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THE
MINISTRY OF HEALTH OF VIETNAM
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THE
SOCIALIST REPUBLIC OF VIET NAM
Independence-Freedom-Happiness
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No.
12/2025/TT-BYT
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Hanoi,
May 16, 2025
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CIRCULAR
PRESCRIBING MARKETING AUTHORIZATION OF DRUGS AND MEDICINAL
MATERIALS
Pursuant to the Law on Pharmacy
dated April 06, 2016;
Pursuant to the Law on
amendments to the Law on Pharmacy dated November 21, 2024;
Pursuant to the Law on
Technology Transfer dated June 19, 2017;
Pursuant to the Government’s
Decree No. 69/2018/ND-CP dated May 15, 2018 elaborating some articles of the
Law on Foreign Trade Management;
Pursuant to the Government’s
Decree No. 76/2018/ND-CP dated May 15, 2018 elaborating and providing
guidelines for implementation of the Law on Technology Transfer;
Pursuant to the Government’s
Decree No. 42/2025/ND-CP dated February 27, 2025 defining functions, tasks,
powers and organizational structure of the Ministry of Health of Vietnam (MoH);
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The Minister of Health of
Vietnam promulgates a Circular prescribing marketing authorization of drugs and
medicinal materials.
Chapter I
GENERAL PROVISIONS
Article 1.
Scope
1. This Circular elaborates and
provides guidelines for implementation of some Articles of the Law on Pharmacy
dated April 06, 2016 and the Law on amendments to the Law on Pharmacy dated
November 21, 2024 (hereinafter referred to as “the Pharmacy Law”), including:
a) Regulations on clinical data
about drug safety and efficacy in the application for marketing authorization,
criteria for exemption from clinical trial or certain stages thereof in
Vietnam, and drugs that have to undergo stage 4 clinical trial in clause 4
Article 89 of the Pharmacy Law;
b) Documentation requirements,
procedures for issuance, renewal, approval of variations and revocation of
marketing authorizations of chemical drugs, vaccines, biologicals, herbal drugs
and medicinal materials for human use in Vietnam 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 performing
pharmacovigilance activities as prescribed in clause 2 Article 78 of the
Pharmacy Law;
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2. This Circular does not apply to
applications for marketing authorization of traditional drugs; applications for
marketing authorization of medicinal materials which are herbal materials or
traditional medicinal materials.
Article 2.
Definitions
For the purposes of this Circular,
the terms used herein are construed as follows:
1. ASEAN common technical
dossier (ACTD) means a standardized format of common technical dossier for
registration of drugs of the Association of Southeast Asian Nations
(ASEAN).
2. ICH-CTD means the Common
Technical Document (CTD) developed by the International Conference on
Harmonisation (ICH) of Technical Requirements for Registration of
Pharmaceuticals for Human Use.
3. Major variations (MaV) are
variations that may affect significantly and/or directly the aspects of
quality, safety and efficacy of the drug, specified in Appendix II hereof.
4. Minor variations (MiV) are
variations with minimal or no significant impact on the aspects of quality,
safety and efficacy of the drug, specified in Appendix II hereof.
5. Applicant means the
establishment whose name appears on the application for issuance, renewal or
approval of variations to marketing authorization of a drug or medicinal
material.
6. Drug manufacturer means
the establishment that carries out one or some or all of the manufacturing
processes or release of the batch of drug.
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8. Certificate of Pharmaceutical
Product (CPP) means a certificate issued in the format recommended by the
World Health Organization (WHO) according to WHO’s certification scheme on the
quality of pharmaceutical products moving in international commerce.
9. European Medicines Agency
(EMA) and Stringent Regulatory Authorities (SRAs) are the following
agencies:
A) European Medicines Agency (EMA);
b) Stringent Regulatory Authorities
(SRAs): drug regulatory authorities that are considered as SRAs by WHO. SRAs
include:
- Members of ICH established before
October 23, 2015, including: US-FDA, drug regulatory authorities of European
Union, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), and
Japan’s Pharmaceuticals Medical Devices Agency (PMDA);
- ICH observers established before
October 23, 2015, including: drug regulatory authorities of European Free Trade
Association (EFTA), and representatives of Swissmedic and Health Canada;
- Regulatory authorities associated
with ICH members through legally-binding, mutual recognition agreements made
before October 23, 2015, including: Australia, Iceland, Liechtenstein and
Norway.
10. Product license holder or
marketing authorization holder means the establishment that holds the
marketing authorization of the drug written on the Certificate of
Pharmaceutical Product (CPP) issued using WHO's format.
11. Drug processing means
manufacturing of a drug under a lawfully signed processing contract under which
the processing facility takes charge of one, some or all of the stages in the
manufacturing process at the request of the ordering facility and receives
processing costs in return.
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13. Ordering facility means
the party that provides a part or all of ingredients, materials, manufacturing
process, and technical documents proving the quality, safety, and efficacy of
the drug for the processing facility to process the drug under a processing
contract signed by and between the parties.
14. Processing facility means
the party that uses a part or all of ingredients, materials, manufacturing
process, and technical documents provided by the ordering facility to perform
one, some or all of the stages in the manufacturing process at the request of
the ordering facility, and receives processing costs under a processing
contract signed by and between the parties.
15. Sending facility means
the party that transfers its lawfully acquired ownership of, or right to use,
the drug manufacturing technology to a receiving facility for application to one,
some or all of the stages in the drug manufacturing process.
16. Receiving facility means
the party that receives the ownership of, or right to use, the drug
manufacturing technology transferred from the sending facility under a
technology transfer contract signed by and between the parties for application
to one, some or all of the stages in the drug manufacturing process.
17. Drug ordered for processing means
a drug which has been granted the marketing authorization in Vietnam or the
product license in at least one country in the world, and one, some or all of
the stages in the manufacturing process of which shall be performed at the
processing facility's facility at the request of the ordering facility under a
processing contract signed by and between the parties.
18. Processed drug means a
drug one, some or all of the stages in the manufacturing process of which are
performed by the processing facility at the request of the ordering facility
under a processing contract signed by and between the parties.
19. Drug before technology
transfer means a drug which has been granted the marketing authorization in
Vietnam or the product license in at least one country in the world, and the
ownership of, or right to use, the technology for manufacturing of which is
transferred from the sending facility to the receiving facility for application
to one, some or all of the stages in the manufacturing process.
20. Drug manufactured adopting
transferred technology means a drug one, some or all of the stages in the
manufacturing process of which are performed by the receiving facility adopting
the technology transferred, as prescribed in clause 1 Article 4 of the Law on
Technology Transfer, from the sending facility under a technology transfer
contract signed by and between the parties.
Article 3.
Responsibilities of applicants
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1. Assume the full legal
responsibility for accuracy, legitimacy and truthfulness of all documents
included in its marketing authorization application (MAA) for drugs/medicinal
materials, except the cases specified in clause 1 Article 4 hereof; Cooperate
with domestic and foreign authorities and manufacturers in responding to
inquiries of DAV regarding the authenticity of legal documents included in its
MAA.
2. Ensure quality, safety and
efficacy of the drugs/medicinal materials as declared in its MAA.
3. Send a written notice to DAV
within 15 days from the date on which a decision to revoke the marketing
authorization or decision to recall the drug/medicinal material is issued in
any country in the world if the drug/medicinal material has been granted the
marketing authorization in Vietnam which has not yet expired, except cases of
voluntary withdrawal of the marketing authorization for commercial reasons in
the countries other than the country where CPP which is included in the
submitted MAA is issued; the reasons for such revocation or recall must be also
specified in the notice.
4. Cooperate, at the request of
competent authorities, with the drug manufacturer in doing studies or providing
additional information about the registered drug when there is information or
evidence about the safety and efficacy of the drug during its marketing.
5. Cooperate with the drug
manufacturer, importer and distributor in monitoring, supervising, collecting,
consolidating and analyzing information, and sending reports to the National
Centre of Drug Information and Adverse Reactions Monitoring (National DI &
ADR Centre) on post-vaccination reactions and adverse reactions of the drug in
accordance with Clause 5 Article 77 of the Pharmacy Law, National
Pharmacovigilance Guidelines issued by MoH and relevant regulations.
6. Take responsibility for issues
relating to intellectual property rights of the drugs/medicinal materials
registered in Vietnam in accordance with regulations of law on intellectual
property.
7. Implement the approved risk
management plan included in MAA for a new chemical drug, vaccine or biological
(except probiotic biological products).
8. An applicant for the marketing
authorization for a processed drug shall discharge the responsibilities set
forth in clauses 1, 2, 3, 4, 5, 6, 7 and 10 of this Article, and the following:
a) Send a written notice to DAV
within 30 days from the date on which a competent authority gives approval of
variations to technical documents of the drug ordered for processing during its
marketing in case the processed drug meets the requirements laid down in clause
1 Article 9 hereof;
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c) Send a written notice to DAV
within 30 days from the date on which the manufacturing of the drug ordered for
processing is stopped;
d) Regarding the processed drug
which meets the requirements laid down in clause 1 Article 9 hereof, within 03
months from the date on which changes in the formulation, manufacturing
process, quality specifications of materials, or quality specifications of drug
products, or trade name of the drug ordered for processing which is being
manufactured and placed on the market in its country of origin are approved by
a competent authority of its country of origin, the applicant must make changes
corresponding to those changes in the drug ordered for processing.
9. An applicant for the marketing
authorization for a drug manufactured adopting transferred technology shall
discharge the responsibilities set forth in clauses 1, 2, 3, 4, 5, 6, 7 and 10
of this Article, and the following:
a) Send a written notice to DAV
within 30 days from the date on which a competent authority gives approval of
variations to technical documents of the drug before technology transfer during
its marketing in case the drug manufactured adopting transferred technology
meets the requirements laid down in clause 1 Article 9 hereof;
b) Send a written notice to DAV
within 15 days from the date on which a decision to revoke the marketing
authorization of the drug before technology transfer is issued in any country
in the world (during the validity period of the marketing authorization of the
drug manufactured adopting transferred technology);
c) Send a written notice to DAV
within 30 days from the date on which the manufacturing of the drug before
technology transfer is stopped;
d) Regarding the drug manufactured
adopting transferred technology which meets the requirements laid down in
clause 1 Article 9 hereof, within 03 months from the date on which changes in
the formulation, manufacturing process, quality specifications of materials, or
quality specifications of drug products, or trade name of the drug before
technology transfer which is being manufactured and placed on the market in its
country of origin are approved by a competent authority of its country of
origin, the applicant must make changes corresponding to those changes in the
drug before technology transfer.
10. Fulfill other relevant
responsibilities as prescribed in relevant laws.
Article 4.
Responsibilities of drug/medicinal material manufacturers
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2. Closely cooperate with the
applicant in fulfilling the responsibility in clause 3 Article 3 hereof.
3. Cooperate with the applicant in
complying with competent authorities’ requests for inspection or evaluation of
the manufacturing site.
4. Within 15 days from the date on
which a competent regulatory authority of its country of origin issues a notice
that the manufacturer has its license revoked or fails to meet GMP (Good
Manufacturing Practices) requirements for drugs/medicinal materials, the
manufacturer shall send a written notice of such event to DAV.
5. Retain all documents on
registration of the drug/medicinal material and provide them to competent
regulatory authorities upon their request, including those documents specified
in point e clause 7 Article 22 hereof.
6. Implement the approved risk
management plan included in MAA for a new chemical drug, vaccine or biological
(except probiotic biological products).
7. A manufacturer that is a processing
facility shall discharge the responsibilities set forth in clauses 1, 2, 3, 4,
5, 6 and 9 of this Article, and the following:
a) Fulfill the obligations as
prescribed in Article 182 of the Law on Commerce and clause 2 Article 42 of the
Government’s Decree No. 69/2018/ND-CP dated May 15, 2018 elaborating some
Articles of the Law on Foreign Trade Management (hereinafter referred to as
“Decree No. 69/2018/ND-CP”);
b) Regarding the processed drug
which meets the requirements laid down in clause 1 Article 9 hereof, within 03
months from the date on which changes in the formulation, manufacturing
process, quality specifications of materials, or quality specifications of drug
products, or trade name of the drug ordered for processing which is being manufactured
and placed on the market in its country of origin are approved by a competent
authority of its country of origin, the manufacturer must cooperate with the
applicant in making changes corresponding to those changes in the drug ordered
for processing.
c) Follow procedures for applying
for a processing permit to be eligible to perform the drug processing at the
request of a ordering facility that is a foreign trader as prescribed in clause
4 Article 38 of the Decree No. 69/2018/ND-CP in respect of MAA for the
processed drug which is imported and exported with permit.
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a) Fulfill the obligations set out
in Article 26 of the Law on Technology Transfer;
b) Regarding the drug manufactured
adopting transferred technology which meets the requirements laid down in
clause 1 Article 9 hereof, within 03 months from the date on which changes in
the formulation, manufacturing process, quality specifications of materials, or
quality specifications of drug products, or trade name of the drug before
technology transfer which is being manufactured and placed on the market in its
country of origin are approved by a competent authority of its country of
origin, the manufacturer must cooperate with the applicant in making changes
corresponding to those changes in the drug before technology transfer;
c) Carry out procedures for
registration of technology transfer as prescribed in Article 31 of the Law on
Technology Transfer, Article 5 of the Government’s Decree No. 76/2018/ND-CP
dated May 15, 2018 elaborating some Articles of the Law on Technology Transfer.
9. Fulfill other relevant
responsibilities as prescribed in relevant laws.
Article 5.
Responsibilities of ordering facilities
1. Fulfill the obligations of an
ordering facility as prescribed in Article 181 of the Law on Commerce and
Clause 1 Article 42 of the Decree No. 69/2018/ND-CP.
2. Provide the processing facility
with:
a) A part or all of materials, and
technical documents, including manufacturing process, quality specifications
and test methods for starting materials, semi-finished products, finished
products and auxiliary materials of the ordered processing stage(s).
b) Other documents relating to
application for marketing authorization of processed drug and relating to the
drug processing.
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4. Cooperate with the applicant for
marketing authorization for processed drug in fulfilling the responsibility in
clause 8 Article 3 hereof.
5. Fulfill other relevant
responsibilities as prescribed in relevant laws.
Article 6.
Responsibilities of sending facilities
1. Fulfill the obligations of a
technology sending facility as prescribed in clause 2 Article 25 of the Law on
Technology Transfer.
2. Provide the receiving facility
with:
a) Technical documents, including
manufacturing process, quality specifications and test methods for starting
materials, semi-finished products, finished products and auxiliary materials of
the stage(s) performed using transferred technology;
b) Other documents relating to
application for marketing authorization of the drug manufactured adopting
transferred technology and relating to the drug manufacturing technology
transfer.
3. Assume responsibility for the
accuracy, legitimacy and truthfulness of technical documents provided for the
receiving facility in comparison to the dossier on the drug before technology
transfer approved by a competent authority.
4. Cooperate with the applicant for
marketing authorization for the drug manufactured adopting transferred
technology in fulfilling the responsibility in clause 9 Article 3 hereof.
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Article 7. Drug
processing contract
In addition to the contents prescribed
in Article 39 of the Decree No. 69/2018/ND-CP, a drug processing contract must
also include:
1. Agreements on supply of
materials. Agreements on provision by the ordering facility of the following
technical documents for the processing facility, including: manufacturing
process, quality specifications and test methods for starting materials,
semi-finished products, finished products and auxiliary materials, and other
documents relating to the drug processing.
2. Rights and responsibilities of
the ordering facility, the processing facility and the applicant (if any), in
respect of:
a) in each stage of the
manufacturing process, the manufacturing process, quality control, storage and
transport of starting materials, semi-finished products, drug products,
auxiliary materials, procedures for packaging, printing or labeling of
processed drug, and responsibilities of the signatories of the certificate of
analysis for each batch of drug products and the release certificate of the
processed drug; and
b) the retention of documents and
records relating to manufacturing, quality control, distribution, marketing of
the drug, retention of drug samples, settlement of issues relating to quality,
complaints, and recall of the drug products.
3. Responsibilities of the ordering
facility, the processing facility and the applicant (if any) for the matters
relating to the intellectual property rights over the processed drug.
4. Procedures for inspection or
supervision of the manufacturing site.
5. Contract termination cases and
responsibility for breach of agreements.
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In addition to the contents
prescribed in Article 23 of the Law on Technology Transfer, a technology
transfer contract must also include:
1. Agreements on provision by the
sending facility of the following technical documents for the receiving
facility, including: manufacturing process, quality specifications and test
methods for starting materials, semi-finished products, finished products and
auxiliary materials, and other documents relating to the drug manufacturing
technology transfer.
2. Responsibilities of the sending
facility, the receiving facility and the applicant for the matters relating to
the intellectual property rights over the drug manufactured adopting transferred
technology.
3. Contract termination cases and
responsibility for breach of agreements.
Article 9.
Classification of processed drugs, drugs manufactured adopting transferred
technology
Processed drugs/drugs manufactured
adopting transferred technology are classified as:
1. Processed drug/drug manufactured
adopting transferred technology having the same trade name, formulation,
quality specifications of materials, quality specifications of drug products
as, and having manufacturing process similar to that of, the drug ordered for
processing/the drug before technology transfer.
In case of any changes in the
abovementioned criteria (except change in the trade name) of the processed
drug/the drug manufactured adopting transferred technology or any other changes
in the quality of the drug, the applicant must provide the comparative
tabulated summary of such changes (Form 01/TT) and relevant technical documents
according to guidelines in Appendix II enclosed herewith in order to prove the
quality equivalence between the processed drug/the drug manufactured adopting
transferred technology and the drug ordered for processing/the drug before
technology transfer.
2. Other processed drug/drug
manufactured adopting transferred technology which does not fall in the case
specified in clause 1 of this Article.
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1. Each applicant shall submit the
following reports to serve the monitoring of safety and efficacy of the drug
during its marketing:
a) Periodic report, for new drugs,
vaccines and biologicals (except probiotic biological products) (Form 2A/TT
enclosed herewith);
b) Individual case safety report
(ICSR) on adverse events (including adverse drug reactions, medication errors,
suspected counterfeit or substandard medicines and therapeutic ineffectiveness
or lack of efficacy) which occur in Vietnam (Form 2B/TT enclosed herewith).
2. Reporting time:
a) For periodic reports as
prescribed in point a clause 1 of this Article:
After obtaining a marketing
authorization, the applicant shall submit reports on a periodical basis of
every 06 months within the first 02 years; from the third year to the fifth
year, the applicant shall submit reports on an annual basis;
b) For ICSRs as prescribed in point
b clause 1 of this Article:
The applicant shall submit ICSRs
within the time limit prescribed in the National Pharmacovigilance Guidelines
issued by MoH.
3. Submission methods, recipients:
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4. Handling and assessment of
reports, and provision of information for state regulatory authorities and
Specialized Councils of MoH to serve management of marketing
authorization-related tasks:
Comply with the National
Pharmacovigilance Guidelines issued by MoH.
Article 11.
Language, format of documents, submission methods, inclusion of multiple
drugs/medicinal materials in an MAA, validation methods
1. Language of documents included
in an MAA:
All documents included in an MAA
shall be written in either Vietnamese or English language. The package insert
of the drug to be marketed in Vietnam shall be written in Vietnamese language.
2. Format of documents:
a) Documents included in an MAA for
drug/medicinal material must be prepared according to ACTD or ICH-CTD
guidelines and provisions herein;
b) Regarding an MAA imposing data
confidentiality requirements, the applicant shall comply with provisions of the
Circular No. 05/2010/TT-BYT dated March 01, 2010 of the Minister of Health of
Vietnam providing guidelines for confidentiality of test data in marketing
authorization application (hereinafter referred to as “Circular No.
05/2010/TT-BYT”).
3. MAA submission methods:
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b) In case MAAs are submitted via
the online public service portal of MoH, applicants shall comply with
provisions of the Government’s Decree No. 45/2020/ND-CP dated April 08, 2020
prescribing completion of administrative procedures in electronic environment,
as amended by the Government’s Decree No. 59/2022/ND-CP dated September 05,
2022 prescribing electronic identification and authentication, the Government’s
Decree No. 68/2024/ND-CP dated June 25, 2024 prescribing specialized digital
signatures for public services, and the Government’s Decree No. 69/2024/ND-CP
dated June 25, 2024 prescribing electronic identification and authentication.
4. Multiple drugs may be included
in a single MAA if they:
a) are of the same manufacturer;
and
b) have the same name; drug
substances or herbal materials; strength, concentration, or weight of drug
substances or herbal materials in a single dose; dosage form; administration
route; formulation; quality specifications of the drug.
5. MAA validation methods:
a) An MAA shall be considered by
different teams in charge of validating legal documents, quality
specifications, dosage form, pharmacology, clinical data and bioequivalence,
depending on constituent parts of the submitted application for issuance,
renewal or approval of variations to the marketing authorization;
b) Parts of legal documents,
quality specifications, dosage form, pharmacology, clinical data and
bioequivalence must be adequately validated according to ACTD or ICH-CTD
guidelines and provisions herein, including name of the document to be
validated and requirements to be satisfied corresponding to each matter of
validation as prescribed in this Circular;
c) Validation of an MAA in the case
prescribed in clause 10 Article 26 hereof is subject to the following
provisions:
- Based on the documents specified
in clause 10 Article 26 hereof, validation is carried out to verify the
consistency of the technical documents included in the MAA submitted in Vietnam
with those of the drug granted product license by a drug regulatory authority
mentioned in clause 9 Article 2 hereof.
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Article 12.
Validity periods, symbols of marketing authorizations, deadline for application
submission
1. The validity period of a
marketing authorization is 05 years from the issuance date or renewal date,
except for the cases specified in clause 2 of this Article.
2. The validity period of a
marketing authorization of the following drugs subject to extended monitoring
of safety and efficacy is 03 years from the issuance date or renewal date:
a) New drugs, vaccines and
biologicals (except probiotic biological products) which are granted the
marketing authorization in Vietnam for the first time;
b) Drugs having the same drug substance(s),
concentration, strength or dosage form as those of a new drug which has not
been granted a 05-year marketing authorization;
c) Any of the drugs specified in
point a or b of this clause which is not actually placed on the market during
the validity period of its marketing authorization;
d) A drug which is mentioned in
neither of points a, b and c of this clause but is subject to an extended
monitoring of safety and efficacy as advised by the Marketing Authorization
Advisory Board (hereinafter referred to as “the Advisory Board”).
3. When a marketing authorization
of drug or medicinal material expires after DAV has received an application for
renewal thereof, it may be used until an official approval for renewal is
granted or DAV issues a notification that the application for renewal is
rejected or the marketing authorization is suspended in case the drug or
medicinal material is found potentially unsafe for users or legal documents in
the application are suspected of being forged.
4. Each approved MAA shall be
granted a marketing authorization with a unique marketing authorization number
whose structure is specified in Appendix V enclosed herewith.
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6. An MAA which is to be validated
using reference to available validation results must be submitted to DAV within
05 years from the date on which the drug is approved for the first time by a
drug regulatory authority prescribed in clause 9 Article 2 hereof according to
the validation report.
Article 13.
Criteria for classification of original brand-name drugs and reference
biologicals
1. Criteria for classification of
original brand-name drugs and reference biologicals:
a) A drug which has been granted
marketing authorization shall be classified as an original brand-name drug when
it meets all of the following criteria:
- 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 hereof.
b) A drug which has been granted
marketing authorization shall be classified as a reference biological when it
meets all of the following criteria:
- It is granted a marketing authorization
in Vietnam on the basis of sufficient quality, safety and efficacy data;
- Its clinical data meets the
requirements laid down in Article 18 hereof and is sufficient to prove that it
is developed as a biological product other than a biosimilar product from the
first stage.
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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 in the new manufacturing site, they must be approved by the
drug regulatory authority that issued the marketing authorization for that drug
or the applicant must provide the comparative tabulated summary of such changes
(Form 01/TT) and relevant technical documents according to the guidelines in
Appendix II enclosed herewith in order to prove the quality equivalence between
the drug manufactured by the new manufacturer or in the new manufacturing site
and the original brand-name drug or reference biological.
Regarding changes in the
manufacturer or manufacturing site of reference biologicals, additional
documents proving quality equivalence must be provided according to guidelines
of US FDA, ICH, WHO, EMA, and international organizations to which Vietnam is a
member, and guidelines given by the drug regulatory authorities prescribed in
clause 9 Article 2 hereof.
3. If a drug ordered for processing
or drug before technology transfer, whether it has been classified as original
brand-name drug or reference biological or not, has clinical data meeting the
requirements laid down in point a or b clause 1 of this Article and is
processed or manufactured adopting transferred technology in Vietnam, the
processed drug or the drug manufactured adopting transferred technology shall
be classified as original brand-name drug or reference biological if it fully
meets the criteria set out in clause 2 of this Article and in point d clause 2
Article 38 hereof.
4. Cases in which drugs are
classified as original brand-name drugs or reference biologicals:
a) The request for classification
of original brand-name drug or reference biological is included in the
submitted MAA of the drug:
The applicant shall submit a
request for classification of original brand-name drug or reference biological
when submitting an MAA of the drug. The MAA which is validated and approved for
grant of the marketing authorization must meet the criteria set out in clause
1, 2 or 3 of this Article;
b) Request for classification of a
drug which has been granted marketing authorization as an original brand-name
drug or reference biological:
The applicant shall submit a
request for classification of a drug which has been granted marketing
authorization as an original brand-name drug or reference biological in the
form of variations to the marketing authorization as prescribed in Appendix II
enclosed herewith. An application for approval of variations to the marketing
authorization which is validated and approved must meet the criteria set out in
clause 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 an
application for renewal or approval of variations to its marketing
authorization is put under consideration. The applicant is not required to
submit request for classification of the drug as an original brand-name drug or
reference biological.
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Drugs granted the marketing
authorization in Vietnam shall be classified as drugs having demonstrated
bioequivalence when their bioequivalence study reports on meet the requirements
laid down in the Circular No. 07/2022/TT-BYT dated September 05, 2022 of the
Minister of Health of Vietnam 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 Vietnam (hereinafter referred to as
“Circular No. 07/2022/TT-BYT”).
Article 15.
Principles, criteria and methods for classification of OTC drugs
1. Principles for classification of
OTC drugs:
a) Ensure safety for drug users;
b) Ensure people’s timely access to
drugs;
c) Conform to the reality of use
and supply of drugs in Vietnam;
d) Be harmonized with principles
and regulations on classification of OTC drugs announced by the States in the
region and the world.
2. Criteria for determination of
OTC drugs:
A drug shall be classified as an
OTC drug if it meets all criteria below:
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b) It is indicated to be used for
short-term treatment of common diseases which can be treated by patients
themselves without prescription and monitoring by healthcare workers;
c) It rarely causes dependency;
does not pose risks of overdose or misuse, which will cause harm to users’
health; does not hide symptom indicators of a serious disease, potentially
leading to delayed diagnosis and treatment;
d) It must have simple dosage form
and route of administration that allow users to take it on their own without
the need for technical assistance or instructions from physicians or healthcare
workers; not require any special conditions for storage or handling before and
after use;
dd) It does not contain any of
herbal ingredients on the List of toxic herbal ingredients announced by
Minister of Health.
3. Methods for classification of
OTC drugs
a) Generic drugs are classified as
OTC drugs according to the classification of the original brand-name drugs
granted marketing authorization in Vietnam;
b) If the original brand-name drugs
granted marketing authorization in Vietnam are not available, drugs are
classified as OTC drugs according to the classification of drugs which have the
same active ingredients, herbal materials, strength, concentration and dosage
forms as those of drugs granted marketing authorization in the countries of the
drug regulatory authorities prescribed in clause 9 Article 2 hereof;
c) Drugs are classified as OTC
drugs according to the classification of the drugs which have the same active
ingredients, herbal materials, strength, concentration and dosage forms and
have been granted marketing authorization in Vietnam if meeting the principles
and criteria set out in clauses 1 and 2 of this Article;
d) Classification of OTC drugs in
other cases shall be subject to opinions given by the Advisory Council on the
basis of the principles and criteria set out in clauses 1 and 2 of this
Article.
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Applicants that wish to keep the
information in their MAAs confidential shall follow the guidelines in the
Circular No. 05/2010/TT-BYT and include their request (which is made using Form
No. 4A/TT enclosed herewith) in their submitted MAAs.
Article 17.
Verification of legal documents in applications for issuance, renewal or
approval of variations to marketing authorization
1. The authenticity of CPP included
in an application for issuance, renewal or approval of variations to marketing
authorization must be verified in the following cases:
a) Information on the CPP is
founded to have been erased or altered;
b) The manufacturer or applicant
has incurred administrative penalties imposed by Vietnam’s competent
authorities for the violation in point q clause 2 Article 42 of the Pharmacy
Law. Verification of CPP shall be required for 03 years from the issue date of
the penalty imposition decision or, if the violating manufacturer or applicant
is suspended from submitting applications for issuance or renewal of marketing
authorization, from the end of the suspension period;
c) The manufacturer applies for
marketing authorization in Vietnam for the first time, including the cases
where the manufacturer only engages in one or some stages of the manufacturing
process;
d) CPP is an electronic copy issued
by a foreign country’s competent authority but cannot be found by accessing the
website or database provided by the applicant during validation;
dd) The verification is made at the
request of the Advisory Board.
2. The authenticity of legal
documents in MAAs shall be also verified in some other cases:
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b) The legal documents issued by
competent authorities of foreign countries do not yet meet the requirements
laid down in point b clause 1 Article 22 hereof.
3. Regarding drugs granted the
marketing authorization, DAV shall carry out verification of legal documents
when it receives information relating to the licensing and/or marketing of the
drug in its country of origin which needs to be verified or clarified, or any
information about the failure to satisfy operating conditions by the foreign
manufacturer or applicant from the following sources:
a) Written document sent to DAV,
which includes adequate information about the name and address of the sender,
and is accompanied with relevant supporting documents;
b) Information obtained from the
mass media.
4. Verification of the authenticity
of CPP and legal documents included in MAAs shall be carried out in the following
forms:
a) Verification of the authenticity
of legal documents concerning consular legalization:
DAV shall cooperate with the
Consular Department affiliated to the Ministry of Foreign Affairs of Vietnam or
Vietnamese diplomatic missions performing consular legalization tasks in
foreign countries to verify the competence and information concerning the
consular legalization of foreign legal documents for use in Vietnam in the
cases specified in point c clause 1 and point a clause 2 of this Article;
b) Verification of the authenticity
of legal documents:
DAV shall cooperate with issuing
authorities to verify the information on such legal documents in the cases
specified in points a, b, d and dd Clause 1 and point b clause 2 of this
Article;
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d) A request for verification of
the authenticity of legal documents shall be also sent to the relevant
applicant.
5. Regarding an application for
issuance of marketing authorization containing the legal documents subject to
verification as prescribed in clauses 1 and 2 of this Article, the
drug/medicinal material shall only be granted a marketing authorization if
competent authorities are satisfied with verification results as prescribed in
clause 4 of this Article.
6. Regarding an application for
renewal or approval of variations to the marketing authorization containing the
legal documents subject to verification as prescribed in clauses 1 and 2 of
this Article, it is not mandatory to obtain verification results before the
grant of approval for renewal or variations.
Chapter II
CLINICAL DATA REQUIREMENTS FOR ASSURANCE OF DRUG
SAFETY AND EFFICACY, AND CRITERIA FOR EXEMPTION FROM CLINICAL TRIAL OR CERTAIN
STAGES THEREOF, AND DRUGS THAT HAVE TO UNDERGO STAGE 4 CLINICAL TRIAL IN
VIETNAM
Article 18.
Clinical data requirements for assurance of drug safety and efficacy
1. Any drug for which an MAA is
submitted must have sufficient clinical data to prove its safety and efficacy.
2. Sufficient clinical data means
data obtained from studies conducted, reported and assessed in conformity with
guidelines given by MoH or other organizations accredited by Vietnam (ICH, WHO,
EMA, and other international organizations of which Vietnam is a member,
guidelines given by the drug regulatory authorities prescribed in clause 9
Article 2 hereof).
Article 19.
Criteria for exemption from clinical trial in Vietnam
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1. It is a generic drug meeting any
of the following criteria:
a) It has bioequivalence data as
prescribed in the Circular No. 07/2022/TT-BYT;
b) It is not subject to
bioequivalence study reporting upon submission of MAA in Vietnam as prescribed
in the Circular No. 07/2022/TT-BYT.
2. It is a new drug (except
vaccines) meeting all criteria below:
a) It has been granted marketing
authorization in at least one country in the world;
b) It is supported by adequate
clinical data as prescribed in Article 18 hereof;
c) Its clinical data is sufficient
for analysis and justification of the impact of ethnic factors of Asian
populations on the safety and efficacy of the drug according to ICH-E5 guidelines.
3. It is an herbal drug granted the
marketing authorization before January 01, 2017.
Article 20.
Criteria for exemption from certain stages of clinical trial in Vietnam
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a) The drug or vaccine is meant to
serve urgent needs for national defense and security, epidemic prevention and
control, disaster recovery and cannot be replaced by any other drug available
on the market; it is meant to treat a rare or fatal disease;
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 hereof on the basis of a reduced
clinical data package as prescribed by this authority.
2. A new drug or vaccine exempted
from certain stages of clinical trial in Vietnam must meet all criteria below:
a) It has been granted marketing
authorization in at least one country in the world;
b) Its clinical data is not yet
adequate as prescribed in Article 18 hereof or its clinical data is adequate as
prescribed in Article 18 hereof but does not include sufficient assessment of the
impact of ethnic factors on the safety and efficacy of the drug.
Article 21.
Criteria for drugs that have to undergo stage 4 clinical trial
Drugs have been granted marketing
authorization but their safety and efficacy need additional evaluation as proposed
by the Advisory Board.
Chapter III
MARKETING AUTHORIZATION APPLICATIONS FOR
DRUGS/MEDICINAL MATERIALS
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Article 22.
General provisions on administrative documents
1. The documents specified in
clauses 3, 4, 5, 6 and 7 Article 26 hereof (hereinafter referred to as “legal
documents”) included in an MAA must meet the following requirements:
a) The legal documents included in
an MAA must be originals or copies as prescribed in the Government’s Decree No.
23/2015/ND-CP dated February 16, 2015 prescribing issuance of copies extracted
from master registers, certified true copies of originals, signature
certification and certification of contracts and transactions. The legal
documents issued by foreign competent authorities must bear consular
legalization in accordance with regulations of law on consular legalization,
unless such consular legalization procedures are exempted in accordance with
regulations of law;
b) Legal documents must bear
authorized signatures, full names of signatories, issue dates and seals of
competent authorities of their issuing countries, unless a legal document which
does not bear all of these required information pieces is still considered
valid according to the domestic legislation of the issuing country;
c) In case of an electronic legal
document (which does not have to bear the authorized signature, name of the
signatory or seal of the issuing authority), the applicant is required to
submit one of the following documents:
- The legal document printed from
the website or database of the issuing authority or from the website operated
by a competent authority of the country of origin or regional authority;
- The result of searching for the
legal document from the English database or website of the issuing authority or
from the website operated by a competent authority of the country of origin or
regional authority. This result must bear the applicant’s seal and be
accompanied with a document providing information about the search link;
d) A legal document which has
validity period written thereon must be still valid on the date of receipt
specified on the MAA receipt note. In case a CPP does not contain the validity
period thereon, it shall be 24 months from its issue date.
2. For CPPs:
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b) CPP must be issued by a
competent authority of the manufacturing country or the authority competent to
issue CPP of the country of one of the drug regulatory authorities prescribed
in clause 9 Article 2 hereof to certify that the drug has been granted
marketing authorization and is actually placed on the market of that country;
c) In case of serving the purpose
of meeting the needs for prevention and treatment of any group A infectious
disease causing an epidemic which has been declared in accordance with
regulations of law on prevention and control of infectious diseases, the CPP
may be replaced by another document issued by a competent authority confirming
that the drug has been granted marketing authorization and is being used in the
country of origin and fully stating information about name and address of the
manufacturer and licensing conditions;
d) Where a CPP fails to meet the
requirements laid down in points a, b of this clause, it shall be subject to
the decision issued by the Minister of Health on the basis of opinions given by
the Advisory Board if the drug has been granted marketing authorization by a
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 meant to serve the needs for national defense and security, epidemic
prevention and control, disaster recovery, or a state health program;
- It is a vaccine used in the
national expanded immunization program for which another substitute vaccine
with equivalent quantity, quality, safety, efficacy or costs is not available
on the market;
- In other cases under a mutual
recognition agreement between competent authorities in terms of conditions for
manufacturing and marketing of drugs, vaccines and biologicals;
dd) The information displayed on
the CPP must be consistent with relevant information in the MAA. In case the
information on the CPP is not consistent with that in the administrative
documents of the MAA, the applicant shall provide an explanatory report and
relevant documentary evidence.
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
authorized signatures and seals. Digital signatures are permitted but signature
stamps are not permitted;
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- Chairperson of the Board of
Members or the Board of Directors; general director; chief executive officer;
director of the manufacturer or applicant;
- A person who is assigned to sign
documents as defined in the company charter, written task assignment or another
document proving his/her authority to sign documents;
- Persons who are authorized by the
persons mentioned in paragraph 1 or 2 of this point.
4. For letters of authorization:
a) The letter of authorization to
act as an applicant must be the original containing adequate information as
follows:
- Name and address of the
authorizing product license holder/marketing authorization holder or
manufacturer;
- Name and address of the
authorized applicant;
- Name, concentration, strength of
drug substance, and dosage form of the drug;
- Contents of authorization.
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b) The letter of authorization to
sign the documents included in the MAA must be the original containing adequate
information as follows:
- Name and address of the
applicant;
- Names and titles of the
authorizing person and the authorized person;
- Name, concentration, strength of
drug substance, and dosage form of the drug;
- Contents of authorization;
- Validity period of the letter of
authorization.
In case the authorization involves
multiple drugs, the letter of authorization shall have a list of drugs with
adequate information as prescribed in paragraph 3 of this point;
c) Quantity of the letter of
authorization in an MAA:
- In case the applicant is not the
manufacturer or the product license holder/marketing authorization holder, each
submitted MAA shall include a letter of authorization to act as the applicant;
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5. An applicant must have one of
the following legal documents:
a) A Vietnamese applicant must have
a certificate of satisfaction of conditions for pharmaceutical business
covering one of the following business lines: manufacture, wholesaling, import
and export of drugs/medicinal materials;
b) A foreign applicant must have a
license to manufacture and trade drugs which is issued by a foreign competent
authority and covers one of the following business lines: manufacture,
wholesaling, import and export of drugs/medicinal materials, and a license to
establish representative office in Vietnam.
If the applicant’s name or address
on the license to establish representative office in Vietnam is different from
that on its legal documents issued by foreign competent authorities,
documentary evidence therefor is required.
In cases where the applicant is
also the manufacturer written on the CPP, the legal documents mentioned in this
Clause are not required.
In cases where the license for
manufacture, wholesaling, export or import of drugs/medicinal materials is not
issued in any country, it is required to have an establishment license or
business registration license which covers at least one of the following business
lines: manufacture, wholesaling, export or import of drugs/medicinal materials,
and is accompanied with a certification issued by a competent authority that
the applicant meets relevant business conditions and is operating in the
pharmaceutical field, or one of the following documents: certificate of GMP
(Good Manufacturing Practices) compliance, certificate of GDP (Good
Distribution Practices) compliance, certificate of GSP (Good Supply Practices)
compliance or certificate of GSP (Good Storage Practices) compliance.
Regarding medicinal materials: if
the country of origin does not grant pharmaceutical business licenses to
medicinal material traders, other licenses which are issued according to the
domestic legislation of the country of origin and cover one of the following
business lines: manufacture, wholesaling, export or import of medicinal
materials, shall be accepted.
6. The certificate that the
medicinal material is permitted to be manufactured or marketed in the
manufacturing country must have the following information: name of the
medicinal material, name and address of the manufacturer, the manufacturing
country, signature, seal and full name of the signatory.
7. Documents proving compliance
with GMP guidelines submitted by a manufacturer of drug substances, excipients,
capsule shells, or herbal materials (for manufacture of herbal drugs) may be
any of the following documents:
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b) The manufacture license
containing certification of GMP compliance;
c) For a drug substance, the CPP
containing certification of GMP compliance;
d) The Certificate of suitability
to the Monographs of the European Pharmacopoeia (CEP);
dd) Other legal documents which are
issued by competent authorities and have the following mandatory information:
name and address of the manufacturer, certification of GMP compliance, and name
of the drug substance, herbal material, excipient or capsule shell;
e) For the excipients in an MAA:
In case the documents specified in
points a, b, d and dd of this clause cannot be provided, the manufacturer of
drug products or semi-drug products shall carry out self-evaluation of GMP
compliance for excipients manufacturers according to regulations in point dd
clause 1 Article 3, point b clause 3 Article 3 and point dd clause 5 Article 20
of the Circular No. 35/2018/TT-BYT dated November 22, 2018 of the Minister of
Health (as amended in points a, b, and dd clause 6 Article 1 of the Circular
No. 29/2020/TT-BYT dated December 31, 2020 of MoH), include in its submitted MAA
a declaration of GMP compliance (using Form No. 05/TT enclosed herewith), and
take legal responsibility for such provided declaration;
g) For herbal materials in an MAA:
In case the documents specified in
points a and b of this clause cannot be provided, a certificate of compliance
with GACP (Good Agricultural and Collection Practices) for starting materials
of herbal origin shall be submitted.
8. The samples of the label and
package insert of the drug to be marketed in Vietnam shall comply with the
Circular No. 01/2018/TT-BYT dated January 18, 2018 of the Minister of Health of
Vietnam prescribing labeling and package inserts of drugs and medicinal
materials, as amended by the MoH’s Circular No. 23/2023/TT-BYT dated November
30, 2023 providing amendments to the Circular No. 01/2018/TT-BYT dated January
18, 2018 of the Minister of Health of Vietnam prescribing labeling and package
inserts of drugs and medicinal materials, (hereinafter referred to as “Circular
No. 01/2018/TT-BYT”) and the following provisions:
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b) The secondary package label of
the drug/medicinal material must bear a printed barcode, QR code, DataMatrix
code or another printed code, as prescribed by relevant laws, of the
manufacturer to serve management, identification and tracing of origin of the
drugs and medicinal materials placed on the market according to the roadmap
prescribed in point h clause 1 Article 55 hereof;
c) The secondary package label of
the drug product/semi-drug product must have the name of every drug substance
or herbal material in the formulation, and strength, weight or concentration
thereof in a smallest dose or smallest package unit of the drug
product/semi-drug product;
d) Regarding the dosage form or
packaging form which requires stability study after opening according to ACTD
or ICH-CTD guidelines, the package insert must include information on the shelf
life and storage conditions after opening;
dd) The samples of the label and
package insert of a biosimilar must clearly provide information on its
reference biological.
Article 23.
General provisions on quality documents
1. Specifications, test method,
certificate of analysis and stability study documents (for both drug substances
and drug product) must be original copies bearing the seal of the manufacturer;
in case there are multiple establishments participating in the manufacture of
the drug product, the seal of the establishment responsible for quality control
of the drug or batch release shall be accepted.
In case the manufacturer uses a
digital signature instead of a seal, the applicant shall append its seal to and
assume legal responsibility for the accuracy, legitimacy and truthfulness of
these documents.
2. The certificate of analysis of a
drug/medicinal material must meet the following requirements:
a) The testing report shall be made
in either Vietnamese or English language. If it is made in a language
other than Vietnamese or English language, a notarized Vietnamese or English
translation shall be required;
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c) A certificate of analysis shall,
inter alia, include:
- Name and address of the
manufacturer, number of the certificate of analysis, name and signature of the
responsible person, and issuance date of the certificate of analysis. In case a
certificate of analysis is made using an electronic signature, regulations of
law on electronic transactions shall apply. In case a certificate of analysis
does not bear the signature of the responsible person, the certificate of
analysis bearing the manufacturer's seal shall be accepted. The applicant shall
assume the full legal responsibility for the accuracy and legitimacy of the
submitted certificate of analysis;
- Information on the sample of
drug/medicinal material, including: name of the product; batch number, shelf
life/expiry date or retest date (for medicinal material), applied
specifications, quality indicators, quality requirements, test results,
conclusion on quality of the batch.
3. Certificate of analysis, results
of validation of specifications, and experimental test methods adopted by state
laboratories in charge of testing drugs/medicinal materials at the request of
regulatory authorities:
The certificate of analysis,
results of validation of specifications, and experimental test methods must
bear certification of GLP-compliant state laboratories in charge of testing
drugs/medicinal materials.
Article 24.
Clinical documents required for assurance of the drug safety and efficacy in
MAAs
1. For new chemical drugs, vaccines
and biologicals:
a) Clinical data must be sufficient
to prove safety and efficacy and meet the following requirements:
- Clinical studies on the drug,
data included in the clinical documents must be in conformity with ICH
guidelines, guidelines given by MoH or other organizations accredited by
Vietnam (including international organizations of which Vietnam is a member,
and the drug regulatory authorities prescribed in clause 9 Article 2 hereof);
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- A drug with new combination of
drug substances must have sufficient clinical data according to guidelines of
WHO, US FDA, EMA on clinical development of fixed combination medicinal
products as prescribed in Appendix I enclosed herewith;
b) If a vaccine has sufficient
clinical data for evaluation of its safety and efficacy as prescribed in point
a of this clause but is yet to be granted marketing authorization by a drug
regulatory authority prescribed in clause 9 Article 2 hereof, it is required to
have clinical data pertinent to its safety and immunogenicity in the target
populations in Vietnam before granting marketing authorization;
c) Biosimilars must have sufficient
clinical data according to the guidelines of MoH or WHO, US FDA, EMA for
development of biosimilar products as prescribed in Appendix I enclosed
herewith;
d) In case of changes in the
manufacturer (including such a change in the manufacturing site) of a
biological, additional documents proving quality equivalence between biological
products of the former manufacturer and those of the new manufacturer shall be
provided according to guidelines of US FDA, ICH, WHO, EMA, and international
organizations to which Vietnam is a member, and guidelines given by the drug
regulatory authorities prescribed in clause 9 Article 2 hereof.
2. For chemical drugs which are new
drugs other than original brand-name drugs:
One of the following clinical data
shall be submitted:
a) Clinical data meeting the
requirements laid down in point a clause 1of this Article;
b) Clinical data of a similar drug
with the same drug substances, concentration, strength, dosage form and
administration route, granted marketing authorization by one of the drug
regulatory authorities prescribed in clause 9 Article 2 hereof, which is used
with the permission of the clinical data owner. The clinical data of the
similar drug must also meet the requirements laid down in point a clause 1of
this Article;
c) Clinical data obtained from
researches published in medical literatures which are scientific documents in
medical sector, including clinical study or trial reports, scientific articles,
medical journals, pharmaceutical journals, medical and pharmaceutical books
(hereinafter referred to as "medical publications") and data on
comparative bioequivalence studies involving similar drugs which have the same
drug substances, concentration, strength, dosage form and administration route,
have been granted marketing authorization by one of the drug regulatory
authorities prescribed in clause 9 Article 2 hereof, and are in compliance with
MoH's regulations on reference drugs in bioequivalence studies.
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It is required to have clinical
data or data obtained from documents meeting one of the following requirements:
a) Clinical studies of the drug, data
in clinical documents must meet the requirements laid down in Article 18 hereof
or be conformable with the guidelines for preclinical and clinical studies of
herbal drugs of MoH as prescribed in Appendix III enclosed herewith or of other
organizations accredited by Vietnam, including WHO’s Research guidelines for
evaluating the safety and efficacy of herbal medicines, or of the drug
regulatory authorities prescribed in clause 9 Article 2 hereof;
b) Drug/medicinal material
monographs of pharmacopoeias or drug formularies of Vietnam or other countries
in the world;
c) Articles on evaluation of safety
and efficacy of the drug published on international journals of WOS (Web of
Science) and Scopus, clinical data obtained from researches published in other
medical publications;
d) Reports on evaluation of safety
and efficacy in a national, ministerial or provincial research which has been
accepted.
4. For chemical drugs which have
the same drug substances, strength, concentration, administration route and
dosage form as those of drugs granted marketing authorization by one of the
drug regulatory authorities prescribed in clause 9 Article 2 hereof but do not
have original brand-name drugs granted marketing authorization in Vietnam or
whose strength, concentration, administration route or dosage form is different
from that of original brand-name drugs granted marketing authorization in
Vietnam, one of the following clinical data must be submitted:
a) Clinical data meeting the
requirements laid down in point a clause 1 of this Article;
b) Clinical data collected from
researches published in medical publications, accompanied with the package
insert or summary of product characteristics of the drug which has the same
drug substances, strength, concentration, administration route and dosage form
and has been granted marketing authorization by one of the drug regulatory
authorities prescribed in clause 9 Article 2 hereof.
5. Submission of safety and
efficacy documents in MAAs for the following drugs is exempted:
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b) Drugs which have the same drug
substances, strength, concentration, administration route and dosage form as
those of the drugs granted marketing authorization as prescribed in clause 4 of
this Article. In this case, the drug package insert must be conformable with
that of the drug granted marketing authorization as prescribed in clause 4 of
this Article.;
c) Probiotic biological products
with origins, bacterial strain, concentration, strength, indications and doses
that are similar to biologicals licensed by one of the drug regulatory
authorities prescribed in clause 9 Article 2 hereof;
d) Topical chemical drugs with
direct local action which have the same drug substances, strength,
concentration, dosage form and indications as those of the drugs granted
marketing authorization in Vietnam for at least 30 years and included in the
monographs of Vietnamese pharmacopoeia or reference pharmacopoeia or Vietnamese
National Drug Formulary;
dd) Topical drugs which contain
drug substances being essential oils or purified essential oil extracts
(including synthetic and semi-synthetic substances) and have the same drug
substances, strength, concentration, and dosage form as those of a drug which
has been granted marketing authorization in Vietnam for at least 10 years or
which has been licensed and marketed in at least one country in the world for
at least 10 years;
e) Orally administered drugs
containing herbal materials combined with drug substances which are essential
oils or purified essential oil extracts (including synthetic and semi-synthetic
substances) or drugs containing purified active ingredients extracted from
herbal materials with the same drug substances, herbal materials, strength,
concentration, dosage form and indications as those of a drug granted marketing
authorization in Vietnam;
g) Herbal drugs which have the same
herbal materials, strength, concentration or weight of herbal materials, dosage
form, indications and administration route as those of a drug granted marketing
authorization by one of the drug regulatory authorities prescribed in clause 9
Article 2 hereof or a drug granted marketing authorization in Vietnam (even if
it has expired).
6. MAAs for any drugs other than
those specified in clauses 1, 2, 3, 4 and 5 of this Article must have
sufficient clinical data to prove their safety and efficacy in conformity with
the guidelines of ICH, WHO, US FDA, EMA, Ministry of Health of Vietnam or other
organizations accredited by Vietnam.
7. If a clinical study has been
carried out before the regulations or guidelines mentioned in point a clause 1
and point a clause 3 of this Article are adopted, the data of such study may be
acceptable.
Section 2.
STRUCTURE AND COMPOSITION OF MARKETING AUTHORIZATION APPLICATIONS FOR
DRUGS/MEDICINAL MATERIALS
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1. MAAs shall be prepared according
to ACTD or ICH-CTD, and in compliance with regulations herein.
2. Structure of MAAs for chemical
drugs, vaccines and biologicals:
a) The ASEAN Common Technical
Dossier (ACTD) is organized into four parts as follows:
- Part I: Administrative Document.
- Part II: Quality Document.
- Part III: Nonclinical Document.
- Part IV: Clinical Document.
b) ICH-CTD:
- Module I: Administrative
Document.
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- Module III: Quality Document.
- Module IV: Nonclinical Document.
- Module V: Clinical Document.
3. Structure of MAAs for herbal
drugs; orally administered drugs containing herbal materials combined with drug
substances which are essential oils or purified essential oil extracts
(including synthetic and semi-synthetic substances); drugs containing purified
active ingredients extracted from herbal materials:
a) For herbal drugs which are new
drugs; orally administered drugs containing herbal materials combined with drug
substances which are essential oils or purified essential oil extracts
(including synthetic and semi-synthetic substances); drugs containing purified
active ingredients extracted from herbal materials:
- Part I: Administrative Document.
- Part II: Quality Document:
Comply with the guidelines in
Appendix III enclosed herewith.
- Part III: Clinical data or data
obtained from the sources prescribed in clause 3 Article 24 hereof;
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- Part I: Administrative Document.
- Part II: Quality Document:
Comply with the guidelines in
Appendix III enclosed herewith.
4. Structure of MAAs for medicinal
materials:
a) Part I: Administrative Document.
b) Part II: Quality Document:
Comply with the guidelines in
Appendix IV enclosed herewith.
Article 26.
Administrative Document
1. Application forms are made using
Form 4A/TT, Form 4B/TT, Form 4C/TT enclosed herewith.
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a) Letter of authorization to act
as applicant, if the applicant is not the manufacturer;
b) Letter of authorization to sign
documents in MAA (if any).
3. CPP (for imported drugs).
4. License to manufacture and trade
drugs in the country of origin; license to establish representative office in
Vietnam (for a foreign applicant).
5. Certificate of satisfaction of
conditions for pharmaceutical business (for a Vietnamese applicant).
6. Legal documents of the
manufacturer of drug substances, excipients, capsule shells or herbal materials
as prescribed in clause 7 Article 22 of this Circular.
7. Certificate that the medicinal
material is permitted to be manufactured or marketed in the manufacturing
country (for medicinal materials manufactured in a foreign country).
8. Samples of the label of drug/medicinal
material and the package insert:
a) of the drug/medicinal material
to be marketed in Vietnam;
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9. Summary of product
characteristics or package insert approved at the country of origin (for new
drugs, vaccines, biologicals, or drugs of which MAA is validated using
reference to available validation results as requested by applicant).
10. Regarding an MAA to be
validated using reference to available validation results or an MAA for a drug
which is manufactured in a country where none of the drug regulatory
authorities prescribed in clause 9 Article 2 hereof is located but is only
supported by 01 CPP issued by the authority competent to issue CPP of the
country of one of the drug regulatory authorities prescribed in clause 9
Article 2 hereof to certify that the drug has been granted marketing
authorization and is actually placed on the market of that country, the
following documents must be additionally submitted:
a) The validation report which is
made by one of the drug regulatory authority prescribed in clause 9 Article 2
hereof and meets the requirements laid down in Article 30 hereof;
b) Comparative tabulated summary of
similarities between the MAA in Vietnam and information on the drug granted
marketing authorization in the country of origin, which is made using Form
09/TT enclosed herewith.
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.
Biosimilars must have sufficient
documents and data to prove their quality similarity with reference biologicals
according to the guidelines of WHO, US FDA, EMA.
2. If materials are supported by
CEP, the documents on the drug substance may be replaced by the following
documents:
- The CEP for the drug substance,
accompanied with all annexes issued by the European Directorate for the Quality
of Medicines & Healthcare (EDQM);
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- If the quality retest date of the
drug substance is not specified in the CEP, the stability study data of the
drug substance shall be submitted.
3. For vaccines, antisera,
derivatives of human blood and plasma, documents shall be submitted according
to clause 1 of this Article and include the following:
a) The batch release certificate
issued by a competent authority of the country in which the CPP is issued or
one of the drug regulatory authorities prescribed in Clause 9 Article 2 of this
Circular;
b) The certificate of analysis,
specifications and test method certified by the National Institute for Control
of Vaccines and Biologicals (NICVB) or state drug testing facilities in charge
of testing, evaluating and monitoring vaccines and medical biological as
assigned by MoH.
4. For rare drugs, drugs serving
national defense and security, epidemic prevention and control, disaster
recovery, and drugs serving special treatment needs:
a) Rare drugs which are used for
treating rare diseases:
Existing stability study data
obtained according to the guidelines of ASEAN or ICH shall be accepted;
b) For drugs serving national
defense and security, epidemic prevention and control, disaster recovery:
Stability study data existing at
the application submission date shall be accepted for consideration of the
expiry date of the drug according to opinions given by the Advisory Board if
the time period covered by the stability study data fails to meet the minimum
study period requirements laid down in the ASEAN guidelines.
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If the stability study result of
the drug fails to meet the study proposal included in the marketing
application, the applicant shall submit a report to DAV for submission to the
Advisory Board for considering the drug’s expiry date.
Based on opinions given by the
Advisory Board, DAV shall consider making decision on the expiry date of drug,
including the batch of drugs manufactured, according to the actual stability
study data;
c) For drugs serving special
treatment needs:
Existing stability study data
according to ASEAN or ICH guidelines shall be accepted according to the
Minister of Health’s decision issued on the basis of opinions given by the
Advisory Board if the applicant proves that the drug cannot be stored in
climatic zone IVb according to ASEAN guidelines.
5. With regard to the cases
prescribed in clause 2 Article 13 hereof:
The applicant is required to submit
a comparative tabulated summary (Form 01/TT enclosed herewith) of the drug
before and after the change, and relevant technical documents according to the
guidelines in Appendix II enclosed herewith.
Article 28.
Nonclinical Document
Nonclinical documents are prepared
and submitted according to the guidelines in Part III of ACTD or Module 2 and
Module 4 of ICH-CTD and relevant guidelines or the guidelines in Appendix III
enclosed herewith.
Article 29.
Clinical Document
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Article 30.
Documents on validation results given by drug regulatory authorities prescribed
in clause 9 Article 2 hereof in case MAAs are validated using reference to
available validation results
1. They must be official validation
reports which are issued by the drug regulatory authorities prescribed in
clause 9 Article 2 hereof and include details of the validation and evaluation
of quality, safety and efficacy of the drug as well as the scientific and legal
grounds for issuance of the marketing authorization in the country of origin.
2. Validation reports must be final
reports used by the drug regulatory authorities as the basis for grant of
marketing authorization for the drug product, and reports on validation and
approval of changes or variations to the drug product after grant of marketing
authorization.
3. A validation report which is
used as reference for valuation of an MAA shall, inter alia, include the
following contents:
a) Administrative information must
include:
- Particulars of the drug;
- List of all approved packaging
specifications;
- Pharmacological class;
- Particulars of the
manufacturer/marketing authorization holder:
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- Assessment of composition
and manufacturing process;
- Assessment of quality
control;
- Assessment of stability,
including conclusions regarding product quality;
c) Safety and efficacy information
must include:
- Summary assessment of primary
nonclinical data;
- Summary assessment of primary
clinical data;
- Assessment of benefits and risks;
- Basis for approved indications.
4. If validation reports issued by
the drug regulatory authorities prescribed in clause 9 Article 2 hereof are
made in a language other than English, their notarized English or Vietnamese
transactions are required.
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Article 31.
Marketing authorization applications for drugs prescribed in clauses 1, 2 and 6
Article 24 hereof
1. Administrative Document:
As prescribed in Article 26 hereof.
2. Quality Document:
As prescribed in Article 27 hereof.
3. Nonclinical Document:
Include the documents prescribed in
clauses 1, 2, 6 and 7 Article 24 hereof and comply with provisions of Article
28 hereof.
4. Clinical Document:
Include the documents prescribed in
clauses 1, 2, 6 and 7 Article 24 hereof and comply with provisions of Article
29 hereof.
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Article 32.
Marketing authorization applications for generic drugs and drugs prescribed in
points b, c and d clause 5 Article 24 hereof
1. Administrative Document:
As prescribed in Article 26 hereof.
2. Quality Document:
a) The documents prescribed in
Article 27 hereof;
b) Documentary evidence of the drug
having demonstrated bioequivalence, for drugs containing drug substances or in
dosage forms requiring bioequivalence study reporting upon submission of an
MAA.
Article 33.
Marketing authorization applications for drugs prescribed in clause 4 Article
24 hereof
1. Administrative Document:
As prescribed in Article 26 hereof.
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a) The documents prescribed in
Article 27 hereof;
b) Documentary evidence of the drug
having demonstrated bioequivalence, for drugs containing drug substances or in
dosage forms requiring bioequivalence study reporting upon submission of an
MAA.
3. Clinical Document:
Include the documents prescribed in
clause 4 Article 24 hereof and comply with provisions of Article 29 hereof.
4. The package insert or summary of
product characteristics of the drug which has the same drug substances,
strength, concentration, administration route and dosage form and has been
granted marketing authorization by one of the drug regulatory authorities prescribed
in clause 9 Article 2 hereof, in case of submission of clinical data collected
from researches published in medical publications.
5. Where necessary, additional
safety and efficacy data must be submitted according to opinions given by the
Advisory Board.
Article 34.
Marketing authorization applications for drugs prescribed in points dd and e
clause 5 Article 24 hereof
1. Administrative Document:
As prescribed in Article 26 hereof.
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As prescribed in Appendix III
enclosed herewith.
Article 35.
Marketing authorization applications for drugs prescribed in clause 3 Article
24 hereof
1. Administrative Document:
As prescribed in Article 26 hereof.
2. Quality Document:
As prescribed in Appendix III
enclosed herewith.
3. Clinical data or data obtained
from the sources prescribed in clause 3 Article 24 hereof.
Article 36.
Marketing authorization applications for drugs prescribed in point g clause 5
Article 24 hereof
1. Administrative Document:
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2. Quality Document:
As prescribed in Appendix III
enclosed herewith.
Article 37.
Marketing authorization applications for medicinal materials
1. Administrative Document:
As prescribed in Article 26 hereof.
2. Quality Document:
As prescribed in Appendix IV
enclosed herewith.
Section 4.
SPECIFIC PROVISIONS ON MARKETING AUTHORIZATION APPLICATIONS FOR PROCESSED DRUGS
AND DRUGS MANUFACTURED ADOPTING TRANSFERRED TECHNOLOGY IN VIETNAM
Article 38.
Marketing authorization applications for processed drugs and drugs manufactured
adopting transferred technology which are chemical drugs, vaccines and
biologicals
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a) The administrative documents of
the processed drug/drug manufactured adopting transferred technology as
prescribed in Article 26 hereof. The submission of legal documents of the
manufacturer of drug substances, excipients, capsule shells or herbal materials
shall not be required if the processing or technology transfer contract only
covers the packaging stage;
b) Other documents concerning the
processing or technology transfer, including:
- The drug processing contract or
technology transfer contract. In case the ordering facility or the processing
facility is not the applicant, the drug processing contract must bear
signatures of legal representatives of the ordering facility, the applicant and
the processing facility.
- Processing permit as prescribed
in clause 4 Article 38 of the Decree No. 69/2018/ND-CP, in respect of an MAA
for the processed drug which is imported and exported with permit;
- Certificate of registration of
technology transfer as prescribed in Article 31 of the Law on Technology
Transfer, in respect of an MAA for the drug manufactured adopting transferred
technology;
c) CPP of the drug ordered for
processing or the drug before technology transfer if it is imported drug which
is not yet granted marketing authorization in Vietnam or whose marketing
authorization in Vietnam has expired at the time of MAA submission.
2. Quality Document:
a) The quality documents of the
processed drug, drug manufactured adopting transferred technology, drug ordered
for processing and drug before technology transfer as prescribed in Articles
31, 32, 33, 34 and 35 hereof;
b) The comparative tabulated
summary (Form 01/TT enclosed herewith) of changes between the drug ordered for
processing and the processed drug or between the drug before technology
transfer and the drug manufactured adopting transferred technology, and
relevant technical documents as prescribed in Appendix II enclosed herewith;
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d) If an MAA includes a request for
classification of the processed drug/drug manufactured adopting transferred
technology as an original brand-name drug or as drug having demonstrated
bioequivalence, the following documents must be additionally submitted:
- Bioequivalence study report of
the processed drug/drug manufactured adopting transferred technology;
The applicant may replace the
bioequivalence study report of the processed drug/drug manufactured adopting
transferred technology with dissolution similarity study reports between the
processed drug and the drug ordered for processing or between the drug
manufactured adopting transferred technology and the drug before technology
transfer, if the processed drug or the drug manufactured adopting transferred
technology has the same formulation, manufacturing process, specifications of
materials, specifications of drug product as those of the drug ordered for
processing or the drug before technology transfer according to the guidelines
of US FDA SUPAC, ICH, WHO, EMA, international organizations to which Vietnam is
a member, or the guidelines given by the drug regulatory authorities prescribed
in clause 9 Article 2 hereof.
In case of changes in the
abovementioned contents which do not require submission of the bioequivalence
study report of the drug, the applicant shall submit documents relevant to each
change according to the guidelines of US FDA SUPAC, ICH, WHO, EMA,
international organizations to which Vietnam is a member, or the guidelines
given by the drug regulatory authorities prescribed in clause 9 Article 2
hereof.
- The bioequivalence study report
of the drug ordered for processing or the drug before technology transfer, if
the drug ordered for processing or the drug before technology transfer is not
yet declared as a drug having demonstrated bioequivalence in Vietnam and a
request for declaration of bioequivalence of the processed drug or the drug
manufactured adopting transferred technology is submitted.
3. Nonclinical and clinical
documents:
a) For the processed drug or the
drug manufactured adopting transferred technology:
The nonclinical documents as
prescribed in clause 3 Article 31 hereof and the clinical documents as
prescribed in clause 4 Article 31 hereof, in respect of the processed drug or
the drug manufactured adopting transferred technology which is a new chemical
drug, vaccine or biological.
Submission of nonclinical and
clinical documents is not required in the following cases:
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- The drug ordered for processing
or the drug before technology transfer is a biological granted a marketing
authorization in Vietnam which is still valid at the time of MAA submission or
whose nonclinical documents, as prescribed in clause 3 Article 31 hereof, and
clinical documents, as prescribed in clause 4 Article 31 hereof, have been
submitted, and there are sufficient documents to prove quality equivalence
between the processed drug and the drug ordered for processing or between the
drug manufactured adopting transferred technology and the drug before
technology transfer;
- The drug ordered for processing
or the drug before technology transfer is a vaccine granted a marketing
authorization in Vietnam which is still valid at the time of MAA submission and
there are sufficient documents to prove quality equivalence between the
processed drug and the drug ordered for processing or between the drug
manufactured adopting transferred technology and the drug before technology
transfer;
b) For the drug ordered for
processing or the drug before technology transfer:
The nonclinical documents as
prescribed in clause 3 Article 31 hereof and the clinical documents as
prescribed in clause 4 Article 31 hereof, in case the processed drug or the
drug manufactured adopting transferred technology is a new chemical drug,
vaccine or biological, or the MAA includes a request for classification of the
processed drug or the drug manufactured adopting transferred technology as an
original brand-name drug or reference biological if the drug ordered for
processing or the drug before technology transfer is yet to be classified as an
original brand-name drug or reference biological.
4. The risk management plan, for
new chemical drugs, vaccines and biologicals (except probiotic biological
products) (Form 03/TT enclosed herewith).
Article 39.
Marketing authorization applications for processed drugs and drugs manufactured
adopting transferred technology which are herbal drugs
1. Administrative Document:
a) The administrative documents of
the processed drug/drug manufactured adopting transferred technology as
prescribed in Article 26 hereof. The submission of legal documents of the
manufacturer of herbal materials, excipients, or capsule shells shall not be
required if the processing or technology transfer contract only covers the
packaging stage;
b) Other documents concerning the
processing or technology transfer, including:
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- The processing permit as
prescribed in clause 4 Article 38 of the Decree No. 69/2018/ND-CP, in respect
of an MAA for the processed drug which is imported and exported with permit;
- Certificate of registration of
technology transfer as prescribed in Article 31 of the Law on Technology
Transfer, in respect of an MAA for the drug manufactured adopting transferred
technology;
c) CPP of the drug ordered for processing
or the drug before technology transfer if it is an imported drug which is not
yet granted marketing authorization in Vietnam or whose marketing authorization
in Vietnam has expired at the time of MAA submission.
2. Quality Document:
a) The quality documents of the
processed drug, drug manufactured adopting transferred technology, drug ordered
for processing and drug before technology transfer as prescribed in Articles 35
and 36 hereof;
b) The comparative tabulated
summary (Form 01/TT enclosed herewith) of changes between the drug ordered for
processing and the processed drug or between the drug before technology
transfer and the drug manufactured adopting transferred technology, and
relevant technical documents as prescribed in Appendix II enclosed herewith.
3. Clinical Document:
a) For the processed drug or the
drug manufactured adopting transferred technology:
The clinical documents as
prescribed in clause 3 Article 35 hereof, if the processed drug or the drug
manufactured adopting transferred technology is a new drug.
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b) For the drug ordered for
processing or the drug before technology transfer:
- The clinical documents as
prescribed in clause 3 Article 35 hereof, if the processed drug or the drug
manufactured adopting transferred technology is a new drug;
- The clinical documents as
prescribed in Article 18 hereof, for an MAA including a request for
classification of the processed drug or the drug manufactured adopting
transferred technology as an original brand-name drug if the drug ordered for
processing or the drug before technology transfer is yet to be classified as an
original brand-name drug.
Article 40.
Marketing authorization application for a drug processed adopting technology
transferred from the ordering facility to the processing facility
1. The MAA includes the documents
prescribed in Article 38 or 39 of this Circular.
2. The applicant must also submit:
a) The drug processing contract and
the technology transfer contract;
b) The processing permit as
prescribed in clause 4 Article 38 of the Decree No. 69/2018/ND-CP, in respect
of an MAA for the processed drug which is imported and exported with permit,
and the certificate of registration of technology transfer as prescribed in
Article 31 of the Law on Technology Transfer.
Section 5.
SPECIFIC PROVISIONS ON APPLICATIONS FOR RENEWAL OR APPROVAL OF VARIATIONS TO
MARKETING AUTHORIZATION OF DRUGS/MEDICINAL MATERIALS
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1. An application form for renewal
of marketing authorization of drug/medicinal material which is made using Form
4B/TT enclosed herewith.
2. The unexpired CPP (for an
imported drug).
3. A report on safety and efficacy
of the drug during its marketing which is made using Form 2C/TT enclosed
herewith.
Article 42.
Application for approval of variations to marketing authorization of
drug/medicinal material
1. An application form for approval
of variations to the marketing authorization of drug/medicinal material which
is made using Form 4C/TT enclosed herewith and the letter of authorization to
sign documents in the application (if any).
2. Documents relevant to major
variations/minor variations as prescribed in Appendix II enclosed herewith.
3. Regarding changes in the
technical documents of the processed drug/the drug manufactured adopting
transferred technology which have been declared conformable with the criteria
set out in clause 1 Article 9 hereof, the applicant shall provide evidence that
changes in the drug ordered for processing/the drug before technology transfer
which is being manufactured and marketed in the country of origin has been
approved by a competent regulatory authority.
Chapter IV
AUTHORITY TO APPROVE AND PROCEDURES FOR ISSUANCE,
RENEWAL AND APPROVAL OF VARIATIONS TO MARKETING AUTHORIZATION OF DRUGS AND
MEDICINAL MATERIALS
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1. DAV shall consider issuing,
renewing and approving variations to marketing authorizations of
drugs/medicinal materials on the basis of the application validation results
and consulting opinions given by the Advisory Board in the following cases:
a) Issue marketing authorizations
of drugs/medicinal materials;
b) Grant approval of renewal of
marketing authorizations of drugs/medicinal materials on the basis of the
application validation results and consulting opinions given by the Advisory
Board in the following cases:
- The drugs prescribed in clause 2
Article 12 of this Circular;
- The drugs or medicinal materials
subject to decisions on mandatory or voluntary recall due to nonconformance
with quality specifications during their marketing from the latest issuance or
renewal of marketing authorization;
- The drug which is reported using
Form 2C/TT enclosed herewith to have new adverse events or adverse events that
are known but occur at a higher frequency than the frequency stated in the
approved package insert or adverse events that are known but require further
evaluation;
c) Grant approval of variations to
the marketing authorization as prescribed in Appendix II enclosed herewith in
respect of:
Classification of prescription
drugs, OTC drugs, changes in indications, dose, administration route, intended
users; classification of original brand-name drugs, reference biologicals, and
drugs having demonstrated bioequivalence.
2. DAV shall consider granting
approval of renewal and variations to marketing authorizations of
drugs/medicinal materials on the basis of the application validation results
without requiring application validation results and consulting opinions given
by the Advisory Board in the following cases:
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b) Grant approval of variations to
marketing authorizations of drugs/medicinal materials in cases other than those
prescribed in point c clause 1 and clause 3 of this Article, and updates to the
package insert according to the relevant original brand-name drug.
3. DAV shall publish on the web
portal of MoH and on its website the variations to marketing authorization of
drugs/medicinal materials without requiring application validation in respect
of the minor variations that only require notification.
Article 44.
Submission of additional documents during validation, cases in which variation
application is not required, and periods of applying existing information
before approving or publishing variations
1. The applicant is required to
submit additional documents within 06 months from the date on which it receives
a written request from DAV. Otherwise, its submitted application will no longer
be valid.
The period of time starting from
the date on which DAV sends a request for additional documents to the date on
which additional documents are submitted shall not be included in the
calculation of the time limit prescribed in clause 6 Article 56 of the Pharmacy
Law.
2. Times of submission of
additional documents to an application for issuance, renewal or approval of
variations to marketing authorization of drug/medicinal material:
a) Additional documents to an
application for issuance, renewal or approval of variations to marketing
authorization of drug/medicinal material may be submitted up to 02 times.
In case an application is
considered unsatisfactory by validators after 02 times of submission of
additional documents, DAV shall request the Advisory Board to refuse to issue
or renew the marketing authorization or refuse to approve variations thereto,
in respect of the drugs prescribed in clause 1 Article 43 hereof, or shall give
written notices of refusal to renew the marketing authorization or to approve
variations thereto, in respect of the drugs prescribed in clause 2 Article 43
hereof.
If an application is considered
unsatisfactory by validators after 02 times of submission of additional
documents as a result of a new issue found, DAV shall request the Advisory
Board to allow the applicant to submit additional documents one more time in
order to provide justifications for the issue, in respect of the drugs
prescribed in clause 1 Article 43 hereof, or shall give a written request for
submission of additional documents one more time, in respect of the drugs
prescribed in clause 2 Article 43 hereof;
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3. During the validation of an
application, the applicant shall not be allowed to make any variations in terms
of the contents of the submitted application other than those requested by DAV,
except the following documents:
a) Documents providing safety and
efficacy updates to the package insert, in respect of an application for
issuance of marketing authorization or approval of variations thereto;
b) Documents providing updated
administrative information in terms of change of the name or address of the
manufacturer without replacing the manufacturer, in respect of an application
for issuance of marketing authorization or approval of variations thereto;
c) Documents providing updated
administrative information in terms of change of the name or method of writing
address of the manufacturer without replacing the manufacturer and changing the
manufacturing site, in respect of an application for issuance of marketing
authorization or approval of variations thereto;
d) Documents providing updated
information on the actual marketing of the drug in Vietnam, in respect of an
application for renewal of the marketing authorization.
4. Regarding an application for
renewal of the marketing authorization of the drug/medicinal material
prescribed in Article 41 hereof, the applicant shall only be allowed to make
change of the drug product name specified in the submitted application package
and the application form for renewal.
5. When considering issuing the marketing
authorization for a new drug which is indicated to serve the prevention and
treatment of any group A infectious disease causing an epidemic which has been
declared in accordance with regulations of law on prevention and control of
infectious diseases, DAV must not carry out validation of technical documents
and assessment of compliance with GMP requirements on the basis of recognizing
licensing results given by one of the drug regulatory authorities prescribed in
clause 9 Article 2 hereof.
6. The applicant or manufacturer
shall themselves update the label and package insert of the drug without
submitting a variation application or sending notification to DAV in the
following cases:
a) The information position or
information about the importer of the drug/medicinal material on the label or
package insert is changed;
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c) The label or package insert is
revised according to the Official Dispatch given by DAV on the basis of
consulting opinions given by the Advisory Board;
d) Unless the sample label or
package insert has to be re-submitted in cases of variations specified in
Appendix II enclosed herewith, other changes in the information on the label or
package insert shall be updated by the applicant or manufacturer after they are
approved by DAV;
dd) Other contents:
- Change of the information
position or information about the importer of the drug/medicinal material on
the label or package insert;
- Correction of spelling errors on
the label or package insert;
- Change of the layout of
information items on the package insert without altering the meaning of the
approved information thereon;
- Change or addition of
specifications on the label or package insert as approved by DAV;
- Deletion of information other
than the compulsory one on the label or package insert.
7. At the latest 12 months after
DAV issues an official dispatch approving or publishing variations, the
application of such approved variations to the drug/medicinal material is
compulsory. Within 12 months after DAV issues an official dispatch approving or
publishing variations, the application of such variations shall be subject to
the following provisions:
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b) Any drug/medicinal material
manufactured in Vietnam shall continue to be manufactured and marketed until
the end of its shelf life with its information existing before such variations
are approved or announced.
8. At the latest 12 months after
grant of an approval for renewal of the marketing authorization of the
drug/medicinal material which covers the change of its name, the use of the new
name of the drug/medicinal material which is approved upon grant of such
approval is compulsory. Within 12 months after grant of an approval for renewal
of the marketing authorization, the use of the drug name is subject to the
following provisions:
a) An imported drug/medicinal
material shall continue to be imported and marketed until the end of its shelf
life using its name existing before grant of an approval for renewal of the
marketing authorization provided that the shipment departs from the port of the
exporting country before the date on which the new name which is covered in
such approval is compulsorily used as prescribed;
b) Any drug/medicinal material
manufactured in Vietnam shall continue to be manufactured and marketed until
the end of its shelf life using its name existing before grant of an approval
for renewal of the marketing authorization.
Article 45.
Procedures for issuance of marketing authorizations of drugs/medicinal
materials
1. Application submission method:
Applications shall be submitted
according to provisions of Article 16 of the Decree No. 61/2018/ND-CP.
2. Application receipt and
processing time limit:
a) Application receipt:
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DAV shall receive the application
without requesting the applicant to submit a CPP in the case prescribed in
point d clause 2 Article 22 hereof and the documents prescribed in point b
clause 3 Article 27 hereof at the time of application submission;
b) Time limits for processing
applications counted from the date of application receipt:
- Application for issuance of
marketing authorization of a drug: not exceeding 12 months;
- Application for issuance of
marketing authorization of a drug which is validated using reference to
available validation results: not exceeding 09 months;
- Application for issuance of
marketing authorization of a processed drug/drug manufactured adopting
transferred technology, in case the drug ordered for processing/drug before
technology transfer has been granted a marketing authorization in Vietnam which
is still valid at the date of application submission, or a drug processed
adopting technology transferred from the ordering facility to the processing
facility, in case the drug ordered for processing has been granted a marketing
authorization in Vietnam which is still valid at the date of application
submission: not exceeding 03 months;
- Application for issuance of
marketing authorization of a processed drug/drug manufactured adopting
transferred technology, in case the drug ordered for processing/drug before
technology transfer is yet to be granted a marketing authorization in Vietnam
or has been granted a marketing authorization but it has expired at the date of
application submission, or a drug processed adopting technology transferred
from the ordering facility to the processing facility, in case the drug ordered
for processing is yet to be granted a marketing authorization in Vietnam or has
been granted a marketing authorization but it has expired at the date of
application submission: not exceeding 09 months.
- Application for issuance of
marketing authorization of a new drug which is indicated to serve the
prevention and treatment of any group A infectious disease causing an epidemic
which has been declared in accordance with regulations of law on prevention and
control of infectious diseases: not exceeding 15 days;
- Application for issuance of
marketing authorization of a drug in case of prioritized administrative
procedures prescribed in clause 5 Article 7 of the Pharmacy Law: not exceeding
06 months;
- Application for issuance of
marketing authorization of a medicinal material: not exceeding 06 months.
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a) Upon its receipt of an
application, DAV shall review, classify and transfer the received application
to qualified validators or validating units within the following time limits:
- Application for issuance of
marketing authorization of a drug: 10 days, in respect of initial and
additional submission;
- Application for issuance of
marketing authorization of a drug which is validated using reference to
available validation results: 10 days, in respect of initial and additional
submission;
- Application for issuance of
marketing authorization of a processed drug/drug manufactured adopting
transferred technology, in case the drug ordered for processing/drug before
technology transfer has been granted a marketing authorization in Vietnam which
is still valid at the date of application submission, or a drug processed
adopting technology transferred from the ordering facility to the processing
facility, in case the drug ordered for processing has been granted a marketing
authorization in Vietnam which is still valid at the date of application
submission: 03 working days, in respect of initial and additional submission;
- Application for issuance of
marketing authorization of a processed drug/drug manufactured adopting
transferred technology, in case the drug ordered for processing/drug before
technology transfer is yet to be granted a marketing authorization in Vietnam
or has been granted a marketing authorization but it has expired at the date of
application submission, or a drug processed adopting technology transferred
from the ordering facility to the processing facility, in case the drug ordered
for processing is yet to be granted a marketing authorization in Vietnam or has
been granted a marketing authorization but it has expired at the date of
application submission: 10 days, in respect of initial and additional
submission;
- Application for issuance of
marketing authorization of a new drug which is indicated to serve the
prevention and treatment of any group A infectious disease causing an epidemic
which has been declared in accordance with regulations of law on prevention and
control of infectious diseases: 01 working day, in respect of initial and
additional submission;
- Application for issuance of
marketing authorization of a drug in case of prioritized administrative
procedures prescribed in clause 5 Article 7 of the Pharmacy Law: 03 working
days, in respect of initial and additional submission;
- Application for issuance of
marketing authorization of a medicinal material: 03 working days, in respect of
initial and additional submission;
b) Upon their receipt of an
application from DAV, validators and validating units shall conduct validation,
prepare and send a complete validation record to DAV within the following time
limits:
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- Application for issuance of
marketing authorization of a drug which is validated using reference to
available validation results: 04 months, for initial submission, and 02 months,
for additional submission;
- Application for issuance of
marketing authorization of a processed drug/drug manufactured adopting
transferred technology, in case the drug ordered for processing/drug before
technology transfer has been granted a marketing authorization in Vietnam which
is still valid at the date of application submission, or a drug processed
adopting technology transferred from the ordering facility to the processing
facility, in case the drug ordered for processing has been granted a marketing
authorization in Vietnam which is still valid at the date of application
submission: 01 month, in respect of initial and additional submission;
- Application for issuance of
marketing authorization of a processed drug/drug manufactured adopting
transferred technology, in case the drug ordered for processing/drug before
technology transfer is yet to be granted a marketing authorization in Vietnam
or has been granted a marketing authorization but it has expired at the date of
application submission, or a drug processed adopting technology transferred
from the ordering facility to the processing facility, in case the drug ordered
for processing is yet to be granted a marketing authorization in Vietnam or has
been granted a marketing authorization but it has expired at the date of
application submission: 04 months, for initial submission, and 01 month, for
additional submission;
- Application for issuance of
marketing authorization of a new drug which is indicated to serve the
prevention and treatment of any group A infectious disease causing an epidemic
which has been declared in accordance with regulations of law on prevention and
control of infectious diseases: 03 working days, in respect of initial and
additional submission;
- Application for issuance of
marketing authorization of a drug in case of prioritized administrative
procedures prescribed in clause 5 Article 7 of the Pharmacy Law: 04 months, for
initial submission, and 01 month, for additional submission;
- Application for issuance of
marketing authorization of a medicinal material: 04 months, for initial
submission, and 01 month, for additional submission.
4. Actions taken after validation:
Upon its receipt of the validation
record, DAV shall, on the basis of validation opinions given by validators,
validating units and regulations in force, send a written request for
additional documents to the applicant, if the application is not yet
satisfactory, or send the application to the Advisory Board, if it is
considered satisfactory, unsatisfactory or requires additional opinions, and is
to be approved, refused or given additional opinions of the Advisory Board as
proposed by DAV within the following time limits:
a) Application for issuance of
marketing authorization of a drug: 02 months, for initial submission, and 01
month, for additional submission;
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c) Application for issuance of marketing
authorization of a processed drug/drug manufactured adopting transferred
technology, in case the drug ordered for processing/drug before technology
transfer has been granted a marketing authorization in Vietnam which is still
valid at the date of application submission, or a drug processed adopting
technology transferred from the ordering facility to the processing facility,
in case the drug ordered for processing has been granted a marketing
authorization in Vietnam which is still valid at the date of application
submission: 15 days, in respect of initial and additional submission;
d) Application for issuance of
marketing authorization of a processed drug/drug manufactured adopting
transferred technology, in case the drug ordered for processing/drug before
technology transfer is yet to be granted a marketing authorization in Vietnam
or has been granted a marketing authorization but it has expired at the date of
application submission, or a drug processed adopting technology transferred
from the ordering facility to the processing facility, in case the drug ordered
for processing is yet to be granted a marketing authorization in Vietnam or has
been granted a marketing authorization but it has expired at the date of
application submission: 02 months, for initial submission, and 01 month, for
additional submission;
dd) Application for issuance of
marketing authorization of a new drug which is indicated to serve the
prevention and treatment of any group A infectious disease causing an epidemic
which has been declared in accordance with regulations of law on prevention and
control of infectious diseases: 01 working day, in respect of initial and
additional submission;
e) Application for issuance of
marketing authorization of a drug in case of prioritized administrative
procedures prescribed in clause 5 Article 7 of the Pharmacy Law: 15 days, in
respect of initial and additional submission;
g) Application for issuance of
marketing authorization of a medicinal material: 15 days, in respect of initial
and additional submission.
5. Meeting of the Advisory Board:
Upon its receipt of the documents
from DAV, the Office of the Advisory Board shall hold a meeting within the
following time limits:
a) Application for issuance of
marketing authorization of a drug: 01 month, in respect of initial and
additional submission;
b) Application for issuance of
marketing authorization which is validated using reference to available
validation results: 01 month, in respect of initial and additional submission;
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d) Application for issuance of
marketing authorization of a processed drug/drug manufactured adopting
transferred technology, in case the drug ordered for processing/drug before
technology transfer is yet to be granted a marketing authorization in Vietnam
or has been granted a marketing authorization but it has expired at the date of
application submission, or a drug processed adopting technology transferred from
the ordering facility to the processing facility, in case the drug ordered for
processing is yet to be granted a marketing authorization in Vietnam or has
been granted a marketing authorization but it has expired at the date of
application submission: 01 month, for initial submission, and 15 days, for
additional submission;
dd) Application for issuance of
marketing authorization of a new drug which is indicated to serve the
prevention and treatment of any group A infectious disease causing an epidemic which
has been declared in accordance with regulations of law on prevention and
control of infectious diseases: 03 working days, in respect of initial and
additional submission;
e) Application for issuance of
marketing authorization of a drug in case of prioritized administrative
procedures prescribed in clause 5 Article 7 of the Pharmacy Law: 15 days, in
respect of initial and additional submission;
g) Application for issuance of
marketing authorization of a medicinal material: 15 days, in respect of initial
and additional submission.
6. Actions taken after the meeting
of the Advisory Board:
a) Completing the meeting minutes:
From the date of its meeting, the
Office of the Advisory Board shall complete the meeting minutes and send them
to DAV within the following time limits:
- a) Application for issuance of
marketing authorization of a drug: 01 month, in respect of initial and
additional submission;
- Application for issuance of
marketing authorization which is validated using reference to available validation
results: 01 month, in respect of initial and additional submission;
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- Application for issuance of
marketing authorization of a processed drug/drug manufactured adopting
transferred technology, in case the drug ordered for processing/drug before
technology transfer is yet to be granted a marketing authorization in Vietnam
or has been granted a marketing authorization but it has expired at the date of
application submission, or a drug processed adopting technology transferred
from the ordering facility to the processing facility, in case the drug ordered
for processing is yet to be granted a marketing authorization in Vietnam or has
been granted a marketing authorization but it has expired at the date of
application submission: 01 month, for initial submission, and 15 days, for
additional submission;
- Application for issuance of
marketing authorization of a new drug which is indicated to serve the
prevention and treatment of any group A infectious disease causing an epidemic
which has been declared in accordance with regulations of law on prevention and
control of infectious diseases: 01 working day, in respect of initial and
additional submission;
- Application for issuance of
marketing authorization of a drug in case of prioritized administrative
procedures prescribed in clause 5 Article 7 of the Pharmacy Law: 10 days, in
respect of initial and additional submission;
- Application for issuance of
marketing authorization of a medicinal material: 10 days, in respect of initial
and additional submission;
b) Upon its receipt of the minutes
of the meeting of the Advisory Board, DAV shall issue a marketing authorization
using Form 6A/TT enclosed herewith, for a satisfactory application, or give a
written notice which is made according to the conclusions given by the Advisory
Board to the applicant, for an application which is not yet satisfactory or
unsatisfactory, within the following time limits:
- Application for issuance of
marketing authorization of a drug: 20 days, in respect of initial and
additional submission;
- Application for issuance of
marketing authorization which is validated using reference to available
validation results: 20 days, in respect of initial and additional submission;
- Application for issuance of
marketing authorization of a processed drug/drug manufactured adopting
transferred technology, in case the drug ordered for processing/drug before
technology transfer has been granted a marketing authorization in Vietnam which
is still valid at the date of application submission, or a drug processed
adopting technology transferred from the ordering facility to the processing
facility, in case the drug ordered for processing has been granted a marketing
authorization in Vietnam which is still valid at the date of application
submission: 15 days, in respect of initial and additional submission;
- Application for issuance of
marketing authorization of a processed drug/drug manufactured adopting
transferred technology, in case the drug ordered for processing/drug before
technology transfer is yet to be granted a marketing authorization in Vietnam
or has been granted a marketing authorization but it has expired at the date of
application submission, or a drug processed adopting technology transferred
from the ordering facility to the processing facility, in case the drug ordered
for processing is yet to be granted a marketing authorization in Vietnam or has
been granted a marketing authorization but it has expired at the date of
application submission: 20 days, in respect of initial and additional
submission;
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- Application for issuance of
marketing authorization of a drug in case of prioritized administrative
procedures prescribed in clause 5 Article 7 of the Pharmacy Law: 15 days, in
respect of initial and additional submission;
- Application for issuance of
marketing authorization of a medicinal material: 15 days, in respect of initial
and additional submission.
Article 46.
Procedures for renewal of marketing authorizations of drugs/medicinal materials
1. Application submission method:
Applications shall be submitted
according to provisions of Article 16 of the Decree No. 61/2018/ND-CP.
2. Application receipt and
processing time limit:
a) Application receipt:
Upon receipt of an adequate
application, DAV shall give an application receipt note to the applicant as
prescribed;
b) Time limit for processing an
application counted from the date of application receipt: not exceeding 03
months.
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a) Within 03 working days from its
receipt of an application as prescribed in clause 2 of this Article, DAV shall
review, classify and transfer the received application to validators or
validating units;
b) Within 01 month from their
receipt of an application from DAV, validators and validating units shall
conduct validation, prepare and send a complete validation record to DAV.
4. Actions taken after validation:
a) For a renewal application
prescribed in point b clause 1 Article 43 hereof:
Within 15 days from its receipt of
the validation record, DAV shall, on the basis of validation opinions given by
validators, validating units and regulations in force, send a written request
for additional documents to the applicant, if the application is not yet
satisfactory, or send the application to the Advisory Board, if it is
considered satisfactory, unsatisfactory or requires additional opinions, and is
to be approved, refused or given additional opinions of the Advisory Board as
proposed by DAV;
b) For a renewal application
prescribed in point a clause 2 Article 43 hereof, on the basis of validation
opinions given by validators, validating units and regulations in force, DAV
shall:
- Send a written request for
additional documents to the applicant, if the application is not yet
satisfactory, or send a written notice of refusal to renew the marketing
authorization, if the application is considered unsatisfactory, within 10 days;
- Renew the marketing authorization
using Form 6B/TT enclosed herewith, if the application is considered
satisfactory, within 15 days.
5. Meeting of the Advisory Board:
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6. Actions taken after the meeting
of the Advisory Board:
a) Within 10 days from the date of
its meeting, the Office of the Advisory Board shall complete the meeting
minutes and send them to DAV;
b) Within 15 days from its receipt
of the minutes of the meeting of the Advisory Board, DAV shall renew the
marketing authorization using Form 6B/TT enclosed herewith, for a satisfactory
application, or give a written notice which is made according to the
conclusions given by the Advisory Board to the applicant, for an application
which is not yet satisfactory or unsatisfactory.
Article 47.
Procedures for approval of variations to marketing authorizations of
drugs/medicinal materials
1. Application submission method:
Applications shall be submitted
according to provisions of Article 16 of the Decree No. 61/2018/ND-CP.
2. Application receipt and
processing time limit:
a) Application receipt:
Upon receipt of an adequate
application, DAV shall give an application receipt note to the applicant as
prescribed;
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- For a variation application
prescribed in clause 3 Article 43 hereof: not exceeding 20 days;
- For a variation application
prescribed in point c clause 1 or point b clause 2 Article 43 hereof: not
exceeding 03 months.
3. Organization of validation:
a) Upon its receipt of the
application as prescribed in clause 2 of this Article, DAV shall publish
variations, for an application prescribed in clause 3 Article 43 hereof, within
20 days; review, classify and transfer the application to validators or
validating units, for an application prescribed in point c clause 1 or point b
clause 2 Article 43 hereof, within the following time limits:
- Regarding an application
prescribed in point c clause 1 Article 43 hereof: 03 working days, for initial
submission, or 02 workings days, for additional submission;
- Regarding an application
prescribed in point b clause 2 Article 43 hereof: 03 working days, for initial
and additional submission;
b) Upon their receipt of an
application from DAV, validators and validating units shall conduct validation,
prepare and send a complete validation record to DAV within the following time
limits:
- Regarding an application
prescribed in point c clause 1 Article 43 hereof: 01 month, for initial
submission, or 15 days, for additional submission;
- Regarding an application
prescribed in point b clause 2 Article 43 hereof: 01 month, for initial and
additional submission.
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a) For a variation application
prescribed in point c clause 1 Article 43 hereof:
Upon its receipt of the validation
record, DAV shall, on the basis of validation opinions given by validators,
validating units and regulations in force, send a written request for
additional documents to the applicant, if the application is not yet
satisfactory, or send the application to the Advisory Board, if it is
considered satisfactory, unsatisfactory or requires additional opinions, and is
to be approved, refused or given additional opinions of the Advisory Board as
proposed by DAV, within 15 days, for initial submission, or 10 days, for
additional submission;
b) For a variation application
prescribed in point b clause 2 Article 43 hereof:
Upon its receipt of the validation
record, DAV shall, on the basis of validation opinions given by validators,
validating units and regulations in force, send a written request for
additional documents to the applicant, if the application is not yet
satisfactory, or grant a written approval of variations to the marketing
authorization, if the application is considered satisfactory, or issue a
written notice of refusal to grant approval, if the application is considered
unsatisfactory, within 25 days, for initial and additional submission.
5. Meeting of the Advisory Board:
Within 15 days from its receipt of
the documents from DAV, the Office of the Advisory Board shall hold a meeting
of the Advisory Board.
6. Actions taken after the meeting
of the Advisory Board:
a) Within 10 days from the date of
its meeting, the Office of the Advisory Board shall complete the meeting
minutes and send them to DAV;
b) Within 15 days, for initial
submission, or 08 days, for additional submission, from its receipt of the
minutes of the meeting of the Advisory Board, DAV shall grant a written
approval of variations to the marketing authorization, for a satisfactory
application, or give a written notice which is made according to the
conclusions given by the Advisory Board to the applicant, for an application
which is not yet satisfactory or unsatisfactory.
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DOCUMENTATION REQUIREMENTS, PROCEDURES FOR WITHDRAWAL
AND REVOCATION OF MARKETING AUTHORIZATIONS OF DRUGS AND MEDICINAL MATERIALS
Article 48.
Documentation requirements for withdrawal and revocation of marketing
authorizations of drugs/medicinal materials
1. If a marketing authorization of
drug is revoked as prescribed in points a, b clause 1 Article 58 of the
Pharmacy Law, the following documents shall be required:
a) Decision on imposition of
administrative penalties issued by a competent regulatory authority;
b) Document on the drug recall made
by a competent regulatory authority.
2. If a marketing authorization of
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:
The written conclusion drawn by a
competent regulatory authority that the documents used as the basis for grant
of the marketing authorization are forged, or the drug/medicinal material is
manufactured at a place other than that specified in the submitted MAA.
3. If a marketing authorization of
drug/medicinal material is revoked as prescribed in point c clause 1 Article 58
of the Pharmacy Law, the following documents shall be required:
The notice, issued by the competent
CPP issuing authority, of revocation of the issued CPP which is used as the
basis for DAV to issue the marketing authorization of the drug/medicinal
material in Vietnam.
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The notice, issued by WHO or a
competent regulatory authority of Vietnam 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. If a marketing authorization of
drug/medicinal material is withdrawn as prescribed in point g clause 1 Article
58 of the Pharmacy Law, the following documents shall be required:
The written request for withdrawal
of the marketing authorization of drug/medicinal material in Vietnam which is
made by the manufacturer or applicant using Form 07/TT enclosed herewith.
Article 49.
Procedures for revocation and withdrawal of marketing authorizations of
drugs/medicinal materials
1. Within a maximum duration of 30
days from its receipt of the documents prescribed in clause 1 Article 48
hereof, DAV shall issue a decision to revoke the marketing authorization of
drug.
2. Within a maximum duration of 30
days from its receipt of the documents prescribed in clause 2 Article 48
hereof, DAV shall issue a decision to revoke the marketing authorization of
drug/medicinal material.
3. Within a maximum duration of 10
days from its receipt of the documents prescribed in clause 3 or 4 Article 48
hereof, DAV shall issue a decision to revoke the marketing authorization of
drug/medicinal material.
4. Within a maximum duration of 20
days from its receipt of the documents prescribed in clause 5 Article 48
hereof, DAV shall issue a decision to withdraw the marketing authorization of
drug/medicinal material.
Chapter VI
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Article 50.
Organization and operation of Advisory Board
1. The Advisory Board is
established by the Minister of Health of Vietnam. The Advisory Board is
composed of experts whose qualifications and experience are appropriate for
validating applications, questioning opinions of validators and proposals of
DAV, and providing the Minister of Health with advice about the matters
concerning pharmacy laws, and safety and efficacy documents of drugs/medicinal
materials.
2. The Advisory Board has the
responsibility to provide the Minister of Health of Vietnam with advice on
issuance, renewal, and approval of variations to marketing authorizations of
drugs/medicinal materials on the basis of validation conclusions given by validators
and DAV’s proposals, and relevant issues at the request of the Minister of
Health of Vietnam. The Advisory Board shall assume responsibility before the
Minister of Health of Vietnam for its advice and opinions.
3. Operational principles of the
Advisory Board:
a) The Advisory Board operates
following the principles of unanimity, democratic centralism, objectivity,
openness and transparency. The Advisory Board shall give opinions on a
scientific and lawful basis while taking account of validation conclusions
given by validators, clinical reality and DAV’s proposals;
b) Every meeting of the Advisory
Board shall be conducted if it is attended by at least 2/3 of its qualified
members (according to the regulations on organization and operation of the
Advisory Board announced by MoH), including those who send their opinions in
writing without directly attending the meeting;
The Chairperson of the Advisory
Board or the person authorized by the Chairperson to chair the meeting shall
draw the conclusion when it is approved by at least 2/3 of the participants.
Dissenting opinions shall be reserved.
Opinions, including dissenting
opinions, of its members and the conclusions drawn by the Advisory Board shall
be included in the meeting minutes;
c) If its meeting is not held, the
Chairperson of the Advisory Board shall collect written opinions from its
members;
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The Advisory Board shall reach
conclusions on the basis of consenting opinions of at least 2/3 of its members,
the consolidated report and proposal of DAV;
The conclusions of the Advisory
Board shall be written in the Statement of conclusions of its Chairperson or
his/her authorized person;
d) Where necessary, members of the
Advisory Board are entitled to consider and validate the application, and the
Chairperson of the Advisory Board may seek additional opinions from independent
experts other than its members before reaching final conclusions. These experts
may directly attend the meeting of the Advisory Board or give their written
opinions, have the same responsibilities and rights as those of the members of
the Advisory Board;
dd) Conflicts of interest rule must
be complied with.
4. DAV shall propose to the
Minister of Health of Vietnam regulations on organization and operation of the
Advisory Board, the mechanism for cooperation between the Advisory Board and
validators regarding issuance, renewal and approval of variations to marketing
authorizations of drugs/medicinal materials.
5. Funding for covering operating
expenses of the Advisory Board shall comply with regulations of law.
6. The standing committee of the
Advisory Board shall be located on the same premises as DAV.
Article 51.
Organization and operation of validating units and validators
1. DAV and validating units shall
establish validator teams in charge of validating legal documents, quality
specifications, dosage form, pharmacology, clinical data, bioequivalence, and
lists of validators of teams in charge of validating applications for issuance,
renewal and approval of variations to marketing authorizations of
drugs/medicinal materials. The composition of each validator team shall be
suitable for the product category and registration form.
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a) All validation opinions must be
given on a lawful and scientific basis, and included in the validation record;
b) Validators shall assume
responsibility before the DAV’s Director and validating units for their
validation works and opinions about applications for issuance, renewal and
approval of variations to marketing authorizations of drugs/medicinal
materials.
3. DAV shall, within the ambit of
its assigned functions and tasks, formulate and issue regulations on
organization and operation of validator teams (including those of validating
units) in charge of validating applications for issuance, renewal and approval
of variations to marketing authorizations of drugs/medicinal materials; sign
contracts with validators or validating units;
DAV and validating units shall
provide training courses for validators; organize assessment of the validators’
knowledge and compliance with regulations of law, which is the basis for
replacement or employment of validators.
4. Funding for covering validation
expenses shall comply with regulations of law.
Chapter VII
IMPLEMENTATION PROVISIONS
Article 52.
Effect
1. This Circular comes into force
from July 01, 2025.
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a) Regulations on chemical drugs,
biologicals and herbal drugs in the Circular No. 07/2017/TT-BYT dated May 03,
2017 of the Minister of Health prescribing list of OTC drugs;
b) Paragraph 1 point a clause 1
Article 16 and paragraph 2 point c clause 3 Article 29 of the Circular No.
01/2018/TT-BYT dated January 18, 2018 of the Minister of Health of Vietnam
prescribing labeling and package inserts of drugs and medicinal materials;
c) The Circular No. 08/2022/TT-BYT
dated September 05, 2022 of the Minister of Health of Vietnam prescribing
marketing authorization of drugs and medicinal materials;
d) The Circular No. 16/2023/TT-BYT
dated August 15, 2023 of the Minister of Health of Vietnam prescribing
marketing authorization of processed drugs and drugs manufactured adopting
transferred technology in Vietnam;
dd) The Circular No. 55/2024/TT-BYT
dated December 31, 2024 of the Minister of Health of Vietnam providing
amendments to some articles on renewal of marketing authorization of drugs and
medicinal materials in the Circular No. 08/2022/TT-BYT dated September 05, 2022
of Minister of Health of Vietnam prescribing marketing authorization of drugs
and medicinal materials.
3. When applying for import of
medicinal materials which are excipients and capsule shells for manufacturing
of domestically manufactured drugs/medicinal materials which have been granted
the marketing authorization before October 20, 2022:
Before the first shipment to
Vietnam, the applicant shall adequately update information about the medicinal
materials which are excipients and capsule shells in its approved application
on the DAV’s online public service system. Within 05 working days from the date
on which information is updated on the system, DAV shall complete the
publishing of information on such medicinal materials which are excipients and
capsule shells on its website. The applicant shall assume responsibility for
the accuracy of its updated information in comparison with the information
included in its approved application, and shall not be required to update
information for the following shipment.
4. At the latest 12 months after
the marketing authorization of a drug/medicinal material which has been granted
before January 01, 2023 is renewed, its label and package insert must bear the
marketing authorization number with the structure prescribed in Appendix V
enclosed herewith. Within 12 months after grant of an approval for renewal of
the marketing authorization of a drug/medicinal material, the marketing
authorization number shall be written according to the following provisions:
a) A domestically manufactured
drug/medicinal material shall continue to be manufactured and marketed until
the end of its shelf life with its label indicating the marketing authorization
number granted before such grant of approval for renewal;
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5. Re-classification of
prescription drugs and OTC drugs which have been classified before the
effective date of this Circular is not required during the validity periods of
the marketing authorizations. A drug shall be classified as a prescription drug
or OTC drug according to provisions of this Circular during processing of
application for renewal of its marketing authorization. The applicant that
wishes to apply for change in the category of a prescription drug or OTC drug
shall comply with provisions in Appendix II enclosed herewith.
6. Classification of OTC drugs
covered by applications which have been submitted to DAV before the effective
date of this Circular but are yet to be processed (i.e. the marketing
authorization is yet to be issued or renewed) shall comply with provisions
herein.
Article 53.
Transition
1. Applications submitted before
the effective date of this Circular shall continue to be processed in
compliance with the regulations in force at the time of application submission
or the regulations herein as of the effective date of this Circular, whichever
is more convenient for the applicants.
2. DAV is assigned to modify or
update variations to the published information about the drugs which have been
classified and declared by MoH as original brand-name drugs or reference
biologicals or drugs having demonstrated bioequivalence at the request of
applicants.
Article 54.
Terms of reference
If any legislative documents and
regulations referred to in this Circular are amended, supplemented or
superseded, the new ones shall apply.
Article 55.
Implementation organization
1. DAV shall, within the ambit of
its assigned functions and tasks, and pursuant to the roadmap for ASEAN
harmonization of drug registration, take the responsibility to:
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b) Publish the following on its
website:
- The list of drugs and medicinal
materials granted or having marketing authorizations renewed (including
information on the drugs before technology transfer, for drugs manufactured
adopting transferred technology in Vietnam, and information on the drugs
ordered for processing, for drugs processed in Vietnam) within 05 days from the
date on which the marketing authorization is granted or renewed, and
information on classification of prescription drugs or OTC drugs and other
information about marketing authorization of drugs and medicinal materials;
- The list of drugs having
demonstrated bioequivalence, drugs declared as original brand-name drugs or
reference biologicals within 05 days from the date on which the marketing
authorization of the drug is granted, and information on variations to such a
listed drug within 07 days from the date on which such variations to the
marketing authorization are approved;
- The lists of processed drugs and
drugs manufactured adopting transferred technology which are made using Form
8A/TT, Form 8B/TT and Form 8C/TT enclosed herewith;
c) Remove drugs from the lists of
drugs having demonstrated bioequivalence, and drugs declared as original
brand-name drugs or reference biologicals when these drugs no longer meet
relevant classification criteria set out herein on the basis of consulting
opinions given by the Advisory Board;
d) Remove drugs from the lists of
processed drugs and drugs manufactured adopting transferred technology
published as prescribed in paragraph 3 point b on the basis of consulting opinions
given by the Advisory Board when these drugs no longer meet the requirements
laid down in clause 1 Article 9 hereof;
dd) Formulate, promulgate, and
organize implementation of standard operating procedures (SOPs) in
marketing authorization application; manuals for marketing authorization
application; manuals for validation of MAAs;
e) Cooperate with the Traditional
Medicine Administration of Vietnam in renewing and approving variations to the
marketing authorizations of traditional drugs and herbal materials granted
according to provisions of the Circular No. 44/2014/TT-BYT dated November 25,
2014 of the Minister of Health prescribing marketing authorization of drugs;
g) Where necessary, DAV shall hold
meetings with applicants, manufacturers and validators to clarify the issues
that arise during validation of MAAs;
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i) Within 15 days from the date of
issuance or renewal, or 07 working days from the date of approval of variations
to the marketing authorization, DAV shall share quality specifications with the
testing system; share information on risk management plans with the National DI
& ADR Centre, with respect of applications for marketing authorization of
new chemical drugs, vaccines and biologicals (except probiotic biological
products); publish information on materials, in respect of domestically
manufactured drugs; publish the list of drugs classified as original brand-name
drugs or reference biologicals, and drugs having demonstrated bioequivalence;
k) Within 03 working days from its
receipt of an application for renewal of marketing authorization of
drug/medicinal material, DAV shall publish information on the received
application on MoH’s web portal and on its website;
l) Within 03 working days from the
date on which DAV gives a notification that the application for renewal is
rejected or the marketing authorization is suspended in case the drug or
medicinal material is found potentially unsafe for users or legal documents are
suspected of being forged, DAV shall publish information thereon on MoH’s web
portal and on its website;
m) Publish on its website the
technical documents prescribed in Appendix I enclosed herewith.
2. When writing the expiry dates on
labels of their drugs/medicinal materials, manufacturers shall comply with
provisions on labeling in the Circular No. 01/2018/TT-BYT and the following:
The expiry date of a drug/medicinal
material on its label must not be later than the ending date of its shelf life
as specified in the approved MAA and must not be sooner than its shelf life by
more than 31 days.
Article 56.
Responsibility for implementation
1. DAV shall assume responsibility
to provide guidelines for implementation of regulations herein; play the
leading role or cooperate with the MoH Inspectorate, functional Departments,
Administrations, and provincial Departments of Health in conducting inspection
of the implementation of regulations herein by pharmaceutical manufacturers and
traders nationwide.
2. MoH’s affiliated units, Vietnam
Pharmaceutical Corporation (Vinapharm), and pharmaceutical manufacturers and
traders are responsible for implementation of this Circular.
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PP.
MINISTER
DEPUTY MINISTER
Do Xuan Tuyen
APPENDIX II
MAJOR
VARIATIONS, MINOR VARIATIONS TO DRUGS/MEDICINAL MATERIALS GRANTED MARKETING
AUTHORIZATION
(Enclosed with the Circular No. 12/2025/TT-BYT dated May 16, 2025 of the
Ministry of Health of Vietnam)
A. GENERAL GUIDELINES
1. Some definitions used in this
Appendix:
1.1. Lead compendium refers to
Vietnamese pharmacopoeia, British Pharmacopeia (BP), United States Pharmacopeia
(USP), European Pharmacopeia (EP), International Pharmacopeia (IP), and
Japanese Pharmacopeia (JP).
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1.3. Bulk product means a drug
product that has completed all manufacturing stages up to, but not including,
final packaging.
1.4. Data of stability study, validation
of analytical procedures, manufacturing process validation, bioavailability/
bioequivalence studies, etc. are obtained according to ASEAN technical
guidelines enclosed with the Circular prescribing marketing authorization.
1.5. Comparative dissolution tests
are conducted and assessed according to US FDA SUPAC-IR and SUPAC-MR
Guidelines.
2. Abbreviations:
MaV
=
Major Variation
MiV-N
=
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MiV-PA
=
Minor Variation (Prior Approval)
SUPAC
=
Guidance of US FDA (U.S. Food and
Drug Administration) on Scale-up and Post-approval Changes
TSE
=
Transmissible Spongiform
Encephalopathy
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=
Bovine spongiform encephalopathy
3. In respect of changes in
drugs/medicinal materials granted marketing authorizations which are yet to be
classified in this Appendix (except those prescribed in clause 2 Article 55 of
the Pharmacy Law), changes in excipients as prescribed in MiV-N3 and MiV-N6,
changes in drug substances and/or drug products as prescribed in MiV-N6 (in
case current specifications remain unchanged), submission of applications for
approval of such changes to the Drug Administration of Vietnam (DAV) is not
required.
The applicant must implement and
retain all documents, as prescribed, concerning the changes mentioned in MiV-N3
and MiV-N6. In case the applicant voluntarily submits an application for
registration of such changes, such application comprises corresponding required
documents as prescribed in MiV-N3 and MiV-N6 or relevant documents according to
the guidelines of EMA or US-FDA or WHO;
Regarding the changes which are yet
to be classified in this Appendix, the changes in technical documents shall be
treated as variations requiring prior approval and the changes in
administrative information shall be treated as variations requiring
notification. An application for approval of such a change, comprising an
application form and relevant documents, must be submitted to DAV for
consideration.
4. Documents to be submitted as
prescribed in this document are enclosed with the application form as provided
in the Circular prescribing marketing authorization. Any commitments (if any)
may be included in the application form and must be certified as required.
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 which are of the
same applicant and the same drug product manufacturer, and have the same
following changes in administrative information (such drugs have the same approved
information, proposed changes and supporting documents, except product
information of each drug): change of the name and/or address of the applicant,
ordering facility or sending facility; change of the name and/or address of the
manufacturer of drug product; change of the name and/or address of the
manufacturer of the drug substance; change of the name and/or address of the
manufacturer of excipients/capsule shells (the manufacturing site remains
unchanged).
6. Multiple changes to the same
drug may be included in a single variation application package which must
comprise adequate required documents for each of such changes as prescribed.
If an application which includes
variations requiring prior approval and minor variations requiring notification
is submitted, it shall be considered following the same procedures as
variations requiring prior approval.
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B. LIST OF VARIATIONS DURING
MARKETING
I. MAJOR VARIATION (MaV)
1. MaV-1
Change and/or additional
indication/dosing regimen/patient population/route of administration/
inclusion of clinical information extending the usage of the product
Conditions to be fulfilled (C)
1. As a subsequent change due to
revision of Summary of Product Characteristics (SmPC) or equivalent document
(USPI), leading to change of content of the package insert and/or label
2. When updating the package
insert of a generic drug according to the package insert of its original
brand-name drug in Vietnam or the package insert approved by SRA, if the
original brand-name drug in Vietnam is not available, refer to MiV-PA2.
Documents to be submitted (D)
1. Proposed package insert and/or
label. Comparative tabulated format of the approved and proposed package
insert and/or label.
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3. Reference documents and/or
clinical expert reports (where applicable).
4. Approved package
insert/SmPC/Patient Information Leaflet (PIL) from the authority issuing
marketing authorization of the country of origin or a reference country
containing the proposed changes or approval letters from the authority
issuing marketing authorization of the country of origin or reference
countries which have approved the proposed changes/additions or inclusions
(for changes to a drug manufactured overseas which are made according to
changes made in the country of origin or reference countries)
5. Clinical documents as per
ASEAN Common Technical Dossier (ACTD) part IV
6. Comparative tabulated format
of approved contents and proposed changes (highlighted).
2. MaV-2
Change of content of package
insert and/or label
Conditions to be fulfilled (C)
1. The change is not a minor
variation and not within the scope of MaV-1.
2. As a subsequent change due to
revision of Summary of Product Characteristics (SmPC) or equivalent document
(USPI).
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Documents to be submitted (D)
1. Proposed package insert and/or
label. Comparative tabulated format of the approved and proposed package
insert and/or label.
2. Justifications for the changes
proposed.
3. Reference documents and/or
supporting clinical documents.
4. Approved package insert (PI)/
Summary of Product Characteristics (SmPC)/Patient Information Leaflet (PIL)
from the authority issuing marketing authorization of the country of origin
or reference country containing the proposed changes (for changes to a drug
manufactured overseas which are made according to changes made in the country
of origin or reference country)
5. Comparative tabulated format
of approved contents and proposed changes (highlighted).
3. MaV-3
Addition or replacement of
alternative manufacturer/manufacturing site of drug substance (where European
Pharmacopoeial Certificate of Suitability (CEP) is not available)
Conditions to be fulfilled (C)
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2. For change and/or addition of
alternative manufacturer/site of drug substance where European Pharmacopoeial
Certificate of Suitability (CEP) is available, refer to MiV-PA4.
3. If there are changes to
specifications of drug substances, MAV-6 or MiV- PA8 or MiV-N6 is also
applicable.
Documents to be submitted (D)
1. One of the following documents
is submitted:
a) Complete ACTD section S1-S7;
b) Both the open and closed parts
of the drug substance master file (the closed part, with the letter of access
thereto, may be provided directly by the drug substance manufacturer for
DAV);
c) Equivalent audit document or
certification from one of the reference countries specified in the Circular
prescribing marketing authorization.
2. Comparative tabulated format
of the drug substance manufacturing processes at the approved and proposed
manufacturing sites (where applicable).
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 manufacturing
sites.
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4. Comparative dissolution
profile data of the drug product manufactured with the drug substance from
the approved and proposed manufacturers/sites, in respect of the drug having
demonstrated bioequivalence.
5. A letter of commitment from
the drug product manufacturer to conduct long-term and accelerated stability
studies for the drug product manufactured with the drug substance from the
proposed manufacturing site, and report if any results fall outside
shelf-life specifications (with proposed action).
6. Legal documents of the drug
substance manufacturer proving its compliance with Good Manufacturing
Practice (GMP) guidelines for manufacture of medicinal materials as
prescribed in clause 7 Article 22 of this Circular.
If a material has been granted
the marketing authorization in Vietnam, the documents in clauses 1, 6 of this
section are not required.
7. Comparative tabulated
format of approved contents and proposed changes (highlighted).
4. MaV-4
Addition or replacement of the
manufacturing site of:
a) The bulk product;
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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. The manufacturer of the drug
product/ bulk product remains unchanged.
3. The proposed manufacturing
site must meet GMP requirements for the pharmaceutical form concerned. For
the manufacturing activity performed in Vietnam, the proposed manufacturing
site must have been granted Certificate of satisfaction of conditions for
pharmaceutical business.
4. For addition or replacement of
the company/ site responsible for batch release, refer to MiV-PA3.
5. If there are changes to the
manufacturing process, MaV-9 is also applicable.
Documents to be submitted (D)
1. For the manufacturing activity
performed in a foreign country: CPP or GMP certificate proving that the
proposed manufacturing site is appropriately authorized for the
pharmaceutical form concerned.
2. Batch analysis data (in a
comparative tabulated format) of a drug product/ bulk product of at least 02
production batches (or 01 production batch and 02 pilot batches) from the
proposed site and last 03 production batches from the approved site.
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3. Stability data of the drug
product after the change made and report if any results fall outside
shelf-life specifications (with proposed action).
4. Validation scheme and/or
report of the manufacturing process of the drug product/ bulk product at the
proposed site.
5. For oral solid dosage forms:
Comparative dissolution profile data of the drug product/ bulk product
manufactured in the approved and proposed manufacturing sites.
6. Approved formula of the drug
product.
7. Approved release and
shelf-life specifications of the drug product.
8. Approved specifications of the
drug substance.
9. Holding time studies testing
of bulk product during storage and transportation between the bulk production
site and the primary packager (where applicable).
10. In case of a contract
manufacturer of bulk product, letter of appointment and letter of acceptance
for the proposed site to manufacture the bulk product, and stating the types
of activity to be performed at this proposed site.
11. Comparative tabulated format
of approved contents and proposed changes (highlighted).
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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 addition and/or
replacement of alternative packager/site for primary packaging for
non-sterile product, refer to MiV-PA 44.
Documents to be submitted (D)
1. Revised draft(s) of the label
and/or package insert incorporating the proposed variation (where
applicable).
2. For the packaging activity
performed in a foreign country: CPP or GMP certificate proving that the
proposed site is appropriately authorized for the primary packaging activity
of the pharmaceutical form concerned.
3. In case of a contract primary
packager, letter of appointment and letter of acceptance for the proposed
packager/site to package the product and stating the types of packaging
activity to be performed by the proposed packager/at the proposed site.
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5. Holding time studies testing
of bulk product during storage and transportation between the bulk production
site and the primary packager (where applicable).
6. Stability data of the drug
product after the change made and report if any results fall outside
shelf-life specifications (with proposed action).
7. Comparative tabulated format
of approved contents and proposed changes (highlighted).
6. MaV-6
Change of the specification of
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)
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2. Not applicable to compendial
drug substances/drug products.
3. For change of specification of
drug substance where a CEP is available, refer to MiV-PA12.
4. The change should not be the
result of unexpected events arising during manufacture or because of
stability concerned.
Documents to be submitted (D)
(a) Specification limits
are widened
1. Justification for change
substantiated with scientific data to be provided.
2. Comparative tabulated format
of the approved and proposed specification of drug substance/drug product
with the changes highlighted.
3. Revised specification of drug
substance/ drug product.
4. Certificate of analysis and/or
batch analysis data of the drug substance/drug product for all tests in the
proposed specification for 02 pilot or production scale batches.
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6. Comparative tabulated format
of approved contents and proposed changes (highlighted).
(b) Deletion of test
parameter and limits
1. All of the documents specified
in D1-D4.
2. Certificate of analysis of
drug substance/drug product according to the proposed specification/proposed
shelf-life specifications.
3. Comparative tabulated format
of approved contents and proposed changes (highlighted).
7. MaV-7
Addition or change of batch
size of sterile drug product
Conditions to be fulfilled (C)
1. The change does not affect
consistency of production.
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3. The product formulation
remains unchanged.
Documents to be submitted (D)
1. Validation scheme and/or
report of the manufacturing process of at least 03 production batches
manufactured according to the proposed batch size.
2. Comparative tabulated format
of approved and proposed batch manufacturing formula.
3. Batch analysis data (in a
comparative tabulated format) of drug product of at least 02 production
batches manufactured according to approved and proposed batch sizes.
4. Approved release and
shelf-life specifications of the drug product.
5. Stability data of the drug
product after the change made and report if any results fall outside
shelf-life specifications (with proposed action).
6. Comparative tabulated format
of approved contents and proposed changes (highlighted).
8. MaV-8
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Conditions to be fulfilled (C)
1. 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.
2. The change does not affect
consistency of production.
3. Release and shelf-life
specifications of drug product remain unchanged.
Documents to be submitted (D)
1. Validation scheme and/or
report of the manufacturing process of at least 03 production batches
manufactured according to the proposed batch size.
2. Comparative tabulated format
of approved and proposed batch manufacturing formula.
3. 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.
4. Stability data of the drug
product after the change made and report if any results fall outside
shelf-life specifications (with proposed action).
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6. For oral solid dosage forms:
Comparative dissolution profile data of at least 01 production batch of the
drug product manufactured in the approved and proposed batch sizes.
7. Comparative tabulated format
of approved contents and proposed changes (highlighted).
9. MaV-9
Major change in the
manufacturing process for drug product
Conditions to be fulfilled (C)
1. The manufacturing site remains
unchanged. If there is a change in manufacturing site, MaV-4 is also
applicable.
2. The change does not cause a
negative impact on the quality, safety and efficacy of the drug product.
3. For minor change of the
manufacturing process for non-sterile product, refer to MiV-PA20.
Documents to be submitted (D)
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2. Validation scheme and/or
report of the proposed manufacturing process.
3. Approved release and
shelf-life specifications of the drug product. Or, alternatively, copy of
proposed release and shelf-life specifications that support that the proposed
process must lead to an identical or better product regarding all aspects of
quality, safety and efficacy.
4. 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.
5. 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).
6. For oral solid dosage forms:
Comparative dissolution profile data of the drug product manufactured in the
approved and proposed manufacturing processes.
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).
8. Comparative tabulated format
of approved contents and proposed changes (highlighted).
10. MaV-10
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a) For immediate release oral
dosage forms (as per Level 2 and 3, Part III (Components and composition) -
SUPAC-IR guideline);
b) For modified release oral
dosage forms;
c) For other critical dosage
forms such as sterile preparations.
Conditions to be fulfilled (C)
1. Approved release and
shelf-life specifications and levels thereof of the drug product remain
unchanged, except for update of product description with respect to
appearance of the drug product as a consequence of the change (where
applicable).
2. The dissolution profile of the
proposed product is comparable to that of the approved product according to
SUPAC-IR or SUPAC-MR guideline.
3. Replacement of an excipient
with a comparable excipient of the same functional characteristics (where
applicable).
4. For other qualitative or
quantitative changes of excipient for immediate release oral dosage forms and
other non-critical dosage forms, refer to MiV-PA15.
For qualitative change of
excipient, the excipient manufacturer is required to meet the following
condition:
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Documents to be submitted (D)
1. Justification for the change
which must be given by appropriate development of pharmaceutics.
2. Stability data of the drug
product after the change made and report if any results fall outside
shelf-life specifications (with proposed action).
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 formulation.
4. 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).
5. 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.
6. Release and shelf-life
specifications of the drug product after the change with updated product
description with respect to its appearance as a consequence of the change
(where applicable).
7. Batch analysis data (in a
comparative tabulated format) of drug product on at least 02 production
batches (or 01 production batch and 02 pilot batches) according to approved
and proposed formula.
8. Specifications of the proposed
excipient (if an excipient which is not included in the approved product
formulation is used).
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10. Revised batch manufacturing
formula.
11. Validation scheme and/or
report of the manufacturing process of the drug product of at least 03
production batches according to the proposed product formula.
12. ACTD Section P3.1 to P3.4
which have been revised appropriately to the proposed product formulation.
13. A declaration substantiated
with experimental data (where necessary) that the proposed product
formulation does not interfere with the approved drug product release and
shelf-life specifications test procedures. If the proposed product formulation
interferes with the approved drug product release and shelf-life
specifications test procedures, additional documents shall be submitted
according to MiV-PA27.
14. For quantitative and
qualitative changes in preservative, results of Preservative Effectiveness
Test (PET) at lowest specified preservative level (where applicable).
15. Legal documents of the
manufacturer of the proposed excipient as prescribed in clause 7 Article 22
of this Circular. If the proposed excipient has been granted a marketing
authorization in Vietnam, these documents shall not be required.
16. Comparative tabulated format
of approved contents and proposed changes (highlighted).
11. MaV-11
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Conditions to be fulfilled (C)
1. The dissolution profile of the
proposed product is comparable to that of the approved product according to
SUPAC-MR guideline.
2. Approved release and
shelf-life specifications and levels thereof of the drug product remain
unchanged, except for update of product description with respect to
appearance of the drug product as a consequence of the change (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. Comparative dissolution
profile data of at least 01 pilot/production batch of the drug product
manufactured in the approved and proposed composition.
2. 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).
3. Revised release and shelf-life
specifications of the drug product with updated product description with
respect to its appearance as a consequence of the change (where applicable).
4. Letters of declaration made by
the drug product manufacturer and the applicant that the change does not
interfere with the approved drug product release and shelf-life
specifications test procedure.
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6. Stability data of the drug
product after the change made and report if any results fall outside
shelf-life specifications (with proposed action).
7. ACTD Section P3.1 to P3.4
which have been revised appropriately to the proposed product formulation.
8. Comparative tabulated format
of approved contents and proposed changes (highlighted).
12. 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
c) Inclusion of primary
packaging material.
Conditions to be fulfilled (C)
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2. For change in the primary
packaging material for non-sterile drug product, refer to MiV-PA28.
Documents to be submitted (D)
1. Validation scheme and/or
report of the manufacturing and sterilization processes appropriate to the
proposed change in primary packaging material during the manufacturing of
drug product.
2. 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).
3. Proof that no interaction
between the content and the primary packaging material occurs.
4. Comparative tabulated format
of specifications of the approved and proposed primary packaging material.
5. 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).
6. ACTD Section P3 and P7 which
have been revised appropriately to the change.
7. Approved shelf-life
specifications of drug product.
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9. Comparative tabulated format
of approved contents and proposed changes (highlighted).
13. 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. Approved release and
shelf-life specifications of drug product are not affected, except pack
size/fill volume specifications.
2. The proposed pack size is
consistent with the dosage regimen and duration of use as approved in the
package insert.
3. The packaging material remains
unchanged.
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.
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1. Justification that the
proposed pack size is consistent with the dosage regimen and duration of use
as approved in the package insert.
2. Validation data of the
manufacturing process, sterilization and container closure system.
3. Stability data of the drug
product in the proposed pack size and report if any results fall outside
shelf-life specifications (with proposed action).
4. Approved shelf-life
specifications of drug product.
5. Revised draft label (where
applicable).
6. Comparative tabulated format
of approved contents and proposed changes (highlighted).
14. MaV-14
Inclusion or replacement of
the solvent/diluent for the drug product
Conditions to be fulfilled (C)
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2. For deletion of the
solvent/diluent for the drug product, 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-PA34 and/or MaV-16/MiV-PA35.
Documents to be submitted (D)
1. Complete ACTD section P for
the proposed solvent/diluent and ACTD section S for the ingredients having
pharmacological effects of the proposed solvent/diluent if they are included
in the formula of the approved solvent/diluent. Specifications of the
proposed solvent (where applicable).
2. Legal documents proving that
the proposed manufacturer/manufacturing site of solvents/diluents complies
with GMP standards currently applied to this dosage form (where applicable).
3. Revised draft label (where
applicable).
4. Comparative tabulated format
of approved contents and proposed changes (highlighted).
15. MaV-15
Extension of shelf-life of the
drug product:
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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.
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-PA34
Documents to be submitted (D)
1. Results of appropriate
long-term stability studies covering the duration of proposed shelf-life of
at least 02 pilot or production batches of the product, including results of
appropriate microbiological testing, in the following cases:
a) As a primary package in
approved pack size and/or
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c) After dilution/reconstitution
2. Technical justification for
the proposed change.
3. Approved shelf-life
specifications of drug product.
4. Comparative tabulated format
of approved contents and proposed changes (highlighted).
MaV-16
Change of storage conditions
of the drug product (lowering from the approved storage condition):
a) As a primary package in the
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 change of storage
condition (increasing from the approved storage condition), refer to
MiV-PA35.
Documents to be submitted (D)
1. Results of appropriate
long-term stability studies covering the duration of approved shelf-life at
proposed storage condition of at least 02 pilot or production batches of the
product, including results of appropriate microbiological testing, in the
following cases:
a) As a primary package in
approved pack size and/or
b) After first opening and/or
c) After dilution/reconstitution
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3. Approved shelf-life
specifications of drug product.
4. Comparative tabulated format
of approved contents and proposed changes (highlighted).
17. MaV-17
Major change in the
manufacturing process of the drug substance (where European Pharmacopoeial
Certificate of Suitability (CEP) is not available)
Conditions to be fulfilled (C)
1. The change does not result in
any potential change in qualitative and/or quantitative impurity profile
which would require further qualifications in safety studies.
2. The synthetic route is
different. If the synthetic route of the drug substance remains unchanged,
refer to MiV-PA7.
3. 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.
4. Physicochemical
characteristics and other relevant properties of drug substance remain
unchanged.
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6. If there are changes to the
specification of drug substance, MiV-PA8 is also applicable.
Documents to be submitted (D)
1. The Drug Master File (DMF) of
the drug substance or relevant ACTD sections or equivalent audit document
from one of the reference countries mentioned in the Circular prescribing
marketing authorization.
2. Comparative tabulated format
of the approved and proposed processes with changes highlighted.
3. For sterile drug substance,
report on validation of the proposed manufacturing process.
4. A letter of declaration from
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
drug substance manufacturer stating that the approved specifications of the
drug substance have not changed; if there are any changes in specifications
of the drug substance (e.g. tightened specifications), the comparative
tabulated format of the approved and proposed specifications of the drug
substance should also be submitted.
6. Certificate of analysis and/or
batch analysis data (in a comparative tabulated format) of drug product of at
least two pilot or production batches manufactured with the drug substance
according to the approved and proposed processes.
7. A letter of declaration from
the drug product manufacturer that the relevant stability studies of the drug
product manufactured with the drug substance according to the proposed
process have been started and will be finalized, and report if any results
fall outside shelf-life specifications (with proposed actions).
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9. Comparative tabulated format
of approved contents and proposed changes (highlighted).
18. MaV-18
Prescription-to-Nonprescription
switch
(applicable to the first drug
for which a request for reclassification as nonprescription is submitted)
Conditions to be fulfilled (C)
Drugs have been selling in
Vietnam for at least 03 years.
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 nonprescription and approved by the authority issuing marketing
authorization of the country prescribed in clause 9 Article 2 of this
Circular.
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- 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 Vietnam, and from post-marketing safety monitoring;
- List of issues concerning
safety of the drug if used without supervision of healthcare professionals;
- Analysis of the dangers arising
from overdose or drug abuse, whether intentional or accidental, for example:
consequences of delayed medical care.
4. Comparative tabulated format
of approved contents and proposed changes (highlighted).
II. MINOR VARIATIONS REQUIRING
PRIOR APPROVAL
19. MiV-PA1
Change of drug product name
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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 product name
complies with regulations on drug names laid down in the Circular prescribing
marketing authorization and the Circular prescribing labeling of drugs.
Documents to be submitted (D)
1. Certificate of Pharmaceutical
Product (CPP) updated with the proposed name (for drugs manufactured
overseas).
2. Comparative tabulated format
of approved contents and proposed changes (highlighted).
20. MiV-PA2
Change or addition of contents
of package insert and/or label, including:
a) Change of the layout
without altering meaning;
b)
Addition/deletion/replacement of pictures, diagrams, or texts;
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d) Tightening of product’s
target population;
e) Deletion of indication;
g) Updates to the package
insert according to the package insert of the original brand-name drug in
Vietnam or the package insert approved by SRA, if the original brand-name
drug in Vietnam is not available.
Conditions to be fulfilled (C)
1. The change is not MaV and does
not contain promotional information, does not fall in the case prescribed in
clause 2 Article 35 of the Circular No. 01/2018/TT-BYT dated January 18, 2018
of the Ministry of Health of Vietnam prescribing labeling of drugs.
2. For a major change in
label/package insert, refer to MaV-1 and MaV-2.
Documents to be submitted (D)
1. Proposed package insert and/or
label. Detailed comparative tabulated format of the approved and proposed
package inserts (where applicable).
2. Justifications for the changes
proposed.
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4. Comparative tabulated format
of approved contents and proposed changes (highlighted).
21. MiV-PA3
Addition or replacement of the
company/site responsible for batch release
Conditions to be fulfilled (C)
1. Only applicable for batch
release.
2. Test procedure transfer from
the approved to the proposed test laboratory/company responsible for batch release
has been successfully completed.
3. The manufacturer of the drug
product remains unchanged.
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1. Legal documents proving that
the proposed company/site is appropriately authorized by a competent
authority to be responsible for batch release such as a valid GMP or GLP
certificate, or CPP which covers the certification of compliance by the
proposed company/site with GMP or GLP guidelines.
2. Approved test procedure
verification/validation data at the proposed site for batch release or
documents on test procedure transfer from the approved to the proposed site
(where applicable).
3. Letter of authorization from
the product owner authorizing the company to be responsible for batch release
(where applicable).
4. Comparative tabulated format
of approved contents and proposed changes (highlighted).
22. 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)
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2. For change and/or addition of
alternative manufacturer/site of drug substance where CEP is not available,
refer to MaV-3.
Documents to be submitted (D)
1. A valid CEP for the drug
substance, latest version, accompanied with all annexes issued by the
European Directorate for the Quality of Medicines & Healthcare (EDQM).
2. Batch analysis data (in a
comparative tabulated format) for at least 02 pilot batches of the drug
substance from the approved and proposed manufacturing sites. For a drug
having demonstrated bioequivalence, such comparative tabulated format must
indicate the quality criteria included in the approved specifications of the
drug substance and those which are not included in such approved
specifications but have been established during the drug product development
(i.e. those quality criteria described in P2. Pharmaceutical development of
the marketing authorization application, e.g. particle size, polymorphism,
hydration/solvation state, solubility characteristics, density and
flowability of the drug substance) and is accompanied with supporting
documents, where applicable.
3. Comparative dissolution
profile data of the drug product manufactured with the drug substance from
the approved and proposed manufacturers/sites, in respect of the drug having
demonstrated bioequivalence.
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 manufacturing site should be provided.
5. A letter of commitment from
the drug product manufacturer to conduct long-term and accelerated stability
studies for the drug product manufactured with the drug substance from the
proposed manufacturing site, and report if any results fall outside
shelf-life specifications (with proposed action).
6. Comparative tabulated format
of approved contents and proposed changes (highlighted).
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23. MiV-PA5
Change of batch size of drug
substance [where European Pharmacopoeial Certificate of Suitability (CEP) is
not available]
Conditions to be fulfilled (C)
1. The change does not affect the
reproducibility of the process.
2. Specifications of the drug substance
remain unchanged.
Documents to be submitted (D)
1. Batch analysis data (in a
comparative tabulated format) with approved specifications 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. During the batch analysis, any results fall
outside specifications (with proposed actions) must be reported.
2. A letter of declaration from
the drug substance manufacturer that the specifications of drug substance
have not changed, and the reproducibility of the process has not been
affected.
3. Amended relevant ACTD Section
S.
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24. 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)
1. In-process control limits are
tightened or new tests are added.
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 test method does not
concern a novel non-standard technique or a standard technique used in a
novel way.
Documents to be submitted (D)
1. A description of the analytical
method and summary of validation data for all new analytical methods.
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3. Batch analysis data (in a
comparative tabulated format) of 02 production batches of the drug substance
for all tests in the proposed specification.
4. Comparative tabulated format
of approved contents and proposed changes (highlighted).
25. MiV-PA7
Minor change in manufacturing
process of the drug substance [where European Pharmacopoeial Certificate of
Suitability (CEP) is not available]
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. Stability performance of drug
substance remains unchanged.
3. The synthetic route remains
unchanged (for example, intermediates remain unchanged).
4. Manufacturing process of drug
substance does not use any materials of human/animal origin for which
assessment is required of viral safety.
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Documents to be submitted (D)
1. The Drug Master File (DMF) of
the drug substance or relevant ACTD sections or equivalent audit document from
one of the reference countries mentioned in the Circular prescribing
marketing authorization.
2. Comparative tabulated format
of the approved and proposed processes with changes highlighted.
3. Certificate of analysis for 02
batches of the drug substance manufactured according to the proposed process.
4. Batch analysis data (in a
comparative tabulated format) of drug product of at least 02 pilot or
production batches manufactured with the drug substance according to the
approved and proposed processes.
5. A letter of declaration from
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.
6. A letter of declaration from
drug substance manufacturer stating that the approved specifications of the
drug substance have not changed; if there are any changes in specifications
of the drug substance (e.g. tightened specifications), the comparative
tabulated format of the approved and proposed specifications of the drug
substance should also be submitted.
7. A letter of declaration from
the drug product manufacturer that the relevant stability studies of the drug
product manufactured with the drug substance according to the proposed
process have been started and will be finalized, and report if any results
fall outside shelf-life specifications (with proposed actions).
8. For sterile drug substance,
report on validation of the proposed manufacturing process.
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10. Comparative tabulated format of
approved contents and proposed changes (highlighted).
26. MiV-PA8
Change of the specification of
drug substance, including:
a) Specification limits are
tightened;
b) Addition of new test
parameter and limits.
Conditions to be fulfilled (C)
1. This is only applicable for
drug substances which are non-compendial and generic drug substances without
European Pharmacopoeial Certificate of Suitability (CEP).
2. For (b) - applicable to
non-compendial method only.
3. For change of specification of
drug substance where a CEP is available, refer to MiV-PA12.
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5. The change should not be the
result of unexpected events arising during manufacture or because of
stability concerns.
6. Test procedures in the
approved specification of drug substance remain unchanged, or changes in the
test procedure are minor (it is not necessary to carry out re-validation of
the test procedure).
Documents to be submitted (D)
a) Specification limits are
tightened:
1. Comparative tabulated format
of the approved and proposed test parameter and limits of drug substance with
the changes highlighted.
2. Comparative batch analysis
data of the drug substance in the proposed specification for 02 pilot or
production batches.
3. Technical justification for
the change.
4. Comparative tabulated format
of approved contents and proposed changes (highlighted).
b) Addition of new test
parameter and limits:
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Description of any new analytical
method and summary of the validation data.
27. MiV-PA9
Change of the test procedure
in specification of non-compendial drug substance
Conditions to be fulfilled (C)
1. Results of method validation
show proposed test 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.
Documents to be submitted (D)
1. Description and verification/validation
data of the proposed test procedure with a summary of change(s) from the
approved test procedure.
2. Specification of the drug
substance updated with changes in the test procedure.
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4. Comparative tabulated format
of approved contents and proposed changes (highlighted).
28. 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.
3. For change of specification of
drug substance where a CEP is available, refer to MiV-PA12.
Documents to be submitted (D)
1. 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.
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3. Comparative tabulated format
of approved contents and proposed changes (highlighted).
29. 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.
Documents to be submitted (D)
1. Approved specifications of the
drug substance.
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3. Comparative tabulated format
of approved contents and proposed changes (highlighted).
30. 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. Results of batch analysis data
from the drug substance manufacturer demonstrating compliance with the Ph.
Eur monograph and including additional test/limits listed on the CEP (where
applicable).
3. 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).
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5. If the approved specification
of drug substance is not EP specification (and the drug product manufacturer
claims otherwise to inspect quality of the drug substance before used for
manufacturing of the drug product), and there is a change in the drug
substance specification, data covering ACTD section S4-S5 shall be submitted.
6. Comparative tabulated format
of approved contents and proposed changes (highlighted).
31. MiV-PA13
Addition or change of batch size
of non-sterile drug product
Conditions to be fulfilled (C)
1. This is applicable to change
of batch size up to 10-fold compared to the approved batch size.
2. The change does not affect
consistency of production.
3. Release and shelf-life
specifications of drug product remain unchanged.
4. 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.
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1. Validation scheme and/or report
of the manufacturing process of at least 03 production batches manufactured
according to the proposed batch size.
2. Comparative tabulated format
of approved and proposed batch manufacturing formula.
3. 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 a
letter of undertaking of the drug product manufacturer to submit batch
analysis data on the next one full production batch.
4. Stability data of the drug
product after the change made and report if any results fall outside the
approved shelf-life specifications (with proposed action).
5. Approved release and
shelf-life specifications of the drug product.
6. ACTD section P1-P3 revised in
conformity with the proposed batch size.
7. Comparative tabulated format
of approved contents and proposed changes (highlighted).
32. MiV-PA14
Reduction or removal of
overages
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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 changes.
2. Comparative tabulated format
of approved and proposed batch manufacturing formula.
3. Certificate of analysis for 02
batches of the finished product manufactured according to the proposed batch
manufacturing formula.
4. Stability data of the drug
product manufactured according to the proposed batch manufacturing formula
and report if any results fall outside shelf-life specifications (with
proposed action).
5. Comparative tabulated format
of approved contents and proposed changes (highlighted).
33. MiV-PA15
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a) For immediate release oral
dosage forms (as per Level 1, Part III (Components and composition) -
SUPAC-IR guideline);
b) For other non-critical
dosage forms, e.g. oral liquid, external preparation.
Conditions to be fulfilled (C)
1. Approved release and
shelf-life specifications and levels thereof of the drug product remain
unchanged, except for update of product description with respect to
appearance of the drug product as a consequence of the change (where
applicable).
2. For oral solid dosage forms:
The dissolution profile of the proposed product is comparable to that of the
approved product in conformity with SUPAC-IR standards.
3. Replacement of an excipient
with a comparable excipient of the same functional characteristics (where
applicable).
4. For qualitative or
quantitative change of excipient for immediate release (as per Level 2 and 3,
Part III (Components and composition) - SUPAC-IR guideline) and modified
release oral dosage forms and other critical dosage forms, refer to MaV-10.
5. The excipient manufacturer
complies with Good Manufacturing Practice (GMP) guidelines (carried out
according to the prescribed roadmap).
Documents to be submitted (D)
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2. Stability data of the drug
product after the change made and report if any results fall outside
shelf-life specifications (with proposed action).
3. 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.
4. 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).
5. 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.
6. Release and shelf-life
specifications of the drug product after the change with updated product
description with respect to its appearance as a consequence of the change
(where applicable).
7. Batch analysis data (in a
comparative tabulated format) of drug product on at least 02 production
batches (or 01 production batch and 02 pilot batches) according to approved
and proposed formula.
8. Specifications of the proposed
excipient (if an excipient which is not included in the approved product
formulation is used).
9. For proposed excipients made
of ruminant source, TSE-free certificate or BSE-free certificate issued from
a relevant animal health authority.
10. Revised batch manufacturing
formula.
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12. ACTD Section P3.1 to P3.4
which have been revised appropriately to the proposed product formulation.
13. A declaration substantiated
with experimental data (where necessary) that the proposed excipient does not
interfere with the approved drug product release/shelf-life specifications
test procedures. If the proposed excipient interferes with the approved drug
product release/ shelf-life specifications test procedures, additional
documents shall be submitted according to MiV-PA27.
14. Legal documents of the
manufacturer of the proposed excipient as prescribed in clause 7 Article 22
of this Circular. If the proposed excipient has been granted a marketing authorization
in Vietnam, these documents shall not be required.
15. Comparative tabulated format
of approved contents and proposed changes (highlighted).
34. MiV-PA16
Quantitative change in coating
of tablets or weight and/or size of capsule shell for immediate release oral
solid dosage form
Conditions to be fulfilled (C)
1. For oral solid dosage forms:
The dissolution profile of the proposed product is comparable to that of the
approved product in conformity with SUPAC-IR standards.
2. Approved release and
shelf-life specifications and levels thereof of the drug product remain
unchanged, except for update of product description with respect to
appearance of the drug product as a consequence of the change (where
applicable).
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Documents to be submitted (D)
1. Comparative dissolution
profile data of at least 01 pilot or production batch of the drug product
manufactured in the approved and proposed composition.
2. 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).
3. Release and shelf-life
specifications of the drug product after the change with updated product
description with respect to its appearance as a consequence of the change
(where applicable).
4. Letters of declaration made by
the drug product manufacturer and the applicant that the change does not
interfere with the approved drug product release and shelf-life
specifications test procedure.
5. Comparative tabulated format
of approved and proposed 01-dose and batch manufacturing formula.
6. For quantitative change in
coating of tablets: Stability study data of the drug product after the change
and report if any results fall outside shelf-life specifications (with
proposed action). For the change in weight and/or size of capsule shell, a
letter of declaration from the drug product manufacturer that the relevant
stability studies of the drug product have been started and will be
finalized.
7. ACTD Section P3.1 to P3.4
which have been revised appropriately to the change.
8. Comparative tabulated format
of approved contents and proposed changes (highlighted).
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Change of the colouring
agent/flavouring agent of the drug product [addition, deletion or replacement
of colouring agent(s)/flavouring agent(s)]
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 must not have been rejected for pharmaceutical use.
3. Approved release and
shelf-life specifications and levels thereof of the drug product remain
unchanged, except for update of product description with respect to colour
and/or odour as a consequence of the change.
Documents to be submitted (D)
1. Qualitative and quantitative
information of the approved and proposed colouring agent/flavouring agent in
a comparative table.
2. Revised 01-dose formulation
and batch manufacturing formula.
3. Revised release and shelf-life
specifications of the drug product with updated product description with
respect to colour and/or odour as a consequence of the change.
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5. For proposed excipients made
of ruminant source, TSE-free certificate or BSE-free certificate issued from
a relevant animal health authority.
6. A declaration substantiated
with experimental data (where necessary) that the proposed colouring
agent/flavouring agent does not interfere with the approved drug product
release/ shelf-life specifications test procedures. If the proposed colouring
agent/flavouring agent interferes with the approved drug product shelf-life
specifications test procedures, additional documents shall be submitted
according to MiV-PA27.
7. ACTD Section P3.1 to P3.4
which have been revised appropriately to the change.
8. Comparative tabulated format
of approved contents and proposed changes (highlighted).
36. MiV-PA18
Deletion 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, treatment regimen, indication,
method of administration of the product.
Documents to be submitted (D)
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37. 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)
1. Release and shelf-life
specifications of drug product remain unchanged.
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 test method does not
concern a novel non-standard technique or a standard technique used in a
novel way.
Documents to be submitted (D)
1. A description of the analytical
methodology and summary of validation data must be provided for all new
analytical methods (where applicable).
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3. Batch analysis data (in a comparative
tabulated format) of drug product of at least 02 pilot or production batches
manufactured under the proposed in-progress controls.
4. Comparative tabulated format
of approved and proposed in-process controls.
5. Comparative tabulated format
of approved contents and proposed changes (highlighted).
38. MiV-PA20
Minor change of the
manufacturing process for non-sterile product
Conditions to be fulfilled (C)
1. The manufacturing site remains
unchanged.
2. The overall manufacturing
principle remains unchanged.
3. The change does not cause a
negative impact on the quality, safety and efficacy of the drug product.
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5. For oral solid dosage forms:
The dissolution profile of the proposed product is comparable to that of the
approved product in conformity with SUPAC-IR and SUPAC-MR standards.
6. For major change in the
manufacturing process for drug product, refer to MaV-9.
Documents to be submitted (D)
1. Description of the proposed
manufacturing process and technical justification for the change.
2. For semi-solid and suspension
products: Validation scheme and/or report of the manufacturing process.
3. For oral solid dosage forms:
Comparative dissolution profile data of at least 01 production batch of the
drug product manufactured in the approved and proposed manufacturing process.
4. Approved release and
shelf-life specifications of the drug product.
5. 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).
6. Batch analysis data (in a
comparative tabulated format) of drug product on a minimum of 01 batch
manufactured to both the approved and the proposed process; batch analysis
data on the next 02 full production batches should be made available upon
request.
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8. Comparative tabulated format
of the approved and proposed processes with changes highlighted.
9. Comparative tabulated format
of approved contents and proposed changes (highlighted).
39. MiV-PA21
Change of specifications of
excipient, including:
a) Specification limits are
tightened/widened
b) Addition/replacement/deletion
of test parameter and limits
Conditions to be fulfilled (C)
1. Applicable to approved
specifications of non-compendial excipients. For approved specifications of
compendial excipients, refer to MiV-N6.
2. Release and shelf-life
specifications of drug product remain unchanged.
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Documents to be submitted (D)
1. Comparative tabulated format
of the approved and proposed specification of the excipient with changes
highlighted.
2. Description of new method
(applicable for addition of new parameter).
3. Certificate of analysis of the
excipient for all tests in the proposed specification.
4. Comparative tabulated format
of approved contents and proposed changes (highlighted).
40. MiV-PA22
Change of a test procedure for
an excipient, including replacement of an approved test procedure by a new
test procedure.
Conditions to be fulfilled (C)
1. Appropriate method validation
studies have been performed.
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3. The change does not result in
changes of the total impurity limits.
4. Only applicable to the
approved test parameters and limits.
5. No new unqualified impurities
are detected.
6. This applies to non-compendial
excipients.
Documents to be submitted (D)
1. Description of the proposed
analytical methodology with a comparative tabulated format of the changes.
2. For quantitative test change
(including quantitative test for impurities): Comparative analytical
validation results showing that the approved and proposed tests are
equivalent.
3. Comparative tabulated format
of approved contents and proposed changes (highlighted).
41. MiV-PA23
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a) Change in the source of
materials used for manufacturing of empty hard capsule;
b) Change/addition of empty
hard capsule manufacturer.
Conditions to be fulfilled (C)
1. The change is from TSE-risk
animal-sourced 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. Approved specifications of
excipients (except specifications of the proposed empty hard capsule),
release and shelf-life specifications of finished product remain unchanged.
5. The empty hard capsule
manufacturer complies with Good Manufacturing Practice (GMP) guidelines
(carried out according to the prescribed roadmap).
Documents to be submitted (D)
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2. Composition and technical
specifications of the empty hard capsule of the proposed source.
3. Certificate of analysis of the
empty hard capsule of the proposed source.
4. Stability data of the drug
product after the change made and report if any results fall outside
shelf-life specifications (with proposed action).
5. For empty hard capsule made of
ruminant source, TSE-free certificate or BSE-free certificate issued from a
relevant animal health authority.
6. A letter of declaration from
the drug manufacturer that the material for manufacturing empty hard capsule
is purely of vegetable, animal or synthetic origin.
7. Data proving that the empty
hard capsule of the proposed source does not affect dissolution test results
according to the approved drug product specification test procedure (where
applicable).
8. Legal documents proving that
the empty hard capsule manufacturer complies with Good Manufacturing Practice
(GMP) guidelines (carried out according to the prescribed roadmap). If the
empty hard capsule of the proposed source has been granted a marketing
authorization in Vietnam, these documents shall not be required.
9. Comparative tabulated format
of approved contents and proposed changes (highlighted).
42. MiV-PA24
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a) Specification limits are
tightened;
b) Addition of new test
parameter and limits.
Conditions to be fulfilled (C)
1. Applicable to non-compendial
drug product specification.
2. The change should not be the
result of unexpected events arising during manufacture or because of
stability concerns.
3. Test procedures remain
unchanged, or changes in the test procedure are minor (the validation of test
procedure is not necessary).
4. If there are changes to the
test 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)
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1. Comparative tabulated format
of the approved and proposed release and shelf-life specifications of the
drug product with changes highlighted.
2. Certificate of analysis or
batch analysis data (in a comparative tabulated format) of the drug product
for all tests in the proposed specification of at least 02 production
batches.
3. Technical justification for
the change.
4. Comparative tabulated format
of approved contents and proposed changes (highlighted).
b) Addition of new test
parameter and limits:
In addition to the above
documents:
5. Description of any new analytical
method for the drug product and summary of validation data for this
analytical method (for non-compendial method or a method in the new
pharmacopeia different from that in the one pharmacopeia).
6. Stability data of the drug
product after the change made and report if any results fall outside
shelf-life specifications (with proposed action).
43. MiV-PA25
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Conditions to be fulfilled (C)
a) All changes in this
section, except score/break-line:
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 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.
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a) All changes in this
section, except score/break-line:
1. Composition and specifications
of the proposed ink.
2. Certificate of analysis of the
proposed ink/printing material (pharmaceutical grade and of food grade).
3. Detailed (drawing or written)
description of the approved and proposed imprint/bossing/markings.
4. Release and shelf-life
specifications of drug product with the proposed product description with
respect to appearance.
5. Comparative tabulated format
of approved contents and proposed changes (highlighted).
b) Change of
score/break-line:
In addition to the above
documents:
6. Justification for the change
(e.g. change in dosing regimen).
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8. Data on test of uniformity of
the subdivided parts of the tablets at release (for addition of
score/break-line).
44. 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. If appropriate, the
dissolution profile of the proposed product is comparable to that of the
approved product according to SUPAC-IR and SUPAC-MR guidelines.
2. Approved release and shelf-life
specifications of the drug product remain unchanged, except for dimension
and/or shape.
Documents to be submitted (D)
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1. Detailed (drawing or written)
description of the approved and proposed dimensions/ shape.
2. Release and shelf-life
specifications of the drug product with updated product description with
respect to the proposed dimensions/ shape.
3. Comparative dissolution
profile data of at least 01 pilot or production batch of the drug product
manufactured in the approved and proposed dimensions/ shape.
4. Data on test of uniformity of
the subdivided parts of tablets at release as conformed to compendial
requirement (for scored tablets).
5. Comparative tabulated format
of approved contents and proposed changes (highlighted).
b) Other than immediate
release oral solid dosage forms, suppositories and pessaries:
In addition to the above
documents:
6. Justification for not
submitting a new bioequivalence study of the drug product in the proposed
dimensions/ shape (for a drug granted marketing authorization and having
demonstrated bioequivalence).
45. MiV-PA27
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Conditions to be fulfilled (C)
1. Approved drug product
specifications and levels thereof are not adversely affected, unless the
specifications are tightened.
2. Results of method
verification/validation show proposed test 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.
Documents to be submitted (D)
1. Justification for the proposed
change.
2. Appropriate verification/validation
data and comparative analytical results between the approved and proposed
test.
3. Certificate of analysis of the
finished product of 02 production batches according to the proposed
specification.
4. Justification for the proposed
change.
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6. Comparative tabulated format
of approved contents and proposed changes (highlighted).
46. MiV-PA28
Change or inclusion of primary
packaging material for non-sterile drug product, including:
a) Qualitative and
quantitative composition of primary packaging material;
b) Type of container and/or
primary packaging material.
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 sterile drug product, refer to MaV-12.
Documents to be submitted (D)
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2. 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).
3. Comparative tabulated format
of the approved and proposed specifications of the primary packaging
material.
4. 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).
5. Draft label (where
applicable).
6. Comparative tabulated format
of approved contents and proposed changes (highlighted).
47. MiV-PA29
Addition or replacement of a
manufacturer for secondary packaging
Conditions to be fulfilled (C)
There is no change in other
contents, except addition or replacement of a manufacturer for secondary
packaging
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1. GMP certificate or CPP for an
overseas packager and certificate of eligibility for a domestic packager.
2. Official letter from product
owner authorizing the proposed packager to perform secondary packaging (where
applicable).
3. Comparative tabulated format
of approved contents and proposed changes (highlighted).
48. 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. Release and shelf-life
specifications of drug product remain unchanged.
2. The proposed pack size is
consistent with the dosage regimen and duration of use as approved in the
package insert.
3. For 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, refer to MaV-13.
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Documents to be submitted (D)
1. Justification for the proposed
pack size.
2. Draft label (where
applicable).
3. Revised ACTD Sections P3
and/or P7 (where applicable).
4. Letters of declaration from
the drug product manufacturer and the applicant that the relevant stability
studies of the drug product in the proposed pack size have been started and
will be finalized, and report if any results fall outside shelf-life
specifications (with proposed actions).
5. Revised drug product
specifications and certificate of analysis for the proposed pack size in case
of change in fill volume or weight.
6. Comparative tabulated format
of approved contents and proposed changes (highlighted).
49. MiV-PA31
Change or addition of outer
carton pack sizes for a drug product
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1. The proposed pack sizes are
adequate to accommodate the dosing regimen as per the approved package
insert.
Documents to be submitted (D)
1. The approved package insert.
2. Draft label (where
applicable).
3. Justification for the proposed
pack size which is adequate to accommodate the dosing regimen as per the
approved package insert.
4. Comparative tabulated format
of approved contents and proposed changes (highlighted).
50. MiV-PA32
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 (different plastic used)
Conditions to be fulfilled (C)
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Documents to be submitted (D)
1. Amendment of the relevant
section(s) of the dossier (presented in the ACTD format).
2. Comparative tabulated format
of the changes.
3. Draft label (where
applicable).
4. Comparative tabulated format
of approved contents and proposed changes (highlighted).
51. MiV-PA33
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.
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Documents to be submitted (D)
1. Description of the proposed
device (including a drawing, where applicable).
2. Information on the composition
of the device material. The materials used for manufacturing of the proposed
device should comply with specifications in the reference pharmacopoeia
(where applicable).
3. Justification that size and
accuracy of the proposed device are adequate for the posology as approved in
the product labeling.
4. Comparative tabulated format
of approved contents and proposed changes (highlighted).
52. MiV-PA34
Reduction of shelf-life of the
drug product
a) As a primary package in the
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 extension of shelf-life,
refer to MaV-15.
Documents to be submitted (D)
1. Results of appropriate
long-term stability studies covering the duration of proposed shelf-life of
at least 02 pilot or production batches of the product, including results of
appropriate microbiological testing, in the following cases:
a) As a primary package in
approved pack size and/or
b) After first opening and/or
c) After the
dilution/reconstitution
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3. Report on quantity of drug
placed on the market.
4. Approved shelf-life
specifications of drug product.
5. Comparative tabulated format
of approved contents and proposed changes (highlighted).
53. MiV-PA35
Change of storage conditions
of the drug product (increasing from the approved storage condition)
a) As a primary package in the
approved pack size and/or
b) After first opening and/or
c) After
dilution/reconstitution.
Conditions to be fulfilled (C)
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2. For (c) - The studies must
show conformance to the approved shelf-life specification for the
reconstituted product.
3. For change of storage
condition (lowering from the approved storage condition), refer to MaV-16.
Documents to be submitted (D)
1. Results of appropriate long
term stability studies covering the duration of approved shelf-life (at
proposed storage condition) of at least 02 pilot or production scale batches
of the product which should be accompanied with results of microbiological
testing in the following cases:
a) As a primary package in
approved pack size and/or
b) After first opening and/or
c) After
dilution/reconstitution.
2. Technical justification for
the proposed change.
3. Approved shelf-life
specifications of drug product.
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54. MiV-PA36
Change of the applicant
Conditions to be fulfilled (C)
1. Applicable to change of the
applicant
Documents to be submitted (D)
1. Certificate of satisfaction of
business conditions 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 to establish representative office in Vietnam 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).
55. MiV-PA37
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Conditions to be fulfilled (C)
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 Vietnam.
56. MiV-PA38
Declaration of original
brand-name drugs and reference biologicals
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 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 manufacturer or manufacturing site is changed and it is issued with
a new marketing authorization if it meets the criteria set out in clause 2
Article 13 hereof.
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3. Case 3: If a drug which
has not yet declared by the Ministry of Health of Vietnam as original
brand-name drug or reference biological meets the requirements laid down in
clause 1 Article 13 of this Circular, it shall be classified as original
brand-name drug or reference biological.
Documents to be submitted (D)
1. Case 1: 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 manufacturer or manufacturing site is changed and it is
issued with a new marketing authorization if it meets the criteria set out in
clause 2 Article 13 hereof
- The comparative tabulated
summary (Form 01/TT) of the drug requesting declaration as original
brand-name drug or reference biological and the drug which has been declared
as original brand-name drug or reference biological, and supporting
documents.
- For change of the manufacturer
or manufacturing site of reference biologicals, the request for
classification as reference biological must also include additional documents
proving quality equivalence according to guidelines of US FDA, ICH, WHO, EMA,
and international organizations to which Vietnam is a member, and guidelines
given by the drug regulatory authorities prescribed in clause 9 Article 2
hereof.
2. Case 2: If a drug
ordered for processing or drug before technology transfer, whether it has
been classified as original brand-name drug or reference biological or not,
has clinical data meeting the requirements laid down in point a or b clause 1
Article 13 of this Circular and is processed or manufactured adopting
transferred technology in Vietnam, the processed drug or the drug
manufactured adopting transferred technology shall be classified as original
brand-name drug or reference biological if it meets the criteria set out in
clause 2 Article 13 of this Circular
- Proof that the drug ordered for
processing or drug before 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 proving that the drug
has been declared as 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 before technology transfer which is yet to be declared as
original brand-name drug or reference biological in Vietnam.
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- For an application for
declaration as original brand-name drug, bioequivalence study reports of the
processed drug/drug manufactured adopting transferred technology which meet
the requirements laid down in point d clause 2 Article 38 of this Circular
must be provided.
- For change of the manufacturer
or manufacturing site of reference biologicals, the request for
classification as reference biological must also include additional documents
proving quality equivalence according to guidelines of US FDA, ICH, WHO, EMA,
and international organizations to which Vietnam is a member, and guidelines
given by the drug regulatory authorities prescribed in clause 9 Article 2
hereof.
3. Case 3: If a drug which
has not yet declared by the Ministry of Health of Vietnam as original brand-name
drug or reference biological meets the requirements laid down in clause 1
Article 13 of this Circular, it shall be classified as original brand-name
drug or reference biological.
- Clinical documents meeting the
requirements laid down in Article 18 of this Circular, unless the drug
requesting declaration as original brand-name drug 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.
57. MiV-PA39
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Conditions to be fulfilled (C)
1. The change/addition requires
prior approval but does not result in any change in information on the label
and package insert of the drug (*)
2. The information to be
additionally provided or updated as prescribed in this section is the new
information which is found or obtained from scientific studies or during
monitoring of the drug product placed on the market but does not fall in any
of the cases in section 1 through 7 of this Appendix.
3. Additional or updated
information is presented in the same format as that used for provision of
drug information.
Documents to be submitted (D)
1. Information to be updated.
2. Reference documents.
3. Copy of the latest revised
package insert which has been approved by the Ministry of Health and bears
the seal of the applicant.
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(*) Notes:
1. Purpose of the change/addition:
Information is added or updated with
the aim of supporting or clarifying the information available on the package
insert. Information added or updated to the marketing authorization application
is used for provision of drug information and advertising and ensuring the
safe, appropriate and efficient use of the drug.
2. Information to be changed/added:
- Pharmacokinetic parameters of the
drug on a specific study population (including comparison of pharmacokinetic
parameters between the drugs).
- Pharmacodynamic parameters:
mechanism of action; studies on the antibiotic susceptibility of strains of
bacteria at a given point of time in a specific study population, etc.
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- Treatment regimens or clinical
guidelines relating the drug.
- In vivo bioequivalence study
results.
- Detailed information on unwanted
side effects of the drug as written on its package insert;
- Study results evaluating
improvement in quality of life of patients, satisfaction of patients and
physicians with treatment convenience, ease of use, adherence to treatment and
effectiveness, etc. of the drug.
- Other information concerning
quality, safety and efficacy of the drug.
3. Format of information:
- The proposed information must be
presented in a clear, adequate, accurate and well-grounded manner which is easy
to understand and suitable for the target users.
- Additional or updated information
is accurately presented in the same format as that used for provision of drug
information.
- A list of reference documents
used as the basis for the proposed information in which the ordinal number and
name of each reference document, name of study, author and year of publication
are clearly specified must be provided.
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- In case the reference document is
a study on an active ingredient, the citation must be provided using the name
of the active ingredient (replacement of the name of active ingredient with the
original brand name is not allowed); in case the reference document is a study
on an original brand name drug, the citation must be provided using original
brand name.
- The ordinal number of the
reference document is written following the citation.
- Adequate interpretation of study
results, accompanied with study figures, must be provided; provision of overall
conclusions is not accepted.
- Do not use printed bold and large
fonts for the names of reference document, the organization conducting the
study, the study method, and the organization giving the treatment regimen or
clinical guidelines.
4. Requirements for reference
documents:
4.1. Types of reference documents
include:
- The monographs relating the drug
in latest versions of the Vietnamese National Drug Formulary, Martindale, AHFS,
BNF, FDA, EMC…;
- Articles on clinical studies and
other studies on the drug published on the journals indexed in SCI (Science Citation
Index);
- Treatment regimens or clinical
guidelines relating the drug;
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4.2. Criteria for reference
documents:
- Reference documents must be
obtained from clear and reliable sources, and be adequate, detailed and
up-to-date texts; name of the document, author and publication date must be
clearly indicated;
- In case the reference document is
a clinical study, information about the clinical study (including objectives,
study method, sample sizes, description of study steps, study results,
discussions and conclusions, etc.) must be adequately provided.
- Reference documents which are
studies conducted on animals or in vitro studies shall not be accepted.
- Language of reference documents:
Vietnamese or English. If a reference document is written in a language which
is neither Vietnamese nor English, a notarized Vietnamese translation thereof
bearing the applicant’s seal is required.
- Parts of the reference document
which are cited to support the updated information must be clearly stated.
58. MiV- PA40
Addition or replacement of the
company/site responsible for quality control testing
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1. Only applicable to
company/site responsible for quality control testing.
2. The manufacturer and secondary
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)
1. Declaration from the drug
product manufacturer/product owner on the following:
a) The change does not affect the
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. Documentary evidence that the
proposed quality control testing company/site or test laboratory is
appropriately accredited (according to GMP/GLP/ISO/IEC standards).
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4. Analytical method transfer
data/verification data (where applicable).
5. Revised ACTD Sections S2 or
P3.
6. Comparative tabulated format
of approved contents and proposed changes (highlighted).
59. MiV- PA41
List of domestically
manufactured drugs granted marketing authorization by a drug regulatory
authority included in the list of SRAs
Conditions to be fulfilled (C)
1. Drugs are entirely
manufactured on a production line in Vietnam.
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Documents to be submitted (D)
1. Legal documents which are
issued by SRAs and bear at least the following information: the drug name,
active ingredients, their concentration or strength, dosage form, name and
address of the manufacturer, and certification that the drug is granted
marketing authorization in that country.
2. Statements proving that the
drug sold in Vietnam and the drug granted marketing authorization by a SRA
have the same formulation, manufacturing process, specifications and test
method; the drug substance and excipients have the same specifications and
are manufactured by the same manufacturer or at the same manufacturing site.
60. MiV-PA42
List of drugs manufactured
using materials (drug substance) granted CEP
Conditions to be fulfilled (C)
Drugs are manufactured using
materials (drug substance) granted CEP
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CEP (Certificate of Suitability
to the Monographs of the European Pharmacopoeia) of the drug material.
61. MiV-PA43
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 draft(s) of the label
and/or package insert incorporating the proposed variation (where
applicable).
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3. In case of a contract primary
packager, letter of appointment and letter of acceptance for the proposed
packager/site to package the product and stating the types of packaging
activity to be performed by the proposed packager/at the proposed site.
4. Holding time studies testing
of bulk product during storage and transportation between the bulk production
site and the primary packager (where applicable).
5. A letter of commitment from
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).
6. Comparative tabulated format
of approved contents and proposed changes (highlighted).
62. MiV-PA44
Change of an ordering facility
Conditions to be fulfilled (C)
Applicable to the change of
ordering facility
Documents to be submitted (D)
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2. A letter of commitment from
the proposed order facility to remain the manufacturing site unchanged and
continue performing rights and responsibilities of an ordering facility
according to the application for marketing authorization of the processed
drug in Vietnam which has been approved.
3. Comparative tabulated format
of approved contents and proposed changes (highlighted).
63. MiV-PA45
Change of a sending facility
(in case of drug technology transfer)
Conditions to be fulfilled (C)
Applicable to the change of
sending facility
Documents to be submitted (D)
1. A letter of declaration from
the proposed sending facility to continue performing the drug technology
transfer contract signed with the approved sending facility;
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3. Comparative tabulated format
of approved contents and proposed changes (highlighted).
64. MiV-PA46
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 risk
management plan for a drug granted marketing authorization
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.
6. Comparative tabulated format
of approved contents and proposed changes (highlighted).
65. MiV-PA47
Prescription-to-Nonprescription
switch according to classification of a similar drug (having the same active
ingredient, strength or concentration, and dosage form) granted marketing
authorization in Vietnam
Conditions to be fulfilled (C)
There is a similar drug granted
marketing authorization in Vietnam and classified as nonprescription drug.
Documents to be submitted (D)
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2. Comparative tabulated format
of the approved and proposed package inserts.
3. Information about the similar
drug granted marketing authorization in Vietnam and classified as
nonprescription drug.
4. Comparative tabulated format
of the proposed drug and the drug classified as nonprescription drug in terms
of indication, usage - dosing regimen and patient population.
5. Comparative tabulated format
of approved contents and proposed changes (highlighted).
66. MiV-PA48
Nonprescription-to-Prescription
switch
Conditions to be fulfilled (C)
The drug is reclassified at the
request of a regulatory authority
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1. Revised drafts of the label
and package insert (after reclassification)
2. Comparative tabulated format
of the approved and proposed package inserts.
3. Comparative tabulated format
of approved contents and proposed changes (highlighted).
III. MINOR VARIATION
NOTIFICATION (MiV-N)
67. MiV-N1
Change in name and/or address
of or updating of information on the applicant or ordering facility or
sending facility
Conditions to be fulfilled (C)
The applicant or ordering
facility or sending facility remains unchanged.
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1. An application form covering
the commitment to assume responsibility for the change of name and/or address
of the applicant or ordering facility or sending facility.
2. Official document from the
relevant competent authority confirming the change with the proposed name
and/or address or legal documents of the applicant or ordering facility or
sending facility proving the change.
3. Relevant legal documents.
68. 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. If there are changes to
specifications of the excipient, MiV- PA21 or MiV-N6 is also applicable.
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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 Vietnam, these documents shall not be required.
2. Approved specifications of the
excipient.
3. Certificate of analysis of the
excipient from the excipient manufacturer.
69. MiV-N3
Change of the name and/or
address (for example: postal code, street name) of a manufacturer of the drug
substance, excipient, capsule shell
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.
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1. Updated information of the
manufacturer of the drug substance, excipient or capsule shell.
2. Comparative tabulated format
of the approved and proposed manufacturer information (for change of the name
and/or address of a manufacturer of the excipient or capsule shell)
3. The applicant’s letter of
commitment and certification to assume legal responsibility for the change of
name and/or address (for example: postal code, street name) of a manufacturer
of the drug substance, excipient or capsule shell (the manufacturing site
remains unchanged).
70. MiV-N4
Deletion of drug substance
manufacturer
Conditions to be fulfilled (C)
1. An alternative manufacturer is
registered.
Documents to be submitted (D)
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71. MiV-N5
Re-registration of European
Pharmacopoeial Certificate of Suitability (CEP)
Conditions to be fulfilled (C)
1. Only applicable if the
re-registration of CEP does not involve any variation.
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.
72. MiV-N6
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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.
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 test procedure,
appropriate verification data of the proposed test procedure (where
applicable).
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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 approved dosing regimen.
2. For change 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. Justification for the reason
for deletion.
74. MiV-N8
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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.
75. MiV-N9
Change in name and/or address
(for example: postal code, street name) of manufacturer of drug product,
processing facility, receiving facility, manufacturer of drug ordered for
processing, manufacturer of drug before technology transfer (hereinafter
referred to as “manufacturer” in this variation section)
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1. The manufacturing site remains
unchanged.
2. Not applicable to the change
in ownership of manufacturer. For change in ownership of manufacturer, refer
to MiV-N8.
3. No other changes except for
the change of the name and/or address of a manufacturer.
Documents to be submitted (D)
1. GMP or CPP certificate confirming
the proposed name and/or address of the manufacturer.
2. The written certification from
relevant competent authority confirming the change of name and/or address
without the change in manufacturing site which is located in a foreign
country.
3. The certificate of
satisfaction of conditions for pharmaceutical business bearing the proposed
name and/or address of the domestic manufacturer.
76. MiV-N10
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Conditions to be fulfilled (C)
1. The manufacturer of the drug
product remains unchanged.
2. Not applicable to the change
in ownership of manufacturer. For change in ownership of manufacturer, refer
to MiV-PA37.
3. The batch release site remains
unchanged.
Documents to be submitted (D)
1. 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 which is located in a foreign country.
2. The certificate of
satisfaction of conditions for pharmaceutical business bearing the proposed
name and/or address of the domestic company or manufacturer responsible for
batch release.
77. MiV-N11
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Conditions to be fulfilled (C)
1. The manufacturer of the drug
product remains unchanged.
2. The quality control testing
site remains unchanged.
Documents to be submitted (D)
1. Documentary evidence that the
proposed quality control testing company/site or test laboratory is
appropriately accredited (according to GMP/GLP/ISO/IEC standards).
2. The official letter from
product owner authorizing the proposed quality control testing company/site
or test laboratory to be responsible for quality control testing (where
available).
3. A declaration from the
marketing authorization holder that the change does not involve change of
quality control testing site.
C. GUIDELINES ON VARIATIONS
I. FOR NEW CHEMICAL DRUGS AND
MEDICINAL MATERIALS
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II. BIOLOGICALS
1. For biologicals, antisera
(except probiotic biological products), submit administrative documents as
prescribed in Section B of this Appendix; quality specifications 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.
III. VACCINES
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-PA36 (Change of the
applicant).
- Minor variations which only
require notification: MiV-N1 (Change in name and/or address of or updating of
information on the applicant), MiV-N3 (Change of the name and/or address (for
example: postal code, street name) of a manufacturer of the drug substance,
excipient, capsule shell), MiV-N4 (Deletion of drug substance manufacturer),
MiV- N7 (Deletion of pack size for a drug product), MiV-N8 (Change of the name
of the manufacturer due to change in ownership of manufacturer), MiV-N9 (Change
in name and/or address (for example: postal code, street name) of manufacturer
of drug product), MiV-N10 (Change of the name and/or address (for example:
postal code, street name) of the company or manufacturer responsible for batch
release), MiV-N11 (Change of the name and/or address (for example: postal code,
street name) of the company or party responsible for quality control testing
site (where the 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’s guidelines on changes to vaccines (WHO TRS 993 or its
version) or the guidelines of EMA or US FDA.
3. In order to meet regulatory
requirements in Vietnam, 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):
- Application form (using the
prescribed form).
- Certificate of Pharmaceutical
Product (CPP).
- Batch release certificate or
quality control certificate issued by a competent authority of the country in
which the CPP is issued (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 facility in charge
of testing, evaluating and monitoring vaccines and medical biologicals as
assigned by the Ministry of Health shall be submitted.
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- WHO’s warnings.
- Drafts of label and package
insert approved by the Drug Administration of Vietnam.
- 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.2 of this Appendix.
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.
IV. HERBAL DRUGS AND MATERIALS
USED FOR MANUFACTURING HERBAL DRUGS
Comply with the guidelines in
Section B of this Appendix (with appropriate justifications for failure to
submit adequate documents as required due to specific characteristics of the
herbal drugs) or the following guidelines for specific changes in the herbal
drugs:
1. MAJOR VARIATION
MaV-1.D
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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.
Documents to be submitted (D)
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;
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- 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.
Contents of change/addition
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)
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- Application form (using the
prescribed form).
Part II (Quality documents):
- Justification for the change
- Comparative tabulated format of
the approved drug product specification and that after change of the titrant
- 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
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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):
- Application form (using the
prescribed form).
Part II (Quality documents):
- Specifications of the packaging
material (where applicable)
- Certificate of analysis for the
packaging material
MiV-PA3.D
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Conditions to be fulfilled (C)
- This is only applicable to
approved specifications of semi-finished herbal materials which are
non-compendial
- 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):
- Application form (using the
prescribed form).
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.
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- 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 test procedure
according to the changes in the proposed/updated specifications of the herbal
material, appropriate verification data of the proposed test procedure (where
applicable).
COMPARATIVE
TABULATED SUMMARY OF PROCESSED DRUG/DRUG MANUFACTURED ADOPTING TRANSFERRED
TECHNOLOGY/DRUG REQUESTING DECLARATION AS ORIGINAL BRAND-NAME DRUG OR REFERENCE
BIOLOGICAL AND DRUG ORDERED FOR PROCESSING/DRUG BEFORE TECHNOLOGY TRANSFER/DRUG
DECLARED AS ORIGINAL BRAND-NAME DRUG OR REFERENCE BIOLOGICAL (1)
1. GENERAL INFORMATION
1.1. Applicant
- Applicant’s name:
- Address:
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Entry
Processed drug/drug manufactured
adopting transferred technology/drug requesting declaration as original
brand-name drug or reference biological
Drug ordered for processing/drug
before technology transfer/drug declared as original brand-name drug or
reference biological
Drug name
Active ingredient, herbal
material, concentration/strength
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Marketing authorization number
(if any)
Name and address of manufacturer
2. DETAILED TABULATED COMPARISON
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Identical(2)
Different(3)
Differences
and attached documents(4) (if any)
Classification
of variations in case of differences (5)
1. Basic information
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Dosage form
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Taste (if any)
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Drug substance
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Capsule shell (if any)
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3. Quality of materials
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Properties of drug substance
(purity, impurity strength, physico-chemical characteristics, size)
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Country of origin of drug
substances
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Drug manufacturing process
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Critical Control Points (CCP)
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5. Testing and quality
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Test method
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6. Packaging and label
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Packaging color
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Information on label
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Storage conditions
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8. Other parameters (if any)
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……[place
name],... (dd) ... (mm) .... (yyyy)
Legal representative of the applicant (6)
(Signature, full name, title, seal)
Notes:
(1) Title of the comparative
tabulated summary may be changed to match various situations;
(2) Put an x if the
parameters are identical;
(3) Put an x if the
parameters are different;
(4) Write a brief summary of
the difference (if any) and list the attached documents corresponding to the
difference according to Appendix II of this Circular (for the drug requesting
declaration as original brand-name drug or reference biological, it is possible
to provide documents proving that these variations have been approved by the
drug regulatory authority that has granted the marketing authorization to that
drug);
(5) Classified according to
Appendix II to this Circular (Mav, Miv, etc.);
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FORM 2A/TT.
PERIODIC BENEFIT-RISK EVALUATION REPORT
PERIODIC
BENEFIT-RISK EVALUATION REPORT
I. Title page
II. Summary report
III. Detailed report
1. General information
2. Worldwide marketing approval status
3. Actions taken in the reporting
interval for safety reasons
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5. Estimated exposure and use
patterns
5.1. Exposure in clinical
trials
5.2. Patterns of use on the
market
6. Cumulative summary tabulations
of adverse events
6.1. Reference information
6.2. Information about serious
adverse events from clinical trials
6.3. Information about serious
adverse events recorded during marketing
7. Summaries of significant safety
concerns from clinical trials
7.1. Completed clinical trials
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7.3. Long-term follow-up
7.4. Other use of
medicinal product
7.5. New safety data
related to fixed combination therapies
8. Summary of safety and efficacy
information from non-interventional studies
9. Information from other clinical
trials and sources
10. Non-clinical data
11. Updated data from medical
publications
12. Updated safety date from other
sources
13. Lack of efficacy in controlled
clinical trials
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15. Overview of safety signals
(New, ongoing or closed)
16. Signal and risk evaluation
16.1. Summary of safety concerns
16.2. Signal evaluation
16.3. Evaluation of risks and
new information
16.4. Characterization of risks
16.5. Effectiveness of risk
minimization (if applicable)
17. Benefit evaluation
17.1. Important baseline
efficacy/effectiveness information
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17.3. Characterization of
benefits
18. Benefit-risk analysis for
approved indications
18.1. Benefit-Risk
context - medical need and important alternatives
18.2. Benefit-Risk
analysis evaluation
19. Conclusions and Actions
20. Appendix (report forms and
other attached documents (if any))
For more detailed guidance on the
Periodic Benefit-Risk Evaluation Report, please refer to the ICH Guidance E2C
(Periodic Benefit-Risk Evaluation Report - PBRER). All information fields must
be completed. In case information is not available, clearly specify “Not available”.
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Notes:
(*) The person competent to
sign this document is determined according to point b clause 3 Article 22 of
this Circular.
APPENDIX
PERIODIC
BENEFIT-RISK EVALUATION REPORT IN VIETNAM
(Enclosed with the Periodic Benefit-Risk Evaluation Report)
I. General information about the
product in Vietnam
Date of submission:
DD/MM/YYYY
Submission number (PBRER cover
period):
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Product name:
Active ingredient(s):
Dosage form:
Route of administration:
Marketing authorization number:
...
...
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Date of first marketing approval
in Vietnam:
DD/MM/YYYY
International Birth Date (IBD):
DD/MM/YYYY
Product category:
e.g. New chemical drug/
Biological/ Vaccine/ Others
Applicant:
Applicant’s name:
Address:
...
...
...
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Full name:
Title:
Email:
Telephone number:
Approved indication(s):
Estimated sales of the product
and number of patients using it in Vietnam:
During clinical trials (if
any): number of users.
During its marketing (from
DD/MM/YYYY to DD/MM/YYYY): estimated sales, estimated number of users.
...
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Number (list the countries in
which the product is approved)
Summary of overall benefit-risk
evaluation:
Actions taken or proposed for
safety reasons:
e.g. significant changes to
the reference product information/ other risk minimization activities
Conclusion:
II. Summary of changes to safety
information
a) Actions taken in the
reporting period for safety reasons
...
...
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Regulatory
authorities’ actions
Description
Status
E.g.
US FDA
The
applicant was requested to include liver injury to the Warnings and
Precautions section of the US Product Information (PI).
Updated
PI was approved on DD/MM/YYYY
b) Changes to Reference Safety
Information (RSI)
Brief tabulated summary of changes
in RSI during the reporting interval.
Version
(Date)
...
...
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Applicable
to Vietnam (Yes/No)
E.g,
Version 3.0 (DD/MM/YYYY)
Update
to the Warnings and Precautions section regarding the risk of heart
failure
Yes
c) Actions taken or planned in
Vietnam
State whether or not a specific
action has been taken or is planned for, pertaining to the actions taken or RSI
changes listed above in II (a) and II (b). If any actions are taken, the status
of the actions should be listed.
Type
of action/plan
Detailed
description
Safety-related
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Non safety-related
III. List of signals evaluated
To list all signals that were
closed (e.g. the evaluation was completed) during the reporting interval
as well as ongoing signals that were undergoing evaluation, at the end of
reporting interval (The description(s) of the signal evaluations are not to
be included).
ADVERSE
DRUG EVENT REPORT
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...
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I.
INFORMATION ABOUT ADVERSE EVENTS
1. PATIENT’S FULL NAME
1a. COUNTRY
2. DATE OF BIRTH
2a. AGE
3. SEX
...
...
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8-12. SERIOUSNESS OF ADVERSE
EVENT
□ DEATH
□ HOSPITALIZATION OR PROLONGED
HOSPITALIZATION
□ PERSISTENT/SIGNIFICANT
DISABILITY
□ LIFE THREATENING
□ BIRTH DEFECT
□ OTHER
Day
...
...
...
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Year
Day
Month
...
...
...
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7-13. DESCRIPTION OF ADVERSE
EVENT (including relevant tests/lab data)
Manifestations of adverse event
[NAME OF ADVERSE EVENT standardized according to MedDRA] (Related symptoms
(if any) separated by commas)
Detailed description of clinical
case: (Full description, adverse event, seriousness of adverse event,
start date of adverse event and end date of adverse event (or interval
of adverse event), information and reaction of adverse event after stopping
and reintroducing the suspected drug (if any); outcome after treatment of
adverse event (recovered/not recovered/deceased/unknown); assessment of
causal relationship).
(More
on the next page)
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II.
SUSPECTED DRUG(S) INFORMATION
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20. DID THE ADVERSE EVENT ABATE
AFTER STOPPING DRUG?
□ YES
□ NO
□ NA
15. DAILY DOSE(S)
16. ROUTE(S) OF ADMINISTRATION
21. DID THE ADVERSE EVENT AFTER
RE-INTRODUCTION?
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17. INDICATION(S) FOR USE
□ YES
□ NO
□ NA
18. THERAPY DATES (from
dd/mm/yyyy to dd/mm/yyyy)
...
...
...
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III.
CONCOMITANT DRUG(S) AND HISTORY
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23. OTHER RELEVANT HISTORY (e.g.:
principal diagnosis, comorbidity, allergies, pregnancy status (with last
month of period), etc.).
Time (from ..... (date) to
.....(date))
Type of medical
history
Detailed description
IV.
APPLICANT/MANUFACTURER INFORMATION
...
...
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MANUFACTURER (Name, address)
26. FOR APPLICANT/MANUFACTURER
USE
24b. APPLICANT’S REPORT NO.
24c. DATE RECEIVED BY APPLICANT
...
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24d. REPORT SOURCE
□ STUDY
□ SCIENTIFIC LITERATURE
□ HEALTH PROFESSIONAL
□ OTHER
25b. INFORMATION OF REPORTER
Full name:
...
...
...
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Email:
Telephone number:
DATE
OF THIS REPORT
25a. REPORT TYPE
□ INITIAL
□ FOLLOW-UP
DETAILED
INFORMATION
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...
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7-13. DESCRIPTION OF ADVERSE
EVENT (continued)
14-19. SUSPECTED DRUG(S)
(continued)
14. SUSPECTED DRUG(S) (including
trade name, active ingredients and number of marketing authorization in
Vietnam)
15. DAILY DOSE(S)
18. THERAPY DATE
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17. INDICATION(S)
19. THERAPY DURATION
#1)
#2)
26. FOR APPLICANT/MANUFACTURER
USE (continued)
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.......
……[place name], ..... (dd) ..... (mm) ..... (yyyy)
Legal representative of the applicant (2)
(Signature, full name, title, seal)
Notes:
(1) Refer to the reporting
form of the Council for International Organizations of Medical Sciences (CIOMS
I).
(2) The person competent to
sign this document is determined according to point b clause 3 Article 22 of
this Circular
FORM 2C/TT. Report on safety and efficacy of drug during
marketing
REPORT ON SAFETY AND EFFICACY OF DRUG DURING MARKETING
To:
The
Drug Administration of Vietnam
Address: 138 A Giang Vo, Ba Dinh, Hanoi
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1.1.
Applicant:
Address:
Telephone number:
1.2.
Representative office in Vietnam (for a foreign applicant):
Address:
Telephone number:
1.3.
Manufacturer:
Address:
Telephone number:
1.4. Drug
name:
1.5.
Active ingredient, concentration/strength thereof:
1.6.
Dosage form:
1.7. Marketing
authorization number:
1.8. Date
of issue/latest
renewal:
Expiration date:
...
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3.
Reporting of quality of the drug during its marketing:
No.
Revocation decision number
Recalled drug batch number
Quantity of drugs recalled
Degree of violation
Recall type
(voluntary/compulsory)
...
...
...
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...
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5.
Information about the estimated use of the drug marketed in Vietnam
5.1.
Quantity of drugs supplied on the market
5.2. List
of medical facilities using the drug (2)
No.
Name of facility
Estimated quantity of drugs used
(expressed as the smallest unit)
1.
...
...
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....
6.
Consolidation and analysis of information about adverse events of the drug
recorded during its marketing in Vietnam
6.1.
Information consolidation:
No.
Description of adverse event
...
...
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Outcome after treatment of adverse event
...
...
...
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7. Safety
information different from the approved drug information in the drug's package
insert (only applicable to generic drugs without an original brand name
granted the marketing authorization in Vietnam)
7.1.
Safety information from SRA:
7.2.
Safety information obtained from medical publications:
8.
Evaluation of risks related to drug safety and efficacy, evaluation of the
benefit-risk balance, and measures to minimize risks.
9.
Conclusions and recommendations
10.
Appendix
To list
documents on safety and efficacy monitoring enclosed with this Report and
explanatory notes thereto (if any).
We hereby
undertakes that the contents of this report are truthful, and that we will be
legally responsible if any part of it is found to be untruthful./.
...
...
...
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.......[place name],..... (dd)..... (mm) ..... (yyyy)
Legal representative of the applicant (3)
(Signature, full name, title, seal)
Notes:
(1) The
applicant shall list the updates submitted to drug regulatory authorities
according to warnings given by regulatory authorities or findings related to
drug safety (such as contraindications, warnings, precautions, ADR, overdose,
drug interactions, etc.).
(2) In
case figures are unavailable, please specify the reasons therefor.
(3) The
person competent to sign this document is determined according to point b
clause 3 Article 22 of this Circular.
FORM 3/TT.
Risk management plan
RISK
MANAGEMENT PLAN
A risk management plan for a
medicinal product is central to risk management activities for that product.
The aim of a risk management plan is to document the risk management system
considered necessary to identify, characterize and minimize a medicinal
product’s important risks.
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Part 1 Overview of
medicinal product(s)/preparation(s) Part
2 Safety specification
Module 2.1 “Epidemiology of
the indication(s) and target population(s)
Module 2.2 Non-clinical
safety data
Module 2.3 Populations
studied in clinical trials
Module 2.4 Populations
not/not yet studied in clinical trials
Module 2.5 Post-authorization
data
Module 2.6 Additional
regulatory authority requirements for the safety specification
Module 2.7 Identified and
potential risks
Module 2.8 Summary of the
safety concerns
...
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Part 4 Plans for
post-authorization efficacy studies
Part 5 Risk minimization
measures (including evaluation of the effectiveness of risk minimization
activities)
Part 6 Summary of the risk
management plan
Part 7 Annexes to the risk
management plan in Vietnam
ANNEX
TO RISK MANAGEMENT PLAN FOR A NEW CHEMICAL MEDICINAL PRODUCT, VACCINE OR
BIOLOGICAL IN VIETNAM
I. General information about new
chemical medicinal product, vaccine or biological
Product name:
...
...
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<applicable to the updated
and additional risk management plan>
Active ingredient(s),
strength/concentration:
Dosage form:
Route of administration:
Type of medicinal product
□ New medicinal product
...
...
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□ Vaccine
Other:
___________________________________________
Applicant:
Name:
Address:
Telephone number:
Name of representative office
in Vietnam (if any):
Address:
Telephone number:
...
...
...
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Name:
Address:
Telephone number:
Details of person responsible
for pharmacovigilance:
Full name:
Position:
Email:
Telephone number:
Approved indication(s) in
Vietnam:
...
...
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II. Changes from previous risk
management plan
Brief summary of changes from the
previous RMP submission.
This section may not be applicable
for the first RMP.
III. Summary of
changes/additions to risk management plan over time
Brief tabulated summary of
changes/additions to risk management plan:
No.
Date
of submission
Description
of change
1
...
...
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First
application submitted
2
3
IV. Safety concerns
To list all safety concerns in
relation to the approved indication(s) in Vietnam.
...
...
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(List adverse reactions for
which there is sufficient evidence that they are caused by the medicinal
product)
Important potential risks
(List adverse events for
which there is evidence to suspect the possibility of a causal relationship
with the medicinal product, but where there is currently insufficient evidence
to conclude that this association is causal)
Missing information
(List gaps in knowledge
about the safety of a medicinal product for certain anticipated utilization
or for use in particular patient populations, for which there is insufficient
knowledge to determine whether the safety profile differs from that
characterized so far)
V. Pharmacovigilance plan
implemented in Vietnam
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1. Routine pharmacovigilance
activities
Routine pharmacovigilance is the
set of activities required for all medicinal products, including:
√
Submission of reports on single
drug safety cases/or reports on adverse events following immunization related
to vaccines occurring in the territory of Vietnam, which are made using the
prescribed form, to the National DI & ADR Centre.
√
Submission of periodic reports on
drug safety and efficacy to the National DI & ADR Centre.
√
Timely submission of updates on
important safety issues that may affect the benefit-risk balance for the
medicinal product to the Drug Administration of Vietnam and the National
Center for Drug Information and Adverse Drug Reactions Monitoring.
√
...
...
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2. Additional pharmacovigilance
activities
Additional pharmacovigilance
activities are carried out when necessary. They may be non-clinical studies,
clinical trials or epidemiological studies related to drug safety. If
applicable, there should be specific timelines for these activities. If no
additional pharmacovigilance activities are deemed necessary, it should be
indicated as “nil”.
Safety
concerns
Additional
pharmacovigilance activities
Notes
Important identified risks:
<Safety issue 1>
<Additional: Clinical
study>
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<Safety issue 2>
<Additional: Clinical
study>
Missing information:
<Safety issue 3>
<Additional: Nil>
VI. Risk minimization plan upon
marketing of a medicinal product, vaccine or biological in Vietnam
To describe the risk minimization
activities (routine and/or additional) that are planned to address the safety
concern in Vietnam.
...
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- To sufficiently provide
information and promptly and sufficiently update information, such as
indications, doses, instructions for use, warnings, precautions, adverse
effects, on the label and the package insert according to applicable
regulations.
- To sufficiently update guiding
Official Dispatches of the Drug Administration of Vietnam relating to drug
safety and efficacy.
2. Additional risk minimization
activities
- If no additional risk
minimization activities are deemed necessary, it should be indicated as “nil”.
- If applicable, to clearly
describe proposed additional risk minimization activities upon marketing of the
medicinal product in Vietnam.
- Additional risk minimization
activities may include:
+ Providing information and
training materials for healthcare professionals: designed to highlight
identified safety concerns, signs and symptoms to watch for and highlight potential
risks associated with dispensing errors and medication errors.
+ Providing drug instructions to
patients: designed to highlight identified safety concerns, signs and symptoms
to watch for and when to seek medical attention.
+ Managing users according to
active monitoring program, implementing pregnancy prevention program, etc.
...
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...
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Risk
minimization activities
Notes
Important identified risks:
<Safety issue 1>
<Routine: Update to the
Warnings and Precautions section on the package insert>
<Additional: Providing
information/training materials to healthcare professionals. Providing guiding
materials to patients>
Important potential risks:
<Safety issue 2>
...
...
...
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<Additional: Providing
information/training materials to healthcare professionals>
Missing information:
<Safety issue 3>
<Routine: Nil>
<Additional: Nil>
V. Other information (if any)
To list risk management documents
enclosed with this plan and explanatory notes thereto (if any).
...
...
...
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- Latest version of the approved
EU-RMP or Risk Evaluation and Mitigation Strategy (REMS) approved by US
FDA;
- Proposed training materials
for healthcare professionals or instructions for use of medicinal product;
We hereby undertake and assume the
full responsibility for the accuracy and truthfulness of the information
provided herein./.
……[place
name], ..... (dd) ..... (mm) ..... (yyyy)
Legal representative of the applicant(1)
(Signature, full name, title, seal)
Notes:
(1) The person competent to
sign this document is determined according to point b clause 3 Article 22 of
this Circular
...
...
...
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APPLICATION
FOR REGISTRATION OF DRUG/MEDICINAL MATERIAL
(Initial
registration)
A. Details of the applicant and
the manufacturer:
1. Applicant:
1.1. Name of the applicant:
1.2. Address (1) :
Website
(if any):
1.3. Telephone
number:
Email:
1.4. Name of the representative
office in Vietnam (for a foreign applicant):
Address:
...
...
...
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2.1. Name of the manufacturer:
2.2. Address(1):
Website
(if any):
2.3. Telephone
number:
Email:
Other manufacturer (if any) (3):
Name
and address
Role(2)
...
...
...
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1. Ordering facility or sending
facility
1.1. Name of the ordering
facility/sending facility
Address:
Website (if any):
Telephone
number:
Email:
1.2. Name of representative office
in Vietnam (if any):
1.3.
Address:
Telephone number:
2.1. Name of the manufacturer of
drugs ordered for processing/manufacturer of drugs before technology transfer
2.2.
Address:
Website (if any):
2.3. Telephone
number:
Email:
...
...
...
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□ Herbal drug
□ Vaccine
□ Biological
□ Medicinal material
1. Name of drug/medicinal
material:
2. Active ingredient,
concentration/strength thereof (5):
3. ATC code:
4. Dosage form:
5. Description of dosage
form:
...
...
...
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7. Quality specification (6):
8. Shelf life:
9. Storage conditions:
10. Description of packaging
specifications:
11. Regulatory
classification:
a) Category of prescription
drug/over-the-counter drug (check one of the boxes):
□ Prescription drug
□ Over-the-counter drug
b) Category of narcotic
drug/psychotropic drug/precursor drug (check one of the boxes):
...
...
...
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□ Narcotic drug/ drug containing
narcotic drug substance
□ Drug precursor/ drug containing
precursor
c) Category of other controlled
drug (check in appropriate box):
□ Toxic drug
□ Radioactive drug
□ Drug prohibited for use by ministries
and central authorities
12. Formulation (of a
single dose or smallest packaging unit)
a) Drug substance, herbal
material, medicinal material:
Name
(7)
...
...
...
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Manufacturer
(detailed name, address)
Standard(3)
b) Excipient, capsule shell
Excipient
Concentration/
strength
...
...
...
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Standard(3)
DD. Technical document (9)
1. Part I: Administrative document
2. Part II: Quality document
3. Part III: Nonclinical document
(if any)
...
...
...
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E. Drug data requiring
confidential treatment □
The Drug Administration of Vietnam
is requested to provide confidential treatment of the following data included
in the application dossier:
□ Toxicology test
data
(Document No. .... )
□ Clinical trial
data
(Document No. .... )
G. Drug of which the marketing
authorization application is validated using reference to available validation
results as requested by applicant
1. Drug regulatory authorities
granting the marketing authorization:
No.
Name
of regulatory authority (10)
Date
of approval (11)
...
...
...
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Contact
information (13)
...
...
...
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2. A validation report including
the following minimum contents for use in the method of referencing validation
results (X in appropriate box):
- Drug information
- List of all approved packaging
specifications;
- Pharmacological class
- Information about manufacturer
and marketing authorization holder
...
...
...
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- Evaluation of composition and
manufacturing process
- Evaluation of quality control
- Evaluation of stability,
conclusions on product quality
- Evaluation of synopsis of main
nonclinical data
- Evaluation of synopsis of main
clinical data
...
...
...
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- Evaluation of benefits and
risks
- Bases for approved indications
H. Contents of classification
between processed drug and drug ordered for processing or drug manufactured
adopting transferred technology and drug before technology transfer(4) (√
in appropriate box)
1. Registration type
1.1. Processed drug
□
...
...
...
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□
1.3. Drug processed adopting
transferred technology
□
2. Stage of processing or
technology transfer
2.1. All stages of manufacture
□
2.2. One or several stages of
manufacture
□
Specify the stage of processing
or technology transfer:
...
...
...
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3.1. No marketing authorization
□
3.2. Expired marketing
authorization
□
3.3. Marketing authorization
unexpired at the time of submission
□
G. Other contents (√ in
appropriate box)
□ Application given administrative
procedure priority (14)
□ Application for marketing
authorization of a new drug which has indications for use in prevention and
treatment of any group A infectious disease that causes an epidemic which has
been declared in accordance with regulations of law on prevention and control
of infectious diseases
...
...
...
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□ Drug requesting declaration as
reference biological
□ Drug requesting declaration of
bioequivalence
□ Other request (if any, please
specify)
We hereby covenant to assume the
full responsibility before the law for the accuracy, legitimacy and
truthfulness of all documents included in the marketing authorization
application dossier.
...
(dd) ... (mm) .... (yyyy)
Legal representative of the applicant (15)
(Signature, full name, title, seal)
Notes:
(1) The information must be
consistent with that on the documents in the dossier. In case of change in
format, the instructions on how to write addresses in the Appendix I to this
Circular should be followed.
...
...
...
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(3) Any facility that has
engaged in the manufacturing process; clearly specify the role of each of such
manufacturing facilities such as “production of semi-finished products”,
“primary packaging”, “secondary packaging”, “granulation”, etc.
(4) For processed drug, drug
manufactured adopting transferred technology.
(5) Refer to the instructions
on how to write concentration/strength of active ingredients specified in the
Appendix I to this Circular.
(6) If a pharmacopoeia
is employed, the name and version or year of publication of that pharmacopoeia
or the text “current version of the pharmacopoeia” shall be indicated.
(7) Exactly specify
the form of the drug substance (ester salt/ other derivative).
(8) If a dose is based on the
moiety having pharmacological effects of the drug substance (base moiety,
etc.), the strength of the drug substance in the form of the corresponding
moiety having pharmacological effects must be indicated.
If a drug substance is used in the
form of a semi-finished product mixed with excipients, all excipients included
in the formulation of the semi-finished product containing this drug substance
must be indicated.
(9) List the documents
included in the dossier
(10) The drug regulatory
authorities are specified in clause 9 Article 2 of this Circular and a validation
report shall be in place.
...
...
...
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(12) Specify the approval
type (e.g. marketing authorization approval under routine procedure,
conditional approval procedure or special procedure, etc.)
(13) Specify the official
address and email of the regulatory authority to serve verification when
necessary.
(14) Specify the eligibility
for priority specified in clause 5 Article 7 of the Law on Pharmacy amended by
clause 4 Article 1 of the Law on amendments to certain Articles of the Law on
Pharmacy
(15) The person competent to
sign this document is determined according to point b clause 3 Article 22 of
this Circular
FORM 4B/TT.
Application for renewal of marketing authorization of drug/medicinal material
APPLICATION
RENEWAL
OF DRUG/MEDICINAL MATERIAL
I. Information about
drug/medicinal material granted the marketing authorization:
...
...
...
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1.1. Name of the applicant:
1.2. Address: Website
(if any):
1.3. Telephone
number:
Email:
1.4. Name of the representative
office in Vietnam (for a foreign applicant):
- Address:
- Telephone number:
2. Manufacturer (1)/processing
facility/receiving facility:
2.1. Name of the manufacturer:
2.2.
Address:
Website (if any):
...
...
...
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Name
and address
Role
3. Ordering facility or sending
facility
3.1. Name of the ordering
facility/sending facility
3.2.
Address:
Website (if any):
...
...
...
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3.4. Name of representative office
in Vietnam (if any):
- Address:
- Telephone number:
4. Manufacturer of drugs ordered
for processing/manufacturer of drugs before technology transfer
4.1. Name of the manufacturer of
drugs ordered for processing/manufacturer of drugs before technology transfer
4.2.
Address: Website
(if any):
4.3. Telephone
number:
Email:
5. Name of drug/medicinal material:
6. Active ingredient,
concentration/strength thereof:
...
...
...
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8. Dosage form:
9. Quality specification:
10. Shelf life:
11. Storage conditions:
12. Marketing authorization number:
13. Date of first issue/latest
renewal:
Expiration date:
14. Stage of processing or
technology transfer of the drug granted the marketing authorization (if any)
15. Status of registration and
marketing in Vietnam:
15.1. Status of marketing in
Vietnam (tick √ in the box):
...
...
...
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□ Drug not granted the marketing
authorization
15.2. Status of drug registration
in Vietnam:
No.
Number
of issuance of marketing authorization
Approval
decision number
Date
of issue
Notes
1.
Initial
...
...
...
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2.
… (time) renewal
…
...
...
...
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16. Drug classification as approved
by the Drug Administration of Vietnam:
□
Chemical drug
□
Over-the-counter drug
□
Narcotic drug/ drug containing
narcotic drug substance
...
...
...
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Processed drug
□
Herbal drug
□
Drug manufactured adopting
transferred technology
...
...
...
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Vaccine
□
Psychotropic drug/ drug
containing psychotropic drug substance
□
Biological
...
...
...
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Prescription drug
□
Drug processed adopting
transferred technology
□
Medicinal material
...
...
...
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Drug precursor/ drug containing
precursor
□
Toxic drug
...
...
...
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□
Drug prohibited for use by
ministries and central authorities
□
Radioactive drug
16.1. Drug declared as original
brand-name drug or reference biological (if any, specify the decision
number, date of issue).
16.2. Drug declared
bioequivalent (if any, specify the decision number, date of issue).
1. Variation to drug name:
2. Report on drugs which the same
active ingredients, herbal material, dosage form, route of administration,
strength or concentration thereof in a unit dose and the same manufacturer as
the of which the marketing authorization is to be renewed.
...
...
...
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Drug
name
Marketing
authorization number
Drug
or medicinal product of which marketing authorization is to be renewed
Renewed
Not
renewed
...
...
...
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We hereby covenant to assume the
full responsibility before the law for the accuracy, legitimacy and
truthfulness of all documents included in the dossier on application for
renewal of marketing authorization.
...
(dd) ... (mm) .... (yyyy)
Legal representative of the applicant (4)
(Signature, full name, title, seal)
Notes:
(1) The final manufacturer
responsible for release of the drug batch;
(2) Any facility that has
engaged in the manufacturing process; clearly specify the role of each of such
manufacturing facilities such as “production of semi-finished products”, “primary
packaging”, “secondary packaging”, etc.
(3) In case of any other
variation, the applicant shall follow the procedure specified in the Appendix
II to this Circular.
(4) The person competent to
sign this document is determined according to point b clause 3 Article 22 of
this Circular
...
...
...
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FORM 4C/TT.
Variation application
VARIATION
APPLICATION
A. Product information (1)
1. Name of drug/medicinal
material:
2. Active ingredient,
concentration/strength thereof:
3. Dosage form:
4. Marketing authorization number:
5. Date of issue/latest
renewal:
Expiration date:
6. Name of the manufacturer:
Manufacturing country:
...
...
...
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Variation
type
Reference
code/Name
Notes
Major variation
□
Minor variation
...
...
...
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□
Minor variation
(notification)
□
C. Details of the applicant;
ordering facility or sending facility; processing facility or receiving
facility (manufacturer); manufacturer of drugs ordered for processing/manufacturer
of drugs before technology transfer which has been approved
...
...
...
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1.1. Name of the applicant:
1.2.
Address:
Website (if any):
1.3. Telephone
number:
Email:
1.4. Name of the representative
office in Vietnam (for a foreign applicant):
Address:
Telephone number:
2. Ordering facility or sending
facility
2.1. Name of the ordering
facility/sending facility
2.2.
Address:
Website (if any):
...
...
...
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2.4. Name of representative office
in Vietnam (if any):
Address:
Telephone number:
3. Processing facility or
receiving facility (manufacturer)
3.1. Name of the manufacturer:
3.2.
Address:
Website
(if any):
3.3. Telephone
number:
Email:
Other manufacturer (if any)(2):
Name
and address
...
...
...
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4. Manufacturer of drugs ordered
for processing/manufacturer of drugs before technology transfer
4.1. Name of the manufacturer of
drugs ordered for processing/manufacturer of drugs before technology transfer
4.2.
Address:
Website (if any):
D. Description of variation (specify
reasons thereof)
- Clearly specify the variation and
its code (if any) based on categorization of variations:
...
...
...
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- Contents of variation(2):
DD. Required technical document
- The approved formulation in a
smallest dose (including information on the composition, strength, quality
specification, name and address of the manufacturer) in respect of changes
concerning the quality document.
- Other related approved
documentary evidences.
E. Applicant’s statement
We hereby covenant to have examined
and appended signature and seal to relevant parts or sections of the documents
included in this application dossier, and certifies that these documents are
lawful and authentic. The applicant shall assume the full responsibility for
any forged or false documents and be willing to accept penalties in accordance
with regulations of law.
……[place
name], ..... (dd) ..... (mm) ..... (yyyy)
Legal representative of the applicant (4)
(Signature, full name, title, seal)
...
...
...
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(1) In case there is the same
variation of different drugs, the product information shall be provided in a
list corresponding to each drug (including the information prescribed in
Sections A 1,2,3,4 of this application).
(2) Any facility that has
engaged in the manufacturing process; clearly specify the role of each of such
manufacturing facilities such as “production of semi-finished products”,
“primary packaging”, “secondary packaging”, “granulation”, etc.
(3) These contents may
be provided in the comparative tabulated format accompanied with the
application, provided that they are supported by the applicant’s certification.
(4) In case of change of the
applicant, the certification of both the former applicant and the new applicant
is required. In case the manufacturer is entitled to replace the applicant
under an official dispatch of the Drug Administration of Vietnam, the
certification of the manufacturer and the new applicant is required. The person
competent to sign this document is determined according to point b clause 3
Article 22 of this Circular
FORM 4D.TT.
Application for information updating for provision of drug information and
advertising
APPLICATION
FOR INFORMATION UPDATING FOR PROVISION OF DRUG INFORMATION AND ADVERTISING
1. Applicant
1.1. Name of the applicant:
...
...
...
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1.3. Telephone number:
1.4. Name of the representative
office in Vietnam (for a foreign applicant):
Address:
Telephone number:
2. Product information
2.1. Drug name:
2.2. Marketing authorization
number:
Date of
issue:
Expiration date:
2.3. Dosage form:
2.4. Active ingredient,
concentration/strength thereof:
...
...
...
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3. We hereby request the
approval of its updated information to provide drug information and drug
advertising as prescribed in Appendix II to the Circular prescribing the
marketing authorization of drugs and medicinal materials.
4. Required attached documents
4.1. Information to be updated;
purpose and entities entitled to access such updated information.
4.2. The copy of the approved
package insert.
4.3. Documentary evidences (specify
names of documents).
We hereby undertake and assume
responsibility for the accuracy of the contents of this application and
documents enclosed herewith.
……[place
name], ..... (dd) ..... (mm) ..... (yyyy)
Legal representative of the applicant (*)
(Signature, full name, title, seal)
...
...
...
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(*): The person competent to
sign this document is determined according to point b clause 3 Article 22 of
this Circular
FORM 05/TT.
Declaration of conformity with GMP standards or excipient production standards
applied by regulatory authorities of other countries or international
organizations
DECLARATION
CONFORMITY
WITH GMP STANDARDS OR EXCIPIENT PRODUCTION STANDARDS APPLIED BY REGULATORY
AUTHORITIES OF OTHER COUNTRIES OR INTERNATIONAL ORGANIZATIONS
We, ___________________________________________________
are the manufacturer of the drug or
semi-finished medicinal material:
Name of the drug or semi-finished
medicinal material:
Active ingredient,
concentration/strength thereof:
...
...
...
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registered with the Ministry of
Health of Vietnam (the Drug Administration of Vietnam).
Based on the purpose and scope of
use of excipients included in the formula for production of finished drug or
semi-finished medicinal material;
Based on the company’s
self-assessment of risks and impacts of excipients on the safety of users,
dosage form, manufacturing process and material supplier assessment results,
We hereby certify that the following
excipients have been manufactured by the manufacturer that conforms to GMP
standards or excipient production standards applied by regulatory authorities
of other countries or international organizations as prescribed in clause 7
Article 22 of this Circular, and are appropriate to the manufacturer of the
finished drug or semi-finished medicinal material. To be specific:
No.
Name
of excipient
Manufacturer
Address
of the manufacturer
Standard
applied (1)
...
...
...
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...
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We undertake to assume legal
responsibility for this declaration./.
……[place
name], ..... (dd) ..... (mm) ..... (yyyy)
Legal representative of the manufacturer of finished or semi-finished drugs (2)
(Signature, full name, title, seal)
Notes:
...
...
...
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(2) The person competent to
sign this document is determined according to point b clause 3 Article 22 of
this Circular
Form 6A/TT. Form of the marketing authorization (Initial)
BỘ Y TẾ
MINISTRY OF HEALTH
CỤC QUẢN LÝ DƯỢC
DRUG ADMINISTRATION OF VIETNAM
-------
CỘNG HÒA XÃ HỘI CHỦ NGHĨA VIỆT NAM
SOCIALIST REPUBLIC OF VIETNAM
Độc lập - Tự do - Hạnh phúc
Independence - Freedom - Happiness
---------------
GIẤY ĐĂNG KÝ LƯU HÀNH
MARKETING AUTHORIZATION
Tên
thuốc (Name of drug):
...
...
...
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Dạng
bào chế (Dosage form):
Quy
cách đóng gói (Packing size):
Tiêu
chuẩn chất lượng:
Tuổi
thọ (Shelf-life):
(Quality
specification):
Số
đăng ký (Marketing Authorization
number):
Số
quyết định cấp (Approval decision
number):
Ngày
cấp (Date of issuance):
Hiệu
lực của giấy đăng ký lưu hành:
(Expiration
date of this Marketing authorization):
...
...
...
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Tên và
địa chỉ (Name and address)
Cơ sở
sản xuất (Manufacturer):
- Tên,
địa chỉ và vai trò của cơ sở sản xuất 1 (name, address and role of
manufacturer 1)
- Tên,
địa chỉ và vai trò của cơ sở sản xuất 2 (name, address and role of manufacturer
1)
…
Cơ sở
đặt gia công (Ordering facility)
- Tên và
địa chỉ (Name and address)
...
...
...
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Ghi chú:
(Note)
Giấy đăng
ký lưu hành là bản điện tử có thể tra cứu trên trang thông tin điện tử của Cục
Quản lý dược - Bộ Y tế tại địa chỉ: https://dav.gov.vn/(The electronic
marketing authorization can be found on the website of the Drug Administration
of Vietnam - the Ministry of Health at https://dav.gov.vn/)
Form 6B/TT. Form of the marketing authorization (Renewed)
BỘ Y TẾ
MINISTRY OF HEALTH
CỤC QUẢN LÝ DƯỢC
DRUG ADMINISTRATION OF VIETNAM
-------
CỘNG HÒA XÃ HỘI CHỦ NGHĨA VIỆT NAM
SOCIALIST REPUBLIC OF VIETNAM
Độc lập - Tự do - Hạnh phúc
Independence - Freedom - Happiness
---------------
GIẤY ĐĂNG KÝ LƯU HÀNH
MARKETING AUTHORIZATION
...
...
...
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Tên
thuốc (Name of drug):
Hoạt
chất, hàm lượng (Active Ingredients,
strength):
Dạng
bào chế (Dosage form):
Quy
cách đóng gói (Packing size):
Tiêu
chuẩn chất lượng:
Tuổi
thọ (Shelf-life):
(Quality
specification):
Số
đăng ký (Marketing Authorization
number):
Số
quyết định cấp (Approval decision
number):
Ngày
cấp (Date of issuance):
...
...
...
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(Expiration
date of this Marketing authorization):
Cơ sở
đăng ký (Marketing authorization
holder):
Tên và
địa chỉ (Name and address)
Cơ sở
sản xuất (Manufacturer):
- Tên,
địa chỉ và vai trò của cơ sở sản xuất 1 (name, address and role of
manufacturer 1)
- Tên,
địa chỉ và vai trò của cơ sở sản xuất 2 (name, address and role of
manufacturer 1)
…
Cơ sở
đặt gia công (Ordering facility)
- Tên và
địa chỉ (Name and address)
...
...
...
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Hà Nội, ngày tháng năm
CỤC TRƯỞNG CỤC QUẢN LÝ DƯỢC
GENERAL-DIRECTOR OF THE DRUG ADMINISTRATION OF VIETNAM
Ghi chú:
(Note)
Giấy đăng
ký lưu hành là bản điện tử có thể tra cứu trên trang thông tin điện tử của Cục
Quản lý dược - Bộ Y tế tại địa chỉ: https://dav.gov.vn/ (The electronic
marketing authorization can be found on the website of the Drug Administration
of Vietnam – the Ministry of Health at https://dav.gov.vn/)
Form 7/TT. Written request for withdrawal of marketing
authorization of drug or medicinal material
WRITTEN REQUEST FOR WITHDRAWAL OF MARKETING AUTHORIZATION
OF DRUG OR MEDICINAL MATERIAL
To:
The
Drug Administration of Vietnam
138 A Giang Vo, Ba Dinh, Hanoi
...
...
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Applicant:
Address:
Telephone
number:
Manufacturer:
Address:
...
...
...
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Representative
office in Vietnam (for a foreign applicant)
Address:
Telephone
number:
(Name of
the applicant) hereby requests the Drug Administration of Vietnam to consider
withdrawing the marketing authorization of the following drug or medicinal
material:
Name of
drug/medicinal material:
Active
ingredient, concentration/strength thereof:
Marketing
authorization number:
...
...
...
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Expiration
date of marketing authorization number:
Reasons
for requesting withdrawal of marketing authorization: Specific reasons and supporting documents (if any) are
provided
The
applicant for withdrawal of the marketing authorization hereby covenants
to strictly comply with regulations and assume legal responsibility for this
request for withdrawal of the marketing authorization of the drug/medicinal
material mentioned above.
.......[place name],..... (dd)..... (mm) ..... (yyyy)
Legal representative of the applicant (*)
(Signature, full name, title, seal)
...
...
...
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(*) The
person competent to sign this document is determined according to point b
clause 3 Article 22 of this Circular.
Form 8A/TT. List of processed drugs (without adopting
transferred technology) which are granted marking authorization/have their
marking authorization renewed in accordance with clause 1 Article 9 of the
Circular No. ..../TT-BYT dated
(dd) (mm) (yyyy)
LIST OF PROCESSED DRUGS (WITHOUT ADOPTING TRANSFERRED
TECHNOLOGY) WHICH ARE GRANTED MARKING AUTHORIZATION/HAVE THEIR MARKING
AUTHORIZATION RENEWED
(In accordance with clause 9 Article
2025 of the Circular No. ..../TT-BYT dated (dd)
(mm) 2025)
Date of
update:
No.
Drug name
Marketing authorization number
Applicant
...
...
...
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Manufacturer of drugs ordered for processing
Address of manufacturer of drugs ordered for processing
State of processing in Vietnam (*)
Notes
...
...
...
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...
...
...
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...
...
...
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Note:
(*)
Specify which stages are carried out in Vietnam. If all stages are carried out
in Vietnam, write (“Toàn bộ”) (“All stages”)
Form 8B/TT- List of processed drugs (adopting transferred
technology) which are granted marking authorization/have their marking
authorization renewed in accordance with clause 1 Article 9 of the Circular No.
..../TT-BYT dated (dd)
(mm) (yyyy)
LIST OF PROCESSED DRUGS (ADOPTING TRANSFERRED TECHNOLOGY)
WHICH ARE GRANTED MARKING AUTHORIZATION/HAVE THEIR MARKING AUTHORIZATION
RENEWED
(In accordance with clause 9 Article
2025 of the Circular No. ..../TT-BYT dated (dd) (mm)
2025)
Date of
update:
No.
Drug name
...
...
...
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Applicant
Processing facility
Manufacturer of drugs ordered for processing
Address of manufacturer of drugs ordered for processing
State of processing in Vietnam (*)
Notes
...
...
...
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...
...
...
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...
...
...
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Note:
(*)Specify
which stages are carried out in Vietnam. If all stages are carried out in
Vietnam, write (“Toàn bộ”) (“All stages”)
Form 8C/TT. List of drugs which are manufactured adopting
transferred technology and granted marketing authorization/have their marketing
authorization renewed in accordance with clause 1 Article 9 of the Circular No.
..../TT-BYT dated (dd)
(mm) (yyyy)
LIST OF DRUGS WHICH ARE MANUFACTURED ADOPTING TRANSFERRED
TECHNOLOGY AND GRANTED MARKETING AUTHORIZATION/HAVE THEIR MARKETING
AUTHORIZATION RENEWED
(In accordance with clause 9 Article
2025 of the Circular No. ..../TT-BYT dated (dd)
(mm) 2025)
Date of
update:
...
...
...
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Drug name
Marketing authorization number
Applicant
Receiving facility
Manufacturer of drugs before technology transfer
Manufacturer of drugs before technology transfer
State of manufacturing in Vietnam (*)
Notes
...
...
...
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...
...
...
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...
...
...
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Note:
(*)
Specify which stages are carried out in Vietnam. If all stages are carried out
in Vietnam, write (“Toàn bộ”) (“All stages”)
Form 9/TT. Comparative tabulated summary of similarities
between the marketing authorization application in Vietnam and information on
the drug granted marketing authorization by the drug regulatory authority
specified in clause 9 Article 2 of the Circular No. ……/TT-BYT dated (dd) (mm) (yyyy)
...
...
...
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Parameters
(1)
Identical
(2)
Different
(3)
Notes to differences between documents submitted in
Vietnam and documents approved by regulatory authorities
(4)
Quality
document
...
...
...
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S.1
General information
S.2:
Manufacturer
...
...
...
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S.2.1:
Manufacturer
S.2.2:
Description of manufacturing process and process controls
...
...
...
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S.2.4:
Controls of critical steps and intermediates
S.2.5:
Process validation and/ or evaluation
...
...
...
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S.2.6:
Manufacturing process development
S.3
Characterization
...
...
...
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S.3.2:
Impurities
S.4:
Control of drug substance
...
...
...
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S.4.1:
Quality specification
S.4.2:
Analytical procedures
...
...
...
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S.4.4:
Batch analyses
S.4.5:
Justification of specification
...
...
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S.5
Reference standards or materials
S.6
Container closure system
...
...
...
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Stability
summary and conclusion
Post-approval
stability protocol and stability commitment
...
...
...
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Stability
data
P. DRUG
PRODUCT
P.1.
Description and composition
...
...
...
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P.2.
Pharmaceutical development
P.3:
Manufacture
...
...
...
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P.3.2:
Batch formula
P.3.3:
Manufacturing process and process control
...
...
...
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P.3.4:
Controls of critical steps and intermediates
P.3.5:
Process validation and/or evaluation
...
...
...
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P.4.1:
Quality specification
P.4.2:
Analytical procedures
...
...
...
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P.4.3:
Validation of analytical procedures (if any)
P.4.4:
Justification of specification (if any)
...
...
...
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P.4.6.
Novel excipients
P.5:
Control of finished product
...
...
...
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P.5.1:
Quality specification
P.5.2:
Analytical procedures
...
...
...
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P.5.4:
Batch analyses
P.5.5:
Characterization of impurities
...
...
...
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P.5.6:
Justification of specification(s)
P.6
Reference standards or materials
...
...
...
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P.8:
Stability
Stability
summary and conclusion
...
...
...
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Post-approval
stability protocol and stability commitment
Stability
data
(specify
storage conditions, batch number, duration of stability data)
...
...
...
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P.9:
Product interchangeability
Nonclinical
document
Overview
of nonclinical studies:
-
Pharmacology
-
Pharmacokinetics/Pharmacodynamics
-
Toxicology
...
...
...
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Tabulation
of nonclinical safety studies
(Confirm
whether these comply with GLP or OECD)
Nonclinical
document
...
...
...
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(Confirm
whether these are the same as approved by the reference authorities/SRA)
Clinical
pharmacology
Dose /
dosage regimen
(In the
target population)
...
...
...
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ADME
(Applicability
in the target population)
Interaction
studies
...
...
...
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Pharmacodynamics
Statistical
methods for additional analysis, such as subgroup analysis
Benefit–risk
analysis
...
...
...
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Relevance
of reference authority- and SRA-approved conditions of use (proposed
indications, dose and directions of use) as regards epidemiology and disease
pattern in the target countries, as well as other implications for efficacy
and safety, for example, feasibility of monitoring and precautionary
measures(such as, microbial resistance testing or therapeutic drug
monitoring)
The
adequacy of the directions for use
...
...
...
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The
therapeutic role of a product and its recommended use according to relevant
national and international treatment guidelines
Other
related quality issues, including but not limited to, storage conditions and
conditions of administration and use (if any)
...
...
...
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Bioequivalence
document
Study #
...
...
...
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Study
title
Approval
from the Ethics Committee (protocol number and EC meeting date/ approval
date)
...
...
...
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Research
institution
Analytical
facility
...
...
...
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Data
management and analysis department
Description
of the overall study design and plan
...
...
...
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Reference
drug
Manufacturer
of reference drugs
...
...
...
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Result
discussion
For
vaccines, biologicals
Risk
management plan (RMP) was provided with the submission
...
...
...
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Epidemiology
of the indications and target population
Relevance
of the clinical trial population to the intended target population
Assessment
of identified and potential risks, including all important risks related to
the active substance, formulation, route of administration, target population
and the potential for interaction
...
...
...
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-
Ongoing and planned studies
-
Post-authorization pharmacovigilance development plan in the target
population
Plans
for post-authorization efficacy studies (if applicable)
...
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Summary
of the RMP
Comments on the RMP
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Notes:
Guidelines
on filling in the comparative tabulated summary of similarities:
- In case
there is not any difference between the documents submitted in Vietnam and the
documents approved by the regulatory authorities specified in clause 9 Article
2 of this Circular, put a tick in the box saying “Giống nhau” (“Identical”) in
column (2).
- In case
there is any difference between the documents submitted in Vietnam and the
documents approved by the regulatory authorities specified in clause 9 Article
2 of this Circular, put a tick in the box saying “Khác nhau” (“Different”) in
column (3) and briefly write the difference in column (4), e.g. to meet ASEAN’s
regulations on data stability. It is permissible to write the document name and
identification information such as version number or page number in column (4)
if the difference cannot be fully shown in the comparative tabulated summary.
- In case
there is any revision approved or published by a drug regulatory authority
specified in clause 9 Article 2 of this Circular, put a tick in the box saying
“Giống nhau” (“Identical”) in column (2) and write the supporting document in
column (4). It is permissible to write the document name and identification
information such as version number or page number in column (4) if the
difference cannot be fully shown in the comparative tabulated summary.
(*) The
person competent to sign this document is determined according to point b
clause 3 Article 22 of this Circular.
Form 10/TT. Title page of application for marketing
authorization of drug/medicinal material
TITLE PAGE
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1. Name
and address of the applicant:
2. Name
and address of the ordering facility/sending facility (if applicable):
3. Name
and address of the manufacturer/processing facility/receiving facility
(manufacturer):
4. Name
of the drug/medicinal material, concentration/content, dosage form:
5. Type
of the drug/medicinal material:
Clearly
specify the type: chemical drug/radioactive drug/ vaccine/biological/herbal
drug/medicinal material (drug substance/ excipient/ capsule shell).
6. Type
of registration:
Clearly
specify the type: Initial registration/Renewal/Registration of processing,
technology transfer(1)/Registration of major variation/Registration
of minor variation requiring approval/Registration of minor variation requiring
notification/Declaration of original brand-name drug/Declaration of
bioequivalence/Declaration of reference biological/Updating of drug
information.
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(1)
Method of processing, technology transfer:
Please
specify:
-
Processing, transfer of all stages of manufacturing/Processing, transfer of one
or several stages of manufacturing at the time of registration and with a
roadmap for processing, transfer of all stages of manufacturing /Processing,
transfer of one or several stages of manufacturing/Processing adopting
technology transfer.
- Drug
ordered for processing/Drug before technology transfer with unexpired marketing
authorization/not yet granted marketing authorization or with an expired
marketing authorization.
FORM 11/TT. Table of contents
TABLE OF CONTENTS
1.
Administrative document
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1.2.
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2.
Quality document
2.1.
2.2.
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3.
Nonclinical document
3.1.
3.2.
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4.
Clinical document
4.1.
4.2.
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5.
Other documents (if any)
5.1.
5.2.
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