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关于印发《境外投资外汇风险及外汇资金来源审查的审批规范》的通知

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关于印发《境外投资外汇风险及外汇资金来源审查的审批规范》的通知

国家外汇管理局


关于印发《境外投资外汇风险及外汇资金来源审查的审批规范》的通知
1993年9月20日,国家外汇管理局

国家外汇管理局各省、自治区、直辖市分局,计划单列市、经济特区分局:
为了加强我国境外投资外汇管理,根据《境外投资外汇管理办法》和《境外投资外汇管理办法实施细则》,我们制定了《境外投资外汇风险及外汇资金来源审查的审批规范》,现将该规范印发给你们,请遵照执行。

附件:境外投资外汇风险及外汇资金来源审查的审批规范
根据1989年2月5日国务院批准,同年3月6日国家外汇管理局公布的《境外投资外汇管理办法》(以下简称《投资管理办法》),以及《境外投资外汇管理办法实施细则》(以下简称《投资实施细则》),现制定《境外投资的投资外汇风险审查和外汇资金来源审查》的内部操作规范,国家外汇管理局及其各省、自治区、直辖市、计划单列市、经济特区分局在对境外投资项目进行审查时都应严格遵守。
一、境外投资外汇事宜审查程序
负责境外投资项目审批的国家主管部门为国家计委及对外贸易经济合作部和各省、自治区、直辖市、计划单列市人民政府指定的综合部门。国家外汇管理局及其各省、自治区、直辖市、计划单列市、经济特区分局(以下简称外汇管理部门)负责境外投资的投资外汇风险审查和外汇资金来源审查。
按国务院有关规定,中方投资额在100万美元以上的项目及虽在100万美元以下,但需向国家申请资金,或在境外贷款需国内担保,或产品返销国内等需国家综合平衡的项目,报国家计委审批;中方投资额在3000万美元以上的项目,由国家计委初审后报国务院审批。
中方投资额在100万美元以下,且不涉及国家综合平衡的项目,由国务院各有关部门或各省、自治区、直辖市及计划单列市指定的综合部门审批;其中前往未建交国家,港澳及其他敏感地区投资的项目,送外经贸部会同有关部门审批,报国家计委备案。在境外设立金融机构的项目,由中国人民银行审批。
(一)拟以外汇资金在境外投资的境内投资者,在向有关审批部门办理境外投资审批事项前,应根据《投资实施细则》第五条的规定提供有关资料和证明,由外汇管理部门进行投资外汇风险审查和外汇资金来源审查。
(二)拟以设备、原材料、工业产权等形式在境外进行投资的境内投资者,在向有关审批部门办理境外投资审批事项时,除应提交细则中列明的资料和证明外,还应提交用以投资的设备、原材料、工业产权等的外汇价格资料。
根据国务院国发(1992)33号文的规定,到原苏联东欧各国以实物进行投资的企业不受上述规定的限制,事前不需审批,但事后应报有关审批部门备案。
(三)两个或两个以上的境内投资者共同投资于境外项目的,按如下手续办理:
1.同一辖区的,由出资较多的一方向所在地外汇管理部门办理有关手续。
2.不同辖区内的,由经投资者协商同意的一方(以下简称申请者),向所在地外汇管理部门办理投资外汇风险审查,并提交合作协议,其他投资者所在地外汇管理部门凭外汇风险审查证书的抄送件办理有关投资外汇资金的配汇及汇往申请者的外汇资金帐户等手续,由申请者在所在地外汇管理部门统一办理汇回利润保证金和所投外汇资金汇出手续。
经外汇管理部门进行投资外汇风险和资金来源审查之后,境内投资者持外汇管理部门的批件到有关审批部门办理项目审批;项目经有关审批部门批准后,持项目批准书到外汇管理部门办理登记备案,在办理汇回利润保证金和资金汇出手续之前,投资者应到国有资产管理局办理登记手续。
凡境内投资者委托他人进行境外投资的,须报经外汇管理部门和其主管部门批准同意,并向外汇管理部门报送委托书及受托人所在地律师事务所出具的受托人资信证书。资金汇出按《投资管理办法》及细则有关规定办理。委托人应按期报送受托人使用资金情况、经营情况、利润回收情况、财务状况等材料。
二、对境外投资立项前的外汇管理
根据《投资管理办法》和《投资实施细则》规定,在境内投资者提出对境外投资立项申请时,外汇管理部门主要进行三项审查工作。
(一)对境内投资者的资格审查
(1)境内投资者必须是有关部委或境内登记注册,拥有相当的资本金和营运资金,独立核算自负盈亏的企业法人。
(2)境内投资者境外投资期限应与其所持的工商登记执照的有效期限相一致。
(3)境内投资者应拥有熟悉该项业务的专业人才。
(4)境内投资者应具备投资需要的自有外汇或实物。
(二)对境外投资的外汇风险审查
投资风险是指由于投资所在国(地区)政府变更、社会、政治经济环境变化等原因而产生投资不能回收的风险。
1.风险审查的范围和重点
投资风险主要从政治风险、财务风险和商业风险三方面来评估和审查。
(1)政治风险:指投资所在国(地区)政治、社会的稳定程度。主要从发生内乱、暴乱或战争的危险性,现行体制的稳定性,政权更迭可能引起政策、法令的变化来分析风险程度。如因该国政权变更而引起对外国企业财产的没收、征收和国有化,加强外汇管制等。
(2)财务风险:指在投资所在国在资金筹集、税收制度、通货膨胀率、利润汇出,以及国际收支状况和国内经济状况对汇率可能产生的变化等方面的评估。
(3)商业风险:指该投资项目因国际市场环境变化,经济活动中的失误,供货不能按时,原材料品质欠佳等引起成本上升,产品滞销等所带来的风险。
外汇管理部门依法对投资外汇风险进行的评估和审查,主要通过对投资所在国的外汇管理法规和经济可行性报告的评审看投资所汇出的外汇资金能否安全、按时、足额地汇回国内。
2.外汇管理部门进行审查的要点:
(1)投资所在国的国际信誉和投资风险等级;风险越低,投资获利可能性越大。
(2)投资所在国的有关法律、法规和执法状况;法制健全、法制程度高的,投资安全系数也大些。
(3)投资所在国的外汇管制状况。对实行外汇管制的国家应考虑对非居民携带外币出入境的限额、汇出利润税率、外国投资者合法收益是否允许自由兑换以及外汇汇出境外的限制条款。
(4)投资所在国的货币风险、汇率和利率的变化趋势。即对投资、使用、收益和回收资本的货币是否一致;如属不同货币,其间的汇率变化,有无采取降低风险的措施保障投资安全。
(5)投资回收计划,资金回收率,即利润率及其回收期限是否合理,利润率至少不应低于同期银行贷款利率。
(三)对境外投资外汇资金来源审查
1.允许用于境外投资的外汇资金
用于境外投资的外汇资金限于境内投资者的自有外汇;未经国家外汇管理局批准,不得使用其他外汇资金。使用国际商业贷款进行境外投资须报国家计委批准。
2.境内投资者向境外投资应有足够的外汇资金来源,应向外汇管理部门提供有关的证明,同时还应备足占投资额5%的汇回利润保证金。
外汇管理部门对境外投资项目的投资外汇风险审查和外汇资金来源审查,应在境内投资者提供符合要求的资料和证明后30天之内作出书面审查结论。
三、批准境外投资项目后的外汇管理
境外投资项目经有关审批部门批准后,境内投资者应持《投资管理办法》第四条规定的材料到所在地外汇管理部门办理以下有关手续:
(一)登记建档
境内投资者所在地外汇管理部门应将交来的有关审批部门批准文件、外汇管理部门关于投资外汇风险审查和外汇资金来源审查的书面结论和投资项目的合同或者其它可证明境内投资者应当汇出外汇资金(或实物物资)数额的文件,按境外投资企业名称进行登记编号,建立专门档案,实行监督管理。
(二)汇出投资资金的手续
1.缴存汇回利润保证金或交“书面承诺”。境内投资者以外汇资金在境外投资的,应向所在地外汇管理部门缴存投资资金5%作为汇回利润保证金,并存入所在地外汇管理部门指定的银行开立的保证金专户。
境内投资者也呈交国家外汇管理局批准办妥的“书面承诺”。
2.以实物进行投资可区分两类型处理:
(1)全部以实物进行投资的,由所在地外汇管理部门根据具体情况决定该境内投资者缴存汇回利润保证金的数额或只需作出“书面承诺”。
(2)以部分外汇资金和部分实物进行投资的,该境内投资者应按汇出外汇资金数的5%缴存汇回利润保证金,如确有困难,需以“书面承诺”的,仍应报国家外汇管理局批准,实物部分按上项办理。
3.外汇管理部门在境内投资者办妥前两项手续后,方予办理汇出资金的手续或批准实物出运,同时出具证明向出口收汇核销部门办理核销手续。但应注意以下特殊情况的妥善处理。
(1)属特殊需要,汇出后必须以个人名义开户存放境外的必须事前报经国家外汇管理局批准,方予汇出。
(2)因投资所在国法律规定,汇出资金必须以个人名义持有投资企业股份的有价证券的,除事前须报国家外汇管理局批准外,还必须通过当地律师事务所办妥持有价证券实际受益人的有关公证,办妥后立即报送所在地外汇管理部门备案。
4.境外投资企业在当地注册和开户后,应在30天内将当地注册证明及企业开户银行帐号等有关材料,由其境内投资者报送各有关外汇管理部门备案。
(三)境内投资者应向外汇管理部门定期(规定在投资当地会计年度终了后6个月内)报送境外投资企业的年度财务报表(包括资产负债表、损益表等),外汇管理部门有权对境外投资项目的外汇收支状况进行监督、检查;其境内投资者应提供有关材料,不得拒绝或隐瞒,外汇管理部门通过对报表的定期分析,掌握该境外投资企业的经济现状,找出实际盈亏同原定计划差额的原因,并向总局综合反映。
(四)境外借款和担保问题
境外投资企业可以根据经营需要,在境外自行筹借和运用资金。但未经境内投资者所在地外汇管理部门审查,并转报经国家外汇管理局批准,其境内投资者、境内金融机构以及其他部门、单位一律不得以任何方式为境外投资企业提供外汇担保。
(五)境外投资企业汇回利润的管理
1.汇回利润的留成比例
境内投资者从境外投资企业分得利润或其他外汇收益,应从该境外投资企业注册之日起5年内享受全额留成。5年后依照国家规定20%上缴国家,80%留给境内投资者,均由各境内投资者所在地的外汇管理部门办理。以实物进行境外投资所分得的利润或其他外汇收益,也按上述规定办理留成,境内投资者报经外汇管理部门批准,也可留成一定比例的现汇。
2.按经批准的利润回收计划提前超计划汇回利润,可从境外企业设立之日起,5年内,经所在地外汇管理部门批准,可开立外汇现汇帐户,全额保留现汇。
3.以其他方式返还利润的,须事先经所在地外汇管理部门批准后第五条第二项执行。(具体批准办法在分局上报意见后再行列明)
4.不汇回利润的扣缴问题
(1)境外投资企业未按利润计划汇回利润或其他外汇收益的,其境内投资者应向外汇管理部门提交不能按照完成利润计划或经营亏损的报告书。如果经外汇管理部门审查,不属于正当理由(政治风险、自然灾害),外汇管理部门将依法处理。
可以从其缴纳的保证金中将相应比例的外汇数额结汇,将额度上缴给国家。
对未缴保证金的,应从其境内投资者的留成外汇额度帐户中扣缴相应数额上缴国家。
以上扣缴数额累计不超过汇出外汇资金(或实物)数额的20%。
(2)境外投资企业不调回利润或其他收益,擅自挪作他用或存放境外者,外汇管理部门将依法查处。
5.对境外投资企业开业以后,业绩不佳或无利润汇回,有严重问题的,或有特殊异常情况的境内投资者,所在地外汇管理部门应及时向国家外汇管理局和有关主管部门反映。
(六)增资和再投资以及转让股份的管理
境外投资企业的中方如需增资,在报经国内原审批部门批准前,应出具增资理由的报告并提供境外企业历年的经营情况材料等,报经所在地外汇管理部门再次进行外汇风险审查和资金来源审查。如经批准同意增资,境内投资者应按增资额的5%再缴存汇回利润保证金。增资后中方投资外汇资金总额累计达到100万美元以上(含100万美元)的,由外汇管理总局审批。
境外投资企业中方所得利润或其他外汇收益如需作为原缴资不足部分,须报外汇管理部门,经批准同意后,其境内投资者应按补充资金数额5%缴存汇回利润保证金。
境外投资企业的再投资活动应按《投资管理办法》及《投资实施细则》办理。
境外投资企业转让股份须经外汇管理局审批后按有关规定办理。
(七)对停业清盘的管理
境外投资企业依法宣告停业或解散后,其境内投资者应将清盘后的资产负债表、财产目录、财产估价等资料报送外汇管理部门备案,并将中方应得外汇资产在清算结束后30天内调回境内,未经外汇管理部门批准不得擅自挪作他用或存放境外。
四、对违反境外投资法规的处罚规定
《投资管理办法》和《投资实施细则》对境外投资的有关各方均明确规定了应执行的事项,由外汇管理部门进行监督管理,对违反规定者依法进行查处。
(一)对国内有关金融机构的要求
1.未经外汇管理部门进行投资外汇风险审查和外汇资金来源审查的项目,其境内投资者不得汇出外汇资金,国内金融机构应监督执行。境内投资者也不得将已经出口的商品(实物)转作投资,而将应收外汇截留境外,监督收汇的银行发现后应及时报告外汇管理部门。
2.国内金融机构在未经外汇管理部门批准的情况下,将境内投资者的投资外汇资金汇出境外的,外汇管理部门可对其处以人民币10万元以下的罚款。
(二)对境内投资者违反法规的处罚规定
1.未按规定报经外汇管理部门作境外投资外汇风险审查和外汇资金来源审查的,国家主管部门应不予审批,退回申请,责令境内投资者向外汇管理部门补报,对未经审批擅自开办境外投资企业已成事实者,对其中未按规定向外汇管理部门办理登记手续及缴存汇回利润保证金的,外汇管理部门可处以境内投资者人民币10万元以下的罚款。
2.未经外汇管理部门批准,私自汇出外汇资金的;或以出口商品或劳务等的应收外汇截留境外转作投资的,均按逃汇查处。
3.境内投资者不按期汇回来源于境外投资的利润或者其他外汇收位置;或未经外汇管理部门批准擅自挪作他用、存放境外的;外汇管理部门应当责令境内投资者限期调回,并可按应调回资金数额的10%—20%处以外汇罚款。
4.不按期向外汇管理部门报送境外投资企业的年度会计报表的,情节严重者,外汇管理部门对境内投资者处以人民币10万元以下的罚款。
5.未经国内主管部门批准,私自变更境外投资企业资本的,情节严重者,外汇管理部门对境内投资者处以人民币10万元以下的罚款。
6.未经批准,境内投资者对境外投资企业的投资以个人名义将外汇存放境外的,或以个人名义持有有价证券的,外汇管理部门按逃套汇论处。
7.境内投资者转让境外投资企业股份,或者境外投资企业破产按当地法律清算后,不按期将外汇收入调回境内的,外汇管理部门应责令境内投资者限期调回,并可按应调回资金数额的10%—20%处以外汇罚款。
(三)对《投资管理办法》施行前已设立的境外投资企业的补报登记工作。
按《投资管理办法》第十五条之规定,境内投资者应自1989年3月6日《投资管理办法》发布施行之日起的60天内,依照《投资管理办法》规定向外汇管理部门补报有关材料,办理登记手续,并依照规定将外汇收益调回境内。
境内投资者在未获主管部门批准继续设置其境外投资企业之前,也应主动向外汇管理部门申报,等正式批准之后,立即补办一切手续。如已明确属于撤并类的,应依照规定将有关资料和外汇状况报告外汇管理部门,补办有关手续。并入其他境外投资企业的,其原有投资资金应依法缴存5%的汇回利润保证金,如转让给境外其他企业的股份,收入应依法调回境内。撤销清盘的,应依法调回清算后的全部外汇资金。
在《投资管理办法》施行前,未经国内主管部门审批,擅自设立的境外投资企业,在《投资管理办法》施行后,无正当理由,一直隐瞒拒不向外汇管理部门申报补办登记的,外汇管理部门依法进行查处。


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廊坊市人民政府办公室关于印发廊坊市消防工作目标考评办法的通知

河北省廊坊市人民政府办公室


廊坊市人民政府办公室关于印发廊坊市消防工作目标考评办法的通知

(2010)125号


各县(市、区)人民政府,廊坊开发区管委会,市政府有关部门:
现将《廊坊市消防工作目标考评办法》印发给你们,请认真抓好组织实施,努力营造良好的消防安全环境。


廊坊市人民政府办公室
二○一○年十一月十八日


廊坊市消防工作目标考评办法


第一条 为推动全市消防安全责任制的落实,预防火灾和减少火灾危害,保障公民人身、财产和公共财产安全,依据《中华人民共和国消防法》、国务院《关于进一步加强消防工作的意见》、《河北省消防条例》等规定,结合本市实际,制定本办法。
第二条 本办法适用于对各县(市、区)政府、廊坊开发区管委会、职能部门消防安全责任制落实情况的考核。
第三条 考核工作在市政府领导下,由市消防安全委员会办公室具体负责,遵循客观公正、注重实效的原则,督促落实全市消防工作“政府统一领导、部门依法监管、单位全面负责、公民积极参与”的社会化格局。
第四条 考核内容:
(一)与各乡镇政府是否签订《消防工作目标责任书》,以及《消防工作目标责任书》中任务完成情况。
(二)各县(市、区)政府、廊坊开发区管委会、职能部门消防安全职责履行情况。
(三)消防法律、法规、规章宣传贯彻情况。
(四)农村、社区防火工作开展情况。
(五)城市公共消防基础设施建设和装备建设情况。
(六)社会消防力量发展和经费投入情况。
(七)分析本单位、本行业、本系统火灾形势及防控情况。
(八)监督本单位、本行业、本系统依法履行消防工作职责情况。
(九)落实市政府或消防安全委员会组织的消防专项工作开展情况。
(十)重大火灾隐患整治情况。
(十一)有关法律、法规、规章规定的其他消防工作职责。
第五条 消防工作目标责任制考核采取自查自评与组织考核相结合的办法。市政府每年组织一次自查自评,自查自评情况及当年工作总结书面报告于当年6月、12月底前上报市政府办公室和市消防安全委员会办公室。市政府每年组织一或两次对各县(市、区)政府、廊坊开发区管委会、职能部门消防工作目标责任制考核。
第六条 考核采取百分制具体评分细则由消防安全委员会确定。
第七条 考核结果分优秀、良好、达标和不达标四个等级:
(一)凡考核得分在90分以上的,确定为消防工作优秀单位。
(二)凡考核得分在80—89分的,确定为消防工作良好单位。
(三)凡考核得分在70—79分的,确定为消防工作达标单位。
(四)凡考核得分在70分以下或者有以下情形的,确定为消防工作不达标单位:
1.本年度发生1次重大以上火灾或发生2次较大以上火灾的;
2.未定期召开消防安全委员会研究、解决消防规划、公共消防基础建设等重大事项的;
3.本年度内因消防工作不利导致集体上访事件的;
4.存在严重影响公共消防安全的不安定因素,未能有效处置的其他事项。
第八条 考核程序。
(一)听取汇报。即由各县(市、区)政府、廊坊开发区管委会、职能部门主要负责同志向考核组汇报。汇报内容为本地区、本单位、本行业、本系统主要消防工作、责任制落实情况、火灾防控工作开展情况、消防工作社会化建设情况、存在的突出问题、原因分析及解决措施等。
(二)查阅资料。查阅各县(市、区)政府、廊坊开发区管委会、职能部门研究部署消防工作的会议记录,制发的文件和主要领导关于消防工作的批示,以及组织开展专项检查、考核资料等。
(三)实地检查。随机抽查3个被考核的单位、2家社会单位和消防队、站及部分街道,重点检查各县(市、区)政府、廊坊开发区管委会、职能部门履责情况、社会单位消防安全管理情况、火灾隐患整治情况、消防车辆、装备建设和资金投入情况及市政公共消防设施建设情况等。
(四)反馈交流。检查结束后,由考核组向各区管委、镇政府、职能部门反馈检查情况,指出存在问题并提出改进建议,各区管委、镇政府、职能部门对反馈意见予以确认。
(五)限时督办。对存在的问题,由市消防安全委员会办公室予以专项督办,限时办结。
第九条 消防工作目标责任制纳入各县(市、区)政府、廊坊开发区管委会、职能部门各级政府目标责任考核和各级领导干部政绩考核、社会治安综合治理考评和文明城市(乡镇、村、社区)创建内容。考核评定为优秀的单位,经市政府批准后予以通报表彰;考核评定为不达标的单位,全市通报批评并责令限期整改,情节严重的按照行政管理权限和规定程序对相关责任人实施问责或者给予行政处分。
第十条 考核结果适时向社会公告。
第十一条 各县(市、区)政府、廊坊开发区管委会、职能部门应按照市政府考核组的要求提供有关文件、资料、记录,并保证其真实性。对弄虚作假者一经核实,移交有关部门追究责任。
第十二条 考核人员滥用职权、徇私舞弊、弄虚作假的,由监察部门予以追究责任。
第十三条 本办法自公布之日起施行。




Provisions for Drug Advertisement Examination

State Food and Drug Administration,State Administration for Industry and Commerceof the People’s Republic of China


Provisions for Drug Advertisement Examination



(SFDA Decree No. 27)

The Provisions for Drug Advertisement Examination, adopted by the State Food and Drug Administration and the State Administration for Industry and Commerce of the People’s Republic of China, is now issued in the decree sequence number of the State Food and Drug Administration. The Provisions shall go into effect as of the date of May 1, 2007.



Shao Mingli
Commissioner
State Food and Drug Administration

Zhou Bohua
Minister
State Administration for Industry and Commerceof the People’s Republic of China

March 13, 2007





Provisions for Drug Advertisement Examination


Article 1 The Provisions are formulated for the purposes of strengthening regulation on drug advertisements and ensuring the authenticity and legality of drug advertisements in accordance with the Advertisement Law of the People’s Republic of China (hereinafter referred to as Advertisement Law), the Drug Administration Law of the People's Republic of China (hereinafter referred to as Drug Administration Law), the Regulations for the Implementation of Drug Administration Law of the People's Republic of China (hereinafter referred to as Regulations for the Implementation of Drug Administration Law) and other regulations related to supervision on advertisements and drugs.

Article 2 A drug advertisement refers to any advertisement published through various media or forms containing drug name, indications (functions) or other relevant contents, and shall be examined and approved in accordance with the Provisions.

Where only the names of non-prescription drugs (including adopted names and trade names) are publicized or only the names of prescription drugs (including adopted names and trade names) are publicized in professional medical or pharmaceutical journals, the examination is not required.

Article 3 The drug advertisement applied for examination shall be approved provided that it conforms to the following laws, regulations and related provisions:
(1) Advertisement Law;
(2) Drug Administration Law;
(3) Regulations for Implementation of Drug Administration Law;
(4) Criteria for Examining and Publishing Drug Advertisement;
(5) Other provisions of the State on advertisement regulation.

Article 4 The drug regulatory departments of the provinces, autonomous regions or municipalities directly under the Central Government are the drug advertisement examination authorities responsible for examining drug advertisements within their administrative regions. The administrative departments for industry and commerce at or above the county level are supervision and control authorities for drug advertisements.

Article 5 The State Food and Drug Administration shall guide and supervise the examination conducted by drug advertisement examination authorities and punish, in accordance with law, the examination authorities that have violated the Provisions.

Article 6 An applicant for a drug advertisement approval number must be an eligible drug manufacturer or distributor. Where the applicant is a drug distributor, the consent of the drug manufacturer is required.

An applicant may entrust an agent with the application for a drug advertisement approval number.

Article 7 An application for a drug advertisement approval number shall be submitted to the drug advertisement examination authority in the place where the drug manufacturer is located.

An application for an import drug advertisement approval number shall be submitted to the drug advertisement examination authority in the place where the agent of the import drug is located.

Article 8 Where a drug manufacturer or distributor applies for a drug advertisement approval number, it shall submit an Application Form for Drug Advertisement (Appendix 1) with sample manuscript (sample film or sample record) of which the content is consistent with that to be published attached, and an electronic document of drug advertisement application. It shall also submit the following proof documents that are authentic, legal and valid:
(1) Copy of the Business License of the applicant;
(2) Copy of the Drug Manufacturing Certificate or the Drug Supply Certificate of the applicant;
(3) Where the applicant is a drug distributor, the original document proving that the drug manufacturer authorizes the drug distributor to be the applicant shall be submitted;
(4) Where an agent submits an application for a drug advertisement approval number on behalf of the applicant, an original authorization letter given by the applicant to the agent, a copy of business license of the agent and other documents proving the subject’s qualifications shall be submitted;
(5) Copies of the drug approval document (including Import Drug License or Pharmaceutical Product License), copy of approved insert sheet, and label and insert sheet used in practice;
(6) For non-prescription drug advertisement, a copy of registration certificate of non-prescription drug examination or copies of relevant certificates is required;
(7) Where an applicant applies for an import drug advertisement approval number, copies of qualification certificates of the agent of the import drug shall be submitted;
(8) Where the trade name, registered trademark and patent of the drug are involved in an advertisement, copies of the valid certificates and other relevant documents proving the authenticity of the advertisement shall be submitted.

The copy of any approval document prescribed in this Article shall be sealed by the document holder.

Article 9 An advertisement application by an enterprise for a drug shall not be accepted by the drug advertisement examination authorities under any of the following circumstances:
(1) Any of the circumstances under which the application shall be rejected as prescribed in Article 20, Article 22 and Article 23 of the Provisions;
(2) An administrative procedure to withdraw a drug advertisement approval number is in process.

Article 10 After receiving an application for drug advertisement approval number, where the dossier is complete and in conformity with statutory requirements, the drug advertisement examination authority shall issue an Acceptance Notice of Drug Advertisement; where the dossier is incomplete or not conforming to the statutory requirements, one notification on all the content to be supplemented or corrected shall be given to the applicant on the spot or within five working days; if the notification to the applicant is not issued within the timeline, the application is deemed as being accepted upon the date when the dossier is received.

Article 11 Within ten working days upon accepting an application, the drug advertisement examination authority shall check the authenticity, legality and validity of the documents submitted by the applicant, and shall examine the advertisement content in accordance with law. For the drug advertisement in conformity with statutory requirements, a drug advertisement approval number shall be issued; for those not in conformity with statutory requirements, the authority shall make a decision of not issuing a drug advertisement approval number and notify the applicant of the decision with reasons in written form and the applicant’s right to apply for administrative reconsideration or to bring an administrative suit by law.

For approved drug advertisement, the drug advertisement examination authority shall report to the State Food and Drug Administration for records and send the approved Application Form for Drug Advertisement to the authority responsible for advertisement supervision and control at the same level for records. Where there is any problem in the drug advertisement reported to the State Food and Drug Administration for records, the State Food and Drug Administration shall instruct the drug advertisement examination authority to correct it.

The drug regulatory departments shall announce the approved drug advertisement timely.

Article 12 Where a drug advertisement is to be published in the province, autonomous region or municipality directly under the Central Government other than the place where the drug manufacturer and the agent of the import drug are located (hereinafter referred to as “non-local drug advertisement”), it shall, before being published, be submitted for records to the drug advertisement examination authority in the place where the advertisement is to be published.

Article 13 The following materials for non-local drug advertisement shall be submitted for record:
(1) Copy of the Application Form for Drug Advertisement;
(2) Copy of the approved drug insert sheet;
(3) For television or audio broadcast advertisement, it is required to submit the audio tape, compact disc or other medium carrier on which the content is consistent with the approved content.

The copy of any document prescribed in this Article shall be sealed by the document holder.

Article 14 For application for putting non-local drug advertisement on record in accordance with Articles 12 and Article 13 of the Provisions, the drug advertisement examination authority shall, within five working days after accepting the application, put such drug advertisement on record, endorse the word “recorded” on the Application Form for Drug Advertisement, affix the seal specific for drug advertisement examination and send the form to the supervision and control authorities for advertisements at the same level for future reference.

Where the drug advertisement examination authority of a place where a drug advertisement is to be put on record finds that the drug advertisement is not conformed with the relevant provisions, it shall fill in the Opinion on the Record of Drug Advertisement Examination (Appendix 2), submit it to the original drug advertisement examination authority for check, and copy it to the State Food and Drug Administration.

Within five working days upon receiving the Opinion on the Record of Drug Advertisement Examination, the original drug advertisement examination authority shall give its opinions to the drug advertisement examination authority of the place where the drug advertisement is to be put on record. Where no consensus is achieved between the original drug advertisement examination authority and the drug advertisement examination authority of the place where a drug advertisement is to be put on record, the case may be submitted to the State Food and Drug Administration that shall make a final judgment.

Article 15 The valid term of a drug advertisement approval number is one year. It shall become invalid upon expiration.

Article 16 The content of an approved drug advertisement is not allowed to be changed when being published. Where any change to the drug advertisement is needed, a new drug advertisement approval number shall be obtained.

Article 17 Where an advertisement applicant publishes a drug advertisement by itself, it shall keep the original Application Form for Drug Advertisement for two years for future check.

Where an advertisement publisher or advertising operator is authorized by the applicant to publish a drug advertisement, it shall check the original Application Form for Drug Advertisement, publish the advertisement in accordance with the approved content and keep a copy of the Applicant Form for Drug Advertisement for two years for future check.

Article 18 Where there is any of the following circumstances for an approved drug advertisement, the original drug advertisement examination authority shall issue a Notice of Drug Advertisement Re-examination (Appendix 3) and conduct the re-examination. The drug advertisement may continue to be published during the re-examination.

(1) The State Food and Drug Administration finds that the content of the drug advertisement approved by the drug advertisement examination authority is not in conformity with the provisions;
(2) A supervision and control authority for advertisement at or above provincial level makes a re-examination proposal;
(3) Other circumstances where a re-examination is required by a drug advertisement examination authority.

After re-examination, where the drug advertisement is not in conformity to the statutory requirements, the Application Form for Drug Advertisement shall be taken back and the original drug advertisement approval number shall become invalid.

Article 19 Drug advertisement examination authorities shall cancel the drug advertisement approval number in any of the following circumstances:
(1) Where a Drug Manufacturing Certificate or the Drug Supply Certificate is revoked;
(2) Where a drug approval document is withdrawn or cancelled;
(3) Where the State Food and Drug Administration or the drug regulatory department of the province, autonomous region or municipality directly under the Central Government instructs to stop the production, sales and use of the drug.

Article 20 For any alteration to the approved content of a drug advertisement for false propaganda, the drug regulatory departments shall instruct to stop the publication of the advertisement immediately, revoke the drug advertisement approval number, and shall not accept any application for advertisement of the drug within one year.

Article 21 Where any illegal advertisement in which the scope of indications (functions) of the drug is expanded without authorization, the therapeutic effectiveness is exaggerated extremely, or which seriously cheats or misleads the customers, is found, the drug regulatory department at or above the provincial level shall take mandatory administrative measures to suspend the sales of the drug within their administrative area and order the enterprise that illegally publishes the drug advertisement to issue a correction notice in relevant local media.

After the enterprise that illegally publishes the drug advertisement issues a correction notice as required, the drug regulatory department at or above the provincial level shall make a decision on lifting the mandatory administrative measures within 15 working days; where it is necessary to test the drug, the drug regulatory departments shall determine whether to lift the mandatory administrative measures within 15 days as from the day when the test report is issued.

Article 22 Where a drug advertisement application providing false materials is found by the drug advertisement examination authority during the examination, no further application of the enterprise in respect of the advertisement of the drug shall be accepted within one year.

Article 23 Where a drug advertisement with an approval number is found by the drug advertisement examination authority to have provided false materials, such drug advertisement approval number shall be revoked and no further application from the enterprise in respect of the advertisement of the drug shall be accepted within three years.

Article 24 Any drug advertisement, of which the approval number is taken back, cancelled or revoked in accordance with Article 18, Article 19, Article 20 and Article 23 of the Provisions, shall be discontinued for publication immediately; non-local drug advertisement examination authorities shall stop filing the record of the advertisement of the enterprise with the drug advertisement approval number.

Where a drug advertisement examination authority takes back, cancels or withdraws a drug advertisement approval number in accordance with Article 18, Article 19, Article 20 and Article 23 of the Provisions, it shall notify the supervision and control authority for advertisements at the same level within five working days from the day when the administrative decision on the matter is made; the supervision and control authority for advertisements shall handle it in accordance with law.

Article 25 Where a non-local drug advertisement is found not put on record in the drug advertisement examination authority of the place where it is published, the authority shall instruct to file its record within a time limit. If the record is not filed within the time limit, the drug advertisement in the above-mentioned place shall be suspended.

Article 26 The drug regulatory department at or above the county level shall monitor and check the publishing of drug advertisement that has been examined and approved. For any illegal drug advertisements, drug regulatory departments at all levels shall fill in the Notice on the Transfer of Illegal Drug Advertisement (Appendix 4) and transfer it to an supervision and control authority for advertisements at the same level together with such materials as samples of illegal drug advertisement; where the content of approved non-local drug advertisement is altered without permission, the drug advertisement examination authority of the place where the advertisement is published shall advise the original drug advertisement examination authority to revoke its approval number in accordance with Article 92 of the Drug Administration Law and Article 20 of the Provisions.

Article 27 Where an illegal drug advertisement is published and the circumstances are serious, the drug regulatory department of province, autonomous region or municipality directly under the Central Government shall announce the matter to the public and timely report it to the State Food and Drug Administration. The State Food and Drug Administration shall summarize and release the collected information periodically.

Where any false or illegal drug advertisement is published and the circumstances are serious, it shall be announced to the public jointly by the State Administration for Industry and Commerce and the State Food and Drug Administration if necessary.

Article 28 For any drug advertisement published without approval, or the contents published inconsistent with the approved ones, the supervision and control authority for advertisements shall impose a punishment in accordance with Article 43 of the Advertisement Law; where it constitutes false advertisement or misleading propaganda, the supervision and control authorities for advertisements shall impose a punishment in accordance with Article 37 of the Advertisement Law and Article 24 of Anti-Unfair Competitions Law.

In the process of investigation of an illegal drug advertisement, where there is a need to affirm any drug technical information, the supervision and control authority for advertisements shall notify the drug regulatory department at or above the provincial level. The drug regulatory department at or above the provincial level shall give the affirmation result to the supervision and control authorities for advertisements within ten working days after receiving the notification.

Article 29 The staff members that examine and supervise drug advertisements shall be trained in such laws and regulations as the Advertisement Law and the Drug Administration Law. Where the staff members in drug advertisement examination department or in supervision and control authority for drug advertisements neglect their duty, abuse their power, or practice favoritism and commit irregularities, they shall be given an administrative sanction in accordance with law. If a crime is constituted, they shall be investigated for their criminal liabilities in accordance with law.

Article 30 A drug advertisement approval number shall be “X Yao Guang Shen (Shi) No. 0000000000", “X Yao Guang Shen (Sheng) No. 0000000000", “X Yao Guang Shen (Wen) No. 0000000000". “X” is the abbreviation for a province, autonomous region or municipality directly under the Central Government. “0000000000” is a number with ten digits, in which the first six represent year and month of the examination, and the last four represent advertisement approval sequence number. “Shi”, “Sheng” or “Wen” represents certain classification code used in advertising media.

Article 31 These Provisions shall come into force as of May 1, 2007. The Provisions for Drug Advertisement Examination issued by the State Administration for Industry and Commerce and the Ministry of Health (Decree of State Administration for Industry and Commerce No. 25) on March 22, 1995 shall be annulled therefrom.