Circular 21/2015/tt-Bnnptnt: On The Management Of Medicines And Plant Protection

Original Language Title: Thông tư 21/2015/TT-BNNPTNT: Về quản lý thuốc bảo vệ thực vật

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CIRCULAR on management plant protection drugs _ _ _ _ _ _ _ _ _ _ _ _ pursuant to Decree No. 199/2013/ND-CP on November 26, 2013 of government functions, tasks, powers and organizational structure of the Ministry of agriculture and rural development;
Pursuant to the law to protect and quarantine of 41/2013/QH13 on November 25, 2013;
Pursuant to the law of chemicals 2007/QH12 on November 21, 2007;
Pursuant to the law of product quality, commodity number 06/2007/QH12 on November 21, 2007;
Pursuant to the law of standards and technical regulation No. 69/2006/QH11 on June 29, 2006;
Pursuant to Decree No. 14/2015/ND-CP of August 13, 2015 the Government detailing and guiding the implementation of some articles of the law on the railways;
Pursuant to Decree No. 104/2009/ND-CP on November 9th, 2009 by government regulations dangerous goods list and shipping dangerous goods by motor transport by road;
Pursuant to Decree No. 26/2010/ND-CP on April 8, 2012 of the Government revising, supplementing a number of articles of Decree No. 109/2008/ND-CP dated 07/10/2008 from the Government detailing and guiding the implementation of some articles of the law on chemicals;
Pursuant to Decree No. 181/2013/ND-CP on November 14, 2013 detailing the Government's implementation of some articles of the law on advertising;
At the suggestion of Director of Department of plant protection;
The Minister of agriculture and rural development issued circulars on the management of medicines and plant protection.
Chapter I GENERAL PROVISIONS article 1. Scope this regulation circulars on the management of medicines and plant protection include: registration; the assay; manufacturing, trade; export and import; quality control; certificate of conformity and conformity; preservation, transport; use; record labels; packing; advertising; withdrawal, destruction of plant protection drugs in Vietnam.
Article 2. The object application this circular apply to organizations and individuals in the country and abroad have activities related to medicines and plant protection in Vietnam.
Article 3. Explanation of terms In this circular, the terms below are interpreted as follows: 1. biologic effect assay is determined valid, except for pests or regulate growth for crops (including the safety for the plant).
2. assay determines the quarantine time is the time (in units of days) from when using plant protection drugs for the last time until harvest products that people use drugs must be taken to ensure food safety.
3. Quality control for plant protection drugs is to identify active content, the form of the drug, the concentrations of potentially toxic substances for plants, people or pollute the environment (if applicable); additive content of work augmented safety of products for people, crops (if available); the physicochemical properties relevant to active and the safety of plant protection drugs.
4. plant protection drugs Batch import is a set of goods plant protection drugs identified in number, have the same names, uses, type style, brand, technical characteristics of the same basis in the same import and record sets are imported at the same time.
5. Smoking is biological plant protection plant protection drugs are effective components are live microorganisms or chemicals derived from microorganisms, plants, animals.
6. Smoking chemical plant protection plant protection drugs containing the active ingredient is the chemical synthesis of organic or inorganic.
Article 4. Fees and charges the Organization, individuals with activities related to plant protection drugs must pay fees according to the provisions of the law on fees and charges.
Chapter II REGISTRATION of PLANT PROTECTION DRUGS section 1 GENERAL PROVISIONS on PLANT PROTECTION DRUGS REGISTRATION article 5. General principles of plant protection drugs registration 1. All plant protection drugs used to the room except for plant pests; automatic growth of plants; preservation of plant; disinfection of the repository; except termite damage buildings and embankments; except the grass on land not cultivated; increase safety, efficacy when used in (commercial name) must be registered on the list of medicines and plant protection are allowed to use in Vietnam (hereinafter the list).
2. organizations and individuals in the country or abroad (Representative Office, the company, the company's branch plant protection drugs business are allowed to operate in Vietnam) production plant protection agents (hereafter referred to as the active ingredient), plant protection drugs (hereinafter the smoking technique) or plant protection products from smoking techniques (hereinafter is smoking finished products) are directly registered name plant protection drugs produced.
3. organizations and individuals active in production, engineering or medicine finished products not directly name registration is authorized only for 1 individual organizations eligible as defined in paragraph 3 to article 50 of the law on protection and quarantine registration name every plant protection drugs.
4. Each individual organization authorized to name registration is granted only one of 12 active producers, drug or drug product engineering for each active ingredient, drug or drug product engineering.
5. Organize, personal name registration: a) are registered commercial name 1st for each active ingredient, drug or drug product engineering to the room, except for pests or regulate plant growth. The case of the active ingredient, the drug or drug product engineering is used to disinfect the repository; preservation of plant; except termite damage buildings, dykes; seed processing drugs must register more brand name 1st;
b) registered Only 1 active content for each product form of the drug plant protection;
c) transferable commercial name, the assignment must ensure the regulation in item 2, 3, 4 and a, b paragraph 5 of this Article;
d) do not change the name of the drug plant protection products in the category unless a competent State Agency on intellectual property or the Court has concluded in writing about the trademark infringement of commercial name in the category;
DD) Are changing the manufacturer indicated on the certificate of registration of plant protection drugs in case the manufacturer discontinue products or have the authorization to terminate the agreement in writing between the manufacturer and the Organization, individuals are authorized.
6. after 5 years from the date of first registration, the individual is granted official registration certificate for plant protection drugs have not yet in Active Directory, organizations, individuals filing new additional commercial name registration for new plant protection drugs containing the active ingredient.
7. plant protection drugs containing the active ingredient is a mixture of chemical and biological substances are managed as chemical drugs.
Article 6. Plant protection drugs are not allowed to register in Vietnam 1. Plant protection drugs in the formulary and plant protection prohibits the use in Vietnam (hereinafter called prohibited list).
2. Medicinal products or active substances in acute toxic products drug types I, II according to the classification of the global harmonization of systems of classification and labelling of chemicals (KS RAO), except for biological plant protection drugs, plant protection drugs used for disinfection-steam mouse; termite pesticide damage buildings, dykes; smoking preserved forest products that forest products that are not used as food and medicinal herbs.
3. plant protection drugs have high risk of adversely affecting human health, animals, ecology, environment, including: a) plant protection drugs was warned by the food and Agriculture Organization of the United Nations (FAO), the environmental program of the United Nations (UNEP), the World Health Organization (WHO); Plant protection drugs contained in annex III of the Rotterdam Convention;
b) Smoking chemical plant protection is the mixture of plant protection drugs have different uses (except the grass, except for the disease, regulate growth) except seed handling medication;
c) plant protection drugs contain pathogenic microorganisms to the person;
d) plant protection drugs cause genetic mutations, cancer, reproductive toxicity for humans;
DD) chemical plant protection Drugs register in the room except for plant pests or regulate growth for fruit trees, vegetable crops, tea tree or to the preservation of agricultural produce after harvest of acute toxic active ingredients or finished products of type III, IV under KS RAO; organic chlorine group; the quarantine time in Vietnam on 7 August.
4. plant protection drugs commercial namesake with the active ingredient or the name of a commercial plant protection drugs in the category.
5. plant protection drugs containing the active ingredient methyl bromides.
6. plant protection drugs registered to the room except the species of organisms are not harmful organisms of plant in Vietnam.
7. plant protection drugs are patent abroad but have not been allowed to use abroad.
Article 7. Plant protection drugs were eliminated from the index 1. Plant protection drugs were eliminated from the index in the following cases: a) plant protection Drugs in one of the circumstances specified in paragraph 2 to article 49; point b, paragraph 1 c of Article 54 of law protection and quarantine;
b) plant protection drugs in annex III of the Rotterdam Convention, warned by the food and Agriculture Organization of the United Nations (FAO), the environmental program of the United Nations (UNEP), the World Health Organization (WHO).
2. process of plant protection drugs from category a) specified in point b of paragraph 1 of this article, the plant protection department reports and proposals to the Minister of agriculture and rural development in writing to remove the drug from the index plant protection;
b) specified in point a, b item 2 Article 49 of law protection and quarantine, plant protection Bureau General information, establishing the Scientific Council to review, advise removing plant protection drugs, report and proposals to the Ministry of agriculture and rural development plant protection drugs removed from the index. The Minister of agriculture and rural development decided removing plant protection drugs from the index;
c) specified in point c of paragraph 2 Article 49; point b, paragraph 1 c of Article 54 of law protection and quarantine, plant protection Department of the Ministry of agriculture and rural development, removal from the list.

3. plant protection drugs specified in point b of paragraph 1 of this article; points a, b, item 2 Article 49 of law protection and quarantine of plants produced only import a maximum of 1 year, to be traded, using a maximum of 2 years from the date the decision to plant protection drugs from the list of the Ministry of agriculture and rural development.
Article 8. Registration form 1. Officially registered, including: a) plant protection drugs contain active substances not yet in the category or plant protection drugs have a new combination of proportion, composition of the active substances already in the category due to the Organization, the individual patents in foreign countries and have been registered for use in overseas;
b) plant protection drugs contain active substances not yet in the category or plant protection drugs have a new combination of proportion, composition of the active substances already in the category due to the Organization, the individual domestic patent and Scientific Council by plant protection Bureau established the proposed plant protection Bureau recognized as a drug plant protection.
2. additional registration, including: a) plant protection drugs already have commercial names in the category but supplements the range of use, change the dose to use, how to use, the form of finished products, active content changes;
b) plant protection drugs contain active ingredients already in the category but the brand name registration.
Section 2 grants, GRANT LEAVE of LICENSE PLANT PROTECTION DRUGS ASSAY article 9. General principles of licensing plant protection drugs assay 1. Plant protection drugs registered on the list must be the Bureau of licensing plant protection plant protection drugs assay (hereinafter the assay license) under the provisions of article 10, article 11 of this circular and perform assay as defined in chapter III of this circular.
2. License the assay for biological plant protection drugs.
a) biological plant protection Drugs require only the biological potency assay, assay not determine quarantine period except in cases specified in point b of this paragraph;
b) biological plant protection Drugs containing the active ingredient pyrethrins, rotenone, avermectin groups officially registered, registration of commercial names complement assay of biological effect is narrow and wide. If the first sign used on fruit trees, vegetable crops, tea tree and the preservation of agricultural products after harvesting should conduct the assay determines the quarantine time in Vietnam.
3. assay licensed for smoking plant protection chemistry a) chemical plant protection Drugs officially registered, registration of commercial names complement assay of biological effect is narrow and wide;
b) chemical plant protection Drugs register supplements the range of use, change the dose to use, how to use, the form of finished products, active content changes to biological potency assay scale;
c) chemical plant protection Drugs for the first sign used on fruit trees, vegetable crops, tea tree and the preservation of agricultural products after harvesting should conduct the assay determines the quarantine time in Vietnam (except in the case of herbicide used for fruit trees, perennial nature leads example insects the drug, used to treat the soil before planting, except the disease killed seedlings, seed processing, smoking drugs treat cuttings, layering).
4. On the license record both Vietnamese name assay and the scientific name of the harmful organism.
Article 10. Profile, sequence, the licensing procedure to assay the official registration 1. Filing a) Organization, individuals filing directly or sent by mail or submitted online to the Department of plant protection;
b) to check the validity of the record within 10 working days. If a valid records according to the rules, then the receiving records, if invalid, then return the record for individual organizations and additional requirements, complete the profile;
c) number of records: 1 a paper and electronic PDF format version 01.
2. Record a) licensing form drug plant protection assay according to the form prescribed in annex I attached to this circular;
b) evidence of the Organization, the individual is registered plant protection drugs in Vietnam: the original or a copy of a certificate confirmation text is a manufacturer which has plant protection drugs recommended assay licensed by the competent authorities of the country (for foreign producers).
Authenticated copy or copies (bring the original to collate) license companies, branch companies or representative offices in Vietnam (for foreign manufacturers to register first).
The original authorization of the manufacturer for the Organization, individuals register (authorized cases stand registered name). Authorization of foreign manufacturers must be legalized by the Consulate of Vietnam law provisions, except where exempted legalized under the international treaties to which Vietnam is a member.
Copies of certificates of eligibility plant protection drugs trafficking (for organizations, individuals in the country authorized to register names stand first);
c) technical document plant protection drugs prescribed in Appendix III attached to this circular.
3. The appraisal of records and license the assay a) plant protection Bureau verified records within 10 working days from the date of receipt of the full records as defined in paragraph 2 of this Article. Recommended records issued on 3 March or crop pests object, the time limit for the evaluation profile is not too 15 working days.
Case profiles meet the requirements according to the provisions of this circular, the plant protection Department of the Ministry of agriculture and rural development;
Case records are not yet meet the requirements under the provisions of this circular, plant protection Bureau to notify the Organization, individuals need additional content, complete records;
b) Ministry of agriculture and rural development (science technology and environment) verifies the prescribed records within 10 working days from receipt from the Department of plant protection;
c) within 2 working days of receipt of the opinion of the Minister, the Department of licensing plant protection plant protection drugs assay according to the form prescribed in annex IV attached to this circular;
d) case no license assay, plant protection Bureau to notify the Organization, individuals in writing and stating the reason.
Article 11. Profile, sequence, the licensing procedure to register additional assay 1. The filing made under the provisions of article 10 paragraph 1 of this circular;
2. Record a) licensing form drug plant protection assay according to the form prescribed in annex I attached to this circular;
b) copies of certificates of registration of plant protection drugs has been granted (additional cases the range of use, change the form of finished products, change the amount of the active ingredient, dosage used, usage);
c) technical documentation of medicines and plant protection products as defined in annex III attached to this circular (in case of changing the form of finished products, active content changes);
d) documents specified in point b and c item 2 article 10 of this circular (case brand name supplements).
3. The appraisal of records and license the assay performed according to the provisions of article 10 paragraph 3 of this circular.
Article 12. Profile, sequence, procedure of reissuing permits assay 1. Submission of implementation as defined in points a and b of paragraph 1 of article 10 of this circular. Number of records: 1 a paper.
2. Record a) petition reissued license plant protection drugs assay according to the form prescribed in annex I attached to this circular;
b) assay license was granted (except in the case of loss).
3. The appraisal of records and reissued the license of assay plant protection Bureau verified records within 10 working days from receipt of the full prescribed: a) valid records case, plant protection department reissued a license plant protection drugs assay according to the form prescribed in annex IV attached to this circular. Term of validity of the licence to the new assay keep the duration of the paper was issued;
b) where a valid profile, plant protection Bureau to notify the Organization, individuals need additional content, complete the prescribed records;
c) case no license reissued assay, plant protection Bureau to notify the Organization, individuals in writing and stating the reason.
Category 3 levels, LEVEL BACK, to RENEW the CERTIFICATE of REGISTRATION of the DRUG PLANT PROTECTION article 13. Profile, sequence, procedure for certification of registered plant protection drugs 1. Filing a) perform as specified in points a and b of paragraph 1 of article 10 of this circular;
b) number of records: 1 a paper and electronic version 01 word or excel or power point for model labels.
2. Record a) certification application registered plant protection drugs according to the form prescribed in annex II attached to this circular;
b) copy of the capture assay license has been granted;
c) form prescribed medication labels in Categories 1, 2, 3 Chapter X of this circular;
d) main results of biological effect assay, assay results determine the quarantine period and report the results of the assay according to the form prescribed in annex VI, Appendix VII and annex XI attached to this circular.
3. The appraisal of records and certificate of registration of plant protection drugs within 6 months from the date of receipt of a valid application, plant protection Bureau organized the appraisal, the Minister of agriculture and rural development, bringing the plant protection drugs on the list; certificate of registered plant protection drugs according to the form prescribed in Appendix V attached to this circular. No case level, plant protection Bureau answers for organizations, individuals in writing and stating the reason.
Article 14. Profile, sequence, procedure for renewal of the certificate of registration of plant protection drugs 1. Before 3 months as of the date the certificate of registration of plant protection drugs expire, organizations, individuals wishing to renew must renew the proposal submission.
2. a filing made pursuant to the provisions in point a, b, paragraph 1 article 10 of this circular. Number of records: 1 a paper.
3. Record a) petition to renew the certificate of registration of plant protection drugs according to the form prescribed in annex II attached to this circular;
b) original certificate of registration of the drug plant protection has been granted.

4. The evaluation and renewal of the certificate of registration of the drug plant protection plant protection Bureau verified records within 10 working days from the date of receipt of a valid application in accordance with paragraph 3 of this article: a) the case documents, meet the provisions of this circular Plant Protection Department, certification of registered plant protection drugs according to the form prescribed in Appendix V attached herewith;
b) case records are not yet valid, do not meet the provisions of this circular, plant protection Bureau to notify the Organization, individuals need additional content, complete the prescribed records;
c) case does renew the certificate of registration of the drug plant protection Plant Protection Department, to notify the Organization, individuals in writing and stating the reason.
Article 15. Profile, sequence, procedure of reissuing a certificate of registered plant protection drugs for cases lost, errors, damaged 1. Submission of implementation as defined in points a, b, paragraph 1 article 10 of this circular. Number of records: 1 a paper.
2. Record a) petition reissued certificate of registered plant protection drugs according to the form prescribed in annex II attached to this circular;
b) original certificate of registration of the drug plant protection has been granted, except in case of loss.
3. The order and procedure of reissuing a certificate of registered plant protection drugs.
Made under the provisions of paragraph 4 of article 14 of this circular. Term of validity of the certificate of registration of plant protection drugs to keep the duration of the paper was issued.
Article 16. Profile, sequence, procedure of reissuing a certificate of registered plant protection drugs for commercial name change cases, information relating to the Organization, individuals register 1. Submission of implementation as defined in Points a, b, paragraph 1 article 10 of this circular. Number of records: 1 a paper.
2. Record a) petition to change the name, commercial information related to the Organization, individuals register according to the form prescribed in annex II attached to this circular;
b) original certificate of registered plant protection drugs has been granted;
c) certificate copy or copies (bring the original to collate) the text of the authorized State Agency of intellectual property or of the Court regarding the violation of trademarks (brand names change case);
d) certificate copy or copies (bring the original to collate) the certificate of registration of a new business (case name of organization or individual register changes);
DD) transfer of commercial name: original or certified copy of the contract or agreement assignor plant protection drugs; The original power of Attorney register of manufacturers for the Organization, the individual assignee (authorized cases stand registered name).
3. The appraisal of records and reissued certificate registered plant protection drugs.
a) plant protection Bureau verified records within 10 working days from the date of receipt of the full records as defined in paragraph 2 of this Article: the case duly records plant protection Bureau, the Minister of agriculture and rural development put into the category as defined in paragraph 3 , Article 13 of this circular;
Case records are not yet valid, do not meet the provisions of this circular, plant protection Bureau to notify the Organization, individuals need additional content, complete the prescribed records;
b) where no grant registered certificate back smoking plant protection Plant Protection Department, to notify the Organization, individuals in writing and stating the reason;
c) time limit effect of certificate of registered plant protection drugs to keep the duration of the paper was issued.
Article 17. Profile, sequence, procedure of reissuing a certificate of registered plant protection drugs for case changes the manufacturer 1. The filing made under the provisions of article 10 paragraph 1 of this circular.
2. Record a) petition reissued certificate of registered plant protection drugs according to the form prescribed in annex II attached to this circular;
b) original or a copy certified papers the agreement termination of authorisation between manufacturers are recorded in the certificate of registration of medicines and plant protection organization, the individual is authorized to register;
c) originals or certified copies of documents is a manufacturer of plant protection drugs of new producer by the competent administration of the country (for foreign producers);
d) original power of Attorney registered by new manufacturers for the Organization, individuals register (authorized cases stand registered name). Authorization of foreign manufacturers must be legalized by the Consulate of Vietnam law provisions, except where exempted legalized under the international treaties to which Vietnam is a Member;
DD) technical document plant protection drugs prescribed in Appendix III attached to this circular;
e) original certificate of registration of the drug plant protection was granted.
3. The appraisal of records and reissued certificate registered plant protection drugs a) made under the provisions of paragraph 4 of article 14 of this circular;
b) time limit effect of certificate of registered plant protection drugs to keep the duration of the paper was issued.
Chapter III PLANT PROTECTION DRUGS ASSAY Article 18. General principles of implementation of assay plant protection drugs 1. Plant protection drugs assay was conducted only when a permit assay.
2. plant protection drugs assay aims to sign up on the list include the effect of biological assay and assay determines the quarantine time (for the cases specified in point b of paragraph 2 and point c paragraph 3 article 9 of this circular).
3. Base implemented plant protection drugs assay is the national technical regulation (QCVN), national standards (ISO), the standard basis (TC) of the plant protection department.
4. plant protection drugs assay to subscribe to the list by the qualified organization defined in article 20 of this circular made.
5. narrow assay must proceed before the assay.
Article 19. Perform the assay the assay plant protection drugs against harmful organisms object 01 on 01 crop object for the purpose of registration as follows: 1. the biological potency assay of biological plant protection drugs (except in the case specified in clause 2 of this); chemical plant protection drugs register supplements the range of use, change the dose to use, how to use, the products form, change the active content includes extensive, specific assay: for plants or pests are in 2 regions (North and South) , each assay zone at 2 locations (each location in 7 provinces) or 2 the district/province (in the case of plants or pests only at the 1st of the production).
For plants or pests only at 1 or 1 the assay, in 4 regional locations (each location in the 1st region) or 4 locations of the province (in at least 10 districts of that province).
2. assay the effect of biological plant protection chemical drugs; biological plant protection drugs containing the active ingredient pyrethrins, rotenone, avermectin groups officially registered, additional commercial names including 8 narrow assay and 2 wide area assay. If plants or pests only at production region, number of 1st assay consists of 6 narrow assay and 2 wide area, specific assay: a) an assay for narrow crops or pests in 2 regions (North and South), each of the assay in 4 locations (each location in 7 provinces). The case is not enough 4 the production in each region, each of the assay in 4 locations (each location in 1 district of the region).
For plants or pests in 7 regions, assay at 6 locations (each location at 1 January in the district or province).
For plant pests or only in 1 the manufacture, assay at 6 locations of at least 10 districts in the province.
For herbicide on rice should be made in the assay 2 different service.
b) extensive assay for plants or pests are in 2 regions (North and South), each of the assay at 1 location.
For plant pests or only in 1 region of manufacture, assay conducted in 2 locations of the region (each location in the 1st region) or 2 locations (each location in 1 district if pests only in 7 provinces).
3. assay determines the quarantine time for active 01 on 01 crop object includes extensive, specific assay: for many crops service/year in 2 regions (North and South), each assay zone at 2 locations (each location in 02, each province 1 case or each location in that region's District 1 , each District 1 service).
For crops have more service per year in 12 regions of the assay in 4 locations (2 location/service; every location in the province or district of the 1st 1st it).
For the plant only 1 case per year, in 2 regions (North and South), each assay zone at 2 locations (each location at each location or province at 01 01 arrondissement of that region).
For the plant only 1 case per year and only in 7 regions, the assay in 4 regional locations (each location in the 1st region) or 4 locations of the province (at least 2).
Article 20. Guide for organizational conditions make assay plant protection drugs 1. Have legal personality, active registration in the field of plant protection drugs assay;
2. The head of the Organization of the University level in the field of plant protection, horticulture, agronomy, biology, chemistry; certified training drug assay by plant protection Plant Protection Department.
3. Have at least 5 people in payroll or long term University level specialized in prescribed in clause 2 of this Thing and plant protection department certification training plant protection drugs assay.
4. the base material-technical guarantee for plant protection drugs assay:

a) media full, catering equipment for plant protection drugs assay prescribed in annex X attached herewith;
b) perform or coordinate with other organizations perform full assay according to the provisions of article 19 of this circular to a drug are eligible to register on the list of medicines and plant protection are allowed to use in Vietnam.
The organization coordinating the assay to have legal personality, there are human resources and adequate facilities, equipment for performing the assay prescribed in clause 2; point a paragraph 4 of this Article.
c) Have the laboratory analysis of residues are the Ministry of agriculture and rural development, indicated with the corresponding test (for assay organization determined the time quarantined plant protection drugs).
5. Do not direct the registered name, the registered name authorised plant protection drugs in Vietnam.
Article 21. Profile, sequence, procedure for recognition of qualified organizations perform assay plant protection drugs 1. Filing a submission) held directly or sent by mail or submitted online to the Department of plant protection;
b) number of records: 1;
c) to check the validity of the record upon receipt or within a period of 10 working days for the record sent by post. Valid profile case, plant protection agency receiving records, case is not valid then the additional organization requirements, complete the profile.
2. Record a) petition to recognize qualified organizations make the drug plant protection assay according to the form prescribed in annex IX attached herewith;
b) authenticated copy or copies (bring the original to collate) decided to establish or decide the functions, duties or business registration certificate to operations in the field of plant protection drugs assay;
c) certificate copy or copies (bring the original to collate) graduate from University in the field of plant protection, horticulture, agronomy, biology, chemistry and assay training certificate for drugs and plant protection of the head of the organization performing the assay and participants;
d) A demonstration ensure conditions make drug assay of plant protection organizations eligible to perform the assay and coordination units according to the form prescribed in annex X attached herewith;
3. The appraisal, assessment records suggest that recognize and publicize the organization eligible to perform the assay smoking a plant protection plant protection Bureau) receive and assess records suggest recognition of eligible organizations make the drug plant protection assay. As soon as the evaluation results, finishing plant protection Bureau records suggest recognition of eligible organizations make the drug plant protection assay the Minister of agriculture and rural development. Duration within 15 working days;
b) Ministry of agriculture and rural development (science technology and environment) verifies the prescribed records within 10 working days from receipt from the Department of plant protection;
c) within 3 working days of receipt of the opinion of the Minister, plant protection Bureau issued a decision recognizing the organization eligible to perform the assay plant protection drugs;
d) where the organization is not eligible for recognition as qualified organizations make pharmacies assay plant protection, plant protection Bureau to notify the Organization, individuals in writing and stating the reason.
Article 22. Training in plant protection drugs assay 1. Training content a) the provisions of the current legislation on plant protection drugs assay;
b) safe in the preservation, use of medicines and plant protection;
c) process for biological potency assay and assay determines the time in quarantine plant protection drugs;
d) data processing, data retention, reporting results the assay.
2. Registration of training organizations, organization, individual training needs assay plant protection drugs register list of participants directly or by post or online with plant protection department.
3. Plant Protection Department organized training on plant protection drugs assay according to the content specified in paragraph 1 of this article. Training time is 4 days.
The base test results after training, plant protection Bureau certification training plant protection drugs assay according to the form prescribed in annex XIII attached to this circular.
Article 23. Rights and obligations of the organization performing the assay plant protection drugs 1. Made according to the provisions of article 60 of law protection and quarantine and reporting drug assay results and plant protection according to the form prescribed in annex VI and annex VII attached to this circular.
2. General reporting drug assay results and plant protection according to the form prescribed in annex XI attached to this circular.
3. periodic reports on annual results of activity assay of plant protection drugs organized according to the form prescribed in annex XII attached to this circular or irregular reports as required by the plant protection department. The time limit for filing reports on 25 December of the year preceding the year of the report.
Article 24. The liability of the Organization, the individual assay plant protection drugs 1. Provide qualified organizations perform assay license assay, drug information, declarations and plant protection assay according to the form prescribed in annex VIII, attached to this circular and drugs assay samples (in the right category, active content, the form of the drug is noted in the assay license; enough number to sample and assay; is packed in airtight packaging , was sealed by the Organization, individuals register assay).
2. Sign the contract and pay the fee prescribed in the current assay.
3. in case the assay drugs bad for crops, human and environment organizations, individual plant protection drugs assay must be responsible in damages under the provisions of the law.
Chapter IV DRUG TRAFFICKING, PRODUCTION and PLANT PROTECTION category 1 CERTIFICATION of ELIGIBLE DRUG MANUFACTURING PLANT PROTECTION article 25. Scope of production plant protection drugs must meet the provisions of article 61 of the law on plant protection (excluding basis only produce biological plant protection drugs containing the active ingredient is the useful microbial) and detailed instructions from Article 26 to article 29 of this circular. The facilities are allowed to operate the production plant protection drugs since January are qualified certificates under the provisions of article 30 of this circular.
The only basis for the production of biological plant protection drugs containing the active ingredient is beneficial microorganisms do not need a certificate of eligible production but still have to comply with the provisions of the law on environmental protection.
Article 26. Details about the conditions of factory 1. Location a) workshops are arranged in the industrial zone must comply with the provisions of the industrial park;
b) drug production factory and plant protection is not located in the industrial zone must be deployed at the venue to ensure: the location of factories are far from schools, hospitals, markets and a minimum of 500 metres (m); to ensure the requirements of the electric supply, water supply, drainage, handling of pollution and traffic.
Walled buildings separated from the outside. Internal road systems were deployed to ensure security for transportation and fire fighting.
2. the layout, structure and layout of a factory architecture) the factory and warehouses are separate;
b) factory premises to arrange reasonable work items and have a clear function;
c) standard factory workshop design, build standard regulations in Vietnam TCVN 4604/2012: industrial, manufacturer-design standards; TCVN: 2622/1995: fire against fire for the home and the work-design requirements;
d) building materials factory is non-flammable, difficult to fire; the frame house was built of brick, made of concrete or steel. The floor is made of a material impervious to liquids, flat, non-slippery, no rift and to have the flange or the surrounding margins;
DD) workshops must have exits, are clear indications by signs, diagrams and easy to escape when the incident occurred.
Article 27. Details about the condition of the equipment 1. The device produces a) Have necklaces, matching production types and ensure the quality of medicines and plant protection of the production facility;
b) equipment is deployed, installed in accordance with each of the stages of production and achieve the safety requirements as specified in standard ISO Vietnam 2290-1978 production equipment-General requirements for safety;
c) devices have operating instructions, check the specifications, testing according to the regulations, be maintenance, industrial hygiene procedures;
d) means of lighting and other electrical equipment to be installed at the required position, temporary installation is not allowed. All electrical equipment must have the switches when the electrical leak, overload.
2. Transport and unloading must meet current technical standards about the types of dangerous goods need to be transported and the design guarantee prevention of leakage, or distribute the drug plant protection on the environment. Has a map of warning, signaling danger on transport.
3. The equipment, safety means a) and labor protection when used in the production of medicines and plant protection;
b) Have tools, medical, emergency equipment;
c) fully equipped devices, rescue tools, incident at the facility, fire prevention system, were installed in the appropriate position and check regularly to ensure that the State is ready for use.
4. a waste treatment system) has factory exhaust gas treatment systems. Emissions of factories must reach the national technical regulation QCVN 19:2009/BTNMT-national technical regulation of industrial emissions for dust and inorganic and QCVN 20:2009/BTNMT-national technical regulation of industrial emissions for some organic substances;

b) of factory waste water treatment system. Waste water after the handle reaches the national technical regulation QCVN 7:2009/BTNMT-national technical regulation on hazardous waste and the threshold QCVN 40:2011/BTNMT-national technical regulation on industrial waste water;
c) solid waste disposal in compliance with the provisions of Decree No. 59/2007/ND-CP dated 9 April 2007 from the Government on the management of solid waste. There where solid waste collection are screened carefully, there are tools for collecting, transporting solid waste.
Article 28. Quality management system 1. The new production facility case works to build and apply a quality management system according to ISO 9001:2008 standard or equivalent.
The case of the base was operational from 8 years and older, must have a quality management system is accredited to ISO 9001:2008, or the equivalent.
2. production process plant protection drugs stating the information: commercial name, code number, purpose, procedures and norms of production (raw materials, additives, quantitative, the amount of the expected products, limited), location, equipment, steps, quality control, warehousing, storage, packing, labels , the score note. 3. The test suite to check product quality has been accredited to ISO 17025:2005 or equivalent to quality control of plant protection drugs for each batch of products marketed.
4. where no test room specified in paragraph 3 of this article must have a contract with the testing room has been ISO 17025:2005 accreditation or equivalent to quality control for each batch of products marketed.
5. where the facility was operational, must have saved the test results for the quality of each batch of products marketed, published standards and conformity product quality law, goods and standard Law and technical standards.
Quality control samples must be saved for each batch of products produced a minimum of 3 months.
Article 29. Details about the conditions of human resources 1. Direct people management, executive producer of university degree or above majored in chemistry, plant protection, biological.
2. direct People Management, operator; people directly in production; store keeper must be fostered, knowledge about plant protection drugs; chemical safety engineering.
Article 30. Profile, sequence, procedure for certification of eligible drug manufacturing plant protection 1. Filing a) production base submission directly or sent by mail or submitted online to the Department of plant protection;
b) number of records: 1 a paper and 1 electronic version in PDF format;
c) records within 10 working days. If a valid records according to the rules, then the receiving records, if invalid, then return the record for individual and organization required by additional text, complete the profile.
2. Record a) certification application eligible production plant protection drugs according to the form prescribed in annex XIV attached herewith;
b) A demonstration production plant protection drugs as defined in appendix XV attached herewith;
c) precautions or plan, chemical incident response according to the form prescribed in annex XXI attached herewith; A photocopy of proof production facilities meet environmental protection regulations by the competent agency on the environment;
d) where there is room to experiment, the filed copies of certificates or other documents relating to the recognition of quality management system conformity ISO 17025:2005 or equivalent;
DD) the absence of the test room shall submit a copy of the contract with the testing room has been ISO 17025:2005 accreditation or equivalent;
e) base case was active from 2 years upwards, additional copies or copies certified (carry a key to collate) the certificate or the documents related to the recognition of quality management system conformity ISO 9001:2008, or the equivalent.
3. Evaluation and certification of qualified drug production and plant protection.
a) plant protection Bureau verified within 5 working days from receipt of a full, valid. Case profiles meet the requirements, the Director of plant protection Bureau decided to set up the delegation. Reviewers include 3-5 members have the expertise and specialized management services in the field of evaluation.
Group reviews the notice in writing prior to the time base reviews on 7 working. Notice stating the composition, scope, content, evaluation time at not more than 7 days.
b) content reviews of the suitability of the facility with the conditions specified in section 1 of this chapter and the ability to maintain the conditions specified.
c) the method of inspection, reviews the actual layout, environmental conditions, equipment status, the other conditions of the facility;
Interview the person in charge, employees of the basis of the information concerned;
Considering an archive, the relevant documents of the base.
d) results reviews the conditions have yet to match the specified in section 1 of this chapter discovered in the evaluation process to be put into a condition assessment of production plant protection drugs according to the form prescribed in annex XVII attached to this circular.
Record reviews are full of content and signed confirmation of the base Chief and Union representative reviews.
In case a representative basis to disagree with the results of the evaluation of the delegation, representative of the base have the right to write its recommendations at the end of the minutes before the signed and stamped validation. Report reviews still have legal value in case the base representation does not sign the minutes.
DD) certification eligible drug manufacturing plant protection plant protection agency review resume evaluation results and the results of reviews to the certification of qualified drug production and plant protection: duly records case, satisfactory evaluation results , within a period not exceeding 15 days work plant protection Bureau certification eligible drug manufacturing plant protection for the base according to the form prescribed in annex XIX attached to this circular.
The case of the profile is invalid or results reviews not yet satisfactory, plant protection Bureau reported in writing to the basis of unsatisfactory conditions and time limit fix. Within 5 working days of receiving the report of remedy facility or test results back (when necessary). A valid case, plant protection Bureau certification eligible drug manufacturing plant protection for the base according to the form prescribed in annex XIX attached to this circular.
The case fit the profile is invalid or results unsatisfactory rating, plant protection Bureau not certification eligible production plant protection drugs and answer in writing and stating the reason.
Article 31. Re-issuance of certificates of qualified drug production plant protection 1. Before 3 months as of the date the certificate of eligible drug manufacturing plant protection expires, if the organization or individual wishing to continue producing plant protection drugs must submit grant proposals back to the certificate. Profile, sequence, procedures are performed as prescribed in article 30 of this circular.
2. During operation, if the production base was checked, reviews A rating according to the regulations of the Minister of agriculture and rural development on the inspection, assessment and business facilities, agricultural materials and products of agriculture and forestry aquatic products and does not expand the scope of production of active substances Engineering, medicine, the form of the drug product, then follow the provisions in clause 1, article 30 2 of this circular. Plant Protection Bureau certification eligible production plant protection drugs within 5 working days from receipt of valid records, not Union fact check at the production facility.
Category 2 CERTIFICATION ELIGIBLE PLANT PROTECTION DRUGS TRAFFICKING Article 32. Detail the human condition home base (the Director or General Manager of limited liability companies, joint stock companies, private enterprises, the Member companies; the head of the branch or of the head of the branch of business; one of those drug trafficking base management and plant protection at the shop's business agent cooperative plant protection service; the direct store manager for store trafficking at a fixed location) and the direct sale of plant protection drugs must have intermediate or above majored in plant protection, horticulture, biology, chemistry or certified professional training on plant protection drugs.
Article 33. Details of the location conditions 1. Drug dealers store location and plant protection must have clear, stable address, owned the home base or have the lease location set minimum legal shop is 1 year.
2. The area consistent with the scale of the business, a minimum 10 square metres (m2). The fortified houses, arranged in a high place, airy.
3. Not be sold plant protection drugs with food commodities, food, beverages, animal feed, medical, veterinary drugs. 3. Shop plant protection drugs trafficking cannot be located in the service area dining, entertainment, schools, hospitals.
5. to store away from sources of water (River, Lake, Canal, water wells) a minimum of 20 metres (m); have high background, waterproof, not submerged; the walls and roof are built with materials that do not catch on fire.
6. Where the container store's plant protection must meet the provisions of article 61 of this circular.
The base case traders do not have to store the business registration; have fixed trading place, legally, clearly address; There are notes of the sale, export, import plant protection drugs and satisfying the provisions of article 32 of this circular.
Article 34. Details of the condition of the equipment 1. There is a display cabinet, shelf or shelves of medicines and plant protection.
2. Ensuring sufficient brightness in order to identify the drug. Lighting equipment must ensure the safety of fire prevention.

3. Have rules and fire vehicles and fire at the request of the Fire Department, fire to in a convenient place, ready for use when needed.
4. labor protection personal protection such as gloves, masks, SOAP, clean water.
5. is the material, the tool to handle the issue in a timely manner according to the requirements of the environmental management agency.
Article 35. Profile, sequence, procedure for certification of qualified plant protection drugs trafficking 1. Filing a) establishments apply directly or sent by mail or submitted online to the plant protection Bureau or Bureau cultivation and plant protection;
b) number of records: 1;
c) to check the validity of the profile during 2 working days. If a valid records according to the rules, then the receiving records, if invalid, then return the record for individual organizations and additional requirements, complete the profile.
2. Record a) certification application eligible plant protection drugs trafficking according to the form prescribed in annex XIV attached herewith;
b) authenticated copy or copies (bring the original to collate) business registration certificate;
c) A demonstration condition plant protection drugs trafficking as defined in Appendix XVI attached to this circular.
3. Evaluation of the condition and certification of eligible drug trafficking a) plant protection plant protection Bureau or Bureau cultivation and plant protection in the province, the city of evaluation within 3 working days from the date of receipt of the full profile.
b) Union reviews within 5 working days from the date of receiving the full records Bureau Director plant protection Bureau or Bureau cultivation and plant protection the Group decided to establish the assessment and conduct the assessment. Reviewers include 3-5 members have the expertise and specialized management services in the field of evaluation.
Group reviews the notice in writing to the basis of assessment before the plan reviews for at least 5 days. Notice stating the composition, scope, content, evaluation time at not more than 7 days.
c) content of the reviews of the suitability of the facility with the conditions specified in section 2 of this chapter.
d) evaluation method to directly interview the person in charge, employees of the basis of the information concerned;
Considering an archive, the relevant documentation of the facility;
The actual observation of the layout of premises, environmental conditions, equipment status, other facilities of the base.
DD) results reviews The conditions consistent with the provisions of section 2 of this chapter discovered in the evaluation process to be put into a condition rating plant protection drugs trafficking according to the form prescribed in annex XVIII attached to this circular.
Record reviews are full of content and signed confirmation of the base Chief and Union representative reviews.
In case a representative basis to disagree with the results of the evaluation of the delegation, representative of the base have the right to write its recommendations at the end of the minutes before the signed and stamped validation. Report reviews still have legal value in case the base representation does not sign the minutes.
e) certification eligible drug trafficking plant protection plant protection Bureau or Bureau cultivation and plant protection review results and profile evaluation results evaluation for certification of eligible drug trafficking and plant protection: the case of valid records evaluation results, satisfactory, within 5 working days from the end date reviews plant protection Bureau or Bureau cultivation and plant protection certificate eligible plant protection drugs trafficking for the base according to the form prescribed in annex XX attached to this circular.
The case is not yet eligible, plant protection or Bureau cultivation and plant protection notice in writing to the facility does not meet the conditions, requirements and timelines to remedy within 60 days. Within 3 working days of receiving the report of remedy facility or test results back (when necessary), a legitimate case, plant protection or Bureau cultivation and plant protection certificate eligible plant protection drugs trafficking for the base according to the form prescribed in annex XX attached to circular This time.
The absence of certification of eligible drug trafficking and plant protection, plant protection or Bureau cultivation and plant protection respond in writing and stating the reason.
Article 36. Re-issuance of certificates of eligibility plant protection drugs trafficking 1. Before 3 months as of the date the certificate of eligible drug trafficking expires, plant protection organization, individuals wishing to continue plant protection drugs trafficking to review grant proposals submission certificate. Profile, sequence, procedures are performed as prescribed in article 35 of this circular.
During operation, if the basis is checked, reviews A rating according to the regulations of the Minister of agriculture and rural development about the checked, reviews production facilities business supplies of agricultural and fisheries agriculture and forestry products, the recommended procedures to grant qualified certificates again traded plant protection drugs prescribed in clause 1 35 Article 2, of this circular. Plant Protection Bureau or Bureau cultivation and plant protection certificate eligible plant protection drugs trafficking within 5 working days from receipt of valid records, not Union fact check at the establishments.
Item 3 SPECIALIZED TRAINING, training on CHEMICAL SAFETY PLANT PROTECTION DRUGS Article 37. Content, professional training programs, training on chemical safety plant protection drugs 1. The content of training, the training include: a) prescribed medication management and plant protection, the conditions of production, plant protection drugs trafficking, rights and obligations of the individual organization of production, plant protection drugs trafficking;
b) regulations on handling administrative violations up to the plant protection drugs;
c) sketchy plant protection drugs;
d) classify hazardous plant protection drugs, characteristics of the plant protection drugs;
DD) safety in the production, trade, transport, storage and use of plant protection drugs;
e) precautions, troubleshooting plant protection drugs;
g) how to read drug labels;
h) instructions for use plant protection drugs, effectively;
I) General plant pests, some common pests and preventive measures except;
k) knowledge of laws related to the fire, fire;
l) practice, actuality.
2. The program of training, training a) professional training program on plant protection drugs for drug trafficking base, the base operating direct trafficking, trafficking people directly (no intermediate or above majored in plant protection, horticulture, biological , chemistry) fostering time is 3 months with full content specified in paragraph 1 of this article and be issued a certificate of training expertise on plant protection drugs according to the model in annex I, section XXII of this circular.
b) training programs safe plant protection chemicals for direct management, the operating parts are directly related to the production, the production directly, storekeepers training time is 3 days with the content outlined in points a, b, e, e, paragraph 1 of this article and are issued a certificate of training safe plant protection chemicals according to the model in section II of Annex XXII of this circular;
3. The responsibility for the organisation of training, training and certification of training expertise on plant protection drugs, safety training certificate for plant protection chemicals.
a) plant protection Bureau is responsible for building the content, training, refresher program knowledge plant protection drugs, chemical safety engineering;
b) plant protection Bureau or Bureau cultivation and plant protection responsible for the Organization of training, training and certification of training expertise on plant protection drugs, safety training certificate for plant protection chemicals according to the right content, the programme referred to in paragraph 1 , paragraph 2 of this Article.
Article 38. Professional training, training on chemical safety plant protection drugs 1. organizations and individuals who have professional training needs, training about chemical safety plant protection drugs register list of participants directly or by post or online with plant protection Bureau or Bureau cultivation and plant protection.
2. Plant Protection Bureau or Bureau cultivation and plant protection organization fostered expertise on plant protection drugs, training safety plant protection chemicals according to the right content, the programme provided for in paragraph 1, paragraph 2 Article 37 of this circular;
As soon as the test results are satisfactory plant protection Bureau or Bureau cultivation and plant protection certification according to the form prescribed in Annex XXII attached to this circular.
Chapter V import, EXPORT of the DRUG PLANT PROTECTION Article 39. General principles 1. Import, export of plant protection drugs made under article 67 of law protection and quarantine and circular No. 04/2015/TT-BNNPTNT December 2, 2015 of the Minister of agriculture and rural development guide and implementation of some of the content of the Decree No. 187/2013/ND-CP dated 20/11/2013 of government regulation in detail Trade Law enforcement activities the sale of goods and international dealers, buying, selling, processing and transiting goods with foreign countries in the field of agriculture, forestry and fisheries (hereinafter referred to as the circular No. 04/2015/TT-BNNPTNT).
2. where import authorization, the Organization, individuals granted the authorization certificate of the Organization, personal name registrations for organizations and individuals to import at the customs.
3. plant protection drugs in the category when imports must meet the following requirements: a) Smoking techniques must have active content with minimum amount of active drug in the category engineering and must be imported from the native manufacturers, made clear;

b) Smoking finished products with the active ingredient, the form of the drug and the manufacturer of the drug product with the right certificate of registered plant protection drugs in Vietnam and must remain at least 2/3 of the term use is indicated on the drug label since coming to Vietnam;
c) Drug products must meet the physical nature of the rate hovering, the durability of emulsion for each finished product form respectively.
d) Smoking techniques, the drug product must meet the regulations of toxic impurities at the national technical regulation (QCVN), national standards (ISO) and the standard basis (TC) of the plant protection department.
Article 40. Profile, sequence, import licensing procedures for plant protection drugs to produce aims to export 1. Profile a Single licensing proposal) imported plant protection drugs according to the 01/HERBICIDE attached to circular No. 04/2015/TT-BNNPTNT.
b) authenticated copy or copies (bring the original to collate) the certificate of registration of business or investment licenses (only the first submission).
c) originals or authenticated copies of import contracts, contracts or outsourcing contracts with foreign partners in the case of a temporary import, re-export or import to manufacture for export purposes.
2. The procedures for licensing plant protection drugs imported to manufacture for export purposes comply with the provisions of article 24 of the circular No. 04/2015/TT-BNNPTNT.
Article 41. Reporting organization, individual export, import plant protection drugs must report in writing in the form prescribed in annex XXIII of this circular export situation, drug imports for plant protection Plant Protection Department. The time limit for filing reports first years ago on July 15, and reported on Jan. 15 years ago next year.
Chapter VI CHECKING the QUALITY of MEDICINES and PLANT PROTECTION Article 42. Test base to base drug quality control and plant protection in the process of production, circulation is the national technical regulation (QCVN), national standards (ISO) or the standard base (TC) of the plant protection department.
43 things. Check the State of the quality of imported plant protection drugs 1. Plant protection drugs must be tested on the quality including smoking techniques and the drug imported products except the following cases: smoking pattern plant protection; plant protection drugs exhibit; plant protection drugs to temporarily enter the re-export, export processing; plant protection drugs transshipped in transit; plant protection drugs send bonded; plant protection drugs used with the purpose of research, experiment, assay; plant protection drugs imported under the import permit for use in foreign investment projects and other drugs imported under licence no business purpose.
2. the State Inspection Agency for the quality of medicines imported plant protection plant protection Bureau's or conformity assessment organization are authorized plant protection Bureau.
3. Quality control for plant protection drugs imported by the conformity assessment organizations are the Ministry of agriculture and rural development or the specified plant protection Bureau make check, are published on the website of the plant protection department.
4. The shipment of imported plant protection drugs only be adopted when it was reported by the agency or organization specified in paragraph 2 of this Article on State test results about the quality of imported plant protection drugs meet the requirements according to the form prescribed in annex XXVI attached to this circular.
5. plant protection drugs are allowed on the preservation repository before having the test results is performed according to the provisions of article 35 circular 38/2015/TT-BTC on 25/3/2015 of the Finance Ministry regulations on customs procedures; check, customs supervision; the export tax, import tax and tax administration for export and import goods.
Article 44. Records, state test sequence for the quality of medicines and plant protection import 1. Filing a) Organization, individuals filing directly or sent by mail or submitted online to the State Agency for the quality of medicines and plant protection import regulations in paragraph 2 Article 43 of this circular;
b) number of records: 1 a paper or electronic copy;
c) to check the validity of the registration records check in 7 working days.
The case resumes full and valid registration: quality control and validation at the State checking registration certificate for the quality of medicines and plant protection import.
Cases of incomplete records: return profile for the Organization, personal imports and additional requirements, complete the profile.
2. the registration records to check the quality of imported plant protection drugs include: a) check the State registration certificate of the quality of imported plant protection drugs according to the form prescribed in Annex XXIV attached to this circular. The number 2.
b) A copy of the following documents: contract of purchase and sale;
Import license (for plant protection drugs prescribed in clause 2 Article 67 of law protection and quarantine);
The list of goods accompanied (packing list): specify the number of the registration, the code name of each batch (batch No.);
The invoice of the goods;
Invoices (for the case of the goods imported by air, sea or rail);
Quality certificate for imported steam sterilization pill.
3. Perform a test) test and test sample within 2 working days from when the Organization, individuals present import declarations imported goods, notice of the time and place of sampling: the case of batches of the drug plant protection is still quo and match records signed the check state for the quality of medicines and plant protection Declaration of goods imported, the conformity assessment organization conducting sampling, sample record-setting check the quality of imported plant protection drugs according to the form prescribed in Annex XXV attached to this circular and records the shipment. Steam sterilization drug test records, only the status of the shipment.
The case of the batch plant protection drugs no longer the status quo and do not match the registered profile testing, conformity assessment organizations not test samples and record-setting the offense defined in State drug quality inspection and plant protection import according to the form prescribed in annex XXVIII of this circular.
b) reported test results within 10 working days from when the sample testing, conformity assessment organizations announce test results state the quality of imported plant protection drugs according to the form prescribed in annex XXVI attached to this circular. Cases must extend the time check the conformity assessment organizations must notify individuals, organizations to unify to solve.
The case of a shipment of imported plant protection drugs quality conformity assessment organization must promptly notify the organization or individual importing know simultaneously report to the Directorate of plant protection to the decision process.
The case of a shipment of imported plant protection drugs forced to re-export, import personal, organizations have to re-export within the time limit specified in the decision of the processing plant protection Department and send the text confirmed by the customs authority (a copy) of the Agency checks to save the profile.
c) save the profile check state on plant protection drugs must be stored within a period of 3 years from the date issued announcing the test results.
Article 45. Complaint resolution and processed in violation of the State inspection of the quality of imported plant protection drugs 1. Complaints and complaint resolution a) Organization, personal imports of plant protection drugs have the right to complain about test results or require conformity assessment organization to review test results;
b) receiving inspection agency, complaints, denunciations of the Organization, the individual plant protection drugs imported under the provisions of the law on complaint and denunciation Law.
2. Rules of re-examining a) within a period of 7 working days from receipt of the notification of the shipment does not reach the quality of import, organize, import personal plant protection drugs have the power to recommend the Organization reviews the fit has conducted quality control for its shipment to review test results or re-examined with shipment conditions still keep the status quo;
b) If the results re-examined contrary to initial results, the Organization, the individual does not pay import costs for the re-test, if consistent with the initial test results, the individual importing organizations must pay for the check;
c) case fault of conformity assessment organizations in testing the quality of imports causing damage to the Organization, the individual importing organizations assess the fit must repay the entire cost of the test, and have to compensate the damage to the Organization personal imports, according to the provisions of the law.
3. Handle the offense held, personal imports of plant protection drugs in violation of the provisions of this circular and other related documents, the sanctioned under regulations on handling violations in the field of measurement and the quality of the goods and the provisions on sanctioning administrative violations in the field of plant quarantine and protection.
Article 46. The Organization's responsibility to assess the suitability of 1. Just be reviews of the suitability for the specified test.
2. Receiving, checking records, announced the results of registration of the Organization's quality control, personal imports in the allotted time.
3. Responsible for the results of drug quality control plant protection import.
4. periodic reports 6 months and for the plant protection Department of the situation and the results of quality control of medicinal plant protection import according to the form prescribed in Annex XXVII attached to this circular. The report before the deadline on June 25 and on December 25th each year.
5. Subject to the checking, monitoring of plant protection department.
6. Charge quality control for plant protection drugs prescribed.
7. Preservation of samples to check quality of plant protection drugs during 12 months from the date of receipt of the sample.
8. Store the results of quality control of plant protection drugs within a period of 3 years from the date issued.
Article 47. The liability of the Organization, the individual imported plant protection drugs

1. Sign up and implementation of the rules on quality control of medicinal plant protection import.
2. Is responsible for providing the necessary documents on imported plant protection drugs, facilitate conformity assessment organizations place on hold, preservation and transport of plant protection import drugs to test samples.
3. Accept the decision handling of plant protection Bureau if a shipment of imported plant protection drugs not satisfactory quality or infringement of the provisions of this circular.
4. Have the right to complain about the results of drug quality control plant protection import and accusations of illegal behavior in the operation to check the quality of imported plant protection drugs.
5. The case was allowed to take the medication on the preservation repository before having the test results of the next Agency, organization, personal imports are responsible for preserving plant protection drugs status quo, not put the drug into the business, used until the test results are satisfactory.
Article 48. Check the State of quality plant protection drugs circulating on the market 1. Check the State of quality plant protection drugs circulating on the market are made according to the law on product quality, goods and circular No. 26/2012/TT-BKHCN on December 12, 2012 of the Minister of science and technology of the State inspection regulations on the quality of the goods circulation market.
2. check the State of quality plant protection drugs circulating on the market are made in organizations that are qualified by the Ministry of agriculture and rural development or the plant protection department.
3. Specifying the test organization be made according to the regulations of the Minister of agriculture and rural development about reviews, specify and test management agriculture and rural development.
Chapter VII CERTIFICATE of CONFORMITY and CONFORMITY of MEDICINES and PLANT PROTECTION Article 49. Require proper disclosure rules Smoking is plant protection product portfolios in commodities, commodity group 2 attached to circular No. 50/2009/TT-BNNPTNT on August 30, 2010 by the Minister of agriculture and rural development on the revision, additional products, commodity group 2 attached to circular No. 50/2009/TT-BNNPTNT on 18/8/2009 of the Minister Agriculture and rural development, are required to be published conformity before making circulation on the market.
Article 50. The sequences, procedures, conformity certificate and appropriate disclosure rules 1. Certificate of conformity and conformity of medicines and plant protection performed as specified in circular No. 55/2012/TT-BNNPTNT on October 31, 2012 of the Minister of agriculture and rural development, guide the procedure specified conformity and certification organizations announced the combination drug rules the management scope of State of the Ministry of agriculture and rural development.
2. Pursuant to the certificate of conformity, conformity about the announced plant protection drugs is the technical criteria specified in national technical regulation (QCVN), national standards (ISO); The standard base (TC) of the plant protection department by plant protection Bureau Announces every year.
Chapter VIII, PRESERVED PLANT PROTECTION DRUGS 1 DRUG TRANSPORT PLANT PROTECTION Article 51. General principles of plant protection drugs transport 1. The transport of plant protection drugs must comply with the provisions of Decree No. 104/2009/ND-CP on November 9th, 2009 by government regulations dangerous goods list and shipping dangerous goods by motor transport by road; The Decree 14/2015/ND-CP of August 13, 2015 the Government detailing and guiding the implementation of some articles of the law on the railways; regulations on the transport of dangerous goods by inland waterway law, aviation, marine; the provisions of the relevant laws and the international treaties to which Vietnam is a member.
2. The transport of plant protection drugs (except the plant protection drugs is microbial products) must be licensed under the provisions of article 4 paragraph 1 of Decree 104/2009/ND-CP on November 9th, 2009 by government regulations dangerous goods list and shipping dangerous goods by motor transport by road; clause 1 Article 22 of Decree 14/2015/ND-CP of August 13, 2015 the Government detailing and guiding the implementation of some articles of the law. 3. The transport of plant protection drugs must in accordance with the schedule stated in the contract or other papers are concerned about the transport of plant protection drugs between media owners and cargo owners.
4. The transport of plant protection drugs are safe for people, pets, environment. Not stop the car where people, close to schools, hospital, market, the source of living water.
5. plant protection drugs only be shipped when it is packaged, labeled and be competent authority granted the license to transport medicines and plant protection according to the provisions of article 54 of this circular.
6. The plant protection drugs capable of reacting to one another are not transported on the same media.
7. do not transport of plant protection drugs on the same passenger vehicles, pets, food, food, substances that cause fire, explosion and other goods except fertilizers.
Article 52. Transport of plant protection drugs 1. The transport of plant protection drugs a) who controls the media, escorts must clearly understand the nature and dangers of smoking such as plant protection: toxic, flammable, explosive, corrosive and must know the preliminary processing when the incident occurred during the transport of plant protection drugs and follow the provisions of the law on the transport of dangerous goods;
b) Who controls the transport of medicines and plant protection by means of motor traffic roads in addition to the certificate for media control in traffic according to the current rules of the State must have a certificate of training on labour safety in transportation, the preservation of medicinal and plant protection;
c) escorts cargo plant protection drugs must receive training on occupational safety in transportation, the preservation of medicinal and plant protection.
2. The packaging, the container or the container that contains the drug plant protection in the process of shipping a) Must be made of tough, durable materials, less absorbent;
b) to paste the picture map of warning with skull, cross bones black on a white background in a square set and the deviation map alerts corresponding to the nature of the plant protection drugs are transported according to the form prescribed in annex XXXIII attached to this circular. The size of the image map warning stickers on each of self-destroying plant protection drugs is 100 x 100 mi-li-meter (mm) and paste on the container is 250 x 250 mi-li-meter (mm);
c) must have signaled danger, rectangular, orange-yellow, in the middle of the record code United Nations (UN), the dangerous signal size is 300 x 500 mi-li-meter (mm) in the form prescribed in annex XXXII attached herewith, the position in the bottom image map warns. For packaging and tank then signal the danger have smaller size consistent with the rate with the packaging and container but must ensure clear view signal danger.
3. Transport plant protection drugs a) The usual means of transport is the competent authority to allow circulation to transport cargo, was carrying the drug plant protection.
b) transports the drug plant protection must ensure the following technical conditions: have tools, fire equipment, fire suit plant protection drugs when shipping;
Has awning cover, hood, be sure the entire passenger compartment ensure waterproof during transport;
Do not use car trailers machinery to transport medicines and plant protection.
c) transportation plant protection drugs ranked last of every ferry, if no ferries ferry used for dangerous goods.
d) means of transport the tank plant protection must be pasted image map warning of the type of goods being transported. The size of the warning stickers on the media map is 500 x 500 mi-li-metric (mm). Paste the image location map alerts in the sides and rear of the vehicles.
Article 53. Troubleshooting event of leakage problems, distribute medicines and plant protection during shipping, who controls the media, owners, owners of the media have the responsibility to adopt the necessary measures to limit the consequences, troubleshoot, and report to the people's Committee of social level where the problem to continue to track and measure the scene report, prevention of consequences. Violators must bear all the costs to remedy.
Article 54. Shipping license plant protection drugs 1. Plant Protection Bureau or Bureau cultivation and plant protection transport licensing plant protection drugs for the following cases: a) Organization, individual plant protection drugs transport volume from 1000 kilometers grams (kg)/upward trip by motorized transport by road;
b) Who hired plant protection drugs transport volume from 1000 kilometers grams (kg)/upward trip by rail transport.
2. license to transport plant protection drugs worth in circulation across the country.
3. The term of the licence to transport medicines and plant protection level for each trip (for transport by road), each shipment (for transport by rail) or each period not to exceed 12 months from the date of grant.
4. Sample shipping license real protection drugs prescribed in Appendix XXX attached to this circular.
Article 55. Profile, sequence, procedure for licensing plant protection drugs transportation.
1. Submission of the Organization, the individual proposed for licensing plant protection drugs transport filed directly or sent by mail or submitted online 1 record to the competent authority as defined in Article 54 paragraph 1 of this circular.
2. Record a) Single transport licensing proposal plant protection drugs according to the form prescribed in annex XXIX attached herewith;

b) copies of certificates of training on labour safety in transportation, the preservation of medicinal and plant protection of the means of control or escorts portfolio, when filed to bring the original to compare (for transport by road);
c) one of the copies of the following documents: contract of supply; Contract of carriage plant protection drugs; The financial Bill of goods import export plant protection drugs; Cargo declaration (confirmation and seal of the company);
d) freight schedules, addresses and cell phone owners (validated and the seal of the company).
3. The appraisal of records and license the transport of plant protection drugs within 3 working days from receipt of the full records as defined in paragraph 2 of this article, the competent authorities verify the record. Valid profile case, the Agency has the jurisdiction to provincial licensing plant protection drugs transportation.
Case records are not yet valid, within 7 working days from receipt of the full record, the Agency has the authority to notify the Organization, individuals need additional content, complete records as prescribed.
The case does not permit the transport of medicines and plant protection, within 7 working days, the competent authority to notify the Organization, individuals in writing and stating the reason.
Category 2 PRESERVE the DRUG PLANT PROTECTION Article 56. General provisions on plant protection drugs warehouse 1. Plant protection drugs warehouse must make sure the requirements of ISO 5507:2002 dangerous chemicals-rules of safety in production, sales, use, storage and transport.
2. Sufficient to contain the entire amount of the drug plant protection of the facility any time;
3. specialized Repositories for preservation of biological plant protection drugs are not required to comply with the provisions of this Section but are guaranteed not to pollute the environment.
Article 57. Detailed rules on plant protection drugs warehouse 1. Plant protection drugs warehouses of the manufacturing plant protection drugs a) store keeper storekeepers are trained on occupational safety in preserving plant protection drugs, training on plant protection drugs, chemical safety engineering as defined in section 3 of this chapter and must have certification or certificate of labor safety and hygiene , fire prevention.
b) location is in the Warehouse industry must comply with the provisions of the industrial zone.
The depot is located outside industrial zones must be positioned at the location in accordance with the conditions of the local planning and must be approved by the people's Committee of social level;
Arsenal are away from schools, hospitals, markets, water supply 200 metres (m) minimum; are in place to ensure the requirements of the electricity supply, water supply, drainage, environmental pollution and processing traffic; are walled to the outside.
c) specifications Repository repository must be arranged, arranged neat, logical, categorized by risk, fire, explosion and ensure separate the plant protection drugs capable of causing chemical reactions with each other.
Plant protection drugs are listed on the manifest higher shelf at least 10 cen-ti-meter (cm), a wall at least 20 cen-ti-metric (cm). The main wide aisle a minimum 1.5 metres (m), convenient for the operating room fires, examining, monitoring.
Building materials warehouse is non-flammable, difficult to fire; the frame house was built of brick, made of concrete or steel. The floor is made of a material impervious to liquids, non-slip, flat no crevices and ledges in spill prevention must be the door. The door must be locked to protect for sure.
The repository must be exits, are clear indications (in table, diagram) and easy to open when the incident occurred.
The repository must have waste treatment systems; must comply with the provisions of Decree No. 59/2007/ND-CP dated 9 April 2007 from the Government on the management of solid waste; must have ventilation systems; There are tools for collecting and transporting waste out of the warehouse area.
The repository must be the table of chemical safety rules, the system image map warning line with dangerous levels of plant protection drugs. Chemical hazard characteristics are more different then the picture map of warning must be full of dangerous characteristics.
The repository must have safety rules, have armed and use safety equipment (gloves, masks, eye goggles, protective clothing) when exposed to plant protection drugs, have first aid and medicine cabinet.
Must have a separate area to dressing, bathing for workers after working in the warehouse.
Plant protection drugs warehouses must meet the requirements of explosion protection by law, fire and fire.
Outside the repository must have "Banned", "non-smoking", font, Red; fire protection regulations, fire command is to easy to see.
Fully-equipped devices, rescue tools, incident at the facility, fire extinguishing, fire alarm system were installed in the appropriate position and check regularly to ensure always in ready status to good use.
The operation in warehouses to ensure safety, prevent the risk may occur as fires, leaks, drains overflowed. Store keeper to comply with the instructions in the votes of all chemical safety plant protection drugs are stored, the guidelines on work safety, hygiene, the guidelines when there is trouble.
2. plant protection drugs Warehouse base of plant protection drugs trafficking a) away from the source of water (Lake, River, Canal) at least about 20 metres (m) and must be reinforced embankment sure, against the flow. To dry, airy, impervious, dilapidated condemned or attenuated, ensure the prevention of fire and explosion;
b) wall and roof of where to build the cutting-edge non-material fire. The wall and the background is flat, waterproof, easy to clean, not to be flooded;
c) Must be guaranteed sufficient brightness in order to identify the goods. Lighting equipment ensure the safety of fire prevention;
d) goods are listed on the manifest higher shelf at least 10 cen-ti-meter (cm), a wall at least 20 cen-ti-meter (cm); must be preserved in sealed packaging, limited spread out around the smell;
DD) commodity arrangements must ensure not to cause the crash, leak, have wide enough entrance to a minimum and to separate each type;
e) Have rules and fire equipment and fire at the request of the Fire Department, fire to where convenient, ready to use when needed;
g) Have labor protection personal protection such as gloves, masks, SOAP, clean water;
h) material, tools for timely processing of incidents.
Section 3 TRAINING on OCCUPATIONAL SAFETY in transportation, the PRESERVATION of MEDICINAL and PLANT PROTECTION Article 58. Content training on occupational safety in transportation, the preservation of plant protection drugs 1. The driver of the means of transportation, escorts portfolio, training the following: a) shipping safety, preservation of plant protection drugs;
b) provisions of the law on transport, storage of dangerous chemicals;
c) characteristics of the plant protection drugs;
d) Image Map, signaling warnings of dangerous goods.
DD) measures to ensure the safe transport of plant protection drugs include emergency, road safety, basic knowledge about the use of the instruments of protection measures for the prevention and handling of incidents for each type of plant protection drugs;
g) safety practices in preservation and transportation of drugs.
2. Plant Protection Bureau is responsible for building the content, the training program for escorts and who controls the transport of medicines and plant protection.
3. Plant Protection Bureau or Bureau cultivation and plant protection organizations or in cooperation with the vocational training establishments, enterprises organised training for organizations and individuals related to the transportation of the drug, raw material, plant protection drugs, who controls the media escorts portfolio, plant protection drugs in the correct program content specified in paragraph 1 of this article.
Article 59. Training on occupational safety in transportation, the preservation of plant protection drugs 1. The organization or individual that needs training on occupational safety in transportation, the preservation of plant protection drugs register list of participants directly or by post or online with plant protection Bureau or Bureau cultivation and plant protection.
2. Plant Protection Bureau or Bureau cultivation and plant protection training organized for the participants of training on labour safety in transportation, the preservation of plant protection drugs according to the content of the provisions in clause 1 Article 58 of this circular. The training time is 3 days.
3. The base test results after training, plant protection or Bureau cultivation and plant protection training certification of labor safety in transportation, the preservation of plant protection drugs according to the form prescribed in annex XXXI attached to this circular.
Chapter IX PLANT PROTECTION DRUGS AD Article 60. Advertising content plant protection drugs 1. Plant protection drugs ads are required to have the following content except as prescribed in clause 2 of this: a commercial Name), the active plant protection agents;
b) features work and things to note when using, preserving plant protection drugs;
c) Organization's name, address, personal, distributing registration;
d) instructions for use;
DD) warned about dangerous levels of toxic, and instructions to prevent the harmful effects of smoking and plant protection.
2. The content of drug advertising and plant protection across the Board, sea, panels, shelves, manifest other widgets, objects in the air, under water, mobile objects, electronic equipment, terminal equipment and other telecommunications equipment, means of transport, the transfer of advertising products is not necessarily contain adequate content required.
3. Workshop on plant protection drugs must have guidelines about safe, effective in using plant protection drugs under the standard basis of TCCS 20:2010/HERBICIDE use guide plant protection drugs safely and effectively.
4. plant protection drugs toxic acute category I, II according to the classification of KS RAO Workshop only intended to recommend safe use.
5. Advertising Content plant protection drugs must be the competent agency specified in article 61 of this circular.

Article 61. Authority to confirm the content of drug advertising plant protection 1. Plant Protection Bureau certificate level advertising content plant protection drugs for press, electronic information, electronic equipment, terminal equipment and other telecommunications equipment, the product prints, sound recordings, video recordings and other technological equipment of Central , released nationally.
2. Plant Protection Bureau or Bureau cultivation and plant protection certificate grants the advertising content of medicines and plant protection for cases of ads on the media: a) press, electronic information, electronic equipment, terminal equipment and other telecom equipment , print products, sound recordings, video recordings and the equipment for other local technologies;
b) banner, banners, signboards, light box, screen advertising professional.
c) means of transport;
d) fairs, seminars, conferences, events, exhibitions, cultural and sports programs;
DD) The conveyed product advertising, advertising material;
e) other advertising media in accordance with the law.
Article 62. Profile, sequence, procedure for granting confirmation drug ad content and plant protection 1. Filing a) Organization, individuals filing directly or sent by mail or submitted online to the competent State agencies under the provisions of article 61 of this circular;
b) number of records: 1 a paper or an electronic version.
2. Record a) petition to confirm the content of drug advertising plant protection according to the form prescribed in annex XXXIV attached herewith;
b) copies of certificates of registration of medicines and plant protection;
c) product advertisement (content, forms of advertising are represented by pictures, sounds, voices, text, icons, colors, lighting and similar forms);
d) rapporteurs list full record information about qualifications or scientific title of Rapporteur (for the case of fairs, seminars, conferences, events, exhibitions, cultural and sports programs).
3. The appraisal of records and certificate level advertising content plant protection drugs within 10 working days from receipt of a valid application, the competent State bodies specified in article 61 of this circular granting confirmed drug ad content and plant protection according to the form prescribed in annex XXXV attached to this circular. The case of not granting the confirmation of advertising content the competent State bodies must respond in writing and stating the reason is not granted.
Chapter X LABEL PLANT PROTECTION DRUGS section 1 GENERAL PRINCIPLES of DRUG LABEL PLANT PROTECTION Article 63. Drug labeling guidelines plant protection 1. Plant protection drugs circulating in the country, export, import is consistent with labeling regulations on tangle in Decree No. 89/2006/ND-CP on August 30, 2006 by the Government, the direction of the global harmonization of systems of classification and labelling of chemicals (KS RAO) and of this circular.
2. hazardous levels of plant protection drugs is shown on the label of the plant protection drugs and the drug's chemical safety Slips and plant protection. Classification of hazardous plant protection drugs is done according to the rules, KS RAO's technical guide, based on the hazardous material; the level of harmful effects to human health and the environment. Details of the group classified hazardous plant protection drugs specified in annex XXXVI attached to this circular.
Article 64. The location, the size label plant protection drugs 1. Medicinal plant protection labels must be printed or stuck on the packaging plant protection drugs in recognizable location, full of content regulation of the label without having to dismantle the parts of the packaging.
2. The size of the label smoking plant protection organization, the individual self-determination but must ensure the full record required content as defined in section 2 of this chapter.
Article 65. The colors, the way the presentation of words, symbols and images on plant protection drugs label color a) the color of letters, numerals, drawings, pictures, signs, symbols, write on the label must be legible;
b) Letters, numbers must be of a color contrasting with the background color of the label with respect to the required content on the label (for example, black-white, black-pale yellow, dark brown-green, purple and white-white);
c) background color labels not coincide with color only toxic plant protection drugs.
2. How to present a minimum font size) of the label is 8 (point), the font Times New Roman (or equivalent);
b) does not print vertical text, diagonal or winding;
c) If in the photo, illustration or plant pests on the label only in the objects already registered;
d) does not print the picture sank under the content required to be indicated on the label;
DD) name of the active ingredient listed on the label only in the "components".
Article 66. The language of presentation on the drug label plant protection 1. On the record label language is Vietnamese;
2. The following text may be written in other languages have Latin letters original: a) the name of the active ingredient;
b the common Name) or the name of the component, the quantitative component of the drug in the case of not translate out Vietnamese or Vietnamese but that doesn't mean being out;
c) name and address of organization, foreign individuals register production and plant protection.
Article 67. The content recorded on the label plant protection drugs 1. The content recorded on the label is honest, clear, accurate, properly reflect the nature of the plant protection drugs (including manual sheet), true to the provisions in section 2 of this chapter and the certificate of registration of plant protection drugs.
2. Changing the contents listed on the label must be approved plant protection Bureau.
Section 2 REQUIRED CONTENTS RECORDED on LABEL PLANT PROTECTION DRUGS Article 68. Mandatory content indicated on the labels of medicines and plant protection products 1. Commercial name;
2. Drugs;
3. The form of finished products;
4. The name, ingredients, concentrations of the active ingredient;
5. Quantitative;
6. Registration Number;
7. Date of production;
8. The number of the manufacturing batch;
9. Term of use;
10. Origin;
11. organized information, personal drug production and plant protection products;
12. The information about the Organization, personal, distributing registration;
13. Instructions for use, maintenance instructions;
14. Information on the threat;
15. The guide measures the use of medicines safer plant protection;
16. The name, of the content of solvents, additives to alter the acute toxicity level of the drug product (if available).
Article 69. Extra label of the drug plant protection products 1. Label size case not enough to write all the content of the mandatory provisions of article 70 of this circular to the minimum records on major labels the content specified in the paragraph 1, 5, 7, 9, 10, 12, 14 Article 68 and has added extra label.
2. extra Label must be attached to each packing plant protection drugs to not be separated in the process of circulation and use.
3. On the main label to write instructions to "READ the LABEL BEFORE USE ACCESSORIES".
4. The content recorded on the extra label must include the entire content of the required items on the label.
Article 70. The content required to be indicated on the label of the drug plant protection technique 1. The active ingredient;
2. The composition, the amount of active ingredient;
3. The volume, net weight;
4. Name, address, unit;
5. Origin;
6. the date of manufacture, the duration of use;
7. Information on the threat;
8. Guide the measures used plant protection drugs safe.
Item 3 ways RECORD LABEL PLANT PROTECTION DRUGS Article 71. How to burn the contents required on the label of the plant protection drugs 1. Commercial commercial Name name not misrepresent the nature and uses of the drug; not violate traditional customs of Vietnam; not reading or writing the name of the leader, a national hero, celebrity, landmarks of Vietnam or abroad, the foods, beverages, pharmaceutical products.
2. Drugs: according to the uses of the drug, including pesticides, pesticides and other diseases in the category. Biological plant protection drugs shall be added the word "Biology" in the following inscription inscribed drugs (for example: bio-pesticides).
3. The form of finished products: write the symbol of the form of finished products according to Croplife International guidelines regarding technical and plant protection products (Croplife International Codes for Technical and Formulated Pesticides) are regulated in Annex XL attached to this circular.
4. The name, ingredients, concentrations of the active ingredient a) Record the names of all the active ingredients in the drug product. The active ingredient in the common name (common name), if there is no common name, the IUPAC name record;
b) Record of each content of active ingredient in the drug product units g/kg (three digits) or percentage of full volume two digits (% w/w) for solid, liquid and viscous drugs, sol-air or volatile liquids; the Unit g/l (three digits) or volume percentage (% w/w) for other liquid; units IU or UI (International Unit)/mg, CFU (Colony-Unit Habit-forming)/g (or ml) for micro-organisms.
5. a quantitative) plant protection Drugs quantified by measuring quantities are recorded in accordance with the law of Vietnam about the measure.
b) batching plant protection Drugs by the number they must record the count naturally.
c) plant protection drugs liquid, viscous liquid burn real volume, units are litres (l) or mi-li-liters (ml); powder, granules, viscous liquid, aerosol or volatile liquid recorded net weight, the unit is kilometers grams (kg) or grams (g); pellets burn the number and volume of a member, the unit is kilometers grams (kg) or grams (g).
d) case in a commercial packaging of plant protection drugs packaging units are more then must the quantitative recording of each unit of packaging and packing unit quantity.
DD) plant protection Drugs are pre-packaged goods must comply with the provisions in circular No. 21/2014/TT-BKHCN on 15 July 2014 of the Ministry of science and technology rules of measurement for the amount of pre-packaged goods.
6. The registration number is the number of the certificate of registration of medicines by plant protection Plant Protection Department.
7. Date of production, shelf

a) on production, the expiry date on the label is full or burn off with capital letters is: "NSX" order of the day, month and year of the calendar year. Each number only, only, only five days, recorded by two-digit numbers are allowed, only four-digit year. The number of days, months, years of just a timeline should recorded along a line;
b) where not scoring "NSX" together with digits only days, months, years, to instructions on the label. For example: at the bottom of the packaging production time record is "right on the label then recorded" 020406 "View NSX at the bottom of the packaging".
8. The batch number of manufacture, write as follows: production batch Number: XXXX; or batch number: XXXX. The structure of the production batch number, owing to production base of self regulation.
9. Made a) record "produced in" or "origin" with the name of the country or territory to produce medicines and plant protection;
b) for plant protection drugs made in Vietnam to the circulation in the country, has recorded the address of where the produce drugs that are not required to record the origin plant protection drugs.
10. Organization of information, personal registration, distribution, production and plant protection.
a) Organization, personal information: name, address and telephone number of the Organization, the individual is granted a certificate of registration of plant protection drugs;
b) information held, personal distribution: Write your name, address and telephone number of the Organization, the individual plant protection drugs distributed in Vietnam;
c) Organization, personal information: names, addresses of organizations, individuals produce medicines and plant protection products.
11. Instructions of use, preserving a) uses, the audience in the room except (born pests, crops);
b) dosage, the concentration, the number, timing and method of handling;
c) mixing, blending, dosing rate and sprayed spray;
d) quarantine period;
DD) the ability to coordinate with other drugs (if any);
e) precautions, drug resistance and management information (if available);
g) plant protection drugs for high toxicity to honey bees use for fruit trees, keep warning: "do not spray plants flowering stage";
h) for plant protection drugs high toxicity to fish according to the classification of KS RAO used for rice to write warning: "the poison with fish, not used in the aquaculture sector";
I) information to prevent misuse or inappropriate;
k) preserving, handling and packaging of drugs during and after use;
l) Must specify the conditions necessary to preserve the drugs on drug labels. For example, preserved in a dry airy place, temperature not exceeding 30° c.
12. Information about a hazard) to drug Labels warn, warning from the map, color marking, risk warnings prescribed in Appendix XXXVII attached to this circular line with classified hazardous plant protection drugs;
b) From warning is shown by the printed word often, bold or capital letters with a height of not less than 2 mi-li-metric (mm). From the alert is used as defined by KS RAO include the words: "DANGER" is used for the more serious risk level; "Warning" is used for the less dangerous than the risk;
c) planned height of warning colors not less than 10% of the height of the label.
13. The guide measures the use of plant protection drugs safe.
a) including the paraphrase, indications and symbols safety instructions description the solutions, requests made to minimize or prevent the bad effects of smoking plant protection caused by contact, transport or preservation of plant protection drugs. The safety instructions on the label of the plant protection drugs specified in annex XXXVIII attached herewith;
b) information about the symptoms of poisoning, first aid instructions, medical processing. Information on the antidote (if available).
Section 4 of the VOTES of CHEMICAL SAFETY PLANT PROTECTION DRUGS Article 72. General principles 1. The Organization, individual manufacturing, importing medicines and plant protection must establish secure Votes for chemical plant protection according to the provisions of article 29 of the chemical Law.
2. organizations and individuals, producers, traders, importers, shipping the drug to keep plant protection chemical safety Votes for all plant protection drugs available in the base or their vehicles and when required, ensure all the objects related to plant protection drugs can control the information in secure Votes the drug's chemical plant protection.
Article 73. The form and content of chemical safety Votes plant protection drugs 1. The votes of chemical safety plant protection drugs are expressed in Vietnamese. The case of the imported plant protection drugs, must accompany the original version or the English of the manufacturer in the form of printouts. 2. The case of chemical safety Votes plant protection drugs have more pages, the pages must be numbered consecutively from the first page to the last page. Guest number on every page including the page number and the total number of pages of the entire Vote of chemical safety plant protection drugs and stamped by the manufacturer.
3. The content of chemical safety Votes plant protection drugs according to the form prescribed in annex XXXIX attached to this circular.
Chapter XI PACKAGING PLANT PROTECTION DRUGS Article 74. Asked about the drug packaging plant protection requirements on packing plant protection drugs be applied with all types of packaging plant protection drugs including the type of packaging to be recycled or reused.
1. Packaging must ensure: a good quality) can withstand bumps and shocks normally during shipping, cargo forwarding between the means and the unloading to the treasure by manual or motorized equipment;
b) must be sealed to ensure no loss of chemicals in the process of preparing the shipping or when shipping with the impacts such as vibration, temperature, humidity and pressure;
c) the outer packaging must ensure clean and do not stick any dangerous chemicals.
2. The parts of the packing of the exposure to the drug plant protection must ensure: a) are not affected or impaired the quality due to the impact of chemicals packed inside;
b) no dangerous effects, impacts or catalytic reaction with plant protection drugs in packaging;
c) used an inert liner lining proper to protect quarantine, packing with plant protection drugs packed inside.
3. The packaging layer inside when plant protection drugs are packaged in two layers to ensure during normal transport conditions, they cannot break, leak or puncture the substance is packing out the external packaging class.
4. The type of packing of the inside in susceptible to rupture or puncture as the type of glass, porcelain or some kind of certain plastic needs to be fixed with packaging layer insertion in addition by the absorber cushion insert, material appropriate.
5. The plant protection drugs not included in the package together in the same outer packaging or in class a large transport compartment, as these chemicals can react with each other and cause: fire or large heat release; play heat or flames, generating oxygen or toxic gases; create strong corrosive substances; create the non-durable.
6. Packing plant protection drugs in liquid a) must have the appropriate stamina with the pressure from the inside was born in transit;
b) must have the necessary space to ensure packaging is not leaking or distortion occurs due to the increase in the volume of the liquid to be packing when the temperature increase in the transport process;
c) To test for leaks before use.
7. Packaging of plant protection drugs are volatile enough to ensure the sealed during transportation of fluid level not down low under the limit.
8. Packing plant protection drugs in the form of powder or granules need to be closed enough to avoid falling finalist or need the enclosed sealing layer.
9. Packing plant protection drugs used are managed as packaging containing plant protection drugs.
10. personal, organization of production, plant protection drugs imported to build standard for packaging plant protection drugs prescribed in point c paragraph 1 Article 71 of law protection and quarantine.
Chapter XII USING PLANT PROTECTION Article 75. Rights and obligations of the Organization, individuals using plant protection rights and obligations of individual organizations using plant protection drugs are prescribed in clause 2 Article 72 protection and quarantine.
Article 76. Training content using plant protection drugs 1. Guide to using the drug safety and effectiveness;
2. How to read drug labels and plant protection;
3. The harmful effects of smoking and plant protection with users and prevention;
4. environmental protection, food safety;
5. Rights and obligations of users of the drug.
Article 77. Responsible for training organizations using plant protection drugs 1. Plant Protection Department is responsible for building the content, programs, training on manual plant protection drugs.
2. Plant Protection Bureau or Bureau cultivation and plant protection chaired or coordinated with the training establishments, vocational, business-training organizations using plant protection drugs in the correct program content specified in article 76 of this circular.
3. The manufacturing plant protection drugs actively training organisation manual, plant protection drugs, prevention of incidents caused by plant protection drugs cause when in use.
Chapter XIII the REVOCATION, DESTRUCTION of PLANT PROTECTION DRUGS Article 78. The recovery process required plant protection drugs When plant protection drugs detected are recovered as specified in paragraph 1 to article 73 of law protection and quarantine, the competent agencies on protection and quarantine provisions of article 79 of this circular performs the following sequence : 1. forced decision to revoke.
2. Send the decision to the Organization, the individual plant protection drugs to recall: personal organization requests that stop plant protection drugs business to recover, identify and submit the notice revoked plant protection drugs to places where plant protection drugs must be distributed to make a withdrawal by the exported documents.
3. Send the notice revoked plant protection drugs to the relevant management bodies.
4. Sealing plant protection drugs are withdrawn.
5. organizations and individuals have recovered plant protection drugs set up process plant protection drugs recovered the competent authority specified in article 79 of this circular look.

6. decision on measures to handle and oversee the handling of plant protection drugs a) re-export measures apply to plant protection drugs case;
b) case measures by recycling plant protection Bureau decision; the implementation of recycling must be monitored by the Agency mandatory recall decision;
c) remedy the error label packing applied for plant protection drugs labeled packaging errors or not properly regulated;
d) remedies culled applies to the case of organisations, individual plant protection drugs must withdraw proposed culling or not cured by other disposal measures according to regulations.
7. The destroyed plant protection drugs made under the provisions of article 74 of law protection and quarantine.
Article 79. Decision-making authority required recovery of plant protection drugs 1. Plant Protection Department has decision-making authority required withdrawal for the plant protection drugs must be revoked; the decision of the measures and the time limit for handling the drug recovered plant protection; check the recovery and processing of production facilities; processed in breach of the recovered plant protection drugs of establishments when the recovery of the drug occurred in many provinces and cities under central.
2. Plant Protection Bureau or Bureau cultivation and plant protection authority decision required withdrawal for the plant protection drugs must be revoked; the decision of the measures and the time limit for handling the drug recovered plant protection; check the recovery and processing of drug establishments; processed in breach of the recovered plant protection drugs of the establishments in the area according to the regulations.
Chapter XIV the ORGANIZATION Doing 80. The responsibility of the Directorate of plant protection 1. About the registration of plant protection drugs a) receiving, appraisal, retention and security of registration records. The storage time is the minimum records for 5 years for a paper, 10 years for the electronic version. When the time runs out the archives, records are destroyed according to the current regulations;
b) level, level back and revoke the license of the assay; granted, renewal, revocation and re-issuance of certificates of registration of medicines and plant protection;
c) hosted the session of the Council to approve the drug establishment registration and process the Minister of agriculture and rural development issued circular category, listing banned after already Advisory Council to consider and recommend to subscribe to the list;
d) costs, fees and license again assay, drug registration certificate for plant protection; renewal of the certificate of registration of plant protection drugs.
2. assay Of plant protection drugs a) management, organized the activity assay of plant protection drugs ensure objectivity, accuracy;
b) appraisal of records suggest the eligible organization recognition assay plant protection drugs;
c) training and certification of training drug assay plant protection for people working on plant protection drugs assay;
d) inspect, evaluate the results of assay plant protection drugs;
DD) assay results used to organize reviews drug registration service;
e) construction, the process of enacting the national technical regulation (QCVN), national standards (ISO), standard base (TC) on plant protection drugs assay.
3. About drug manufacturing plant protection a) supervised and required the facility to overcome the shortcomings of drug production conditions and plant protection;
b) requires the facility to provide the records, document and create favorable conditions for the evaluation of the observance of the provisions of this circular and the other legal texts concerned about drug production and plant protection;
c) plant protection Bureau implementation level, level back and withdraw the certificate of eligible production in accordance with the provisions of the law on protection and quarantine and guide of this circular;
d) periodically check or irregularly for the facility was granted the certificate of eligible drug manufacturing plant protection upon request of competent State agencies;
DD) handle infringement, resolved the complaint accusations as prescribed by law;
e) building content, enrichment programs, training drug knowledge and plant protection.
4. On the export, import plant protection drugs a) reception, evaluation of imported records plant protection drugs prescribed in clause 2 Article 67 of law protection and quarantine;
b) import licensing plant protection drugs.
5. Quality control of medicinal plant protection a) manage the activities of quality control of medicines and plant protection;
b) guidance, operational management of the Organization reviews the fit specified quality control for medicines and plant protection;
c) handling, complaint resolution, the report of the Organization, the individual cases of imported plant protection drugs do not meet quality requirements;
d) training of officers to do the work of quality control for medicines and plant protection;
DD) construction, the process of enacting the national technical regulation (QCVN), national standards (ISO), standard base (TC) about the quality control of medicines and plant protection.
6. The certificate of conformity and conformity plant protection drugs a) specify the conformity certification organization, testing on the drug plant protection according to the regulations of the Minister of agriculture and rural development;
b) announced the list of conformity certification organizations, laboratories, national technical regulation (QCVN), national standards (ISO), standard (TC) on basis of plant protection Bureau website.
7. Build the content, training programs on occupational safety in transportation, the preservation of medicinal and plant protection.
8. Build the content, programs, training on manual plant protection drugs.
9. About plant protection drugs ad a) reception and evaluation of drug ad content in plant protection authority specified in Article 61 paragraph 1 of this circular;
b) certificate-level advertising content.
10. forced decision to revoke the drug plant protection authority as defined in Article 79 paragraph 1 of this circular.
Article 81. The responsibility of the Department of agriculture and rural development 1. Receiving registration documents, reported receiving announced conformity, establish tracking and managing book records announced the conformity of medicines and plant protection.
2. Coordination with the Directorate of plant protection guide perform the conformity certification, announced the conformity of medicines and plant protection.
3. submit reports to General plant protection Bureau, the Ministry of agriculture and rural development on the operation announced conformity plant protection drugs when required.
4. Steer, guide and test plant protection Bureau or Bureau cultivation and plant protection in the implementation of the tasks of this circular.
Article 82. The responsibility of plant protection Bureau or Bureau cultivation and plant protection 1. About drug trafficking and plant protection a) supervised and required the facility to overcome the shortcomings of drug trade conditions and plant protection;
b) requires the facility to provide the records, document and create favorable conditions for the evaluation of the observance of the provisions of this circular and the other legal texts concerned about drug trafficking and plant protection;
c) plant protection Bureau or Bureau cultivation and plant protection implementation grant, grant and revoke a certificate eligible plant protection drugs trade locally managed in accordance with the provisions of the law on protection and quarantine and guide of this circular;
d) periodically check or irregularly for facilities have been certified eligible plant protection drugs trafficking when required by the competent State agencies;
DD) handle infringement, resolved the complaint accusations as prescribed by law;
e) refresher training, organization of knowledge plant protection drugs, chemical safety engineering.
2. The preservation, transportation of plant protection drugs a) to receive and verify the profile of drug transport licensing plant protection;
b) licensed to transport medicines and plant protection;
c) organized training and certification training on occupational safety in transportation, the preservation of medicinal and plant protection.
3. plant protection drugs use a) fostering organizations, training on the use of medicines and plant protection;
b) organizing advocacy, dissemination and education in order to enhance the sense of executive law on protection and quarantine, sense of responsibility, the use of medicines and plant protection for the community, the environment;
c) in collaboration with the functional sectors held to check the use of medicines and plant protection in the area of production, especially in the regions specializing in the production of vegetables, fruit, tea;
d) detect and handle cases of intentionally violating regulations about the use of medicines and plant protection.
4. plant protection drugs ad a) reception and evaluation of drug ad content in plant protection regulatory authority in paragraph 2 Article 61 of this circular;
b) certificate-level advertising content.
5. Recovery of plant protection drugs forced decision to revoke the drug plant protection jurisdiction prescribed in clause 2 Article 79 of this circular.
Chapter XV Article 83 ENFORCEMENT TERMS. Transitional provisions 1. Plant protection drugs already in the category but does not meet specified in point b of paragraph 5 article 5 this circular allowed maximum circulation after 5 years from the date of this circular effect.
2. Before 1 year to implement the provisions in paragraph 1 of this article, organization, personal name registered plant protection drugs don't meet specified in point b of paragraph 5 article 5 this circular must register with content 01 plant protection Bureau for submission to the Ministry of agriculture and rural development put into categories according to the regulations.
In the case of organizations, personal name registered plant protection drugs have multiple levels of non-performing register 1, Department of plant protection option 1 most of the drug content of that which has been registered to the Ministry of agriculture and rural development included in the category.
3. plant protection drugs don't meet specified in point b of Article 5, paragraph 5; item 2 article 6; points b, c, d paragraph 3 article 6; paragraph 6 article 6 of this circular:

a) Have been licensed but not yet perform assay the assay: to cancel the incorrect object to the provisions of this circular in the license from the date of the circular in force;
b) for performing the assay or assay has been completed but has not yet completed the registration procedure the assay and to subscribe to the list. If registered on the list then just released a maximum of 5 years from the date of the circular in force;
c) for plant protection drugs do not meet prescribed in clause 2 article 6; points b, c, d paragraph 3 article 6; paragraph 6 article 6 of this circular was to subscribe to the list before this circular effect, when the certificate of registration of plant protection drugs expires: just renewed for 2 years from enough on this circular effect.
4. Medicines and plant protection products specified in point 3 of article 6 paragraph Ridin this circular acute toxic category III, type IV according to the classification of KS RAO, just imported, produced a maximum of 1 year; only be traded, using a maximum of 2 years from the date of this circular effect.
5. Smoking chemical plant protection, biological plant protection drugs containing the active ingredient pyrethrins, rotenone, avermectin Group registered on vegetable plants, fruit trees and tea plants have been licensed assay that is not specified quarantine time assay prior to the time this circular effect they must quarantine time assay.
6. plant protection drugs Label content as specified in circular No. 03/2013/TT-BNNPTNT on June 11, 2013 of the Minister of agriculture and rural development regulation on plant protection drugs management continued to use a maximum of 5 years from the date of this circular effect.
7. Certificate of specialized training on plant protection drugs was granted before the date of this circular effect is considered to be equivalent to a certificate of specialized training on plant protection drugs according to the provisions of this circular.
8. The assay has signed a contract with qualified organizations prior to assay this circular effect is continuing to follow the provisions of circular No. 03/2013/TT-BNNPTNT on June 11, 2013 of the Minister of agriculture and rural development.
Article 84. Effective enforcement of this circular are effective since August 1, 2015.
This circular replaces circular No. 03/2013/TT-BNNPTNT on June 11, 2013 of the Minister of agriculture and rural development regulation on the management of medicines and plant protection;
Circular No. 14/2013/TT-BNNPTNT February 25-2013 of the Minister of agriculture and rural development regulation certification eligible production, plant protection drugs business;
Circular No. 77/2009/TT-BNNPTNT on December 10, 2009 by the Minister of agriculture and rural development regulation on State drug quality inspection and plant protection;
Article 2 of circular No. 18/2011/TT-BNNPTNT January 6, 2011 by Secretary of the Ministry of agriculture and rural development on the revision, Supplement, abolish some regulations on administrative procedures in the field of protection and quarantine according to resolution No. 57/NQ-CP on December 15, 2010;
Decision No. 97/2008/QD-BNN on February 6th, 2008 by the Minister of agriculture and rural development regulation on the grant of the certificate of practice in manufacturing, processing, to the bottle, packaging, plant protection drugs trafficking;
Article 2 of circular No. 85 on 14 December 2011/2011/TT-BNNPTNT of the Minister of agriculture and rural development, on the amendments and supplements to some articles of the decision No 89/2007/QD-BNN on 01 November 2007 governance rules about sauna disinfection operation in an unidentified quarantine and decision No. 97/2008/QD-BNN on 6/10/2008 rules about the grant of the certificate of practice in manufacturing, processing, to the bottle, packaging, plant protection drugs trafficking of the Ministry of agriculture and rural development.
In the process of implementation of the circular, if there are difficulties and obstacles, organizations, personal reflections on the Ministry of agriculture and rural development (through the Directorate of plant protection) to review, amend, Supplement.