Circular No. 18/2011/TT-BNNPTNT Amending, supplementing, and abolishing certain provisions on administrative procedures in the field of plant protection and quarantine according to Resolution No. 57/NQ-CP dated December 15, 2010.

CIRCULAR

Amending, supplementing, and abolishing certain provisions on administrative procedures in the field of plant protection and quarantine pursuant to Resolution No. 57/NQ-CP dated December 15, 2010

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On the basis of Decree No. 01/2008/ND-CP dated January 3, 2008 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Agriculture and Rural Development; Decree No. 75/2009/ND-CP of the Government amending Article 3 of Decree No. 01/2008/ND-CP dated January 3, 2008 of the Government;

On the basis of Resolution No. 57/NQ-CP dated December 15, 2010 of the Government on the Plan for Simplifying Administrative Procedures within the scope of management of the Ministry of Agriculture and Rural Development;

The Minister of Agriculture and Rural Development promulgates this Circular amending, supplementing, and abolishing certain provisions on administrative procedures in the field of plant protection and quarantine pursuant to Resolution No. 57/NQ-CP dated December 15, 2010 as follows:

Article 1. Amending, supplementing, and abolishing certain Articles of Circular No. 38/2010/TT-BNNPTNT dated June 28, 2010 on the management of plant protection chemicals (hereinafter referred to as Circular No. 38/2010/TT-BNNPTNT)

1. Clause 3 shall be amended and supplemented as follows:

"Article 3. General Principles

1. Each type of active ingredient or technical product of a manufacturer shall only be registered with one trade name for pest control or crop growth regulation.

If these products are used for warehouse fumigation, storage of agricultural and forestry products, or termite control in construction projects and dyke systems, they may be registered with an additional trade name.

2. Domestic or foreign organizations or individuals who produce active ingredients or technical products may directly register their own trade name or authorize another organization or individual once to register a trade name for one active ingredient or technical product produced by themselves.

3. Organizations or individuals authorized to register may only register one trade name for one type of active ingredient or raw material (technical product) from any authorizing entity. The registering organization or individual has the right to change the producer according to requirements or transfer the registered product name according to agreement. After the transfer, the registering entity and the entity receiving the transfer of registration rights shall not use the same type of active ingredient to register another product name. Any changes in producers or transfers of registered product names must be approved by the Plant Protection Department and relevant legal procedures must be completed.

4. Chemical plant protection products with acute toxicity levels of active ingredients classified under Group III or Group IV as specified in Item 1, Item 7, Appendix 4 of Circular No. 38/2010/TT-BNNPTNT, which do not belong to the chlorinated organic group, have a maximum isolation period in Vietnam of seven (7) days, and have efficacy test results meeting the requirements, may be registered for use in pest control, crop growth regulation for fruit trees, tea plants, and vegetables, or post-harvest preservation of agricultural products.

5. Plant protection products that have been individually registered for controlling the same type of pest may be recommended for mixing when used, but they may not carry a separate name unless approved by the Ministry of Agriculture and Rural Development.

6. Plant protection products may only change their trade name if there is a written conclusion by a competent state agency regarding intellectual property rights or by a court regarding trademark infringement. The old trade name will be canceled and cannot be reused."

2. Article 6 is amended and supplemented as follows:

"Article 6. Registration of Plant Protection Products

1. Efficacy Testing Registration

a) All types of plant protection products intended for use in Vietnam must undergo efficacy testing in Vietnam. Efficacy testing shall be conducted in accordance with Chapter XII of Circular No. 38/2010/TT-BNNPTNT.

Chemical plant protection products undergoing formal registration, trade naming, or mixture registration must undergo narrow and wide-scale efficacy testing.

Biological plant protection products undergoing formal registration, trade naming, or mixture registration; plant protection products undergoing supplementary registration for expanded usage range, dosage, application method, formulation, and active ingredient concentration must undergo wide-scale efficacy testing.

b) Chemical plant protection products being registered for the first time for pest control (excluding herbicides for fruit trees and tea); for crop growth regulation for specific fruit tree varieties from the fruit setting stage, tea plants, specific vegetable varieties; for post-harvest preservation of agricultural products must re-determine the isolation period in Vietnam and follow the regulations set out in Chapter XII of Circular No. 38/2010/TT-BNNPTNT.

2. Official registration

Types of plant protection products for formal registration include:

a) Newly created domestically and recognized by the Plant Protection Department as a plant protection product;

b) Already a commercial product abroad but being introduced for the first time in Vietnam.

3. Supplementary registration

Types of plant protection products for supplementary registration include:

a) Containing an active ingredient similar to that of another organization or individual's product that has been formally registered for three (3) years since the effective date of the Circular on the list of permitted plant protection products issued by the Ministry of Agriculture and Rural Development;

b) Carrying a different trade name than the product with the same active ingredient in the list of permitted plant protection products;

c) Supplementing the usage range, dosage, application method, formulation, and active ingredient concentration;

d) Combinations of two (2) or more active ingredients into a new product".

3. Supplementing Article 6a

"Article 6a. Extension of Registration

a) Extension of registration applies to plant protection products listed in the catalog of permitted and restricted use in Vietnam when the Certificate of Registration expires.

b) Applications for extension of registration must be submitted within three (3) months before the expiration of the Certificate of Registration. Plant protection products that do not complete the extension of registration procedure within the prescribed timeframe will be removed from the catalog of permitted and restricted use in Vietnam.

c) Not to extend registration for plant protection products specified in Clauses 4 and 5 of Article 5 of Circular 38/2010/TT-BNNPTNT at the time when the registration certificate expires.

4. Supplement Article 6b

“Article 6b. Procedures and formalities for registering plant protection products

1. Efficacy Testing Registration

a) Submission of the application dossier

 Organizations and individuals with registered plant protection products for trial submit directly or send via postal service one (01) set of application files to the Plant Protection Department.

b) Examination of the application file and issuance of the Trial Registration Permit

- Within fifteen (15) working days from the date of receipt of a complete and valid application file, the Plant Protection Department examines the application file, and if it is complete and valid, issues the Trial Registration Permit for plant protection products according to the model prescribed in Appendix 12 of Circular 38/2010/TT-BNNPTNT.

- In case the application file is incomplete or invalid, within fifteen (15) working days from the date of receipt of the file, the Plant Protection Department notifies the organization or individual of the contents that need to be supplemented or completed in accordance with the regulations.

2. Official registration, supplementary registration of plant protection products

a) Submission of the application dossier

 Organizations and individuals with officially registered plant protection products or supplementary registrations submit directly or send via postal service one (01) set of application files to the Plant Protection Department.

b) Examination of the application file

- Within fifteen (15) working days from the date of receipt of a complete and valid application file, the Plant Protection Department examines the application file, and if it is complete and valid, proceeds with the procedures as stipulated in Point c, Clause 2 of this Article.

- In case the registration application file is incomplete or invalid, within fifteen (15) working days from the date of receipt of the file, the Plant Protection Department notifies the organization or individual of the contents that need to be supplemented or completed in accordance with the regulations.

c) Issuance of the Registration Certificate

- The Plant Protection Department organizes a meeting of the Advisory Council on plant protection products to examine and approve the officially requested registered and supplementary registered plant protection products.

- The Plant Protection Department informs organizations and individuals requesting registration in writing of the Advisory Council's conclusions regarding the contents that need to be supplemented or completed in the application file or rejection due to technical reasons.

- The Plant Protection Department prepares files of all types of products reviewed and recommended for recognition by the Advisory Council and submits them to the Ministry of Agriculture and Rural Development. Within fifteen (15) working days from the date of submission by the registration authority, the Ministry of Agriculture and Rural Development promulgates a Circular listing the permitted, restricted, and prohibited plant protection products.

- The Plant Protection Department issues the Registration Certificate for plant protection products according to the model prescribed in Appendix 13 of Circular 38/2010/TT-BNNPTNT.

3. Transfer of registered products, change of manufacturer, change of trade name of registered plant protection products, extension of registration

a) Submission of the application dossier

 Organizations and individuals transferring registered products, changing manufacturers, changing the trade name of registered plant protection products, or extending registration submit directly or send via postal service one (01) set of application files to the Plant Protection Department.

b) Examination of the application file and issuance of the Registration Certificate

- Within five (05) working days from the date of receipt of a complete and valid application file, the Plant Protection Department examines the application file, and if it is complete and valid, issues the Registration Certificate for plant protection products according to the model prescribed in Appendix 13 of Circular 38/2010/TT-BNNPTNT.

- In case the application file is incomplete or invalid, within five (05) working days from the date of receipt of the file, the Plant Protection Department notifies the organization or individual of the contents that need to be supplemented or completed in accordance with the regulations.

- In case the application file is not complete or valid, the Plant Protection Department informs the organization or individual in writing of the reasons for not issuing the Registration Certificate for plant protection products.

5. Article 7 is amended and supplemented as follows:

“Article 7. Application Files for Registering Plant Protection Products

1. Application Files for Trial Registration

a) Purpose of official registration, naming, formulation

- The application form for trial registration of plant protection products as prescribed in Appendix 1 attached to this Circular;

- Authorization letter from the active ingredient manufacturer or technical product applying for registration;

- Confirmation letter (original or certified copy) issued by the competent authority of the country of origin certifying the applicant as the active ingredient manufacturer or technical product manufacturer;

- Detailed technical documentation of the finished product in Vietnamese or English, copied and translated from the original, stamped with confirmation by the active ingredient manufacturer or technical product manufacturer as prescribed in Appendix 3 of Circular 38/2010/TT-BNNPTNT;

- Copy of the drug registration certificate abroad for officially registered products;

- Drug label sample as prescribed in Chapter IX of Circular 38/2010/TT-BNNPTNT;

- Certified copy of industrial property rights certificates issued by the Vietnam Intellectual Property Office or legally authorized copies of power of attorney or transfer agreements for the use of such certificates for products in Vietnam by the owners of such products (if applicable).

b) Purpose of supplementary registration for scope of use, dosage, method of use

- The application form for trial registration of plant protection products as prescribed in Appendix 1 attached to this Circular;

- Copy of the Registration Certificate for plant protection products;

- Drug label sample as prescribed in Chapter IX of Circular 38/2010/TT-BNNPTNT.

c) Purpose of supplementary registration for type of product, active ingredient content

- The application form for trial registration of plant protection products as prescribed in Appendix 1 attached to this Circular;

- Copy of the Registration Certificate for plant protection products;

- Drug label sample as prescribed in Chapter IX of Circular 38/2010/TT-BNNPTNT;

- Detailed technical documentation in Vietnamese or English, copied and translated from the original, stamped with confirmation by the active ingredient manufacturer or technical product manufacturer as prescribed in Section II, Appendix 3 of Circular 38/2010/TT-BNNPTNT;

2. Application Files for Registering Plant Protection Products

a) Application form for registering plant protection products as prescribed in Appendix 2 of this Circular;

b) Original of the Trial Registration Permit for plant protection products issued by the Plant Protection Department;

c) Drug label sample as prescribed in Chapter IX of Circular 38/2010/TT-BNNPTNT;

d) Results of biological efficacy trials and results of isolation period determination trials as prescribed in Appendices 16 and 17 of Circular 38/2010/TT-BNNPTNT.

3. Application Files for Extending Registration

a) Application form for registering plant protection products as prescribed in Appendix 2 attached to this Circular;

b) Original of the Registration Certificate for plant protection products;

c) Drug label sample as prescribed in Chapter IX of Circular 38/2010/TT-BNNPTNT.

Application Files for Changing Manufacturer

a) Request form as prescribed in Appendix 2 of Circular 38/2010/TT-BNNPTNT;

b) Power of attorney from the active ingredient manufacturer or technical pesticide manufacturer;

c) Confirmation certificate (original or certified copy) issued by the competent authority of the country of origin confirming the entity as the active ingredient or technical pesticide manufacturer;

d) Detailed technical documentation in Vietnamese or English, copied and translated from the original, bearing the stamp of confirmation of the active ingredient or technical pesticide manufacturer as specified in Appendix 3 of Circular 38/2010/TT-BNNPTNT;

đ) Original Certificate of Registration for Plant Protection Products;

e) Label sample of the plant protection product as prescribed in Chapter IX of Circular 38/2010/TT-BNNPTNT.

5. Documents for changing trade name

a) Request form as prescribed in Appendix 2 of Circular 38/2010/TT-BNNPTNT;

b) Official document from the competent state agency on intellectual property rights or court ruling regarding trademark infringement;

c) Original Certificate of Registration for Plant Protection Products;

d) Label sample of the plant protection product as prescribed in Chapter IX of Circular 38/2010/TT-BNNPTNT.

6. Documents for transferring plant protection products

a) Request form as prescribed in Appendix 2 of Circular 38/2010/TT-BNNPTNT;

b) Legal copy of the transfer contract or agreement;

c) Original Certificate of Registration for Plant Protection Products;

d) Label sample of the plant protection product as prescribed in Chapter IX of Circular 38/2010/TT-BNNPTNT”.

6. Article 9 shall be amended and supplemented as follows:

“Article 9. Registration Authority and Responsibilities of the Registration Authority

1. The Plant Protection Department is the registration authority for plant protection products in Vietnam.

2. Responsibilities of the registration authority:

a) Accepting registration files and reference standards;

b) Reviewing, retaining, and securing files;

c) Respond with the results of the review and issue the Plant Protection Product Field Trial Permit according to the model in Appendix 12 of Circular 38/2010/TT-BNNPTNT;

d) Organize meetings of the Advisory Council to examine officially registered products, seek opinions from Advisory Council members on supplementary registered products, and prepare files to submit to the Ministry of Agriculture and Rural Development for issuance of the list of permitted, restricted, and prohibited plant protection products after the Advisory Council has reviewed and recommended approval;

Immediately after the Advisory Council meeting, the Plant Protection Department will consider issuing the Certificate of Registration for Plant Protection Products, allowing such products to be circulated;

đ) Issue the Certificate of Registration for Plant Protection Products according to the model in Appendix 13 of Circular 38/2010/TT-BNNPTNT;

e) Reissue the Certificate of Registration for Plant Protection Products;

g) Collect fees and charges for issuing the Field Trial Permit and the Certificate of Registration for Plant Protection Products as stipulated”.

7. Article 17 is amended and supplemented as follows:

“Article 17. Issuance of Import Permits for Plant Protection Products and Active Ingredients

1. Documents for Issuing Import Permits

a) Application form for Import Permit for Plant Protection Products and Active Ingredients as specified in Appendix 6 of Circular 38/2010/TT-BNNPTNT;

b) Certified copy of the Business Registration Certificate for Plant Protection Products or Agricultural Supplies (only submitted once);

c) In cases of temporary import-re-export, transshipment, import for processing, bottling, packaging for re-export of Plant Protection Products and Active Ingredients, one legal copy of the export contract and one legal copy of the import contract with foreign partners must be submitted. In cases of import for processing, bottling, packaging for foreign traders, one legal copy of the processing contract must be submitted;

d) In cases of importing Plant Protection Products and Active Ingredients without trade names or active ingredients listed in the permitted use directory for use in foreign investment projects in Vietnam, a legal copy of the Foreign Investment License issued by the competent Vietnamese authority (only submitted once) must be provided;

đ) In cases of importing Plant Protection Products outside the Directory or not listed in the permitted use directory in Vietnam for use in agricultural production facilities under economic contracts with foreign partners; processing wooden goods, rattan and bamboo products for export, use in entertainment facilities; Plant Protection Products outside the Directory or not listed in the permitted use directory in Vietnam imported for processing under economic contracts with foreign countries, a legal copy of the Free Circulation Certificate (CFS) at the exporting country must be submitted;

e) In cases of importing fumigant disinfectants, a legal copy of the Certificate of Eligibility for Fumigation Disinfection must be submitted.

2. Procedures for Implementation

a) Submission of the application dossier

 Organizations and individuals applying for import permits for Plant Protection Products shall submit directly or send via postal service one set of documents to the Plant Protection Department as prescribed in Clause 1, Article 17 of Circular 38/2010/TT-BNNPTNT.

b) Reviewing the documents and issuing Import Permits for Plant Protection Products

- Within five (05) working days from receipt of the application, the Plant Protection Department will review the documents. If the documents are complete and valid, an Import Permit for Plant Protection Products according to the model specified in Appendix 7 of Circular 38/2010/TT-BNNPTNT will be issued.

- If the registration documents are incomplete or invalid within five (05) working days from receipt of the application, the Plant Protection Department will notify the organization or individual of the required supplements and corrections according to the prescribed documents.

If the documents are invalid, the Plant Protection Department will notify the organization or individual in writing and specify the reasons for not issuing the Import Permit for Plant Protection Products”.

8. Clause 6 of Article 47 is amended and supplemented as follows:

“6. State inspection of the quality of plant protection products and residues in agricultural products circulating in the market shall be carried out in accordance with the Law on Product Quality and Goods and Circular No. 16/2009/TT-BKHCN dated June 2, 2009 guiding state inspection of the quality of goods circulating in the market”.

9. Supplement Article 48a

“Article 48a. Procedures and Methods of Implementation

1. Submission of Samples

 Organizations and individuals with plant protection products requiring quality testing or agricultural products requiring residue testing (collectively referred to as samples) shall submit a quantity of samples according to the sampling standards for testing, the test request form specified by the testing organizations, and the Sampling Record (if any) directly or through postal service.

Upon receiving the sample, the recipient reviews the test request form, examines the condition of the sample, and schedules the time for result delivery as prescribed.

2. Testing and Issuing Test Results

Within three to fifteen working days from receipt of the samples, the testing organizations will notify the test results. In case of extended testing time, immediate notification and discussion with the organizations or individuals submitting the samples for testing will take place”.

10. Amend and Supplement Appendices

Supplement Appendix 1, Sample Application Form for Plant Protection Product Field Trials, issued together with this Circular.

Amend and supplement Appendix 1 issued together with Circular No. 38/2010/TT-BNNPTNT to become Appendix 2, Model Registration Form for Plant Protection Chemicals issued together with this Circular.

11. Repeal Article 13, Clause 1 and 2 of Article 15 of Circular No. 38/2010/TT-BNNPTNT.

"Article 6. Registration Documents for Quality Inspection

1. The registration documents for quality inspection of imported plant protection chemicals include:

a) The "State Registration for Quality Inspection of Imported Plant Protection Chemicals" form as prescribed in Appendix 1 issued together with Circular No. 77/2009/TT-BNNPTNT. Two (02) copies.

b) Photocopies of the following documents:

- Purchase and sale contract;

- Import permit (for restricted-use plant protection chemicals);

- Goods list (packing list): Clearly stating the quantity registered and batch number of each consignment;

- Invoice;

- Bill of lading (for goods imported by sea or rail);

- Certificate of origin;

- Certificate of goods quality of the consignment (if available)."

Article 3. Amend and supplement certain contents of Decision No. 16/2004/QĐ-BNN-BVTV dated April 20, 2004 on procedures for inspecting objects and compiling phytosanitary inspection records.

1. Repeal the validity period of the Phytosanitary Certificate for imported, transiting, and domestically transported goods in Model No. 7 issued together with Decision No. 16/2004/QĐ-BNN-BVTV.

Amend and supplement Model No. 7 issued together with Decision No. 16/2004/QĐ-BNN-BVTV dated April 20, 2004 to become Appendix 3 issued together with this Circular.

2. Repeal Model No. 13, Phytosanitary Certificate for imported goods issued together with Decision No. 16/2004/QĐ-BNN-BVTV dated April 20, 2004.

Article 4. Effective date

1. This Circular shall take effect 45 (forty-five) days from the date of issuance.

2. The Director of the Plant Protection Department, the Head of the Ministry's Office, the Director of the Legal Affairs Department, Heads of units under the Ministry, and related organizations and individuals are responsible for implementing this Circular./.