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落實四個最嚴要求 統一三品一械廣告審查管理

時間:2020-01-02 11:25來源:中國市場監管報 作者:中國市場監管報 點擊:
為貫徹落實“四個最嚴”要求,加強“三品一械”廣告監督管理,規范廣告審查工作,國家市場監督管理總局制定出臺《藥品、醫療器械、保健食品、特殊醫學用途配方食品廣告審查管
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【直報網北京1月2日訊】(中國市場監管報)為貫徹落實“四個最嚴”要求,加強“三品一械”廣告監督管理,規范廣告審查工作,國家市場監督管理總局制定出臺《藥品、醫療器械、保健食品、特殊醫學用途配方食品廣告審查管理暫行辦法》(2019年12月24日國家市場監督管理總局令第21號,以下簡稱“辦法”),將自2020年3月1日起施行。

SHICHANGJIANGUANZONGJUCHENGLIHOU,ANZHAO“TONGYIGUANGGAOGUANLI”DEYAOQIU,GENJUJIGOUZHENGHE、ZHINENGDIAOZHENGHEGONGZUOSHIJIANDEXUYAO,JIXUDUIGUANGGAOSHENCHAGUIZEJINXINGTONGYIWANSHAN。YISHIYUAN“SANPINYIXIE”GUANGGAOSHENCHAXIANGGUANDEGUIZHANGHEGUIFANXINGWENJIANSUOYIJUDE《GUANGGAOFA》《YAOPINGUANLIFA》DENGYUJINNIANXIANGJIXIUDING,PEITAOGUIZHANGXUYAOJINXINGXIANGYINGXIUGAI。ERSHIJIGOUGAIGEQIAN,YUANSHIPINYAOPINJIANGUANBUMENFUZE“SANPINYIXIE”GUANGGAOSHENCHA,YUANGONGSHANGBUMENFUZEGUANGGAOJIANGUAN。ANZHAOJIGOUGAIGEYAOQIU,GUOJIASHICHANGJIANDUGUANLIZONGJUFUZEZHIDAO“SANPINYIXIE”GUANGGAOSHENCHAGONGZUO,YINCIXUYAOZAIGUIZHANGCENGMIANZUOHAODINGCENGSHEJI,DUISHENCHABIAOZHUNHECHENGXUJINXINGTONGYIWANSHAN。SANSHIBANFAZHENDUIJINYINIANLAIGEDI“SANPINYIXIE”GUANGGAOSHENCHAGONGZUOSHIJIANZHONGBAOLUCHUDEWENTI,DUISHENCHAGONGZUOZHIDUJINXINGLEWANSHAN,ZENGQIANGLEDUIJICENGGONGZUOSHIJIANDEZHIDAO。

BANFAGONG34TIAO,DUI“SANPINYIXIE”GUANGGAOSHENCHADELIFAYIJU、SHIYONGFANWEI、ZHUGUANBUMEN、NEIRONGBIAOZHUN、SHENCHACHENGXU、FABUYAOQIU、FALVZERENDENGZUOLEXITONGQUANMIANDEGUIDING,BENZHU“YAN”SHENCHA、“KUAN”CHENGXUDEZONGTIYAOQIU,LIQIUZUODAONEIRONGBIAOZHUNYANGE、QINGXI,LIUCHENGBIANJIE、YOUHUA,ZHUYAOBAOKUOYIXIANEIRONG:

明確“三品一械”廣告審查管理機構職能與分工

大家乐彩票开户 GENJU《XINGZHENGXUKEFA》《SHIPINANQUANFA》《YAOPINGUANLIFA》《YILIAOQIXIEJIANDUGUANLITIAOLI》DENGFALVFAGUIHE《GUOJIASHICHANGJIANDUGUANLIZONGJUZHINENGPEIZHI、NEISHEJIGOUHERENYUANBIANZHIGUIDING》,BANFADISITIAOGUIDING,SHENG、ZIZHIQU、ZHIXIASHIRENMINZHENGFUGUANGGAOSHENCHAJIGUANFUZE“SANPINYIXIE”GUANGGAODESHENCHA。GUOJIASHICHANGJIANDUGUANLIZONGJUFUZEDUI“SANPINYIXIE”GUANGGAOSHENCHAGONGZUOJINXINGZHIDAO。TONGSHI,WEIFANGBIANGEDIJIEHEGONGZUOSHIJIZUOHAOGUANGGAOSHENCHAGONGZUO,GUIDINGGUANGGAOSHENCHAJIGUANZAIFADINGZHIQUANFANWEINEI,YIFAKEYIWEITUOQITAXINGZHENGJIGUANJUTISHISHIGUANGGAOSHENCHA。

嚴格“三品一械”廣告審查標準

大家乐彩票开户 GENJU《YAOPINGUANLIFA》DIJIUSHITIAO、《GUANGGAOFA》DISHILIUTIAODENGYOUGUANGUIDING,BANFAMINGQUEGUIDINGGUANGGAONEIRONGYINGDANGYICHANPINZHUCEZHENGMINGWENJIANHUOZHEBEIANPINGZHENG、CHANPINSHUOMINGSHUZHONGDENEIRONGWEIZHUN。GUANGGAOZHONGSHEJICHANPINZHUCEZHENGMINGWENJIANZAIMINGDEGONGNENGZHUZHIDENGSHIXIANGDE,BUDECHAOCHUJINGGUOZHUGUANBUMENSHENCHAPIZHUNDECHANPINZHUCEZHENGMINGWENJIANFANWEI,JILUOSHIZUIYANYAOQIU,YOUJIANJUGUANGGAODECHUANGYIHEBIAOXIANXING。

大家乐彩票开户 TONGSHI,DUI《GUANGGAOFA》DIJIUTIAO、DISHILIUTIAO、DISHIQITIAO、DISHIBATIAO、DISHIJIUTIAODENGTIAOKUANJI《YAOPINGUANLIFA》DENGFALVFAGUIZHONGDEXIANGGUANTIAOKUANZUOLEJINYIBUXIHUA,XISHOUBINGZHENGHELEYUAN“SANPINYIXIE”GUANGGAOSHENCHAGUIZHANG、GUIFANXINGWENJIANDEYOUGUANNEIRONG,YILIEJU+DOUDIDEFANGSHIGUIDINGLE“SANPINYIXIE”GUANGGAOZHONGBUDECHUXIANDENEIRONGHEQINGXING,BAOKUOBUDESHIYONGHUOZHEBIANXIANGSHIYONGGUOJIAJIGUAN、GUOJIAJIGUANGONGZUORENYUAN、JUNDUIDANWEIHUOZHEJUNDUIRENYUANDEMINGYIHUOZHEXINGXIANG,HUOZHELIYONGJUNDUIZHUANGBEI、SHESHIDENGCONGSHIGUANGGAOXUANCHUAN;SHIYONGKEYANDANWEI、XUESHUJIGOU、XINGYEXIEHUIHUOZHEZHUANJIA、XUEZHE、YISHI、YAOSHI、LINCHUANGYINGYANGSHI、HUANZHEDENGDEMINGYIHUOZHEXINGXIANGZUOTUIJIAN、ZHENGMING;BUDESHENGCHENGHUOZHEANSHIGUANGGAOSHANGPINWEIBAOZHANGJIANKANGSUOBIXU;BUDESHEJIBIAOSHIGONGXIAO、ANQUANXINGDEDUANYANHUOZHEBAOZHENG;BUDEHANYOU“REXIAO、JIATINGBIBEI”DENGYOUDAOXINGNEIRONG,“PINGBI、TUIJIAN、HUOJIANG”DENGZONGHEXINGPINGJIANEIRONG,“WUXIAOTUIKUAN”DENGBAOZHENGXINGNEIRONG,SONGYONGXIAOFEIZHERENYI、GUOLIANGSHIYONGYAOPIN、BAOJIANSHIPINHETESHUYIXUEYONGTUPEIFANGSHIPINDENEIRONG;BUDEHANYOUYILIAOJIGOUJIYILIAOFUWUDENGNEIRONGYIJIFALV、XINGZHENGFAGUIGUIDINGBUDEHANYOUDEQITANEIRONG。

明確并精簡“三品一械”廣告應當顯著標明的內容

大家乐彩票开户 ANZHAOBAOHUXIAOFEIZHEZHIQINGQUANHEXUANZEQUANDEYUANZE,BANFAGUIDINGLE“SANPINYIXIE”GUANGGAOZHONGYINGDANGXIANZHUBIAOMINGDENEIRONG,ZHUYAOBAOKUO《GUANGGAOFA》DISHILIUTIAO、DISHIBATIAOZHONGGUIDINGXUYAOXIANZHUBIAOMINGDENEIRONG,YIJIGUANGGAOPIZHUNWENHAO,FEICHUFANGYAOBIAOSHI,BAOJIANSHIPINBIAOZHI、SHIYIRENQUNHEBUSHIYIRENQUN,TESHUYIXUEYONGTUPEIFANGSHIPINDESHIYONGRENQUNDENG。WEILEJIANGUGUANGGAODEBIAOXIANXINGSHIHEXIAOGUO,BIANLIQIYEGUANGGAOXUANCHUAN,YUYUANSHENCHABIAOZHUNXIANGBI,BANFAZHONGSHANCHULESHENGCHANQIYEMINGCHENG、CHANPINZHUCEZHENGMINGWENJIANHUOZHEBEIANPINGZHENGBIANHAODENGKEYITONGGUOCHAXUNGUANGGAOPIZHUNWENHAOHUODEDEXINXI。

壓縮申請證明材料

大家乐彩票开户 ANZHAO“ZHENGZHAOFENLI”GAIGEDEGONGZUOYAOQIU,JINYIBUYASUOSHENQING“SANPINYIXIE”GUANGGAOSHENCHASUOXUZHENGMINGCAILIAO。BANFAGUIDINGCHUTIJIAO《GUANGGAOSHENCHABIAO》、YUFABUNEIRONGYIZHIDEGUANGGAOYANGGAOWAI,ZHIXUZAITIJIAOSHENQINGRENDEZHUTIZIGEZHENGMINGCAILIAO、CHANPINZHUCEZHENGMINGWENJIAN、SHENGCHANXUKEWENJIANYIJIYUGUANGGAOYOUGUANDEZHISHICHANQUANZHENGMINGJIKEBANLI。

延長“三品一械”廣告批準文號有效期

YUANSHENCHABANFAGUIDINGGUANGGAOPIZHUNWENHAOYOUXIAOQIWEI1NIAN,ZAIZHENGQIUYIJIANGUOCHENGZHONG,QIYEPUBIANFANYING1NIANYOUXIAOQIBUNENGMANZUGUANGGAOFABUXUQIU。WEIGENGHAODIFUWUQIYE,GEIYUQIYEGENGDADEZIZHUQUAN,JIANQINGBUBIYAODEZHONGFUSHENQINGFUDAN,BANFAGUIDING,YAOPIN、YILIAOQIXIE、BAOJIANSHIPINHETESHUYIXUEYONGTUPEIFANGSHIPINGUANGGAOPIZHUNWENHAODEYOUXIAOQIYUCHANPINZHUCEZHENGMINGWENJIAN、BEIANPINGZHENGHUOZHESHENGCHANXUKEWENJIANZUIDUANDEYOUXIAOQIYIZHI。CHANPINZHUCEZHENGMINGWENJIAN、BEIANPINGZHENGHUOZHESHENGCHANXUKEWENJIANWEIGUIDINGYOUXIAOQIDE,GUANGGAOPIZHUNWENHAOYOUXIAOQIBUDECHAOGUO2NIAN。

推行全流程網上辦理

大家乐彩票开户 WEIFANGBIANBANLIGUANGGAOSHENQING,TIGAOGONGZUOXIAOLV,GENJUZHENGWUFUWU“YIWANGTONGBAN”YOUGUANGONGZUOYAOQIU,BANFAGUIDING“SANPINYIXIE”GUANGGAOSHENQINGRENKEYIDAOGUANGGAOSHENCHAJIGUANSHOULICHUANGKOUTICHUSHENQING,YEKEYITONGGUOXINHAN、CHUANZHEN、DIANZIYOUJIANHUOZHEDIANZIZHENGWUPINGTAITIJIAOYAOPIN、YILIAOQIXIE、BAOJIANSHIPINHETESHUYIXUEYONGTUPEIFANGSHIPINGUANGGAOSHENQING。

統一“三品一械”廣告審查程序等內容

大家乐彩票开户 BANFADUIYUAN“SANPINYIXIE”GUANGGAOSHENCHACHENGXUZHONGBUYIZHIDEGUIDINGJINXINGLETONGYI,RUJIANGYAOPIN、YILIAOQIXIEGUANGGAOXUYAOXIANZHUBIAOMINGDENEIRONGZAISHIPINGUANGGAOZHONGBUDESHAOYU5MIAOGAIWEIYINGDANGCHIXUXIANSHI,YUDUIBAOJIANSHIPINDEGUIDINGBAOCHIYIZHI,YICHONGFENBAOZHANGXIAOFEIZHEDEZHIQINGQUAN;JIANGYUANBAOJIANSHIPINGUANGGAOSHENCHASHIJIANCONG20TIANGAIWEI10TIAN,YUQITACHANPINGUANGGAOSHENCHASHIJIANYIZHI。

進一步明確“三品一械”廣告公開時間、途徑及內容

辦法按照“誰審查、誰公開”的原則,規定廣告審查機關應當通過本部門網站以及其他方便公眾查詢的方式,在10個工作日內向社會公開。公開的信息應當包括廣告批準文號、申請人名稱、廣告發布內容、廣告批準文號有效期、廣告類別、產品名稱、產品注冊證明文件或者備案憑證編號等內容。該規定也為簡化異地藥品廣告備案程序、減輕企業負擔提供了進一步支持。

(YUANBIAOTI:LUOSHI"SIGEZUIYAN"YAOQIU,TONGYI"SANPINYIXIE"GUANGGAOSHENCHAGUANLI)

ZERENBIANJI:LANMEI

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