THE MINISTRY OF AGRICULTURE AND RURAL DEVELOPMENT
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SOCIALIST
REPUBLIC OF VIETNAM
Independence – Freedom - Happiness
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No. 23/2015/TT-BNNPTNT
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Hanoi, June 22, 2015
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CIRCULAR
MANAGEMENT OF ENVIRONMENTAL REMEDIATION
AND TREATMENT PRODUCTS USED IN LIVESTOCK PRODUCTION AND AQUACULTURE
Pursuant to the
Fisheries Law in 2003;
Pursuant to the Law
on Product and Goods Quality in 2007;
Pursuant to the Law
on Chemicals in 2007;
Pursuant to the Law
on Commerce in 2005;
Pursuant to the Law
on Land in 2014;
Pursuant to the Law
on Enterprise in 2014;
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Pursuant to the
Government's Decree No. 33/2005/NĐ-CP dated March 15, 2005 detailing the
implementation of a number of articles of the Ordinance on Veterinary Medicine
and the Government's Decree No. 119/2008/NĐ-CP dated November 28, 2008 amending
and supplementing a number of articles of the Government's Decree No.
33/2005/NĐ-CP;
Pursuant to the
Government’s Decree No. 89/2006/NĐ-CP dated August 30, 2006 regulating
trademarks of goods;
Pursuant to the
Government's Decree No. 132/2008/NĐ-CP dated December 31, 2008, detailing the
implementation of a number of articles of the Law on Product and Goods Quality;
Pursuant to the
Government’s Decree No. 199/2013/NĐ-CP dated November 26, 2013 defining the
functions, tasks, entitlements and organizational structure of the Ministry of
Agriculture and Rural Development;
At the request of
Director General of Vietnam Directorate of Fisheries, the Director of the
Department of Livestock Production,
The Minister of
Agriculture and Rural Development promulgates the Circular on management of
environmental remediation and treatment products used in livestock production
and aquaculture.
Chapter
I
GENERAL
PROVISIONS
Article
1. Scope and regulated entities
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2. Regulated entities:
This Circular applies to organizations, individuals related to production,
trading, experimentation, testing, examination and verification of
environmental remediation and treatment products within Vietnam’s territory.
Article
2. Interpretation of terms
In this Circular, some
terms are construed as follows:
1. New product
means the product with formula containing new active ingredients, new
combination, and new dosage forms that result in change of product quality,
give new uses and have new users.
2. Certificate of
analysis means product quality analysis sheet issued by competent agencies
or independent laboratory of exporting country.
Article
3. Fees, charges and other expenses
1. Fees, charges
arising from the management of environmental remediation and treatment products
are prescribed according to current regulations of the Ministry of Finance.
2. Expenses for
experimentation, testing, examination and verification shall be based on the
negotiation between facilities conducting experimentation, testing, examination
and verification (hereinafter referred to as the testing facility) and
facilities having products in need of experimentation, testing, examination and
verification (hereinafter referred to as the farming facility) according to the
law provisions.
Chapter
II
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Article
4. Conditions of production facility
Conditions of
production facility (including facilities that carry out processing, portioning
and packing) are prescribed in Clauses 1, 2, 3, 5, 6, 7, 8 of Article 38 of the
Ordinance on Veterinary Medicine, and Clauses 2, 4, 5, 6, 7, 8, Article 52 of
the Government's Decree No. 33/2005/NĐ-CP dated March 15, 2005 detailing the
implementation of a number of articles of the Ordinance on Veterinary Medicine.
Particularly, Clauses 1, 5, 6, Article 38 of the Ordinance on Veterinary
Medicine are detailed as follows:
1. Have Certificate of
enterprise registration or Certificate of investment registration;
2. Persons who
directly involved in production must have health certificate issued by medical
centers from commune level and over; persons who directly involved in
production, testing must obtain the certificate of production and testing
practice for environmental remediation and treatment products
Article
5. Conditions of trading facilities
Conditions for trading
environmental remediation and treatment products (including import, export
facilities) are prescribed in Article 39 of the Ordinance on Veterinary
Medicine and Clause 1, Article 54, Clause 3, Article 55 of the Government's
Decree No. 33/2005/NĐ-CP dated March 15, 2005 detailing the implementation of a
number of the Ordinance on Veterinary Medicine. Particularly, Clauses 1, 3,
Article 39 of the Ordinance on Veterinary Medicine are detailed as follows:
1. Have Certificate of
enterprise registration or Certificate of investment registration;
2. Managers, sale
persons must obtain certificate of business practice for environmental
remediation and treatment products; owners or technical staff of import, export
facilities must obtain certificate of import, export practice for environmental
remediation and treatment products;
Chapter
III
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Article
6. Conditions of facilities conducting experimentation and testing
Conditions of the
testing facility are prescribed in Clause 2, Article 55 of the Government's
Decree No. 33/2005/NĐ-CP dated March 15, 2005 detailing the implementation of a
number of articles of the Ordinance on Veterinary Medicine. Particularly, Point
dd, Clause 2, Article 55 of the Decree No. 33/2005/NĐ-CP are detailed as
follows:
Have adequate tools,
facilities and equipment meeting requirements of experimentation and testing;
In case the testing facility does not have adequate tools, facilities and
equipment for analysis of key factors, they may sign a contract with other
facilities appointed by the Ministry of Agriculture and Rural Development.
Article
7. Documentation, sequence in recognition of facilities' satisfaction of
experimentation and testing conditions
1. Documentation
includes:
a) Request form for
recognition of the testing facility (according to Form No. KN-1 in Appendix I
enclosed herewith);
b) Copy (with
confirmations by facilities) of one of the following papers: Public Service
Provider Establishment Decision; Certificate of enterprise registration (or
Certificate of business registration); Investment registration certificate (or investment
license)
c) Explanation of
conditions of the testing facility (original) (according to Form KN-2a or Form
KN-2b prescribed in Appendix 1 enclosed herewith);
d) Copy of practice
certificate (with confirmations by the testing facility) of facility owners or
technical manager;
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2. Sequence in
recognition of the facilities’ satisfaction of experimentation and testing
conditions:
a) Facilities that
need registration for recognition of satisfaction of experimentation and
testing conditions must formulate one (01) set of documentation sent directly
or by post to Vietnam Directorate of Fisheries (for products used in
aquaculture) or to the Department of Livestock production (for products used in
livestock production);
b) Within two working
days since receipt of documentation, Vietnam Directorate of Fisheries or the
Department of Livestock production shall issue a written request for
supplements if registration documentation is ineligible;
c) Within two working
days since receipt of eligible documentation, Vietnam Directorate of Fisheries
or the Department of Livestock production shall carry out examination and
verification of the documentation and assessment of conditions of the testing
facility;
d) In case conditions
of facilities are found unsatisfactory, Vietnam Directorate of Fisheries or the
Department of Livestock production shall issue a written notification to the
testing facility about non-conformities and issue a written request for
remedial work. Within two working days since receipt of remedial report from
the facility, Vietnam Directorate of Fisheries or the Department of Livestock
production shall carry out consideration of the remedial report and conduct
examination of remedied issues if necessary;
dd) In case conditions
of the testing facility are found satisfactory, Vietnam Directorate of
Fisheries or the Department of Livestock production shall make the submission
to the Ministry for consideration within five working days.
e) Within two working
days after receipt of written approval from the Minister, Vietnam Directorate
of Fisheries or the Department of Livestock production shall issue a written
recognition that the facility meets all conditions for experimentation and
testing (hereinafter referred to as the Recognition). Otherwise, Vietnam
Directorate of Fisheries or the Department of Livestock production shall issue
a written notice to the facility specifying reasons.
g) This Recognition
shall be effective for five years. Six months before the Recognition expires,
if the facility needs extension of the Recognition, it can make re-registration
as prescribed in Clause 1 of this Article.
Article
8. Cases subject to experimentation and testing, content of experimentation and
testing
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a) New products
(domestically produced) prior to registration for circulation;
b) Products imported into
Vietnam for the first time and not on the list of environmental remediation and
treatment products used in livestock production and aquaculture and permissible
for circulation in Vietnam;
2. Content of
experimentation and testing:
a) Inspect components
and quality of products under the announced standard;
b) Assess
characteristics, uses of the products through assessment of variation of
physical, chemical and biological criteria (for aquaculture, it also includes
criteria of total microbial count, plankton, benthos and microorganisms) in the
environment of livestock production and aquaculture; assess other technical
criteria as specified in product documentation.
c) Assess safety level
for human health, farmed subjects and environment during the use: Product
component residues in the environment and animals during the harvest
(applicable to products with chemical components or components limited for use
in livestock production and aquaculture; residues of heavy metal in the
environment and animals during the harvest (applicable to products as natural
minerals); rate of survival and growth of farmed subjects.
Article
9. Documentation and sequence of conducting experimentation and testing
1. Documentation:
a) Request form for
experimentation and testing (according to Form KN-3 in Appendix I enclosed
herewith);
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a) Description of
technical specifications of products (according to Form KN-4 in Appendix I
enclosed herewith);
d) Product quality
test sheet (original);
dd) Outline of
experimentation and testing (original) (according to Form KN-5a or Form KN-5b
prescribed in Appendix 1 enclosed herewith);
e) Contract for
experimentation and testing (original);
g) Certificate of free
sale (original or certified copy) issued by competent state agencies of
countries of origin (applicable to imported products);
2. Sequence of
implementation
a) The farming
facility in need of experimentation and testing of the environmental
remediation and treatment products may choose the testing facility recognized by
Vietnam Directorate of Fisheries or the Department of Livestock production and
formulate a set of documentation as prescribed in Clause 1 of this Article sent
directly or by post to Vietnam Directorate of Fisheries (for products used in
aquaculture) or to the Department of Livestock production (for products used in
livestock production);
b) Within two working
days since receipt of documentation, Vietnam Directorate of Fisheries or the
Department of Livestock production shall issue a written request for supplements
if the documentattion is ineligible;
c) Within 12 working
days since receipt of eligible documentation, Vietnam Directorate of Fisheries
or the Department of Livestock production shall carry out examination and
verification of the documentation under technical standards; In case the
technical standards are not available, Vietnam Directorate of Fisheries or the
Department of Livestock production shall organize a Council of Science for
assessment of the outline of experimentation and testing;
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dd) Within two working
days since receipt of consent of the Minister, Director General of Vietnam
Directorate of Fisheries or Director of the Department of Livestock Production
shall ratify the outline of experimentation and testing, promulgate decision on
experimentation and testing and assign supervision of experimentation and
testing;
In case results of
examination and assessment of the documentation and outline of experimentation
and testing are found unsatisfactory or not approved by the Ministry, Vietnam
Directorate of Fisheries or the Department of Livestock production shall issue
a written notice specifying the reasons;
g) The testing
facility shall carry out experimentation and testing according to the outline
approved by Vietnam Directorate of Fisheries or the Department of Livestock
production.
3. Inspecting
experimentation and testing
a) Fashion of
inspection: Vietnam Directorate of Fisheries or the Department of Livestock
production shall conduct inspection of experimentation and testing no more than
two times during the experimentation and testing of the product or conduct
unexpected inspection if necessary.
b) Content of
inspection: in accordance with the outline of experimentation and testing
approved by Vietnam Directorate of Fisheries or the Department of Livestock
production;
4. Supervision of
experimentation and testing
a) Agency supervising activities
of experimentation and testing (hereinafter referred to as the monitoring
agency) is the agency that administers livestock production or aquaculture and
is subordinate to the Service of Agriculture and Rural development in the
locality where experimentation and testing take place.
b) Content of
supervision of experimentation and testing is instructed in accordance with the
approved outline of experimentation and testing;
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5. Post-monitoring
handling and remedy
a) Based on proposals
from Inspectorate, monitoring agency; Vietnam Directorate of Fisheries or the
Department of Livestock Production shall decide modification of content,
remedial measures and regulations on remedying time.
b) The testing
facility and the farming facility shall carry out modification and remedial
work as decided by Director General of Vietnam Directorate of Fisheries or
Director of the Department of Livestock Production and make the report
according to the prescribed time.
c) Organize
re-inspection of the issues decided by Director General of Vietnam Directorate
of Fisheries or Director of the Department of Livestock Production;
d) Documentation of
inspection and supervision of experimentation and testing of environmental
remediation and treatment products used in livestock production or aquaculture
shall be kept at the Department of Livestock production or Vietnam Directorate
of Fisheries respectively and shall be included in the documentation of
assessment and recognition of products that shall be submitted to the Council
of Science as foundations for assessment.
Article
10. Analysis of products
1. Cases subject to
analysis upon registration for circulation or importation: Products that are
not on the list of environmental remediation and treatment products permissible
for circulation in Vietnam;
2. Content of
analysis: Conduct thorough analysis of key components (containing active
ingredients for environmental remediation and treatment) of the product under
applied or registered standards and other components under corresponding
technical regulations (if any).
3. Facility conducting
analysis (hereinafter referred to as the analyzing facility) is the facility
that is appointed under the Ministry of Agriculture and Rural Development’s
Circular No. 16/2011/TT-BNNPTNT dated April 01, 2011 regulating assessment,
appointment and administration of laboratories in the sector of agriculture and
rural development.
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1.
The environmental remediation and treatment products shall be subject to
examination and verification in the following cases:
a) Upon complaints or
denunciation of quality;
b) At the request of
competent state agencies;
2. Content of
examination and verification: Re-conduct examination and verification of
quality of the products that have undergone experimentation, testing and
analysis, or in circulation.
3. Implementation of
examination and verification: Vietnam Directorate of Fisheries or the
Department of Livestock production shall cooperate with competent agencies and
the examining and verifying facility (facility that conducts examination and
verification of products) appointed by the Ministry of Agriculture and Rural
Development in organizing inspection, collection of specimen, re-verification
of product quality and handling within authority or transferring the result to
competent agencies for handling according to applicable regulations.
4. The examining and
verifying facility is appointed by the Ministry of Agriculture and Rural
Development in accordance with content of examination and verification.
Chapter
IV
SEQUENCE,
PROCEDURES FOR REGISTRATION FOR CIRCULATION OF ENVIRONMENTAL REMEDIATION AND
TREATMENT PRODUCTS
Article
12. First registration, re-registration for circulation, extension of
circulation and change of information about products in circulation
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a) Products are the
result of a research work recognized by the Ministry of Agriculture and Rural
Development as an advance in biological technology according to the Circular
No. 23/2010/TT-BNNPTNT dated April 07, 2010 on recognition of advances in
biological technology of the sector of agriculture and rural development;
b)
New products (domestically produced), products (imported into Vietnam for the
first time) that have undergone experimentation and testing as prescribed in
Article 9 hereof;
c)
Products that meet provisions as set out in Appendix IIA or Appendix IIB
enclosed herewith and corresponding national technical regulations (if any)
2. Re-registration for
circulation: Products eligible for circulation in Vietnam shall be subject to
re-registration in one of the following cases: Changes of components, formula,
dosage forms, users, and methods, production process resulting in change of
product quality; changes resulting from re-assessment of product quality,
efficiency and safety level of products.
3. Registration for
extension of circulation: Six months before circulation of the product expires;
4. Registration for
changes of information about products in circulation
Products eligible for circulation
in Vietnam shall be subject to re-registration in one of the following changes;
a) Change of business
type, business name;
b) Change of label’s
presentation;
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d) Change of head office
or production location;
dd) Change of looks,
color of products without change of quality
Article
13. Documentation for first registration for circulation, re-registration for
circulation, registration for extension of regulation and change of information
about products in circulation
1. Documentation of
first registration:
a) Registration form
for circulation of product (according to Form ĐKLH-1 in Appendix I
enclosed herewith);
b) Copy (with
confirmations by the facility) of one of the following papers: Certificate of
Business registration (or Certificate of Enterprise registration); Investment
registration certificate (or Investment Certificate); Public Service Provider
Establishment Decision;
c) Copy (with confirmations
by the facility) of practice certificate for production or importation of
environmental remediation and treatment products used in livestock production
or aquaculture;
d) Facility standard
(original) or applied standard (copy) with confirmations by the facility;
dd) Label of product
with confirmations by the facility (according to Form ĐKLH-2 in Appendix I
prescribed in Appendix 1 enclosed herewith);
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g) Explanation of
production process (original) (according to Form ĐKLH-e in Appendix I
prescribed in Appendix 1 enclosed herewith) for domestically produced products;
h) Report on results
of research, production and experimentation, and Decision on recognition of
advances in biological technologies issued by the Ministry of Agriculture and
Rural Development (original or copy with confirmations by the facility) with
respect to products as result of research works recognized as advances in
biological technology by the Ministry of Agriculture and Rural Development;
i) Report on result of
experimentation and testing of products (original) (according to Form KN-7
prescribed in Appendix 1 enclosed herewith) applicable to products that have
undergone experimentation and testing;
k) Result of analysis
of products applicable to products registered in accordance with Points a, c,
Clause 1, Article 12 hereof;
l) Certificate of free
sale (original or certified copy) issued by competent state agencies of
producing countries (applicable to imported products) as prescribed in Point c,
Clause 1, Article 12 hereof.
2. Documentation of
re-registration:
a) Requirements as
prescribed in Points a, b, c, d, dd, e, g, Clause 1 hereof;
b) Certificate of free
sale (copy with confirmations by the facility) issued by competent agencies;
c) Report on result of
re-conducting experiment and testing (original) (according to Form KN-7 in
Appendix I enclosed herewith);
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a) Requirements as
prescribed in Points a, b, c, d, dd, e, Clause 1 hereof;
b) Certificate of free
sale (copy with confirmations by the facility) issued by competent agencies;
c) Report on result of
re-conducting experiment and testing (according to Form KN-7 in Appendix I
enclosed herewith);
4. Registration for
changes of information about products in circulation:
a) Requirements as
prescribed in Points b, d, dd, e, Clause 1 hereof;
b) Certificate of free
sale (copy with confirmations by the facility) issued by competent agencies;
c) Written request for
changes of information about the product (according to Form ĐKLH-5
in Appendix I enclosed herewith);
In case registration
is made for multiple products, only one copy of the papers as prescribed in
Points b, c, e, Clause 1, Article 01 hereof is required.
Article
14. Sequence of certifying first registration, re-registration, registration
for extension of circulation and change of information about products in
circulation
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2. Within two working
days since receipt of documentation, Vietnam Directorate of Fisheries or the
Department of Livestock production shall issue a written request for
supplements if the documentation is ineligible;
3. First registration,
re-registration
a) Within 20 working
days since receipt of eligible documentation, Vietnam Directorate of Fisheries
or the Department of Livestock production shall be responsible for carrying out
examination and verification of the documentation according to Form as
prescribed in Appendix III enclosed herewith; organize a council to assess
results of experimentation, testing and analysis of products.
b)
If result of examination, verification and assessment of the documentation
conducted by the Council is found satisfactory, Vietnam Directorate of
Fisheries or the Department of Livestock production shall give comments on
recognition of the product. Comments made by the Ministry shall be given within
five working days.
c) Within two working
days since receipt of written approval from the Minister, Vietnam Directorate
of Fisheries or the Department of Livestock production shall issue certificate
of free sale for individual registered products (according to Form in Appendix
IV enclosed herewith).
d) Otherwise, Vietnam Directorate
of Fisheries or the Department of Livestock production shall issue a written
notice to the facility specifying the reasons.
4. Registration for
extension of circulation:
Within 10 working days
since receipt of eligible documentation, Vietnam Directorate of Fisheries or
the Department of Livestock production shall be responsible for:
a) Organizing
examination and verification of the documentation (according to Form in
Appendix III enclosed herewith) and assessment of result of experimentation, and
reporting the process of production, trading and use of products. If result of
examination, verification and assessment is found satisfactory, Director
General of Vietnam Directorate of Fisheries or the Director of the Department
of Livestock Production shall issue certificate of free sale to each
environmental remediation and treatment product used in aquaculture or in
livestock production respectively to the facility that registers extension of
circulation (according to Form in Appendix IV enclosed herewith);
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5. Registration for
changes of information about products in circulation:
Within 08 working days
since receipt of eligible documentation, Vietnam Directorate of Fisheries or
the Department of Livestock production shall be responsible for:
a) Conducting
examination and verification of the documentation (according to Form in
Appendix IIII enclosed herewith); Issuing certificate of free sale of each
product to the facility (according to Form in Appendix IV enclosed herewith) if
result of examination, verification of the documentation is found satisfactory;
b) Making written
notice to the facility specifying the reasons for not issuing certificate of
free sale;
6. Validity of
certificate of free sale:
a) Validity of
certificate of free sale for products subject to first registration and
re-registration is five years.
b) Validity of
certificate of free sale for products subject to registration for extension of
circulation is three years.
c) Validity of
certificate of free sale for products subject to registration for changes of
information about products is the rest of the validity of the product before
change of information.
7. List of
environmental remediation and treatment products eligible for circulation;
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b) Every first quarter
of year, Vietnam Directorate of Fisheries or the Department of Livestock
production shall make checks, compilation and promulgation of the list of
environmental remediation and treatment products eligible for circulation in
Vietnam and make public announcement on the website of Vietnam Directorate of
Fisheries, the Department of Livestock production and the Ministry of
Agriculture and Rural Development.
Article
15. Products taken out of the list eligible for circulation
1. Products that contain
banned active ingredients according to applicable regulations of the Ministry
of Agriculture and Rural Development;
2. Products that cause
harm to production, environment, food safety and human health and are subject to
re-assessment by the Council of Science as prescribed;
3. Products that are
in circulation but not in conformity with the international regulations to
which Vietnam is committed;
4. Certificate of free
sale that expires but facility owner fails to make registration for extension
of circulation;
5. Products that have
been registered for circulation but their production and trading facility has
stopped its operation;
6. Products that
violate industrial property rights;
7.
Imported products with certificate of free sale being revoked in exporting
country;
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Chapter
V
INSPECTION
OF CONDITIONS OF THE PRODUCTION AND TRADING FACILITY
Article
16. Inspection of conditions of the production and trading facility
1. Inspection agency:
a) Vietnam Directorate
of Fisheries or the Department of Livestock production shall administer
inspection of the facility’s production and trading conditions conducted by
localities and coordinate with local management agencies in conducting
inspection of the production and trading facility as planned or unexpectedly;
b) Local state
management agencies for livestock production and aquaculture shall conduct
inspection of conditions of the production and trading facility in the
administrative division.
2. Sequence and
content of inspection as instructed in the Ministry of Agriculture and Rural
Development’s Circular No. 45/2014/TT-BNNPTNT dated December 03, 2014
regulating inspection of facilities involved in production and trading of
agricultural materials, inspection and certification of satisfaction of food
safety conditions for facilities involved in production and trading of
agricultural, forestry and fisheries products.
Article
17. Product quality inspection
1. Inspection agency:
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b) Management agencies
for livestock production and aquaculture at provincial level shall conduct
quality inspection at the trading facility in the administrative division
within management.
2. Foundations for
inspection:
a) Information and
warnings about exported products that are not in conformity with the conditions
as prescribed in Article 32 of the Law on Product and goods quality;
b)
Result of inspection and survey of product quality, or upon complaints about
quality of products in circulation not in conformity with applied standards,
corresponding national technical regulation or registration for circulation;
c)
Annual inspection plan approved by competent agencies;
3. Fashion of
inspection: Inspectorate established under the decision by the inspection
agency;
4. Content of
inspection:
a) Inspect compliance
with requirements, provisions prescribed in corresponding national technical
regulation related to production conditions and state management measures for product
quality in production; inspect compliance with other provisions prescribed by
the Ministry of Agriculture and Rural Development on product quality
management;
b) Inspect conformity
assessment results, presentation of label, standard and conformity marks, and
documents accompanying product; If necessary, the inspection agency can employ
an expert to carry out assessment of requirements of corresponding technical
regulations; Such expert must be independent, objective, and responsible to the
law for his/her own assessment;
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5. Sequence and
procedures for inspection are instructed in accordance with Clause 3, Article
29 of the Law on Product and goods quality.
6. Handling of result
of inspection of quality of domestically produced products is instructed in
accordance with Article 30 of the Law on Product and goods quality, and Article
6 of the Government’s Decree No. 132/2008/NĐ-CP dated December 31, 2008 providing
guidance on the Law on Product and Goods quality.
Article
18. Imported product quality inspection
1. Inspection agency:
Vietnam Directorate of Fisheries or the Department of Livestock production, or
state management agencies empowered by Vietnam Directorate of Fisheries or the
Department of Livestock production.
2. Cases subject to
inspection:
a) Cases subject to
inspection: Products being imported into Vietnam must be subject to quality
inspection (except products as prescribed in Point b, Clause 2 of this
Article);
b) Cases not subject
to quality inspection: samples, products for demonstration at exhibitions,
trade fairs, products as gifts; temporarily imported goods for re-exportation;
goods in transit; goods in bonded warehouses; goods manufactured for foreign
traders by Vietnamese enterprises; imported products decided by the Ministry of
Agriculture and Rural Development in case of necessity.
3. Foundations for
inspection: technical standards, applied standards, regulations on goods labels
and other law provisions.
4. Content of
inspection:
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b) Inspect labels of
products and regulation conformity marks applicable to products declared as
conformable and conformity with import documentation: Check essential
information written on labels (including secondary labels) including product
names, name and address of facilities responsible for the product; origin of
products and other information as prescribed; conduct organoleptic inspection;
c) Take specimen for
inspection of product quality in following cases: Products receiving
complaints, denunciation or under suspicion of conformity assessment results;
Products with quality found not in conformity with applicable standards and
corresponding technical regulations, or registration for circulation through
result of surveying or inspecting quality of products in circulation conducted
by the inspection agency. Permissible tolerance when performing quality
inspection as instructed in Appendix V enclosed herewith;
5. Handling of inspection
result
Handling of result of
product quality inspection is instructed in accordance with Article 36 of the
Law on Product and goods quality.
Article
19. Documentation and sequence of imported product quality inspection
1. Documentation:
a) Registration form
for quality inspection (according to Form KTCL-1 n Appendix I enclosed
herewith) (two copies);
b) Copy (with
confirmations by the facility) of the following papers: Purchase Agreement,
Packing list;
c) Certificate of
Analysis (certified copy);
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2. Sequence of
implementation
a) Facilities that
register imported product quality inspection should formulate one (01) set of
documentation sent directly or by post to Vietnam Directorate of Fisheries (for
products used in aquaculture) or to the Department of Livestock production (for
products used in livestock production);
b) Within two working
days since receipt of documentation, Vietnam Directorate of Fisheries or the
Department of Livestock production shall issue a written request for
supplements if the documentation is ineligible;
c) Within three
working days since receipt of eligible documentation, Vietnam Directorate of
Fisheries or the Department of Livestock production shall be responsible for
carrying out examination and verification of the documentation as prescribed in
Points a, b, Clause 4, Article 18 hereof. If the documentation is eligible,
Vietnam Directorate of Fisheries or the Department of Livestock production
shall make notification about result of state inspection of imported product
quality (according to Form KTCL-2 in Appendix I enclosed herewith) to importers
and customs authorities for performing customs clearance procedures for the
batch;
d) If the
documentation fails to meet requirements set out in Points a, b, Clause 4,
Article 18 hereof, Vietnam Directorate of Fisheries or the Department of
Livestock production shall make the notice to the importer specifying non-conformities
and remedial time (according to Form KTCL-3 in Appendix I enclosed herewith).
Vietnam Directorate of Fisheries or the Department of Livestock production
shall issue a written notice about satisfaction of quality (of the batch of
imported goods) only if the importer provides proof of satisfactory remedial
work;
dd) If imported
products fall within the cases as prescribed in Point c, Clause 4, Article 18
hereof, Vietnam Directorate of Fisheries or the Department of Livestock
production shall make written confirmations of the registration note for
quality inspection and make notice to the importer and customs authorities for
performing customs declaration. Upon receipt of confirmed registration note,
the importers is permitted to transfer the batch to the address specified in
the registration note, keeps the batch intact without production, trading or
using before result of quality inspection is available. Within no more than ten
working days, Vietnam Directorate of Fisheries or the Department of Livestock
production shall carry out collection of specimen, analysis of quality and
notify the result to the importer. If quality of imported products is found
unsatisfactory, Vietnam Directorate of Fisheries or the Department of Livestock
production shall handle in accordance with Article 36 of the Law on product and
goods quality.
Article
20. Quality inspection for products in circulation
1. Inspection agency:
a) Vietnam Directorate
of Fisheries or the Department of Livestock production shall conduct inspection
of responsibilities of local management agencies for the management of quality
of products in circulation, and irregular inspection of products at the
production and trading facility;
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2. Content, sequence
and procedures for inspection of quality of environmental remediation and treatment
products in circulation are instructed in accordance with Circular No.
26/2012/TT-BKHCN dated December 12, 2012 of the Ministry of Science and
Technology regulating state inspection for quality of products in circulation.
Article
21. Exported product quality inspection
1. Inspection agency:
Vietnam Directorate of Fisheries or the Department of Livestock production or
state management agencies empowered by Vietnam Directorate of Fisheries or the
Department of Livestock production.
2. Subjects under
inspection:
a) Products subject to
recall Sequence, procedures and content of inspection are instructed in
accordance with Article 17 hereof.
b) Exported products
that need inspection, confirmation or certification by competent agencies in
Vietnam. Facilities that have products in need of quality inspection,
confirmation must make registration as prescribed in Clauses 5, 6 of this
Article.
3. Foundations for
inspection: applied standards, regulations of exporting countries, contracts or
International Agreement, international agreements for mutual recognition with
regard to conformity assessments with relevant countries and territories.
4. Content of
inspection: at the request of the facility or conduct inspection in accordance
with regulations of importing countries, contracts or International Agreement,
international agreements for mutual recognition with regard to conformity
assessments with relevant countries and territories.
5. Registration
documentation for product quality inspection at the request of exporters
includes:
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b)
Copy (with confirmations by the facility) of the following papers: Purchase
Agreement, applied standards, product labels and other relevant documents;
c) Copy (with
confirmations by the facility) of either of the following papers: Certificate
of Business registration (or Certificate of Enterprise registration);
Investment Certificate; Public Service Provider Establishment Decision;
d) Copy (with
confirmations by the facility) of result of inspection, assessment and
classification of facility conditions as A or B.
6. Sequence of product
quality inspection at the request of exporters:
a) Facilities that register
exported product quality inspection should formulate one (01) set of
documentation sent directly or by post to Vietnam Directorate of Fisheries (for
products used in aquaculture) or to the Department of Livestock production (for
products used in livestock production);
b) Within two working
days since receipt of documentation, Directorate of Fisheries or the Department
of Livestock production shall issue a written request for supplements if the
documentation is ineligible;
c) Within 10 working
days since receipt of eligible documentation, Vietnam Directorate of Fisheries
or the Department of Livestock production shall carry out examination and
verification of the documentation, make notification to the facility about
plans for collection of specimen; organize collection of specimen or empower
local agencies charged with managing livestock production and aquaculture to
carry out collection of specimen for inspection, transfer the specimen to the
analyzing facility for analysis of product quality;
d) Make notification
of result of exported product quality inspection upon receipt of analysis sheet
issued by the analyzing facility according to Form KTCL-2 in Appendix I
enclosed herewith (if result is satisfactory) or to Form KTCL-3 (if result is
not satisfactory).
Article
22. Inspection of facilities involved in production of environmental
remediation and treatment products in exporting countries
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2. Budget for
inspection shall be allocated by state budget according to applicable
regulations.
Chapter
VI
ISSUANCE OF
PRACTICE CERTIFICATE
Article
23. Conditions on issuance of practice certificate
Conditions on issuance
of certificates of practice of production, trading, importation, exportation,
experimentation and testing of environmental remediation and treatment
productions are instructed in accordance with Article 64 of the Government's
Decree No. 33/2005/NĐ-CP dated March 15, 2005 detailing the implementation of a
number of articles of the Ordinance on Veterinary Medicine, particularly as
follows:
1. Conditions of
degrees in production, trading, importation, exportation, experimentation and
testing of environmental remediation and treatment productions used in
livestock production.
a) Owners or technical
personnel of the facility involved in the production and analysis of
environmental remediation and treatment products used in livestock production
must obtain at least engineering degree in veterinary medicine, livestock
production, and pharmacy degree; have at least two years of experience in the
area registered for practice.
b) Owners of shops
selling environmental remediation and treatment products used in livestock
production must obtain at least vocational certificates in livestock
production, veterinary medicine. Sale persons must obtain at least training
certificate in the area registered for practice issued by state management
agencies.
c) Owners or technical
personnel of the testing facility (in livestock production) must obtain at
least engineering degree in veterinary medicine, livestock production; have at
least two years of experience in the area registered for practice.
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2. Conditions of
degrees in production, trading, importation, exportation, experimentation and
testing of environmental remediation and treatment productions used in
aquaculture.
a) Owners or technical
personnel of facilities involved in production and analysis of environmental
remediation and treatment products used in aquaculture must obtain at least
Bachelor of science degree in chemistry or biology or engineering degree in
aquaculture and have at least two years of experience in the area registered
for practice.
b) Owners of shops
selling environmental remediation and treatment products must obtain at least
vocational certificates in biology or aquaculture. Sale persons must obtain at
least training certificate in the area registered for practice issued by state
management agencies for aquaculture at provincial level;
c) Owners or technical
personnel of the testing facilities must obtain at least Bachelor of science
degree in biology or biochemistry or engineering degree in aquaculture along
with training certificate and have at least two years of experience in the area
registered for practice.
d)
Owners or technical personnel of importers and exporters must obtain at least
Bachelor of science degree in biology or biochemistry or engineering degree in
aquaculture along with training certificate in the area registered and issued
by state management agencies at provincial level.
3. Conditions on
health
Conditions on health
of persons who practice veterinary medicine are instructed in accordance with
Clause 2, Article 64 of the Decree No. 33/2005/NĐ-CP.
4. Conditions on issuance
of practice certificates to foreigners are instructed in accordance with Clause
3, Article 64 of the Decree No. 33/2005/NĐ-CP.
1. Vietnam Directorate
of Fisheries shall award practice certificates in the following areas:
production, trading, importation, exportation, experimentation and testing of
environmental remediation and treatment products used in aquaculture according
to Form CCHN-3 in Appendix I enclosed herewith.
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3. Administration
agencies for aquaculture at provincial level shall award practice certificates
in trading of environmental remediation and treatment products used in
aquaculture according to Form CCHN-4 in Appendix 1 enclosed herewith.
4. Administration
agencies for livestock production at provincial level shall award practice
certificates in trading of environmental remediation and treatment products
used in livestock production according to Form CCHN-4 in Appendix 1 enclosed
herewith.
1. Documentation for
issuance of the first practice certificate:
c) Written request for
issuance of practice certificates (according to Form CCHN-1 in Appendix I
enclosed herewith) accompanied by two color 4x6 photos;
b) Degrees,
certificates (certified copy);
c) Resume;
d) Health certificates
bearing confirmations issued by medical facility from district level and
higher;
dd) Written confirmations
issued by the production facility, testing facility of the period of practice
at the facility applicable to the cases as prescribed in Points a, c, Clauses
1, 2 of Article 23 hereof;
e) Written approval of
head of the agency where the applicant works applicable to the case that
applicants are officials, public servants.
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a) Written request for
extension of practice certificates (according to Form CCHN-2 in Appendix I
enclosed herewith) accompanied by two color 4x6 photos;
b) Awarded practice
certificate (certified copy);
c) Health certificates
bearing confirmations issued by medical facility from district level and
higher;
3. Sequence of
issuance of practice certificate
a) Persons who are in
need of practice certificate must formulate one (01) set of documentation as
prescribed in Clause 1 of this Article sent directly or by post to competent
agencies for issuance of practice certificate as stated in Article 24 hereof.
b) Within two working
days since receipt of documentation, competent agencies for issuance of
practice certificates shall issue a written request for supplements if the
documentation is ineligible;
c) Within two working
days since receipt of documentation, competent agencies shall award the
practice certificate to the applicant if the documentation is ineligible; In
case the practice certificate can not be awarded, competent agencies shall
issue a written notice to the applicant specifying the reasons.
d) Validity of
practice certificate is five years. One month before the practice certificate
expires, any person who needs extension of practice must make submission of one
set of documentation as prescribed in Clause 2 of this Article to competent
agencies for issuance of practice certificate. Sequence of extension of
practice certificate is prescribed in Points b, c, Clause 3 of this Article.
RESPONSIBILITIES
OF RELEVANT PARTIES
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2. Conduct quality
inspection for imported, exported environmental remediation and treatment
products used in aquaculture or empower local management agencies to do the
job;
3. Carry out
examination and verification of documentation and recognize the facility meets
conditions on experimentation and testing of environmental remediation and
treatment products used in aquaculture; carry out examination and verification
of documentation and award certificate of free sale, make checks, compilation
and promulgation of the list of environmental remediation and treatment
products eligible for circulation in Vietnam and post on the website of Vietnam
Directorate of Fisheries and the Ministry of Agriculture and Rural Development;
4.
Award practice certificates in production, experimentation, testing, and
importation, exportation of environmental remediation and treatment products
used in aquaculture;
5. Make submission to
the Ministry of Agriculture and Rural Development for taking the products out
of the list of environmental remediation and treatment products used in
aquaculture eligible for circulation in Vietnam;
6. Make submission to
the Ministry of Agriculture and Rural Development for promulgation of National
technical regulations relating to environmental remediation and treatment
products used in aquaculture;
7. Conduct inspection
of environmental remediation and treatment products across the country; conduct
inspection of responsibilities of local management agencies for management of
environmental remediation and treatment products used in aquaculture;
8. Organize
instruction and execution of this Circular;
1. Perform state
management for environmental remediation and treatment products used in
livestock production across the country; Direct and provide professional
instructions on management of environmental remediation and treatment products
used in livestock production;
2. Conduct quality
inspection for imported, exported environmental remediation and treatment
products used in livestock production or empower local management agencies to
do the job;
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4. Award practice
certificates in production, experimentation, testing, importation, exportation
of environmental remediation and treatment products used in livestock
production;
5. Make submission to
the Ministry of Agriculture and Rural Development for taking the products out
of the list of environmental remediation and treatment products used in
livestock production eligible for circulation in Vietnam according to the law
provisions;
6. Make submission to
the Ministry of Agriculture and Rural Development for promulgation of National
technical regulations relating to environmental remediation and treatment
products used in livestock production;
7. Conduct inspection
of environmental remediation and treatment products across the country; conduct
inspection of responsibilities of local management agencies for management of
environmental remediation and treatment products used in livestock production;
8. Organize
instruction and execution of this Circular;
1. Perform state
management for environmental remediation and treatment products as prescribed
hereof in the administrative division within management;
2. Direct, instruct,
inspect and monitor the management of environmental remediation and treatment
products by subordinate agencies in the administrative division within
management;
3. Organize investigation,
inspection and handling of violations within competence and report result of
management of environmental remediation and treatment products after completion
of investigation and inspection;
4. Assign and direct
local management agencies for livestock production and aquaculture to perform
the followings:
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b) Organize
statistical work, inspection, assessment and classification of the production
and trading facility; carry out quality inspection for environmental remediation
and treatment products in the administrative division as prescribed;
c) Conduct quality
inspection for imported, exported environmental remediation and treatment
products as authorized by Vietnam Directorate of Fisheries or the Department of
Livestock production;
d) Award practice
certificates in trading of environmental remediation and treatment products;
dd) Preside over and
cooperate with relevant management agencies in organizing investigation and inspection
of the production and trading facility at the same time;
e) Organize training
and disseminate regulations of the law on production and trading of
environmental remediation and treatment products;
g) Conduct other tasks
relating to environmental remediation and treatment products as authorized by
Vietnam Directorate of Fisheries or the Department of Livestock production;
h) Compile and report
production and trading, quality of environmental remediation and treatment
products in the administrative division to Vietnam Directorate of Fisheries,
the Department of Livestock production on a six-month basis as assigned;
conduct general reports, annually or unexpectedly at the request of Vietnam
Directorate of Fisheries or the Department of Livestock production; Report
result of investigation, inspection and handling of violations after completion
of investigation and inspection (if any);
1. Formulate outline
and conduct experimentation and testing according to approved outline;
2. Keep confidential
figures and information about test products;
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4. Compensate the
farming facility for expenses for experimentation and testing as well as the
losses caused during the production;
5. Make notification
to Vietnam Directorate of Fisheries, the Department of Livestock production in
case of dissolution or no longer operating in the recognized area;
1. Strictly comply
with provisions as prescribed hereof and other relevant regulations;
2. Take responsibility
to the law and consumers for quality of products produced, imported, recalled
during circulation and distribution;
3. Be subject to
inspection and investigation by competent state agencies; Provide technical
documents, relevant papers, product samples and create favorable conditions for
the inspection agency to fulfill its tasks;
4. Be permitted to
produce and trade environmental remediation and treatment products that are
eligible for circulation in Vietnam.
5. Keep records during
production and trading as prescribed;
6. The production
facility must have regulations and comply fully with such regulations
including: quality control for raw materials, semi-finished products, finished
products, product recycling; arrangement, storage, regular inspection regime,
early handling of problems arising during the production, storage; operation of
equipment, factory clean-up, wastewater treatment, labor safety, fire,
explosion prevention and fighting;
7. Production facility
must conduct quality inspection according to the announced standards, make
registration before delivery and keep product sample for a period at least
equal to product shelf life plus six months;
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9. Carry out
declaration and putting up price according to the law provisions;
10. Report production
and trading of environmental remediation and treatment products to the
management agency on request;
11. Pay fees, charges
as prescribed in Article 3 hereof;
12. Make written notification
to local management agencies for livestock production or aquaculture in case of
change of production location, dissolution or no longer producing registered
product;
13. Make written
notification to local management agencies for livestock production or
aquaculture about content and location for putting the production model into
practice in the administrative division;
IMPLEMENTATION
1. Any facility
recognized as the testing facility as prescribed in the Decision No.
18/2002/QÐ-BTS dated June 03, 2002 promulgating regulations on experimentation
and testing of aquatic breeds, feeds, drugs, chemicals and biological
preparations used in aquaculture, within 12 months since the effective date of
this Circular must carry out registration for re-recognition of the testing
facility as prescribed hereof.
2. Any environmental
remediation and treatment product used in livestock production, aquaculture
that is issued certificate of free sale before June 30, 2011 shall be eligible
for circulation up to June 30, 2016. Any environmental remediation and
treatment product used in livestock production, aquaculture that is issued
certificate of free sale since June 30, 2011 shall be eligible for circulation
until the product completes its five-year circulation time limit. At least
three months before the transitional time limit expires, any facility that
needs extension of circulation of this product must carry out registration as
prescribed in Clause 3, Article 13, and Clause 4, Article 14 hereof.
1. This Circular takes
effect since August 06, 2015.
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Difficulties that
arise during the implementation of this Circular should be reported to Vietnam
Directorate of Fisheries or the Department of Livestock production for early
submission to the Minister of Agriculture and Rural Development for amendments
and supplements./.
PP THE MINISTER
DEPUTY MINISTER
Vu Van Tam
(Enclosed
with Circular No. 23/2015/TT-BNNPTNT dated June 22, 2015 of the Ministry of
Agriculture and Rural Development)
No.
Group
of indicators
Quality
requirements
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All constituents of the
product other than live useful organism and enzymes
± 10% tolerance compared to
the content on certificate of free sale, no banned chemicals found.
2
Live useful organism and
enzymes
Not lower than 90% of the
content on certificate of free sale, no pathogenic microorganisms causing
diseases to animals/aquatic enimals, or environmental pollution found.
3
Net weight, actual volumn on
the lable
± 5% tolerance compared to
information on the label