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.




国家开发银行


国家开发银行贷款项目工程监理管理暂行规定

第一条 为了保证国家建设项目工程质量和国家开发银行（以下称开发银行）的信贷资产安全，防范信贷风险，在贷款项目评审、合同谈判和信贷管理中落实监理工作，根据国家有关法律、法规，制定本规定。
第二条 开发银行人民币贷款的国家大中型建设项目以及贷款额在3000万元（含3000万元）以上的其他建设项目，必须实行全过程工程监理。
本规定所称全过程工程监理，是指工程设计、施工、材料设备采供、安装、调试等的质量、造价、工期的监督与管理。
第三条 开发银行评审部门、信贷部门应依其职责分工负责落实各个环节的监理管理工作。
开发银行的分行（包括资产管理部）应把监理管理工作纳入日常信贷管理工作中。
第四条 借款人向开发银行申请贷款的同时，应当提交实行工程监理的“承诺函”（参考格式见附件一），作为开发银行贷款项目评审的条件。
借款人对申请贷款的项目不承诺实行工程监理的，开发银行评审部门不予评审。
第五条 开发银行在评审贷款项目时，应将监理费用列入工程项目总投资
第六条 开发银行总行的信贷业务部门或分行在合同谈判时应当要求借款人落实有关工程监理事宜。
借款合同中应当约定借款人承担以下义务：
（一）借款人聘用的监理公司应经开发银行认可；
（二）借款人应督促监理公司按期向开发银行报送监理工作月度报告及监理业务范围内的专项报告；
（三）借款人支付工程款时应向开发银行提交由监理公司和借款人共同签署同意的“工程进度款支付证书”（参考格式见附件二）。
（四）借款人与中标监理公司签订监理合同之前，应要求监理公司向开发银行提交“履行责任承诺函”（参考格式见附件三）。
第七条 借款人应依照法律、法规的规定采用公开招标的方式或邀请招标方式聘请监理公司。
借款人对监理公司招标应委托专业招标机构进行；符合有关规定的，经开发银行认可，借款人也可自行组织招标。
第八条 参加投标的监理公司必须具有建设部和行业主管部门颁发的双“甲级”资格。
第九条 开发银行总行的信贷业务部门或分行应派人参加监理公司的招标，对招标、评标过程进行监督。
第十条 开发银行对监理公司的招标没有提出异议的，借款人与中标的监理公司应签订监理合同。监理合同应当符合建设部、国家工商局颁布的《工程建设监理合同》示范文本的要求。
借款人与监理公司签订的《工程建设监理合同》在签字生效前，应送开发银行审查认可。
第十一条 借款人未按国家有关法律、法规及本规定进行监理招标而直接影响监理公司聘用的公正性的，开发银行有权要求借款人重新招标选定监理公司。借款人不重新招标的，开发银行有权拒绝发放贷款。
第十二条 中标受聘的监理公司应将有权签字的监理工程师及监理代表的名单、签字和监理公司印章在项目所在地的开发银行分行备案，如有更改应及时通知开发银行。
第十三条 借款人向施工方支付工程款时必须向开发银行提交由监理公司和借款人共同签署同意的“工程进度款支付证书”，作为开发银行付款审核的依据。
第十四条 开发银行贷款项目经理应对借款人提交的“工程进度款支付证书”进行审核，审核其是否符合贷款支付范围、工程量及结算是否准确，有无高估冒算。审核无误的，贷款项目经理应在借款人的“工程进度款支付证书”上签字同意，借款人据此到会计营业部门办理付款手续。
第十五条 开发银行贷款项目经理应定期或不定期地深入现场检查监理情况，监督监理合同执行。
第十六条 监理公司不认真履行职责致使监理项目在施工过程中有挪用贷款、增加工程概算、拖延工期及发生工程质量问题时，开发银行有权要求借款人取消监理公司的资格，解除监理合同，并依监理公司的承诺函追究其经济责任。
第十七条 借款人弄虚作假，聘请非法的监理公司的，开发银行有权要求更换监理单位，借款人拒不执行的，开发银行有权停止发放贷款或收回已发放的贷款。
第十八条 监理公司与借款人有串通行为，损害开发银行利益的，开发银行有权追究其法律责任。
第十九条 开发银行已经发放贷款的项目，借款人未实行监理的，信贷业务部门应当要求借款人根据项目的实际情况按照本规定补办监理；已实行监理的，应将监理合同送开发银行备案。
第二十条 开发银行外汇固定资产贷款项目工程监理管理参照本规定执行。
第二十一条 本规定由国家开发银行法律事务局负责解释。
第二十二条 本规定自一九九九年十月十二日起施行。

附件一：关于××建设项目实行工程监理的承诺函
国家开发银行：
我单位就××建设项目向你行申请贷款。我单位向你行承诺：贷款批准后，我单位保证按照国家有关法律、法规和你行的《国家开发银行贷款项目工程监理管理暂行规定》的要求，聘请监理公司对该建设项目实行全过程的工程监理，并接受你行的监督、审查。
借款人：（公章）
法定代表人（或授权代理人）：（签字）
××××年××月××日

附件二：
编号:
工程进度款支付证书
工程名称: 施工单位: 合同号:
经审核,根据建设单位和施工单位双方签订的合同,建设单位应支付以下数额的工程款:
备注:
监理单位 建设单位
监理工程师 建设单位代表
日期 日期
填表人 填表日期 年 月 日
本表一式三份,建设单位、施工单位、监理单位各一份。

附件三：××监理公司履行责任承诺函
国家开发银行：
我公司将受××建设单位（业主）之聘担任你行贷款的××建设项目的工程监理工作，我公司承诺将根据我公司与××建设单位（业主）签订的《工程建设监理合同》履行监理工作职责，并向你行报送有关资料，接受你行的监督。如因我公司不认真履行职责，而给你行带来损失的，我公司愿承担一切经济责任。
××监理公司：（公章）
法定代表人（或授权代理人）：（签字）
××××年××月××日