Circular No. 20/2014/TT-BNNPTNT stipulates certain contents regarding the division of responsibilities and management authority for agricultural inputs.

CIRCULAR

Prescribing certain contents

concerning the allocation of responsibilities and management authority for agricultural materials

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Pursuant to the Fisheries Law 2003;

BASED ON THE LAW ON PRODUCT QUALITY 2007;

On the basis of Pursuant to the Plant Protection and Quarantine Ordinance 2001;

Pursuant to the Livestock Breeding Ordinance 2004;

Pursuant to the Crop Breeding Ordinance 2004;

On the basis of the Veterinary Law 2004;

Pursuant to the Government Decree Decision No. 08/2010/NĐ-CP dated February 5, 2010 on the management of livestock feed;

Pursuant to Decree No. 199/2013/NĐ-CP dated November 26, 2013 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Agriculture and Rural Development;

At the proposal of the Director of the Legal Department;

The Minister of Agriculture and Rural Development issues this Circular stipulating certain contents regarding the allocation of responsibilities and management authority for agricultural materials.

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

Article 1. This Circular stipulates certain contents regarding the allocation of responsibilities and management authority for agricultural materials related to the recognition of facilities meeting the conditions for testing and trial; testing, trial, inspection, recognition, registration for circulation of agricultural materials in Vietnam under the responsibility of the Ministry of Agriculture and Rural Development.

Article 2. Agricultural materials referred to in this Circular include:

a) Livestock breeds (including livestock breeds and aquaculture breeds);

b) Crop seeds (including major crop seeds and forestry seeds);

c) Livestock feed (including livestock feed, growth promoters used in livestock farming and aquaculture feed);

d) Products for treating and improving the environment used in aquaculture;

đ) Plant protection chemicals, including plant growth regulators;

e) Veterinary drugs.

Article 2. Applicability

This Circular applies to organizations and individuals engaged in activities related to the recognition of facilities meeting the conditions for testing and trial; testing, trial, inspection, recognition, registration for circulation of agricultural materials in Vietnam.

Article 3. Implementation of intellectual property law provisions

The specialized management agencies for agricultural materials as prescribed in Article 4 of this Circular shall be responsible for inspecting and monitoring compliance with intellectual property laws during the process of examining, recognizing, and allowing registration for circulation of agricultural materials in Vietnam.

Chapter II

PROVISIONS ON

THE ALLOCATION OF RESPONSIBILITIES AND MANAGEMENT AUTHORITY FOR AGRICULTURAL MATERIALS

Article 4. Allocation of specialized management agencies for agricultural materials

The lead agency for specialized management of testing, trial, inspection, recognition, and registration for circulation of agricultural materials in Vietnam is allocated as follows:

1. The General Department of Fisheries receives, reviews, and processes files on aquaculture breeds, aquaculture feed, and products for treating and improving the environment used in aquaculture;

2. The General Department of Forestry receives, reviews, and processes files on forestry seeds;

3. The Livestock Production Department receives, reviews, and processes files on livestock breeds, livestock feed, including growth promoters used in livestock farming;

4. The Crop Production Department receives, reviews, and processes files on major crop seeds;

5. The Plant Protection Department receives, reviews, and processes files on plant protection chemicals, including plant growth regulators;

6. The Animal Health Department receives, reviews, and processes files on veterinary drugs.

Article 5. Authority to recognize facilities meeting the conditions for testing and trial of agricultural materials

1. The specialized management agencies as prescribed in Article 4 of this Circular shall be responsible for:

a) Receiving files, organizing reviews, and evaluating facilities meeting the conditions for testing and trial of agricultural materials;

b) Submitting to the Minister for comments on the recognition of facilities meeting the conditions for testing and trial of agricultural materials;

c) Issuing a Decision to recognize facilities meeting the conditions for testing and trial of agricultural materials after approval by the Minister;

d) Inspecting and supervising the operations of testing and trial facilities for agricultural materials.

2. The Science, Technology and Environment Department shall take the lead and coordinate with the Legal Affairs Department to review files submitted by specialized management agencies to the Minister.

3. Contents of the review of files submitted to the Minister:

a) Completeness and validity of the files;

b) Compliance with the recognition procedures for testing and trial facilities.

4. Contents of the files submitted to the Minister:

a) A report to the Minister, specifying: necessity; implementation process; summary of the results of the evaluation of facilities meeting the conditions for testing and trial of agricultural materials; specific assessment and recommendations for each case of recognition of facilities meeting the conditions for testing and trial of agricultural materials;

b) List of testing and trial facilities that have been reviewed, evaluated, and recommended for recognition by the specialized management agencies;

c) Report of the inspection and evaluation team;

d) Registration file for recognition of facilities meeting the conditions for testing and trial;

đ) Draft Decision on recognition of facilities meeting the conditions for testing and trial.

Article 6. Competence to approve trials and tests of agricultural materials, except for major food crop seeds and forestry seeds

1. The specialized management agency shall be responsible for:

a) Receiving applications, organizing the examination of registration applications for trials and tests of agricultural materials that require such trials and tests;

b) Submitting to the Minister for comments on the approval of trials and tests of agricultural materials;

c) Issuing a Decision approving trials and tests or a Trial Permit after receiving the Minister's approval.

2. The Science, Technology and Environment Department shall take the lead and coordinate with the Legal Affairs Department to review files submitted by specialized management agencies to the Minister.

3. Content of the examination of applications submitted to the Minister:

a) The completeness and validity of the application;

b) The implementation of the procedures for approving trials and tests.

4. Components of the application submitted to the Minister:

a) A report to the Minister, specifying: necessity; implementation process; summary of the results of the examination of the trial and test outline or technical assessment according to national technical standards (if applicable); specific evaluation and recommendations for each registration application for trials and tests of agricultural materials;

b) An examination report from the specialized management agency;

c) The application for permission and registration for trials and tests from the entity;

d) A draft Decision approving trials and tests or a Trial Permit.

5. The specialized management agency shall guide, inspect, and supervise the trials and tests of agricultural materials.

6. The specialized management agency shall develop and submit for issuance National Technical Regulations on trials and tests of agricultural materials. Based on the National Technical Regulations on trials and tests, the head of the specialized management agency shall approve the trial outlines and organize supervision of the trial processes. In cases where there are no National Technical Regulations, the head of the specialized management agency shall guide the development and approval of trial and test outlines based on the opinions of the Department of Science, Technology, and Environment and the specialized scientific council or advisory board (hereinafter referred to as the Council).

Article 7. Competence to recognize and register the circulation of agricultural materials

1. For cases requiring trials and tests:

The head of the specialized management agency shall be responsible for:

a) Receiving applications, organizing the examination of applications and the results of trials and tests in accordance with current laws;

b) Organizing a Council to evaluate the results of trials and tests;

c) Considering the results of trials and examining the opinions of the specialized scientific council;

d) Submitting to the Minister for comments on the recognition and registration of the circulation of agricultural materials;

đ) Issuing a Decision recognizing or a Certificate of Registration or a Certificate of Registration for the circulation of new agricultural materials after receiving the Minister's approval.

2. For cases not requiring trials and tests:

The head of the specialized management agency shall be responsible for:

a) Supervising the testing process;

b) Examining the registration application for the circulation of agricultural materials in accordance with current laws;

c) Submitting to the Minister for comments on the approval of the registration for the circulation of agricultural materials;

d) Issuing a Decision recognizing or a Circulation Certificate after receiving the Minister's approval.

3. The Department of Science, Technology, and Environment shall take the lead and coordinate with the Legal Affairs Department to examine the applications submitted by specialized management agencies to the Minister as specified in point d, Clause 1, and point c, Clause 2 of this Article.

4. Content of the examination of applications submitted to the Minister:

a) The completeness and validity of the application;

b) Implementation of the procedures for recognizing agricultural materials.

5. Components of the documents to be submitted to the Minister:

a) A report to the Minister, specifying: necessity; implementation process; summary of the results of trials and tests; specific evaluation and recommendations for each agricultural material;

b) List of agricultural materials that have been examined, evaluated, and recommended for recognition by the specialized management agency;

c) Minutes of the meeting of the examination council for products requiring trials and tests;

d) Examination report from the specialized management agency;

đ) Application for recognition or application for issuance of a certificate of registration for agricultural materials.

Article 8. Issuing the List of Agricultural Inputs Allowed for Circulation in Vietnam 1. Annually in the first quarter, specialized management agencies shall review and submit to the Minister for issuing the List of Agricultural Inputs Allowed for Circulation in Vietnam according to their assigned functions and tasks.

2. Quarterly, specialized management units shall compile and submit to the Minister for issuing Circulars amending and supplementing the List of Agricultural Inputs Allowed for Circulation in Vietnam.

Removing from the List of Agricultural Inputs Allowed for Circulation in Vietnam

Article 9. 3. Amend Clause 3 Article 2 as follows:1. Removing from the List of Agricultural Inputs Allowed for Circulation in Vietnam:

a) Products containing prohibited active ingredients as stipulated by current regulations of the Ministry of Agriculture and Rural Development;

b) Products causing harm to production, environment, food safety, and human health as assessed by the Re-evaluation Council according to regulations;

c) Products currently circulating but not compliant with international standards to which Vietnam is a member;

d) Certificates or Decisions recognizing products that have expired circulation validity but the entity has not re-registered for circulation;

đ) Products that have been registered for circulation but the production and business entity has ceased operations;

e) Products infringing industrial property rights of registered circulating products;

g) Products withdrawn from circulation certificates at the exporting country.

2. Based on the cases specified in Clause 1 of this Article, specialized management agencies shall compile and submit to the Minister for deciding to remove agricultural inputs from the List of Agricultural Inputs Allowed for Circulation in Vietnam.

Effective Date

Chapter III

IMPLEMENTING PROVISIONS

Article 101. This Circular takes effect from August 11, 2014.

a) Clause 2, Article 5 of Circular No. 66/2011/TT-BNNPTNT dated October 10, 2011, issued by the Minister of Agriculture and Rural Development detailing certain provisions of Government Decree No. 08/2010/NĐ-CP regarding animal feed management;

2. This Circular abolishes the following provisions:

b) Article 15 of Decision No. 10/2006/QĐ-BNN dated February 10, 2006, issued by the Minister of Agriculture and Rural Development promulgating procedures for registering production, importation, and circulation of veterinary drugs, raw materials for veterinary drugs, biological preparations, microorganisms, and chemicals used in veterinary medicine;

c) Point c, Clause 4, Article 7 of Circular No. 03/2013/TT-BNNPTNT dated January 11, 2013, issued by the Minister of Agriculture and Rural Development on plant protection chemical management.

Implementation Responsibility

Article 111. Units under the Ministry and related organizations and individuals are responsible for implementing this Circular.

2. During the implementation of this Circular, if there are difficulties or obstacles, agencies, units, organizations, and individuals shall report to the Ministry of Agriculture and Rural Development for consolidation and submission to the Minister for consideration and decision./.

2. During the implementation of the Circular, if there are difficulties or obstacles, agencies, units, organizations, and individuals shall report to the Ministry of Agriculture and Rural Development for consolidation and submission to the Minister for consideration and decision./.