厦门市实施《中华人民共和国气象法》办法

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厦门市实施《中华人民共和国气象法》办法

福建省厦门市人民政府


厦门市实施《中华人民共和国气象法》办法

厦门市人民政府令第124号


  《厦门市实施〈中华人民共和国气象法〉办法》已经2007年5月9日市政府常务会议通过,现予发布,自2007年7月1日起施行。

                                  市长 刘赐贵

                                  二OO七年五月十四日

厦门市实施《中华人民共和国气象法》办法



  第一条 为了实施《中华人民共和国气象法》,结合本市实际,制定本办法。

  第二条 本市行政区域内的气象探测、预报、服务和气象灾害防御、气候资源利用、气象科学技术研究及其相关管理活动,适用本办法。

  第三条 气象事业是科技型、基础性公益事业。气象工作应当坚持公共气象、安全气象和资源气象的发展方向,将公益性气象服务放在首位,为经济建设、社会发展、人民生活提供气象服务。

  第四条 市、区人民政府应当加强对气象工作的领导和协调,将中小尺度区域气象观测系统、气象信息共享平台、气象预报预测系统、气象灾害预警应急体系及公共气象服务体系等地方气象事业,纳入本级国民经济和社会发展计划及财政预算,以保障其充分发挥为社会公众、政府决策和经济发展服务的功能。

  第五条 市、区气象主管机构在上级气象主管机构和本级人民政府的领导下,负责本行政区域内的气象工作。未设立气象主管机构的区,其气象工作由市气象主管机构负责。

  非气象主管机构所属的气象台站,应当接受市气象主管机构对其气象工作的指导、监督和行业管理。

  第六条 市、区人民政府应当按照法定标准分别划定市、区气象台站气象探测环境的保护范围,并纳入城市规划或者村镇规划。气象探测环境保护范围应当向社会公布。

  经依法批准迁移气象台站的,新旧气象台站气象对比观测时间不少于一年。在对比观测期内,旧气象台站保护范围内不得实施影响对比观测的拆迁、建设等活动。

  气象台站的气象探测环境不符合保护标准的,经市气象主管机构提出意见,由市、区人民政府组织有关部门进行治理。

  第七条 本市建立气象探测信息资料共享系统,由市气象主管机构负责维护和管理,并按照国家有关规定提供信息资料的共享、共用服务。

  气象主管机构以及其他从事气象探测的部门,在气象探测活动中应当遵守国家和省制定的气象技术标准、规范和规程,并按规定及时向气象探测信息资料共享系统汇交所获得的气象探测数据信息。

  本市气象探测信息资料提供和共享的具体办法,由市气象主管机构会同有关部门另行制定,报市人民政府批准后实施。

  第八条 任何组织和个人不得向未经批准的境外组织、机构和个人提供气象探测场所和气象资料,不得将涉及国家秘密的气象资料以任何方式提供给其他组织和个人或者予以发表。气象主管机构应当加强辖区内的涉外气象探测和气象资料的监督管理。

  第九条 气象主管机构所属的气象台站按照职责向社会发布公众气象预报,统一使用本市突发气象灾害预警信号向社会发布突发性、灾害性天气警报,并根据天气变化情况及时补充或订正。其他任何组织和个人不得向社会发布公众气象预报和突发性、灾害性天气警报。

  气象主管机构可以利用公共场所、主要道路的信息显示装置播发灾害性天气警报信息。鼓浪屿升旗山信号台接受市气象主管机构所属的气象台站提供的有关气象预报和突发性、灾害性天气警报,按照沿海港口信号规定显示相应的风情信号。机场、车站、码头、海滨浴场、旅游景点等公共场所的管理单位,应当及时向公众提示灾害性天气警报信息。

  第十条 气象主管机构及其所属的气象台站应当提高公众气象预报和突发性、灾害性天气警报的准确性、及时性和服务水平,为本市举办的重大活动提供定时、定点、定量的精细化气象预报。

  气象主管机构所属的气象台站发布台风、暴雨、大雾等重大灾害性天气警报时,应当及时报告本级人民政府和通报有关部门,并提出相应的防灾减灾建议。重大灾害性天气紧急警报发布时,市、区人民政府指定的广播、电视台站等媒体应当配合气象主管机构所属的气象台站采用连线直播、滚动播出等方式,及时通报台风、暴雨等重大灾害性天气的最新动向和未来趋势,提供公共气象服务。

  气象主管机构应当采取电话查询、互联网查询、手机短信等方式方便公众了解气象信息。适时召开新闻发布会,通报公众关心的气象信息。

  第十一条 气象台站应当结合本地天气气候特点,及时提供下列专业、专项气象服务:

  (一)根据种植业、养殖业等农业生产需要,对高温、寒潮、干旱、暴雨、连阴雨、台风、大风等进行实时监测、分析、预报,为农业部门指导农业生产提供服务;

  (二)根据防汛防灾需要,对台风、大风、暴雨等进行实时监测、分析、预报,为防汛防灾指挥机构指挥防御和抢险提供服务;

  (三)根据港口、海上作业、海上运输的需要,对台风、大风、大雾等进行实时监测、分析、预报,为港口、海事、渔业等部门落实安全生产工作提供服务;

  (四)根据道路交通、旅游的需要,对高温、大雾、台风、暴雨、大风、雷电等进行实时监测、分析、预报,为公安、交通、市政、旅游等部门做好安全防护和疏导指引工作提供服务;

  (五)根据厦金航线等海峡两岸航运的需要,开展海峡两岸航运气象保障专项预报,为交通、港口等部门做好安全保障工作提供服务;

  (六)根据水、电、燃气供应的季节特点,对持续高温、持续低温等进行实时监测、分析、预报,为供水、供电、供气单位制定保障供应的应对措施提供服务;

  (七)根据森林防火工作的需要,对森林火险气象等级进行实时监测、分析、预报,为森林防火部门做好野外用火监管提供服务;

  (八)其他需要提供的专业、专项气象服务。

  第十二条 广播、电视、报刊、互联网、电信、移动通信以及其他面向社会公众的媒体,传播本市气象预报和突发性、灾害性天气警报时,必须使用气象主管机构所属的气象台站提供的适时气象信息,并标明提供气象信息的气象台站名称和发布时间。媒体不得擅自更改气象信息,不得刊播气象台站没有对外公开使用的气象信息,不得以任何形式转播、转载其他来源的气象预报。

  第十三条 市、区人民政府根据人工影响天气工作的需要,建立统一协调的指挥和作业体系,建设人工影响天气作业基地,开发空中云水资源。

  第十四条 组织实施人工增雨等人工影响天气作业,应当具备适宜的天气条件,全面考虑实际需要和作业效果。市有关行政部门或者区人民政府,根据下列需要及时提出实施人工影响天气作业的建议报市人民政府决定:

  (一)发生森林火灾或者气象台站发布森林火险警报;

  (二)出现干旱征兆,且预计旱情将会加重;

  (三)水工程蓄水严重不足;

  (四)出现大气、水源等突发性公共污染事件;

  (五)城市空气质量严重下降影响市民正常生活;

  (六)其他需要实施人工影响天气作业的情况。

  第十五条 本市人工影响天气工作,由市气象主管机构在市人民政府领导和协调下组织和实施。飞行管制、公安、水利、农业、林业等相关部门以及区人民政府,应当按照各自职责,配合市气象主管机构做好人工影响天气工作。

  实施人工影响天气作业使用的炮弹、火箭弹,由军队、当地人民武装部协助存储;需要调运的,由有关部门依照国家有关武器装备、爆炸物品管理的法律、法规的规定办理手续。

  实施人工影响天气作业,应当执行国家规定的作业规范和操作规程,保证作业安全。实施人工影响天气作业过程中发生意外事故的,由市、区人民政府及其有关部门依法处理。

  第十六条 按照国家有关规定应当进行防雷装置设计审核的建(构)筑物或者设施,建设单位应当委托施工图审查机构进行防雷装置施工图设计审查。施工图审查机构应当在做出审查结论后3日内将防雷装置施工图及其审查结论报气象主管机构。气象主管机构应当加强防雷装置设计审查的监督检查。

  前款规定的建(构)筑物或者设施竣工时,建设单位应当组织气象主管机构参加竣工验收。气象主管机构应当按照国家有关规定对防雷装置作出竣工验收决定。防雷装置经验收合格的,颁发防雷装置验收合格证。建设单位应当将防雷装置验收合格证报建设行政主管部门备案。防雷装置竣工未经验收合格的,不得投入使用。

  第十七条 投入使用后的防雷装置,应当按照国家有关规定由具有相应资质的机构定期进行检测,出具检测报告;对检测不合格的,应当按检测报告提出的意见进行整改。

  防雷装置所有者或其委托的管理单位应当做好防雷装置的日常检查、维护工作,发现防雷装置存在隐患时,应当及时采取措施进行处理。物业管理企业或其他管理单位发现防雷装置受损的,应当及时报修。

  气象主管机构应当无偿提供雷电防护技术咨询服务。

  第十八条 在厦门高崎国际机场的跑道两端延长线各15公里、两侧宽度各6公里围成的净空保护区域内,禁止升放气球;但用于气象业务探测、科研试验等国家另有规定的除外。

  在机场净空保护区域外施放气球的,应当按照国家有关规定报市气象主管机构及有关部门批准。

  第十九条 市气象主管机构负责组织气候资源综合调查,并进行气候监测、分析、评价及气候变化的研究,按规定发布气候状况公报。

  城市规划、重点建设工程、重大区域性经济开发、农业综合开发、云水资源、风能、太阳能开发利用等项目的气候可行性论证,由市气象主管机构组织。具有大气环境影响评价资格的组织在本市进行工程建设项目大气环境影响评价时,应当使用市气象主管机构提供或者经其审查的气象资料。

  第二十条 违反本办法规定,由气象主管机构责令停止违法行为,按照有关法律、法规、规章的规定给予行政处罚。

  第二十一条 气象主管机构及其所属气象台站的工作人员玩忽职守、滥用职权、徇私舞弊的,依法给予行政处分;构成犯罪的,依法追究刑事责任。

  第二十二条 本办法自2007年7月1日起施行。




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  为了促进刑事案件的快速解决,合理配置司法资源、追求公正与效率的平衡和协调。我国新刑事诉讼法也对刑事简易程序进行了大幅度的修订,在有限的司法资源配置条件下通过程序的简化让效率和公正这两个司法活动追求的价值目标达到了动态的平衡。简易程序是一把双刃剑,在获得减少讼累的优惠后,会付出丧失权利和利益的代价。简易只是简化审判程序,而不是简化被告人权益,如何将这种损害降到最低,以实现简易程序的效率价值,同时又不贬损司法的终极价值公正,平衡司法权利高效行使与被告人权益缺位之间的失衡,是刑事诉讼需要解决的问题。

  一、刑事简易程序对被告人权益的损害

  我国基于国家本位主义的司法理念衍生出的重视打击犯罪,忽视人权保障的传统根深蒂固,虽然这种传统正在我国社会主义法治国家的建设进程中逐渐转变,新刑诉法也对保障犯罪嫌疑人、被告人的权益作出了有益的尝试和探索。但是要达到刑事程序法律发达的西方国家的标准,还有很长的路要走,我国在人权保障功能上的先天不足,也同样体现在了刑事简易程序的设置中。

  纵观各国的刑事简易程序,其共同特点是都诞生于社会关系日趋复杂,犯罪率持续上升,司法资源相对匮乏的背景之下,出发点都是提高诉讼效率、缓解司法机关办案压力、加速惩罚和教育罪犯、尽快恢复被犯罪行为侵害的社会秩序。然而,程序的简化是一把双刃剑,在简化繁琐的案件审理的同时,也对刑事诉讼主体特别是被告人的权利和利益造成了损害,削弱了对被告人的权益保障。虽然刑事简易程序的优点众多,然而瑜不掩瑕,在对被告人适用简易程序审理案件的同时,被告人也相应地丧失了一部分权利和利益。

  (一)被告人程序选择权的缺失

  依照上文的分析,刑事简易程序的启动权和变更权都不在被告人手里,他仅有效力非常弱的否决权。即便如此,否决权还受到以下一些因素的影响。

  1、知悉权

  这里的知悉权,不是指被告人在诉讼过程中享有的知道和了解自己被指控的犯罪事实和公诉机关据以指控的证据的权利,而主要是指被告人对于简易程序的适用条件和适用流程的知悉。根据新刑诉法的规定,适用简易程序的条件是被告人承认自己所犯罪行,对指控的犯罪事实没有异议,并且对于适用简易程序没有异议。由此可以把被告人简易程序知悉权分为以下两个部分:被告人对于简易程序的适用条件的知悉,被告人对于简易程序的适用流程的知悉。

  首先,简易程序的适用条件是被告人认罪,对指控的犯罪事实没有异议。按照该条件,被告人对适用条件的知悉也当然包括被告人知悉案件情况也即公诉机关指控的犯罪事实和据以指控的证据,否则也谈不上对指控的犯罪事实没有异议。案件审理阶段被告人知悉案件情况的起点,是在送达起诉书副本时,公诉机关会将被告人所犯罪行和定罪量刑的证据在起诉书中予以载明。然而,被告人此时只是知悉被指控的犯罪事实,对于证据,因为一一列明证据既不现实、也无必要,被告人实际上对于指控自己的证据仅仅知道证据名称,而且对于被告人个人来讲,想要查阅案卷的资料,了解证据的全貌是近乎不可能的事情,此时需要有辩护人的介入才能使被告人对于证据的内容有一个清晰且完整的认识。 而有相当数量的被告人没有委托辩护人,也不具备法律援助的条件,对于他们,谈不上知悉指控的犯罪事实和证据,也就谈不上承认所犯罪行,更遑论让其同意适用简易程序。

  其次,简易程序的适用流程包括送达、法庭调查、法庭辩论、最后陈述等各阶段,还包括对于审理期限的规定,这些流程在简易程序中都进行了一定的简化和省略,有些简化和省略有利于被告人,有些不利于被告人。即使被告人是多次参与庭审的“常客”,也不能保证被告人对于审理的流程烂熟于心。要让被告人充分了解每个环节,知道自己参与的庭审简化和省略了哪些部分,以及这些部分的利弊,对于文化程度不同的被告人来说,势必会有很大的差异。而且这种认知的差异可能会滋生诱导性选择,比如,若司法机关想适用简易程序审理,只需告知被告人简易程序的优点比如审理期限较短,而故意忽略对于简易程序缺点如简化辩护权等的告知,那么被告人为了早日结案,在不知道其他权益受损的情况下,会有很大的倾向同意适用简易程序,反之亦然。

  最后,讯问被告人是否同意适用简易程序一般是在送达起诉书副本的时候,被告人甫一接到起诉书副本,尚未知悉简易程序的适用条件,也未知悉简易程序的适用流程,就被讯问是否适用简易程序,没有留足充分的权衡和考虑时间,此时的被告人大多是一头雾水,很容易出现信口选择或者诱导性选择的情况。待到司法机关依照简易程序进行开庭,被告人又因为考虑之后提出异议而变更为普通程序重新审理,徒然浪费司法资源,对控辩审三方都是不小的损失。

  2、异议权

  此处的异议权,不是指被告人对简易程序选择的异议,因为被告人对简易程序的否决权,就是以异议的形式出现的,被告人只要对指控的犯罪事实提出异议,或者对适用简易程序提出异议,都会终止简易程序的适用。

  影响被告人否决权的异议权,在这里主要是指被告人对指控的犯罪事实的异议。被告人对适用简易程序提出异议,可以看成是对简易程序否决权的直接行使,而被告人对指控的犯罪事实提出异议,就可以看做是对简易程序否决权的间接行使。法律仅规定对犯罪事实提出异议就不得适用简易程序,但未规定何种程度的异议可以否决简易程序的适用。

  司法实践中就可能出现这种情况,一旦被告人对犯罪事实或者指控的证据提出意见,审判人员迫于办案质量的压力,无论其意见是否属于不宜适用简易程序的异议,都一概变更为普通程序重新审理。虽然这样有助于查明案情,但是却在一定程度上否定了被告人经过权衡利弊后作出的适用简易程序的选择。

  应该说,这种细致审理的精神是值得肯定的,但是被告人以牺牲一定的权益想获取的利益被轻易剥夺了。实际上一些被告人对犯罪事实和证据提出意见是其辩护权的表现,他有权对犯罪的事实和证据发表意见,提出自己的不同意见,既不能否认其认罪态度,也不能认为其否认简易程序的适用。再者,即使变更为普通程序,被告人受到的心理压力也会大增,再次开庭的时候被告人因为顾忌庭审再有任何变动,可能会从庭审到宣判都噤若寒蝉甚至唯唯诺诺,等于从心理上施加压力让被告人不敢轻易行使辩护权,这样反而不容易查清案件事实,难以做到正确定罪量刑,也不利于让被告人服判息诉和改造罪犯。

  (二)被告人辩护权的缺失

  被告人享有的辩护权,是基本人权原则在刑事审判中的重要体现。刑事诉讼中的辩护权主要有两种类型:被告人自己行使辩护权,即自行辩护,以及由律师或其他辩护人代为行使辩护权,即委托辩护。刑事简易程序由于简化了相关的诉讼环节,被告人无法获得普通程序对辩护权那样全面的保障,这体现在以下方面:

  1、自行辩护的弊端

  “一个人代理自己,将自己作为当事人是趋向于愚蠢的做法”。 刑事诉讼活动是一个法律适用的过程,需要具备专业的法律知识和法律素养的人来参与,被告人自行代理,在一定程度上削弱了自己的辩护说服力。

  这是因为,被告人作为刑事案件的被指控者,公诉机关的所有不利指控都加诸其身,被告人为了应对这种不利指控,难免会丧失理性思考的能力,提出的辩护意见可能虽然以情感人,但却不是符合刑事诉讼的辩护要求,即使被告人声泪俱下,也难以左右作为中立裁判者的法官的立场,他们只能根据查明的事实和证据依法判处。如果不能将自己当成一个旁观者,在既有的指控事实和证据中找到对自己有利的材料进而作出有证据支持的辩护,自行辩护就难免流于形式。

  在刑事普通程序中,因为被告人对审理的所有流程都要经历,他的辩护即使再蹩脚,但是在各个阶段都可以行使自己的辩护权,虽然不能保证充分行使,但是至少能够在一定程度上将自己的意见和异议向裁判者提出。而在简易程序中,只有最后陈述是不可省略的,然而在最后陈述中,被告人对于案件事实的意见已经微乎其微了,更多地是表达能够对自己从轻处罚的近乎恳求的希望。简易程序简化了法庭调查和法庭辩论等阶段,被告人更多地是作为一个沉默的倾听者,很少能发表辩护意见。

  再者,被告人的文化程度参差不齐,在司法实践中,适用简易程序审理的案件的被告人普遍存在着文化程度不高的现象,在对指控的犯罪事实和证据的理解上也存在着偏差,不能正确认识自己所犯的罪行,不能完全理解指控的证据证明的内容,甚至不理解自己的行为为什么是犯罪。新刑诉法规定,被告人是聋、盲、哑人,或者是尚未完全丧失辨认或者控制自己能力的精神病人的不适用简易程序,这样规定的出发点是人道主义,而文化程度偏低的被告人,在庭审中的表现可能还不如这些有限制的被告人。

  2、委托辩护的弊端

  “认真负责、积极热心的辩护律师是自由的最后堡垒——是抵抗气势汹汹的政府欺负他的子民的最后一道防线。” 根据以上对自行辩护的分析,可以看出被告人如果获得具有专业知识的法律人特别是律师的帮助,对被告人的辩护权的保障会产生质的飞跃。 尽管如此,在刑事简易程序中委托辩护也存在着一些不足之处。

Provisions for Import and Export of Anabolic Agents and Peptide Hormones (Interim)

State Food and Drug Administration General Administration of Customs of the People’s Republic of China


Provisions for Import and Export of Anabolic Agents and Peptide Hormones (Interim)




(SFDA Decree No. 25)

The Provisions for Import and Export of Anabolic Agents and Peptide Hormones (Interim), adopted by the State Food and Drug Administration, the General Administration of Customs of the People’s Republic of China and the General Administration of Sport of China, is hereby promulgated in the decree sequence number of the State Food and Drug Administration and shall come into force as of September 1, 2006.


Shao Mingli
Commissioner
State Food and Drug Administration

Mou Xinsheng
Minister
General Administration of Customs of the People’s Republic of China

Liu Peng
Minister
General Administration of Sport of China
July 28, 2006





Provisions for Import and Export of Anabolic Agents and Peptide Hormones (Interim)


Article 1 The Provisions are formulated with a view to standardizing the administration of import and export of anabolic agents and peptide hormones in accordance with the Drug Administration Law of the People’s Republic of China, Customs Law of People's Republic of China, Anti-doping Regulations and other relevant laws and administrative regulations.

Article 2 The State adopts license control on the import and export of anabolic agents and peptide hormones.

Article 3 The importer shall apply for the importation of anabolic agents and peptide hormones to the State Food and Drug Administration.

Article 4 For the importation of anabolic agents and peptide hormones for medical purpose, the importers shall submit the following materials:
(1) Application Form for Drug Import;
(2) Copy of the purchasing contract or order form;
(3) Copy of the Import Drug License (or the Pharmaceutical Product License) (original or duplicate);
(4) Copy of the Drug Supply Certificate, Business License for Enterprises as a Legal Person, Qualification Certificate for Import and Export Enterprise (or Foreign Trade Operator Filing and Registration Form) and Organization Code Certificate of the importer; to import drug substance and intermediate preparations including preparations to be repackaged in China for their own needs, drug manufacturers shall submit copies of the Drug Manufacturing Certificate, Corporate Business License and Organization Code Certificate;
(5) Where holders of the Import Drug License (or the Pharmaceutical Product License) entrust other companies to export their drugs, they shall provide the authorization letter for export.

All copies mentioned above should be stamped with the official seal of the importer.

Article 5 For the importation of anabolic agents and peptide hormones for teaching and scientific research purposes, the importers shall submit the following materials:
(1) Application Form for Drug Import;
(2) Copy of the purchasing contract or order form;
(3) Certificates of legitimate qualifications of users in China, calculation basis for the quantity of the drug in use and letter of guarantee issued by the user for legitimate use and management of the drug;
(4) Approval documents for relevant scientific research projects or approval documents of relevant competent authority;
(5) Where entrusted by users for importation, importers shall provide copies of the authorization agreement, the Business License for Enterprises as a Legal Person, Qualification Certificate for Import and Export Enterprise (or Foreign Trade Operator Filing and Registration Form) and Organization Code Certificate of the importers.

All copies mentioned above should be stamped with the official seal of the importer.

Article 6 Where a enterprise in China entrusted by an overseas enterprise for contract manufacturing needs to import anabolic agents and peptide hormones, it shall provide materials required in Items (1), (3) and (5) of Paragraph 1 of Article 5, in addition, official documents to prove recorded by the local (food and) drug regulatory department of the province, autonomous region or municipality directly under the Central Government.

All copies mentioned above should be stamped with the official seal of the importer.

Article 7 The State Food and Drug Administration shall decide whether or not to approve the import within 15 working days after receiving the application for import and the relevant materials. Where the application is approved, the State Food and Drug Administration shall issue the Import License for the drug; where the application is not approved, the State Food and Drug Administration shall give reasons in writing.

Article 8 The importer may declare to the customs of the ports where drug importation is permitted upon presenting the Import License for the drug issued by the State Food and Drug Administration. The customs shall clear the drug in the presence of the Import License for the drug.
The Drug Import Note is not required for import of anabolic agents and peptide hormones.

Article 9 To import anabolic agents and peptide hormones including those sold in China for the first time for medical purpose, the importer shall fill in the Import Drug Clearance Form timely after going through the import formalities and submit the following materials in duplicate to the (food and) drug regulatory department where the port of entry is located, upon presenting the original Import Drug License (or the Pharmaceutical Product License) (original or duplicate) and the original Import License for the drug, to apply for the Notice of Import Drug Port Test:
(1) Copies of the Import Drug License (or Pharmaceutical Product License) (original or duplicate) and the Import License for the drug;
(2) Copies of the Drug Manufacturing Certificate or Drug Supply Certificate, and Copy of the Business License for Enterprises as a Legal Person.
(3) Copy of the certificate of origin;
(4) Copy of the purchasing contract;
(5) Copies of packing list, bill of lading and freight invoice;
(6) Copy of the certificate of analysis;
(7) Format of drug insert sheet, package and label (except for drug substance and intermediate preparation);

All copies mentioned above should be stamped with the official seal of the importer.

Article 10 After checking the received Import Drug Clearance Form and relevant materials, the port (food and) drug regulatory department shall return the original Import Drug License (or Pharmaceutical Product License) (original or duplicate) and the original Import License for the drug to the importer, and send the Notice of Import Drug Port Test, along with a copy of the dossier as prescribed in Article 9 of the Provisions, to the port drug testing institute on the same day.

After receiving the Notice of Import Drug Port Test, the port drug testing institute shall contact the importer within two working days and conduct sampling on the storage site. Upon the completion of the sampling, the mark “sampled” shall be stamped on the back of the first page of the original Import License for the drug, with the seal of sampling institute affixed.

Article 11 Anabolic agents and peptide hormones imported for teaching and research purposes or for the domestic manufacturing contracted by overseas enterprises are exempted from testing.

Article 12 The port (food and) drug regulatory department shall report timely to the State Food and Drug Administration in any of the following circumstances:
(1) The port (food and) drug regulatory department refuses to issue the Notice of Import Drug Port Test in accordance with the provisions in Article 17 of the Provisions for Import Drug (Decree No. 4 of the State Food and Drug Administration and the General Administration of Customs);
(2) The port (food and) drug testing institute refuses the sampling in accordance with the requirements in Article 25 of the Provisions for Import Drug.

The port (food and) drug regulatory department shall take mandatory administrative measures to seal up or seize all the imported drugs within the situations prescribed in the previous paragraph. It shall make the decision of allowing shipping back within seven days from the date of the seal-up or seizure, and inform the importer of applying for the Export License for the drug according to the export procedures for anabolic agents and peptide hormones prescribed in the Provisions and return all the import drugs to the original exporting country.

Where the importer fails to respond or make clear its intention to ship back the drugs within ten days after being informed of the decision, the sealed up or seized drugs shall be destroyed under the supervision of the port (food and) drug regulatory department.

Article 13 For imported anabolic agents and peptide hormones out of specifications upon testing by the port drug testing institute, the importer shall provide a detailed report about the distribution and use of all the imported drugs to the port (food and) drug regulatory department where the importer is located within two days after receiving the Import Drug Test Report.

After receiving the Import Drug Test Report, the port (food and) drug regulatory departments shall take mandatory administrative measures to timely seal up or seize all the drugs and, within seven days, decide whether or not to place the case on file.

Where the importer fails to apply for a retesting within the specified timeline or the result of the retesting is still out of specifications, the port (food and) drug regulatory department shall make the decision of allowing shipping back and notify the importer to apply for the Export License for the drug according to export procedures for anabolic agents and peptide hormones prescribed in the Provisions to return all the imported drugs to the original exporting country. Where the importer fails to respond or make clear its intention to ship back the drugs within ten days from the date of receiving the decision, the drugs shall be destroyed under the supervision of the port (food and) drug regulatory department.

Where the result of retesting is in compliance with the specifications, the port (food and) drug regulatory department shall remove the mandatory administrative measures of seal-up and seizure.

The port (food and) drug regulatory department shall handle the case according to the provisions in Paragraph 2, Paragraph 3 and Paragraph 4 of this Article and report the result to the State Food and Drug Administration, and, at the same time, notify the (food and) drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government as well as other port (food and) drug regulatory departments.

Article 14 Where domestic drug manufacturers, distributors and medical institutions purchase imported anabolic agents and peptide hormones, the supplier shall provide copies of the Import Drug License (or Pharmaceutical Product License), the Import License for the drug and the Import Drug Test Report, and affix its official seal to the abovementioned copies.

Article 15 The exporter shall apply for exportation of anabolic agents and peptide hormones to the (food and) drug regulatory department of the province, autonomous region or municipality directly under the Central Government, where it is located, and submit the following materials:
(1) Application Form for Drug Export;
(2) Original import permit (or its copy with notarization) provided by the drug regulatory authority of the importing country or region.
If the importing country or region has no license system in the importation of anabolic agents and peptide hormones, the exporter shall provide the official document (original) of the drug regulatory authority of the importing country or region to prove that the import of the drugs of this type is exempted from the import permit, along with one of the following documents:
a. Original official document (or its copy with notarization) granting import provided by the drug regulatory authority of the importing country or region;
b. Certificates of legitimate qualifications of importers and original supporting document (or its copy with notarization) proving legitimate use of the drug;
(3) Copy of the purchasing contract or order form (except for manufacturers that export their own products);
(4) Copy of the export contract or order form;
(5) Where the export drug is an approved one produced by a domestic manufacturer, the Drug Manufacturing Certificate and Business License for Enterprises as a Legal Person of the manufacturer and a copy of the approval document of the drug shall be provided;
Where the export drug is produced by a domestic enterprise under contract of an overseas enterprise, the exporter shall provide a copy of the official document to prove recorded by the local (food and) drug regulatory department of the province, autonomous region and municipality directly under the Central Government.
(6) Copies of the Business License for Enterprises as a Legal Person, Qualification Certificate for Import and Export Enterprise (or Foreign Trade Operator Filing and Registration Form) and Organization Code Certificate of the exporter.

All copies mentioned above should be stamped with the official seal of the exporter.

Article 16 Where the drugs are to be shipped back in accordance with the requirements in Article 12 and Article 13 of the Provisions, the exporter shall provide the following materials to apply for the Export License for the drug:
(1) Documents proving the request for return of goods made by the original exporter of the exporting country;
(2) Import License for the drug.

Article 17 The (food and) drug regulatory department of the province, autonomous region and municipality directly under the Central Government shall decide whether or not to approve the export within 15 working days after receiving the export application and relevant materials.

Where the application is approved, the regulatory department shall issue the Export License for the drug; where the application is not approved, the regulatory department shall give reasons in writing.

Where the Export License for the drug is applied for in accordance with the requirements in Article 16 of the Provisions, the issuing authority shall mark “return of the original goods” on the Export License for the drug.

Article 18 The exporter may go through the customs formalities upon presenting the Export License for the drug issued by the (food and) drug regulatory department of the province, autonomous region and municipality directly under the Central Government. The customs shall clear the drug in the presence of the Export License for the drug.

Article 19 The importer and exporter shall provide one more sheet of customs declaration form and apply for sign-back of the sheet when going through the customs formalities. The customs shall stamp the “proof seal” on the sheet in the presence of the Import License for the drug and Export License for the drug. The customs shall charge the cost according to the relevant regulations for issuing certificates.

The importer and exporter shall return the first sheet of the Import License for the drug or Export License for the drug along with the customs declaration form with the seal of the customs, to the issuing regulatory department within one month after completing the import and export.

Where the importer or exporter conducts no relevant importation or exportation after obtaining the Import License for the drug and Export License for the drug, the importer or exporter shall return the original license to the issuing regulatory department within one month after expiration of the license.

Article 20 The validation of the Import License for the drug is one year; the validation of the Export License for the drug is no more than three months (valid within the calendar year).

“One license for one customs clearance” is implemented for the Import License for the drug and Export License for the drug. The license shall be used only once within the validation and its content shall not be altered. Where the import or export is postponed for some reasons, the importer or exporter may request for a new license once with the original one.

Article 21 Where the Import License for the drug or Export License for the drug is lost, the importer or exporter shall report the loss to the original issuing authority in writing immediately. After receiving the loss report, the original issuing authority shall notify the port customs and reissue the license if no harmful consequences are found through confirmation.

Article 22 The Import License for the drug and Export License for the drug are uniformly printed by the State Food and Drug Administration.

Article 23 Where anabolic agents and peptide hormones are imported or exported in the form of processing trade, the customs shall go through and supervise the clearance formalities upon presentation of the Import License for the drug or Export License for the drug. Those not exported for special reasons shall be transferred to and handled by the local (food and) drug regulatory department in accordance with relevant regulations, and the customs shall conduct the verification and cancellation procedures in the presence of relevant documents.

Article 24 Anabolic agents and peptide hormones entering or leaving between bonded zones, export processing zones, other special Customs controlling areas, Customs bonded and controlling areas, with overseas, or between the special Customs controlling areas and the Customs bonded and controlling areas are exempt from application for the Import License for the drug or Export License for the drug, and supervised by the Customs.

Import License for the drug shall be applied for anabolic agents and peptide hormones entering from bonded zones, export processing zones, other special Customs controlling areas and Customs bonded and controlling areas into other places in China.

Export License for the drug shall be applied for anabolic agents and peptide hormones entering bonded zones, export processing zones, other special Customs controlling areas and Customs bonded and controlling areas from other places of China.

Article 25 Where an individual carries or mails anabolic agents and peptide hormones, within a reasonable amount, into or out of China for medical needs, the customs shall clear the drugs in the presence of prescriptions of medical institutions in accordance with relevant regulations on prescriptions of the competent health department.

Article 26 Besides prescribed in the Provisions, the importation, port test, supervision and control of anabolic agents and peptide hormones for medical purpose are implemented with reference to requirements related to drug importation in the Provisions for Drug Importation.

Article 27 Anabolic agents and peptide hormones imported for medical purpose mentioned in the Provisions refer to the import anabolic agents and peptide hormones to be used for preparation production or to be marketed in China.

Importer refers to the importer specified on the Import License for the drug obtained in accordance with the Provisions.

Exporter refers to the exporter specified on the Export License for the drug obtained in accordance with the Provisions.

Article 28 These Provisions shall go into effect as of September 1, 2006. The Notice on Import and Export of Anabolic Agents and Peptide Hormones (Guo Shi Yao Jian An [2004] No. 474) issued by the State Food and Drug Administration on September 30, 2004 shall be annulled therefrom.