Circular No. 03/2013/TT-BNNPTNT dated January 11, 2013 of the Ministry of Agriculture and Rural Development on management of plant protection drugs

THE MINISTRY OF AGRICULTURE AND RURAL DEVELOPMENT

Circular No. 03/2013/TT-BNNPTNT dated January 11, 2013 of the Ministry of Agriculture and Rural Development on management of plant protection drugs

Pursuant to the  Decree No. 01/2008/ND-CP dated January 03, 2008 of the Government defining the functions, tasks, powers and organizational structure of the Ministry of Agriculture and Rural Development, and the Decree No. 75/2009/ND-CP dated September 10, 2009 of the Government amending article 3 of the Government’s Decree No. 01/2008/ND-CP dated January 3, 2008, 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 dated June 03, 2002 of the Government 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 dated November 09, 2010 of the Government providing for the list of dangerous goods and the transport of dangerous goods by road motor 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.

Chapter 1

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 regulation 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

Article 4. General principles

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 register 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.

The change of producer, transfer of trade names and rename of plant protection drugs have to follow relevant legal procedures prescribed in Article 11, Article 12 and Article 13 of this Circular.

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 pharmaceuticals; 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 substances invented by foreign organizations or individuals but not yet registered for use in foreign countries.

3. Drugs with trade names identical with the names of active ingredients or trade names of registered drugs;

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 pharmaceutical; 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 Program (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.

c) The biological plant protection drugs applied for official registration, trade name; plant protection drugs registered for additional range of use, dosage, method of use, form of drug, the content of active ingredients must be done bio-effect tests on a small scale and large scale.

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.

4. Renewal of certificate of registration of plant protection drugs.

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

a) For official registration and additional registration of trade names

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;

A copy of the certificate of registration of plant protection drug issued;

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).

3. Appraisal of dossier and grant of permit of testing plant protection drugs

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

a) An application for registration of plant protection drug in the form prescribed in Appendix II issued together with this Circular;

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:

Acceptance of plant protection drugs applied for registration and grant of certificate of registration of plant protection drugs in the form prescribed in Appendix XIV issued together with this Circular and such drug is permitted for circulation.

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

a) An application for renewal of certificate of registration of plant protection drugs in the form specified in Appendix II issued together with this Circular;

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.

2. Dossier

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 authority 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;

dd) 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 unchanged the valid term of the permits granted.

b) If the dossier has not been valid, has not met those 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 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;

d) The original power of attorney of the producer of the active ingredient or technical drugs to the organization, individual who receives the transfer;

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 unchanged the valid term of the permits granted.

Article 13. The order and procedures for change of trade names 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

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

Comply with the provisions of Clause 3, Article 12 of this Circular.

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

a) Comply with the provisions of Point a, c, Clause 1, Article 8 of this Circular.

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.

If the dossier is valid, then inform the organizations and individuals the contents needed to add, complete documents as prescribed.

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

1. Organizations, individuals with chemical plant protection drugs (official registration, trade article name) must submit 02 (two) gram (g) of standard substance for each active ingredient of the drug registered to the Registry when receiving permits of testing plant protection drugs.

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.

Article 18. Validity of the certificate, permit

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

Article 20. General principles

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.

Article 22. Responsibilities of the organizations and individuals producing, processing, bottling and packaging plant protection drugs

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 writing 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

EXPORT, IMPORT OF PLANT PROTECTION DRUGS

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:

a) Finished plant protection drugs must have a content of active ingredient, drug form and manufacturer in compliance with the certificate of registration of plant protection drugs in Vietnam.

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.

a) Import, export plant protection drugs containing methyl bromide only from or to the countries joining the Montreal Protocol.

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 January 15 of the following year.

4. The organizations shall not import methyl bromide if they violate one of the following cases:

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.

4. The ones who directly trade plant protection drugs and the managers of the facilities trading plant protection drugs must have practicing certificates issued by the Department of Provincial-level Plant Protection.

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

TRANSPORTATION, STORAGE OF DRUGS AND DRUG MATERIALS OF PLANT PROTECTION

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

1. The carriers of plant protection drugs, drug materials

a) The drivers of the vehicles, the goods scoters 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 scoters 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.

b) Means of transportation of plant protection drugs, drug materials must meet the following technical conditions:

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, scoters 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.

2. Permit for transportation of plant protection drugs, drug materials is valid for nationwide circulation.

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 escorted (bring the original for comparison when filing);

c) One of the following papers (certified copy):

Supply contract;

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

The driver of vehicle, the goods escorted, storekeepers shall be trained the following contents:

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 scoters 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.

3. The organizations, individuals involved in the transportation of plant protection drugs, drug materials must ensure storekeepers, the goods scoters and vehicle drivers of plant protection drugs are trained according to the contents provided for in Article 35 of this Circular.

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.

Chapter VII

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:

a) Use of drugs not compliance with technique recommended, not ensuring the isolation period;

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

Article 42. General principles

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.

2. Main labels and auxiliary labels are printed in normal font size, a minimum size of eight (font Times New Roman or equivalent), it is clear, easy to read, not tarnished or easily torn in the process of circulation, storage, transportation and use.

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 Aluminous 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

1. Finished drugs

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;

The safe measures when using and after using and poisoning first aid measures in accordance with the provisions of Section 5 and Section 6, Appendix V issued together with this Circular.

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;

Origin of goods;

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).

Chapter X

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;

b) There are no dangerous effects, effects interacting or reacting with drugs of plant protection in the package;

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.

7. The tightness of the package for the volatile substances must be tight enough to ensure that in the process of transportation, liquid level does not fall below the limit level.

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.

Drugs in the list of plant protection drugs restricted use in Vietnam are only for seminar to recommend the safe use.

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 guidance 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, clarity, 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;

b) The advertising of plant protection drugs must be accompanied by warning on toxic, hazardous properties and guidelines to prevent the harmful effects of plant protection drugs advertised;

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 the main production area on the territory of Vietnam.

4. Testing of plant protection drugs aimed at registration for being included in the list of plant protection drugs permitted for use in Vietnam includes:

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.

2. Testing for determining the isolation duration

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 testing 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

1. To register to participate in network of testing plant protection drugs with the Plant Protection Department.

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.

2. Submission of drug sample tested must ensure the following requirements:

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.

5. To use the testing results for the evaluation to serve the registration of drugs and instructions for use when the drugs have been permitted for use in Vietnam.

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.

7. State management agencies on plant protection and quarantine take samples for quality inspection of finished product of plant protection drugs in the facilities of production, processing, bottling, packaging once a year for the facilities certified GMP (Good Manufacturing Practices), ISO (International Standards Organization) or equivalent quality management system; not more than twice a year for the remaining facilities without detection of violations. When detecting violations, inspection frequency may be higher.

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.

5. Result of inspection of quality and residues of plant protection drugs must be archived for a period of 03 (three) years from the date of issuance of the result.

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 returning 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 a 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

1. Manage the inspection activities of quality and residues of plant protection drugs;

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 Program of the 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.

4. Plant protection drug label with content in accordance with provisions of 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 shall be continued to use for a maximum period of 02 (two) years from the effective date of this Circular.

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. Implementation responsibilities

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. /.

For the Minister

Deputy Minister

Bui Ba Bong