Law: 15 days, for both the initial submission and any
supplementary submission;
g) An MAA for a medicinal
material: 15 days, for both the initial submission and any supplementary
submission.
5. Meeting of the Council:
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a) An MAA for a drug: 01
month, for both the initial submission and any supplementary submission;
b) An MAA for a drug
validated by reference to available validation results: 01 month, for both the
initial submission and any supplementary submission;
c) An MAA for a processed
drug or a drug manufactured using transferred technology, where the drug
ordered for processing or the drug prior to technology transfer has a valid
marketing authorization in Viet Nam at the time of MAA submission, or an MAA
for a processed drug involving the transfer of drug manufacturing technology
from the ordering establishment to the processing establishment, where the drug
ordered for processing has a valid marketing authorization in Viet Nam at the
time of MAA submission: 15 days for both the initial submission and any
supplementary submission;
d) An MAA for a processed
drug or a drug manufactured using transferred technology, where the drug
ordered for processing or the drug prior to technology transfer does not have a
marketing authorization in Viet Nam or has an expired marketing authorization
at the time of MAA submission, or an MAA for a processed drug involving the
transfer of drug manufacturing technology from the ordering establishment to
the processing establishment, where the drug ordered for processing does not
have a marketing authorization in Viet Nam or has an expired marketing
authorization at the time of MAA submission: 01 month for the initial
submission and 15 days for a supplementary submission;
dd) An MAA for a new drug
indicated for the prevention or treatment of a Group A infectious disease for
which an epidemic has been declared in accordance with the Law on disease prevention:
03 working days, for both the initial submission and any supplementary
submission;
e) An MAA for a drug
eligible for administrative-procedure priority as prescribed in Clause 5
Article 7 of the Pharmacy Law: 15 days, for both the initial submission and any
supplementary submission;
g) An MAA for a medicinal
material: 15 days, for both the initial submission and any supplementary
submission.
6. Actions following the
Council meeting:
a) Finalization of the
minutes of the Council meeting:
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- An MAA for a drug: 15
days, for both the initial submission and any supplementary submission.
- An MAA for a drug
validated by reference to available validation results: 15 days, for both the
initial submission and any supplementary submission.
- An MAA for a processed
drug or a drug manufactured using transferred technology, where the drug ordered
for processing or the drug prior to technology transfer has a valid marketing
authorization in Viet Nam at the time of MAA submission, or an MAA for a
processed drug involving the transfer of drug manufacturing technology from the
ordering establishment to the processing establishment, where the drug ordered
for processing has a valid marketing authorization in Viet Nam at the time of
MAA submission: 10 days, for the initial submission or a supplementary
submission.
- An MAA for a processed
drug or a drug manufactured using transferred technology, where the drug
ordered for processing or the drug prior to technology transfer does not have a
marketing authorization in Viet Nam or has an expired marketing authorization
at the time of MAA submission, or an MAA for a processed drug involving the
transfer of drug manufacturing technology from the ordering establishment to
the processing establishment, where the drug ordered for processing does not
have a marketing authorization in Viet Nam or has an expired marketing
authorization at the time of MAA submission: 15 days, for the initial
submission or a supplementary submission.
- An MAA for a new drug
indicated for the prevention or treatment of a Group A infectious disease for
which an epidemic has been declared in accordance with the Law on disease
prevention: 01 working day, for the initial submission or a supplementary
submission.
- An MAA for a drug
eligible for administrative-procedure priority as prescribed in Clause 5
Article 7 of the Pharmacy Law: 10 days, for the initial submission or a
supplementary submission.
- An MAA for a medicinal
material: 10 days, for the initial submission or a supplementary submission;
b) From the date of receipt
of the minutes of the Council meeting, the DAV shall grant marketing
authorization using Form 6A/TT in Appendix IX to this Circular where the MAA
meets the requirements; or issue a written notice to the applicant on the basis
of the Council’s conclusion where the MAA has not yet met, or fails to meet,
the requirements, within the following time limits:
- An MAA for a drug: 35
days, for the initial submission or a supplementary submission.
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- An MAA for a processed
drug or a drug manufactured using transferred technology, where the drug
ordered for processing or the drug prior to technology transfer has a valid
marketing authorization in Viet Nam at the time of MAA submission, or an MAA
for a processed drug involving the transfer of drug manufacturing technology
from the ordering establishment to the processing establishment, where the drug
ordered for processing has a valid marketing authorization in Viet Nam at the
time of MAA submission: 15 days, for the initial submission or a supplementary
submission.
- An MAA for a processed
drug or a drug manufactured using transferred technology, where the drug
ordered for processing or the drug prior to technology transfer does not have a
marketing authorization in Viet Nam or has an expired marketing authorization
at the time of MAA submission, or an MAA for a processed drug involving the
transfer of drug manufacturing technology from the ordering establishment to
the processing establishment, where the drug ordered for processing does not
have a marketing authorization in Viet Nam or has an expired marketing
authorization at the time of MAA submission: 35 days for the initial submission
and 20 days for a supplementary submission.
- An MAA for a new drug
indicated for the prevention or treatment of a Group A infectious disease for
which an epidemic has been declared in accordance with the Law on disease
prevention: 02 working days, for the initial submission or a supplementary
submission.
- An MAA for a drug
eligible for administrative-procedure priority as prescribed in Clause 5
Article 7 of the Pharmacy Law: 15 days, for the initial submission or a
supplementary submission.
- An MAA for a medicinal
material: 15 days, for the initial submission or a supplementary submission.
Article
46. Procedures for renewal of marketing authorizations for drugs/medicinal
materials
1. Method of submission of
an application for renewal of marketing authorization (“renewal application”):
The applicant shall submit
the renewal application in accordance with Article 15 of Decree No.
118/2025/ND-CP.
2. Receipt and time limits
for processing of the renewal application:
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Upon receipt of a complete
renewal application, the DAV shall give an application receipt to the applicant
as prescribed;
b) Time limits for
processing a renewal application from the date of its receipt: not exceeding 03
months.
3. Organization of
validation of the renewal application:
a) Within 03 working days
from the date of receipt of the renewal application as prescribed in Clause 2
of this Article, the DAV shall review and classify the application and refer it
to the validators or validating units;
b) Within 01 month from
the date of receipt of the renewal application from the DAV, the validators and
validating units shall conduct the validation, complete the validation record,
and submit it to the DAV.
4. Actions following
validation of the renewal application:
a) For a renewal
application prescribed in Point b Clause 1 Article 43 of this Circular:
Within 15 days from its
receipt of the validation record, the DAV shall, based on the consolidated
report on validation opinions of the validators or validating units and the
regulations in force, issue a written request to the applicant for additional
documents if the application has not yet met the requirements, or refer the
application to the Council if the validation result indicates that the
application meets the requirements, fails to meet the requirements, or requires
the Council’s opinion, together with the DAV’s proposal to renew, refuse to
renew, or seek the Council’s opinion on the renewal of, the marketing
authorization;
b) For a renewal
application prescribed in Point a Clause 2 Article 43 of this Circular, based
on the consolidated report on validation opinions of the validators or
validating units and the regulations in force, the DAV shall:
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- within 15 days, renew
the marketing authorization (using Form 6B/TT in Appendix IX to this Circular)
where the application meets the requirements.
5. Meeting of the Council:
Within 15 days from its
receipt of the documents from DAV, the Council’s Office shall convene a meeting
of the Council.
6. Actions following the
Council meeting:
a) Within 10 days from the
date of the Council meeting, the Council’s Office shall finalize the minutes of
the Council meeting and send them to the DAV;
b) Within 15 days from the
date of receipt of the minutes of the Council meeting, the DAV shall renew the
marketing authorization (using Form 6B/TT in Appendix IX to this Circular)
where the application meets the requirements; or issue a written notice to the
applicant on the basis of the Council’s conclusion where the application has
not yet met, or fails to meet, the requirements.
Article
47. Procedures for approval of variations to marketing authorizations for
drugs/medicinal materials
1. Method of submission of
an application for approval of variations to a marketing authorization
(“variation application”):
The applicant shall submit
the variation application in accordance with Article 15 of Decree No.
118/2025/ND-CP.
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a) Receipt of the
variation application:
Upon receipt of a complete
variation application, the DAV shall give an application receipt to the
applicant as prescribed;
b) Time limits for
processing a variation application from the date of its receipt:
- For a variation
application prescribed in Clause 3 Article 43 of this Circular: not exceeding
20 days.
- For a variation
application prescribed in Point c Clause 1 or Point b Clause 2 Article 43 of
this Circular: not exceeding 03 months.
3. Organization of
validation of the variation application:
a) Upon its receipt of the
variation application as prescribed in Clause 2 of this Article, the DAV shall
publish the application prescribed in Clause 3 Article 43 of this Circular within
20 days; or review, classify and refer the application prescribed in Point c
Clause 1 or Point b Clause 2 Article 43 of this Circular to the validators or
validating units within the following time limits:
- For a variation
application prescribed in Point c Clause 1 Article 43 of this Circular: 03
working days for the initial submission and 02 working days for a supplementary
submission.
- For a variation
application prescribed in Point b Clause 2 Article 43 of this Circular: 03
working days for both the initial submission and any supplementary submission;
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- For a variation
application prescribed in Point c Clause 1 Article 43 of this Circular: 01
month for the initial submission and 15 days for a supplementary submission.
- For a variation
application prescribed in Point b Clause 2 Article 43 of this Circular: 01
month for both the initial submission and any supplementary submission.
4. Actions following
validation of the variation application:
a) For a variation
application prescribed in Point c Clause 1 Article 43 of this Circular:
From the date of its
receipt of the validation record, the DAV shall, based on the consolidated
report on validation opinions of the validators or validating units and the
regulations in force, issue a written request to the applicant for additional documents
if the application has not yet met the requirements, or refer the application
to the Council if the validation result indicates that the application meets
the requirements, fails to meet the requirements, or requires the Council’s
opinion, together with the DAV’s proposal to approve, refuse to approve, or
seek the Council’s opinion on the approval of, variations to the marketing
authorization, within 15 days for the initial submission and 10 days for a
supplementary submission;
b) For a variation application
prescribed in Point b Clause 2 Article 43 of this Circular:
From the date of its
receipt of the validation record, the DAV shall, based on the consolidated
report on validation opinions of the validators or validating units and the
regulations in force, issue a written request to the applicant for additional
documents if the application has not yet met the requirements, or issue a
written approval of the variations to the marketing authorization where the
application meets the requirements, or issue a written notice of refusal to
approve the variations where the application fails to meet the requirements,
within 25 days for both the initial submission and any supplementary submission.
5. Meeting of the Council:
Within 15 days from its
receipt of the documents from DAV, the Council’s Office shall convene a meeting
of the Council.
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a) Within 10 days from the
date of the Council meeting, the Council’s Office shall finalize the minutes of
the Council meeting and send them to the DAV;
b) Within 15 days for the
initial submission, and 08 days for a supplementary submission, from the date
of its receipt of the minutes of the Council meeting, the DAV shall issue a
written approval of the variations to the marketing authorization where the
application meets the requirements; or issue a written notice to the applicant
on the basis of the Council’s conclusion where the application has not yet met,
or fails to meet, the requirements.
Chapter
V
DOCUMENTATION
REQUIREMENTS AND PROCEDURES FOR WITHDRAWAL AND REVOCATION OF MARKETING
AUTHORIZATIONS FOR DRUGS AND MEDICINAL MATERIALS
Article
48. Documentation requirements for withdrawal and revocation of marketing
authorizations for drugs/medicinal materials
1. Where the marketing authorization
for a drug is revoked as prescribed in Points a, b Clause 1 Article 58 of the
Pharmacy Law, the following documents are required:
A written drug recall
notice issued by a competent regulatory authority.
2. Where the marketing
authorization for a drug/medicinal material is revoked as prescribed in Points
d, dd Clause 1 Article 58 of the Pharmacy Law, the following documents shall be
required:
A written conclusion drawn
by a competent regulatory authority stating that the MAA on the basis of which
the marketing authorization was granted is forged, or that the drug/medicinal
material was manufactured at a location other than that specified in the MAA.
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A notice, issued by the
competent CPP-issuing authority, of the revocation of the CPP on which the
DAV’s grant of the marketing authorization for the drug/medicinal material in
Viet Nam was based.
4. Where the marketing
authorization for a drug/medicinal material is revoked as prescribed in Point e
Clause 1 Article 58 of the Pharmacy Law, the following documents shall be
required:
A notice, issued by WHO or
a competent regulatory authority of Viet Nam or of the country of origin of the
drug/medicinal material, of warning that the drug/medicinal material is
ineffective or unsafe for human use.
5. Where the marketing
authorization for a drug/medicinal material is withdrawn as prescribed in Point
g Clause 1 Article 58 of the Pharmacy Law, the following documents shall be
required:
A written request for
withdrawal of the marketing authorization for drug/medicinal material in Viet
Nam which is made by the manufacturer or applicant using Form 07/TT in Appendix
IX to this Circular.
Article
49. Procedures for revocation and withdrawal of marketing authorizations for
drugs/medicinal materials
1. Within a maximum
duration of 30 days from its receipt of the documents specified in Clause 1
Article 48 of this Circular, the DAV shall issue a decision to revoke the
marketing authorization for the drug.
2. Within a maximum
duration of 30 days from its receipt of the documents specified in Clause 2
Article 48 of this Circular, the DAV shall issue a decision to revoke the
marketing authorization for the drug/medicinal material.
3. Within a maximum
duration of 10 days from its receipt of the documents specified in Clauses 3
and 4 Article 48 of this Circular, the DAV shall issue a decision to revoke the
marketing authorization for the drug/medicinal material.
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Chapter
VI
REGULATIONS
ON ORGANIZATION AND OPERATION OF ADVISORY COUNCIL FOR GRANT OF MARKETING
AUTHORIZATIONS FOR DRUGS AND MEDICINAL MATERIALS, VALIDATING UNITS, AND
VALIDATORS
Article
50. Organization and operation of the Council
1. The Council for the
grant of marketing authorizations for drugs and medicinal materials shall be
established by the Minister of Health. The Council is composed of experts whose
qualifications and experience are appropriate to ensure their capacity to
assess applications, provide critical review of the opinions of validators and
the proposals of the DAV, and advise the Minister of Health on matters relating
to pharmacy legislation and the quality, safety and efficacy of drugs and medicinal
materials.
2. The Council shall
advise the Minister of Health and shall be accountable to the Minister of
Health and before the law for its validation opinions and advice on:
a) the grant and renewal
of marketing authorizations for drugs/medicinal materials, and approval of
variations to such marketing authorizations, based on the validation results of
validators, the proposals of the DAV, and relevant matters at the request of
the Minister of Health;
b) the grant of import
licenses for drugs that are not yet granted a marketing authorization in Viet
Nam, in respect of applications for import licenses received and processed by
the MOH, based on the validation results of validators, the proposals of the
DAV, and relevant matters at the request of the Minister of Health;
c) assessing the
conformity of the GMP principles and standards of an exporting country that are
different from the manufacturing principles and standards issued or recognized
by the Minister of Health as prescribed in Point c Clause 1 Article 97 of the
Government’s Decree No. 163/2025/ND-CP;
d) proposing guidelines
and policies relating to the grant of marketing authorizations for
drugs/medicinal materials and matters relating to ensuring the quality, safety
and efficacy of drugs.
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4. The management of
conflicts of interest of members of the Council is prescribed in Appendix VII
to this Circular.
5. Funding for covering
operating expenses of the Council shall comply with regulations of law.
6. The standing committee
of the Council shall be located on the same premises as DAV.
Article
51. Organization and operation of validating units and validators
1. The DAV and validating units
shall establish sub-committees of validators to validate relevant documents in
MAAs for drugs/medicinal materials relating to legal compliance, quality
specifications, pharmaceutical formulation, pharmacology, clinical data and
bioequivalence, and shall compile lists of validators who are members of such
sub-committees for the validation of applications for the grant and renewal of,
and approval of variations to, marketing authorizations for drugs/medicinal
materials. The composition of each sub-committee of validators shall be
appropriate to the classification of the product for which the application is
submitted and the type of application.
2. The responsibilities,
organization and operation of validating units and validators are prescribed in
Appendix VIII to this Circular.
3. The management of
conflicts of interest of validators is prescribed in Appendix VII to this
Circular.
4. Funding for covering
expenses associated with the validation of applications shall comply with
regulations of law.
Chapter
VII
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Article
52. Effect
1. This Circular comes
into force from October 01, 2026.
2. The following
regulations and Circulars shall cease to have effect from the effective date of
this Circular:
a) The Circular No.
12/2025/TT-BYT of the Minister of Health;
b) The first sub-point of
Point a Clause 1 Article 16 and the second sub-point of Point c Clause 3
Article 29 of the Circular No. 01/2018/TT-BYT;
c) Clause 8 Article 1 and
Clause 10 Article 1 of the Circular No. 23/2023/TT-BYT of the Minister of
Health.
3. For medicinal materials
that are excipients or capsule shells for which no marketing authorization has
been granted, intended for use in the manufacture of a drug under an MAA for
which the marketing authorization was granted before October 20, 2022 and which
have not yet been published on the DAV’s website, where an establishment wishes
to import such excipients or capsule shells into Viet Nam for the manufacture
of that drug:
The applicant shall update
all information concerning medicinal materials that are excipients and capsule
shells contained in its approved application on the DAV’s online public service
system. Within 05 working days from the date on which the information is
updated on the system, the DAV shall publish information on the sources of
medicinal materials that are excipients and capsule shells on its website. The
applicant shall be responsible for the accuracy of the updated information as
compared with the information in the approved application and shall not be required
to update the information again for each subsequent importation.
4. For a drug/medicinal
material for which a marketing authorization was granted before January 01,
2023, the label of the drug/medicinal material must bear the registration
number in the format specified in Appendix V to this Circular no later than 12
months after the date on which the marketing authorization is renewed. Within
12 months from the date on which the marketing authorization for a
drug/medicinal material is renewed, the registration number shall be indicated
in accordance with the following provisions:
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b) An imported
drug/medicinal material may continue to be imported and placed on the market
with its label bearing the registration number granted before the renewal of
the marketing authorization, provided that the shipment is delivered at the
port of departure in the exporting country before the date from which the
registration number is required to be indicated on the label under this Clause.
5. Drugs that were
classified as prescription drugs or OTC drugs before the effective date of this
Circular shall not be required to undergo reclassification during the validity
period of their marketing authorizations. A drug shall be reviewed for
classification as a prescription drug or OTC drug in accordance with this
Circular upon renewal of its marketing authorization. Where the applicant
proposes a change in the classification of a drug as a prescription drug or OTC
drug, the applicant shall comply with Appendix II to this Circular.
6. For an MAA submitted to
the DAV before the effective date of this Circular, where the marketing
authorization for the drug covered by the MAA has not yet been granted or
renewed, the classification of the drug as an OTC drug shall be reviewed in
accordance with this Circular.
Article
53. Transition
1. MAAs for
drugs/medicinal materials submitted before the effective date of this Circular
shall continue to be processed in accordance with the regulations in force at
the time of the MAA submission, or may, from the effective date of this
Circular, be processed in accordance with this Circular where this facilitates
and simplifies administrative procedures for enterprises, organizations and
individuals.
2. A drug that has been
classified as an original brand-name drug, a reference biological, a drug with
demonstrated bioequivalence, or a drug for which all manufacturing stages are
carried out in Viet Nam on a manufacturing line complying with EU-GMP
principles and standards or equivalent standards and has been granted a
marketing authorization by the drug regulatory authority of a country on the
SRA list or by the EMA before the effective date of this Circular shall retain
its classification for the validity period of its marketing authorization,
unless the DAV, at the request of the applicant, reviews and updates or makes
variations to the information published on the DAV’s website.
Article
54. Terms of reference
Where any legislative
documents or regulations referred to in this Circular are amended or replaced, the
new ones shall apply.
Article
55. Implementation organization
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a) Provide guidelines for
and organize the implementation of this Circular;
b) Publish the following
on the DAV’s website:
- The list of drugs and
medicinal materials for which marketing authorizations have been granted or
renewed (including information on the drug prior to technology transfer, for
drugs manufactured using transferred technology in Viet Nam, and on the drug
ordered for processing, for processed drugs manufactured in Viet Nam), within
05 working days from the date of grant or renewal of the marketing
authorization, together with information on whether the drug is classified as a
prescription drug or OTC drug and other information relating to the marketing
authorization of drugs and medicinal materials.
- The list of drugs with
demonstrated bioequivalence and drugs classified as original brand-name drugs
or reference biologicals within 05 working days from the date on which the
marketing authorization for the drug is granted, and information on variations
to such drugs within 07 working days from the date on which an approval of the
variations to the marketing authorization for the drug is granted.
- The lists of processed
drugs and drugs manufactured using transferred technology which are made using
Form 8A/TT, Form 8B/TT and Form 8C/TT in Appendix IX to this Circular, within
07 working days from the date on which the marketing authorization for the drug
is granted.
- Drugs for which all
manufacturing stages are carried out in Viet Nam at a manufacturing line that
complies with EU-GMP principles and standards or equivalent standards, and
which have been granted a marketing authorization by the drug regulatory
authority of a country on the SRA list or by the EMA, within 07 working days
from the date of approval of the variation to the marketing authorization;
c) Remove from the lists
any drug classified as an original brand-name drug, a reference biological, or
a drug with demonstrated bioequivalence that no longer meets the classification
criteria prescribed in this Circular, based on the advisory opinion of the
Council; remove any published drug for which all manufacturing stages are
carried out in Viet Nam at a manufacturing line that complies with EU-GMP
principles and standards or equivalent standards and which has been granted a
marketing authorization by the drug regulatory authority of a country on the
SRA list or by the EMA, where such drug no longer meets the requirements set
out in this Circular;
d) Remove drugs from the
lists of processed drugs and drugs manufactured using transferred technology
published as prescribed in the third sub-point of Point b of this Clause, based
on the advisory opinion of the Council, when such drugs no longer meet the
requirements prescribed in Clause 1 Article 9 of this Circular;
dd) Formulate, promulgate,
and organize the implementation of standard operating procedures (SOPs) in the
registration of drugs; guidelines on the application for marketing
authorization of drugs and medicinal materials; and guidelines on the
validation of MAAs for drugs and medicinal materials;
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g) Where necessary, the
DAV shall hold meetings with applicants, manufacturers, and validators to
clarify the issues that arise during the validation of MAAs for drugs and
medicinal materials;
h) Formulate regulations
on use of barcodes, QR codes, DataMatrix codes, or other forms of printed
codes, as prescribed by relevant laws, to the outer packaging of drugs and
medicinal materials manufactured by manufacturers, for the management,
identification, and traceability of drugs and medicinal materials placed on the
market, and formulate a roadmap for implementation in accordance with
regulations of the Minister of Health;
i) Within 15 days from the
date of grant or renewal of a marketing authorization, or 07 working days from
the date of approval of variations to a marketing authorization, the DAV shall
share quality specifications for drugs with the testing system; share
information on risk management plans with the National DI & ADR Centre in
respect of MAAs for new chemical drugs, vaccines, and biologicals (except
probiotic biological products); publish information on medicinal materials for
domestically manufactured drugs; and publish the list of drugs classified as original
brand-name drugs, reference biologicals, or drugs with demonstrated
bioequivalence;
k) Within 03 working days
from the date of receipt of an application for renewal of the marketing
authorization of a drug or medicinal material, the DAV shall publish on the
MOH’s web portal and the DAV’s website information on the drug or medicinal
material for which an application for renewal has been received in accordance
with regulations and whose marketing authorization may continue to be used in
accordance with Point c Clause 8 Article 56 of the Pharmacy Law;
l) For drugs and medicinal
materials already published on the DAV’s website as prescribed in Point k of
this Clause, within 03 working days from the date on which the DAV issues a
written notice of refusal to renew, or a written notice of suspension of the
use of, the marketing authorization on the grounds that the drug or medicinal
material poses a potential safety risk to users or is suspected of involving
forged legal documents, or a written notice of the validation result of the
renewal application indicating that the time limit for submission of
supplementary documents prescribed in Clause 1 Article 44 of this Circular has
expired, the DAV shall publish on the MOH’s web portal and the DAV’s website the
drugs and medicinal materials that no longer meet the requirements for
continued use of the marketing authorization;
m) Publish on the DAV’s
website the technical documents prescribed in Appendix I to this Circular;
n) Remove medicinal
materials already published on the MOH’s web portal and the DAV’s website upon
receipt of written notice from a competent authority that such medicinal
materials are no longer permitted for use;
o) Publish on the MOH’s
web portal and the DAV’s website information on a subsequent MAA that relies on
the fact that a drug has already been granted a marketing authorization, or on
data demonstrating the safety and efficacy of a drug that has already been
granted a marketing authorization, to obtain a marketing authorization for another
drug, in accordance with Clause 3 Article 128 of the Law on Intellectual
Property;
p) Within 01 month from
the date on which the DAV issues a written notice to the applicant of its
refusal to grant or renew, or approve variations to, the marketing authorization
of a drug/medicinal material, where a written request from the applicant for
reconsideration of the application processing result is received, the DAV shall
review the case and report it to the Council or refer the applicant’s request
to validators for consideration. Procedures for handling the case:
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- Where the Council or the
validators do not accept the applicant’s explanation, the DAV shall issue a
written notice of refusal to grant or renew the marketing authorization, or
approve the variations to the marketing authorization;
q) Issue a written request
for a Phase IV clinical trial of a drug in accordance with Clause 2 Article 87
of the Pharmacy Law, on the basis of the advisory opinion of the Council.
2. Manufacturers of
drugs/medicinal materials shall comply with the labeling requirements set out
in Circular No. 01/2018/TT-BYT and the following requirements when stating the
expiry date of their drugs/medicinal materials on the labels:
The expiry date of a
drug/medicinal material stated on the label must not be later than the end of
its shelf life as approved in the MAA, and must not be more than 31 days
earlier than that shelf life.
Article
56. Responsibility for implementation
The Chief of the
Ministry’s Office, the Director of the Drug Administration of Vietnam, heads of
departments and affiliates of the Ministry of Health, Directors of
Provincial-level Departments of Health, and relevant authorities, organizations
and individuals are responsible for the implementation of this Circular.
Difficulties that arise
during the implementation of this Circular should be promptly reported to the
Ministry of Health (via the Drug Administration of Vietnam) for consideration./.
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APPENDIX II
MAJOR VARIATIONS AND MINOR VARIATIONS TO DRUGS AND
MEDICINAL MATERIALS GRANTED MARKETING AUTHORIZATION
(Enclosed with the Circular No. 32/2026/TT-BYT dated July 29, 2026 of
the Ministry of Health of Viet Nam)
A. GENERAL
GUIDELINES
1.
Definitions used in this Appendix:
1.1.
Lead compendia include the Vietnamese Pharmacopoeia, British Pharmacopeia (BP),
United States Pharmacopeia (USP), European Pharmacopeia (EP), International
Pharmacopeia (IP), and Japanese Pharmacopeia (JP).
1.2.
Specifications (of drug substances, excipients, or drug products) refer to
quality test parameters and corresponding acceptance limits, together with the
analytical procedures used to test each parameter.
1.3.
Bulk product means a drug product that has undergone all manufacturing stages
up to, but not including, packaging in the primary container.
1.4.
Stability study data, analytical procedure validation, manufacturing process
validation, and bioavailability/bioequivalence study data, etc., shall be
generated in accordance with the applicable ASEAN technical guidelines issued
together with the Circular prescribing marketing authorization for drugs.
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2.
Abbreviations:
MaV
=
Major Variation
MiV-N
=
Minor Variation (Notification only)
MiV-PA
=
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SUPAC
=
Guidance of US FDA (the United States Food
and Drug Administration) on Scale-up and Post-approval Changes
TSE
=
Transmissible Spongiform Encephalopathy
BSE
=
Bovine
Spongiform Encephalopathy
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-
No application for approval of such variations is required to be submitted to
the Drug Administration of Viet Nam (DAV).
-
For variations addressed in MiV-N6 and MiV-N9: the applicant shall update and
retain the relevant documentation at its premises as prescribed. Where the
applicant voluntarily submits an application for such variations, the applicant
may submit the documents specified in the corresponding MiV-N6 or MiV-N9, or
relevant documents in accordance with the guidelines of the EMA, U.S. FDA, or
WHO;
-
For variations that are not specifically classified in this Appendix, where the
applicant voluntarily submits an application for registration of variations,
variations relating to technical documents shall be approved prior to
implementation, while administrative variations shall be subject to
notification. The application shall comprise an application form and
relevant supporting documents.
4.
All documents required to be submitted under this Guideline shall be submitted
together with the application form prescribed in the Circular prescribing
marketing authorization for drugs, accompanied by a comparative table
summarizing the proposed variations (setting out the approved content and the
proposed content), with the content proposed for publication on the website of
the DAV separately identified.
5.
A single variation application package, comprising a single application form
which is made using the form provided in this Circular, may be submitted for
multiple drugs of the same applicant and the same drug product manufacturer,
where the drugs are subject to the same administrative variations as follows,
provided that the approved information, proposed variations and supporting
documents are identical for all such drugs, except product-specific
information: change of the name and/or address of the applicant, ordering
establishment, or transferor establishment; change of the name and/or address
of the drug product manufacturer; change of the name and/or address of the drug
substance manufacturer; change of the name and/or the manner of stating the
address of the excipient/capsule shell manufacturer (provided that the
manufacturing site remains unchanged); or change to the package insert where
multiple strengths of the drug share the same package insert.
6.
Multiple variations relating to the same drug may be combined in a single
variation application package, comprising the complete set of documents
relevant to each variation as prescribed.
Where
an application submitted by the applicant includes both variations requiring
prior approval and minor variations requiring notification only, the
application shall be processed in accordance with the procedure applicable to
variations requiring prior approval.
7.
In addition to the documents required to be submitted under this Guideline, the
DAV may request additional information where deemed necessary.
B. LIST OF VARIATIONS
DURING MARKETING
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MaV-1
Change and/or addition of
indication(s)/dosage regimen/ patient population or addition of clinical
information to extend the scope of use of the drug, or addition of a route of
administration without a change in the dosage form
Conditions to be fulfilled (C)
1. As a subsequent change due to a revision
to the Summary of Product Characteristics (SmPC) or an equivalent document
(e.g. USPI), leading to a change to the package insert and/or label sample.
2. For generic drugs whose package insert is
updated in line with that of the original brand-name drug in Viet Nam, refer
to MiV-PA2.
3. For drugs whose package insert is updated
in line with a package insert approved by an SRA for a drug for which no
original brand-name drug is available in Viet Nam, refer to MaV-2.
Documents to be submitted (D)
1. The proposed package insert and/or label
sample. A comparative table summarizing the approved and proposed content of
the package insert and/or label sample.
2. The Package Insert (PI), Summary of
Product Characteristics (SmPC), or Patient Information Leaflet (PIL), approved
by the authority issuing the marketing authorization in the country of origin
or a reference country, containing the proposed change and/or addition (where
applicable).
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4. The written approval issued by the regulatory
authority of the reference country or the country of manufacture approving
the change and/or addition to the indication(s) or dosage regimen (where
applicable).
5. Clinical expert reports and/or clinical
study reports (where applicable).
6. Clinical documents as per Part IV of the
ASEAN Common Technical Dossier (ACTD) (where applicable).
MaV-2
Change to the content of the package
insert and/or label
Conditions to be fulfilled (C)
1. The change is not a minor variation and
does not fall within the scope of MaV-1.
2. The change results from a revision to the
Summary of Product Characteristics (SmPC) or an equivalent document (e.g.
USPI).
Documents to be submitted (D)
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2. The Package Insert (PI), Summary of
Product Characteristics (SmPC), or Patient Information Leaflet (PIL),
approved by the authority issuing the marketing authorization in the country
of origin or a reference country, containing the proposed change and/or
addition (where applicable).
3. Justification for the proposed change,
together with supporting clinical documentation (where applicable).
MaV-3
Addition or replacement of an
alternative drug substance manufacturer/manufacturing site (where no European
Pharmacopoeial Certificate of Suitability (CEP) is available)
Conditions to be fulfilled (C)
1. The specifications of the drug substance remain
unchanged.
2. For a change and/or addition of an
alternative drug substance manufacturer/manufacturing site where a European
Pharmacopoeia Certificate of Suitability (CEP) is available, refer to
MiV-PA4.
3. Where the specifications of the drug
substance are changed, the requirements under MaV-6, MiV-PA8, or MiV-N9, as
applicable, shall also apply.
Documents to be submitted (D)
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a) Complete ACTD Sections S1-S7;
b) The complete drug substance master file,
comprising both the open and closed parts (the closed part, together with the
letter of access, shall be provided directly by the drug substance
manufacturer to the DAV);
c) A certificate or equivalent inspection/audit
document issued by one of the reference countries specified in the Circular
prescribing marketing authorization for drugs.
2. A comparative table of the differences
between the drug substance manufacturing information at the proposed
manufacturing site and that at the approved manufacturing site, where
applicable.
3. Certificates of analysis and/or batch
analysis data (in a comparative tabulated format) for at least two pilot
batches of the drug substance manufactured at the proposed and approved manufacturing
sites (*).
4. A letter of commitment from the drug
product manufacturer or the applicant to conduct long-term and accelerated
stability studies of the drug product manufactured using the drug substance
from the proposed manufacturing site, and to report any results that do not
comply with the approved shelf-life specifications, together with proposed
appropriate actions.
5. Comparative dissolution profile data for
the drug product manufactured using the drug substance from the approved and
proposed manufacturing sites, where the drug has demonstrated bioequivalence.
6. Legal documents of the drug substance
manufacturer demonstrating compliance with GMP guidelines for the manufacture
of medicinal materials, as prescribed in Clause 7 Article 22 of this
Circular.
Where the drug substance already been granted
a marketing authorization in Viet Nam, the documents specified in Clauses 1
and 6 of this Section are not required.
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MaV-4
Addition or replacement of the
manufacturing site for the drug product
Conditions to be fulfilled (C)
1. Not applicable to changes relating to
manufacturer responsible for batch release or a site where only batch release
takes place.
2. For the addition or replacement of a
manufacturer/site responsible for batch release, refer to MiV-PA3.
3. Where there are changes to the
manufacturing process, the requirements under MaV-9, MiV-PA20, or MiV-N11, as
applicable, shall also apply.
Documents to be submitted (D)
1. Revised draft(s) of the label and/or
package insert incorporating the proposed variation (where applicable).
2. Proof that the proposed site is
appropriately authorized for the relevant dosage form, such as a valid GMP
certificate and/or a CPP which covers GMP certification.
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4. For a contract manufacturer, a letter of appointment
and a letter of acceptance for the proposed site to manufacture the drug
product, stating the manufacturing activities to be performed at the proposed
site (where applicable).
5. Specifications of the drug substance.
6. Product formula and/or batch manufacturing
formula.
7. For oral solid dosage forms, comparative
dissolution profile data for at least one (01) pilot/production batch of the
drug product manufactured at the approved site and the proposed site, in
accordance with the US-FDA SUPAC-IR or SUPAC-MR Guidelines.
8. Validation scheme and/or report for the
manufacturing process of the drug product at the proposed site.
9. Holding time studies testing of the bulk
product during storage and transportation between the bulk production site
and the primary packaging site (where applicable).
10. Release and shelf-life specifications of
the drug product.
11. Certificates of Analysis (CoA) and/or
batch analysis data (in a comparative tabulated format) of the drug product
for at least 02 production batches (or 01 production batch and 02 pilot
batches) from the proposed site and the last 03 production batches from the
approved site.
Batch analysis data for the next 02 full
production batches should be available upon request. If any result obtained
during batch analysis does not comply with the specifications, a report shall
be submitted together with proposed appropriate actions.
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13. Justification for not submitting a
bioequivalence study, in accordance with the ASEAN guideline on the conduct
of bioavailability and bioequivalence studies (where applicable).
MaV-5
Addition or replacement of alternative
packager/site for primary packaging (direct contact with drug product) for
sterile product
Conditions to be fulfilled (C)
1. No other changes except for the addition
and/or replacement of the alternative packager/site for primary packaging.
2. For the addition and/or replacement of an
alternative packager/site for primary packaging for non-sterile drug
products, refer to MiV-PA35.
Documents to be submitted (D)
1. Revised draft(s) of the label and/or
package insert incorporating the proposed variation (where applicable).
2. Proof that the proposed packager/site is
appropriately authorized for the primary packaging activity of the relevant
dosage form, such as a valid GMP Certificate and/or a CPP certifying GMP
compliance.
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4. Validation scheme and/or report on primary
packaging processes performed by the proposed packager/at the proposed site.
5. Holding time studies of the bulk product
during storage and transportation between the bulk production site and the
proposed primary packager/site (where applicable).
6. Stability data of the drug product
following the change, and a report of any results falling outside shelf-life
specifications, together with the proposed action.
MaV-6
Change of the specifications of the
drug substance [where European Pharmacopoeial Certificate of Suitability
(CEP) is not available] and/or drug product in the following cases:
a) Specification limits are widened;
b) Deletion of test parameter and
limits.
Conditions to be fulfilled (C)
1. Analytical procedures remain unchanged, or
changes in the analytical procedures are minor.
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3. The change should not be the result of
unexpected events arising during manufacture or related to stability
concerns, unless otherwise justified.
4. For changes to the specification of the
drug substance that may necessitate a review of the CEP, refer to MiV-PA12.
Documents to be submitted (D)
(a) Specification limits are widened
1. Revised specifications of the drug
substance/ drug product.
2. Comparative tabulated format of the
approved and proposed specifications of the drug substance/drug product, with
the changes highlighted.
3. Certificate(s) of analysis and/or batch
analysis data (in a comparative tabulated format) of the drug substance/drug
product for all tests in the proposed specifications for 02 pilot or
production-scale batches.
4. Justification for the proposed change,
substantiated with scientific data.
5. For a change to the specifications of the
drug substance involving stability-indicating parameters: stability data of
the drug substance and a report if any results fall outside the
re-test/shelf-life specifications, with proposed action.
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(b) Deletion of test parameters and limits:
Documents referred in D1-D4 shall be provided.
MaV-7
Change and/or addition of batch size
for sterile drug products
Conditions to be fulfilled (C)
1. The change does not affect consistency of
production.
2. The product formulation remains unchanged.
3. Release and shelf-life specifications of
drug product remain unchanged.
4. Process validation scheme and/or report is
available or validation of the manufacturing process has been successfully
carried out according to protocol with at least 03 batches appropriate to the
proposed batch size in accordance with the ASEAN Guideline on Submission of
Manufacturing Process Validation Data For Drug Registration.
Documents to be submitted (D)
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2. Validation scheme and/or report of the
manufacturing process as per ASEAN Guideline on Submission of Manufacturing
Process Validation Data for Drug Registration of the proposed batch size
should be provided upon submission.
3. Approved release and shelf-life
specifications of the drug product.
4. Batch analysis data (in a comparative
tabulated format) and/or Certificate of analysis (CoA) of drug product of at
least 02 production batches manufactured according to approved and proposed
batch sizes.
5. Stability data of the drug product
following the change, and a report if any result falls outside the shelf-life
specifications, with proposed action.
MaV-8
Addition or change of batch size of
non-sterile drug product
Conditions to be fulfilled (C)
1. The change does not affect consistency of
production.
2. The product formulation remains unchanged.
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4. Process validation scheme and/or report is
available or validation of the manufacturing process has been successfully
carried out according to protocol with at least 03 batches appropriate to the
proposed batch size in accordance with the ASEAN Guideline on Submission of
Manufacturing Process Validation Data For Drug Registration.
5. This is applicable to change of batch size
more than 10-fold compared to the approved batch size. For change of batch
size up to 10-fold compared to the approved batch size, refer MiV-PA13.
Documents to be submitted (D)
1. For oral solid dosage forms: Comparative
dissolution profile data of at least 01 pilot/production batch of the drug
product manufactured in the approved and proposed batch size as per US FDA
SUPAC IR or MR Guidelines (where applicable).
2. Comparative tabulated format of approved
and proposed batch manufacturing formula.
3. Validation scheme and/or report of the
manufacturing process as per ASEAN Guideline on Submission of Manufacturing
Process Validation Data for Drug Registration of the proposed batch size
should be provided upon submission.
4. Release and shelf-life specifications of
the drug product.
5. Certificate of analysis and/or batch
analysis data (in a comparative tabulated format) of drug product on a
minimum of 01 production batch manufactured according to approved and
proposed batch sizes, and letters of undertaking of the drug product
manufacturer and the applicant to submit batch analysis data on the next one
full production batch.
6. Stability data of the drug product
following the change, and a report of any results falling outside shelf-life
specifications, together with the proposed action.
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Major change in the manufacturing
process for drug product
Conditions to be fulfilled (C)
1. The change does not cause a negative
impact on the quality, safety and efficacy of the drug product.
2. The manufacturing site remains unchanged.
If there is a change in manufacturing site, MaV-4 is also applicable.
3. For minor change of the manufacturing
process for non-sterile product, refer to MiV-PA20 or MiV-N11.
Documents to be submitted (D)
1. Description of the proposed manufacturing
process and technical justification for the change.
2. For oral solid dosage forms: Comparative
dissolution profile data of at least 01 pilot/production batch of the drug
product manufactured in the approved and proposed manufacturing process as
per US FDA SUPAC IR or MR Guidelines.
3. Validation scheme and/or report of the
proposed manufacturing process as per ASEAN Guideline on Submission of
Manufacturing Process Validation Data for Drug Registration should be
provided upon submission.
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5. Certificate of analysis and/or batch
analysis data (in a comparative tabulated format) of drug product for a
minimum of 01 production batch manufactured according to approved and
proposed processes.
6. Stability data of the drug product
manufactured according to the proposed process and report if any results fall
outside shelf-life specifications (with proposed action).
7. Justification for not submitting a new
bioequivalence study of the drug product manufactured according to the
proposed manufacturing process (for a drug granted marketing authorization
and having demonstrated bioequivalence).
MaV-10
Qualitative or quantitative change of
excipient
a) For immediate release oral dosage
forms (as per Level 2 and 3, Part III (Components and Composition)- SUPAC
guideline);
b) For modified release oral dosage
forms;
c) For other critical dosage forms
such as sterile preparations.
Conditions to be fulfilled (C)
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2. Replacement of an excipient with a
comparable excipient of the same functional characteristics.
3. The dissolution profile of the proposed
product is comparable to that of the approved product.
4. Process validation scheme and/or report is
available or validation of the manufacturing process has been successfully
carried out according to protocol with at least 03 batches of the proposed
product formula in accordance with the ASEAN Guideline on Submission of
Manufacturing Process Validation Data For Drug Registration.
5. For other qualitative or quantitative
changes of excipient for immediate release oral dosage forms and other
non-critical dosage forms, refer to MiV-PA15.
Documents to be submitted (D)
1. Revised draft(s) of the label and/or
package insert incorporating the proposed variation (where applicable).
2. A declaration that the proposed
qualitative or quantitative change of the excipient does not interfere with
analytical procedures in the approved drug product release and shelf-life
specifications (where applicable).
3. Justification for the change which must be
given by appropriate development of pharmaceutics.
4. Comparative tabulated format of the
approved and proposed product formulation with calculated changes highlighted
(state changes in the percentage of the proposed excipient out of the total
target dosage form weight (where applicable).
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6. Revised batch manufacturing formula.
7. Validation scheme and/or report of the
manufacturing process as per ASEAN Guideline on Submission of Manufacturing
Process Validation Data for Drug Registration appropriate to the proposed
change in product formula should be provided upon submission.
8. ACTD Section P3.1 to P3.4 which have been
revised appropriately to the proposed product formulation (where applicable).
9. Specifications of the proposed excipient.
10. For proposed excipients made of ruminants
source, TSE-free certificate or BSE-free certificate issued from relevant
authority of the issuing country and/or documentary evidence from the
supplier (where applicable).
11. Revised release and shelf-life
specifications of the drug product.
12. Certificate of analysis and/or batch
analysis data (in a comparative tabulated format) of drug product on at least
02 production (or 01 production batch and 02 pilot batches) according to
approved and proposed product formula.
13. Stability data of the drug product
following the change and report if any results fall outside shelf-life
specifications (with proposed action).
14. Justification for not submitting a new
bioequivalence study of the drug product manufactured according to the
proposed formulation (for a drug granted marketing authorization and having
demonstrated bioequivalence).
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16. Legal documents of the manufacturer of
the proposed excipient as prescribed in Clause 7 Article 22 of this Circular.
If the excipient has been granted a marketing authorization in Viet Nam,
these documents shall not be required.
MaV-11
Quantitative change in coating of
tablets or weight and/or size of capsule shell for modified release oral
dosage form
Conditions to be fulfilled (C)
1. The dissolution profile of the proposed product
is comparable to that of the approved product.
2. The test parameters and limits in approved
release and shelf-life specifications of the drug product remain unchanged,
except for update of product description with respect to the weight and/or
size (where applicable).
3. For quantitative change in coating of
tablets or weight and/or size of capsule shell for immediate release oral
solid dosage forms, refer to MiV-PA16.
Documents to be submitted (D)
1. Revised draft(s) of the label and/or
package insert incorporating the proposed variation (where applicable).
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3. For oral solid dosage forms: Comparative
dissolution profile data of at least 01 pilot/production batch of the drug
product manufactured in the approved and proposed composition as per US FDA
SUPAC IR or MR Guidelines (where applicable).
4. Approved and proposed 01-dose and batch
manufacturing formula.
5. Revised release and shelf-life
specifications of the drug product.
6. Stability data of the drug product
following the change, and a report of any results falling outside shelf-life
specifications, together with the proposed action.
7. Justification for not submitting a new
bioequivalence study of the drug product manufactured according to the
proposed composition (for a drug granted marketing authorization and having
demonstrated bioequivalence).
MaV-12
Change in primary packaging material
for sterile product in the following cases:
a) Qualitative and quantitative
composition and/or
b) Type of container and/or
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Conditions to be fulfilled (C)
1. Release and shelf-life specifications of
drug product remain unchanged.
2. For change in the primary packaging
material for non-sterile drug product, refer to MiV-PA28.
Documents to be submitted (D)
1. Revised draft(s) of the label and/or
package insert incorporating the proposed variation (where applicable).
2. Scientific data proving the appropriacy of
the proposed primary packaging material (comparative data on permeability of
the approved and proposed primary packaging material, e.g. moisture, O2,
CO2).
3. Proof that no interaction between the content
and the primary packaging material occurs (where applicable).
4. Validation scheme and/or report of the
manufacturing and sterilization process appropriate to the proposed change in
primary packaging material should be provided upon submission.
5. Comparative tabulated format of
specifications of the approved and proposed primary packaging material.
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7. Stability data of the drug product in the
proposed primary packaging material and report if any results fall outside
shelf-life specifications (with proposed action).
MaV-13
Change or addition of pack size/fill
volume and/or change of shape or dimension of container or closure for
sterile solid and liquid drug product.
Conditions to be fulfilled (C)
1. The proposed pack size is consistent with
the dosage regimen and duration of use as approved in the package insert.
2. The packaging material remains unchanged.
3. Approved release and shelf-life specifications
of drug product are not affected, except pack size/fill volume
specifications.
4. For change or addition of pack size/fill
volume and/or change of shape or dimension of container or closure for
non-sterile drug product, refer to MiV-PA30.
Documents to be submitted (D)
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2. Justification that the proposed pack size
is consistent with the dosage regimen and duration of use as approved in the
package insert.
3. Validation data of the manufacturing
process, sterilization and container closure system (where applicable).
4. Stability data of the drug product in the
proposed pack size and report if any results fall outside shelf-life specifications
(with proposed action).
MaV-14
Inclusion or replacement of the
solvent/diluent for the drug product
Conditions to be fulfilled (C)
1. The proposed change does not result in any
change in the dosage form, regimen, indication, method of administration of
the product.
2. For deletion of the solvent/diluent, refer
to MiV-PA18.
3. For change of shelf-life and/or storage
conditions of the drug product after first opening and/or after
dilution/reconstitution, additional documents shall be also submitted
according to MaV-15/MiV-PA33 and/or MaV-16/MiV-PA34.
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1. Revised draft(s) of the label and/or
package insert incorporating the proposed variation.
2. Documentary evidence to certify that the
proposed manufacturer/manufacturing site of solvents/diluents complies with
GMP standards currently applied to this dosage form (where applicable).
3. Batch numbering system (where applicable).
4. A declaration from the applicant or the
drug product manufacturer that the release and shelf-life specifications of
drug product are not affected.
5. In addition to the complete ACTD section P
for the proposed solvent/diluent and reconstitution stability data, ACTD
section S is also required (where applicable).
MaV-15
Extension of shelf-life of the drug
product:
a) As a package in approved pack size
and/or
b) After first opening and/or
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Conditions to be fulfilled (C)
1. For (a) & (b) - The studies must show
conformance to the approved shelf-life specification for the drug product.
2. For (c) - The studies must show
conformance to the approved shelf-life specification for the reconstituted
product.
3. For reduction of shelf-life, refer to
MiV-PA33.
Documents to be submitted (D)
1. Revised draft(s) of the label and/or
package insert incorporating the proposed variation (where applicable).
2. Technical justification for the proposed
change (where applicable).
3. A letter of commitment from the applicant
or the drug product manufacturer to inform users of the relevant change
(where applicable).
4. Results of long-term stability studies of
the drug product in accordance with the ASEAN Guidelines on Stability Study
of Drug Product, accompanied with results of appropriate microbiological testing
(where appropriate), in the following cases:
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b) After first opening and/or
c) After dilution/reconstitution.
MaV-16
Change of storage conditions of the
drug product (lowering from the approved storage condition)
a) As a package in approved pack size
and/or
b) After first opening and/or
c) After dilution/reconstitution
Conditions to be fulfilled (C)
1. For (a) & (b) - The studies must show
conformance to the approved shelf-life specification for the drug product.
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3. For change of storage condition
(increasing from the approved storage condition), refer to MiV-PA34.
Documents to be submitted (D)
1. Revised draft(s) of the label and/or
package insert incorporating the proposed variation (where applicable).
2. Technical justification for the proposed
change.
3. Results of appropriate long-term stability
studies of the drug product in accordance with the ASEAN Guidelines on
Stability Study of Drug Product, accompanied with results of appropriate
microbiological testing (where appropriate), in the following cases:
a) As a package in approved pack size and/or
b) After first opening and/or
c) After dilution/reconstitution.
MaV-17
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Conditions to be fulfilled (C)
1. The synthetic route is different with
potential change in qualitative and/or quantitative impurity profile which
would require further qualifications in safety studies. Where the synthetic
route remains unchanged, refer to MiV-PA7.
2. Manufacturing process of drug substance
does not use any materials of human/animal origin for which assessment is
required of viral safety, unless otherwise justified.
3. Physicochemical characteristics and other
relevant properties of drug substance remain unchanged.
4. Stability performance of drug substance
remains unchanged.
5. If there are changes to the specification
of drug substance, MiV-PA8 is also applicable.
Documents to be submitted (D)
1. One of the following documents may be
submitted:
a) Complete revised relevant ACTD sections S1-S7;
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c) A certificate or equivalent inspection/audit
document issued by one of the reference countries specified in the Circular
prescribing marketing authorization for drugs.
2. Comparative tabulated format of the
approved and proposed processes with changes highlighted (where applicable).
3. For sterile drug substance, report on
validation of the proposed manufacturing process (where applicable).
4. A letter of declaration from the applicant
or the drug product manufacturer or the drug substance manufacturer stating
that no new impurities have been introduced at or above the accepted
threshold for qualification of impurities or that there is no increase in the
levels of impurities, which require further safety studies.
5. A letter of declaration from the applicant
or the drug product manufacturer or the drug substance manufacturer stating
that the approved specifications of the drug substance have not changed
(where applicable).
6. Certificate of analysis and/or batch
analysis data (in a comparative tabulated format) for at least two batches of
the drug substance from the approved and proposed process.
7. A declaration from the drug product
manufacturer or the applicant that the relevant stability studies of the drug
product manufactured with the drug substance from the proposed process (in accordance
with the ASEAN Guideline On Stability Study Of Drug Product) have been
started and will be finalized, and report if any results fall outside
shelf-life specifications (with proposed actions).
8. Certificate of analysis and/or batch
analysis data (in a comparative tabulated format) of drug product of at least
two batches (pilot or production scale) manufactured with the drug substance
according to the approved and proposed processes.
MaV-18
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Conditions to be fulfilled (C)
The drug has been marketed in Viet Nam for a
minimum of 03 years (where there is no drug with the same active
ingredient(s), medicinal herb(s), strength, concentration, and dosage form as
the drug that has been granted marketing authorization and marketed in a
country whose drug regulatory authority is one of those specified in Clause 9
Article 2 of this Circular)
Documents to be submitted (D)
1. Revised drafts of the label and package
insert (after reclassification) and comparative tabulated format of the
approved and proposed package inserts.
2. Package Insert (PI)/Summary of Product
Characteristics (SmPC)/Patient Information Leaflet (PIL) of the drug
classified as OCT drug and approved by the authority issuing marketing
authorization of the country prescribed in clause 9 Article 2 of this
Circular.
3. In case the documents in Clause 2 of this
Section are not available, the following clinical safety summaries as per
ACTD part IV or Module 5 ICH-CTD shall be submitted:
- Patient use of drug: quantity of drug,
number of patients, etc.;
- Summary safety profile of the drug which is
made on the basis of reports on adverse drug reactions occurred in the world
and in Viet Nam, and from post-marketing safety monitoring;
- List of issues concerning safety of the
drug if used without supervision of healthcare professionals;
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II. MINOR VARIATIONS REQUIRING PRIOR APPROVAL
MiV-PA1
Change of drug product name
Conditions to be fulfilled (C)
1. There is no change to the product (formulation,
quality specifications, source of materials, and manufacturing process,
etc.), except for the product name change.
2. The proposed name must meet the relevant
requirements for names of drugs set forth in the Circular prescribing
marketing authorization for drugs and medicinal materials and the Circular
prescribing labeling of drugs and medicinal materials and package inserts.
Documents to be submitted (D)
1. Revised draft package insert and/or label
incorporating the proposed name.
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3. A declaration from the applicant that
there is no other changes to the product or label/package insert, except for
the change of the drug product name.
MiV-PA2
Change or addition of contents of
package insert and/or label, including:
a) Change of the layout/artwork
without altering meaning;
b) Addition/deletion/replacement of
pictures, diagrams, or texts;
c) Addition/strengthening of warnings,
precautions, contraindications and/or adverse events/effects to the approved
product labeling;
d) Tightening of product’s target
population;
e) Deletion of indication;
g) Updating of the package insert to
conform to the package insert of the original brand-name drug in Viet Nam.
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The change is not a MaV and does not contain
promotional information. For a major change in label/package insert, refer to
MaV-1 and MaV-2.
Documents to be submitted (D)
1. The proposed package insert and/or label
sample. A comparative tabulated format of the approved and proposed contents
of the package insert and/or label.
2. Letter of declaration from the applicant
stating that no other changes on the label/package insert, except for the
intended change.
3. Relevant document/reference to support the
changes (where applicable).
MiV-PA3
Addition or replacement of the company
or party responsible for batch release
Conditions to be fulfilled (C)
1. Only applicable for batch release.
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3. Analytical procedure transfer from the
approved to the proposed test laboratory/company responsible for batch
release has been successfully completed.
Documents to be submitted (D)
1. Revised draft(s) of the package insert
and/or label incorporating the proposed variation (where applicable).
2. Proof that the proposed company/site is
appropriately authorized by a competent authority to be responsible for batch
release such as a valid GMP and/or CPP which covers the certification of
compliance by the proposed company/site with GMP guidelines.
MiV-PA4
Addition or replacement of alternative
manufacturer/manufacturing site of drug substance [where European Pharmacopoeial
Certificate of Suitability (CEP) is available]
Conditions to be fulfilled (C)
1. The specifications of the drug substance
remain unchanged.
2. For change and/or addition of alternative
manufacturer/site of drug substance where CEP is not available, refer to
MaV-3.
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1. A valid European Pharmacopoeial
Certificate of Suitability (CEP) for the drug substance, latest version,
accompanied with all annexes issued by EDQM (European Directorate for the
Quality of Medicines & Healthcare).
2. A letter of commitment from the drug
product manufacturer or the applicant to conduct long-term and accelerated
stability studies of the drug product manufactured with the drug substance
from the proposed manufacturer/manufacturing site, and report if any results
fall outside the approved shelf-life specifications (with proposed action) or
when requested.
3. Certificate of analysis and/or batch
analysis data (in a comparative tabulated format) for at least 02 pilot
batches of the drug substance from the approved and proposed
manufacturers/manufacturing sites (*).
4. If the re-test period is not stated in the
CEP, long-term and accelerated stability data up to the proposed re-test
period on 02 pilot batches of the drug substance manufactured from the
proposed manufacturers/manufacturing sites should be provided.
5. Comparative dissolution profile data for
the drug product manufactured using the drug substance from the approved and
proposed manufacturers/manufacturing sites, where the drug is classified as a
drug with demonstrated bioequivalence.
(*) For a drug classified as a drug
with demonstrated bioequivalence, the comparative batch analysis data shall
include the quality criteria specified in the approved specifications of the
drug substance, as well as quality criteria not included in the approved
specifications but established during the development of the drug product
(i.e. quality criteria described in Part P2. Pharmaceutical Development of
the marketing authorization application, such as particle size, polymorphism,
hydration/solvation state, dissolution characteristics, bulk density, and
flowability of the drug substance), together with supporting documentation,
where applicable.
MiV-PA5
Change of batch size of drug substance
[where European Pharmacopoeial Certificate of Suitability (CEP) is not
available]
Conditions to be fulfilled (C)
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2. The specifications of the drug substance
remain unchanged.
3. For change of specification of drug
substance where a CEP is available, refer to MiV-PA12.
Documents to be submitted (D)
1. A letter of declaration from the drug
product manufacturer or the applicant that the specifications of drug
substance have not changed and the reproducibility of the process has not
been affected.
2. Certificate of analysis and/or batch
analysis data with specification and results (in a comparative tabulated
format) on a minimum of 01 production or pilot batch manufactured to both the
approved and proposed batch sizes. Batch analysis data on the next 02 full
production batches should be available on request or reported if outside
specification (with proposed action).
3. Amended relevant ACTD Section S (where
applicable).
MiV-PA6
Change of in-process controls applied
during the manufacture of the drug substance (including tightening and
addition of new in-process test and where European Pharmacopoeial Certificate
of Suitability (CEP) is not available)
Conditions to be fulfilled (C)
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2. The change is not a consequence of any
commitment from previous assessments to review specification limits.
3. The change does not result from unexpected
events arising during manufacture, e.g. new unqualified impurity, change in
total impurity limits, etc.
4. Any new analytical procedure does not
concern a novel non-standard technique or a standard technique used in a
novel way.
5. For change of specification of drug
substance where a CEP is available, refer to MiV-PA12.
Documents to be submitted (D)
1. A description of the analytical procedure
and summary of validation data must be provided for all new analytical
procedures (where applicable).
2. Comparative tabulated format of the approved
and proposed in-process controls with the changes highlighted.
3. Certificate of analysis and/or batch
analysis data (in a comparative tabulated format) of 02 production batches of
the drug substance for all tests in the proposed specification (where applicable).
MiV-PA7
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Conditions to be fulfilled (C)
1. No adverse change in qualitative and/or
quantitative impurity profile which would require further qualifications in
safety studies.
2. The synthetic route remains unchanged (for
example, intermediates remain unchanged). If the synthetic route is
different, refer to MaV-17.
3. Manufacturing process of drug substance
does not use any materials of human/animal origin for which assessment is
required of viral safety.
4. Physicochemical characteristics and other
relevant properties of drug substance remain unchanged.
5. Specifications and stability performance of
drug substance remain unchanged.
Documents to be submitted (D)
1. The Drug Master File (DMF) or relevant
updated ACTD drug substance section or equivalent audit document.
2. Comparative tabulated format of the
approved and proposed processes with changes highlighted.
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4. A letter of declaration from the drug
product manufacturer or the applicant stating that no new impurities have
been introduced at or above the accepted threshold for qualification of
impurities or that there is no increase in the levels of impurities, which
require further safety studies.
5. A letter of declaration from the drug
product manufacturer or the applicant stating that specifications of the drug
substance have not changed.
6. Certificate of analysis and/or batch
analysis data (in a comparative tabulated format) for 02 batches of the drug
substance.
7. A declaration from the drug product
manufacturer or the applicant that the relevant stability studies of the drug
product manufactured with the drug substance from the proposed process (in
accordance with the ASEAN Guideline On Stability Study Of Drug Product) have
been started and will be finalized, and report if any results fall outside
shelf-life specifications (with proposed actions).
8. Certificate of analysis and/or batch
analysis data (in a comparative tabulated format) of drug product of at least
02 batches (pilot/production scale) manufactured with the drug substance
according to the approved and proposed processes.
MiV-PA8
Change of the specification of drug
substance, including:
a) Specification limits are tightened;
b) Addition of new test parameter and
limits.
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1. This is only applicable for drug
substances which are non-compendial and generic drug substances without
European Pharmacopoeial Certificate of Suitability (CEP).
2. The change should not be the result of
unexpected events arising during manufacture or because of stability concerns,
unless otherwise justified.
3. Analytical procedures in the specification
of drug substance remain unchanged, or changes in the analytical procedure
are minor.
4. For (b) - applicable to non-compendial
method only.
5. For change of specification of drug
substance where a CEP is available, refer to MiV-PA12.
6. For widening of specification limits
and/or deletion of test parameter and limits of drug substance, refer to
MaV-6.
Documents to be submitted (D)
a) Specification limits are tightened:
1. Technical justification for the change.
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3. Comparative batch analysis data of the
drug substance for all tests in the proposed specification for 02 pilot or
production scale batches.
b) Addition of new test parameter and limits:
In addition to the above documents, the following shall be submitted:
4. Description of any new analytical
procedure and summary of the validation data.
5. For change of drug substance specification
that involved stability-indicating parameters: stability data of drug
substances and report if any results fall outside re-test/shelf-life
specifications (with proposed action).
MiV-PA9
Change of the analytical procedure in
specification of non-compendial drug substance
Conditions to be fulfilled (C)
1. Results of method validation show proposed
analytical procedure to be at least equivalent to the approved procedure.
2. For change of specification of drug
substance where a CEP is available, refer to MiV-PA12.
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1. Description of the proposed analytical
procedure with a summary of change(s) from the approved analytical procedure.
2. Appropriate verification/validation data of
the proposed analytical procedure.
3. Specifications of the drug substance.
4. Certificate of analysis and/or batch
analysis data (in a comparative tabulated format) for at least 02 pilot
batches of the drug substance from the approved and proposed analytical
procedures.
MiV-PA10
Change of shelf-life or re-test period
for drug substance
Conditions to be fulfilled (C)
1. The stability studies must show compliance
with the approved specification of the drug substance.
2. There is no change in storage condition.
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Documents to be submitted (D)
1. Specifications of the drug substance.
2. Stability data of the drug substance which
should be presented on at least 02 pilot or production scale batches of the
proposed shelf-life or retest period.
MiV-PA11
Change of storage condition for drug
substance
Conditions to be fulfilled (C)
1. The stability studies must show compliance
with the approved specification of the drug substance.
2. There is no change in shelf-life/re-test
period for drug substance.
3. For change of specification of drug
substance where a CEP is available, refer to MiV-PA12.
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1. Specifications of the drug substance.
2. Stability data of the drug substance which
should be presented on at least 02 pilot or production scale batches of the
proposed storage condition.
MiV-PA12
Revision of European Pharmacopoeial
Certificate of Suitability (CEP) of drug substance
Conditions to be fulfilled (C)
None.
Documents to be submitted (D)
1. A valid European Pharmacopoeial
Certificate of Suitability (CEP) for the drug substance, latest version, accompanied
with all annexes issued by EDQM (European Directorate for the Quality of
Medicines & Healthcare).
2. If this change is due to drug substance
specification change, a declaration from the drug product manufacturer or the
applicant that the relevant stability studies of the drug product
manufactured with the drug substance according to the proposed specification
(in accordance with ASEAN Guideline On Stability Study Of Drug Product) have
been started and will be finalized, and report if any results fall outside
the approved shelf-life specifications of the drug product (with proposed
actions).
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4. Certificate of analysis and/or results of
batch analysis data (in a comparative tabulated format) from the drug
substance manufacturer (*), demonstrating compliance with the Ph. Eur
monograph and including additional test/limits listed on the CEP (where
applicable).
5. Additional data to address any relevant
parameter(s) not addressed in the CEP and announced by the drug substance
manufacturer such as stability data (S7) (if a re-test period is not stated
on the CEP) and physicochemical characteristics, e.g. particle size,
polymorphism etc. (if applicable).
(*) If the drug substance manufacturer is CEP
certified and the drug product manufacturer claims otherwise (e.g. USP, JP,
In-house etc.), data covering S4.1 to S4.5 from the drug product manufacturer
should be submitted.
MiV-PA13
Addition or change of batch size of
non-sterile drug product
Conditions to be fulfilled (C)
1. The change does not affect consistency of
production.
2. The product formulation remains unchanged.
3. Process validation scheme and/or report is
available or validation of the manufacturing process has been successfully
carried out according to protocol with at least 03 batches at the proposed
batch size in accordance with the ASEAN Guideline on Submission of
Manufacturing Process Validation Data For Drug Registration.
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5. This is applicable to change of batch size
up to 10-fold compared to the approved batch size.
6. For change of batch size for sterile
products, refer to MaV-7. For change of batch size more than 10-fold compared
to the approved batch size, refer MaV-8.
Documents to be submitted (D)
1. Comparative tabulated format of approved
and proposed batch manufacturing formula.
2. Validation scheme and/or report of the
manufacturing process as per ASEAN Guideline on Submission of Manufacturing
Process Validation Data for Drug Registration appropriate to the proposed
batch size should be provided upon submission.
3. Revised ACTD Section P3.1- P3.4 (where
applicable).
4. Approved release and shelf-life
specifications of the drug product.
5. Certificate of analysis and/or batch
analysis data (in a comparative tabulated format) of drug product on a
minimum of 01 production batch manufactured according to approved and
proposed batch sizes and letter of undertaking to submit batch analysis data
on the next 01 full production batch.
6. Stability data of the drug product
following the change made (as per ASEAN Guideline On Stability Study Of Drug
Product) and report if any results fall outside the approved shelf-life
specifications (with proposed action).
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Reduction or removal of overages
Conditions to be fulfilled (C)
1. Changes of approved manufacturing overages
of drug substance only.
2. Release and shelf-life specifications of
drug product remain unchanged.
Documents to be submitted (D)
1. Justification for the change.
2. Comparative tabulated format of approved
and proposed batch manufacturing formula.
3. Certificate of analysis and/or batch
analysis data (in a comparative tabulated format) for 02 batches of the
finished product.
4. Stability data of the drug product
manufactured according to the proposed batch manufacturing formula (as per
ASEAN Guideline On Stability Study Of Drug Product) and report if any results
fall outside the approved shelf-life specifications (with proposed action).
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Qualitative and/or quantitative change
of excipient
a) For immediate release oral dosage
forms (as per Level 1, Part III (Components and Composition)- SUPAC
guideline);
b) For other non-critical dosage forms
e.g. oral liquid, external preparation.
Conditions to be fulfilled (C)
1. Replacement of an excipient with a
comparable excipient of the same characteristics or functions (where
applicable).
2. The dissolution profile of the proposed product
is comparable to that of the approved product.
3. Process validation scheme and/or report is
available or validation of the manufacturing process has been successfully
carried out according to protocol with at least 03 batches of the proposed
product formula in accordance with the ASEAN Guideline on Submission of
Manufacturing Process Validation Data For Drug Registration.
4. Approved release and shelf-life
specifications of drug product remain unchanged, except for the update of
product description with respect to appearance/odour/taste as a consequence
of the change (where applicable).
5. For qualitative or quantitative change of
excipient for immediate release (Level 2 and 3 change as per SUPAC) and
modified release oral dosage forms and other critical dosage forms, refer to
MaV-10.
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1. Revised drafts of the package insert
and/or label incorporating the proposed variation (where applicable).
2. A declaration that the proposed excipient
does not interfere with the analytical procedures in the drug product release
and shelf-life specifications (where applicable).
3. Justification for the change which must be
given by appropriate development of pharmaceutics.
4. Comparative tabulated format of the
approved and proposed product formulation (with calculated changes
highlighted) in which changes in the percentage of the proposed excipient out
of the total target dosage form weight must be stated (where applicable).
5. For oral solid dosage forms: comparative
dissolution profile data of at least 01 pilot or production batch of the drug
product manufactured in the approved and proposed formulation as per US FDA
SUPAC-IR or SUPAC-MR Guidelines (where applicable).
6. Revised batch manufacturing formula.
7. Validation scheme and/or report of the
manufacturing process as per ASEAN Guideline on Submission of Manufacturing
Process Validation Data for Drug Registration appropriate to the proposed
change in product formula, which should be provided upon submission (where
applicable).
8. ACTD Section P3.1 to P3.4 which have been
revised appropriately to the proposed product formula (where applicable).
9. Specifications of the proposed excipient.
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11. Release and shelf-life specifications of
the drug product.
12. Certificate of analysis and/or batch
analysis data (in a comparative tabulated format) of drug product of at least
02 production (or 01 production batch and 02 pilot batches) according to
approved and proposed product formula.
13. Stability data of the drug product (as
per ASEAN Guideline On Stability Study Of Drug Product) and report if any
results fall outside the approved shelf-life specifications (with proposed
action).
14. Justification for not submitting a new
bioequivalence study of the drug product manufactured according to the
proposed product formula (for a drug granted marketing authorization and
having demonstrated bioequivalence) as per ASEAN Guidelines for the Conduct
of Bioavailability and Bioequivalence Studies.
15. For quantitative and qualitative changes
in preservative, results of Preservative Effectiveness Test (PET) at lowest
specified preservative level (where applicable).
16. Legal documents of the manufacturer of
the proposed excipient as prescribed in Clause 7 Article 22 of this Circular.
If the excipient has been granted a marketing authorization in Viet Nam,
these documents shall not be required.
MiV-PA16
Quantitative change in coating of
tablets and/or size of capsule shell for immediate release oral solid dosage
form
Conditions to be fulfilled (C)
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2. The test parameters and limits in approved
release and shelf-life specifications of the drug product remain unchanged, except
for update of product description with respect to the weight and/or size.
3. For quantitative change in coating of
tablets and/or size of capsule shell for modified release oral solid dosage
form, refer to MaV-11.
Documents to be submitted (D)
1. Revised drafts of the package insert
and/or label incorporating the proposed change (where applicable).
2. A declaration from the drug product
manufacturer or the applicant that the change does not interfere with
analytical procedures in the approved drug product release and shelf-life
specifications.
3. Comparative tabulated format of approved
and proposed 01-dose and batch manufacturing formula.
4. For oral solid dosage forms: Comparative
dissolution profile data of at least 01 pilot or production batch of the drug
product manufactured in the approved and proposed composition as per US FDA
SUPAC-IR or SUPAC-MR Guidelines (where applicable).
5. Revised release and shelf-life
specifications of the drug product.
6. Stability data of the drug product (as per
ASEAN Guideline On Stability Study Of Drug Product) and report if any results
fall outside the approved shelf-life specifications (with proposed action).
Except for the change in weight and/or size of capsule shell, a letter of
declaration from the drug product manufacturer or the applicant that the
relevant stability studies of the drug product in accordance with ASEAN
Guideline on Stability Study of Drug Product have been started will suffice.
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MiV-PA17
Change of the colouring agent/flavouring
agent/capsule shell colour of the product
Conditions to be fulfilled (C)
1. Same functional characteristics. There is
no change in dissolution profile for solid oral dosage forms.
2. The proposed colouring agents /flavouring
agents/capsule shell must not have been rejected for pharmaceutical use.
3. The test parameters and limits in approved
release and shelf-life specifications of the drug product remain unchanged,
except for update of product description with respect to
appearance/odour/taste as a consequence of the change (where applicable).
4. If there is a change to the source of
capsule shell, MiV-PA23 is also applicable.
Documents to be submitted (D)
1. Revised drafts of the package insert and/or
label incorporating the proposed variation (where applicable).
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3. A letter of commitment from the applicant
or the drug product manufacturer to inform users of the relevant change
(where applicable).
4. Revised 01-dose formulation and batch
manufacturing formula.
5. Qualitative and quantitative information
of the approved and proposed colouring agent/flavouring agent/capsule shell
colour in a comparative table.
6. For proposed excipients made of ruminants
source, TSE-free certificate or BSE-free certificate issued from relevant
competent authority of the issuing country and/or documentary evidence from
the supplier (where applicable).
7. Revised release and shelf-life
specifications of the drug product.
8. Stability data of the drug product (as per
ASEAN Guideline on Stability Study of Drug Product) and report if any results
fall outside the approved shelf-life specifications (with proposed action).
9. Certificate of analysis of proposed
coloring agent/flavoring agent/capsule shell (where applicable).
10. Legal documents of the manufacturer of
the proposed excipient as prescribed in Clause 7 Article 22 of this Circular.
If the excipient has been granted a marketing authorization in Viet Nam,
these documents shall not be required.
MiV-PA18
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Conditions to be fulfilled (C)
The proposed change does not result in any
change in the dosage form, treatment regimen, indication, method of
administration of the product.
Documents to be submitted (D)
1. Revised drafts of the package insert
and/or label incorporating the proposed variation (where applicable).
2. Justification for the deletion of the
solvent/diluent, including a statement regarding alternative means to obtain
the solvent/diluent.
3. Amended relevant ACTD Section P (where
applicable).
MiV-PA19
Change of in-process controls applied
during the manufacture of the drug product, including tightening and addition
of new in-process test.
Conditions to be fulfilled (C)
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2. The change is not a consequence of any
commitment from previous assessments to review specification limits.
3. The change does not result from unexpected
events arising during manufacture, e.g. new unqualified impurity, change in
total impurity limits.
4. Any new analytical procedure does not
concern a novel non-standard technique or a standard technique used in a
novel way.
Documents to be submitted (D)
1. Comparative tabulated format of approved
and proposed in-process controls.
2. A description of the analytical procedure
and summary of validation data must be provided for all new analytical
procedures (where applicable).
3. Proposed in-process specifications
together with justification and relevant process validation data.
4. Certificate of analysis and/or batch
analysis data (in a comparative tabulated format) of drug product of at least
02 production or pilot batches.
MiV-PA20
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Conditions to be fulfilled (C)
1. The manufacturing site remains unchanged.
2. The overall manufacturing principle
remains unchanged.
3. The change does not cause negative impact
on the quality, safety and efficacy of the drug product.
4. The dissolution profile of the proposed
product is comparable to that of the approved product.
5. Release and shelf-life specifications of
the drug product remain unchanged.
6. For major change in the manufacturing
process for drug product, refer to MaV-9.
7. For minor change in the manufacturing
process of an immediate release solid oral dosage form, semi solid or oral
solutions, refer to MiV-N11.
Documents to be submitted (D)
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2. Description of the proposed manufacturing
process and technical justification for the change.
3. Comparative tabulated format of approved
and proposed process with changes highlighted.
4. For semi solid and suspension products:
validation scheme and/or report of the manufacturing process as per ASEAN
Guideline on Submission of Manufacturing Process Validation Data for Drug Registration,
which should be provided upon submission.
5. Copy of approved release and shelf-life
specifications.
6. Certificate of analysis and/or batch
analysis data (in a comparative tabulated format) of drug product on a
minimum of 01 batch manufactured according to both the approved and the
proposed process; batch analysis data on the next 02 full production batches
should be made available upon request.
7. A declaration from the drug product
manufacturer or the applicant that the relevant stability studies of the drug
product in accordance with the ASEAN Guideline on Stability Study of Drug
Product have been started and that the relevant stability studies will be
finalized; data should be provided only if outside specification (with
proposed action).
8. Justification for not submitting a
bioequivalence study according to the current Bioavailability and
Bioequivalence guidance (where applicable).
MiV-PA21
Change of specifications of
non-compendial excipient
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a) Specification limits are tightened
or widened;
b) Addition, replacement or deletion
of test parameter and limits.
Conditions to be fulfilled (C)
1. Release and shelf-life specifications of
the drug product remain unchanged.
2. The change should not be the result of
unexpected events arising during manufacture or because of stability
concerns, unless otherwise justified.
3. Applicable to non-compendial excipients.
For compendial excipients, refer to MiV-N9.
Documents to be submitted (D)
1. Description of new analytical procedure
and summary of analytical validation (applicable for addition or replacement
of new parameter).
2. Comparative tabulated format of the
approved and proposed specification of the excipient with changes
highlighted.
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MiV-PA22
Change of an analytical procedure for
an excipient, including replacement of an approved analytical procedure by a
new analytical procedure
Conditions to be fulfilled (C)
1. Appropriate method validation studies have
been performed in accordance with the ASEAN Guidelines for Validation of
Analytical Procedures.
2. Results of method validation show proposed
analytical procedure to be at least equivalent to the approved procedure.
3. The change does not result in changes of
the total impurity limits.
4. Only applicable to the approved test
parameters and limits. For addition, replacement or deletion of test
parameter and limits, refer to MiV-PA21/MiV-N9.
5. No new unqualified impurities are
detected.
6. This applies to non-compendial excipients.
For compendial excipients, refer to MiV-N9.
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1. Description of the proposed analytical
methodology with a comparative tabulated format of the changes.
2. For quantitative test change: comparative
analytical validation results showing that the approved and proposed tests
are equivalent.
MiV-PA23
Change in the source of empty hard
capsule
Conditions to be fulfilled (C)
1. The change is from TSE-risk material to
vegetable-sourced or synthetic empty hard capsules or vice versa.
2. The formulation and manufacturing process
of drug product remain unchanged.
3. Not applicable to change from hard capsule
to soft gel.
4. Excipient and finished product release and
shelf-life specifications remain unchanged.
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1. A letter of declaration from the drug
product manufacturer or the applicant of the material that it is purely of
vegetable, animal or synthetic origin.
2. Composition and technical specifications
of the empty hard capsule of the proposed source.
3. For empty hard capsule made of ruminants
source, TSE-free certificate or BSE-free certificate issued from relevant
competent authority of the issuing country and/or documentary evidence from
the supplier.
4. For oral solid dosage forms: Comparative
dissolution profile data of at least 01 pilot/production batch of the drug
product using hard capsule between the two sources, as per US FDA SUPAC-IR or
SUPAC-MR Guidelines (where applicable).
5. Certificate of analysis of the empty hard
capsule of the proposed source.
6. Stability data as per ASEAN Guideline on
Stability Study of Drug Product of the drug product following the change, and
report if any results fall outside the approved shelf-life specifications
(with proposed action).
7. Legal documents proving that the empty
hard capsule manufacturer complies with GMP guidelines. If the empty hard
capsule of the proposed source has been granted a marketing authorization in
Viet Nam, these documents shall not be required.
MiV-PA24
Change of release and shelf-life
specifications of the drug product, including:
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b) Addition of new test parameter and
limits
Conditions to be fulfilled (C)
1. Applicable to non-compendial method.
2. The change should not be the result of
unexpected events arising during manufacture or because of stability
concerns, unless otherwise justified.
3. Analytical procedures remain unchanged, or
changes in the analytical procedures are minor.
4. If there are changes to the analytical
procedure, MiV-PA27 is also applicable.
5. For widening of specification limits and
deletion of test parameter and limits of drug product, refer to MaV-6.
Documents to be submitted (D)
a) Specification limits are tightened:
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2. Comparative tabulated format of the
approved and proposed release and shelf-life specifications of the drug
product with changes highlighted.
3. Certificate of analysis and/or batch
analysis data (in a comparative tabulated format) of the drug product for all
tests in the proposed specification of at least 02 batches.
b) Addition of new test parameter and limits:
In addition to the documents specified in point
a), the following documents shall be submitted:
4. Description of any new analytical method
and summary of analytical validation data for non-compendial method.
5. Stability data, as per ASEAN Guideline on
Stability Study of Drug Product, of the drug product and report if any
results fall outside the approved shelf-life specifications (with proposed
action) (where applicable).
MiV-PA25
Change of imprints, bossing or other
markings on tablets or printing on capsules including addition or change of
inks used for product marking
Conditions to be fulfilled (C)
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1. Proposed markings do not cause confusion
with other registered drug products.
2. Any ink proposed must not be included in
the list of banned substances, and must meet relevant standards of food grade
or for pharmaceutical use.
3. Approved release and shelf-life
specifications of drug product remain unchanged, except for appearance.
b) Change of score/break-line:
In addition to the above conditions:
4. Score/break-line is not meant for cosmetic
purpose.
5. Applicable to addition or removal of
score/break-line.
Documents to be submitted (D)
a) All changes in this section, except
score/break-line:
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2. A letter of commitment from the applicant
or the drug product manufacturer to inform users of the relevant change
(where applicable).
3. Composition and specifications of the
proposed inks (where applicable).
4. Detailed (drawing or written) description
of the approved and proposed imprint/bossing/markings.
5. Certificate of analysis of ink/printing
material (pharmaceutical grade and of food grade) (where applicable).
6. Release and shelf-life specifications of
drug product with the proposed product description with respect to
appearance.
b) Change of score/break-line:
In addition to the documents specified in
point a), the following documents shall be submitted:
7. Justification for the change (i.e. change
in dosing regimen).
8. Data on test of uniformity of the
subdivided parts of tablets at release as conformed to compendial
requirement.
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MiV-PA26
Change of dimensions and/or shape of
tablets, capsules, suppositories or pessaries without change in qualitative
and quantitative composition and mean mass:
a) Immediate release oral solid dosage
form, suppositories and pessaries;
b) Other than immediate release oral
solid dosage forms, suppositories and pessaries
Conditions to be fulfilled (C)
1. The dissolution profile of the proposed
product is comparable to that of the approved product (if appropriate).
2. Release and shelf-life specifications of
the drug product remain unchanged, except for dimension and/or shape.
Documents to be submitted (D)
a) Immediate release oral solid dosage form,
suppositories and pessaries:
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2. Detailed (drawing or written) description
of the approved and proposed dimensions/shape.
3. For oral solid dosage forms: Comparative
dissolution profile data of at least 01 pilot/production batch of the drug
product manufactured in the approved and proposed dimensions/shape, as per US
FDA SUPAC-IR or SUPAC-MR Guidelines (where applicable).
4. For scored tablets, data on test of
uniformity of the subdivided parts of tablets at release as conformed to
compendial requirement.
5. Release and shelf-life specifications of
the drug product with updated product description with respect to the
proposed dimensions/shape.
b) Other than immediate release oral solid
dosage forms, suppositories and pessaries:
In addition to the documents specified in
point a), the following documents shall be submitted:
6. Justification for not submitting a new
bioequivalence study of the drug product following the change according to
the ASEAN Guidelines for the Conduct of Bioavailability and Bioequivalence
Studies (where applicable).
MiV-PA27
Change in the analytical procedure in
specification of the drug product (including replacement or addition of an
analytical procedure)
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1. The test parameter and limits in approved
drug product specifications are not adversely affected, unless the
specifications are tightened.
2. Results of procedure validation show
proposed analytical procedure to be at least equivalent to the approved
procedure.
3. The change should not be the result of
unexpected events arising during manufacture or because of stability
concerns, unless otherwise justified.
Documents to be submitted (D)
1. Justification for the proposed change.
2. Comparative tabulated format of the
approved and proposed release/ shelf-life specifications of the drug product.
3. Description of the analytical methodology.
4. Appropriate verification/validation data
and comparative analytical results between the approved and proposed test.
5. Certificate of analysis and/or batch
analysis data (in a comparative tabulated format) of the finished product of
02 production batches.
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Change in or inclusion of primary
packaging material for non-sterile drug product, including:
a) Change in or inclusion of
qualitative and quantitative composition of packaging material; and/or
b) Change in or inclusion of type of
container; and/or
c) Inclusion of primary packaging
material.
Conditions to be fulfilled (C)
1. The proposed packaging material must be at
least equivalent to or better than the approved material in respect of its
relevant properties.
2. Release and shelf-life specifications of
the drug product remain unchanged.
3. For change in the primary packaging
material for sterile drug product, refer to MaV-12.
Documents to be submitted (D)
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2. Justification for the change in primary
packaging material and appropriate scientific studies on the proposed primary
packaging.
3. For semi-solid and liquid dosage forms,
proof must be provided that no interaction between the content and the
packaging material occurs (e.g. no migration of components of the proposed
material into the content and no loss of components of the product into the
pack).
4. Comparative tabulated format of the
approved and proposed specifications of the primary packaging material (where
applicable).
5. Revised ACTD Sections P3 and/or P7 (where
applicable).
6. Stability data, as per ASEAN Guideline on
Stability Study of Drug Product, of the drug product and report if any
results fall outside the shelf-life specifications (with proposed action).
MiV-PA29
Addition or replacement of a
manufacturer for secondary packaging
Conditions to be fulfilled (C)
None.
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1. Revised drafts of the package insert and
label incorporating the proposed variation (where applicable).
2. Proof that the proposed site is
appropriately authorized for the packaging activity of the dosage form
concerned, such as a valid GMP certificate and/or a CPP which covers the GMP
certification.
MiV-PA30
Change or addition of pack size/fill
volume and/or change of shape or dimension of container or closure for
non-sterile drug product
Conditions to be fulfilled (C)
1. The packaging type and material remain
unchanged.
2. The proposed pack size is consistent with
the dosage regimen and duration of use as approved in the package insert.
3. Change in the dimension of the primary
packaging (where applicable).
4. Release and shelf-life specifications of
the drug product remain unchanged.
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Documents to be submitted (D)
1. Revised drafts of the package insert and
label incorporating the proposed variation (where applicable).
2. Justification for the proposed pack size.
3. Revised ACTD Sections P3 and/or P7 (where
applicable).
4. A declaration from the drug product
manufacturer or the applicant that the relevant stability studies of the drug
product in the proposed pack size (in accordance with the ASEAN Guideline on
Stability Study of Drug Product) have been started and will be finalized, and
report if any results fall outside shelf-life specifications (with proposed
actions).
MiV-PA31
Change or addition of outer carton
pack sizes for a drug product
Conditions to be fulfilled (C)
1. Primary packaging materials remain
unchanged.
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3. The proposed pack sizes are adequate to
accommodate the dosing regimen as per the approved package insert.
Documents to be submitted (D)
1. Revised drafts of the package insert and
label incorporating the proposed variation (where applicable).
2. Letter of declaration from the applicant
stating that no other changes except for the change of outer carton pack
sizes for a drug product.
MiV-PA32
Addition or replacement of measuring
device for oral liquid dosage forms and other dosage forms
Conditions to be fulfilled (C)
1. The size and where applicable, the
accuracy of the proposed measuring device must be compatible with the
approved posology.
2. The proposed device is compatible with the
drug product.
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1. Revised drafts of the package insert and
label incorporating the proposed variation (where applicable).
2. Description of the proposed device
(including a drawing, where applicable).
3. Information on the composition of the
device material. Where applicable, the materials should comply with the
pharmacopoeia.
4. Justification that size and accuracy of
the proposed device are adequate for the posology as approved in the product
labeling.
5. Data on test of uniformity of delivered
dose as per compendium.
MiV-PA33
Reduction of shelf-life of the drug
product:
a) As a package in approved pack size;
and/or
b) After first opening; and/or
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Conditions to be fulfilled (C)
1. For (a) & (b): - The studies must show
conformance to the approved shelf-life specifications of the drug product.
2. For (c) - The studies must show
conformance to the approved shelf-life specification for the reconstituted
product.
3. For extension of shelf-life, refer to
MaV-15.
Documents to be submitted (D)
1. Revised drafts of the package insert and
label incorporating the proposed variation (where applicable).
2. Justification for the proposed reduction
of the shelf-life of the drug product (where applicable).
3. A letter of commitment from the applicant
or the drug product manufacturer to inform users of the relevant change
(where applicable).
4. Results of appropriate long-term stability
studies covering the duration of the proposed shelf-life of the drug product
in accordance with the ASEAN Guidelines on Stability Study of Drug Product,
including results of appropriate microbiological testing (where appropriate),
in the following cases:
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b) After first opening; and/or
c) After dilution/reconstitution.
MiV-PA34
Change of storage conditions of the
drug product (increasing from the approved storage condition), applicable to:
a) As a package in approved pack size;
and/or
b) After first opening; and/or
c) After dilution/reconstitution.
Conditions to be fulfilled (C)
1. For (a) & (b) - The studies must show
conformance to the approved shelf-life specification for the drug product.
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3. For change of storage condition (lowering
from the approved storage condition), refer to MaV-16.
4. General precautionary statements on
storage conditions in product labeling may be included but should not be used
due to stability concerns.
Documents to be submitted (D)
1. Revised drafts of the package insert and
label incorporating the proposed variation (where applicable).
2. Technical justification for the proposed
change.
3. Results of appropriate long-term stability
studies covering the duration of the approved shelf-life of the drug product
in accordance with the ASEAN Guidelines on Stability Study of Drug Product,
including results of appropriate microbiological testing (where appropriate),
in the following cases:
a) As a package in approved pack size; and/or
b) After first opening; and/or
c) After dilution/reconstitution.
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MiV-PA35
Addition or replacement of alternative
packager/site for primary packaging (direct contact with drug product) for
non-sterile product
Conditions to be fulfilled (C)
1. No other changes except for the addition
and/or replacement of the alternative packager/site for primary packaging.
2. For addition and/or replacement of
alternative packager/site for primary packaging for sterile product, refer to
MaV-5.
Documents to be submitted (D)
1. Revised drafts of the label and/or package
insert incorporating the proposed variation (where applicable).
2. Proof that the proposed site is
appropriately authorized for the packaging activity of the dosage form
concerned, such as a valid GMP certificate and/or a CPP which covers the GMP
certification.
3. In case of a contract primary packager,
letter of appointment and letter of acceptance for the proposed site to
package the product and stating the types of activity to be performed by the
packager (where applicable).
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5. Holding time studies testing of bulk
product during storage and transportation between the bulk production site
and the primary packaging site (where applicable).
6. A letter of commitment from the applicant
or the drug product manufacturer to conduct long-term and accelerated
stability studies for the drug product packed at the proposed packager/site,
and report if any results fall outside shelf-life specifications (with
proposed actions).
MiV-PA36
Addition or replacement of the
company/site responsible for quality control testing
Conditions to be fulfilled (C)
1. Only applicable to the company/site
responsible for quality control testing.
2. The manufacturer and primary packager of
the drug product remain unchanged.
3. Method transfer from the approved to the proposed
company/site or test laboratory has been successfully completed.
Documents to be submitted (D)
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a) The change does not affect the release and
shelf-life specifications of the drug product.
b) The tests used by the proposed quality
control testing company/site or test laboratory are equivalent to the
registered methods.
c) List of tests used by the proposed quality
control testing company/site or test laboratory with indication if the method
transfer has been completed for each test.
2. Revised drafts of the package insert and
label incorporating the proposed variation (where applicable).
3. Documentary evidence that the proposed
quality control testing company/site or test laboratory is appropriately
accredited (according to GMP/GLP/ISO/IEC standards).
4. Analytical method transfer
data/verification data (where applicable).
5. Revised ACTD Sections S2 or P3.
MiV-PA37
Change of the applicant
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1. Applicable to change of the applicant
Documents to be submitted (D)
1. Certificate of eligibility for
pharmaceutical business bearing the proposed name and/or address or of the
proposed applicant (for a Vietnamese applicant).
2. License to manufacture and trade drugs
issued by a competent regulatory authority of a foreign country and License
for establishment of a representative office in Viet Nam bearing the proposed
name and/or address or of the proposed applicant (for a foreign applicant).
3. Comparative tabulated format of approved
contents and proposed changes (highlighted).
4. Letter of authorization appointing the
proposed applicant, where the applicant is not the manufacturer, the product
license holder/marketing authorization holder, ordering establishment, or
transferor establishment.
5. Application form for variation approval
bearing confirmation of both the approved and proposed applicants.
MiV-PA38
Designation as a drug with
demonstrated bioequivalence
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Bioequivalence study reports are available as
prescribed.
Documents to be submitted (D)
Bioequivalence study reports which meet the
requirements laid down in ASEAN technical guidelines and the Circular No.
07/2022/TT-BYT dated September 05, 2022 of the Minister of Health prescribing
pharmaceutical products for which in vivo bioequivalence studies are required
and requirements for documentation of bioequivalence study reporting during
application for marketing authorization of these pharmaceutical products in
Viet Nam.
MiV-PA39
Classification as original brand-name
drug or reference biological
Conditions to be fulfilled (C)
A drug to be considered and classified as an
original brand-name drug or reference biological if the following conditions
are met:
1. Case 1: A drug that has been classified as
an original brand-name drug or reference biological shall continue to be
classified as original brand-name drug or reference biological following a
change in the manufacturer or manufacturing site and the grant of a new
marketing authorization, provided that it meets the criteria set out in
Clause 2 Article 13 of this Circular.
2. Case 2: Where a drug ordered for
processing, or a drug prior to technology transfer, that has been classified
as an original brand-name drug or reference biological, or has not been so
classified but has clinical data meeting the requirements laid down in Point
a or b Clause 1 Article 13 of this Circular, is processed or manufactured
using transferred technology in Viet Nam, the processed drug or the drug
manufactured using transferred technology shall be classified as an original
brand-name drug or reference biological, provided that it meets the criteria
set out in Clause 2 Article 13 of this Circular and Point d Clause 2 Article
38 of this Circular.
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Documents to be submitted (D)
1. Case 1: A drug that has been classified as
an original brand-name drug or reference biological shall continue to be
classified as original brand-name drug or reference biological following a
change in the manufacturer or manufacturing site and the grant of a new
marketing authorization, provided that it meets the criteria set out in
Clause 2 Article 13 of this Circular
- The comparative tabulated summary (Form
01/TT in Appendix IX to this Circular), comparing the drug for which
classification as an original brand-name drug or reference biological is
sought with the drug already classified as an original brand-name drug or
reference biological, together with supporting documents.
- Where the manufacturer or manufacturing
site of a reference biological is changed, the application for classification
as reference biological must also include additional documents demonstrating
quality equivalence according to the guidelines of the US FDA, ICH, WHO, EMA,
international organizations of which Viet Nam is a member, and the drug
regulatory authorities prescribed in Clause 9 Article 2 of this Circular.
2. Case 2: Where a drug ordered for
processing, or a drug prior to technology transfer, that has been classified
as an original brand-name drug or reference biological, or has not been so
classified but has clinical data meeting the requirements laid down in Point
a or b Clause 1 Article 13 of this Circular, is processed or manufactured
using transferred technology in Viet Nam, the processed drug or the drug
manufactured using transferred technology shall be classified as an original
brand-name drug or reference biological, provided that it meets the criteria
set out in Clause 2 Article 13 of this Circular and Point d Clause 2 Article
38 of this Circular
- Proof that the drug ordered for processing
or drug prior to technology transfer is eligible to be classified as an
original brand-name drug or reference biological as prescribed in Clause 1
Article 13 of this Circular, including:
+ Documents demonstrating that the drug has
been classified as an original brand-name drug or reference biological; or
+ Clinical documents meeting the requirements
laid down in Article 18 of this Circular of the drug ordered for
processing/drug prior to technology transfer where it has not been classified
as original brand-name drug or reference biological in Viet Nam.
- The comparative tabulated summary (Form
01/TT in Appendix IX to this Circular), comparing the drug processed in or
manufactured using transferred technology in Viet Nam for which
classification as an original brand-name drug or reference biological is
sought with the drug ordered for processing or the drug prior to technology
transfer, together with supporting documents.
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- Where the manufacturer or manufacturing
site of a reference biological is changed, the application for classification
as reference biological must also include additional documents demonstrating
quality equivalence according to the guidelines of the US FDA, ICH, WHO, EMA,
international organizations of which Viet Nam is a member, and the drug
regulatory authorities prescribed in Clause 9 Article 2 of this Circular.
3. Case 3: A drug that has not been
classified by the Ministry of Health of Vietnam as an original brand-name
drug or reference biological shall be classified as an original brand-name
drug or reference biological if it meets the requirements laid down in Clause
1 Article 13 of this Circular
- Clinical documents meeting the requirements
laid down in Article 18 of this Circular, unless the drug for which
classification as an original brand-name drug is sought has been granted a
marketing authorization according to ACTD or ICH-CTD dossier which includes
clinical documents meeting the requirements laid down in Article 18 of this
Circular.
MiV-PA40
Adjustment of registration number in
decision on grant or renewal of marketing authorization for drug/medicinal
material
Conditions to be fulfilled (C)
Not applicable
Documents to be submitted (D)
One of the following supporting documents
shall be submitted:
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2. Supporting documents for the proposed
change.
MiV-PA41
Classification of a drug manufactured
entirely in Viet Nam on a manufacturing line complying with EU-GMP principles
and standards or equivalent standards, and authorized for marketing by the
drug regulatory authority of a country included in the SRA list or by the EMA
Conditions to be fulfilled (C)
1. The drug has been granted a marketing
authorization and is manufactured entirely in Viet Nam on a manufacturing
line that has been declared by the DAV to comply with EU-GMP principles and
standards or equivalent standards.
2. The drug has been authorized for marketing
by the drug regulatory authority of a country included in the SRA list or by
the EMA (including cases where the drug has been authorized for marketing in
a country included in the SRA list with the involvement of a different
quality control establishment or batch release establishment, as prescribed
by the relevant SRA).
3. The marketing authorization application in
Viet Nam and the marketing authorization application in a country included in
the SRA list or the application submitted to the EMA must contain the same
information on the formulation, manufacturing process, quality specifications
and test methods of the drug; and the quality specifications, manufacturer
and manufacturing site of the drug substance and excipients.
Documents to be submitted (D)
1. Legal documents demonstrating that the
drug has been authorized for marketing by the drug regulatory authority of a
country included in the SRA list or by the EMA (Marketing Authorization or CPP).
Such a legal document must contain at a minimum the following information:
name of the drug; the name, strength or concentration of the drug substance;
dosage form; name and address of the manufacturer.
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MiV-PA42
Classification of a drug manufactured
using a material (drug substance) granted CEP
Conditions to be fulfilled (C)
The drug is manufactured using a material
(drug substance) that has been granted a CEP
Documents to be submitted (D)
The CEP (Certificate of Suitability to the
Monographs of the European Pharmacopoeia) of the drug material.
MiV-PA43
Replacement of an ordering
establishment
Conditions to be fulfilled (C)
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Documents to be submitted (D)
1. The official document showing the transfer
of rights and responsibilities between the approved and proposed ordering
establishments in performing the drug processing contract included in the
submitted marketing authorization application;
2. A letter of commitment from the proposed
ordering establishment confirming that the manufacturing site will remain
unchanged and undertaking to continue performing rights and responsibilities
of the ordering establishment under the approved marketing authorization
application for the processed drug in Viet Nam.
3. Comparative tabulated format of approved
contents and proposed changes (highlighted).
MiV-PA44
Replacement of a transferor
establishment (in case of technology transfer in drug manufacturing)
Conditions to be fulfilled (C)
Applicable to the replacement of a transferor
establishment
Documents to be submitted (D)
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2. Revised technology transfer registration
certificate (where applicable).
3. Comparative tabulated format of approved
contents and proposed changes (highlighted).
MiV-PA45
Change or addition of the risk management
plan for a new chemical drug, vaccine, or biological (except probiotic
biological products)
Conditions to be fulfilled (C)
There are changes in the following sections
of the risk management plan for a drug that has been granted a marketing authorization:
“Summary of safety issues”, “Additional pharmacovigilance activities”, and
“Additional risk minimization activities”
Documents to be submitted (D)
1. The risk management plan included in the
submitted marketing authorization application.
2. The proposed risk management plan.
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4. Justification for the change.
5. Specifications, non-clinical and clinical
documents relevant to the change.
MiV-PA46
Reclassification from
prescription-only drug to OTC based on the classification of a similar drug
(with the same active ingredient, strength or concentration, and dosage form)
that has been granted a marketing authorization in Viet Nam
Conditions to be fulfilled (C)
There is a similar drug that has been granted
a marketing authorization in Viet Nam and is classified as an OTC drug.
Documents to be submitted (D)
1. Revised drafts of the label and package
insert (after reclassification)
2. Comparative tabulated format of the
approved and proposed package inserts.
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4. Comparative tabulated format of the
proposed drug and the drug already classified as OTC drug in terms of
indication, usage - dosing regimen and patient population.
5. Comparative tabulated format of approved
contents and proposed changes (highlighted).
MiV-PA47
Reclassification from OTC drug to
prescription drug
Conditions to be fulfilled (C)
The drug is reclassified at the request of a
regulatory authority
Documents to be submitted (D)
1. Revised drafts of the label and package
insert (after reclassification)
2. Comparative tabulated format of the
approved and proposed package inserts.
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III. MINOR VARIATION NOTIFICATION (MiV-N)
MiV-N1
Change in name and/or address (for
example: postal code, street name) of, or updating of information on, the applicant
or ordering establishment or transferor establishment
Conditions to be fulfilled (C)
1. The applicant or ordering establishment or
transferor establishment remains unchanged.
2. For the change on the part of name and/or address
of the applicant or ordering establishment or transferor establishment on the
label and package insert only. For change in other parts of the label and
package insert, refer to MaV-2 and MiV-PA2.
Documents to be submitted (D)
1. Revised draft(s) of the label and/or
package insert incorporating the proposed variation (where applicable).
2. An application form indicating the
undertaking to assume responsibility for the change in name and/or address.
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MiV-N2
Addition or replacement of alternative
manufacturer/manufacturing site of excipient
Conditions to be fulfilled (C)
1. Specifications of the excipient remain
unchanged;
2. For a change in specifications of the
excipient, MiV- MiV-PA21 or MiV-N9 is also applicable.
Documents to be submitted (D)
1. Legal documents of the proposed excipient
manufacturer/manufacturing site as prescribed in Clause 7 Article 22 of this
Circular. If the excipient has been granted a marketing authorization in Viet
Nam, these documents shall not be required.
2. Approved specifications of the excipient.
3. Certificate of analysis of the excipient
from the excipient manufacturer.
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Change of the name of the manufacturer
due to change in ownership of manufacturer
Conditions to be fulfilled (C)
1. The manufacturing site remains unchanged.
2. No other changes except for the change in
ownership of manufacturer.
Documents to be submitted (D)
1. GMP or CPP certificate stating the name of
the proposed manufacturer or written certification of the transfer of
ownership to the proposed manufacturer given by a competent drug regulatory
authority.
2. The former manufacturer’s official letter
stating the transfer of ownership to the proposed manufacturer.
MiV-N4
Change of the name and/or address (for
example: postal code, street name) of, or updating of information on, the
drug product manufacturer, processing establishment, transferee
establishment, or the manufacturer of the drug ordered for processing or the
drug prior to technology transfer
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1. The manufacturing site remains unchanged.
2. No other changes except for the change of
the name and/or address.
3. Not applicable to the change in ownership
of manufacturer. For change in ownership of manufacturer, refer to MiV-N3.
Documents to be submitted (D)
1. Revised draft(s) of the label and/or
package insert incorporating the proposed variation (where applicable).
2. A valid GMP certificate, CPP which covers
the GMP certification, or official document from relevant competent authority
confirming the change of name and/or address without the change in
manufacturing site, for a drug manufactured in a foreign country.
3. Certification or official document from
the relevant competent authority confirming, or legal documents of relevant
manufacturer or establishment demonstrating, the change with the proposed
name and/or address.
MiV-N5
Change of the name and/or address (for
example: postal code, street name) of the company or manufacturer responsible
for batch release
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1. The manufacturer of the drug product
remains unchanged.
2. The batch release site remains unchanged.
3. Not applicable to the change in ownership
of manufacturer. For change in ownership of manufacturer, refer to MiV-N3.
Documents to be submitted (D)
1. Revised draft(s) of the label and/or
package insert incorporating the proposed variation (where applicable).
2. GMP or CPP certificate bearing the
proposed name and/or address of the company or manufacturer responsible for batch
release and the written certification from relevant competent authority
confirming the change of name and/or address without the change in batch
release site, for a drug manufactured in a foreign country.
3. Certification or official document from the
relevant competent authority confirming, or legal documents of relevant
company or manufacturer demonstrating, the change with the proposed name
and/or address, for a domestically manufactured drug.
4. A declaration from the applicant that the
change does not involve change of batch release site.
MiV-N6
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Conditions to be fulfilled (C)
1. The manufacturing site of the drug
substance, excipient or capsule shell remains unchanged.
2. No other changes except for the change of
the name and/or address of a manufacturer of the drug substance, excipient or
capsule shell.
Documents to be submitted (D)
1. Updated information of the manufacturer of
the drug substance, excipient or capsule shell.
2. Legal documents/evidence (where
applicable). For excipients, a declaration of GMP principles and standards or
of the principles and standards applicable to the manufacture of the
excipient, using Form 05/TT in Appendix IX to this Circular may be submitted
in lieu thereof.
MiV-N7
Withdrawal/deletion of the alternative
manufacturer(s) for drug substance and/or drug product packager
Conditions to be fulfilled (C)
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Documents to be submitted (D)
Reason for withdrawal/deletion.
MiV-N8
Re-registration of European
Pharmacopoeial Certificate of Suitability (CEP)
Conditions to be fulfilled (C)
Only applicable if the re-registration of CEP
does not involve any variation.
Documents to be submitted (D)
A valid European Pharmacopoeial Certificate
of Suitability (CEP) for the drug substance, latest version, accompanied with
all annexes issued by EDQM (European Directorate for the Quality of Medicines
& Healthcare).
MiV-N9
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Conditions to be fulfilled (C)
1. Applicable to compendial specifications of
the drug product/drug substance/excipient only.
2. Change is made exclusively to comply with
an update of the relevant monograph within the same compendium.
3. For change from non-compendial to
compendial specifications, or vice versa, or change from one compendium to
another, based on the specific changes in test parameters and limits, refer
to the appropriate MaV or MiV-PA.
Documents to be submitted (D)
1. Comparative tabulated format of the
approved and proposed specifications (with changes highlighted).
2. Batch analysis data (in comparative
tabulated format) of the drug product for all tests in the approved and
proposed specifications of at least 02 batches and/or certificate of analysis
of drug substance and/or excipient in the proposed specification.
3. Revised specifications.
4. For change in analytical procedure,
appropriate verification/validation data of the proposed analytical procedure
(where applicable) shall be provided.
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Deletion of pack size for a drug
product.
Conditions to be fulfilled (C)
1. The remaining pack sizes are adequate to
accommodate the dosing regimen as per the approved product label and/or
package insert.
2. For addition of pack size for sterile and
non-sterile products, refer to MaV-13 and MiV-PA30 respectively. For change
in the outer carton pack size, refer to MiV-PA31.
Documents to be submitted (D)
1. Revised drafts of the package insert and
label incorporating the proposed variation (where applicable).
2. Justification for the reason for deletion.
MiV-N11
Minor change in the manufacturing
process of an immediate release solid oral dosage form, semi solid or oral
solutions
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1. The change, as per Level 1, Part VI Manufacturing,
SUPAC Guideline, includes:
a) Change from non-automated or
non-mechanical equipment to automated or mechanical equipment to move
ingredients;
b) Change to alternative equipment of the
same design and operating principles of the same or of a different capacity;
c) Process changes including changes such as mixing times and operating
speeds within application/validation ranges.
2. No change in qualitative and quantitative
impurity profile or in physico-chemical properties.
3. The manufacturing principle for individual
manufacturing steps remains unchanged, e.g. there are no changes in the
processing intermediates and manufacturing solvent(s) used in the process.
4. The proposed process has to be controlled
by relevant in-process controls used in the approved process and no changes
(widening or deletion of limits) are required for these controls.
5. The specifications of the finished product
and/or process intermediates remain unchanged.
6. The proposed process must lead to an
identical product regarding all aspects of quality, safety and efficacy.
Documents to be submitted (D)
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2. Copy of approved release and shelf-life
specifications.
3. Certificate of analysis and/or batch
analysis data (in a comparative tabulated format) of drug product on a
minimum of 01 batch manufactured according to both the approved and the
proposed process. Batch analysis data on the next 02 full production batches
should be available upon request and reported by the drug product
manufacturer or the applicant if outside specification (with proposed
action).
4. A declaration from the drug product
manufacturer or the applicant that the relevant stability studies of the drug
product have been started and that the relevant stability studies will be
finalized; data should be provided only if outside specification (with
proposed action).
MiV-N12
Change in any part of the primary
packaging material not in contact with the finished product formulation such
as colour of flip-off caps, colour code rings on ampoules, change of needle
shield due to different plastic used
Conditions to be fulfilled (C)
1. The change does not concern a part of the packaging
material, which affects the delivery, use, safety or stability of the
finished product.
Documents to be submitted (D)
1. Amendment of the relevant section(s) of
the dossier (presented in the ACTD format), including revised product label
and/or package insert as appropriate.
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Change of the name or address (for
example: postal code, street name) of the company or party responsible for
quality control testing site
Conditions to be fulfilled (C)
1. The manufacturer of the drug product remains
unchanged.
2. The quality control testing site remains
unchanged.
3. For change in ownership of manufacturer,
refer to MiV-N3.
Documents to be submitted (D)
1. Revised drafts of the package insert and
label incorporating the proposed variation (where applicable).
2. Documentary evidence that the proposed
quality control testing company/site or test laboratory is appropriately
accredited (according to GMP/GLP/ISO/IEC standards) (where applicable).
3. A declaration from the applicant that the
change does not involve change of quality control testing site.
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I. FOR NEW CHEMICAL DRUGS AND MEDICINAL MATERIALS
Comply
with ASEAN Guidelines and some other provisions on variations in respect of new
chemical drugs granted marketing authorization in Section B.
1.
For biologicals, antisera (except probiotic biological products), submit
administrative documents as prescribed in Section B of this Appendix; quality
documents as prescribed in Section B of this Appendix or the guidelines of WHO,
US-FDA, EMA; clinical documents as prescribed in the guidelines of WHO, US-FDA,
EMA according to Appendix I enclosed with this Circular.
2.
For probiotic biological products, comply with the guidelines in section B of
this Appendix.
1.
The guidelines in Section B of this Appendix apply to the following variations:
-
Minor variations requiring prior approval: MiV-PA1 (Change of the drug product name),
MiV-PA37 (Change of the applicant), MiV-PA45 (Change or addition of the risk
management plan for a new chemical drug, vaccine, or biological (except
probiotic biological products)).
-
Minor variations requiring notification only: MiV-N1 (Change in name and/or
address of or updating of information on the applicant), MiV-N3 (Change of the
name of the manufacturer due to change in ownership of manufacturer), MiV-N4
(Change of the name and/or address (for example: postal code, street name) of
the drug product manufacturer), MiV-N5 (Change of the name and/or address (for
example: postal code, street name) of the company or manufacturer responsible
for batch release), MiV-N6 (Change of the name and/or address (for example:
postal code, street name) of a manufacturer of the drug substance, excipient,
capsule shell), MiV-N7 (Withdrawal/deletion of the alternative manufacturer(s)
for drug substance), MiV-N10 (Deletion of pack size for a drug product),
MiV-N13 (Change of the name or address (for example: postal code, street name)
of the company or party responsible for quality control testing site (where the
quality control testing site remains unchanged)).
2.
Apart from the variations specified in Clause 1 of this Section, any changes in
specifications, safety and efficacy of vaccines must be approved before
implementation; documents to be submitted shall comply with WHO guidelines on
changes to approved vaccines (WHO TRS 993 or its version) or the guidelines of
EMA or US-FDA.
3.
In order to meet regulatory requirements in Viet Nam, changes relating to
seasonal influenza and SARS-CoV-2 virus strains are subject to the following
provisions:
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Updating of seasonal influenza and
SARS-CoV 2 virus strains
Conditions to be fulfilled (C)
None
Documents to be submitted (D)
Part I (Administrative documents):
1. Application form (using the prescribed
form).
2. Certificate of Pharmaceutical Product
(CPP).
3. Batch release certificate or quality
control certificate issued by a competent authority of the CPP-issuing country
(i.e. manufacturing country or the country of one of the drug regulatory
authorities prescribed in Clause 9 Article 2 of this Circular). If the above
document is not available, certificate of quality control and general safety
issued by the National Institute for Control of Vaccines and Biologicals
(NICVB) or a state drug testing establishment in charge of testing,
evaluating and monitoring vaccines and medical biologicals as assigned by the
Ministry of Health shall be submitted.
4. Documents on origin of the original
strain.
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6. Drafts of label and package insert
approved by the DAV.
7. Revised drafts of the label and package
insert incorporating updated information on the new influenza strain.
Part II: Relevant quality documents as
prescribed in section C.III.2 of this Appendix.
1. For updates of SARS-CoV 2 virus strains:
Relevant quality, safety and efficacy documents shall be prepared and
submitted according to WHO’s official guidelines or the guidelines of EMA or
US-FDA regarding SARS-CoV updates.
Comply
with the guidelines in Section B of this Appendix (with appropriate
justifications for not submitting adequate documents as required due to specific
characteristics of the herbal drugs) or the following guidelines for specific
changes in the herbal drugs:
MaV-1.D
Change or addition of the source of
herbal materials
Conditions to be fulfilled (C)
The change or addition leads to a new source
of herbal materials with equivalent or better quality control.
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Part I (Administrative documents)
- Application form (using the prescribed
form).
- Legal documents of the manufacturer of the proposed
semi-finished herbal materials and herbal materials as prescribed in Clause 7
Article 22 of this Circular.
Part II (Quality documents):
- Quality documents in the part of documents
on materials as prescribed in Appendix III enclosed with this Circular;
- Certificate of analysis for the drug
product;
- Stability study data of the drug product
which is the same as those required for change/addition of the source of
materials for a chemical drug.
2.
MINOR VARIATIONS REQUIRING PRIOR APPROVAL FROM REGULATORY AUTHORITIES
No.
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MiV-PA1.D
Change of the titrant used for testing
materials
Conditions to be fulfilled (C)
Specifications of the material remain
unchanged, except the used titrant.
Documents to be submitted (D)
Part I (Administrative documents):
- Application form (using the prescribed
form).
Part II (Quality documents):
- Justification for the change
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- Revised specifications of the drug product
- Certificate of analysis of the drug product
according to the drug product specification after change of the titrant
- Certificate of analysis of the proposed
titrant
- Other relevant documents (if any).
MiV-PA2.D
Replacement/addition/deletion of
packaging material manufacturer
Conditions to be fulfilled (C)
- There is no change in the quality and
stability of the drug
Documents to be submitted (D)
Part I (Administrative documents):
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Part II (Quality documents):
- Specifications of the packaging material
(where applicable)
- Certificate of analysis for the packaging material.
MiV-PA3.D
Change of specifications of
semi-finished herbal materials
Conditions to be fulfilled (C)
- For non-compendial specifications of
semi-finished herbal materials only.
- Change is made exclusively to match
updates/changes in the relevant specifications of herbal materials in the
formula of semi-finished herbal materials according to the new version of the
same compendium (for compendial specifications) or updates in specifications
in the lead compendium (for non-compendial specifications).
Documents to be submitted (D)
Part I (Administrative documents):
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Part II (Quality documents):
- Comparative tabulated format of the
approved and proposed/updated specifications of the herbal material.
- Certificate of analysis for the herbal material
according to the proposed/updated specification.
- Comparative tabulated format of the
approved and proposed specifications of the semi-finished herbal material.
- Batch analysis data (in comparative
tabulated format) of the semi-finished herbal material for all tests in the
approved and proposed specifications.
- Revised specifications of herbal material
and semi-finished herbal material.
For change in analytical procedure according
to the changes in the proposed/updated specifications of the herbal material,
appropriate verification data of the proposed analytical procedure must be
provided.