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.
乌鲁木齐市养犬管理规定实施办法
新疆维吾尔自治区乌鲁木齐市人民政府
乌鲁木齐市人民政府令第70号
《乌鲁木齐市养犬管理规定实施办法》已经2005年9月20日市人民政府第29次常务会议通过，现予公布，自2005年12月20日起施行。
市长：雪克莱提·扎克尔
二○○五年十一月十八日
乌鲁木齐市养犬管理规定实施办法
乌鲁木齐市养犬管理规定实施办法
第一条 为实施《乌鲁木齐市养犬管理规定》，结合本市实际，制定本办法。
第二条 本市行政区域内的公民、法人和其他组织均应遵守本办法。
第三条 本市对养犬实行严格管理，限管结合的原则。
第四条 公安机关是本市养犬管理工作的主管机关。
兽医检疫、卫生、工商、行政综合执法、市政市容等部门应按照各自职责做好养犬管理工作。
第五条 社区居民委员会、村民委员会和其他基层组织应当协助政府各有关部门做好养犬管理工作。
社区居民委员会、村民委员会、业主委员会可以召集居民会议、村民会议、业主会议，就本居住地区有关养犬管理事项依法制定公约，组织监督实施。居民、村民、业主应当遵守公约。
第六条 本市行政区域内养犬地区分为重点管理区和一般管理区，其范围是：
（一）天山区、沙依巴克区、新市区、水磨沟区、乌鲁木齐经济技术开发区和高新技术产业开发区为重点管理区。其他地区为一般管理区；
（二）一般管理区内的风景旅游点、城镇和大中型企业的生产厂区、居民住宅区为重点管理区；
（三）重点管理区内的农村、牧区、农场为一般管理区。
第七条 本市实行养犬注册登记和年审制度。
警犬和军犬的饲养按有关规定办理。
单位因警卫或科研工作需要养犬的应按本规定办理手续。
第八条 重点管理区内个人登记养犬的，每户只准饲养一只高度不超过35公分的小型观赏犬。
第九条 单位和个人应在养犬的30日内，携犬到市兽医检疫部门免疫并领取家犬免疫证后，到居住地公安派出所注册登记，领取养犬证和犬牌。
第十条 养犬证年审时间为每年１月１日至３月３１日。
养犬人办理年审时，应当出示有效的养犬证和家犬免疫证。
第十一条 养犬人办理养犬证后，将犬转让他人的，应当按规定程序办理变更登记。犬死亡或失踪的，应办理注销手续；未办理注销手续的，不得再养犬。
第十二条 养犬者住所变更的，应当自变更之日起30日内持养犬证到新住所地公安派出所办理变更登记。养犬者将一般管理区登记的犬，转移到重点管理区饲养的，应当符合重点管理区的养犬条件，并自转移之日起30日内，持养犬证到饲养地公安派出所办理变更登记。
第十三条 养犬者丢失养犬证和犬牌的，应当在丢失之日起15日内，向原登记机关申请补发。
第十四条 单位和个人符合本办法规定申请养犬的，公安机关应当在5个工作日内予以注册登记。
第十五条 养犬者应遵守下列规定：
（一）按规定为犬注射疫苗；
（二）不准携犬进入商店、饭店、学校、医院、展览馆、影剧院、公园、体育馆、游乐场、车站、航空港等公共场所；
（三）不准携犬乘公共交通工具（小型出租汽车除外）；
（四）经登记饲养的大型犬应当实行拴养或圈养，不得出户。饲养的小型观赏犬出户时，必须挂牌并由成年人牵领；
（五）养犬不得侵扰他人的正常生活，犬吠影响他人休息时养犬者应当采取有效措施予以制止；
（六）携犬人对犬在户外排泄的粪便应立即清除；
（七）犬病死或死因不明的，应在兽医检疫部门监督下，进行无害化处理。
第十六条 犬伤害他人的，养犬人应当立即将被伤者送至医疗机构诊治，并先支付医疗费用。
因养犬者过错致使犬伤害他人的，养犬者应当负担被伤害人的全部医疗费用，并依法赔偿被伤害人的其他损失。
伤人的犬染疫或疑似染疫的，由兽医检疫部门按照动物防疫有关规定进行处理。
第十七条 从事犬类养殖或举办犬类展览的，须经所在地公安机关同意后，依法到工商行政管理机关办理有关手续。
重点管理区内禁止从事犬类养殖和举办犬类展览。
第十八条 在本市进行犬类交易的，须持家犬免疫证在合法场所交易。进出本市的犬，应有市兽医检疫部门的畜禽运输检疫证明，运输部门方可承运。
第十九条 犬类交易市场和从事犬类养殖、犬类展览应当具备必要的安全防护条件，制定有效的管理制度和应急处置方案。
第二十条 对违反本办法的养犬行为，任何单位和个人都有权批评、劝阻或者举报，有关部门接到举报后应当及时处理。
第二十一条 因养犬干扰他人正常生活发生纠纷的，当事人可以向人民调解委员会申请调解，也可以直接向人民法院起诉。
第二十二条 公安机关应当建立养犬者违法记录档案，对多次被举报或者处罚的养犬者进行重点管理。
养犬者因违反本办法，被公安机关没收其犬、吊销养犬证的，在五年内不予办理养犬登记。
第二十三条 违反本办法擅自养犬的，由公安机关予以没收，并对养犬者按每只犬处以1000元罚款。
养犬者不按期审验养犬证的，由公安机关责令限期审验。逾期不审验的，按前款规定处罚。
第二十四条 违反本办法第十五条（二）、（三）、（四）、 （五）项的，由公安机关责令改正，并处以100元以上200元以下罚款；情节严重的，没收其犬，吊销养犬证。
违反本办法的第十五条（六）项的，由行政综合执法机关处以100元以上200元以下的罚款。
第二十五条 公安机关对没收的犬应当委托犬类交易市场变卖，变卖后所得款项上缴国库。
对于流浪犬、狂犬，公安机关应当组织进行捕捉、捕杀。对捕捉的流浪犬为名贵犬只的，应当委托犬只养殖者代养，并公告寻找失主；失主领回其犬只的，应当依法承担相应的费用；公告期满没有找到失主的，由公安机关依照前款规定处理。
第二十六条 违反本办法应当受到行政处罚的其他行为，依照有关法律、法规予以处罚。
第二十七条 拒绝、阻碍执法人员依法执行公务的，依照《中华人民共和国治安管理处罚条例》处罚；构成犯罪的，依法追究刑事责任。
第二十八条 养犬管理部门的工作人员有下列行为之一的，由其所在单位或上级主管部门给与行政处分；构成犯罪的，依法追究刑事责任；
（一）不依法履行职责的；
（二）违法行政造成后果的；
（三）不按规定登记、审验养犬证的；
（四）对群众举报不及时处理造成后果的；
（五）其他玩忽职守、滥用职权、徇私舞弊的。
第二十九条 当事人对行政处罚决定不服的，可依法申请行政复议或提起行政诉讼。
第三十条 本办法自2005年12月20起施行。2001年8月31日市人民政府公布施行的《乌鲁木齐市养犬管理规定实施细则》同时废止。
