Thông tư 23/2015/TT-BNNPTNT

CIRCULAR

MANAGEMENT OF ENVIRONMENTAL REMEDIATION AND TREATMENT PRODUCTS USED IN LIVESTOCK PRODUCTION AND AQUACULTURE

Pursuant to the Fisheries Law in 2003;

Pursuant to the Law on Product and Goods Quality in 2007;

Pursuant to the Law on Chemicals in 2007;

Pursuant to the Law on Commerce in 2005;

Pursuant to the Law on Land in 2014;

Pursuant to the Law on Enterprise in 2014;

Pursuant to the Ordinance on Veterinary Medicine in 2004;

Pursuant to the Government's Decree No. 33/2005/NĐ-CP dated March 15, 2005 detailing the implementation of a number of articles of the Ordinance on Veterinary Medicine and the Government's Decree No. 119/2008/NĐ-CP dated November 28, 2008 amending and supplementing a number of articles of the Government's Decree No. 33/2005/NĐ-CP;

Pursuant to the Government’s Decree No. 89/2006/NĐ-CP dated August 30, 2006 regulating trademarks of goods;

Pursuant to the Government's Decree No. 132/2008/NĐ-CP dated December 31, 2008, detailing the implementation of a number of articles of the Law on Product and Goods Quality;

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

At the request of Director General of Vietnam Directorate of Fisheries, the Director of the Department of Livestock Production,

The Minister of Agriculture and Rural Development promulgates the Circular on management of environmental remediation and treatment products used in livestock production and aquaculture.

Chapter I

GENERAL PROVISIONS

Article 1. Scope and regulated entities

1. Governing scope: This Circular regulates production, trading, experimentation, testing, examination and verification; registration for circulation; quality management for bio-preparations, cultures, chemicals (except chemicals prescribed in the lists of national reserve goods in agricultural sector), environmental remediation and treatment products used in livestock production and aquaculture (hereinafter referred to as environmental remediation and treatment products) and responsibilities of relevant organizations and individuals.

2. Regulated entities: This Circular applies to organizations, individuals related to production, trading, experimentation, testing, examination and verification of environmental remediation and treatment products within Vietnam’s territory.

Article 2. Interpretation of terms

In this Circular, some terms are construed as follows:

1. New product means the product with formula containing new active ingredients, new combination, and new dosage forms that result in change of product quality, give new uses and have new users.

2. Certificate of analysis means product quality analysis sheet issued by competent agencies or independent laboratory of exporting country.

Article 3. Fees, charges and other expenses

1. Fees, charges arising from the management of environmental remediation and treatment products are prescribed according to current regulations of the Ministry of Finance.

2. Expenses for experimentation, testing, examination and verification shall be based on the negotiation between facilities conducting experimentation, testing, examination and verification (hereinafter referred to as the testing facility) and facilities having products in need of experimentation, testing, examination and verification (hereinafter referred to as the farming facility) according to the law provisions.

Chapter II

CONDITIONS OF FACILITIES INVOLVED IN PRODUCTION AND TRADING OF ENVIRONMENTAL REMEDIATION AND TREATMENT PRODUCTS (HEREINAFTER REFERRED TO AS THE PRODUCTION AND TRADING FACILITY)

Article 4. Conditions of production facility

Conditions of production facility (including facilities that carry out processing, portioning and packing) are prescribed in Clauses 1, 2, 3, 5, 6, 7, 8 of Article 38 of the Ordinance on Veterinary Medicine, and Clauses 2, 4, 5, 6, 7, 8, Article 52 of the Government's Decree No. 33/2005/NĐ-CP dated March 15, 2005 detailing the implementation of a number of articles of the Ordinance on Veterinary Medicine. Particularly, Clauses 1, 5, 6, Article 38 of the Ordinance on Veterinary Medicine are detailed as follows:

1. Have Certificate of enterprise registration or Certificate of investment registration;

2. Persons who directly involved in production must have health certificate issued by medical centers from commune level and over; persons who directly involved in production, testing must obtain the certificate of production and testing practice for environmental remediation and treatment products

Article 5. Conditions of trading facilities

Conditions for trading environmental remediation and treatment products (including import, export facilities) are prescribed in Article 39 of the Ordinance on Veterinary Medicine and Clause 1, Article 54, Clause 3, Article 55 of the Government's Decree No. 33/2005/NĐ-CP dated March 15, 2005 detailing the implementation of a number of the Ordinance on Veterinary Medicine. Particularly, Clauses 1, 3, Article 39 of the Ordinance on Veterinary Medicine are detailed as follows:

1. Have Certificate of enterprise registration or Certificate of investment registration;

2. Managers, sale persons must obtain certificate of business practice for environmental remediation and treatment products; owners or technical staff of import, export facilities must obtain certificate of import, export practice for environmental remediation and treatment products;

Chapter III

EXPERIMENTATION, TESTING, EXAMINATION AND VERIFICATION OF ENVIRONMENTAL REMEDIATION AND TREATMENT PRODUCTS

Article 6. Conditions of facilities conducting experimentation and testing

Conditions of the testing facility are prescribed in Clause 2, Article 55 of the Government's Decree No. 33/2005/NĐ-CP dated March 15, 2005 detailing the implementation of a number of articles of the Ordinance on Veterinary Medicine. Particularly, Point dd, Clause 2, Article 55 of the Decree No. 33/2005/NĐ-CP are detailed as follows:

Have adequate tools, facilities and equipment meeting requirements of experimentation and testing; In case the testing facility does not have adequate tools, facilities and equipment for analysis of key factors, they may sign a contract with other facilities appointed by the Ministry of Agriculture and Rural Development.

Article 7. Documentation, sequence in recognition of facilities' satisfaction of experimentation and testing conditions

1. Documentation includes:

a) Request form for recognition of the testing facility (according to Form No. KN-1 in Appendix I enclosed herewith);

b) Copy (with confirmations by facilities) of one of the following papers: Public Service Provider Establishment Decision; Certificate of enterprise registration (or Certificate of business registration); Investment registration certificate (or investment license)

c) Explanation of conditions of the testing facility (original) (according to Form KN-2a or Form KN-2b prescribed in Appendix 1 enclosed herewith);

d) Copy of practice certificate (with confirmations by the testing facility) of facility owners or technical manager;

In case of re-registration, only copy is required (with confirmations by the testing facility) if content of documentation remains unchanged versus previous registration.

2. Sequence in recognition of the facilities’ satisfaction of experimentation and testing conditions:

a) Facilities that need registration for recognition of satisfaction of experimentation and testing conditions must formulate one (01) set of documentation sent directly or by post to Vietnam Directorate of Fisheries (for products used in aquaculture) or to the Department of Livestock production (for products used in livestock production);

b) Within two working days since receipt of documentation, Vietnam Directorate of Fisheries or the Department of Livestock production shall issue a written request for supplements if registration documentation is ineligible;

c) Within two working days since receipt of eligible documentation, Vietnam Directorate of Fisheries or the Department of Livestock production shall carry out examination and verification of the documentation and assessment of conditions of the testing facility;

d) In case conditions of facilities are found unsatisfactory, Vietnam Directorate of Fisheries or the Department of Livestock production shall issue a written notification to the testing facility about non-conformities and issue a written request for remedial work. Within two working days since receipt of remedial report from the facility, Vietnam Directorate of Fisheries or the Department of Livestock production shall carry out consideration of the remedial report and conduct examination of remedied issues if necessary;

dd) In case conditions of the testing facility are found satisfactory, Vietnam Directorate of Fisheries or the Department of Livestock production shall make the submission to the Ministry for consideration within five working days.

e) Within two working days after receipt of written approval from the Minister, Vietnam Directorate of Fisheries or the Department of Livestock production shall issue a written recognition that the facility meets all conditions for experimentation and testing (hereinafter referred to as the Recognition). Otherwise, Vietnam Directorate of Fisheries or the Department of Livestock production shall issue a written notice to the facility specifying reasons.

g) This Recognition shall be effective for five years. Six months before the Recognition expires, if the facility needs extension of the Recognition, it can make re-registration as prescribed in Clause 1 of this Article.

Article 8. Cases subject to experimentation and testing, content of experimentation and testing

1. Cases subject to experimentation and testing:

a) New products (domestically produced) prior to registration for circulation;

b) Products imported into Vietnam for the first time and not on the list of environmental remediation and treatment products used in livestock production and aquaculture and permissible for circulation in Vietnam;

2. Content of experimentation and testing:

a) Inspect components and quality of products under the announced standard;

b) Assess characteristics, uses of the products through assessment of variation of physical, chemical and biological criteria (for aquaculture, it also includes criteria of total microbial count, plankton, benthos and microorganisms) in the environment of livestock production and aquaculture; assess other technical criteria as specified in product documentation.

c) Assess safety level for human health, farmed subjects and environment during the use: Product component residues in the environment and animals during the harvest (applicable to products with chemical components or components limited for use in livestock production and aquaculture; residues of heavy metal in the environment and animals during the harvest (applicable to products as natural minerals); rate of survival and growth of farmed subjects.

Article 9. Documentation and sequence of conducting experimentation and testing

1. Documentation:

a) Request form for experimentation and testing (according to Form KN-3 in Appendix I enclosed herewith);

b) Copy (with confirmations by the facility) of one of the following papers: Certificate of Business registration (or Certificate of Enterprise registration); Investment registration certificate (or Investment Certificate); Public Service Provider Establishment Decision;

a) Description of technical specifications of products (according to Form KN-4 in Appendix I enclosed herewith);

d) Product quality test sheet (original);

dd) Outline of experimentation and testing (original) (according to Form KN-5a or Form KN-5b prescribed in Appendix 1 enclosed herewith);

e) Contract for experimentation and testing (original);

g) Certificate of free sale (original or certified copy) issued by competent state agencies of countries of origin (applicable to imported products);

2. Sequence of implementation

a) The farming facility in need of experimentation and testing of the environmental remediation and treatment products may choose the testing facility recognized by Vietnam Directorate of Fisheries or the Department of Livestock production and formulate a set of documentation as prescribed in Clause 1 of this Article sent directly or by post to Vietnam Directorate of Fisheries (for products used in aquaculture) or to the Department of Livestock production (for products used in livestock production);

b) Within two working days since receipt of documentation, Vietnam Directorate of Fisheries or the Department of Livestock production shall issue a written request for supplements if the documentattion is ineligible;

c) Within 12 working days since receipt of eligible documentation, Vietnam Directorate of Fisheries or the Department of Livestock production shall carry out examination and verification of the documentation under technical standards; In case the technical standards are not available, Vietnam Directorate of Fisheries or the Department of Livestock production shall organize a Council of Science for assessment of the outline of experimentation and testing;

d) In case results of examination and assessment of the documentation and outline of experimentation and testing are found satisfactory, Vietnam Directorate of Fisheries or the Department of Livestock shall make submission to the Ministry for suggestions on permission for experimentation and testing of the product within five working days;

dd) Within two working days since receipt of consent of the Minister, Director General of Vietnam Directorate of Fisheries or Director of the Department of Livestock Production shall ratify the outline of experimentation and testing, promulgate decision on experimentation and testing and assign supervision of experimentation and testing;

In case results of examination and assessment of the documentation and outline of experimentation and testing are found unsatisfactory or not approved by the Ministry, Vietnam Directorate of Fisheries or the Department of Livestock production shall issue a written notice specifying the reasons;

g) The testing facility shall carry out experimentation and testing according to the outline approved by Vietnam Directorate of Fisheries or the Department of Livestock production.

3. Inspecting experimentation and testing

a) Fashion of inspection: Vietnam Directorate of Fisheries or the Department of Livestock production shall conduct inspection of experimentation and testing no more than two times during the experimentation and testing of the product or conduct unexpected inspection if necessary.

b) Content of inspection: in accordance with the outline of experimentation and testing approved by Vietnam Directorate of Fisheries or the Department of Livestock production;

4. Supervision of experimentation and testing

a) Agency supervising activities of experimentation and testing (hereinafter referred to as the monitoring agency) is the agency that administers livestock production or aquaculture and is subordinate to the Service of Agriculture and Rural development in the locality where experimentation and testing take place.

b) Content of supervision of experimentation and testing is instructed in accordance with the approved outline of experimentation and testing;

c) Within five working days since the end of the process of experimentation and testing, the monitoring agency shall make the report (according to Form KN-6) to Vietnam Directorate of Fisheries or the Department of Livestock production.

5. Post-monitoring handling and remedy

a) Based on proposals from Inspectorate, monitoring agency; Vietnam Directorate of Fisheries or the Department of Livestock Production shall decide modification of content, remedial measures and regulations on remedying time.

b) The testing facility and the farming facility shall carry out modification and remedial work as decided by Director General of Vietnam Directorate of Fisheries or Director of the Department of Livestock Production and make the report according to the prescribed time.

c) Organize re-inspection of the issues decided by Director General of Vietnam Directorate of Fisheries or Director of the Department of Livestock Production;

d) Documentation of inspection and supervision of experimentation and testing of environmental remediation and treatment products used in livestock production or aquaculture shall be kept at the Department of Livestock production or Vietnam Directorate of Fisheries respectively and shall be included in the documentation of assessment and recognition of products that shall be submitted to the Council of Science as foundations for assessment.

Article 10. Analysis of products

1. Cases subject to analysis upon registration for circulation or importation: Products that are not on the list of environmental remediation and treatment products permissible for circulation in Vietnam;

2. Content of analysis: Conduct thorough analysis of key components (containing active ingredients for environmental remediation and treatment) of the product under applied or registered standards and other components under corresponding technical regulations (if any).

3. Facility conducting analysis (hereinafter referred to as the analyzing facility) is the facility that is appointed under the Ministry of Agriculture and Rural Development’s Circular No. 16/2011/TT-BNNPTNT dated April 01, 2011 regulating assessment, appointment and administration of laboratories in the sector of agriculture and rural development.

Article 11. Examination and verification of products

1. The environmental remediation and treatment products shall be subject to examination and verification in the following cases:

a) Upon complaints or denunciation of quality;

b) At the request of competent state agencies;

2. Content of examination and verification: Re-conduct examination and verification of quality of the products that have undergone experimentation, testing and analysis, or in circulation.

3. Implementation of examination and verification: Vietnam Directorate of Fisheries or the Department of Livestock production shall cooperate with competent agencies and the examining and verifying facility (facility that conducts examination and verification of products) appointed by the Ministry of Agriculture and Rural Development in organizing inspection, collection of specimen, re-verification of product quality and handling within authority or transferring the result to competent agencies for handling according to applicable regulations.

4. The examining and verifying facility is appointed by the Ministry of Agriculture and Rural Development in accordance with content of examination and verification.

Chapter IV

SEQUENCE, PROCEDURES FOR REGISTRATION FOR CIRCULATION OF ENVIRONMENTAL REMEDIATION AND TREATMENT PRODUCTS

Article 12. First registration, re-registration for circulation, extension of circulation and change of information about products in circulation

1. First registration for circulation:

a) Products are the result of a research work recognized by the Ministry of Agriculture and Rural Development as an advance in biological technology according to the Circular No. 23/2010/TT-BNNPTNT dated April 07, 2010 on recognition of advances in biological technology of the sector of agriculture and rural development;

b) New products (domestically produced), products (imported into Vietnam for the first time) that have undergone experimentation and testing as prescribed in Article 9 hereof;

c) Products that meet provisions as set out in Appendix IIA or Appendix IIB enclosed herewith and corresponding national technical regulations (if any)

2. Re-registration for circulation: Products eligible for circulation in Vietnam shall be subject to re-registration in one of the following cases: Changes of components, formula, dosage forms, users, and methods, production process resulting in change of product quality; changes resulting from re-assessment of product quality, efficiency and safety level of products.

3. Registration for extension of circulation: Six months before circulation of the product expires;

4. Registration for changes of information about products in circulation

Products eligible for circulation in Vietnam shall be subject to re-registration in one of the following changes;

a) Change of business type, business name;

b) Change of label’s presentation;

c) Amendments or supplements made to specifications, packages;

d) Change of head office or production location;

dd) Change of looks, color of products without change of quality

Article 13. Documentation for first registration for circulation, re-registration for circulation, registration for extension of regulation and change of information about products in circulation

1. Documentation of first registration:

a) Registration form for circulation of product (according to Form ĐKLH-1 in Appendix I enclosed herewith);

b) Copy (with confirmations by the facility) of one of the following papers: Certificate of Business registration (or Certificate of Enterprise registration); Investment registration certificate (or Investment Certificate); Public Service Provider Establishment Decision;

c) Copy (with confirmations by the facility) of practice certificate for production or importation of environmental remediation and treatment products used in livestock production or aquaculture;

d) Facility standard (original) or applied standard (copy) with confirmations by the facility;

dd) Label of product with confirmations by the facility (according to Form ĐKLH-2 in Appendix I prescribed in Appendix 1 enclosed herewith);

e) Result of inspection, assessment and classification of facility conditions (copy with confirmations by the facility) as prescribed by the Ministry of Agriculture and Rural Development;

g) Explanation of production process (original) (according to Form ĐKLH-e in Appendix I prescribed in Appendix 1 enclosed herewith) for domestically produced products;

h) Report on results of research, production and experimentation, and Decision on recognition of advances in biological technologies issued by the Ministry of Agriculture and Rural Development (original or copy with confirmations by the facility) with respect to products as result of research works recognized as advances in biological technology by the Ministry of Agriculture and Rural Development;

i) Report on result of experimentation and testing of products (original) (according to Form KN-7 prescribed in Appendix 1 enclosed herewith) applicable to products that have undergone experimentation and testing;

k) Result of analysis of products applicable to products registered in accordance with Points a, c, Clause 1, Article 12 hereof;

l) Certificate of free sale (original or certified copy) issued by competent state agencies of producing countries (applicable to imported products) as prescribed in Point c, Clause 1, Article 12 hereof.

2. Documentation of re-registration:

a) Requirements as prescribed in Points a, b, c, d, dd, e, g, Clause 1 hereof;

b) Certificate of free sale (copy with confirmations by the facility) issued by competent agencies;

c) Report on result of re-conducting experiment and testing (original) (according to Form KN-7 in Appendix I enclosed herewith);

3. Documentation of registration for extension of circulation:

a) Requirements as prescribed in Points a, b, c, d, dd, e, Clause 1 hereof;

b) Certificate of free sale (copy with confirmations by the facility) issued by competent agencies;

c) Report on result of re-conducting experiment and testing (according to Form KN-7 in Appendix I enclosed herewith);

4. Registration for changes of information about products in circulation:

a) Requirements as prescribed in Points b, d, dd, e, Clause 1 hereof;

b) Certificate of free sale (copy with confirmations by the facility) issued by competent agencies;

c) Written request for changes of information about the product (according to Form ĐKLH-5 in Appendix I enclosed herewith);

In case registration is made for multiple products, only one copy of the papers as prescribed in Points b, c, e, Clause 1, Article 01 hereof is required.

Article 14. Sequence of certifying first registration, re-registration, registration for extension of circulation and change of information about products in circulation

1. Facilities that need to make first registration, re-registration, registration for extension of circulation, change of information about products in circulation should formulate one (01) set of documentation as prescribed in Article 13 hereof sent directly or by post to Vietnam Directorate of Fisheries (for products used in aquaculture) or to the Department of Livestock production (for products used in livestock production).

2. Within two working days since receipt of documentation, Vietnam Directorate of Fisheries or the Department of Livestock production shall issue a written request for supplements if the documentation is ineligible;

3. First registration, re-registration

a) Within 20 working days since receipt of eligible documentation, Vietnam Directorate of Fisheries or the Department of Livestock production shall be responsible for carrying out examination and verification of the documentation according to Form as prescribed in Appendix III enclosed herewith; organize a council to assess results of experimentation, testing and analysis of products.

b) If result of examination, verification and assessment of the documentation conducted by the Council is found satisfactory, Vietnam Directorate of Fisheries or the Department of Livestock production shall give comments on recognition of the product. Comments made by the Ministry shall be given within five working days.

c) Within two working days since receipt of written approval from the Minister, Vietnam Directorate of Fisheries or the Department of Livestock production shall issue certificate of free sale for individual registered products (according to Form in Appendix IV enclosed herewith).

d) Otherwise, Vietnam Directorate of Fisheries or the Department of Livestock production shall issue a written notice to the facility specifying the reasons.

4. Registration for extension of circulation:

Within 10 working days since receipt of eligible documentation, Vietnam Directorate of Fisheries or the Department of Livestock production shall be responsible for:

a) Organizing examination and verification of the documentation (according to Form in Appendix III enclosed herewith) and assessment of result of experimentation, and reporting the process of production, trading and use of products. If result of examination, verification and assessment is found satisfactory, Director General of Vietnam Directorate of Fisheries or the Director of the Department of Livestock Production shall issue certificate of free sale to each environmental remediation and treatment product used in aquaculture or in livestock production respectively to the facility that registers extension of circulation (according to Form in Appendix IV enclosed herewith);

b) Otherwise, Vietnam Directorate of Fisheries or the Department of Livestock production shall issue a written notice to the facility specifying the reasons.

5. Registration for changes of information about products in circulation:

Within 08 working days since receipt of eligible documentation, Vietnam Directorate of Fisheries or the Department of Livestock production shall be responsible for:

a) Conducting examination and verification of the documentation (according to Form in Appendix IIII enclosed herewith); Issuing certificate of free sale of each product to the facility (according to Form in Appendix IV enclosed herewith) if result of examination, verification of the documentation is found satisfactory;

b) Making written notice to the facility specifying the reasons for not issuing certificate of free sale;

6. Validity of certificate of free sale:

a) Validity of certificate of free sale for products subject to first registration and re-registration is five years.

b) Validity of certificate of free sale for products subject to registration for extension of circulation is three years.

c) Validity of certificate of free sale for products subject to registration for changes of information about products is the rest of the validity of the product before change of information.

7. List of environmental remediation and treatment products eligible for circulation;

a) On a monthly basis, Vietnam Directorate of Fisheries or the Department of Livestock production shall promulgate an additional list of environmental remediation and treatment products eligible for circulation in Vietnam and make public announcement on the website of Vietnam Directorate of Fisheries, the Department of Livestock production and the Ministry of Agriculture and Rural Development.

b) Every first quarter of year, Vietnam Directorate of Fisheries or the Department of Livestock production shall make checks, compilation and promulgation of the list of environmental remediation and treatment products eligible for circulation in Vietnam and make public announcement on the website of Vietnam Directorate of Fisheries, the Department of Livestock production and the Ministry of Agriculture and Rural Development.

Article 15. Products taken out of the list eligible for circulation

1. Products that contain banned active ingredients according to applicable regulations of the Ministry of Agriculture and Rural Development;

2. Products that cause harm to production, environment, food safety and human health and are subject to re-assessment by the Council of Science as prescribed;

3. Products that are in circulation but not in conformity with the international regulations to which Vietnam is committed;

4. Certificate of free sale that expires but facility owner fails to make registration for extension of circulation;

5. Products that have been registered for circulation but their production and trading facility has stopped its operation;

6. Products that violate industrial property rights;

7. Imported products with certificate of free sale being revoked in exporting country;

Based on one of the aforesaid cases, Vietnam Directorate of Fisheries or the Department of Livestock production shall make submission to the Ministry for decision on removal from the list eligible for circulation in Vietnam. Based on the Ministry's approval, Vietnam Directorate of Fisheries or the Department of Livestock production shall make public announcement of the products taken out of the list on the website of Vietnam Directorate of Fisheries, the Department of Livestock production and the Ministry of Agriculture and Rural Development.

Chapter V

INSPECTION OF CONDITIONS OF THE PRODUCTION AND TRADING FACILITY

Article 16. Inspection of conditions of the production and trading facility

1. Inspection agency:

a) Vietnam Directorate of Fisheries or the Department of Livestock production shall administer inspection of the facility’s production and trading conditions conducted by localities and coordinate with local management agencies in conducting inspection of the production and trading facility as planned or unexpectedly;

b) Local state management agencies for livestock production and aquaculture shall conduct inspection of conditions of the production and trading facility in the administrative division.

2. Sequence and content of inspection as instructed in the Ministry of Agriculture and Rural Development’s Circular No. 45/2014/TT-BNNPTNT dated December 03, 2014 regulating inspection of facilities involved in production and trading of agricultural materials, inspection and certification of satisfaction of food safety conditions for facilities involved in production and trading of agricultural, forestry and fisheries products.

Article 17. Product quality inspection

1. Inspection agency:

a) Vietnam Directorate of Fisheries or the Department of Livestock production shall conduct inspection of responsibilities of local management agencies for the management of quality of domestically produced products, and irregular inspection of products at the trading facility;

b) Management agencies for livestock production and aquaculture at provincial level shall conduct quality inspection at the trading facility in the administrative division within management.

2. Foundations for inspection:

a) Information and warnings about exported products that are not in conformity with the conditions as prescribed in Article 32 of the Law on Product and goods quality;

b) Result of inspection and survey of product quality, or upon complaints about quality of products in circulation not in conformity with applied standards, corresponding national technical regulation or registration for circulation;

c) Annual inspection plan approved by competent agencies;

3. Fashion of inspection: Inspectorate established under the decision by the inspection agency;

4. Content of inspection:

a) Inspect compliance with requirements, provisions prescribed in corresponding national technical regulation related to production conditions and state management measures for product quality in production; inspect compliance with other provisions prescribed by the Ministry of Agriculture and Rural Development on product quality management;

b) Inspect conformity assessment results, presentation of label, standard and conformity marks, and documents accompanying product; If necessary, the inspection agency can employ an expert to carry out assessment of requirements of corresponding technical regulations; Such expert must be independent, objective, and responsible to the law for his/her own assessment;

c) During the inspection conducted at the production facility, upon finding that the product shows no signs of quality assurance or has foundations as prescribed in Points a, b, Clause 2 of this Article, take the specimen for analysis; the specimen must be sent to the analyzing facility appointed by the Ministry of Agriculture and Rural Development for analysis of product quality. Result of analysis is legal foundations for the inspection agency to deal with during the inspection. Permissible tolerance when performing quality inspection is instructed in Appendix V enclosed herewith;

5. Sequence and procedures for inspection are instructed in accordance with Clause 3, Article 29 of the Law on Product and goods quality.

6. Handling of result of inspection of quality of domestically produced products is instructed in accordance with Article 30 of the Law on Product and goods quality, and Article 6 of the Government’s Decree No. 132/2008/NĐ-CP dated December 31, 2008 providing guidance on the Law on Product and Goods quality.

Article 18. Imported product quality inspection

1. Inspection agency: Vietnam Directorate of Fisheries or the Department of Livestock production, or state management agencies empowered by Vietnam Directorate of Fisheries or the Department of Livestock production.

2. Cases subject to inspection:

a) Cases subject to inspection: Products being imported into Vietnam must be subject to quality inspection (except products as prescribed in Point b, Clause 2 of this Article);

b) Cases not subject to quality inspection: samples, products for demonstration at exhibitions, trade fairs, products as gifts; temporarily imported goods for re-exportation; goods in transit; goods in bonded warehouses; goods manufactured for foreign traders by Vietnamese enterprises; imported products decided by the Ministry of Agriculture and Rural Development in case of necessity.

3. Foundations for inspection: technical standards, applied standards, regulations on goods labels and other law provisions.

4. Content of inspection:

a) Check content of certificate of analysis of the batch of imported goods against requirements set out in technical standards, applied standards and applicable regulations. Inspect shelf life of products (only products of more than two-thirds of shelf life are eligible for importation);

b) Inspect labels of products and regulation conformity marks applicable to products declared as conformable and conformity with import documentation: Check essential information written on labels (including secondary labels) including product names, name and address of facilities responsible for the product; origin of products and other information as prescribed; conduct organoleptic inspection;

c) Take specimen for inspection of product quality in following cases: Products receiving complaints, denunciation or under suspicion of conformity assessment results; Products with quality found not in conformity with applicable standards and corresponding technical regulations, or registration for circulation through result of surveying or inspecting quality of products in circulation conducted by the inspection agency. Permissible tolerance when performing quality inspection as instructed in Appendix V enclosed herewith;

5. Handling of inspection result

Handling of result of product quality inspection is instructed in accordance with Article 36 of the Law on Product and goods quality.

Article 19. Documentation and sequence of imported product quality inspection

1. Documentation:

a) Registration form for quality inspection (according to Form KTCL-1 n Appendix I enclosed herewith) (two copies);

b) Copy (with confirmations by the facility) of the following papers: Purchase Agreement, Packing list;

c) Certificate of Analysis (certified copy);

d) Other relevant documents: bill of lading (copy with confirmations by the facility); invoices; declaration of imported goods; certificate of origin; photos or product description; labels of imported goods (stamped with regulation conformity mark if the product is declared as conformable to the regulation) and secondary labels (if primary labels lack information as prescribed)

2. Sequence of implementation

a) Facilities that register imported product quality inspection should formulate one (01) set of documentation sent directly or by post to Vietnam Directorate of Fisheries (for products used in aquaculture) or to the Department of Livestock production (for products used in livestock production);

b) Within two working days since receipt of documentation, Vietnam Directorate of Fisheries or the Department of Livestock production shall issue a written request for supplements if the documentation is ineligible;

c) Within three working days since receipt of eligible documentation, Vietnam Directorate of Fisheries or the Department of Livestock production shall be responsible for carrying out examination and verification of the documentation as prescribed in Points a, b, Clause 4, Article 18 hereof. If the documentation is eligible, Vietnam Directorate of Fisheries or the Department of Livestock production shall make notification about result of state inspection of imported product quality (according to Form KTCL-2 in Appendix I enclosed herewith) to importers and customs authorities for performing customs clearance procedures for the batch;

d) If the documentation fails to meet requirements set out in Points a, b, Clause 4, Article 18 hereof, Vietnam Directorate of Fisheries or the Department of Livestock production shall make the notice to the importer specifying non-conformities and remedial time (according to Form KTCL-3 in Appendix I enclosed herewith). Vietnam Directorate of Fisheries or the Department of Livestock production shall issue a written notice about satisfaction of quality (of the batch of imported goods) only if the importer provides proof of satisfactory remedial work;

dd) If imported products fall within the cases as prescribed in Point c, Clause 4, Article 18 hereof, Vietnam Directorate of Fisheries or the Department of Livestock production shall make written confirmations of the registration note for quality inspection and make notice to the importer and customs authorities for performing customs declaration. Upon receipt of confirmed registration note, the importers is permitted to transfer the batch to the address specified in the registration note, keeps the batch intact without production, trading or using before result of quality inspection is available. Within no more than ten working days, Vietnam Directorate of Fisheries or the Department of Livestock production shall carry out collection of specimen, analysis of quality and notify the result to the importer. If quality of imported products is found unsatisfactory, Vietnam Directorate of Fisheries or the Department of Livestock production shall handle in accordance with Article 36 of the Law on product and goods quality.

Article 20. Quality inspection for products in circulation

1. Inspection agency:

a) Vietnam Directorate of Fisheries or the Department of Livestock production shall conduct inspection of responsibilities of local management agencies for the management of quality of products in circulation, and irregular inspection of products at the production and trading facility;

b) Management agencies for livestock production and aquaculture at local level shall conduct quality inspection at the trading facility in the administrative division.

2. Content, sequence and procedures for inspection of quality of environmental remediation and treatment products in circulation are instructed in accordance with Circular No. 26/2012/TT-BKHCN dated December 12, 2012 of the Ministry of Science and Technology regulating state inspection for quality of products in circulation.

Article 21. Exported product quality inspection

1. Inspection agency: Vietnam Directorate of Fisheries or the Department of Livestock production or state management agencies empowered by Vietnam Directorate of Fisheries or the Department of Livestock production.

2. Subjects under inspection:

a) Products subject to recall Sequence, procedures and content of inspection are instructed in accordance with Article 17 hereof.

b) Exported products that need inspection, confirmation or certification by competent agencies in Vietnam. Facilities that have products in need of quality inspection, confirmation must make registration as prescribed in Clauses 5, 6 of this Article.

3. Foundations for inspection: applied standards, regulations of exporting countries, contracts or International Agreement, international agreements for mutual recognition with regard to conformity assessments with relevant countries and territories.

4. Content of inspection: at the request of the facility or conduct inspection in accordance with regulations of importing countries, contracts or International Agreement, international agreements for mutual recognition with regard to conformity assessments with relevant countries and territories.

5. Registration documentation for product quality inspection at the request of exporters includes:

a) Registration form for quality inspection (according to Form KTCL-1 n Appendix I enclosed herewith);

b) Copy (with confirmations by the facility) of the following papers: Purchase Agreement, applied standards, product labels and other relevant documents;

c) Copy (with confirmations by the facility) of either of the following papers: Certificate of Business registration (or Certificate of Enterprise registration); Investment Certificate; Public Service Provider Establishment Decision;

d) Copy (with confirmations by the facility) of result of inspection, assessment and classification of facility conditions as A or B.

6. Sequence of product quality inspection at the request of exporters:

a) Facilities that register exported product quality inspection should formulate one (01) set of documentation sent directly or by post to Vietnam Directorate of Fisheries (for products used in aquaculture) or to the Department of Livestock production (for products used in livestock production);

b) Within two working days since receipt of documentation, Directorate of Fisheries or the Department of Livestock production shall issue a written request for supplements if the documentation is ineligible;

c) Within 10 working days since receipt of eligible documentation, Vietnam Directorate of Fisheries or the Department of Livestock production shall carry out examination and verification of the documentation, make notification to the facility about plans for collection of specimen; organize collection of specimen or empower local agencies charged with managing livestock production and aquaculture to carry out collection of specimen for inspection, transfer the specimen to the analyzing facility for analysis of product quality;

d) Make notification of result of exported product quality inspection upon receipt of analysis sheet issued by the analyzing facility according to Form KTCL-2 in Appendix I enclosed herewith (if result is satisfactory) or to Form KTCL-3 (if result is not satisfactory).

Article 22. Inspection of facilities involved in production of environmental remediation and treatment products in exporting countries

1. Based on International Agreement or cooperation in livestock production or aquaculture with relevant management agencies from exporting countries, the Ministry of Agriculture and Rural Development shall decide to establish the inspectorate, formulate plans for physical inspection of the production facilities in the exporting counties that have products exported to Vietnam.

2. Budget for inspection shall be allocated by state budget according to applicable regulations.

Chapter VI

ISSUANCE OF PRACTICE CERTIFICATE

Article 23. Conditions on issuance of practice certificate

Conditions on issuance of certificates of practice of production, trading, importation, exportation, experimentation and testing of environmental remediation and treatment productions are instructed in accordance with Article 64 of the Government's Decree No. 33/2005/NĐ-CP dated March 15, 2005 detailing the implementation of a number of articles of the Ordinance on Veterinary Medicine, particularly as follows:

1. Conditions of degrees in production, trading, importation, exportation, experimentation and testing of environmental remediation and treatment productions used in livestock production.

a) Owners or technical personnel of the facility involved in the production and analysis of environmental remediation and treatment products used in livestock production must obtain at least engineering degree in veterinary medicine, livestock production, and pharmacy degree; have at least two years of experience in the area registered for practice.

b) Owners of shops selling environmental remediation and treatment products used in livestock production must obtain at least vocational certificates in livestock production, veterinary medicine. Sale persons must obtain at least training certificate in the area registered for practice issued by state management agencies.

c) Owners or technical personnel of the testing facility (in livestock production) must obtain at least engineering degree in veterinary medicine, livestock production; have at least two years of experience in the area registered for practice.

d) Owners or technical personnel of importers and exporters of environmental remediation and treatment products used in livestock production must obtain at least engineering degree in veterinary medicine, livestock production.

2. Conditions of degrees in production, trading, importation, exportation, experimentation and testing of environmental remediation and treatment productions used in aquaculture.

a) Owners or technical personnel of facilities involved in production and analysis of environmental remediation and treatment products used in aquaculture must obtain at least Bachelor of science degree in chemistry or biology or engineering degree in aquaculture and have at least two years of experience in the area registered for practice.

b) Owners of shops selling environmental remediation and treatment products must obtain at least vocational certificates in biology or aquaculture. Sale persons must obtain at least training certificate in the area registered for practice issued by state management agencies for aquaculture at provincial level;

c) Owners or technical personnel of the testing facilities must obtain at least Bachelor of science degree in biology or biochemistry or engineering degree in aquaculture along with training certificate and have at least two years of experience in the area registered for practice.

d) Owners or technical personnel of importers and exporters must obtain at least Bachelor of science degree in biology or biochemistry or engineering degree in aquaculture along with training certificate in the area registered and issued by state management agencies at provincial level.

3. Conditions on health

Conditions on health of persons who practice veterinary medicine are instructed in accordance with Clause 2, Article 64 of the Decree No. 33/2005/NĐ-CP.

4. Conditions on issuance of practice certificates to foreigners are instructed in accordance with Clause 3, Article 64 of the Decree No. 33/2005/NĐ-CP.

Article 24. Agencies to award practice certificate

1. Vietnam Directorate of Fisheries shall award practice certificates in the following areas: production, trading, importation, exportation, experimentation and testing of environmental remediation and treatment products used in aquaculture according to Form CCHN-3 in Appendix I enclosed herewith.

2. The Department of Livestock production shall award practice certificates in the following areas: production, trading, importation, exportation, experimentation and testing of environmental remediation and treatment products used in livestock production according to Form CCHN-3 in Appendix I enclosed herewith.

3. Administration agencies for aquaculture at provincial level shall award practice certificates in trading of environmental remediation and treatment products used in aquaculture according to Form CCHN-4 in Appendix 1 enclosed herewith.

4. Administration agencies for livestock production at provincial level shall award practice certificates in trading of environmental remediation and treatment products used in livestock production according to Form CCHN-4 in Appendix 1 enclosed herewith.

Article 25. Sequence and procedures for issuance of practice certificate

1. Documentation for issuance of the first practice certificate:

c) Written request for issuance of practice certificates (according to Form CCHN-1 in Appendix I enclosed herewith) accompanied by two color 4x6 photos;

b) Degrees, certificates (certified copy);

c) Resume;

d) Health certificates bearing confirmations issued by medical facility from district level and higher;

dd) Written confirmations issued by the production facility, testing facility of the period of practice at the facility applicable to the cases as prescribed in Points a, c, Clauses 1, 2 of Article 23 hereof;

e) Written approval of head of the agency where the applicant works applicable to the case that applicants are officials, public servants.

2. Documentation for extension of practice certificate:

a) Written request for extension of practice certificates (according to Form CCHN-2 in Appendix I enclosed herewith) accompanied by two color 4x6 photos;

b) Awarded practice certificate (certified copy);

c) Health certificates bearing confirmations issued by medical facility from district level and higher;

3. Sequence of issuance of practice certificate

a) Persons who are in need of practice certificate must formulate one (01) set of documentation as prescribed in Clause 1 of this Article sent directly or by post to competent agencies for issuance of practice certificate as stated in Article 24 hereof.

b) Within two working days since receipt of documentation, competent agencies for issuance of practice certificates shall issue a written request for supplements if the documentation is ineligible;

c) Within two working days since receipt of documentation, competent agencies shall award the practice certificate to the applicant if the documentation is ineligible; In case the practice certificate can not be awarded, competent agencies shall issue a written notice to the applicant specifying the reasons.

d) Validity of practice certificate is five years. One month before the practice certificate expires, any person who needs extension of practice must make submission of one set of documentation as prescribed in Clause 2 of this Article to competent agencies for issuance of practice certificate. Sequence of extension of practice certificate is prescribed in Points b, c, Clause 3 of this Article.

Chapter VII

RESPONSIBILITIES OF RELEVANT PARTIES

Article 26. Vietnam Directorate of Fisheries

1. Perform state management for environmental remediation and treatment products used in aquaculture across the country; Direct and provide professional instructions on management of environmental remediation and treatment products used in aquaculture;

2. Conduct quality inspection for imported, exported environmental remediation and treatment products used in aquaculture or empower local management agencies to do the job;

3. Carry out examination and verification of documentation and recognize the facility meets conditions on experimentation and testing of environmental remediation and treatment products used in aquaculture; carry out examination and verification of documentation and award certificate of free sale, make checks, compilation and promulgation of the list of environmental remediation and treatment products eligible for circulation in Vietnam and post on the website of Vietnam Directorate of Fisheries and the Ministry of Agriculture and Rural Development;

4. Award practice certificates in production, experimentation, testing, and importation, exportation of environmental remediation and treatment products used in aquaculture;

5. Make submission to the Ministry of Agriculture and Rural Development for taking the products out of the list of environmental remediation and treatment products used in aquaculture eligible for circulation in Vietnam;

6. Make submission to the Ministry of Agriculture and Rural Development for promulgation of National technical regulations relating to environmental remediation and treatment products used in aquaculture;

7. Conduct inspection of environmental remediation and treatment products across the country; conduct inspection of responsibilities of local management agencies for management of environmental remediation and treatment products used in aquaculture;

8. Organize instruction and execution of this Circular;

Article 27. Department of Livestock production

1. Perform state management for environmental remediation and treatment products used in livestock production across the country; Direct and provide professional instructions on management of environmental remediation and treatment products used in livestock production;

2. Conduct quality inspection for imported, exported environmental remediation and treatment products used in livestock production or empower local management agencies to do the job;

3. Carry out examination and verification of documentation and recognize the facility meets conditions on experimentation and testing of environmental remediation and treatment products used in livestock production; carry out examination and verification of documentation and award certificate of free sale, make checks, compilation and promulgation of the list of environmental remediation and treatment products eligible for circulation in Vietnam and post on the website of the Department of Livestock production and the Ministry of Agriculture and Rural Development;

4. Award practice certificates in production, experimentation, testing, importation, exportation of environmental remediation and treatment products used in livestock production;

5. Make submission to the Ministry of Agriculture and Rural Development for taking the products out of the list of environmental remediation and treatment products used in livestock production eligible for circulation in Vietnam according to the law provisions;

6. Make submission to the Ministry of Agriculture and Rural Development for promulgation of National technical regulations relating to environmental remediation and treatment products used in livestock production;

7. Conduct inspection of environmental remediation and treatment products across the country; conduct inspection of responsibilities of local management agencies for management of environmental remediation and treatment products used in livestock production;

8. Organize instruction and execution of this Circular;

Article 28. Service of Agriculture and Rural Development

1. Perform state management for environmental remediation and treatment products as prescribed hereof in the administrative division within management;

2. Direct, instruct, inspect and monitor the management of environmental remediation and treatment products by subordinate agencies in the administrative division within management;

3. Organize investigation, inspection and handling of violations within competence and report result of management of environmental remediation and treatment products after completion of investigation and inspection;

4. Assign and direct local management agencies for livestock production and aquaculture to perform the followings:

a) Aquaculture management agencies shall perform management of environmental remediation and treatment products used in aquaculture. Livestock production management agencies shall perform management of environmental remediation and treatment products used in livestock production.

b) Organize statistical work, inspection, assessment and classification of the production and trading facility; carry out quality inspection for environmental remediation and treatment products in the administrative division as prescribed;

c) Conduct quality inspection for imported, exported environmental remediation and treatment products as authorized by Vietnam Directorate of Fisheries or the Department of Livestock production;

d) Award practice certificates in trading of environmental remediation and treatment products;

dd) Preside over and cooperate with relevant management agencies in organizing investigation and inspection of the production and trading facility at the same time;

e) Organize training and disseminate regulations of the law on production and trading of environmental remediation and treatment products;

g) Conduct other tasks relating to environmental remediation and treatment products as authorized by Vietnam Directorate of Fisheries or the Department of Livestock production;

h) Compile and report production and trading, quality of environmental remediation and treatment products in the administrative division to Vietnam Directorate of Fisheries, the Department of Livestock production on a six-month basis as assigned; conduct general reports, annually or unexpectedly at the request of Vietnam Directorate of Fisheries or the Department of Livestock production; Report result of investigation, inspection and handling of violations after completion of investigation and inspection (if any);

Article 29. Testing facility

1. Formulate outline and conduct experimentation and testing according to approved outline;

2. Keep confidential figures and information about test products;

3. Take responsibility for result of experimentation, testing and keeping records for at least five years;

4. Compensate the farming facility for expenses for experimentation and testing as well as the losses caused during the production;

5. Make notification to Vietnam Directorate of Fisheries, the Department of Livestock production in case of dissolution or no longer operating in the recognized area;

Article 30. Production and trading facility

1. Strictly comply with provisions as prescribed hereof and other relevant regulations;

2. Take responsibility to the law and consumers for quality of products produced, imported, recalled during circulation and distribution;

3. Be subject to inspection and investigation by competent state agencies; Provide technical documents, relevant papers, product samples and create favorable conditions for the inspection agency to fulfill its tasks;

4. Be permitted to produce and trade environmental remediation and treatment products that are eligible for circulation in Vietnam.

5. Keep records during production and trading as prescribed;

6. The production facility must have regulations and comply fully with such regulations including: quality control for raw materials, semi-finished products, finished products, product recycling; arrangement, storage, regular inspection regime, early handling of problems arising during the production, storage; operation of equipment, factory clean-up, wastewater treatment, labor safety, fire, explosion prevention and fighting;

7. Production facility must conduct quality inspection according to the announced standards, make registration before delivery and keep product sample for a period at least equal to product shelf life plus six months;

8. When putting the product into circulation, importers and exporters must provide authenticated copy of certificate of free to the production and distribution facility or at the request of competent inspection agency.

9. Carry out declaration and putting up price according to the law provisions;

10. Report production and trading of environmental remediation and treatment products to the management agency on request;

11. Pay fees, charges as prescribed in Article 3 hereof;

12. Make written notification to local management agencies for livestock production or aquaculture in case of change of production location, dissolution or no longer producing registered product;

13. Make written notification to local management agencies for livestock production or aquaculture about content and location for putting the production model into practice in the administrative division;

Chapter VIII

IMPLEMENTATION

Article 31. Transitional provisions

1. Any facility recognized as the testing facility as prescribed in the Decision No. 18/2002/QÐ-BTS dated June 03, 2002 promulgating regulations on experimentation and testing of aquatic breeds, feeds, drugs, chemicals and biological preparations used in aquaculture, within 12 months since the effective date of this Circular must carry out registration for re-recognition of the testing facility as prescribed hereof.

2. Any environmental remediation and treatment product used in livestock production, aquaculture that is issued certificate of free sale before June 30, 2011 shall be eligible for circulation up to June 30, 2016. Any environmental remediation and treatment product used in livestock production, aquaculture that is issued certificate of free sale since June 30, 2011 shall be eligible for circulation until the product completes its five-year circulation time limit. At least three months before the transitional time limit expires, any facility that needs extension of circulation of this product must carry out registration as prescribed in Clause 3, Article 13, and Clause 4, Article 14 hereof.

Article 32. Implementary clause

1. This Circular takes effect since August 06, 2015.

2. This Circular shall replace provisions on environmental remediation and treatment products used in aquaculture as prescribed in the Ministry of Fisheries’ Decision No. 03/2007/QĐ-BTS dated April 03, 2007 promulgating regulations on registration for circulation of aquaculture drugs, environmental remediation and treatment products used in aquaculture, and the Decision No. 18/2002/QÐ-BTS dated June 03, 2002 promulgating regulations on experimentation of aquatic breeds, feeds, drugs, chemicals and biological preparations used in aquaculture.

Article 33. Implementation

Difficulties that arise during the implementation of this Circular should be reported to Vietnam Directorate of Fisheries or the Department of Livestock production for early submission to the Minister of Agriculture and Rural Development for amendments and supplements./.

Appendix V: PERMISSIBLE LEVELS FOR PRODUCT QUALITY INSPECTION

(Enclosed with Circular No. 23/2015/TT-BNNPTNT dated June 22, 2015 of the Ministry of Agriculture and Rural Development)