您的位置: 首页 » 法律资料网 » 法律法规 »

国家发展改革委办公厅关于请组织申报高性能纤维复合材料高技术产业化专项的通知

时间:2024-07-08 12:44:32 来源: 法律资料网 作者:法律资料网 阅读:9459
下载地址: 点击此处下载

国家发展改革委办公厅关于请组织申报高性能纤维复合材料高技术产业化专项的通知

国家发展和改革委员会办公厅


国家发展改革委办公厅关于请组织申报高性能纤维复合材料高技术产业化专项的通知

发改办高技[2007]3177号


各省、自治区、直辖市、计划单列市及新疆生产建设兵团发展改革委,国务院有关部门、直属机构办公厅,有关中央管理企业,有关单位:

根据《国民经济和社会发展第十一个五年规划纲要》和《高技术产业发展“十一五”规划》,为满足国民经济和社会发展的需求,促进新材料产业的发展,我委决定于2008-2009年组织实施高性能纤维复合材料高技术产业化专项。现将有关事项通知如下:
一、专项的主要内容
高性能纤维复合材料是指用高性能纤维与高性能基体按性能设计要求,用专门的工艺复合而成的一类新型工程材料,是新材料产业发展的重要方向之一。发展高性能纤维复合材料,对促进国民经济的发展,提升国家的综合实力起着重要的作用。根据我国新材料产业的现状及发展目标,按照“加速发展新材料产业,满足国家重大需求”的原则,专项重点支持碳纤维、芳纶纤维、高强聚乙烯纤维及其高性能复合材料的生产技术及关键装备的产业化示范,满足国民经济以及航空航天等高技术产业发展的总体需求。具体如下:
(一)高性能碳纤维复合材料。开展高性能碳纤维及复合材料的产业化、研发以及相关标准的制定,重点支持千吨级高性能碳纤维和聚丙烯腈原丝生产工艺技术,预氧化炉、碳化炉等大型关键设备制造,纺丝油剂、碳纤维上浆剂、预浸料等重要辅助材料,以及高性能树脂基体材料、高性能碳纤维复合材料应用技术等的产业化;制定和完善高性能碳纤维生产、产品和应用的相关标准。
(二) 高性能芳纶纤维复合材料。开展高性能芳纶及复合材料的产业化,重点支持千吨级芳纶-II生产工艺技术、关键技术装备,以及高性能芳纶-II复合材料关键生产工艺技术等的产业化。
(三)超高强聚乙烯纤维复合材料。开展超高强聚乙烯纤维及复合材料的产业化,重点支持超高强聚乙烯纤维及复合材料生产工艺技术、关键技术装备、表面改性技术等的产业化;以及超高强聚乙烯纤维在海洋工程、交通、通讯等领域应用技术的产业化。
二、专项的实施目标
实施高性能纤维复合材料高技术产业化专项的主要目标是突破制约我国高性能纤维及复合材料产业发展的关键技术瓶颈,缩小我国同发达国家的差距,带动相关产业的技术升级和发展,提高我国高性能复合材料设计、制造和开发应用的水平,建立一批具有我国自主知识产权和创新能力的新型产业群和研发基地,培育一批具有国际竞争力的龙头企业,加快提升我国新材料产业的自主创新能力。
三、专项实施的原则
为确保高性能纤维复合材料高技术产业化专项能够取得应有的效果,在专项的组织实施过程中,要把握好以下原则:
(一)鼓励自主创新。着重推动具有我国自主知识产权成果和自有品牌产品的产业化,促进我国产业技术基础和优势领域的形成。
(二)促进产学研用联合。重点支持合作关系清晰、合作实体明确、合作任务落实的产学研用合作项目。
(三)培育龙头企业。充分运用市场机制,发挥国家投资的引导作用,充分带动社会资源投资新材料领域,培育具有较强技术开发能力和市场竞争力的龙头企业。
(四)重视项目的产业化基础和申报单位的建设条件。申报单位应具备较强的研发、管理、筹资等方面的能力。
四、具体要求和进度安排
(一)专项项目应按照我委颁布的《国家高技术产业发展项目管理暂行办法》(国家发展改革委令第43号),开展项目组织、资金申请报告编制和申报工作。
(二)主管部门要严格审查项目的产业化基础和申报单位的建设条件。申报单位(包括技术依托单位)应是行业或区域有实力、影响力的单位,应具备较强的技术开发、经营管理、资金筹集等方面的能力。项目需要提供有关部门出具的相关生产许可文件。
(三)项目主管部门应对资金申请报告及相关附件(如银行贷款承诺、自有资金证明、生产许可文件等)进行认真核实,并负责对其真实性予以确认。
(四)每个项目主管部门申报项目的数量原则上不超过3项。
请你们对已完成项目备案程序、并符合专项重点内容的项目进行认真审查,组织编写资金申请报告(具体要求见附件),于2008年4月15日前,将项目资金申请报告、项目简介和有关附件等材料一式三份报送我委,同时提供电子文本。
在项目主管部门申报的基础上,我委将按照公正、公平的原则组织专家评选,择优支持。
特此通知。


附件:国家高技术产业化项目资金申请报告编制要点





国家发展和改革委员会办公厅

二〇〇七年十二月二十四日



主题词:高技术 新材料 专项 通知


附件:


国家高技术产业化项目资金申请报告编制要点



一、项目意义和必要性。国内外现状和技术发展趋势,对产业发展的作用与影响,产业关联度分析,市场分析,与国家高技术产业化专项总体思路、原则、目标等关联情况。
二、项目技术基础。成果来源及知识产权情况,已完成的研究开发工作及中试情况和鉴定年限,技术或工艺特点以及与现有技术或工艺比较所具有的优势,该重大关键技术的突破对行业技术进步的重要意义和作用。
三、项目建设方案。项目的产能规模、建设的主要内容、采用的工艺技术路线与技术特点、设备选型及主要技术经济指标、建设地点、建设工期和进度安排、建设期管理等。
四、项目投资。项目总投资规模,投资使用方案、资金筹措方案以及贷款偿还计划。
五、环境保护、资源综合利用、节能与原材料供应及外部配套条件落实情况等。其中节能分析章节按照《国家发展改革委关于加强固定资产投资项目节能评估和审查工作的通知》(发改投资[2006]2787号)要求进行编写。
六、项目法人基本情况。项目法人的所有制性质,主营业务,近三年来的销售收入、利润、税金、固定资产、资产负债率、银行信用等级,项目负责人基本情况及主要股东的概况等。
七、项目财务分析、经济分析及主要指标。内部收益率、投资利润率、投资回收期、贷款偿还期等指标的计算和评估,项目风险分析,经济效益和社会效益分析。
八、项目招标内容(适用于申请国家补贴资金500万元及以上的投资项目),并填写招标事项核准意见(见附表),主管部门提出初审意见并盖章。
九、资金申请报告附件:
1、银行承贷证明(省分行以上)文件;
2、项目法人近三年的经营状况(包括损益表、资产负债表、现金流量表)和项目法人自筹资金保证落实文件;
3、地方、部门配套资金及其它资金来源证明文件;
4、前期科研成果证明材料(需经权威机构认证或出具技术检测报告、专利证书等);前期科研成果的成熟度,应能够满足产业化试验或产业化示范的要求;
5、相应的环境保护主管部门意见;
6、城市规划部门出具的城市规划选址意见(适用于城市规划区域内的项目);
7、有关部门出具的产品生产、经营许可文件等;
8、土地、重要原材料以及其它所需证明材料;
9、政府投资项目需提供可行性研究报告的批准文件,企业投资项目需提供核准或备案的批准文件(在有效期内且未满两年);已开工项目需提供投资完成、工程进度以及生产情况证明材料;
10、项目单位填报对项目资金申请报告内容和附属文件真实性负责的声明。



附表:



招标事项核准意见



基本条目
招标范围
招标组织形式
招标方式
不采用招标方式

全部

招标
部分

招标
自行

招标
委托

招标
公开

招标
邀请

招标

勘查








设计








建筑工程








安装工程








监理








主要设备








重要材料








其他








审评部门核准意见说明:



(此栏由主管部门填写具体意见)





                        

                      年  月  日




注:在空格中打“∨”

丽水市食品卫生监督管理办法

浙江省丽水市人民政府


丽水市食品卫生监督管理办法

丽政令〔2003〕33号


《丽水市食品卫生监督管理办法》已经市人民政府第19次常务会议审议通过,现予发布,自2003年3月1日起施行。







二○○三年一月二十四日


  
  
丽水市食品卫生监督管理办法




  
  第一章 总 则
  
  第一条 为保证食品卫生,防止食品污染和有害因素对人体的危害,保障人民身体健康,增强人民体质,根据《中华人民共和国食品卫生法》(以下简称《食品卫生法》)等有关法律、法规的规定,结合我市实际,制定本办法。


  第二条 凡在本市行政区域内从事食品生产经营的,都必须遵守本办法。


  本办法适用于一切食品、食品添加剂、食品容器、包装材料和食品用工具、设备、洗涤剂、消毒剂,也适用于食品的生产经营场所、设施、有关环境。


  第三条 市卫生行政部门主管全市食品卫生监督管理工作,县(市、区)卫生行政部门负责本行政区域内食品卫生监督管理工作。


  计划、工商、建设、土地、公安、农业、环保、旅游、技术监督等部门按照各自的职责做好食品卫生管理工作。
  
  第二章 食品的卫生
  
  第四条 食品应当无毒无害,符合应当有的营养要求和国家卫生标准,具有相应的色、香、味等感官性状。


  第五条 禁止生产经营下列食品:


  (一) 腐败变质、油脂酸败、霉变、生虫、污秽不洁、混有异物或其他感官性状异常,可能对人体健康有害的;


  (二) 含有毒、有害物质或者被有毒、有害物质污染,可能对人体健康有害的,如河豚鱼、毒蘑菇、织纹螺等含有毒有害的动植物食品与掺入罂粟壳等有毒、有害物质的食品;


  (三) 含有致病性寄生虫、微生物的,或者微生物毒素含量超过国家限定标准的;

 
  (四) 未经兽医卫生检验或者检验不合格的肉类及其制品;


  (五) 病死、毒死或死因不明的禽、畜、兽、水产等及其制品;


  (六) 容器包装污秽不洁、严重破损或运输工具不洁造成污染的;


  (七) 掺假、掺杂、伪造,影响营养、卫生的;


  (八) 用非食品原料加工的,加入非食品用物质的或者将非食品当作食品的;


  (九)用非食用化学物品浸泡水产品、畜禽产品或者注水的肉类、家禽、水产品;


  (十)超过保质期限的;


  (十一)含有未经国务院卫生行政部门批准使用的添加剂或者超过标准使用添加剂的;


  (十二)使用高毒、高残留农药或者农药残留量超过国家规定标准的;


  (十三)加药的食品,但是按照传统既是食品又是药品的作为原料、调料或者营养强化剂加入的除外;


  (十四)未经国家卫生部批准的新资源食品;


  (十五)无卫生许可证生产的食品;


  (十六)未按规定进行检验或者检验不合格的食品;


  (十七)不符合国家卫生标准或者卫生管理办法的进口食品;


  (十八)为防病等特殊需要,国家卫生部或者省、市人民政府专门规定禁止出售的食品;


  (十九)其他不符合食品卫生标准和卫生要求的。
  
  第三章 食品生产经营过程的卫生
  
  第六条 食品生产加工单位通用卫生要求:


  (一)生产加工场所内外环境清洁,远离粪堆(缸)、厕所、垃圾存放场所等污染源20米以上。


  (二)生产加工场所有良好的采光、照明、通风和有效的防蝇、防尘等设施。


  (三)设置运转良好的清洗、洗手、消毒、更衣等卫生设施。


  (四)从业人员上岗操作时应穿戴清洁工作衣帽,保持手部清洁;接触直接入口食品人员应第二次更换工作衣帽、戴口罩。从业人员不得戴戒指等手饰上岗,不得在加工场所吸烟。


  (五)食品生产加工所用的原、辅料和食品添加剂、营养强化剂、接触食品的容器包装材料,以及食品用洗涤剂和消毒剂应当符合卫生标准和卫生要求。


  (六)具有与生产加工规模相适应的原料存放、粗加工、半成品、成品等室、仓库以及合理的工艺流程。


  (七)厂房或加工场所地面应由防水、不吸潮、可洗刷的材料建造,具有一定坡度,易于清洗,并有良好的污水排放系统。

  
  (八)墙体须有1.5米以上的瓷砖或其他防水、防潮、可清洗的材料制成的墙裙。


  (九)生产(加工)用水必须符合生活饮用水标准。


  (十)定型包装的成品或按规定要求检验合格方能出厂销售的食品,必须按照国家有关卫生标准检验合格后方可出厂。


  (十一)食品运输工具保持整洁卫生,运输过程应防止食品污染。


  第七条 食品经营企业除禁止销售本办法第五条规定的食品外,还禁止销售下列食品:


  (一)无产品名称、无厂名和厂址、无生产日期和保质期的食品;


  (二)无中文标识的进口食品;


  (三)非保健食品冒充保健食品以及保健食品夸大保健作用或宣传疗效的食品。


  第八条 食品经营企业采购食品应向供货方索取食品卫生许可证和该产品的检验(检疫)合格证。


  第九条 经营非定型包装的直接入口食品,应有清洁外罩等防蝇、防尘设施。销售时,从业人员应穿戴工作衣帽,保持手部清洁,并使用专用取货工具,附带清洁无菌的包装材料,货款分开,防止食品污染。


  第十条 食品经营企业的仓储应设专用的库、架,各类食品应隔墙离地分类存放,先进先出;场所应有相应的防潮、防霉、防蛀、防鼠或其它防虫害的设施;不得存放与食品无关的其它物品;须冷冻、冷藏的食品,存放场所应符合相应的温度条件。
第十一条 食品经营企业运输食品的工具应专用,并保持清洁,防止食品污染。


  第十二条 餐饮服务业通用卫生要求:


  (一)饮食作业场所和周围环境要保持清洁,作业场所必须远离粪堆(缸)、厕所、垃圾堆放场所等污染源20米以上,并有防蝇、防尘等设施。


  (二)饮食业经营者采购的食品必须符合国家有关卫生标准和要求。


  (三)饮食业贮存食品的场所、设备应当保持清洁,无霉斑、鼠迹、苍蝇、蟑螂,并禁止存放有毒有害物品和个人生活用品。食品应当分类、分架、隔墙离地存放,并定期检查。


  (四)必须保证食品原料或半成品的卫生质量,发现超过保质期、腐败变质或含有毒有害的应及时处理,不得使用或销售。


  (五)生、熟食品分开贮存,生、熟食品加工的用具、容器要分开,并要有明显标志,可直接入口的或半成品食品盛放应有防蝇、防尘等设备。


  (六)严禁重复使用一次性使用的餐饮具,不得使用无证生产和未经检验或检验不合格的一次性餐饮具、餐巾、餐纸等产品。

 
  (七)餐饮具使用前必须彻底清洗、消毒,符合国家有关卫生标准,同时还应符合下列卫生要求:


  1、洗刷餐饮具必须要用有明显标记的专用水池,不得与清洗蔬菜、肉类等其他水池混用;


  2、洗涤、消毒餐饮具所使用的洗涤剂、消毒剂必须符合国家有关食品用洗涤剂、消毒剂的卫生标准和要求;


  3、消毒后的餐饮具必须贮存在餐饮具专用保洁柜内备用,并在贮存柜上有明显标记。


  (八)禁止使用非食品用包装物包装食品。


  (九)食品从业人员必须做到:工作前洗手,勤剪指甲,勤理发;上岗时穿戴清洁工作衣帽,不吸烟,不戴手饰。


  (十)饮用水质应符合国家生活饮用水卫生标准。
  
  第四章 食品卫生监督与管理
  
  第十三条 食品生产经营企业新建、改建、扩建工程和食品集市贸易场所的选址、设计,应当符合卫生要求。其设计审查和工程验收,召集单位应当通知卫生行政部门参加。


  第十四条 举办临时食品集市,举办者应向所在地卫生行政部门报送参展单位(户)和食品的相关材料,并协助卫生行政部门进行监督管理。

 
  第十五条 食品生产经营者必须先取得卫生行政部门发放的卫生许可证,方可向工商行政管理部门申领营业执照。未取得卫生许可证的,不得从事食品生产经营活动。


  卫生许可证应悬挂上墙,并易于查看。


  第十六条 食品生产经营人员(包括临时工作人员),每年必须进行健康检查。健康检查由县级以上卫生行政部门指定的有资质的医疗卫生机构负责实施。食品生产经营人员必须按照国家和省卫生行政部门的规定,接受食品卫生知识和食品卫生法律、法规知识的培训并经考核合格后,方可从事生产经营工作。


  患有痢疾、伤寒、病毒性肝炎等消化道传染病者(包括病原携带者),活动性肺结核、化脓性或渗出性皮肤病以及其他有碍食品卫生的疾病的人员,不得从事直接入口食品的工作。


  第十七条 食品生产经营单位应当建立本单位的食品卫生管理制度,配备专职或兼职的食品卫生管理人员,对其生产经营的食品进行管理。


  第十八条 县级以上卫生行政部门应当秉公执法,实行行政执法责任制,建立健全巡回监督检查和监督监测制度,加强对食品和食品用产品的检查、监测,并公布食品卫生检查、监测结果。


  第十九条 县级以上卫生行政部门应当建立健全食品卫生监督举报制度,公布举报电话。


  第二十条 县级以上卫生行政部门设立食品卫生监督员。食品卫生监督员由符合国家和省卫生行政部门规定条件的专业人员担任,由同级卫生行政部门发给证书。


  食品卫生监督员应当严格遵守法律、法规的有关规定,切实履行食品卫生监督职责。


  第二十一条 为有效防止食物中毒事件的发生,可以实行大型聚餐申报制度,由各县(市、区)人民政府结合本地实际,制定相应管理办法。


  第二十二条 食物中毒或其它食源性疾患的防治,应当纳入乡(镇)政府、街道办事处社会综合管理目标考核内容。


  第二十三条 发生食物中毒的单位和接收病人进行治疗的单位应当采取抢救措施,并根据国家有关规定及时向当地卫生行政部门报告。


  各级卫生监督所负责食物中毒的现场调查和控制;疾病预防控制中心负责样品的检验并协助现场调查;医疗单位应当协助调查。


  第二十四条 城乡从事大型聚餐的厨师必须取得健康合格证明和食品卫生知识培训考核合格证明后方可从业,并在县级以上卫生监督所建立备查档案,由其所在地的乡(镇)政府、街道办事处、村委会(居委会)协助做好管理工作。
  
  第五章 法律责任
  
  第二十五条 生产经营禁止生产经营的食品的,按照《食品卫生法》和《浙江省实施〈中华人民共和国食品卫生法〉办法》的有关规定予以处罚。

 
  生产经营不符合卫生标准的食品,造成食物中毒事故或其它食源性疾患的,按照《食品卫生法》第三十九条规定予以处罚。

 
  第二十六条 食品生产经营过程不符合卫生要求的,按照《食品卫生法》第四十一条规定予以处罚。


  第二十七条 未取得卫生许可证从事食品生产经营活动的,按照《食品卫生法》第四十条规定予以处罚。


  第二十八条 食品生产经营人员未取得健康证明而从事食品生产经营活动的,或患有疾病不得接触直接入口食品的生产经营人员不按规定调离的,按照《食品卫生法》第四十七条规定予以处罚。
第二十九条 食品生产经营人员未取得食品卫生知识培训考核合格证明从事食品生产经营的,按照《浙江省实施〈中华人民共和国食品卫生法〉办法》第三十七条规定予以处罚。


  第三十条 食品卫生监督管理人员滥用职权、玩忽职守、徇私舞弊,不履行职责,造成重大事故,构成犯罪的,依法追究刑事责任;不构成犯罪的,给予行政处分。
  
  第六章 附 则
  
  第三十一条 本办法下列用语的含义是:


  食品经营企业(行业):是指从事食品成品、半成品、原料销售服务的农贸(菜)市场、粮油批发市场、食品商行(超市)、副食品店(包括仓储)等销售服务企业(行业)。


  大型聚餐:是指城乡居民自行举办的、就餐人数为50人以上的集体聚餐。


  第三十二条 酒类、调味品、粮油、肉品屠宰、糕点、冷饮与饮料、乳与乳制品、豆制品、熟肉制品、炒货制品等生产加工过程的特殊卫生要求由市卫生行政部门另行公布。


  酒家或酒店、快餐或小炒、早点、茶座、熟食零售、街头食品等餐饮服务业的特殊卫生要求由市卫生行政部门另行公布。


  第三十三条 本办法自2003年3月1日起施行。
  




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.