江苏省村镇规划建设管理条例（1997年修正）
江苏省人大常委会
江苏省村镇规划建设管理条例（修正）
江苏省人大常委会
（1994年6月25日江苏省第八届人民代表大会常务委员会第八次会议通过 1994年6月25日公布施行 根据1997年7月31日江苏省第八届人民代表大会常务委员会第二十九次会议《关于修改〈江苏省村镇规划建设管理条例〉的决定》修正）
第一章 总 则
第一条 为了适应我省农村经济和社会发展的需要，加强村镇规划建设管理，改善村镇生产、生活环境，促进农村社会主义现代化建设和小城镇建设，根据国家有关法律、法规，结合本省实际，制定本条例。
第二条 本条例适用于全省行政区域内村镇的规划、建设和管理等活动。本条例所称村镇，包括建制镇、集镇、独立工矿区和村庄。
城市规划区内村镇的规划管理，《城市规划法》另有规定的，从其规定。
第三条 村镇规划建设管理，应当坚持全面规划、合理布局、节约用地、因地制宜、量力而行、逐步建设的原则，实现经济效益、社会效益和环境效益的统一。
第四条 县级以上人民政府建设行政主管部门和乡（镇）人民政府负责本行政区域内的村镇规划建设管理工作。
第二章 村镇规划的制定
第五条 村镇规划的编制，应当以县域规划和县域土地利用总体规划为依据，并与基本农田保护区等专业规划相协调。
村镇规划的编制应遵循下列原则：
（一）根据国民经济和社会发展计划，结合当地自然环境、资源条件以及社会经济发展的历史和现状，统筹兼顾，综合部署村镇的各项建设；
（二）处理好近期建设与远景发展、改造与新建的关系，使村镇的性质和建设的规模、速度和标准，同经济发展和农民生活水平相适应；
（三）合理用地，节约用地，保护耕地和林地；
（四）合理安排住宅、乡镇企业、公共设施和公益事业的布局，缩并零散的自然村落，逐步建成相对集中、设施配套的现代化村落，引导乡镇工业向工业区集中，并适当留有发展余地；
（五）保护和改善生活环境与生态环境，防治污染和其他公害，加强绿化和村容镇貌、环境卫生建设。
第六条 村镇规划包括乡（镇）域规划，建制镇、集镇总体规划和详细规划，村庄建设规划。
乡（镇）域规划的主要内容包括：乡（镇）行政区域内村镇布点，村镇的位置、性质、规模和发展方向，村镇规划建设用地范围，村镇基础设施以及其他各项生产和生活服务设施的配置。
建制镇、集镇总体规划的主要内容包括：建制镇、集镇的性质和发展方向，人口和建设用地发展规模，住宅、乡镇企业、公共设施和公益事业街道中项建设的用地布局和功能分区，有关的技术经济指标。对建设项目或者重点地段的具体安排和规划设计编制详细规划。
村庄建设规划应当以乡（镇）域规划为依据，其主要内容包括：人口和建设用地发展规模，建设用地范围，住宅、公共设施和公益事业等各项建设用地的布局，有关技术经济指标。
第七条 村镇规划由乡（镇）人民政府统一组织编制，经乡（镇）人民代表大会审查同意，由乡（镇）人民政府报县级人民政府批准。有关村庄建设规划，还应当先由村民会议讨论同意。
村镇规划经批准后，由乡（镇）人民政府公布。如确需修改或者变更的，必须按本条第一款规定的程序报原批准机关批准。
第三章 村镇规划的实施
第八条 在村镇范围内进行的各项建设必须服从规划管理。
第九条 任何单位和个人不得阻挠和拖延规划的实施。因实施规划给村（居）民或者单位造成损失的，用地单位必须按照有关规定给予牙应补偿。
第十条 所有村镇工程建设项目必须安排在村镇规划建设用地范围内，严禁在基本农田保护区内兴建厂房、住宅以及从事工业开发区等建设。但经省级以上行政机关批准的交通、水利、能源、通讯等国家基础设施工程建设除外。
第十一条 村民建住宅，应当先向村民委员会提出建房申请。使用原有宅基地、村内空闲地和其他非耕地的，经村同委员会讨论同意后，向乡（镇）人民政府申请核发村镇规划选址意见书；需要使用耕地的，由县级人民政府建设行政主管部门核发村镇规划选址意见书，并按土地管理的
法律、法规规定的程序办理土地使用手续。
城镇非农业户口居民在村镇范围内需要使用集体所有的土地建住宅的，应当经其所在单位或者居民委员会同意后，依照本条第一款规定的审批程序办理。
回原籍落户的职工、退伍军人和离休、退休干部以及回乡定居华侨、港澳台同胞，在村镇范围内需要使用集体所有的土地建住宅的，依照本条第一款规定的审批程序办理。
第十二条 新建、扩建各类企业，建设单位必须持县级以上人民政府批准的设计任务或者其他批准文件，向县级人民政府建设行政主管部门申请选址定点，经审查同意并出具村镇规划选址意见书后，方可向县级人民政府土地管理部门申请用地。
第十三条 村镇公共设施、公益事业建设，必须经乡（镇）人民政府审核、县级人民政府建设行政主管部门审查同意并出具村镇规划选址意见书后，建设单位方可向县级人民政府土地管理部门申请用地。
第十四条 国有企业单位和行政机关的派出机构在村镇范围内，需征用集体土地进行建设的，必须持建设项目的有关批准文件，向县级人民政府建设行政主管部门申请选址定点，经审查同意并出具村镇规划选址意见书后，建设单位方可向县级人民政府土地管理部门申请用地。
第十五条 凡在村镇范围内进行各类建设的单位和个人，必须向乡（镇）人民政府申请核发村镇工程建设许可证。
建设单位或个人持建设项目批准文件、村镇规划选址意见书、建设用地批准证件、建设工程图纸向乡（镇）人民政府提出申请，经其初审后，报县级人民政府建设行政主管部门核发村镇工程许可证。
村（居）民个人建住宅，向乡（镇）人民政府申请核发村镇工程建设许可证。
在村镇主要街道装饰房屋门面的，建设单位或者个人持建设工程施工图纸向乡（镇）人民政府申请核发村镇工程建设许可证。
第十六条 建设单位或者个人取得村镇工程建设证后，须经乡（镇）人民政府村镇建设管理部门现场放样、验线、方可正式施工。
建设单位或者个人在取得村镇工程建设许可证后6个月内未开工，又未办理延期手续的，此证自行失效。
第十七条 乡（镇）人民政府村镇建设管理部门，负责村镇的规划建设管理的日常工作。应当对规划的实施进行检查。被检查者应当如实提供情况和资料，不得隐瞒和阻挠。检查者应当为被检查者保守技术秘密和业务秘密。
第四章 村镇的建设与管理
第十八条 村镇的各种房屋建筑（单层个人住宅除外）和各类基础设施等建设工程，必须由取得相应的设计资格证书的单位或者个人进行设计。严禁列证设计和无设计施工。
第十九条 在村镇进行各类施工活动的企业和个体工匠，必须持资质证书等有关文件到乡（镇）人民政府登记注册，领取村镇建设工程施工许可证，按照规定的范围进行施工。严禁无证施工和越级施工。
第二十条 施工企业和个体工匠应当按照设计图纸施工。任何单位和个人不得擅自修改设计图纸；确需修改的，须经原设计单位或者个人同意并出具变更设计通知单。涉及重大设计变更的，须经原批准机关批准。
第二十一条 县级人民政府建设行政主管部门和乡（镇）人民政府村镇建设管理部门，应当对村镇建设工程的施工质量进行监督检查和竣工验收。工程质量不合格的建设项目不得交付使用。
第二十二条 县级人民政府建设行政主管部门和乡（镇）人民政府村镇建设管理部门，应当建立、健全村镇建设档案管理制度。对建设中形成的规划、设计、施工等具有保存价值的各种资料，应当及时整理归档。新建工程竣工后，建设单位和个人必须在竣工验收后3个月内向乡（镇）
人民政府村镇建设管理部门报送工程资料。
第二十三条 村镇建设综合开发必须服从村镇规划，配套进行各类基础设施和生活服务设施的建设。
凡进行村镇建设综合开发的单位，必须到开发项目所在地乡（镇）人民政府登记注册，按规定缴纳开发管理费。严禁无证开发和越级开发。
第二十四条 村镇房屋实行产权登记制度。县级以上人民政府建设行政主管部门应当加强村镇房屋产权产籍管理，依法保护房屋所有人的房屋所有权。房屋产权证件由县级人民政府颁发。
第二十五条 乡（镇）人民政府应当加强村镇房屋拆迁管理，保护公民、法人或其他组织的合法权益。
村镇房屋的拆迁，应当根据规划，有计划地进行。在规划确定要搬迁的村庄内，不得进行房屋翻建、扩建、改建等活动。
第二十六条 在建制镇、集镇范围内进行各类建设的单位和个人，应当缴纳基础设施配套费。中小学校和幼儿园教室、民政福利事业设施、市政公用设施减免基础设施配套费。
基础设施配套费专项用于村镇基础设施的建设，不得挪作他用。
第二十七条 建制镇、集镇城市维护税的使用，由县级人民政府建设行政主管部门编制使用计划，报县级人民政府批准后实施，用于市政公用设施的维护和建设，并接受财政、审计部门的监督。
第二十八条 未经乡（镇）人民政府批准，任何单位和个人不得擅自在村镇的街道、广场、市场和车站、码头等公共场所修建临时建筑物、构筑物和其他设施。
第二十九条 乡（镇）人民政府应当采取措施，维护村容镇貌和环境卫生；保护村镇饮用水源，有条件的地方，可以集中供水，使水质逐步达到国家规定的生活饮用水卫生标准。
第三十条 负责村镇建设的各级管理人员必须依法行政，秉公执法，提高素质，搞好服务。
第五章 法律责任
第三十一条 违反本条例规定，未按规划审批程序批准而取得建设用地批准文件，占用土地的，批准文件无效，占用的土地由当地乡级以上人民政府责令退回，对批准单位和用地单位的直接责任人给予行政处分。
第三十二条 违反本条例规定，未按规划审批程序批准或者违反规划的规定进行建设，严重影响村镇规划的，由县级人民政府建设行政主管部门责令停止建设，限期拆除或者没收违法建筑物、构筑物和其他设施；影响村镇规划，尚可采取改正措施的，由县级人民政府建设行政主管部门
责令限期改正，处以罚款。对单位的罚款幅度为土建工程造价的百分之三以上百分之十以下，对个人的罚款幅度为土建工程造价的百分之一以上百分之五以下。
村（居）民未经批准或者违反规划的规定建住宅的，由乡（镇）人民政府依照前款的规定处罚。
第三十三条 违反本条例规定，有下列行为之一的，由县级人民政府建设行政主管部门责令停止设计、施工或者开发，限期改正，没收非法所得，并对直接责任人员处以设计、施工或者开发收入的百分之一以上百分之十以下的罚款。
（一）未取得设计资格证书承担设计任务（单层个人住宅除外）或者未按设计资格规定的范围承担设计任务的；
（二）未取得施工资质证书或者未按施工资质规定的范围承担施工任务的；
（三）未取得村镇建设工程施工许可证而擅自施工的；
（四）未按设计图纸施工或者擅自修改设计图纸的；
（五）未取得开发资质证书或者未按资质规定的范围承担开发任务的。
第三十四条 取得设计、施工、开发资格（质）证书的勘察设计、施工、开发单位，违反本条例规定，为无证单位或者个人提供资格（质）证书的，由工程所在地县人民政府建设行政主管部门没收待证单位的全部非法所得。
情节严重的，除按前款规定进行处罚外，由原发证机关吊销设计、施工、开发资格（质）证书。
第三十五条 违反本条例第二十八条规定的，由乡（镇）人民政府责令限期拆除，并处以工程造价的百分之二以上百分之八以下的罚款。
第三十六条 违反本条例规定，构成违反治安管理行为的，依照治安管理处罚条例的规定处罚；构成犯罪的，依法追究刑事责任。
第三十七条 村镇建设管理部门在办理村镇规划选址意见书、村镇工程建设许可证、房屋产权证件时，只准收取工本费。
村镇建设管理人员玩忽职守、滥用职权、徇私舞弊的，由所在单位或者上级主管部门给予行政处分，构成犯罪的，依法追究刑事责任。
第三十八条 当事人对行政处罚决定不服的，可以在接到处罚通知书之日起十五日内，向作出处罚决定机关的上一级机关申请复议。对复议决定不服的，可以在接到处罚决定通知书之日起十五日内，向人民法院起诉。当事人也可以在接到处罚决定通知书之日起十五日内，直接向人民法
院起诉。当事人逾期不申请复议，也不向人民法院起诉、又不履行处罚决定的，由作出处罚决定的机关申请人民法院强制执行。
第六章 附 则
第三十九条 未设镇建制的国有农（林）场场部及其基层居民点的规划建设管理，分别由国有农（林）场主管部门参照本条例执行，并服从所在地县级人民政府建设行政主管部门的管理。
第四十条 本条例自公布之日起施行。
附：江苏省人民代表大会常务委员会关于修改《江苏省村镇规划建设管理条例》的决定
（1997年7月31日江苏省第八届人民代表大会常务委员会第二十九次会议通过 1997年7月31日公布施行）
决定
江苏省第八届人民代表大会常务委员会第二十九次会议根据《中华人民共和国行政处罚法》和其他有关法律、行政法规，结合本省具体情况，决定将《江苏省村镇规划建设管理条例》第三十一条修改为：“违反本条例规定，未按规划审批程序批准而取得建设用地批准文件，占用土地的
，批准文件无效，占用的土地由乡级以上人民政府责令退回，对批准单位和用地单位的直接责任人给予行政处分。”
本决定自公布之日起施行。
1997年7月31日
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.
