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THE MINISTRY
OF AGRICULTURE AND RURAL DEVELOPMENT
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SOCIALIST
REPUBLIC OF VIET NAM
Independence - Freedom – Happiness
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No.
03/2013/TT-BNNPTNT
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Hanoi, January
11, 2013
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CIRCULAR
ON MANAGEMENT OF PLANT PROTECTION DRUGS
Pursuant to the Government's
Decree No. 01/ 2008/ND-CP dated January 03, 2008, defining the functions, tasks, powers and organizational
structure of the Ministry of Agriculture and Rural Development, and the
Government's Decree No. 75/2009/ND-CP of September 10, 2009, amending Article 3
of Decree No. 01/2008/ND-CP defining the functions, tasks, powers and
organizational structure of the Ministry of Agriculture and Rural Development;
Pursuant to the Ordinance on
Plant Protection and Quarantine dated July 25,
2001;
Pursuant to the Decree No. 58/2002/ND-CP of the Government dated June 03, 2002 promulgating the Regulation on plant protection, the Regulation
on plant quarantine and the Regulation on
management of plant protection drugs;
Pursuant to the Decree No. 104/2009/ND-CP of the Government
dated November 9, 2009, providing for the list of
dangerous goods and the transportation of dangerous goods by road motorized vehicles;
At the request of the Director of Plant
Protection Department;
The Minister of Agriculture and Rural Development issues the Circular on the management of plant protection drugs.
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GENERAL PROVISIONS
Article 1. Scope of
regulation
This Circular provides for the management of
plant protection drugs including: registration; production, processing, bottling,
packaging; import and export; trading; preservation and transportation; usage;
destruction; labeling; packaging; seminars, advertisement; testing and quality
inspection and residues; certification of regulation conformity and publication
of egulation conformity of plant protection drugs in Vietnam.
Article 2. Subjects of
application
This Circular applies to domestic and foreign
organizations and individuals engaging activities related to plant protection
drugs in Vietnam.
Article 3. Fees and charges
Organizations and individuals engaging in
activities related to plant protection drugs shall pay charges and fees in
accordance with the law provisions on charges and fees.
Chapter II
REGISTRATION OF PLANT
PROTECTION DRUGS
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1. All plant protection drugs which are used to
prevent, eliminate pests or regulate plant growth; to disinfect warehouses and
yards; to preserve agricultural and forest products not using for food and
pharmaceuticals; termite extermination in construction
works, dikes; to do seed treatment must be registered in Vietnam.
2. Domestic or foreign organizations and
individuals (having representative offices, companies, branches of companies
trading plant protection drugs with permission to operate
in Vietnam) that are producers of active ingredient or technical drugs may directly
register one trade name for one active ingredient or
technical drug produced by them.
3. If organizations and individuals that produce
the active ingredient or technique drugs do not directly register the product
under their name, they may authorize one time for domestic or foreign
organizations and individuals (having representative offices, companies,
branches of companies trading plant protection drugs with
permission to operate in Vietnam) to register one trade name for one active ingredient or technical drug produced by them.
4. Each organization or individual who is
authorized for registration can receive only one authorization from one
producer for one active ingredient (can not receive any more authorization from
other producer for the authorized active ingredient) to register for one trade
name.
5. Each organization or individual that produces
the active ingredient or technique drug is allowed to register or authorized to
registere only 01 trade name for 01 active ingredient or technique drug to
prevent and eliminate pests or to regulate plant growth. If the active
ingredients or technique drugs are used for disinfection of warehouses and
yards; preservation of agricultural and forest products but not used for food
and pharmaceuticals, treatment of post-harvest agricultural products; killing
termite in construction works, dikes, seed treatment, they must be registered
under one other trade name.
6. Organizations or individuals taking the name
of registration may change the producer or transfer the trade name or change
the trade name.
Organizations and individuals can be allowed to
transfer only the trade name of plant protection drug that has not yet been
registered.
After the transfer, the unit named in the
registration and the unit transferred the right to name in the registration may
not use the active ingredient of the same type for registering another trade
name.
Registered plant protection drug can be changed trade name only if there is written conclusion by the competent
State agency on intellectual property or the court on the violation of
trademark. The old trade name is canceled and can not be reused.
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7. Organizations and individuals can only apply
for additional registration of trade name of plant protection drug having new
active ingredient that has been named in the registration by other organization
or individual (this new active ingredient is registered for the first time in
Vietnam) for (05) years from the date of issuance of the certificate of
registration of plant protection drugs.
Article 5. Plant protection
drugs subject to permission for registration in Vietnam
1. Plant protection drugs with active
ingredients not yet named on the list of plant protection drugs permitted for
use in Vietnam;
2. Plant protection drugs with active
ingredients named on the list of plant protection drugs permitted for use in
Vietnam but bearing other trade names;
3. Plant protection drugs with trade names on
the list of plant protection drugs permitted for use in Vietnam which have
usages and dosage; use method, formulation and contents of active ingredients
added, or mixed with other to form new ones.
4. Plant protection drugs with active
ingredients named on the list of plant protection drugs limited use in Vietnam
for disinfection of storehouses and yards; for preservation of forest products
and not used as food and pharmaceticals; for termite extermination for
construction works and dikes:
Article 6. Plant protection
drugs not subject to permission for registration in Vietnam
1. Drugs on the list of plant protection drugs
banned from use in Vietnam; drugs on the list of plant protection drugs
restricted from use in Vietnam for control of pests on field.
2. Drugs with active ingredients of single or
mixed suntances invented by foreign organizations or individuals but not yet
registered for use in foreign countries.
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4. Drugs with mixed active ingredients of the
same organizations and individuals to register additional change of active
ingredient ratio but the total content of active ingredients is unchanged
compared with the registered drugs.
5. Drugs in the form of finished products of
group-I acute toxicity or drugs in the form of finished products of group-II
acute toxicity with active ingredients of group-I acute toxicity according to
the classification of WHO, except drugs used for disinfection of storehouses
and yards; drugs for preservation of forest products not used as food and
pharmacetical; for termite extermination for construction works and dikes:
mouse pesticides.
6. Active ingredient or finished product of
plant protection drugs specified in Annex III of the Rotterdam Convention;
active ingredients or finished products of plant protection drugs warned by the
Food and Agriculture Organization of the United Nations (FAO), the United
Nations Environment Programme (UNEP) or the scientific Council of the Ministry
of Agriculture and Rural Development proposed to ban in use in Vietnam.
7. Drugs with chemical toxicity of group I, II,
according to the WHO classification; with active ingredients of organic
chlorine group; with isolation time in Vietnam over 07 (seven) days shall not
be registered for pest prevention, growth regulation for fruit, tea and
vegetables or for after-harvest preservation of agricultural products.
8. Drugs containing methyl bromide.
Article 7. Registration of
plant protection drugs
1. Registration for permit of testing plant
protection drugs
a) The plant protection drugs registered for use
in Vietnam must be registered for permit of testing plant protection drugs in
Vietnam.
b) The chemical plant protection drugs applied
for official registration, trade name must be done bio-effect tests on a small
scale and large scale.
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d) Chemical plant protection drugs firstly
registered for use on fruit trees, tea, vegetables must be done test to
determine the isolated time in Vietnam (except herbicide for fruit trees) .
2. Official registration
The plant protection drugs officially registered
on the list of plant protection drugs permitted for use, restricted use in
Vietnam include:
a) Plant protection drugs containing the active
ingredients firstly registered in Vietnam or a mixture of active ingredients
included in the list of new products invented by foreign organizations
and individuals and registered for use in foreign countries;
b) Plant protection drugs containing the active
ingredients firstly registered in Vietnam or a mixture of active ingredients
included in the list of new products invented by domestic organizations and
individuals and recognized as a plant protection drug by Plant Protection
Department.
3. Additional registration
The plant protection drugs registered
additionally into the list of plant protection drugs permitted for use,
restricted use in Vietnam include:
a) The name for articles of trade different from
plant protection drugs with the same active ingredients in the list;
b) Addition for range of use, dosage, method of
use, form of drug, the content of active ingredients of
plant protection drugs included in the list.
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a) Renewal of registration is applied to drugs on
the list of plant protection drugs permitted for use, restricted use in Vietnam
(for disinfectants for warehouses, yards; preservation for agricultural and
forestry products and not used as food and pharmaceuticals; termite extermination in the buildings, dikes) when the certificate of
registration of plant protection drugs expires.
b) Time limit to apply for renewal registration
is 03 (three) months before the certificate of registration of plant protection
drugs expires.
c) The plant protection drugs which are not made
procedures for renewal registration under the provisions will be excluded from
the list of plant protection drugs permitted for use, restricted use in
Vietnam.
Article 8. The order and
procedures of registration for permit of testing plant protection drugs
1. Filing
a) Organizations and individuals shall apply in
person or send by post to the Department of Plant Protection.
b) Number of dossiers: 02 (two) sets, including
01 (one) hard copy (paper records) and 01 (one) soft copy under PDF format.
c) Inspection of the adequacy of the dossier is
made within 03 (three) working days. If the dossier is complete under
provisions, then receive dossier, if it is not complete, then return the
dossier to organizations, individuals, and request for addition, completion of
dossier.
2. Dossier
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An application for permit of testing plant
protection drug in the form prescribed in Appendix I attached to this Circular;
The original power of attorney of the producer
of the active ingredient or technical drug applying for registration (For the
case of authorization by the manufacturer to other organization, individual);
The original or certified copy of certificate as
the manufacturer of the active ingredient or technical drug issued by the
competent authority of the home country;
The original or certified copy of the
certificate of registration to use drugs in foreign countries for
officially-registered drugs invented in foreign countries or a decision of the
Department of Plant Protection on recognition of it as a plant protection drug
for drugs officially registered in the domestic country;
Detailed technical documentation in Vietnamese
or English, copied, translated from the originals, certified by the producer of
the active ingredient or technical drug defined in Appendix IV issued together
with this Circular;
Drug label sample defined in Chapter IX of this
Circular;
Certified copy of the protection certificate of
industrial property rights issued by the National Office of Intellectual
Property of Vietnam or written proxy, transfer of the right to use the
protection certificates of the ownership rights of products in Vietnam by
owners of such products (if any).
b) For additional registration for range of use,
dosage, use method
An application for permit of testing plant
protection drug in the form prescribed in Appendix I attached to this Circular;
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Drug label sample defined in Chapter IX of this
Circular.
c) For additional registration for form of drug,
content of active ingredient
An application for permit of testing plant
protection drug in the form prescribed in Appendix I attached to this Circular;
A copy of the certificate of registration of
plant protection drug issued;
Drug label sample defined in Chapter IX of this
Circular;
Detailed technical documentation in Vietnamese
or English, copied, translated from the originals, certified by the producer of
the active ingredient or technical drug defined in Section II, Appendix IV
issued together with this Circular.
d) Registration for testing (for the new active
ingredient not included in the list of plant protection drugs permitted for
use, restricted use in Vietnam)
An application for permit of testing plant
protection drug in the form prescribed in Appendix I attached to this Circular;
Chemical safety data sheet (material safety data
sheet).
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The Department of Plant Protection appraises
dossier within 15 (fifteen) working days from the date of receipt of the
complete dossier as prescribed (for the cases prescribed at Point d, Clause 2
of this Article, dossier shall be appraised within 05 (five) working days):
a) If the dossier is valid, meets the technical
requirements specified in Appendix IV issued together with this Circular, then
issue permit of testing plant protection drugs in the form prescribed in Annex
XIII issued together with this Circular.
b) If the dossier has not been valid, has not
met the technical requirements specified in Appendix IV issued together with
this Circular, then inform the organizations and individuals the contents
needed to add, complete documents as prescribed.
c) In case of refusal to grant permit of testing
plant protection drugs, Plant Protection Department informs the organizations
and individuals in writing, stating clearly the reasons.
Article 9. The order and
procedures for official and additional registration of plant protection drugs
1. Filing
a) Comply with the provisions of Point a, c,
Clause 1, Article 8 of this Circular.
b) Number of dossier: 01 (one) hard copy (paper
records) and 01 (one) soft copy under word or excel format for label form.
2. Dossier
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b) A copy of the permit of testing plant
protection drugs issued by the Department of Plant Protection;
c) Drug label sample defined in Chapter IX of
this Circular;
d) The original of biological effect testing
result, testing result of determining isolation duration in the form prescribed
in Annex XVII and XVIII issued together with this Circular.
3. Appraisal of dossier and grant of permit of
testing plant protection drugs
a) The Department of Plant Protection appraises
dossier within 15 (fifteen) working days from the date of receipt of the
complete dossier as prescribed.
If the dossier is valid, meets those specified
in Chapter IX, Chapter XII and the other provisions of this Circular, conduct
the procedures prescribed in point b, c, d, đ, Clause 3 of this Article.
If the dossier has not been valid, has not met
those specified in Chapter IX, XII and other provisions in this Circular, then
inform the organizations and individuals the contents needed to add, complete
documents as prescribed.
b) The Department of Plant Protection holds the
meetings of Advisory Council of plant protection drugs for evaluation and
approval of plant protection drugs requested for official registration and
additional registration for 03 (three) times per year.
c) Right after the result of the meeting of the
Advisory Council is issued, within a maximum period of 10 working days, the
Department of Plant Protection informs the organizations and individuals in
writing the conclusion of the Advisory Council on:
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Acceptance of plant protection drugs applied for
registration but it needs to supplement and complete dossier.
Refusal to accept plant protection drugs applied
for registration and its reasons.
d) The Department of Plant Protection prepares
documentation of drugs reviewed and requested for recognition by the Advisory
Council to submit to the Ministry of Agriculture and Rural Development.
đ) During a period of not more than 15 (fifteen)
working days from the submission date by the Registry, the Minister of
Agriculture and Rural Development issues a Circular of List of plant protection
drugs permitted for use, limited use and banned from use in Vietnam.
Article 10. The order and
procedures for renewal of certificate of registration of plant protection drugs
1. Filing
a) Comply with the provisions of Point a, c,
Clause 1, Article 8 of this Circular.
b) Number of dossier: 01 (one) hard copy (paper
records) and 01 (one) soft copy under word or excel format for label form.
2. Dossier
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b) The original of the certificate of
registration of plant protection drugs issued;
c) Drug label circulated or drug label sample if
any changes to the contents provided for in Chapter IX of this Circular.
3. The Department of Plant Protection appraises
dossier within 5 (five) working days from the date of receipt of the complete
dossier as prescribed
a) If the dossier is valid, meets those
specified in Chapter IX and the other provisions of this Circular, the certificate
of registration of plant protection drugs shall be issued in the form
prescribed in Appendix XIV issued together with this Circular.
b) If the dossier has not been valid, has not
met those specified in Chapter IX and other provisions in this Circular, then
inform the organizations and individuals the contents needed to add, complete
documents as prescribed.
c) In case of refusal to grant permit of testing
plant protection drugs, the Plant Protection Department informs the
organizations and individuals in writing, stating clearly the reasons.
Article 11. The order and
procedures for changing the producer of plant protection drugs
1. Filing
Comply with the provisions of Clause 1, Article
8 of this Circular.
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a) An application for changing the producer in
the form specified in Appendix III issued together with this Circular;
b) The original power of attorney of the
producer of the active ingredient or technical drugs (In case of authorization
by the producer to other organizations, individuals);
c) The original or certified copy of the
certificate as the producer of the active ingredient or technical drugs issued
by the competent authoriy of the home country;
d) Detailed technical documentation in
Vietnamese or English, copied, translated from the originals, certified by the
producer of the active ingredient or technical drug defined in Appendix IV
issued together with this Circular;
đ) The original of the permit of testing plant
protection drugs, plant protection drug registration certificate granted;
e) Drug label sample defined in Chapter IX of
this Circular.
3. Appraisal of dossier and grant of permit of
testing plant protection drugs, plant protection drug registration certificate
Department of Plant Protection appraises dossier
within 15 (fifteen) working days from the date of receipt of the complete
dossier as prescribed.
a) If the dossier is valid, meets those
specified in Appendix IV issued together with this Circular, then issue permit
of testing plant protection drugs, plant protection drug registration
certificate in the form prescribed in Appendix XIII, XIV, issued together with
this Circular. The validity of the new permit of testing plant protection
drugs, certificate of registration of plant protection drug shall unchange the
valid term of the permits granted.
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c) In case of refusal to grant permit of testing
plant protection drugs, plant protection drug registration certificate, the
Plant Protection Department informs the organizations and individuals in
writing, stating clearly the reasons.
Article 12. The order and
procedures for the transfer of the trade name of plant protection drug.
1. Filing
a) Comply with the provisions of Point a, c,
Clause 1, Article 8 of this Circular.
b) Number of dossier: 01 (one) hard copy (paper
records) and 01 (one) soft copy under word or excel format for label form.
2. Dossier
a) An application for transfer of trade name in
the form specified in Appendix III issued together with this Circular;
b) The original or certified copy of the transfer
contract or agreement to transfer product;
c) The original of permit of testing plant
protection drugs, plant protection drug registration certificate granted;
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đ) Drug label sample defined in Chapter IX of
this Circular.
3. Appraisal of dossier and grant of permit of
testing plant protection drugs, plant protection drug registration certificate:
a) Department of Plant Protection appraises
dossier within 15 (fifteen) working days from the date of receipt of the
complete dossier as prescribed.
If the dossier is valid, meets those specified
in this Circular, permit of testing plant protection drugs shall be issued in
the form prescribed in Appendix XIII issued together with this Circular.
If the dossier has not been valid, then inform
the organizations, individuals the contents needed to add, complete documents
as prescribed.
In case of refusal to grant permit of testing
plant protection drugs, plant protection drug registration certificate, the
Plant Protection Department informs the organizations, individuals in writing,
stating clearly the reasons.
b) For trade names of plant protection drugs included
in the List of plant protection drugs permitted for use, restricted use in
Vietnam: If the dossier is valid, meets those specified in this Circular, the
Plant Protection Department submits to the Ministry of Agriculture and Rural
Development. Within a period of less than 15 (fifteen) working days from the
submission date by the Registry, the Minister of Agriculture and Rural
Development issues a Circular of the List or Circular amending, supplementing
the List of plant protection drugs permitted for use, restricted use, banned
from use in Vietnam.
Within 10 (ten) working days from the signing
date of this Circular, the Department of Plant Protection shall grant
certificate of registration of plant protection drugs in the form prescribed in
Appendix XIV issued together with this Circular.
c) The validity of the new permit of testing
plant protection drugs, certificate of registration of plant protection drug
shall unchange the valid term of the permits granted.
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1. Filing
a) Comply with the provisions of Point a, c,
Clause 1, Article 8 of this Circular.
b) Number of dossier: 01 (one) hard copy (paper
records) and 01 (one) soft copy under word or excel format for label form.
2. Dossier
a) An application for change of trade names in
the form specified in Appendix III issued together with this Circular;
b) The original of permit of testing plant
protection drugs, plant protection drug registration certificate granted;
c) Drug label sample defined in Chapter IX of
this Circular;
d) The original or certified copy of the
document issued by the competent State agency on intellectual property, or of
the court of violating trademark for plant protection drug which has been
granted certificate of registration of plant protection drug.
3. Appraisal of dossier and grant of permit of
testing plant protection drugs, plant protection drug registration certificate
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Article 14. The order and
procedures for re-grant of permit of testing plant protection drugs, plant
protection drug registration certificate
1. The cases subject to re-grant
a) The original permit of testing plant
protection drug, plant protection drug registration certificate remaining valid
but lost, misplaced;
b) The original permit of testing plant
protection drug, plant protection drug registration certificate remaining valid
but damaged, unable to continue the use;
c) Upon detection of errors or change of the
information in the permit of testing plant protection drug, plant protection
drug registration certificate;
d) Change of the name of the organization or
individual that registers;
đ) Change of the permit of testing chemical plant
protection drugs on the list to register additionally range of use and dosage
to use, method of use, form of drugs, content of the active ingredient;
e) Adding up the certificates of registration as
required by the organizations and individuals that register.
2. Filing
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b) Number of dossier: 01 (a) hard copy (paper
records).
3. Dossier
a) An application for re-grant in the form
specified in Appendix III issued together with this Circular;
b) The original permit of testing plant
protection drugs, plant protection drug registration certificate (for the cases
specified at Point b, c, d, đ, e, Clause 1 of this Article);
c) A copy of the business registration
certificate (for the cases specified at Point d, Clause 1 of this Article);
d) Drug label sample defined in Chapter IX of
this Circular (for the cases specified at Point c, d, Clause 1 of this
Article).
3. Appraisal of dossier and re-grant
a) Department of Plant Protection appraises
dossier within 05 (five) working days after receiving a complete dossier in
accordance with provisions:
If the dossier is valid, then grant permit of
testing plant protection drugs, plant protection drug registration certificate
in the form prescribed in Appendix XIII, XIV, issued together with this
Circular.
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If refusing to grant permit of testing plant protection
drugs, plant protection drug registration certificate, Plant Protection
Department informs the organizations, individuals in writing and stating
clearly the reasons.
b) In the case specified at Point d, Clause 1 of
this Article, it shall comply with the provisions of Point b, Clause 3, Article
12.
c) The validity of the permit of testing plant
protection drugs, plant protection drug registration certificate re-granted
shall be remained the valid term of the permit granted. For the cases specified
at Point e, Clause 1 of this Article, the validity of the plant protection drug
registration certificate re-granted is the shortest term of the certificate of
registration of plant protection drugs granted.
Article 15. Withdrawal of
the permit of testing plant protection drugs, plant protection drug
registration certificate granted
The cases required to be withdrawn:
1. Permit of testing plant protection drugs,
plant protection drug registration certificate erased, repaired its content;
2. Use of false documents and information
provided untruthfully in the registration dossier;
3. There are other violations required to be
withdrawn by law.
Article 16. Standard
substance
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2. Standard substance is required to have a
analysis certificate issued by a laboratory obtained ISO standards or
equivalence and with use life from 02 (two) years or more.
Article 17. Registry and
responsibilities of the Registry
1. Department of Plant Protection is the
Registry of plant protection drugs in Vietnam.
2. Responsibilities of the Registry:
a) To receive registration dossiers and standard
substance;
b) To appraise, archive and keep secret records;
c) To give the results of appraisal, grant and revoke
the certificate of registration of plant protection drugs, permit of testing of
plant protection drugs;
d) To organize the meetings of the Advisory
Council to approve the drugs applied for official registration, consult the
members of the Advisory Council on the drugs registered additionally and
prepare documentation to submit to the Minister of Agriculture and Rural
Development for issuing Circular of the List of plant protection drugs
permitted for use, restricted use, banned from use in Vietnam after being
proposed for recognition by the Advisory Council;
e) To collect fees, charges for issuance and
re-issuance of permits of testing plant protection drugs; certificate of
registration of plant protection drugs; to renew the certificate of registration
of plant protection drugs according to current regulations.
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1. Certificate of registration of plant
protection drugs is valid for a period of 05 (five) years.
03 (three) months before the certificates of
registration of plant protection drugs expire, the organizations and
individuals must apply for renewal of registration certificate in case of
having renewal demand to the Plant Protection Department. Dossiers, order and
procedures for renewal of certificate of registration of plant protection drugs
shall comply with the provisions of Article 10 of this Circular.
2. Permit of testing plant protection drugs is
valid within a period of 05 (five) years.
Permit of testing plant protection drug is not
extended. In case the organizations, individuals have not conducted the test,
but the duration of the permit of testing plant protection drug expires, the
organizations, individuals shall register for grant of permit of testing plant
protection drug as defined in Article 8 of this Circular.
Article 19. Duration for
recordkeeping
1. Recordkeeping duration: 05 (five) years for
hard copy, 10 (ten) years for soft copy.
2. When the recordkeeping duration expires,
records shall be destroyed in accordance with current regulations.
Chapter III
PRODUCTION, PROCESSING,
BOTTLING, PACKAGING OF PLANT PROTECTION DRUGS
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1. Only manufacturing, processing, bottling and
packaging the drugs on the list of plant protection drugs permitted for use, restricted
use in Vietnam and the drugs permitted to import for processing, bottling and
packaging for re-export purpose under contracts signed with foreign countries.
2. Organizations and individuals producing,
processing, bottling and packaging plant protection drugs must meet the
conditions set out in Article 7 of the Regulation on the management of plant
protection drugs, issued together with the Decree No. 58/2002/ND-CP of June 03,
2002, Decree No. 59/2006/ND-CP of June 12, 2006 of the Government detailing the
implementation of the Commercial Law on goods and services banned business,
limited business and traded with conditions and Article 12 of the Decree No.
108/2008/ND-CP of October 07, 2008 of the Government detailing and guiding the
implementation of a number of Articles of the Law on Chemicals.
3. Those who directly operate the producing,
processing, bottling and packaging of plant protection drugs must have a
practicing certificate issued by the provincial-level Branch of Plant
Protection.
Article 21. Registration
for production, processing, bottling and packaging of plant protection drugs
1. Competent State agency grants business
registration for the production, processing, bottling and packaging of plant
protection drugs only when those who directly manage and operate these
activities have practicing certificates issued by local State management agency
on plant protection.
2. Applicants for a practicing certificate of
production, processing, bottling and packaging of plant protection drugs must meet
the conditions set out in Article 8 of the Regulation on the management of
plant protection drugs, issued together with the Decree No. 58/2002/ND-CP of
June 03, 2002.
Procedures for grant of practicing certificate
of production, processing, bottling and packaging of plant protection drugs
shall comply with the provisions of the Minister of Agriculture and Rural
Development.
3. Facilities producing, processing, bottling
and packaging plant protection drugs are permitted their operations only when
they are granted certificates of eligibility for production, processing,
bottling and packaging of plant protection drugs under the provisions of the
Decree No. 59/2006/ND-CP of June 12, 2006 of the Government detailing the
implementation of the Commercial Law on goods and services banned from
business, limited business and traded with condition.
The order and procedures for granting
certificates of eligibility for production, processing, bottling and packaging
of plant protection drugs shall comply with the provisions of the Minister of
Agriculture and Rural Development.
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1. Production, processing, bottling and
packaging of drugs must comply with the production process, technical
regulations and quality standards registered.
2. To take responsibility before the law if
their production, processing, bottling and packaging of plant protection drugs
cause adverse effects to humans, animals and the environment.
3. To take responsibility for quality and other
law provisions for drugs produced by the facilities within the use life
circulated in the market.
4. To report periodically in writting to the Department
of Plant Protection and Plant Protection Branch in the area of the
production, processing, bottling and packaging of plant protection drugs in the
quarter IV of each year.
5. To notify in writing to the Department of
Plant Protection upon relocation of factories, workshops; production capacity,
operation forms, type of drugs produced, processed, bottled, packaged;
discontinuity of production, processing, bottling and packaging.
Article 23.
Responsibilities of the Department of Plant Protection
1. To receive the reports on the production,
processing, bottling and packaging; the notices of discontinuity of production,
processing, bottling and packaging of plant protection drugs of the
organizations, individuals and synthesize to report to the Ministry of
Agriculture and Rural Development.
2. To inspect and examine annually; to take
irregular inspection and examination of the facilities of production,
processing, bottling and packaging of plant protection drugs when required.
Chapter IV
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Article 24. General
principles
1. The organizations, individuals with business
registration certificates of plant protection drugs or agricultural supplies
are allowed to export and import plant protection drugs.
2. Only allowed to import drugs, plant
protection drug materials in the list of plant protection drugs permitted for
use in Vietnam issued by the Minister of Agriculture and Rural Development,
when the import is not required permit, but conduct import procedures at the
customs office.
3. For plant protection drugs authorized to
export, import, units receiving authorization of export, import must present a
letter of attorney (authorized by the producer to the exporter; authorized by
the registration unit to the importer) to the customs office.
4. Import of drugs, plant protection drug
materials in the following cases must be permitted by the Plant Protection
Department:
a) Drugs, plant protection drug materials in the
list of plant protection drugs restricted use in Vietnam;
b) Drugs, plant protection drug materials
outside the List of plant protection drugs permitted for use in Vietnam: drugs
used for scientific research and testing; used in foreign projects in Vietnam;
drugs for processing, bottling, packaging and re-export under contracts signed
with foreign countries; drugs as goods samples, for exhibitions, fairs and
drugs used in other particular cases;
c) The standard substance of plant protection
drugs outside the List of plant protection drugs permitted for use in Vietnam
to serve the inspection, research.
5. Plant protection drugs in the List of plant
protection drugs permitted for use or restricted use in Vietnam which are
imported must meet the following requirements:
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b) Raw materials or technical drugs must have a
minimum content of active ingredient equal to the active ingredient content of
raw materials or technical drugs in the List of plant protection drugs
permitted for use, restricted use in Vietnam and imported from the producers
with clear origin.
6. Do not import the active ingredients or
finished plant protection drugs in Appendix III of the Rotterdam Convention.
7. Form of permit to import drugs and plant
protection drug materials is specified in Appendix VII issued together with
this Circular.
Article 25. Grant of import
permit of drugs and plant protection drug materials
The order and procedures for granting import
permits of drugs and plant protection drug materials shall comply with the
provisions of the Circular No. 88/2011/TT-BNNPTNT dated November 28, 2011 of
the Minister of Agriculture and Rural Development Rural guiding the
implementation of the Decree No. 12/2006/ND-CP detailing the implementation of
the Commercial Law on agent activities, purchase, sale, processing and transit
of goods with foreign countries in the fields of Agriculture, Forestry and
Fisheries.
Article 26. Report regime
At the end of the quarter IV of each year, the
organizations and individuals that export, import plant protection drugs must
make written reports, statistics on the export and import of plant protection
drugs to the Plant Protection Department.
Article 27. Export and
import of plant protection drugs containing methyl bromide active
ingredient
1. Conditions for export and import of methyl
bromide.
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b) Register with the Department of Plant
Protection a import volume of methyl bromide used for different purposes: plant
quarantine; export disinfection (QPS) and other purposes (non-QPS) of the
following year before December 15 of the previous year.
c) Department of Plant Protection allocates
volume of methyl bromide imported in year before January 30 of the following year
based on the registration and operation scale of the fumigation practicing
organization and roadmap of eliminating gradually methyl bromide which Vietnam
has signed internationally.
d) Permit to import methyl bromide is specified
in Appendix VIII issued together with this Circular. Validity period of the
import permit is December 31 of the licensing year and may not be extended in
any case.
đ) With certificate of business registration of
plant protection drugs or agricultural materials allowed to export and import
plant protection drugs.
2. The order and procedures for granting import
permit of methyl bromide shall comply with the provisions of the Circular No.
88/2011/TT-BNNPTNT dated November 28, 2011 of the Minister of Agriculture and
Rural Development guiding the implementation of the Decree No. 12/2006/ND-CP
detailing the implementation of the Commercial Law on agent activities,
purchase, sale, processing and transit of goods with foreign countries in the
fields of Agriculture, Forestry and Fisheries.
3. Responsibility of the organizations exporting
and importing plant protection drugs containing methyl bromide
a) Only permitted to use methyl bromide in
accordance with registration with the Department of Plant Protection and shall
be subject to inspection and examination by state management agencies in the
use of methyl bromide;
b) Permitted to sell drugs containing methyl
bromide only for the organizations eligible to practice fumigation in
accordance with the law provisions;
c) Make annual report to the Department of Plant
Protection on the situation of fumigation activities in the form prescribed in
Appendix 7 regulating state management on fumigation of objects subject to
plant quarantine issued together with the Decision No. 89/2007/QD-BNN dated
November 01, 2007 of the Minister of Agriculture and Rural Development on the
sale of methyl bromide in the form prescribed in Appendix IX issued together
with this Circular. The deadline for submission of the 06-earlier-month report
of the year is before July 15 and annual report before Janualy 15 of the
following year.
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a) Failing to comply with report regime
according to regulations or making dishonest report on the import, use and sale
of methyl bromide.
b) Using methyl bromide for improper purpose
with the one registered or changing export disinfection use purpose in plant
quarantine (QPS) to the other purposes (non-QPS).
c) Importing additionally for the activities
other than the purposes of quarantine and export disinfection (non-QPS).
Chapter V
SALE OF PLANT PROTECTION
DRUG
Article 28. General
principles
1. Organizations and individuals trading plant
protection drugs must meet the conditions specified in Article 16 of the
Regulation on the Management of plant protection drugs, issued together with
the Decree No. 58/2002/ND-CP of June 03, 2002 and Article 7 of the Government's
Decree No. 59/2006/ND-CP of June 12, 2006 of the Government detailing the
implementation of the Commercial Law regarding goods and services banned from
business, restricted business and traded with conditions.
2. Only traded plant protection drugs on the
list of plant protection drugs permitted for use, restricted use in Vietnam
issued by the Minister of Agriculture and Rural Development.
3. Only traded plant protection drugs of
finished product form which are still in use life, with clear origin, clear
label in accordance with the provisions of Chapter IX of this Circular and other
provisions of law on goods label.
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5. The foreign or domestic organizations,
individuals registering, distributing plant protection drugs in Vietnam must
take responsibility for the quality of plant protection drugs circulated in the
market.
Article 29. Registration of
plant protection drug trade
1. Competent State agencies grant business
registration only for the trade of plant protection drugs when the traders of
plant protection drugs have practice certificates issued by the
provincial-level Plant Protection Branches.
2. Applicants for practice certificates of
trading plant protection drugs must meet the conditions specified in Article 17
of the Regulation on the Management of plant protection drugs, issued together
with the Decree No. 58/2002/ND-CP dated June 03, 2002 of the Government and
Article 3 of the Decree No. 98/2011/ND-CP of October 26, 2011 of the Government
amending, supplementing some Articles of the Decree on agriculture.
3. Organizations, individuals that trade plant
protection drugs are only permitted to operate when they are issued
certificates of eligibility for trading plant protection drugs under the
provisions of the Decree No. 59/2006/ND-CP dated June 12, 2006 of the
Government detailing the implementation of the Commercial Law regarding goods
and services banned from business, limited business and traded with conditions.
4. The order, procedures for granting practice
certificates of trading plant protection drugs, certificates of eligibility for
trading plant protection drugs shall comply with the provisions of the Minister
of Agriculture and Rural Development.
Article 30. Location of
trading plant protection drugs
Location for trading plant protection drugs must
be approved by the commune-level authorities; it must be away from schools,
hospitals, markets and water source; must ensure the safety for humans, animals
and the environment; it must not be flooded in all circumstances; have adequate
fire fighting facilities and meet the requirements specified in Clause 2,
Article 19 of the Regulation on the Management of plant protection drugs issued
together with the Decree No. 58/2002/ND CP dated June 03, 2002 of the
Government.
Chapter VI
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Article 31. General
principles
1. The transportation of drugs, plant protection
drug materials must comply with the provisions of the Decree No. 104/2009/ND-CP
of November 09, 2009 of the Government on the list of dangerous goods and the
transportation of dangerous goods by road motorized vehicles, the law on
traffic order and safety of road, railway, inland waterway and the provisions
of the relevant law.
Plant protection drugs prescribed in Appendix I
attached to the Government's Decree No. 104/2009/ND-CP dated 01/09/2009 must be
permitted transportation.
2. The transportation of drugs, plant protection
drug materials must comply with the schedule specified in the contract or other
documents related to the transportation of plant protection drugs between the
means owner and the owner of the goods.
3. The transportation of drugs, plant protection
drug materials must ensure the safety to people and the environment. Do not
stop the vehicle in crowded areas, near schools, hospitals, markets, sources of
drinking water.
4. Drugs, materials of plant protection drug are
transported only when they are packaged and labeled and be granted permit for
transportation of drugs, materials of plant protection drug by the competent
authority as provided for in Article 33 of this Circular.
5. The plant protection drugs that have the
ability to react to each other should not be transported on the same vehicle.
6. It must be not transported plant protection
drugs, drug materials on the same vehicles carrying passenger, pets, food,
flammable, explosive substances and other goods, except fertilizers.
Article 32. Transportation
of plant protection drugs, drug materials
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a) The drivers of the vehicles, the goods
escorters must understand clearly the dangerous nature of plant protection
drugs, drug materials such as: toxic, flammable, explosive, corrosive, and must
know the preliminary treatment when problems occur during the transportation of
plant protection drugs, drug materials and shall comply with the provisions of
the law on transportation of dangerous goods.
b) Addition to the certificate of the driver’s
license in accordance with the current regulations of the State, the drivers of
transportation means of plant protection drugs, drug materials must also have
occupational safety training certificate in transportation, storage of plant
protection drugs, drug materials.
c) The escorters of goods as plant protection
drugs, drug materials must be trained in occupational safety in transportation,
storage of plant protection drugs, drug materials.
2. Packaging, barrel or containers of plant
protection drugs, drug materials in the process of transportation
a) Must be made of durable and waterproof, tough
materials;
b) Must be pasted up with dangerous symbol of
black skull and crossbones on a white background in a lopsided square. The size
of the dangerous symbol pasted up on each barrel of plant protection drugs,
drug materials is 100 mi-li-meters (mm) x 100 mi-li-meters (mm) and pasted up
on the container is 250 mi- li-meters (mm) x 250 mi-li-meters (mm) in the form
prescribed in Appendix VI attached to this Circular;
c) Must have dangerous sign of rectangular,
orange yellow color, in the middle stated the code of the United Nations (UN),
the dangerous sign size is 300 mi-li-meters (mm) x 500 mi-li- meters (mm) in
the form prescribed in Appendix VI attached to this Circular, located at the
bottom of dangerous symbol. For drug packaging and barrel, the dangerous sign
is smaller in accordance with the rate of packaging and barrel, but it must be
ensured a clear view of the dangerous sign.
3. Means of transportation of plant protection
drugs, drug materials
a) The common means of transportation permitted
the circulation for transportation of goods by the competent agencies shall
transported plant protection drugs, drug materials.
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With tools, equipment of fire-fighting and
prevention appropriate to plant protection drugs, drug materials as
transportation;
With hood, canvas to cover totally the goods
compartment to ensure waterproof during the transportation;
Do not use trailers to transport plant
protection drugs.
c) Transportation means of plant protection
drugs, drug materials will be loaded at the end of each ferry, if the ferry
does not have exclusively used ferry for dangerous goods.
d) Transportation means of barrels of plant
protection drugs, drug materials must be pasted up dangerous symbol of the
transported goods group. The size of the dangerous symbol pasted up on vehicles
is 500 mi-li-meters (mm) x 500 mi-li-meters (mm). Location of dangerous symbol
is on the sides and rear of vehicles.
4. Troubleshooting
When getting trouble caused by broken, traffic
accidents during transportation of plant protection drugs, drug materials,
drivers, escorters or owners of the goods must take troubleshooting and
simultaneously announce immediately to the local authorities or nearest
competent state agency to take measures to prevent and remedy the consequences
caused by the drug leakage. The offender shall bear all costs for remedy.
Article 33. Permit of
transportation of plant protection drugs, drug materials.
1. Organizations, individual transporting a
quantity of plant protection drugs, drug materials from 1,000kg/vehicle or more
are required to have permit for transportation of plant protection drugs, drug
materials issued by Branch of Plant Protection at provincial level.
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3. The valid duration of permit for
transportation of plant protection drugs, drug materials is granted according
to each batch or from time to time but not exceeding 12 months from the date of
issuance.
4. Form of permit for transportation of plant
protection drugs, drug materials is specified in Appendix XI issued together
with this Circular.
Article 34. The order and
procedures for grant of permits for transportation of plant protection drugs,
drug materials
1. Filing
Organizations, individuals requesting for
permits for transportation of plant protection drugs, drug materials shall
submit in person or send by post one (01) set of dossier to the competent
authority in accordance with provisions of Clause 1 of Article 33 of this
Circular.
2. Dossier
a) An application for a permit for
transportation of plant protection drugs, drug materials in the form prescribed
in Appendix X, issued together with this Circular;
b) A copy of the certificate of training in
occupational safety in transportation, storage of plant protection drugs, drug
materials of the vehicle driver or the goods escorter (bring the original for
comparison when filing);
c) One of the following papers (certified copy):
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Contract of transporting plant protection drugs,
drug materials;
Financial invoice on export, import of goods as
plant protection drugs;
The declaration of transporting goods of the company
(with certification and seal of the company)
d) Freight schedule, address and telephone
number of the goods owner (with certification and seal of the company).
3. Appraisal of dossier and grant of permit for
transporting plant protection drugs, drug materials
Within 03 (three) working days after receiving a
complete dossier in accordance with provisions, the competent agency shall
appraise dossier, if the dossier is valid, a permit for transporting plant
protection drugs, drug materials shall be issued.
if the dossier is not valid, within 01 (a)
working day after receiving complete dossier, the competent agency informs the
organization, individual the contents needed to add, complete the dossier in
accordance with regulations.
If refusing to grant permit for transporting
plant protection drugs, drug materials, within 01 (a) working day, the
competent agency informs the organization, individual in writing and states
clearly the reasons.
Article 35. Content of the
training on occupational safety in transportation, storage of plant protection
drugs, drug materials
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1. The contents of training on occupational
safety regulated in the Circular No. 37/2005/TT-BLDTBXH dated December 29, 2005
of the Ministry of Labor, War Invalids and Social Affairs guiding the training
on occupational safety and health;
2. The documents related to the transportation
and storage of dangerous chemicals;
3. The characteristics of plant protection
drugs;
4. Signals, symbols and signs of dangerous
goods;
5. The measures to ensure the safe
transportation of plant protection drugs, drug materials (first aid, road
safety, basic knowledge on the use of protective instruments);
6. The measures of precaution and
troubleshooting for each type of plant protection drug.
Article 36. Responsibility
for the organization of training and granting training certificate
1. Plant Protection Department under the Ministry
of Agriculture and Rural Development is responsible for setting up contents,
training program for storekeepers, the goods escorters and drivers of
transportation means of plant protection drugs.
2. Provincial-level Plant Protection Branch
collaborates with the training facilities, vocational facilities, enterprises
to organize training according to program content provided for in Article 35 of
this Circular and grants training certificate in form provided in Appendix XII
issued together with this Circular.
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Article 37. Warehouses of
plant protection drugs, drug materials
1. Locations of the warehouses of plant
protection drugs, drug materials outside the industrial zones must be
approved by the commune-level authorities.
2. Warehouses must be built solidly, made of
refractory materials, not be flooded, ensured an aeration and convenience for
the facilities of fire-fighting to operate; ensured the requirements of TCVN
5507:2002 Dangerous chemicals - safety regulations in production, sales, use,
storage and transportation.
3. Warehouses must be equipped with fire
extinguisher, poison prevention tools, emergency instruments and with dangerous
symbol printed black skulls, crossbones on a white background in a lopsided
square with the size like the symbol of dangerous goods of the vehicle or
container specified in Appendix VI issued together with this Circular.
4. Drug warehouses must meet the provisions of
the law on environmental protection.
Article 38. Preservation of
plant protection drugs
1. The preservation of plant protection drugs
must ensure the safety to humans, animals and the environment in the
surrounding area.
2. The storekeepers must be trained in
occupational safety in the preservation of plant protection drugs.
3. In the case of drug leakage, diffusion
causing harm to the environment, drug owners are responsible for overcoming
consequences under the supervision or inspection of plant protection agencies,
environmental management agencies , commune-level authorities and bear all
expenses for such remedy.
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USE OF PLANT PROTECTION
DRUGS
Article 39. General
principles
1. Only use plant protection drugs on the list
of plant protection drugs permitted for use or the list of plant protection
drugs restricted use in Vietnam issued by the Minister of Agriculture and Rural
Development.
2. Use plant protection drugs in compliance with
instructions that have been written on the label.
3. The use of plant protection drugs must ensure
the principle of four rights: right drug, right time, right dose and right
method; must comply with the isolation time indicated on the label.
4. Prohibit the use of plant protection drugs in
the list of plant protection drugs banned from use in Vietnam; drugs outside
the list allowed to use, outside the list restricted use in Vietnam; drugs of
unknown origin; drugs without labels or with label in foreign languages only.
Article 40.
Responsibilities of users of plant protection drugs
1. Use plant protection drugs for the right purpose
and ensure the safety for their own, the community and the environment.
2. The users of plant protection drugs must take
responsibility before law for the following acts:
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b) Use of banned drugs, use of drugs outside the
list of plant protection drugs permitted for use, the list of plant protection
drugs restricted use in Vietnam, use of drugs of unknown origin;
c) Dispose of the packaging used to contain the
drugs, pouring of the drugs not compliance with provisions causing adverse
impact on the health of humans, animals and the environment.
3. If the use of plant protection drugs causes
physical damage to others, it must pay compensation or causes damage on the
health and lives of others, in addition to compensation, it must also be
handled according to law.
Article 41.
Responsibilities of the management agencies and the units trading plant
protection drugs
1. State management agencies on plant protection
and quarantine of the provinces and cities directly under the Central
Government collaborate with the authorities to inspect the use of plant
protection drugs in the manufacturing sectors, particularly in the areas
specialized in the production of vegetables, tea, and fruit trees; to detect
and handle the cases of deliberate violation of the general principles on the
use of plant protection drugs prescribed in Article 39 of this Circular; to
instruct the collection of packaging of plant protection drugs after they are
used to dispose in accordance with regulations.
2. Commune People's Committees are responsible
for managing the local sale and use of plant protection drugs; coordinating
with the specialized agencies on plant protection and quarantine to organize
the dissemination, guiding the effective use of plant protection drugs,
prescribing locations of drug packaging collection after they are used and
handling the violations.
3. Organizations, individuals trading plant
protection drugs must instruct specifically, clearly the drug buyers, and take
responsibility before law and pay compensation for economic damages due to the
inadequate, incorrect, inaccurate propagation, advertising, using instruction
of plant protection drugs making drug buyers and users confuse, causing harm to
the health of humans, animals, the environment and harm to production.
Chapter VIII
DESTRUCTION OF PLANT
PROTECTION DRUGS AND PACKAGING
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Destruction of plant protection drugs, packaging
must meet the requirements specified in Article 22 of the Regulation on
management of plant protection drugs, issued together with the Decree No.
58/2002/ND-CP of June 03, 2002 of the Government and the provisions of the law
on hazardous waste disposal.
Article 43. The destruction
1. The process of collection, destruction of
plant protection drugs, packaging may not scatter, spread or increase hazardous
waste into the environment; must ensure the safety to humans, animals and the
environment.
2. The destruction of plant protection drugs and
packaging shall comply with the provisions of the law on environmental
protection.
3. Organizations, individuals having plant
protection drugs and packaging forced the destruction shall bear all costs of
destruction. If plant protection drugs and packaging forced the destruction
without owner on any locality, provincial-level People's Committee use the
budget to carry out the destruction according to regulations.
Chapter IX
LABEL OF PLANT
PROTECTION DRUGS
Article 44. General
principles
1. All plant protection drugs when being sold
and used must have labels in Vietnamese, the label contents must be consistent
with the contents of the label sample approved by the Plant Protection
Department upon registration, in compliance with the provisions of the Decree
No. 89/2006/ND-CP dated August 30, 2006 of the Government on the goods label
and instructions of the Globally Harmonized System of classification and
labeling of goods.
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If major label is not written adequately the
required information, it must have auxiliary labels attached to each package.
The contents: the trade name; name of the
organization or individual being responsible for the drug; origin;
quantitative; production date; use term of the drug must be written on the
major label.
3. The label must be stuck or printed on the
drug packaging.
4. Label background is not coincided with the
color indicating the toxicity of plant protection drugs.
5. Names of active ingredient or materials (technical
drugs) are written only on the label in the item "components".
6. Any change in the content of label against
the label sample approved upon registration must be approved by the Plant
Protection Department.
7. Plant protection drugs restricted use must be
stated "drugs restricted in use" on the label (for example: drug for
warehouse disinfection restricted use Alumifos 56% TB).
8. Some drugs that are required by the
management agency of plant protection drugs to warn the drug users, on their
labels, it must be recorded the proper warnings on demand (for example: may not
use drugs on rice after flowering; may not use drugs in the aquaculture
sector).
Article 45. Content written
on labels of plant protection drugs
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a) Product information
Trade name;
Finished product form denoted according to the
provisions on system of international sign on raw materials and finished
products of plant protection drugs of CropLife Organization (CropLife International
Codes for Technical and Formulated Pesticides) is defined in the Appendix XX
issued together with this Circular;
The name, composition and content of active
ingredient: specify unit in g/kg (for plant protection drugs under solid,
viscous liquid, aerosol or volatile liquid forms); unit in g/l (for other
liquid form) or percentage of weight (% w/w);
Solvent (if it alters the toxicity of the drug):
the name and content of the solvent. Unit and recording method as for the
active ingredient;
Real volume, unit of l or ml (for liquid drugs);
net weight in kg or g (for drugs in the form of powder, granules); number of
pellets, net weight in kg or g (for pellet drugs).
b) Information on safety
Information on toxicity in accordance with the
provisions of Section 1 and Section 7 of Appendix V issued together with this
Circular;
Image, color bar indicating the toxicity, toxic
group of drugs in accordance with the provisions of Appendix VI issued together
with this Circular;
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c) Information on use
Using instructions appropriate with the contents
registered;
Image for instruction of preservation,
preparation and use (if any);
Isolation duration (days);
The ability to mix with other drugs (if any).
d) Other information
Number of registration of plant protection
drugs;
Name of organization or individual registering;
Name and address of the unit taking final
responsibility for the products in Vietnam;
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Date of processing or bottling and packaging;
use life (recorded in the same place, it is able to be abbreviated);
Preservation conditions.
2. Technical drugs
a) Name of the active ingredient;
b) Name, composition and content of active
ingredient: specify unit in g/kg, g/l or percentage of weight (% w/w);
c) The real volume, net weight;
d) Name and address of the importer;
đ The producer's name, address of the producer;
e) Date of manufacture; use life (recorded in
the same place, it is able to be abbreviated).
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PACKAGING OF PLANT
PROTECTION DRUGS
Article 46. General
principles
The packaging of plant protection drugs must comply
with the requirements of TCVN 5507:2002 Dangerous chemicals - safety
regulations in production, sales, use, storage and transportation, and the
following requirements:
1. Plant protection drugs must be packed in good
quality packaging; applied to all types of packaging of plant protection drugs
including the type of packaging recycled or reused. Packaging must ensure that:
a) Good quality that can withstand normal impact
and shocks during the transportation and transfer of goods between the vehicles
and unloading them into warehouse manually or with motorized equipment;
b) It must be closed to ensure that there is no
loss of chemicals in the process of preparing transportation or transportation
with effects such as vibration, increase of temperature, moisture and pressure;
c) The outer packaging must be clean and free
from any dangerous chemicals.
2. The parts of the packaging exposed to plant
protection drugs must ensure that:
a) It is not be affected or impaired quality due
to the chemical’s influence packed inside;
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c) It is used the appropriate inert lining to be
the protective lining layer, isolate the packaging with plant protection drugs
packed inside.
3. When packing plant protection drugs in liquid
form, it is necessary to leave the space needed to ensure that the package does
not leaked or deformed because of the increased volume of the liquid packaged
when the temperature increases the during transportation.
4. The inner packaging layers (when the plant
protection drugs are packed two layers) must ensure that under normal
conditions of carriage, they can not be broken, punctured or leaked out the
substances packed into the outer packaging layer.
5. The inner packaging in the form of easy to
break or puncture as glass, porcelain, or a certain type of plastics need to be
inserted firmly to the outer packaging with appropriate insert materials,
vibration reducing buffer.
6. The plant protection drugs which are not
packed together in the same outer packaging or in a large cellular, as these
chemicals can react with each other and cause:
a) fire or great heat
b) heat or burning creating suffocating gas,
oxidization or toxic gases;
c) Create the strong corrosive substances;
d) Create the instable substances.
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8. Liquid must be packed with appropriate
packaging resistant to pressure from the inside generated in the process of
transportation.
9. The packaging of plant protection drug
produced or recycled, reused must ensure the technical requirements as prescribed.
10. The types of empty containers, packaging
contained plant protection drugs must be managed as the packaging that is
containing plant protection drugs.
11. All containers used for storage of liquid
plant protection drugs must be tested the leak before use.
12. Packaging of plant protection drugs in the
form of granules or powder should be tight enough so as not to fall or need the
closed padding layers.
Chapter XI
INFORMATION, SEMINAR,
ADVERTISING OF PLANT PROTECTION DRUGS
Article 47. General
principles
1. Only conduct information, seminar,
advertising of drugs in the list of plant protection drugs permitted for use in
Vietnam.
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2. Contents of seminars, advertising of plant
protection drugs must be consistent with the contents of the certificate of
registration of plant protection drugs of such drugs.
3. All commercial seminars on plant protection
drugs of the business organizations, individuals must have introduction program
on "Safety in the use of plant protection drugs". Content of the
program according to the Decision No. 779/QD-BVTV dated 22/5/2011 of the Plant
Protection Department issuing basic standards of TCCS 20:2010/BVTV on guidances
of effective and safe use of plant protection drugs.
4. Do not conduct information, seminars,
advertising, recommendation of the use of plant protection drugs which are not
in compliance with provisions in Article 48, not be consistent with the use
purpose of the drugs registered; recommend the use of drugs contrary to the
technical process issued by the authorities.
Article 48. Information,
seminar, advertising of plant protection drugs
1. Plant protection drug information must
ensure:
a) Honesty, clearity, objectiveness on function,
effect, features and method to use the drug as well as the bad effects of drugs
on humans, animals and the environment;
b) Guidance of drug use must be adequate, easy
to understand, not misleading, misunderstood and confused; consistent with the
contents registered, to ensure that drugs are used rationally, safely and
effectively.
2. Seminar, advertising of plant protection
drugs:
a) Advertising of plant protection drugs must
comply with the provisions of the law on advertising;
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3. Information on seminars, conferences, events,
exhibitions, those who transfer advertising products, advertising objects and
other advertising media having introduction of plant protection drug product,
marketing of plant protection drug, science education program sponsored by the
plant protection drug company on the local media is required to have written
consent of the content of Provincial-level Plant Protection Branch.
4. The order, method to perform and dossier’s
component registering for advertisement shall comply with the law on
advertisement.
Chapter XII
TESTING OF PLANT
PROTECTION DRUGS
Article 49. General
principles
1. Only conduct testing of plant protection drugs
in the field in Vietnam when having permit for testing in Vietnam. For tested
drugs for registration purpose, the testing must be made by qualified
organizations.
Organizations and individuals directly
conducting the testing of plant protection drug are not allowed to know the
name of drug tested to ensure the objectivity.
2. Make biological effect testing to determine
the effectiveness of pest prevention or plant growth regulation (including the
safety for plant) in the cultivation conditions of the main production areas on
the territory of Vietnam.
3. Testing for determining the isolation
duration is to determine a duration from the last use of plant protection drug
until product is harvested in cultivation conditions of of the main production
area on the territory of Vietnam.
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a) Biological effect testing;
b) Testing for determining the isolation
duration;
c) For drugs of plant growth regulation, in
addition to the biological effect testing, testing for determining the
isolation duration, it also evaluates the effects of drugs to a number of
indicators of the quality of products corresponding to each kind of plant.
Article 50. Form and scale
of testing for registration purpose
The forms, scale of testing for an plant object
and a kind of pest:
1. Biological effect testing
a) Narrow area testing is the testing on a
small-scale. Testing area is from 25-50 square meters (m2)/square,
repeat 3-4 times; must conduct at least 02 (two) production areas (north and
south), each testing area is made at 02 (two) locations and should be conducted
in 02 (two) different production seasons. For plants or pest that only have at
01 (one) the production area, it conducts testing only at 03 (three) different
locations in 02 (two) seasons of the production area.
b) Large area testing is the testing made on a
large-scale, with an area of 300-500 square meters (m2);
it must conduct at least 02 (two) production areas (north and south), each area
is made at 01 (one) location and is carried out in 01 (one) production season.
For plants or pest that only have at 01 (one) the production area, it conducts
testing in 02 (two) different locations in such production area.
c) For perennial plants and special testing
objects (agricultural pests in warehouse, processing of after-harvest
agricultural products, forest pests, field rat, warehouse rat and
agglomeration, work termites), the size of the testing square must comply with
specialized testing process.
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a) Testing for determining the isolation
duration of plant protection drugs for crops is carried out on a large scale,
with an area of 300-500 square meters (m2),
shall not repeat, at 02 (two) production areas (north and south) in 02 (two)
production seasons.
b) For plants only 01 season/year, the testing
is conducted in 02 (two) different locations in 01 (one) production season.
c) For plants only having at 01 (one) production
area, conduct the determination of isolation duration in 02 (two) locations in
02 (two) of production seasons of such area. For plants only having in 01 (one)
production area and having 01 season/year, the testings are conducted in 04
(four) different locations in such production area.
Article 51. Conditions for
the implementation of testing plant protection drugs
1. The head of the organization must have a
university degree or higher specialized in plant protection or in cultivation,
biology, and chemical with training certificate of testing plant protection
drugs.
2. Having a team of staffs who work as plant
protectors and have been trained in testing of plant protection drugs.
3. Having technical facilities meeting the
requirements of the plant protection drug testing.
4. It may not be directly tested plant
protection drugs registered by the testing organization or authorized to
register plant protection drugs in Vietnam.
Article 52. Responsibilities
of the organization conducting the testing of plant protection drugs
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2. To perform full, serious testing process and
testing requirements.
3. Not to organize, guide for visiting the field
tested plant protection drugs without the consent of the Department of Plant
Protection.
4. To take responsibility before law for the
accuracy of testing result.
5. To report testing results in the form
prescribed in Appendix XVII and Appendix XVIII issued together with this
Circular.
6. To keep all the raw data of the testing at
least 05 (five) years from the ending date of the testing.
Article 53.
Responsibilities of the organizations and individuals that have plant
protection drug products need tested
1. Organizations and individuals having plant
protection drugs need to be tested shall send in person or by post 01 (a) set
of dossier to the organization testing plant protection drug, including:
- A certified copy of the permit of testing
plant protection drugs issued by the Department of Plant Protection;
- The drug sample.
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a) True type, quality as for testing requirements
and specified in the permit of testing plant protection drugs;
b) Adequate quantity;
c) Packed carefully with seal or intact in the
producer's packaging.
3. To provide the Department of Plant Protection
full information on the products need to be tested as provided for in Article
8, Article 16 of this Circular and propose dose, concentration for testing. To
take responsibility for the accuracy of such information. In case the tested
products cause damage to humans, plants, animals and the environment, the
organizations and individuals having products must take responsibility for
paying compensation for damages under Vietnamese law.
Article 54.
Responsibilities of the Department of Plant Protection
1. To manage and organize the activities on
plant protection drug testing to ensure objectivity and accuracy.
2. To specify the organizations to conduct the
testing of plant protection drugs.
3. To train staffs working in the field of
testing plant protection drugs.
4. To organize the inspection, evaluation of the
results of the testing of plant protection drugs.
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Chapter XIII
INSPECTION OF QUALITY,
RESIDUES, CERTIFICATION AND DISCLOSURE OF THE PLANT PROTECTION DRUGS
Article 55. General
principles
1. Inspection of quality of plant protection
drugs is the determination of the active ingredient, form of drug, content of
impurities potentially causing toxicity to plants, humans or contamination to
the environment (if any), the content of additives having the effect of
enhancing the safety of the product to humans, plants (if any); chemical and
physical properties related to the biological activity and safety of the drug
in the preservation and use.
2. Inspection of plant protection drug residues
in agricultural and forest products, food and the environment (called as
articles) is the determination of the amount of the active ingredient and other
metabolic products of plant protection drug having toxicity remaining in the
articles.
3. Plant protection drugs required to be
inspected quality include technical drugs and finished product of imported
plant protection drugs; finished product of in-warehouse plant protection
drugs, factories for production, processing, bottling, packaging, and sale.
4. Plant protection drugs and materials imported
must be sampled to inspect the quality before being imported and comply with
the Circular No. 77/2009/TT-BNNPTNT dated December 10,
2009 of the Minister Ministry of Agriculture and Rural Development regulating
the state inspection on the quality of imported plant protection drugs.
5. The state inspection of plant protection drug
residues in agricultural products of imported plant product shall comply with
the Circular No. 13/2011/TT-BNNPTNT dated March 16, 2011 of the Minister of
Agriculture and Rural Development guiding the food safety inspection of
imported plant products and the current legal documents.
6. The state inspection of quality of plant
protection drugs and plant protection drug residues in agricultural products of
plant product circulated on the market shall comply with the Law on Quality of
Products, Goods and the Circular No. 16/2009/TT-BKHCN dated June 02, 2009 of
the Minister of Science and Technology guiding the state inspection on quality
of goods circulated on the market.
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8. The state inspection of quality of plant
protection drugs and plant protection drug residues in agricultural products of
plant product is made in eligible organizations designated by the Ministry of
Agriculture and Rural Development or agencies decentralized by the Ministry of
Agriculture and Rural Development.
The designation of the testing organizations
shall comply the Circular No. 16/2011/TT-BNNPTNT dated April 01, 2011 of the
Minister of Agriculture and Rural Development regulating assessment,
designation and management of the laboratories of agriculture and rural development
and the Circular No. 52/2012/TT-BNNPTNT dated October 22, 2012, amending and
supplementing a number of Articles of the Circular No. 16/2011/TT-BNNPTNT dated
April 01, 2011 and the Circular No. 54/2011/TT-BNNPTNT dated August 03, 2011.
9. Certification of regulation conformity and
announcement of regulation conformity are the activities required for the
organizations and individuals engaged in production and trading of plant
protection drugs.
Article 56. Bases for
inspection of plant protection drug quality, residues, certification of
regulation conformity and announcement of regulation conformity.
1. Sampling for inspection of quality and
residues of plant protection drugs must comply with the national standard TCVN
8143: 2009: plant protection drugs - Determination of the content of
cypermethrin active ingredient, Appendix A, the sampling method; TCVN 5139 :
2008: The sampling recommendation method to determine the residues of plant
protection drugs in accordance with the maximum residue limits (MRL).
Minute of sampling for inspection of quality and
residues of plant protection drugs shall be in the form prescribed in Appendix
XV and Appendix XVI issued together with this Circular.
2. Inspection of quality and residues of plant
protection drugs must comply with the national technical regulation (QCVN),
national standards (TCVN); basis standards (TC) of the Plant Protection
Department (if there is no national technical regulations, national standards).
In case of having no above bases, apply the international documents, regional
documents and producers of plant protection drugs.
3. Bases for certification of regulation
conformity and announcement of regulation conformity of plant protection drugs
shall be specified in the national technical regulation (QCVN), national
standards (TCVN), basis standards (TC) of the Plant Protection Department
announced annually by the Plant Protection Department.
4. Sample for inspection of quality and residues
of plant protection drugs must be preserved for a period of 03 (three) months
from the date of receipt of sample.
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Article 57. The order and
method of implementation
1. Inspection of quality and residues of plant
protection drugs
a) Sample sending
Organizations and individuals having plant
protection drugs required for inspection of quality or agricultural products
need to be inspected residues of plant protection drugs (collectively called as
sample) send in person or send via post an amount of samples in accordance with
provisions of sampling standard for inspection, inspection requirement slip is
specified by the inspection organization and sampling minute (if any).
The persons who receive samples shall review the
requirement slip, inspect sample status and give time limit for returing result
according to provisions.
b) Inspection and inspection result issuance
Within a period of not more than 15 (fifteen)
working days from receipt of samples, the inspection organizations shall inform
the inspection results.
2. Certification and announcement of regulation
conformity of plant protection drugs shall comply with the provisions of the
Circular No. 55/2012/TT-BNNPTNT dated October 31, 2012 of the Minister of
Agriculture and Rural Development guiding procedures to designate the
organizations of regulation conformity certification and and announcement of
regulation conformity of drugs, the scope of State management of the Ministry
of Agriculture and Rural Development.
Article 58.
Responsibilities of the Department of Plant Protection
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2. Train staffs working in the inspection
activities of quality and residues of plant protection drugs;
3. Designate the regulation conformity
certification organizations, laboratories of plant protection drugs in
accordance provisions of the Circular No.55/2012/TT-BNNPTNT, the Circular
No.16/2011/TT-BNNPTNT and the Circular No. 52/2012/TT-BNNPTNT. A List of
regulation conformity certification organizations, laboratories, national
technical standards (QCVN), national standards (TCVN), basis standards (TC) are
publicly announced on the website of the Department of Protection plant.
Chapter XIV
IMPLEMENTATION
PROVISIONS
Article 59. Transitional
provisions
1. Plant protection drugs specified in Clause 7,
Article 6 of this Circular are only imported, manufactured, sold, used for a
maximum period of 02 (two) years from the effective date of this Circular; if
the Certificate of registration of plant protection drugs expires, it shall be
extended only for enough 02 (two) years from the effective date of this Circular.
2. Plant protection drugs specified in Clause 5,
Article 6 of this Circular are only sold, used for a maximum period of 06 (six)
months from the effective date of this Circular.
If the plant protection drugs are newly added to
Appendix III of the Rotterdam Convention, the plant protection drugs are warned
by the Food and Agriculture Organization of the United Nations (FAO), the
Environment Programme of the United United Nations (UNEP) or are proposed for
banning use in Vietnam by the Scientific Council of the Ministry of Agriculture
and Rural Development, they were excluded from the list of plant protection
drugs permitted for use, restricted use and are imported, manufactured, traded
and used only for a maximum period of 02 (two) years from the effective date of
the decision of the competent authorities.
3. Chemical plant protection drugs registered on
vegetables, fruit trees and tea trees which have been granted permit for
inspection but did not provide for testing the isolation duration prior to the effective
date of this Circular, it must test the isolation duration.
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5. Foreign organizations and individuals
directly bearing the name of registration but have not met the provisions of
Clauses 2, 3 and 4 of this Circular shall comply with the provisions for a
period of 01 (one) year from the effective date of this Circular.
Article 60. Effect
This Circular takes effect from February 25,
2013.
This Circular replaces the Circular No.
38/2010/TT-BNNPTNT dated June 28, 2010 of the Minister of Agriculture and Rural
Development regulating management of plant protection drugs and Article 1 of
the Circular No. 18/2011/TT-BNNPTNT dated April 06, 2011 of the Minister of
Agriculture and Rural Development on the amendment, supplement or annulling of
a number of provisions of the administrative procedures in the field of plant
protection and quarantine under the Resolution No. 57/NQ-CP dated December 15,
2010.
Article 61. Responsibility
for implementation
The units of the Ministry of Agriculture and
Rural Development, Departments of Agriculture and Rural Development of the
provinces and cities directly under the central government, the relevant
organizations and individuals shall implement this Circular;
In the course of implementation, if there are
difficulties and problems, the organizations and individuals should reflect to
the Ministry of Agriculture and Rural Development (Department of Plant
Protection) for prompt settlement. /.
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FOR THE
MINISTER
DEPUTY MINISTER
Bui Ba Bong