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THE
MINISTRY OF HEALTH OF VIETNAM
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SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
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No.
16/2023/TT-BYT
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Hanoi,
August 15, 2023
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CIRCULAR
MARKETING AUTHORIZATION REGISTRATION OF PROCESSED MEDICINE,
MEDICINE OF TECHNOLOGY TRANSFER IN VIETNAM
Pursuant to the Law on
Pharmaceutical No. 105/2016/QH13 dated April 6, 2016;
Pursuant to the Law on Commerce
No. 36/2005/QH11 dated June 14, 2005;
Pursuant to the Law on Foreign
Trade Management No. 05/2017/QH14 dated June 12, 2017;
Pursuant to the Law on
Technology Transfer No. 07/2017/QH14 dated June 19, 2017;
Pursuant to Decree No.
54/2017/ND-CP dated May 8, 2017 of the Government elaborating the Law on
Pharmaceutical;
Pursuant to Decree No.
155/2018/ND-CP dated November 12, 2018 of the Government on amendment to
regulations relating to investment and business conditions under state
management of the Ministry of Health;
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Pursuant to Decree No.
95/2022/ND-CP dated November 15, 2022 of the Government on functions, tasks,
powers, and organizational structures of Ministry of Health;
At request of Director of the
Drug Administration of Vietnam;
The Minister of Health
promulgates Circular on marketing authorization registration of processed
medicine and medicine of technology transfer in Vietnam.
Chapter I
GENERAL PROVISIONS
Article 1.
Scope and regulated entities
1. This Circular prescribes marketing
authorization registration of processed medicine, medicine of technology
transfer in Vietnam; application and procedures for issuance, extension,
revision, addition, and revocation of marketing authorization of processed
medicine, medicine of technology transfer (pharmaceutics, vaccine, biologicals,
herbal medicine) in Vietnam.
2. This Circular applies to
domestic and foreign agencies, organizations, individuals relating to processing
of medicine and transfer of medicine technology in Vietnam.
Article 2.
Definitions
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1. Medicine processing means
to legally produce medicine under processing contract where processor performs
one, several, or all stages in medicine production process at request of
ordering facility for a payment.
2. Medicine manufacturing
technology transfer means to transfer hirership or use right of medicine
manufacturing technology from a sending facility to a receiving facility to
perform one, several or all stages of medicine production under contract
between the parties in a law-compliant manner.
3. Ordering party
(hereinafter referred to as “hirer”) means the party that provides a
part or all ingredients, materials, production process, technical instruments
proving quality, safety, and efficacy to processor in order to order medicine
production under processing contract between the parties.
4. Processor means the party
that uses a part or all ingredients, materials, production process, and
technical instruments of the hirer to perform one, several, or all medicine
manufacturing stages at request of the hirer in exchange for a payment
according to contract between the parties.
5. Facility sending medicine
manufacturing technology (hereinafter referred to as “sending facility”)
means the party that possesses technology hirership or use right of medicine
manufacturing technology as per the law and transfers technology hirership or
use right of medicine manufacturing technology to processor for application in
one, several, or all medicine production process.
6. Facility receiving medicine
production transfer (hereinafter referred to as “receiving facility”)
means the party that receives technology hirership or use right of medicine
manufacturing technology from the sending facility according to contract
between the parties in order to apply in one, several, or all medicine
production stages.
7. Medicine ordered for
processing means a medicine whose marketing authorization in Vietnam has
been/has not been granted and whose one, several, or all production stages
executed by a processor have been requested by an hirer in accordance with processing
contract between the parties.
8. Processed medicine means
a medicine whose one, several, or all production stages are executed by a processor
at request of an hirer according to processing contract between the parties.
9. Medicine for technology
transfer means a medicine whose marketing authorization in Vietnam has
been/has not been granted and whose technology hirership or use right is
transferred by sending facility to receiving facility for application in one,
several, or all drug production stages.
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Chapter II
GENERAL PROVISIONS ON MARKETING AUTHORIZATION
REGISTRATION OF PROCESSED MEDICINE
Article 3.
Rights and responsibilities of hirers and facilities registering for marketing
authorization (hereinafter referred to as “applicants”) of processed medicine
In addition to rights and
obligations under Article 181 of the Law on Commerce and Clause 1 Article 42 of
Decree No. 69/2018/ND-CP dated May 15, 2018 of the Government elaborating the
Law on Foreign Trade Management (hereinafter referred to as “Decree No.
69/2018/ND-CP”), hirers have rights, obligations, and responsibilities below:
1. Hirers have the right to:
a) authorize eligible facilities to
register for marketing authorization of medicine as per the law;
b) register for marketing
authorization of medicine when:
- They possess certificate of
eligibility for pharmaceutical business which permits them to: manufacture,
trade, export, or import medicine, medicinal ingredients in regard to
Vietnamese hirers;
- They possess legitimate documents
issued by foreign competent authority and granting them permission to:
manufacture, trade, export, or import medicine, medicinal ingredients and
license to establish representative office in Vietnam in regard to foreign hirers.
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a) comply with Article 3 of
Circular No. 08/2022/TT-BYT dated September 5, 2022 of the Minister of Health
on marketing authorization registration of medicine and medicinal ingredients
(hereinafter referred to as “Circular No. 08/2022/TT-BYT”);
b) provide processors with:
- Partial or total ingredients,
materials, and technical specifications including production procedures,
quality standards, testing methods for starting ingredients, semi-finished
products, finished products, and excipients for the purpose of processing;
- Other documents relating to
market authorization registration of processed medicine and processing of
medicine.
c) be responsible for legitimacy
and authenticity of intellectual property of processed medicine, ingredients,
materials, production procedures, and technical specifications transferred to processor;
d) cooperate with applicants in
staying up-to-date with quality standards of medicine and medicinal ingredients
in accordance with Circular No. 11/2018/TT-BYT dated May 4, 2018 of the
Minister of Health on quality of medicine and medicinal ingredients, Circular
No. 03/2020/TT-BYT dated t h1 22, 2020 of the Minister of Health on amendment
to Circular No. 11/2018/TT-BYT dated May 4, 2018;
d) examine and supervise processor
regarding production of processed medicine with the right transferred
ingredients, materials, specifications, documents, and approved medicine
marketing authorization in order to properly adhere to processing contract and
comply with GMP;
e) assume responsibility for
quality, safety, and efficacy of processed medicine;
g) file report or cooperate with
applicants of processed medicine (if the hirer does not register for marketing
authorization) in filing report on monitoring and assessment of safety and
efficacy of processed medicine in accordance with Clause 2 Article 5 of
Circular No. 08/2022/TT-BYT.
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- Issues relating to medicine
ordered for processing in terms of safety or efficacy;
- Change or addition to technical
specifications of medicine ordered for processing during circulation;
- Decision on revocation of market
authorization of medicine ordered for processing issued in any country.
3. Applicants are responsible for
cooperating with hirers and processors in informing Drug Administration of
Vietnam in writing within 30 days from the date on which decision on revocation
of marketing authorization of medicine ordered for processing is issued in any
country (if current marketing authorization is still effective) and exercising
other responsibilities under Article 3 of Circular No. 08/2022/TT-BYT.
4. Exercise other rights, obligations,
and responsibilities as per relevant law provisions.
Article 4.
Rights and responsibilities of processors
In addition to rights and
obligations under Article 181 of the Law on Commerce and Clause 2 Article 42 of
Decree No. 69/2018/ND-CP , processors have rights, obligations, and
responsibilities below:
1. Processors have the right to:
a) manufacture medicine under
contract in a manner that is appropriate to the scope of certificate of
eligibility for pharmacy business with respect to processors that are
manufacturing facilities in Vietnam issued with certificate of eligibility for
pharmacy business;
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c) register processed medicine
under their name if they are authorized by hirers.
2. Processors have the
responsibility to:
a) exercise responsibilities of
medicine manufacturing facilities under Article 4 of Circular No.
08/2022/TT-BYT ;
b) manufacture medicine under
contract in a manner that is appropriate to the scope under certificate of
eligibility for pharmacy business or GMP certificate with respect to facilities
that conduct pharmacy business for non-commercial purposes under Point a Clause
1 Article 35 of the Law on Pharmacy;
c) manufacture medicine under
contract with the right ingredients, materials, production procedures, and
technical specifications transferred by hirers, ensure medicine quality
according to marketing authorization, and comply with GMP requirements and
request of the hirers under processing contracts. Store documents, files,
medicine samples relating to medicine processing and provide the documents for
competent authority upon requested;
d) make changes relating to
formula; production procedure; ingredient quality standards; finished product
quality standards; trade name in case of processed medicine satisfying Point a
Clause 1 Article 6 hereof if corresponding changes of processed medicine have
been approved by competent authority are made. Changes to processed medicine
shall only be implemented if hirers require and if the Drug Administration of
Vietnam approves these changes;
dd) exercise regulations pertaining
to production, transportation, import, export, circulation, use, disposal,
delivery, reporting, documentation, and storage of documents relating to processed
medicine and ingredients thereof that are controlled drugs according to Decree
No. 54/2017/ND-CP dated May 8, 2017 of the Government elaborating the Law on
Pharmacy (hereinafter referred to as “Decree No. 54/2017/ND-CP”), Decree No.
155/2018/ND-CP dated November 12, 2018 of the Government on amendment to
business and investment conditions under state management of the Ministry of
Health (hereinafter referred to as “Decree No. 155/2018/ND-CP”), Circular No.
20/2017/TT-BYT dated May 10, 2017 of the Minister of Health elaborating the Law
on Pharmacy and Decree No. 54/2017/ND-CP dated May 8, 2017 of the Government on
controlled medicine and medicinal ingredients (hereinafter referred to as
“Circular No. 54/2017/ND-CP”) and other relevant law provisions on controlled
drugs;
e) apply for processing permit in
order to manufacture medicine under contract with hirers that are foreign
traders in accordance with Clause 4 Article 38 of Decree No. 69/2018/ND-CP.
3. Exercise other rights,
obligations, and responsibilities as per relevant law provisions.
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In addition to satisfying
provisions under Article 39 of Decree No. 69/2018/ND-CP , drug processing contracts
must contain:
1. Agreement on supply of
ingredients and materials. Technical specifications provided for processors by hirers
include: production procedures, quality standard, test methods for starting
ingredients, semi-finished products, finished products, excipients, and other
documents relating to processing of medicine.
2. Hirers, processors, and
applicants (if any) have rights and responsibilities pertaining to:
a) production procedures, quality
inspection, preservation and transportation of starting ingredients,
semi-finished products, finished products, excipients, packaging procedures,
printing or application of label of processed medicine and detailing of
responsibilities of facilities signing batch certificate of analysis and
factory release certificate of processed medicine;
b) storage of recordings pertaining
to production, quality inspection, distribution, circulation, storage of drug
samples, settlement of issues relating to quality, complaints, product recall.
3. Responsibilities of hirers, processors,
and applicants (if any) regarding intellectual property issues relating to processed
medicine.
4. Procedures for inspecting, supervising
processors.
5. Processing roadmap for
production stages of processed medicine in Vietnam and responsibilities of
relevant parties in regard to processed medicine under Clause 2 Article 6
hereof.
6. Situations that lead to
termination of the agreement and responsibilities of infringing party.
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1. For the purpose of registration
for marketing authorization, processed medicine shall be classified as follows:
a) Processed medicine share the
followings with medicine ordered for processing: formula; production
procedures; ingredient quality standards; finished product quality standards;
trade name;
If changes to at least one
criterion under this Point (not including trade name) or to quality have been
made to processed medicine relative to medicine ordered for processing which
has had original proprietary drug and reference product declared by the
Ministry of Health, either these changes must be approved by pharmacy authority
of manufacturing country or authority under Clause 9 Article 2 of Circular No.
08/2022/TT-BYT which previously granted marketing authorization for the
medicine or applicants must provide proof that the processed medicine has
quality equivalent to that of medicine ordered for processing.
b) Other processed medicine that
does not fall under cases of Point a of this Clause.
2. In regard to processed medicine
whose contract production stages in Vietnam follow a roadmap, applicants or processors
implement processing of medicine under Point a Clause 1 of this Article must
file report on processing progress of production stages of finished products in
Vietnam to the Ministry of Health (via the Drug Administration of Vietnam)
using Form No. 04/TT under Appendix 1 attached hereto on an annual basis from
the date on which marketing authorization is issued.
3. Effective period of marketing
authorization of processed medicine shall conform to Clause 1 and Clause 2
Article 8 of Circular No. 08/2022/TT-BYT.
4. Deadline for applying for
marketing authorization of processed medicine shall conform to Clause 4 Article
8 of Circular No. 08/2022/TT-BYT.
Chapter III
GENERAL PROVISIONS ON MARKETING AUTHORIZATION
REGISTRATION OF MEDICINE OF TECHNOLOGY TRANSFER
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In addition to rights and
obligations under Clause 1 and Clause 2 Article 25 of the Law on Technology
Transfer, sending facilities have rights, obligations, and responsibilities
below:
1. Sending facilities have the
right to:
Register medicine of technology
transfer for market authorization under their name when:
a) they have certificate of
eligibility for pharmacy business which grants them permission to: produce,
trade, export, and import medicine and medicinal ingredients for Vietnamese
sending facilities; or
b) They possess legitimate
documents issued by foreign competent authority and granting them permission
to: manufacture, trade, export, or import medicine, medicinal ingredients and
license to establish representative office in Vietnam in regard to foreign
sending facilities.
2. Sending facilities have the
responsibility to:
a) comply with Article 3 of
Circular No. 08/2022/TT-BYT if they register medicine of technology transfer
for marketing authorization under their name;
b) provide receiving facilities
with:
- Technical specifications
including production procedures, quality standards and test methods of starting
ingredients, semi-finished products, finished products, and excipients of
technology transfer;
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c) assume responsibility for
legitimacy and authenticity of intellectual property of documents transferred
to receiving facilities;
d) inform receiving facilities and
applicants of medicine of technology transfer about:
- Issues relating to medicine for
technology transfer in terms of safety or efficacy;
- Changes to technical
specifications of medicine for technology transfer during circulation;
- Decision on revocation of
marketing authorization of medicine for technology transfer in any country;
3. Applicants of medicine of
technology transfer are responsible for cooperating with sending facilities and
receiving facilities in notifying Drug Administration of Vietnam in writing
within 30 days from the date on which decision on revocation of marketing
authorization of medicine for technology transfer is issued in any country
during effective period of marketing authorization of medicine of technology
transfer and fulfill other responsibilities under Article 3 of Circular No.
08/2022/TT-BYT.
4. Exercise other rights,
obligations, and responsibilities as per relevant law provisions.
Article 8.
Rights and responsibilities of receiving facilities
In addition to rights and
obligations under Article 26 of the Law on Technology Transfer, receiving
facilities have rights, obligations, and responsibilities below:
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a) receive technology to
manufacture medicine in a manner that is appropriate to the scope of
certificate of eligibility for pharmacy business with respect to receiving
facilities that are manufacturing facilities in Vietnam issued with certificate
of eligibility for pharmacy business;
b) manufacture medicine under
contract in a manner that is appropriate to the scope of GMP certificate with
respect to processors that conduct pharmacy business for non-commercial
purposes under Point a Clause 1 Article 35 of the Law on Pharmacy;
c) register medicine of technology
transfer for marketing authorization under their name or authorize eligible
facilities to register medicine of technology transfer for marketing
authorization under their name as per the law, unless otherwise agreed upon by
the parties.
2. Receiving facilities have the
responsibility to:
a) exercise responsibilities of
medicine manufacturing facilities under Article 4 of Circular No. 08/2022/TT-BYT ;
b) manufacture medicine of
technology transfer in a manner that is appropriate to the scope under
certificate of eligibility for pharmacy business or GMP certificate with
respect to facilities that conduct pharmacy business for non-commercial purposes
under Point a Clause 1 Article 35 of the Law on Pharmacy;
c) produce medicine of technology
transfer in accordance with production procedures, technical specifications,
ensure medicine quality as per medicine marketing authorization, comply with GMP
requirements and request of sending facilities under technology transfer
agreement. Store documents, files, medicine samples relating to manufacturing
process of medicine of technology transfer and provide the documents for
competent authority upon requested;
d) make changes relating to
formula; production procedure; ingredient quality standards; finished product
quality standards; trade name in case of medicine of technology transfer
satisfying Point a Clause 1 Article 10 hereof if corresponding changes of
medicine of technology transfer have been approved by competent authority are
made. Changes to medicine of technology transfer shall only be implemented if
sending facilities notify and if the Drug Administration of Vietnam approves
these changes;
dd) comply with regulations on
manufacturing, transportation, import, export, circulation, use, disposal,
delivery, reporting, documents, filing, and storage of documents relating to
medicine of technology transfer and ingredients thereof that are controlled drugs
in accordance with Decree No. 54/2017/ND-CP , Decree No. 155/2018/ND-CP ,
Circular No. 20/2017/TT-BYT and other relevant law provisions regarding
controlled drugs;
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3. Exercise other rights,
obligations, and responsibilities as per relevant law provisions.
Article 9.
Technology transfer agreement
In addition to fulfilling Article
23 of the Law on Technology Transfer, technology transfer agreement for
medicine manufacturing technology must also include:
1. Agreement on provision of
technical specifications of sending facilities for receiving facilities
includes:
2. Responsibilities of sending
facilities, receiving facilities, and applicants regarding intellectual
property relating to medicine of technology transfer.
3. Technology transfer roadmap for
medicine production stages in Vietnam and responsibilities of relevant parties
in regard to medicine of technology transfer under Clause 2 Article 10 hereof.
4. Situations that lead to
termination of the agreement and responsibilities of infringing party.
Article 10.
Market authorization registration of medicine of technology transfer
1. For the purpose of registering
for market authorization, medicine of technology transfer shall be classified
as follows:
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If changes to at least one
criterion under this Point (not including trade name) or to quality have been
made to medicine of technology transfer relative to medicine for technology
transfer which has had original proprietary drug and reference product declared
by the Ministry of Health, either these changes must be approved by pharmacy
authority of manufacturing country or authority under Clause 9 Article 2 of
Circular No. 08/2022/TT-BYT which previously granted marketing authorization
for the medicine or applicants must provide proof that the medicine of
technology transfer has quality equivalent to that of medicine for technology
transfer.
b) Other medicine of technology
transfer that does not fall under cases of Point a of this Clause.
2. In regard to medicine of
technology transfer whose production stages in Vietnam follow a roadmap,
applicants or receiving facilities implement technology transfer of medicine
under Point a Clause 1 of this Article must file report on technology transfer
progress of production stages of finished products in Vietnam to the Ministry
of Health (via the Drug Administration of Vietnam) using Form No. 04/TT under
Appendix 1 attached hereto on an annual basis from the date on which marketing
authorization is issued.
3. Effective period of marketing
authorization of medicine of technology transfer shall conform to Clause 1 and
Clause 2 Article 8 of Circular No. 08/2022/TT-BYT.
4. Deadline for applying for
marketing authorization of medicine of technology transfer shall conform to
Clause 4 Article 8 of Circular No. 08/2022/TT-BYT.
Chapter IV
APPLICATION AND PROCEDURES FOR ISSUANCE, EXTENSION,
REVISION, REVOCATION OF MARKETING AUTHORIZATION OF PROCESSED MEDICINE AND
MEDICINE OF TECHNOLOGY TRANSFER IN VIETNAM
Article 11.
Regulation on application for marketing authorization of processed medicine and
medicine of technology transfer
1. Language of the application:
Application for marketing authorization of processed medicine, medicine of
technology transfer must be filed in Vietnamese or English. Package insert and
summary of product characteristics must be written in Vietnamese.
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a) Bioequivalence study documents;
b) Nonclinical and clinical
documents.
3. Application must bear
verification seal of applicants or receiving facilities, manufacturing
facilities on the first page of each component of the application set (seal of
representative office is acceptable with respect to application of foreign
applicants).
Documents provided by hirers or
sending facilities must bear verification seal of appropriate establishments. If
hirers or sending facilities do not use seals in accordance with regulation of
their home country, applicants for marketing authorization of processed
medicine or medicine of technology transfer must append verification seals to
these documents declare that home country of hirers or sending facilities does
not use verification seals, and assume responsibilities for authenticity of the
documents.
4. It is possible to apply for
multiple medicines in the same application if they share: name; dosage form; administration;
standard quality; name and address of manufacturer (manufacturing facilities or
receiving facilities); formula, in which:
a) Solid dosage medicine: Having
the same active pharmaceutical ingredients (API) per unit dose;
b) Medicines of non-dosage solid,
liquid, or semi-solid form of the same concentration or API; injection and
intravenous injection medicines of the same concentration or API and primary
packaging materials.
5. Regulations regarding contents
of application for issuance, extension, revision of marketing authorization of processed
medicine, medicine of technology transfer shall conform to Article 22 of
Circular No. 08/2022/TT-BYT.
6. Number of documents required in
application for issuance, extension of marketing authorization:
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b) In addition to documents under
Point a Clause 6 of this Article, one copy of the application with respect to
vaccine, biologicals and two copies of written applications, quality standards,
and test methods with respect to other cases;
c) 2 sets of prescription label and
package insert of medicine to be sold bearing verification seals of applicants
(seal of representative office is acceptable in case of foreign applicants) or
manufacturing facilities (this does not apply to application for extension of
marketing authorization). Prescription labels shall be displayed, designed on
A4 format. In case of online application, one set of prescription label and package
insert is sufficient.
7. Number of documents required in
application for revision to marketing authorization;
a) 1 set containing adequate
documents under Article 15 hereof;
b) 2 sets of prescription label and
package insert to which revision is requested in case of changing labels,
instructions bearing verification seals of applicants (seal of representative
office is acceptable in case of foreign applicants) or manufacturing.
Prescription labels shall be displayed, designed on A4 format. In case of
online application, one set of prescription label and package insert is
sufficient.
8. Regulations on online
application:
Online application shall conform to
Clause 6 Article 6 of Circular No. 08/2022/TT-BYT
9. Registration fee: Applicants are
required to pay fee in accordance with applicable fees and charges laws.
10. Verification of authenticity of
legal documents in application for marketing authorization of processed
medicine, medicine of technology transfer shall conform to Article 12 of
Circular No. 08/2022/TT-BYT.
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1. Application for marketing
authorization of processed medicine, medicine of technology transfer when
marketing authorization has been granted to medicine ordered for processing or
medicine for technology transfer and is still effective at the time of
application:
a) Administrative documents
- Application using Form No. 02A/TT
- Appendix 1 attached hereto;
- Documents mentioned under Points
b, c, d, g, i, and k Clause 1 Article 23 of Circular No. 08/2022/TT-BYT ;
- Documents mentioned under Point e
Clause 1 Article 23 of Circular No. 08/2022/TT-BYT in case of foreign
applicants:
- Documents mentioned under Point
dd Clause 1 Article 23 of Circular No. 08/2022/TT-BYT in case of domestic
applicants;
- Documents mentioned under Point h
Clause 1 Article 23 of Circular No. 08/2022/TT-BYT , unless processing or
technology transfer only covers the packaging stage;
- Processing contract or technology
transfer contract;
If hirers or manufacturing
facilities are not the applicants, medicine processing contract must bear
signatures of legal representatives of hirers, applicants, and manufacturing
facilities.
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- Registration certificate of
technology transfer according to Clause 1 Article 31 of the Law on Technology
Transfer in regard to application for marketing authorization of medicine of
technology transfer;
- Processing roadmap for processed
medicine under Clause 2 Article 6 or technology transfer roadmap for medicine
of technology transfer under Clause 2 Article 10 hereof using Form No. 03/TT -
Appendix 1 attached hereto.
b) Quality records:
- Quality records for
pharmaceutics, vaccine, biologicals shall conform to Article 13 hereof;
- Quality records for herbal
medicines shall conform to Article 14 hereof.
c) Non-clinical and clinical
documents for vaccine, biologicals under Article 25 and Article 26 of Circular
No. 08/2022/TT-BYT.
Requirements regarding clinical
data for safety, efficacy assurance, and criteria for identifying cases of
non-clinical trial exemption, non-clinical trial stage exemption, medicines
required to undergo phase 4 clinical trial in Vietnam shall conform to Chapter
II of Circular No. 08/2022/TT-BYT.
d) Documents of medicine ordered
for processing, medicine for technology transfer
Report on monitoring, evaluation of
safety and efficacy and drug use using Form No. 2/TT attached to Circular No.
08/2022/TT-BYT in case of medicine ordered for processing, medicine for
technology transfer that requires report on monitoring and evaluation of
safety, efficacy in accordance with Clause 2 Article 5 of Circular No.
08/2022/TT-BYT.
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a) Administrative documents:
- Application using Form No. 02A/TT
- Appendix 1 attached hereto;
- Documents mentioned under Points
b, c, d, g, i, and k Clause 1 Article 23 of Circular No. 08/2022/TT-BYT ;
- Documents mentioned under Point e
Clause 1 Article 23 of Circular No. 08/2022/TT-BYT in case of foreign
applicants:
- Documents mentioned under Point
dd Clause 1 Article 23 of Circular No. 08/2022/TT-BYT in case of domestic
applicants;
- Processing contract or technology
transfer contract;
If hirers or manufacturing
facilities are not the applicants, medicine processing contract must bear
signatures of legal representatives of hirers, applicants, and manufacturing
facilities.
- Processing permit under Point e
Clause 2 Article 4 hereof in case of application for marketing authorization of
processed medicine;
- Registration certificate of
technology transfer according to Clause 1 Article 31 of the Law on Technology
Transfer in regard to application for marketing authorization of medicine of
technology transfer;
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b) Quality records:
- Quality records for
pharmaceutics, vaccine, biologicals shall conform to Article 13 hereof;
- Quality records for herbal
medicines shall conform to Article 14 hereof.
c) Non-clinical and clinical
documents for new pharmaceutics, vaccine, biologicals shall conform to Article
25 and Article 26 of Circular No. 08/2022/TT-BYT , except for cases where medicine
ordered for processing or medicine for technology transfer that are
pharmaceutics whose non-clinical and clinical documents have been submitted in
accordance with Point dd Clause 2 of this Article;
Requirements regarding clinical
data for safety, efficacy assurance, and criteria for identifying cases of
non-clinical trial exemption, non-clinical trial stage exemption, medicines
required to undergo phase 4 clinical trial in Vietnam shall conform to Chapter
II of Circular No. 08/2022/TT-BYT.
dd) Documents on safety and
efficacy for herbal medicine according to Article 29 of Circular No.
08/2022/TT-BYT ;
dd) Documents of medicine ordered
for processing, medicine for technology transfer:
- Documents with respect to
application for marketing authorization of new pharmaceutics, vaccine,
biologicals under Points b, c, and d Clause 1 Article 27 of Circular No.
08/2022/TT-BYT or generic drugs under Point b Clause 2 Article 27 of Circular
No. 08/2022/TT-BYT or herbal medicine under Point b and Point c Clause 1
Article 30 of Circular No. 08/2022/TT-BYT ;
- Certificate of pharmaceutical
products of medicine ordered for processing or medicine for technology transfer
according to Point c Clause 4 Article 22 of Circular No. 08/2022/TT-BYT in case
medicine ordered for processing or medicine for technology transfer is foreign
medicine.
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a) Documents under Clause 1 or
Clause 2 of this Article;
b) Technology transfer agreement;
c) Registration certificate of
technology transfer acceding to Clause 1 Article 31 of the Law on Technology
Transfer.
Article 13.
Regulations on quality records of application for marketing authorization of processed
medicine, medicine of technology transfer that are pharmaceutics, vaccine,
biologicals
Quality records in application for
marketing authorization of processed medicine, medicine of technology transfer
that are pharmaceutics, vaccine, biologicals shall conform to guidance under
section II-ACTD or joint section 3-ICH-CTD, Clauses 1, 2, 3, and 5 Article 24
of Circular No. 08/2022/TT-BYT and:
1. Quality records of medicine
ordered for processing or medicine for technology transfer which have not been
granted marketing authorization in Vietnam: conform to guidance under Section
II-ACTD of Appendix I attached to Circular No. 08/2022/TT-BYT or Joint Section
3-TCH-CTD.
2. Summary of changes (if any)
between medicine ordered for processing and processed medicine, medicine for
technology transfer and medicine of technology transfer and technical
specifications according to guidance under Appendix II attached to Circular No.
08/20227TT-BYT.
3. API master file of processed
medicine provided by manufacturing facilities or that of medicine of technology
transfer provided by receiving facilities in case of changes to API
manufacturers in relative to medicine ordered for processing or medicine for
technology transfer.
4. Finished product documents of processed
medicine produced by manufacturing facilities or those of medicine of
technology transfer produced by receiving facilities include:
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b) Assessment report of
manufacturing procedures (for stages implemented at manufacturing facilities or
receiving facilities);
c) Conformity assessment report of
analysis process (which can be replaced by documents on transfer of analysis
process produced by hirers and manufacturing facilities or sending facilities
and receiving facilities);
d) Batch analysis data, and
certificate of analysis of finished products;
dd) Data on stability: submit
stability research data of registered medicine under 4.7,9 of ASEAN guideline
on stability study of drug product - Part II Appendix I attached to Circular
No. 08/2022/TT-BYT.
If medicine ordered for processing
or medicine for technology transfer lacks stability data of zone IVb: submit
stability study data of registered medicine in zone IVb in accordance with
ASEAN guideline on stability study of drug product Part II Appendix I attached
to Circular No. 08/2022/TT-BYT ;
e) Documents on bioequivalence
study of processed medicine, medicine of technology transfer that requires
original proprietary drug classification, and medicine with bioequivalence proof
(including: medicine that requires bioequivalence study report according to
Circular No. 07/2022/TT-BYT dated September 5, 2022 of the Minister of Health,
medicine that does not require bioequivalence study report according to
regulations of Minister of Health but is requested by applicants to be
classified as medicine that requires bioequivalence study report). Applicants
are allowed to replace with equivalence dissolution study between processed
medicine and medicine ordered for processing or between medicine of technology
transfer and medicine for technology transfer if all conditions below are met:
- Medicine ordered for processing,
medicine for technology transfer has been granted marketing authorization in
Vietnam and declared as original proprietary drug, medicine requiring
bioequivalence study or medicine requested to be classified as original
proprietary drug, as medicine requiring bioequivalence study; medicine ordered
for processing, medicine for technology transfer has not been granted marketing
authorization in Vietnam but has been requested to be classified as original
proprietary drug, medicine requiring bioequivalence at the time of application;
- Processed medicine, medicine of
technology transfer have the same formula; manufacturing procedures, ingredient
quality standards; quality standards of finished products relative to medicine
ordered for processing, medicine for technology transfer. In case of changes
relating to details above that do not require submission of bioequivalence study,
applicants must submit documents appropriate to each change according to
regulations under guidelines on increasing batch size and implement the changes
after obtaining marketing authorization for solid oral dosage forms under the
US - FDA (SUPACs).
5. In regard to processed medicine,
medicine of technology transfer during secondary packaging stage, documents
under Points dd and e Clause 4 of this Article are not required.
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Quality records in application for
marketing authorization of processed medicine, medicine of technology transfer
that are herbal medicine shall conform to Article 28 of Circular No. 08/2022/TT-BYT
and:
1. Quality records of medicine
ordered for processing or medicine for technology transfer in case said medicine
ordered for processing or medicine for technology transfer have not been
granted marketing authorization in Vietnam: conform to Article 28 of Circular
No. 08/2022/TT-BYT.
2. Summary of changes (if any)
between medicine ordered for processing and processed medicine, medicine for
technology transfer and medicine of technology transfer and technical
specifications according to guidance under Appendix II attached to Circular No.
08/2022/TT-BYT.
3. Documents produced by
manufacturing facilities or receiving facilities:
a) Ingredient: certificate of
analysis of medicinal herbs or certificate of analysis of semi-finished
products of medicinal herbs, bone glue;
b) Finished product: certificate of
analysis of finished products; stability study report according to guidance on
stability study under Part II of Appendix I attached to Circular No.
08/2022/TT-BYT.
Article 15.
Application for revision to marketing authorization of processed medicine,
medicine of technology transfer
1. Application for revision shall
use Form No. 02C/TT - Appendix I attached hereto.
2. Application for revision to
marketing authorization of processed medicine, medicine of technology transfer
shall conform to Appendix II of Circular No. 08/2022/TT-BYT.
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In regard to vaccine of the same
manufacturers or holders of medicine marketing authorization, changes to
location of manufacturers in the same country or outside of the country where
the vaccine has been granted marketing authorization are allowed.
3. Changes to details relating to hirers
a) Changes to name, address of hirers,
update to information relating to hirers (while the hirers do not change):
Application shall conform to regulations on changing name, address of applying
company (MiV-N1) Section 7 of Appendix II attached to Circular No.
08/2022/TT-BYT ;
b) Changes to hirers:
Documents required;
- Documents indicating carry-over
of rights and responsibilities between previous hirers and new hirers regarding
execution of processing contract in application for marketing authorization;
- Documents of new hirers declaring
unchanged location of manufacturing facilities and declaring further execution
of rights and responsibilities of hirers according to application for marketing
authorization of processed medicine.
4. Changes of details relating to
sending facilities
a) Changes to name, address of
sending facilities, update to information relating to sending facilities (while
the sending facilities are not changed): Application shall conform to
regulations on changing name, address of applying company (MiV-N1) under
section 7 Appendix II attached to Circular No. 08/2022/TT-BYT ;
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Documents required:
- Documents of new sending
facilities declaring further execution of medicine manufacturing technology
transfer agreement signed by previous sending facilities;
- Registration certificate of
technology transfer (if any).
Article 16.
Application for extension of marketing authorization of processed medicine,
medicine of technology transfer
1. Application shall use Form No.
02B/TT - Appendix 1 attached hereto.
2. Processing contract or
technology transfer contract.
3. Pharmaceutics, vaccine,
biologicals: Application for extension of marketing authorization of processed
medicine, medicine of technology transfer shall conform to Clause 3 Article 27
of Circular No. 08/2022/TT-BYT.
4. Herbal medicine: Application for
extension of marketing authorization of processed medicine, medicine of
technology transfer shall conform to Clause 2 Article 30 of Circular No.
08/2022/TT-BYT.
5. Report on progress of processing
roadmap for processed medicine under Clause 2 Article 6 or technology transfer
roadmap for medicine of technology transfer under Clause 2 Article 10 hereof
using Form No. 04/TT - Appendix 1 attached hereto.
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1. Procedures for issuing marketing
authorization for processed medicine, medicine of technology transfer when
marketing authorization has been granted to medicine ordered for processing or
medicine for technology transfer and is still effective at the time of
application:
a) Within 3 months from the date on
which application is received, the Drug Administration of Vietnam shall issue
marketing authorization for processed medicine, medicine of technology
transfer. If marketing authorization is not issued or not issued immediately,
the Drug Administration of Vietnam shall respond in writing and provide reason.
Time limit for resolving each step is as follows:
- Within 8 working days from the
date on which application is received, the Drug Administration of Vietnam shall
review, classify, and send the application to assessing experts or assessing
bodies. Within 1 month from the date on which application sent by the Drug
Administration of Vietnam is received, assessing experts or assessing bodies
must finalize assessment records and file to the Drug Administration of Vietnam
for conclusion in accordance with Clause 4 Article 35 of Circular No.
08/2022/TT-BYT ;
- Within 12 working days from the
date on which assessment records are received, the Drug Administration of
Vietnam shall issue written response for inadequate application and state
reason. In regard to applications approved, rejected, or deemed requiring
assessment of Advisory Council for marketing authorization of medicine and
medicinal ingredients (hereinafter referred to as “Council”) by the Drug
Administration of Vietnam, the Drug Administration of Vietnam shall send the
applications to office of the Council;
- Within 6 working days from the
date on which applications sent by the Drug Administration of Vietnam are
received, office of the Council shall hold council meetings and send meeting
records to the Drug Administration of Vietnam;
- Within 18 working days from the
date on which meeting records sent by the Council are received, the Drug
Administration of Vietnam shall promulgate decision issuing marketing authority
for processed medicine, medicine of technology transfer if the application is
adequate; the Drug Administration of Vietnam shall issue written response
according to conclusion of the Council if the application is inadequate and
state reason.
b) The Drug Administration of
Vietnam shall request applicants to submit additional documents and the
applicants must fulfill said request within 36 months in case additional
documents are non-clinical and clinical documents, bioequivalence documents,
stability study or within 12 months in case additional documents are other
documents. If applicants fail to submit additional documents within the time
limit above, the filed applications are no longer valid.
While filed application is being
assessed, the applicants are allowed to notify Drug Administration of Vietnam
in writing of update to information relating to safety, efficacy of medicine or
legal documents of the applicants, manufacturers of medicine and medical
ingredients relative to filed applications.
The period between the date on
which the Drug Administration of Vietnam sends request to the date on which the
applicants submit additional documents shall be added to time limit under
Clause 5 Article 56 of the Law on Pharmacy.
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Procedures and time limit for
reviewing additional documents shall conform to Point a Clause 1 of this
Article.
2. Procedures for issuing marketing
authorization for processed medicine, medicine of technology transfer when
marketing authorization has not been granted to medicine ordered for processing
or medicine for technology transfer or has expired by the time of application:
a) Within 9 months from the date on
which application is received, the Drug Administration of Vietnam shall issue
marketing authorization for processed medicine, medicine of technology
transfer. If marketing authorization is not issued or not issued immediately,
the Drug Administration of Vietnam shall respond in writing and provide reason.
Time limit for resolving each step is as follows:
- Within 2 months from the date on
which application is received, the Drug Administration of Vietnam shall review,
classify, and send the application to assessing experts or assessing bodies.
Within 4 months from the date on which application sent by the Drug Administration
of Vietnam is received, assessing experts or assessing bodies must finalize
assessment records and file to the Drug Administration of Vietnam for
conclusion in accordance with Clause 4 Article 35 of Circular No.
08/2022/TT-BYT ;
- Within 01 month from the date on
which assessment records are received, the Drug Administration of Vietnam shall
issue written response for inadequate application and state reason. In regard
to applications approved, rejected, or deemed requiring assessment of the
Council by the Drug Administration of Vietnam, the Drug Administration of
Vietnam shall transfer the applications to office of the Council;
- Within 1 month from the date on
which applications sent by the Drug Administration of Vietnam are received,
office of the Council shall hold council meetings and send meeting records to
the Drug Administration of Vietnam;
- Within 01 month from the date on
which meeting records sent by the Council are received, the Drug Administration
of Vietnam shall promulgate decision issuing marketing authority for processed
medicine, medicine of technology transfer if the application is adequate; the
Drug Administration of Vietnam shall issue written response according to
conclusion of the Council if the application is inadequate and state reason.
b) The Drug Administration of
Vietnam shall request applicants to submit additional documents and the
applicants must fulfill said request within 36 months in case additional
documents are non-clinical and clinical documents, bioequivalence documents,
stability study or within 12 months in case additional documents are other
documents. If applicants fail to submit additional documents within the time
limit above, the filed applications are no longer valid.
While filed application is being
assessed, the applicants are allowed to notify Drug Administration of Vietnam
in writing of update to information relating to safety, efficacy of medicine or
legal documents of the applicants, manufacturers of medicine and medical
ingredients relative to filed applications.
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c) Within 4 months from the date on
which adequate additional documents are received, the Drug Administration of
Vietnam shall promulgate decision on marketing authorization for processed
medicine, medicine of technology transfer if the application is adequate; the
Drug Administration of Vietnam shall issue written respond based on conclusion
of the Council if the application is inadequate and state reason. Time limit
for resolving each step is as follows:
- Within 12 working days from the
date on which application is received, the Drug Administration of Vietnam shall
review, classify, and send the application to assessing experts or assessing
bodies. Within 1 month from the date on which application sent by the Drug
Administration of Vietnam is received, assessing experts or assessing bodies
must finalize assessment records and file to the Drug Administration of Vietnam
for conclusion in accordance with Clause 4 Article 35 of Circular No.
08/2022/TT-BYT ;
- Within 01 month from the date on
which assessment records are received, the Drug Administration of Vietnam shall
issue written response for inadequate application and state reason. In regard
to applications approved, rejected, or deemed requiring assessment of the
Council by the Drug Administration of Vietnam, the Drug Administration of
Vietnam shall transfer the applications to office of the Council;
- Within 1 month from the date on
which they receive applications from the Drug Administration of Vietnam.
Council office shall hold meetings and send meeting records to the Drug
Administration of Vietnam;
- Within 10 working days from the
date on which meeting records sent by the Council are received, the Drug
Administration of Vietnam shall promulgate decision issuing marketing authority
for processed medicine, medicine of technology transfer if the application is
adequate; the Drug Administration of Vietnam shall issue written response
according to conclusion of the Council if the application is inadequate and
state reason.
3. Procedures for issuing marketing
authorization for processed medicine which involves technology transfer from hirers
to manufacturing facilities shall conform to Clause 1 of this Article if
marketing authorization in Vietnam of medicine ordered for processing is still
valid at the time of application or Clause 2 of this Article if marketing
authorization has not been granted to medicine ordered for processing or has
expired at the time of application.
4. Marketing authorization of processed
medicine, medicine of technology transfer shall be issued as a single document
in case of medicine under Point a Clause 4 Article 11 of this Circular or as
several documents in case of medicine under Point b Clause 4 Article 11 of this
Circular.
5. Procedures for extending,
revising marketing authorization of processed medicine, medicine of technology
transfer shall conform to procedures for extending, revising medicine marketing
authorization under Article 37 and Article 38 of Circular No. 08/2022/TT-BYT.
6. Entitlement to issue, extend,
revise marketing authorization of processed medicine, medicine of technology
transfer shall conform to Article 34 of Circular No. 08/2022/TT-BYT.
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Article 18.
Revocation of marketing authorization, temporary rejection of application for
issuance, extension of marketing authorization of processed medicine, medicine
of technology transfer
1. Entitlement to revoke and
responsibility for notifying revocation of marketing authorization shall
conform to Clause 1 Article 40 of Circular No. 08/2022/TT-BYT.
2. Procedures for revoking
marketing authorization of processed medicine, medicine of technology transfer
shall conform to Article 40 of Circular No. 08/2022/TT-BYT.
3. Cases of temporary rejection of
application for issuance, extension of application for marketing authorization
of processed medicine, medicine of technology transfer shall conform to Article
41 of Circular No. 08/2022/TT-BYT.
Chapter V
ENTRY INTO FORCE
Article 19.
Entry into force
1. This Circular comes into force
from October 1, 2023.
2. Circular No. 23/2013/TT-BYT
dated August 13, 2013 of the Minister of Health guiding processing of medicine
expires from the effective date hereof.
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1. Applications submitted before
the effective date hereof shall conform to regulations applicable at the date
of submission, unless the applicants state their wish to conform to regulations
applicable from the signing date of this Circular under written presentation,
additional documents, or written request.
2. If facilities wish to have processed
medicine, medicine of technology transfer that has been granted marketing
authorization before the effective date hereof declared in accordance with
Clause 1 Article 22 hereof, they must submit application for new marketing
authorization in accordance with this Circular.
Article 21.
Terms of reference
If documents referred to in this
Circular are replaced or amended, the replacing or amending version shall
prevail.
Article 22.
Organizing implementation
1. The Drug Administration of
Vietnam is responsible for publicizing the following medication lists on their
website, “Sức khỏe và Đời sống” Newspaper in accordance with guidelines under
Appendix 2 hereof:
a) List of processed medicine
(without manufacturing technology transfer) with new/extended marketing
authorization satisfying Point a Clause 1 Article 6 hereof;
b) List of processed medicine (with
manufacturing technology transfer) with new/extended marketing authorization
satisfying Point a Clause 1 Article 6 hereof;
c) List of medicine of technology
transfer with new/extended marketing authorization satisfying Point a Clause 1
Article 10 hereof.
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a) Report on progress of processing
roadmap for processed medicine under Clause 2 Article 6 or progress of
technology transfer roadmap for medicine of technology transfer under Clause 2
Article 10 hereof is not produced;
b) Production stages in Vietnam
under processing roadmap or technology transfer roadmap according to
application for marketing authorization are not adequately adhered to;
c) Processed medicine no longer
satisfies Point a Clause 1 Article 6 hereof; medicine of technology transfer no
longer satisfies Point a Clause 1 Article 10 hereof.
3. Labeling of processed medicine,
medicine of technology transfer shall conform to Circular No. 01/2018/TT-BYT
dated January 18, 2018 of the Minister of Health.
4. In regard to medicine processed
under contract with hirers that are foreign traders for trading in Vietnam,
once processed medicine is granted as per the law, import and export procedures
for processed medicine shall be conducted in accordance with Decree No.
69/2018/ND-CP.
5. Foreign-invested enterprises
engaging in processing of medicine shall exercise the right to import,
distribute medicine in accordance with Clause 10, Clause 11 Article 91 of
Decree No. 54/2017/ND-CP.
6. Each processed medicine and
medicine of technology transfer granted marketing authorization shall be
assigned with a registration number whose structure conforms to Appendix VI
attached to Circular No. 08/2022/TT-BYT. In regard to processed medicine that
involves manufacturing technology transfer, medicine category under Appendix VI
is as follows:
Medicine
category
(1 digit)
8:
Processed medicine with manufacturing technology transfer
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8. Other details pertaining to
marketing authorization registration of processed medicine and medicine of
technology transfer in Vietnam that have not been prescribed under this
Circular shall conform to relevant provisions under Circular No. 08/2022/TT-BYT
Article 23.
Responsibilities for implementation
1. The Drug Administration of
Vietnam is responsible for providing guidelines on implementation of this
Circular; taking charge or cooperating with Inspectorates of the Ministry of
Health, departments and agencies in examining and supervising implementation of
this Circular in pharmaceutical manufacturing and trading entities across the
country.
2. Departments of Health of
provinces and central-affiliated cities are responsible for examining and
inspecting implementation of this Circular in local pharmaceutical
manufacturing and trading entities.
3. Entities affiliated with the
Ministry of Health, Vinapharm, and pharmaceutical manufacturing and trading
entities are responsible for the implementation of this Circular.
Difficulties that arise during the
implementation of this Circular should be reported to the Ministry of Healthy
(Drug Administration of Vietnam) for consideration./.
PP.
MINISTER
DEPUTY MINISTER
Do Xuan Tuyen
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Appendix
1
(Attached
to Circular No. 16/2023/TT-BYT dated August 15, 2023 of the Minister of
Health)
1. Form No. 01/TT: Cover of
application for marketing authorization of medicine of processing, medicine of
technology transfer.
2. Form No. 02/TT: Application for
marketing authorization of medicine of processing, medicine of technology
transfer.
3. Form No. 03/TT: Roadmap for processing/technology
transfer for stages of finished product manufacturing process in Vietnam.
4. Form No. 04/TT: Report on
schedule of roadmap for processing/technology transfer for stages of finished
product manufacturing process in Vietnam.
5. Form No. 05/TT: Appendix
Form No. 01/TT
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APPLICATION
FOR MARKETING AUTHORIZATION OF MEDICINE OF PROCESSING, MEDICINE OF TECHNOLOGY
TRANSFER
1. Name and address of facility
applying for marketing authorization (applicant):
2. Name and address of facility
requesting processing of medicine (ordering facility)/facility transferring
medicine manufacturing technology (sending facility):
3. Name and address of facility
manufacturing medicine/facility receiving medicine manufacturing technology
transfer (processor):
4. Name, concentration/API, dosage
form:
5. Type of medicine to be
registered:
(Specify:
Pharmaceutics/vaccine/biologicals/herbal medicines).
6. Application purpose:
(Specify: First-time
application/Renewal application/Application for major change/Application for
minor change requiring approval/Application for minor changes requiring
announcement).
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Specify:
- Manufacturing, transfer of all
manufacturing stages/Manufacturing, transfer of manufacturing stage or stages
at the time of application and roadmap for manufacturing, transfer of all
manufacturing stages/Manufacturing, transfer of manufacturing stage or
stages/Manufacturing that involves transferred technology.
- Medicine of which processing is
ordered/Medicine prior to technology transfer of which marketing authorization
is effective/has not been issued/has expired.
Form No. 02A/TT:
APPLICATION
FOR MARKETING AUTHORIZATION OF MEDICINE OF PROCESSING, MEDICINE OF TECHNOLOGY
TRANSFER
A. Information on applicant;
ordering facility or sending facility; processor; manufacturer of medicine of processing
or facility manufacturing medicine before technology transfer
1. Applicant
1.1. Name of applicant:
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1.3. Telephone:
Fax:
Email:
1.4. Name of representative office
in Vietnam (in case of foreign applicant):
Address:
Telephone:
2. Ordering facility or sending
facility
2.1. Name of ordering
facility/sending facility
2.2. Address:
Website (if any):
2.3. Telephone:
Fax:
Email:
2.4. Name of representative office
in Vietnam (if any):
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Telephone:
3. Processor
3.1. Name of processor:
3.2. Address:
Website (if any):
3.3. Telephone:
Fax:
Email:
Other processors (if any) (*):
Name
and address
Role
(*)
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(*) Facilities taking part in
manufacturing process and role of individual facilities such as “manufacturing
semi-finished products”, “primary packaging”, “secondary packaging”, “granule
making”, etc.
4. Manufacturer of medicine of processing
or facility manufacturing medicine before technology transfer
4.1. Manufacturer of medicine of processing
or facility manufacturing medicine before technology transfer
4.2. Address:
Website (if any):
4.3. Telephone:
Fax:
Email:
B. Product details
1. Name of medicine:
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3. Dosage form:
4. Description of dosage form:
5. Administration route:
6. Quality standards (***):
7. Expiry date:
8. Preservation:
9. Description of packaging:
10. Analysis (tick the appropriate
field):
Prescription drugs
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Non-prescription drugs
Psychotropic drugs
Finished combination drugs
containing psychotropic substances
Addictive drugs
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Finished combination drugs
containing addictive ingredients
Medicinal precursors
Finished combination drugs
containing medicinal precursors
Herbal medicine
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Toxic drugs
ATC code
Radioactive drugs
11. Generic name and formula
(including quantity of active ingredients and excipients) per smallest unit
dose or smallest packaging unit.
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Active
ingredient (*)
Concentration/content
(**)
Processor
(name, address in detail)
Standard
(***)
Excipients
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Processor
(name, address in detail)
Standard
(***)
(*) Specify dosage form of
active ingredients (ester salts/other derivative forms).
(**) Where use dose is
determined by bases with pharmacology properties of the active ingredients
(alkaline base, etc.), additional information concentration of active
ingredients determined from these pharmacological bases must be
added.
Where active ingredients are
used in form of semi-finished products mixed with excipients, all excipients
present in formula of semi-finished products containing these active
ingredients.
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C. Technical documents
1. Part I: Administration
2. Part II: Quality
3. Part III: Nonclinical
4. Part IV: Clinical
Note: Documents (Part I, II, III,
IV) to be submitted depend on classification of product/product group.
D. Changes between processed
medicine and medicine ordered for processing or medicine of technology transfer
and medicine prior to technology transfer
No.
Changed
details
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Summary
of details of processed medicine or medicine of technology transfer
Technical
document attachment
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.
DD. Special request
for medicine of which marketing authorization is applied for
1. Medicine of which data must be
confidential □
Applicant shall submit request for
confidentiality for data below to the Drug Administration of Vietnam together
with marketing authorization application:
□ Toxicity test data (Document No.
…)
□ Clinical test data (Document No.
…)
Applicant hereby guarantees that
the aforementioned data meets data confidential requirements as per the law and
undertakes to bear obligation of proof at request of competent authority.
2. Application under quick
appraisal procedures
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3. Medicine of which
bioequivalence statement is requested:
□
4. Clinical documents:
□
5. Medicine of which proprietary
drug classification is requested:
□
6. Medicine of which reference
biological statement is requested:
□
7. Other request (if any,
specify):
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E. Classification of processed
medicine relative to medicine ordered for processing or medicine of technology
transfer relative to medicine prior to technology transfer (tick appropriate
box)
1. Application type
1.1. Processed medicine
□
1.2. Medicine of technology
transfer
□
1.3. Processed medicine with
manufacturing technology transfer
□
2. Porcessing stage or technology
transfer stage
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2.1. All processing stages
□
2.2. Processing stage or stages
□
Specify processing stage or
technology transfer stage:
3. Medicine ordered for
processing or medicine prior to technology transfer
3.1. Has not possessed marketing
authorization
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3.2. Has possessed marketing
authorization which is expired
□
3.3. Has possessed marketing
authorization effective at the time of application
□
4. Details of processed medicine
relative to medicine ordered for processing or medicine of technology transfer
relative to medicine prior to technology transfer
Changed
Unchanged
4.1. Formula
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□
4.2. Manufacturing process
□
□
4.3. Quality standards of
ingredients
□
□
4.4. Quality standards of
finished products
□
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4.5. Trade name of medicine
□
□
4.6. Documentary proof in case of
changes related to 4.1; 4.2; 4.3; 4.4 in respect of medicine under Point a
Clause 1 Article 6 or Point a Clause 1 Article 10: ………………………………….
G. Statement of applicant
Applicant hereby undertakes:
1. To update and revise package
insert based on proprietary medicines, reference biologicals for cases detailed
under Clause 3 Article 38 of Circular No. 01/2018/TT-BYT dated January 18, 2018
of the Ministry of Health.
2. To have examined, appended
signature and seal as per the law, and verified legitimacy of the documents and
honesty of information. In case of fabrication or any deviation from the
truth, the applicant hereby assumes full responsibilities and will be met with
legal actions.
3. To ensure that medicine is
manufactured in accordance with submitted application.
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5. To assume full responsibility
pertaining to intellectual property related to medicine in question.
………………(Date)
………………(Date)
………………(Date)
Legal
representative of processor
(Directly sign, specify full name, position, and seal)
Legal
representative of ordering facility/sending facility
(Directly sign, specify full name, position, and seal)
Legal
representative of applicant
(Directly sign, specify full name, position, and seal)
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APPLICATION
FOR MARKETING AUTHORIZATION OF MEDICINE OF PROCESSING, MEDICINE OF TECHNOLOGY
TRANSFER
(Application
for renewal)
A. Details of processed medicine
or medicine of technology transfer of which marketing authorization
registration has been issued
1. Applicant
1.1. Name of applicant:
1.2. Address:
Website (if any):
1.3. Telephone:
Fax:
Email:
1.4. Name of representative office
in Vietnam (in case of foreign applicant):
Address:
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2. Ordering facility or sending
facility
2.1. Name of ordering
facility/sending facility
2.2. Address:
Website (if any):
2.3. Telephone:
Fax:
Email:
2.4. Name of representative office
in Vietnam (if any):
Address:
Telephone:
3. Processor
3.1. Name of processor:
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3.3. Telephone:
Fax:
Email:
Other manufacturing facilities (if
any) (*):
Name
and address
Role
(*)
(*) Facilities taking part in
manufacturing process and role of individual facilities such as “manufacturing
semi-finished products”, “primary packaging”, “secondary packaging”, “granule
making”, etc.
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4.1. Manufacturer of medicine ordered
for processing or facility manufacturing medicine before technology
transfer
4.2. Address:
Website (if any):
4.3. Telephone:
Fax:
Email:
5. Name of medicine/medicinal
ingredients;
6. Primary active ingredients,
concentration/content:
7. Packaging:
8. Dosage form:
9. Quality standards:
10. Expiry date:
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12. Stage(s) of medicine
manufacturing or technology transfer of which marketing authorization has been
issued (if any)
B. Information changed, added
upon renewal application:
1. Change and addition upon
applying for renewal
2. Medicine of which original
proprietary drugs, reference biologicals have been stated (if yes, specify).
3. Medicine of which bioequivalence
has been stated (if yes, specify).
C. Attachments
D. Declaration of applicant
Applicant hereby undertakes:
1. To update and revise package
insert based on proprietary medicines, reference biologicals for cases detailed
under Clause 3 Article 38 of Circular No. 01/2018/TT-BYT dated January 18, 2018
of the Ministry of Health.
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3. To have examined, appended
signature and seal as per the law, and verified legitimacy of the documents and
honesty of information. In case of fabrication or any deviation from the
truth, the applicant hereby assumes full responsibilities and will be met with
legal actions.
4. To ensure that medicine is
manufactured in accordance with submitted application.
5. To apply for change and addition
as per the law when marketing authorization registration is renewed.
6. To assume full responsibility
pertaining to intellectual property related to medicine/medicinal ingredient to
be registered.
7. To ensure honesty of all
information stated herein. In case of errors, the applicant shall be held
legally accountable.
………………(Date)
………………(Date)
………………(Date)
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Legal
representative of ordering facility
(Directly sign, specify full name, position, and seal)
Legal
representative of applicant
(Directly sign, specify full name, position, and seal)
Form No. 02C/TT
APPLICATION
FOR CHANGE, ADDITION (1)
(Major
changes/Minor changes requiring approval/Minor changes requiring announcement)
A. Product information (1)
1. Name of medicine:
2. Active ingredients,
concentration/content of active ingredients
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4. Registration
No.
Date of
issue:
Expiry date:
5. Name of processor:
Country of manufacturing:
B. Classification of change,
addition
Type
of change, addition
Reference
code
Type
of change, addition
Note
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□
Statement of original proprietary
drugs
□
Statement of reference
biologicals
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Minor changes (requiring
approval)
□
Statement of bioequivalence
□
Minor changes (requiring
announcement)
□
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Update of medicine information
□
C. Information on applicant;
ordering facility or sending facility; processor; manufacturer of medicine ordered
for processing or facility manufacturing medicine before technology
transfer
1. Applicant
1.1. Name of applicant:
1.2. Address:
Website (if any):
1.3. Telephone:
Fax:
Email:
1.4. Name of representative office
in Vietnam (in case of foreign applicant):
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Telephone:
2. Ordering facility or sending
facility
2.1. Name of ordering
facility/sending facility
2.2. Address:
Website (if any):
2.3. Telephone:
Fax:
Email:
2.4. Name of representative office
in Vietnam (if any):
Address:
Telephone:
3. Processor
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3.2. Address:
Website (if any):
3.3. Telephone:
Fax:
Email:
Other manufacturing facilities (if
any) (*):
Name
and address
Role
(*)
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4. Manufacturer of medicine ordered
for processing or facility manufacturing medicine before technology
transfer
4.1. Manufacturer of medicine ordered
for processing or facility manufacturing medicine before technology
transfer
4.2. Address:
Website (if any):
4.3. Telephone:
Fax:
Email:
D. DETAILS OF CHANGES (and
reason for changes)
1. Specify which category the
changes and addition fall under and code thereof (if any) based on
classification of changes and addition:
2. Approved details*:
3. Details requested for change,
addition:
* It is possible to present in form
of comparison table attached to application and containing signature of the
applicant.
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4.1. Approval has been granted □
Attached documentary proof:
…………………………………………………………………
4.2. Approval has not been granted
□
DD. ATTACHED
TECHNICAL DOCUMENTS
- Relevant approved documentary
proof.
E. DECLARATION OF APPLICANT
The applicant hereby undertakes to
have examined and appended seal in relevant sections in all documents contained
herein and verified legitimacy of the documents and honesty of
information. In case of fabrication or any deviation from the
truth, the applicant hereby assumes full responsibilities and will be met with
legal actions.
………………(Date)
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………………(Date)
Legal
representative of processor
(Directly sign, specify full name, position, and seal)
Legal
representative of ordering facility
(Directly sign, specify full name, position, and seal)
Legal
representative of applicant (2)
(Directly sign, specify full name, position, and seal)
(1) Where a change or addition
occurs to multiple medicines: Product information shall be listed in a manner
corresponding to each medicine (including information under A 1, 2, 3, and 4 of
the application).
(2) Where changes occur to the
applicant, verification of previous applicant and new applicant shall be
required in the application. Where an authorized processor applies for
changes to the applicant in accordance with notifying official dispatch of the
Drug Administration of Vietnam, verification of both manufacturing and new
applicant shall be required.
Form No. 03/TT
ROADMAP
FOR PROCESSING/TECHNOLOGY TRANSFER FOR STAGES OF FINISHED PRODUCT MANUFACTURING
PROCESS IN VIETNAM
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1. Applicant
1.1. Name of applicant:
1.2. Address:
1.3. Telephone:
1.4. Name of representative office
in Vietnam (in case of foreign applicant):
Address:
Telephone:
2. Ordering facility or sending
facility:
2.1. Name of ordering
facility/sending facility:
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2.3. Telephone:
3. Processor
3.1. Name of processor:
3.2. Address:
3.3. Telephone:
4. Manufacturer of medicine ordered
for processing or facility manufacturing medicine before technology
transfer
4.1. Manufacturer of medicine ordered
for processing or facility manufacturing medicine before technology
transfer
4.2. Address:
Website (if any):
4.3. Telephone:
Fax:
Email:
...
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1. Name of medicine:
2. Active ingredients,
concentration/content:
3. Dosage form:
4. Administration route:
5. Quality standards:
6. Production stage registered for
manufacturing/technology transfer:
7. Undertaken roadmap for
manufacturing/technology transfer of remaining stages:
No.
Manufacturing/technology
transfer work
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The first year
1
Task 1
2
Task 2
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Task 3
The second year
4
Task 4
5
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6
Task 6
The third year
7
Task 7
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8
Task 8
9
Task 9
…
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………………(Date)
………………(Date)
………………(Date)
Legal
representative of ordering facility/sending facility
(Directly sign, specify full name, position, and seal)
Legal
representative of processor
(Directly sign, specify full name, position, and seal)
Legal
representative of applicant
(Directly sign, specify full name, position, and seal)
Form No. 04/TT
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To:
The Ministry of Health (Drug Administration of Vietnam)
A. Information on applicant;
ordering facility or sending facility; processor; manufacturer of medicine ordered
for processing or facility manufacturing medicine before technology
transfer
1. Applicant
1.1. Name of applicant:
1.2. Address:
1.3. Telephone:
1.4. Name of representative office
in Vietnam (in case of foreign applicant):
Address:
Telephone:
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2.1. Name of ordering
facility/sending facility:
2.2. Address:
2.3. Telephone:
3. Processor
3.1. Name of processor:
3.2. Address:
3.3. Telephone:
4. Manufacturer of medicine ordered
for processing or facility manufacturing medicine before technology
transfer
4.1. Manufacturer of medicine ordered
for processing or facility manufacturing medicine before technology
transfer
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4.3. Telephone:
Fax:
Email:
B. Product details:
1. Name of medicine:
2. Active ingredients,
concentration/content:
3. Dosage form:
4. Administration route:
5. Quality standards:
6. Registration
No.
Date of
issue:
Expiry date:
C. Basis for report on schedule
of roadmap for processing/technology transfer for stages of finished product manufacturing
process in Vietnam for medicine of which marketing authorization registration
has been issued, to be specific:
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Manufacturing/technology
transfer work
Roadmap
under decision issuing marketing authorization registration
Implementation
result
Starting
date
Concluding
date
Starting
date
Concluding
date
Completed
(*)
Not
completed
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Manufacturing stage 1
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Task 1
2
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3
Task 3
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Manufacturing stage 2
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4
Task 4
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5
Task 5
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6
Task 6
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Manufacturing stage 3
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7
Task 7
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8
Task 8
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Task 9
(*) Attach documentary proof of
completed task.
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The facilities hereby guarantee and
assume responsibility for accuracy of information provided in the report and
attachments.
………………(Date)
………………(Date)
………………(Date)
Legal
representative of ordering facility/sending facility
(Directly sign, specify full name, position, and seal)
Legal
representative of processor
(Directly sign, specify full name, position, and seal)
Legal
representative of applicant
(Directly sign, specify full name, position, and seal)
...
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TABLE
OF CONTENTS
I. Administration documents
II. Quality
documents
III. Nonclinical documents
IV. Clinical documents
V. Other documents
Appendix
2
(Attached
to Circular No. 16/2023/TT-BYT dated August 15, 2023 of the Minister of
Health)
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List
of processed medicine (without transfer of manufacturing technology) of which
marketing authorization registration is issued/renewed satisfactory to Point a
Clause 1 Article 6 of Circular No. 16/2023/TT-BYT dated August 15, 2023
No.
Name
of medicine
Registration
number
Applicant
Processor
Facility
manufacturing medicine of processing
Manufacturing
stage
Roadmap
(if any)
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Form No. 02:
List
of processed medicine (with transfer of manufacturing technology) of which
marketing authorization registration is issued/renewed satisfactory to Point a
Clause 1 Article 6 of Circular No. 16/2023/TT-BYT dated August 15, 2023
No.
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Registration
number
Applicant
Processor
Manufacturer
of medicine ordered for processing
Manufacturing
stage
Manufacturing
stage for technology transfer
Roadmap
for manufacturing/technology transfer (if any)
Note
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List
of medicine of technology transfer of which marketing authorization
registration is issued/renewed satisfactory to Point a Clause 1 Article 10 of
Circular No. 16/2023/TT-BYT dated August 15, 2023
No.
Name
of medicine
Registration
number
Applicant
Processor
Facility
manufacturing medicine before technology transfer
Manufacturing
stage for technology transfer
Roadmap
(if any)
...
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