中新网2月3日电 据国家食品药品监督管理局网站消息，国家食品药品监督管理局日前发布通知，要求要求做好进口药品电子监管的相关工作。

February 3, according to the state food and drug administration website news,State food and drug administration issued a notice,Requirements for imported drugs do electronic supervision of the relevant work.

　　为落实国家食品药品监督管理局《关于印发2011-2015年药品电子监管工作规划的通知》(国食药监办〔2012〕64号)等有关工作要求，日前，国家食品药品监督管理局就进口药品实施电子监管有关事宜印发通知。

For the implementation of the state food and drug administration[About 2011-2015 issued by the drug electronic monitoring program of work of the notice](Countries food also do [2012] no. 64)And other relevant job requirements,a,State food and drug administration imported drug implement electronic supervision issued by the relevant matters notice.

　　通知指出，境外制药厂商(即《进口药品注册证》或《医药产品注册证》“公司名称”项下企业)应对其进口到我国药品的电子监管实施工作负总责，按国家食品药品监督管理局规定品种和期限实施药品电子监管，并应在我国境内指定一家药品生产企业、药品批发企业、其在境内设立的子公司或办事机构，作为其药品电子监管工作的代理机构(以下简称电子监管代理机构)。境外制药厂商应授权委托其电子监管代理机构作为同我国药品监督管理部门和相关机构的固定联系单位，协助其在境内办理实施药品电子监管有关事务，并可协助境外工厂进行电子监管码申请、数据上传及相关的药品召回等具体工作。

Notice points out that,Overseas pharmaceutical manufacturers(namely[Imported drug registration certificate]or[Pharmaceutical products registration certificate]"Company name"Captioned enterprise)Deal with the imported into our drug electronic monitoring implementation overall responsibility,According to the state food and drug administration regulations varieties and term implementation drug electronic monitoring,And in China should be designated a pharmaceutical production enterprise/Pharmaceutical wholesale enterprises/Its subsidiary in China or offices,As its drug electronic supervision work of the agency(Hereinafter referred to as the electronic supervision agency).Overseas pharmaceutical manufacturers shall authorize the electronic supervision agency as in our country with the pharmaceutical supervisory and administrative departments and organizations of the fixed contact unit,To assist the implementation in China to deal with drug electronic monitoring relevant affairs,And can assist overseas factory electronic monitoring code application/Upload data and related drug recall specific work.

　　通知强调，境外制药厂商应按国家食品药品监督管理局《药品电子监管工作指导意见》和《药品电子监管技术指导意见》要求开展进口药品电子监管实施工作。赋码工作(包括建立各级药品包装的关联关系)应在进口药品注册证书载明的生产厂或包装厂内完成。获得批准在境内分包装的品种，可在批准的分包装企业内赋码。禁止在其他场所将已完成大包装的产品拆箱赋码。因互联网通讯等问题，在境外访问中国药品电子监管网存在困难时，可委托电子监管代理机构代为申请电子监管码，上传赋码、关联关系数据以及药品入库、出库数据，进行核注核销。应在2013年12月31日前实施电子监管的进口药品，其电子监管代理机构应在2013年2月28日前提交报告，并将相关机构加入中国药品电子监管网。此前已入网进口企业，亦应按《进口药品企业入网登记表》要求补报所需信息。2013年1月1日以后新增补的国家和地方基本药物，其境外制药厂商未指定电子监管代理机构的应及时指定，并按本通知要求报告信息、办理入网登记，在新目录发布后12个月内完成相关进口药品的赋码，并开展核注核销等工作。。

Notice emphasizes,Overseas pharmaceutical manufacturers should be according to the state food and drug administration[Drug electronic supervision work instruction opinion]and[Drug electronic monitoring technical guidance]For the imported drugs in electronic supervision and implementation work.Fu code work(At all levels including establish drug packaging relationship)In the imported drugs shall be specified in the registration certificate within a manufacturing plant or packaging plant.Approved in domestic points packaging varieties,May, within the approved points within the packaging enterprise fu code.Banned in other places will have completed packaging products devanning fu code.Because of the Internet communication problems,In the overseas visit China electronic supervision network drugs when difficulty,Can entrust electronic supervision agency to apply for electronic monitoring code,Upload fu code/The relationship data and drug/Outbound data,Nuclear note cancel after verification.Should be in before December 31, 2013 implementation of electronic supervision of imported drugs,The electronic supervision agency should be in February 2013 and submit report,And the related institutions to join China's drug electronic monitoring network.Had the net import enterprise,Should also be according to[Imported drugs into the enterprise registration form]Request information owed.After January 1, 2013 new follow-up state and local basic drugs,Its overseas pharmaceutical manufacturer has not designated electronic supervision agency should be specified,And according to the notice requirements report information/Registration for access,In the new directory release of 12 months after complete the relevant import drug fu code,And to carry out nuclear note cancel after verification, etc..

　　通知要求，各省级药品监督管理部门应根据国家食品药品监督管理局网站公开的进口药品电子监管代理机构名单和进口药品数据，将该代理机构及所代理境外制药厂商注册的全部进口药品纳入本级药品电子监管监督实施工作范围，对电子监管代理机构开展培训、指导，督促其境外制药厂商按规定时限、品种和要求完成电子监管相关工作。对违反规定拆箱赋码的应责令其立即改正。口岸药品监督管理局要按照国家食品药品监督管理局规定的电子监管品种实施时限，在进口备案审查时对应实施电子监管品种按其标示生产日期查验产品赋码情况，未按要求赋码者不予办理进口备案，并通报其电子监管代理机构所在地省级食品药品监督管理部门。口岸药品监督管理局对应于2013年12月31日前实施电子监管的品种，自2014年1月1日开始查验。此日期后生产的产品须按规定赋码，方可办理进口备案；此日期前已生产的未赋码产品最迟应于2014年4月30日前完成进口备案，逾期不予办理。

Notice requirements,The pharmaceutical supervisory and administrative departments at the provincial level shall be according to the state food and drug administration website open imported drugs electronic supervision agency list and imported drugs data,The agency and overseas pharmaceutical manufacturers registered agent all the imported drugs into the drug electronic supervision supervision and implementation scope of work,The electronic supervision agency to carry out training/guidance,Supervise and urge its overseas pharmaceutical manufacturers time limit in accordance with the provisions/Variety and complete the required electronic supervision related work.In violation of provisions devanning fu code should instruct its immediate correction.The port drug administration according to the provisions of the state food and drug administration of the electronic supervision varieties implementation time limit,In the import record during the implementation of the corresponding electronic supervision varieties according to the date of production inspection mark product ode code situation,Not according to requirements fu code is not for import record,And announced to the electronic supervision agency the local provincial food and drug supervision and administration department.The port drug administration corresponding to the before December 31, 2013 implementation of electronic supervision varieties,Since January 1, 2014 start inspection.After this date the production of products in accordance with the provisions shall assign code,Can for import record;This has not before the date of the production of fu code product is due in 2014 April 30 complete import record,Overdue shall not process the.