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国度药监局对进一步完美药品接洽干系审评审批和羁系任务有关事件的告诉布告 (2019 年 第 56 号)

2021-12-10

WEILUOSHIZHONGGONGZHONGXINBANGONGTING、GUOWUYUANBANGONGTING《DUISHENRUSHENPINGSHENPIGUIZHIDINGXINGUDONGMIANLIYAOPINYILIAODONGXILIYIDEDINGJIAN》,YUANSHIWUYAOPINJIXIZONGJUFABULE《DUIDIAOJIZHILIAOYAO、YAOYONGFULIAOHEYAOBAOCAISHENPINGSHENPISHIBIANDEGAOSUBUGAO》(2017 NIANDI 146 HAO),XIANJIUJINYIBUMINGBAIZHILIAOYAO、YAOYONGFULIAO、JIANJIEDAZHANGYAOPINDEBAOZHUANGCAILIAOHERONGQI(YIXIAJIANCHENGYUANFUBAO)YUYAOPINZHIJIJIEQIAGANXISHENPINGSHENPIHEJIXIYOUGUANSHIJIANGAOSUBUGAOYIXIA:


一、全体请求

(YI)YUANFUBAODELIYONGBIXUHESHIYAOYONGQINGQIU,SHOUYAOSHIZHIYUANFUBAODEPINDE、NINGJINGJIGONGXIAOGAIDANGZHIZUYAOPINZHIJIDEXUYAO。YUANFUBAOYUYAOPINZHIJIJIEQIAGANXISHENPINGSHENPIYOUYUANFUBAOGUAHAORENZAIGUAHAOPINGTAISHANGGUAHAO,YAOPINZHIJIZHUCEQINGQIURENTIJIAOZHUCEQINGQIUSHIYUPINGTAIGUAHAOCAILIAOTINGZHIJIEQIAGANXI;YINCHUGEYUANYOUMEIFAZAIPINGTAIGUAHAODEYUANFUBAO,YEKEZAIYAOPINZHIJIZHUCEQINGQIUSHI,YOUYAOPINZHIJIZHUCEQINGQIURENYIBINGGONGJIYUANFUBAOYANTAOCAILIAO。

(ER)YUANFUBAOGUAHAORENDANRENYANHUGUAHAOPINGTAIDEGUAHAOXINXI,BINGDUIGUAHAOCAILIAODESHIZAIXINGHEWANQUANXINGDANREN。JINGNEIYUANFUBAOGONGJISHANGZUOWEIYUANFUBAOGUAHAORENGAIDANGDUISUOCHIYOUDECHANWUZIXINGGUAHAO。JINGWAIYUANFUBAOGONGJISHANGKEYOUCHANGZHUZHONGGUODAIBIAOJIGOUHUOBAITUOZHONGGUODAIBANSHULIJIGOUTINGZHIGUAHAO,GUAHAOCAILIAOGAIDANGWEIZHONGWEN,JINGWAIYUANFUBAOGONGJISHANGHEDAIBANSHULIJIGOUGONGTONGDUIGUAHAOCAILIAODESHIZAIXINGHEWANQUANXINGDANREN。

(SAN)YAOPINZHIJIZHUCEQINGQIURENBAOGAOYAOPINZHUCEQINGQIUSHI,XUGONGJIYUANFUBAOGUAHAOHAOHEYUANFUBAOGUAHAORENDELIYONGSHOUQUANSHU。

(SI)YAOPINZHIJIZHUCEQINGQIURENHUOYAOPINSHANGSHIYUNXUCHIYOURENDUIYAOPINPINDECHENGDANGZHUTIZEREN,GENJUYAOPINZHUCECAOCHIHESHANGSHIHOUCHUCHANCAOCHIDEYOUGUANQINGQIU,DUIYUANFUBAOGONGJISHANGPINDECAOCHITIXITINGZHISHENJI,BAOZHANGHESHIYAOYONGQINGQIU。

(WU)JIXIJUBUDUIYUANFUBAOGUAHAORENTIJIAODEJISHUCAILIAOFUYOUSHIMIZEREN,DUIGUAHAOPINGTAIDEJISHUXINXISHIMI,GUAHAOPINGTAIZHIGONGRANGUAHAOZHONGLEIDEGUAHAOZHUANGKUANGBIAOSHI(A HUO I)、GUAHAOHAO、ZHONGLEICHENGHAO、QIYECHENGHAO(DAIBANSHULIJIGOUCHENGHAO)、QIYECHUCHANDIDIAN、YUANYAOPINHEZHUNWENHAO(RUOYOU),YUANHEZHUNZHENGSHIWENJIANYOUYONGQI(RUOYOU),CHANWULAIYUAN、GUIGE、GENGXINRIQIHEQIYUXUYAODEXINXI。


二、产物挂号操持

(LIU)YUANFUBAOGUAHAORENGENJUGUAHAOCAILIAOJISHUQINGQIUZAIPINGTAIGUAHAO,QUDEGUAHAOHAO。CIZHONG,ZHILIAOYAOZAIGUAHAOQIANYINGQUDEXIANGYINGCHUCHANFANWEIDE《YAOPINCHUCHANYUNXUZHENG》,BINGGENJUYUANSHIWUYAOPINJIXIZONGJU《DUIFABUHUAXUEYAOPINXINZHUCEFENLEIBAOGAOCAILIAOQINGQIU(SHIXING)DEBUGAO》(2016 NIANDI 80 HAO)QINGQIUTINGZHIGUAHAO;YAOYONGFULIAOHEYAOBAOCAIGUAHAOGENJUBENGAOSUBUGAOFUJIAN 1、FUJIAN 2 DECAILIAOQINGQIUTINGZHIGUAHAO。GUAHAOCAILIAOJISHUQINGQIUGENJUCAICHANSHENGZHANGHEKEXUEJISHUQIANJINBUSHIWANMEI,YOUGUODUYAOPINJIANSHICAOCHIJUYAOPINSHENPINGZHONGXIN(YIXIAJIANCHENGYAOSHENZHONGXIN)DANGLINGGENGXINBANBU。

(QI)YAOPINZHIJIZHUCEQINGQIUYUYIGUAHAOYUANFUBAOTINGZHIJIEQIAGANXI,YAOPINZHIJIQUDEHEZHUNSHI,JIBIAOMINGQIJIEQIAGANXIDEYUANFUBAOJINGYOUJINCHENGLEJISHUSHENPING,GUAHAOPINGTAIBIAOSHIWEI“A”;WEIJINGYOUJINCHENGJISHUSHENPINGHUOHAIBUYUZHIJIZHUCETINGZHIJIEQIAGANXIDEBIAOSHIWEI“I”。

(BA)CHUGUODUBANBUZHIZHILIYONG、CAIJIANHUOKANCHUDEYUANFUBAOWAI,HESHIYIXIAJINGXIANGDEYUANFUBAOYOUYAOSHENZHONGXINJIANGXIANGGANXINXIZHUANRUGUAHAOPINGTAIBINGCIYUGUAHAOHAO,GUAHAOZHUANGKUANGBIAOSHIWEI“A”

 1.HEZHUNZHENGSHIWENJIANYOUYONGQIJIEMANRIBUZAOYU 2017 NIAN 11 YUE 27 RIDEZHILIAOYAO;

 2.YISHOULIBINGSHIXIANSHENPINGSHENPIDEZHILIAOYAO,HANSHENGJUGENJUGUOSHIYAOJIANZHU〔2013〕38 HAOWENSHENPINGDEZHILIAOYAOJISHURANGDUQINGQIU;

 3.YISHOULIBINGSHIXIANSHENPINGDEYAOYONGFULIAOHEYAOBAOCAI;

 4.CENGQUDEHEZHUNZHENGSHIWENJIANDEYAOYONGFULIAO;

 5.HEZHUNZHENGSHIWENJIANYOUYONGQIJIEMANRIBUZAOYU 2016 NIAN 8 YUE 10 RIDEYAOBAOCAI。

ZHUANRUGUAHAOPINGTAIDEYUANFUBAOGUAHAORENYINGGENJUBENGAOSUBUGAOGUAHAOCAILIAOQINGQIUZAIGUAHAOPINGTAIBUCHONGTIJIAOYANTAOCAILIAO,WANMEIGUAHAOXINXI,TONGSHITIJIAOCAILIAOFENQIXINGXUNUOSHU(XUNUOGUAHAOPINGTAITIJIAODEJISHUCAILIAOYUZHUCEHEZHUNJISHUCAILIAOFENQI)。

(JIU)FANGZAOHUORUKOUJINGNEIYISHANGSHIYAOPINZHIJISUOYONGDEZHILIAOYAO,ZHILIAOYAOGUAHAORENGUAHAOHOU,KETINGZHILINGDINGSHENPINGSHENPI,JINGYOUJINCHENGSHENPINGSHENPIDEGUAHAOZHUANGKUANGBIAOSHIWEI“A”,WEIJINGYOUJINCHENGSHENPINGSHENPIDEBIAOSHIWEI“I”。SHENPINGSHENPISHIXIANHEQINGQIUGENJUXIANXING《YAOPINZHUCECAOCHITILI》DENGYOUGUANHUADINGSHISHI。

(SHI)YIZAISHIWU、YAOPINZHONGCHIJIULIYONGQIENINGJINGXINGQUDECHENGRENDEYAOYONGFULIAOKEBUTINGZHIGUAHAO(MINGDANXIANGJIANFUJIAN 3),YOUYAOPINZHIJIZHUCEQINGQIURENZAIZHIJIBAOGAOCAILIAOZHONGLIEMINGCHANWUQINGDANHEGENJIXINXI。DANYAOSHENZHONGXINZAIYAOPINZHIJIZHUCEQINGQIUDESHENPINGJINCHENGZHONGYIWEIYOUXUYAODE,KEQINGQIUYAOPINZHIJIZHUCEQINGQIURENBUCHONGGONGJIXIANGYINGJISHUCAILIAO。GAILEIYAOYONGFULIAOZHONGLEIMINGDANYOUYAOSHENZHONGXINDANGLINGGENGXINBANBU。

(SHIYI)YAOYONGFULIAO、YAOBAOCAIYIDAXIAOXINGZHENGYUNXU,PINGTAIGUAHAOBUSHOUQUYONGDU。ZHILIAOYAORENGWEIXINGZHENGYUNXU,PINGTAIGUAHAOJISHUSHENPINGXIANGGANQINGQIUANXIANXINGHUADINGHEGUIFANSHISHI。


三、原辅包挂号信息的利用和操持

(SHIER)YAOPINZHIJIZHUCEQINGQIUJIEQIAGANXISHENPINGSHI,YUANFUBAOGUAHAOPINGTAIYANTAOCAILIAOBUNENGZHIZUSHENPINGXUYAODE,YAOSHENZHONGXINNENGGOUHUOXUQINGQIUYAOPINZHIJIZHUCEQINGQIURENHUOYUANFUBAOGUAHAORENTINGZHIBUCHONG。BUCHONGCAILIAODEBAOSONGLUZIYOUYAOSHENZHONGXINZAIFABUGAOSUZHONGMINGBAI。

(SHISAN)ZHILIAOYAOBIAOSHIWEI“A”DE,BIAOMINGZHILIAOYAOYIYOUJINCHENGSHENPINGSHENPI。ZHILIAOYAOGUAHAORENNENGGOUHUOXUZAIGUAHAOPINGTAIZIXINGDAYINHEZHUNZHENGSHIWENJIAN、PINDEGUIFANHEBIAOQIANDENG,YONGYUCAOCHI GMPCHACHAO、RUKOUTONGGUANDENG。

WEITINGZHIPINGTAIGUAHAOERYUYAOPINZHIJIZHUCEBAOGAOCAILIAOYIBINGTIJIAOYANTAOCAILIAODEZHILIAOYAO,JIXIJUBUZAIYAOPINZHIJIHEZHUNZHENGSHIWENJIANZHONGBIAOZHUZHILIAOYAOXIANGGANXINXI,KEYONGYUCAOCHIZHILIAOYAOGMP CHACHAO、RUKOUTONGGUANDENG。

(SHISI)ZHILIAOYAOCHUCHANQIYEQINGQIU GMP CHACHAOFASHIJIQINGQIUGENJUXIANXINGFALINGLVLIYOUGUANHUADINGSHISHI,JINGYOUJINCHENGYAOPIN GMP CHACHAOHOUYINGZAIGUAHAOPINGTAIGENGXINGUAHAOXINXI。

(SHIWU)BIAOSHIWEI“A”DEZHILIAOYAOCHANSHENGJISHUBIANGEDE,GENJUXIANXINGYAOPINZHUCECAOCHIYOUGUANHUADINGTIJIAOBIANGEQINGQIU,JINGHEZHUNHOUSHISHI。ZHILIAOYAODEQIYUBIANGE、YAOYONGFULIAOHEYAOBAOCAIDEBIANGEYINGSHISHIZAIGUAHAOPINGTAIGENGXINXINXI,BINGZAIMEIYINIANDIYIJIDUTIJIAODESHANGYINIANNIANDUBAOGAOZHONGHUIZONG。

(SHILIU)YUANFUBAOCHANSHENGBIANGESHIYUANFUBAOGUAHAORENYINGZIDONGZHANKAIYANTAO,BINGSHISHIGAOSUXIANGGANYAOPINZHIJICHUCHANQIYE(YAOPINSHANGSHIYUNXUCHIYOUREN),BINGSHISHIGENGXINGUAHAOCAILIAO,BINGZAINIANBAOZHONGBIAOXIAN。

YAOPINZHIJICHUCHANQIYE(YAOPINSHANGSHIYUNXUCHIYOUREN)JIEDAOSHANGSHUGAOSUHOUYINGSHISHIJIUXIANGYINGBIANGEDUIYAOPINZHIJIPINDEDEYINGXIANGHUANJINGTINGZHIPINGGUHUOYANTAO,SHUYUYINGXIANGYAOPINZHIJIPINDEDE,YINGBAOBUCHONGQINGQIU。

(SHIQI)YISHANGSHIYAOPINZHIJIBIANGEYUANFUBAOJIYUANFUBAOGONGJISHANGDE,YINGGENJU《YISHANGSHIHUAXUEYAOPINBIANGEYANTAOJISHUZHIDIANZHUNSHENG(YI)》《YISHANGSHIHUAXUEYAOPINCHUCHANGONGYIBIANGEYANTAOJISHUZHIDIANZHUNSHENG》《YISHANGSHIZHONGYAOBIANGEYANTAOJISHUZHIDIANZHUNSHENG(YI)》JISHENGWUZHIPINSHANGSHIHOUBIANGEYANTAOXIANGGANZHIDIANZHUNSHENGDENGQINGQIUZHANKAIYANTAO,BINGGENJUXIANXINGYAOPINZHUCECAOCHIYOUGUANHUADINGSHISHI。

(SHIBA)JINGWAIYUANFUBAOGONGJISHANGGAIHUANGUAHAODAIBANSHULIJIGOUDE,TIJIAOXIANGGANWENJIANCAILIAOHOUYUYIBIANGE。BAOLUO: BIANGEYUANYOUSHENMING、JINGWAIYUANFUBAOGONGJISHANGBAITUOSHU、GONGZHENGWENSHUJICIZHONGWENYIBEN、XINDAIBANSHULIJIGOUTINGYEZHIZHAOFUYINJIAN、JINGWAIYUANFUBAOGONGJISHANGXIAOCHUYUANDAIBANSHULIJIGOUBAITUOGANXIDEWENSHU、GONGZHENGWENSHUJICIZHONGWENYIBEN。


四、监视操持

(SHIJIU)GESHENG(QU、SHI)YAOPINJIANSHICAOCHIJUDUIGUAHAOZHUANGKUANGBIAOSHIWEI“A”DEZHILIAOYAO,GENJUYAOPINTINGZHISHANGSHIHOUCAOCHI,BINGZHANKAIYAOPIN GMP CHACHAO。

(ERSHI)GESHENG(QU、SHI)YAOPINJIANSHICAOCHIJUYINGZENGQIANGDUIBENXINGZHENGDIQUNEIYAOPINZHIJICHUCHANQIYE(YAOPINSHANGSHIYUNXUCHIYOUREN)DEJIANSHICHACHAO,CUICUYAOPINZHIJICHUCHANQIYE(YAOPINSHANGSHIYUNXUCHIYOUREN)SHISHIZHILIAOYAO、YAOYONGFULIAOHEYAOBAOCAIDEGONGJISHANGSHENJIZEREN。YAOYONGFULIAOHEYAOBAOCAICHUCHANQIYEJUBEI《YAOPINCHUCHANYUNXUZHENG》DE,CHIXUANYUANCAOCHIQINGQIUCAOCHI,YUNXUZHENGDAOQIHOUANBENGAOSUBUGAOQINGQIUGUAHAOYUANDIXINXI。

(ERSHIYI)GESHENG(QU、SHI)YAOPINJIANSHICAOCHIJUGENJUGUAHAOXINXIDUIYAOYONGFULIAOHEYAOBAOCAIGONGJISHANGZENGQIANGJIANSHICHACHAOHEYANZHANGCHACHAO。FAMINGYAOYONGFULIAOHEYAOBAOCAICHUCHANCUNZAIPINDETIMUBIAO,YINGYIFAYIGUISHISHICHACHU,BINGQINGQIUYAOPINZHIJICHUCHANQIYE(YAOPINSHANGSHIYUNXUCHIYOUREN)BUDELIYONGXIANGGANCHANWU,BINGDUIYISHANGSHICHANWUZHANKAIPINGGUHECUOZHI。YANZHANGCHACHAOYINGYOUYAOPINZHIJICHUCHANQIYE(YAOPINSHANGSHIYUNXUCHIYOUREN)DIDIANDISHENGJUGOUZAOZHANKAI。YAOYONGFULIAOHEYAOBAOCAIGONGJISHANGDEPINGCHANGCHACHAOYOUDIDIANDISHENGJUGOUZAOZHANKAILIANXICHACHAO。

YAOYONGFULIAOCHUCHANXIANCHANGCHACHAOCANZHAO《YAOYONGFULIAOCHUCHANWUZICAOCHIGUIFAN》(GUOSHIYAOJIANAN〔2006〕120HAO)ZHANKAICHACHAO,YAOBAOCAICHUCHANXIANCHANGCHACHAOCANZHAO《JIANJIEDAZHANGYAOPINDEBAOZHUANGCAILIAOHERONGQICAOCHITILI》(YUANGUODUSHIWUYAOPINJIANSHICAOCHIJUJULINGDI 13 HAO)ZHONGSUOFU《YAOBAOCAICHUCHANXIANCHANGCHAHEGONGLI》ZHANKAICHACHAO。GESHENG(QU、SHI)YAOPINJIANSHICAOCHIJUKEGENJUJIXIXUYAOJINYIBUWANMEIXIANGGANJISHUGUIFANHECHACHAOGUIFAN,ZENGJINFULIAOHEYAOBAOCAIPINDESHUIANWENBUJINSHENG。

GUODUYAOPINJIANSHICAOCHIJUJIANGGENJUGESHENGJIANSHICHACHAOZHANKAIHUANJINGHEXUYAO,DANGLINGDINGZHENGXIANGGANCHACHAOGUIFAN。


五、其余

(ERSHIER)ZAIZHONGHUAGUOMINGONGHEGUOJINGNEIYANZHI、CHUCHAN、RUKOUHELIYONGDEZHILIAOYAO、YAOYONGFULIAO、YAOBAOCAIHEYONGYUBENGAOSUBUGAOQINGQIU。

(ERSHISAN)BENGAOSUBUGAOZI 2019NIAN 8YUE 15RIQISHISHI。YUANFABUDEYUANFUBAOXIANGGANWENJIANYUBENGAOSUBUGAOQINGQIUBUFENQIDE,YIBENGAOSUBUGAOWEIZHUN。YUANSHIWUYAOPINJIXIZONGJUFABUDE《DUIFABUYAOBAOCAIYAOYONGFULIAOBAOGAOCAILIAOQINGQIU(SHIXING)DEBUGAO》(2016 NIANDI 155 HAO)TONGSHIFEICHU。

 

TECIGAOSUBUGAO。

 

附件:

1.药用辅料挂号材料请求(试行)

2.药包材挂号材料请求(试行)

3.可免挂号的产物目次(2019 年版)

4.药用原辅料、药包材年度报告根基请求


GUODUYAOJIANJU

2019 NIAN 7 YUE 15 RI



附件一

药用辅料挂号材料请求(试行)

12.PNG

一、挂号材料名目

1 GUAHAORENGENJIXINXI

1.1 GUAHAORENCHENGHAO、DIDIAN、CHUCHANDIDIAN

1.2 ZHENGSHIXINGWENJIAN

1.3 YANTAOCAILIAOBAOGUANDIDIAN

2 FULIAOGENJIXINXI

2.1 CHENGHAO

2.2 BUJUYUGOUCHENG

2.3 LIHUAXINGZIJIGENJITEDIAN

2.4 JINGBIAOLIHEZHUNSHANGSHIJILIYONGXINXI

2.5 GUOBIAOLIYAODIANSHOUZAIHUANJING

3 CHUCHANXINXI

3.1 CHUCHANGONGYIHEJINCHENGJIEZHI

3.2 WULIAOJIEZHI

3.3 GUANJIANBUZHOUHEZHONGXINTIDEJIEZHI

3.4 GONGYIKAOZHENGHEPINGGU

3.5 CHUCHANGONGYIDEKAIPI

4 TEDIANPANDING

4.1 BUJUHELIHUAXINGZIYANTAO

4.2 ZAZHIYANTAO

4.3 GONGXIAOTEDIAN

5 PINDEJIEZHI

5.1 PINDEGUIFAN

5.2 CHANFATILIDEKAOZHENG

5.3 PINDEGUIFANNIDINGGENJU

6 PICHAYANBAOGAO

7 BUBIANXINGYANTAO

7.1 BUBIANXINGZONGJIE

7.2 BUBIANXINGSHUJU

7.3 FULIAODEBAOZHUANG

8 YAOLIDULIYANTAO

二、挂号材料注释及撰写请求

1 GUAHAORENGENJIXINXI

1.1 GUAHAORENCHENGHAO、GUAHAODIDIAN、CHUCHANDIDIAN

GONGJIGUAHAORENDECHENGHAO、GUAHAODIDIAN、CHUCHANCHANG、CHUCHANDIDIAN。

CHUCHANDIDIANYINGQIEQUEZHICHUCHANCHEJIAN、CHUCHANXIAN。

1.2 ZHENGSHIXINGWENJIAN

JINGNEIYAOYONGFULIAOGUAHAORENXUTIJIAOYIXIAZHENGSHIWENJIAN:

(1)GUAHAORENTINGYEZHIZHAOFUYINJIAN。DUIGUAHAORENBAITUODISANFANGTINGZHICHUCHANDE,YINGTONGSHITIJIAOBAITUOSHUDENGXIANGGANWENJIAN、CHUCHANZHEXIANGGANXINXIJITINGYEZHIZHAOFUYINJIAN。

(2)DUIQINGQIUYAOYONGMINGJIAOKONGXINJIAONANG、JIAONANGYONGMINGJIAOHEYAOYONGMINGJIAODEJINGNEIGUAHAOREN,XULINGGONGJI: ①QINGQIUYAOYONGKONGXINJIAONANGDE,YINGGONGJIMINGJIAODEZHENGDANGLAIYUANZHENGSHIWENJIAN,BAOLUOYAOYONGMINGJIAODEHEZHUNZHENGSHIWENJIAN、GUIFAN、CHAYANBAOGAO、YAOYONGMINGJIAOCHUCHANQIYEDETINGYEZHIZHAO、《YAOPINCHUCHANYUNXUZHENG》、FAMAIFAPIAO、GONGHUOHETANDENGDEFUYINJIAN;②QINGQIUJIAONANGYONGMINGJIAO、YAOYONGMINGJIAODE,YINGGONGJIMINGJIAOZHIBEIZHILIAODELAIYUAN、ZHONGLEI、GUIFANDENGXIANGGANCAILIAOHEZHENGSHI。JINGWAIYAOYONGFULIAOGUAHAORENYINGSHOUQUANZHONGGUODAIBIAOJIGOUTIJIAOYIXIAZHENGSHIWENJIAN:

(1)GUAHAORENZHENGDANGCHUCHANZILIZHENGSHIWENJIAN、GONGZHENGWENJIANJICIZHONGWENYIWEN。DUIGUAHAORENBAITUODISANFANGTINGZHICHUCHANDE,YINGTONGSHITIJIAOBAITUOSHUDENGXIANGGANWENJIANJICHUCHANZHEXIANGGANXINXIJIZHENGSHIWENJIAN(RUOYOU)。

(2)GUAHAORENBAITUOZHONGGUOJINGNEIDAIBANSHULIJIGOUZHUCEDESHOUQUANWENSHU、GONGZHENGWENJIANJICIZHONGWENYIWEN。

ZHONGGUOJINGNEIDAIBANSHULIJIGOUDETINGYEZHIZHAOHUOGUAHAORENCHANGZHUZHONGGUOJINGNEIBANSHIJIGOUDE《BENGUOQIYECHANGZHUZHONGGUODAIBIAOJIGOUGUAHAOZHENG》。

(3)GUAHAOYAOYONGKONGXINJIAONANG、JIAONANGYONGMINGJIAO、YAOYONGMINGJIAODENGNIUYUANXINGYAOYONGFULIAORUKOUDE,XUGONGJIZHIBEIJIAONANGDESHOUYAOYUANCAILIAO——MINGJIAODEZHIBEIZHILIAODELAIYUAN、ZHONGLEIDENGXIANGGANCAILIAOHEZHENGSHI,BINGGONGJIZHIBEIZHILIAOLAIYUANYUBUCHANSHENGFENGNIUBINGYIQINGGUODUDEDANGJUZHENGSHIWENJIAN。JINGWAIYAOYONGFULIAOCHANGYIGONGJIRENYUANHUODONGWUYUANXINGFULIAODEXIANGGANZHENGSHIWENJIAN。

1.3 YANTAOCAILIAOBAOGUANDIDIAN

GONGJIYAOYONGFULIAOYANTAOCAILIAODEBAOGUANDIDIAN,YINGQIEQUEZHIMENSHANGBIAO。RUYANTAOCAILIAOYOUDUOGEBAOGUANDIDIANDE,JUNXUTIJIAO。

2 FULIAOGENJIXINXI

2.1 CHENGHAO

GONGJIFULIAODEZHONGWENTONGYONGMING(RUHEYONG,YIZHONGGUOYAODIANMINGWEIZHUN)、YINGWENMING、HANYUPINYIN、HUADAMING、CENGYONGMING、HUAXUEWENZHAI(CAS)HAODENG。RUOYOU UNII HAOJIQIYUCHENGHAO(BAOLUOGUOBIAOLIYAODIANSHOUZAIDECHENGHAO)CHANGYIYIBINGGONGJI。YUHUNFULIAO[ZHU 1]HEGONGCHUZHIFULIAO[ZHU 2]YINGMINGBAISUOLIYONGDEDANYIFULIAOBINGTINGZHIDINGXINGHEDINGLIANGDEMIAOXIE,KETIJIAODIANFANPEIFANGYONGYUSHENMING,XIANSHILIYONGDEXIANGXIPEIFANGYINGGENJULIYONGHUANJINGZUOWEIFUJIANBAOLUOZAIGUAHAOCAILIAOZHONGHUOZAIYAOPINZHUCESHITINGZHIGONGJI。

ZHU 1: YUHUNFULIAO(pre-mixed excipient)SHIZHILIANGZHONGHUOLIANGZHONGYISHANGFULIAOJINGYOUJINCHENGDIZHIZHONGDENGJIANQIELITINGZHIJIAZA,ZHEISHIYIZHONGJIANLVEDEWULIJIAZAWU。GEZUFENJIAZAHOURENGJIANCHIWEIZILIDEHUAXUESHITI,GECHENGFENDEHUAXUETEDIANBINGWEIBIANGE。YUHUNFULIAONENGGOUHUOXUSHIGUTAIHUOYETAI,CHUNZHENDEWULIJIAZASHIHOUJIAODUAN。

ZHU 2: GONGCHUZHIFULIAO(co-processed excipient)SHILIANGZHONGHUOLIANGZHONGYISHANGFULIAODELIANXIWU,GAILIANXIWUDEWULITEDIANCHANSHENGLEZHUANBIANDANHUAXUETEDIANWUJIAOZHEBIANGE。ZHEILEIWULITEDIANDEZHUANBIANMEIFAJINGYOUJINCHENGCHUNZHENDEWULIJIAZAERQUDE,ZAIMOUXIEHUANJINGXIA,YOUNENGGOUHUOXUYICHENGYANQINGSHICUNZAI。

2.2 BUJUYUGOUCHENG

GONGJIFULIAODEBUJUYUGOUCHENGXINXI,RUBUJUSHI、FENZISHI、FENZILIANG,GAOFENZIYAOYONGFULIAOYINGMINGBAIXINGHAO、FENZILIANGFANWEI、JUHEDU、DAITIDUDENG。YOULITIBUJUHEDUOJINGXINGJINGXIANGYINGCHUGESHENMING。YUHUNFULIAOHEGONGCHUZHIFULIAOYINGTIJIAOMEIZUFENDEBUJUXINXI。

2.3 LIHUAXINGZIJIGENJITEDIAN

GONGJIFULIAOYIZHIDEWULIHEHUAXUEXINGZI,RU: XINGZHUANG(RUWAIBIAO,SECAI,WULIZHUANGKUANG)、RONGDIANHUOFEIDIAN、BIXUANDU、XIAORONGXING、RONGYE pH、LIDU、MIDU(DUIMIDU、ZHENSHIMIDUDENG)HEGONGXIAOXIANGGANXINGMUBIAODENG。YUHUNFULIAOYINGTIJIAOCHANWUXINGZHUANGDENGGENJITEDIANXINXI。

2.4 JINGBIAOLIHEZHUNGUAHAODENGXIANGGANXINXIJIYONGCHU

2.4.1 JINGNEIHANQINGHEZHUNXINXI

GONGJIJINGNEIHANQINGHEZHUNDEXIANGGANXINXI(RUOYOU)。

2.4.2 QIYUGUODUDEXIANGGANXINXI

GONGJINIGUAHAOCHANWUZAIJINGWAIZUOWEIYAOYONGFULIAODEXIANGGANXINXI(RUHEYONG)。

2.4.3 YONGCHUXINXI

GONGJIGAIFULIAODEJIYAOLUZIXINXIHEZUIDAZHURICANKAOJILIANGJICANKAOGENJU。LIYONGGAIFULIAODEYAOPINYIZAIJINGBIAOLIHUOZHUNSHANGSHIDE,GONGJIXIANGGANYAOPINDEJIXING、JIYAOLUZIDENG;HAIBUYOULIYONGGAIFULIAODEYAOPINHUOZHUNSHANGSHIDE,YINGGONGJIGAIYAOYONGFULIAODEYUQIJIYAOLUZIHEZHENGZAILIYONGGAIFULIAOTINGZHIZHUCEDEYAOPINXINXI。RUOYOUCHUCHANSHANGYIZHIDEBUCHANGYIDEJIYAOLUZIHUOXIANZHIDELIYONGJILIANG,YEYINGYUYIMINGBAIBINGGONGJIXIANGGANCANKAOSHENMING。YISHANGXINXIYINGJINNENGGOUHUOXUGONGJI。

2.5 GUOBIAOLIYAODIANSHOUZAIHUANJING

GONGJIGAIYAOYONGFULIAOBEIGUOBIAOLIYAODIANJIWOGUOGUODUGUIFANSHOUZAIDEXINXI。

3 CHUCHANXINXI

3.1 CHUCHANGONGYIHEJINCHENGJIEZHI

(1)GONGYIZONGSHU: ANGONGYIBUZHOUGONGJIGONGYILIUCHENGTU,BINGTINGZHICHUCHANGONGYIZONGSHU。

(2)GONGYILUCHEN: ANGONGYILIUCHENGBIAOMINGGONGYICANSHUHESUOYONGRONGJIDENG。RUWEIHUAXUEFENJIEDEYAOYONGFULIAO,HAIYINGGONGJIFANYINGQIANTI(RUWENDU、YALI、SHIHOU、CUIHUAJIDENG)JIQIHUAXUEFANYINGSHI,CIZHONGYINGBAOLUOZHAODUANZHILIAO、ZHONGXINTI、SUOYONGFANYINGSHIJIDEFENZISHI、FENZILIANG、HUAXUEBUJUSHI。YIMAOYIPIWEIDAIBIAO,LIEMINGSHOUYAOGONGYIBUZHOU、GEFANYINGWULIAODETOULIAOLIANGJIGEBUSHOULVFANWEI,MINGBAIGUANJIANCHUCHANBUZHOU、GUANJIANGONGYICANSHUHEZHONGXINTIDEZHIKONGMUBIAO。DUIRENHUODONGWULAIYUANDEFULIAO,GAIFULIAODECHUCHANGONGYIZHONGYINGYOUMINGBAIDEBINGDUMIEHUOYUDUANGENDEGONGYIBUZHOU,BINGXUDUIQITINGZHIKAOZHENG。

(3)SHENMINGMAOYICHUCHANDEFENHEZHUNSHENG、PILIANGFANWEIHEGENJU。

(4)ZHUANGBEI: GONGJISHOUYAOHECHUGEDECHUCHANZHUANGBEI。

CHUCHANZHUANGBEICAILIAONENGGOUHUOXUGENJUXIASHUBIAOGEQINGSHITIJIAO:

CHUCHANZHUANGBEIYILANBIAO

1.PNG

3.2 WULIAOJIEZHI

3.2.1 GUANJIANWULIAOJIEZHIXINXI

DUIGUANJIANWULIAODEJIEZHIANXIABIAOGONGJIXINXI。

GUANJIANWULIAOJIEZHIXINXI

2.PNG

ZHU: RUDONGWULAIYUAN、DONGWULAIYUAN、HUAXUEFENJIEDENG。

3.2.2 WULIAOJIEZHIXINXILUCHEN

GENJUGONGYILIUCHENGTUZHONGDEGONGXU,YIBIAOGEDEQINGSHILIEMINGCHUCHANDINGYONGDAODEYIQIEWULIAO(RUZHAODUANWULIAO、FANYINGSHIJI、RONGJI、CUIHUAJIDENG),BINGSHENMINGSUOLIYONGDEBUZHOU,SHILIYIXIA。

WULIAOJIEZHIXINXI

3.PNG 

ZHU: RUDONGWULAIYUAN、DONGWULAIYUAN、HUAXUEFENJIEDENG。

GONGJIYISHANGWULIAODELAIYUAN、MINGBAIYUANYONGGUIFAN,HUOGONGJINEIKONGGUIFAN(BAOLUOMINGMU、JIANCETILIHEXIANZHI),XUYAOSHIGONGJITILIXUEKAOZHENGCAILIAO。

3.3 GUANJIANBUZHOUHEZHONGXINTIDEJIEZHI

LIECHUGUANJIANBUZHOU(RU: ZHONGCHANWUDEJINGZHI、CHUNHUAGONGYIBUZHOU,RENHUODONGWULAIYUANFULIAODEBINGDUMIEHUO/QUCHUBUZHOU)。HEYONGSHI,GONGJIGUANJIANJINCHENGJIEZHIJICANSHU,GONGJIXIANGXIDEYANTAOCAILIAO(BAOLUOYANTAOTILI、YANTAOCHENGGUOHEYANTAOLUNDUAN),CHENGCHIGUANJIANBUZHOUKENDINGDEHEGANXINGHEGONGYICANSHUJIEZHIFANWEIDEHEGANXING。CUNZAIFENSHOUDEZHONGXINTISHI,YINGLIECHUQIPINDEJIEZHIGUIFAN,BAOLUOMINGMU、TILIHEXIANZHI,BINGGONGJIXUYAODETILIXUEKAOZHENGCAILIAO。

3.4 GONGYIKAOZHENGHEPINGGU

3.4.1 GONGYIBUBIANXINGPINGGU

GONGJIFULIAOGONGYIBUBIANDEXIANGGANPINGGUCAILIAO,RU 5 PIYISHANGDECHANWUPINDEHUISHOUXINGBAOGAODENG。

3.4.2 GONGYIKAOZHENG

GONGJIGONGYIKAOZHENGJIHUA、KAOZHENGBAOGAODENGCAILIAO,XUYAOSHIGONGJIPICHUCHANJISHIYANGGAO。

3.5 CHUCHANGONGYIDEKAIPI

GONGJIGONGYIXIANLUDETIAOXUANGENJU(BAOLUOWENXIANGENJUHE/HUOSHIJIGENJU)。

GONGJIXIANGXIDEYANTAOCAILIAO(BAOLUOYANTAOTILI、YANTAOCHENGGUOHEYANTAOLUNDUAN)YISHENMINGGUANJIANBUZHOUKENDINGDEHEGANXINGHEGONGYICANSHUJIEZHIFANWEIDEHEGANXING。

XIANGXISHENMINGZAIGONGYIKAIPIJINCHENGZHONGCHUCHANGONGYIDESHOUYAOBIANGE(BAOLUOGONGYIXIANLU、GONGYICANSHU、PILIANGHEZHUANGBEIDENGDEBIANGE)JIXIANGGANDECHENGCHIXINGKAOZHENGYANTAOCAILIAO。GONGJIGONGYIYANTAOSHUJUHUIZONGBIAO,SHILIYIXIA:

GONGYIYANTAOSHUJUHUIZONGBIAO

4.PNG

ZHU 1: SHENMINGCHUCHANGAIPICIDEMUBIAOHEYANGPINYONGCHU,BIFANGGONGYIKAOZHENG/BUBIANXINGYANTAO。

ZHU 2: SHENMINGBIAOZHONGSUOLIEPICIDECHUCHANGONGYISHIBUSHIYU 3.1 XIANGXIAGONGYIFENQI,RUBUFENQI,YINGMINGBAICHABIEDIAN。

4 TEDIANPANDING

4.1 BUJUHELIHUAXINGZIYANTAO

4.1.1 BUJUQUEZHENGYANTAO

(1)BUJUQUEZHENGXINXI

GONGJIKEYONGYUDUIYAOYONGFULIAODEBUJUTINGZHIQUEZHENGHUOBIAOZHENGDEXIANGGANXINXI。

(2)BUJUQUEZHENGYANTAO

YINGLIANXIZHIBEIGONGYIXIANLUHEGELEIBUJUQUEZHENGSHOUWANDUICHANWUDEBUJUTINGZHIPOUXI,RUNENGGOUHUOXUHANYOULITIBUJU、JIEJINGSHUI/JIEJINGRONGJIHUODUOJINGXINGTIMUYAOXIANGXISHENMING,DUIGAOFENZIYAOYONGFULIAO,HAIXUCUNJUANFENZILIANGJIFENZILIANGSANBU、JUHEDU、DAITIDU、HONGWAIGUANGPUDENGBUJUQUEZHENGXINXI。GONGJIBUJUQUEZHENGYONGYANGPINDEJINGZHITILI、CHUNDU、PIHAO;GONGJIXIANGXIDEYANTAOSHUJUHETUPUBINGTINGZHIPOUXI。WEILEQUEBAOSHENGWUZHIPINLAIYUANDEYAOYONGFULIAOPINDEDEFENQIXING,XUYAOCHENGLIGUIFANPIN/DUIBIPINHUOJIANGFULIAOYUQIZIRANJINSIWUTINGZHIBINI。DUISHENGWUZHIPINLEIFULIAOXIANGXIJIAN ICH DUISHENGWUJISHU/SHENGWUCHANWUDEZHINAN。

DUILAIYUANYUHUAXUEFENJIETIHUOLAIYUANYUDONG/DONGWUDEYUHUNFULIAO,XUYAOYONGCHABIEDETILIMIAOXIEQITEDIAN,BINGTINGZHIDINGLIANGHEDINGXINGDEMIAOXIE,BAOLUOYIQIECHUGEXINXI。

4.1.2 LIHUAXINGZI

GONGJIFUBINGDANGHUAXINGZIYANTAOCAILIAO,RU: XINGZHUANG(RUWAIBIAO,SECAI,WULIZHUANGKUANG)、RONGDIANHUOFEIDIAN、BIXUANDU、XIAORONGXING、XISHIXING、RONGYE pH、FENPAIXISHU、JIELICHANGSHU、JIANGYONGYUZHIJICHUCHANDEWULIWAIXING(RUDUOJINGXING、RONGJIHUAWUHUOSHUIHEWU)、LIDU、LAIYUANDENG。

4.2 ZAZHIYANTAO

4.2.1 ZAZHIXINXI

LIANXIFULIAOCHUCHANGONGYI,MIAOXIEZAZHIHUANJING。

4.2.2 ZAZHIYANTAO

YINGGENJUYAOYONGFULIAODEFENZITEDIAN、LAIYUAN、ZHIBEIGONGYIDENGTINGZHIZAZHIYANTAO,RUDUIGAOFENZIFULIAO,YINGZHONGDIANYANTAOCANLIUDANTI、CUIHUAJIHECHUCHANGONGYIDAILAIDEZAZHI。PINGGUZAZHIDUIYAOYONGFULIAONINGJINGXING、GONGXIAOXINGDENGDEYINGXIANG,BINGTINGZHIXIANGYINGDEJIEZHI。

4.3 GONGXIAOTEDIAN

4.3.1 GONGXIAOTEDIANXINXI

LIANXIFULIAOZAIZHIJIZHONGDEYONGCHUJIJIYAOLUZI,GONGJIFULIAOYOUGUANGONGXIAOXINGMUBIAOXINXI(RUHEYONG)。

4.3.2 GONGXIAOTEDIANYANTAO

LIANXIFULIAOZAIZHIJIZHONGDEYONGCHUJIJIYAOLUZI,XIANGXISHENMINGGAIYAOYONGFULIAODESHOUYAOGONGXIAOTEDIANBINGGONGJIXIANGYINGDEYANTAOCAILIAO。

RU: ZHANHEJIKEGONGJIWAIBIAOZHANGLI、LIDUJILIDUSANBU、XIAORONGXING、ZHANDU、BIWAIBIAOJI、JUJIDUDENGHEYONGDETEDIANMUBIAO。

5 PINDEJIEZHI

5.1 PINDEGUIFAN

GONGJIYAOYONGFULIAODEPINDEGUIFAN。PINDEGUIFANGAIDANGHESHI《ZHONGHUAGUOMINGONGHEGUOYAODIAN》XIANXINGBANDETONGYONGJISHUQINGQIUHEGEJU,BINGLIYONGQISHUYUHEJILIANGDANWEI。

5.2 CHANFATILIDEKAOZHENG

GONGJIPINDEGUIFANZHONGYOUGUANMINGMUBIAOTILIXUEKAOZHENGCAILIAO。DUIXIANXINGBANZHONGGUOYAODIAN/MEIGUOYAODIAN/OUZHOUYAODIAN/YINGGUOYAODIAN/RIBENYAODIANYISHOUZAIDEZHONGLEI,RUJIENAYAODIANGUIFANTILI,KESHIHUANJINGZHANKAITILIXUEQUEREN。

5.3 PINDEGUIFANNIDINGGENJU

SHENMINGGEMINGMUSHEDINGDEZHENZHUO,ZONGJIECHANFAGECHACHAOTILITIAOXUANHEXIANZHIKENDINGDEGENJU。PINDEGUIFANCAONISHENMINGGAIDANGBAOLUOGUIFANZHONGJIEZHIMINGMUBIAOXUANDING、TILITIAOXUAN、CHACHAOJICHUNDUHEXIANZHIFANWEIDENGDENIDINGGENJU。

6 PICHAYANBAOGAO

GONGJIBUSHAOYUSANPICHUCHANYANGPINDECHAYANBAOGAO。RUOSHIYOUBAITUOWAIDANWEICHAYANDEMINGMUXUSHENMING。BAITUOCHAYANDESHOUTUOFANGXUJUBEIXIANGGANTIANZI。

7 BUBIANXINGYANTAO

BUBIANXINGYANTAODECHANGSHICAILIAOJIWENXIANCAILIAO。BAOLUOJIENAJIANJIEDAZHANGYAOYONGFULIAODEBAOZHUANGCAILIAOHERONGQIGONGTONGTINGZHIDEBUBIANXINGCHANGSHI。RUHEYONG,MIAOXIEZHENDUISUOXUANYONGBAOCAITINGZHIDEXIANGRONGXINGHECHENGCHIXINGYANTAO。

7.1 BUBIANXINGZONGJIE

ZONGJIESUOTINGZHIDEBUBIANXINGYANTAODEYANGPINHUANJING、KAOCHAQIANTI、KAOCHAMUBIAOHEKAOCHACHENGGUO,DUIGEMINGMUBIAOBIANGEQUXIANGTINGZHICHANFA,BINGTICHUCHUCUNQIANTIHEYOUYONGQI。

7.2 BUBIANXINGSHUJU

YIBIAOGEQINGSHIGONGJIBUBIANXINGYANTAODEXIANGXICHENGGUO,BINGJIANGBUBIANXINGYANTAOZHONGDEXIANGGANTUPUZUOWEIFUJIAN。

7.3 FULIAODEBAOZHUANG

SHENMINGFULIAODEBAOZHUANGJITIAOXUANGENJU,GONGJIBAOZHUANGBIAOQIANYANGGAO。

8 YAOLIDULIYANTAO

PUTONGXUGONGJIDEYAOLIDULIYANTAOCAILIAOHE/HUOWENXIANCAILIAOBAOLUO:

(1)YAOLIDULIYANTAOCAILIAOZONGSHU。

(2)DUINILIYONGYAOWUDEYAOXIAOXUEYINGXIANGCHANGSHICAILIAOHE/HUOWENXIANCAILIAO。

(3)FEILINCHUANGYAODAINENGYUANXUECHANGSHICAILIAOHE/HUOWENXIANCAILIAO。

(4)NINGJINGYAOLIXUEDECHANGSHICAILIAOHE/HUOWENXIANCAILIAO。

(5)DANCIJIYAODUGANXINGDECHANGSHICAILIAOHE/HUOWENXIANCAILIAO。

(6)FANFUJIYAODUGANXINGDECHANGSHICAILIAOHE/HUOWENXIANCAILIAO。

(7)GUOMINXING(JUBU、MANSHENHEGUANGMINDUXING)、RONGXUEXINGHEJUBU(XUEGUAN、PIFU、ZHANMO、JIROUDENG)ANWEIXINGDENGSHOUYAOYUJUBU、MANSHENJIYAOXIANGGANDECHUGENINGJINGXINGCHANGSHIYANTAOHE/HUOWENXIANCAILIAO。

(8)YICHUANDUXINGCHANGSHICAILIAOHE/HUOWENXIANCAILIAO。

(9)SHENGZHIDUXINGCHANGSHICAILIAOHE/HUOWENXIANCAILIAO。

(10)ZHIAICHANGSHICAILIAOHE/HUOWENXIANCAILIAO。

(11)QIYUNINGJINGXINGCHANGSHICAILIAOHE/HUOWENXIANCAILIAO。

GENJUYAOYONGFULIAODESHANGSHIZHUANGKUANG、LIYONGHUANJING、WEIXIANSHUIPINGDENGKENDINGXUTIJIAODEYANTAOCAILIAOHE/HUOWENXIANCAILIAO,RUBUXUYAOMOUXIANGYANTAOCAILIAOSHI,YINGZAIXIANGYINGDEYANTAOMINGMUXIAYUYISHENMING。YAOYONGFULIAODEYAOLIDULIYANTAOKELINGDINGTINGZHIYEKEJINGYOUJINCHENGGONGDAOSHEXIANGYUJIEQIAGANXIZHIJIDEYAOLIDULIYANTAOGUIBINGTINGZHI。

三、挂号材料申明

1 JIYUFULIAO(ZAIZHIJIZHONG)DELIYONGHANQINGJIYAODIANSHOUZAIHUANJING,FUBIAO 1 LIECHULECHABIEZHONGBIEFULIAOSUOXUGONGJIDECAILIAOWENJIAN。

2 GUAHAOCAILIAOYINGLIECHUQUANSHUCAILIAOMINGMU,DUIANFUBIAO 1 HUADINGWUXUGONGJIDECAILIAO,YINGZAIGAIXIANGCAILIAOMINGMUXIATINGZHISHENMING。

3 DUIZHIQIANANZHUCEFASHIYIHUOHEZHUNZHENGSHIWENJIANDEYAOYONGFULIAO,RUGUAHAOKEANFUBIAO 1 DI 2.4LEICAILIAOQINGQIUGONGJICAILIAO。SHENPINGJINCHENGZHONGKEGENJUXUYAOBUCHONGCAILIAO。

4 FULIAOYIYOULIYONGHANQINGDEJIESHUO: GAIFULIAOYIZAIJINGBIAOLIHEZHUNZHIJIZHONGLIYONGQIEJIYAOLUZIBUYI。

5 JINGWAIHEZHUNZHIJIDEFANWEI: JINXIANZAIMEIGUO、OUMENG、RIBENHEZHUNSHANGSHIDEZHIJI。

6 DUIFENLEIWEIHANGAIDEYAOYONGFULIAO,QINGTIAOXUAN“QIYU”,QIGUAHAOCAILIAODEQINGQIUGENJULIYONGHANQINGHEYAODIANSHOUZAIHUANJINGTIJIAOXIANGGANDEGUAHAOCAILIAO。

7 JINGBIAOLISHANGSHIYAOPINZHONGYIYOULIYONGHANQINGDE,DUIZHONGGUOYAODIANYISHOUZAI,USP/EP/BP/JP JUNWEISHOUZAIDEYAOYONGFULIAOCANZHAO 2.2 LEITIJIAOGUAHAOCAILIAO。

8 DUITONGYIFULIAOTONGSHISHUYUCHABIEFENLEIDEHUANJING,YINGGENJUWEIXIANPINJIGAODEFENLEITINGZHIGUAHAOTIJIAOXIANGGANJISHUCAILIAO。

 

FUBIAO 1

YAOYONGFULIAOGUAHAOCAILIAOBIAO

5.PNG

ZHU: + XUGONGJIXIANGGANCAILIAODEMINGMU

- WUXUGONGJIXIANGGANCAILIAODEMINGMU

± GENJUXUYAOGONGJIXIANGGANCAILIAODEMINGMU


备注: *

JINGBIAOLISHANGSHIYAOPINZHONGWEIYOULIYONGHANQINGDE,BAOLUO

1.1 XINDEFENZIBUJUDEFULIAOHEBUSHUYUDI 1.2、1.3 DEFULIAO;

1.2 YOUYIYOULIYONGHANQINGDEFULIAOJINGJIANLVEHUAXUEBUJUZHUANBIAN(RUYANJI,SHUIHEWUDENG);

1.3 ERZHEJIERZHEYISHANGYIYOULIYONGHANQINGDEFULIAOJINGGONGCHUZHIQUDEDEFULIAO;

1.4 YIYOULIYONGHANQINGDANZHUANBIANJIYAOLUZIDEFULIAO。

JINGBIAOLISHANGSHIYAOPINZHONGYIYOULIYONGHANQINGDE,QIE

2.1 ZHONGGUOYAODIAN/USP/EP/BP/JP JUNWEISHOUZAIDEFULIAO;

2.2 USP/EP/BP/JP ZHIYIYISHOUZAI,DANWEIZAIJINGNEISHANGSHIYAOPINZHONGLIYONGDEFULIAO;

2.3 USP/EP/BP/JP ZHIYIYISHOUZAI,ZHONGGUOYAODIANWEISHOUZAIDEFULIAO;

2.4 ZHONGGUOYAODIANYISHOUZAIDEFULIAO。

ZAISHIWUHUOHUAZHUANGPINZHONGYIYOULIYONGHANQINGDE,QIE

3.1 JUBEISHIWUNINGJINGGUODUGUIFANDEYONGYUKOUFUZHIJIDEFULIAO;

3.2 JUBEIHUAZHUANGPINGUODUHUOXINGYEGUIFANDEYONGYUWAIYONGZHIJIDEFULIAO。

ZHU:

(1)GAOWEIXIANYAOYONGFULIAOPUTONGBAOLUO: DONGWUYUANMOURENYUANDEYAOYONGFULIAO;YONGYUDAZHENJI、YANYONGZHIJI、XIRUZHIJIDENGDEYAOYONGFULIAO。DUIGAOWEIXIANFULIAODEGUAHAOCAILIAOQINGQIU,KEGENJUFULIAOZAITEDINGZHIJIZHONGDELIYONGHEXIANGYINGDEJISHUQINGQIU,ANXUGONGJI,HUOZAISHENPINGJINCHENGZHONGGENJUTEDINGZHIJIJIFULIAOZAIZHIJIZHONGDELIYONGHUANJINGGENJUXUYAOBUCHONGCAILIAO。

(2)DUIYIYOULIYONGHANQINGDEFULIAO,RUOGAIFULIAOCHAOYUEXIANGYINGJIYAOLUZIDEHANQINGZUIDALIYONGLIANG,YINGGONGJIXIANGGANNINGJINGXINGSHUJUDENGCAILIAO。

(3)DUIYUHUNFULIAO,YINGGENJUQIZAIZHIJIZHONGDELIYONGJIPEIFANGGOUCHENGZHONGGEFULIAOCHENGFENHUANJING,TIAOXUANHESHIDECAILIAOQINGQIUTINGZHIGUAHAO。

(4)YISHANGGUAHAOCAILIAOFENLEIQINGQIUZUOWEIGUAHAORENCAILIAOCHOUBANDEZHIDIAN,YAOPINSHENPINGZHONGXINKEGENJUZHIJIDEJISHUSHENPINGXUYAOTICHUCAILIAOBUCHONGQINGQIU。

(5)GENJUFULIAOFENLEICHABIE,GUAHAOCAILIAO 3.2.1 YU 3.2.2,3.4.1 YU 3.4.2,4.1.1(1)YU(2)ZHONGGONGJIYIZUYANTAOCAILIAOBIANKE。



附件 2

药包材挂号材料请求(试行)

 113.PNG

一、挂号材料名目

1 GUAHAORENGENJIXINXI

1.1 CHENGHAO、DIDIAN、CHUCHANCHANG、CHUCHANDIDIAN

1.2 ZHENGSHIXINGWENJIAN

1.3 YANTAOCAILIAOBAOGUANDIDIAN

2 YAOBAOCAIGENJIXINXI

2.1 YAOBAOCAICHENGHAO

2.2 BAOZHUANGTIXI/ZUJIAN

2.3 PEIFANG

2.4 GENJITEDIAN

2.5 JINGBIAOLIHEZHUNSHANGSHIJILIYONGXINXI

2.6 GUODUGUIFANHEGUOBIAOLIYAODIANSHOUZAIHUANJING

3 CHUCHANXINXI

3.1 CHUCHANGONGYIHEJINCHENGJIEZHI

3.2 WULIAOJIEZHI

3.3 GUANJIANBUZHOUHEBANZHIPIN/ZHONGXINTIDEJIEZHI

3.4 GONGYIKAOZHENGHEPINGGU

4 PINDEJIEZHI

4.1 PINDEGUIFAN

4.2 CHANFATILIDEKAOZHENG

4.3 PINDEGUIFANNIDINGGENJU

5 PICHAYANBAOGAO

6 BENSHENBUBIANXINGYANTAO

7 XIANGRONGXINGHENINGJINGXINGYANTAO

7.1 XIANGRONGXINGYANTAO

7.2 NINGJINGXINGYANTAO

FUBIAO 1 GAOWEIXIANYAOBAOCAILIYONGHUANJINGYUGUAHAOCAILIAOBIAO

FUBIAO 2 FEIGAOWEIXIANYAOBAOCAILIYONGHUANJINGYUGUAHAOCAILIAOBIAO

FUBIAO 3 SHISHIJIEQIAGANXISHENPINGSHENPIDEYAOBAOCAIJIWEIXIANFENLEI

二、挂号材料注释及撰写请求

1 GUAHAORENGENJIXINXI

1.1 CHENGHAO、ZHUCEDIDIAN、CHUCHANCHANG、CHUCHANDIDIAN

GONGJIGUAHAORENDECHENGHAO、ZHUCEDIDIAN。

GONGJICHUCHANCHANGDECHENGHAO、CHUCHANDIDIAN(RUOYOUDUOGECHUCHANYUANDI,DOUYINGTIJIAO)。

CHUCHANDIDIANYINGQIEQUEZHICHUCHANCHEJIAN。

1.2 ZHENGSHIXINGWENJIAN

JINGNEIYAOBAOCAIGUAHAORENXUTIJIAOYIXIAZHENGSHIWENJIAN:

GUAHAORENTINGYEZHIZHAOFUYINJIAN,TINGYEZHIZHAOGUBAOLUOZHEICIGUAHAOCHANWU。DUIGUAHAORENBAITUODISANFANGTINGZHICHUCHANDE,YINGTONGSHITIJIAOBAITUOSHUDENGXIANGGANWENJIAN、CHUCHANZHEXIANGGANXINXIJITINGYEZHIZHAO。

JINGWAIYAOBAOCAIGUAHAORENYINGSHOUQUANZHONGGUODAIBIAOJIGOUTIJIAOYIXIAZHENGSHIWENJIAN(CANZHAORUKOUYAOPINZHUCEYOUGUANHUADING):

(1)GUAHAORENZHENGDANGCHUCHANZILIZHENGSHIWENJIAN、GONGZHENGWENJIANJICIZHONGWENYIWEN。DUIGUAHAORENBAITUODISANFANGTINGZHICHUCHANDE,YINGTONGSHITIJIAOCHUCHANZHEXIANGGANXINXIJIZHENGSHIWENJIAN(RUHEYONG)。

(2)GUAHAORENRUBAITUOZHONGGUOJINGNEIDAIBANSHULIJIGOUGUAHAO,XUTIJIAOSHOUQUANWENSHU、GONGZHENGWENJIANJICIZHONGWENYIWEN。ZHONGGUOJINGNEIDAIBANSHULIJIGOUXUTIJIAOQIGONGSHANGZHIZHAOHUOZHUCECHANWUCHUCHANCHANGSHANGCHANGZHUZHONGGUOJINGNEIBANSHIJIGOUDE《BENGUOQIYECHANGZHUZHONGGUODAIBIAOJIGOUGUAHAOZHENG》。

(3)CHANWUZAIJINGWAIDECHUCHAN、FAMAI、LIYONGHUANJINGZONGSHUJIZAIZHONGGUOQINGQIUXUCHUGESHENMINGDELAIYOU。

1.3 YANTAOCAILIAOBAOGUANDIDIAN

GONGJIYANTAOCAILIAOBAOGUANDIDIAN,YINGQIEQUEZHIMENSHANGBIAO。RUYANTAOCAILIAOYOUDUOGEBAOGUANDIDIANDE,DOUYINGTIJIAO。

2 YAOBAOCAIGENJIXINXI

JIENABUYIDECHUCHANGONGYIHECAILIAO、JUBEIBUYIGONGXIAODECHANWUNENGGOUHUOXUZUOWEITONGYIYAOBAOCAIGUAHAO,YAOBAOCAIQIYEKEZAITONGYIGUAHAOHAOXIAANCHABIEDEXINGHAOHEGUIGETINGZHIGUAHAO。

2.1 YAOBAOCAICHENGHAO

GONGJIYAOBAOCAIDEZHONGYINGWENTONGYONGCHENGHAO、HUAXUECHENGHAO(RUHEYONG)、CENGYONGMING,DUISHANGMEIFAKENDINGTONGYONGCHENGHAODE,XUGONGJINIDINGCHENGHAO。YAOBAOCAICHENGHAOYINGYUZHONGLEIPINDEGUIFANZHONGDECHENGHAOFENQI,YEKECANKAOZHUGUANJUBUNIDINGDEDINGMINGZHUNSHENGTINGZHIDINGMING。GAIDANGCANZHAOYIHEZHUNDEYAOBAOCAICHENGHAOHUOGUODUGUIFANDINGMINGZHUNSHENGDUICHANWUTINGZHIDINGMING。

2.2 BAOZHUANGTIXI/ZUJIAN

YAOBAOCAINENGGOUHUOXUSHIBAOZHUANGTIXI,YENENGGOUHUOXUSHIBAOZHUANGZUJIAN,ZUJIANXUSHENMINGHEYONGDEBAOZHUANGTIXI。BAOZHUANGTIXI/ZUJIANXUBIELIGONGJIMEIYIGELINGDINGZUJIAN/CAILIAODEXIANGGANXINXI,BAOLUOGOUCHENGTIXIDEZUJIANCHANWUCHENGHAO、LAIYUAN、CHUCHANDIDIANDENGXIANGGANXINXIJIPINDEGUIFAN、CHAYANBAOGAODENG。RUOSHIYOUDUOGELAIYUAN,XUBIELIJICHUWEILINGDINGGUAHAODEZUJIANCAILIAOHUOGONGJIZUJIANDEGUAHAOHAO。

SHENMING: QINGGENJUFUJIANTIANXIEBAOZHUANGTIXIGEBAOZHUANGZUJIANDECHENGHAO。RU: JINGKOUBIXIRUZHIJIYINGTIANXIERONGQI(RUGUAN、TONG)、FAMENDENGPEIJIAN。

DUIMOUXIEZHIJI,RUXUZAIJIANJIEDAZHANGYAOPINDEYAOBAOCAIWAIZENGTIANGONGXIAOXINGCIJIBAOZHUANGCAILIAO(RUGAOGEDUANXINGWAIDAI),HUOXUBAOZHUANGDIJIHECIJIBAOZHUANGCAILIAOHOUTINGZHIMIEJUNCHUZHIDEZHIJI,XUJIANGDIJIHECIJIBAOZHUANGCAILIAOZUOWEIBAOZHUANGTIXI,YIBINGTINGZHITIANXIE,BIFANGMOUXIEJIENADIJIJICIJISULIAOBAOZHUANGCAILIAODEDAZHENZHIJI,DUISUOYONGDEKUZAOJI、XIYANGJI、SUOSHIJIDENG,YEYINGTIANXIE,RUYINGXIANGZHIJIPINDEDE,XUDINGRUBAOCAIDEPINDEGUIFANZHONG。ZHIJICHUCHANJINCHENGZHONGBUDAOCHANGMIEJUNCHUZHI,JINWEIFANGCHENYONGDEWAIDAI,KEBUZUOWEIGONGXIAOXINGCIJIBAOZHUANGCAILIAO。

2.3 PEIFANG

YINGBIELITIANXIEYAOBAOCAIZHONGGEGEZUJIANDEPEIFANGXINXI,BAOLUOZUFENCHENGHAO、LAIYUAN、PINDEGUIFANJICHAYANBAOGAO、YONGLIANGPEIBIHEYUQIYONGCHU、HUAXUEPINNINGJINGSHENMINGSHU(MSDS)。YOUGUAHAOHAODEZUJIANYEKEGONGJIGUAHAOHAO。PEIFANGXINXIYINGLONGGAIYAOBAOCAISUOCHUJIDEYIQIEGOUCHENGJUBUJIYONGLIANGGENJU,RUZENGTIANJIZAIJINGBIAOLIYAODIAN、GUOBIAODENGLVLIGUIFANSHOUZAIDEYONGLIANGFANWEI。

2.3.1 CHENGHAO: BAOLUOYUANFULIAOJIZENGTIANJI(ZHESEJI、FANGFUJI、ZENGSUJI、ZHEGUANGJIJIYOUMODENG)DEHUADAMING(IUPAC MINGHE/HUO CAS MING)、ZHONGWENYIMINGHESHANGPINMINGDENG。

SHENMING: YUANFULIAOCHENGHAOZHONGYINGTONGSHISHENMINGGAIZHILIAODELIYONGPINJI(RUOYOU,XUGONGJI),JUHEWUHEJINSHUCAILIAOYINGSHENMINGSHANGBIAO。

2.3.2 来源:网上十大正规赌网址

2.3.3 JUEDUIFENZILIANG、FENZISHI、HUAXUEBUJU: WEILIYONGYUBUYIJIYAOLUZIDETIXIHUOZUJIANZHONGDEXINWUZIXUGONGJIHUAXUEBUJUJIANZHIRENGENJU(RUHECIGONGZHENPUTU、YUANSUCHANFA、ZHIPU、HONGWAIPUTUDENG)JIQIPOUXICHENGGUO。

2.3.4 LIHUAXINGZI: BAOLUOGEZUFENDELIHUAXINGZI,RUSECAI、QIXI、ZHUANGKUANG、XIAORONGDU、FENZILIANG、JUHEDUDENG(RUHEYONGKEGONGJI)。

2.3.5 YONGLIANGPEIBIHEYUQIYONGCHU: DUIYUANFULIAODEYONGLIANG/YONGLIANGFANWEI/BILITINGZHISHENMING,BINGDUIQIZAICAILIAOCHUCHAN、JIAGONGJILIYONGJINCHENGZHONGSUOQIDAODEGANHUABIELITINGZHIMIAOXIE。

2.3.6 HUAXUEPINNINGJINGSHENMINGSHU(MSDS): YINGGONGJIYUANFULIAOCHUCHANCHANGJIAGONGJIDEHUOCONGGONGRANLUZIQUDEDESUOLIYONGGELEIWUZIDEHUAXUEPINNINGJINGSHENMINGSHU。GONGJIPEIFANGHUIZONGBIAO,SHILIYIXIA:

PEIFANGHUIZONGBIAO

1.PNG

ZHU: LAIYUANSHIZHIZHIBEICAILIAODELAIYUAN,RU: ZIRAN(DONGDONGWU)MOURENGONGFENJIEDENG。

2.4 GENJITEDIAN

2.4.1 GENJIXINXI

GENJUXIANGXIYAOBAOCAIZHONGLEI,BIELIGONGJIYAOBAOCAIHEGEZUJIANDEGENJITEDIANXINXI。

BIFANG: DUIXIRUZHIJI,YINGTIANXIEQUANTIYAOBAOCAIDEXIANGGANGUITIANXINGZI,RUWAIBIAO、CHICUN、WAIXING、SECAI、GOUCHENG、GUIGE、YONGCHUDENG,HAIYINGTIANXIEFAMENDENGZUJIANDEXIANGGANGUITIANXINGZI(XIANGXIKECANKAOYAOBAOCAIDEXIANGGANJISHUZHIDIANZHUNSHENG)。

2.4.2 YANHUXINGHEGONGXIAOXING

RUOSHIGUAHAODESHIBAOZHUANGZUJIAN,YANHUXINGHEGONGXIAOJINENGGOUHUOXUXUYAOYOUBAOZHUANGTIXIDEZUHEDANWEITINGZHIXIANGYINGYANTAO。

YANHUXING: YAOBAOCAIYINGBAOZHANGDUIYAOPINZHIJIZAICHUCHAN、YUNSHU、CHUCUNJILIYONGJINCHENGZHONGDEYANHUJINENG,BAOLUOGUANGMANG、WENDU、SHIDUHEZAISHOULIQIANTIXIADUICAILIAOJIRONGQIYANHUJINENGDEYINGXIANGTINGZHIXIANGGANYANTAO(HUOGONGJICHIJIUSHANGSHILIYONGDEZHENGSHIHUOXIANGGANWENXIANCAILIAO)。

XUGENJUYAOBAOCAIDEYONGCHU,GONGJIXIANGYINGDEYANHUXINGHEGONGXIAOXINGYANTAOCAILIAO,HETILIXUEKAOZHENGCAILIAO(RUHEYONG)。RU: BIGUANGFANGHU、BIMIANRONGJISANSHI/SHENLOU、YANHUMIEJUNCHANWUHUOYOUWEISHENGWUXIANZHIQINGQIUDECHANWUMIANSHOUXIJUNJINGHUA、BIMIANCHANWUDAZHANGSHUIQI、BIMIANCHANWUDAZHANGFANYINGXINGQITIDENG。SHENMINGYAOBAOCAIPINDEGUIFANZHONGSHIBUSHIYOUXIANGYINGDEZHIKONGMINGMU。BIFANG: TOUGUANGLV,YANGQI、SHUIFEN、DANQI、ERYANGHUATANTOUGUOLVDENGMIBIJINENGDEKAOZHENGSHUJUDENG。DUIXUMIEJUNCHUZHIDEWUJUNZHIJIYONGBAOZHUANG,BIXUGONGJIMIEJUNGONGYISHUNYINGXINGDEKAOZHENGCAILIAO,JINCHAOJINGCHANGLIYONGDEMIEJUNGONGYIBAOLUOHUANYANGYIWANMIEJUN、GANLENGMIEJUN、FUSHEMIEJUNDENG,XUKAOCHAMIEJUNGONGYIDUICAILIAODEYINGXIANG(SHIBUSHIHESHIMIEJUNJINCHENG),HUANYANGYIWANMIEJUNHAIXUKAOCHAHUANYANGYIWANJIQIXIANGGANWUZIDECANLIUHUANJING。ZHONGDUANMIEJUNZHIJIBAOZHUANGXUGONGJIWENDUSHUNYINGXINGYANTAOCAILIAO,BINGZAIPINDEGUIFANZHONGLIECHUKENAISHOUDEMIEJUNQIANTIDENGXINXI。RUHEYONG,WUJUNZHIJIYONGBAOZHUANGHAIXUYAOTINGZHIMIEJUNCHENGGUODEKAOZHENG,BINGDUIBAOZHUANGCAILIAODEWEISHENGWUXUEXINGZITINGZHIYANTAO,CONGERKENDINGWUJUNBAOZHUANGDECHUCUNQI。

GONGXIAOXING: YAOBAOCAIGONGXIAOXINGSHIZHIBAOZHUANGTIXIGENJUYUQISHEXIANGCHANYANGGANHUADECAINENG,RUZHIZUCHUGERENQUN(ERTONG、LAONIANREN、GUZHEDENG)YONGYAO、JINBUHUANZHEYONGYAOYUNCONGXINGHEFUDAIJIYAOZHUANGPEIDEJINENG。XUGENJUYAOBAOCAIDEYONGCHU,GONGJIXIANGYINGDEGONGXIAOXINGYANTAOCAILIAO,HETILIXUEKAOZHENGCAILIAO。RUOSHIJIENAGUODUGUIFAN/XINGYEGUIFANCHANGSHITILI,ZEBUXUGONGJITILIXUEKAOZHENGCAILIAO。DUIJUBEITEDINGGONGXIAODEBAOZHUANG,RUJIEZHIYAOWUKAISHIDEPENWUJIDINGLIANGJIYAOZHUANGPEI、DAIGAOGEDUANXINGWAIDAIDESULIAOYAOBAOCAIDENG,XUGONGJIZHENDUITEDINGGONGXIAOTINGZHIDEXIANGGANKAOZHENGCAILIAO,YIZHIZUTEDINGDEGONGXIAOXINGQINGQIU。DUIJINBUYONGYAOYUNCONGXING,XIAJIANGMAOBINGYONGYAODEBAOZHUANGQINGSHI,RUERTONGNINGJINGGAI、FENYESHUANGSHIDAI、MANGWENYINSHUA、LAONIANRENYIKAIQIDENG,HAIYINGGONGJICAOZONGKEXINGXINGCHANGSHICHANFAHEBIRANRENQUNFANWEIDELIYONGSHUJUCHANFA。

2.5 JINGBIAOLIHEZHUNJILIYONGXINXI

2.5.1 JINGWAIHEZHUNSHANGSHIDEXIANGGANZHENGSHIXINGWENJIAN

DUIRUKOUYAOBAOCAI,GONGJIJINGWAIYAOPINJIANSHICAOCHIJUBUDEXIANGGANZHENGSHIXINGWENJIAN,RU DMF BEIANWENJIAN(SHENMINGZHUANGKUANG)、HEZHUNSHIHOUHE/HUOQIYUZHENGSHIXINGWENJIAN,BINGJIANSHUZAIZHIJIZHONGDELIYONGHUANJING。

2.5.2 CHUCHAN、FAMAI、LIYONGHUANJINGZONGSHU

TIANXIEBENQIYESUOCHUCHANYAOBAOCAIZAIJINGNEISHANGSHI(BAOLUORUKOU)DEZHIJIZHONGSHIBUSHIYILIYONG,HESUOLIYONGDEJIXING、CHANWU。

2.6 GUODUGUIFANHEGUOBIAOLIYAODIANSHOUZAIHUANJING

GONGJIGAIYAOBAOCAIJIGEZUJIANBEIGUODUGUIFANJIGUOBIAOLIYAODIANHEXIANGGANGUOJIGUIFANSHOUZAIDEXINXI。

3 CHUCHANXINXI

3.1 CHUCHANGONGYIHEJINCHENGJIEZHI

GONGJICHUCHANCHANGQUJIGANJINGSHI(QU)LITITUJIGANJINGQUDEJIANCEBAOGAO。

(1)GONGYILIUCHENGTU: ANGONGYIBUZHOUGONGJIGONGYILIUCHENGTU,BIAOMINGGONGYICANSHU、GUANJIANBUZHOUDENG。

RUOLIYONGRONGJIQINGLIECHUSUOYONGRONGJIZHONGLEI。

(2)GONGYIMIAOXIE: GENJUGONGYILIUCHENGLAIMIAOXIEGONGYICAOZONG,YIMAOYIPIWEIDAIBIAO,LIEMINGSHOUYAOZHAODUANYUANCAILIAO、GONGYIBUZHOU、ZENGTIANJI、ZHANHEJI、CHUCHANQIANTI(WENDU、YALI、SHIHOUDENG)HECAOZONGFASHIDENG,RUCHANWUCHUJIYINSHUA,XUSHENMINGYINSHUAGONGYIJIJIENADEYINSHUAJIEZHIDENGXIANGGANXINXI,SHENMINGCHUCHANGONGYIDETIAOXUANGENJU。

MIEJUNDEYAOBAOCAIKEZENGTIANBAOCAILIYONGQIANXIZHUOZHUANGKUANGJIHONGGAN、MIEJUNQINGQIUDENG。

(3)SHENMINGMAOYIHUACHUCHANDEFENHEZHUNSHENG、PILIANGFANWEIHEGENJU。

(4)ZHUANGBEI: GONGJISHOUYAOHECHUGEDECHUCHAN、CHAYANZHUANGBEIDEXINGHAOHUOJISHUCANSHU。

CHUCHAN、CHAYANZHUANGBEICAILIAONENGGOUHUOXUGENJUXIASHUBIAOGEQINGSHITIJIAO:

YAOBAOCAICHUCHANZHUANGBEIYILANBIAO

 2.PNG

YAOBAOCAICHAYANZHUANGBEIYILANBIAO

 3.PNG

3.2 WULIAOJIEZHI

GENJUGONGYILIUCHENGTUZHONGDEGONGXU,YIBIAOGEDEQINGSHILIEMINGCHUCHANDINGYONGDAODEYIQIEWULIAOHEZENGTIANJI,RUYOUMOHEZHANHEJIDENGBINGSHENMINGSUOLIYONGDEBUZHOU,SHILIYIXIA:

WULIAOJIEZHIXINXI

 4.PNG

ZHU: RUDONGWULAIYUAN、DONGWULAIYUAN、HUAXUEFENJIEDENG。

GONGJIYISHANGWULIAODEPINDEJIEZHIXINXI,MINGBAIYUANYONGGUIFAN,HUOGONGJINEIKONGGUIFAN(BAOLUOMINGMU、JIANCETILIHEXIANZHI)BINGGONGJIXUYAODETILIXUEKAOZHENGCAILIAO。

3.3 GUANJIANBUZHOUHEBANZHIPIN/ZHONGXINTIDEJIEZHI

LIECHUYIQIEGUANJIANBUZHOU,GONGJIGUANJIANJINCHENGJIEZHIJICANSHU,GONGJIKEKENDINGGUANJIANBUZHOUHEGANXINGHEGONGYICANSHUJIEZHIFANWEIHEGANXINGDEYANTAOCAILIAO。XUSHENMINGGECHUCHANBUZHOUSHIBUSHIWEICHIXUCHUCHAN。RUOYOUBANZHIPIN/ZHONGXINTI,LIECHUBANZHIPIN/ZHONGXINTIDEPINDEJIEZHIGUIFAN,BAOLUOMINGMU、TILIHEXIANZHI,BINGGONGJIXUYAODETILIXUEKAOZHENGCAILIAO。

3.4 GONGYIKAOZHENGHEPINGGU

DUICHANWUPINDEYOUYANZHONGYINGXIANGDEGONGYI,YINGGONGJIKAOZHENGJIHUA、KAOZHENGBAOGAO、PICHUCHANJISHIDENGCAILIAO,HUOGONGJICHONGZUXINXIYIZHENGSHICHUCHANGONGYINENGBUBIANCHUCHANCHUHESHIPINDEQINGQIUDEBAOCAI。

4 PINDEJIEZHI

4.1 PINDEGUIFAN

GONGJIYAOBAOCAIDEGUIFAN:

YIYOUGUODUGUIFANDEGUAHAOCHANWU,KELIYONGGUODUGUIFANZUOWEIGUAHAOCHANWUDEPINDEGUIFAN,RUOSHIYUGUODUGUIFANHUOYAODIANGUIFANBUFENQI,XULIANXICHANWUDEXINGZI,LUNZHENGQIYEGUIFANKENDINGDEHEGANXING。GUAHAOCHANWUDECAILIAO、YONGCHU、CHUCHANGONGYI(HEYONGSHI)、ZUHEJIANGONGTONGTILI(HEYONGSHI)DEQINGQIUYINGYUPINDEGUIFANDEHUADINGHESHI。

DUIQIYEGUIFANDEQINGQIU:

PINDEGUIFANGAIDANGHESHIXIANXINGBANZHONGGUOYAODIANHEGUODUGUIFANDEJISHUQINGQIUHEGEJU,BINGLIYONGQISHUYUHEJILIANGDANWEI。HAIBUZHICHUGUODUGUIFANDEGUAHAOCHANWU,GUAHAOQIYEYINGGENJUGUAHAOCHANWUDECAIZHI、YONGCHU、JINENGDENGTEDIAN,SHELIXIANGGANCHAYANMINGMU、CHAYANTILIHEJISHUQINGQIU,ZIXINGNIDINGCHANWUZHUCEGUIFAN,BINGTINGZHITILIXUEKAOZHENG;GONGJIGUIFANTILIHECAONISHENMING,GONGJIMINGMU、TILI、MUBIAOSHELIDEGENJUDENGWAIRONG。TONGYIGEBAOZHUANGTIXI/ZUJIANYONGYUCHABIEDEZHIJIHUOCHABIEDEZHIJIQIYE,JIANCEMINGMUHEMUBIAONENGGOUHUOXUCHABIE。NINGJINGXINGMUBIAOYINGBUDEDIYUGUODUGUIFANTONGLEICHANWUDEQINGQIU;GENJUYAOBAOCAICHANWUZHONGLEIJIQIHEYONGJIXINGDECHABIE,ZAIPINDEGUIFANZHONGXUBAOLUOCAILIAO、RONGQIDEGEDUANJINENGHEMIBIJINENGDENGXIANGYINGDEYANHUXINGJIANCEMINGMU: RUBIGUANG、FANGCHAO、GEDUANQITI(YANGQI、SHUIFEN、DANQI、ERYANGHUATANTOUGUOLVDENG)、MIBI、BIMIANWEISHENGWUJINGHUADENGYANHUXINGJIANCEMINGMU。KELIYONGYAODIANDENGTILITINGZHITOUGUANGXING,FANGCHAOXING,WEISHENGWUXIANZHIHEWUJUNCESHI。XUYAOSHI,CHUYAODIANDENGGUIFANLILIECHUDEZHEIXIECESHIYIWAI,NENGGOUHUOXUZENGTIANYOUGUANJINENGCESHI(RUQITICHUANDAO,RONGJISHENLOU,RONGQIWANQUANXING);PINDEGUIFANZHONGXUBAOLUOYAOBAOCAININGJINGXING、YANHUXING、GONGXIAOXINGYUCHUCHANJINCHENGXIANGGANDEJIANCEMINGMU;GONGJICHANWUDEBUJUBIAOSHITU(BAOLUOCHICUNXINXI)HESHIYANGTUPIAN。

4.2 CHANFATILIDEKAOZHENG

GONGJIPINDEGUIFANZHONGXIANGGANMINGMUBIAOTILIXUEKAOZHENGCAILIAO。MOUXIEWUXUTINGZHIKAOZHENGDECHACHAOXIANG,RUSUANJIANDUDIDING,SHUIFENCEDINGDENG,WUXUGONGJI;DUIJIENAGUODUYAOBAOCAIGUIFANDECHANFATILIWUXUGONGJICHANFATILIDEKAOZHENG;DUIJIENAXIANGGANGUOJIGUIFANHUOWAIYANGYAODIANSHOUZAIDETILI,KESHIHUANJINGZHANKAITILIXUEQUEREN。

4.3 PINDEGUIFANNIDINGGENJU

QIYEGUIFANXUYAOSHENMINGGEMINGMUSHEDINGDEZHENZHUO,ZONGJIECHANFAGECHACHAOTILITIAOXUANHEXIANZHIKENDINGDEGENJU。PINDEGUIFANCAONISHENMINGGAIDANGBAOLUOGUIFANZHONGJIEZHIMINGMUBIAOXUANDING、TILITIAOXUANDEGENJUDENG。

5 PICHAYANBAOGAO

ZHUPICHAYANMINGMUXUGONGJIBUSHAOYUSANPIYANGPINDECHAYANBAOGAO,YBB ZHONG*HE**HAOCHAYANMINGMUNENGGOUHUOXUJIANYIPI。RUOSHIBAITUOYOUTIANZIDANWEITINGZHICHAYANDEMINGMUXUYUYISHENMING。BAITUOCHAYANDESHOUTUOFANGXUJUBEIXIANGGANTIANZI。

6 BENSHENBUBIANXINGYANTAO

GONGJIYAOBAOCAIBENSHENDEBUBIANXINGYANTAOCAILIAO,MIAOXIEZHENDUISUOXUANYONGBAOCAITINGZHIDECHENGCHIXINGYANTAO。

YAOBAOCAIBENSHENBUBIANXINGZHONGDIANKAOCHABAOZHUANGTIXIHUOBAOZHUANGZUJIANZAIHUADINGDEWENDUJISHIDUHUANJINGXIASUISHIHOUBIANGEDEJILV,YIQUERENYAOBAOCAICHANWUZAIHUADINGDECHUCUNQIANTIXIADEWENANKERI。SHENMINGBUBIANXINGYANTAODEYANGPINHUANJING(BAOLUOPIHAO、PILIANGDENGXINXI)、KAOCHAQIANTI、KAOCHAMUBIAOHEKAOCHACHENGGUO,DUIBIANGEQUXIANGTINGZHICHANFA,BINGTICHUCHUCUNQIANTIHELIYONGKERI。YIBIAOGEQINGSHIGONGJIBUBIANXINGYANTAODEXIANGXICHENGGUO,BINGJIANGBUBIANXINGYANTAOZHONGDEXIANGGANTUPUZUOWEIFUJIAN。YAOBAOCAIBUBIANXINGYANTAOKECANPAIZHAOGANJISHUZHIDIANZHUNSHENGTINGZHI,RUJIAKUAIQIANTIXIADELAOHUAYANTAO,YE

KEGONGJIYAOBAOCAIZAIWENANQINEIDECHIJIUCHANGSHISHUJU。BUBIANXINGPINGGUDEYANGPINYINGJUBEIDAIBIAOXING,FANSHIYINGJIENABUBIANFANWEICHUCHANDEYANGPIN。YANGPINDEPINDEGUIFANYINGYUFANWEICHUCHANSUOLIYONGDEPINDEGUIFANFENQI。YAOBAOCAIBENSHENBUBIANXINGYANTAOPUTONGHEYONGYUYAOYONGSULIAOHEXIANGJIAODENGGAOFENZICAILIAO。

7 XIANGRONGXINGHENINGJINGXINGYANTAO

7.1 XIANGRONGXINGYANTAO

YONGYUXIRUZHIJI、DAZHENJI、YANYONGZHIJIDEYAOBAOCAI,GUAHAORENYINGGENJUPEIFANGGONGJITIQUCHANGSHIXINXI,BAOLUODINGLIANGHUODINGXINGDIQUDECAILIAOZHONGHUIFAXINGHUOBUHUIFAXINGTIQUWUDETIQUTEDIAN(TIQUWUKU)HEXIANGYINGDEPUTU。RUOYOUNENGGOUHUOXU,KETONGSHIGONGJIQIANFUDEJINCHUWUTIXINGXINXI,GONGZHIJICHUCHANQIYETINGZHIZHIJIYUYAOBAOCAIDEXIANGRONGXINGCHANGSHILIYONG。

TIQUCHANGSHIKECANZHAOGUODUFABUDEXIANGGANJISHUZHIDIANZHUNSHENGHUOGUOBIAOLIYAODIANSHOUZAIDEXIANGGANGUIFANTINGZHI。TIQUCHANGSHIDETILIHERONGJIDEBAQUYINGGENJUTIQUMUBIAOHEBAOZHUANGZUJIANDEXINGZIJUEYI。BAOFUHUANJINGXIATIQURONGJIYINGYUZHIJIDUITIQUWUZIJUBEIBUYIDETEDIANYIQUDEYIYANGDEDINGLIANGTIQUTEDIAN。

7.2 NINGJINGXINGYANTAO

YIXIACHANWUXUYAOTINGZHININGJINGXINGYANTAO:

7.2.1 XINCAILIAO,XINBUJU,XINYONGCHUDEYAOBAOCAI: YINGGONGJICHANWUJISUOYONGYUANCAILIAOXIANGGANDENINGJINGXING(SHENGWUXUEHEDULIXUE)YANTAOCAILIAO,XIANGXICHANWUNINGJINGXINGYANTAOCAILIAOKECANKAOXIANGYINGJISHUQINGQIUTINGZHI。

7.2.2 YONGYUXIRUZHIJI、DAZHENJIHEYANYONGZHIJIDEYAOBAOCAI: WUMINGBAIZHENGJULIYONGYUCILEIBAOZHUANGDECAILIAOHEZENGTIANJI,XUGONGJIXIANGYINGDENINGJINGXINGCAILIAO。WEIZHENGSHIXIANGRONGXING,DUIYOUNENGGOUHUOXUCHANSHENGYAOPINYUBAOZHUANGCAILIAOCHANSHENGBICIGANHUADEHUANJING,YINGTIJIAOKETIQUWUDEDULIXUEYANTAO,XUYAOSHIGONGJIKETIQUWUDESHENGWUXUENINGJINGXINGPINGGUCAILIAO;YINGTIJIAOYIZHIKETIQUWUDEBUJU(BAOLUOBUJUYIZHIQIEDULIXUESHUJUMINGBAIDEKETIQUWU,HEBUJUYIZHIDANDULIXUESHUJUBUMINGBAIDEKETIQUWU)。

三、挂号材料申明

1 YAOBAOCAIGUAHAOCAILIAOSHIZHIJIZHUCECAILIAOZHONGDEYIJUBU,YUZHIJIDEGUAHAOCAILIAOZUHEHOU,YINGNENGGOUHUOXUZHENGSHIGAICHANWUNENGGOUHUOXUZHIZUYUQIBAOZHUANGYAOPINDEQINGQIU。

2 GUAHAOCAILIAOGENJUYAOBAOCAIWEIXIANSHUIPINGHEYAOBAOCAILIYONGHUANJINGTINGZHIFENLEI,KENDINGZUISHAOXUYAOTIJIAODEGUAHAOCAILIAO,XIANGXINEIRONGJIANFUBIAO 1 HEFUBIAO 2。

3 YAOBAOCAICHANWUJISUOYONGYUANCAILIAO、ZENGTIANJIXIANGGANDENINGJINGXINGYANTAOCAILIAO,KEBAOLUOYIXIACAILIAO: GUOBIAOLIYAOBAOCAIGUIFANHUOYAODIANZHONGDESHENGWUXUECESHI;GUOBIAOLIDULIXUEWENXIANCAILIAO;CAILIAODESHENGWUXUENINGJINGXINGCESHIDENG。

4 DUIFEIGAOWEIXIANZHIJILIYONGDEYAOBAOCAI,PUTONGBUQINGQIUGONGJI 3.4 GONGYIKAOZHENGHEPINGGUJI 7.1XIANGRONGXINGYANTAOCAILIAO。DANJIENAWUJUNGONGYIDEWAIYONGZHIJI,HEYIQIEDEYETIXITILIJILIYONGDEYAOBAOCAIYINGSHIHUANJINGZHANKAIXIANGYINGDEYANTAO。

5 RUOSHIQINGQIUDEYAOBAOCAICHUJIDUOGEZUJIANGOUCHENGBAOZHUANGTIXI,CHUBAOZHUANGTIXIYAOTIANBAOWANQUANDEGUAHAOCAILIAOWAI,MEIYIGEZUJIANXUBIELIGONGJICAILIAO 2.2~7。BIFANGDARONGLIANGDAZHENJIDESHUYEDAIBAOZHUANG,XUBIELITIANXIEDUOCENGGONGJISHUYEDAI、SULIAOZUHEGAI、GEDUANWAIDAIDENGXINXI。RUOSHIJINGUAHAOBAOZHUANGZUJIAN,RUYAOYONGJIAOSAI,KEJINTIANXIEJIAOSAIDEXIANGGANXINXI。

6 DUIFENLEIWEIHANGAIDEYAOBAOCAI,QINGTIAOXUAN“QIYU”,QIGUAHAOCAILIAOQINGQIUGENJUWEIXIANSHUIPINGHELIYONGHANQINGTIJIAOXIANGGANDEGUAHAOCAILIAO。

 

FUBIAO 1

GAOWEIXIANYAOBAOCAIGUAHAOCAILIAOBIAO

5.PNG

ZHU: + XUGONGJIXIANGGANCAILIAODEMINGMU

- WUXUGONGJIXIANGGANCAILIAODEMINGMU

± GENJUXUYAOGONGJIXIANGGANCAILIAODEMINGMU

 

FUBIAO 2

FEIGAOWEIXIANYAOBAOCAIGUAHAOCAILIAOBIAO

6.PNG

ZHU: + XUGONGJIXIANGGANCAILIAODEMINGMU

- WUXUGONGJIXIANGGANCAILIAODEMINGMU

± GENJUXUYAOGONGJIXIANGGANCAILIAODEMINGMU

 

备注: *

1 WEIZAIJINGBIAOLISHANGSHIYAOPINZHONGLIYONGGUODEYAOBAOCAI(RUXINCAILIAO、XINBUJU);

2 YIZAIJINGBIAOLISHANGSHIYAOPINZHONGLIYONGGUO,DANZHUANBIANYAOPINJIYAOLUZIQIEWEIXIANJINBUDEYAOBAOCAI;

3 WEIZAIJINGBIAOLISHANGSHIYAOPINZHONGLIYONGGUO,KESHIKEZHENGSHIZAISHIWUBAOZHUANGZHONGLIYONGGUODEYUSHIWUJIANJIEDAZHANGDEYAOBAOCAI(JINXIANYONGYUKOUFUZHIJI);

4 YIZAIBUYIJIYAOLUZIDESHANGSHIYAOPINZHONGLIYONGGUODEYAOBAOCAI

4.1 WUZHUCEZHENGDEYAOBAOCAI

4.2 YOUZHUCEZHENGDEYAOBAOCAI


附件3

可免挂号的产物目次(2019 年版)

YAOPINZHIJISUOYONGDEJUBUJIAOWEIJI、XIANGJING、SESU、pH DIAOLIJIDENGYAOYONGFULIAOKEBUGENJU 146HAOGAOSUBUGAOQINGQIUTINGZHIGUAHAO,XIANGXIYIXIA:

1.JIAOWEIJI(TIANWEIJI): RUZHETANG、DANTANGJIANG、GANLUCHUN、SHANLICHUN、TANGJINGNA、ASIPATAN、SANLVZHETANG、TIANJUTANGGAN、PUTAOTANG、MUTANGCHUN、MAIYATANGCHUNDENG。GAILEIZHONGLEIJINXIANYUZAIZHIJIZHONGZUOWEIJIAOWEIJI(TIANWEIJI)LIYONG。

2.XIANGJING、XIANGLIAO: RUJIEZIXIANGJING、XIANGJIAOXIANGJING、XIANGLANSUDENG。SHISHISHIWUGUIFANDE,YINGHESHIXIANXINGBAN GB 2760《SHIWUNINGJINGGUODUGUIFAN SHIWUZENGTIANJILIYONGGUIFAN》、GB 30616《SHIWUNINGJINGGUODUGUIFAN SHIWUYONGXIANGJING》JI GB 29938《SHIWUNINGJINGGUODUGUIFAN SHIWUYONGXIANGLIAOGONGLI》DENGXIANGGANQINGQIU。

3.SESU(ZHESEJI): RUYANGHUATIE、DONGWUTANHEI、YANZHICHONGHONGDENG。SHISHISHIWUGUIFANDE,YINGHESHIXIANXINGBAN GB2760《SHIWUNINGJINGGUODUGUIFAN SHIWUZENGTIANJILIYONGGUIFAN》DENGXIANGGANQINGQIU。

4.pH DIAOLIJI(BAOLUODAZHENJIZHONGLIYONGDE pH DIAOLIJI): RUPINGGUOSUAN、FUMASUAN、CUSUAN、CUSUANNA、GOUYUANSUAN(NA、JIAYAN)、JIUSHISUAN、QINGYANGHUANA、NONGANRONGYE、YANSUAN、LIUSUAN、LINSUAN、RUSUAN、LINSUANERQINGJIA、LINSUANQINGERJIA、LINSUANQINGERNA、LINSUANERQINGNADENG。

5.JINZUOWEIFULIAOLIYONG、ZHIBEIGONGYIJIANLVE、LIHUAXINGZIBUBIANDEWUJIYANLEI(BAOLUODAZHENJIZHONGLIYONGDEWUJIYANLEI): RUTANSUANGAI、TANSUANNA、LVHUAJIA、LVHUAGAI、LVHUAMEI、LINSUANGAI、LINSUANQINGGAI、LIUSUANGAI、TANSUANQINGNADENG。

6.KOUFUZHIJIYINZILIYONGDEWUBENYOUMO。

SHANGSHUYAOYONGFULIAO,XIANXINGBAN《ZHONGGUOYAODIAN》YISHOUZAIDE,YINGHESHIXIANXINGBAN《ZHONGGUOYAODIAN》QINGQIU;XIANXINGBAN《ZHONGGUOYAODIAN》WEISHOUZAIDE,YINGHESHIGUODUSHIWUGUIFANHUOXIANXINGBANMEIGUOYAODIAN/GUODUCHUFANGJI、OUZHOUYAODIAN、RIBENYAODIAN、YINGGUOYAODIANGUIFANQINGQIU;QIYUFULIAO,YINGHESHIYAOYONGQINGQIU。

(ZHU: BENQINGDANSUOLIEFULIAOYONGYUBENQINGDANBIAOMINGYONGCHUYIWAIDEQIYUYONGCHUDE,XUYAOGENJUQINGQIUTINGZHIGUAHAO,HUOGENJUYAOPINSHENPINGDEQINGQIUGONGJIXIANGGANCAILIAO)

 

附件 4

药用原辅料、药包材年度报告根基请求

YI、YUANFUBAOGUAHAORENYINGZAIMEIYINIANDIYIJIDUJINGYOUJINCHENGQINGQIURENZHICHUANGTIJIAOSHANGYINIANNIANDUBAOGAO。

ER、NIANDUBAOGAOZHONGYINGBAOLUOSHANGYINIANDUCHANWUBIANGEHUIZONG,RUWURENHEBIANGEYINGYOUXIANGGANSHENMING。

SAN、NIANDUBAOGAOZHONGYINGYOUXIANGGANZHIJICHANWUXINXI,RUQIYECHENGHAO、YAOPINCHENGHAODENG。





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