PRC Regulations for the Administration of Industrial Product Production Permits

中华人民共和国工业产品生产许可证管理条例

These Regulations aim to ensure the quality and safety of important industrial products, to implement state industrial policy, and to promote the healthy and coordinated development of the socialist market economy.

Clp Reference: 5700/05.07.09 Promulgated: 2005-07-09 Effective: 2005-09-01

(Promulgated by the State Council on July 9 2005 and effective as of September 1 2005.)

(国务院于二零零五年七月九日公布,自二零零五年九月一日起施行。)

Order of the State Council No.440

国务院令第440号

PART ONE: GENERAL PROVISIONS

第一章总则

Article 1: These Regulations have been formulated in order to ensure the quality and safety of important industrial products that have a direct connection with public safety, human health and the safety of lives and property, to implement state industrial policy and to promote the healthy and coordinated development of the socialist market economy.

第一条为了保証直接关系公共安全、人体健康、生命财产安全的重要工业产品的质量安全,贯彻国家产业政策,促进社会主义市场经济健康、协调发展,制定本条例。

Article 2: The state subjects producers of the following important industrial products to a production permit system:

第二条国家对生产下列重要工业产品的企业实行生产许可証制度:

(1) processed foodstuffs that have a direct connection with human health, such as dairy products, meat products, beverages, rice, noodles, edible oils, alcoholic beverages, etc.;

(一)  乳制品、肉制品、饮料、米、面、食用油、酒类等直接关系人体健康的加工食品;

(2) products that may threaten the safety of the person or property, such as electric blankets, pressure cookers, gas water heaters, etc.;

(二)  电热毯、压力锅、燃气热水器等可能危及人身、财产安全的产品;

(3) products that have a connection with finance security and communications quality and security, such as fiscal cash registers, anti-counterfeiting bill scanners, satellite television broadcast ground receiving equipment, wireless radio and television transmission equipment, etc.;

(三)  税控收款机、防伪验钞仪、卫星电视广播地面接收设备、无线广播电视发射设备等关系金融安全和通信质量安全的产品;

(4) labour safety protection products, such as safety nets, safety helmets, construction fasteners, etc.;

(四)  安全网、安全帽、建筑扣件等保障劳动安全的产品;

(5) products that affect work safety and public safety, such as electric pylons, bridge supports, railway industrial products, hydraulic metal structures, hazardous chemicals and their packaging and containers, etc.; and

(五)  电力铁塔、桥梁支座、铁路工业产品、水工金属结构、危险化学品及其包装物、容器等影响生产安全、公共安全的产品;

(6) other products that laws and administrative regulations require be subject to production permits in accordance with these Regulations.

(六)  法律、行政法规要求依照本条例的规定实行生产许可証管理的其他产品。

Article 3: The Catalogue of industrial products subject to the state's production permit system (the Catalogue) shall be formulated by the State Council's industrial product production permit department together with the relevant departments of the State Council, which shall seek the opinions of consumers' associations and of the industry associations for the relevant products and, after the approval of the State Council, make such Catalogue public.

第三条国家实行生产许可証制度的工业产品目录(以下简称目录)由国务院工业产品生产许可証主管部门会同国务院有关部门制定,并征求消费者协会和相关产品行业协会的意见,报国务院批准后向社会公布。

Industrial products whose quality and safety can effectively be assured by the judgment of consumers themselves, enterprise self-regulation and market competition shall not be subject to the production permit system.

工业产品的质量安全通过消费者自我判断、企业自律和市场竞争能够有效保証的,不实行生产许可証制度。

Industrial products whose quality and safety can effectively be assured through a certification and accreditation system shall not be subject to the production permit system.

工业产品的质量安全通过认証认可制度能够有效保証的,不实行生产许可証制度。

As appropriate, the State Council's industrial product production permit department together with the relevant departments of the State Council shall evaluate, revise and progressively shorten the Catalogue and, after the approval of the State Council, make the same public.

国务院工业产品生产许可証主管部门会同国务院有关部门适时对目录进行评价、调整和逐步缩减,报国务院批准后向社会公布。

Article 4: These Regulations shall be complied with when producing, selling or, in the course of business activities, using products listed in the Catalogue in the People's Republic of China.

第四条在中华人民共和国境内生产、销售或者在经营活动中使用列入目录产品的,应当遵守本条例。

The administration of the import and export of products listed in the Catalogue shall be handled in accordance with laws, administrative regulations and relevant state provisions.

列入目录产品的进出口管理依照法律、行政法规和国家有关规定执行。

Article 5: No enterprise that has not obtained a production permit may produce the products listed in the Catalogue. No work unit or individual may sell or, in the course of business activities, use a product that is listed in the Catalogue and for which a production permit has not been obtained.

第五条任何企业未取得生产许可証不得生产列入目录的产品。任何单位和个人不得销售或者在经营活动中使用未取得生产许可証的列入目录的产品。

Article 6: The State Council's industrial product production permit department shall be responsible for the centralized administration of industrial product production permits nationwide in accordance with these Regulations and the competent local industrial product production permit departments at the county level and above shall be responsible for the administration of industrial product production permits within their jurisdictions.

第六条国务院工业产品生产许可証主管部门依照本条例负责全国工业产品生产许可証统一管理工作,县级以上地方工业产品生产许可証主管部门负责本行政区域内的工业产品生产许可証管理工作。

With respect to industrial products subject to the industrial product production permit system, the state shall place them in a single Catalogue, make them subject to uniform examination requirements, use uniform certificates and marks and subject them to uniform oversight.

国家对实行工业产品生产许可証制度的工业产品,统一目录,统一审查要求,统一証书标志,统一监督管理。

Article 7: The administration of industrial product production permits shall conform with the principles of objectivity, impartiality, transparency, lawful procedure, convenience to the public and high efficiency.

第七条工业产品生产许可証管理,应当遵循科学公正、公开透明、程序合法、便民高效的原则。

Article 8: Competent industrial product production permit departments at the county level and above and their personnel, as well as inspection institutions and their personnel, shall bear an obligation of maintaining the confidentiality of the state secrets and trade secrets that they learn.

第八条县级以上工业产品生产许可証主管部门及其人员、检验机构和检验人员,对所知悉的国家秘密和商业秘密负有保密义务。

PART TWO: APPLICATION AND ACCEPTANCE

第二章申请与受理

Article 9: To obtain a production permit, an enterprise shall satisfy the following conditions:

第九条企业取得生产许可証,应当符合下列条件:

(1) having a business licence;

(一)  有营业执照;

(2) having the professional technicians appropriate for the products that it is to produce;

(二)  有与所生产产品相适应的专业技朮人员;

(3) having the production resources and inspection and quarantine measures appropriate for the products that it is to produce;

(三)  有与所生产产品相适应的生产条件和检验检疫手段;

(4) having the technical documents and process documents appropriate for the products that it is to produce;

(四)  有与所生产产品相适应的技朮文件和工艺文件;

(5) having a sound and efficient quality control system and responsibility system;

(五)  有健全有效的质量管理制度和责任制度;

(6) having products that comply with the requirements of relevant state standards and industry standards and of assuring human health and the safety of the person and property; and

(六)  产品符合有关国家标准、行业标准以及保障人体健康和人身、财产安全的要求;

(7) complying with state industrial policy and not using obsolete processes that the state has ordered be eliminated and has prohibited the investment in and use of, not consuming large amounts of energy, not causing environmental pollution and not wasting resources.

(七)  符合国家产业政策的规定,不存在国家明令淘汰和禁止投资建设的落后工艺、高耗能、污染环境、浪费资源的情况。

If laws or administrative regulations have additional provisions, the enterprise shall also comply with such provisions.

法律、行政法规有其他规定的,还应当符合其规定。

Article 10: The State Council's industrial product production permit department shall formulate and issue the specific requirements for obtaining production permits for the products listed in the Catalogue based on the conditions set forth in Article 9 hereof and on the different characteristics of different industrial products. If special provisions on the specific requirements for the production permit for a product listed in the Catalogue need to be made, the State Council's industrial product production permit department shall formulate and issue the same together with relevant State Council departments.

第十条国务院工业产品生产许可証主管部门依照本条例第九条规定的条件,根据工业产品的不同特性,制定并发布取得列入目录产品生产许可証的具体要求;需要对列入目录产品生产许可証的具体要求作特殊规定的,应当会同国务院有关部门制定并发布。

When formulating the specific requirements for production permits for products listed in the Catalogue, the opinions of consumers' associations and of the industry associations for the relevant products shall be sought.

制定列入目录产品生产许可証的具体要求,应当征求消费者协会和相关产品行业协会的意见。

Article 11: If an enterprise wishes to produce a product listed in the Catalogue, it shall apply for and obtain a production permit from the competent industrial product production permit department of the province, autonomous region or municipality directly under the central government where the enterprise is located.

第十一条企业生产列入目录的产品,应当向企业所在地的省、自治区、直辖市工业产品生产许可証主管部门申请取得生产许可証。

If a product currently being produced by an enterprise is listed in the Catalogue, the enterprise shall apply for and obtain a production permit within the period of time specified by the State Council's industrial product production permit department.

企业正在生产的产品被列入目录的,应当在国务院工业产品生产许可証主管部门规定的时间内申请取得生产许可証。

An enterprise's application may be submitted by letter, telegram, telex, facsimile, electronic data interchange or e-mail, etc.

企业的申请可以通过信函、电报、电传、传真、电子数据交换和电子邮件等方式提出。

Article 12: Once the competent industrial product production permit department of a province, autonomous region or municipality directly under the central government receives an application from an enterprise, it shall handle the same in accordance with the relevant provisions of the PRC Administrative Licensing Law.

第十二条省、自治区、直辖市工业产品生产许可証主管部门收到企业的申请后,应当依照《中华人民共和国行政许可法》的有关规定办理。

Article 13: Neither the competent industrial product production permit department of the province, autonomous region or municipality directly under the central government or any other work unit may add any other conditions and restrict an enterprise from applying for a production permit.

第十三条省、自治区、直辖市工业产品生产许可証主管部门以及其他任何单位不得另行附加任何条件,限制企业申请取得生产许可証。

PART THREE: EXAMINATION AND DECISION

第三章审查与决定

Article 14: Once the competent industrial product production permit department of a province, autonomous region or municipality directly under the central government has accepted the application of an enterprise, it shall arrange for an examination of the enterprise to be conducted. If, pursuant to the specific requirements for a production permit for a product listed in the Catalogue, the State Council's industrial product production permit department is required to make the arrangements for conducting the examination of the enterprise, the competent industrial product production permit department of the province, autonomous region or municipality directly under the central government shall forward all of the application materials to the State Council's industrial product production permit department within five days of the date of acceptance of the enterprise's application.

第十四条省、自治区、直辖市工业产品生产许可証主管部门受理企业申请后,应当组织对企业进行审查。依照列入目录产品生产许可証的具体要求,应当由国务院工业产品生产许可証主管部门组织对企业进行审查的,省、自治区、直辖市工业产品生产许可証主管部门应当自受理企业申请之日起5日内将全部申请材料报送国务院工业产品生产许可証主管部门。

The examination of an enterprise shall consist of an on-the-spot check of the enterprise and an inspection of its products.

对企业的审查包括对企业的实地核查和对产品的检验。

Article 15: To conduct an on-the-spot check of an enterprise, the State Council's industrial product production permit department or the competent industrial product production permit department of the province, autonomous region or municipality directly under the central government shall assign two to four checkers, and the enterprise shall cooperate with them.

第十五条对企业进行实地核查,国务院工业产品生产许可証主管部门或者省、自治区、直辖市工业产品生产许可証主管部门应当指派2至4名核查人员,企业应当予以配合。

Article 16: Checkers shall have passed the evaluation organized by the State Council's industrial product production permit department and obtained a checker's permit, only after which may they engage in such checking work.

第十六条核查人员经国务院工业产品生产许可証主管部门组织考核合格,取得核查人员証书,方可从事相应的核查工作。

Article 17: The inspectors shall conduct the on-the-spot check of the enterprise based on the conditions set forth in Article 9 hereof and the specific requirements for the production permit for the product listed in the Catalogue.

第十七条核查人员依照本条例第九条规定的条件和列入目录产品生产许可証的具体要求对企业进行实地核查。

When conducting the on-the-spot check of the enterprise, the checkers may not deliberately make things difficult for the enterprise, or solicit or accept property from the enterprise or seek other improper benefits.

核查人员对企业进行实地核查,不得刁难企业,不得索取、收受企业的财物,不得谋取其他不当利益。

Article 18: The State Council's industrial product production permit department or the competent industrial product production permit department of the province, autonomous region or municipality directly under the central government shall inform the enterprise of the results of the on-the-spot check in writing within 30 days of the date of its acceptance of the application. If the enterprise fails the check, it shall be informed of the reason.

第十八条国务院工业产品生产许可証主管部门或者省、自治区、直辖市工业产品生产许可証主管部门应当自受理企业申请之日起30日内将对企业实地核查的结果书面告知企业。核查不合格的,应当说明理由。

Article 19: The product inspection shall be conducted promptly after an enterprise has passed the on-the-spot check. If samples need to be sent for inspection, the checkers shall seal the samples and inform the enterprise to send them to a qualified inspection institution within seven days. If an onsite inspection is required, the checkers shall notify the inspection institution to conduct the onsite inspection.

第十九条企业经实地核查合格的,应当及时进行产品检验。需要送样检验的,核查人员应当封存样品,并告知企业在7日内将该样品送达具有相应资质的检验机构。需要现场检验的,由核查人员通知检验机构进行现场检验。

Article 20: The inspection institution shall conduct the product inspection in accordance with relevant state standards and requirements and complete the same within the prescribed period of time.

第二十条检验机构应当依照国家有关标准、要求进行产品检验,在规定时间内完成检验工作。

The inspection institution and inspectors shall issue an objective and impartial inspection report in a timely manner. Once the inspection report has been signed by the inspectors, it shall be signed by the person in charge of the inspection institution. The inspection institution and inspectors shall be liable for the inspection report.

检验机构和检验人员应当客观、公正、及时地出具检验报告。检验报告经检验人员签字后,由检验机构负责人签署。检验机构和检验人员对检验报告负责。

Article 21: When conducting a product inspection, an inspection institution and its inspectors shall comply with the principles of good faith and making things convenient for the enterprise, provide the enterprise with a reliable and convenient inspection service and may not delay or deliberately make things difficult for the enterprise.

第二十一条检验机构和检验人员进行产品检验,应当遵循诚信原则和方便企业的原则,为企业提供可靠、便捷的检验服务,不得拖延,不得刁难企业。

Article 22: Inspection institutions and inspectors may not engage in production and sales activities relating to the products listed in the Catalogue that they inspect. They may not use their names to recommend a product listed in the Catalogue that they inspect or have the same manufactured or sold under their supervision.

第二十二条检验机构和检验人员不得从事与其检验的列入目录产品相关的生产、销售活动,不得以其名义推荐或者监制、监销其检验的列入目录产品。

Article 23: If the examination of an enterprise was arranged by the competent industrial product production permit department of a province, autonomous region or municipality directly under the central government, it shall forward its comments on the examination and all of the application materials to the State Council's industrial product production permit department after completing its examination.

第二十三条由省、自治区、直辖市工业产品生产许可証主管部门组织对企业进行审查的,省、自治区、直辖市工业产品生产许可証主管部门应当在完成审查后将审查意见和全部申请材料报送国务院工业产品生产许可証主管部门。

Article 24: The State Council's industrial product production permit department shall render its decision on whether or not to grant permission within 60 days of the date of accepting an enterprise's application. If it renders a decision granting permission, it shall issue the enterprise an industrial product production permit certificate (a Certificate) within 10 days of the date of rendering its decision. If it withholds permission, it shall notify the enterprise thereof in writing and explain the reason therefor.

第二十四条自受理企业申请之日起60日内,国务院工业产品生产许可証主管部门应当作出是否准予许可的决定,作出准予许可决定的,国务院工业产品生产许可証主管部门应当自作出决定之日起10日内向企业颁发工业产品生产许可証証书(以下简称许可証証书);作出不准予许可决定的,国务院工业产品生产许可証主管部门应当书面通知企业,并说明理由。

The time required by the inspection institution to conduct the product inspection shall not be counted as part of the aforementioned time limits.

检验机构进行产品检验所需时间不计入前款规定的期限。

The State Council's industrial product production permit department shall promptly inform such departments as the State Council's reform and development department, health department, industry and commerce department, etc. concerning its decision to grant permission for a relevant product.

国务院工业产品生产许可証主管部门应当将作出的相关产品准予许可的决定及时通报国务院发展改革部门、国务院卫生主管部门、国务院工商行政管理部门等有关部门。

Article 25: A production permit shall be valid for five years, with the exception of the production permits of foodstuff processing enterprises, which shall be valid for three years. If at the expiration of a production permit an enterprise wishes to continue production, it shall submit an application for a replacement certificate to the competent industrial product production permit department of the province, autonomous region or municipality directly under the central government where it is located six months prior to the expiration of the production permit. The State Council's industrial product production permit department or the competent industrial product production permit department of the province, autonomous region or municipality directly under the central government shall conduct an examination of the enterprise by the procedures specified in these Regulations.

第二十五条生产许可証有效期为5年,但是,食品加工企业生产许可証的有效期为3年。生产许可証有效期届满,企业继续生产的,应当在生产许可証有效期届满6个月前向所在地省、自治区、直辖市工业产品生产许可証主管部门提出换証申请。国务院工业产品生产许可証主管部门或者省、自治区、直辖市工业产品生产许可証主管部门应当依照本条例规定的程序对企业进行审查。

Article 26: If the standards and requirements for a product are changed during the term of a production permit, the State Council's industrial product production permit department or the competent industrial product production permit department of the province, autonomous region or municipality directly under the central government may arrange for new checks of the concerned enterprises and inspections of their products in accordance with these Regulations.

第二十六条在生产许可証有效期内,产品的有关标准、要求发生改变的,国务院工业产品生产许可証主管部门或者省、自治区、直辖市工业产品生产许可証主管部门可以依照本条例的规定重新组织核查和检验。

If an enterprise's production resources, inspection measures, production technology or process change during the term of its production permit, it shall promptly submit an application to the competent industrial product production permit department of the province, autonomous region or municipality directly under the central government where it is located, and the State Council's industrial product production permit department or the competent industrial product production permit department of the province, autonomous region or municipality directly under the central government shall arrange for a new check of the enterprise and inspection of its products in accordance with these Regulations.

在生产许可証有效期内,企业生产条件、检验手段、生产技朮或者工艺发生变化的,企业应当及时向所在地省、自治区、直辖市工业产品生产许可証主管部门提出申请,国务院工业产品生产许可証主管部门或者省、自治区、直辖市工业产品生产许可証主管部门应当依照本条例的规定重新组织核查和检验。

Article 27: If the State Council's industrial product production permit department considers it necessary to conduct a hearing on material permit particulars that involve the public interest, it shall make a public announcement to that effect and hold the hearing.

第二十七条国务院工业产品生产许可証主管部门认为需要听証的涉及公共利益的重大许可事项,应当向社会公告,并举行听証。

The decisions to grant permission rendered by the State Council's industrial product production permit department shall be made public.

国务院工业产品生产许可証主管部门作出的准予许可的决定应当向社会公布。

The State Council's industrial product production permit department and the competent industrial product production permit departments of the provinces, autonomous regions and municipalities directly under the central government shall place the relevant materials from the handling of production permit applications on file, and the public shall have the right to review the same.

国务院工业产品生产许可証主管部门和省、自治区、直辖市工业产品生产许可証主管部门应当将办理生产许可証的有关材料及时归档,公众有权查阅。

PART FOUR: CERTIFICATE AND MARK

第四章証书和标志

Article 28: Certificates shall consist of the original and duplicates. A Certificate shall state such relevant particulars as the enterprise's name, domicile, production address and product name, as well as the certificate number, issuance date and term.

第二十八条许可証証书分为正本和副本。许可証証书应当载明企业名称和住所、生产地址、产品名称、証书编号、发証日期、有效期等相关内容。

The format of the Certificates shall be prescribed by the State Council's industrial product production permit department.

许可証証书格式由国务院工业产品生产许可証主管部门规定。

Article 29: If the name of an enterprise changes, the enterprise shall submit an application to the competent industrial product production permit department of the province, autonomous region or municipality directly under the central government where it is located and carry out the procedures for the change.

第二十九条企业名称发生变化的,企业应当及时向企业所在地的省、自治区、直辖市工业产品生产许可証主管部门提出申请,办理变更手续。

Article 30: An enterprise shall duly keep its Certificate. If its Certificate is lost or damaged, it shall apply for a replacement. The competent industrial product production permit department of the province, autonomous region or municipality directly under the central government where the enterprise is located shall promptly accept the application and carry out the procedures for the replacement.

第三十条企业应当妥善保管许可証証书,许可証証书遗失或者损毁,应当申请补领,企业所在地的省、自治区、直辖市工业产品生产许可証主管部门应当及时受理申请,办理补领手续。

Article 31: If an enterprise ceases the production of a product listed in the Catalogue during the term of its production permit, it shall carry out the procedures to cancel such permit. If an enterprise fails to carry out the cancellation procedures, the State Council's industrial product production permit department shall cancel its production permit and announce the same.

第三十一条在生产许可証有效期内,企业不再从事列入目录产品的生产活动的,应当办理生产许可証注销手续。企业不办理生产许可証注销手续的,国务院工业产品生产许可証主管部门应当注销其生产许可証并向社会公告。

Article 32: The production permit marks and samples thereof shall be prescribed by the State Council's industrial product production permit department and made public.

第三十二条生产许可証的标志和式样由国务院工业产品生产许可証主管部门规定并公布。

Article 33: An enterprise shall mark its production permit mark and number on its products or their packaging and the instructions therefor.

第三十三条企业必须在其产品或者包装、说明书上标注生产许可証标志和编号。

For bare foodstuffs and other bare products on which, due to the characteristics of the product, it is difficult to place the mark, it is permissible not to indicate the product permit mark and number.

裸装食品和其他根据产品的特点难以标注标志的裸装产品,可以不标注生产许可証标志和编号。

Article 34: Enterprises that sell or, in the course of business activities, use products listed in the Catalogue shall verify the products' production permit marks and numbers.

第三十四条销售和在经营活动中使用列入目录产品的企业,应当查验产品的生产许可証标志和编号。

Article 35: No unit or individual may counterfeit or alter Certificates, production permit marks or numbers. An enterprise that has obtained a production permit may not lease, lend or otherwise transfer its Certificate or production permit mark.

第三十五条任何单位和个人不得伪造、变造许可証証书、生产许可証标志和编号。取得生产许可証的企业不得出租、出借或者以其他形式转让许可証証书和生产许可証标志。

PART FIVE: SUPERVISORY INSPECTIONS

第五章监督检查

Article 36: The State Council's industrial product production permit department and the competent local industrial product production permit departments at the county level and above shall be responsible for conducting in accordance with these Regulations supervisory inspections of enterprises that produce products listed in the Catalogue and the relevant activities of checkers, inspection institutions and their inspectors.

第三十六条国务院工业产品生产许可証主管部门和县级以上地方工业产品生产许可証主管部门依照本条例规定负责对生产列入目录产品的企业以及核查人员、检验机构及其检验人员的相关活动进行监督检查。

The State Council's industrial product production permit department shall supervise the production permit administration work of the competent local industrial product production permit departments at the county level and above.

国务院工业产品生产许可証主管部门对县级以上地方工业产品生产许可証主管部门的生产许可証管理工作进行监督。

Article 37: A competent industrial product production permit department at the county level or above shall investigate and handle a suspected violation of these Regulations based on the evidence of the suspected violation already obtained or a report and may exercise the following functions and powers while doing so:

第三十七条县级以上工业产品生产许可証主管部门根据已经取得的违法嫌疑証据或者举报,对涉嫌违反本条例的行为进行查处并可以行使下列职权:

(1) investigating and obtaining information on the suspected engagement in activities that violate these Regulations from the legal representative, principal person in charge and other related personnel of the relevant work unit that produces, sells or, in the course of business activities, uses a product listed in the Catalogue or of the inspection institution;

(一)  向有关生产、销售或者在经营活动中使用列入目录产品的单位和检验机构的法定代表人、主要负责人和其他有关人员调查、了解有关涉嫌从事违反本条例活动的情况;

(2) reviewing and reproducing the relevant contracts, invoices, accounts and other related information of the relevant work unit that produces, sells or, in the course of business activities, uses a product listed in the Catalogue or of the inspection institution;

(二)  查阅、复制有关生产、销售或者在经营活动中使用列入目录产品的单位和检验机构的有关合同、发票、账簿以及其他有关资料;

(3) placing under seal or impounding products listed in the Catalogue for which there is evidence that they have been produced, sold or, in the course of business activities, used in violation of these Regulations.

(三)  对有証据表明属于违反本条例生产、销售或者在经营活动中使用的列入目录产品予以查封或者扣押。

When an administration for industry and commerce at the county level or above investigates and handles a suspected violation of these Regulations in accordance with the law, it may also exercise the functions and powers set forth in the preceding paragraph.

县级以上工商行政管理部门依法对涉嫌违反本条例规定的行为进行查处时,也可以行使前款规定的职权。

Article 38: An enterprise shall ensure that the quality of its products is stable and compliant and shall regularly submit reports to the competent industrial product production permit department of the province, autonomous region or municipality directly under the central government. It shall be liable for the truthfulness of its reports.

第三十八条企业应当保証产品质量稳定合格,并定期向省、自治区、直辖市工业产品生产许可証主管部门提交报告。企业对报告的真实性负责。

Article 39: The State Council's industrial product production permit department and the competent local industrial product production permit departments at the county level and above shall conduct regular or ad hoc supervisory inspections of enterprises. If a product needs to be inspected, the same shall be handled in accordance with the relevant provisions of the PRC Product Quality Law.

第三十九条国务院工业产品生产许可証主管部门和县级以上地方工业产品生产许可証主管部门应当对企业实施定期或者不定期的监督检查。需要对产品进行检验的,应当依照《中华人民共和国产品质量法》的有关规定进行。

When a supervisory inspection or a product inspection is conducted, there shall be at least two members of the department's working personnel participating and they shall present their credentials.

实施监督检查或者对产品进行检验应当有2名以上工作人员参加并应当出示有效証件。

Article 40: When conducting a supervisory inspection, the State Council's industrial product production permit department or the competent local industrial product production permit department at the county level or above may not interfere with the normal production and business activities of the enterprise, may not solicit or accept property from the enterprise or seek other benefits.

第四十条国务院工业产品生产许可証主管部门和县级以上地方工业产品生产许可証主管部门对企业实施监督检查,不得妨碍企业的正常生产经营活动,不得索取或者收受企业的财物或者谋取其他利益。

Article 41: When conducting, in accordance with the law, a supervisory inspection, the State Council's industrial product production permit department or the competent local industrial product production permit department at the county level or above shall make a record of the supervisory inspection and the handling thereof, which shall be placed on file after it is signed by the persons who conducted the supervisory inspection. The public has the right to review such supervisory inspection records.

第四十一条国务院工业产品生产许可証主管部门和县级以上地方工业产品生产许可証主管部门依法对企业进行监督检查时,应当对监督检查的情况和处理结果予以记录,由监督检查人员签字后归档。公众有权查阅监督检查记录。

Article 42: The State Council's industrial product production permit department shall, through the review of inspection reports, comparison of inspection conclusions and other such means, conduct supervisory inspections to determine whether the inspection procedures and inspection reports of inspection institutions are objective, impartial and timely in nature.

第四十二条国务院工业产品生产许可証主管部门应当通过查阅检验报告、检验结论对比等方式,对检验机构的检验过程和检验报告是否客观、公正、及时进行监督检查。

Article 43: If a checker, an inspection institution or any of its inspectors deliberately makes things difficult for an enterprise, the enterprise has the right to make a complaint to the State Council's industrial product production permit department or the competent local industrial product production permit department at the county level or above. The State Council's industrial product production permit department or the competent local industrial product production permit department at the county level or above shall promptly investigate and handle the matter after receipt of the complaint.

第四十三条核查人员、检验机构及其检验人员刁难企业的,企业有权向国务院工业产品生产许可証主管部门和县级以上地方工业产品生产许可証主管部门投诉。国务院工业产品生产许可証主管部门和县级以上地方工业产品生产许可証主管部门接到投诉,应当及时进行调查处理。

Article 44: Any work unit or individual has the right to report violations of these Regulations to the State Council's industrial product production permit department or the competent local industrial product production permit department at the county level or above. The State Council's industrial product production permit department or the competent local industrial product production permit department at the county level or above shall promptly investigate and handle the matter after receipt of the report and ensure the confidentiality of the party that made the report.

第四十四条任何单位和个人对违反本条例的行为,有权向国务院工业产品生产许可証主管部门和县级以上地方工业产品生产许可証主管部门举报。国务院工业产品生产许可証主管部门和县级以上地方工业产品生产许可証主管部门接到举报,应当及时调查处理,并为举报人保密。

PART SIX: LEGAL LIABILITY

第六章法律责任

Article 45: If an enterprise produces a product listed in the Catalogue without applying for and obtaining a product permit in accordance with these Regulations, the competent industrial product production permit department shall order it to halt production, confiscate the illegally produced products and fine it not less than the monetary value and not more than three times the monetary value of the illegally produced products; if there is illegal income, such illegal income shall be confiscated; if a criminal offence is constituted, criminal liability shall be pursued in accordance with the law.

第四十五条企业未依照本条例规定申请取得生产许可証而擅自生产列入目录产品的,由工业产品生产许可証主管部门责令停止生产,没收违法生产的产品,处违法生产产品货值金额等值以上3倍以下的罚款;有违法所得的,没收违法所得;构成犯罪的,依法追究刑事责任。

Article 46: If the production resources, inspection measures, production technology or process of an enterprise that has obtained a production permit change and it fails to carry out the procedures for a new examination in accordance with these Regulations, it shall be ordered to halt production and sales, the products produced and to be sold shall be confiscated and it shall carry out the relevant procedures within a specified period of time. If it fails to carry out the procedures within the specified period of time, it shall be fined not more than three times the monetary value of the illegally produced and sold products (here and hereinafter including both those that have been sold and those not yet sold); if there is illegal income, such illegal income shall be confiscated; if a criminal offence is constituted, criminal liability shall be pursued in accordance with the law.

第四十六条取得生产许可証的企业生产条件、检验手段、生产技朮或者工艺发生变化,未依照本条例规定办理重新审查手续的,责令停止生产、销售,没收违法生产、销售的产品,并限期办理相关手续;逾期仍未办理的,处违法生产、销售产品(包括已售出和未售出的产品,下同)货值金额3倍以下的罚款;有违法所得的,没收违法所得;构成犯罪的,依法追究刑事责任。

If the name of an enterprise that has obtained a production permit changes and it fails to carry out the procedures for the change in accordance with these Regulations, it shall be ordered to carry out the relevant procedures within a specified period of time; if it fails to do so within the specified period of time, it shall be ordered to halt production and sale, the illegally produced and sold products shall be confiscated and it shall be fined not more than the monetary value of the illegally produced and sold products; if there is illegal income, such illegal income shall be confiscated.

取得生产许可証的企业名称发生变化,未依照本条例规定办理变更手续的,责令限期办理相关手续;逾期仍未办理的,责令停止生产、销售,没收违法生产、销售的产品,并处违法生产、销售产品货值金额等值以下的罚款;有违法所得的,没收违法所得。

Article 47: If an enterprise that has obtained a production permit fails to mark its production permit mark and number on its products, their packaging or their instructions in accordance with these Regulations, it shall be ordered to rectify the matter within a specified period of time. If it fails to rectify the matter within the specified period of time, it shall be fined not more than 30% of the monetary value of the illegally produced and sold products; if there is illegal income, such illegal income shall be confiscated; if the circumstances are serious, its production permit shall be revoked.

第四十七条取得生产许可証的企业未依照本条例规定在产品、包装或者说明书上标注生产许可証标志和编号的,责令限期改正;逾期仍未改正的,处违法生产、销售产品货值金额30%以下的罚款;有违法所得的,没收违法所得;情节严重的,吊销生产许可証。

Article 48: If products listed in the Catalogue for which a production permit has not been obtained are sold or, in the course of business activities, used, the perpetrator shall be ordered to rectify the matter and fined not less than Rmb50,000 and not more than Rmb200,000; if there is illegal income, such illegal income shall be confiscated; if a criminal offence is constituted, criminal liability shall be pursued in accordance with the law.

第四十八条销售或者在经营活动中使用未取得生产许可証的列入目录产品的,责令改正,处5万元以上20万元以下的罚款;有违法所得的,没收违法所得;构成犯罪的,依法追究刑事责任。

Article 49: If an enterprise that has obtained a production permit leases, lends or otherwise transfers its Certificate, production permit mark or number, it shall be ordered to rectify the matter within a specified period of time and fined not more than Rmb200,000; if the circumstances are serious, its production permit shall be revoked. If a party illegally accepts and uses the Certificate, production permit mark or number provided by another, it shall be ordered to halt production and sale, its illegally produced and sold products shall be confiscated and it shall be fined not less than the monetary value and not more than three times the monetary value of the illegally produced and sold products; if there is illegal income, such illegal income shall be confiscated; if a criminal offence is constituted, criminal liability shall be pursued in accordance with the law.

第四十九条取得生产许可証的企业出租、出借或者转让许可証証书、生产许可証标志和编号的,责令限期改正,处20万元以下的罚款;情节严重的,吊销生产许可証。违法接受并使用他人提供的许可証証书、生产许可証标志和编号的,责令停止生产、销售,没收违法生产、销售的产品,处违法生产、销售产品货值金额等值以上3倍以下的罚款;有违法所得的,没收违法所得;构成犯罪的,依法追究刑事责任。

Article 50: If sealed or impounded property is employed, replaced or relocated without authorization or damaged, the perpetrator shall be ordered to rectify the matter and fined not less than 5% and not more than 20% of the value of the property that was employed, replaced, relocated or damaged. If the perpetrator refuses to rectify the matter, it shall be fined not less than the value and not more than three times the value of the property that was employed, replaced, relocated or damaged.

第五十条擅自动用、调换、转移、损毁被查封、扣押财物的,责令改正,处被动用、调换、转移、损毁财物价值5%以上20%以下的罚款;拒不改正的,处被动用、调换、转移、损毁财物价值1倍以上3倍以下的罚款。

Article 51: If a Certificate, production permit mark or number is counterfeited or altered, the perpetrator shall be ordered to rectify the matter, its illegally produced and sold products shall be confiscated and it shall be fined not less than the monetary value and not more than three times the monetary value of the illegally produced and sold products; if there is illegal income, such illegal income shall be confiscated; if a criminal offence is constituted, criminal liability shall be pursued in accordance with the law.

第五十一条伪造、变造许可証証书、生产许可証标志和编号的,责令改正,没收违法生产、销售的产品,并处违法生产、销售产品货值金额等值以上3倍以下的罚款;有违法所得的,没收违法所得;构成犯罪的,依法追究刑事责任。

Article 52: If an enterprise obtains a production permit through fraud, bribery or other such improper means, the competent industrial product production permit department shall fine it not more than Rmb200,000, and handle the matter in accordance with the relevant provisions of the PRC Administrative Licensing Law.

第五十二条企业用欺骗、贿赂等不正当手段取得生产许可証的,由工业产品生产许可証主管部门处20万元以下的罚款,并依照《中华人民共和国行政许可法》的有关规定作出处理。

Article 53: If an enterprise that has obtained a production permit fails to submit regular reports to the competent industrial product production permit department of the province, autonomous region or municipality directly under the central government in accordance with these Regulations, such department shall order it to rectify the matter within a specified period of time; if it fails to rectify the matter within the specified period of time, it shall be fined not more than Rmb5,000.

第五十三条取得生产许可証的企业未依照本条例规定定期向省、自治区、直辖市工业产品生产许可証主管部门提交报告的,由省、自治区、直辖市工业产品生产许可証主管部门责令限期改正;逾期未改正的,处5000元以下的罚款。

Article 54: If in a state product quality supervisory spot check or provincial level supervisory spot check a product for which a production permit has been obtained is found to be non-compliant, the competent industrial product production permit department shall order rectification within a specified period of time. If the product is still found non-compliant in a recheck conducted at the end of the specified period of time, the producer's production permit shall be revoked.

第五十四条取得生产许可証的产品经产品质量国家监督抽查或者省级监督抽查不合格的,由工业产品生产许可証主管部门责令限期改正;到期复查仍不合格的,吊销生产许可証。

Article 55: If an enterprise has its production permit revoked, it may not apply for a production permit for the same product listed in the Catalogue for a period of three years.

第五十五条企业被吊销生产许可証的,在3年内不得再次申请同一列入目录产品的生产许可証。

Article 56: If an inspection institution responsible for the inspection of products for which permits are issued falsifies its inspection conclusions or issues false supporting documentation, it shall be ordered to rectify the matter by the competent industrial product production permit department, fined not less than Rmb50,000 and not more than Rmb200,000 and the person directly in charge and other persons directly responsible shall be fined not less than Rmb10,000 and not more than Rmb50,000; if there is illegal income, such illegal income shall be confiscated; if the circumstances are serious, the inspection institution's inspection qualifications shall be revoked; if a criminal offence is constituted, criminal liability shall be pursued in accordance with the law.

第五十六条承担发証产品检验工作的检验机构伪造检验结论或者出具虚假証明的,由工业产品生产许可証主管部门责令改正,对单位处5万元以上20万元以下的罚款,对直接负责的主管人员和其他直接责任人员处1万元以上5万元以下的罚款;有违法所得的,没收违法所得;情节严重的,撤销其检验资格;构成犯罪的,依法追究刑事责任。

Article 57: If an inspection institution or one of its inspectors engages in production and sales activities relating to the products listed in the Catalogue that it/he/she inspects, or if it/he/she uses its/his/her name to recommend a product listed in the Catalogue that it/he/she inspects or has such product manufactured or sold under its/his/her supervision, the competent industrial product production permit department shall fine it not less than Rmb20,000 and not more than Rmb100,000; if there is illegal income, such illegal income shall be confiscated; if the circumstances are serious, the inspection institution's or inspector's inspection qualifications shall be revoked.

第五十七条检验机构和检验人员从事与其检验的列入目录产品相关的生产、销售活动,或者以其名义推荐或者监制、监销其检验的列入目录产品的,由工业产品生产许可証主管部门处2万元以上10万元以下的罚款;有违法所得的,没收违法所得;情节严重的,撤销其检验资格。

Article 58: If an inspection institution or one of its inspectors deliberately makes things difficult for an enterprise during an inspection, the competent industrial product production permit department shall order it/him/her to rectify the matter. If it/he/she refuses to rectify the matter, its/his/her inspection qualifications shall be revoked.

第五十八条检验机构和检验人员利用检验工作刁难企业,由工业产品生产许可証主管部门责令改正;拒不改正的,撤销其检验资格。

Article 59: If a competent local industrial product production permit department at the county level or above violates these Regulations by making products other than those listed in the Catalogue subject to production permits, it shall be ordered to rectify the matter by the State Council's industrial product production permit department, or the State Council's industrial product production permit department shall revoke such act in accordance with the law.

第五十九条县级以上地方工业产品生产许可証主管部门违反本条例规定,对列入目录产品以外的工业产品设定生产许可的,由国务院工业产品生产许可証主管部门责令改正,或者依法予以撤销。

Article 60: If a competent industrial product production permit department or a member of its working personnel violates these Regulations by committing any of the acts set forth below, it/he/she shall be ordered to rectify the matter by the administrative authority or supervisory authority at the next higher level; if the circumstances are serious, the person directly in charge and other directly responsible persons shall be subjected to administrative penalties in accordance with the law:

第六十条工业产品生产许可証主管部门及其工作人员违反本条例的规定,有下列情形之一的,由其上级行政机关或者监察机关责令改正;情节严重的,对直接负责的主管人员和其他直接责任人员依法给予行政处分:

(1) it/he/she refuses to accept an application that complies with the conditions specified in these Regulations;

(一)  对符合本条例规定的条件的申请不予受理的;

(2) it fails to display on its office premises materials it is required to display in accordance with the law;

(二)  不在办公场所公示依法应当公示的材料的;

(3) in the course of accepting an application, conducting the examination or rendering the decision, it/he/she fails to perform its/his/her obligation to notify the applicant and/or materially interested party in accordance with the law;

(三)  在受理、审查、决定过程中,未向申请人、利害关系人履行法定告知义务的;

(4) if the application materials submitted by an applicant are incomplete or not in compliance with the statutory format, it/he/she fails to inform the applicant one time as to all the materials that are required or must be corrected;

(四)  申请人提交的申请材料不齐全、不符合法定形式,不一次告知申请人必须补正的全部内容的;

(5) it/he/she fails to explain, in accordance with the law, the reason for refusing to accept an application or refusing to grant a permit; or

(五)  未依法说明不受理申请或者不予许可的理由的;

(6) it fails to hold a hearing where such a hearing is required under these Regulations and the PRC Administrative Licensing Law.

(六)  依照本条例和《中华人民共和国行政许可法》应当举行听証而不举行听証的。

Article 61: If a member of the working personnel of a competent industrial product production permit department solicits or accepts another's property or seeks other benefits when carrying out the procedures for an industrial product production permit or when conducting a supervisory inspection and such act constitutes a criminal offence, his legal liability shall be pursued in accordance with the law; if a criminal offence is not constituted, he shall be subjected to administrative penalties in accordance with the law.

第六十一条工业产品生产许可証主管部门的工作人员办理工业产品生产许可証、实施监督检查,索取或者收受他人财物或者谋取其他利益,构成犯罪的,依法追究刑事责任;尚不构成犯罪的,依法给予行政处分。

Article 62: If a competent industrial product production permit department commits any of the acts set forth below, it shall be ordered to rectify the matter by its administrative authority, supervisory authority or relevant authority at the next higher level and matters shall be dealt with in accordance with the law; the person directly in charge and other directly responsible persons shall be subjected to the administrative penalties of demotion or dismissal in accordance with the law; if a criminal offence is constituted, criminal liability shall be pursued in accordance with the law:

第六十二条工业产品生产许可証主管部门有下列情形之一的,由其上级行政机关、监察机关或者有关机关责令改正,依法处理;对直接负责的主管人员和其他直接责任人员依法给予降级或者撤职的行政处分;构成犯罪的,依法追究刑事责任:

(1) it grants permission to an applicant that does not satisfy the conditions specified in these Regulations or renders a decision to grant permission ultra vires;

(一)  对不符合本条例规定条件的申请人准予许可或者超越法定职权作出准予许可决定的;

(2) it fails to grant permission to an applicant that satisfies the conditions specified in these Regulations or fails to render its decision to grant permission within the statutory period of time;

(二)  对符合本条例规定条件的申请人不予许可或者不在法定期限内作出准予许可决定的;

(3) it discovers that a producer is producing products listed in the Catalogue without having applied for and obtained a production permit in accordance with these Regulations, but fails to promptly investigate and handle the matter in accordance with the law;

(三)  发现未依照本条例规定申请取得生产许可証擅自生产列入目录产品,不及时依法查处的;

(4) it discovers that the inspection reports or inspection conclusions of an inspection institution seriously misstate the facts but fails to promptly investigate and handle the matter in accordance with the law; or

(四)  发现检验机构的检验报告、检验结论严重失实,不及时依法查处的;

(5) it violates laws, administrative regulations or these Regulations by the arbitrary charging of fees.

(五)  违反法律、行政法规或者本条例的规定,乱收费的。

Article 63: If a competent industrial product production permit department imposes permissions in violation of the law, harming the lawful rights and interests of concerned parties, it shall pay compensation in accordance with the PRC State Compensation Law.

第六十三条工业产品生产许可証主管部门违法实施许可,给当事人的合法权益造成损害的,应当依照《中华人民共和国国家赔偿法》的规定给予赔偿。

Article 64: If a competent industrial product production permit department fails to perform its supervisory duties in accordance with the law or is lax in its supervision, thereby causing serious consequences, it shall be ordered to rectify the matter by its administrative authority or supervisory authority at the next higher level and its person directly in charge and other directly responsible persons shall be subjected to administrative penalties in accordance with the law; if a criminal offence is constituted, criminal liability shall be pursued in accordance with the law.

第六十四条工业产品生产许可証主管部门不依法履行监督职责或者监督不力,造成严重后果的,由其上级行政机关或者监察机关责令改正,对直接负责的主管人员和其他直接责任人员依法给予行政处分;构成犯罪的,依法追究刑事责任。

Article 65: The decision of imposing the administrative punishment of revoking a production permit specified in these Regulations shall be made by the competent industrial product production permit department. The competent industrial product production permit department shall promptly notify such departments as the development and reform department, health department, administration for industry and commerce, etc. of its decisions to revoke production permits for relevant products.

第六十五条本条例规定的吊销生产许可証的行政处罚由工业产品生产许可証主管部门决定。工业产品生产许可証主管部门应当将作出的相关产品吊销生产许可証的行政处罚决定及时通报发展改革部门、卫生主管部门、工商行政管理部门等有关部门。

The administrative punishments specified in Articles 46 to 51 hereof shall be decided by the competent industrial product production permit department or administration for industry and commerce within the scopes of their authority specified by the State Council. If laws or administrative regulations provide otherwise concerning the government authority that is to exercise the power to impose administrative punishments, matters shall be handled in accordance with the relevant laws or administrative regulations.

本条例第四十六条至第五十一条规定的行政处罚由工业产品生产许可証主管部门或者工商行政管理部门依照国务院规定的职权范围决定。法律、行政法规对行使行政处罚权的机关另有规定的,依照有关法律、行政法规的规定执行。

PART SEVEN: SUPPLEMENTARY PROVISIONS

第七章附则

Article 66: If laws or administrative regulations provide otherwise in respect of the administration of industrial products, such provisions shall prevail.

第六十六条法律、行政法规对工业产品管理另有规定的,从其规定。

Article 67: The fee items charged by the State Council's industrial product production permit department and the competent industrial product production permit departments of the provinces, autonomous regions and municipalities directly under the central government in connection with carrying out the procedures for industrial product production permits shall be handled in accordance with the relevant provisions of the State Council's finance department and pricing department. The fee rates for industrial product production permits shall be handled in accordance with the relevant provisions of the State Council's pricing department and finance department and shall be publicly available and transparent. All fees charged must be paid into the state treasury and may not be retained, misappropriated, privately apportioned or privately apportioned in disguised form. The finance department may not return in any form or return in disguised form any of the fees charged.

第六十七条国务院工业产品生产许可証主管部门和省、自治区、直辖市工业产品生产许可証主管部门办理工业产品生产许可証的收费项目依照国务院财政部门、价格主管部门的有关规定执行,工业产品生产许可証的收费标准依照国务院价格主管部门、财政部门的有关规定执行,并应当公开透明;所收取的费用必须全部上缴国库,不得截留、挪用、私分或者变相私分。财政部门不得以任何形式向其返还或者变相返还所收取的费用。

Article 68: As required, the industrial product production permit departments of the provinces, autonomous regions and municipalities directly under the central government may be assigned responsibility for conducting the examinations and issuing the production permits for certain products listed in the Catalogue. The specific measures therefor shall be formulated separately by the State Council's industrial product production permit department.

第六十八条根据需要,省、自治区、直辖市工业产品生产许可証主管部门可以负责部分列入目录产品的生产许可証审查发証工作,具体办法由国务院工业产品生产许可証主管部门另行制定。

Article 69: If a family proprietor produces or sells products listed in the Catalogue, matters shall be handled in accordance with these Regulations.

第六十九条个体工商户生产或者销售列入目录产品的,依照本条例的规定执行。

Article 70: These Regulations shall be effective as of September 1 2005. The Trial Regulations for Industrial Product Production Permits promulgated by the State Council on April 7 1984 shall be repealed simultaneously.

clp reference:5700/05.07.09prc reference:国务院令第 440 号promulgated:2005-07-09effective:2005-09-01

第七十条本条例自2005年9月1日起施行。国务院1984年4月7日发布的《工业产品生产许可証试行条例》同时废止。

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