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.
商业部发展机电产品出口管理工作细则（试行）
商业部
商业部发展机电产品出口管理工作细则（试行）
1992年1月14日，商业部
全文
第一章 总 则
第一条 为促进商业部系统机电产品出口持续、稳定增长，维护出口机电产品的信誉，增强竞争能力，发挥群体优势，努力开拓国际市场，根据《国务院批转国务院机电产品出口办公室关于“八五”期间进一步扩大机电产品出口意见的通知》精神，制定本细则。
第二条 本细则适用于商业部系统机电产品生产企业、外贸企业。
第三条 商业部机电产品出口办公室负责商业部系统机电出口产品的组织、协调、监督、检查工作，其职责与任务是：
（一）贯彻执行国家有关机电出口产品的方针、政策，结合商业部系统的实际制订商业部系统机电出口产品的发展目标和规划及具体政策措施。
（二）编制商业部系统机电出口产品年度工作计划并组织实施。
（三）会同国家进出口商品检验局全面负责实施商业部出口机电产品质量许可证组织指导协调工作，制定颁发质量许可证考核办法、认可检测单位、审批颁发和吊销质量许可证。
（四）制定商业部机电出口产品的指导性最低限价；审批重要成套设备的出口价格；负责商业部系统出口机电产品价格协调工作。
（五）负责商业部出口机电产品质量的监督检查，组织重大技术攻关和重点技改项目的开发与实施。
（六）协调商业部机电出口产品生产企业与有关外贸单位的关系，帮助解决工作中出现的问题，沟通信息，做好服务。
（七）承办国务院机电产品出口办公室和领导交办的有关任务。
第二章 出口产品的管理
第四条 出口的机电产品，必须是经过鉴定、产品定型、达到稳定生产的产品。
第五条 出口机电产品的质量应符合下列要求：
（一）符合国际标准、国家标准和产品归口部门行业标准。没有上述标准的，则应符合经标准部门认可的企业标准。
（二）对外贸易合同或者协议有约定检验标准和要求的，应符合对外贸易合同或者协议约定的检验标准和要求。
（三）对来图来样加工的产品，应符合由生产企业、出口经营单位和所在地商检局按来图来样共同制定的出口产品技术要求。
（四）出口机电产品的包装应符合经贸部、国家进出口商品检验局有关出口机电产品包装的要求。
第六条 凡出口产品因质量、包装等问题而发生的退货、索赔和其他违约现象造成的经济损失，生产企业要负责赔偿，属于个人失职的要追究直接责任者。
第三章 生产企业的管理
第七条 生产出口机电产品的企业，必须具备下列条件：
（一）有完整、统一、正确的产品图纸、技术要求和检验规程。
（二）有保证原材料、零部件和产品质量所需的生产设备、工艺装备和计量器具、检测仪器和实验设备。
（三）具有相应的专业技术人员、熟练技术工人和计量检验人员，并能严格按照图纸、工艺文件和技术标准进行生产、试验和检测。
（四）建立有效的质量保证、监督、检验体系，并经有关主管部门考核达标。
（五）建立文明生产的管理与考核制度，能按期完成出口任务。
第八条 生产企业要按照商业部机电产品出口办公室的要求，按期报送商业部出口机电产品统计报表和有关资料。
第九条 生产企业要积极与各外贸企业合作，加强与系统内外贸企业的合作。服从商业部机电产品出口办公室的协调与管理。
第十条 生产企业要主动与所在省、自治区、直辖市、计划单列市机电产品出口办公室和当地商检部门联系，争取他们的指导、帮助和支持。
第十一条 生产已实施出口机电产品质量许可证产品的企业，必须取得质量许可证，方能提供出口机电产品。
第十二条 生产企业要有计划地培养机电外贸人才，选送人员参加各类培训，以适应扩大机电产品出口，开拓国际市场的需要。
第四章 出口的协调管理
第十三条 商业部系统机电产品出口企业，遵照国家有关机电产品出口的各项法规和规定，享受国家给予机电产品出口的各项扶持和优惠政策。
第十四条 坚持多渠道出口的原则，积极与有机电产品出口经营权的各外贸企业合作，共同开拓国际市场。
第十五条 要加强系统内生产企业与外贸企业的合作，生产企业要优先保证系统内外贸企业的出口任务。系统内外贸企业要努力搞好规划，开拓市场，为生产企业和外商提供优质服务。
第十六条 鼓励开拓新市场和出口新产品，保护开拓者的利益。本着谁开拓谁经营的原则，对已开拓的出口产品市场，由商业部机电产品出口办公室商中国机电产品进出口商会予以协调保护，其他经营者未经协调同意，不得在该市场经营同样产品。
第十七条 商业部归口管理的成套设备出口，其外贸经营企业的报价，由商业部机电产品出口办公室商中国机电产品进出口商会共同协调。不经协调造成同规模报价混乱的，商业部机电产品出口办公室有权要求生产企业不予供货。
第十八条 对出口量大、产品信誉好、市场稳定的已出口产品和出口潜力大的主要产品，要逐步实行出口价格保护。由商业部机电产品出口办公室商中国机电产品进出口商会，协调制定有关产品外销最低限价。
第十九条 外贸企业与生产企业要本着互惠互利的原则，积极合作，协商办事。外贸企业与生产企业直接协调有困难时，可报请部机电产品出口办公室帮助协调。
第二十条 逐步实施出口机电产品质量许可证制度。按照国家进出口商品检验局、国务院机电产品出口办公室颁发的《出口机电产品质量许可证管理办法》，商业部机电产品出口办公室会同国家进出口商品检验局，负责实施商业部归口管理的出口机电产品质量许可证的领导和管理工作，制定和组织实施质量许可证考核办法，认可检测单位，签发和吊销质量许可证，协调和处理有关事宜。
《商业部实施出口机电产品质量许可证产品目录》和《商业部出口机电产品质量许可证实施细则》，由商业部会同国家进出口商品检验局制定发布。
第二十一条 商业部机电产品出口办公室负责编制商业部系统机电出口产品年度计划和发展规划，报国务院机电产品出口办公室审批并组织实施。各有关单位要按要求认真上报有关资料，共同编制好年度计划和发展规划。
第五章 申报项目管理
第二十二条 大力支持出口机电产品生产企业的技术改造，商业部每年安排的技术改造项目中，优先安排重点出口产品和企业的技术改造。申报程序按正常技改手续办理。
第二十三条 机电产品出口专项贷款的使用。机电产品出口专项贷款是国家为鼓励、扶持、扩大机电产品出口而设立的专项使用的贷款，主要用于机电产品出口基地企业和扩大机电产品出口生产企业为扩大机电产品出口进行技术改造、技术引进和产品研究开发。国务院机电产品出口办公室每年组织审批下达。
（一）申请机电产品出口专项贷款的企业，必须具备下列基本条件：
1．经过批准的机电产品出口基地企业、扩大出口企业和经特别批准的少数确需进行技术改造的一般出口企业，以及为出口服务的少数科研机构；
2．有按程序正式批准的技术改造、技术引进和研究开发项目的可行性方案，可明显提高经济效益和出口创汇能力；
3．具有按期还本付息的能力。
（二）贷款项目的申请与审批：
凡具备条件的企业可提出贷款申请计划，于每年三月一日前编写好机电产品出口技改专贷项目建议书（包括企业概况、出口产品国际市场需求情况、需要改造的理由、技术改造的主要内容、改造后预期达到的经济效益、投资概算和资金来源）送至省商办机械工业主管部门（省商业、粮食厅（局）、供销社）和省机电产品出口办公室；经审查同意后，由省级主管部门、省机电办、省工商银行或农业银行分行、省经委（或计经委）共同进行审定；审定后于四月十五日前由省级主管部门寄送至商业部机电产品出口办公室（一式四份）；部机电办审查同意盖章后，于五月底前送国务院机电产品出口办公室审批。
第二十四条 机电产品出口生产体系建设。商业部机电产品出口办公室每年组织商业部系统机电产品出口企业，向国务院机电产品出口办公室申报机电产品出口基地企业（以下简称基地企业）和扩大机电产品出口生产企业（以下简称扩大出口企业）。具体申报办法详见商业部部发（91）工字第1182号。
部机电产品出口办公室负责对系统内已批准出口基地企业或扩大出口企业的考核。
第二十五条 为鼓励商办机械工业企业出口创汇的积极性，商业部机电产品出口办公室每年对年创汇超过50万美元和在出口方面作出显著成绩的企业进行表彰。
第六章 附 则
第二十六条 本细则由商业部机电产品出口办公室负责解释。
第二十七条 本细则自发布之日起试行。
