pc加拿大

市市场监管局召开《大连市开办药品零售企业验收实施细则》培训会

为进一步促进我市(shi)药品(pin)零(ling)售(shou)行业(ye)高质量发(fa)展,加强和规(gui)范(fan)药品(pin)零(ling)售(shou)行业(ye)的(de)管理,按照国务院及辽(liao)宁省 pc加拿大官网全面(mian)加强药品(pin)监(jian)管能力建设的(de)实施(shi)意见有关(guan)要求,近日,大连市(shi)市(shi)场监(jian)管局印发(fa)了新修订的(de)《大连市(shi)开办药品(pin)零(ling)售(shou)企业(ye)验收实施(shi)细则》。

10月22日,市市场监管局专门组织召开培训会,为(wei)该(gai)细(xi)则(ze)正式实施做好(hao)准(zhun)备(bei)。各(ge)区(qu)市县(先导(dao)区(qu))及自贸区(qu)(大连(lian)片区(qu))药品监管、行(xing)政(zheng)审(shen)(shen)批(pi)部(bu)门负责人(ren)(ren)近30人(ren)(ren)参(can)(can)会。会议就新修订的《大连(lian)市开办药品零售(shou)企业(ye)验收实施细(xi)则(ze)》进行(xing)了逐(zhu)条解(jie)读,进一步统一政(zheng)务服务标准(zhun),规范行(xing)政(zheng)审(shen)(shen)批(pi)流程。会上,各(ge)参(can)(can)会单位(wei)还就药品零售(shou)企业(ye)行(xing)政(zheng)许可审(shen)(shen)批(pi)过程存在热(re)点和难点问题进行(xing)了研讨(tao)交流。

《大(da)连市开(kai)办(ban)药(yao)(yao)品(pin)(pin)(pin)零(ling)售(shou)(shou)企(qi)业验(yan)收实(shi)施细则》是依据《中(zhong)(zhong)华(hua)人民(min)共(gong)(gong)和(he)国(guo)行(xing)政(zheng)许(xu)可法(fa)》《中(zhong)(zhong)华(hua)人民(min)共(gong)(gong)和(he)国(guo)药(yao)(yao)品(pin)(pin)(pin)管(guan)理法(fa)》《药(yao)(yao)品(pin)(pin)(pin)经(jing)(jing)营质量管(guan)理规范(fan)》等有关(guan)法(fa)律法(fa)规,结(jie)合(he)我市实(shi)际(ji),经(jing)(jing)广泛(fan)调研,先(xian)后召开(kai)企(qi)业代表(biao)座谈会(hui)、监(jian)管(guan)部门研讨会(hui),并经(jing)(jing)市场监(jian)管(guan)局官方(fang)网站(zhan)公(gong)开(kai)面向社(she)会(hui)征求意见等环节,严格(ge)按照《大(da)连市行(xing)政(zheng)规范(fan)性(xing)文(wen)件(jian)管(guan)理办(ban)法(fa)》要求,经(jing)(jing)公(gong)平(ping)交易审(shen)查(cha)(cha)、合(he)法(fa)性(xing)审(shen)查(cha)(cha)后出台的(de)规范(fan)性(xing)文(wen)件(jian),将于2021年11月(yue)1日(ri)起施行(xing),全市药(yao)(yao)品(pin)(pin)(pin)零(ling)售(shou)(shou)企(qi)业《药(yao)(yao)品(pin)(pin)(pin)经(jing)(jing)营许(xu)可证(zheng)》的(de)核发、换(huan)证(zheng)和(he)变更均适用该(gai)细则。

《大连(lian)市开(kai)办(ban)药(yao)(yao)(yao)品零(ling)售(shou)企(qi)业验收实施细则》共七章、三十五条,分(fen)(fen)别对药(yao)(yao)(yao)品零(ling)售(shou)企(qi)业机构与(yu)人员、设施与(yu)设备(bei)、制(zhi)度与(yu)管(guan)(guan)理(li)(li)等进(jin)行(xing)了明确的规(gui)定(ding)。为进(jin)一(yi)(yi)(yi)步(bu)适应(ying)新业态、新模(mo)式(shi)发展需要,细则还体现了药(yao)(yao)(yao)店分(fen)(fen)级(ji)分(fen)(fen)类管(guan)(guan)理(li)(li)模(mo)式(shi),允许(xu)以(yi)连(lian)锁或特许(xu)方式(shi)经(jing)(jing)营非(fei)药(yao)(yao)(yao)品的企(qi)业可以(yi)申(shen)请只经(jing)(jing)营乙(yi)类非(fei)处方药(yao)(yao)(yao)专(zhuan)柜,可不(bu)配(pei)备(bei)执(zhi)业药(yao)(yao)(yao)师,药(yao)(yao)(yao)品经(jing)(jing)营区(qu)域面积与(yu)经(jing)(jing)营规(gui)模(mo)相适应(ying)即可,不(bu)做(zuo)硬性规(gui)定(ding)。鼓(gu)励药(yao)(yao)(yao)品零(ling)售(shou)企(qi)业连(lian)锁经(jing)(jing)营,要求各连(lian)锁门(men)店应(ying)实行(xing)统(tong)(tong)(tong)一(yi)(yi)(yi)企(qi)业标(biao)识、统(tong)(tong)(tong)一(yi)(yi)(yi)管(guan)(guan)理(li)(li)制(zhi)度、统(tong)(tong)(tong)一(yi)(yi)(yi)计算(suan)机系统(tong)(tong)(tong)、统(tong)(tong)(tong)一(yi)(yi)(yi)人员培训、统(tong)(tong)(tong)一(yi)(yi)(yi)采购配(pei)送、统(tong)(tong)(tong)一(yi)(yi)(yi)票据管(guan)(guan)理(li)(li)、统(tong)(tong)(tong)一(yi)(yi)(yi)药(yao)(yao)(yao)学服务(wu)标(biao)准的“七统(tong)(tong)(tong)一(yi)(yi)(yi)”管(guan)(guan)理(li)(li)模(mo)式(shi)。为进(jin)一(yi)(yi)(yi)步(bu)满足(zu)市民24小时购药(yao)(yao)(yao)需求,还允许(xu)依托实体药(yao)(yao)(yao)店设置自动(dong)售(shou)药(yao)(yao)(yao)机,实行(xing)备(bei)案制(zhi),仅(jin)限经(jing)(jing)营乙(yi)类非(fei)处方药(yao)(yao)(yao)。

《大连市(shi)开办药品零售(shou)企业(ye)验收(shou)实(shi)(shi)施(shi)细则》正式施(shi)行(xing)后(hou),将在推动我市(shi)药品零售(shou)行(xing)业(ye)健(jian)康有(you)序(xu)发展(zhan)、积(ji)极打造(zao)营(ying)商(shang)环境、切(qie)实(shi)(shi)提(ti)升监管(guan)(guan)(guan)能力(li)等(deng)方面发挥积(ji)极作用。下(xia)一步(bu),市(shi)市(shi)场监管(guan)(guan)(guan)局将进一步(bu)加强政策解(jie)读指(zhi)导,深入(ru)了解(jie)药品零售(shou)企业(ye)需求,切(qie)实(shi)(shi)强化(hua)事中事后(hou)监管(guan)(guan)(guan),保障百姓(xing)用药安全,不断满足人民群众日(ri)益增长的(de)健(jian)康需求。

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