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无直接证据的情况下如何审核认定相关证据/陈现杰

作者:法律资料网 时间:2024-07-09 11:02:25  浏览:8033   来源:法律资料网
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  这是一份有关劳动争议纠纷的判决,双方争议焦点在于上诉人西哈公司与被上诉人张德义之间是否存在事实劳动关系。双方均未能提举直接证据;而针对被上诉人提交的书证尤其是证人证言双方存在重大争议。因此,对相关证据的审核认定就成为分析判断本案事实劳动关系是否存在的关键。

  纵观本案判决,有如下几个突出的特点:

  第一,善用逻辑推理与经验法则对证据进行审核认定。

  运用逻辑推理和经验法则对证据进行审核认定,是《民事诉讼证据规定》司法解释第六十四条确立的法官依法独立审核认定证据的重要方法。但在实践中,如何正确地运用逻辑推理和经验法则来审核认定证据,一直是法官职业技能养成中的难点,从而绝大多数裁判文书中,都难得看到敢用并善用逻辑推理和经验法则来审核认定证据的范例。本案判决的一大亮点,就是自觉地采用逻辑推理和经验法则对证据进行审核认定,并在文书中进行了明确的表达。

  例如,上诉人二审中对被上诉人提供的证人林立的证言提出两点异议:一是收据上注明的收款人是“吴”,而林立证言是被上诉人张德义收的款;二是林立证言是2010年7月13日由张德义送钢琴到其家,而质保服务卡注明的送货时间是7月12日上午。上诉人认为,这两点说明林立的证言不可信,从而林立不具备证人资格,应当排除其证言。对此异议,判决中分析认为,开具收据通常是财务人员的职责,仅此不足以否定张德义系销售人员并在交易过程中代理收款的证言;质保卡上注明的送货时间与实际送货时间不一致,依据经验法则,亦是交易中可能发生之事。上诉人认可林立质保卡的真实性,但却不认可林立的证人身份,该抗辩显然自相矛盾,不足以否认林立的证人身份;而林立证言的真实性,亦得到其他证人证言等相关证据的印证,形成了有证明力的证据链,故法院予以采信。判决对上诉人主张林立证言与事实矛盾,从而其证人身份不成立、证言不具有关联性的抗辩,就是依据经验法则揭示出抗辩理由逻辑上不周延,不足以推翻证言,从而确认了证人证言具有证据能力及证言具有可采性。同样,对西哈公司主张王晓军与张德义为亲戚,两人身份证号码前六位一致,故王晓军的证言不应采信的抗辩,判决指出:西哈公司对其该项主张,未提举任何证据予以证实,仅据王晓军与张德义身份证号码前六位一致,并不能认定其具有亲戚关系。这也是依据经验法则和逻辑推理方法,对相关证言的证据效力作出认定。不仅对作为单一证据的证人证言如此,对各项证据的综合分析认定,该判决同样运用逻辑推理和经验法则,依法作出审核认定。

  判决是这样表述的:“本院从上述西哈公司认可真实性的王乐、张欣、林立、王晓军的四套质保服务卡和收据可以得出上述四人均从西哈公司购买了各自的钢琴,是西哈公司的顾客的结论。考虑到钢琴是价格昂贵的消费品且需要一定的销售专业知识,为此,顾客对接待并曾为其服务的销售人员通常有较深的印象,这是生活常识。所以,上述四位西哈公司的顾客中王乐、张欣出具书面证言证实通过张德义在西哈公司购买了各自的钢琴,并表达了不能到庭的理由;林立、王晓军出庭作证、接受了法官和双方当事人的询问,出庭证言均证实是通过张德义在西哈公司购买了各自的钢琴。上述书面证言、出庭证言与各自所提举的钢琴质保服务卡、收据一致吻合、形成证据链。从证明程度上讲,在西哈公司未提举有实质意义的证据予以反驳的情形下,张德义提举的上述一组证据构成证据链足以形成本院对张德义的主张确认为真的心证。”可以说,这是一段相当精彩的论述,对事实认定所遵循的经验法则,对形成法官内心确信的心证过程均作了清楚、明确、逻辑严谨的分析表述。

  第二,围绕证据认定的核心和实质确定证据的可采性。

  证据的审核认定,其核心就是确定证据是否具有证据能力(证据资格)和证据是否具有证明力以及证明力的大小,实务中对此概括为对证据“三性”即证据的合法性、真实性和相关性的审核判断。证据审核认定的实质,就是确认证据本身是否合法有效,其与待证事实是否具有关联。本案因当事人之间未签订书面劳动合同,对事实劳动关系是否存在没有直接证据予以证明,原告一方(被上诉人)只能通过提举证人证言和其他相关书证等间接证据来证明自己的主张,从而间接证据是否具有证据能力,是否具有关联性,就成为双方争议的焦点。

  上诉人认为证人林立不具有证人身份,理由是林立的证言与事实不符。从证据的审核认定来看,所谓不具有证人身份,也就是认为林立不具有证人资格或其证言不具有证据能力。法定证据制度通常会对证据能力作出规定,但在自由心证证据制度下通常不对证据能力作出规定,而代之以对证据形式的合法性和证据取得程序的合法性等进行审查,以确定其是否具有证据能力。上诉人并未就出庭作证之林立与质保卡持有人之林立是否同一人提出质疑,亦未就证人林立之心理、身理状况是否适宜作证提出质疑,而是以林立证言与事实不符,主张林立不具有证人资格,虽非无的放矢,但显然射错了靶子;而上诉人主张的两个事实细节,依据经验法则亦未能在逻辑上动摇证言的核心内容即张德义代表西哈公司进行钢琴销售这一关键事实;判决据此认为,上诉人的抗辩未触及到证言核心内容和证人资格,不影响法院对该证人证言的采信。这一分析过程,充分表现了本案判决在证据的审核认定方面遵循了证据规定相关规则,展示了法官在审核认定证据时应有的职业法律素养,对该案当事人也具有现身说法的重要意义。

  第三,心证公开,彰显司法公信。

  现代自由心证证据制度不同于传统自由心证制度的重要特征,就是其公开性与民主性。公开包括心证过程的公开和心证结果的公开。由于法官在对证据审核认定时是遵循良知与理性独立作出判断,因此,就需要其公开对证据进行审核认定时的内心确信形成过程以及内心确信的结果,使这种心证过程不再沦为神秘主义的职业游戏,不受任何监督。公开的目的就是要接受监督,使心证的自由始终以严格遵循法律规定为条件,是法律规定范围内的自由。同时,这种接受监督的自由也是司法公正得以彰显并取得司法公信力的必要前提。近年来的司法改革,已经触及到了公开是公信的命脉这一命题。最高人民法院在此前的三个五年改革纲要中对司法公开包括庭审公开,裁判文书公开和法官的心证公开这样几个环节也进行了有益的探索。但毋庸讳言,法官心证的公开在过去的改革实践中并未得到切实有效的推进,致使增强裁判文书的说理性等“阳光司法”理念流为一纸空言。本案裁判有意识地对运用逻辑推理和经验法则方法形成内心确信的过程作了充分的揭示和明确的表达,是对法官心证过程予以公开的自觉实践,也是推进“以公开促公正,以公开促公信”的司法改革进路的有益尝试。

  该判决对事实认定的最后部分是这样表述的:“张德义作为普通劳动者,在日常工作过程中留存或现阶段收集相关证据中,受其客观条件限制和劳动诉讼的特殊性限制,其提举上述这些证据以证明其主张,应视为其已经穷尽了举证手段。而西哈公司作为用人单位未提供证据以证明张德义非其职工,仅在张德义提举的证据如收据收款人表述、送货时间、股东名册、出庭证人的地址等枝节问题上辩解。因此,在西哈公司未能提供有效证据予以证实其抗辩理由的情况下,从举证证明的高度上讲,仅凭第一组王乐、张欣、林立、王晓军的四套质保服务卡和收据以及四份证言等证据所形成的链条就足以认定张德义与西哈公司存在事实劳动关系。”该项表述就是心证结论的公开。经过前述的对相关证人证言的逐个分析认定和综合分析认定,亦即心证过程的公开,该结论的作出给人以水到渠成之感,具有令人信服的无可辩驳的逻辑力量,充满了理性之美和逻辑之美。

如果我们回顾判决理由部分对每一份证据所涉两造观点的分析评论,一开始总是有扑朔迷离之感;而在逐一厘清的过程中,观点越来越清晰,事实也不断水落石出,最终完全浮出水面。这就是心证公开的魅力,也是理性与良知的魅力,更是公正、公开与公信的魅力!司法公正是司法公信的前提和基础,只有公正司法,才能有司法公信。然而司法公正也需要适当的途径予以彰显,看得见,听得懂,感受得到,同时也接受监督,才能取信于民,才能有司法公信。这个途径,就是司法公开。过去的司法改革为司法公开开拓了道路,但仍未免“犹抱琵琶半遮面”之憾。从每一个案环节着手来彰显公平正义,为重塑司法公信、重建法治信仰奠定基石,须进一步推进司法公开。这应当也可以从法官心证公开找到新的突破口,——这也就是本篇判决值得推介的意义之所在。

(作者简介:最高法院赔偿办副主任、法学博士)

  相关判决书

  北京市第一中级人民法院民事判决书   

  上诉人西哈乐器销售有限公司(以下简称西哈公司)因与被上诉人张德义劳动争议纠纷一案,不服北京市西城区人民法院(2012)西民初字第23841号民事判决,向本院提起上诉。本院于2013年1月18日受理后,依法由审判长王忠担任、代理审判员刘芳和徐钟佳组成合议庭,于同年3月12日公开开庭进行了审理。上诉人西哈公司的委托代理人唐涣,被上诉人张德义及其代理人郭兴昌到庭参加了诉讼。本案现已审理终结。

  张德义在一审中起诉称:其系农业户口,2010年6月14日入职西哈公司,担任销售总监,月均工资5000元,下发制现金发放,领工资时在财务处签字领取。因西哈公司未与其签订劳动合同,亦未为其缴纳社会保险,其于2012年1月20日离职,自此不再前往西哈公司上班。工作时间为每周休息一天,周六日、法定节假日不休息;工作内容为在前台接电话、销售钢琴、接待客户;工作地点在北京市西城区北三环中路甲29号。现不服仲裁裁决起诉至法院请求判令确认其与西哈公司2010年6月14日至2012 年1月20日期间存在劳动关系;西哈公司支付其2010年7月至2011年6月期间未签订劳动合同的二倍工资差额55 000元;西哈公司支付其2010年6月14日至2012年1月20日期间法定节假日加班工资6620元以及25%的经济补偿金1655元;西哈公司支付其2010年6月14日至2012年1月20日期间的养老、失业保险的补偿金(具体数额由法院酌定)。诉讼费由西哈公司承担。

  西哈公司在一审中答辩称:其与张德义之间不存在劳动关系,西哈公司没有张德义。张德义与其公司原股东伪造证据,报复其公司。不同意张德义的诉讼请求。

  一审法院经审理查明:张德义自述其于2010年6月14日入职西哈公司,担任销售总监,月工资5000元,因西哈公司未为其缴纳社会保险、未签订书面劳动合同,其于2012年1月20日离职。西哈公司不认可双方存在劳动关系。

  为证明双方劳动关系情况,张德义向法院出示了王乐的证言(未出庭质证)、王乐购买钢琴质量保修卡、张欣的证言(未出庭质证)、张欣购买钢琴质量保修卡、购买钢琴收据照片、刘昌升证言(未出庭质证)、林立证言(出庭作证)、王晓军证言(出庭作证)、侯伟证言(出庭作证)、薛瀛证言(出庭作证)、王淇证言(出庭作证)、照片。其中王乐、张欣、刘昌升、林立、王晓军的证人证言、质量保修卡显示,其均从西哈公司处购买钢琴,由张德义负责接待销售。购买钢琴质量保修卡均有西哈公司合同专用章、收据上均有西哈公司财务专用章。侯伟出庭作证时称其于2011年5月至2012年1月12日期间在西哈公司处担任销售工作,张德义任店长、总监,对其进行培训。同时,侯伟向法院提交了照片,表示其工作地点的玻璃上有“百汇钢琴城”字样,其与公司同事共同聚餐、工作。王淇出庭作证时表示其系北京君乐轩钢琴培训中心的业主,2010年5月开始与西哈公司合作至2012年4月,合同期间,均由张德义负责洽谈。王淇向法院出示的照片上显示有“君乐轩钢琴培训中心”与“百汇钢琴城”字样,同时还显示本案张德义在活动现场。薛瀛出庭作证时表示其原系西哈公司股东,2010年4月与现法定代表人成立西哈公司。2010年6月张德义在西哈公司工作,月均工资5000元,担任销售总监。

  针对张德义出示的证据,西哈公司表示对证人证言不认可,主张王乐、张欣、刘昌升未出庭质证;对张德义出示的收据、质保卡真实性予以认可,不认可关联性;对张德义出示照片的真实性不认可。此外,西哈公司向法院出示了股东会决议,该决议载明,同意聘任吴德雄为经理,同意选举薛瀛为监事,新股东签字处签有上述二人的名字,时间为2012年6月12日。薛瀛出庭作证时对该股东决议上签字的真实性认可。

  诉讼中,张德义未就其主张的存在法定节假日加班向法院出示证据。

  另查,张德义系农业户口,在职期间西哈公司未为张德义缴纳社会保险。张德义就与西哈公司的劳动争议向北京市西城区劳动争议仲裁委员会申请仲裁,该委作出京西劳仲字[2012]第1605号裁决书,裁决驳回张德义的申请请求,张德义在法定时限内向法院提起诉讼。

  上述事实,有王乐的证言、王乐购买钢琴质量保修卡、张欣的证言、张欣购买钢琴质量保修卡、购买钢琴收据照片、刘昌升证言、林立证言、王晓军证言、侯伟证言、薛瀛证言、王淇证言、照片、股东会决议及当事人的陈述等材料在案佐证。

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宁夏回族自治区财政监督条例

宁夏回族自治区人大常委会


宁夏回族自治区人民代表大会常务委员会公告

第一百零四号



《宁夏回族自治区财政监督条例》已由宁夏回族自治区第十届人民代表大会常务委员会第三十一次会议于2012年8月1日通过,现予公布,自2012年10月1日起施行。









宁夏回族自治区人民代表大会常务委员会

二〇一二年八月一日





宁夏回族自治区财政监督条例

(2012年8月1日宁夏回族自治区第十届人民代表大会常务委员会第三十一次会议通过)



第一章 总 则

第一条 为了加强财政监督工作,规范财政监督行为,维护财政经济秩序,根据有关法律、法规,结合自治区实际,制定本条例。

第二条 县级以上人民政府财政部门对国家机关、企业事业单位、社会团体,以及其他组织和个人(以下统称被监督对象)涉及财政、财务和会计等事项实施的核查、监控和处理等活动,适用本条例。

第三条 财政监督应当遵循客观、公正、公开的原则,坚持日常监督和专项监督相结合、源头监管和过程监督相结合。

第四条 县级以上人民政府应当建立健全财政、审计、税务等部门监督工作的协调机制,统筹安排监督事项。

第五条 开展财政监督,不得收取任何费用,所需经费列入本级财政预算。

第六条 任何单位和个人有权举报财政、财务、会计违法行为。

财政部门应当依法受理举报,并为举报人保密。



第二章 监督内容和权限

第七条 财政部门依法对下列事项实施监督:

(一)财政、税收法律、法规的执行情况;

(二)部门预算的编制、执行、调整和部门决算等情况;

(三)税收收入和非税收入的征收、管理情况;

(四)国库集中收付和预算单位银行账户的使用、管理情况;

(五)政府采购活动;

(六)行政、事业单位国有资产的管理情况;

(七)政府性债务资金的管理、使用情况;

(八)财务会计制度的执行情况;

(九)法律、法规规定的其他财政监督事项。

第八条 自治区人民政府财政部门依法对会计师事务所和资产评估机构的设立、执业情况实施监督。

第九条 财政部门按照财政管理体制和财务隶属关系对财政、财务事项实施监督,按照行政区域对会计事项实施监督。

上级财政部门可以对下级财政部门监督的重大事项直接实施监督,也可以将本级财政部门监督的事项委托下级财政部门实施监督。

第十条 财政部门实施监督,可以行使下列职权:

(一)要求被监督对象以及与被监督对象有经济业务往来的单位和个人,提供与监督事项有关的资料;

(二)调取、查阅、复制与监督事项有关的资料;

(三)经财政部门负责人批准,对可能灭失或者以后难以取得的证据,可以先行登记保存,并在七日内作出处理决定;

(四)经财政部门负责人批准,凭查询存款通知书,向金融机构查询被监督对象的单位存款;

(五)对财政违法行为,责令停止;拒不执行的,暂停拨付与财政违法行为直接有关的款项;已经拨付的,责令暂停使用;

(六)法律、法规规定的其他财政监督职权。

第十一条 财政部门及其监督检查人员应当遵守国家有关保密规定,不得泄漏国家秘密和被监督对象的商业秘密,不得将监督检查中取得的资料用于与监督检查工作无关的事项,不得利用职务之便谋取不正当利益。



第三章 监督方式和程序

第十二条 财政部门应当对被监督对象涉及财政、财务和会计的事项,通过核查、监控等方法,实施日常监督;对涉及经济社会发展、与人民群众生活密切相关的重大事项,实施专项监督。

第十三条 财政部门根据监督工作的需要,可以聘请具备相应资格的机构或者专业人员,协助开展财政监督工作。

财政部门进行监督检查时,应当出示行政执法证件,财政监督检查人员不得少于二人。

第十四条 财政监督检查人员与被监督检查单位、监督事项有利害关系的,应当回避。

被监督对象认为财政监督检查人员与监督事项有利害关系的,有权申请回避。

第十五条 被监督对象在接受财政监督检查时,应当真实、完整、及时的提供与财政监督有关的资料和情况,如实回答财政监督工作人员的询问,并在有关证明资料和笔录上签字、盖章,不得拒绝、阻挠。

第十六条 财政部门在监督检查结束前,应当书面征求被监督对象的意见。

被监督对象对财政监督的基本情况、认定的事实、发现的问题和相关证据、材料有异议的,应当自收到征求意见函之日起十日内,将书面意见送交财政部门。被监督对象未在规定期限内提出异议的,视为无异议。

财政部门应当自收到被监督对象的书面意见之日起十日内,对其进行复核,并将复核结果书面告知被监督对象。

第十七条 财政监督检查结束后,财政部门对有财政、财务、会计违法行为的,应当依法作出处理、处罚决定;对不属于财政部门职权范围的事项,应当按照法定程序移送有关机关处理。

财政部门依法作出处理、处罚决定的,应当按照法定期限送达被监督对象,并监督处理、处罚决定的执行情况。

第十八条 被监督对象对财政部门作出的处理、处罚决定的事实、理由以及依据,有权进行陈述和申辩;对符合听证条件的,有权要求听证。

第十九条 财政部门应当向本级人民政府和上一级财政部门报告监督情况,向有关部门通报或者向社会公布监督检查结论。



第四章 法律责任

第二十条 被监督对象有下列情形之一的,由财政部门责令改正,给予警告;直接负责的主管人员和其他直接责任人员属于国家工作人员的,由财政部门提出给予处分的建议;构成犯罪的,依法追究刑事责任:

(一)拒绝、阻挠财政部门依法实施监督的;

(二)拒绝提供或者不如实提供有关资料的;

(三)威胁、打击、报复财政监督工作人员、举报人和证人的;

(四)其他妨害财政监督的行为。

第二十一条 被监督对象对行政处罚决定不服的,可以依法申请行政复议或者提起行政诉讼。

第二十二条 财政部门工作人员在财政监督工作中有下列行为之一的,由所在单位或者上级主管部门、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处分;构成犯罪的,依法追究刑事责任:

(一)玩忽职守、滥用职权、徇私舞弊的;

(二)泄露在财政监督工作中知悉的国家秘密和商业秘密的;

(三)其他违法行为。



第五章 附 则

第二十三条 本条例自2012 年10月1日起施行。2002年1月4日宁夏回族自治区人民政府公布的《宁夏回族自治区财政监督办法》同时废止。






 
 

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.