PRC Law on the Administration of Pharmaceuticals (2nd Revision)
中华人民共和国药品管理法 (第二次修正)
Pharmaceutical manufacturers and distributors no longer need a pharmaceutical licence before getting a business licence.
(Adopted at the 14th Session of the Standing Committee of the 12th National People's Congress on, and effective as of, April 24 2015.)
(第十二届全国人民代表大会常务委员会第十四次会议于二零一五年四月二十四日通过施行。)
中华人民共和国主席令 (十二届第27号)
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。
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》。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。
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》。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，发给认证证书。
《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
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。
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。
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。
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；
（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。
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。
第五十六条药品的生产企业、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。
第五十七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。
第五十八条 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。
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。
第五十九条 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。
第六十一条省、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。
第六十二条药品价格和广告，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
第六十三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。
第六十四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。
第六十五条国务院和省、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。
第六十六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。
第六十七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。
第六十八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。
第六十九条 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。
第七十一条药品生产企业、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
第七十二条未取得《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。
第七十三条生产、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。
第七十四条生产、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。
第七十五条从事生产、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。
第七十六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。
第七十七条对假药、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。
第七十八条药品的生产企业、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。
第七十九条药品的生产企业、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。
第八十一条伪造、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。
第八十二条违反本法规定，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。
第八十三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。
第八十四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》。
第八十五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。
第八十六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。
第八十七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。
第八十八条违反本法第五十五条、第五十六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。
第八十九条药品的生产企业、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。
第九十条 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。
第九十一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。
第九十二条药品的生产企业、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。
第九十三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。
第九十四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。
第九十五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。
第九十六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。
第九十七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。
第九十八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。
第九十九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。
第一百零一条中药材的种植、采集和饲养的管理办法，由国务院另行制定。
第一百零二条 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。
第一百零三条 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。
第一百零四条 本法自2001年12月1日起施行。
PRC President's Order (No.27 of the 12th NPC)
Part One: General Provisions
Article 1: This Law has been specially formulated in order to strengthen the supervision and administration of pharmaceuticals, ensure pharmaceutical quality and the safety of pharmaceuticals used by human beings and safeguard people's health and their lawful rights and interests with respect to the use of pharmaceuticals.
Article 2: Work units and individuals involved in the development, production, trading, use, supervision and administration of pharmaceuticals in the People's Republic of China must comply with this Law.
Article 3: The State develops modern and traditional medicines and fully exploits their function in the prevention and treatment of disease and in health care.
The State protects non-cultivated and non-domesticated medicinal resources and encourages the cultivation of traditional Chinese medicinal materials.
Article 4: The State encourages research and development of new pharmaceuticals and protects the lawful rights and interests of citizens and those of legal persons and other organizations in the research and development of new pharmaceuticals.
Article 5: The State Council's pharmaceutical regulatory department is charged with pharmaceutical supervision and administration nationwide. Relevant departments of the State Council are charged with pharmaceuticals related supervision and administration within the scopes of their respective duties.
The pharmaceutical regulatory departments of the people's governments of provinces, autonomous regions and municipalities directly under the central government are charged with pharmaceutical supervision and administration within their respective administrative areas. The relevant departments of the people's governments of provinces, autonomous regions and municipalities directly under the central government are charged with pharmaceuticals related supervision and administration within the scopes of their respective duties.
The State Council's pharmaceutical regulatory department shall cooperate with the State Council's department charged with the overall administration of the economy in implementing the pharmaceutical industry development plans and industrial policies formulated by the State.
Article 6: The pharmaceutical inspection institutes established or designated by pharmaceutical regulatory departments shall be responsible for carrying out the pharmaceutical inspections required for the examination and approval of pharmaceuticals and for the supervision and inspection of pharmaceutical quality.
Part Two: Administration Of Pharmaceutical Producers
Article 7: The establishment of a pharmaceutical producer shall be subject to the approval of the pharmaceutical regulatory department of the people's government of the province, autonomous region or municipality directly under the central government where the producer is located, which shall issue the producer a Pharmaceutical Production Licence upon approval. The production of pharmaceuticals may not be engaged in without a Pharmaceutical Production Licence.
A Pharmaceutical Production Licence shall specify the term thereof and the scope of production. At the expiration of the term thereof, the producer shall be reexamined and issued a new licence.
When approving the establishment of pharmaceutical producers, pharmaceutical regulatory departments shall, in addition to basing their approvals on the conditions stipulated in Article 8 hereof, comply with the pharmaceutical industry development plans and industrial policies formulated by the State, so as to avoid redundant establishment of producers.
Article 8: The following conditions must be met when establishing a pharmaceutical producer:
(1) having pharmaceutical and engineering technicians whose qualifications have been recognized in accordance with the law and workers with the appropriate technical skills;
(2) having the factory, facilities and hygienic environment appropriate to the pharmaceutical producer's pharmaceutical production;
(3) having an organization, the personnel, and the necessary instruments and equipment to carry out quality control for, and quality inspections on, the pharmaceuticals to be produced; and
(4) having rules and regulations that ensure pharmaceutical quality.
Article 9: Pharmaceutical producers must arrange production in accordance with the Control of Pharmaceutical Production Quality Standards to be formulated by the State Council's pharmaceutical regulatory department in accordance herewith. Pharmaceutical regulatory departments shall certify whether pharmaceutical producers comply with the requirements of the Control of Pharmaceutical Production Quality Standards. Those producers that pass certification shall be issued written proof of certification.
The specific implementing procedures and implementation stages for the Control of Pharmaceutical Production Quality Standards shall be stipulated by the State Council's pharmaceutical regulatory department.
Article 10: With the exception of the preparation of traditional Chinese medicines ready for decoction, pharmaceuticals must be produced in accordance with State pharmaceutical standards and the production processes approved by the State Council's pharmaceutical regulatory department. Production records must be complete and accurate. If a change to a pharmaceutical producer's production process affects pharmaceutical quality, it must report such change to its original approval department for examination and approval.
Traditional Chinese medicines ready for decoction must be prepared in accordance with State pharmaceutical standards. Those of such medicines on which State pharmaceutical standards are silent must be prepared in accordance with the preparation standards formulated by the pharmaceutical regulatory departments of the people's government of the provinces, autonomous regions and municipalities directly under the central government. The preparation standards formulated by the pharmaceutical regulatory departments of the people's governments of the provinces, autonomous regions and municipalities directly under the central government shall be submitted to the State Council's pharmaceutical regulatory department for its records.
Article 11: The raw materials and excipients required in the production of pharmaceuticals must comply with the requirements for use thereof in pharmaceuticals.
Article 12: Pharmaceutical producers must subject the pharmaceuticals that they produce to quality inspection. A pharmaceutical that does not meet State pharmaceutical standards or a traditional Chinese medicine ready for decoction not prepared in accordance with the standards for the preparation of traditional Chinese medicines ready for decoction formulated by the pharmaceutical regulatory department of the people's government of the province, autonomous region or municipality directly under the central government may not leave the factory.
Article 13: Subject to the approval of the State Council's pharmaceutical regulatory department or the pharmaceutical regulatory department of the people's government of the province, autonomous region or municipality directly under the central government authorized by the State Council's pharmaceutical regulatory department, a pharmaceutical producer may produce pharmaceuticals upon entrustment by others.
Part Three: Administration Of Pharmaceutical Traders
Article 14: The establishment of a pharmaceutical wholesaler shall be subject to the approval of the pharmaceutical regulatory department of the people51s government of the province, autonomous region or municipality directly under the central government where the wholesaler is located, which shall issue the wholesaler a Pharmaceutical Trading Licence upon approval. The establishment of a pharmaceutical retailer shall be subject to the approval of the local pharmaceutical regulatory department at or above the county level of the place where the retailer is located, which shall issue the retailer a Pharmaceutical Trading Licence upon approval. Pharmaceuticals may not be traded in without a Pharmaceutical Trading Licence.
A Pharmaceutical Trading Licence shall specify the term thereof and the scope of business. At the expiration of the term thereof, the pharmaceutical trader shall be re-examined and issued a new licence.
When approving the establishment of pharmaceutical traders, the pharmaceutical regulatory departments shall, in addition to basing their approvals on the conditions stipulated in Article 15 hereof, abide by the principles of rational geographic distribution and making the purchase of pharmaceuticals by the public convenient.
Article 15: The following conditions must be met when establishing a pharmaceutical trader:
(1) having pharmaceutical technicians whose qualifications have been recognized in accordance with the law;
(2) having a place of business, equipment, storage facilities and a hygienic environment appropriate to pharmaceutical trading;
(3) having a quality control organization or quality control personnel appropriate to pharmaceutical trading; and
(4) having rules and regulations ensuring the quality of the pharmaceuticals to be traded.
Article 16: Pharmaceutical traders must trade in pharmaceuticals in accordance with the Control of the Quality of Pharmaceutical Trading Standards to be formulated by the State Council's pharmaceutical regulatory department in accordance herewith. Pharmaceutical regulatory departments shall certify whether pharmaceutical traders comply with the requirements of the Control of the Quality of Pharmaceutical Trading Standards. Those enterprises that pass certification shall be issued written proof of certification.
The specific implementing procedures and implementation stages for the Control of the Quality of Pharmaceutical Trading Standards shall be stipulated by the State Council's pharmaceutical regulatory department.
Article 17: Pharmaceutical traders must establish and implement a system for the examination and acceptance of the pharmaceuticals that they purchase, the function of which system shall be to verify the pharmaceutical quality certificates and other marks. Pharmaceuticals that do not meet the specified requirements may not be purchased.
Article 18: When purchasing and selling pharmaceuticals, pharmaceutical traders must keep true and complete purchase and sale records. Purchase and sale records must indicate the pharmaceutical's generic name, dosage form, specifications, batch number, time of or until expiration, producer, purchasing (selling) work unit, quantity purchased (sold), purchase (sale) price, date of purchase (sale) and other particulars specified by the State Council's pharmaceutical regulatory department.
Article 19: The sale of a pharmaceutical by a pharmaceutical trader must be error free and accompanied by an accurate explanation of the directions for use, dosage and warnings. Compounded prescriptions must be checked and the pharmaceuticals specified on a prescription may not be changed or substituted without authorization. The compounding of prescriptions containing incompatibilities or overdoses shall be refused. If necessary, such a prescription may be compounded only after it has been corrected or signed anew by the issuing physician.
Pharmaceutical traders that sell traditional Chinese medicinal materials must indicate the places of origin thereof.
Article 20: A pharmaceutical trader must formulate and implement a system for the safe storage of pharmaceuticals, taking such necessary measures as refrigeration and precautions against freezing, moisture, insects, mice, etc. so as to ensure pharmaceutical quality.
Pharmaceuticals entering or leaving the warehouse must be subjected to a system of inspections.
Article 21: Traditional Chinese medicinal materials may be sold at urban and rural fairs and markets, unless otherwise stipulated by the State Council.
Pharmaceuticals other than traditional Chinese medicinal materials may not be sold at urban and rural fairs and markets. However, pharmaceutical retailers holding a Pharmaceutical Trading Licence may, within the stipulated scope, establish outlets in urban and rural fairs and markets to sell pharmaceuticals other than traditional Chinese medicinal materials. The specific procedures therefor will be formulated by the State Council.
Part Four: Administration Of Medicinal Preparations Of Medical Institutions
Article 22: Medical institutions must have pharmaceutical technicians whose qualifications have been recognized in accordance with the law. Non-pharmaceutical technicians may not directly engage in work involving pharmaceutical technology.
Article 23: The compounding of medicinal preparations by medical institutions shall be subject to the examination and agreement of the health administration department of the people's government of the province, autonomous region or municipality directly under the central government and the approval of the pharmaceutical regulatory department of the people's government of the province, autonomous region or municipality directly under the central government where it is located, after which the said pharmaceutical regulatory department shall issue the medical institution a Preparation Compounding Licence for a Medical Institution. Medicinal preparations may not be compounded without a Preparation Compounding Licence for a Medical Institution.
A Preparation Compounding Licence for a Medical Institution shall specify the term thereof. At the expiration of the term thereof, the medical institution shall be reexamined and issued a new licence.
Article 24: A medical institution that compounds medicinal preparations must have the facilities, management system, inspection instruments and hygienic conditions that can ensure the quality of the medicinal preparations.
Article 25: The medicinal preparations compounded by a medical institution must be products that the work unit needs for clinical reasons and that are not available on the market. Such medicinal preparations must be approved by the pharmaceutical regulatory department of the people's government of the province, autonomous region or municipality directly under the central government where the medical institution is located before they may be compounded. Compounded medicinal preparations shall be subjected to quality inspection in accordance with regulations. Those that are found to meet the standards shall be used in the medical institution on the strength of a physician's prescription. Under special circumstances, with the approval of the State Council's pharmaceutical regulatory department or the pharmaceutical regulatory department of the people's government of the province, autonomous region or municipality directly under the central government, medicinal preparations compounded by a medical institution may be used among designated medical institutions to make up for each other's needs.
Medicinal preparations compounded by medical institutions may not be sold on the market.
Article 26: Medical institutions must establish and implement a system for the examination and acceptance of the pharmaceuticals that they purchase, the function of which system shall be to verify the pharmaceutical quality certificates and other marks. Pharmaceuticals that do not meet the specified requirements may not be purchased or used.
Article 27: The prescriptions compounded by the pharmacy personnel of a medical institution must be checked and the pharmaceuticals specified on a prescription may not be changed or substituted without authorization. The compounding of prescriptions containing incompatibilities or overdoses shall be refused. If necessary, such a prescription may be compounded only after it has been corrected or signed anew by the issuing physician.
Article 28: A medical institution must formulate and implement a system for the safe storage of pharmaceuticals, taking such necessary measures as refrigeration and precautions against freezing, moisture, insects, mice, etc. so as to ensure pharmaceutical quality.
Part Five: Administration Of Pharmaceuticals
Article 29: When developing a new pharmaceutical, true relevant information such as the production method and quality norms for, and results of pharmacological and toxicological experiments on the pharmaceutical must be submitted, together with specimens thereof, in accordance with the regulations of the State Council's pharmaceutical regulatory department. Only after the approval of the foregoing by the State Council's pharmaceutical regulatory department may clinical trials be conducted. The procedures for recognizing the qualifications of institutions that conduct clinical trials of pharmaceuticals shall be jointly formulated by the State Council's pharmaceutical regulatory department and the State Council's health administration department.
A new pharmaceutical that has been examined and approved after the completion of clinical trials shall be approved, and a "new pharmaceutical certificate" issued in respect thereof, by the State Council's pharmaceutical regulatory department.
Article 30: Research institutes for the appraisal of the non-clinical safety of pharmaceuticals and clinical trial institutions must respectively implement the standards for the control of the quality of non-clinical research of pharmaceuticals and the standards for the control of the quality of clinical trials on pharmaceuticals.
Standards for the control of the quality of non-clinical research of pharmaceuticals and standards for the control of the quality of clinical trials on pharmaceuticals will be formulated by the department determined by the State Council.
Article 31: The production of new pharmaceuticals or of pharmaceuticals for which State standards already exist shall be subject to the approval of, and the issuance of a pharmaceutical approval number by, the State Council's pharmaceutical regulatory department. However, the production of those traditional Chinese medicinal materials and those traditional Chinese medicines ready for decoction that are not subject to the issuance of approval numbers shall be exempt from the foregoing provision. The catalogue of traditional Chinese medicinal materials and traditional Chinese medicines ready for decoction subject to the issuance of approval numbers shall be formulated by the State Council's pharmaceutical regulatory department in conjunction with the State Council's department for the administration of traditional Chinese medicines.
A pharmaceutical producer may only commence production of a pharmaceutical after obtaining a pharmaceutical approval number therefor.
Article 32: Pharmaceuticals must comply with State pharmaceutical standards. Traditional Chinese medicines ready for decoction shall be handled in accordance with Paragraph Two of Article 10 hereof.
The PRC, Pharmacopoeia and the pharmaceutical standards promulgated by the State Council's pharmaceutical regulatory department are the State pharmaceutical standards.
The State Council's pharmaceutical regulatory department shall organize a pharmacopoeia committee. Such committee shall be charged with the formulation and revision of State pharmaceutical standards.
The pharmaceutical inspection institute of the State Council's pharmaceutical regulatory department is charged with the definition of State pharmaceutical standard products and control products.
Article 33: The State Council's pharmaceutical regulatory department shall arrange to have pharmacological, medical and other technical personnel appraise new pharmaceuticals and reappraise pharmaceuticals that have been approved for production.
Article 34: With the exception of traditional Chinese medicinal materials not subject to the issuance of approval numbers, pharmaceutical producers, pharmaceutical traders and medical institutions must purchase pharmaceuticals from enterprises qualified to produce or trade in pharmaceuticals.
Article 35: The State subjects narcotics, psychotropic pharmaceuticals, toxic pharmaceuticals for medicinal purposes and radiopharmaceuticals to special administration. The procedures for the administration thereof will be formulated by the State Council.
Article 36: The State implements a system for the protection of traditional Chinese medicine varieties. The specific procedures therefor will be formulated by the State Council.
Article 37: The State implements systems for the separate administration of prescription medicines and over-the-counter medicines. The specific procedures therefor will be formulated by the State Council.
Article 38: The import of pharmaceuticals that have no clear curative effects, that cause strong adverse reactions or that otherwise harm human health is prohibited.
Article 39: The import of a pharmaceutical shall be subject to an examination arranged by the State Council's pharmaceutical regulatory department. A pharmaceutical may only be approved for import and an imported pharmaceutical registration certificate issued therefor after the examination confirms that it meets quality standards and that it is safe and effective.
The procedures for the import of small quantities of pharmaceuticals by a medical work unit for a clinical emergency or by an individual for personal use shall be handled in accordance with the relevant State regulations.
Article 40: Pharmaceuticals must be imported through a port through which the import of pharmaceuticals is permitted and the import shall be registered by the importer with the pharmaceutical regulatory department of the place where the port is located. Customs shall release the imported pharmaceuticals on the strength of the Customs Passage Form for Imported Pharmaceuticals issued by the pharmaceutical regulatory department. Customs may not release imported pharmaceuticals without a Customs Passage Form for Imported Pharmaceuticals.
The pharmaceutical regulatory department of the place where the port is located shall notify the pharmaceutical inspection institute to carry out a spot check of imported pharmaceuticals in accordance with the regulations of the State Council's pharmaceutical regulatory department, and charge an inspection fee therefor in accordance with Paragraph Two of Article 41 hereof.
Ports through which the import of pharmaceuticals is permitted shall be proposed by the State Council's pharmaceutical regulatory department in conjunction with the General Administration of Customs and reported to the State Council for approval.
Article 41: The State Council's pharmaceutical regulatory department shall designate a pharmaceutical inspection institute to inspect the pharmaceuticals set forth below before their sale or at the time of their import; those pharmaceuticals that fail inspection may not be sold or imported:
(1) biological products specified by the State Council's pharmaceutical regulatory department;
(2) pharmaceuticals to be sold in China for the first time;
(3) other pharmaceuticals specified by the State Council.
The inspection fee items and fee rates chargeable for the pharmaceuticals stipulated in the preceding paragraph will be set and announced by the State Council's financial department in conjunction with the State Council's department in charge of pricing. The procedures for the collection of inspection fees will be formulated by the State Council's financial department in conjunction with the State Council's pharmaceutical regulatory department.
Article 42: The State Council's pharmaceutical regulatory department shall arrange for surveys of pharmaceuticals that have already been approved for production or import. The approval number or imported pharmaceutical registration certificate of pharmaceuticals that have unclear curative effects, that cause strong adverse reactions or that otherwise harm human health shall be revoked.
A pharmaceutical whose approval number or imported pharmaceutical registration certificate has been revoked may not be produced, imported, sold or used. Those of such pharmaceuticals that have already been produced or imported shall be destroyed under the supervision or otherwise disposed of by the local pharmaceutical regulatory department.
Article 43: The State implements a pharmaceutical reserve system.
When a major disaster, epidemic or other sudden event occurs in the country, the departments specified by the State Council may requisition the pharmaceuticals of enterprises on an emergency basis.
Article 44: The State Council has the power to restrict or prohibit the export of pharmaceuticals that are in short supply in the country.
Article 45: An entity importing or exporting narcotics, or psychotropic pharmaceuticals falling within the scope specified by the State, must be in possession of an Import Permit or Export Permit issued by the State Council's pharmaceutical regulatory department.
Article 46: Medicinal materials that are newly discovered or are introduced from abroad may only be sold subject to the examination and approval of the State Council's pharmaceutical regulatory department.
Article 47: The procedures for the administration of medicinal materials commonly used by people in certain regions will be formulated by the State Council's pharmaceutical regulatory department in conjunction with the State Council's department for the administration of traditional Chinese medicines.
Article 48: The production (here and hereafter including the compounding) and sale of fake pharmaceuticals is prohibited.
A pharmaceutical shall be deemed a fake pharmaceutical if:
(1) the ingredients of the pharmaceutical do not conform with the ingredients specified in the State pharmaceutical standard; or
(2) it is a non-pharmaceutical product being passed off as a pharmaceutical or it is a pharmaceutical being passed off as another pharmaceutical.
A pharmaceutical shall be treated as a fake pharmaceutical if:
(1) the State Council's pharmaceutical regulatory department has prohibited the use thereof;
(2) this Law requires that approval be obtained for the production or import of the pharmaceutical but it is produced or sold without such approval, or this Law requires that the pharmaceutical be inspected but it is sold without having been inspected;
(3) it has turned;
(4) it has been contaminated;
(5) it was produced with pharmaceutical raw materials for which this Law requires an approval number, but no such approval number has been obtained; or
(6) the indication(s) or primary function(s) indicated on the pharmaceutical exceed/exceeds the stipulated scope of indications or primary functions.
Article 49: The production and sale of inferior pharmaceuticals are prohibited.
Pharmaceuticals the ingredient content of which does not conform with State pharmaceutical standards shall be deemed inferior pharmaceuticals.
A pharmaceutical shall be treated as an inferior pharmaceutical if:
(1) the time of or until expiration thereof is not indicated or has been altered;
(2) the batch number thereof is not indicated or has been altered;
(3) its expiration date has passed;
(4) the packaging materials or the container in direct contact with the pharmaceutical has not been approved;
(5) a colorant, preservative, flavouring, corrective or excipient has been added to it without authorization; or
(6) another circumstance not conforming with pharmaceutical standards exists.
Article 50: The name of a pharmaceutical as specified in the State pharmaceutical standards shall be the generic name of the pharmaceutical. A term that is already being used as the generic name of a pharmaceutical may not be used as a pharmaceutical trademark.
Article 51: The personnel of pharmaceutical producers, pharmaceutical traders and medical institutions who come into direct contact with pharmaceuticals must undergo an annual physical examination. Personnel who have contracted a contagious disease or another illness that could contaminate pharmaceuticals may not engage in work that involves direct contact with pharmaceuticals.
Part Six: Administration Of The Packaging Of Pharmaceuticals
Article 52: Packaging materials and containers that are in direct contact with pharmaceuticals must comply with the requirements for use with pharmaceuticals and the standards for ensuring human health and safety and shall be subject to examination and approval by the pharmaceutical regulatory department at the same time as the pharmaceuticals are approved and examined.
Pharmaceutical producers may not use unapproved packaging materials and containers that are in direct contact with pharmaceuticals.
The pharmaceutical regulatory department shall order a halt to the use of those packaging materials and containers in direct contact with pharmaceuticals that do not meet the standards.
Article 53: Pharmaceutical packaging must satisfy pharmaceutical quality requirements and must be convenient for storage, transport and medical use.
Traditional Chinese medicinal materials must be packaged prior to transportation. The product name, place of origin, date and the transferor must be indicated on the packaging and a mark indicating they meet quality standards affixed thereto.
Article 54: A label must be printed on or affixed to pharmaceutical packaging and directions for use included therewith in accordance with regulations.
The label or the directions must indicate the pharmaceutical's generic name, ingredients, specifications, producer, approval number, product batch number, production date, time of or until expiration, indication(s) or primary function(s), method of administration, dosage, contraindications, adverse reactions and warnings.
The prescribed mark must be printed on the labels of narcotics, psychotropic pharmaceuticals, toxic pharmaceuticals for medicinal purposes, radiopharmaceuticals, pharmaceuticals for external use and prescription medicines.
Part Seven: Administration Of Pharmaceutical Pricing And Advertising
Article 55: For pharmaceuticals lawfully subject to market-regulated pricing, pharmaceutical producers, pharmaceutical traders and medical institutions shall set prices in accordance with the principles of fairness, reasonableness, good faith and balance of quality and price, so as to provide pharmaceutical users with pharmaceuticals at a reasonable price.
Pharmaceutical producers, pharmaceutical traders and medical institutions shall abide by the regulations on the administration of pharmaceutical pricing of the State Council's department in charge of pricing when setting and marking the retail prices of pharmaceuticals. Price fraud that is carried out for the purpose of reaping windfall profits or that prejudices the interests of pharmaceutical users is prohibited.
Article 56: Pharmaceutical producers, pharmaceutical traders and medical institutions shall provide to the government's department in charge of pricing such information as the actual prices and quantities, etc. of the pharmaceuticals purchased and sold by them.
Article 57: A medical institution shall provide its patients with a price list of the pharmaceuticals they are using. Furthermore, medical institutions designated by a medical insurance scheme shall truthfully publish the prices of their frequently used pharmaceuticals and strengthen their administration of the reasonable use of pharmaceuticals in accordance with the stipulated procedures. The specific procedures therefor will be formulated by the State Council's health administration department.
Article 58: Pharmaceutical producers, pharmaceutical traders and medical institutions are prohibited from secretly giving or accepting rebates or other benefits off the books when selling or purchasing pharmaceuticals.
Pharmaceutical producers, pharmaceutical traders and their agents are prohibited from proffering property or other benefits under any guise to such relevant personnel of the medical institutions that use their pharmaceuticals as the persons in charge, pharmaceutical procurement personnel, physicians, etc. Such relevant personnel of medical institutions as the persons in charge, pharmaceutical procurement personnel, physicians, etc. are prohibited from accepting property or other benefits under any guise that are proffered by pharmaceutical producers, pharmaceutical traders or their agents.
Article 59: Advertising for a pharmaceutical shall be subject to the approval of the pharmaceutical regulatory department of the people's government of the province, autonomous region or municipality directly under the central government in which the enterprise is located and a pharmaceutical advertising approval number shall be issued therefor. Advertisements for which no pharmaceutical advertising approval number has been obtained may not be published.
Prescription pharmaceuticals may be introduced in specialized medical and pharmacological journals jointly designated by the State Council's health administration department and the State Council's pharmaceutical regulatory department. However, such pharmaceuticals may not be advertised in the mass media or otherwise advertised or publicized to the public.
Article 60: The content of pharmaceutical advertisements must be true and lawful and based on the directions for use approved by the State Council's pharmaceutical regulatory department. Such advertisements may not contain false claims.
Pharmaceutical advertisements may not contain unscientific assertions or guarantees of efficacy and may not use the name or image of a State authority, medical research work unit, academic institution, expert, scholar, physician or patient as proof.
Advertisements for non-pharmaceutical products may not contain publicity for pharmaceuticals.
Article 61: The pharmaceutical regulatory department of the people's government of a province, autonomous region or municipality directly under the central government shall inspect the pharmaceutical advertisements it has approved and shall inform the advertising regulatory department of advertisements that violate this Law or the PRC, Advertising Law and submit a proposal for the handling thereof. The advertising regulatory department shall handle the matter in accordance with the law.
Article 62: Where this Law is silent on the pricing and advertising of pharmaceuticals, the provisions of the PRC, Pricing Law and the PRC, Advertising Law shall govern.
Part Eight: Supervision Of Pharmaceuticals
Article 63: After a pharmaceutical regulatory department has examined and approved an application for pharmaceutical development, pharmaceutical production or trading, or a medical institution51s use of pharmaceuticals, it has the power to supervise and inspect the same in accordance with laws and administrative regulations. The relevant work units and individuals may not refuse to cooperate therewith or conceal information.
When a pharmaceutical regulatory department conducts supervision and inspections, it must present supporting documentation and must maintain the confidentiality of the technical secrets and business secrets of the subject learned while conducting the supervision or inspection.
Article 64: Depending on supervision or inspection requirements, the pharmaceutical regulatory departments may conduct spot checks of pharmaceutical quality. Specimens for spot checks shall be taken in accordance with regulations and no fee may be charged therefor. The expenses required therefor shall be listed as expense items in accordance with State Council regulations.
The pharmaceutical regulatory departments may take the administrative enforcement measures of placing under seal or impounding pharmaceuticals for which they have proof they may be harmful to human health, as well as the related materials; if they take such measures, they shall render a decision on their administrative handling of the matter within seven days. If the pharmaceutical requires inspection, the decision on the administrative handling of the matter must be rendered within 15 days from the date of issue of the inspection report.
Article 65: The State Council's pharmaceutical regulatory department and the pharmaceutical regulatory departments of the people's governments of the provinces, autonomous regions and municipalities directly under the central government shall regularly announce the results of spot checks of pharmaceutical quality. If an announcement contains an error, such error must be corrected within the scope of coverage of the original announcement.
Article 66: If a party concerned objects to the inspection result of the pharmaceutical inspection institute, it may apply for re-inspection to the original pharmaceutical inspection institute or a pharmaceutical inspection institute established or designated by the pharmaceutical regulatory department one level higher, or apply directly for a new inspection to a pharmaceutical inspection institute established or designated by the State Council's pharmaceutical regulatory department, within seven days of the date of receipt of the pharmaceutical inspection result. The pharmaceutical inspection institute handling the re-inspection must render its inspection conclusion within the time specified by the State Council's pharmaceutical regulatory department.
Article 67: A pharmaceutical inspection institute shall, in accordance with regulations and on the basis of the Control of Pharmaceutical Production Quality Standards and the Control of the Quality of Pharmaceutical Trading Standards, conduct post-certification follow-up inspections of the pharmaceutical producers and pharmaceutical traders that it has certified as qualified.
Article 68: Local people's governments and pharmaceutical regulatory departments may not use such means as requiring the conduct of pharmaceutical inspections, examination and approval, etc. to limit or bar the entry into their areas of pharmaceuticals produced in accordance herewith by pharmaceutical producers not located in their areas.
Article 69: Pharmaceutical regulatory departments, the pharmaceutical inspection institutes that they have established and the institutions professionally engaged in pharmaceutical inspections that they have designated may not participate in the production of, or trading in, pharmaceuticals, or use their own names to recommend pharmaceuticals or supervise the manufacture or sale of pharmaceuticals.
The personnel of pharmaceutical regulatory departments, the pharmaceutical inspection institutes that they have established and the institutions professionally engaged in pharmaceutical inspections that they have designated may not participate in the production of, or trading in, pharmaceuticals.
Article 70: The State implements a system for reporting adverse reactions caused by pharmaceuticals. Pharmaceutical producers, pharmaceutical traders and medical institutions must frequently inspect the quality and efficacy of, and the reactions from, the pharmaceuticals that they produce, trade in or use. If they discover serious adverse reactions possibly related to a pharmaceutical being used, they must report the same in a timely manner to the pharmaceutical regulatory department and the health administration department of the people's government of the province, autonomous region or municipality directly under the central government concerned. The specific procedures therefor shall be formulated by the State Council's pharmaceutical regulatory department in conjunction with the State Council's health administration department.
The State Council's pharmaceutical regulatory department or the pharmaceutical regulatory department of the people's government of a province, autonomous region or municipality directly under the central government may take the emergency control measure of halting the production, sale and use of a pharmaceutical that has been confirmed to cause serious adverse reactions and shall arrange for the expert evaluation of such pharmaceutical within five days. The said department shall render a decision on the administrative handling of the matter within 15 days of the date the expert conclusion is issued.
Article 71: The pharmaceutical inspection organizations or personnel of pharmaceutical producers, pharmaceutical traders and medical institutions shall be subject to the business guidance of the pharmaceutical inspection institute established by the local pharmaceutical regulatory department.
Part Nine: Legal Liability
Article 72: If pharmaceuticals are produced or traded in without a Pharmaceutical Production Licence, Pharmaceutical Trading Licence or Preparation Compounding Licence for a Medical Institution, such operation shall be closed down in accordance with the law, the pharmaceuticals illegally produced or sold and the illegal income derived therefrom confiscated and a fine of not less than twice and not more than five times the merchandise value of the illegally produced or sold pharmaceuticals (here and hereafter including both the pharmaceuticals that have been sold and those that have not) shall be imposed. If a criminal offence is constituted, the criminal liability of the perpetrator shall be pursued in accordance with the law.
Article 73: If fake pharmaceuticals are produced or sold, the pharmaceuticals illegally produced or sold and the illegal income derived therefrom shall be confiscated and a fine of not less than twice and not more than five times the merchandise value of the illegally produced or sold pharmaceuticals shall be imposed; if the perpetrator holds a pharmaceutical approval certificate therefor, such certificate shall be revoked and it shall be ordered to suspend production or business and undergo rectification. If the case is serious, the Pharmaceutical Production Licence, Pharmaceutical Trading Licence or Preparation Compounding Licence for a Medical Institution shall be revoked. If a criminal offence is constituted, the criminal liability of the perpetrator shall be pursued in accordance with the law.
Article 74: If inferior pharmaceuticals are produced or sold, the pharmaceuticals illegally produced or sold and the illegal income derived therefrom shall be confiscated and a fine of not less than once and not more than three times the merchandise value of the illegally produced or sold pharmaceuticals shall be imposed; if the case is serious, an order to suspend production or business and undergo rectification shall be issued or the pharmaceutical approval certificate and the Pharmaceutical Production Licence, Pharmaceutical Trading Licence or Preparation Compounding Licence for a Medical Institution shall be revoked. If a criminal offence is constituted, the criminal liability of the perpetrator shall be pursued in accordance with the law.
Article 75: The personnel directly in charge and other directly responsible personnel of an enterprise or other work unit, the circumstances of whose production or sale of fake or inferior pharmaceuticals are serious, shall not be permitted to engage in the production of, or trade in, pharmaceuticals for ten years.
The raw materials, excipients, packaging materials and production equipment exclusively used in the production of the fake or inferior pharmaceuticals by the producer shall be confiscated.
Article 76: If anyone provides such facilitating conditions as transportation, safekeeping or storage for what he knows or ought to know to be fake or inferior pharmaceuticals, all revenue derived from the transportation, safekeeping or storage thereof shall be confiscated and a fine of not less than 50% and not more than three times the illegal revenue shall be imposed. If a criminal offence is constituted, the criminal liability of the perpetrator shall be pursued in accordance with the law.
Article 77: The punishment notice for fake or inferior pharmaceuticals must indicate the quality inspection results issued by the pharmaceutical inspection institute, except in the circumstances specified in Items (1), (2), (5) and (6) of Paragraph Three of Article 48 and Paragraph Three of Article 49 hereof.
Article 78: If a pharmaceutical producer, pharmaceutical trader, research institute for the appraisal of the non-clinical safety of pharmaceuticals or clinical trial institution fails to implement the Control of Pharmaceutical Production Quality Standards, the Control of the Quality of Pharmaceutical Trading Standards, the standards for the control of the quality of non-clinical research of pharmaceuticals or the standards for the control of the quality of clinical trials on pharmaceuticals, it shall be warned, and ordered to correct the matter within a specified time limit; if it fails to correct the matter within the specified time limit it shall be ordered to suspend production or business and undergo rectification and fined not less than Rmb5,000 and not more than Rmb20,000. If the case is serious, its Pharmaceutical Production Licence, Pharmaceutical Trading Licence or qualifications as an institution for conducting clinical trials of pharmaceuticals shall be revoked.
Article 79: If a pharmaceutical producer, pharmaceutical trader or medical institution violates Article 34 hereof by purchasing pharmaceuticals from an enterprise that does not have a Pharmaceutical Production Licence or Pharmaceutical Trading Licence, it shall be ordered to correct the matter, its illegally purchased pharmaceuticals shall be confiscated and it shall be fined the equivalent of not less than twice and not more than five times the merchandise value of the illegally purchased pharmaceuticals. If there is illegal income, such illegal income shall be confiscated. If the case is serious, its Pharmaceutical Production Licence, Pharmaceutical Trading Licence or medical institution practice licence shall be revoked.
Article 80: If the importer of a pharmaceutical for which an imported pharmaceutical registration certificate has been obtained fails to register the import with the pharmaceutical regulatory department of the place where the port through which the import of pharmaceuticals is permitted is located in accordance with this Law, it shall be warned and ordered to correct the matter within a specified time limit; if it fails to correct the matter within the specified time limit, its imported pharmaceutical registration certificate shall be revoked.
Article 81: If a licence or a pharmaceutical approval certificate is forged, altered, bought, sold, leased out or lent, the illegal income derived therefrom shall be confiscated and a fine of not less than once and not more than three times the illegal income shall be imposed; if there is no illegal income, a fine of not less than Rmb20,000 and not more than Rmb100,000 shall be imposed. If the case is serious, the seller's, lessor's or lender's Pharmaceutical Production Licence, Pharmaceutical Trading Licence, Preparation Compounding Licence for a Medical Institution or pharmaceutical approval certificate shall be revoked as well. If a criminal offence is constituted, the criminal liability of the perpetrator shall be pursued in accordance with the law.
Article 82: If the provisions hereof are violated by providing false certificates, documents, information or specimens or using other fraudulent means to obtain a Pharmaceutical Production Licence, Pharmaceutical Trading Licence, Preparation Compounding Licence for a Medical Institution or pharmaceutical approval certificate, the Pharmaceutical Production Licence, Pharmaceutical Trading Licence, Preparation Compounding Licence for a Medical Institution or pharmaceutical approval certificate shall be revoked, no application of the perpetrator shall be accepted for five years and a fine of not less than Rmb10,000 and not more than Rmb30,000 shall be imposed.
Article 83: If a medical institution puts on the market a medicinal preparation that it formulated, it shall be ordered to correct the matter, the illegally sold medicinal preparation shall be confiscated and it shall be fined not less than once and not more than three times the merchandise value of the illegally sold medicinal preparation. If there is illegal income, such illegal income shall be confiscated.
Article 84: If pharmaceutical trader violates Article 18 or 19 hereof, it shall be ordered to correct the matter and warned. If the case is serious, its Pharmaceutical Trading Licence shall be revoked.
Article 85: If a pharmaceutical label does not comply with Article 54 hereof, the perpetrator shall be ordered to rectify the matter and warned, in addition to the pharmaceuticals being treated as fake or inferior pharmaceuticals. If the case is serious, the approval certificate for the said pharmaceutical shall be revoked.
Article 86: If a pharmaceutical inspection institute issues a sham inspection report and such act constitutes a criminal offence, its criminal liability shall be pursued in accordance with the law. If no criminal offence is constituted, it shall be ordered to correct the matter and given a warning, and the work unit shall additionally be fined not less than Rmb30,000 and not more than Rmb50,000. The personnel directly in charge and other directly responsible personnel shall be demoted, relieved of their positions or dismissed and fined not more than Rmb30,000, in accordance with the law. If there is illegal income, such illegal income shall be confiscated. If the case is serious, the inspection qualifications of the institute shall be revoked. If losses arise due to the untruthfulness of the inspection results issued by a pharmaceutical inspection institute, the institute shall be liable for the corresponding damages.
Article 87: The administrative punishments specified in Articles 73 to 87 hereof shall be decided by pharmaceutical regulatory departments at and above the county level in accordance with the division of responsibilities stipulated by the State Council's pharmaceutical regulatory department. Decisions on the revocation of Pharmaceutical Production Licences, Pharmaceutical Trading Licences, Preparation Compounding Licences for a Medical Institution, medical institution practice licences and pharmaceutical approval certificates shall be rendered by the original issuing or approval department.
Article 88: Violations of the provisions of Article 55 or 56 hereof on the administration of pharmaceutical pricing shall be punished in accordance with the PRC Pricing Law.
Article 89: If a pharmaceutical producer, pharmaceutical trader or medical institution secretly gives or accepts rebates or other benefits when selling or purchasing pharmaceuticals, or if a pharmaceutical producer, pharmaceutical trader or an agent thereof proffers property or other benefits to such relevant personnel as the persons in charge, pharmaceutical procurement personnel, physicians, etc. of a medical institution that uses its pharmaceuticals, it shall be fined not less than Rmb10,000 and not more than Rmb200,000 by the administration for industry and commerce; if there is illegal income, such illegal income shall be confiscated. If the case is serious, the administration for industry and commerce shall revoke the business licence of the pharmaceutical producer or pharmaceutical trader and notify the pharmaceutical regulatory department, which shall revoke the producer's or trader's Pharmaceutical Production Licence or Pharmaceutical Trading Licence. If a criminal offence is constituted, its criminal liability shall be pursued in accordance with the law.
Article 90: If such relevant personnel of a pharmaceutical producer or pharmaceutical trader as the persons in charge, the pharmaceutical procurement personnel, etc. accept property or other benefits proffered by another pharmaceutical producer, pharmaceutical trader or an agent thereof when selling or purchasing pharmaceuticals, they shall be disciplined and their illegal income confiscated in accordance with the law. If a criminal offence is constituted, their criminal liability shall be pursued in accordance with the law.
If such relevant personnel of a medical institution as the persons in charge, pharmaceutical procurement personnel, physicians, etc. accept property or other benefits proffered by a pharmaceutical producer, pharmaceutical trader or an agent thereof, they shall be disciplined by the health administration department or their work unit and their illegal income shall be confiscated. If the circumstances of an illegal act committed by a practising physician are serious, his licence to practise shall be revoked by the health administration department. If a criminal offence is constituted, the criminal liability of the perpetrator(s) shall be pursued.
Article 91: If a provision concerning the administration of pharmaceutical advertising hereof is violated, punishment shall be imposed in accordance with the PRC, Advertising Law, the advertising approval number shall be revoked by the pharmaceutical regulatory department that issued such number and no applications for the examination and approval for the advertising of the product in question shall be accepted for a period of one year. If a criminal offence is constituted, the criminal liability of the perpetrator shall be pursued in accordance with the law.
If a pharmaceutical regulatory department fails to perform its duty of examining a pharmaceutical advertisement in accordance with the law and the advertisement it approved for publication contains falsehoods or other content that violates laws or administrative regulations, the personnel directly in charge and other personnel directly responsible shall be disciplined in accordance with the law. If a criminal offence is constituted, their criminal liability shall be pursued in accordance with the law.
Article 92: If a pharmaceutical producer, pharmaceutical trader or medical institution violates the provisions hereof causing loss to a pharmaceutical user, it shall be liable for compensation in accordance with the law.
Article 93: If a pharmaceutical regulatory department violates the provisions hereof by committing any of the acts set forth below, the higher authority in charge of it or the supervising authority at a higher level shall order it to recover the illegally issued certificate, or to revoke the pharmaceutical approval certificate, and subject the personnel directly in charge and other directly responsible personnel to administrative punishments; if a criminal offence is constituted, their criminal liability shall be pursued in accordance with the law:
(1) issuing an enterprise with proof of certification of its compliance with the Control of Pharmaceutical Production Quality Standards or Control of the Quality of Pharmaceutical Trading Standards when the enterprise does not meet such standards, or failing to perform its duty of subjecting enterprises that have obtained proof of certification to follow-up inspections in accordance with regulations, or failing to order enterprises that do not meet the conditions for certification to rectify the matter or to revoke their proof of certification in accordance with the law;
(2) issuing a Pharmaceutical Production Licence, Pharmaceutical Trading Licence or Preparation Compounding Licence for a Medical Institution to a work unit that does not meet the statutory conditions;
(3) issuing an imported pharmaceutical registration certificate for a pharmaceutical that does not meet the import conditions; or
(4) approving the conduct of clinical tests or issuing a new pharmaceutical certificate or pharmaceutical approval number to an entity that does not meet the clinical testing conditions or production conditions.
Article 94: If a pharmaceutical regulatory department or a pharmaceutical inspection institute that it has established or an institute professionally engaged in pharmaceutical inspections that it has designated participates in the production of, or trading in, pharmaceuticals, its superior authority or the supervisory authority at a higher level shall order it to correct the matter and if there is illegal income, such illegal income shall be confiscated. If the case is serious, the personnel directly in charge and other directly responsible personnel shall be subjected to administrative punishments in accordance with the law.
If personnel of a pharmaceutical regulatory department, or of a pharmaceutical inspection institute that it has established or of an institute professionally engaged in pharmaceutical inspections that it has designated participate in the production of, or trading in, pharmaceuticals, they shall be subjected to administrative punishments in accordance with the law.
Article 95: If a pharmaceutical regulatory department or a pharmaceutical inspection institute that it has established or designated illegally charges inspection fees when conducting inspections for supervisory purposes, the relevant government department shall order it to refund the fees and the personnel directly in charge and other directly responsible personnel shall be subjected to administrative punishments in accordance with the law. If the circumstances of the illegal charging of inspection fees by the department or institute are serious, its inspection qualifications shall be revoked.
Article 96: Pharmaceutical regulatory departments shall perform their supervision and inspection duties in accordance with the law and supervise enterprises that have obtained Pharmaceutical Production Licences or Pharmaceutical Trading Licences as to whether they engage in the production of, or trading in, pharmaceuticals in accordance herewith.
If an enterprise that has obtained a Pharmaceutical Production Licence or Pharmaceutical Trading Licence produces or sells fake or inferior pharmaceuticals, then, in addition to pursuing the legal liability of the said enterprise in accordance with the law, the personnel directly in charge and other directly responsible personnel of the pharmaceutical regulatory department who have been neglectful or derelict in their duties shall be subjected to administrative punishments in accordance with the law. If a criminal offence is constituted, their criminal liability shall be pursued in accordance with the law.
Article 97: A pharmaceutical regulatory department shall order a lower level pharmaceutical regulatory department that has carried out an administrative act in violation hereof to rectify the matter within a specified time limit. If it fails to do so within the specified time limit, the higher level department has the power to change or shut down the lower level department.
Article 98: If personnel of pharmaceutical regulatory departments abuse their authority, practise graft or are derelict in their duties and the same constitutes a criminal offence, their criminal liability shall be pursued in accordance with the law. If the same is not sufficient to constitute a criminal offence, they shall be subjected to administrative punishments in accordance with the law.
Article 99: The merchandise value stipulated in this Part shall be calculated according to the marked price of the illegally produced or sold pharmaceutical. If there is no marked price, the merchandise value shall be calculated according to the market price of similar pharmaceuticals.
Part Ten: Supplementary Provisions
Article 100: For the purposes of this Law, the following terms have the meanings set forth below:
The term "pharmaceutical" means a substance that is to be used to prevent, treat or diagnose human illnesses and to purposely regulate human physiological functions and that is required to have (an) indication(s) or primary function(s), method of administration and dosage, and includes traditional Chinese medicinal materials, traditional Chinese medicines ready for decoction, prepared traditional Chinese medicines, chemical raw materials for pharmaceuticals and medicinal preparations made therefrom, antibiotics, biochemical pharmaceuticals, radiopharmaceuticals, blood serum, vaccines, blood products and diagnostic pharmaceuticals, etc.
The term "excipients" means the vehicles and additives used in the production of pharmaceuticals and the compounding of prescriptions.
The term "pharmaceutical producer" means an enterprise that produces pharmaceuticals as its sole line of business or as a sideline.
The term "pharmaceutical trader" means an enterprise that trades in pharmaceuticals as its sole line of business or as a sideline.
Article 101: The procedures for the administration of the cultivation, gathering and raising of traditional Chinese medicinal materials will be formulated separately by the State Council.
Article 102: The State subjects the circulation of prophylactic biological products to special control. The specific procedures therefor will be formulated by the State Council.
Article 103: The specific procedures for the implementation hereof by the People's Liberation Army will be formulated by the State Council and the Central Military Commission on the basis hereof.
Article 104: This Law shall be effective as of December 1 2001.
clp reference:1740/15.04.24prc reference:中华人民共和国主席令 (十二届第27号)promulgated:2015-04-24effective:2015-04-24This premium content is reserved for
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