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THE GOVERNMENT
OF VIETNAM
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THE SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom – Happiness
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No. 129/2024/ND-CP
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Hanoi, October
10, 2024
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DECREE
AMENDMENTS TO GOVERNMENT'S
DECREE NO. 91/2016/ND-CP DATED JULY 01, 2016 ON MANAGEMENT OF INSECTICIDAL AND
GERMICIDAL CHEMICALS AND PREPARATIONS FOR HOUSEHOLD AND MEDICAL USE, AND
GOVERNMENT'S DECREE NO. 155/2018/ND-CP DATED NOVEMBER 12, 2018 PROVIDING
AMENDMENTS TO REGULATIONS RELATING TO BUSINESS CONDITIONS UNDER STATE
MANAGEMENT OF MINISTRY OF HEALTH
Pursuant to the Law on Government Organization
dated June 19, 2015; the Law on Amendments to the Law on Government
Organization and the Law on Local Government Organization dated November 22,
2019;
Pursuant to the Law on Chemicals dated November
21, 2007;
Pursuant to the Law on Investment dated June 17,
2020;
And at the request of the Minister of Health of
Vietnam;
The Government promulgates a Decree providing
amendments to the Government's Decree No. 91/2016/ND-CP dated July 01, 2016 on
management of insecticidal and germicidal chemicals and preparations for
household and medical use, and the Government's Decree No. 155/2018/ND-CP dated
November 12, 2018 providing amendments to regulations relating to business
conditions under state management of the Ministry of Health of Vietnam.
Article 1. Amendments to Government's Decree No.
91/2016/ND-CP dated July 01, 2016 on management of insecticidal and germicidal
chemicals and preparations for household and medical use
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“Article 8. Declaration of eligibility to
produce preparations
1. Before starting the production of preparations,
the legal representative of the manufacturer must submit an application for
declaration of eligibility to produce preparations, comprising the documents
prescribed in Article 7 of this Decree, directly, online or by post, to the
Department of Health of province or city where it is headquartered. The
manufacturer is allowed to start its production after the information
prescribed in clause 2 of this Article is published by the Provincial
Department of Health on its website.
2. Within 03 working days from its receipt of an
application from the manufacturer, the Provincial Department of Health shall
publish the following information on its website and send the same to the
Ministry of Health of Vietnam, including: name, address and telephone number of
the manufacturer.
3. Within 15 days from the occurrence of any change
in its name or address, the manufacturer shall send notice of such change to
the Department of Health of province or city where it is headquartered;
The manufacturer shall also send annual notice of
changes (if any) other than those prescribed in this clause to the Department
of Health of province or city where it is headquartered for updating.
4. Within 03 working days from its receipt of the
notice from the manufacturer as prescribed in clause 3 of this Article, the
Department of Health of province or city where the manufacturer is
headquartered shall update such changes on its website and send them to the
Ministry of Health.”
2. Point d is added to
Clause 2 Article 9 as follows:
“d) There are changes in the content of active
ingredients and/or form of the preparations that have been granted registration
number."
3. Clause 1 Article 18 is
amended as follows:
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4. Point c clause 1 Article
20 is amended as follows:
“c) A representative office in Vietnam of a foreign
trader that is authorized by the owner of preparations to apply for the
registration of such preparations."
5. Point d is added to Clause 1; Points b, dd
Clause 2 Article 21 are amended as follows:
a) Point d is added to clause 1:
“d) There are changes in the active ingredients
and/or adjuvant of the preparations that have been granted registration
number.”
b) Point b Clause 2 is amended as follows:
“b) The relevant type of preparations is
renamed for the purpose of export or in case of infringement upon the
intellectual property rights;".
c) Point dd clause 2 is amended as follows:
“dd) There is any change in effects, dosage, method
of use, content of active ingredients, content of adjuvant, form of
preparations, expiry date, and source of active ingredients."
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a) Clause 5 is amended as follows:
“5. Testing results for content of active
ingredients in preparations.”
b) Clause 6 is amended as follows:
“6. The report on experiment results:
a) is included in the submitted application in the
following cases:
- Insecticidal preparations for household use
contain active ingredients, content of active ingredients, and form of
preparations as recommended by WHO and in conformity with the Ministry of
Health’s regulations on list of active ingredients banned from use or with
restricted use in insecticidal and germicidal preparations for household and
medical use;
- Germicidal preparations for household use contain
Ethanol or Isopropanol or isopropanol-ethanol mixture with total content of 60%
- 90%, and may contain Chlorhexidine at content not exceeding 0,5%.
b) is additionally submitted after the Ministry of
Health after the Ministry of Health gives a written approval of experiment in
cases other than those specified in point a of this clause."
c) Clause 9 is amended as follows:
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7. Point dd is added to Clause 2; heading of Clause
5 and point d Clause 5 Article 23 are amended as follows:
a) Point dd is added to clause 2:
“dd) A document given by a competent authority on
infringement upon the intellectual property rights regarding name of
preparations.”
b) Heading of Clause 5 is amended as follows:
“5. In case of changes in effects, dosage, method
of use, content of active ingredients, content of adjuvant, form of
preparations, expiry date, and source of active ingredients:"
c) Point d clause 5 is amended as follows:
“d) Testing results for the content of active
ingredients (in case of changes in content of active ingredients and/or form of
preparations;”.
8. Clause 2 Article 24 is
amended as follows:
“2. An application for extension of registration
number must be submitted within 03 to 12 months before the registration number
expires;
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9. Points c, e are amended; point h is added to
Clause 4 Article 26 as follows:
a) Point c is amended as follows:
“c) The original or valid copy of the report on
experiment results made by an independent experiment establishment that has
successfully completed procedures for declaration of eligibility to conduct
experiment as prescribed, except the manufacturer and applicant for
registration of preparations. For germicidal preparations, experiment results
given by a foreign independent experiment establishment designated or
accredited by a competent authority of its home country or recognized, by an
accredited certification body, to be conformable with ISO/IEC 17025 or ISO
15189 or standards on quality management system for testing laboratories
conducting experiments may be accepted;
In case a report on experiment results given by a
foreign independent experiment establishment is submitted, this report must
include microbiological indicators and insecticidal effect as prescribed in
experiment procedures adopted by the Ministry of Health, and must bear consular
legalization as prescribed.”
b) Point e is amended as follows:
“e) Valid copies of documents proving the legal
status of the applicant or the manufacturer which must bear the seal of the
document holder;”.
c) Point h is added as follows:
“h) A valid copy of the document given by a
competent authority on infringement upon the intellectual property rights
regarding name of preparations.”
10. Clause 3, Clause 4 and Clause 6 Article 27 are
amended as follows:
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“3. Within 30 days from the date written on the
Receipt note prescribed in clause 2 of this Article:
a) For an application for registration of
preparations prescribed in point a clause 6 Article 22 of this Decree, the
Ministry of Health shall give a written response requesting modification of the
application or indicating whether or not the registration number is granted to the
applicant;
In case of modification of the application, the
response must clearly indicate required modifications. If an application is
refused, reasons for such refusal shall be provided.
b) For an application for registration of
preparations other than those prescribed in point a clause 6 Article 22 of this
Decree, the Ministry of Health shall give a written response requesting
modification of the application or indicating whether or not the experiment is
approved to the applicant; Consideration and processing of an application for
registration of a new type of preparations as prescribed in clause 9 Article 22
of this Decree must be finished within 90 days;
In case of modification of the application, the
response must clearly indicate required modifications. If an application is
refused, reasons for such refusal shall be provided.”
b) Clause 4 is amended as follows:
“4. In case the application must be modified at the
request of the Ministry of Health, within 90 days from the date written on the
request, the applicant shall send written explanation about required
modifications to the Ministry of Health. Over the said time limit, if no
explanation is received, the application shall be canceled. The date of receipt
of the modified application is specified in the Receipt note;
In case of force majeure events such as disaster,
epidemics, conflagration, etc., the application may be submitted after the
prescribed deadline but must be within 12 months from the deadline for
submission of additional documents. In this case, a written explanation must be
also provided;"
The modified application shall be received and
appraised according to provisions of clause 3 of this Article.”
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“6. Within 36 months from the date stated in the
written approval for the experiment, the applicant shall be responsible for
completing the experiment and submit the report on experiment results. The date
of receipt of the report on experiment results is specified in the Receipt
note. Over the said 36-month time limit, if no report is received, the
application shall be canceled.”
11. Clause 5 Article 28 is
amended as follows:
“5. In case the application must be modified at the
request of the Ministry of Health, within 90 days from the date written on the
request, the applicant shall send the modified application and written
explanation about required modifications to the Ministry of Health. The date of
receipt of the modified application is specified in the Receipt note. Over the
said time limit, if the modified application is not submitted, the application
for additional registration of preparations shall be canceled;
In case of force majeure events such as disaster,
epidemics, conflagration, etc., the application may be submitted after the
prescribed deadline but must be within 12 months from the deadline for
submission of additional documents. In this case, a written explanation must be
also provided.”
12. Clause 4 Article 29 is
amended as follows:
“4. Within 30 days from the date stated in the
written request for modification but at least 10 days before the registration
number expires, the applicant shall submit the modified application and
explanation about required modifications to the Ministry of Health. The date of
receipt of the modified application is specified in the Receipt note. Over the
said time limit, if the modified application is not submitted, the application
for extension of registration number shall be canceled.
In case of force majeure events such as disaster,
epidemics, conflagration, etc., the application may be submitted after the
prescribed deadline but must be within 12 months from the deadline for
submission of additional documents. In this case, a written explanation must be
also provided;
The modified application shall be appraised according
to provisions of clause 3 of this Article.”
13. Clause 6 is added to
Article 31 as follows:
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14. Article 43 is amended
as follows:
“Article 43. Declaration of eligibility to
provide preparations-used insecticidal and germicidal services
1. Before starting provision of preparations-used
insecticidal and germicidal services, the legal representative of the service
provider must submit an application for declaration of eligibility to provide
preparations-used insecticidal and germicidal service, comprising the documents
prescribed in Article 42 of this Decree, directly, online or by post, to the
Department of Health of province or city where it is headquartered. The service
provider is allowed to start its provision of services after the information
prescribed in clause 2 of this Article is published by the Provincial
Department of Health on its website.
2. Within 03 working days from its receipt of an
application from the service provider, the Provincial Department of Health
shall publish the following information on its website and send the same to the
Ministry of Health of Vietnam, including: name, address and telephone number of
the service provider.
3. Within 15 days from the occurrence of any change
in its name or address, the service provider shall send notice of such change
to the Department of Health of province or city where it is headquartered;
The service provider shall also send annual notice
of changes (if any) other than those prescribed in this clause to the
Department of Health of province or city where it is headquartered for
updating.
4. Within 03 working days from its receipt of the
notice from the service provider as prescribed in clause 3 of this Article, the
Department of Health of province or city where the service provider is
headquartered shall update such changes on its website and send them to the
Ministry of Health.”
15. Point e Clause 2
Article 49 is amended as follows:
“e) In case similar products and methods are not
available in the market, documents proving the preparations for which the
import license is applied have been approved for use by a competent authority
of the exporting country shall be submitted.”
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“1. The legal representative shall make
declaration, download electronic documents, append his/her digital signature to
the online registration application, and pay fees/charges online according to
procedures on the National public service portal or the website of the Ministry
of Health of Vietnam or the relevant provincial Department of Health.”
17. Clause 1 Article 54 is
amended as follows:
“1. In case of online registration application, the
retention of the physical copies of the documents which have been created
online and bear lawful digital signature of a competent person shall not be
required.”
18. Clause 2 Article 55 is
amended as follows:
“2. Organize implementation of legislative
documents on chemicals and preparations; get advice from or hold meetings of
the Advisory Board to serve the issuance of certificates of registration of
insecticidal and germicidal chemicals and preparations for household and
medical use in respect of preparations containing active ingredients or having
a product form or use scope or effects to be registered in Vietnam for the
first time.”
19. Clause 2 is amended and Clause 4 is added to
Article 57 as follows:
a) Clause 2 is amended as follows:
“2. Direct provincial Departments of Health to
publish information on local entities that have successfully completed
procedures for declaration of eligibility to produce preparations, conduct
testing for or experiment on preparations, or provide preparations-used
insecticidal and germicidal services on their websites and send the same to the
Ministry of Health of Vietnam.”
b) Clause 4 is added as follows:
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20. Appendix XI enclosed
herewith is added.
21. The phrase “tiêu chuẩn
ISO 17025:2005 hoặc tiêu chuẩn ISO 15189:2012 hoặc phiên bản cập nhật”
(“standards of ISO 17025:2005 or ISO 15189:2012 or their latest versions”) is replaced
with the phrase “được công nhận phù hợp ISO/IEC 17025 hoặc ISO 15189”
(“recognized to be conformable with standards of ISO/IEC 17025 or ISO 15189”)
in clause 4 Article 15 and Form 02 of Appendix I.
22. The phrase “tên thương
mại” (“trade name”) is replaced with the phrase “tên chế phẩm” (“name of
preparations”) in clause 3 and point a clause 4 Article 2; points b and c
clause 2 Article 23; heading of Section 3 Chapter IV; clauses 1 and 2 Article
31; Form 07 and Form 09 of Appendix I;
The phrase “tên thương mại của chế phẩm” (“trade
name of preparations”) is replaced with the phrase “tên chế phẩm” (“name of
preparations”) in clause 2 Article 23; heading of Article 31, clauses 3, 4
Article 31; Appendix IV; Appendix V;
The phrase “tên thương mại cho chế phẩm” (“trade
name of preparations”) is replaced with the phrase “tên chế phẩm” (“name of
preparations”) in clause 5 Article 31.
23. The phrase “Bộ Y tế” (“Ministry
of Health”) is replaced with the phrase “Sở Y tế” (“Provincial Department of
Health”) in clause 6 Article 61 and clause 3 Article 62.
24. The phrase “Bộ Y tế (Cục
Quản lý môi trường y tế)” (“Ministry of Health (Health Environment Management
Agency)”) is replaced with the phrase “Sở Y tế” (“Provincial Department of
Health”) in Form 02 and Form 03 of Appendix I.
Article 2. Amendments to Government’s Decree No.
155/2018/ND-CP dated November 12, 2018 providing amendments to regulations
relating to business conditions under state management of Ministry of Health of
Vietnam
1. Clause 5 Article 9 is
amended as follows:
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2. Clause 6 Article 9 is
amended as follows:
“6. Clause 12 Article 91/2016/ND-CP is amended as
follows:
Article 12. Declaration of eligibility to
conduct testing
1. Before starting its provision of testing
services, the testing establishment must submit an application for declaration
of eligibility to conduct testing, comprising the documents prescribed in
Article 11 of this Decree, directly, online or by post, to the Department of
Health of province or city where it is headquartered. The testing establishment
is allowed to start its provision of testing services after the information
prescribed in clause 2 of this Article is published by the Provincial
Department of Health on its website.
2. Within 03 working days from its receipt of an
application from the testing establishment, the Provincial Department of Health
shall publish the following information on its website and send the same to the
Ministry of Health of Vietnam, including: name, address and telephone number of
the testing establishment, and the list of active ingredients for which it is
capable of testing.
3. Within 15 days from the occurrence of any change
in its name, address or list of active ingredients for which it is capable of
testing, the testing establishment shall send notice of such change to the
Department of Health of province or city where it is headquartered;
The testing establishment shall also send annual
notice of changes (if any) other than those prescribed in this clause to the
Department of Health of province or city where it is headquartered for
updating.
4. Within 03 working days from its receipt of the
notice from the testing establishment as prescribed in clause 3 of this
Article, the Department of Health of province or city where the testing
establishment is headquartered shall update such changes on its website and
send them to the Ministry of Health.”
3. Clause 9 Article 9 is
amended as follows:
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Article 16. Declaration of eligibility to
conduct experiments
1. Before starting its conduct of experiments, the
experiment establishment must submit an application for declaration of
eligibility to conduct experiment, comprising the documents prescribed in
Article 15 of this Decree, directly, online or by post, to the Department of
Health of province or city where it is headquartered. The experiment
establishment is allowed to start its conduct of experiments after the
information prescribed in clause 2 of this Article is published by the
Provincial Department of Health on its website.
2. Within 03 working days from its receipt of an
application from the experiment establishment, the Provincial Department of
Health shall publish the following information on its website and send the same
to the Ministry of Health of Vietnam, including: name, address and telephone
number of the experiment establishment, and the list of experiment processes
which it is capable of conducting.
3. Within 15 days from the occurrence of any change
in its name, address or list of experiment processes which it is capable of
conducting, the experiment establishment shall send notice of such change to
the Department of Health of province or city where it is headquartered;
The experiment establishment shall also send annual
notice of changes (if any) other than those prescribed in this clause to the
Department of Health of province or city where it is headquartered for
updating.
4. Within 03 working days from its receipt of the
notice from the experiment establishment as prescribed in clause 3 of this
Article, the Department of Health of province or city where the experiment
establishment is headquartered shall update such changes on its website and
send them to the Ministry of Health.”
4. Clause 10 Article 9 is
amended as follows:
“d) The original or valid copy of the report on
testing results for content of active ingredients in preparations. This report
on testing results must be given by an entity that has successfully completed
procedures for declaration of eligibility to conduct testing as prescribed or a
foreign testing establishment that has been recognized to be conformable with
standards of ISO/IEC 17025 or ISO 15189 or equivalent;
In case a report on testing results given by a
foreign testing establishment is submitted, this report must bear consular
legalization as prescribed.”
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6. The phrase “tên thương
mại” (“trade name”) is replaced with the phrase “tên chế phẩm” (“name of
preparations”) in Form 04, Form 05 and Form 06 of Appendix I, and Appendix VI.
Article 3. Abrogation and replacement of some
regulations of Decree No. 91/2016/ND-CP and Decree No. 155/2018/ND-CP
1. Some regulations of the Decree No. 91/2016/ND-CP
are abrogated and replaced as follows:
a) Regulations are abrogated: clause 1 Article 14;
clause 8 Article 38; Form 01, Form 02, Form 03 and Form 08 of Appendix III.
b) Regulations are replaced: Appendix VIII is
replaced with Appendix VIII enclosed herewith.
2. Some regulations of the Decree No.
155/2018/ND-CP are abrogated and replaced as follows:
a) Regulations are abrogated: Clause 3 and Clause 4
Article 9 are abrogated.
b) Regulations are replaced: Appendixes VII and IX
are replaced with Appendixes VII and IX enclosed herewith.
Article 4. Transition
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2. If preparations whose labels comply with the
Government's Decree No. 43/2017/ND-CP dated April 14, 2017, the Government's
Decree No. 111/2021/ND-CP dated December 09, 2021, and the Government Decree
No. 155/2018/ND-CP dated November 12, 2018 have been produced, imported or
placed on the market before the effective date of this Decree, they shall
continue to be sold and used until the expiry dates on their labels.
3. Labels which are conformable with the
Government's Decree No. 43/2017/ND-CP dated April 14, 2017, the Government's
Decree No. 111/2021/ND-CP dated December 09, 2021, and the Government Decree
No. 155/2018/ND-CP dated November 12, 2018 and have been produced or printed
before the effective date of this Decree shall continue to be used in
production of preparations for a maximum period of 02 years from the effective
date of this Decree.
Article 5. Effect
This Decree comes into force from November 30,
2024.
Article 6. Responsibility for implementation
1. The Minister of Health is responsible for
organizing the implementation of this Decree.
2. Ministers, heads of ministerial agencies, heads
of Governmental agencies, Chairpersons of Provincial People’s Committees and
relevant authorities, organizations and individuals are responsible for the
implementation of this Decree./.
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