山东省兽药经营质量管理规范实施细则

山东省兽药经营质量管理规范实施细则第一章总则第一条为加强兽药经营质量管理，保证兽药产品质量和兽药安全使用，保障动物健康和动物产品安全，根据国务院《兽药管理条例》、农业部《兽药经营质量管理规范》和《动物诊疗机构管理办法》，制定本《细则》。

第二条本《细则》是山东省兽药经营质量管理工作的基本准则，适用于省境内所有从事兽药经营活动的企业和单位。

兼营兽药的动物诊疗机构、从事兽药经营和供应活动的动物防疫机构，适用本《细则》。

第三条县级以上畜牧兽医管理部门按照规范竞争、有效供应、合理布局的原则，负责辖区内兽药经营质量管理规范组织实施和监督管理工作。

畜牧兽医管理部门应鼓励和支持兽药经营企业实施兽药经营质量管理规范，并依法查处不符合规范的兽药经营企业。

第二章场所与设施第四条兽药经营企业应具有固定的经营场所和仓库，经营场所和仓库应布局合理，相对独立。

经营场所和仓库的距离应就近、方便。

兽药经营场所和仓库地点应标识明显。

第五条兽药经营企业经营场所的面积和所需设施、设备应与所经营的兽药品种、规模相适应。

兽药经营场所的面积应不少于20平方米，仓库总面积应不少于40平方米;兽用生物制品储存冷库面积应不少于30立方米。

动物诊疗机构兼营兽药的，应设立独立的药房(仓库)，其面积应不少于20平方米。

第六条兽药经营企业兼营其他产品的，兽药经营区域应与其他兼营产品及生活、居住区域有效隔离，不得影响所经营的兽药产品质量。

兽药经营企业从事动物诊疗活动的，动物诊疗区域应独立设置，避免与兽药经营场所人、物流交叉污染。

第七条兽药经营地点应与《兽药经营许可证》载明的地址相一致。

兽药经营企业的《兽药经营许可证》和《工商营业执照》，应悬挂在营业场所的正面显著位置。

兽药经营企业欲变更经营地点、企业法人，或者经营场所的地址名称发生变化的，应向原发证机关申请换发《兽药经营许可证》。

兽药经营企业变更兽药经营场所面积，或者变更仓库位置、面积以及相关设rocess. 2. land and China has a vast territory, but its arable land is limited. According to statistics, only 106.67 million hectares of cultivated land could be used (1.6 billion acres), only 867 square metres of cultivated land per capita (1.3 acres). With the growing population, modern economic development, as well as the gradual transition of urbanization in rural areas, farmland will be reduced. Development of poultry industry will occupy a certain area of land, there is a modern product with comprehensive rollup of 50,000 chickens laying hens, covers an area of 14.87 hectares (233 acres) more (including Office of hatching, brood rearing, and laying House, eggs, feed processing workshop, Office, etc). The poultry industry should work in land conservation, not accounted for or less cultivated land, wasteland, the principle of slope land. When the chicken farm should generally not available to local arable land area to determine anappropriate level of breeding size and not, as in the past, first determine the size, then go to the expropriation. 3. energy-saving,water-saving awareness2 ... Chicken coop to keep dry, especially flat-raised floors and bedding to keep dry: shed the wet for a long time, weakened resistance in chickens, feather contamination, growth retardation, oocysts are easy to develop, as chickens live in moist environments in all the year round, the resistance will gradually reduce. appetite. production: reduction in egg. Test upon e ming, meat with Tsai chicken in relative humidity for 90% Shi, on feed into rate, and out feather, and increased heavy, are has bad effect j General chicks homes 施、设备的，不应影响兽药经营活动和所经营的兽药产品质量，并应在变更后30个工作日内向《兽药经营许可证》发证机关申报备案。

第八条兽药经营场所的货架、柜台及相关设施、设备应齐备、整洁、完好，能够陈列所经营的全部兽药品种的样品，并应根据经营兽药的品种、类别、用途等不同，设立醒目标志。

第九条兽药经营场所应具有下列设施、设备:(一)与所经营的兽药品种相适应的陈列货架、柜台;(二)兽药经营场所应具有通风、防火和照明设施、设备;(三)经营的兽药中，有需要避光和控温陈列的，应具有符合兽药陈列条件要求的温度、湿度、光照等控制设施、设备和监控仪表;(四)防尘、防潮、防污染和防虫、防鼠、防鸟的设施、设备;(五)环境和人员卫生、清洁的设施、设备等;(六)在营业场所显著位置设置兽药质量信息公示板，张贴兽药管理法规、人员职责和分工，明示服务公约、质量承诺和服务监督电话，设置意见簿。

第十条兽药经营企业应具有保证兽药质量、安全的常温库、阴凉库、冷藏库、冷冻库等仓库，相关设施、设备应齐备、整洁、完好。

乡镇以下小型兽药经营企业可以只设置阴凉库。

仓库内应设置合格区、不合格区、待验区、退货区等各类区域，并有明显标识。

仓库面积和相关设施、设备应满足不同存放区域，以及不同品种兽药分类、分批保管、储存的要求。

第十一条兽药仓库应具有下列设施、设备:(一)设置兽药防潮隔板或货架;(二)具有防虫、防鼠、防鸟、防火和通风、照明等设施、设备;(三)具有防止不同品种和批次的兽药之间混淆和污染的隔离设施;(四)具有兽药拆包和打包工具、设备;(五)对有避光、控温等特殊要求的兽药，应具有相应的控制设施、设备和监控仪表;(六)存放兽用精神药品、毒性药品、麻醉药品、放射性药品、易制毒化学药品等的，应具有保险柜等安全监控设施、设备;(七)经营兽用生物制品的，应具备发电机、真空检测仪等设施、设备。

第十二条同属一个法人的兽药直营连锁经营企业，在同一县(市)内有多家经营门店的，可以统一标准配置仓储和相关设施、设备。

第十三条兽药营业场所和仓库的地面、墙壁、顶棚等应平整、干燥、洁净;门、窗等结构严密，可以上锁封闭、易清洁。

第十四条兽药经营企业配备车辆等运输工具的，运输工具的性能应满足兽药储存、运输要求，不损害兽药包装和产品质量。

经营兽用生物制品的，应配备与经营规模相适应的冷藏运输车、保温箱或冷rocess. 2. land and China has a vast territory, but its arable land islimited. According to statistics, only 106.67 million hectares of cultivated land could be used (1.6 billion acres), only 867 squaremetres of cultivated land per capita (1.3 acres). With the growing population, modern economic development, as well as the gradualtransition of urbanization in rural areas, farmland will be reduced. Development of poultry industry will occupy a certain area of land,there is a modern product with comprehensive rollup of 50,000 chickens laying hens, covers an area of 14.87 hectares (233 acres) more(including Office of hatching, brood rearing, and laying House, eggs, feed processing workshop, Office, etc). The poultry industry should work in land conservation, not accounted for or less cultivated land, wasteland, the principle of slope land. When the chicken farm should generally not available to local arable land area to determine an appropriate level of breeding size and not, as in the past, first determine the size, then go to the expropriation. 3. energy-saving,water-saving awareness2 ... Chicken coop to keep dry, especially flat-raised floors and bedding to keep dry: shed the wet for a long time, weakened resistance in chickens, feather contamination, growth retardation, oocysts are easy to develop, as chickens live in moist environments in all the year round, the resistance will gradually reduce. appetite. production: reduction in egg. Test upon e ming, meat with Tsai chicken in relative humidity for 90% Shi, on feed into rate, and out feather, and increased heavy, are has bad effect j General chicks homes 藏运输包。