Circular No. 14/2013/TT-BNNPTNT dated February 25, 2013 of the Ministry of Agriculture and Rural Development regulation on issuing eligible certificate for production and trading of plant protection medicines

CIRCULAR

REGULATION ON ISSUING ELIGIBLE CERTIFICATE FOR PRODUCTION AND TRADING OF PLANT PROTECTION MEDICINE

Pursuant to Decree No. 01/2008/ND-CP dated January 03, 2008 of the Government defining the functions, tasks and organizational structure of the Ministry of Agriculture and Rural Development;

Pursuant to the Ordinance on Plant Protection and Quarantine dated July 25, 2001;

Pursuant to the Regulation on management of plant protection medicines, issued together with Decree No. 58/2002/ND-CP dated June 03, 2002 of the Government;

Pursuant to the Decree No. 59/2006/ND-CP dated 12/6/2006 of the Government detailing the Commercial Law regarding goods and services banned from business, limited and conditioned business;

Decree No. 108/2008/ND-CP dated October 07, 2008 of the Government detailing and guiding the implementation of a number of articles of the Law on Chemicals;

Decree No. 26/2011/ND-CP dated April 08, 2011 of the Government amending and supplementing a number of articles of Decree No. 108/2008/ND-CP dated October 07, 2008 of the Government detailing and guiding the implementation of some articles of the Law on Chemicals;

At the proposal of the Director of Department of Plant Protection;

Minister of Agriculture and Rural Development issues the Circular stipulating the granting of Certificate of eligibility for production and trading of plant protection medicines.

Chapter I

GENERAL PROVISIONS

Article 1. Scope of regulation

This Circular stipulates the conditions, order and procedures for granting certificate of eligibility for production, processing, bottling, packaging (hereinafter referred to as the production) and business (trading) of plant protection medicines.

Article 2. Subject of application

This Circular applies to the organization and individual having activities relating to production and trading plant protection medicines (except for organization and individual only producing biological plant protection medicines with active substances as useful microorganism) in the territory of Vietnam.

Chapter II

CONDITIONS FOR ESTABLISHMENTS PRODUCING PLANT PROTECTION MEDICINES

Article 3. Conditions for workshop and warehouse

1. Location

a) Workshop and warehouse of plant protection medicines located in industrial park must comply with regulations of the industrial park.

b) In case the location is outside the industrial park:

Location of workshop and warehouse must be approved by the local authority from communal-level or higher level; located far away from schools, offices, hospitals and markets for at least 200 meters (m); ensure requirements on power and water supply, drainage, pollution and traffic handling.

Warehouse and warehouse with walls separated from the outside. Internal road system is arranged to ensure safe transport and fire fighting.

2. Layout of site, structure and architecture of workshop and warehouse

a) Factory and warehouse area must be separated.

b) Factory

Factory must meet design and construction standards specified in Vietnamese Standard TCVN 4604/1988: Industrial Enterprise, manufacturers - Design Standard; TCVN: 2622/1995: Fire prevention and fighting Fire Protection for houses and works - Design requirements.

c) Warehouse

Warehouse with separated finished product and the material area.

The material warehouse is arranged depending on the type of material to be stored, classified according to the risk of explosion, fire and explosion, fire and ensure the separation of substances likely to cause chemical reactions with each other.

The finished product warehouse must be arranged tidily and reasonably. The goods on the shelf of at least 10 centimeters (cm) from the ground and 20 centimeters (cm) from the wall. The main walkway is 1.5 meters (m) minimally to facilitate the fire-fighting activities, inspection and supervision.

d) Material for building workshop and warehouse is the non-flammable materials, fireproof, house framework is built of brick, concrete or steel. The floor is made​​of liquid proofed material, non-slip and flat, without cracks and the surrounding edges or margins.

dd) Workshop and warehouse must have exit way with clear instruction (with signboard and diagram) and easily opened upon occurrence of incident.

Article 4. Conditions for equipment

1. Production equipment

a) Having production line and technology to ensure the type and quality of plant protection medicines of the manufacturing facility.

b) Equipment shall be placed and installed to suit each stage of production and meets the requirements of labor safety in accordance with Vietnamese Standard TCVN 2290 - 1978 Production equipment - General safety requirements.

c) Equipment with the operation manual, checked with technical parameters, maintained and having industrial hygiene process.

d) Lighting equipment and other electrical equipment installed at necessary location without temporary installation. All electrical equipment must have circuit breaker upon circuit leakage and overload

2. Emission and waste treatment system.

a) Factory has the emission treatment system, warehouse with ventilation system. The emission from workshop and warehouse must meet the national technical regulation QCVN 19:2009 / BTNMT - National Technical Regulation on industrial emissions for dust and other inorganic matters and QCVN 20:2009 / BTNMT- National technical Regulation on industrial emission of some organic matters.

b) Factory has a waste water treatment system. Wastewater after treatment shall meet the national technical regulation QCVN 07:2009 / BTNMT - National Technical Regulation on hazardous waste threshold and QCVN 24:2009 / BTNMT - National Technical Regulation on industrial wastewater.

c) Treatment of solid waste of workshop and warehouse shall comply with provisions in Decree No. 59/2007/ND-CP dated April 09, 2007 of the Government on management of solid waste. The workshop and warehousemust have equipment collecting and transporting the waste substance out of the production area after each production shift. The place containing waste substance must be close and separated from the production area.

Article 5: Conditions for safe operation

1. The manufacturing facility shall satisfy all requirements on chemical safety specified in Vietnamese Standard TCVN 5507 – 2002 Dangerous chemicals – Regulation on safety in production, trading, use, preservation and transportation.

2. The manufacturing facility has the labor safety rule, with separate areas for dressing, bathing for workers before and after the production shift.

3. The manufacturing facility builds the rule table on chemical safety, signaling systems in accordance with dangerous levels of the chemical. In case the chemicals have different hazardous properties, the warning symbol must be fully shown with dangerous properties.

4. The manufacturing facility is equipped with and uses labor safety equipment (gloves, gauze mask, eye-protection glasses, protective clothing) when exposed to plant protection medicines, instruments, medicines, emergency equipment.

5. The operation at the warehouse must ensure the safety and prevent risks possibly happening such as fire, leakage, and spill. For storage of raw materials: warehouse worker must comply with the instructions in the chemical safety data sheet of all chemicals stored, the instructions on the safety, hygiene, instruction upon occurrence of incidents.

Article 6: Conditions for fire and explosion prevention and fighting

1. The manufacturing facility shall satisfy all requirements on fire and explosion prevention and fighting under the Law on fire prevention and fire fighting.

2. The manufacturing facility shall satisfy all requirements on fire and explosion.

3. The manufacturing facility has the rule of fire prevention and fighting. The fire-fighting command and signboards "No fire" are at conspicuous place.

Article 7. Conditions for manpower

1. The person directly operating manufacturing facility must have certificate of practice of production, processing, bottling and packing of plant protection medicines granted by Provincial Sub-Department of plant protection.

2. Leadership, person managing parts directly related to the production of plant protection medicines, the person directly producing, trading, transporting, storing, preserving is trained with chemical safety techniques.

3. Leadership, technical personnel and storekeeper are trained and firmly understand the regulations on management of chemical activities; fire prevention and fighting; safe distance; implementation of measures and plans to prevent and respond   incidents.

4. Employee are trained on the production process, labor safety, fire and explosion prevention and fighting, preventive measures, handling of problems for plant protection medicines.

Article 8. Quality management system

1. Havingquality management system.

2. Having process of production technology of plant protection medicines approved by the owner of manufacturing facility.

3. Having lab to test product quality.

The lab must be separated from the production area, equipped with minimum equipment used for testing quality of plant protection medicines of the manufacturing facility.

4. In case the manufacturing facility of plant protection medicines does not have the lab for testing quality of product, it must have a quality testing contract with laboratory eligible for quality testing of plant protection medicines of the manufacturing facility and have record to keep the testing results for each batch of product before delivery.

5.The quality control samples of the batch are stored for at least 03 (three) months.

Article 9. Requirements on environmental protection

1. The manufacturing facility of plant protection medicines shall apply environmental management system by standard of ISO 14001 or equivalent standard to prevent environment and pollution.

2. The manufacturing facility of plant protection medicines shall make a report on assessment of environmental impact or commitment to protect the environment or plan on environmental protection as prescribed by law on environmental protection.

Chapter III

CONDITIONS FOR TRADING ESTABLISHMENT OF PLANT PROTECTION MEDICINES

Article 10. General conditions

1. The types of plant protection medicines sold at the stores in the form of finished products in the List of plant protection medicines permitted or restricted for use in Vietnam.

2. Do not sell plant protection medicines together with other types of goods such as: food, foodstuff, drinks, animal feed, medicines, veterinary drugs and other consumer goods.

3. The stores selling plant protection medicines must not be located in the areas of goods and foodstuffs trading, food service and recreation areas, schools, hospitals.

Article 11. Specific conditions

1. Human resources

a) The direct manager of the store must have certificate of plant protection medicines’s trading practice granted by Provincial Sub-Department of plant protection.

b) The person directly selling products is trained on plant protection medicines organized by Provincial Sub-Department of plant protection or has intermediate graduation diploma from specialized cultivation, plant protection, biology, agricultural pedagogy or higher.

2. Location

a) The store selling plant protection medicines must be approved by communal-level local authority, with clear and stable address, owned by the facility owner or with legal house leasing contract of at least 01 (one) year in case of location leasing for store.

b) Having area in line with business scale of at least 5 square meter (m2). It must be a 4-grade house or higher, located at a high, clean, well-ventilated place and meets the requirements on buying, selling, preservation without affecting the quality of plant protection medicines.

c) Located away from water sources (rivers, lakes, canals) at least 10 meters (m) and reinforced by embankments to ensure anti-erosion, the store floor must be high and un-flooded.

d) The wall and roof are built by anti-fire materials. The walls and floor must be flat, waterproof, easy to clean and un-flooded.

3. Equipment

a) Having display cabinets, counters, shelves or racks for holding plant protection medicines, preservation equipment in accordance with preservation requirement on the drug label.

b) Ensuring sufficient illumination to identify drug. The lighting equipment must ensure fire prevention and fighting safety.

c) Having rule and equipment of fire prevention and fighting as required by the agency of fire prevention and fighting is place at convenient place and available for use in case of necessity.

d) Having personal labor protection such as gloves, gauze masks, clean water and soap.

e) Having materials and devices to promptly handle incidents as required by environmental management agency.

4. Other requirements

a) Having signboard in clear Vietnamese language specifying name of facility owner or enterprise name, address and telephone number.

b) Having books recording the entry and exit of plant protection medicines

c) Having price list of plant protection medicines.

5. Storage of plant protection medicines.

a) For trading establishments which have storage of plant protection medicine from 5,000 kilograms (kg) or more shall comply with Clause 2, Article 3 and Clause 2, Article 9 of this Circular.

b) For trading establishments which have storage of plant protection medicines of less than 5,000 kilograms (kg).

The storage of plant protection medicines must be dry, ventilated, waterproofed, un-flooded, un-leaked and ensure fire and explosion prevention and fighting.

Shelves and racks of goods are at least 10 centimeters (cm) from the ground, and at least 20 centimeters(cm) from the wall

The layout of types of plant protection medicines ensures no breakdown, leakage and with large entrance and separated from each type.

Chapter IV

PROCEDURES FOR GRANTING ELIGIBLE CERTIFICATE FOR PRODUCTION, TRADING OF PLANT PROTECTION MEDICINES

Article 12. Competence to grant certificate of eligibility for production, trading of plant protection medicines

1. Department of Plant Protection, shall grant, renew, re-grant and revoke of eligibility for production of plant protection medicines

2. Provincial-level Sub-Department of plant protection shall grant, renew, re-grant and revoke certificate of eligibility for production and trading of plant protection medicines at the management locality.

3. The term of certificate of eligibility for production and trading of plant protection medicines is 05 (five) years.

4. The form of certificate of eligibility for production and trading of plant protection medicines is prescribed in Annex VI and VII issued together with this Circular.

Article 13. Procedures for granting certificate of eligibility for production ofplant protection medicines

1. Submission of dossier

a) The manufacturing facility shall submit directly or via post to Department of plant protection.

b) Number of dossier: 01 paper set and 01 electronic file in PDF form.

c) Checking of completion of dossier right after direct receipt of dossier or within 02 (two) working days for dossier sent by post. If the dossier is complete, the Department of plant protection shall receive it and require supplementation if the dossier is not complete.

2. Dossier

a) Application for granting certificate of eligibility for production of plant protection medicines under the form prescribed in Annex I issued together with this Circular.

b) A copy (with the original for comparison) or copy of Certificate of business registration or Certificate of investment on production, processing, bottling, packing of plant protection medicines.

c) A copy (with the original for comparison) or copy of certificate of practice of production, processing, bottling and packing of plant protection medicines granted to the person directly directing the manufacturing facility.

d) A copy (with the original for comparison) or copy of certificate of Decision on approval of production works construction investment project in accordance with the law on management and construction investment (if any).

e) A copy (with the original for comparison) or copy of certificate of Decision on approval of Report on assessment of environmental impact or commitment of environmental protection or scheme of environmental protection granted by the competent authority.

g) A copy (with the original for comparison) or copy of certificate of fire fighting scheme or record of examination to ensure fire prevention and fighting safety approved by district-level fire prevention and fighting police agency.

h) Declaration sheet on the conditions for production of plant protection medicines specified in Annex II issued together with this Circular.

3. Appraising dossier and granting Certificate of eligibility for production of plant protection medicines.

a) Department of plant protection shall appraise the dossier within 05 (five) working days after receipt of complete dossier.

b) Establishing assessment group

Within 15 (fifteen) working days after receipt of complete dossier, Department of plant protection shall issue a Decision on establishment of assessment group and conduct actual assessment. The assessment group includes 3-5 members with professional knowledge and experience on the areas of assessment and representative of specialized management agency.

Making written notice to the facility on assessment plan 05 (five) working days before the time of assessment. Specifying the content, time, group component and scope of assessment in the notice.

c) Content of assessment

The compatibility of the facility with the conditions specified in Chapter II of this Circular.

d) Method of assessment

Making direct interview to the person in charge and employee of the facility on related information;

Reviewing records and related documents of the facility;

Actually observing the surface layout, environmental and equipment condition and other amenities of the facility;

e) Result of assessment

The conditions not in accordance with provision in Chapter II of this Circular detected during the assessment must be specified in the Record of assessment under the form prescribed in Annex IV issued together with this Circular.

The Record of assessment with full contents and signature of facility’s representative and the head of assessment group.

In case the facility’s representative does not agree upon the result of assessment of the group, he/she shall write down proposal at the end of the record before signing and affixing seal. The record of assessment is still legally valid in case the representative does not sign in the record.

g) Granting certificate of eligibility for production of plant protection medicines.

Department of plant protection shall review the result of assessment within 05 (five) working days after the end of assessment:

If the dossier meets the requirements, the facility shall be granted certificate of eligibility for production of plant protection medicines under the form prescribed in Annex VI issued together with this Circular.

If the dossier is not satisfactory, the facility shall be notified in writing of unsatisfactory conditions, requirements and remedial deadline. Within 05 (five) working days after receipt of report on remedy of the facility or result of re-inspection (in case of necessity). If find it valid, the Department of plant protection shall grant certificate to the facility eligible for production of plant protection medicines under the form prescribed in Annex VI issued together with this Circular.

In case of failing to grant Certificate, the Department of plant protection shall reply in writing and clearly specify the reason.

Article 14. Procedures for granting Certificate of eligibility for trading of plant protection medicines.

1. Submission of dossier

a) The trading establishment shall submit dossier directly or by post to provincial-level Sub-Department of plant protection.

b) Number of dossier: 01 set

c) Checking the completeness of the dossier upon direct receipt or within 02 (two) working days for dossier sent by post. If the dossier is complete, the Sub-Department of plant protection shall receive or return it to the organization for supplementation and completion if incomplete.

2. Dossier

a) Application for granting Certificate of eligibility for trading plant protection medicines under the form prescribed in Annex I issued together with this Circular.

b) A copy (with the original for comparison) or copy of certificate of business registration of plant protection medicines or agricultural materials.

c) A copy (with the original for comparison) or copy of certificate of plant protection medicines trading practice of the facility owner.

d) A declaration sheet on conditions for plant protection medicines trading as prescribed in Annex III issued together with this Circular.

e) A copy (with the original for comparison) or copy of certificate of Decision on approval of Report on assessment of environmental impact or commitment of environmental protection or scheme of environmental protection granted by the competent authority (for trading establishment with storage of 5000 kg or more.)

3. Appraisal of dossier and granting of Certificate of eligibility for trading of plant protection medicines

a) The Sub-Department of plant protection shall appraise dossier within 03 (three) working days after receipt of complete dossier.

b) Establishment of assessment group

Within 07 (seven) working days after receipt of complete dossier, the Sub-Department of plant protection shall issue Decision on establishment of assessment group and conducts actual assessment. The group includes 2-3 members having professional knowledge and experience on area of assessment and representative of specialized management agency.

Making written notice to the facility on assessment plan 05 (five) working days before the time of assessment. Specifying the content, time, group component and scope of assessment in the notice.

c) Content of assessment

The compatibility of the facility with the conditions specified in Chapter III of this Circular.

d) Method of assessment:

Making direct interview to the person in charge and employee of the facility on related information;

Reviewing records and related documents of the facility;

Actually observing the surface layout, environmental and equipment condition and other amenities of the facility;

e) Result of assessment

The conditions not in accordance with provision in Chapter III of this Circular detected during the assessment must be specified in the Record of assessment under the form prescribed in Annex V issued together with this Circular.

The Record of assessment with full contents and signature of facility’s representative and the head of assessment group.

In case the facility’s representative does not agree upon the result of assessment of the group, he/she shall write down proposal at the end of the record before signing and affixing seal. The record of assessment is still legally valid in case the representative does not sign in the record.

e. Granting certificate of eligibility for trading of plant protection medicines.

The Sub-Department of plant protection shall review the result of assessment within 05 (five) working days after the end of assessment:

If the dossier meets the requirements, the facility shall be granted certificate of eligibility for trading of plant protection medicines under the form prescribed in Annex VII issued together with this Circular.

If the dossier is not satisfactory, the facility shall be notified in writing of unsatisfactory conditions, requirements and remedial deadline. Within 03 (five) working days after receipt of report on remedy of the facility or result of re-inspection (in case of necessity). If find it valid, the Sub-Department of plant protection shall grant certificate to the facility eligible for trading of plant protection medicines under the form prescribed in Annex VII issued together with this Circular.

In case of failing to grant Certificate, the Sub-Department of plant protection shall reply in writing and clearly specify the reason.

Article 15. Procedures for renewal of Certificate of eligibility for production of plant protection medicines

1. Submission of dossier

a) 3 (three) months prior to the expiration date of Certificate of eligibility for production of plant protection medicines, the manufacturing facility shall submit dossier directly or by post to the Department of plant protection.

b) Number of dossier: 01 paper set and 01 electronic file in PDF form.

c) Checking of completion of dossier right after direct receipt of dossier or within 02 (two) working days for dossier sent by post. If the dossier is complete, the Department of plant protection shall receive it and require supplementation if the dossier is not complete.

2. Dossier

a) Application for granting certificate of eligibility for production of plant protection medicines under the form prescribed in Annex I issued together with this Circular.

b) A copy (with the original for comparison) or copy of Certificate of business registration or Certificate of investment on production, processing, bottling, packing of plant protection medicines ( if there is modification).

c) A copy (with the original for comparison) or copy of certificate of practice of production, processing, bottling and packing of plant protection medicines granted to the person directly directing the manufacturing facility ( if there is modification).

d) A copy (with the original for comparison) or copy of certificate of fire fighting scheme or record of examination to ensure fire prevention and fighting safety approved by the competent police agency (if there is modification)

e) The original of the granted Certificate of eligibility for production of plant protection medicines.

g) Declaration sheet on the conditions for production of plant protection medicines specified in Annex II issued together within this Circular.

h) A copy (with the original for comparison) or certified copy of the Form or record of examination, assessment and classification of the conditions for quality assurance of the facility producing, processing, bottling and packing of plant protection medicines of the competent authorities as prescribed in Circular No. 14/2011/TT-BNNPTNT dated March 29, 2011 of the Minister of Agriculture and Rural Development (if any).

3. Appraising dossier and granting Certificate of eligibility for production of plant protection medicines.

Department of plant protection shall appraise the dossier within 05 (five) working days after receipt of complete dossier.

a) If the dossier is valid, it shall perform the procedures as prescribed at Point b, c, d, e, g, Clause 3, Article 13 of this Circular.

In case the facility has results of periodic testing as prescribed in Circular No. 14/2011/TT-BNNPTNT dated March 29, 2011 of the Minister of Agriculture and Rural Development with grade A within 01 (one) year to the time of renewal, the Department of plant protection shall grant Certificate of eligibility for production of plant protection medicines under the form prescribed in Annex  VI issued together with this Circular without establishing the field assessment group.

b) If the dossier is not valid, the Department shall notify organization or individual of the contents in need of supplementation and completion.

Article 16. Procedures for renewal of Certificate of eligibility for trading plant protection medicines.

1. Submission of dossier

a) 3 (three) months prior to the expiration date of Certificate of eligibility for trading of plant protection medicines, the manufacturing facility shall submit dossier directly or by post to the Sub-Department of plant protection.

b) Number of dossier: 01 set

c) Checking the completeness of the dossier upon direct receipt or within 02 (two) working days for dossier sent by post. If the dossier is complete, the Sub-Department of plant protection shall receive or return it to the organization for supplementation and completion if incomplete.

2. Dossier

a) Application for granting certificate of eligibility for production of plant protection medicines under the form prescribed in Annex I issued together with this Circular.

b) A copy (with the original for comparison) or copy of certificate of business registration of plant protection medicines or agricultural materials (if there is modification).

c) A copy (with the original for comparison) or copy of certificate of plant protection medicines trading practice of the facility owner (if there is modification).

d) The original of the granted Certificate of eligibility for trading of plant protection medicines.

e) Declaration sheet on the conditions for trading of plant protection medicines prescribed in Annex III issued together with this Circular.

g) A certified copy of the Form or record of examination, assessment and classification of the conditions for quality assurance of the plant protection medicines trading facility of the competent authorities as prescribed in Circular No. 14/2011/TT-BNNPTNT dated March 29, 2011 of the Minister of Agriculture and Rural Development (if any).

3. Appraising dossier and granting Certificate of eligibility for production of plant protection medicines.

The Sub-Department of plant protection shall appraise dossier within 03 (three) working days after receipt of complete dossier.

a) If the dossier is valid, it shall perform the procedures as prescribed at Point b, c, d, e, g, Clause 3, Article 14 of this Circular.

In case the facility has results of periodic testing as prescribed in Circular No. 14/2011/TT-BNNPTNT dated March 29, 2011 of the Minister of Agriculture and Rural Development with grade A within 01 (one) year to the time of renewal, the Department of plant protection shall grant Certificate of eligibility for production of plant protection medicines under the form prescribed in Annex  VII issued together with this Circular without establishing the field assessment group.

b) If the dossier is not valid, the Department shall notify organization or individual of the contents in need of supplementation and completion.

Article 17. Procedures for re-granting Certificate of eligibility for production and trading of plant protection medicines

1. Cases of re-granting

a) The Certificate is still valid but was lost or miscarried;

b) The Certificate is still valid but is damaged and cannot be used.

c) Upon detection of errors or change of information in the Certificate.

Cases specified at point b, c of this Clause, the Certificate shall be revoked upon re-granting.

2. Submission of dossier

a) The production and trading facility requesting the re-granting of Certificate of eligibility for production and trading of plant protection medicines shall submit dossier directly or by post to the competent authority as prescribed in Article 12 of this Circular.

b) Number of dossier: 01 set

c) Checking of completion of dossier right after direct receipt of dossier or within 02 (two) working days for dossier sent by post. If the dossier is complete, the competent authority as prescribed in Article 12 of this Circular shall receive it and require supplementation if the dossier is not complete.

3. Dossier component

a) Application for granting certificate of eligibility for production of plant protection medicines under the form prescribed in Annex I issued together with this Circular.

b) The granted Certificate (for the case specified at Point b, c, Clause 1 of this Article).

4. Re-granting Certificate of eligibility for production and trading of plant protection medicines

The competent authority shall review and compare it with the record within 05 (five) working days after receipt of complete dossier.

a) If the dossier is valid, it shall grant the Certificate of eligibility for production and trading of plant protection medicines under the form prescribed in Annex VI or Annex VII of this Circular. The number, issue date and expiration date are the same as those in the original Certificate and specify the copy from the original.

b) If the dossier is not valid, it shall notify the organization and individual of the contents in need of supplementation and completion.

c) In case of failing to grant Certificate of eligibility for production and trading of plant protection medicines, the competent authority shall reply in writing specifying the reason.

Article 18. Revocation of the granted Certificate

a) The facility has no longer met the conditions for production and trading of plant protection medicines specified in this Circular and legal documents related to the production and trading of plant protection medicines.

b) The facility has been dissolved and no longer operated in the area of production and trading of plant protection medicines.

c) The facility has acts of violation from which the law requires revocation

Article 19. Fees and charges

The collection of fees and charges to certify the facility meets the conditions for production and trading shall comply with the current regulations of the Ministry of Finance and other relevant legal documents.

Chapter V

RIGHT AND RESPONSIBILITIES OF THE PARTIES CONCERNED

Article 20. Rights and responsibilities of the facility of production and trading of plant protection medicines

1. Rights of the facility of production and trading of plant protection medicines: Having the right to complain when it does not agree with the conclusion in the record of assessment.

2. Responsibilities of the facility of production and trading of plant protection medicines

a) Registering the procedures for granting, renewal and re-granting of Certificate of eligibility for production and trading of plant protection medicines and complying with provisions in this Circular.

b) Supplying adequate relevant information and dossier and facilitating the assessment of implementation of tasks by the agencies.

c) Regularly maintaining and ensuring conditions in production and trading of certified plant protection medicines.

d) Seriously remedying defects specified in the record of assessment of the agency granting Certificate of eligibility for production and trading of plant protection medicines.

e) Participating in training courses on production and trading of plant protection medicines organized by the state management agency on plant protection.

g) Making payment of fees and charges as prescribed.

Article 21. Rights and responsibilities of the agency granting Certificate of eligibility for production and trading.

2. The agency granting Certificate of eligibility for production and trading has the following powers:

a) Monitoring and requiring facility to remedy defects on conditions for production and trading of plant protection medicines.

b) Requiring facility to supply dossier and documents and facilitate the assessment of compliance of provisions of this Circular and legal documents related to production and trading of plant protection medicines.

1. The agency granting Certificate of eligibility for production and trading of plant protection medicines is responsible for:

a) Granting, renewing, re-granting and revoking Certificate of eligibility for production and trading of plant protection medicines in accordance with provisions in this Circular.

b) Establishing assessment group

c) Ensuring the objectivity and fairness in activities of assessment and granting of Certificate of eligibility for production and trading of plant protection medicines.

d) Periodically or irregularly inspecting the facilities which have been granted Certificate of eligibility for production and trading of plant protection medicines upon requirement from the competent state authority.

e) Handling violations and settling complaints and denunciations as prescribed by law.

Article 22. Rights and responsibilities of the assessment group.

1. Assessing and considering the compatibility of the facility in comparison with provisions in Chapter II (for manufacturing facility) of this Circular.

2. Ensuring the objectivity in the inspection and assessment.

3. Honestly reporting the result of assessment to the competent authority.

4.Ensuring thesecurityof anyconfidential information related to the confidentiality of facility under assessment and complying with regulations of current laws.

5. Given permission for interview and requiring examination of books, documents related to the facility; collecting and noting necessary information, requiring implementation of specialized work and providing evidence in service of assessment.

Chapter VI

EFFECT

Article 23.Transitional provisions

1. The facilities operating the production and trading of plant protection medicines before the effective date of this Circular and granted Certificate of practice of production and trading of plant protection medicines shall make the procedures to request the granting of Certificate of eligibility for production and trading of plant protection medicines as prescribed in Article 13 or 14 of this Circular.

For facility which is ranked grade A as specified in Circular No. 14/2011/TT-BNNPTNT dated March 29, 2011 of the Minister of Agriculture and Rural Development within one (01) year to the time of filing of application shall make the procedures to request the granting of Certificate of eligibility for production and trading of plant protection medicines specified in Clause 1 and 2, Article 13 or Clause 1 and 2, Article 14 of this Circular. The competent authority shall grant Certificate of eligibility for production and trading of plant protection medicines within 05 (five) working days after the receipt of valid dossier without establishing field assessment group.

2. The time to implement Clause 1 of this Article within 02 (two) years from the effective date of this Circular.

Article 24. Effect

This Circular takes effect on April 11, 2013.

Annulling Article 5 of the Regulation on the granting of Certificate of practice of production, processing, bottling, packaging and trading of plant protection medicines issued together with Decision No. 97/2008/QD-BNN dated October 06, 2008 of the Minister of Agriculture and Rural Development.

Article 25. Responsibilities for implementation

Plant Protection Department and provincial-level Plant Protection Department shall popularize and guide production facilities and trading of plant protection medicines to implement this Circular.

Any problems arising during the course of implementation should be promptly reported to the Ministry of Agriculture and Rural Development for regulation and supplementation.