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.
邢台市酒类产（商）品专卖管理规定
河北省邢台市人民政府
邢台市酒类产（商）品专卖管理规定
邢政[1996]8号 1996年4月8日
第一条 为加强酒类产（商）品生产和流通管理，维护酒类市场秩序，严厉打击制造、经销假冒伪劣酒的违法行为，保护生产者、经营者和消费者的合法权益，增加财政收入，根据《河北省酒类产（商）品专酿专卖管理规定》，结合我市的具体情况，特制定本规定。
第二条 凡在邢台市辖区内，从事酒类产（商）品生产（包括加工、改装、勾兑）、流通（包括采购、销售、调运和储存）活动的企业、单位和个人，必须遵守本规定。
第三条 酒类产（商）品专卖管理的范围包括含一度以上酒精成份的白酒、黄酒、啤酒、葡萄酒、果露酒、配制酒、食用酒精及各种进口酒等。
第四条 酒类专卖管理坚持“生产管严、批发管住、零售搞活、重点打假”的原则，不准个体工商户开办酒厂、生产酒类产品；不准个体工商户开展酒类批发业务，要尽量多开设酒类产（商）品零售摊点，以方便群众购货。
第五条 市、县酒类专卖管理局是全面负责所辖区域酒类专卖管理的行政管理部门，统一负责酒类产（商）品的流通管理工作，受当地人民政府和上级酒类专卖管理局双重领导。
第六条 各级工商、技术监督、公安、卫生、交通、铁路、银行等部门，按各自的职责，积极协助酒类专卖管理部门做好酒类产（商）品专卖管理工作。
第七条 酒类产（商）品的批发、零售、运输实行许可证制度。各种许可证由市酒类专卖管理局根据省有关规定统一印制、审核和颁发。
第八条 凡从事酒类批发（包括零集兼批发）业务的单位，均应向当地酒类专卖管理局进行登记申请，经当地酒类专卖管理局审查同意并逐级报省酒类专卖管理局批准，发给《酒类批发证》后方可向当地工商行政管理部门申请领取营业执照。未取得《酒类批发许可证》的单位，不得从事酒类商品批发业务。
第九条 从事酒类零售业务，必须经当是县、市酒类专卖管理部门审核批准，发给《酒类零集许可证》，工商行政管理部门凭《酒类零售许可证》办理经营酒类的营业执照。经销酒类商品的单位和个体工商户只能向证照齐全的生产企业、批发企业进货。严禁销售掺杂使假、冲水降度和假冒伪劣类商品。
第十条 有计划的调控省外酒调入我市，需要从省外调入或进行品种调剂的酒类商品，必须在市酒类专卖管理局统一安排的数量档次内，发给《酒类调入许可证》，方可人事外采业务。严禁任何单位和个体户自行向省外采购。对未取得《酒类调入许可证》而擅自从省外购进酒类商品的，运输部门不予运输，银行不予结算，市场不准销售。
第十一条 凡需运往省外的酒类产品。须由市酒类专卖管理局发给《酒类调出许可证》方可调运。全市鼓励市内酒调出，县、市酒类专卖管理局应对调出酒类提供方便。
第十二条 从事进口酒类批发业务，从事国家名酒类和进口酒类的零售业务，必须持有相应的特种酒类经营许可证。特种酒类经营许可证由市酒类专卖管理局代省签发。
第十三条 对经批准从省外调入的酒类产（商）品，调入单位应将样品连同有关证件交送市酒严专卖管理局审验。经批准后方可销售。
第十四条 外省、市及省内外地、市生产或经销酒类产（商）品企业到我市辖区内销售酒类产（商）品的，必须到当地酒类专卖管理局申请，经批准后方可销售。
第十五条 刊登、播放以及利用其它形式所作的酒类产（商）品广告，必须经当地酒类专卖管理局批准。
第十六条 违反下列规定，各级酒类专卖管理局可根据《河北省酒类产（商）品专酿专卖管理规定》（河北省人民政府第48号令）和河北省人民政府法制局、河北省商业厅《关于进一步贯彻执行省政府48号令加强酒类专卖管理的通知》（冀商糖[1993]23号）进行处罚：
（一）未取得酒类经营许可证，擅自从事酒类批发、零售、调运的，酒类专卖管理局可根据情节轻重，没收其非法所得，并处以违法商品总额15-20%的罚款。
（二）已经取得《酒类零售许可证》的单位、个体户擅自从事酒类批发业务的，可根据情节轻重，没收其非法所得，并处以违法商品总额15-20%的罚款，并责令停止批发业务。情节严重、屡教不改的，吊销其零售许可证。
（三）对未经批准擅自从省外调入酒类商品的，可根据情节轻重，处以违法商品额15-20%的罚款。对已经出售的酒类商品没收其非法所得。对经批准购进的省外酒未经审验，擅自批发、销售的，酒类专卖管理局没收其非法所得，并处以违法商品总额8-10%的罚款。
（四）酒类产品生产企业，向无酒类经营许可证的单位批发酒类商品的，酒类商品零售企业、单位和个体户向未取得《酒类批发许可证》的批发企业、单位购进酒类商品的，根据情节轻重，没收其非法所得，并处以违法商品总额10-15%的罚款。
（五）酒类商品在省内运输，应持有酒类经营许可证副本和随货同行发票。没有调出单位随货同行发票或发货票的，责令其在5日内补办手续。逾期不办发货票手续或者没有酒类经营许可证的，处以违法商品总额10-15%的罚款。
（六）对擅自印制、伪造的证件和非法所得，并处以5000元-7000元的罚款，情节严重构成犯罪的，移送司法机关，依法追究刑事责任。
第十七条 对制售假冒劣质酒的，责令停止生产、销售、没收商品、原材料、作案工具及非法所得，对未售出版社以商品货值金额30-50%的罚款。已经售出的，并处违法所得2-5倍的罚款。经销假冒劣质酒的，可令其停止销售或停业整顿，没收非法所得，没收或销毁酒类商品，并根据情节轻重，处以违法商品总额15-20%罚款，情节严重构成犯罪的，由司法机关追究刑事责任。
第十八条 酒类专卖管理执法人员依照法定权限和程序，查处假冒伪劣酒类商品时，需要对生产、经销者应给予积极配合，不得擅自解封、转移、隐匿被扣押、查封酒类商品及违法所得。需要对有关酒类商品的质量、商标标识及其他标志进行检验、鉴定时，商品生产、经销者应提供必要的样品，经检验合格的，其费用由酒类专卖管理执法部门承担；不合格的，由生产、经销者负担。
第十九条 拒绝、阻碍酒类专卖管理执法人员执行职务的，酒类专卖管理部门吊销酒类专卖有关证伯，共处2000元-4000元的罚款；情节严重，构成犯罪的，由司法机关依法追究刑事责任。
第二十条 酒类专卖管理执法人员应严格按照执法程序处罚，佩带标识，出示省统一印制的行政执法证，对不持证件的，被检查企业、单位和个体户有权拒绝检查。
第二十一条 酒类专卖管理人员及其他国家机关的工作人员滥用职权、徇私舞弊，玩忽职守，索贿受贿，或者非法干预酒类专卖管理人员依法行使职权的，由其所在单位和上级主管部门给予行政处分；给受害人造成经济损失的，由侵害人所在机关或单位负行政赔偿责任；情节严重构成犯罪的，由司法机关依法追究刑事责任。
第二十二条 当事人对行政处罚决定不服的，可以在接到行政处罚决定之日起15日内，向作出处罚决定机关的本级人民政府或上级主管部门申请复议；也可以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，作出处罚决定的机关，可以申请人民法院强制执行。
第二十三条 对检举违反酒类（商）品专卖管理规定的单位和个人，经查实后，由酒类专卖管理规定的单位和个人，经查实后，由酒类专卖管理局给予一定的奖励。
第二十四条 本规定由邢台市酒类专卖管理局负责解释。
第二十五条 本规定自发布之日起施行。
