论审前准备程序中几对关系问题的定位/陈冲

作者:法律资料网 时间:2024-06-24 21:58:59   浏览:8714   来源:法律资料网
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论审前准备程序中几对关系问题的定位

陈冲
(海门市人民法院)


摘要:审前准备程序的设置已成为各国民事诉讼立法的共同选择。我国尚未形成严格意义上的审前准备程序。构建审前准备程序应考虑三大关系问题的定位:(1)审前准备程序与庭审程序的关系;(2)法官诉讼指挥权与当事人权利的关系;(3)审前准备程序中法官介入度(基于公正与效率的关系)。
关键词:审前准备程序;民事诉讼;当事人

在民事诉讼制度中设置审前准备程序是大多数国家的共同选择,无论是英美法系国家还是大陆法系国家,民事诉讼法中均有关于审前准备程序的规定。我国民事诉讼法虽然在第一审普通程序中对审前准备作出了规定,但尚未形成严格意义上的审前准备程序,不具备审前准备程序所具有的确定争点、固定证据、促进和解的功能。设立审前准备程序的必要性已成为不争之论,现在的问题是如何设立审前准备程序。通过合理的审前准备程序的设置,实现两大目标:一是促进审理集中化,二是寻求替代性纠纷解决的可能 。审理准备程序的构建应考虑以下几对关系问题:(1)审前准备程序与庭审程序的关系;(2)法官诉讼指挥权与当事人权利的关系;(3)审前准备程序中法官介入度(基于公正与效率的关系)
一、审前准备程序和庭审程序
各国不管设置什么样的审前准备程序,其设立的主要目的都是为了庭审目标的实现 。基于程序公正和公开的要求,法律设定某种特定的形式和程序来约束法官的审理行为是必须的,这种形式和程序便是开庭审理。现代民事诉讼的基本法理是法官应当通过公开、对决的开庭审理获得有关案件的信息资料,并在此基础上形成案件当事人孰胜孰负的最终结论,即以庭审为中心。庭审需要当事人和法官对席、公开、直接、言词,故庭审应尽可能通过一次性集中审理而结束。审前准备程序基此产生了存在的必要。“完备的庭前准备+一次性集中审理”成为理想的纠纷解决模式。各国设立审前准备程序最初目的都是为了实现集中化审理,避免当事人的诉讼突袭,提高庭审的效率。
审前准备程序在自身的发展过程中,除了实现立法者在设立时确立的上述价值外,渐渐衍生出其具有削减纠纷的独特价值,通过当事人和解、简易判决、不应诉判决等审前排解纠纷的形式,使大量案件消减在庭前。使庭审程序真正适用于哪些存在实质性争点的案件。这可能是当初立法者没有明确确立的立法目的,在不经意间反而成为审前准备程序一个重要的功能和价值。审前准备程序的存在决不是程序的繁琐和复杂,而是程序公正和庭审效率的内在要求,审前准备程序具有的消减纠纷、排除庭审的功能,使“准备程序+一次性开庭审理”成为既确保程序公正,又保证诉讼效率的一种理想的诉讼模式,现代西方国家纷纷采用这一模式即说明了这一点。
民事诉讼活动的规律决定了审前准备程序存在的必然性,无论简单案件还是复杂案件,其进入民事诉讼便意味着审前准备程序的启动。所不同的只是:适用于简单民事案件的审前准备程序相对简单,而复杂民事案件所适用的审前准备程序则应当相对复杂而已。我们必须根据每一案件的复杂程度,在程序的设计上安排多种形式的审前准备程序,供当事人选择。那种认为简单民事案件可不适用审前准备程序直接实行“一步到庭”的观点,是对民事诉讼规律的漠视。
庭审程序对于案件审理具有重要意义,但并非每一案件都必经庭审程序。开庭审理的本质目的在于解决当事人的事实争议,因程序公正的需要,法官必须通过直接、言辞、公开的庭审方式听取。如果当事人对事实无争议或者自愿放弃庭审权利,案件就没有必要通过开庭方式加以解决。因此在程序的设计上,除了设置司法ADR等当事人庭前和解程序,还必须设置简易判决、不应诉判决等无须通过开庭解决案件的程序。西方国家纷纷改革民事诉讼程序,一定程度上就是改革审前准备程序,而审前准备程序的改革一定程度上就是如何发挥审前准备程序消减纠纷的功能,以适应民众诉求与司法资源不匹配的矛盾,以缓减司法迟延,司法ADR等由此应运而生。我们在改革审前准备程序的时候,必须注意到这一新动向,在保证当事人有被听审权利的同时,发挥审前准备程序消减纠纷的功能,节约国家宝贵的庭审资源,同时减轻当事人在诉讼阶段的投入。
二、法官诉讼指挥权与当事人权利的关系
“民事诉讼中法官与当事人相互之间的地位问题,是一切民事诉讼制度的中心问题” 。当事人权利与法官职权,是推动诉讼程序运行的动力,当事人权利与法官职权在程序控制中的动态均衡,决定了不同诉讼结构、模式及其功能的差异。审前准备程序作为诉讼程序中的重要一环,该阶段当事人权利与法官权力的不同配置,决定了不同的审前程序的模式。
以诉讼中法官职权和当事人诉权的不同作用来划分,根据民事诉讼法学者的研究,当今世界各国的民事诉讼制度可以类型化为当事人主义和职权主义两大基本模式。至于当事人主义和职权主义各自的构成特征和划分标准问题,学者们在认识上分歧很大。主要有两种划分标准。一种是根据程序主体对诉讼程序的控制权作划分,如果当事人掌握了诉讼程序运行的主导权,就称为当事人进行主义,反之,如果法官负责程序的运行,就称为职权进行主义。另一种是根据程序主体在形成审理对象上的不同作用作划分,如果认定案件事实的有关诉讼资料只能由当事人提出,就称之为辩论主义,反之,如果法官在收集证据及诉讼资料上拥有主导权,则称之为职权探知主义 。
根据当事人和法官在审前准备程序运作中的不同主导权来加以区分。英美法系审前准备程序采当事人进行主义,程序的运作由当事人主导,比较强调当事人的程序保障,法官在审前准备程序中相对消极。德国和日本等大陆法系国家审前准备程序采职权进行主义,法官被课以一种促进诉讼的义务,准备程序展开后的各种程序问题几乎都是由法官主动负责处理,法官甚至可以采取所有具有准备性质的诉讼指挥权,法官在案件早期阶段就积极介入,以求得案件的迅速解决。大陆法系的法国虽然在法律上赋予准备程序法官极大的诉讼指挥权,法官可以决定程序的启动、终结、确定当事人准备活动的期限,但大部分法官的职权活动都是依当事人的申请而启动的。两大法系各国民事诉讼目前都面临着如何公正、迅速、经济地解决民事纠纷的共同任务,因此各国都在加强法官职权作用。德、日等大陆法系国家通过法官依职权运作诉讼,是一种加强法官职权作用的做法。英美法系加强法官职权作用是另一种做法,并不是以法官职权运作程序的方式完全取代当事人运作诉讼,而是法官依职权对当事人运作的诉讼程序加强管理和监督。美国1983年修改的《联邦民事诉讼规则》将对发现程序的管理作为法官的职责,通过从发现程序开始时指定其结束期限,到实际展开过程中对种种程序问题的调整,法官开始日益普遍地发挥更为积极的管理职能。
根据当事人和法官在争点确定和诉讼资料的收集和提供上的不同主导权加以区分。无论是英美法系和大陆法系,就当事人决定事实争点并负责就争点提供证据而言,两大法系国家均采同一立场,采辩论主义。辩论主义体现了现代民事诉讼的基本法理。民事诉讼解决的是当事人间私权利的纠纷,在国家权力与当事人权利的关系上,国家权力要受当事人处分权的限制和约束,当事人不主张、不争执的事实,法院不能主动审判。在辩论主义的原则下,法院的审理范围被当事人所提出的主张所限制,禁止法官主动处理当事人双方都未提出的事实,在这个意义上,体现了当事人主张对法官行动的限制。就决定被审理的案件实体而言,两大法系当事人均处于支配诉讼的地位,实际均是当事人主义。
我国目前诉讼程序存在的主要问题不是诉讼迟延,而是法官的超职权作用。我国传统民事诉讼模式被认为是一种超职权主义模式,此模式片面地认为民事诉讼的本质是法院查清案情,解决纠纷,而忽略了当事人的程序主体地位,忽略了当事人的程序保障权。传统民事诉讼模式要求法官在审前准备阶段就必须对案件从实体和程序上予以全面审核,主动调查收集证据,要求在庭前把案件事实搞清,造成庭审形式化。民事审判方式改革已经认识到了这种超职权主义的危害,逐步弱化法官的职权。可以说,与世界各国不断强化法官职权的时代潮流相较而言,对于实行典型职权主义模式的我国,审前准备程序的改革恰恰是从英美法日等国的对岸出发,向他们迎面走去,需要弱化法官的职权 。审前准备程序的设置应以当事人行使诉权为本位,把诉权置于制约审判权的优先地位,而审判权的行使则以保障当事人诉权的充分实现为宗旨。就我国民事诉讼审前准备程序而言,就是要发挥当事人对争点形成和证据收集的决定作用,当事人没有提出的事实和证据法官不得主动依职权调查收集,当事人没有争议的事实,法官应当作为判决的事实依据,法官庭审中对事实和证据的审查范围也仅限于当事人提出的事实和证据。
同时,我国审前准备程序的构建也应尽量避免西方国家走过的弯路。法院除对当事人的争议拥有认定事实并依法作出裁判权外,还有一个主要职权,就是保障当事人进行的民事诉讼活动在法律规定的程序框架内顺利进行。我们在审前准备程序的设计时,除了保障当事人诉权的充分实现,还必须加强法官对审前准备程序的监督和管理,以促使审前准备程序发挥正当功能,防止当事人滥用诉权。我国民事诉讼立法主要来自大陆法系的德国法传统,我国审前准备程序的程序设计应借鉴德国和日本等国的经验。程序运作由法官依职权主导,但就争点的形成和证据资料的提供而言,应采辩论主义原则,由当事人进行主导。
三、审前准备程序中法官介入度(基于公正与效率的关系)
日本学者小岛武司在其《诉讼法系之再考察》中的总结报告中指出,民事诉讼的普遍理想在于实现妥当、公正、迅速、廉价的纠纷解决。妥当和公正代表了诉讼的正当性概念,迅速和廉价代表了诉讼的效率性要求。诉讼的正当和效率要求贯穿整个诉讼过程,两者有时能相互促进、相互补充,但有时又处于相互抵触、相互矛盾状态 。
在制度上以获得判决为目标的民事审判中,法官被要求必须主要通过开庭审理这种场合和形式来了解把握案情,这个规范性的要求主要来自于诉讼的正当性要求,而并非效率性要求。以典型的调解过程为例,调解者可以不拘形式地分别询问当事人,随时提示自己的解决方案并说服当事人接受这种解决方案,一定程度上要比公开对抗的庭审程序更为容易“吃透案情”,更具效率。但是为了使判决本身获得正当性,审判者的权力必须受到当事人诉权的制约,法官把握了解案情的过程在相当程度上必须按一定的程序要求,于特定的场合或形式下进行,这就是开庭审理。开庭审理不可能随时随地进行,如无必要的准备,往往会造成审理时间的拖延,庭审的内容也无法达到充实及集中的要求,大大影响庭审的功效。为了使法官真正通过有限的开庭审理来取得作为判决基础的诉讼资料,在开庭之前作一定的准备就成为必要。为防制当事人滥用审前准备程序,法官介入和控制审前准备程序便成为必要。如何合理界定法官在审前准备程序的介入度,既保证法官不至于在没有充分程序保障的情况下形成对案情的实体性判断,又保证为开庭作好准备,使庭审在有限的时间内能够有效进行,便成为准备程序设计和运作中最基本的问题之一。
我国传统“四步到庭”的弊端在于法官在庭前对案情介入过深,职权过大,容易形成思维定势,庭审成为法官验证先验观点的场所,使庭审形式化。而“直接开庭”、“一步到庭”的弊端却在于法官对案情丝毫不介入,法官与当事人间缺乏案件信息的必要交流,造成庭审的非效率化。
合理界定法官在审前准备程序的介入度,既保证审前准备程序有序进行,不致拖沓,又防止法官介入过深,导致思维定势。理想的制度设计是当事人在准备程序中,在实体和程序均已作好充分准备,而法官只能在程序上作好充分准备,而不能在实体上作好充分准备。法官在准备程序中只能从事准备行为,而不能从事审理行为。

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国家计委、财政部关于统一涉及境内外双重收费标准的通知

国家计委 财政部


国家计委、财政部关于统一涉及境内外双重收费标准的通知
国家计委 财政部
计价格(2001)523号




民政部、公安部、交通部、农业部,各省、自治区、直辖市计委、物价局、财政厅(
局):
根据建立社会主义市场经济体制的要求,为适应我国改革开放的新形势,国家计委、财政部对涉及境内外双重标准的有关收费进行了清理,决定以对内的收费标准为基准,实行统一的收费标准。现将有关具体事宜通知如下:
一、民政部(2项)
(一)婚姻登记收费。各级民政部门办理涉外(指中国公民与外国人或外籍华人,来华外国人之间)结婚或复婚登记;办理内地公民同港、澳、台、华侨结婚或复婚登记,以及办理离婚登记的收费标准,均按办理国内婚姻证书费及离婚、解除夫妻关系证明书收费标准收取。即结婚证书精装本每对9元,简装本每对2元,婚姻登记人可自愿选择;离婚、解除夫妻关系证明书的收费标准由省级物价部门会同同级财政部门按不高于婚姻登记收费标准的原则核定。
(二)收养登记费。民政部门为中国公民和外国人办理收养登记,均按对中国公民(包括港澳同胞、台湾居民、华侨)办理登记时的收费标准执行,即申请手续费每件20元、收养证工本费每证10元、收养登记调查费每件220元。
二、公安部(1项)
口岸以外边防检查、监护费。边防检查站应外国交通运输工具的负责人要求派员监护,或海事法院要求派员看押船只时,监护费按照国家正式对外开放口岸以外的地方对人员、交通运输工具进行检查、监护时的收费标准执行,即每派出一人工作一天收费50元人民币,工作半天收费30元人民币。
三、交通部(2项)
(一)港务监督管理费。1、船员适任证书申请考试发证费,对港澳船员和外国籍船员,均按原国家物价局、财政部《关于发布交通部水上安全监督收费项目及标准的通知》(〔1992〕价费字191号)中规定的对国内船员的收费标准执行;2、港澳船员和外国籍船员参加各项海员专业训练的考试费、证书费和翻译费,按〔1992〕价费字191号文件规定的国内海员专业训练的收费标准收取。
(二)危险货物安全装载证书费。港务监督签发的《危险货物安全装载证书》,无论任何国籍的船舶,均按现行对中国籍船舶的收费标准收取。即,500总吨以下船舶装载危险货物不足10吨,证书费20元;500总吨以下船舶装载危险货物超过10吨而不足50吨的,证书费60元,除此之外,正本每份100元,副本30元。
四、农业部(3项)
(一)海洋渔业船舶船员考试发证收费。对港澳台和外国籍渔船船员的所有考试发证,均按原国家物价局、财政部《关于发布农业系统行政事业性收费项目和标准的通知》(〔1992〕价费字452号)规定的对中国籍渔船船员的考试发证费收费标准执行。
(二)农药登记费。对境外企业的农药登记费标准,按对境内企业的收费标准收取。即,正式登记每个品种2500元,改变剂型(包括含量)登记每个品种1000元,变更使用范围登记每个品种100元,临时登记每个品种500元。
(三)肥料土壤调理剂、植物生产调节剂登记费。对境外厂商的肥料土壤调理剂、植物生产调节剂登记费标准按对境内厂商的收费标准执行。即,品种登记每类2000元,系列产品每个品种另收200元;变更登记中改变剂型每类1000元、改变含量每类300元、变更使用范围每类100元;登记证每证10元。
上述规定自文件发布之日起执行,过去与本通知不符的规定同时废止。


2001年4月5日

Provisions for Supervision of Drug Distribution

Commissioner of SFDA


Provisions for Supervision of Drug Distribution



(SFDA Decree No.26)

The Provisions for Supervision of Drug Distribution, adopted at the executive meeting of the State Food and Drug Administration on December 8, 2006, is hereby promulgated and shall go into effect as of May 1, 2007.


Shao Mingli
Commissioner of SFDA
January 31, 2007





Provisions for Supervision of Drug Distribution


Chapter I

Article 1 These Provisions are formulated for the purposes of strengthening drug supervision, regulating drug distribution order and ensuring drug quality in accordance with the Drug Administration Law of the People’s Republic of China (hereinafter referred to as Drug Administration Law), the Regulations for Implementation of the Drug Administration Law of the People’s Republic of China (hereinafter referred to as Regulations for Implementation of the Drug Administration Law) and the requirements of the relevant law and regulations.

Article 2 Any institutions or individuals engaged in the purchase, sales and supervision of drugs in the People’s Republic of China shall abide by the Provisions.

Article 3 Drug manufacturers, distributors and medical institutions shall be responsible for the quality of the drugs that they produce, distribute or use.

Drug manufacturers and distributors shall carry out reforms and innovations in the direction of pharmaceutical logistics provided that drug quality is assured.

Article 4 The drug regulatory departments encourage individuals and organizations to involve in the social supervision on drug distribution. Individuals or organizations have the right to report or accuse of any violation of the Provisions to the drug regulatory departments.


Chapter II Supervision on Drug Purchase and Sales by Manufacturers and Distributors

Article 5 Drug manufacturers or distributors shall be responsible for their drug purchases and sales, and liable for the purchases and sales activities of their sales staff or offices in the name of their enterprise.

Article 6 Drug manufacturers or distributors shall train their purchase and sales staff on drug related laws, regulations and professional knowledge, and establish training records including time, venue, content and trainees.

Article 7 Drug manufacturers or distributors shall strengthen the management of the sales staff and set up specific rules for their sales behaviors.

Article 8 Drug manufacturers or distributors shall not store or spot trade drugs on the premises not approved by the drug regulatory departments.

Article 9 Drug manufacturers shall sell drugs that they produce in the name of themselves, and shall not sell any drug that they produce for contract manufacturing or any drugs produced by others.

Article 10 Where a drug manufacturer or wholesaler sells drugs, it shall provide the following materials:
(1) Copies of the Drug Manufacturing Certificate or Drug Supply Certificate, stamped with the seal of the enterprise, and the business license;
(2) Copies of the approval documents for the drug to be sold, stamped with the seal of the enterprise ;
(3) For import drug sales, relevant proof documents should be provided in accordance with the related provisions of the State.

Where a drug manufacturer or wholesaler sends any of its sales staff to sell drugs, it shall, in addition to the materials prescribed in the previous paragraph of this Article, provide a copy of the authorization letter with the seal of the enterprise. The original authorization letter shall contain the authorized drugs, regions and time of validity for drug sales, indicate the identity card numbers of the sales staff, and be stamped with the enterprise seal and legal representative seal (or signature). The sales staff shall show the original authorization letter and identity card for the check by drug purchasers.

Article 11 Where a drug manufacturer or wholesaler sells drugs, it shall provide sales document indicating supplier’s name, drug name, manufacturer, batch number, quantity, price, etc.

Where a drug retailer sells drugs, it shall provide sales document indicating drug name, manufacturer, quantity, price, batch number, etc.

Article 12 Where a drug manufacturer or distributor purchases drugs, it shall request, examine and retain the relevant certificates and documents of the supplier in accordance with the requirements set forth in Article 10 of the Provisions, and request and retain sales document in accordance with the requirements set forth in Article 11 of the Provisions.

The documents retained by the drug manufacturer or distributor in accordance with the previous paragraph of this Article shall be kept till one year after the date of expiry, but not less than three years.

Article 13 Where a drug manufacturer or distributor knows or should know that any person without certificates produces or distributes drugs, it shall not provide the person with any drug.

Article 14 A drug manufacturer or distributor shall not provide premises, qualifications documents, notes, etc. as conveniences for others to distribute drugs in its own name.

Article 15 A drug manufacturer or distributor shall not spot trade drugs by means of exhibition, exposition, trade fair, commodity fair or product promotion event.

Article 16 A drug distributor shall not purchase or sell pharmaceutical preparations prepared by medical institutions.

Article 17 A drug distributor shall not change its distribution mode without approval of the drug regulatory department.

A drug distributor shall operate within the approved distribution scope in the Drug Supply Certificate.

Article 18 A drug retailer shall, pursuant to the requirements of drug classification regulations set forth by the State Food and Drug Administration, sell prescription drugs in the presence of prescriptions.

Any drug retailer selling prescription drugs or Class A non-prescription drugs shall, in the absence of its licensed pharmacists and other qualified pharmaceutical professionals, put up a public notice and stop selling prescription drugs and Class A non-prescription drugs.

Article 19 For drugs that need low-temperature or cold storage as specified in drug insert sheets, the drug manufacturer or distributor shall transport and store the drugs with low-temperature or cold storage facilities in accordance with the relevant provisions.

When finding any drug manufacturer or distributor violates the requirements in the previous paragraph of this article, the drug regulatory department shall seal up or seize the drugs concerned immediately and deal with the matter in accordance with law.

Article 20 A drug manufacturer or distributor shall not provide the public with prescription drug or Class A non-prescription drug by means of tie-in sale, offering free drugs in association with sales of drug or commodity sale, etc.

Article 21 A drug manufacturer or distributor shall not sell prescription drugs directly to the public by post or over internet.

Article 22 Any illegal purchase of drugs is prohibited.


Chapter III Supervision on Drug Purchase and Storage by Medical Institutions

Article 23 The pharmacy established by a medical institution shall have the premise, equipment, storage facilities, hygienic environment, and pharmaceutical professionals required for drug dispensing. It shall also have the drug quality control units or personnel, and establish a system for drug storage.

Article 24 Where a medical insititution purchases drugs, it shall request, examine and retain the relevant certificates, documents and notes of the supplier in accordance with the requirements set forth in Article 12 of the Provisions.

Article 25 Where a medical institution purchases drugs, it shall establish and apply an examination and acceptance system, and keep authentic and complete purchase records. Purchase records shall indicate the adopted name of the drug in China, manufacturer (for Chinese crude drug, the origin should be noted), dosage form, date of expiry, drug approval number, supplier, quantity, price and date of purchase.

Drug purchase records shall be kept till one year after the date of expiry, but not less than three years.

Article 26 A medical institution shall establish and apply a system for drug storage and maintenance, and take necessary measures to ensure drug quality, such as cold storage, protection against freeze and humidity, ventilation, moisture proof, protection from direct light and fire, and avoidance of insects and rodents.

A medical institution shall store drugs and non-drug products separately; Chinese crude drugs, prepared slices of Chinese crude drugs, pharmaceuticals, and traditional Chinese medicine preparations shall be stored separately by category.

Article 27 A medical institution or family planning technical service institution shall not directly provide drugs for patients without diagnosis or treatment.

Article 28 A medical institution shall not sell prescription drugs directly to the public by post or over internet.

Article 29 Where a medical institution purchases drugs via a centralized tendering, it shall comply with the relevant requirements of the Drug Administration Law, Regulations for Implementation of the Drug Administration Law and the Provisions.


Chapter IV Legal Liabilities

Article 30 In any of the following circumstances, the drug manufacturer or distributor shall be instructed to rectify within a time limit and given a disciplinary warning; and if the drug manufacturer or distributor fails to do so, it shall be fined not less than RMB 5,000 yuan but not more than RMB 20,000 yuan:
(1) any drug manufacturer or distributor in violation of Article 6 of the Provisions;
(2) any drug manufacturer or wholesaler in violation of the first paragraph of Article 11 of the Provisions;
(3) any drug manufacturer or distributor, in violation of Article 12 of the Provisions, failing to keep the relevant documents as required.

Article 31 Any drug manufacturer or distributor in violation of Article 7 of the Provisions shall be given a disciplinary warning and instructed to rectify within a time limit.

Article 32 In accordance with the provisions in Article 73 of the Drug Administration Law, in any of the following circumstances, the drugs illegally sold and the illegal gains therefrom shall be confiscated, and the drug manufacturer or distributor shall be fined not less than two times but not more than five times the value of the drugs illegally sold:
(1) any drug manufacturer or distributor, in violation of Article 8 of the Provisions, spot trading drugs on the premises not approved by the drug regulatory departments.
(2) any drug manufacturer in violation of Article 9 of the Provisions;
(3) any drug manufacturer or distributor in violation of Article 15 of the Provisions;
(4) any drug distributor in violation of Article 17 of the Provisions.

Article 33 Any drug manufacturer or distributor, in violation of Article 8 of the Provisions, storing drugs on the premises not approved by the drug regulatory departments,shall be punished pursuant to the provisions in Article 74 of the Regulations for Implementation of the Drug Administration Law.

Article 34 Any drug retailer in violation of the provisions in the second paragraph of Article 11 of the Provisions shall be instructed to rectify and given a disciplinary warning; and if the drug retailer fails to do so within a time limit, it shall be fined not more than RMB 500 yuan.

Article 35 Where a drug manufacturer or distributor, in violation of Article 13 of the Provisions, knows or should know that any person without certificates produces or distributes drugs, but still provide the person with drugs, they shall be given a disciplinary warning, instructed to rectify and fined not more than RMB 10,000 yuan. If the circumstances are serious, they shall be fined not less than RMB 10,000 yuan but not more than RMB 30,000 yuan.

Article 36 Drug manufacturers and distributors in violation of Article 14 of the Provisions shall be punished pursuant to the provisions in Article 82 of the Drug Administration Law.

Article 37 Where a drug distributor, in violation of Article 16 of the Provisions, purchases or sells pharmaceutical preparations dispensed by medical institutions, it shall be punished pursuant to the provisions in Article 80 of the Drug Administration Law.

Article 38 Any drug retailer in violation of the first paragraph of Article 18 of the Provisions shall be instructed to rectify within a time limit and given a disciplinary warning; if it fails to do so or the circumstances are serious, it shall be fined not more than RMB 1,000 yuan.

Where a drug retailer, in violation of the second paragraph of Article 18 of the Provisions, sells prescription drugs or Class A non-prescription drugs in absence of licensed pharmacists or other qualified pharmaceutical professionals, it shall be instructed to rectify within a time limit and given a disciplinary warning; if it fails to do so, it shall be fined not more than RMB 1,000 yuan.

Article 39 Where a drug manufacturer or wholesaler, in violation of Article 19 of the Provisions, fails to transport drugs under low-temperature or cold storage conditions as specified in insert sheets, it shall be given a disciplinary warning and instructed to rectify within a time limit; if it fails to do as instructed, it shall be fined not less than RMB 5,000 yuan but not more than RMB 20,000 yuan. Where the drugs concerned are legally proved to be counterfeit or substandard drugs, the drug manufacturer or wholesaler shall be punished in accordance with the relevant provisions of the Drug Administration Law.

Where a drug manufacturer or wholesaler, in violation of Article 19 of the Provisions, fails to store drugs under low-temperature or cold storage conditions as specified in insert sheets, it shall be punished pursuant to the provisions in Article 79 of the Drug Administration Law. Where the drugs concerned are legally proved to be counterfeit or substandard drugs, the drug manufacturer or wholesaler shall be punished in accordance with the relevant provisions of the Drug Administration Law.

Article 40 Any drug manufacturer or distributor in violation of Article 20 of the Provisions shall be instructed to rectify within a time limit and given a disciplinary warning; if the drug manufacturer or distributor fails to do so or the circumstances are serious, they shall be fined not more than two times the value of the free drugs offered, but not more than RMB 30,000 yuan.

Article 41 Any institution, in violation of Article 23 to Article 27 of the Provisions, shall be instructed to rectify within a time limit; if the circumstances are serious, it shall be announced.

Article 42 Where a drug manufacturer or distributor in violation of Article 21 of the Provisions or a medical institution in violation of Article 28 of the Provisions sells prescription drugs directly to the public by post, over internet, etc., they shall be instructed to rectify, given a disciplinary warning, and fined not more than two times the value of the drugs sold, but not more than RMB 30,000 yuan.

Article 43 Any illegal purchase of drugs, in violation of Article 22 of the Provisions, shall be punished pursuant to the provisions in Article 73 of the Drug Administration Law.

Article 44 Where a drug regulatory department or its staff that neglects its duty fails to stop or punish illegal activities that should be stopped or punished, administrative sanctions shall be imposed to the person directly in charge and other persons directly responsible. If a crime is constituted, criminal liabilities shall be investigated in accordance with law.


Chapter V Supplementary Provisions

Article 45 Spot trading of drugs in the Provisions refers to the activity that drug manufacturers, distributors or their appointed sales staff carry and sell drugs to unspecified objects on spot other than the premises approved by the drug regulatory departments.

Article 46 With respect to the supervision on the distribution of specially controlled drugs, vaccines, and military medicines, if otherwise provided by the relevant laws, regulations and provisions, they shall prevail.

Article 47 The Provisions shall come into force as of May 1, 2007. As of the date when the Provisions goes into effect, the Provisions for Supervision of Drug Distribution (Interim) (SFDA Decree No.7) implemented on August 1, 1999 shall be annulled therefrom.