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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.




国务院国有资产监督管理委员会


国务院国有资产监督管理委员会令

第12号

　　《企业国有资产评估管理暂行办法》已经国务院国有资产监督管理委员会第31次主任办公会议审议通过，现予公布，自2005年9月1日起施行。

国务院国有资产监督管理委员会主任　李荣融

二ＯＯ五年八月二十五日



企业国有资产评估管理暂行办法

第一章　总　则

　　第一条 为规范企业国有资产评估行为，维护国有资产出资人合法权益，促进企业国有产权有序流转，防止国有资产流失，根据《中华人民共和国公司法》、《企业国有资产监督管理暂行条例》（国务院令第378号）和《国有资产评估管理办法》（国务院令第91号）等有关法律法规，制定本办法。

　　第二条 各级国有资产监督管理机构履行出资人职责的企业（以下统称所出资企业）及其各级子企业（以下统称企业）涉及的资产评估，适用本办法。

　　第三条 各级国有资产监督管理机构负责其所出资企业的国有资产评估监管工作。

　　国务院国有资产监督管理机构负责对全国企业国有资产评估监管工作进行指导和监督。

　　第四条 企业国有资产评估项目实行核准制和备案制。

　　经各级人民政府批准经济行为的事项涉及的资产评估项目，分别由其国有资产监督管理机构负责核准。

　　经国务院国有资产监督管理机构批准经济行为的事项涉及的资产评估项目，由国务院国有资产监督管理机构负责备案；经国务院国有资产监督管理机构所出资企业（以下简称中央企业）及其各级子企业批准经济行为的事项涉及的资产评估项目，由中央企业负责备案。

　　地方国有资产监督管理机构及其所出资企业的资产评估项目备案管理工作的职责分工，由地方国有资产监督管理机构根据各地实际情况自行规定。

　　第五条 各级国有资产监督管理机构及其所出资企业，应当建立企业国有资产评估管理工作制度，完善资产评估项目的档案管理，做好项目统计分析报告工作。

　　省级国有资产监督管理机构和中央企业应当于每年度终了30个工作日内将其资产评估项目情况的统计分析资料上报国务院国有资产监督管理机构。

第二章　资产评估

　　第六条 企业有下列行为之一的，应当对相关资产进行评估：

　　（一）整体或者部分改建为有限责任公司或者股份有限公司；

　　（二）以非货币资产对外投资；

　　（三）合并、分立、破产、解散；

　　（四）非上市公司国有股东股权比例变动；

　　（五）产权转让；

　　（六）资产转让、置换；

　　（七）整体资产或者部分资产租赁给非国有单位；

　　（八）以非货币资产偿还债务；

　　（九）资产涉讼；

（十）收购非国有单位的资产；

（十一）接受非国有单位以非货币资产出资；

（十二）接受非国有单位以非货币资产抵债；

　　（十三）法律、行政法规规定的其他需要进行资产评估的事项。

　　第七条 企业有下列行为之一的，可以不对相关国有资产进行评估：

　　（一）经各级人民政府或其国有资产监督管理机构批准，对企业整体或者部分资产实施无偿划转；

　　（二）国有独资企业与其下属独资企业（事业单位）之间或其下属独资企业（事业单位）之间的合并、资产（产权）置换和无偿划转。

　　第八条 企业发生第六条所列行为的，应当由其产权持有单位委托具有相应资质的资产评估机构进行评估。

　　第九条 企业产权持有单位委托的资产评估机构应当具备下列基本条件：

　　（一）遵守国家有关法律、法规、规章以及企业国有资产评估的政策规定，严格履行法定职责，近3年内没有违法、违规记录；

　　（二）具有与评估对象相适应的资质条件；

　　（三）具有与评估对象相适应的专业人员和专业特长；

　　（四）与企业负责人无经济利益关系；

　　（五）未向同一经济行为提供审计业务服务。

　　第十条 企业应当向资产评估机构如实提供有关情况和资料，并对所提供情况和资料的真实性、合法性和完整性负责，不得隐匿或虚报资产。

　　第十一条 企业应当积极配合资产评估机构开展工作，不得以任何形式干预其正常执业行为。

第三章　核准与备案

　　第十二条 凡需经核准的资产评估项目，企业在资产评估前应当向国有资产监督管理机构报告下列有关事项：

　　（一）相关经济行为批准情况；

　　（二）评估基准日的选择情况；

　　（三）资产评估范围的确定情况；

　　（四）选择资产评估机构的条件、范围、程序及拟选定机构的资质、专业特长情况；

　　（五）资产评估的时间进度安排情况。

　　第十三条 企业应当及时向国有资产监督管理机构报告资产评估项目的工作进展情况。国有资产监督管理机构认为必要时，可以对该项目进行跟踪指导和现场检查。

　　第十四条 资产评估项目的核准按照下列程序进行：

　　（一）企业收到资产评估机构出具的评估报告后应当逐级上报初审，经初审同意后，自评估基准日起8个月内向国有资产监督管理机构提出核准申请；

　　（二）国有资产监督管理机构收到核准申请后，对符合核准要求的，及时组织有关专家审核，在20个工作日内完成对评估报告的核准；对不符合核准要求的，予以退回。

　　第十五条 企业提出资产评估项目核准申请时，应当向国有资产监督管理机构报送下列文件材料：

　　（一）资产评估项目核准申请文件；

　　（二）资产评估项目核准申请表（附件1）；

　　（三）与评估目的相对应的经济行为批准文件或有效材料；

　　（四）所涉及的资产重组方案或者改制方案、发起人协议等材料；

　　（五）资产评估机构提交的资产评估报告（包括评估报告书、评估说明、评估明细表及其电子文档）；

　　（六）与经济行为相对应的审计报告；

　　（七）资产评估各当事方的相关承诺函；

　　（八）其他有关材料。

　　第十六条 国有资产监督管理机构应当对下列事项进行审核：

　　（一）资产评估项目所涉及的经济行为是否获得批准；

　　（二）资产评估机构是否具备相应评估资质；

　　（三）评估人员是否具备相应执业资格；

　　（四）评估基准日的选择是否适当，评估结果的使用有效期是否明示；

　　（五）资产评估范围与经济行为批准文件确定的资产范围是否一致；

　　（六）评估依据是否适当；

　　（七）企业是否就所提供的资产权属证明文件、财务会计资料及生产经营管理资料的真实性、合法性和完整性做出承诺；

　　（八）评估过程是否符合相关评估准则的规定；

　　（九）参与审核的专家是否达成一致意见。

　　第十七条 资产评估项目的备案按照下列程序进行：

　　（一）企业收到资产评估机构出具的评估报告后，将备案材料逐级报送给国有资产监督管理机构或其所出资企业，自评估基准日起9个月内提出备案申请；

　　（二）国有资产监督管理机构或者所出资企业收到备案材料后，对材料齐全的，在20个工作日内办理备案手续，必要时可组织有关专家参与备案评审。

　　第十八条 资产评估项目备案需报送下列文件材料：

　　（一）国有资产评估项目备案表一式三份（附件2）；

　　（二）资产评估报告（评估报告书、评估说明和评估明细表及其电子文档）；

　　（三）与资产评估项目相对应的经济行为批准文件；

　　（四）其他有关材料。

　　第十九条 国有资产监督管理机构及所出资企业根据下列情况确定是否对资产评估项目予以备案：

　　（一）资产评估所涉及的经济行为是否获得批准；

　　（二）资产评估机构是否具备相应评估资质，评估人员是否具备相应执业资格；

　　（三）评估基准日的选择是否适当，评估结果的使用有效期是否明示；

　　（四）资产评估范围与经济行为批准文件确定的资产范围是否一致；

　　（五）企业是否就所提供的资产权属证明文件、财务会计资料及生产经营管理资料的真实性、合法性和完整性作出承诺；

　　（六）评估程序是否符合相关评估准则的规定。

　　第二十条 国有资产监督管理机构下达的资产评估项目核准文件和经国有资产监督管理机构或所出资企业备案的资产评估项目备案表是企业办理产权登记、股权设置和产权转让等相关手续的必备文件。

　　第二十一条 经核准或备案的资产评估结果使用有效期为自评估基准日起1年。

　　第二十二条 企业进行与资产评估相应的经济行为时，应当以经核准或备案的资产评估结果为作价参考依据；当交易价格低于评估结果的90%时，应当暂停交易，在获得原经济行为批准机构同意后方可继续交易。

第四章 监督检查

　　第二十三条 各级国有资产监督管理机构应当加强对企业国有资产评估工作的监督检查，重点检查企业内部国有资产评估管理制度的建立、执行情况和评估管理人员配备情况，定期或者不定期地对资产评估项目进行抽查。

　　第二十四条 各级国有资产监督管理机构对企业资产评估项目进行抽查的内容包括：

　　（一）企业经济行为的合规性；

　　（二）评估的资产范围与有关经济行为所涉及的资产范围是否一致；

　　（三）企业提供的资产权属证明文件、财务会计资料及生产经营管理资料的真实性、合法性和完整性；

　　（四）资产评估机构的执业资质和评估人员的执业资格；

　　（五）资产账面价值与评估结果的差异；

　　（六）经济行为的实际成交价与评估结果的差异；

　　（七）评估工作底稿；

　　（八）评估依据的合理性；

　　（九）评估报告对重大事项及其对评估结果影响的披露程度，以及该披露与实际情况的差异；

　　（十）其他有关情况。

　　第二十五条 省级国有资产监督管理机构应当于每年度终了30个工作日内将检查、抽查及处理情况上报国务院国有资产监督管理机构。

　　第二十六条 国有资产监督管理机构应当将资产评估项目的抽查结果通报相关部门。

第五章　罚则

　　第二十七条 企业违反本办法，有下列情形之一的，由国有资产监督管理机构通报批评并责令改正，必要时可依法向人民法院提起诉讼，确认其相应的经济行为无效：

（一）应当进行资产评估而未进行评估；

　　（二）聘请不符合相应资质条件的资产评估机构从事国有资产评估活动；

　　（三）向资产评估机构提供虚假情况和资料，或者与资产评估机构串通作弊导致评估结果失实的；

（四）应当办理核准、备案而未办理。

　　第二十八条 企业在国有资产评估中发生违法违规行为或者不正当使用评估报告的，对负有直接责任的主管人员和其他直接责任人员，依法给予处分；涉嫌犯罪的，依法移送司法机关处理。

　　第二十九条 受托资产评估机构在资产评估过程中违规执业的，由国有资产监督管理机构将有关情况通报其行业主管部门，建议给予相应处罚；情节严重的，可要求企业不得再委托该中介机构及其当事人进行国有资产评估业务；涉嫌犯罪的，依法移送司法机关处理。

　　第三十条 有关资产评估机构对资产评估项目抽查工作不予配合的，国有资产监督管理机构可以要求企业不得再委托该资产评估机构及其当事人进行国有资产评估业务。

　　第三十一条 各级国有资产监督管理机构工作人员违反本规定，造成国有资产流失的，依法给予处分；涉嫌犯罪的，依法移送司法机关处理。

第六章 附 则

　　第三十二条 境外国有资产评估，遵照相关法规执行。

　　第三十三条 政企尚未分开单位所属企事业单位的国有资产评估工作，参照本办法执行。

　　第三十四条 省级国有资产监督管理机构可以根据本办法，制定本地区相关工作规范，并报国务院国有资产监督管理机构备案。

　　第三十五条 本办法自2005年9月1日起施行。

　　附件1：资产评估项目核准申请表

　　附件2：国有资产评估项目备案表