中华人民共和国出入境汽车运输管理规定
交通部
中华人民共和国出入境汽车运输管理规定
1995年9月12日，交通部
通知
第一条 为加强对出入中华人民共和国边境的汽车运输（以下简称出入境汽车运输）管理，维护正常的国际间汽车运输秩序，促进我国同邻国及港澳地区的经济、文化交流和人员的交往，根据我国有关法律、法规及我国政府与有关国家政府签订的多边、双边汽车运输协定的有关内容，制定本规定。
第二条 本规定适用于
（一）在我国境内注册从事出入境汽车旅客（含游客，下同）运输、货物运输，以及与之相关的车辆维修、搬运装卸和运输代理、货物仓储、转运包（换）装的企业、车辆和人员。
（二）进入我国境内从事汽车旅客、货物运输的外国及港澳地区的车辆和人员。
第三条 从事出入境汽车运输必须遵守下列原则；
一、维护我国国家主权，坚持平等互利；
二、遵守我国有关法律、法规及规章；
三、执行国家政府间汽车运输协定、协议，以及实施细则；
四、有利于促进国家间的友好往来。
第四条 中华人民共和国交通部是全国出入境汽车运输的主管机关。
省级及地级交通主管部门是所在行政区域内对出入境汽车运输进行管理的机关；在经批准开通的公路口岸设置的交通运输管理站是口岸地出入境汽车运输的监督检查机构。
第五条 交通部的职责：
一、拟定国家有关出入境汽车运输政策、法规；制订全国出入境汽车运输发展规划。
二、按国务院的授权，负责签订国家政府间汽车运输协定；协调解决在国家政府间汽车运输协定实施过程中出现的问题。
三、制定统一的出入境汽车运输单证、标志。
四、审批超越口岸地向内地延伸的旅客、货物运输线路。
五、审批口岸交通运输管理站。
六、审批我国汽车运输企业在国外和外国汽车运输企业在我国境内设立出入境汽车运输的代表机构。
七、指导检查全国出入境汽车运输管理工作。
第六条 省级交通主管部门的职责：
一、在本行政区域内，组织实施国家有关出入境汽车运输的政策、法规和政府间汽车运输协定。
二、制定行政区域内出入境汽车运输管理规定和发展规划。
三、审批中外对应口岸间的出入境汽车运输线路；审核申报超越口岸地向内地延伸的旅客、货物运输线路。
四、审定企业从事出入境汽车运输的经营资格。
五、提出口岸交通运输管理站的设置意见。
六、负责交换国际汽车运输行车许可证；印制、发放、管理出入境汽车运输单证、标志。
七、根据交通部授权办理、协调出入境汽车运输的有关事宜。
第七条 口岸所在地的地级交通主管部门的职责由省级交通主管部门根据实际需要确定。
第八条 口岸交通运输管理站在口岸现场负责监督检查出入境汽车运输经营活动，查验国际汽车运输行车许可证、车辆识别标志、营运证件、缴费凭证等，维护口岸正常的出入境汽车运输秩序。
第九条 从事出入境汽车运输的中国企业，必须具备相应的车辆、设施，配有熟悉国际汽车运输商务、技术的业务人员，同时拥有与经营项目相适应的风险资金。经省级交通主管部门审批，领取出入境汽车运输经营许可证后方可经营。
第十条 从事出入境汽车运输的中国车辆，必须达到ＪＴ／Ｔ198—95《汽车技术等级评定标准》中的一级技术标准。
从事出入境汽车运输的车辆须携带国际汽车运输行车许可证和配有出入境汽车运输统一标志，客运车辆还应携带出入境汽车旅客运输行车路单，货运车辆应携带国际汽车货物运单。经审批合格的运输车辆，承运者应提前办理第三者责任保险。
第十一条 从事出入境汽车运输的中方业务人员和司乘人员，须经省级交通主管部门进行出入境汽车运输业务和技术培训，取得资格证书后，方可上岗，并凭资格证书办理国家对出国人员规定的有关证件。
第十二条
一、在中国境内从事出入境汽车货物运输，由货主或货代单位将货物名称、数量、起止地点和运输时间及时提报交通主管部门，由交通主管部门实施管理。
二、国务院和省级人民政府规定限运的货物，货主或货代单位必须按规定办理批准手续；超限及危险品运输须按国家政府间汽车运输协定办理特别行车许可证。
第十三条 出入境汽车旅客运输须按规定线路运行，旅客随身携带的行包可随车同行，托运的行包另行派车装运。
第十四条 外国及港澳地区车辆进行过境运输时，有国家政府间多边汽车运输协定的按协定办理，没有协定的经交通部特别许可后，方可进行。
第十五条 外国车辆进入我国境内后，须遵守国家政府间多边、双边汽车运输协定的有关规定，并不准在我国境内自行承揽货源或招揽旅客。
第十六条 为出入境汽车运输服务的搬运装卸企业和个人，应在省级交通主管部门批准的作业范围内经营。
第十七条 为出入境汽车运输服务的车辆维修、货物仓储、转运包（换）装，由省级交通主管部门统筹规划，合理布局。
第十八条 出入境汽车运输的运价，多边、双边汽车运输协定中有规定的按协定规定执行，没有规定的，中方由省级交通主管部门会同同级物价部门确定。
第十九条 对从事出入境汽车运输的中国籍车辆的费收项目及标准，国家有规定的按规定执行；没有规定的，由省级交通主管部门会同同级物价部门确定。
对从事出入境汽车运输的外国籍车辆在我国境内的费收项目及标准，国家政府间多边、双边汽车运输协定有规定的按协定规定办理；没有规定，按国家或省级有关部门的规定办理。
第二十条 出入境汽车运输中方管理人员在执行任务时，应着统一制服，佩戴徽章，证件齐全，公正廉洁，文明执法。
第二十一条 违反出入境汽车运输有关规定的中国车辆，可参照交通部颁发的《道路运输违章处罚规定》处理。
外国车辆在我国境内违章，按国家政府间多边、双边汽车运输协定的有关规定处理，没有规定的按我国有关规定处理。
第二十二条 省级交通主管部门，可根据本规定制订其实施细则。
第二十三条 本规定未提及的其它事宜，按我国有关规定执行。
第二十四条 本规定由交通部负责解释。
第二十五条 本规定自发布之日起施行。
附件：
1、中华人民共和国出入境汽车运输统一标志（式样）
2、中华人民共和国出入境汽车运输申请开业审批表（式样）
3、中华人民共和国出入境汽车运输经营许可证（式样）
4、中华人民共和国出入境汽车运输人员资格证书（式样）
5、中华人民共和国出入境汽车旅客运输行车路单（式样）
6、国际汽车货物运单（式样）
附件一：中华人民共和国出入境汽车运输统一标志（式样）
（一）标志正面（略）
注：1．此标志分一次性和长期性两种。一次性使用的标志为纸质不干胶片，贴在车辆风档玻璃的右上角；长期性使用的为冲压式铝质标牌，固定在车辆保险杠右侧，也可同时用漆喷制在车厢两侧。
2．尺寸：一次性标志为130ｍｍ×95ｍｍ；长期性标牌为260ｍｍ×190ｍｍ。
3．标志颜色为正红底色，金黄色字母和环边。
4．“ＣＭＴ”的含义：
Ｃ ＣＨＩＮＡ 中国
Ｍ ＭＯＴＯＲ ＶＥＨＩＣＬＥ 汽车（根据ＧＢ8226—87）
Ｔ ＴＲＡＮＳＰＯＲＴ 运输
（二）一次性标志背面（略）
附件二：中华人民共和国出入境汽车运输申请开业审批表（式样）
中华人民共和国出入境汽车运输申请开业审批表
----------------------------------------------------------------------------------------------------------
|1．申请企业| |2．法人代表| |
| 全 称 | | | |
|------------|----------------------------------------------------------------------------------------|
|3．企业地址| |
|------------|----------------------------------------------------------------------------------------|
|4．电 话 | |5．电挂| |6．传真| |
|------------------------------------------------------------------------------|----------------------|
| |7．经济性质 | |8．成立时间 | 年 月 日|
| |----------------------|------------------------------|--------------|----------------------|
| |9．注册资产 | |10．流动资金| |
| |----------------------|------------------------------|--------------|----------------------|
| |11．职工总数 | | ａ．驾驶员| |ｂ．保修技工| |
| | |----------------|------------|--------------|------------|--------|
| 企 |（人） | |ｃ．管理人员| | ｄ．有专业| |
| | | | | | 职称人员 | |
| 业 |----------------------|----------------|------------|--------------|------------|--------|
| |12．车辆总数（辆） | | ａ．客车数| | ｂ．货车数| |
| 基 |----------------------|----------------|------------|--------------|------------|--------|
| |13．总吨（座）位 | | ａ．客座位| | ｂ．货吨位| |
| 本 |----------------------|------------------------------|--------------------------------------|
| |14．主要车型 | 型 辆 | 型 辆 |
| 情 |----------------------|------------------------------|--------------------------------------|
| |15．主要装卸设备 | 台| 台 |
| 况 |----------------------|------------------------------|--------------------------------------|
| |16．站房（Ｍ2） | ａ．客运站房| |ｂ．货运站房| |
| |----------------------|------------------------------|------------|------------|----------|
| |17．库房（Ｍ2） | ａ．行包房| |ｂ．货运库房| |
| |----------------------|------------------------------|--------------------------------------|
| |18．保修车间（Ｍ2）| |19．停车场地（Ｍ2）| |
----------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------
| |20．项目全称 | |
| |----------------------|----------------------------------------------------------------------|
| |21．经营方式 | |22．经营范围| |
| 企 |----------------------|------------------------------|--------------|----------------------|
| |23．投入车型 | 24．投入 | |25．投入吨 | |
| 业 | | 车辆数| | （座）位 | |
| |----------------------|--------------------------------------------------------------|------|
| 申 |26．投入人员 | |ａ．驾驶员| |ｂ．保修工| |ｃ．管理人员| |
| |----------------------|----------------------------------------------------------------------|
| 请 |27．营运线路 | |
| |----------------------|----------------------------------------------------------------------|
| 内 |28．停靠站点 | |
| |----------------------|----------------------------------------------------------------------|
| 容 |29．运行时间 | |
| |----------------------|----------------------------------------------------------------------|
| |30．特别申请 | |
|------|----------------------------------------------------------------------------------------------|
|31．| |申请企业| |
| 经 | | | |
| 办 | |（章） | 年 月 日|
----------------------------------------------------------------------------------------------------------
------------------------------------------------------------
| 交通主管部门审核意见 |
|--------------------------------------------------------|
| |
| |
| |
| 审核机关（章） |
|签发人： |
| 年 月 日 |
|--------------------------------------------------------|
| 审 批 机 关 意 见 |
|--------------------------------------------------------|
| |
| |
| |
| 审核机关（章） |
|签发人： |
| 年 月 日 |
------------------------------------------------------------
注：1．审核机关为地（市、盟、州）级交通局，或审批机关指定的公路运输管理处；审批机关为省（自治区）交通厅（局）。
2．此表一式四份。表左面由申请企业填写，填写后自存一份，其余三份经审核
机关审核后，报审批机关审批，审批后，一份留省交通主管部门存查，一份
由申请企业存档，一份作为到其他部门办理开业手续的凭证。
----------------------------------------------------
|车牌号码-------------------------------- |
|准驾车型--------------------|年度审验| |
|有 效 年 月 日至|--------| |
|期 限 年 月 日止|--------| |
| | | |
| ------------ |
|注：1．本证须加盖发证机关公章。 |
| 2．本证做为出入境汽车运输人员的资格证件，严|
| 禁转借、伪造和涂改。 |
| 3．凡从事出入境汽车运输的人员，必须服从和配|
| 合交通运输管理人员的检查。 |
| 4．本证未经年度审验视为无效证件。 |
| 中华人民共和国交通部制 |
----------------------------------------------------
（背面）
附件三：中华人民共和国出入境汽车运输经营许可证（式样）
------------------------------------------------
| Ｎｏ |
| |
| 中华人民共和国出入境汽车运输 |
| 经 营 许 可 证 |
| 经审核已具备中华人民共和国交通部规定 |
|的出入境汽车运输的经营条件，现核发此证 |
|准予经营。 |
|发证机关： |
|核发日期： 年 月 日 |
| 中华人民共和国交通部制|
------------------------------------------------
注：1．本证尺寸为八开。
2．纸张选用光亮挺华纸样。
3．《许可证》上方为国徽图案。
4．“中华人民共和国出入境汽车运输经营许可证”采用烫金字印刷，其
中“经营许可证”五个字的印刷体略为粗重。
5．《许可证》中的批语、发证机关及核发日期可用黑色毛笔楷书体的字
型印刷。
附件四：“中华人民共和国出入境汽车运输人员资格证”（样式）
|←----------8．7ＣＭ----------→|
----------------------------------------------------------
↑ |中华人民共和国出入境汽车运输人员 | ↑
| | 资 格 证 ---------- |淡天蓝色印刷区
| | | | | ↓
| |----------------------| |--|--------
| | | | | ↑
| |姓 名---------- | | | |
5．7ＣＭ |工作单位---------- | | | |
| |准行国家---------- ---------- |印刷黄色＠徽记
| | 第 号 | 区域
| | | |
↓ |发证机关---------------------- | ↓
----------------------------------------------------------
（正面）
印刷说明：
1．此证件为塑封；
2．严格尺寸规定；
3．此证的“正、反面”面纸用黄色的公路路徽的徽记做图案；
4．“中华人民共和国出入境汽车运输人员资格证”字体采用烫金来印刷；
其中“资格证”三字采用粗重体，比“中华人民共和国出入境汽车运输
人员”的字体略大些。
5．“年度审验”栏下的三个空验格，在塑封皮的对应位置须切空，以便盖
印年度审验章。
6．此证件式样由交通部制定，各省（区）交通厅据此自行印发。
附件五：中华人民共和国出入境汽车旅客运输行车路单（式样）
（中文字下套印相关文字）
中华人民共和国
出入境汽车旅客运输行车路单存根
Ｎｏ：000000
--------------------------------------------------------------------------------------------------------------
|领用单位全称| |营运证号码| |去程线路|自 经 到达 |
|------------|----------|----------|--------|--------|------------------------------------------------|
| 车 型 | |车辆牌号 | |回程线路|自 经 到达 |
|------------|--------------------------------|--------|------------------------------------------------|
|驾驶员姓名 | |有效期 |自19 年 月 日至19 年 月 日|
--------------------------------------------------------------------------------------------------------------
……………………………交运管…………………………………字 第000000号………………………………………………
中华人民共和国
出入境汽车旅客运输行车路单 运（ ）字Ｎｏ：000000
运输单位： 车号：
营运线路：自 （ 时 分）经 （ 时 分）
------------------------------------------------------------------------------
|去程班次编号 |
|--------------------------------------------------------------------------|
| | | | 周转量 |行 包|行包重量|行包周转量 | |
|站 名|里程|人数| | | | |经 办 人|
| | | |（人公里）|（件）|（公斤）|（公斤公里）| |
|------|----|----|----------|------|--------|------------|----------|
| | | | | | | | |
|------|----|----|----------|------|--------|------------|----------|
| | | | | | | | |
|------|----|----|----------|------|--------|------------|----------|
| | | | | | | | |
|------|----|----|----------|------|--------|------------|----------|
| | | | | | | | |
|------|----|----|----------|------|--------|------------|----------|
| | | | | | | | |
|------|----|----|----------|------|--------|------------|----------|
| | | | | | | | |
|------|------------------------------------------------------------------|
|记事栏| |
|------|------------------------------------------------------------------|
| | |
|路 单|自19 年 月 日 |
| | |
|有效期|自19 年 月 日 |
| | |
------------------------------------------------------------------------------
主管机关（章） 路单签发单位
座位： 驾驶员姓名：
（ 时 分）到达 （ 时 分）
------------------------------------------------------------------------------
|回程班次编号 |
|--------------------------------------------------------------------------|
| | | | 周转量 |行 包|行包重量|行包周转量 | |
|站 名|里程|人数| | | | |经 办 人|
| | | |（人公里）|（件）|（公斤）|（公斤公里）| |
|------|----|----|----------|------|--------|------------|----------|
| | | | | | | | |
|------|----|----|----------|------|--------|------------|----------|
| | | | | | | | |
|------|----|----|----------|------|--------|------------|----------|
| | | | | | | | |
|------|----|----|----------|------|--------|------------|----------|
| | | | | | | | |
|------|----|----|----------|------|--------|------------|----------|
| | | | | | | | |
|------|----|----|----------|------|--------|------------|----------|
| | | | | | | | |
|------|------------------------------------------------------------------|
|记事栏| |
|------|------------------------------------------------------------------|
| |旅客运量| |旅客周转量 | |
|运输量| （人）| |（人公里） | |
| |--------|------------------|------------|----------------------|
|统 计|行包运量| |行包周转量 | |
| |（公斤）| |（公斤公里）| |
------------------------------------------------------------------------------
路单签发人 路单回收人
（注：背后套印旅客清单）
旅 客 清 单
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|旅客姓名|国籍|乘车站|到达站|票号|旅客姓名|国籍|乘车站|达到站|票号|
|--------|----|------|------|----|--------|----|------|------|----|
| | | | | | | | | | |
|--------|----|------|------|----|--------|----|------|------|----|
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|--------|----|------|------|----|--------|----|------|------|----|
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|--------|----|------|------|----|--------|----|------|------|----|
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|--------|----|------|------|----|--------|----|------|------|----|
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|--------|----|------|------|----|--------|----|------|------|----|
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|--------|----|------|------|----|--------|----|------|------|----|
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|--------|----|------|------|----|--------|----|------|------|----|
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|--------|----|------|------|----|--------|----|------|------|----|
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|--------|----|------|------|----|--------|----|------|------|----|
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附件六：国际汽车货物运单（式样）
（中文字下套印相关文字）
国际汽车货物运单 Ｎｏ：000000
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|1． 发货人 |2． 收货人 |
|名称 |名称 |
|国籍 市 |国籍 市 |
|------------------------------------------|----------------------------------------------|
|3． 装货地点 |4． 卸货地点 |
|国籍 市 |国籍 市 |
|街 |街 |
|------------------------------------------------------------------------------------------|
| 5． | 6． | 7． | 8． | 9． | 10． |
|标记和号码| 件 数 | 包装种类 | 货 物 名 称 |体积（立方米）|毛重（公斤）|
|----------|----------|------------|----------------------|--------------|------------|
| | | | | | |
|----------|----------|------------|----------------------|--------------|------------|
| | | | | | |
|----------|----------|------------|----------------------|--------------|------------|
| | | | | | |
|----------|----------|------------|----------------------|--------------|------------|
| | | | | | |
|----------|----------|------------|----------------------|--------------|------------|
| | | | | | |
|------------------------------------------------------------------------------------------|
|11．发货人指示 |
|------------------------------------------------------------------------------------------|
| ａ．进／出口许可证Ｎｏ： 从 在 海关 |
|------------------------------------------------------------------------------------------|
| ｂ．货物声明价值 |
|------------------------------------------------------------------------------------------|
| ｃ．发货人随附单证 --------------------------------|
|----------------------------------------------------------|包括运费交货点----------------|
| ｄ．订单或合同号 | |
|----------------------------------------------------------|不包括运费交货点--------------|
| ｅ．其它指示 | |
|------------------------------------------------------------------------------------------|
|12．运送特殊条件 14．应付运费 |
| 发货人| 币别 | 收货人 |
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|13．承运人意见 | 运 费 | | |
| | | |--------------|
| | | | |
|----------------------------------------|--------------------------|----|--------------|
|15．承运人 | | | | |
| |--------------------|----|----|--------------|
| | | | | |
| |--------------------|----|----|--------------|
| | | | | |
| |--------------------|----|----|--------------|
| | | | | |
| |--------------------|----|----|--------------|
| |共计 | | | |
| |--------------------|----|----|--------------|
| | | | | |
|------------------------------------------------------------------------------------------|
| 编制日期 |17．收到本运单货物日期 |
|16．到达装货 时 分 |18．达到卸货 时 分 |
| 离去 时 分 | 离去 时 分 |
| 发货人签字盖章 承运人签字盖章 | 收货人 |
| | 签字盖章 |
|--------------------------------------------------|--------------------------------------|
|19．海关机构记载 |20．收货人可能提出的意见|21．汽车号 |
| | | 拖挂车号 |
| | | 司机姓名-------- |
| | | ------------------ |
| | | 行车许可证号 |
| | |--------------------------------------|
| | |22．运输里程 |
| | | ---------------- |
| | | 过境里程 |
| | | ---------------- |
| | | 收货人境内里程 |
| | | ---------------- |
| | |共计 |
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不需要就划掉
1—12栏以及16栏由发货人填写，18和20栏由收货人填。
Provisions for Supervision of Drug Distribution
Commissioner of SFDA
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.
