关于印发《医药行业统计制度》的通知
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关于印发《医药行业统计制度》的通知
关于印发《医药行业统计制度》的通知
工信厅消费[2008]41号
各省、自治区、直辖市、新疆生产建设兵团经委（经贸委、工业主管部门）：
为了进一步做好医药行业统计工作，我部组织修订了《医药行业统计制度》，并已经国家统计局批准，现印发你们，请认真贯彻执行。现就做好医药行业统计工作通知如下：
一、提高认识，强化医药统计职责
医药行业统计是医药行业管理的一项基础性工作。做好医药行业统计对于制定和组织实施医药行业规划、产业政策，应对突发事件，组织紧急生产和调用，及时掌握医药行业运行情况，以及加强行业运行监测分析和信息服务具有十分重要的意义。要强化医药统计职责，指定专人承担统计工作，创造必要的工作条件，确保医药行业统计工作顺利开展。要依靠相关医药协会，充分发挥其积极性、主动性，共同做好统计工作。
二、组织企业认真学习、严格执行医药行业统计制度
为保证医药行业统计工作的顺利开展，要组织企业认真学习、严格贯彻执行《医药行业统计制度》。任何企业不得拒报、漏报、瞒报、虚报、迟报统计数据，维护统计制度的严肃性；要加强对企业统计人员培训，提高人员素质，确保企业能按规定的时间和内容要求及时上报，确保统计数据的时效性和准确性；要积极推动企业通过中国医药统计网(www.yytj.org.cn)报送行业统计数据；同时加强对统计数据的催报与审核工作，不断提高统计工作质量。
三、及时发布信息，指导企业生产经营
要加强对统计数据的分析，把握行业运行的脉搏，充分发挥统计工作贴近企业、贴近市场、贴近实际的优势，及时发现苗头性、倾向性的问题，提出有针对性、预见性和可操作性的意见和建议。及时发布相关信息，提高信息服务水平，以此带动行业管理工作，指导企业生产和经营，促进医药行业健康发展。
在执行《医药行业统计制度》工作中，有什么问题和建议请及时与我们联系。
联系人：消费品工业司医药处李宏
联系电话：010-66017308,66016330(传真)
邮箱地址：lihong@miit.gov.cn
附 件：
1、医药统计报表制度（略）
2、《国家统计局关于同意执行医药行业统计制度的函》（略）
3、关于医药行业统计工作分工和统计范围的安排（略）
4、医药行业统计工业企业名录（略）
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汕头市环境噪声污染防治条例
汕头市环境噪声污染防治条例
（2008年12月22日汕头市第十二届人民代表大会常务委员会第十六次会议通过 2009年1月16日广东省第十一届人民代表大会常务委员会第八次会议批准）
第一章 总则
第一条 为防治环境噪声污染，保护和改善生活环境，保障人体健康，促进经济和社会可持续发展，根据《中华人民共和国环境噪声污染防治法》等法律、法规，结合本市实际，制定本条例。
第二条 本条例适用于本市行政区域内环境噪声污染的防治。
第三条 市、区（县）人民政府应当将环境噪声污染防治工作纳入环境保护规划，并采取有利于声环境保护的经济、技术政策和措施。根据国家声环境质量标准的规定，划定本行政区域内各类标准适用区，建设环境噪声达标区。
第四条 市、区（县）人民政府在制定城乡规划时，应当充分考虑建设项目和区域开发、改造所产生的噪声对周围生活环境的影响，统筹规划，合理安排功能区和建设布局，防止或者减轻环境噪声污染。
第五条 市、区（县）环境保护行政主管部门（以下简称环保部门）对本辖区内的环境噪声污染防治实施统一监督管理，根据职责对工业生产噪声、建筑施工噪声和社会生活噪声污染防治实施监督管理，督促、指导、协调其他依法行使环境噪声污染监督管理权的部门对噪声污染防治的监督管理工作。
公安机关根据职责对机动车噪声和社会生活噪声污染防治实施监督管理。
质量技术监督行政主管部门对工业产品、设备的标准中规定的噪声限值实施监督管理。
铁路、民航、海事、海洋与渔业行政主管部门根据各自职责分别对火车、航空器、船舶噪声污染防治实施监督管理。
交通、规划、建设行政主管部门根据各自职责，依法对环境噪声污染防治实施监督管理。
工商、文化等行政主管部门和镇人民政府及街道办事处，根据各自职责，依法协助环保部门对环境噪声污染防治进行监督管理。
第六条 任何单位和个人都有保护声环境的义务，并有权对造成环境噪声污染的单位和个人进行投诉、检举和控告。
环保部门和其他依法行使环境噪声监督管理权的部门、机构，应当设置环境噪声污染举报电话、电子邮箱，并向社会公布，及时受理投诉、检举和控告。
第二章 环境噪声污染防治的监督管理
第七条 环保部门应当会同有关部门编制环境噪声污染防治专项规划、拟定区域环境噪声标准适用区和噪声敏感建筑物集中区域划分方案，报本级人民政府批准实施，并抄报上一级环保部门备案。
第八条 环保部门应当组建本行政区域内的环境噪声监测网络，组织对环境噪声质量的常规监测和噪声污染源的监督监测，定期发布声环境质量报告。
第九条 环保部门应当会同有关部门逐步在市区主要交通要道、商业区和人口集中区域合理设置噪声自动监测和显示设施，加强环境噪声监控。
第十条 规划部门在确定城市建设布局时，应当根据国家声环境质量标准和民用建筑隔声设计规范，合理划定建筑物与城市道路、城市高架桥、公路、铁路等交通干线的防噪声距离，并提出相应的规划设计要求。
第十一条 新建、改建、扩建建设项目，建设单位应当依法进行环境影响评价，规定环境噪声污染的防治措施，并按规定报环保部门批准。建设项目的环境影响评价文件未经有审批权的环保部门批准的，建设单位不得开工建设。
第十二条 新建住宅区内不得规划建设可能产生环境噪声污染的餐饮、健身、娱乐和机动车维修等项目。
现有住宅改变为餐饮、健身、娱乐和机动车维修等商业经营性用房的，建设单位在报批环境影响评价文件之前，应当征得有利害关系的业主同意。
第十三条 建设项目需要配套的环境噪声污染防治设施必须与主体工程同时设计、同时施工、同时投产使用；防治设施没有建成或者没有达到国家规定要求的，不得投入生产或使用。
第十四条 向周围环境排放噪声污染的单位（含个体工商户，下同），应当依法申报登记和申领噪声排放许可证，并按噪声排放许可证的规定排放污染物。
第十五条 对排放噪声超过国家环境噪声排放标准的单位，由环保部门或者其他依法行使环境噪声污染防治监督管理权的部门责令限期整改。
对排放噪声不能稳定达标或者造成严重污染和扰民的单位应当限期治理，治理期间环保部门应当限制其生产或排放噪声。限期治理由市、区（县）人民政府按照法定权限决定。小型企业事业单位的限期治理由环保部门决定。
限期整改或者限期治理的单位必须按要求进行整改和治理，按期向环保部门或者其他依法行使环境噪声污染防治监督管理权的部门报送整改或治理进度；整改或治理完成后，必须经环保部门或者其他依法行使环境噪声污染防治监督管理权的部门验收。
第三章 工业噪声污染防治
第十六条 禁止在噪声敏感建筑物集中区域内和风景名胜区、自然保护区或者其他特别需要安静的区域内设立产生噪声污染的工业生产项目或者从事产生噪声污染的生产经营活动。对已设立产生噪声污染的工业生产项目，由市、区（县）人民政府或者环保部门按照法定权限作出决定，责令限期治理；对产生噪声污染的生产加工活动，由环保部门责令整改。
第十七条 产生环境噪声污染的工业企业，应当采取有效措施，减轻噪声对周围生活环境的影响。
工业企业向周围生活环境排放工业噪声的，应当符合国家规定的工业企业厂（场）界噪声标准。
第十八条 在工业生产中因使用固定的设备造成环境噪声污染的单位，必须向所在地环保部门申报拥有造成环境噪声污染的设备的种类、数量以及在正常作业条件下所发出的噪声值和防治环境噪声污染的设施情况，并提供防治噪声污染的技术资料。
造成环境噪声污染的设备的种类、数量、噪声值和防治设施有重大改变的，必须在改变的十五日前申报，并采取有效的防治措施。
第十九条 禁止生产、销售不符合国家、行业、地方噪声质量标准的工业产品。
生产和销售产生噪声的产品，其产品说明书和铭牌中应当如实载明产品使用时产生的噪声强度。
第二十条 在城市范围内从事工程爆破等生产活动确需排放偶发性强烈噪声的，必须事先向当地公安机关提出申请，经批准并由公安机关向社会公告四十八小时后，方可以进行。
第四章 建筑施工噪声污染防治
第二十一条 建筑施工单位排放建筑施工噪声，应当符合国家规定的建筑施工场界环境噪声排放标准。确因经济、技术条件所限，不能通过治理噪声源消除施工作业噪声污染的，必须采取有效措施，把噪声污染危害减少到最小程度，并与受其污染的单位和居民协商，达成协议，采取保护受害人权益的措施。
第二十二条 在城市市区内，建筑施工使用机械设备，可能产生环境噪声污染的，施工单位应当申领噪声排放许可证，并在开工十五日以前向环保部门申报以下情况：
（一）工程的项目名称；
（二）施工场所和期限；
（三）可能产生的环境噪声值以及所采用的防治措施。
建筑施工单位未取得噪声排放许可证的，建设行政主管部门不得发放工程项目施工许可证。
对排放建筑施工噪声超过国家规定标准或危害周围生活环境的，环保部门可以限制其作业时间。
第二十三条 在噪声敏感建筑物集中区域内，除抢修、抢险作业外，禁止在中午和夜间进行产生环境噪声污染的建筑施工作业。因浇灌混凝土不宜留施工缝的作业和为保证工程质量需要的冲孔、钻孔桩成型及其他特殊情况，确需在中午和夜间连续施工作业的，须由建设行政主管部门出具证明，报经原审批的环保部门批准并提前公告附近居民。
临近学校的建筑施工，施工单位应当采取隔离措施降低噪声污染。
第二十四条 在城市市区内建筑施工禁止使用锤击桩机和震动桩机。受地质、地形等条件限制确需使用的，应当制定防噪声方案，经环保部门批准并提前公告附近居民，其作业时间限制在七时至十二时，十四时至二十二时。
第二十五条 建筑施工单位和个人向环保部门提出连续施工作业和桩机使用申请的，环保部门应当在受理申请后三日内作出审批决定，并告知申请人。
第二十六条 在学生中考、高考期间和举办大型公务活动期间，环保部门可以规定禁止施工作业的区域和时间，并提前七日向社会公告。
第五章 交通运输噪声污染防治
第二十七条 新建、改建、扩建穿越噪声敏感建筑物集中区域的城市道路、城市高架桥、高速公路、铁路，或者在城市道路、城市高架桥、高速公路、铁路两侧建设噪声敏感建筑物，建设单位应当按照国家规定间隔一定距离，并采取设置声屏障等措施控制环境噪声污染。
第二十八条 在金平区、龙湖区、濠江区行政区域及澄海区、潮阳区、潮南区城区行驶的机动车辆禁鸣喇叭。在市区范围内未实行禁鸣的区域和南澳县县城行驶的机动车辆必须使用低音喇叭。
第二十九条 警车、消防车、工程抢险车、救护车等机动车辆在夜间执行紧急任务时，应使用回转式标志灯具，一般不使用警报器。
严禁不符合国家规定的机动车辆安装、使用警报器。
第三十条 公安机关交通管理部门应当根据城市市区区域声环境保护需要，划定并公布限制载重四吨以上汽车的通行路线，并在相应路段设置禁行标志。
拖拉机不得在法律、法规以及市、区（县）人民政府明令禁止通行的道路上行驶。对确需过境的，公安机关交通管理部门应当指定行驶路线、行驶时间。指定的行驶路线应当避开噪声敏感建筑物集中区域。
第三十一条 在车站（场）、铁路编组站、港口、码头、机场等区域指挥作业时使用广播喇叭的，应当控制音量，减轻噪声对周围环境的干扰。
禁止营运车站（场）和营运车辆使用广播喇叭招揽顾客。
第三十二条 铁路机车、机动船舶、民用航空器的环境噪声污染防治依照有关法律、法规规定执行。
第六章 社会生活噪声污染防治
第三十三条 营业性文化娱乐场所、体育场（馆）、集贸市场和临街门店的经营者应当采取有效措施，使场界噪声值不超过规定的环境噪声排放标准。
第三十四条 居民使用家用电器、机械设备、娱乐器材或进行娱乐及其他活动时，应当控制音量和采取有效措施降低噪声，不得对周围生活环境造成噪声污染。
已经安装使用的空调器室外机组等设备对相邻方造成环境噪声污染的，使用人应当采取措施消除噪声污染。
第三十五条 禁止中午和夜间在住宅区、居民集中区、文教区和疗养区从事产生环境噪声污染的室内外装修、家具加工、装卸货物等活动。
禁止中午和夜间在住宅区进行产生环境噪声的机动车维修作业。
第三十六条 设置在住宅区和居民集中区的餐饮、娱乐、健身、购物等经营性场所，经营者应当采取控制环境噪声的措施，避免干扰他人。
第三十七条 机关、社会团体、非生产经营活动的事业单位和其他组织在工作和其他活动中，应当控制音量，不得干扰他人。
第三十八条 在学校、机关、科研单位、住宅区和医院附近的街道、广场、公园等公共场所进行体育锻炼、娱乐、集会、促销等活动，应当控制音量，采取其他有效措施降低噪声，不得对周围环境造成噪声污染。
第三十九条 在住宅区设置停车场的，经营管理单位应当采取措施防止机动车噪声对周围居民的正常生活造成影响。
第四十条 机动车辆防盗报警装置应当规范安装、合理使用。机动车辆防盗报警装置一旦失控，机动车辆使用人应及时采取措施，防止噪声排放。
第七章 法律责任
第四十一条 违反本条例第十三条规定的，由批准该建设项目的环境影响评价文件的环保部门责令停止生产或者使用，并可以按下列规定处以罚款：
（一）建设项目中需要配套建设的环境噪声污染防治设施没有建成的，处以一万元以上五万元以下的罚款；
（二）环境噪声污染防治设施没有达到国家规定要求而投入生产或使用的，处以五千元以上二万元以下罚款。
第四十二条 违反本条例第十四条规定，不按噪声排放许可证的规定排放噪声的，由环保部门责令其限期改正，并可处以一万元以上五万元以下罚款；情节严重或者逾期不改正的，吊销其噪声排放许可证。
未取得噪声排放许可证或者被吊销噪声排放许可证后排放噪声的，由环保部门责令停止排放噪声，并处以五万元以上十万元以下罚款；造成严重环境噪声污染或逾期拒不停止排放噪声的，由环保部门报同级人民政府责令其停产停业。
第四十三条 违反本条例第十四条、第十八条、第二十二条第一款规定，拒报或谎报有关环境噪声排放申报登记事项的，由环保部门给予警告或者处以三百元以上三千元以下罚款。
第四十四条 违反本条例第十五条第二款、第十六条规定，对经限期治理逾期未完成治理任务的单位，除依照国家规定加收超标准排污费外，可以根据所造成的危害和损失处以一万元以上十万元以下罚款，或者责令其停业、搬迁、关闭。
前款规定的罚款由环保部门决定。责令停业、搬迁、关闭由作出限期治理决定的人民政府决定或者由作出限期治理决定的环保部门报请同级人民政府决定；责令中央、省直接管辖的单位停业、搬迁、关闭的，须报经国务院、省人民政府批准。
第四十五条 违反本条例第二十条规定，未经当地公安机关批准，进行产生偶发性强烈噪声活动的，由公安机关给予警告或者处以五百元以上五千元以下罚款。
第四十六条 违反本条例第二十二条第三款、第二十三条第一款、第二十四条、第二十六条规定，拒不执行限制施工作业时间的，环保部门可处以三千元以上一万元以下罚款。
第四十七条 违反本条例第二十八条规定，在禁鸣的区域鸣喇叭的，由当地公安机关给予警告或者处以一百元以上三百元以下罚款。
第四十八条 违反本条例第二十九条规定，擅自安装、使用警报器的，由公安机关责令拆除，并可处以一千元罚款。
第四十九条 违反本条例第三十三条规定，造成环境噪声污染的，环保部门可处以二百元以上一千元以下罚款。
第五十条 违反本条例第三十四条、第三十五条、第三十七条、第三十八条、第三十九条规定，造成环境噪声污染的，由公安机关给予警告；警告后不改正的，处以二百元以上五百元以下罚款。
第五十一条 违反本条例规定的行为，触犯其他法律、法规规定的，由有关部门依照其他法律、法规的规定处罚。
第五十二条 当事人对行政处罚决定不服的，可以依法申请复议或者提起诉讼。当事人逾期不申请行政复议，也不提起行政诉讼，又不履行行政处罚决定的，由作出行政处罚决定的行政机关申请人民法院强制执行。
第五十三条 受到环境噪声污染危害的单位和个人，有权要求加害人排除危害；造成损失的，依法赔偿损失。
排放环境噪声污染的单位缴纳超标准排污费或者被处以罚款，不免除其承担消除噪声危害及其他法律责任。
赔偿责任和赔偿金额的纠纷，可以根据当事人请求，由环保部门或者其他行使环境噪声监督管理权的部门调解处理；调解不成的，当事人可以向人民法院起诉。当事人也可以直接向人民法院起诉。
第五十四条 行政主管部门及其工作人员滥用职权、玩忽职守、徇私舞弊，有下列情形之一的，由其所在单位或者上级机关给予行政处分；构成犯罪的，依法追究刑事责任：
（一）接到投诉、检举、控告后不按规定处理或者移交处理的；
（二）对依法应当审批、审核、许可、验收的事项，故意刁难、拖延，不按规定的条件和程序办理的；
（三）不符合审批、审核、许可、验收条件的事项，擅自审批、许可、验收的；
（四）不按规定对产生环境噪声污染的建设项目、建筑施工作业、生产经营活动以及有关设施、设备实施监督管理的；
（五）泄露被检查者的技术秘密和商业秘密的；
（六）为未经噪声检测或超过噪声排放标准的机动车辆办理车辆行使证或通过年审的；
（七）处罚明显不当或违法实施处罚的；
（八）其他滥用职权、玩忽职守、徇私舞弊、索贿受贿、不履行监督管理职责的行为。
第八章 附则
第五十五条 本条例所称的“中午”指十二时至十四时；“夜间”指二十二时至翌晨七时。
第五十六条 本条例自2009年4月1日起施行。
Provisions for Supervision of Drug Distribution
Provisions for Supervision of Drug Distribution
(SFDA Decree No.26)
The Provisions for Supervision of Drug Distribution, adopted at the executive meeting of the State Food and Drug Administration on December 8, 2006, is hereby promulgated and shall go into effect as of May 1, 2007.
Shao Mingli
Commissioner of SFDA
January 31, 2007
Provisions for Supervision of Drug Distribution
Chapter I
Article 1 These Provisions are formulated for the purposes of strengthening drug supervision, regulating drug distribution order and ensuring drug quality in accordance with the Drug Administration Law of the People’s Republic of China (hereinafter referred to as Drug Administration Law), the Regulations for Implementation of the Drug Administration Law of the People’s Republic of China (hereinafter referred to as Regulations for Implementation of the Drug Administration Law) and the requirements of the relevant law and regulations.
Article 2 Any institutions or individuals engaged in the purchase, sales and supervision of drugs in the People’s Republic of China shall abide by the Provisions.
Article 3 Drug manufacturers, distributors and medical institutions shall be responsible for the quality of the drugs that they produce, distribute or use.
Drug manufacturers and distributors shall carry out reforms and innovations in the direction of pharmaceutical logistics provided that drug quality is assured.
Article 4 The drug regulatory departments encourage individuals and organizations to involve in the social supervision on drug distribution. Individuals or organizations have the right to report or accuse of any violation of the Provisions to the drug regulatory departments.
Chapter II Supervision on Drug Purchase and Sales by Manufacturers and Distributors
Article 5 Drug manufacturers or distributors shall be responsible for their drug purchases and sales, and liable for the purchases and sales activities of their sales staff or offices in the name of their enterprise.
Article 6 Drug manufacturers or distributors shall train their purchase and sales staff on drug related laws, regulations and professional knowledge, and establish training records including time, venue, content and trainees.
Article 7 Drug manufacturers or distributors shall strengthen the management of the sales staff and set up specific rules for their sales behaviors.
Article 8 Drug manufacturers or distributors shall not store or spot trade drugs on the premises not approved by the drug regulatory departments.
Article 9 Drug manufacturers shall sell drugs that they produce in the name of themselves, and shall not sell any drug that they produce for contract manufacturing or any drugs produced by others.
Article 10 Where a drug manufacturer or wholesaler sells drugs, it shall provide the following materials:
(1) Copies of the Drug Manufacturing Certificate or Drug Supply Certificate, stamped with the seal of the enterprise, and the business license;
(2) Copies of the approval documents for the drug to be sold, stamped with the seal of the enterprise ;
(3) For import drug sales, relevant proof documents should be provided in accordance with the related provisions of the State.
Where a drug manufacturer or wholesaler sends any of its sales staff to sell drugs, it shall, in addition to the materials prescribed in the previous paragraph of this Article, provide a copy of the authorization letter with the seal of the enterprise. The original authorization letter shall contain the authorized drugs, regions and time of validity for drug sales, indicate the identity card numbers of the sales staff, and be stamped with the enterprise seal and legal representative seal (or signature). The sales staff shall show the original authorization letter and identity card for the check by drug purchasers.
Article 11 Where a drug manufacturer or wholesaler sells drugs, it shall provide sales document indicating supplier’s name, drug name, manufacturer, batch number, quantity, price, etc.
Where a drug retailer sells drugs, it shall provide sales document indicating drug name, manufacturer, quantity, price, batch number, etc.
Article 12 Where a drug manufacturer or distributor purchases drugs, it shall request, examine and retain the relevant certificates and documents of the supplier in accordance with the requirements set forth in Article 10 of the Provisions, and request and retain sales document in accordance with the requirements set forth in Article 11 of the Provisions.
The documents retained by the drug manufacturer or distributor in accordance with the previous paragraph of this Article shall be kept till one year after the date of expiry, but not less than three years.
Article 13 Where a drug manufacturer or distributor knows or should know that any person without certificates produces or distributes drugs, it shall not provide the person with any drug.
Article 14 A drug manufacturer or distributor shall not provide premises, qualifications documents, notes, etc. as conveniences for others to distribute drugs in its own name.
Article 15 A drug manufacturer or distributor shall not spot trade drugs by means of exhibition, exposition, trade fair, commodity fair or product promotion event.
Article 16 A drug distributor shall not purchase or sell pharmaceutical preparations prepared by medical institutions.
Article 17 A drug distributor shall not change its distribution mode without approval of the drug regulatory department.
A drug distributor shall operate within the approved distribution scope in the Drug Supply Certificate.
Article 18 A drug retailer shall, pursuant to the requirements of drug classification regulations set forth by the State Food and Drug Administration, sell prescription drugs in the presence of prescriptions.
Any drug retailer selling prescription drugs or Class A non-prescription drugs shall, in the absence of its licensed pharmacists and other qualified pharmaceutical professionals, put up a public notice and stop selling prescription drugs and Class A non-prescription drugs.
Article 19 For drugs that need low-temperature or cold storage as specified in drug insert sheets, the drug manufacturer or distributor shall transport and store the drugs with low-temperature or cold storage facilities in accordance with the relevant provisions.
When finding any drug manufacturer or distributor violates the requirements in the previous paragraph of this article, the drug regulatory department shall seal up or seize the drugs concerned immediately and deal with the matter in accordance with law.
Article 20 A drug manufacturer or distributor shall not provide the public with prescription drug or Class A non-prescription drug by means of tie-in sale, offering free drugs in association with sales of drug or commodity sale, etc.
Article 21 A drug manufacturer or distributor shall not sell prescription drugs directly to the public by post or over internet.
Article 22 Any illegal purchase of drugs is prohibited.
Chapter III Supervision on Drug Purchase and Storage by Medical Institutions
Article 23 The pharmacy established by a medical institution shall have the premise, equipment, storage facilities, hygienic environment, and pharmaceutical professionals required for drug dispensing. It shall also have the drug quality control units or personnel, and establish a system for drug storage.
Article 24 Where a medical insititution purchases drugs, it shall request, examine and retain the relevant certificates, documents and notes of the supplier in accordance with the requirements set forth in Article 12 of the Provisions.
Article 25 Where a medical institution purchases drugs, it shall establish and apply an examination and acceptance system, and keep authentic and complete purchase records. Purchase records shall indicate the adopted name of the drug in China, manufacturer (for Chinese crude drug, the origin should be noted), dosage form, date of expiry, drug approval number, supplier, quantity, price and date of purchase.
Drug purchase records shall be kept till one year after the date of expiry, but not less than three years.
Article 26 A medical institution shall establish and apply a system for drug storage and maintenance, and take necessary measures to ensure drug quality, such as cold storage, protection against freeze and humidity, ventilation, moisture proof, protection from direct light and fire, and avoidance of insects and rodents.
A medical institution shall store drugs and non-drug products separately; Chinese crude drugs, prepared slices of Chinese crude drugs, pharmaceuticals, and traditional Chinese medicine preparations shall be stored separately by category.
Article 27 A medical institution or family planning technical service institution shall not directly provide drugs for patients without diagnosis or treatment.
Article 28 A medical institution shall not sell prescription drugs directly to the public by post or over internet.
Article 29 Where a medical institution purchases drugs via a centralized tendering, it shall comply with the relevant requirements of the Drug Administration Law, Regulations for Implementation of the Drug Administration Law and the Provisions.
Chapter IV Legal Liabilities
Article 30 In any of the following circumstances, the drug manufacturer or distributor shall be instructed to rectify within a time limit and given a disciplinary warning; and if the drug manufacturer or distributor fails to do so, it shall be fined not less than RMB 5,000 yuan but not more than RMB 20,000 yuan:
(1) any drug manufacturer or distributor in violation of Article 6 of the Provisions;
(2) any drug manufacturer or wholesaler in violation of the first paragraph of Article 11 of the Provisions;
(3) any drug manufacturer or distributor, in violation of Article 12 of the Provisions, failing to keep the relevant documents as required.
Article 31 Any drug manufacturer or distributor in violation of Article 7 of the Provisions shall be given a disciplinary warning and instructed to rectify within a time limit.
Article 32 In accordance with the provisions in Article 73 of the Drug Administration Law, in any of the following circumstances, the drugs illegally sold and the illegal gains therefrom shall be confiscated, and the drug manufacturer or distributor shall be fined not less than two times but not more than five times the value of the drugs illegally sold:
(1) any drug manufacturer or distributor, in violation of Article 8 of the Provisions, spot trading drugs on the premises not approved by the drug regulatory departments.
(2) any drug manufacturer in violation of Article 9 of the Provisions;
(3) any drug manufacturer or distributor in violation of Article 15 of the Provisions;
(4) any drug distributor in violation of Article 17 of the Provisions.
Article 33 Any drug manufacturer or distributor, in violation of Article 8 of the Provisions, storing drugs on the premises not approved by the drug regulatory departments，shall be punished pursuant to the provisions in Article 74 of the Regulations for Implementation of the Drug Administration Law.
Article 34 Any drug retailer in violation of the provisions in the second paragraph of Article 11 of the Provisions shall be instructed to rectify and given a disciplinary warning; and if the drug retailer fails to do so within a time limit, it shall be fined not more than RMB 500 yuan.
Article 35 Where a drug manufacturer or distributor, in violation of Article 13 of the Provisions, knows or should know that any person without certificates produces or distributes drugs, but still provide the person with drugs, they shall be given a disciplinary warning, instructed to rectify and fined not more than RMB 10,000 yuan. If the circumstances are serious, they shall be fined not less than RMB 10,000 yuan but not more than RMB 30,000 yuan.
Article 36 Drug manufacturers and distributors in violation of Article 14 of the Provisions shall be punished pursuant to the provisions in Article 82 of the Drug Administration Law.
Article 37 Where a drug distributor, in violation of Article 16 of the Provisions, purchases or sells pharmaceutical preparations dispensed by medical institutions, it shall be punished pursuant to the provisions in Article 80 of the Drug Administration Law.
Article 38 Any drug retailer in violation of the first paragraph of Article 18 of the Provisions shall be instructed to rectify within a time limit and given a disciplinary warning; if it fails to do so or the circumstances are serious, it shall be fined not more than RMB 1,000 yuan.
Where a drug retailer, in violation of the second paragraph of Article 18 of the Provisions, sells prescription drugs or Class A non-prescription drugs in absence of licensed pharmacists or other qualified pharmaceutical professionals, it shall be instructed to rectify within a time limit and given a disciplinary warning; if it fails to do so, it shall be fined not more than RMB 1,000 yuan.
Article 39 Where a drug manufacturer or wholesaler, in violation of Article 19 of the Provisions, fails to transport drugs under low-temperature or cold storage conditions as specified in insert sheets, it shall be given a disciplinary warning and instructed to rectify within a time limit; if it fails to do as instructed, it shall be fined not less than RMB 5,000 yuan but not more than RMB 20,000 yuan. Where the drugs concerned are legally proved to be counterfeit or substandard drugs, the drug manufacturer or wholesaler shall be punished in accordance with the relevant provisions of the Drug Administration Law.
Where a drug manufacturer or wholesaler, in violation of Article 19 of the Provisions, fails to store drugs under low-temperature or cold storage conditions as specified in insert sheets, it shall be punished pursuant to the provisions in Article 79 of the Drug Administration Law. Where the drugs concerned are legally proved to be counterfeit or substandard drugs, the drug manufacturer or wholesaler shall be punished in accordance with the relevant provisions of the Drug Administration Law.
Article 40 Any drug manufacturer or distributor in violation of Article 20 of the Provisions shall be instructed to rectify within a time limit and given a disciplinary warning; if the drug manufacturer or distributor fails to do so or the circumstances are serious, they shall be fined not more than two times the value of the free drugs offered, but not more than RMB 30,000 yuan.
Article 41 Any institution, in violation of Article 23 to Article 27 of the Provisions, shall be instructed to rectify within a time limit; if the circumstances are serious, it shall be announced.
Article 42 Where a drug manufacturer or distributor in violation of Article 21 of the Provisions or a medical institution in violation of Article 28 of the Provisions sells prescription drugs directly to the public by post, over internet, etc., they shall be instructed to rectify, given a disciplinary warning, and fined not more than two times the value of the drugs sold, but not more than RMB 30,000 yuan.
Article 43 Any illegal purchase of drugs, in violation of Article 22 of the Provisions, shall be punished pursuant to the provisions in Article 73 of the Drug Administration Law.
Article 44 Where a drug regulatory department or its staff that neglects its duty fails to stop or punish illegal activities that should be stopped or punished, administrative sanctions shall be imposed to the person directly in charge and other persons directly responsible. If a crime is constituted, criminal liabilities shall be investigated in accordance with law.
Chapter V Supplementary Provisions
Article 45 Spot trading of drugs in the Provisions refers to the activity that drug manufacturers, distributors or their appointed sales staff carry and sell drugs to unspecified objects on spot other than the premises approved by the drug regulatory departments.
Article 46 With respect to the supervision on the distribution of specially controlled drugs, vaccines, and military medicines, if otherwise provided by the relevant laws, regulations and provisions, they shall prevail.
Article 47 The Provisions shall come into force as of May 1, 2007. As of the date when the Provisions goes into effect, the Provisions for Supervision of Drug Distribution (Interim) (SFDA Decree No.7) implemented on August 1, 1999 shall be annulled therefrom.
