中华人民共和国药品管理法-中华人民共和国药品管理法细则

一 : 中华人民共和国药品管理法细则

发布药品广告,应当向药品生产企业所在地省、自治区、直辖市人民政府药品监督管理部门报送有关材料。省、自治区、直辖市人民政府药品监督管理部门应当自收到有关材料之日起十个工作日内作出是否核发药品广告批准文号的决定;核发药品广告批准文号的,应当同时报国务院药品监督管理部门备案。具体办法由国务院药品监督管理部门制定。 发布进口药品广告,应当依照前款规定向进口药品代理机构所在地省、自治区、直辖市人民政府药品监督管理部门申请药品广告批准文号。

在药品生产企业所在地和进口药品代理机构所在地以外的省、自治区、直辖市发布药品广告的,发布广告的企业应当在发布前向发布地省、自治区、直辖市人民政府药品监督管理部门备案。接受备案的省、自治区、直辖市人民政府药品监督管理部门发现药品广告批准内容不符合药品广告管理规定的,应当交由原核发部门处理。

第一条为了保证药品广告真实、合法、科学,制定本标准。

第二条发布药品广告,应当遵守《中华人民共和国广告法》、《中华人民共和国药品管理法》和《中华人民共和国药品管理法实施条例》、《中华人民共和国反不正当竞争法》及国家有关法规。

第三条下列药品不得发布广告:

(一)麻醉药品、精神药品、医疗用毒性药品、放射性药品;

(二)医疗机构配制的制剂;

(三)军队特需药品;

(四)国家食品药品监督管理局依法明令停止或者禁止生产、销售和使用的药品;

(五)批准试生产的药品。

第四条处方药可以在卫生部和国家食品药品监督管理局共同指定的医学、药学专业刊物上发布广告,但不得在大众传播媒介发布广告或者以其他方式进行以公众为对象的广告宣传。不得以赠送医学、药学专业刊物等形式向公众发布处方药广告。

第五条处方药名称与该药品的商标、生产企业字号相同的,不得使用该商标、企业字号在医学、药学专业刊物以外的媒介变相发布广告。

不得以处方药名称或者以处方药名称注册的商标以及企业字号为各种活动冠名。

第六条药品广告内容涉及药品适应症或者功能主治、药理作用等内容的宣传,应当以国务院食品药品监督管理部门批准的说明书为准,不得进行扩大或者恶意隐瞒的宣传,不得含有说明书以外的理论、观点等内容。

第七条药品广告中必须标明药品的通用名称、忠告语、药品广告批准文号、药品生产批准文号;以非处方药商品名称为各种活动冠名的,可以只发布药品商品名称。

药品广告必须标明药品生产企业或者药品经营企业名称,不得单独出现“咨询热线”、“咨询电话”等内容。

非处方药广告必须同时标明非处方药专用标识(OTC)。

药品广告中不得以产品注册商标代替药品名称进行宣传,但经批准作为药品商品名称使用的文字型注册商标除外。

已经审查批准的药品广告在广播电台发布时,可不播出药品广告批准文号。

第八条处方药广告的忠告语是:“本广告仅供医学药学专业人士阅读”。

非处方药广告的忠告语是:“请按药品说明书或在药师指导下购买和使用”。

第九条药品广告中涉及改善和增强性功能内容的,必须与经批准的药品说明书中的适应症或者功能主治完全一致。

电视台、广播电台不得在7:00—22:00发布含有上款内容的广告。

第十条药品广告中有关药品功能疗效的宣传应当科学准确,不得出现下列情形:

(一)含有不科学地表示功效的断言或者保证的;

(二)说明治愈率或者有效率的;

(三)与其他药品的功效和安全性进行比较的;

(四)违反科学规律,明示或者暗示包治百病、适应所有症状的;

(五)含有“安全无毒副作用”、“毒副作用小”等内容的;含有明示或者暗示中成药为“天然”药品,因而安全性有保证等内容的;

(六)含有明示或者暗示该药品为正常生活和治疗病症所必需等内容的;

(七)含有明示或暗示服用该药能应付现代紧张生活和升学、考试等需要,能够帮助提高成绩、使精力旺盛、增强竞争力、增高、益智等内容的;

(八)其他不科学的用语或者表示,如“最新技术”、“最高科学”、“最先进制法”等。

第十一条非处方药广告不得利用公众对于医药学知识的缺乏,使用公众难以理解和容易引起混淆的医学、药学术语,造成公众对药品功效与安全性的误解。

第十二条药品广告应当宣传和引导合理用药,不得直接或者间接怂恿任意、过量地购买和使用药品,不得含有以下内容:

(一)含有不科学的表述或者使用不恰当的表现形式,引起公众对所处健康状况和所患疾病产生不必要的担忧和恐惧,或者使公众误解不使用该药品会患某种疾病或加重病情的;

(二)含有免费治疗、免费赠送、有奖销售、以药品作为礼品或者奖品等促销药品内容的;

(三)含有“家庭必备”或者类似内容的;

(四)含有“无效退款”、“保险公司保险”等保证内容的;

(五)含有评比、排序、推荐、指定、选用、获奖等综合性评价内容的。

第十三条药品广告不得含有利用医药科研单位、学术机构、医疗机构或者专家、医生、患者的名义和形象作证明的内容。

药品广告不得使用国家机关和国家机关工作人员的名义。

药品广告不得含有军队单位或者军队人员的名义、形象。不得利用军队装备、设施从事药品广告宣传。

第十四条药品广告不得含有涉及公共信息、公共事件或其他与公共利益相关联的内容,如各类疾病信息、经济社会发展成果或医药科学以外的科技成果。

第十五条药品广告不得在未成年人出版物和广播电视频道、节目、栏目上发布。

药品广告不得以儿童为诉求对象,不得以儿童名义介绍药品。

第十六条药品广告不得含有医疗机构的名称、地址、联系办法、诊疗项目、诊疗方法以及有关义诊、医疗(热线)咨询、开设特约门诊等医疗服务的内容。

第十七条按照本标准第七条规定必须在药品广告中出现的内容,其字体和颜色必须清晰可见、易于辨认。上述内容在电视、电影、互联网、显示屏等媒体发布时,出现时间不得少于5秒。



第十八条违反本标准规定发布的广告,构成虚假广告或者引人误解的虚假宣传的,依照《广告法》第三十七条、《反不正当竞争法》第二十四条处罚。

违反本标准第四条、第五条规定发布药品广告的,依照《广告法》第三十九条处罚。

违反本标准第三条、第六条等规定发布药品广告的,依照《广告法》第四十一条处罚。

违反本标准其他规定发布广告,《广告法》有规定的,依照《广告法》处罚;《广告法》没有具体规定的,对负有责任的广告主、广告经营者、广告发布者,处以一万元以下罚款;有违法所得的,处以违法所得三倍以下但不超过三万元的罚款。

第十九条本标准自2007年5月1日起施行。1995年3月28日国家工商行政管理局令第27号发布的《药品广告审查标准》同时废止。

二 : 中华人民共和国药品管理法(2013修订)

中华人民共和国药品管理法(2013修订) (1984年9月20日第六届全国人民代表大会常务委员会第七次会议通过 2001年2月28日第九届全国人民代表大会常务委员会第二十次会议修订 2001年2月28日中华人民共和国主席令第四十五号公布 自2001年12月1日起施行 2013年12月28日第十二届全国人民代表大会常务委员会第六次会议修订)

第一章 总则

第二章 药品生产企业管理

第三章 药品经营企业管理

第四章 医疗机构的药剂管理

第五章 药品管理

第六章 药品包装的管理

第七章 药品价格和广告的管理

第八章 药品监督

第九章 法律责任

第十章 附则

第一章 总则

第一条 为加强药品监督管理,保证药品质量,保障人体用药安全,维护人民身体健康和用药的合法权益,特制定本法。[www.loach.net.cn]

第二条 在中华人民共和国境内从事药品的研制、生产、经营、使用和监督管理的单位或者个人,必须遵守本法。

第三条 国家发展现代药和传统药,充分发挥其在预防、医疗和保健中的作用。

国家保护野生药材资源,鼓励培育中药材。

第四条 国家鼓励研究和创制新药,保护公民、法人和其他组织研究、开发新药的合法权益。

第五条 国务院药品监督管理部门主管全国药品监督管理工作。国务院有关部门在各自的职责范围内负责与药品有关的监督管理工作。

省、自治区、直辖市人民政府药品监督管理部门负责本行政区域内的药品监督管理工作。省、自治区、直辖市人民政府有关部门在各自的职责范围内负责与药品有关的监督管理工作。

国务院药品监督管理部门应当配合国务院经济综合主管部门,执行国家制定的药品行业发展规划和产业政策。

第六条 药品监督管理部门设置或者确定的药品检验机构,承担依法实施药品审批和药品质量监督检查所需的药品检验工作。

第二章 药品生产企业管理

第七条 开办药品生产企业,须经企业所在地省、自治区、直辖市人民政府药品监督管理部门批准并发给《药品生产许可证》,凭《药品生产许可证》到工商行政管理部门办理登记注册。无《药品生产许可证》的,不得生产药品。 《药品生产许可证》应当标明有效期和生产范围,到期重新审查发证。 药品监督管理部门批准开办药品生产企业,除依据本法第八条规定的条件

中国药品管理法 中华人民共和国药品管理法(2013修订)

外,还应当符合国家制定的药品行业发展规划和产业政策,防止重复建设。(www.loach.net.cn]

第八条 开办药品生产企业,必须具备以下条件:

(一)具有依法经过资格认定的药学技术人员、工程技术人员及相应的技术工人;

(二)具有与其药品生产相适应的厂房、设施和卫生环境;

(三)具有能对所生产药品进行质量管理和质量检验的机构、人员以及必要的仪器设备;

(四)具有保证药品质量的规章制度。

第九条 药品生产企业必须按照国务院药品监督管理部门依据本法制定的《药品生产质量管理规范》组织生产。药品监督管理部门按照规定对药品生产企业是否符合《药品生产质量管理规范》的要求进行认证;对认证合格的,发给认证证书。

《药品生产质量管理规范》的具体实施办法、实施步骤由国务院药品监督管理部门规定。

第十条 除中药饮片的炮制外,药品必须按照国家药品标准和国务院药品监督管理部门批准的生产工艺进行生产,生产记录必须完整准确。药品生产企业改变影响药品质量的生产工艺的,必须报原批准部门审核批准。

中药饮片必须按照国家药品标准炮制;国家药品标准没有规定的,必须按照省、自治区、直辖市人民政府药品监督管理部门制定的炮制规范炮制。省、自治区、直辖市人民政府药品监督管理部门制定的炮制规范应当报国务院药品监督管理部门备案。

第十一条 生产药品所需的原料、辅料,必须符合药用要求。

第十二条 药品生产企业必须对其生产的药品进行质量检验;不符合国家药品标准或者不按照省、自治区、直辖市人民政府药品监督管理部门制定的中药饮片炮制规范炮制的,不得出厂。

第十三条 经省、自治区、直辖市人民政府药品监督管理部门批准,药品生产企业可以接受委托生产药品。

第三章 药品经营企业管理

第十四条 开办药品批发企业,须经企业所在地省、自治区、直辖市人民政府药品监督管理部门批准并发给《药品经营许可证》;开办药品零售企业,须经企业所在地县级以上地方药品监督管理部门批准并发给《药品经营许可证》,凭《药品经营许可证》到工商行政管理部门办理登记注册。无《药品经营许可证》的,不得经营药品。

《药品经营许可证》应当标明有效期和经营范围,到期重新审查发证。 药品监督管理部门批准开办药品经营企业,除依据本法第十五条规定的条件外,还应当遵循合理布局和方便群众购药的原则。

第十五条 开办药品经营企业必须具备以下条件:

(一)具有依法经过资格认定的药学技术人员;

(二)具有与所经营药品相适应的营业场所、设备、仓储设施、卫生环境;

(三)具有与所经营药品相适应的质量管理机构或者人员;

(四)具有保证所经营药品质量的规章制度。

第十六条 药品经营企业必须按照国务院药品监督管理部门依据本法制定的《药品经营质量管理规范》经营药品。药品监督管理部门按照规定对药品经营企业是否符合《药品经营质量管理规范》的要求进行认证;对认证合格的,发给

中国药品管理法 中华人民共和国药品管理法(2013修订)

认证证书。(www.loach.net.cn]

《药品经营质量管理规范》的具体实施办法、实施步骤由国务院药品监督管理部门规定。

第十七条 药品经营企业购进药品,必须建立并执行进货检查验收制度,验明药品合格证明和其他标识;不符合规定要求的,不得购进。

第十八条 药品经营企业购销药品,必须有真实完整的购销记录。购销记录必须注明药品的通用名称、剂型、规格、批号、有效期、生产厂商、购(销)货单位、购(销)货数量、购销价格、购(销)货日期及国务院药品监督管理部门规定的其他内容。

第十九条 药品经营企业销售药品必须准确无误,并正确说明用法、用量和注意事项;调配处方必须经过核对,对处方所列药品不得擅自更改或者代用。对有配伍禁忌或者超剂量的处方,应当拒绝调配;必要时,经处方医师更正或者重新签字,方可调配。

药品经营企业销售中药材,必须标明产地。

第二十条 药品经营企业必须制定和执行药品保管制度,采取必要的冷藏、防冻、防潮、防虫、防鼠等措施,保证药品质量。

药品入库和出库必须执行检查制度。

第二十一条 城乡集市贸易市场可以出售中药材,国务院另有规定的除外。 城乡集市贸易市场不得出售中药材以外的药品,但持有《药品经营许可证》的药品零售企业在规定的范围内可以在城乡集市贸易市场设点出售中药材以外的药品。具体办法由国务院规定。

第四章 医疗机构的药剂管理

第二十二条 医疗机构必须配备依法经过资格认定的药学技术人员。非药学技术人员不得直接从事药剂技术工作。

第二十三条 医疗机构配制制剂,须经所在地省、自治区、直辖市人民政府卫生行政部门审核同意,由省、自治区、直辖市人民政府药品监督管理部门批准,发给《医疗机构制剂许可证》。无《医疗机构制剂许可证》的,不得配制制剂。 《医疗机构制剂许可证》应当标明有效期,到期重新审查发证。

第二十四条 医疗机构配制制剂,必须具有能够保证制剂质量的设施、管理制度、检验仪器和卫生条件。

第二十五条 医疗机构配制的制剂,应当是本单位临床需要而市场上没有供应的品种,并须经所在地省、自治区、直辖市人民政府药品监督管理部门批准后方可配制。配制的制剂必须按照规定进行质量检验;合格的,凭医师处方在本医疗机构使用。特殊情况下,经国务院或者省、自治区、直辖市人民政府的药品监督管理部门批准,医疗机构配制的制剂可以在指定的医疗机构之间调剂使用。 医疗机构配制的制剂,不得在市场销售。

第二十六条 医疗机构购进药品,必须建立并执行进货检查验收制度,验明药品合格证明和其他标识;不符合规定要求的,不得购进和使用。

第二十七条 医疗机构的药剂人员调配处方,必须经过核对,对处方所列药品不得擅自更改或者代用。对有配伍禁忌或者超剂量的处方,应当拒绝调配;必要时,经处方医师更正或者重新签字,方可调配。

第二十八条 医疗机构必须制定和执行药品保管制度,采取必要的冷藏、防冻、防潮、防虫、防鼠等措施,保证药品质量。

第五章 药品管理

中国药品管理法 中华人民共和国药品管理法(2013修订)

第二十九条 研制新药,必须按照国务院药品监督管理部门的规定如实报送研制方法、质量指标、药理及毒理试验结果等有关资料和样品,经国务院药品监督管理部门批准后,方可进行临床试验。[www.loach.net.cn)药物临床试验机构资格的认定办法,由国务院药品监督管理部门、国务院卫生行政部门共同制定。

完成临床试验并通过审批的新药,由国务院药品监督管理部门批准,发给新药证书。

第三十条 药物的非临床安全性评价研究机构和临床试验机构必须分别执行药物非临床研究质量管理规范、药物临床试验质量管理规范。

药物非临床研究质量管理规范、药物临床试验质量管理规范由国务院确定的部门制定。

第三十一条 生产新药或者已有国家标准的药品的,须经国务院药品监督管理部门批准,并发给药品批准文号;但是,生产没有实施批准文号管理的中药材和中药饮片除外。实施批准文号管理的中药材、中药饮片品种目录由国务院药品监督管理部门会同国务院中医药管理部门制定。

药品生产企业在取得药品批准文号后,方可生产该药品。

第三十二条 药品必须符合国家药品标准。中药饮片依照本法第十条第二款的规定执行。

国务院药品监督管理部门颁布的《中华人民共和国药典》和药品标准为国家药品标准。

国务院药品监督管理部门组织药典委员会,负责国家药品标准的制定和修订。

国务院药品监督管理部门的药品检验机构负责标定国家药品标准品、对照品。

第三十三条 国务院药品监督管理部门组织药学、医学和其他技术人员,对新药进行审评,对已经批准生产的药品进行再评价。

第三十四条 药品生产企业、药品经营企业、医疗机构必须从具有药品生产、经营资格的企业购进药品;但是,购进没有实施批准文号管理的中药材除外。 第三十五条 国家对麻醉药品、精神药品、医疗用毒性药品、放射性药品,实行特殊管理。管理办法由国务院制定。

第三十六条 国家实行中药品种保护制度。具体办法由国务院制定。

第三十七条 国家对药品实行处方药与非处方药分类管理制度。具体办法由国务院制定。

第三十八条 禁止进口疗效不确、不良反应大或者其他原因危害人体健康的药品。

第三十九条 药品进口,须经国务院药品监督管理部门组织审查,经审查确认符合质量标准、安全有效的,方可批准进口,并发给进口药品注册证书。 医疗单位临床急需或者个人自用进口的少量药品,按照国家有关规定办理进口手续。

第四十条 药品必须从允许药品进口的口岸进口,并由进口药品的企业向口岸所在地药品监督管理部门登记备案。海关凭药品监督管理部门出具的《进口药品通关单》放行。无《进口药品通关单》的,海关不得放行。

口岸所在地药品监督管理部门应当通知药品检验机构按照国务院药品监督管理部门的规定对进口药品进行抽查检验,并依照本法第四十一条第二款的规定收取检验费。

中国药品管理法 中华人民共和国药品管理法(2013修订)

允许药品进口的口岸由国务院药品监督管理部门会同海关总署提出,报国务院批准。[www.loach.net.cn)

第四十一条 国务院药品监督管理部门对下列药品在销售前或者进口时,指定药品检验机构进行检验;检验不合格的,不得销售或者进口:

(一)国务院药品监督管理部门规定的生物制品;

(二)首次在中国销售的药品;

(三)国务院规定的其他药品。

前款所列药品的检验费项目和收费标准由国务院财政部门会同国务院价格主管部门核定并公告。检验费收缴办法由国务院财政部门会同国务院药品监督管理部门制定。

第四十二条 国务院药品监督管理部门对已经批准生产或者进口的药品,应当组织调查;对疗效不确、不良反应大或者其他原因危害人体健康的药品,应当撤销批准文号或者进口药品注册证书。

已被撤销批准文号或者进口药品注册证书的药品,不得生产或者进口、销售和使用;已经生产或者进口的,由当地药品监督管理部门监督销毁或者处理。 第四十三条 国家实行药品储备制度。

国内发生重大灾情、疫情及其他突发事件时,国务院规定的部门可以紧急调用企业药品。

第四十四条 对国内供应不足的药品,国务院有权限制或者禁止出口。 第四十五条 进口、出口麻醉药品和国家规定范围内的精神药品,必须持有国务院药品监督管理部门发给的《进口准许证》、《出口准许证》。

第四十六条 新发现和从国外引种的药材,经国务院药品监督管理部门审核批准后,方可销售。

第四十七条 地区性民间习用药材的管理办法,由国务院药品监督管理部门会同国务院中医药管理部门制定。

第四十八条 禁止生产(包括配制,下同)、销售假药。

有下列情形之一的,为假药:

(一)药品所含成份与国家药品标准规定的成份不符的;

(二)以非药品冒充药品或者以他种药品冒充此种药品的。

有下列情形之一的药品,按假药论处:

(一)国务院药品监督管理部门规定禁止使用的;

(二)依照本法必须批准而未经批准生产、进口,或者依照本法必须检验而未经检验即销售的;

(三)变质的;

(四)被污染的;

(五)使用依照本法必须取得批准文号而未取得批准文号的原料药生产的;

(六)所标明的适应症或者功能主治超出规定范围的。

第四十九条 禁止生产、销售劣药。

药品成份的含量不符合国家药品标准的,为劣药。

有下列情形之一的药品,按劣药论处:

(一)未标明有效期或者更改有效期的;

(二)不注明或者更改生产批号的;

(三)超过有效期的;

(四)直接接触药品的包装材料和容器未经批准的;

中国药品管理法 中华人民共和国药品管理法(2013修订)

(五)擅自添加着色剂、防腐剂、香料、矫味剂及辅料的;

(六)其他不符合药品标准规定的。[www.loach.net.cn)

第五十条 列入国家药品标准的药品名称为药品通用名称。已经作为药品通用名称的,该名称不得作为药品商标使用。

第五十一条 药品生产企业、药品经营企业和医疗机构直接接触药品的工作人员,必须每年进行健康检查。患有传染病或者其他可能污染药品的疾病的,不得从事直接接触药品的工作。

第六章 药品包装的管理

第五十二条 直接接触药品的包装材料和容器,必须符合药用要求,符合保障人体健康、安全的标准,并由药品监督管理部门在审批药品时一并审批。 药品生产企业不得使用未经批准的直接接触药品的包装材料和容器。

对不合格的直接接触药品的包装材料和容器,由药品监督管理部门责令停止使用。

第五十三条 药品包装必须适合药品质量的要求,方便储存、运输和医疗使用。

发运中药材必须有包装。在每件包装上,必须注明品名、产地、日期、调出单位,并附有质量合格的标志。

第五十四条 药品包装必须按照规定印有或者贴有标签并附有说明书。 标签或者说明书上必须注明药品的通用名称、成份、规格、生产企业、批准文号、产品批号、生产日期、有效期、适应症或者功能主治、用法、用量、禁忌、不良反应和注意事项。

麻醉药品、精神药品、医疗用毒性药品、放射性药品、外用药品和非处方药的标签,必须印有规定的标志。

第七章 药品价格和广告的管理

第五十五条 依法实行政府定价、政府指导价的药品,政府价格主管部门应当依照《中华人民共和国价格法》规定的定价原则,依据社会平均成本、市场供求状况和社会承受能力合理制定和调整价格,做到质价相符,消除虚高价格,保护用药者的正当利益。

药品的生产企业、经营企业和医疗机构必须执行政府定价、政府指导价,不得以任何形式擅自提高价格。

药品生产企业应当依法向政府价格主管部门如实提供药品的生产经营成本,不得拒报、虚报、瞒报。

第五十六条 依法实行市场调节价的药品,药品的生产企业、经营企业和医疗机构应当按照公平、合理和诚实信用、质价相符的原则制定价格,为用药者提供价格合理的药品。

药品的生产企业、经营企业和医疗机构应当遵守国务院价格主管部门关于药价管理的规定,制定和标明药品零售价格,禁止暴利和损害用药者利益的价格欺诈行为。

第五十七条 药品的生产企业、经营企业、医疗机构应当依法向政府价格主管部门提供其药品的实际购销价格和购销数量等资料。

第五十八条 医疗机构应当向患者提供所用药品的价格清单;医疗保险定点医疗机构还应当按照规定的办法如实公布其常用药品的价格,加强合理用药的管理。具体办法由国务院卫生行政部门规定。

第五十九条 禁止药品的生产企业、经营企业和医疗机构在药品购销中帐外

中国药品管理法 中华人民共和国药品管理法(2013修订)

暗中给予、收受回扣或者其他利益。[www.loach.net.cn]

禁止药品的生产企业、经营企业或者其代理人以任何名义给予使用其药品的医疗机构的负责人、药品采购人员、医师等有关人员以财物或者其他利益。禁止医疗机构的负责人、药品采购人员、医师等有关人员以任何名义收受药品的生产企业、经营企业或者其代理人给予的财物或者其他利益。

第六十条 药品广告须经企业所在地省、自治区、直辖市人民政府药品监督管理部门批准,并发给药品广告批准文号;未取得药品广告批准文号的,不得发布。

处方药可以在国务院卫生行政部门和国务院药品监督管理部门共同指定的医学、药学专业刊物上介绍,但不得在大众传播媒介发布广告或者以其他方式进行以公众为对象的广告宣传。

第六十一条 药品广告的内容必须真实、合法,以国务院药品监督管理部门批准的说明书为准,不得含有虚假的内容。

药品广告不得含有不科学的表示功效的断言或者保证;不得利用国家机关、医药科研单位、学术机构或者专家、学者、医师、患者的名义和形象作证明。 非药品广告不得有涉及药品的宣传。

第六十二条 省、自治区、直辖市人民政府药品监督管理部门应当对其批准的药品广告进行检查,对于违反本法和《中华人民共和国广告法》的广告,应当向广告监督管理机关通报并提出处理建议,广告监督管理机关应当依法作出处理。

第六十三条 药品价格和广告,本法未规定的,适用《中华人民共和国价格法》、《中华人民共和国广告法》的规定。

第八章 药品监督

第六十四条 药品监督管理部门有权按照法律、行政法规的规定对报经其审批的药品研制和药品的生产、经营以及医疗机构使用药品的事项进行监督检查,有关单位和个人不得拒绝和隐瞒。

药品监督管理部门进行监督检查时,必须出示证明文件,对监督检查中知悉的被检查人的技术秘密和业务秘密应当保密。

第六十五条 药品监督管理部门根据监督检查的需要,可以对药品质量进行抽查检验。抽查检验应当按照规定抽样,并不得收取任何费用。所需费用按照国务院规定列支。

药品监督管理部门对有证据证明可能危害人体健康的药品及其有关材料可以采取查封、扣押的行政强制措施,并在七日内作出行政处理决定;药品需要检验的,必须自检验报告书发出之日起十五日内作出行政处理决定。

第六十六条 国务院和省、自治区、直辖市人民政府的药品监督管理部门应当定期公告药品质量抽查检验的结果;公告不当的,必须在原公告范围内予以更正。

第六十七条 当事人对药品检验机构的检验结果有异议的,可以自收到药品检验结果之日起七日内向原药品检验机构或者上一级药品监督管理部门设置或者确定的药品检验机构申请复验,也可以直接向国务院药品监督管理部门设置或者确定的药品检验机构申请复验。受理复验的药品检验机构必须在国务院药品监督管理部门规定的时间内作出复验结论。

第六十八条 药品监督管理部门应当按照规定,依据《药品生产质量管理规范》、《药品经营质量管理规范》,对经其认证合格的药品生产企业、药品经营企

中国药品管理法 中华人民共和国药品管理法(2013修订)

业进行认证后的跟踪检查。(www.loach.net.cn]

第六十九条 地方人民政府和药品监督管理部门不得以要求实施药品检验、审批等手段限制或者排斥非本地区药品生产企业依照本法规定生产的药品进入本地区。

第七十条 药品监督管理部门及其设置的药品检验机构和确定的专业从事药品检验的机构不得参与药品生产经营活动,不得以其名义推荐或者监制、监销药品。

药品监督管理部门及其设置的药品检验机构和确定的专业从事药品检验的机构的工作人员不得参与药品生产经营活动。

第七十一条 国家实行药品不良反应报告制度。药品生产企业、药品经营企业和医疗机构必须经常考察本单位所生产、经营、使用的药品质量、疗效和反应。发现可能与用药有关的严重不良反应,必须及时向当地省、自治区、直辖市人民政府药品监督管理部门和卫生行政部门报告。具体办法由国务院药品监督管理部门会同国务院卫生行政部门制定。

对已确认发生严重不良反应的药品,国务院或者省、自治区、直辖市人民政府的药品监督管理部门可以采取停止生产、销售、使用的紧急控制措施,并应当在五日内组织鉴定,自鉴定结论作出之日起十五日内依法作出行政处理决定。 第七十二条 药品生产企业、药品经营企业和医疗机构的药品检验机构或者人员,应当接受当地药品监督管理部门设置的药品检验机构的业务指导。

第九章 法律责任

第七十三条 未取得《药品生产许可证》、《药品经营许可证》或者《医疗机构制剂许可证》生产药品、经营药品的,依法予以取缔,没收违法生产、销售的药品和违法所得,并处违法生产、销售的药品(包括已售出的和未售出的药品,下同)货值金额二倍以上五倍以下的罚款;构成犯罪的,依法追究刑事责任。 第七十四条 生产、销售假药的,没收违法生产、销售的药品和违法所得,并处违法生产、销售药品货值金额二倍以上五倍以下的罚款;有药品批准证明文件的予以撤销,并责令停产、停业整顿;情节严重的,吊销《药品生产许可证》、《药品经营许可证》或者《医疗机构制剂许可证》;构成犯罪的,依法追究刑事责任。

第七十五条 生产、销售劣药的,没收违法生产、销售的药品和违法所得,并处违法生产、销售药品货值金额一倍以上三倍以下的罚款;情节严重的,责令停产、停业整顿或者撤销药品批准证明文件、吊销《药品生产许可证》、《药品经营许可证》或者《医疗机构制剂许可证》;构成犯罪的,依法追究刑事责任。 第七十六条 从事生产、销售假药及生产、销售劣药情节严重的企业或者其他单位,其直接负责的主管人员和其他直接责任人员十年内不得从事药品生产、经营活动。

对生产者专门用于生产假药、劣药的原辅材料、包装材料、生产设备,予以没收。

第七十七条 知道或者应当知道属于假劣药品而为其提供运输、保管、仓储等便利条件的,没收全部运输、保管、仓储的收入,并处违法收入百分之五十以上三倍以下的罚款;构成犯罪的,依法追究刑事责任。

第七十八条 对假药、劣药的处罚通知,必须载明药品检验机构的质量检验结果;但是,本法第四十八条第三款第(一)、(二)、(五)、(六)项和第四十九条第三款规定的情形除外。

中国药品管理法 中华人民共和国药品管理法(2013修订)

第七十九条 药品的生产企业、经营企业、药物非临床安全性评价研究机构、药物临床试验机构未按照规定实施《药品生产质量管理规范》、《药品经营质量管理规范》、药物非临床研究质量管理规范、药物临床试验质量管理规范的,给予警告,责令限期改正;逾期不改正的,责令停产、停业整顿,并处五千元以上二万元以下的罚款;情节严重的,吊销《药品生产许可证》、《药品经营许可证》和药物临床试验机构的资格。[www.loach.net.cn]

第八十条 药品的生产企业、经营企业或者医疗机构违反本法第三十四条的规定,从无《药品生产许可证》、《药品经营许可证》的企业购进药品的,责令改正,没收违法购进的药品,并处违法购进药品货值金额二倍以上五倍以下的罚款;有违法所得的,没收违法所得;情节严重的,吊销《药品生产许可证、《药品经营许可证》或者医疗机构执业许可证书。

第八十一条 进口已获得药品进口注册证书的药品,未按照本法规定向允许药品进口的口岸所在地的药品监督管理部门登记备案的,给予警告,责令限期改正;逾期不改正的,撤销进口药品注册证书。

第八十二条 伪造、变造、买卖、出租、出借许可证或者药品批准证明文件的,没收违法所得,并处违法所得一倍以上三倍以下的罚款;没有违法所得的,处二万元以上十万元以下的罚款;情节严重的,并吊销卖方、出租方、出借方的《药品生产许可证》、《药品经营许可证》、《医疗机构制剂许可证》或者撤销药品批准证明文件;构成犯罪的,依法追究刑事责任。

第八十三条 违反本法规定,提供虚假的证明、文件资料样品或者采取其他欺骗手段取得《药品生产许可证》、《药品经营许可证》、《医疗机构制剂许可证》或者药品批准证明文件的,吊销《药品生产许可证》、《药品经营许可证》、《医疗机构制剂许可证》或者撤销药品批准证明文件,五年内不受理其申请,并处一万元以上三万元以下的罚款。

第八十四条 医疗机构将其配制的制剂在市场销售的,责令改正,没收违法销售的制剂,并处违法销售制剂货值金额一倍以上三倍以下的罚款;有违法所得的,没收违法所得。

第八十五条 药品经营企业违反本法第十八条、第十九条规定的,责令改正,给予警告;情节严重的,吊销《药品经营许可证》。

第八十六条 药品标识不符合本法第五十四条规定的,除依法应当按照假药、劣药论处的外,责令改正,给予警告;情节严重的,撤销该药品的批准证明文件。

第八十七条 药品检验机构出具虚假检验报告,构成犯罪的,依法追究刑事责任;不构成犯罪的,责令改正,给予警告,对单位并处三万元以上五万元以下的罚款;对直接负责的主管人员和其他直接责任人员依法给予降级、撤职、开除的处分,并处三万元以下的罚款;有违法所得的,没收违法所得;情节严重的,撤销其检验资格。药品检验机构出具的检验结果不实,造成损失的,应当承担相应的赔偿责任。

第八十八条 本法第七十三条至第八十七条规定的行政处罚,由县级以上药品监督管理部门按照国务院药品监督管理部门规定的职责分工决定;吊销《药品生产许可证》、《药品经营许可证、《医疗机构制剂许可证》、医疗机构执业许可证书或者撤销药品批准证明文件的,由原发证、批准的部门决定。

第八十九条 违反本法第五十五条、第五十六条、第五十七条关于药品价格管理的规定的,依照《中华人民共和国价格法》的规定处罚。

中国药品管理法 中华人民共和国药品管理法(2013修订)

第九十条 药品的生产企业、经营企业、医疗机构在药品购销中暗中给予、收受回扣或者其他利益的,药品的生产企业、经营企业或者其代理人给予使用其药品的医疗机构的负责人、药品采购人员、医师等有关人员以财物或者其他利益的,由工商行政管理部门处一万元以上二十万元以下的罚款,有违法所得的,予以没收;情节严重的,由工商行政管理部门吊销药品生产企业、药品经营企业的营业执照,并通知药品监督管理部门,由药品监督管理部门吊销其《药品生产许可证》、《药品经营许可证》;构成犯罪的,依法追究刑事责任。(www.loach.net.cn)

第九十一条 药品的生产企业、经营企业的负责人、采购人员等有关人员在药品购销中收受其他生产企业、经营企业或者其代理人给予的财物或者其他利益的,依法给予处分,没收违法所得;构成犯罪的,依法追究刑事责任。

医疗机构的负责人、药品采购人员、医师等有关人员收受药品生产企业、药品经营企业或者其代理人给予的财物或者其他利益的,由卫生行政部门或者本单位给予处分,没收违法所得;对违法行为情节严重的执业医师,由卫生行政部门吊销其执业证书;构成犯罪的,依法追究刑事责任。

第九十二条 违反本法有关药品广告的管理规定的,依照《中华人民共和国广告法》的规定处罚,并由发给广告批准文号的药品监督管理部门撤销广告批准文号,一年内不受理该品种的广告审批申请;构成犯罪的,依法追究刑事责任。 药品监督管理部门对药品广告不依法履行审查职责,批准发布的广告有虚假或者其他违反法律、行政法规的内容的,对直接负责的主管人员和其他直接责任人员依法给予行政处分;构成犯罪的,依法追究刑事责任。

第九十三条 药品的生产企业、经营企业、医疗机构违反本法规定,给药品使用者造成损害的,依法承担赔偿责任。

第九十四条 药品监督管理部门违反本法规定,有下列行为之一的,由其上级主管机关或者监察机关责令收回违法发给的证书、撤销药品批准证明文件,对直接负责的主管人员和其他直接责任人员依法给予行政处分;构成犯罪的,依法追究刑事责任:

(一)对不符合《药品生产质量管理规范》、《药品经营质量管理规范》的企业发给符合有关规范的认证证书的,或者对取得认证证书的企业未按照规定履行跟踪检查的职责,对不符合认证条件的企业未依法责令其改正或者撤销其认证证书的;

(二)对不符合法定条件的单位发给《药品生产许可证》、《药品经营许可证》或者《医疗机构制剂许可证》的;

(三)对不符合进口条件的药品发给进口药品注册证书的;

(四)对不具备临床试验条件或者生产条件而批准进行临床试验、发给新药证书、发给药品批准文号的。

第九十五条 药品监督管理部门或者其设置的药品检验机构或者其确定的专业从事药品检验的机构参与药品生产经营活动的,由其上级机关或者监察机关责令改正,有违法收入的予以没收;情节严重的,对直接负责的主管人员和其他直接责任人员依法给予行政处分。

药品监督管理部门或者其设置的药品检验机构或者其确定的专业从事药品检验的机构的工作人员参与药品生产经营活动的,依法给予行政处分。

第九十六条 药品监督管理部门或者其设置、确定的药品检验机构在药品监督检验中违法收取检验费用的,由政府有关部门责令退还,对直接负责的主管人员和其他直接责任人员依法给予行政处分。对违法收取检验费用情节严重的药品

中国药品管理法 中华人民共和国药品管理法(2013修订)

检验机构,撤销其检验资格。(www.loach.net.cn]

第九十七条 药品监督管理部门应当依法履行监督检查职责,监督已取得《药品生产许可证》、《药品经营许可证》的企业依照本法规定从事药品生产、经营活动。

已取得《药品生产许可证》、《药品经营许可证》的企业生产、销售假药、劣药的,除依法追究该企业的法律责任外,对有失职、渎职行为的药品监督管理部门直接负责的主管人员和其他直接责任人员依法给予行政处分;构成犯罪的,依法追究刑事责任。

第九十八条 药品监督管理部门对下级药品监督管理部门违反本法的行政行为,责令限期改正;逾期不改正的,有权予以改变或者撤销。

第九十九条 药品监督管理人员滥用职权、徇私舞弊、玩忽职守,构成犯罪的,依法追究刑事责任;尚不构成犯罪的,依法给予行政处分。

第一百条 依照本法被吊销《药品生产许可证》、《药品经营许可证》的,由药品监督管理部门通知工商行政管理部门办理变更或者注销登记。

第一百零一条 本章规定的货值金额以违法生产、销售药品的标价计算;没有标价的,按照同类药品的市场价格计算。

第十章 附则

第一百零二条 本法下列用语的含义是:

药品,是指用于预防、治疗、诊断人的疾病,有目的地调节人的生理机能并规定有适应症或者功能主治、用法和用量的物质,包括中药材、中药饮片、中成药、化学原料药及其制剂、抗生素、生化药品、放射性药品、血清、疫苗、血液制品和诊断药品等。

辅料,是指生产药品和调配处方时所用的赋形剂和附加剂。

药品生产企业,是指生产药品的专营企业或者兼营企业。

药品经营企业,是指经营药品的专营企业或者兼营企业。

第一百零三条 中药材的种植、采集和饲养的管理办法,由国务院另行制定。 第一百零四条 国家对预防性生物制品的流通实行特殊管理。具体办法由国务院制定。

第一百零五条 中国人民解放军执行本法的具体办法,由国务院、中央军事委员会依据本法制定。

第一百零六条 本法自2001年12月1日起施行。

三 : 中华人民共和国药品管理法-英汉对照法律英语

中华人民共和国药品管理法

LAW OF THE PEOPLE'S REPUBLIC OF CHINA ON THE ADMINISTRATION OF DRUGS

第一条为加强药品监督管理,保证药品质量,增进药品疗效,保障人民用药安全,维护人民身体健康,特制定本法。

[Article 1] This law has been drawn up in order to strengthen drug control and administration, ensure the quality of drugs, enhance the efficacy of drugs, guarantee safe drug use and safeguard the physical health of the people.

第二条国务院卫生行政部门主管全国药品监督管理工作。

[Article 2] The State Council department responsible for health administration is the body in charge of national drug control and administration.

第三条国家发展现代药和传统药,充分发挥其在预防、医疗和保健中的作用。

[Article 3] The State develops both modern medicines and traditional medicines, and fully utilises them in the prevention and treatment of disease, as well as in health care.

国家保护野生药材资源 鼓励培育中药材。

The State safeguards resources of uncultivated medicinal materials and encourages the cultivation of raw materials used for traditional Chinese medicines.

第二章药品生产企业的管理

CHAPTER II ADMINISTRATION OF DRUG-PRODUCING ENTERPRISES

第四条开办药品生产企业必须由所在省、自治区、直辖市药品生产经营主管部门审查同意,经所在省、自治区、直辖市卫生行政部门审核批准,并发给《药品生产企业许可证》。

[Article 4] The establishment of a drug-producing enterprise must be examined and agreed to by the department in charge of drug production and handling in the province, autonomous region or municipality under the direct control of the Central Government in which the enterprise is located. It shall be subject to examination and approval by the department responsible for health administration in the province, autonomous region or municipality under the direct control of the Central Government, which shall issue the "Drug-production Enterprise Licence".

无《药品生产企业许可证》的工商行政管理部门不得发给《营业执照》。

Without a "Drug-production Enterprise Licence", the department administering industry and commerce may not issue a "Business Licence".

《药品生产企业许可证》应当规定有效期,到期重新审查发证。具体办法由国务院卫生行政部门规定。

The "Drug-production Enterprise Licence" shall stipulate its period of validity, and at the expiry of the period the issue of the licence shall be examined afresh. Specific procedures will be determined by the State Council department responsible for health administration.

第五条开办药品生产企业必须具备以下条件:

[Article 5] The establishment of an enterprise to produce drugs must satisfy the following conditions:

(一)具有与所生产药品相适应的药师或者助理工程师以上技术人员及技术工人。

(1) It must employ pharmacists, technical personnel above the rank of assistant engineer and technical workers appropriate to the drug production carried out by the enterprise.

中药饮片加工企业没有药师或者助理工程师以上技术人员,配备熟悉药性并经县级以上卫生行政部门审查登记的药工人员。

Where an enterprise engaged in the processing of traditional Chinese medicine does not have a pharmacist or technical personnel of a rank above that of assistant engineer, it may use drug industry personnel with an intimate knowledge of drugs who have been examined and registered by a department of health administration above the county level.

(二)具有与所生产药品相适应的厂房、设施和卫生环境。

(2) It must have a factory building, facilities and a hygienic environment appropriate to its production of drugs.

(三)具有能对所生产药品进行质量检验的机构或者人员以及必要的仪器设备。

(3) It must have an organisation or personnel capable of carrying out quality examinations on the drugs produced as well as the necessary instruments and equipment.

第六条药品必须按照工艺规程进行生产,生产记录必须完整准确。

[Article 6] The production of drugs must be carried out in accordance with the correct technological procedures; production records shall be kept in detail and accurately.

中药饮片的炮制必须符合《中华人民共和国药典》,或者省、自治区、直辖市卫生行政部门制定的《炮制规范》的规定。

The preparation of Chinese medicines shall be in accordance with the "Pharmacopoeia of the People's Republic of China", or in accordance with the "Preparation Standards" laid down by the department administering health in that province, autonomous region or municipality under the direct control of the Central Government.

第七条生产药品所需的原料、辅料以及直接接触药品的容器和包装材料,必须符合药用要求。

[Article 7] Raw materials and supplementary materials required for the production of drugs as well as containers and packing materials wh(www.loach.net.cn)ich come into direct contact with drugs shall meet standards required for pharmaceutical use.

第八条药品出厂前必须经过质量检验;不符合标准的,不得出厂。

[Article 8] Before drugs leave the factory, they must pass a quality examination. If they do not reach the required standard, they must not leave the factory.

第九条药品生产企业必须按照国务院卫生行政部门制定的《药品生产质量管理规范》的要求,制定和执行保证药品质量的规章制度和卫生要求。

[Article 9] Drug-producing enterprises must formulate and implement a system of rules and regulations and hygiene requirements to guarantee the quality of drugs in accordance with the requirements of the "Standards for the Administration of Drug-production Quality" laid down by the department of the State Council administering health.

第三章药品经营企业的管理

CHAPTER III ADMINISTRATION OF DRUG-HANDLING ENTERPRISES

第十条开办药品经营企业必须由所在地药品生产经营主管部门审查同意,经县级以上卫生行政部门审核批准,并发给《药品经营企业许可证》。无《药品经营企业许可证》的,工商行政管理部门不得发给《营业执照》。

[Article 10] The establishment of a drug-handling enterprise must be examined and agreed to by the department responsible for drug production and handling in the place where the enterprise is situated, and must be examined and approved by a health department at county level or above, which will issue a "Drug-handling Enterprise Licence", without which the department administering industry and commerce may not issue a "Business Licence".

《药品经营企业许可证》应当规定有效期,到期重新审查发证。具体办法由国务院卫生行政部门规定。

A "Drug-handling Enterprise Licence" shall stipulate its period of validity, and at the expiry of the period the issue of the licence shall be examined afresh. Specific procedures will be determined by the department of the State Council administering health.

第十一条开办药品经营企业必须具备以下条件:

[Article 11] The establishment of a drug-handling enterprise must satisfy the following conditions:

(一)具有与所经营药品相适应的药学技术人员。

(1) It must employ pharmaceutical technicians appropriate to the medicines handled.

经营中药的企业和兼营药品的企业没有药学技术人员.配备熟悉所经营药品的药性并经县级以上卫生行政部门审查登记的药工人员。

Where an enterprise engaged in the handling of Chinese medicines or partly engaged in handling drugs does not have a pharmaceutical technician it may use drug industry personnel with an intimate knowledge of the medicinal nature of the drugs handled who have been examined and registered by a department administering health at above county level.

(二)具有与所经营药品相适应的营业场所、设备、仓储设施和卫生环境。

(2) It must have business premises, equipment, storage facilities and a hygienic environment appropriate to the drugs handled.

第十二条收购药品,必须进行质量验收;不合格的,不得收购。

[Article 12] On purchasing drugs, quality examinations must be carried out; if the drugs do not come up to standard, they may not be purchased.

第十三条销售药品必须准确无误,并正确说明用法、用量和注意事项;

[Article 13] In selling drugs, it is necessary to be exact and accurate; the method of use, dosage and points to note must be explained precisely.

调配处方必须经过核对,对处方所列药品不得擅自更改或者代用。

In making up prescriptions, checks must be carried out; the drugs itemised in the prescription must not be altered or substituted without authorisation.

对有配伍禁忌或者超剂量的处方应当拒绝调配;必要时经处方医生更正或者重新签字,方可调配。

Where a prescription contains ingredients that are incompatible or amounts of ingredients in excess of the proper dosage, a request to make up the prescription shall be refused; if necessary, after the prescribing doctor has corrected it and signed it again, it may be made up.

销售地道中药材,必须标明产地。

Where authentic Chinese medicines are sold, they shall be labelled to indicate the place of origin.

第十四条药品仓库必须制定和执行药品保管制度,采取必要的冷藏、防潮、防虫、防鼠等措施。

[Article 14] Drug warehouses shall lay down and implement a system of rules and regulations for the storage of drugs and take measures necessary in relation to cold storage, protection against damp, and protection from insects, rodents, etc.

药品入库出库必须执行检查制度。

An inspection system shall be put into effect in relation to drugs which are brought into or removed from the warehouse.

第十五条城乡集市贸易市场可以出售中药材,国家另有规定的除外。

[Article 15] Chinese medicinal materials may be sold in town and country trading markets except where otherwise stipulated by the State.

城乡集市贸易市场不得出售中药材以外的药品持有《药品经营企业许可证》的除外。

Drugs other than Chinese medicinal materials may not be sold in the trading markets of country towns, unless a "Drug-handling Enterprise Licence" is held.

第四章医疗单位的药剂管理

CHAPTER IV ADMINISTRATION OF DRUGS IN MEDICAL TREATMENT UNITS

第十六条医疗单位必须配备与其医疗任务相适应的药学技术人员,非药学技术人员不得直接从事药剂技术工作。

[Article 16] Medical treatment units must be staffed with the number of pharmaceutical technicians appropriate to their medical treatment responsibilities. Personnel who are not pharmaceutical technicians may not be engaged directly in pharmaceutical technical work.

第十七条医疗单位配制制剂必须经所在省、自治区、直辖市卫生行政部门审查批准,并发给《制剂许可证》。

[Article 17] The making up of drugs by medical treatment units must be examined and approved by the department in charge of health administration in the province, autonomous region or municipality under the direct control of the Central Government where the unit is situated, which will issue a "Dispensing Licence".

《制剂许可证》应当规定有效期,到期重新审查发证。具体办法由国务院卫生行政部门规定。

A "Dispensing Licence" shall stipulate its period of validity, and at the expiry of the period the issue of the licence shall be examined afresh. Specific procedures will be laid down by the department of the State Council administering health.

第十八条医疗单位配制制剂必须具有能够保证制剂质量的设施、检验仪器和卫生条件。

[Article 18] A medical treatment unit which makes up drugs must have adequate facilities, instruments for examination and hygienic conditions to ensure the quality of the drugs prepared.

第十九条医疗单位配制的制剂,必须根据临床需要并按照规定进行质量检验;合格的,凭医生处方使用。

[Article 19] The drugs made up by medical treatment units must comply with clinical requirements and, in accordance with regulations, quality examinations must be conducted. They are only to be used if up to quality and on a doctor's prescription.

医疗单位配制的制剂不得在市场销售。

Drugs made up by medical treatment units may not be sold on the market.

第二十条医疗单位购进药品,必须执行质量验收制度。

[Article 20] When a medical treatment unit purchases drugs, it must implement a system of checking the quality on delivery.

第五章药品的管理

CHAPTER V DRUG ADMINISTRATION

第二十一条国家鼓励研究、创制新药。

[Article 21] The State encourages research into and development of new drugs.

研制新药必须按照规定向国务院卫生行政部门或者省、自治区、直辖市卫生行政部门报送研制方法、质量指标、药理及毒理试验结果等有关资料和样品。经批准后,方可进行临床试验或者临床验证。

Where a new drug has been researched and developed, in accordance with the regulations, a report must be submitted, with samples, to the State Council department administering health or the department of the province, autonomous region or municipality under the direct control of the Central Government administering health, giving details of the method of research and development, quality norms, pharmacological and toxicological tests and other relevant data. Only after it has been approved may clinical tests or clinical verifications be carried out.

完成临床试验或者临床验证并通过鉴定的新药由国务院卫生行政部门批准发给证书。

Where a new drug has completed its clinical tests or clinical verification and has passed an appraisal it may be approved by the department of the State Council administering health, which will issue a certificate.

第二十二条生产新药,必须经国务院卫生行政部门批准,并发给批准文号。但是,生产中药饮片除外。

[Article 22] The production of new drugs must be approved by the department of the State Council administering health which will issue an approval number. However, the production of Chinese medicines sliced and prepared for decoction is excepted.

生产已有国家标准或者省、自治区、直辖市标准的药品,必须经省、自治区、直辖市卫生行政部门征求同级药品生产经营主管部门意见后审核批准,并发给批准文号。但是,生产中药饮片除外。

The production of drugs for which there is already a national drug standard, or a drug standard of a province, autonomous region or municipality under the direct control of the Central Government, must be examined and approved by the department responsible for health administration in the relevant province, autonomous region or municipality under the direct control of the Central Government after seeking the opinion of the corresponding authority responsible for the drug-producing enterprise. An approval number will be issued. However, the production of Chinese medicines sliced and prepared for decoction is excepted.

第二十三条药品必须符合国家药品标准或者省、自治区、直辖市药品标准。

[Article 23] Drugs must comply with the national drug standard, or with the drug standard of the province, autonomous region or municipality under the direct control of the Central Government.

国务院卫生行政部门颁布的《中华人民共和国药典》和药品标准,为国家药品标准。

The "Pharmacopoeia of the People's Republic of China" and drug standards promulgated by the department of the State Council administering health are the national drug standards.

国务院卫生行政部门的药典委员会负责组织国家药品标准的制定和修订。

The Pharmacopoeia Committee of the department of the State Council administering health is the body responsible for handling the setting and revision of national drug standards.

第二十四条国务院卫生行政部门和省、自治区、直辖市卫生行政部门可以成立药品审评委员会,对新药进行审评,对已经生产的药品进行再评价。

[Article 24] The State Council department responsible for health administration and the departments of the provinces, autonomous regions and municipalities under the direct control of the Central Government administering health may establish a Drug Evaluation Committee to evaluate new drugs and re-evaluate drugs already being produced.

第二十五条国务院卫生行政部门对已经批准生产的药品,应当组织调查;对疗效不确、不良反应大或者其他原因危害人民健康的药品,应当撤销其批准文号。

[Article 25] The department of the State Council responsible for administering health shall organise investigation into drugs already approved for production; where the efficacy of a drug is not reliable, the side-effects to a drug are great, or a drug is for any other reason harmful to people's health, the approval number shall be revoked.

已被撤销批准文号的药品不得继续生产、销售;已经生产的由当地卫生行政部门监督销毁或者处理。

Where the approval number of a drug has been revoked, production and sale of the drug may not be continued; what has already been produced shall be burnt or disposed of under the supervision of the local department administering health.

第二十六条禁止进口疗效不确、不良反应大或者其他原因危害人民健康的药品。

[Article 26] It is forbidden to import a drug if its efficacy is not reliable, if its side-effects are great, or it is for any other reason harmful to people's health.

第二十七条首次进口的药品,进口单位必须提供该药品的说明书、质量标准、检验方法等有关资料和样品以及出口国(地区)批准生产的证明文件,经国务院卫生行政部门批准,方可签订进口合同。

[Article 27] Where a drug is being imported for the first time, the importing unit must submit a written description of the drug, details of its quality standards, testing and other relevant data, samples, and documentation proving that the exporting country (place) has approved production. Only when the approval of the department of the State Council administering health has been obtained may the import contract be signed.

第二十八条进口的药品,必须经国务院卫生行政部门授权的药品检验机构检验;检验合格的,方准进口。

[Article 28] Imported drugs must be examined by a drug examination body so authorised by the State Council department responsible for health administration. Only when a drug passes examination will importation be permitted.

医疗单位临床急需或者个人自用进口的少量药品按照海关的规定办理进口手续。

The importation of a small amount of a drug to meet the urgent clinical needs of a medical treatment unit or for the personal use of an individual is to follow the importation procedures stipulated by Customs.

第二十九条对国内供应不足的中药材、中成药,国务院卫生行政部门有权限制或者禁止出口。

[Article 29] Where the supply of Chinese medicinal materials or prepared Chinese medicine is not sufficient for the Chinese domestic market, the State Council department responsible for health administration has the power to restrict or prohibit its export.

第三十条进口、出口麻醉药品和国务院卫生行政部门规定范围内的精神药品,必须持有国务院卫生行政部门发给的《进口准许证》、《出口准许证》。

[Article 30] In order to import or export narcotic drugs or psychotropic drugs which come within the scope laid down by the department of the State Council administering health, it is necessary to hold an "Import Licence" or "Export Licence" issued by the department of the State Council administering health.

第三十一条新发现和从国外引种的药材,经省、自治区、直辖市卫生行政部门审核批准后,方可销售。

[Article 31] Medicinal materials which have been newly discovered or introduced from abroad may only be sold where they have been examined and approved by the department of the province, autonomous region or municipality under the direct control of the Central Government administering health.

第三十二条地区性民间习用药材的具体管理办法,由国务院卫生行政部门制定。

[Article 32] Detailed provisions for the administration of local customarily used folk medicines will be laid down by the State Council department responsible for health administration.

第三十三条禁止生产、销售假药。有下列情形之一的为假药:

[Article 33] The production and sale of spurious drugs is prohibited. A drug is spurious if any one of the following circumstances exists:

(一)药品所含成份的名称与国家药品标准或者省、自治区、直辖市药品标准规定不符合的;

(1) The names of the ingredients contained in the drug do not correspond to the national drug standard or the drug standard set by the province, autonomous region or municipality under the direct control of the Central Government;

(二)以非药品冒充药品或者以他种药品冒充此种药品

(2) A substance that is not a drug is passed off as a drug, or one sort of drug is passed off as another drug.

有下列情形之一,药品按假药处理:

A drug will be treated as a spurious drug if one of the following circumstances exists:

(一)国务院卫生行政部门规定禁止使用的;

(1) The State Council department responsible for health administration has stipulated that its use is forbidden;

(二)未取得批准文号生产的;

(2) It was produced without first obtaining an approval number;

(三)变质不能药用的;

(3) Due to deterioration, it cannot be used for medicinal purposes;

(四)被污染不能药用的。

(4) Due to contamination, it cannot be used for medicinal purposes.

第三十四条禁止生产、销售劣药。有下列情形之一的药品为劣药:

[Article 34] It is forbidden to produce or sell inferior drugs. A drug is inferior if one of the following circumstances exists:

(一)药品成份的含量与国家药品标准或者省、自治区、直辖市药品标准规定不符合的;

(1) The content of its ingredients does not comply with the national drug standard or the drug standard set by the province, autonomous region or municipality under the direct control of the Central Government;

(二)超过有效期的;

(2) Its period of efficacy has expired;

(三)其他不符合药品标准规定的。

(3) It fails in any other way to comply with stipulated drug standards.

第三十五条药品生产企业、药品经营企业和医疗单位直接接触药品的工作人员,必须每年进行健康检查。患有传染病或者其他可能污染药品的疾病的患者,不得从事直接接触药品的工作。

[Article 35] Personnel of drug-producing enterprises, drug-handling enterprises and medical treatment units who come into direct contact with drugs must undergo a medical examination annually. Persons suffering from contagious diseases or any other disease that could contaminate drugs may not engage in work involving direct contact with drugs.

第六章药品的包装和分装

CHAPTER VI THE PACKAGING AND REPACKAGING OF DRUGS

第三十六条药品包装必须适合药品质量的要求,方便储存、运输和医疗使用。规定有效期的药品,必须在包装上注明有效期。

[Article 36] The packaging of drugs must be appropriate to the requirements of the quality of the drug and must facilitate their storage, transportation and use. Where a period of efficacy for a drug has been fixed, the period of efficacy must be clearly indicated on the package.

发运中药材必须有包装。每件包装上必须注明品名、产地、日期、调出单位,并附有质量合格的标志。

Where Chinese medicinal materials are to be transported, they must be packaged. On each package, the name of the product, its place of origin, the date and the name of the dispatching unit must be clearly indicated and it must be marked to indicate that the quality is up to standard.

第三十七条药品包装必须按照规定贴有标签并附有说明书。

[Article 37] Drug packages must, in accordance with regulations, be labelled and have an instruction booklet attached.

标签或说明书上必须注明药品的品名、规格、生产企业、批准文号、产品批号、主要成份、适应症、用法、用量、禁忌、不良反应和注意事项。

The name of the drug, its specifications, the producing unit, approval number, product batch number, principal ingredients, diseases for which it is indicated, manner of use, side-effects and points to note must be clearly set out on the label or in the instruction booklet.

麻醉药品、精神药品、毒性药品、放射性药品和外用药品的标签必须印有规定标志。

The labels of narcotic drugs, psychotropic drugs, poisonous drugs, radioactive drugs and drugs for external use only must bear the prescribed mark.

第三十八条药品经营企业分装药品,必须具有与所分装药品相适应的设施和卫生条件,由药学技术人员负责,分装记录必须完整准确。

[Article 38] A drug-handling enterprise engaged in the repackaging of drugs must have equipment and hygienic conditions appropriate for the quantity of drugs repackaged. It must be under the charge of pharmaceutical technicians; records of the repackaging must be complete and precise.

分装药品必须附有说明书,在包装上注明品名、规格、生产企业和产品批号、分装单位和分装批号。规定有效期的药品,分装后必须注明有效期。

An instruction booklet must be attached to a repackaged drug. The product name, specifications, name of the production unit and product batch number and of the repackaging unit and repackaging batch number shall be set out clearly on the package. Where a period of efficacy has been set for the drug, when it has been repackaged, the period of efficacy must be clearly indicated.

第七章特殊管理的药品

CHAPTER VII DRUGS UNDER SPECIAL CONTROL

第三十九条国家对麻醉药品、精神药品、毒性药品、放射性药品,实行特殊的管理办法。管理办法由国务院制定。

[Article 39] The State imposes special controls on narcotic drugs, psychotropic drugs, poisons and radioactive drugs. The controls will be stipulated by the State Council.

第四十条麻醉药品,包括原植物,只准由国务院卫生行政部门会同有关部门指定的单位生产,并由省、自治区、直辖市卫生行政部门会同有关部门指定的单位按照规定供应。

[Article 40] The production of narcotic drugs, including the original plant, may only be undertaken by units appointed to do so by the department of the State Council administering health and relevant departments acting jointly, and supply may only be undertaken by units appointed by the department of the province, autonomous region or municipality under the direct control of the Central Government administering health and the relevant departments acting jointly.

第八章药品商标和广告的管理

CHAPTER VIII ADMINISTRATION OF DRUG TRADEMARKS AND ADVERTISING

第四十一条除中药材、中药饮片外,药品必须使用注册商标;未经核准注册的,不得在市场销售。

[Article 41] With the exception of Chinese medicinal materials and Chinese medicines sliced and prepared for decoction, drugs must use a registered trademark and may not be sold on the market until examined and approved for registration.

注册商标必须在药品的包装和标签上注明。

The registered trademark must be clearly shown on the package and label of the drug.

第四十二条药品广告必须经省、自治区、直辖市卫生行政部门审查批准;未经批准的,不得刊登、播放、散发和张贴。

[Article 42] An advertisement for a drug must be examined and approved by the department of the province, autonomous region or municipality under the direct control of the Central Government responsible for administering health; unless it is approved, it may not be published, broadcast, distributed or displayed on a poster.

第四十三条外国企业在我国申请办理药品广告,必须提供生产该药品的国家(地区)批准的证明文件、药品说明书和有关资料。

[Article 43] Where a foreign enterprise applies to advertise a drug in this country, it must submit documents proving approval of the drug from the country (or place) of its production, a written description of the drug and relevant material.

第四十四条药品广告的内容必须以国务院卫生行政部门或者省、自治区、直辖市卫生行政部门批准的说明书为准。

[Article 44] The contents of an advertisement for a drug must be in accordance with the explanatory booklet approved by the department of the State Council administering health or the department of the province, autonomous region or municipality under the direct control of the Central Government administering health.

第九章药品监督

CHAPTER IX DRUG CONTROL

第四十五条县级以上卫生行政部门行使药品监督职权。

[Article 45] Departments administering health above the county level exercise the power of supervision over drugs.

县级以上卫生行政部门,可以设置药政机构和药品检验机构。

Departments administering health at above county level may establish drug administration bodies and drug inspection bodies.

第四十六条县级以上卫生行政部门设药品监督员。药品监督员由药学技术人员担任,由同级人民政府审核发给证书。

[Article 46] Departments administering health at above county level will appoint Drug Controllers. Drug Controllers will be appointed from those holding the position of pharmaceutical technicians; they shall be examined, and a certificate will be issued by the People's Governments at that level.

第四十七条药品监督员有权按照规定对辖区内的药品生产企业、药品经营企业和医疗单位的药品质量进行监督、检查、抽验,必要时可以按照规定抽取样品和索取有关资料,有关单位不得拒绝和隐瞒。

[Article 47] A Drug Controller has the power, in accordance with regulations, to control, inspect and test the quality of drugs in drug-producing enterprises, drug-handling enterprises and medical treatment units within the Controller's area of jurisdiction. If necessary, the Drug Controller may, in accordance with regulations, take samples and obtain relevant data which the relevant unit may not refuse to provide and may not conceal.

药品监督员对药品的生产企业和科研单位提供的技术资料,负责保密。

Drug Controllers are responsible for keeping the technical data provided by drug-manufacturing enterprises or scientific research units confidential.

第四十八条药品生产企业、药品经营企业和医疗单位,应当经常考察本单位所生产、经营、使用的药品的质量、疗效和不良反应。

[Article 48] Drug-producing enterprises, drug-handling enterprises and medical treatment units shall regularly inspect and study the quality, efficacy and side-effects of drugs produced, handled or used by them.

医疗单位发现药品中毒事故,必须及时向当地卫生行政部门报止。

If a medical treatment unit discovers a case of poisoning in relation to a drug, it must immediately report it to the department administering health in that area.

第四十九条药品生产企业和药品经营企业的药品检验机构或者人员,受当地药品检验机构的业务指导。

[Article 49] The drug-inspection body or personnel of a drug-producing enterprise or drug-handling enterprise will receive guidance in their professional work from the drug-inspection organ of that area.

第十章法律责任

CHAPTER X LEGAL RESPONSIBILITIES

第五十条生产、销售假药的,没收假药和违法所得,处以罚款,并可以责令该单位停产、停业整顿或者吊销《药品生产企业许可证》、《药品经营企业许可证》、《制剂许可证》。

[Article 50] Where spurious drugs are produced or sold, the spurious drugs and the illegally obtained income will be confiscated and a fine will be imposed. In addition, the relevant unit may be ordered to stop production or stop operations for rectification or its "Drug-production Enterprise Licence", "Drug-handling Enterprise Licence" or "Dispensing Licence" may be revoked.

对生产、销售假药,危害人民健康的个人或者单位直接责任人员,依照刑法第一百六十四条规定追究刑事责任。

In pursuance of the regulations of Article 164 of the Penal Code, criminal liability will be investigated and determined in relation to individuals or units directly involved in the production or sale of spurious drugs endangering the people's health.

第五十一条生产、销售劣药的,没收劣药和违法所得,可以并处罚款;情节严重的,并责令该单位停产、停业整顿或者吊销《药品生产企业许可证》、《药品经营企业许可证》、《制剂许可证》。

[Article 51] Where inferior drugs are produced or sold, the inferior drugs and the illegally obtained income will be confiscated and a fine may also be imposed; if the circumstances are serious, the relevant unit may be ordered to stop production or stop its operations and rectify itself, or its "Drug-production Enterprise Licence", "Drug-handling Enterprise Licence" or "Dispensing Licence" may be revoked.

对生产销售劣药,危害人民健康,造成严重后果的个人或单位直接责任人员,比照刑法第一百六十四条的规定追究刑事责任。

In pursuance of Article 164 of the Penal Code, criminal liability will be investigated and determined in relation to individuals or units directly involved in the production or sale of inferior drugs endangering the people's health.

第五十二条未取得《药品生产企业许可证》、《药品经营企业许可证》、《制剂许可证》生产药品、经营药品或者配制制剂的,责令该单位停产、停业或者停止配制制剂,没收全部药品和违法所得,可以并处罚款。

[Article 52] Where drugs are manufactured, handled or made up without a "Drug-production Enterprise Licence", Drug-handling Enterprise Licence" or "Dispensing Licence", the relevant unit will be ordered to stop production, stop operations or stop preparing medications. All of the illegally-produced drugs and the illegally-obtained income shall be confiscated and a fine may also be imposed.

第五十三条违反本法关于药品生产、药品经营的管理的其他规定的,处以警告或者罚款。

[Article 53] A violation of any other provision of this law in relation to the administration of drug production or handling will be punished by a caution or by a fine.

第五十四条本法规定的行政处罚,由县级以上卫生行政部门决定。违反本法第十五条规定、第八章有关广告管理的规定的行政处罚,由工商行政管理部门决定。

[Article 54] Any decision relating to the imposition of an administrative penalty pursuant to this law shall be made by the department administering health at above the county level. Any decision relating to the imposition of a penalty for and offence against Article 15 of this law or the provisions of Chapter VIII of this law with respect to the advertising of drugs, shall be made by the department administering industry and commerce. In relation to the penalty of ordering a drug-producing enterprise or drug-handling enterprise which is directly under the management of the Central Government or the People's Government of a province, autonomous region or municipality directly under the control of the Central Government to stop production or stop its operations for more than seven days, or of revoking its "Drug-production Enterprise Licence", or "Drug-handling Enterprise Licence", the department of the province, autonomous region or municipality under the direct control of the Central Government administering health shall submit it to the People's Government at the same level for decision.

对中央或者省、自治区、直辖市人民政府直接管辖的药品生产企业、药品经营企业处以停产、停业整顿7天以上或者吊销《药品生产企业许可证》、 《药品经营企业许可证》处罚的,由省、自治区、直辖市卫生行政部门报同级人民政府决定。对市、县或者市、县以下人民政府管辖的药品生产企业、药品经营企业处以停产,停业整顿 7天以上或者吊销《药品生产企业许可证》、《药品经营企业许可证》处罚的,由市、县人民政府卫生行政部门报同级人民政府决定。

In relation to a penalty ordering a drug-producing enterprise or drug-handling enterprise under the direct management of the People's Government at or below the city or county level to stop production or stop operations for more than seven days or of revoking its "Drug-production Enterprise Licence" or its "Drug-handling Enterprise Licence", the department of the city or county People's Government administering health shall submit the matter to the People's Government of the same level for decision.

没收的药品由卫生行政部门监督处理。

Confiscated drugs shall be disposed of under the supervision of the department responsible for health administration.

第五十五条当事人对行政处罚决定不服的,可以在接到处罚通知之日起 15 天内向人民法院起诉。

[Article 55] If a party objects to the decision to impose a penalty on him, he may, within 15 days from the date of receipt of notification of the penalty, bring an action in the People's Court. H

但是,对卫生行政部门作出的药品控制的决定,当事人必须立即执行。对处罚决定不履行逾期又不起诉的,由作出行政处罚决定的机关申请人民法院强制执行。

owever, in the case of a decision relating to drug control taken by the department responsible for health administration, the party shall immediately comply. Where the decision has not been complied with within the time limit and no action has been brought, the People's Court shall compulsorily enforce compliance upon application by the organ which made the decision.

第五十六条违反本法,造成药品中毒事故的,致害单位或者个人应当负损害赔偿责任。受害人可以请求县级以上卫生行政部门处理;当事人不服的,可以向人民法院起诉。受害人也可以直接向人民法院起诉。

[Article 56] In case of drug poisoning caused by a breach of this law, the unit or person who caused it shall be liable to pay compensation. The person suffering harm may request a department administering health at above county level to handle the matter; if the party who caused the harm objects, he or it may bring an action in the People's Court. The person suffering harm may also sue directly in the People's Court.

损害赔偿要求,应当从受害人或者其代理人知道或者应当知道之日起 1年内提出;超过期限的,不予受理。

A demand to be compensated for damage shall be submitted within a period of one year from the date on which the victim or his representative became aware or ought to have become aware of it. When this period has expired, the claim will not be entertained.

第五十七条本法下列用语的含义是:

[Article 57] The expressions used in this law are defined as follows:

药品:指用于预防、治疗、诊断人的疾病,有目的地调节人的生理机能并规定有适应症、用法和用量的物质,

"Drug" refers to a substance used for the prevention, treatment and diagnosis of human diseases, and with the object of regulating human physiological functions, with stipulated indications, usage and dosage.

包括中药材、中药饮片、中成药、化学原料药及其制剂、抗生素、生化药品、放射性药品、血清疫苗、血液制品和诊断药品等。

It includes Chinese medicinal materials and Chinese medicines sliced and prepared for decoction, prepared Chinese medicines, chemical raw material drugs and their components, antibiotics, biochemical drugs, radioactive drugs, blood serums and vaccines, blood products, diagnostic drugs and so on.

新药指我国未生产过的药品。

"New drugs" refers to those drugs which have never been produced in this country.

辅料指生产药品和调配处方时所用的赋形剂和附加剂。

"Supplementary materials" refers to excipients and additives used in the production and making up of drugs.

药品生产企业指生产药品的专营企业或者兼营企业。

"Drug-producing enterprise" refers to those enterprises exclusively or partially engaged in the production of drugs.

药品经营企业指经营药品的专营企业或者兼营企业。

"Drug-handling enterprise" refers to those enterprises exclusively or partially engaged in the handling of drugs.

第五十八条本法所说的药品生产,不包括中药材的种植、采集和饲养。

[Article 58] The production of drugs referred to in this law does not include the cultivation and collection of raw materials for Chinese medicines or the raising of animals in relation to Chinese medicines.

第五十九条国务院卫生行政部门根据本法制定实施办法报国务院批准施行。

[Article 59] Measures for the implementation of this law will be set down by the State Council department responsible for health administration and submitted to the State Council for approval and implementation.

中国人民解放军特需药品的管理办法由国家军事主管部门制定。

Special provisions for the management of drugs in the People's Liberation Army will be laid down by the department in charge of national military affairs.

第六十条本法自一九八五年七月一日起施行。

[Article 60] This law shall come into force on July 1, 1985.

中华人民共和国药品管理法

The Pharmaceutical Administration Law of the People's Republic of China

第一章 总 则

Chapter I General Provisions

第一条 为加强药品监督管理,保证药品质量,保障人体用药安全,维护人民身体健康和用药的合法权益,特制定本法。

Article 1 This law is formulated to enhance the supervision and control of pharmaceuticals, ensure their quality, guarantee safety in medication, and safeguard the health and legal rights and interests of the people.

第二条 在中华人民共和国境内从事药品的研制、生产、经营、使用和监督管理的单位或者个人,必须遵守本法。

Article 2 The law shall be applicable to any units or individuals engaged in research, production, trade, use, supervision and management of pharmaceuticals within the territory of the People's Republic of China.

第三条 国家发展现代药和传统药,充分发挥其在预防、医疗和保健中的作用。

Article 3 The State shall develop both modern and traditional medicines encourage their role in the prevention and treatment of diseases and in health care.

国家保护野生药材资源,鼓励培育中药材。

The State shall protect the resources of wild medicinal resources and encourage the domestic cultivation of Chinese traditional medicinal crops.

第四条 国家鼓励研究和创制新药,保护公民、法人和其他组织研究、开发新药的合法权益。

Article 4 The State shall encourage the research and production of new medicine and protect the legal rights and interests of its citizens, natural persons and other organizations in the research and development of new medicine.

第五条 国务院药品监督管理部门主管全国药品监督管理工作。国务院有关部门在各自的职责范围内负责与药品有关的监督管理工作。

Article 5 The pharmaceuticals supervisory and administrative departments under the State Council shall be responsible for the supervision and control of pharmaceuticals throughout the country. Other relevant departments under the State Council shall be responsible for the supervision and control of pharmaceuticals related to the scope of their functions.

省、自治区、直辖市人民政府药品监督管理部门负责本行政区域内的药品监督管理工作。省、自治区、直辖市人民政府有关部门在各自的职责范围内负责与药品有关的监督管理工作。

The pharmaceutical supervisory and administrative departments of the provinces, autonomous regions and municipalities directly under the central government shall be responsible for the supervision and control of pharmaceuticals within their administrative regions. Other relevant departments of the provinces, autonomous regions and municipalities directly under the central government shall be responsible for the supervision and control of pharmaceuticals related to the scope of their functions.

国务院药品监督管理部门应当配合国务院经济综合主管部门,执行国家制定的药品行业发展规划和产业政策。

The pharmaceutical supervisory and administrative departments under the State Council shall cooperate with the general administrative department of the economy under the State Council to carry out pharmaceutical development plans and industrial policies formulated by the State.

第六条 药品监督管理部门设置或者确定的药品检验机构,承担依法实施药品审批和药品质量监督检查所需的药品检验工作。

Article 6 The pharmaceutical inspection institutions established or approved by the pharmaceutical supervisory and administrative departments shall be charged with the work of pharmaceutical examination and approval, as well as quality inspection, in accordance with laws and regulations.

第二章 药品生产企业管理

Chapter II Administration of Pharmaceutical Producing Enterprises

第七条 开办药品生产企业,须经企业所在地省、自治区、直辖市人民政府药品监督管理部门批准并发给《药品生产许可证》,

Article 7 The establishment of a pharmaceutical producing enterprise must be approved by and issued a Pharmaceutical Production License by the pharmaceutical supervisory and administrative department of the province, autonomous region, or municipality directly under the Central government in which the enterprise is located.

凭《药品生产许可证》到工商行政管理部门办理登记注册。无《药品生产许可证》的,不得生产药品。

The establishment shall be registered at the industry and commerce administrative department based on the Pharmaceutical Production License, without which no pharmaceuticals shall be produced.

《药品生产许可证》应当标明有效期和生产范围,到期重新审查发证。

The Pharmaceutical Production License shall bear the scope of production and a period of validity, and upon expiration a new license shall be issued after examination for its renewal.

药品监督管理部门批准开办药品生产企业,除依据本法第八条规定的条件外,还应当符合国家制定的药品行业发展规划和产业政策,防止重复建设。

The approval of the establishment of pharmaceutical producing enterprises by the pharmaceutical supervisory and administrative departments shall be in conformity with Article 8 of this law, as well as the pharmaceutical development plan and the industrial policies formulated by the State to avoid the instance of a repeat establishment.

第八条 开办药品生产企业,必须具备以下条件:

Article 8 To establish a pharmaceutical producing enterprise, the following requirements must be met:

(一)具有依法经过资格认定的药学技术人员、工程技术人员及相应的技术工人;

(1) It shall be staffed with legally certified pharmaceutical technical personnel, engineering technical personnel, as well as corresponding skilled workers.

(二)具有与其药品生产相适应的厂房、设施和卫生环境;

(2) It shall have factory premises, facilities and a sanitary environment suitable for the medicines produced.

(三)具有能对所生产药品进行质量管理和质量检验的机构、人员以及必要的仪器设备;

(3) It shall have a unit or competent personnel capable of inspecting the quality of the medicines produced, as well as necessary instruments and equipment.

(四)具有保证药品质量的规章制度。

(4) It shall have rules and regulations to ensure the quality of medicines.

第九条 药品生产企业必须按照国务院药品监督管理部门依据本法制定的《药品生产质量管理规范》组织生产。药品监督管理部门按照规定对药品生产企业是否符合《药品生产质量管理规范》的要求进行认证;对认证合格的,发给认证证书。

Article 9 Pharmaceutical producing enterprises must organize production in accordance with the "Standards for Quality Control of Pharmaceutical Production" formulated by the pharmaceutical supervisory and administrative departments under the State Council on the basis of this Law. Pharmaceutical supervisory and administrative departments shall confirm whether the pharmaceutical producing enterprises have met the requirements of the "Standards," and shall issue certificates to those qualified ones.

《药品生产质量管理规范》的具体实施办法、实施步骤由国务院药品监督管理部门规定。

The detailed implementation measures and implementation process of the "Standards for Quality Control of Pharmaceutical Production" shall be formulated by the pharmaceutical supervisory and administrative department under the State Council.

第十条 除中药饮片的炮制外,药品必须按照国家药品标准和国务院药品监督管理部门批准的生产工艺进行生产,生产记录必须完整准确。药品生产企业改变影响药品质量的生产工艺的,必须报原批准部门审核批准。

Article 10 Except in the preparation of traditional Chinese medicines into ready-to-use forms, pharmaceuticals must be produced in accordance with the national pharmaceutical standard and the technological procedures approved by the supervisory and administrative departments of pharmaceuticals under the State Council, and the record of production must be complete and accurate. The changes of technological procedure made by the pharmaceutical producing enterprises which affect the quality of the pharmaceuticals shall be examined and approved by the original approval authorities.

中药饮片必须按照国家药品标准炮制;国家药品标准没有规定的,必须按照省、自治区、直辖市人民政府药品监督管理部门制定的炮制规范炮制。省、自治区、直辖市人民政府药品监督管理部门制定的炮制规范应当报国务院药品监督管理部门备案。

The process for preparing traditional Chinese medicines into ready-to-use forms must conform to the national pharmaceutical standards, and in the absence of such standards, the process must conform to the processing standards stipulated by the supervisory and administrative departments of pharmaceuticals of the provinces, autonomous regions, or municipalities directly under the central government. The processing standards stipulated by the supervisory and administrative departments of pharmaceuticals of the provinces, autonomous regions, or municipalities directly under the central governments shall be placed on record at the pharmaceutical supervisory and administrative department under the State Council.

第十一条 生产药品所需的原料、辅料,必须符合药用要求。

Article 11 The raw and supplementary materials used for the production of pharmaceuticals must conform to the requirements for medicinal use.

第十二条 药品生产企业必须对其生产的药品进行质量检验;不符合国家药品标准或者不按照省、自治区、直辖市人民政府药品监督管理部门制定的中药饮片炮制规范炮制的,不得出厂。

Article 12 The pharmaceutical producing enterprises must conduct quality inspections on the pharmaceuticals they produce; products which do not meet national pharmaceutical standards or are not prepared in conformity with the processing standards stipulated by the pharmaceutical supervisory and administrative departments of the provinces, autonomous regions, or municipalities directly under the central government shall not leave the factory.

第十三条 经国务院药品监督管理部门或者国务院药品监督管理部门授权的省、自治区、直辖市人民政府药品监督管理部门批准,药品生产企业可以接受委托生产药品。

Article 13 Pharmaceutical producing enterprises can accept the authorization to produce pharmaceuticals after they obtain approval from the pharmaceutical supervisory and administrative department under the State Council or the pharmaceutical supervisory and administrative departments of the provinces, autonomous regions, or municipalities directly under the central government authorized by the supervisory and administrative department of pharmaceuticals under the State Council.

第三章 药品经营企业管理

Chapter III Administration of Pharmaceutical Trading Enterprises

第十四条 开办药品批发企业,须经企业所在地省、自治区、直辖市人民政府药品监督管理部门批准并发给《药品经营许可证》;

Article 14 The establishment of pharmaceutical wholesale enterprises must be sanctioned by the competent local authorities of the production and trade of pharmaceuticals of the provinces, autonomous regions or municipalities directly under the central government, which will issue a Pharmaceutical Trade License.

开办药品零售企业,须经企业所在地县级以上地方药品监督管理部门批准并发给《药品经营许可证》,凭《药品经营许可证》到工商行政管理部门办理登记注册。无《药品经营许可证》的,不得经营药品。

The establishment of pharmaceutical retail enterprises must be sanctioned by local authorities for the supervision and control of pharmaceuticals at or above the county level, which will issue a Pharmaceutical Trade License, on the basis of which registration at the industry and commerce administrative departments shall be conducted. Without the Pharmaceutical Trade License, any enterprises shall not engage in the trade of pharmaceuticals.

《药品经营许可证》应当标明有效期和经营范围,到期重新审查发证。

A Pharmaceutical Trade License shall bear a scope of trade and a period of validity, and upon expiration a new license shall be issued after examination for its renewal.

药品监督管理部门批准开办药品经营企业,除依据本法第十五条规定的条件外,还应当遵循合理布局和方便群众购药的原则。

The approval of the establishment of pharmaceutical trading enterprises by the pharmaceutical supervisory and administrative departments shall adhere to the principle of reasonable positioning and convenience for buying of pharmaceuticals, and in addition must conform to Article 15 of this Law.

第十五条 开办药品经营企业必须具备以下条件:

Article 15 To establish a pharmaceutical trading enterprise, the following requirements must be met

(一)具有依法经过资格认定的药学技术人员;

(1) 1 It shall be staffed with legally certified pharmaceutical technical personnel.

(二)具有与所经营药品相适应的营业场所、设备、仓储设施、卫生环境;

(2) It shall have business premises, equipment, storage facilities and a sanitary environment suitable for the pharmaceuticals in which it trades.

(三)具有与所经营药品相适应的质量管理机构或者人员;

(3) It shall have a quality control organ or personnel suitable for the pharmaceuticals in which it trades.

(四)具有保证所经营药品质量的规章制度。

(4) It shall have rules and regulations to ensure the quality of the pharmaceuticals in which it trades.

第十六条 药品经营企业必须按照国务院药品监督管理部门依据本法制定的《药品经营质量管理规范》经营药品。

Article 16 Pharmaceutical producing enterprises must trade in pharmaceuticals in accordance with the "Standards for Quality Control of Pharmaceutical Trading" stipulated by the pharmaceutical supervisory and administrative departments under the State Council on the basis of this Law.

药品监督管理部门按照规定对药品经营企业是否符合《药品经营质量管理规范》的要求进行认证;对认证合格的,发给认证证书。

Pharmaceutical supervisory and administrative departments shall certify whether pharmaceutical trading enterprises meet the requirements of the "Standards for Quality Control of Pharmaceutical Trading" in accordance with relevant regulations, and issue certifications to qualified enterprises.

《药品经营质量管理规范》的具体实施办法、实施步骤由国务院药品监督管理部门规定。

Detailed implementation measures and procedures for the "Standards for Quality Control of Pharmaceutical Trading" shall be stipulated by the pharmaceutical supervisory and administrative departments under the State Council.

第十七条 药品经营企业购进药品,必须建立并执行进货检查验收制度,验明药品合格证明和其他标识;不符合规定要求的,不得购进。

Article 17 Pharmaceutical trading enterprises must formulate and implement check and approval rules for the purchase of pharmaceuticals, and check pharmaceutical certifications and other marks while purchasing pharmaceuticals. Pharmaceuticals that do not meet the required standards must not be purchased.

第十八条 药品经营企业购销药品,必须有真实完整的购销记录。购销记录必须注明药品的通用名称、剂型、规格、批号、有效期、生产厂商、购(销)货单位、购(销)货数量、购销价格、购(销)货日期及国务院药品监督管理部门规定的其他内容。

Article 18 Pharmaceutical trading enterprises shall keep accurate and complete records of purchased pharmaceuticals. Purchasing records must bear information on the pharmaceutical product's generic names, types, specifications, batches, valid periods, producing enterprises, purchasing (selling) units, purchasing (selling) quantity, purchasing and selling price, purchasing (selling) date and other contents required by the pharmaceutical supervisory and administrative department under the State Council.

第十九条 药品经营企业销售药品必须准确无误,并正确说明用法、用量和注意事项;调配处方必须经过核对,对处方所列药品不得擅自更改或者代用。对有配伍禁忌或者超剂量的处方,应当拒绝调配;必要时,经处方医师更正或者重新签字,方可调配。

Article 19 It is imperative for pharmaceutical trading enterprises, in the sale of pharmaceuticals, to be accurate and free of mistakes, and to provide correct directions for use, dosage and precautions. Prescriptions being dispensed must be checked. Pharmaceutical products listed in the prescription must not be presumptuously changed or substituted. Prescriptions containing incompatible substances or excessive dosages shall be rejected by the dispensary. If necessary, such prescriptions can be dispensed after they have been corrected or re-signed by the doctors who wrote them.

药品经营企业销售中药材,必须标明产地。

When traditional Chinese medicinal materials are offered for sale by pharmaceutical trading enterprises, their origin must be indicated.

第二十条 药品经营企业必须制定和执行药品保管制度,采取必要的冷藏、防冻、防潮、防虫、防鼠等措施,保证药品质量。

Article 20 Rules for storage of pharmaceuticals shall be formulated and implemented by pharmaceutical trading enterprises, which must adopt necessary measures to facilitate cold storage and protection against freezing, moisture, insects and rodents to ensure pharmaceutical quality.

药品入库和出库必须执行检查制度。

An inspection system shall be carried out for pharmaceuticals entering or leaving a warehouse

第二十一条 城乡集市贸易市场可以出售中药材,国务院另有规定的除外。

Article 21 Unless otherwise stipulated by the State, traditional Chinese medicinal materials may be marketed at urban or rural fairs.

城乡集市贸易市场不得出售中药材以外的药品,但持有《药品经营许可证》的药品零售企业在规定的范围内可以在城乡集市贸易市场设点出售中药材以外的药品。具体办法由国务院规定。

Pharmaceuticals other than traditional Chinese medicinal materials may not be sold at urban or rural fairs, but those retail enterprises which have the Pharmaceutical Trade License may set up stalls at urban or rural fairs to sell pharmaceuticals other than traditional Chinese medicinal materials within prescribed areas. Detailed measures shall be stipulated by the State Council.

第四章 医疗机构的药剂管理

Chapter IV Administration of Pharmaceuticals at Medical Organizations

第二十二条 医疗机构必须配备依法经过资格认定的药学技术人员。非药学技术人员不得直接从事药剂技术工作。

Article 22 Medical organizations must be staffed with legally certified pharmaceutical technical personnel. Non-pharmaceutical technical personnel may not be directly engaged in the technical work of the pharmacy.

第二十三条 医疗机构配制制剂,须经所在地省、自治区、直辖市人民政府卫生行政部门审核同意,由省、自治区、直辖市人民政府药品监督管理部门批准,发给《医疗机构制剂许可证》。无《医疗机构制剂许可证》的,不得配制制剂。

Article 23 To make medicinal preparations, a medical organization must be examined and approved by the administrative departments of health of the provinces, autonomous regions, or municipalities directly under the central government where the organization is located , and approved and issued a Dispensing Permit for Medical Organizations by the pharmaceutical supervisory and administrative departments of the provinces, autonomous regions or municipalities directly under the central government. No medicinal preparations shall be made without a Dispensing Permit for Medical Organizations.

《医疗机构制剂许可证》应当标明有效期,到期重新审查发证。

The Dispensing Permit for Medical Organizations shall bear a period of validity, and upon expiration a new license shall be issued after examination for its renewal.

第二十四条 医疗机构配制制剂,必须具有能够保证制剂质量的设施、管理制度、检验仪器和卫生条件。

Article 24 Medical organizations that make medicinal preparations must have facilities, a m

第二十五条 医疗机构配制的制剂,应当是本单位临床需要而市场上没有供应的品种,并须经所在地省、自治区、直辖市人民政府药品监督管理部门批准后方可配制。

Article 25 The medicinal preparations made by medical organizations shall be of the kinds that supply the clinical needs of the units themselves but have not been supplied on the market, and must not be made until the approval of the pharmaceutical supervisory and administrative departments of the provinces, autonomous regions and municipalities directly under the central government where the units are located.

配制的制剂必须按照规定进行质量检验;合格的,凭医师处方在本医疗机构使用。特殊情况下,经国务院或者省、自治区、直辖市人民政府的药品监督管理部门批准,医疗机构配制的制剂可以在指定的医疗机构之间调剂使用。

The quality of the medicinal preparations made by medical organizations must be inspected in accordance with relevant regulations. Those preparations conforming to standard can be used as the doctor prescribes. Under special circumstances, with approval from the pharmaceutical supervisory and administrative departments of the central government or of the provinces, autonomous regions and municipalities directly under the central government, the medicinal preparations made by medical organizations can be shared among appointed medical organizations.

医疗机构配制的制剂,不得在市场销售。

Medicinal preparations made by medical organizations may not be sold on the market.

第二十六条 医疗机构购进药品,必须建立并执行进货检查验收制度,验明药品合格证明和其他标识;不符合规定要求的,不得购进和使用。

Article 26 When purchasing pharmaceuticals, medical organizations must formulate and implement a system of quality inspection and check the certificates and other marks of pharmaceuticals. Those pharmaceuticals that do not meet the requirements of relevant regulations shall not be purchased and used.

第二十七条 医疗机构的药剂人员调配处方,必须经过核对,对处方所列药品不得擅自更改或者代用。对有配伍禁忌或者超剂量的处方,应当拒绝调配;必要时,经处方医师更正或者重新签字,方可调配。

Article 27 Prescriptions being dispensed by the dispensers of medical organizations must be checked. Pharmaceuticals listed in prescriptions must not be presumptuously changed or substituted. Prescriptions containing incompatible substances or excessive dosages shall be rejected by the dispensary. If necessary, such prescriptions can be dispensed after they have been corrected or re-signed by the doctors who wrote them.

第二十八条 医疗机构必须制定和执行药品保管制度,采取必要的冷藏、防冻、防潮、防虫、防鼠等措施,保证药品质量。

Article 28 Rules for storage of pharmaceuticals shall be formulated and implemented by medical organizations, which must adopt necessary measures to facilitate cold storage and protection against cold, moisture, insects and rodents to ensure the quality of pharmaceuticals.

第五章 药品管理

Chapter V Pharmaceutical Administration

第二十九条 研制新药,必须按照国务院药品监督管理部门的规定如实报送研制方法、质量指标、药理及毒理试验结果等有关资料和样品,经国务院药品监督管理部门批准后,方可进行临床试验。药物临床试验机构资格的认定办法,由国务院药品监督管理部门、国务院卫生行政部门共同制定。

Article 29 When producing a new medicine, it is necessary to submit information about the methods of production, quality indices, pharmacological and toxicological testing results, and other related materials and sales as required by the pharmaceutical supervisory and administrative department of the State Council, only after whose approval can clinical tests be carried out. Certifying measures for clinical test units shall be jointly formulated by the pharmaceutical supervisory and administrative department under the State Council and the administrative department of health under the State Council.

完成临床试验并通过审批的新药,由国务院药品监督管理部门批准,发给新药证书。

A new medicine which has completed its clinical tests and been approved after appraisal shall be issued a certificate of new medicine by the pharmaceutical supervisory and administrative department under the State Council.

第三十条 药物的非临床安全性评价研究机构和临床试验机构必须分别执行药物非临床研究质量管理规范、药物临床试验质量管理规范。

Article 30 The pharmaceutical non-clinical safety appraisal and research units and the clinical test units must respectively carry out the quality control standard for pharmaceutical non-clinical research and the quality control standard for pharmaceutical clinical test.

药物非临床研究质量管理规范、药物临床试验质量管理规范由国务院确定的部门制定。

The quality control standard for pharmaceutical non-clinical research and the quality control standard for pharmaceutical clinical test shall be formulated by the department appointed by the State Council.

第三十一条 生产新药或者已有国家标准的药品的,须经国务院药品监督管理部门批准,并发给药品批准文号;但是,生产没有实施批准文号管理的中药材和中药饮片除外。

Article 31 A new medicine or medicine standardized by the State can be put into production only after the pharmaceutical supervisory and administrative department under the State Council has approved it and issued a registered document of approval. However, this does not apply to the production of traditional Chinese medicinal herbs and traditional Chinese medicine prepared in ready-to-use forms that are not controlled under a registered document of approval.

实施批准文号管理的中药材、中药饮片品种目录由国务院药品监督管理部门会同国务院中医药管理部门制定。

For those traditional Chinese medicinal herbs and traditional Chinese medicines prepared in ready-to-use forms that are controlled with registered document of approval, the pharmaceutical supervisory and administrative department under the State Council and the administrative department of traditional Chinese medicines under the State Council shall jointly formulate their type catalogue.

药品生产企业在取得药品批准文号后,方可生产该药品。

Pharmaceutical producing enterprises can produce medicine only after obtaining the registered document of approval.

第三十二条 药品必须符合国家药品标准。中药饮片依照本法第十条第二款的规定执行。

Article 32 Pharmaceuticals must meet the pharmaceutical standards of the State. Article 10 (2) of this Law shall be applied to traditional Chinese medicines prepared in ready-to-use forms.

国务院药品监督管理部门颁布的《中华人民共和国药典》和药品标准为国家药品标准。

The "Pharmacopoeia of the People's Republic of China" and the pharmaceutical standards promulgated by the pharmaceutical supervisory and administrative department under the State Council shall be the State pharmaceutical standards.

国务院药品监督管理部门组织药典委员会,负责国家药品标准的制定和修订。

The Pharmacopoeia Committee organized by the pharmaceutical supervisory and administrative department under the State Council shall be responsible for the formulation and revision of the State pharmaceutical standards.

国务院药品监督管理部门的药品检验机构负责标定国家药品标准品、对照品。

The pharmaceutical inspection institutions of the pharmaceutical supervisory and administrative department under the State Council shall be responsible for the designation of State standard and contrastive pharmaceuticals.

第三十三条 国务院药品监督管理部门组织药学、医学和其他技术人员,对新药进行审评,对已经批准生产的药品进行再评价。

Article 33 The pharmaceutical supervisory and administrative department under the State Council may organize pharmaceutical, medicinal and other technological personnel to carry out examination and evaluation of new medicines, and to reevaluate medicines already placed into production.

第三十四条 药品生产企业、药品经营企业、医疗机构必须从具有药品生产、经营资格的企业购进药品;但是,购进没有实施批准文号管理的中药材除外。

Article 34 Pharmaceutical producing enterprises, pharmaceutical trading enterprises and medical organizations must purchase pharmaceuticals from the qualified enterprises with the certificates for production and trade of pharmaceuticals. However, this does not apply to the purchase of the traditional Chinese medicinal herbs which are not controlled under the registered document of approval.

第三十五条 国家对麻醉药品、精神药品、医疗用毒性药品、放射性药品,实行特殊管理。管理办法由国务院制定。

Article 35 For narcotics, psychotropic substances, toxic drugs for medicinal use, and radioactive drugs, the State Council shall formulate administrative measures to carry out special control.

第三十六条 国家实行中药品种保护制度。具体办法由国务院制定。

Article 36 The State Council shall formulate detailed measures to carry out a protection system for the categorization of traditional Chinese medicines.

第三十七条 国家对药品实行处方药与非处方药分类管理制度。具体办法由国务院制定。

Article 37 The State Council shall formulate detailed measures to carry out a classified control system for prescription pharmaceuticals and non-prescription pharmaceuticals.

第三十八条 禁止进口疗效不确、不良反应大或者其他原因危害人体健康的药品。

Article 38 Import of medicines whose curative effects are uncertain or poor, or which produce adverse reactions or have other harmful effects on people's health shall be prohibited.

第三十九条 药品进口,须经国务院药品监督管理部门组织审查,经审查确认符合质量标准、安全有效的,方可批准进口,并发给进口药品注册证书。

Article 39 The import of medicines must go through examinations organized by the pharmaceutical supervisory and administrative department under the State Council. Those confirmed to conform to quality standards to be safe and effective can be approved to be imported and shall be issued a registered certificate for import.

医疗单位临床急需或者个人自用进口的少量药品,按照国家有关规定办理进口手续。

Medicines to be imported in small quantities for urgent clinical needs by medical organizations or for personal use shall go through import formalities according to relevant regulations of the State.

第四十条 药品必须从允许药品进口的口岸进口,并由进口药品的企业向口岸所在地药品监督管理部门登记备案。海关凭药品监督管理部门出具的《进口药品通关单》放行。无《进口药品通关单》的,海关不得放行。

Article 40 Pharmaceuticals must be imported through the ports which allow the import of pharmaceuticals, and the pharmaceutical import enterprise shall submit a report to the pharmaceutical supervisory and administrative department of the place where the port is located. Customs shall rely on the Import Pharmaceuticals Customs Form issued by the pharmaceutical supervisory and administrative department to proceed. Those without the Import Pharmaceuticals Customs Form shall not be permitted to pass through customs.

口岸所在地药品监督管理部门应当通知药品检验机构按照国务院药品监督管理部门的规定对进口药品进行抽查检验,并依照本法第四十一条第二款的规定收取检验费。

The pharmaceutical supervisory and administrative department of the place where the port is located shall notify the pharmaceutical inspection institution to carry out selective examinations and inspections on the imported pharmaceuticals according to the regulations stipulated by the pharmaceutical supervisory and administrative department under the State Council, and to collect inspection fees according to Article 41(2) of this Law.

允许药品进口的口岸由国务院药品监督管理部门会同海关总署提出,报国务院批准。

The nomination of the ports allowable for import of pharmaceuticals shall be jointly conducted by the pharmaceutical supervisory and administrative department under the State Council and the Customs Headquarters, and be reported to the State Council for approval.

第四十一条 国务院药品监督管理部门对下列药品在销售前或者进口时,指定药品检验机构进行检验;检验不合格的,不得销售或者进口:

Article 41 The pharmaceutical supervisory and administrative department under the State Council shall appoint inspection institutions to carry out inspections before the sale and import of the following pharmaceuticals. Those having not passed the inspection shall not be allowed to be sold or imported.

(一)国务院药品监督管理部门规定的生物制品;

(1) Bio-products prescribed by the pharmaceutical supervisory and administrative department of the State Council.

(二)首次在中国销售的药品;

(2) Pharmaceuticals to be sold for the first time in China.

(三)国务院规定的其他药品。

(3) Other pharmaceuticals prescribed by the State Council.

前款所列药品的检验费项目和收费标准由国务院财政部门会同国务院价格主管部门核定并公告。

The inspection fee and charge standards for the above-mentioned pharmaceuticals shall be jointly checked, ratified and promulgated by the financial department under the State Council and the competent authority of price control under the State Council.

检验费收缴办法由国务院财政部门会同国务院药品监督管理部门制定。

The measures for the collection of inspection fees shall be jointly formulated by the financial department under the State Council and the pharmaceutical supervisory and administrative department under the State Council.

第四十二条 国务院药品监督管理部门对已经批准生产或者进口的药品,应当组织调查;对疗效不确、不良反应大或者其他原因危害人体健康的药品,应当撤销批准文号或者进口药品注册证书。

Article 42 The pharmaceutical supervisory and administrative department under the State Council shall organize investigations on medicines which have been approved for production or import. It shall revoke the registered documents of approval or the registered certificate of import if it discovers that the curative effects of the medicines are uncertain or poor, that they produce serious adverse reactions, or that for other reasons they are harmful to people's health.

已被撤销批准文号或者进口药品注册证书的药品,不得生产或者进口、销售和使用;已经生产或者进口的,由当地药品监督管理部门监督销毁或者处理。

The medicines whose registered documents of approval or registered certificate of import have been revoked shall not be allowed to be produced, imported, sold or used. Those which have already been produced or imported shall be destroyed or disposed of under the supervision of the local pharmaceutical supervisory and administrative departments.

第四十三条 国家实行药品储备制度。

Article 43 A pharmaceutical reserve system shall be carried out by the State.

国内发生重大灾情、疫情及其他突发事件时,国务院规定的部门可以紧急调用企业药品。

In case of serious disasters, plagues and other sudden emergencies, the department prescribed by the State Council can requisite the pharmaceuticals of enterprises to deal with such emergencies.

第四十四条 对国内供应不足的药品,国务院有权限制或者禁止出口。

Article 44 The State Council shall have the power to restrict or prohibit the export of the pharmaceuticals which are in short supply in the domestic market.

第四十五条 进口、出口麻醉药品和国家规定范围内的精神药品,必须持有国务院药品监督管理部门发给的《进口准许证》、《出口准许证》。

Article 45 Import or export licenses issued by the pharmaceutical supervisory and administrative department under the State Council are required for the import or export of narcotics and psychotropic substances falling within the restricted scope prescribed by the State.

第四十六条 新发现和从国外引种的药材,经国务院药品监督管理部门审核批准后,方可销售。

Article 46 Newly discovered domestic medicinal plants or medicinal plants introduced from abroad may be sold only after they have been examined and approved by the pharmaceutical supervisory and administrative department under the State Council.

第四十七条 地区性民间习用药材的管理办法,由国务院药品监督管理部门会同国务院中医药管理部门制定。

Article 47 Measures for controlling medicinal materials traditionally used by local people in certain regions shall be jointly formulated by the pharmaceutical supervisory and administrative department under the State Council and the administrative department of traditional Chinese medicines under the State Council.

第四十八条 禁止生产(包括配制,下同)、销售假药。有下列情形之一的,为假药:

Article 48 The production (including preparation, which also applies to the following) and sale of fake medicines are prohibited. A fake medicine has any one of the following characteristics:

(一)药品所含成份与国家药品标准规定的成份不符的;

(1) Its components are different from those prescribed by state pharmaceutical standards.

(二)以非药品冒充药品或以他种药品冒充此种药品的。

(2) A non-medical substance is passed off as a medicine, or one medicine is passed off as another.

有下列情形之一的药品,按假药论处:

A medicine shall be handled as fake medicine in any of the following cases:

(一)国务院药品监督管理部门规定禁止使用的;

(1) Where the use of the medicine has been prohibited by the pharmaceutical supervisory and administrative department under the State Council;

(二)依照本法必须批准而未经批准生产、进口,或者依照本法必须检验而未经检验即销售的;

(2) Where the medicine is produced and imported without an approval dictated according to this Law, or the medicine is sold without being inspected as dictated according to this Law;

(三)变质的;

(3) Where the medicine has deteriorated; or

(四)被污染的;

(4) Where the medicine has been contaminated;

(五)使用依照本法必须取得批准文号而未取得批准文号的原料药生产的;

(5) Where the medicine has been produced with pharmaceutical materials without obtaining the dictated registration document of approval for the materials.

(六)所标明的适应症或者功能主治超出规定范围的。

(6) Where the indications or the functions marked on the labels of the pharmaceuticals do not fall within the prescribed scope.

第四十九条 禁止生产、销售劣药。药品成份的含量不符合国家药品标准的,为劣药。

Article 49 It is prohibited to produce and sell medicines of inferior quality, referring to the medicines whose components do not conform in quantity to that required by State pharmaceutical standards.

有下列情形之一的药品,按劣药论处:

A medicine shall be handled as medicine of inferior quality in any of the following cases:

(一)未标明有效期或者更改有效期的;

(1) An expiry date is not indicated or is altered; or

(二)不注明或者更改生产批号的;

(2) A registration number is not indicated or is altered; or

(三)超过有效期的;

(3) The medicine has passed its expiration date; or

(四)直接接触药品的包装材料和容器未经批准的;

(4) The packages and containers which have direct contact with pharmaceuticals have not obtained approval; or

(五)擅自添加着色剂、防腐剂、香料、矫味剂及辅料的;

(5) The medicine has been added presumptuously with color or preservative additives, spice, disguising odor or supplementary materials; or

(六)其他不符合药品标准规定的。

(6) The medicine fails to meet the prescribed standards in other respects.

第五十条 列入国家药品标准的药品名称为药品通用名称。已经作为药品通用名称的,该名称不得作为药品商标使用。

Article 50 The names of the pharmaceuticals listed in the State pharmaceutical standards are the generic names of the pharmaceuticals. Those names that have become the generic names of pharmaceuticals shall not be used as trademarks of pharmaceuticals.

第五十一条 药品生产企业、药品经营企业和医疗机构直接接触药品的工作人员,必须每年进行健康检查。患有传染病或者其他可能污染药品的疾病的,不得从事直接接触药品的工作。

Article 51 Personnel in pharmaceutical producing or trading enterprises and in medical organizations who have direct contact with medicines must undergo an annual medical examination. Persons who have contracted contagious diseases or any other disease which may contaminate the medicine shall not be allowed to engage in any work which has direct contact with pharmaceuticals.

第六章 药品包装的管理

Chapter VI Administration on Pharmaceutical Packaging

第五十二条 直接接触药品的包装材料和容器,必须符合药用要求,符合保障人体健康、安全的标准,并由药品监督管理部门在审批药品时一并审批。

Article 52 The pharmaceutical packaging materials and containers which have direct contact with pharmaceuticals must meet the requirements of medicinal use, conform with the standards of protecting people's health and safety, and obtain the approval of the pharmaceutical supervisory and administrative departments at the same time as the approval of the pharmaceutical product.

药品生产企业不得使用未经批准的直接接触药品的包装材料和容器。

Pharmaceutical producing enterprises shall use the packaging materials and containers which have direct contact with the pharmaceuticals only after they have obtained approval for them.

对不合格的直接接触药品的包装材料和容器,由药品监督管理部门责令停止使用。

The pharmaceutical supervisory and administrative departments shall stop the use of those unqualified packaging materials and containers which have direct contact with the pharmaceuticals.

第五十三条 药品包装必须适合药品质量的要求,方便储存、运输和医疗使用。

Article 53 Packaging must meet the specific quality requirements of the pharmaceuticals and facilitate their storage, transportation and medical use.

发运中药材必须有包装。在每件包装上,必须注明品名、产地、日期、调出单位,并附有质量合格的标志。

Traditional Chinese medicinal materials must be packaged before transportation. There must appear on the package the name of the medicine, place of production, date, name of the consignor, and an indication showing that the quality of the medicine meets standards.

第五十四条 药品包装必须按照规定印有或者贴有标签并附有说明书。

Article 54 Packages of pharmaceuticals must be labeled and include directions for use in accordance with the regulations.

标签或者说明书上必须注明药品的通用名称、成份、规格、生产企业、批准文号、产品批号、生产日期、有效期、适应症或者功能主治、用法、用量、禁忌、不良反应和注意事项。

The label or directions must indicate the generic name of the medicine, components, specifications, the producer, registration number, batch number of the product, production date, expiry date, indications or major functions, directions for use, dosage, restrictions, adverse reactions and precautions.

麻醉药品、精神药品、医疗用毒性药品、放射性药品、外用药品和非处方药的标签,必须印有规定的标志。

Special indications must be printed as required on the labels of narcotics, psychotropic substances, toxic drugs for medical use, radioactive drugs, medicines for external use and non-prescriptive pharmaceuticals.

第七章 药品价格和广告的管理

Chapter VII Administration of the Prices and Advertising of Pharmaceuticals

第五十五条 依法实行政府定价、政府指导价的药品,政府价格主管部门应当依照《中华人民共和国价格法》规定的定价原则,依据社会平均成本、市场供求状况和社会承受能力合理制定和调整价格,做到质价相符,消除虚高价格,保护用药者的正当利益。

Article 55 For pharmaceuticals controlled by the fixed and directive pricing system of the government, the competent authority of pricing of the government shall fix and adjust the price with reason in conformity with the principles for fixing prices as prescribed by the Price Law of the PRC and according to the considerations of societal average costs, market supply and demand, and the level of societal tolerance to achieve accord between quality and price, to avoid excessive prices, and to safeguard the due interests of the users of the pharmaceuticals.

药品的生产企业、经营企业和医疗机构必须执行政府定价、政府指导价,不得以任何形式擅自提高价格。

Pharmaceutical producing enterprises, trading enterprises and medical organizations must carry out the fixed price and directive price system of the government, and shall not presumptuously raise prices in any form.

药品生产企业应当依法向政府价格主管部门如实提供药品的生产经营成本,不得拒报、虚报、瞒报。

Pharmaceutical producing enterprises shall provide the competent authority of pricing of the government with the producing and trading costs of pharmaceuticals and shall not refuse to report, make a false report or withhold the truth in such a report.

第五十六条 依法实行市场调节价的药品,药品的生产企业、经营企业和医疗机构应当按照公平、合理和诚实信用、质价相符的原则制定价格,为用药者提供价格合理的药品。

Article 56 For the pharmaceuticals whose prices are to be adjusted by the market, the pharmaceutical producing enterprises, trading enterprises, and medical organizations shall fix the price in conformity with the principles of fairness, rationality, honesty, good faith and accord between quality and price to provide the users of the pharmaceuticals with reasonable prices.

药品的生产企业、经营企业和医疗机构应当遵守国务院价格主管部门关于药价管理的规定,制定和标明药品零售价格,禁止暴利和损害用药者利益的价格欺诈行为。

Pharmaceutical producing enterprises, trading enterprises and medical organizations shall abide by the regulations concerning the control on prices of pharmaceuticals prescribed by the competent authority of pricing under the State Council, shall fix and mark the retail prices of pharmaceuticals, and shall avoid sudden excessive profits and deceptive acts on pricing which will harm the interests of the users of the pharmaceuticals.

第五十七条 药品的生产企业、经营企业、医疗机构应当依法向政府价格主管部门提供其药品的实际购销价格和购销数量等资料。

Article 57 Pharmaceutical producing enterprises, trading enterprises and medical organizations shall, in accordance with this Law, provide the competent authority of pricing of the government with information such as the actual purchasing and selling prices and quantities of the pharmaceuticals.

第五十八条 医疗机构应当向患者提供所用药品的价格清单;医疗保险定点医疗机构还应当按照规定的办法如实公布其常用药品的价格,加强合理用药的管理。具体办法由国务院卫生行政部门规定。

Article 58 Medical organizations shall provide the patient with the price list of the pharmaceuticals used. Medical organizations appointed by medical insurance shall faithfully promulgate the prices of frequently used pharmaceuticals according to prescribed measures to enhance the reasonable use of pharmaceuticals.

第五十九条 禁止药品的生产企业、经营企业和医疗机构在药品购销中帐外暗中给予、收受回扣或者其他利益。

Article 59 Pharmaceutical producing enterprises, trading enterprises and medical organizations are prohibited to give or receive secret commissions and other benefits during the purchasing and selling of pharmaceuticals.

禁止药品的生产企业、经营企业或者其代理人以任何名义给予使用其药品的医疗机构的负责人、药品采购人员、医师等有关人员以财物或者其他利益。禁止医疗机构的负责人、药品采购人员、医师等有关人员以任何名义收受药品的生产企业、经营企业或者其代理人给予的财物或者其他利益。

Pharmaceutical producing enterprises, trading enterprises or their representatives are prohibited to give any property or other benefits under any name to the principals, buyers of pharmaceuticals, physicians and other relevant persons in the medical organizations where their pharmaceuticals are used. The principals, buyers of pharmaceuticals, physicians and other relevant persons are prohibited from receiving any property or other benefits under any name from pharmaceutical producing enterprises, trading enterprises or their agents.

第六十条 药品广告须经企业所在地省、自治区、直辖市人民政府药品监督管理部门批准,并发给药品广告批准文号;

Article 60 Advertisements of pharmaceuticals must be approved and issued a registration number of advertisement by the pharmaceutical supervisory and administrative departments of the provinces, autonomous regions, or municipalities directly under the central government of the place where the enterprises are located.

未取得药品广告批准文号的,不得发布。

In the absence of such registration numbers, advertisements for any medicines may not be placed.

处方药可以在国务院卫生行政部门和国务院药品监督管理部门共同指定的医学、药学专业刊物上介绍,但不得在大众传播媒介发布广告或者以其他方式进行以公众为对象的广告宣传。

Prescription pharmaceuticals may be introduced in medicinal and pharmaceutical magazines jointly appointed by the administrative department of health under the State Council and the pharmaceutical supervisory and administrative department under the State Council, but shall not be advertised through mass media or publicized in any other form to the public.

第六十一条 药品广告的内容必须真实、合法,以国务院药品监督管理部门批准的说明书为准,不得含有虚假的内容。

Article 61 The contents of pharmaceutical advertisement must be true, legitimate, and be based on the directions for use approved by the pharmaceutical supervisory and administrative department under the State Council, and be also free of falsehood.

药品广告不得含有不科学的表示功效的断言或者保证;不得利用国家机关、医药科研单位、学术机构或者专家、学者、医师、患者的名义和形象作证明。

Advertisements of pharmaceuticals shall not contain any unscientific assertion or guarantee on effects, and shall not be endorsed using the names and images of government bodies, pharmaceutical scientific research units, academic organizations, experts, scholars, physicians and sufferers.

非药品广告不得有涉及药品的宣传。

The advertisements of non-pharmaceuticals shall not be involved in the publicizing of pharmaceuticals.

第六十二条 省、自治区、直辖市人民政府药品监督管理部门应当对其批准的药品广告进行检查,对于违反本法和《中华人民共和国广告法》的广告,应当向广告监督管理机关通报并提出处理建议,广告监督管理机关应当依法作出处理。

Article 62 The pharmaceutical supervisory and administrative departments of the provinces, autonomous regions and municipalities directly under the central government shall inspect on the pharmaceutical advertisements they approve, and shall notify and advise the administrative departments of advertising if the advertisements is not in conformity with this Law and the Advertisement Law of the PRC. The administrative departments of advertising shall deal with such advertisements according to relevant regulations.

第六十三条 药品价格和广告,本法未规定的,适用《中华人民共和国价格法》、《中华人民共和国广告法》的规定。

Article 63 In the absence of regulations as provided in this Law, the Price Law of the PRC and the Advertisement Law of the PRC shall be applied to the control of pharmaceutical prices and advertisements.

第八章 药品监督

Chapter VIII Supervision over Pharmaceuticals

第六十四条 药品监督管理部门有权按照法律、行政法规的规定对报经其审批的药品研制和药品的生产、经营以及医疗机构使用药品的事项进行监督检查,有关单位和个人不得拒绝和隐瞒。

Article 64 Pharmaceutical supervisory and administrative departments are authorized to conduct, in accordance with laws and administrative regulations, supervision and inspection over the research,development, production and trade of pharmaceuticals which they have approved, as well as the medical organizations' use of pharmaceuticals. The units and individuals concerned shall not refuse to comply.

药品监督管理部门进行监督检查时,必须出示证明文件,对监督检查中知悉的被检查人的技术秘密和业务秘密应当保密。

Pharmaceutical supervisory and administrative departments shall present certificate documents while conducting supervision and inspection, and shall not divulge technological and business.

第六十五条 药品监督管理部门根据监督检查的需要,可以对药品质量进行抽查检验。抽查检验应当按照规定抽样,并不得收取任何费用。所需费用按照国务院规定列支。

Article 65 According to the needs of supervision and inspection, pharmaceutical supervisory and administrative departments may conduct sampling examinations on the quality of pharmaceuticals. The sampling examinations shall be conducted according to relevant regulations and shall not be charged a fee. The expenses incurred shall be dispensed with in conformity with the regulations prescribed by the State Council.

药品监督管理部门对有证据证明可能危害人体健康的药品及其有关材料可以采取查封、扣押的行政强制措施,并在七日内作出行政处理决定;药品需要检验的,必须自检验报告书发出之日起十五日内作出行政处理决定。

Pharmaceutical supervisory and administrative departments may take administrative coercive measures including sequestration and banning against pharmaceuticals and other relevant materials which have been proven to be of possible harm to people's health; administrative measures must be taken within seven days. For pharmaceuticals which need to be inspected, decisions regarding administrative handling must be made within 15 days from the date of issue of the inspection reports.

第六十六条 国务院和省、自治区、直辖市人民政府的药品监督管理部门应当定期公告药品质量抽查检验的结果;公告不当的,必须在原公告范围内予以更正。

Article 66 The pharmaceutical supervisory and administrative departments under the State Council and of the provinces, autonomous regions and municipalities directly under the central government shall regularly promulgate the results of sampling examinations and inspections on the quality of pharmaceuticals, and shall, in the case of improperly published statements, amend such statements in the original published documents.

第六十七条 当事人对药品检验机构的检验结果有异议的,可以自收到药品检验结果之日起七日内向原药品检验机构或者上一级药品监督管理部门设置或者确定的药品检验机构申请复验,也可以直接向国务院药品监督管理部门设置或者确定的药品检验机构申请复验。受理复验的药品检验机构必须在国务院药品监督管理部门规定的时间内作出复验结论。

Article 67 If a party concerned disagrees with the inspection decision made by the inspection institutions, it may apply for re-inspection to the original inspection institutions or ones established or appointed by the pharmaceutical supervisory and administrative departments of superior levels within seven days from the date of receiving the pharmaceutical inspection decision, and may directly apply for re-inspection to the inspection institutions established or appointed by the pharmaceutical supervisory and administrative department under the State Council. The inspection institutions which have accepted the re-inspections shall conclude the re-inspections within the time limit prescribed by the pharmaceutical supervisory and administrative department under the State Council.

第六十八条 药品监督管理部门应当按照规定,依据《药品生产质量管理规范》、《药品经营质量管理规范》,对经其认证合格的药品生产企业、药品经营企业进行认证后的跟踪检查。

rticle 68 Pharmaceutical supervisory and administrative departments shall follow up on the inspections of the pharmaceutical producing enterprises or pharmaceutical trading enterprises which they have certified in conformity with the "Quality Control Standard of Pharmaceutical Production" and the "Quality Control Standard of Pharmaceutical Trade."

第六十九条 地方人民政府和药品监督管理部门不得以要求实施药品检验、审批等手段限制或者排斥非本地区药品生产企业依照本法规定生产的药品进入本地区。

Article 69 The local people's governments and pharmaceutical supervisory and administrative departments shall not restrict or exclude the entrance of pharmaceuticals produced according to this Law by pharmaceutical producing enterprises in other regions of the country through the excuse of conducting inspection , examination and approval of the pharmaceuticals.

第七十条 药品监督管理部门及其设置的药品检验机构和确定的专业从事药品检验的机构不得参与药品生产经营活动,不得以其名义推荐或者监制、监销药品。

Article 70 Pharmaceutical supervisory and administrative departments and the pharmaceutical inspection institutions they have established, as well as the institutions exclusively engaged in pharmaceutical inspection they have appointed, shall not participate in pharmaceutical production and trade, and shall not endorse or supervise the production and sale of pharmaceuticals in their own names.

药品监督管理部门及其设置的药品检验机构和确定的专业从事药品检验的机构的工作人员不得参与药品生产经营活动。

The functionaries of pharmaceutical supervisory and administrative departments, of the pharmaceutical inspection institutions they established, and of the institutions exclusively engaged in the inspection of pharmaceuticals they appointed, shall not participate in pharmaceutical production and trade.

第七十一条 国家实行药品不良反应报告制度。药品生产企业、药品经营企业和医疗机构必须经常考察本单位所生产、经营、使用的药品质量、疗效和反应。

Article 71 A reporting system over any adverse reactions of pharmaceuticals shall be practiced by Sstate. Pharmaceutical producing enterprises, pharmaceutical trading enterprises, and medical institutions shall conduct regular surveys on the quality, curative effects and adverse reactions of the pharmaceuticals they have produced, traded or used.

发现可能与用药有关的严重不良反应,必须及时向当地省、自治区、直辖市人民政府药品监督管理部门和卫生行政部门报告。具体办法由国务院药品监督管理部门会同国务院卫生行政部门制定。

When serious adverse reactions possibly related to the use of the pharmaceuticals are discovered, they must be promptly reported to the pharmaceutical supervisory and administrative departments and the administrative departments of health of the provinces, autonomous regions and municipalities directly under the central government. Detailed measures shall be formulated jointly by the pharmaceutical supervisory and administrative department under the State Council and the administrative department of health under the State Council.

对已确认发生严重不良反应的药品,国务院或者省、自治区、直辖市人民政府的药品监督管理部门可以采取停止生产、销售、使用的紧急控制措施,并应当在五日内组织鉴定,自鉴定结论作出之日起十五日内依法作出行政处理决定。

Regarding the pharmaceuticals which have been confirmed to cause serious adverse reactions, the pharmaceutical supervisory and administrative department under the State Council and of the provinces, autonomous regions and municipalities directly under the central government, shall take urgent control measures including the cessation of the production, sale, and use of the pharmaceuticals, shall organize appraisals within five days, and shall make decisions on their administrative handling within 15 days from the conclusion date of the appraisals.

第七十二条 药品生产企业、药品经营企业和医疗机构的药品检验机构或者人员,应当接受当地药品监督管理部门设置的药品检验机构的业务指导。

Article 72 The organs or personnel in charge of pharmaceutical inspection in pharmaceutical producing enterprises, pharmaceutical trading enterprises and medical organizations shall receive operational guidance from the pharmaceutical inspection institutions established by local pharmaceutical supervisory and administrative departments.

第九章 法律责任

CHAPTER IX Legal Responsibility

第七十三条 未取得《药品生产许可证》、《药品经营许可证》或者《医疗机构制剂许可证》生产药品、经营药品的,依法予以取缔,没收违法生产、销售的药品和违法所得,并处违法生产、销售的药品(包括已售出的和未售出的药品,下同)货值金额二倍以上五倍以下的罚款;构成犯罪的,依法追究刑事责任。

Article 73 Those who produce or trade in medicines without obtaining a Pharmaceutical Production License, Pharmaceutical Trade License, or Dispensing Permit of Medical Organizations, shall be placed under ban, have the unlawfully produced and sold medicines and any unlawful income confiscated, and may concurrently be fined a sum of money more than two but less than five times the value of the medicines unlawfully made or sold (including both sold and unsold pharmaceuticals, which also applies below). Those whose acts constitute a crime shall be investigated for criminal liabilities.

第七十四条 生产、销售假药的,没收违法生产、销售的药品和违法所得,并处违法生产、销售药品货值金额二倍以上五倍以下的罚款;有药品批准证明文件的予以撤销,并责令停产、停业整顿;情节严重的,吊销《药品生产许可证》、《药品经营许可证》或者《医疗机构制剂许可证》;构成犯罪的,依法追究刑事责任。

Article 74 Those who produce and sell fake medicines shall have his unlawfully produced or sold medicines and any unlawful income confiscated, and concurrently be fined a sum of money more than two but less than five times the value value of the medicines unlawfully produced and sold. Those who have an approval certificate of pharmaceuticals shall have the certificate revokeded, and be ordered to suspend production or business operations pending rectification; if the circumstances are serious, the party shall have Pharmaceutical Production License, or Pharmaceutical Trade License or Dispensing Permit of Medical Organizations revoked. Those whose acts constitute a

第七十五条 生产、销售劣药的,没收违法生产、销售的药品和违法所得,并处违法生产、销售药品货值金额一倍以上三倍以下的罚款;情节严重的,责令停产、停业整顿或者撤销药品批准证明文件、吊销《药品生产许可证》、《药品经营许可证》或者《医疗机构制剂许可证》;构成犯罪的,依法追究刑事责任。

Article 75 Those who produce and sell medicines of inferior quality shall have his unlawfully made and sold medicines and any unlawful income confiscated, and be concurrently fined the sum of money more than two but less than three times the value of the medicines unlawfully made or sold; if the circumstances are serious, the party shall be ordered to suspend production or business pending rectification, or have thepharmaceutical approval certificate revoked and his Pharmaceutical Production License, or Pharmaceutical Trade License or Dispensing Permit of Medical Organizations revoked. Those whose acts constitute a crime will be investigated for criminal liabilities.

第七十六条 从事生产、销售假药及生产、销售劣药情节严重的企业或者其他单位,其直接负责的主管人员和其他直接责任人员十年内不得从事药品生产、经营活动。

Article 76 The person-in-charge or personnel directly liable in the enterprise or other unit which produces and sells fake medicines or produces and sells pharmaceuticals of inferior quality shall not be permitted to engage in the production and trade of pharmaceuticals for ten years, if the circumstances are serious.

对生产者专门用于生产假药、劣药的原辅材料、包装材料、生产设备,予以没收。

The producers' supplementary materials, packaging materials and production equipment which are used exclusively for producing fake medicines and medicines of inferior quality shall be confiscated.

第七十七条 知道或者应当知道属于假劣药品而为其提供运输、保管、仓储等便利条件的,没收全部运输、保管、仓储的收入,并处违法收入百分之五十以上三倍以下的罚款;构成犯罪的,依法追究刑事责任。

Article 77 Those who provide facilities including transportation, preservation and storage that have been or should have been aware of the fakery or inferior quality of the pharmaceuticals, shall have the entirety of his income from such transportation, preservation and storage confiscated, and concurrently be fined a sum of money more than 50% but less than three times the value of the unlawful income. Those whose acts constitute a crime shall be investigated for criminal liabilities.

第七十八条 对假药、劣药的处罚通知,必须载明药品检验机构的质量检验结果;但是,本法第四十八条第三款第(一)、(二)、(五)、(六)项和第四十九条第三款规定的情形除外。

Article 78 The notice of penalties on fake medicines and medicines of inferior quality shall indicate the inspection results of the inspection institution. However, this does not apply to the circumstances prescribed by Article 48(3)(a)(b)(e)(f) and Article 49 (3) of this Law.

第七十九条 药品的生产企业、经营企业、药物非临床安全性评价研究机构、药物临床试验机构未按照规定实施《药品生产质量管理规范》、《药品经营质量管理规范》、药物非临床研究质量管理规范、药物临床试验质量管理规范的,给予警告,责令限期改正;逾期不改正的,责令停产、停业整顿,并处五千元以上二万元以下的罚款;情节严重的,吊销《药品生产许可证》、《药品经营许可证》和药物临床试验机构的资格。

Article 79 Pharmaceutical producing enterprises, trading enterprises, pharmaceutical non-clinical safety appraisal research institution, and pharmaceutical clinical testing institutions, shall be served a warning and be ordered to amend themselves within a prescribed time limit if they do not carry out the stipulations of the "Quality Control Standard of Pharmaceutical Production," the "Quality Control Standard of Pharmaceutical Trade," the quality control standard of pharmaceutical non-clinical research, and the quality control standard of pharmaceutical clinical testing. Those who do not rectify their mistakes within the prescribed time limit shall be ordered to suspend production and business operations pending rectification, and be concurrently fined more than 5000 but less than 20,000 RMB. If the circumstances are serious, they shall have their Pharmaceutical Production License, Pharmaceutical Trading License or Dispensing Permit of Medical Organizations revoked.

第八十条 药品的生产企业、经营企业或者医疗机构违反本法第三十四条的规定,从无《药品生产许可证》、《药品经营许可证》的企业购进药品的,责令改正,没收违法购进的药品,并处违法购进药品货值金额二倍以上五倍以下的罚款;有违法所得的,没收违法所得;情节严重的,吊销《药品生产许可证、《药品经营许可证》或者医疗机构执业许可证书。

Article 80 If any pharmaceutical producing enterprises, pharmaceutical trading enterprises or medical organizations violate Article 34 of this Law and purchase medicines from enterprises without the Pharmaceutical Production License or Pharmaceutical Trade License, they shall be ordered to amend themselves, have their unlawfully purchased medicines confiscated, and be concurrently fined the sum of money more than two but less than five times the value of the unlawfully purchased medicines. If they have obtained any unlawful income, the unlawful income shall be confiscated; if the circumstances are serious, their Pharmaceutical Production License, Pharmaceutical Trading License or Practicing Permit of Medical Organizations shall be revoked.

第八十一条 进口已获得药品进口注册证书的药品,未按照本法规定向允许药品进口的口岸所在地的药品监督管理部门登记备案的,给予警告,责令限期改正;逾期不改正的,撤销进口药品注册证书。

Article 81 Those who import pharmaceuticals with a pharmaceutical import registration document and fail to register according to this Law at the pharmaceutical supervisory and administrative department at the location of the port allowed for pharmaceutical import, shall be served a warning and be ordered to correct its mistakes within a prescribed time limit. Those who have not corrected its mistakes within the prescribed time limit shall have their registration document to import pharmaceuticals revoked.

第八十二条 伪造、变造、买卖、出租、出借许可证或者药品批准证明文件的,没收违法所得,并处违法所得一倍以上三倍以下的罚款;没有违法所得的,处二万元以上十万元以下的罚款;情节严重的,并吊销卖方、出租方、出借方的《药品生产许可证》、《药品经营许可证》、《医疗机构制剂许可证》或者撤销药品批准证明文件;构成犯罪的,依法追究刑事责任。

Article 82 Those who forge, alter, trade, lease or lend licenses or pharmaceutical approval certificates, shall have their unlawful income confiscated and be concurrently fined the sum of money more than two but less than three times the amount of the unlawful income. If the party has not obtained unlawful income yet, it will be fined more than 20,000 but less than 100,000 RMB; if the circumstances are serious, the Pharmaceutical Production License, Pharmaceutical trading License or Dispensing Permit of Medical Organizations of the seller, lessor or lender shall be revoked, or the pharmaceutical approval certificate shall be recalled. Those whose acts constitute a crime shall be investigated for criminal liabilities.

第八十三条 违反本法规定,提供虚假的证明、文件资料样品或者采取其他欺骗手段取得《药品生产许可证》、《药品经营许可证》、《医疗机构制剂许可证》或者药品批准证明文件的,吊销《药品生产许可证》、《药品经营许可证》、《医疗机构制剂许可证》或者撤销药品批准证明文件,五年内不受理其申请,并处一万元以上三万元以下的罚款。

Article 83 Those who violate this Law by providing false certificates or samples of documents, or obtaining the Pharmaceutical Production License, the Pharmaceutical Trading License, the Dispensing Permit of Medical Organizations or pharmaceutical approval certificates through cheating, shall have their Pharmaceutical Production License, Pharmaceutical Trade License, or Dispensing Permit of Medical Organizations revoked, have their pharmaceutical approval certificates revoked, have their application rejected for five years, and have a concurrent fine of more than 10,000 but less than 30,000 RMB be imposed upon them.

第八十四条 医疗机构将其配制的制剂在市场销售的,责令改正,没收违法销售的制剂,并处违法销售制剂货值金额一倍以上三倍以下的罚款;有违法所得的,没收违法所得。

Article 84 If a medical organization sells its preparations on the market, it shall be ordered to correct its mistakes, have its unlawfully sold preparations confiscated and concurrently be fined a sum of money more than two but less than three times the value of the unlawfully sold preparations. If it has obtained any unlawful income, the unlawful income shall be confiscated.

第八十五条 药品经营企业违反本法第十八条、第十九条规定的,责令改正,给予警告;情节严重的,吊销《药品经营许可证》。

Article 85 If a pharmaceutical trading enterprise violates Article 18 and Article 19 of this law, it shall be ordered to amend itself and be served a warning. If the circumstances are serious, its Pharmaceutical Trading License shall be revoked.

第八十六条 药品标识不符合本法第五十四条规定的,除依法应当按照假药、劣药论处的外,责令改正,给予警告;情节严重的,撤销该药品的批准证明文件。

Article 86 A medicine whose mark is not in conformity with Article 54 of this Law shall be handled as fake medicine or medicine of inferior quality. In addition, a correction shall be made and a warning shall be served. If the circumstances are serious, the approval certificate of this medicine shall be revoked.

第八十七条 药品检验机构出具虚假检验报告,构成犯罪的,依法追究刑事责任;不构成犯罪的,责令改正,给予警告,对单位并处三万元以上五万元以下的罚款;对直接负责的主管人员和其他直接责任人员依法给予降级、撤职、开除的处分,并处三万元以下的罚款;

Article 87 A pharmaceutical inspection institution which produces false inspection reports, where the circumstances are so serious as to constitute a crime, shall be investigated for criminal liabilities; if a crime is not constituted, it shall be ordered to amend and be served a warning. The institution shall be concurrently imposed a fine of more than 30,000 but less than 50,000 RMB, and the person-in-charge and other personnel directly liable shall be demoted, dismissed from their posts, or expelled according to law, and shall be concurrently be fined less than 30,000RMB.

有违法所得的,没收违法所得;情节严重的,撤销其检验资格。药品检验机构出具的检验结果不实,造成损失的,应当承担相应的赔偿责任。

If any unlawful income has been obtained, the unlawful income shall be confiscated. If the circumstances are serious, the inspection qualification certificate shall be revoked. If an inspection institution produces false inspection reports and causes serious consequences, it shall bear corresponding liabilities for compensation.

第八十八条 本法第七十三条至第八十七条规定的行政处罚,由县级以上药品监督管理部门按照国务院药品监督管理部门规定的职责分工决定;吊销《药品生产许可证》、《药品经营许可证、《医疗机构制剂许可证》、医疗机构执业许可证书或者撤销药品批准证明文件的,由原发证、批准的部门决定。

Article 88 The decision to impose administrative sanctions stipulated from Article 73 to Article 87 by this Law shall be made by the pharmaceutical supervisory and administrative departments at or above the county level in conformity with the division of functions prescribed by the pharmaceutical supervisory and administrative department under the State Council. The original issue and approval departments shall decide regarding the revocation of the Pharmaceutical Production License, the Pharmaceutical Trading License, the Dispensing Permit of Medical Organizations, the practicing permit of medical organizations, and the pharmaceutical approval certificates.

第八十九条 违反本法第五十五条、第五十六条、第五十七条关于药品价格管理的规定的,依照《中华人民共和国价格法》的规定处罚。

Article 89 Violations of Article 55, 56, 57 of this Law concerning the price control of pharmaceuticals shall be punished according to the Price Law of the People's Republic of China.

第九十条 药品的生产企业、经营企业、医疗机构在药品购销中暗中给予、收受回扣或者其他利益的,药品的生产企业、经营企业或者其代理人给予使用其药品的医疗机构的负责人、药品采购人员、医师等有关人员以财物或者其他利益的,由工商行政管理部门处一万元以上二十万元以下的罚款,有违法所得的,予以没收;

Article 90 If pharmaceutical producing enterprises, trading enterprises and medical organizations give or receive commissions or other interests in secret during the purchase or sale of pharmaceuticals; and if pharmaceutical producing enterprises, trading enterprises or their agents give any property or other interests to the directors, buyers, physicians and other relevant persons in the medical organizations where their medicines are used, a fine of more than 10,000 but less than 200,000 RMB shall be imposed and the unlawful income shall be confiscated by the government body of industry and commerce administration

情节严重的,由工商行政管理部门吊销药品生产企业、药品经营企业的营业执照,并通知药品监督管理部门,由药品监督管理部门吊销其《药品生产许可证》、《药品经营许可证》;构成犯罪的,依法追究刑事责任。

who, if the circumstances are serious, shall revoke the business licenses of the pharmaceutical producing enterprises and pharmaceutical trading enterprises, and shall notify the pharmaceutical supervisory and administrative departments which shall revoke the Pharmaceutical Production License and Pharmaceutical Trading License. If a crime is constituted, an investigation shall be made for criminal liabilities.

第九十一条 药品的生产企业、经营企业的负责人、采购人员等有关人员在药品购销中收受其他生产企业、经营企业或者其代理人给予的财物或者其他利益的,依法给予处分,没收违法所得;构成犯罪的,依法追究刑事责任。

Article 91 If directors or buyers of pharmaceutical producing enterprises or trading enterprises receive any property or other interests from other producing enterprises, trading enterprises or their agents during the purchase or sale of medicines, they shall be punished according to relevant regulations and shall have their unlawful income confiscated. If a crime is constituted, an investigation shall be made for criminal liabilities.

医疗机构的负责人、药品采购人员、医师等有关人员收受药品生产企业、药品经营企业或者其代理人给予的财物或者其他利益的,由卫生行政部门或者本单位给予处分,没收违法所得;对违法行为情节严重的执业医师,由卫生行政部门吊销其执业证书;构成犯罪的,依法追究刑事责任。

If the directors, buyers, physicians or other relevant persons in medical organizations receive any property or other interests from pharmaceutical producing enterprises, pharmaceutical trading enterprises or their agents, they shall be punished by the administrative departments of health or the work units where they work, and have their unlawful income confiscated. If practicing physicians seriously violate the law, his practice certificate shall be revoked by the administrative departments of health. If a crime is constituted, an investigation shall be made for criminal liabilities in conformity with relevant laws and regulations.

第九十二条 违反本法有关药品广告的管理规定的,依照《中华人民共和国广告法》的规定处罚,并由发给广告批准文号的药品监督管理部门撤销广告批准文号,一年内不受理该品种的广告审批申请;构成犯罪的,依法追究刑事责任。

Article 92 Those who act against the administrative regulations concerning pharmaceutical advertisement as provided in this Law shall be sanctioned in conformity with the Advertisement Law of the PRC, have its advertisement registration number revoked by the pharmaceutical supervisory and administrative departments from which the registration number has been issued, and its application for the approval of the advertisement regarding this variety of medicines shall not be accepted for one year. If a crime is constituted, an investigation of criminal liabilities shall be made in conformity with relevant laws and regulations.

药品监督管理部门对药品广告不依法履行审查职责,批准发布的广告有虚假或者其他违反法律、行政法规的内容的,对直接负责的主管人员和其他直接责任人员依法给予行政处分;构成犯罪的,依法追究刑事责任。

If a pharmaceutical supervisory or administrative department does not perform its duty of inspection on pharmaceutical advertisements which results in the publishing of advertisements containing falsehoods or other content against laws and administrative regulations, the directly liable person in charge and other responsible personnel shall be subject to administrative sanction. If their acts constitute a crime, they shall be investigated for criminal liabilities in conformity with relevant regulations.

第九十三条 药品的生产企业、经营企业、医疗机构违反本法规定,给药品使用者造成损害的,依法承担赔偿责任。

Article 93 If pharmaceutical producing enterprises, trading enterprises or medical organizations act against this law which results in damages to the users of pharmaceuticals, they shall bear liabilities of compensation in conformity with relevant regulations.

第九十四条 药品监督管理部门违反本法规定,有下列行为之一的,由其上级主管机关或者监察机关责令收回违法发给的证书、撤销药品批准证明文件,对直接负责的主管人员和其他直接责任人员依法给予行政处分;构成犯罪的,依法追究刑事责任:

Article 94 If a pharmaceutical supervisory and administrative department violates this law with one of the following acts, a competent authority of a higher level or a supervisory organization shall order it to withdraw the unlawfully issued certificates, revoke the pharmaceutical approval certificates, and render administrative sanctions against the directly liable person in charge and other responsible personnel. If their acts constitute a crime, they shall be investigated for criminal liabilities.

(一)对不符合《药品生产质量管理规范》、《药品经营质量管理规范》的企业发给符合有关规范的认证证书的,或者对取得认证证书的企业未按照规定履行跟踪检查的职责,对不符合认证条件的企业未依法责令其改正或者撤销其认证证书的;

(1) issue a certificate of qualification to an enterprise which does not meet the requirements of the "Quality Control Standard of Pharmaceutical Production" and the "Quality Control Standard of Pharmaceutical Trading," fail to conduct inspections according to relevant regulations on the enterprises which have already obtained certificates, or fail to order the unqualified enterprises to amend themselves or revoke their certificates according to relevant regulations; or

(二)对不符合法定条件的单位发给《药品生产许可证》、《药品经营许可证》或者《医疗机构制剂许可证》的;

(2) issue a Pharmaceutical Production License, a Pharmaceutical Trading License or a Dispensing Permit of Medical Organizations to a unit which does not meet legal requirements;

(三)对不符合进口条件的药品发给进口药品注册证书的;

(3) issue a registration certificate of import to a medicine which does not meet the requirements for import; or

(四)对不具备临床试验条件或者生产条件而批准进行临床试验、发给新药证书、发给药品批准文号的。

(4) approve a clinic test when the requirements for clinic tests are not met, or issue certificates of new medicines and pharmaceutical approval document numbers when requirements for production are not met.

第九十五条 药品监督管理部门或者其设置的药品检验机构或者其确定的专业从事药品检验的机构参与药品生产经营活动的,由其上级机关或者监察机关责令改正,有违法收入的予以没收;情节严重的,对直接负责的主管人员和其他直接责任人员依法给予行政处分。

Article 95 If a pharmaceutical supervisory and administrative department, or an inspection institution it has established, or an organization exclusively engaged in pharmaceutical inspection it has appointed, participates in the production and trade of pharmaceuticals, the responsible authority of a higher level or a supervisory organization shall order it to amend itself and have its unlawful income confiscated. If the circumstances are serious, the directly liable person in charge and other responsible personnel shall be subject to administrative sanctions.

药品监督管理部门或者其设置的药品检验机构或者其确定的专业从事药品检验的机构的工作人员参与药品生产经营活动的,依法给予行政处分。

If a staff member in a pharmaceutical supervisory and administrative department, or in an inspection institution it has established, or in an organization exclusively engaged in pharmaceutical inspection it has appointed, participates in the production and trade of pharmaceuticals, he or she shall be subject to administrative sanction.

第九十六条 药品监督管理部门或者其设置、确定的药品检验机构在药品监督检验中违法收取检验费用的,由政府有关部门责令退还,对直接负责的主管人员和其他直接责任人员依法给予行政处分。对违法收取检验费用情节严重的药品检验机构,撤销其检验资格。

Article 96 If a pharmaceutical supervisory and administrative department or a pharmaceutical inspection institution it has established or appointed unlawfully collects inspection fees during a pharmaceutical supervision and inspection, it shall be ordered by the government bodies concerned to make reimbursements, and the directly liable person and other responsible personnel shall be subject to administrative sanctions. If the circumstances are serious, the certificate of qualification of the inspection institution which has unlawfully collected inspection fees shall be revoked.

第九十七条 药品监督管理部门应当依法履行监督检查职责,监督已取得《药品生产许可证》、《药品经营许可证》的企业依照本法规定从事药品生产、经营活动。

Article 97 A pharmaceutical supervisory and administrative department shall perform its duty of supervision and inspection according to laws and regulations, and shall supervise the production and trade of the enterprises which have obtained a Pharmaceutical Production License or a Pharmaceutical Trade License according to the regulations of this Law.

已取得《药品生产许可证》、《药品经营许可证》的企业生产、销售假药、劣药的,除依法追究该企业的法律责任外,对有失职、渎职行为的药品监督管理部门直接负责的主管人员和其他直接责任人员依法给予行政处分;构成犯罪的,依法追究刑事责任。

If an enterprise which has obtained a Pharmaceutical Production License or a Pharmaceutical Trade License produces and sells fake medicines and medicines of inferior quality, the enterprise shall be investigated for legal liabilities according to laws and regulations. In addition, the directly liable person in charge and other responsible personnel in the pharmaceutical supervisory and administrative department who have neglected or have been derelict in their duty shall be subject to administrative sanction. If a crime is constituted, the party shall be investigated for criminal liabilities according to laws and regulations.

第九十八条 药品监督管理部门对下级药品监督管理部门违反本法的行政行为,责令限期改正;逾期不改正的,有权予以改变或者撤销。

Article 98 A pharmaceutical supervisory and administrative department shall, within a prescribed time limit, order a pharmaceutical supervisory and administrative department of a lower level to correct an administrative act which is not in conformity with this Law. If the administrative act is not corrected within the prescribed time limit, the department shall have the power to change or repeal it.

第九十九条 药品监督管理人员滥用职权、徇私舞弊、玩忽职守,构成犯罪的,依法追究刑事责任;尚不构成犯罪的,依法给予行政处分。

Article 99 If the personnel of the pharmaceutical supervision and administration misuse their authority, engage in irregular practices due to favoritism, or neglect their duties to such an extent that a crime is constituted, they shall be investigated for criminal liabilities. If their acts have not constituted a crime, they shall be subject to administrative sanctions.

第一百条 依照本法被吊销《药品生产许可证》、《药品经营许可证》的,由药品监督管理部门通知工商行政管理部门办理变更或者注销登记。

Article 100 If a Pharmaceutical Production License or a Pharmaceutical Trade License is revoked according to this Law, the pharmaceutical supervisory and administrative department shall notify the industry and commerce administrative department to alter or annul the registration.

第一百零一条 本章规定的货值金额以违法生产、销售药品的标价计算;没有标价的,按照同类药品的市场价格计算。

Article 101 The value of goods as prescribed in this chapter is designated according to the marked price of the unlawfully made or sold medicines. In the absence of a marked price, the value of goods shall be designated according to the market price of pharmaceuticals of the same kind.

第十章 附则

Chapter X Supplementary Provisions

第一百零二条 本法下列用语的含义是:

Article 102 For the purpose of this Law, the following definitions are offered:

药品,是指用于预防、治疗、诊断人的疾病,有目的地调节人的生理机能并规定有适应症或者功能主治、用法和用量的物质,包括中药材、中药饮片、中成药、化学原料药及其制剂、抗生素、生化药品、放射性药品、血清、疫苗、血液制品和诊断药品等。

" Pharmaceuticals " means the articles intended for use in the prevention, treatment or diagnosis of human diseases, or intended to effect the purposive regulation of human physiological functions, for which indications or major functions, usage and dosage are prescribed. They include raw traditional Chinese medicinal materials, traditional medicines prepared in ready-to-use forms, and other prepared Chinese medicines, medicinal chemicals and their preparations, antibiotics, biochemical medicines, radioactive drugs, serums, vaccines, blood products, diagnostic aids, etc.

辅料,是指生产药品和调配处方时所用的赋形剂和附加剂。

" Supplementary materials " means the excipients and additives used for the production and dispensing of pharmaceuticals.

药品生产企业,是指生产药品的专营企业或者兼营企业。

" Pharmaceutical producing enterprise " means an enterprise exclusively or partly engaged in the production of pharmaceuticals.

药品经营企业,是指经营药品的专营企业或者兼营企业。

" Pharmaceutical trading enterprise " means an enterprise exclusively or partly engaged in the trade of pharmaceuticals.

第一百零三条 中药材的种植、采集和饲养的管理办法,由国务院另行制定。

Article 103 Measures for the control of cultivation, collection and breeding of all categories of medicinal materials used in traditional Chinese medicine shall be seperately formulated by the State Council .

第一百零四条 国家对预防性生物制品的流通实行特殊管理。具体办法由国务院制定。

Article 104 The State Council shall formulate detailed measures to carry out special control on the circulation of preventive bioproducts.

第一百零五条 中国人民解放军执行本法的具体办法,由国务院、中央军事委员会依据本法制定。

Article 105 Detailed measures for the implementation of this law by the Chinese People's Army shall be formulated by the State Council and the Central Military Committee of the State on the basis of this Law.

第一百零六条 本法自2001年12月1日起施行。

Article 106 This Law shall enter into force as of December 1, 2001.

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