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THE MINISTRY OF HEALTH
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THE SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
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No. 5083/QD-BYT
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Hanoi, October 29, 2019
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DECISION
ANNOUNCEMENT OF AMENDED ADMINISTRATIVE PROCEDURES RELATED TO
HEALTH ENVIRONMENT MANAGEMENT UNDER MANAGEMENT OF THE MINISTRY OF HEALTH
PRESCRIBED IN THE GOVERNMENT’S DECREE NO. 155/2018/ND-CP DATED NOVEMBER 12,
2018
THE MINISTER OF HEALTH
Pursuant to the
Government’s Decree No. 75/2017/ND-CP dated June 20, 2017 defining the
functions, tasks, powers and organizational structure of the Ministry of
Health;
Pursuant to the
Government’s Decree No. 63/2010/ND-CP dated June 08, 2010 on control of
administrative procedures and Government’s Decree No. 48/2013/ND-CP dated May
14, 2013 on amendments to Decrees related to control of administrative
procedures; Decree No. 92/2017/ND-CP dated August 08, 2017 on amendments to
Decrees related to control of administrative procedures;
At the request of the
Director General of the Health Environment Management Agency, the Ministry of
Health,
HEREBY DECIDES:
Article 1. Eleven administrative procedures amended by the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 (set out
in the Decision No. 4508/QD-BYT dated August 22, 2016 of the Ministry of
Health) are promulgated together with this Decision.
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Article 3. The Chief of the
Ministry Office, Directors of Departments, Ministry Inspectorate, General
Office for Population and Family Planning, Departments of Health of provinces
and central-affiliated cities and heads of relevant units are responsible for
the implementation of this Decision. /.
PP. THE MINISTER
THE DEPUTY MINISTER
Nguyen Truong Son
AMENDED ADMINISTRATIVE PROCEDURES RELATED TO HEALTH
ENVIRONMENT MANAGEMENT UNDER MANAGEMENT OF THE MINISTRY OF HEALTH
(Enclosed with the Decision No. 5083/QD-BYT dated
October 29, 2019 of the Minister of Health)
PART I.
LIST OF ADMINISTRATIVE PROCEDURES
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No.
Number of administrative procedure document
Name of administrative procedure
Name of legislative document providing for amendments and
replacement
Field
Responsible agency
A. Administrative
procedures of central authorities
1
B-BYT-286739-TT
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Government’s Decree No. 155/2018/ND-CP dated November 12,
2018
Health environment management
Health Environment Management Agency
2
B-BYT-286740-TT
Declaration of eligibility to conduct trial of insecticidal
and germicidal preparations for domestic and medical use
Government’s Decree No. 155/2018/ND-CP dated November 12,
2018
Health environment management
Health Environment Management Agency
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B-BYT-286741-TT
Registration of new insecticidal and germicidal
preparations for domestic and medical use
Government’s Decree No. 155/2018/ND-CP dated November 12,
2018
Health environment management
Health Environment Management Agency
4
B-BYT-286742-TT
Extension of registration number of insecticidal and germicidal
preparations for domestic and medical use
Government’s Decree No. 155/2018/ND-CP dated November 12,
2018
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Health Environment Management Agency
5
B-BYT-286743-TT
Additional registration in case of change of the ownership
of the registration number of insecticidal and germicidal preparations for
domestic and medical use
Government’s Decree No. 155/2018/ND-CP dated November 12,
2018
Health environment management
Health Environment Management Agency
6
B-BYT-286744-TT
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Government’s Decree No. 155/2018/ND-CP dated November 12,
2018
Health environment management
Health Environment Management Agency
7
B-BYT-286745-TT
Additional registration in case of change of
manufacturing site or change of manufacturer of insecticidal and germicidal
preparations for domestic and medical use
Government’s Decree No. 155/2018/ND-CP dated November 12,
2018
Health environment management
Health Environment Management Agency
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B-BYT-286746-TT
Additional registration in case of change of name or
contact address of applicant for registration or manufacturer of insecticidal
and germicidal preparations for domestic and medical use
Government’s Decree No. 155/2018/ND-CP dated November 12,
2018
Health environment management
Health Environment Management Agency
9
B-BYT-286748-TT
Additional registration in case of change of effects,
quality criteria or method of application of insecticidal and germicidal
preparations for domestic and medical use
Government’s Decree No. 155/2018/ND-CP dated November 12,
2018
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Health Environment Management Agency
B. Administrative
procedures of provincial authorities
1
B-BYT-286756-TT
Declaration of eligibility to produce insecticidal and
germicidal preparations for domestic and medical use
Government’s Decree No. 155/2018/ND-CP dated November 12,
2018
Health environment management
Department of Health
2
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Declaration of eligibility to provide preparation-based
insect and germ control services in household and medical fields
Government’s Decree No. 155/2018/ND-CP dated November 12,
2018
Health environment management
Department of Health
PART II.
SPECIFIC CONTENTS OF EACH ADMINISTRATIVE PROCEDURE
I. Administrative
procedures of central authorities
1-Procedure
Declaration of
eligibility to test insecticidal and germicidal preparations for domestic and
medical use
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Step 1: Before conduct testing for the first time, the testing
facility shall submit an application including the documents specified in
Article 11 of the Government’s Decree No. 91/2016/ND-CP to the Health
Environment Management Agency.
Step 2: Within 03 working days from the receipt of the
application, the Health Environment Management Agency shall publish the
following information on the website of the Ministry of Health: name, address
and phone number of the testing facility; list of testable chemicals.
Method of submission
By post or in person at
the Health Environment Management Agency affiliated to the Ministry of Health
(hereinafter referred to as “the Health Environment Management Agency”). If
the Health Environment Management Agency adopts the method of online
declaration, the aforesaid application shall be submitted online.
Composition and
number of application
I. Composition of
the application:
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2. A list of active
ingredients for which the testing facility is capable to conduct the testing,
which is certified by the testing facility;
3. A legitimate copy of
the certificate of conformity with ISO 17025:2005 or its editions.
II. Number of
application: 01 set of physical
application (not applicable to the case of online declaration).
Time limit for
processing the application
Within 03 days.
Entity carrying out
the administrative procedure
Facility testing
insecticidal and germicidal preparations for domestic and medical use.
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The Health Environment
Management Agency
Result of
implementation of the administrative procedure
Publish the following
information on the website of the Ministry of Health: name, address and phone
number of the testing facility; list of testable chemicals.
Fees and charges
Free
Name of forms and
declarations (Attached below)
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Requirements and
conditions for following the administrative procedure
Clause 5 Article 9 of
the Decree No. 155/2018/ND-CP:
Conform to ISO
17025:2005 or its editions certified by the certification body which has
registered in accordance with regulations of law on conditions for provision
of conformity assessment services.
Legal bases of the
administrative procedure
1. Law on Chemicals
dated November 21, 2007;
2. Law on Investment
dated November 26, 2014;
3. Law on Quality of
Products and Goods dated November 21, 2007;
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5. Law on Commerce
dated June 14, 2005;
6. Law on Standards and
Technical Regulations dated June 29, 2006;
7. Law No. 28/2018/QH14
dated June 15, 2018 on amendments to some Articles concerning planning of 11
laws;
8. The Government’s
Decree No. 91/2016/ND-CP dated July 01, 2016;
9. The Government’s
Decree No. 155/2018/ND-CP dated November 12, 2018.
10. The Circular No.
278/2016/TT-BTC dated November 14, 2016 of the Minister of Finance.
* Contents of the
sections: Sequence; Composition of application; Requirements and conditions for
following the administrative procedures; Legal bases are amended under the
Government’s Decree No. 155/218/ND-CP dated November 12, 2018.
Form No. 02
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……1….., date (dd/mm/yyyy) …
DECLARATION OF ELIGIBILITY TO CONDUCT TESTING
To: The Health Environment Management Agency, the Ministry
of Health
1. Name of the declarant:
…………………………………………………………………………………..
Address:
…………………………………………………………………………………..
Phone number:
……………………………Fax:……………………………………………………..
Email: ………………………… Website
(if any): …………………………………….
2. Address of testing
laboratory: ……………………………………………
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Re-declaration
□Receipt form No.……3……..
After considering the
Government’s Decree No. 91/2016/ND-CP dated July 01, 2016, we would like to
declare that our testing facility is eligible to conduct testing and enclose
the following documents:
1
A declaration of eligibility to conduct testing
□
2
A list of active
ingredients for which the testing facility is capable to conduct the testing
□
3
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□
We hereby undertake that
the documents enclosed with this declaration are accurate.
LEGAL REPRESENTATIVE
(Signature, full name and seal)
___________________
1 Place
name
2 Check the box
3 Specify number of the
latest receipt form
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2-Procedure
Declaration of
eligibility to conduct trial of insecticidal and germicidal preparations for
domestic and medical use
Sequence
Step 1: Before conduct trial for the first time, the trial
facility shall submit an application including the documents specified in
Article 15 of the Government’s Decree No. 91/2016/ND-CP and Decree No.
155/2018/ND-CP to the Health Environment Management Agency. If the Health
Environment Management Agency adopts the method of online declaration, the
aforesaid application shall be submitted online.
Step 2: Within 03 working days from the receipt of the notification,
the Health Environment Management Agency shall publish the following
information on the website of the Ministry of Health: name, address and phone
number of the trial facility; list of available trials.
Method of submission
By post or in person at
the Health Environment Management Agency. If the Health Environment
Management Agency adopts the method of online declaration, the application
shall be submitted online.
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I. Composition of
the application:
1. A declaration of
eligibility to conduct trial, which is made using the Form No. 03 in the
Appendix I enclosed with the Decree No. 155/2018/ND-CP;
2. A list of available
trials, which is certified by the trial facility.
3. A list of personnel,
which is made using Form in the Appendix II enclosed with the Decree No.
91/2016/ND-CP.
4. A legitimate copy of
the certificate of conformity with ISO 17025:2005 or ISO 15189: 2012 or their
editions.
5. A list of facilities
and equipment serving trial, which is certified by the trial facility.
II. Number of
application: 01 set of physical
application (not applicable to the case of online declaration)
Time limit for
processing the application
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On the date on which
the application is received
Entity carrying out
the administrative procedure
Facility conducting
trial of insecticidal and germicidal preparations for domestic and medical
use.
Agency carrying out
the administrative procedures
The Health Environment
Management Agency
Result of implementation
of the administrative procedure
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Fees and charges
Free
Name of forms and
declarations (Attached below)
Appendix I: A
declaration of eligibility to conduct trial, which is made using the Form No.
03 provided in the Decree No. 155/2018/ND-CP;
Appendix II: A list of
personnel.
Requirements and
conditions for following the administrative procedure
Clause 1 and Point c
Clause 3 Article 14 of the Decree No. 91/2016/ND-CP and Clauses 7 and 8
Article 9 of the Decree No. 155/2018/ND-CP
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2. Personnel
requirements:
The person in charge of
the trial division must have at least 03 years of experience in trial of
preparations;
3. Infrastructure
requirements:
a) Have a trial
laboratory managed and operated under ISO 17025:2005 or ISO 15189:2012 or
their editions. If testing services are available, such services must be
registered in accordance with regulations of law on conditions for provision
of conformity assessment services;
b) Have species of
insects, germs or viruses sufficient for trials.
Legal bases of the
administrative procedure
1. Law on Chemicals
dated November 21, 2007;
2. Law on Investment
dated November 26, 2014;
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4. Law on Enterprises
dated November 26, 2014;
5. Law on Commerce
dated June 14, 2005;
6. Law on Standards and
Technical Regulations dated June 29, 2006;
7. Law No. 28/2018/QH14
dated June 15, 2018 on amendments to some Articles concerning planning of 11
laws;
8. The Government’s
Decree No. 91/2016/ND-CP dated July 01, 2016;
9. The Government’s
Decree No. 155/2018/ND-CP dated November 12, 2018.
10. The Circular No.
278/2016/TT-BTC dated November 14, 2016 of the Minister of Finance.
* Contents of the
sections: Sequence; Composition of application; Requirements and conditions for
following the administrative procedures; Legal bases; forms and declarations
are amended under the Government’s Decree No. 155/218/ND-CP dated November 12,
2018.
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THE SOCIALIST REPUBLIC OF VIETNAM
Independence – Freedom – Happiness
---------------
……1….., date (dd/mm/yyyy) ….
DECLARATION OF ELIGIBILITY TO CONDUCT TRIAL
To: The Ministry of Health (Health Environment Management
Agency)
1. Name of the declarant:
…………………………………………………………………….
Address:
…………………………………………………………………….
Telephone: ………………….. Fax:
…………………………………………….
Email: ………………………..
Website (if any): …………………………….
2. First-time declaration
□2
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After considering the
Government’s Decree No. 91/2016/ND-CP dated July 01, 2016, we would like to
declare that our testing facility is eligible to conduct preparation trial and
enclose the following documents:
1
A
declaration of eligibility to conduct trial
□
2
A list of available
trials
□
3
A list of personnel
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4
Certificate of
conformity with ISO 17025:2005 or ISO 15189:2012 or its editions
□
We hereby undertake that
the documents enclosed with this declaration are accurate./.
LEGAL REPRESENTATIVE
(Signature, full name and seal)
___________________
1 Place name.
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3 Specify number of the latest receipt form.
APPENDIX II
LIST OF PERSONNEL
(Enclosed with the Government’s Decree No. 91/2016/ND-CP dated July 01,
2016)
THE SOCIALIST REPUBLIC OF VIETNAM
Independence – Freedom – Happiness
----------------
……..1……., date (dd/mm/yyyy) ….
LIST OF PERSONNEL
No.
Full name
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Degree/diploma and certificate
Number of years of experience 2
Position
1
Nguyen Van A
…………..
…………..
…………..
…………..
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3
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LEGAL REPRESENTATIVE
(Signature, full name and seal)
___________________
1 Place name
2 Specify the number of
years of working in a specific field, e.g. 05 years of experience in conducting
insecticide trial or 03 years of experience in being in charge of chemical
safety.
3-Procedure
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Sequence
Step 1: The applicant for registration of insecticidal and
germicidal preparations for household and medical use shall submit an
application to the Health Environment Management Agency affiliated to the
Ministry of Health (hereinafter referred to as “the Health Environment
Management Agency”).
Step 2: After receiving the application and fees for appraising
the application for permission for trial, the Health Environment Management
Agency shall send the applicant an application receipt form made using the
Form No. 04 in the Appendix III enclosed with the Decree No. 91/2016/ND-CP.
Step 3: Within 30 days from the date specified in the application
receipt form, the Health Environment Management Agency shall send a written
notice to the applicant for registration of new preparations of request for
supplement or modification of the application or permission or refusal to
grant permission for trial.
In case of supplement
or modification of the application, within 90 days from the date specified in
the written request, the applicant must complete the application and provide
written explanation for supplemented or modified contents to Health
Environment Management Agency. The date of receiving the supplemented or
modified application is specified in the application receipt form. After the
aforementioned deadline, the application shall be rejected.
Step 4: If the application is valid, the Health Environment
Management Agency shall give a written notice of permission or refusal to
grant permission for trial to the applicant.
Step 5: After obtaining the written permission for trial, the
applicant shall complete the testing and/or trial in accordance with Chapter
II of the Decree No. 91/2016/ND-CP, supplement the application with testing
and/or trial results and pay fees for application appraisal within 12 months
from the date specified in the written permission for trial.
Step 6: Within 30 days from the date specified in the
application receipt form, the Health Environment Management Agency shall send
a written notice to the applicant of the request for supplement or
modification of the application or refusal to issue the registration number.
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By post or in person at
the Health Environment Management Agency. If the Health Environment
Management Agency adopts the method of online declaration, the application
shall be submitted online.
Composition and
number of application
I. Composition of
the application:
1. An application form,
which is made using the Form No. 04 in the Appendix I enclosed with the
Circular No. 155/2018/ND-CP.
2. A document proving
legal status of the applicant or the manufacturer.
3. Letter of
authorization for registration, except for the case stated in Point a Clause
1 Article 20 of the Decree No. 91/2016/ND-CP.
4. Technical documents
of the preparations covered by the sale registration certificate applied for,
including the contents prescribed in the Appendix V enclosed with the Decree
No. 91/2016/ND-CP.
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6. The written notice
of trial results (which is supplemented after the Ministry of Health grants
written permission for trial).
7. Label sample of
preparations.
8. Certificate of Free
Sale (for imported preparations).
9. Documents and/or
results of the research on the safety and effects of preparations, or
recommendations given by WHO or other international organizations about the
use of preparations in household and medical sectors (for the preparations
that have an active ingredient or form that is registered in Vietnam for the
first time).
(Requirements
for an application for registration)
1. Documents
included in the application must be clearly printed and arranged in the order
prescribed in Article 22 of the Decree No. 91/2016/ND-CP. Space must be
provided between content parts in a document and each document and a cover
page and list of documents must be available.
2. English documents
must be translated into Vietnamese and enclosed with the originals thereof.
Documents in a foreign language other than English must be translated into
Vietnamese and Vietnamese translations must be notarized in accordance with
the law.
3. Requirements for
documents in an application for registration:
a) The original
letter of authorization for registration of preparations. The letter of
authorization must meet the requirements in the Appendix VII enclosed with
the Decree No. 155/2018/ND-CP;
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c) The original or
legitimate copy of the written notice of trial results made by an entity that
is independent (that is not the manufacturer or the applicant for
registration of preparations) and eligible to conduct trial as prescribed in
Article 14 of the Decree No. 91/2016/ND-CP;
d) The original or
legitimate copy of the written notice of results of testing for ingredients
and concentration of active ingredients in preparations. The testing results
must be given by an entity that is eligible to conduct testing prescribed in
Article 10 of this Decree. If testing facilities in Vietnam are not
sufficiently competent to conduct testing, the applicant may use the testing
results given by the manufacturer or an independent laboratory that meets ISO
17025:2005 or ISO 15189:2012 or its editions and the applicant shall take
legal responsibility for the legitimacy of the testing results which such
applicant gives.
dd) Label samples of
all packaging specifications according to real package size with
certification of the applicant. If multiple packaging specifications have the
same label design, the applicant shall only submit the label sample of the
packaging specification with the smallest package size. If the label sample
of imported preparations is written in a foreign language, it must be
attached with a secondary label written in Vietnamese. The sample and
contents of the secondary label of preparations must meet the requirements in
the Appendix IX enclosed with the Decree No. 155/2018/ND-CP.
e) Legitimate copy
of the document proving the legal status of the applicant or the
manufacturer;
4. Other documents
in the application for registration must be fan-stamped or stamped on each
page of a document by the applicant.)
II. Number of
application: 01 set of physical
application enclosed with a PDF file (not applicable to the case of
submission of the online application)
Time limit for
processing the application
1. Within 30 days from
receipt of a sufficient application, the Health Environment Management Agency
shall send a written notice to the applicant for registration of new
preparations of the request for supplement or modification of the application
or permission or refusal to grant permission for trial.
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Entity carrying out
the administrative procedure
Owner of the
insecticidal and germicidal chemicals and preparations for household and
medical use or the organization authorized by the owner to apply for registration
Agency carrying out
the administrative procedure
The Health Environment
Management Agency
Result of
implementation of the administrative procedure
The sale registration
certificate or written notice of refusal to issue registration number
specifying reasons thereof
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Fees for appraising an
application for permission for trial (paid upon submitting the application
for registration of new preparations for the first time): VND
2,000,000/application. Fees for appraising the application for registration of
new preparations (paid upon supplementing the written notice of trial results
and results of testing for active ingredients): VND 8,000,000/application
Name of forms and
declarations (attached below)
Appendix I: Application
form for registration of new insecticidal and germicidal chemicals and
preparations for household and medical use - Form No. 04 (enclosed with the
Decree No. 155/2018/ND-CP);
Appendix V: Technical
documents of preparations covered by the sale registration certificate
applied for (enclosed with the Decree No. 91/2016/ND-CP);
Appendix VII:
Requirements for letter of authorization (enclosed with the Decree No.
155/2018/ND-CP);
Appendix VIII:
Requirements for Certificate of Free Sale (enclosed with the Decree No.
91/2016/ND-CP).
Requirements and
conditions for following the administrative procedure
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Article 19 of the
Decree No. 91/2016/ND-CP: Requirements for registered preparations
1. The toxicity of
preparations is not classified into Class Ia or Ib according to WHO’s
classification system for pesticides (or insecticidal preparations), or in
Heading I or II according to the Globally Harmonized System of Classification
and Labeling of Chemicals (GHS).
2. Preparations must
not contain any of active ingredients on the list of active ingredients
banned from use in preparations.
3. The registration of
preparations which contain any of active ingredients on the list of active
ingredients with restricted use in preparations shall be made within the
regulated scope of use only.
4. Registered
preparations must be manufactured by a manufacturer that has declared its
eligibility to produce preparations (for domestic preparations) or attached
with Certificate of Free Sale (for imported preparations).
Article 20 of Decree
No. 91/2016/ND-CP: Holders of sale registration certificates
1. The following
entities may be holders of sale registration certificates:
a) A domestic
enterprise or co-operative or business household that is the owner of the
preparations or a representative office in Vietnam of a foreign trader who is
the owner of relevant preparations;
b) A domestic
enterprise or a co-operative or a business household that applies for the
registration of preparations under the authorization of the owner of such
preparations;
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2. In case of additional
registration of preparations or extension of registration number or
re-issuance of sale registration certificate, the holder of sale registration
certificate is also the registration number holder.
3. If
the owner of preparations gives permission to its authorized entity to
re-authorize another entity to apply for the registration of preparations,
the permitted reauthorization must be specified in the Letter of
Authorization.
Legal bases of the
administrative procedure
1. Law on Chemicals
dated November 21, 2007;
2. Law on Investment
dated November 26, 2014;
3. Law on Quality of
Products and Goods dated November 21, 2007;
4. Law on Enterprises
dated November 26, 2014;
5. Law on Commerce
dated June 14, 2005;
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7. Law No. 28/2018/QH14
dated June 15, 2018 on amendments to some Articles concerning planning of 11
laws;
8. The Government’s
Decree No. 91/2016/ND-CP dated July 01, 2016.
9. The Government’s
Decree No. 155/2018/ND-CP dated November 12, 2018;
10. The Circular No.
278/2016/TT-BTC dated November 14, 2016 of the Minister of Finance.
* The requirements for
applications for registration in the section “composition and number of
applications”; “forms of sample and declarations” prescribed are amended under
Article 9 of the Decree No. 155/218/ND-CP.
Form No. 04
THE SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
……1….., date (dd/mm/yyyy) …
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To: The Ministry of Health (the Health Environment
Management Agency)
2……………hereby would like to apply for registration of a new
preparation as follows:
1. Trade name: ………………..3………..…………………………………………..
2. Active ingredients and
concentration of active ingredients (%):……………4………………………………
3. Form of preparation:
.....................5………………………………………………………..
4. Packaging
specification: ………….6……………………………………………………….
5. Name of
manufacturer:…………………………………………………………………….
6. Address of
manufacturing site: …………….Telephone:…………Fax:…………………………
7. Name of certificate
holder:…………………………………………………………………….
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11. Shelf life:…………….8………………………………………………
12. Applying for import
of preparation (if any)……………….9……………………………………………..
LEGAL REPRESENTATIVE
(Signature, full name and seal)
___________________
1 Place name.
2 Name of the certificate holder.
3 For the imported preparation, accurately write its trade
name stated in the issued Certificate of Free Sale.
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- Concentration of an
active ingredient is expressed as a percentage (%) and clearly specified by
weight/volume (kl/tt or w/v), weight/weight (kl/kl or w/w) or volume/volume
(tt/tt or v/v) depending on properties of the preparation.
5 Specify the finished package form, do not specify the
packaging specification. E.g. the finished product in a sprayer is in liquid
form or in mosquito-repellent incense is in solid form. If the preparation is
in the form of emulsifiable concentrate or suspensive concentrate, write the
form in Vietnamese together with abbreviated name of the preparation in English
in brackets. E.g. huyền phù (SC).
6 Clearly specify bottle, packet, bag, etc. and its
quantity.
7 Briefly write purpose of the preparation and specify
whether the preparation is applied for household or medical purpose or for both
purposes. E.g. mosquito killing for household use; antibacterial hand wash for
household and medical use.
8 Specify number of years or months from the manufacturing
date.
9 If applying for import of the preparation, clearly specify
import of the preparation (regarding imported preparation) or import of
materials for manufacturing of preparation for the testing and trial purposes.
To be specific:
No.
Trade name
Concentration of active ingredients
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Quantity
Name and address of manufacturer
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TECHNICAL DOCUMENTS
(Enclosed with the Government’s Decree No. 91/2016/ND-CP dated July 01,
2016)
I. PREPARATION OF
TECHNICAL DOCUMENTS
1. With regard to
preparations containing active ingredients which are registered in Vietnam for
the first time, technical documents must include all items specified in Section
II.
2. With regard to
preparations containing active ingredients which have been registered in
Vietnam, technical documents must include the items specified in Part 1, Part 3
(preparation documents) and Part 4 of Section II.
II. REQUIREMENTS FOR
TECHNICAL DOCUMENTS:
Part 1
QUALITY CRITERIA
1
Active ingredients and
concentration thereof
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Adjuvants and
concentration thereof
3
Type of preparations
4
Form of preparations
5
Shelf life
6
Source of active
ingredients (name of active ingredient, concentration, manufacturer)
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ACTIVE INGREDIENT
1
Appearance
2
Minimum and maximum
concentrations of active ingredient
3
Identification and
concentrations of isomers and impurities
4
Shelf life
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Methods and process of
analysis to determine concentration of active ingredient
6
CAS number
7
Common name
8
IUPAC name
9
Structural formula
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Molecular formula
11
Molecular mass
12
Chemical family
13
Melting point, boiling
point, breaking down point
14
Vapor pressure
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Density (for liquid
only)
16
Solubility in water and
organic solvent
17
Acute toxicity
17.1
Acute oral toxicity (LD50)
17.2
Acute dermal toxicity
(LD50)
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Acute inhalation
toxicity (LC50)
17.4
Eye irritation
17.5
Skin irritation
17.6
Allergy/sensitization
test
18
Sub-chronic toxicity
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Chronic toxicity
20
Carcinogenicity
21
Mutagenicity
22
Reproductive and
developmental toxicity (including teratogenicity)
23
Other toxicity studies,
if any
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Medical data, poisoning
symptom, antidote, if any
25
Environmental fate
25.1
In soil
25.2
In water
25.3
In air
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Ecotoxicity
26.1
Bird
26.2
Fish and aquatic
organisms
26.3
Bee
26.4
Non-target organisms
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PREPARATIONS
I
PHYSIO-CHEMICAL DATA
1
Preparation identity
1.1
Trade name of
preparation
1.2
Name and address of
manufacturer
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Name and address of
packaging establishment (if any)
1.4
GHS acute toxicity
hazard category
2
Composition
2.1
Concentration of active
ingredient
2.2
Concentration of
adjuvant (including solvent and carrier)
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Physical and chemical
properties of the preparation
3.1
Appearance
3.2
Density (for liquid
only)
3.3
Flammability, flash
point
3.4
Corrosiveness (if any)
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Storage stability
3.6
Acidity, alkalinity or
pH
3.7
Compatibility with
other preparations
4
Analytical methods and
process
5
Process of formulation
of the preparation
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TOXICITY
1
Acute oral toxicity (LD50)
2
Acute dermal toxicity
(LD50)
3
Acute inhalation
toxicity (LC50)
4
Eye irritation
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Skin irritation
6
Allergy/sensitization
test
III
ECOTOXICITY
1
Bird
2
Fish and aquatic
organisms
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Bee
4
Non-target organisms
IV
BIO-EFFICACY
1
Mode of action of the
insecticidal and germicidal preparation
2
Insecticidal and
germicidal ability (types of germs and insects)
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Fields of application
(for household or medical use, etc.)
4
Dosage
5
Interval between times
of application (for long-lasting preparations)
6
Dilution medium, if any
(water, oil, etc.)
7
Application method
(spray, spread, etc.)
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OTHER INFORMATION
1
Instructions for use
2
Instructions for
storage
3
Notes of safety when
using the preparation
4
Adverse effects on the
user of preparation and handling methods
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Methods for destructing
expired or unused preparations
6
Methods for destructing
preparation containers
7
HS code: apply to
imported preparations
8
UN numbers
Part 4
MATERIAL SAFETY DATA SHEET (MSDS)
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APPENDIX VII
REQUIREMENTS FOR LETTER OF AUTHORIZATION
(Enclosed with the Government's Decree No. 155/2018/ND-CP dated
November 12, 2018)
I. Required information:
A letter of authorization
must comprise all of the following information:
- Name and address of the
product’s owner.
- Name and address of the
authorized individual or organization.
- Scope of authorization
(acting as the bearer of registration of sale of the product in Vietnam with
respect to authorization for product registration).
- Trade name of the
authorized product.
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- Term of authorization.
- The product owner’s
commitment to providing the authorized individual or organization with full
product information required for registration of sale.
- Name, title and
signature of the authorizing party’s representative.
2. If the product owner
who has already authorized a facility to register sale of their product in
Vietnam and receive the number of registration for sale wishes to authorize
another facility to do so in Vietnam before the expiry date of such number, the
owner must submit a new letter of authorization granted to the latter,
enclosing the written agreement on discontinuation of their role as the bearer
of registration for sale, and the written request for withdrawal of the number
of registration for sale from the former.
3. Consular legalization:
A letter of authorization
issued by a foreign entity requires consular legalization according to
regulations in force, except for the case in which consular legalization is
exempted under the international agreement to which Vietnam is a signatory.
APPENDIX VIII
REQUIREMENTS FOR CERTIFICATE OF FREE SALE
(Enclosed with the Government's Decree No. 91/2016/ND-CP dated July 01,
2016)
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The Certificate of Free
Sale contains the following information:
- Name of the authority
issuing the certificate;
- Date of issuance;
- Trade name of the
preparation issued with the certificate;
- Ingredients and
concentration of active ingredients (compulsory for insecticidal preparations);
- Name and address of the
manufacturer;
- Certification of free
sale of preparations in the country of origin of the certificate;
- Full name, title and
signature of the certificate holder.
2. Country of origin of
the CFS
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3. Time limit for
issuance
CFS must be issued within
12 months after the date of submission of the application for sale
registration.
4. Effect of CFS
CFS must remain effective
for at least 06 months from the date of submission of the application for sale
registration to the receiving authority if the CFS specifies the expiry date.
5.
Consular legalization
CFS must undergo consular
legalization as prescribed, except for the case in which consular legalization
is exempted under the international agreement to which Vietnam is a signatory.
4-Procedure
Extension of
registration number of insecticidal and germicidal preparations for domestic
and medical use
Sequence
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Step 1: The applicant for extension of registration number shall
submit an application to the Health Environment Management Agency.
Step 2: After receiving a sufficient application and fees for
application appraisal, the Health Environment Management Agency shall
send an application receipt form according to the Form No. 06 in the Appendix
III enclosed with the Decree No. 91/2016/ND-CP.
Step 3: Within 30 days from the date specified in the application
receipt form, the Health Environment Management Agency shall send a written
notice to the applicant of request for supplement or modification of the
application or permission or refusal to grant permission for extension of the
registration number.
Step 4: Upon receipt of the written request, within 30 days from
the date specified in the written request and within 10 days before the
expiry of the registration number, the applicant shall supplement or modify
the application and provide written explanation for supplemented or modified
contents to the Health Environment Management Agency. The date of receiving
the supplemented or modified application is specified in the application
receipt form. After the aforementioned deadline, the application shall be
rejected.
Step 5: If the application is valid, the Health Environment
Management Agency shall extend the registration number.
Method of submission
By post or in person at
the Health Environment Management Agency. If the Health Environment
Management Agency adopts the method of online declaration, the application
shall be submitted online.
Composition and
number of application
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I. Composition of
the application:
1. An application form,
which is made using the Form No. 06 in the Appendix I provided in the Decree
No. 155/2018/ND-CP;
2. A document proving
legal status of the applicant or the manufacturer;
3. A letter of
authorization for registration, except for the case stated in Point a Clause
1 Article 20 of the Decree No. 91/2016/ND-CP;
4. A report on
preparation sale, which is prepared using the form stated in Appendix VI
enclosed with the Decree No. 155/2018/ND-CP.
(Requirements
for the application for registration):
1. Documents included
in the application must be clearly printed and arranged in the order
prescribed in Article 24 of the Decree No. 91/2016/ND-CP. Space must be
provided between content parts in a document and each document and a cover
page and list of documents must be available.
2. English documents
must be translated into Vietnamese and enclosed with the originals thereof.
Documents in a foreign language other than English must be translated into
Vietnamese and Vietnamese translations must be notarized in accordance with the
law.
3. Requirements for
documents in an application for registration:
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b) A legitimate copy
of the document proving legal status of the applicant or the manufacturer;
4. Other documents
in the application for registration must be fan-stamped or stamped on each
page of a document by the applicant.)
II. Number of
application: 01 set of physical
application enclosed with a PDF file (not applicable to the case of
submission of the online application).
Time limit for
processing the application
Within 30 days from the
date specified in the application receipt form, the Health Environment
Management Agency shall send a written notice to the applicant of request for
supplement or modification of the application or permission or refusal to
grant permission for extension of the registration number.
Entity carrying out
the administrative procedure
Owner of the
registration number
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The Health Environment
Management Agency.
Result of
implementation of the administrative procedure
The sale registration
certificate or written notice of refusal to extend registration number
specifying reasons therefor.
Fees and charges
VND
1,000,000/application
Name of forms and
declarations (Attached below)
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Appendix I: Application
form for extension of registration number of insecticidal and germicidal
chemicals and preparations for household and medical use - Form No. 06
(provided in the Decree No. 155/2018/ND-CP);
Appendix VI: A report
on preparation sale (provided in the Decree No. 155/2018/ND-CP);
Appendix VII:
Requirements for letter of authorization (provided in the Decree No.
155/2018/ND-CP).
Requirements and
conditions for following the administrative procedure
The application for
extension of registration number must be submitted to the Health Environment
Management Agency for at least 03 months and up to 12 months before the
expiry of the registration number.
Legal bases of the
administrative procedure
1. Law on Chemicals
dated November 21, 2007;
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3. Law on Quality of
Products and Goods dated November 21, 2007;
4. Law on Enterprises
dated November 26, 2014;
5. Law on Commerce
dated June 14, 2005;
6. Law on Standards and
Technical Regulations dated June 29, 2006;
7. The Government’s
Decree No. 91/2016/ND-CP dated July 01, 2016;
8. Law No. 28/2018/QH14
dated June 15, 2018 on amendments to some Articles concerning planning of 11
laws;
9. The Government’s
Decree No. 155/2018/ND-CP dated November 12, 2018;
10. The Circular No.
278/2016/TT-BTC dated November 14, 2016 of the Minister of Finance.
*The sections: Forms
and declarations; Legal bases are amended under Article 9 of the Government’s
Decree No. 155/2018/ND-CP dated November 12, 2018.
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Form No. 06
THE SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
……1….., date (dd/mm/yyyy) …
APPLICATION FORM FOR EXTENSION OF REGISTRATION NUMBER
To: The Ministry of Health (the Health Environment
Management Agency)
………..2……..
hereby would like to apply for extension of registration number of a
preparation as follows:
1. Trade name: …………………..3……………………………………………..
2. Ingredients and
concentration of active ingredients (%):………………..4……………………...
3. Type of preparation:
………………………………5………………………………….
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5. Changes made during
the sale of the preparation: ………………………6…………………..
6. Name of the
manufacturer:………………………………………………………………..
7. Address of manufacturing
site: ………… Phone number: ………… Fax:……………………...
8. Name of the
applicant:………………………………………………………………..
9.
Address:……………………………………………………………………………
10. Phone number:
…………………………….. Fax:…………………………………..
11. Purpose of the
preparation: ……………………………….7…………………….....
12. Shelf life:
………………………………..8………………………………….
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LEGAL REPRESENTATIVE
(Signature, full name and seal)
___________________
1 Place name.
2 Specify name of the applicant.
3 For the imported preparation, accurately write its trade
name stated in the issued Certificate of Free Sale.
4 Only specify active ingredients and adjuvants that reveal
synergistic effects.
- Concentration of an
active ingredient is expressed as a percentage (%) and clearly specified by
weight/volume (kl/tt or w/v), weight/weight (kl/kl or w/w) or volume/volume
(tt/tt or v/v) depending on properties of the preparation.
5 Specify the finished package form, do not specify the
packaging specification. E.g. the finished product in a sprayer is in liquid
form or in mosquito-repellent incense is in solid form. If the preparation is
in the form of emulsifiable concentrate or suspensive concentrate, write the
form in Vietnamese together with abbreviated name of the preparation in English
in brackets. E.g. huyền phù (SC).
6 List changes made during the sale, including approved and
unapproved changes.
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8 Specify number of years or months from the manufacturing
date.
APPENDIX VI
SALE REPORT
(Enclosed with the Government's Decree No. 155/2018/ND-CP dated November 12,
2018)
THE SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
……………..….., date (dd/mm/yyyy) …
PREPARATION SALE REPORT
To: The Ministry of Health (the Health Environment
Management Agency)
Name of the applicant:
……………………………………………………………...
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Name of the
manufacturer:………………………………………………………………..
Address:…………… Phone
number:…….………. Fax:……………………………
Name of the importer (for
the imported preparation):…………………………..
Address:……………………………………………………………………………
Trade
name:………………………………………………………………...
Ingredients and
concentration of active ingredients (%):………………………………………
Shelf life: ……………………………………………………………………
Form of preparation and
packaging specification:…………………………………………
Year of manufacturing/import
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Quantity manufactured/imported
Quantity sold
Violations against law on chemicals and preparations and
penalties
20…..
20…..
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20…..
20…..
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20…..
Total
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We hereby undertake that
the information furnished above is true and correct. We shall bear full
responsibility to the law if such information is found false. /.
LEGAL REPRESENTATIVE
(Signature, full name and seal)
APPENDIX VII
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I. Required information:
A letter of authorization
must comprise all of the following information:
- Name and address of the
product’s owner.
- Name and address of the
authorized individual or organization.
- Scope of authorization
(acting as the bearer of registration of free sale of the product in Vietnam
with respect to authorization for product registration).
- Trade name of the
authorized product.
- Address of the
manufacturer of the product.
- Term of authorization.
- The product owner’s
commitment to providing the authorized individual or organization with full
product information required for registration of sale.
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2. If the product owner
who has already authorized a facility to register sale of their product in
Vietnam and receive the number of registration for sale wishes to authorize
another facility to do so in Vietnam before the expiry date of such number, the
owner must submit a new letter of authorization granted to the latter,
enclosing the written agreement on discontinuation of their role as the bearer
of registration for sale, and the written request for withdrawal of the number
of registration for sale from the former.
3. Consular legalization:
A letter of authorization
issued by a foreign entity requires consular legalization according to
regulations in force, except for the case in which consular legalization is
exempted under the international agreement to which Vietnam is a signatory.
5-Procedure
Additional
registration in case of change of the ownership of the registration number of
insecticidal and germicidal preparations for domestic and medical use
Sequence
Step 1: The applicant for additional registration shall submit an
application to the Health Environment Management Agency.
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Step 3: Within 30 days from the date specified in the application
receipt form, the Ministry of Health shall send a written notice to the
applicant of request for supplement or modification of the application or
approval or refusal to grant approval for additional registration and reasons
therefor.
Step 4: Within 90 days from the date stated on the written
request for supplement or modification of the application, the applicant must
complete the application and provide written explanation for supplemented or
modified contents to the Health Environment Management Agency. The date of
receiving the supplemented or modified application is specified in the
application receipt form. After the aforementioned deadline, the application
shall be rejected.
Step 5: If the application is valid, the Health Environment
Management Agency shall make an addition to the sale registration
certificate.
Method of submission
By post or in person at
the Health Environment Management Agency. If the Health Environment
Management Agency adopts the method of online declaration, the application
shall be submitted online.
Composition and
number of application
I. Composition of
the application:
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2. A letter of
authorization for registration, except for the case stated in Point a Clause
1 Article 20 of the Decree No. 91/2016/ND-CP;
3. A document
concerning the transfer of the registration number ownership, which is made
by the registration number holder;
4. A document
concerning the receipt of registration number ownership and written
commitment on the continuation of trading in preparations in line with the
application approved by the Health Environment Management Agency;
5. A document proving
legal status of the receiver of registration number;
6. New label sample of
the preparation.
(Requirements
for the application for registration):
1. Documents
included in the application must be clearly printed and arranged in the order
prescribed in Article 23 of the Decree No. 91/2016/ND-CP. Space must be
provided between content parts in a document and each document and a cover
page and list of documents must be available.
2. English documents
must be translated into Vietnamese and enclosed with the originals thereof.
Documents in a foreign language other than English must be translated into
Vietnamese and Vietnamese translations must be notarized in accordance with
the law.
3. Requirements for
documents in an application for registration:
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b) Label samples of
all packaging specifications according to real package size with
certification of the applicant. If several packaging specifications have the
same label design, the applicant shall only submit the label sample of the
packaging specification with the smallest package size. If the label sample
of imported preparations uses a foreign language, it must be attached with a
secondary label with contents in Vietnamese. The sample and contents of the
secondary label of preparations must meet the requirements in the Appendix IX
enclosed with the Decree No. 155/2018/ND-CP.
c) A legitimate copy
of the document proving legal status of the applicant or the manufacturer;
4. Other documents
in the application for registration must be fan-stamped or stamped on each
page of a document by the applicant.)
II. Number of
application: 01 set of physical
application enclosed with a PDF file (not applicable to the case of
submission of the online application).
Time limit for
processing the application
30 days from the date
specified in the application receipt form
Entity carrying out
the administrative procedure
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Agency carrying out
the administrative procedure
The Health Environment
Management Agency
Result of implementation
of the administrative procedure
A document concerning
approval or refusal to grant approval for addition to the sale registration
certificate
Fees and charges
VND
1,000,000/application
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Appendix I: Application
form for additional registration of insecticidal and germicidal chemicals and
preparations for household and medical use - Form No. 05 (provided in the
Decree No. 155/2018/ND-CP);
Appendix VII:
Requirements for letter of authorization (provided in the Decree No.
155/2018/ND-CP).
Requirements and
conditions for following the administrative procedure
Not required
Legal bases of the
administrative procedure
1. Law on Chemicals
dated November 21, 2007;
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
3. Law on Quality of
Products and Goods dated November 21, 2007;
4. Law on Enterprises
dated November 26, 2014;
5. Law on Commerce
dated June 14, 2005;
6. Law on Standards and
Technical Regulations dated June 29, 2006;
7. Law No. 28/2018/QH14
dated June 15, 2018 on amendments to some Articles concerning planning of 11
laws;
8. The Government’s
Decree No. 91/2016/ND-CP dated July 01, 2016;
9. The Government’s
Decree No. 155/2018/ND-CP dated November 12, 2018.
10. The Circular No.
278/2016/TT-BTC dated November 14, 2016 of the Minister of Finance.
*The sections: Forms
and declarations; Legal bases are amended under Article 9 of the Government’s
Decree No. 155/2018/ND-CP dated November 12, 2018.
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Form No. 05
THE SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
……1….., date (dd/mm/yyyy) …
APPLICATION FORM FOR ADDITIONAL REGISTRATION
To: The Ministry of Health (the Health Environment
Management Agency)
………..2……………..hereby
would like to apply for additional registration of a preparation as follows:
1. Trade name:…………………..3…….………………………………………
2. Ingredients and
concentration of active ingredients (%):………………..4……………………..
3. Form of
preparation:………………………………5…………………………………
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6. Registration number:
………………….. expiry date: ………………………….
7. Name of manufacturer:
……………………………………………………………….
8. Address of
manufacturing site: ………… Phone number: ………… Fax:……………………...
9. Name of applicant:
……………………………………………………………….
10.
Address:……………………………………………………………………………
11. Phone number:
…………………………….. Fax:…………………………………..
LEGAL REPRESENTATIVE
(Signature, full name and seal)
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1 Place name.
2 Specify name of the applicant.
3 For the imported preparation, accurately write its trade
name stated in the issued Certificate of Free Sale.
4 - Only specify active ingredients and adjuvants that
reveal synergistic effects.
- Concentration of an
active ingredient is expressed as a percentage (%) and clearly specified by
weight/volume (kl/tt or w/v), weight/weight (kl/kl or w/w) or volume/volume
(tt/tt or v/v) depending on properties of the preparation.
5 Specify the finished package form, do not specify the
packaging specification. E.g. the finished product in a sprayer is in liquid form
or in mosquito-repellent incense is in solid form. If the preparation is in the
form of emulsifiable concentrate or suspensive concentrate, write the form in
Vietnamese together with abbreviated name of the preparation in English in
brackets. E.g. huyền phù (SC).
6 Clearly specify bottle, packet, bag, etc. and its
quantity.
7 Specify contents to be changed regarding certificate
ownership, trade name, address, contact information, purposes and quality
criteria.
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REQUIREMENTS FOR LETTER OF AUTHORIZATION
(Enclosed with the Government's Decree No. 155/2018/ND-CP dated November 12,
2018)
I. Required information:
A letter of authorization
must comprise all of the following information:
- Name and address of the
product’s owner.
- Name and address of the
authorized individual or organization.
- Scope of authorization
(acting as the bearer of registration of free sale of the product in Vietnam
with respect to authorization for product registration).
- Trade name of the
authorized product.
- Address of the
manufacturer of the product.
- Term of authorization.
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- Name, title and
signature of the authorizing party’s representative.
2. If the product owner
who has already authorized a facility to register sale of their product in
Vietnam and receive the number of registration for sale wishes to authorize
another facility to do so in Vietnam before the expiry date of such number, the
owner must submit a new letter of authorization granted to the latter,
enclosing the written agreement on discontinuation of their role as the bearer
of registration for sale, and the written request for withdrawal of the number
of registration for sale from the former.
3. Consular legalization:
A letter of authorization
issued by a foreign entity requires consular legalization according to
regulations in force, except for the case in which consular legalization is
exempted under the international agreement to which Vietnam is a signatory.
6-Procedure
Additional
registration in case of change of the trade name of insecticidal and
germicidal preparations for domestic and medical use
Sequence
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Step 2: After receiving a sufficient application and fees for
application appraisal, the Health Environment Management Agency shall send an
application receipt form according to the Form No. 05 in the Appendix III
enclosed with the Decree No. 91/2016/ND-CP.
Step 3: Within 30 days from the date specified in the application
receipt form, the Health Environment Management Agency shall send a written
notice to the applicant of request for supplement or modification of the
application or approval for or refusal to grant approval for additional
registration and reasons therefor.
Step 4: Within 90 days from the date stated on the written
request for supplement or modification of the application, the applicant must
complete the application and provide written explanation for supplemented or
modified contents to the Health Environment Management Agency. The date of
receiving the supplemented or modified application is specified in the
application receipt form. After the aforementioned deadline, the application
shall be rejected.
Step 5: If the application is valid, the Health Environment
Management Agency shall make an addition to the sale registration
certificate.
Method of submission
By post or in person at
the Health Environment Management Agency. If the Health Environment
Management Agency adopts the method of online declaration, the application
shall be submitted online.
Composition and
number of application
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
1. An application form,
which is made using the Form No. 05 in the Appendix I in the Decree No.
155/2018/ND-CP;
2. A letter of
authorization for registration of preparations under the new trade name,,
except for the case stated in Point a Clause 1 Article 20 of the Decree No.
91/2016/ND-CP;
3. A Certificate of
Free Sale of preparations under new trade name (for the imported
preparations).
4. New label sample of
the preparation.
(Requirements
for the application for registration:
1. Documents
included in the application must be clearly printed and arranged in the order
prescribed in Article 23 of the Decree No. 91/2016/ND-CP. Space must be
provided between content parts in a document and each document and a cover
page and list of documents must be available.
2. English documents
must be translated into Vietnamese and enclosed with the originals thereof.
Documents in a foreign language other than English must be translated into
Vietnamese and Vietnamese translations must be notarized in accordance with
the law.
3. Requirements for
documents in an application for registration:
a) The original
letter of authorization for registration. The letter of authorization must
meet the requirements in the Appendix VII enclosed with the Decree No.
155/2018/ND-CP;
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
c) Label samples of
all packaging specifications according to real package size with
certification of the applicant. If several packaging specifications have the
same label design, the applicant shall only submit the label sample of the
packaging specification with the smallest package size. If the label sample
of imported preparations uses a foreign language, it must be attached with a
secondary label with contents in Vietnamese. The sample and contents of the
secondary label of preparations must meet the requirements in the Appendix IX
enclosed with the Decree No. 155/2018/ND-CP.
4. Other documents
in the application for registration must be fan-stamped or stamped on each
page of a document by the applicant.)
II. Number of
application: 01 set of physical
application enclosed with a PDF file (not applicable to the case of
submission of the online application).
Time limit for
processing the application
30 days from the date
specified in the application receipt form
Entity carrying out
the administrative procedure
Owner of the
registration number
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
The Health Environment
Management Agency
Result of
implementation of the administrative procedure
A document concerning
approval or refusal to grant approval for addition to the sale registration
certificate
Fees and charges
VND
5,000,000/application
Name of forms and
declarations (Attached below)
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Appendix I: Application
form for additional registration of insecticidal and germicidal chemicals and
preparations for household and medical use - Form No. 05 (enclosed with the
Decree No. 155/2018/ND-CP);
Appendix VII:
Requirements for letter of authorization (provided in the Decree No.
155/2018/ND-CP);
Appendix VIII:
Requirements for Certificate of Free Sale (provided in the Decree No.
91/2016/ND-CP).
Requirements and
conditions for following the administrative procedure
Not required
Legal bases of the
administrative procedure
1. Law on Chemicals
dated November 21, 2007;
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
3. Law on Quality of
Products and Goods dated November 21, 2007;
4. Law on Enterprises
dated November 26, 2014;
5. Law on Commerce
dated June 14, 2005;
6. Law on Standards and
Technical Regulations dated June 29, 2006;
7. Law No. 28/2018/QH14
dated June 15, 2018 on amendments to some Articles concerning planning of 11
laws;
8. The Government’s
Decree No. 91/2016/ND-CP dated July 01, 2016;
9. The Government’s
Decree No. 155/2018/ND-CP dated November 12, 2018;
10. The Circular No.
278/2016/TT-BTC dated November 14, 2016 of the Minister of Finance.
*The requirements for
application for registration in the section “composition of the application”;
and the section “forms and declarations” are amended under the Decree No.
155/2018/ND-CP.
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Form No. 05
THE SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
……1….., date (dd/mm/yyyy) …
APPLICATION FORM FOR ADDITIONAL REGISTRATION
To: The Ministry of Health (the Health Environment
Management Agency)
………..2……………..hereby
would like to apply for additional registration of a preparation as follows:
1. Trade name:…………………..3
……………………………………………….
2. Ingredients and
concentration of active ingredients (%):………………..4 …………………….
3. Form of
preparation:………………………………5 ………………………………….
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
5. Contents to be
changed:…………………..7……………..
6. Registration number:
………………….. expiry date: ………………………….
7. Name of manufacturer:
……………………………………………………………….
8. Address of
manufacturing site: ………… Phone number: ………… Fax:……………………...
9. Name of applicant:
……………………………………………………………….
10. Address:
…………………………………………………………………………
11. Phone
number:………………………………….. Fax: ……………………………..
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
___________________
1 Place name.
2 Specify name of the applicant.
3 For the imported preparation, accurately write its trade
name stated in the issued Certificate of Free Sale.
4 - Only specify active ingredients and adjuvants that
reveal synergistic effects.
- Concentration of an
active ingredient is expressed as a percentage (%) and clearly specified by
weight/volume (kl/tt or w/v), weight/weight (kl/kl or w/w) or volume/volume
(tt/tt or v/v) depending on properties of the preparation.
5 Specify the finished package form, do not specify the
packaging specification. E.g. the finished product in a sprayer is in liquid
form or in mosquito-repellent incense is in solid form. If the preparation is
in the form of emulsifiable concentrate or suspensive concentrate, write the
form in Vietnamese together with abbreviated name of the preparation in English
in brackets. E.g. huyền phù (SC).
6 Clearly specify bottle, packet, bag, etc. and its
quantity.
7 Specify contents to be changed regarding certificate
ownership, trade name, address, contact information, purposes and quality
criteria.
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
APPENDIX VII
REQUIREMENTS FOR LETTER OF AUTHORIZATION
(Enclosed with the Government's Decree No. 155/2018/ND-CP dated November 12,
2018)
I. Required information:
A letter of authorization
must comprise all of the following information:
- Name and address of the
product’s owner.
- Name and address of the
authorized individual or organization.
- Scope of authorization
(acting as the bearer of registration of free sale of the product in Vietnam
with respect to authorization for product registration).
- Trade name of the
authorized product.
- Address of the
manufacturer of the product.
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- The product owner’s
commitment to providing the authorized individual or organization with full
product information required for registration of sale.
- Name, title and
signature of the authorizing party’s representative.
2. If the product owner
who has already authorized a facility to register sale of their product in
Vietnam and receive the number of registration for sale wishes to authorize
another facility to do so in Vietnam before the expiry date of such number, the
owner must submit a new letter of authorization granted to the latter,
enclosing the written agreement on discontinuation of their role as the bearer
of registration for sale, and the written request for withdrawal of the number
of registration for sale from the former.
3. Consular legalization:
A letter of authorization
issued by a foreign entity requires consular legalization according to
regulations in force, except for the case in which consular legalization is
exempted under the international agreement to which Vietnam is a signatory.
APPENDIX VIII
REQUIREMENTS FOR CERTIFICATE OF FREE SALE
(Enclosed with the Government's Decree No. 91/2016/ND-CP dated July 01,
2016)
1. Required
information:
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- Name of the authority
issuing the certificate;
- Date of issuance;
- Trade name of the
preparation issued with the certificate;
- Ingredients and
concentration of active ingredients (compulsory for insecticidal preparations);
- Name and address of the
manufacturer;
- Certification of free
sale of preparations in the country of issuing the certificate;
- Full name, title and
signature of the certificate holder.
2. Country of origin
of the CFS:
Country of origin of the
CFS must be the manufacturing country or one of the WTO member countries.
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CFS must be issued within
12 months after the date of submission of the application for sale
registration.
4. Effect of CFS:
CFS must remain effective
for at least 06 months from the date of submission of the application for sale
registration to the receiving authority if the CFS specifies the expiry date.
5. Consular
legalization:
CFS must undergo consular
legalization as prescribed, except for the case in which consular legalization
is exempted under the international agreement to which Vietnam is a signatory.
7-Procedure
Additional registration
in case of change of manufacturing site or change of manufacturer of
insecticidal and germicidal preparations for domestic and medical use
Sequence
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Step 1: The applicant shall submit an application to the Health
Environment Management Agency.
Step 2: After receiving a sufficient application and fees for
application appraisal, the Health Environment Management Agency shall send an
application receipt form according to the Form No. 05 in the Appendix III enclosed
with the Decree No. 91/2016/ND-CP.
Step 3: Within 30 days from the date specified in the application
receipt form, the Health Environment Management Agency shall send a written
notice to the applicant of request for supplement or modification of the
application or permission or refusal to grant permission for trial and
reasons therefor.
Step 4: Within 90 days from the date stated on the written
request for supplement or modification of the application, the applicant must
complete the application and provide written explanation for supplemented or
modified contents to the Health Environment Management Agency. The date of
receiving the supplemented or modified application is specified in the
application receipt form. After the aforementioned deadline, the application
shall be rejected.
Within 12 months from
the date stated in the written permission for trial granted by the Health
Environment Management Agency, the applicant must supplement the application
with trial results.
Step 5: Within 30 days from the receipt of the written
notice of trial results and fees for application appraisal, the Health
Environment Management Agency shall send a written notice to the applicant of
request for supplement or modification of the application or permission or
refusal to grant permission for addition to the sale registration certificate
and reasons therefor.
Method of submission
By post or in person at
the Health Environment Management Agency. If the Health Environment
Management Agency adopts the method of online declaration, the application
shall be submitted online.
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
I. Composition of
the application:
1. An application form,
which is made using the Form No. 05 in the Appendix I in the Decree No.
91/2016/ND-CP;
2. A document proving
legal status of the manufacturer, including information about the new
manufacturing site (if the manufacturer is in Vietnam) or written notice of
change of the manufacturing site or manufacturer (if the manufacturer is in a
foreign country);
3. A written notice of
results of trial of preparations which are manufactured at the new site;
4. A letter of
authorization for registration, except for the case stated in Point a Clause
1 Article 20 of the Decree No. 91/2016/ND-CP;
5. Certificate of Free
Sale, except for the cases where the applicant has been issued with
registration number to manufacture preparations in Vietnam and carries out
the additional registration for manufacturer in a foreign country;
6. New label sample of
the preparation.
(Requirements
for the application for registration):
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2. English documents
must be translated into Vietnamese and enclosed with the originals thereof.
Documents in a foreign language other than English must be translated into
Vietnamese and Vietnamese translations must be notarized in accordance with
the law.
3. Requirements for
documents in an application for registration:
a) The original
letter of authorization for registration. The letter of authorization must
meet the requirements in the Appendix VII enclosed with the Decree No.
155/2018/ND-CP;
b) An original or
legitimate copy of Certificate of Free Sale (for imported preparations). The
letter of authorization must meet the requirements in the Appendix VIII
enclosed with the Decree No. 91/2016/ND-CP;
c) The original or
legitimate copy of the written notice of results of testing for ingredients
and concentration of active ingredients in preparations; The testing results
must be given by an entity that is eligible to conduct testing prescribed in
Article 10 of this Decree. If testing facilities in Vietnam are not
sufficiently competent to conduct testing, the applicant may use the testing
results given by the manufacturer or an independent laboratory that meets ISO
17025:2005 or ISO 15189:2012 or its editions and the applicant shall take
legal responsibility for the legitimacy of the testing results which such
applicant gives;
d) Label samples of
all packaging specifications according to real package size with
certification of the applicant. If several packaging specifications have the
same label design, the applicant shall only submit the label sample of the
packaging specification with the smallest package size. If the label sample
of imported preparations uses a foreign language, it must be attached with a
secondary label with contents in Vietnamese. The sample and contents of the
secondary label of preparations must meet the requirements in the Appendix IX
enclosed with the Decree No. 155/2018/ND-CP;
e) A legitimate copy
of the document proving legal status of the applicant or the manufacturer;
g) The original or
legitimate copy of the written notice of change of manufacturing site or
change of manufacturer of a foreign manufacturer, which must be consularly
legalized in accordance with the law.
4. Other documents
in the application for registration must be fan-stamped or stamped on each
page of a document by the applicant.)
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Time limit for
processing the application
30 days from the date
specified in the application receipt form or the date of receiving the
written notice of trial results and fees for appraising the application for
additional registration
Entity carrying out
the administrative procedure
Owner of the
registration number
Agency carrying out
the administrative procedure
The Health Environment
Management Agency
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A document concerning
approval or refusal to grant approval for addition to the sale registration
certificate
Fees and charges
- Fees for appraising
an application for permission for trial (submitted together with the
application for registration): VND 2,000,000 per application
- Fees for appraising
an application for additional registration (submitted together with the
written notice of trial results): VND 2,000,000 per application.
Name of forms and
declarations (Attached below)
Appendix I: Application
form for additional registration of insecticidal and germicidal chemicals and
preparations for household and medical use - Form No. 05 (provided in the
Decree No. 155/2018/ND-CP);
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Appendix VIII:
Requirements for Certificate of Free Sale (provided in the Decree No.
91/2016/ND-CP).
Requirements and
conditions for following the administrative procedure
Not required
Legal bases of the
administrative procedure
1. Law on Chemicals
dated November 21, 2007;
2. Law on Investment
dated November 26, 2014;
3. Law on Quality of
Products and Goods dated November 21, 2007;
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5. Law on Commerce
dated June 14, 2005;
6. Law on Standards and
Technical Regulations dated June 29, 2006;
7. Law No. 28/2018/QH14
dated June 15, 2018 on amendments to some Articles concerning planning of 11
laws;
8. The Government’s
Decree No. 91/2016/ND-CP dated July 01, 2016;
9. The Circular No.
278/2016/TT-BTC dated November 14, 2016 of the Minister of Finance.
*The requirements for
application for registration in the section “composition of the application”;
and the section “forms and declarations” are amended under the Decree No.
155/2018/ND-CP.
Form No. 05
THE SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
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APPLICATION FORM FOR ADDITIONAL REGISTRATION
To: The Ministry of Health (the Health Environment
Management Agency)
………..2……………..hereby
would like to apply for additional registration of a preparation as follows:
1. Trade name:…………………..3….………………………………………
2. Ingredients and
concentration of active ingredients (%):………………..4……………………….
3. Form of
preparation:………………………………5…………………………………...
4. Packaging
specifications:………………………….6……………………………………...
5. Contents to be
changed:…………………..7…………………..
6. Registration number:
………………….. expiry date: ………………………….
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8. Address of
manufacturing site: ………… Phone number: ………… Fax:……………………...
9. Name of the applicant:
…………………………………………………………………
10.
Address:……………………………………………………………………………
11. Phone number:
…………………………….. Fax:…………………………………..
LEGAL REPRESENTATIVE
(Signature, full name and seal)
___________________
1 Place name.
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3 For the imported preparation, accurately write its trade
name stated in the issued Certificate of Free Sale.
4 - Only specify active ingredients and adjuvants that
reveal synergistic effects.
- Concentration of an
active ingredient is expressed as a percentage (%) and clearly specified by
weight/volume (kl/tt or w/v), weight/weight (kl/kl or w/w) or volume/volume (tt/tt
or v/v) depending on properties of the preparation.
5 Specify the finished package form, do not specify the
packaging specification. E.g. the finished product in a sprayer is in liquid
form or in mosquito-repellent incense is in solid form. If the preparation is
in the form of emulsifiable concentrate or suspensive concentrate, write the
form in Vietnamese together with abbreviated name of the preparation in English
in brackets. E.g. huyền phù (SC).
6 Clearly specify bottle, packet, bag, etc. and its quantity.
7 Specify contents to be changed regarding certificate
ownership, trade name, address, contact information, purposes and quality
criteria.
APPENDIX VII
REQUIREMENTS FOR LETTER OF AUTHORIZATION
(Enclosed with the Government's Decree No. 155/2018/ND-CP dated November 12,
2018)
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A letter of authorization
must comprise all of the following information:
- Name and address of the
product’s owner.
- Name and address of the
authorized individual or organization.
- Scope of authorization
(acting as the bearer of registration of free sale of the product in Vietnam
with respect to authorization for product registration).
- Trade name of the
authorized product.
- Address of the manufacturer
of the product.
- Term of authorization.
- The product owner’s
commitment to providing the authorized individual or organization with full
product information required for registration of sale.
- Name, title and
signature of the authorizing party’s representative.
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3. Consular legalization:
A letter of authorization
issued by a foreign entity requires consular legalization according to
regulations in force, except for the case in which consular legalization is
exempted under the international agreement to which Vietnam is a signatory.
APPENDIX VIII
REQUIREMENTS FOR CERTIFICATE OF FREE SALE
(Enclosed with the Government's Decree No. 91/2016/ND-CP dated July 01,
2016)
1. Required
information:
The Certificate of Free
Sale contains the following information:
- Name of the authority
issuing the certificate;
- Date of issuance;
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- Ingredients and
concentration of active ingredients (compulsory for insecticidal preparations);
- Name and address of the
manufacturer;
- Certification of free
sale of preparations in the country of issuing the certificate;
- Full name, title and
signature of the certificate holder.
2. Country of origin
of the CFS:
Country of origin of the
CFS must be the manufacturing country or one of the WTO member countries.
3. Time limit for
issuance:
CFS must be issued within
12 months after the date of submission of the application for sale
registration.
4. Effect of CFS:
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5. Consular
legalization:
CFS must undergo consular
legalization as prescribed, except for the case in which consular legalization
is exempted under the international agreement to which Vietnam is a signatory.
8-Procedure
Additional
registration in case of change of name or contact address of applicant for
registration or manufacturer of insecticidal and germicidal preparations for
domestic and medical use
Sequence
Step 1: The applicant shall submit an application and pay fees
for application appraisal to the Health Environment Management Agency.
Step 2: After receiving a sufficient application and fees for
application appraisal, the Health Environment Management Agency shall send an
application receipt form according to the Form No. 05 in the Appendix III
enclosed with the Decree No. 91/2016/ND-CP.
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Step 4: Within 90 days from the date stated on the written
request for supplement or modification of the application, the applicant must
complete the application and provide written explanation for supplemented or
modified contents to the Ministry of Health. The date of receiving the
supplemented or modified application is specified in the application receipt
form. After the aforementioned deadline, the application shall be rejected.
Method of submission
By post or in person at
the Health Environment Management Agency. If the Health Environment
Management Agency adopts the method of online declaration, the application
shall be submitted online.
Composition and
number of application
I. Composition of
the application:
1. An application form,
which is made using the Form No. 05 in the Appendix I in the Decree No.
155/2018/ND-CP;
2. A document proving
legal status of the manufacturer, including information about the new
manufacturing site (if the manufacturer is in Vietnam) or written notice of
change of the manufacturing site or manufacturer (if the manufacturer is in a
foreign country);
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(Requirements
for the application for registration):
1. Documents
included in the application must be clearly printed and arranged in the order
prescribed in Article 23 of the Decree No. 91/2016/ND-CP. Space must be
provided between content parts in a document and each document and a cover
page and list of documents must be available.
2. English documents
must be translated into Vietnamese and enclosed with the originals thereof.
Documents in a foreign language other than English must be translated into
Vietnamese and Vietnamese translations must be notarized in accordance with
the law.
3. Requirements for
documents in an application for registration:
a) Label samples of
all packaging specifications according to real package size with
certification of the applicant. If several packaging specifications have the
same label design, the applicant shall only submit the label sample of the
packaging specification with the smallest package size. If the label sample
of imported preparations uses a foreign language, it must be attached with a
secondary label with contents in Vietnamese. The sample and contents of the
secondary label of preparations must meet the requirements in the Appendix IX
enclosed with the Decree No. 155/2018/ND-CP.
b) A legitimate copy
of the document proving legal status of the applicant or the manufacturer;
g) The original or
legitimate copy of the written notice of change of manufacturing site or
change of manufacturer of a foreign manufacturer, which must be consularly
legalized in accordance with the law.
4. Other documents
in the application for registration must be fan-stamped or stamped on each
page of a document by the applicant.)
II. Number of
application: 01 set of physical
application enclosed with a PDF file (not applicable to the case of
submission of the online application).
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30 days from the date
specified in the application receipt form
Entity carrying out
the administrative procedure
Owner of the
registration number
Agency carrying out
the administrative procedure
The Health Environment
Management Agency
Result of
implementation of the administrative procedure
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A document concerning
approval or refusal to grant approval for addition to the sale registration
certificate
Fees and charges
VND
1,000,000/application
Name of forms and
declarations (Attached below)
Appendix I: Application
form for additional registration of insecticidal and germicidal chemicals and
preparations for household and medical use - Form No. 05 (provided in the
Decree No. 155/2018/ND-CP);
Requirements and
conditions for following the administrative procedure
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Legal bases of the
administrative procedure
1. Law on Chemicals
dated November 21, 2007;
2. Law on Investment
dated November 26, 2014;
3. Law on Quality of
Products and Goods dated November 21, 2007;
4. Law on Enterprises
dated November 26, 2014;
5. Law on Commerce
dated June 14, 2005;
6. Law on Standards and
Technical Regulations dated June 29, 2006;
7. Law No. 28/2018/QH14
dated June 15, 2018 on amendments to some Articles concerning planning of 11
laws;
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9. The Government’s
Decree No. 155/2018/ND-CP dated November 12, 2018;
10. The Circular No. 278/2016/TT-BTC
dated November 14, 2016 of the Minister of Finance.
*The requirements for
application for registration in the section “composition of the application”;
and the section “forms and declarations” are amended under the Decree No. 155/2018/ND-CP.
Form No. 05
THE SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------……1….., date
(dd/mm/yyyy) …
APPLICATION FORM FOR ADDITIONAL REGISTRATION
To: The Ministry of Health (the Health Environment
Management Agency)
………..2……………..hereby
would like to apply for additional registration of a preparation as follows:
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
2. Ingredients and
concentration of active ingredients (%):………………..4……………………….
3. Form of
preparation:………………………………5…………………………………...
4. Packaging
specifications:………………………….6…………………………………...
5. Contents to be
changed:…………………..7………………...
6. Registration number:
………………….. expiry date: ………………………….
7. Name of the
manufacturer:………………………………………………………………..
8. Address of manufacturing
site: ………… Phone number: ………… Fax:……………………...
9. Name of the
applicant:………………………………………………………………..
10.
Address:……………………………………………………………………………
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LEGAL REPRESENTATIVE
(Signature, full name and seal)
___________________
1 Place name.
2 Specify name of the applicant.
3 For the imported preparation, accurately write its trade
name stated in the issued Certificate of Free Sale.
4 - Only specify active ingredients and adjuvants that
reveal synergistic effects.
- Concentration of an
active ingredient is expressed as a percentage (%) and clearly specified by
weight/volume (kl/tt or w/v), weight/weight (kl/kl or w/w) or volume/volume
(tt/tt or v/v) depending on properties of the preparation.
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6 Clearly specify bottle, packet, bag, etc. and its
quantity.
7 Specify contents to be changed regarding certificate
ownership, trade name, address, contact information, purposes and quality
criteria.
9-Procedure
Additional
registration in case of change of effects, quality criteria or method of
application of insecticidal and germicidal preparations for domestic and
medical use
Sequence
Step 1: The applicant shall submit an application and pay fees
for application appraisal to the Health Environment Management Agency.
Step 2: After receiving a sufficient application and fees for
application appraisal, the Health Environment Management Agency shall send an
application receipt form according to the Form No. 05 in the Appendix III
enclosed with the Decree No. 91/2016/ND-CP.
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In other cases, within
30 days from the date specified in the application receipt form, the Health
Environment Management Agency shall send a written notice to the applicant of
request for supplement or modification of the application or permission or
refusal to grant permission for trial and reasons therefor.
Step 4: Within 90 days from the date stated on the written
request for supplement or modification of the application, the applicant must
complete the application and provide written explanation for supplemented or
modified contents to the Health Environment Management Agency. The date of
receiving the supplemented or modified application is specified in the
application receipt form. After the aforementioned deadline, the application
shall be rejected.
Within 12 months from
the date stated in the written permission for trial granted by the Health
Environment Management Agency, the applicant must supplement the application
with trial results.
Step 5: Within 30 days from the receipt of the written notice of
trial results and fees for application appraisal, the Health Environment
Management Agency shall send a written notice to the applicant of request for
supplement or modification of the application or permission or refusal to
grant permission for addition to the Certificate of Free Sale and reasons
therefor.
Method of submission
By post or in person at
the Health Environment Management Agency. If the Health Environment
Management Agency adopts the method of online declaration, the application
shall be submitted online.
Composition and
number of application
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
1. An application form,
which is made using the Form No. 05 in the Appendix I in the Decree No.
155/2018/ND-CP;
2. A written notice of
trial results (except for the change of shelf life of preparations);
3. A document
concerning stability research (in case of change of shelf life of
preparations);
4. Results of testing
for ingredients and concentration of active ingredients in preparations (in
case of change of ingredients and concentration of active ingredients);
5. New label sample of
the preparation.
(Requirements
for the application for registration):
1. Documents
included in the application must be clearly printed and arranged in the order
prescribed in Article 23 of the Decree No. 91/2016/ND-CP. Space must be
provided between content parts in a document and each document and a cover
page and list of documents must be available.
2. English documents
must be translated into Vietnamese and enclosed with the originals thereof.
Documents in a foreign language other than English must be translated into
Vietnamese and Vietnamese translations must be notarized in accordance with
the law.
3. Requirements for
documents in an application for registration:
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b) The original or
legitimate copy of the written notice of results of testing for ingredients
and concentration of active ingredients in preparations; The testing results
must be given by an entity that is eligible to conduct testing prescribed in
Article 10 of this Decree. If testing facilities in Vietnam are not
sufficiently competent to conduct testing, the applicant may use the testing
results given by the manufacturer or an independent laboratory that meets ISO
17025:2005 or ISO 15189:2012 or its editions and the applicant shall take
legal responsibility for the legitimacy of the testing results which such
applicant gives;
c) Label samples of
all packaging specifications according to real package size with
certification of the applicant. If several packaging specifications have the
same label design, the applicant shall only submit the label sample of the
packaging specification with the smallest package size. If the label sample
of imported preparations uses a foreign language, it must be attached with a
secondary label with contents in Vietnamese. The sample and contents of the
secondary label of preparations must meet the requirements in the Appendix IX
enclosed with the Decree No. 155/2018/ND-CP.
4. Other documents
in the application for registration must be fan-stamped or stamped on each
page of a document by the applicant.)
II. Number of
application: 01 set of physical
application enclosed with a PDF file (not applicable to the case of
submission of the online application).
Time limit for
processing the application
30 days from the date
specified in the application receipt form or the date of receiving the
written notice of trial results and fees for application appraisal
Entity carrying out
the administrative procedure
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Agency carrying out
the administrative procedure
The Health Environment
Management Agency
Result of
implementation of the administrative procedure
A document concerning
approval or refusal to grant approval for addition to the sale registration
certificate
Fees and charges
- Fees for appraising
an application for permission for trial: VND 2,000,000 per application
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Name of forms and
declarations (Attached below)
Appendix I: Application
form for additional registration of insecticidal and germicidal chemicals and
preparations for household and medical use - Form No. 05 (provided in the
Decree No. 155/2018/ND-CP);
Requirements and
conditions for following the administrative procedure
Not required
Legal bases of the
administrative procedure
1. Law on Chemicals
dated November 21, 2007;
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
3. Law on Quality of
Products and Goods dated November 21, 2007;
4. Law on Enterprises
dated November 26, 2014;
5. Law on Commerce
dated June 14, 2005;
6. Law on Standards and
Technical Regulations dated June 29, 2006;
7. Law No. 28/2018/QH14
dated June 15, 2018 on amendments to some Articles concerning planning of 11
laws;
8. The Government’s
Decree No. 91/2016/ND-CP dated July 01, 2016;
9. The Government’s
Decree No. 155/2018/ND-CP dated November 12, 2018;
10. The Circular No.
278/2016/TT-BTC dated November 14, 2016 of the Minister of Finance.
*The requirements for
application for registration in the section “composition of the application”;
and the section “forms and declarations” are amended under the Decree No.
155/2018/ND-CP.
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THE SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
……1….., date (dd/mm/yyyy) …
APPLICATION FORM FOR ADDITIONAL REGISTRATION
To: The Ministry of Health (the Health Environment
Management Agency)
………..2……………..hereby
would like to apply for additional registration of a preparation as follows:
1. Trade name:…………………..3……………………………………………
2. Ingredients and
concentration of active ingredients (%):………………..4……………………….
3. Form of
preparation:………………………………5…………………………………...
4. Packaging
specifications:………………………….6…………………………………...
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6. Registration number:
………………….. expiry date: ………………………….
7. Name of the
manufacturer:………………………………………………………………..
8. Address of
manufacturing site: ………… Phone number: ………… Fax:……………………...
9. Name of the
applicant:………………………………………………………………..
10.
Address:……………………………………………………………………………
11. Phone number:
…………………………….. Fax:…………………………………..
LEGAL REPRESENTATIVE
(Signature, full name and seal)
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
1 Place name.
2 Specify name of the applicant.
3 For the imported preparation, accurately write its trade
name stated in the issued Certificate of Free Sale.
4 - Only specify active ingredients and adjuvants that
reveal synergistic effects.
- Concentration of an
active ingredient is expressed as a percentage (%) and clearly specified by
weight/volume (kl/tt or w/v), weight/weight (kl/kl or w/w) or volume/volume
(tt/tt or v/v) depending on properties of the preparation.
5 Specify the finished package form, do not specify the
packaging specification. E.g. the finished product in a sprayer is in liquid
form or in mosquito-repellent incense is in solid form. If the preparation is
in the form of emulsifiable concentrate or suspensive concentrate, write the
form in Vietnamese together with abbreviated name of the preparation in English
in brackets. E.g. huyền phù (SC).
6 Clearly specify bottle, packet, bag, etc. and its
quantity.
7 Specify contents to be changed regarding certificate
ownership, trade name, address, contact information, purposes and quality
criteria.
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10-Procedure
Declaration of
eligibility to produce insecticidal and germicidal preparations for domestic
and medical use
Sequence
Step 1: Before producing preparations, the legal
representative of the manufacturer shall submit documents about declaration
of eligibility to the Department of Health of the province where the factory
is located.
Step 2: Upon the receipt of sufficient documents, the Department
of Health shall issue a document receipt form to the declarant according to
the Form No. 01 in the Appendix III enclosed with the Decree No.
91/2016/ND-CP.
Step 3: Within 03 working days from the date stated in the
document receipt form, the Department of Health shall publish the following
information on its website: Name, address and phone number of the
manufacturer.
Method of submission
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Documents and number
of documents
I. Documents:
1. A declaration of
eligibility to produce preparations, which is made using the Form No. 01 in
the Appendix I enclosed with the Decree No. 155/2018/ND-CP;
2. A list of personnel,
which is made using the Form in the Appendix II enclosed with the Decree No.
91/2016/ND-CP;
3. Site plans of the
factory and warehouse.
4. A list of facilities
and equipment for production and response to event of chemical hazards.
(Requirements
for the documents about declaration of eligibility to produce preparations):
a) Documents must be
clearly printed and arranged in the order prescribed in Article 23 of the
Decree No. 91/2016/ND-CP. Space must be provided between content parts in a
document and each document and a cover page and list of documents must be
available.
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
II. Number of
documents: 01 set of physical documents
enclosed with a PDF file (not applicable to the case of submission of the
online documents).
Time limit for
processing the documents
On the date on which
the documents are received.
Entity carrying out
the administrative procedure
The manufacturer of
insecticidal and germicidal preparations for domestic and medical use in
Vietnam
Agency carrying out
the administrative procedure
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Result of
implementation of the administrative procedure
Document receipt form
Fees and charges
VND 300,000
Name of forms and
declarations (Attached below)
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Appendix II: A list of
personnel
Requirements and
conditions for following the administrative procedure
Points a and b
Clause 1 Article 5 of the Decree No. 91/2016/ND-CP: Personnel requirements
At
least 01 person in charge of chemical safety meets all of the following
conditions:
a) Possess at least an
intermediate professional education diploma in chemistry;
b) Work on a full time
basis at the manufacturing facility;
Clause 2 Article 6
of the Decree No. 91/2016/ND-CP and Clause 1 Article 9 of the Decree No.
155/2018/ND-CP: Requirements for infrastructure and equipment
1. Meet the
requirements specified in Section 1 Chapter II of the Government’s Decree No.
113/2017/ND-CP dated October 09, 2017.
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Legal bases of the
administrative procedure
1. Law on Chemicals
dated November 21, 2007;
2. Law on Investment
dated November 26, 2014;
3. Law on Quality of
Products and Goods dated November 21, 2007;
4. Law on Enterprises
dated November 26, 2014;
5. Law on Commerce
dated June 14, 2005;
6. Law on Standards and
Technical Regulations dated June 29, 2006;
7. Law No. 28/2018/QH14
dated June 15, 2018 on amendments to some Articles concerning planning of 11
laws;
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
9. The Government’s
Decree No. 155/2018/ND-CP dated November 12, 2018;
10. The Circular No.
278/2016/TT-BTC dated November 14, 2016 of the Minister of Finance.
* Contents of the
sections: Sequence; Documents; Requirements and conditions for following the
administrative procedures; Legal bases; forms and declarations are amended.
Form No. 01
THE SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
……1….., date (dd/mm/yyyy) …
DECLARATION OF ELIGIBILITY TO PRODUCE PREPARATIONS
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
1. Name of the
declarant:.........................................................................................................
Address:………………………………..3…………………………………
Phone
number:…………………Fax:……………………………………………….
Email: ………………………… Website
(if any): …………………………………….
2. Legal representative
of the manufacturer:
Full
name:……………………………………………………………………….
Fixed phone
number:……......… Mobile phone number:…………………………….
Fax:………………………….
Email:…………………………………………..
3. Address of manufacturing
site:………………………………..4……………………….
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Re-declaration □ Receipt
form No. …………….6…………………………
5. Preparations produced:
No.
Name of preparation
Form of preparation
Capacity
(…....7……./year)
Note
1
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
2
After considering the
Government’s Decree No. 155/2018/ND-CP dated November 12, 2018, we would like
to declare that our manufacturing facility is eligible to produce preparations
and enclose the following documents:
1
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□
2
A list of personnel
□
3
A letter of appointment
of production manager (for the manufacturer of hazardous chemicals)
□
4
Site plans of the
factory and warehouse
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
5
A list of facilities
and equipment for production and response to event of chemical hazards.
□
We hereby undertake that
the documents enclosed with this declaration are accurate./.
LEGAL REPRESENTATIVE
(Signature, full name and seal)
___________________
1 Place name.
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3 Write the address written on the business registration
certificate.
4 If it matches the address where the business is
registered, write “tại trụ sở” (“at the head office”).
5 Check the box.
6 Specify number of the latest receipt form.
7 Weight or volume.
APPENDIX II
A LIST OF PERSONNEL
(Enclosed with the Government’s Decree No. 91/2016/ND-CP dated July
01, 2016)
THE SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
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A LIST OF PERSONNEL
No.
Full name
Professional qualification
Degree/diploma and certificate
Number of years of experience
2
Position
1
Nguyen Van A
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.........................
........................
...................
2
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
LEGAL REPRESENTATIVE
(Signature, full name and seal)
___________________
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2 Specify the number of years of working in a specific field,
e.g. 05 years of experience in conducting insecticide trial or 03 years of
experience in being in charge of chemical safety
11-Procedure
Declaration of
eligibility to provide preparation-based insect and germ control services in
household and medical fields
Sequence
Step 1: The service provider shall submit documents about
declaration of eligibility to the Department of Health of the province where
the service provider is located.
Step 2: Upon the receipt of sufficient documents, the Department
of Health shall issue a document receipt form to the service provider
according to the Form No. 08 in the Appendix III enclosed with the Decree No.
91/2016/ND-CP.
Step 3: Within 03 working days from the date stated in the
document receipt form, the Department of Health shall publish the following
information on its website: Name, address and phone number of the service
provider.
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
In person or by post to
the Department of Health of the province where the service provider is
located. If the Department of Health adopts the method of online declaration,
the documents shall be submitted online.
Documents and number
of documents
I. Documents:
1. A declaration of
eligibility to provide preparation-based insect and germ control services in
household and medical fields, which is made using the Form No. 08 in the
Appendix I enclosed with the Decree No. 155/2018/ND-CP.
2. A list of trainees,
which is certified by the declarant.
II. Number of
documents: 01 set of physical
application (not applicable to the case of submission of online documents)
Time limit for
processing the documents
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
On the date on which
the documents are received.
Entity carrying out
the administrative procedure
Providers of
preparation-based insect and germ control services in household and medical
fields in Vietnam
Agency carrying out
the administrative procedure
Department of Health
Result of implementation
of the administrative procedure
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Fees and charges
VND 300,000
Not required
Name of forms and
declarations (Attached below)
Appendix I: A
declaration of eligibility to provide preparation-based insect and germ
control services in household and medical fields, which is made using the
Form No. 08 provided in the Decree No. 155/2018/ND-CP.
Requirements and
conditions for following the administrative procedure
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
The person directly
performing insecticidal and germicidal works must be trained in the following
knowledge and confirmed by the provider that he/she has been trained in:
a) How to read
information on the label of the preparation;
b) Techniques for
killing insects and germs in a manner that is relevant to the services
provided;
c) Use and safe
disposal of insecticidal and germicidal preparations.
Legal bases of the
administrative procedure
1. Law on Chemicals
dated November 21, 2007;
2. Law on Investment
dated November 26, 2014;
3. Law on Quality of
Products and Goods dated November 21, 2007;
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
5. Law on Commerce
dated June 14, 2005;
6. Law on Standards and
Technical Regulations dated June 29, 2006;
7. Law No. 28/2018/QH14
dated June 15, 2018 on amendments to some Articles concerning planning of 11
laws;
8. The Government’s
Decree No. 91/2016/ND-CP dated July 01, 2016;
9. The Government’s
Decree No. 155/2018/ND-CP dated November 12, 2018;
10. The Circular No.
278/2016/TT-BTC dated November 14, 2016 of the Minister of Finance.
* Contents of the
sections: Sequence; Documents; Requirements and conditions for following the
administrative procedures; Legal bases; forms and declarations are amended.
Form No. 08
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
……1….., date (dd/mm/yyyy) …
DECLARATION OF ELIGIBILITY TO PROVIDE PREPARATION-BASED
INSECT AND GERM CONTROL SERVICES
To:………………2……………………..
1. Name of the declarant:
……………………………………………………………………………………….
Address: 3
……………………………………………………………………………………….
Phone number:…………………………
Fax: …………………………………………………………..
Email: ………………………… Website
(if any): …………………………………….
2. First-time declaration
□ 4
Re-declaration □ Receipt
form………5……….
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
1
A declaration of
eligibility to provide preparation-based insect and germ control services
□
2
A list of
preparation-based insect and germ control services
□
3
A list of trainees,
which is certified by the declarant.
□
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
LEGAL REPRESENTATIVE
(Signature, full name and seal)
___________________
1 Place name.
2 The Department of Health of the province where the service
provider is located.
3 Write the address written on the business registration
certificate.
4 Check the box.
5 Specify number of the latest receipt form.