皇冠篮球比分网

皇冠篮球比分网
广东省发展改革委 广东省财政厅关于明确我省药品 医疗器械产品注册收费标准及有关问题的通知

广东省发展改革委 广东省财政厅关于明确我省药品 医疗器械产品注册收费标准及有关问题的通知

XINXILAIYUAN:JIAGEZONGHEYUSHOUFEIGUANLICHUSHIJIAN:2019-02-19 18:05

皇冠篮球比分网YUEFAGAIJIAGEHAN〔2019〕666HAO  

 

SHENGYAOPINJIANDUGUANLIJU:

皇冠篮球比分网  《GUANYUSHENQINGJIXUANWOSHENGXIANXINGSHENGJIYAOPIN、YILIAOQIXIECHANPINZHUCESHOUFEIBIAOZHUNSHOUFEIDEHAN》(YUEYAOJIANJUCAIHAN〔2018〕34HAO)SHOUXI。GENJUCAIZHENGBU GUOJIAFAZHANGAIGEWEI《GUANYUZHONGXINFABUZHONGYANGGUANLIDESHIPINYAOPINJIANDUGUANLIBUMENXINGZHENGSHIYEXINGSHOUFEIXIANGMUDETONGZHI》(CAISHUI〔2015〕2HAO)JIGUOJIAFAZHANGAIGEWEI CAIZHENGBU《GUANYUYINFA〈YAOPIN、YILIAOQIXIECHANPINZHUCESHOUFEIBIAOZHUNGUANLIBANFA〉DETONGZHI》(FAGAIJIAGE〔2015〕1006HAO)GUIDING,JINGSHENGRENMINZHENGFUTONGYI,XIANJIUWOSHENGYAOPIN、YILIAOQIXIECHANPINZHUCESHOUFEIBIAOZHUNYOUGUANWENTITONGZHIRUXIA:

  YI、YAOPIN、YILIAOQIXIECHANPINZHUCEFEI,SHIZHIYAOPINJIANDUGUANLIBUMENXIANGYAOPIN、YILIAOQIXIECHANPINZHUCESHENQINGRENSHOUQUDEZHUCESHOULI、SHENPING、XIANCHANGJIANCHA(YILIAOQIXIECHANPINZHUCEWEIZHILIANGGUANLITIXIHECHA,XIATONG)DENGFEIYONG。

  ER、SHENGJIYAOPINJIANDUGUANLIBUMENZAISHOULIBUGAIBIANYAOPINNEIZAIZHILIANGDEGUOCHANYAOPINBUCHONGZHUCESHENQINGHEGUOCHANYAOPINZAIZHUCESHENQINGSHI,KEXIANGSHENQINGRENSHOUQUXIANGYINGFEIYONG。JUTISHOUFEIXIANGMUBAOKUO:YAOPINBUCHONGSHENQINGZHUCEFEI(CHANGGUIXIANG)、YAOPINBUCHONGSHENQINGZHUCEFEI(XUJISHUSHENPING)HEYAOPINZAIZHUCEFEI。SHOUFEIBIAOZHUNJIANFUBIAO1。

皇冠篮球比分网  SAN、SHENGJIYAOPINJIANDUGUANLIBUMENZAISHOULIJINGNEIDIERLEIYILIAOQIXIECHANPINZHUCESHENQINGSHI,KEXIANGSHENQINGRENSHOUQUXIANGYINGFEIYONG。JUTISHOUFEIXIANGMUBAOKUO:SHOUCIZHUCEFEI、BIANGENGZHUCEFEI、YANXUZHUCEFEI。YILIAOQIXIECHANPINZHUCESHOUFEIAN《YILIAOQIXIEZHUCEGUANLIBANFA》《TIWAIZHENDUANSHIJIZHUCEGUANLIBANFA》QUEDINGDEZHUCEDANYUANJISHOU。SHOUFEIBIAOZHUNJIANFUBIAO2。

  SI、FUHE《ZHONGXIAOQIYEHUAXINGBIAOZHUNGUIDING》(GONGXINBULIANQIYE〔2011〕300HAO)TIAOJIANDEZHUCESHENQINGREN,JINGRENDINGSHUYUSHENQINGCHUANGXINYILIAOQIXIECHANPINZHUCEDE,KEANZHAOGUOJIASHIPINYAOPINJIANDUGUANLIZONGJUGONGGAO(2015NIANDI53HAO)GUIDING,SHENQINGMIANSHOUSHOUCIZHUCEFEI。

  WU、YAOPINJIANDUGUANLIBUMENZAISHOUQULEYAOPIN、YILIAOQIXIECHANPINZHUCEFEIHOU,BUDEZAISHENPING、XIANCHANGJIANCHAGUOCHENGZHONGZAIXIANGYAOPIN、YILIAOQIXIECHANPINZHUCESHENQINGRENSHOUQUBENGUIDINGZHIWAIDEQITARENHEFEIYONG。

  LIU、YAOPIN、YILIAOQIXIECHANPINZHUCEFEISHUYUXINGZHENGSHIYEXINGSHOUFEI,SHOUFEIDANWEIYAOYANGEANGUIDINGGONGSHISHOUFEIBIAOZHUN,QUANESHANGJIAOGUOKU,NARUCAIZHENGYUSUANGUANLI,ZIJUEJIESHOUJIAGE、CAIZHENGBUMENDEJIANDUJIANCHA。SHENGYAOPINJIANDUGUANLIBUMENXUYUMEINIAN3YUEDIZHIQIANJIANGBENDANWEISHANGYINIANDUYAOPIN、YILIAOQIXIECHANPINZHUCEFEISHOUFEIQINGKUANG,BAOKUOSHOUFEIXIANGMU、SHOUFEISHULIANG、SHOUFEIJINE、CAIZHENGBOKUAN、FEIYONGZHICHUDENG,SHUMIANBAOGAOSHENGFAZHANGAIGEWEI、SHENGCAIZHENGTING。

皇冠篮球比分网  2019NIAN1YUE13RIZHIBENTONGZHIFABUZHIRIQIJIANYISHOULIDESHENQING,ZHUCESHOUFEIBIAOZHUNANBENTONGZHIGUIDINGZHIXING。ZHIXINGQIJIANRUYUGUOJIAHESHENGXIANGGUANSHOUFEIZHENGCEDIAOZHENG,ANXINGUIDINGZHIXING。   

皇冠篮球比分网  FUBIAO:1.YAOPINZHUCESHOUFEIBIAOZHUN

      2.YILIAOQIXIECHANPINZHUCESHOUFEIBIAOZHUN

皇冠篮球比分网                                                                                            GUANGDONGSHENGFAZHANGAIGEWEI  GUANGDONGSHENGCAIZHENGTING 

                                                                                                    2019NIAN2YUE18RI


附表1

 药品注册收费标准

项 目 分 类

收费标准(元)

不改变药品内在质量的国产药品补充申请注册费

常规项

3990

需技术审评的

19180

药品再注册费(五年一次)

18060

皇冠篮球比分网ZHU:1.YAOPINZHUCESHOUFEIANYIGEYUANLIAOYAOHUOYIGEZHIJIWEIYIGEPINZHONGJISHOU,RUZAIZENGJIAYIZHONGGUIGE,ZEANXIANGYINGLEIBIEZENGSHOU20%ZHUCEFEI。

   2.《药品注册管理办法》中属省级药品监管部门备案的药品补充申请事项,不收取补充申请注册费,如此类申请经审核认为申请内容需要技术审评的,申请人应按照需要技术审评的补充申请的收费标准补交费用。



附表2

 

医疗器械产品注册收费标准 

项 目 分 类

收费标准(元)

第二类

首次注册费

57260

变更注册费

23940

延续注册费(五年一次)

23800

注:1.医疗器械产品注册收费按《医疗器械注册管理办法》、《体外诊断试剂注册管理办法》确定的注册单元计收。

   2.《医疗器械注册管理办法》、《体外诊断试剂注册管理办法》中属于注册登记事项变更申请的,不收取变更注册费。

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