辽宁省铁岭市人民政府


铁岭市人民政府令第75号


修订后的《铁岭市行政审批项目目录》业经铁岭市第六届人民政府第21次常务会议审议通过，现予以公布。从即日起凡不在公布目录之内的项目一律不得实施审批。今后，市级政府部门需要新增、变更、取消行政审批(许可)项目、年检(审)项目，须报市行政审批制度改革工作领导小组审核，提请市政府常务会议审定同意后方可进行调整。原《铁岭市行政审批项目目录》(铁岭市人民政府令第63号)同时废止。



市长　　　

二0一0年十月十七日 　







铁岭市行政审批项目目录

市本级部门保留的行政审批项目(51项)

一、设置、使用无线电台、站(含建设布局和台址)，研制生产无线电发射设备进行实效发射实验(市经济和信息化委员会)

二、市直幼儿园、小学、初级中学(限银州区、铁岭经济开发区)及全市高级中学(含中等职业学校)教师资格认定(市教育局)

三、宗教活动场所的确定(市民族事务委员会)

四、购买、运输、使用危险物品(市公安局)

1．焰火晚会烟花爆竹燃放(B级)

2．枪支携运许可，枪支、弹药运输许可

五、因私出入境(市公安局)

1．公民因私护照

2．大陆居民往来台湾通行

3．台湾居民往来大陆通行

4．前往港澳通行

5．中华人民共和国出入境通行证

6．内地居民赴香港商务3个月多次往返签注

六、安全技术防范设计方案(三级风险等级或者总投资额不足人民币50万元)；金融机构营业场所、金库安全防范设施建设方案审批及工程验收(市公安局)

七、集会、游行、示威[跨县(市)区]，大型群众文化体育活动安全(5000人以上)(市公安局)

八、汽车驾驶员证核发，银州区、铁岭经济开发区区域内的三轮汽车、摩托车驾驶员证核发(市公安局)

1．驾驶员考试及驾驶员证核发

2．驾驶员证到期换证，转入、境外驾驶员证换证

3．驾驶员证补证及注销

4．驾驶员证记满12分、24分考试

九、养犬(限银州区、铁岭经济开发区)和全市范围内豢养特种犬(市公安局)

十、社会团体设立、变更、注销登记(市民政局)

十一、市本级会计从业资格(市财政局)

十二、国有企业处置国有资产(市政府国有资产监督管理委员会)

十三、医疗保险定点医疗机构、零售药店审批(市人力资源和社会保障局)

十四、国有土地使用(市国土资源局)

1．国有土地使用登记

2．国有土地使用权的出让、转让、出租

3．临时用地

十五、采矿权(市国土资源局)

十六、污染物排放(市环境保护局)

1．排污申报登记及排污许可(含办理工商营业执照环保前置)

2．医疗废物集中处置经营

3．危险废物经营

4．使用锅炉的环保

十七、城市道路挖掘及特殊车辆在城市道路(桥梁)上行驶许可(限银州区、铁岭经济开发区)(市住房和城乡建设委员会)

1．特殊车辆(履带车、铁轮车或者超重、超高、超长的车辆)在城市道路上行驶(军车执行任务除外)

2．依附于城市道路建设各种管线、杆线等设施

3．临时挖掘城市道路

4．城市桥梁上架设各类市政管线

5．在城市道路上设置各类检查井等设施

十八、城市规划区范围内改变绿化规划、绿化用地的使用性质、占用绿地及树木砍伐移植、非正常剪修(限银州区、铁岭经济开发区)(市住房和城乡建设委员会)

十九、燃气、液化石油气建站、经营、使用(非居民生活使用)(市住房和城乡建设委员会)

二十、城市排水许可(限银州区、铁岭经济开发区)(市住房和城乡建设委员会)

二十一、物业管理企业资质(三级)(市住房和城乡建设委员会)

二十二、道路运输经营(危货运输、水上旅游、跨县客运及银州区、铁岭经济开发区区域内出租车客运)开业、停业、歇业及变更(市交通局)

二十三、船舶营业运输证、船舶登记证、安全配员证、船员证(市交通局)

二十四、危险货物运输从业人员资格(市交通局)

二十五、跨县(市) 区种子生产、经营(市农村经济委员会)

二十六、植物(种子、种苗)产地检疫及调运检疫(市农村经济委员会)

二十七、市本级种畜禽生产经营许可、兽医执业许可(市畜牧业发展局)

二十八、市管河道范围内建设等活动(市水利局)

1．河道采砂许可

2．护堤林、护岸林采伐

3．占用河道规划保留区土地

4．江河故道、旧堤、原有工程设施填堵、占用或者拆除

5．在河道和水库管理范围进行对河道有不利影响的活动

二十九、取水许可(日平均取地下水3000立方米以上、1万立方米以下)(市水利局)

三十、临时占用林地、辽宁省木材经营加工行政许可决定书(市林业局)

三十一、主要林木种子(不含主要林木良种)生产、经营许可(市林业局)

三十二、出省木材运输、森林植物及产品检疫证明(市林业局)

三十三、非国家重点保护野生动物猎捕、省重点保护野生动物驯养繁殖许可；有益的和有价值的野生动物及其产品出售、收购许可；国家和省重点保护野生动物或其产品运输、邮寄、携带运输证明和准运证(市林业局)

三十四、废金属经营资格审批(市服务业委员会)

三十五、粮食收购企业资格(限银州区、铁岭经济开发区)(市粮食局)

三十六、外商投资企业的合并与分立，权限内中外合资、合作企业合同、章程，外资企业章程及企业撤销审批(市对外贸易经济合作局)

三十七、打字、复印单位的设立(市文化广播电视新闻出版局)

三十八、公共文化设施拆除或者改变功能或用途审批(市文化广播电视新闻出版局)

三十九、医疗机构(含助产技术服务机构、婚前医学检查单位)设置及执业许可(市卫生局)

四十、市属医疗机构执业医师注册(含外籍医师在华短期执业)(市卫生局)

四十一、计划生育技术服务机构从事计划生育技术服务人员合格证(市人口和计划生育委员会)

四十二、政策性特殊情况生育指标(市人口和计划生育委员会)

四十三、拆迁企业资格(限银州区、铁岭经济开发区、铁岭高新技术产业开发区、铁岭新城区)(市城市管理综合行政执法局)

四十四、大型户外广告牌匾设置、城市市容和环境卫生管理方面所涉及的临时占用城市道路(限银州区、铁岭经济开发区)(市城市管理综合行政执法局)

四十五、危险化学品经营许可(乙种)(市安全生产监督管理局)

四十六、生产经营单位(含高危企业)主要负责人、安全生产管理人员及危险物品作业人员安全资格(中直在辽及省属企业除外)，特种作业人员上岗资格(市安全生产监督管理局)

四十七、在人防工程范围内埋设管线和修建地面设施及人防工程改造、拆除、报废(市人民防空办公室)

四十八、拖拉机、联合收割机驾驶员证核发(市农机局)

四十九、导游证及出境游领队证核发(市旅游局)

五十、基本建设项目审批

1．政府性投资(中央专项投资，国债、省专项部分补助资金，市本级财政投资)及《辽宁省企业投资项目核准目录》中规定由市级核准的固定资产投资项目(市发展和改革委员会)

2．建筑工程(含跨市)消防设计审核、验收及公众聚集场所消防安全(总建筑面积2万平方米以上的住宅小区及5000平方米以上的其他建筑工程、建筑面积在800平方米以上的公共聚集场所及3000平方米以上的其他场所)(市公安局)

3．国有土地建设用地(市国土资源局)

4．建设项目环境影响报告书(表)、环保设施竣工验收、建设项目厂址选择的环保、建设工程规划许可和竣工验收[一般项目总投资5000万元以上(房地产项目除外)](市环境保护局)

5．9．66千伏输变电工程项目及移动、联通通信基站建设项目的环境影响评价审批(市环境保护局)

6．建筑施工项目许可(市住房和城乡建设委员会)

(1)施工图设计文件审查

(2)建筑工程施工许可(限银州区、铁岭经济开发区)

(3)在城市管道设施管理范围内施工(限银州区、铁岭经济开发区)

(4)因建设等特殊需要在街道两侧和公共场地临时堆放物料，搭建非永久性建筑物、构筑物或者其他设施(限银州区、铁岭经济开发区)

7．商品房预售许可(限银州区、铁岭经济开发区) (市住房和城乡建设委员会)

8．在河道管理范围内(含水库、渠道)建设项目的立项建设、扩大排污口(市水利局)

9．水利工程建设项目、水土保持方案(市水利局)

(1)水土保持方案审批及水土保持设施竣工验收[跨县(市)区、1O公顷以上20公顷以下]

(2)水利工程开工

(3)建设水工程

(4)建设项目水资源论证报告书、水利基建项目初步设计文件

1O．在文物保护单位范围和建设控制地带内进行建设工作或爆破、钻探等作业，因建设工程对文物保护单位进行迁移、拆除(市文化广播电视新闻出版局)

11．建设项目职业病危害预评价审核(市卫生局)

12．建设项目选址意见书，建设用地、建设工程规划(含临时)许可及竣工验收(限银州区、铁岭新城区)(市规划局)

13．房屋拆迁许可(限银州区、铁岭经济开发区、铁岭高新技术产业开发区、铁岭新城区)(市城市管理综合行政执法局)

14．建设项目安全设施“三同时”审查(市安全生产监督管理局)

15．结合民用建筑修建防空地下室方案、设计，缴纳防空地下室易地建设费及竣工验收(市人民防空办公室)

16．建设工程抗震设防要求(市地震局)

五十一、民办非企业单位设立审批

1．设立中等(含高中，教育网站、校)民办教育学校(市教育局)

2．民办非企业单位成立、变更、注销登记(市民政局)

3．新职业办学、职业介绍机构、民办职业培训机构设立(中级)审批(市人力资源和社会保障局)

中、省直属驻铁部门行政审批项目(54项)

一、出入境检验检疫报检员注册(铁岭出入境检验检疫局)

二、防雷装置设计审核及竣工验收(市气象局)

三、施放气球审批(市气象局)

四、施放气球单位资质认定(市气象局)

五、烟草专卖零售许可(限银州区、铁岭县)(市烟草专卖局)

六、涉外建设项目国家安全事项审批(市国家安全局)

七、占用、利用县级公路(铁岭公路路政管理局)

1．挖掘及改线

2．在县级公路控制区内修建建筑物、构造物和架设、埋设管线设施

3．设置非公路标志

4．超限运输车辆行驶上县级公路(不包括不可解体物品超限运输许可)

八、占用、利用干线公路(铁岭公路路政管理局)

1．干线公路占用、挖掘及改线

2．超限运输车辆行驶上干线公路(跨市)(不包括不可解体物品超限运输许可)

3．在干线公路控制区内修建建筑物、构造物和架设、埋设管线设施

4．设置非公路标志

九、企业动产抵押登记(市工商行政管理局)

十、广告经营许可(市工商行政管理局)

十一、企业名称预先核准(市工商行政管理局)

十二、企业(外资、企业集团)核准登记(市工商行政管理局)

十三、个体工商户核准登记(市工商行政管理局)

十四、食品流通许可证(市工商行政管理局)

十五、制造、修理计量器具单位许可(市质量技术监督局)

十六、特种设备使用登记(市质量技术监督局)

十七、计量标准考核及计量检定机构授权(市质量技术监督局)

十八、计量检定人员检定证核发(市质量技术监督局)

十九、特种设备作业人员培训及证书核发(市质量技术监督局)

二十、组织机构代码证的赋予与IC卡应用维护(市质量技术监督局)

二十一、特种设备作业安装、改造、维修的施工告知(市质量技术监督局)

二十二、计量器具强制检定(市质量技术监督局)

二十三、质量检验机构计量认证(省委托实施)(市质量技术监督局)

二十四、部分工业产品、食品生产许可证(省委托实施)(市质量技术监督局)

二十五、出口企业退(免)税认定(市国家税务局)

二十六、出口货物免抵退税审批(市国家税务局)

二十七、出口企业外购货物视同自产产品退税审批(市国家税务局)

二十八、出口企业延期办理退(免)税审批(市国家税务局)

二十九、企业财产损失所得税税前扣除审批(市国家税务局)

三十、对印制企业冠名发票的审批(市国家税务局)

三十一、对增值税防伪税控系统百万元开票限额的审批(市国家税务局)

三十二、对企业汇总缴纳增值税的审批(市国家税务局)

三十三、对企业汇总缴纳消费税的审批(市国家税务局)

三十四、协定国居民申请享受协定待遇审批(市国家税务局)

三十五、出口退税电子化管理审批(市国家税务局)

三十六、林业综合利用产品增值税即征即退审批(市国家税务局)

三十七、软件产品退税审批(市国家税务局)

三十八、对企业所得税减免的审批(实行分级管理)(市国家税务局)

三十九、开采原油过程中用于加热、修井的原油免征资源税的审批(市地方税务局)

四十、对企业内部的易燃易爆危险品安全防范用地土地使用税减免的审批(市地方税务局)

四十一、外企部分应税合同的印花税困难减免的审批(市地方税务局)

四十二、国家征用房产或收回土地、因城市规划纳税人自行出售房地产，免征土地增值税的审批(市地方税务局)

四十三、土地、房屋被县级以上人民政府征用、占用后，重新承受土地、房屋权属的契税减免的审批(减免税额50万元以下的)(市地方税务局)

四十四、对农业产业化经营重点龙头企业减免契税的审批(减免税额50万元以下的)(市地方税务局)

四十五、企业财产损失所得税税前扣除审批(市地方税务局)

四十六、监狱劳改企业所得税减免审批(市地方税务局)

四十七、转制科研机构减免税审批(市地方税务局)

四十八、贷款卡发放核准(市人民银行)

四十九、银行账户开户许可(市人民银行)

五十、商业银行、信用社代理支库业务审批(市人民银行)

五十一、商业银行、信用社代理乡镇国库业务审批(市人民银行)

五十二、外汇管理的行政许可项目(市人民银行)

五十三、银行业金融机构设立、变更及终止(市银监局)

五十四、银行业金融机构的董事和高级管理人员任职资格(市银监局)

市本级部门日常监管项目(73项)

一、限额以下外商投资项目核准(市发展和改革委员会)

二、行政事业性收费(市物价局)

三、市级单位收取的与市域经济发展密切相关的经营性收费(市物价局)

四、城市公交票价(市物价局)

五、企业技术改造审批(市经济和信息化委员会)

1．《辽宁省企业投资项目核准目录》中市属企业技术改造及目录以外的技术改造项目备案、对鼓励类企业投资项目实行备案

2．3000万美元(含3000万)以上5000万美元(不含5000万)以下外商投资鼓励、允许类技改项目的核准

3．3000万美元(不含3000万)以下外商投资鼓励类享受进口设备免税技改项目的核准

六、铁岭市科技型企业技术研究开发中心认定(市科学技术局)

七、宗教方面的外事活动及跨县(市)区的大型宗教活动(市民族事务委员会)

八、民族成分的鉴别和变更(包括对错误民族成分的更改)(市民族事务委员会、市公安局)

九、招商引资及购房落户(市公安局)

十、三轮车、摩托车、机动车注册、变更登记及转移、抵押(市公安局)

十一、机动车运载超限物品运输路线、时间及在禁止通行道路上行驶审批(市公安局)

十二、特种行业许可证发放(市公安局)

十三、安全技术防范产品销售备案(市公安局)

十四、安全技术防范设施竣工验收审批(市公安局)

十五、社会福利基金资助的基建项目(市民政局)

十六、国家级三级殡仪馆审批(市民政局)

十七、法律援助案件、受援人资格审批(市司法局)

十八、劳教人员所外劳务、外宿劳务审查(市司法局)

十九、市直国有企业产权登记(市政府国有资产监督管理委员会)

二十、介绍外国文教专家来我省工作的境外组织资格及外国专家来我省工作许可(省委托实施)(市人力资源和社会保障局)

二十一、特殊工时制度(市人力资源和社会保障局)

二十二、工伤认定(市人力资源和社会保障局)

二十三、企业职工跨地区调动、退休审批及招工(招聘广告)(市人力资源和社会保障局)

二十四、《工资总额使用手册》及工资总额同经济效益挂钩方案审核(市人力资源和社会保障局)

二十五、台港澳人员在我省就业许可(市人力资源和社会保障局)

二十六、工伤保险费率审定(市人力资源和社会保障局)

二十七、城市垃圾处理及环卫设施增减、变更(限银州区、铁岭经济开发区)(市住房和城乡建设委员会)

二十八、市政公用设施拆改迁移(限银州区、铁岭经济开发区)(市住房和城乡建设委员会)

二十九、市管风景名胜区内各项服务(市住房和城乡建设委员会)

三十、城市新建、扩建、改建工程项目需增加用水的审批(市住房和城乡建设委员会)

三十一、液化石油气运输车辆注册登记(市住房和城乡建设委员会)

三十二、城市供水日调水30万吨(含30万吨)以下供水工程的核准(市住房和城乡建设委员会)

三十三、按项目规模界定垃圾、污水、道路建设等城建项目的审批(市住房和城乡建设委员会)

三十四、施工总承包序列三级资质核准(市住房和城乡建设委员会)

三十五、专业承包序列三级资质核准(市住房和城乡建设委员会)

三十六、房地产开发企业四级资质、暂定资质(市住房和城乡建设委员会)

三十七、房地产估价机构资质(市住房和城乡建设委员会)

三十八、营业性道路运输驾驶员从业资格(市交通局)

三十九、汽车驾驶员、修理工技能鉴定《职业资格证书》核发(市交通局)

四十、不可解体物品超限运输许可、路树砍伐许可(市交通局)

四十一、渔业船舶登记、渔业船舶普通船员证书(五等)(市水利局)

四十二、水产苗种生产许可、水产养殖使用许可(市水利局)

四十三、大．中型水库移民后期扶持规划(年度600元以内／每人)项目审批(市水利局)

四十四、林木种子调运(市林业局)

四十五、报废汽车回收企业资格认定(市服务业委员会)

四十六、再生资源回收经营者备案登记证明(市服务业委员会)

四十七、生猪定点屠宰企业设立(市服务业委员会)

四十八、酒类批发经营临时性许可(市服务业委员会)

四十九、权限内外商投资企业投资者股权质押、资产抵押及其解押(市对外贸易经济合作局)

五十、新闻出版活动(市文化广播电视新闻出版局)

1．音像制品批发单位的设立

2．电子出版物批发单位、出版物连锁经营单位的设立

3．报刊批发单位、申请从事书报刊批发业务单位的设立，报刊登记项目变更及报刊临时增版、增期、期刊增刊

4．内部资料性(非宗教内容)出版物准印许可

五十一、拍摄市级文物保护单位审批(市文化广播电视新闻出版局)

五十二、电影放映许可(市文化广播电视新闻出版局)

五十三、互联网上网服务营业场所的设立(市文化广播电视新闻出版局)

五十四、广播电台、电视台开办群众参与的广播电视直播节目审批(实行分级管理)(市文化广播电视新闻出版局)

五十五、麻醉药品、第一类精神药品购用证明核发(市卫生局)

五十六、放射性诊疗许可及放射工作人员证明(市卫生局)

五十七、药品经营(零售)企业、医疗用毒性药品零售企业批准(市食品药品监督管理局)

五十八、第一类医疗器械产品注册审批(市食品药品监督管理局)

五十九、计划生育技术服务机构执业许可(市人口和计划生育委员会)

六十、对银州区及铁岭经济开发区辖区内的商品流通、交易市场的新建、改建进行审核、审批(市城市管理综合行政执法局)

六十一、二级社会体育指导员、裁判员、运动员资格审批(市体育局)

六十二、体育类民办非企业单位成立、变更、注销登记前置审查(市体育局)

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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.