(March 11, 2003 State economic and Trade Commission promulgated as of April 11, 2003, 50th) Chapter I General provisions article I for the production of pesticides management and promote the healthy development of the pesticide industry, according to the regulations on the management of pesticides (hereinafter referred to as the regulations), the formulation of the approach.
Article People's Republic of China territory of production of pesticides shall comply with these measures.
Article pesticide mentioned in these measures refers to prevention, eradication or control agricultural and forest diseases, insect pests and weeds, and other pests, and purposefully regulating chemical synthesis of growth of plants, insects, or from the biological and other natural substances a substance or mixture of substances and preparations.
Article fourth State economic and Trade Commission (hereinafter referred to as State economic and Trade Commission) on the national pesticides production supervision and management for the establishment of pesticide manufacturers for review and approval (hereinafter referred to as approved by the pesticide manufacturer) and the approval of pesticide products.
Fifth of provinces, autonomous regions and municipalities directly under the economic and trade Management Department (hereinafter referred to as the provincial economic and trade authorities) on pesticide production supervision and management within their respective administrative areas.
Chapter Sixth pesticide manufacturers approved establishment of pesticide production enterprises (including joint venture, set up plants and non-pesticide pesticide production plant), should be reported to the State economic and Trade Commission for approval.
Seventh article declared approved, should has following conditions: (a) has with production of pesticide phase adapted of technicians and technology workers; (ii) has with production of pesticide phase adapted of plant, and production facilities and health environment; (three) has meet national labor security, and health standard of facilities and corresponding of labor security, and health management system; (four) has products quality standard and products quality guarantee system; (five) by production of pesticide is law made pesticide registration of pesticide;
(Vi) compliance with national requirements of pollution control facilities and measures for environmental protection, and pollutant emissions do not exceed emission standards at the national and local regulations and (VII) other conditions stipulated by State economic and Trade Commission.
Approved by the eighth report, the following documents shall be submitted: (a) the application form approved by the pesticide manufacturer, (ii) a business license or the industrial and commercial administrative organs of the Enterprise name pre-approval notice issued by copy; (c) feasibility study of the project and (iv) audit observations of the local environmental protection authorities; (v) other materials under the State economic and Trade Commission.
Section Nineth enterprises shall, in accordance with the approach under article eighth required materials submitted to the provincial economic and trade Management Department. Documents for applying for provincial economic and trade Management Department is responsible for the enterprise trial.
For qualified business filings in the first instance, in February or August each year should be submitted to the State economic and Trade Commission.
Tenth State economic and Trade Commission, respectively, in the annual March and September two expert audit and 45 working days to complete the examination.
For approved enterprises, the State economic and Trade Commission confirmed its pesticide production qualification, and announcements.
Declarations that are not audited, no longer as a basis for approved applications. Chapter III pesticide product approvals 11th production have not yet developed national standards and industry standards for pesticide products, shall apply to the State economic and Trade Commission pesticide producing approval documents.
Enterprises approved by the production files, may produce approved products. 12th article application approved file, should has following conditions: (a) has has approved of pesticide production enterprise qualification; (ii) products meet national about legal, and regulations and the industry policy; (three) products effective ingredients exact; (four) has guarantee the products quality of corresponding process technology, and production equipment, and plant, and auxiliary facilities and the measurement and quality detection means; (five) has and the products phase adapted of safety, and labor health facilities and corresponding of management system; (six) has and the products phase adapted of "waste"
Control facilities and measures pollutants treated to meet national and local emission standards; (VII) products and production technologies in accordance with relevant provisions of the protection of intellectual property rights; (VIII) other conditions stipulated by State economic and Trade Commission. 13th article application approved file should submitted following material: (a) pesticide production approved file application table; (ii) license copies; (three) products standard and the prepared description; (four) efficacy test report; (five) toxicity determination report; (six) provincial quality detection institutions issued of products quality detection report; (seven) industrial sales total and the main products production (statistics B201 table); (eight) added original drug production device of construction project feasibility research report; (nine) production device by
In the views of the Department of environmental protection; (j) processing, compounding the original sources (11)-packing the packing of the product license agreement, (12) other materials under the State economic and Trade Commission.
Apply for a new drug product, the preceding paragraph shall be submitted (a), (b), (c), (d), (e), (f), (h), (I) the provision of materials.
Apply for additional processing, composite products, the preceding paragraph shall be submitted (a), (b), (c), (d), (e), (f), (I) and (j) the provision of materials.
Apply for new products, the preceding paragraph shall be submitted (a), (b), and (iii), (vi), (IX) and (11) of material.
Applications for renewal of pesticide producing approval documents shall be submitted to the preceding paragraph (a), (b), and (iii), (vi), (VII) provision of material.
Packaging enterprises to apply for renewal of pesticide producing approval documents shall be submitted (a), (b), (c), (f), (g) and (11) of material.
14th production domestic production of the new drug and its preparation for the first time, you should apply for pesticide registration.
Article 15th enterprises shall, in accordance with the provisions article 13th, the materials submitted to the provincial economic and trade Management Department.
For application materials comply with the requirements of the enterprise, the provincial economic and trade Management Department shall within 45 working days to organize effectively review and product sampling and testing work. Check of the 16th up to the production, quality and safety within the experience industry experts.
Review shall be made out of the examination form for pesticide producing approval document production conditions.
Applications the company has some of the same dosage form products, check of the previous results are valid for 2 years.
17th provincial economic and trade Management Department should be qualified in the first instance before the 20th day of each month of the pesticide product applications production conditions and pesticide production approval file review form submitted to the State economic and Trade Commission. 18th state economic and Trade Commission within 45 working days complete review.
Through the review, approval documents to pesticide production, and announcements.
Supervision and administration of the fourth chapter 19th pesticide products must be marked with pesticide production approval number. Article 20th pesticides approved by the manufacturer for a period of 3 years.
3 years failed to achieve pesticide producing approval document or pesticide productions licenses of its eligibility for the approval void. Pesticide producing approval documents from the date of issuance, raw products is valid for 2 years (trial period), reissue of the original drug product is valid for 5 years, processing and compounding products are valid for 3 years, packaging the product is valid for 2 years.
Aside the approval document is overdue. Article 21st pesticide producing approval expires 3 months ago, companies can apply for renewal.
Change of the approval documents by 12th, 13, 14 the implementation of these measures. 22nd pesticide producing approval file name should make application to the provincial economic and trade authorities.
Provincial economic and trade Management Department application materials for examination and then reported to the approval of the State economic and Trade Commission.
Application for name change should submit the following documents: (a) pesticide producing approval to change the file name of the enterprise application, (ii) new and old business licenses or administration of industry and Commerce of the Enterprise name pre-approval notice issued by copy; (c) the approval of pesticide production files.
Article 23rd pesticide producing approval document is lost or destroyed due to unable to identify, and statement shall be promptly published in the main newspapers above the provincial level, and apply to the provincial economic and trade Management Department for a replacement. Provincial economic and trade Management Department application materials for examination and then reported to the State economic and Trade Commission.
State economic and Trade Commission approved, replacement pesticide producing approval documents.
Applying for the pesticide producing approval shall submit the following materials: (a) the approved pesticide production lost a replacement application form, (ii) published the newspaper declared the original and (iii) copy of business license.
24th province, the production of enterprise relocation, shall be reported to the provincial economic and trade authorities, and submitted to the State economic and Trade Commission records.
25th employed by the provincial economic and trade Management Department site review experts shall be submitted to the State economic and Trade Commission records.
Fifth chapter penalty provisions article 26th has one of the following conditions by the State economic and Trade Commission to revoke its pesticide production qualification: (a) the approved enterprises does not match the actual situation and the escalation of serious material, (ii) unauthorized changes to the contents, (iii) within three years without pesticide producing approval documents (or license).
27th article enterprise has following situation one of of, by national economic and Trade Commission collection or revoked its pesticide production approved file: (a) by review not meet sent card conditions of; (ii) continuous twice by provincial above supervision management sector checks, products quality not qualified of; (three) will pesticide production approved file transfer other enterprise using or for other products of; (four) in pesticide production approved file validity within, national decided stop production the products of; (five) producing fake pesticide of. Article 28th of pesticide product quality testing for breaches of the relevant provisions of deception, by the provincial economic and trade authorities or relevant departments of the State economic and Trade Commission drew attention to cancel its pesticide product quality inspection work eligibility.
29th national staff working in the pesticide producing approval, favoritism, dereliction of duty and abuse of power, shall be given administrative sanctions constitutes a crime, criminal responsibility shall be investigated according to law.
Sixth chapter supplementary articles article 30th pesticide manufacturer in these measures approved application form, review of pesticide producing approval document production table, project feasibility studies, pesticide producing approval documents lost to re-submit applications table and pesticide production approval to change the file format of the name of the enterprise application developed centrally by the State economic and Trade Commission.
31st pesticide manufacturers approved pesticide production and approval of the outcome of the People's Republic of China State economic and Trade Commission notice and the State economic and Trade Commission, published on the Internet.
32nd article this approach by the State economic and Trade Commission is responsible for the interpretation. 33rd article this way as of April 11, 2003.
Published by the former Ministry of chemical industry of the Ministry of chemical industry of implementation measures for the implementation of the pesticide management Ordinance repealed simultaneously.