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省局出臺藥品零售(連鎖)企業許可驗收標準

時間(jian):2015-07-16 09:55:17 點擊:0

省局為進一步促進我省藥品零售企業向連鎖化、規范化、規模化、集約化方向發展,針對全省藥品零售企業多、小、散、弱的現狀,在充分調研和廣泛征求意見的基礎上重新修訂了《安徽省藥品零售連鎖企業許可現場驗收標準》和《安徽省藥品零售企業許可現場驗收標準》。
     《標準》從七個方面(mian)對(dui)開(kai)辦(ban)(ban)(ban)藥(yao)(yao)(yao)(yao)(yao)品(pin)(pin)(pin)(pin)零(ling)(ling)售(連(lian)(lian)鎖(suo))企(qi)(qi)(qi)(qi)業許可(ke)現場驗(yan)收提出了明(ming)確規(gui)定,一(yi)(yi)是(shi)(shi)申(shen)(shen)請開(kai)辦(ban)(ban)(ban)藥(yao)(yao)(yao)(yao)(yao)品(pin)(pin)(pin)(pin)零(ling)(ling)售連(lian)(lian)鎖(suo)企(qi)(qi)(qi)(qi)業須在已具有10家(含(han)10家)以(yi)上零(ling)(ling)售藥(yao)(yao)(yao)(yao)(yao)店(dian)的(de)(de)基礎上申(shen)(shen)報。必(bi)須采(cai)取“六統(tong)(tong)(tong)一(yi)(yi)”管(guan)(guan)(guan)理(li)(li)(li)(即統(tong)(tong)(tong)一(yi)(yi)企(qi)(qi)(qi)(qi)業標識、統(tong)(tong)(tong)一(yi)(yi)質量(liang)控制、統(tong)(tong)(tong)一(yi)(yi)采(cai)購(gou)配(pei)送、統(tong)(tong)(tong)一(yi)(yi)人(ren)員(yuan)管(guan)(guan)(guan)理(li)(li)(li)、統(tong)(tong)(tong)一(yi)(yi)財務(wu)管(guan)(guan)(guan)理(li)(li)(li)、統(tong)(tong)(tong)一(yi)(yi)網絡計算機管(guan)(guan)(guan)理(li)(li)(li))。門(men)店(dian)不得自(zi)行采(cai)購(gou)藥(yao)(yao)(yao)(yao)(yao)品(pin)(pin)(pin)(pin)。二是(shi)(shi)對(dui)藥(yao)(yao)(yao)(yao)(yao)品(pin)(pin)(pin)(pin)零(ling)(ling)售連(lian)(lian)鎖(suo)企(qi)(qi)(qi)(qi)業跨(kua)地區新(xin)(xin)開(kai)辦(ban)(ban)(ban)門(men)店(dian)的(de)(de),應(ying)由門(men)店(dian)所在地食品(pin)(pin)(pin)(pin)藥(yao)(yao)(yao)(yao)(yao)品(pin)(pin)(pin)(pin)監管(guan)(guan)(guan)部門(men)負責受理(li)(li)(li)、驗(yan)收,由門(men)店(dian)所在地設(she)區的(de)(de)市(shi)級食品(pin)(pin)(pin)(pin)藥(yao)(yao)(yao)(yao)(yao)品(pin)(pin)(pin)(pin)監管(guan)(guan)(guan)部門(men)組織GSP認證、審批(pi)。三(san)是(shi)(shi)藥(yao)(yao)(yao)(yao)(yao)品(pin)(pin)(pin)(pin)批(pi)發企(qi)(qi)(qi)(qi)業開(kai)辦(ban)(ban)(ban)藥(yao)(yao)(yao)(yao)(yao)品(pin)(pin)(pin)(pin)零(ling)(ling)售連(lian)(lian)鎖(suo)企(qi)(qi)(qi)(qi)業,其(qi)批(pi)發企(qi)(qi)(qi)(qi)業和(he)零(ling)(ling)售連(lian)(lian)鎖(suo)企(qi)(qi)(qi)(qi)業法(fa)定代表(biao)人(ren)為同(tong)一(yi)(yi)自(zi)然(ran)人(ren)的(de)(de),零(ling)(ling)售連(lian)(lian)鎖(suo)企(qi)(qi)(qi)(qi)業可(ke)以(yi)委托其(qi)批(pi)發企(qi)(qi)(qi)(qi)業儲(chu)存、配(pei)送藥(yao)(yao)(yao)(yao)(yao)品(pin)(pin)(pin)(pin)。四(si)是(shi)(shi)零(ling)(ling)售連(lian)(lian)鎖(suo)企(qi)(qi)(qi)(qi)業總部設(she)置計算機遠程(cheng)管(guan)(guan)(guan)理(li)(li)(li)系統(tong)(tong)(tong)的(de)(de),其(qi)門(men)店(dian)執業藥(yao)(yao)(yao)(yao)(yao)師暫不在崗(臨(lin)時請假)時,可(ke)借助企(qi)(qi)(qi)(qi)業設(she)置的(de)(de)計算機信息化管(guan)(guan)(guan)理(li)(li)(li)系統(tong)(tong)(tong)進(jin)行處方審核(he)(he)、指(zhi)導合(he)理(li)(li)(li)用藥(yao)(yao)(yao)(yao)(yao)和(he)其(qi)他藥(yao)(yao)(yao)(yao)(yao)學(xue)專業服務(wu)。五(wu)是(shi)(shi)新(xin)(xin)開(kai)辦(ban)(ban)(ban)藥(yao)(yao)(yao)(yao)(yao)品(pin)(pin)(pin)(pin)零(ling)(ling)售(含(han)連(lian)(lian)鎖(suo)門(men)店(dian))企(qi)(qi)(qi)(qi)業必(bi)須符合(he)《規(gui)范(fan)》要(yao)求(qiu)。六是(shi)(shi)藥(yao)(yao)(yao)(yao)(yao)品(pin)(pin)(pin)(pin)零(ling)(ling)售企(qi)(qi)(qi)(qi)業(含(han)連(lian)(lian)鎖(suo)門(men)店(dian))經(jing)營(ying)保健品(pin)(pin)(pin)(pin)的(de)(de),應(ying)與藥(yao)(yao)(yao)(yao)(yao)品(pin)(pin)(pin)(pin)實施有效隔(ge)離,防(fang)止發生交叉污染,影響藥(yao)(yao)(yao)(yao)(yao)品(pin)(pin)(pin)(pin)質量(liang)安全(quan)。七是(shi)(shi)藥(yao)(yao)(yao)(yao)(yao)品(pin)(pin)(pin)(pin)零(ling)(ling)售企(qi)(qi)(qi)(qi)業(含(han)連(lian)(lian)鎖(suo)門(men)店(dian)),未(wei)按相關要(yao)求(qiu)配(pei)備執業藥(yao)(yao)(yao)(yao)(yao)師的(de)(de),應(ying)核(he)(he)減其(qi)相應(ying)的(de)(de)經(jing)營(ying)范(fan)圍。

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