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.
嘉兴市人民政府办公室关于印发嘉兴市征地补偿标准争议协调办法的通知
浙江省嘉兴市人民政府办公室
嘉兴市人民政府办公室关于印发嘉兴市征地补偿标准争议协调办法的通知
各县（市、区）人民政府，市政府有关部门、直属有关单位：
《嘉兴市征地补偿标准争议协调办法》已经六届市政府第63次常务会议讨论通过，现印发给你们，请认真贯彻执行。
嘉兴市人民政府办公室
二○一一年九月十五日
嘉兴市征地补偿标准争议协调办法
第一章 总则
第一条 为及时、公正地解决征地补偿标准争议，保护被征地农村集体经济组织和被征地人员的合法权益，保障征地工作顺利进行，根据《中华人民共和国土地管理法实施条例》、《浙江省征地补偿标准争议协调裁决办法（试行）》等规定，结合本市实际，制定本办法。
第二条 在本市行政区域范围内，因实施依法批准的土地征收行为而发生的征地补偿标准争议的协调，适用本办法。法律、法规、规章另有规定的，从其规定。
第三条 按照“谁征地，谁协调”的原则，市、县（市、区）人民政府是所辖行政区域内征地补偿标准争议的协调机关。协调机关设立征地补偿标准争议协调办公室（以下简称协调办公室）。
第四条 征地补偿标准争议协调必须遵循合法、公平、公开、公正、及时、便民的原则。
第五条 征地所在地的人民政府应加强组织领导，法制、国土资源、财政、公安、民政、劳动保障、农业经济、水利等相关职能部门密切配合，做好有关征地补偿标准争议的协调工作。
第六条 征地补偿标准争议协调期间，不影响征地方案的实施。
第二章 申请与受理
第七条 本办法所称的申请人是指被征收集体土地及地上附着物（除房屋外）、青苗的所有权人。对土地补偿费的补偿标准有争议的，由农村集体经济组织提出协调申请；对地上附着物（除房屋外）或青苗补偿费有争议的，由地上附着物或青苗所有权人提出协调申请。
被申请人是指具体实施征收土地补偿的单位或组织。
第八条 申请人对征地补偿标准有争议的，可自征地补偿安置方案公告之日起60日内，向批准征地补偿安置方案的市、县（市、区)人民政府的协调办公室提出协调申请。
第九条 申请人申请协调时，应当提交下列资料：
（一）协调申请书；
（二）申请人及其代理人的身份证明材料；
（三）被征收土地的所有权证或其他权属证明；
（四）因协调需要应当提供的其他资料。
申请人可自行申请协调，也可以委托代理人申请协调，委托的代理人不得超过2人，并应当提交授权委托书、代理人身份证明等相关资料。
第十条 协调申请书应当有明确的申请人、被申请人、协调的具体请求事项及事实、理由与依据。
第十一条 协调办公室应当自收到协调申请之日起10日内对申请人的申请事项进行审查，决定是否受理。符合受理条件的，应当出具受理通知书；不符合受理条件的，应当出具不予受理告知书，告知理由。
第十二条 有下列情形之一的，书面告知不予受理：
（一）不按本办法第八条规定的期限和程序提出协调申请的；
（二）申请人资格不符合本办法规定的；
（三）申请人材料提交不全，经告知，在规定期限内未补正的；
（四）同一事项经过协调后，又以相同事实和理由再次申请协调的；
（五）按本办法第三条规定，不属于本协调机关受理协调的；
（六）裁决机关已作出裁决的；
（七）征地补偿标准争议已经法院判决的；
（八）其他不属于征地补偿标准争议的。
第三章 协调
第十三条 协调办公室应当自受理协调申请之日起5日内，向被申请人送达协调申请书副本及答复通知书。被申请人应当自收到答复通知书之日起10日内，向协调办公室提交书面答复和有关证据材料。
第十四条 协调办公室应当自受理通知书发出之日起30日内组织协调，并提出协调意见。
第十五条 协调办公室应对申请协调事项进行全面、客观、公正的调查，并收集有关证据。调查时，调查人员不少于2人，调查后应制作调查笔录，调查人员应在调查笔录上签字。
第十六条 协调办公室应当在协调前5日告知申请人和被申请人协调的时间和地点。申请人无正当理由不参加协调的，视作撤回申请。被申请人无正当理由不参加协调的，终止协调，告知申请人向浙江省人民政府征地补偿标准争议协调裁决办公室申请协调裁决。
第十七条 协调按以下程序进行：
（一）主持人宣读协调纪律和协调工作要求；
（二）听取申请人陈述意见；
（三）听取被申请人陈述意见；
（四）听取有关单位意见；
（五）核实证据资料；
（六）主持人依据法律、法规和有关规定，提出协调意见；
（七）询问申请人和被申请人是否愿意按照主持人提出的协调意见，协商解决争议事项，或者终止协调。
第十八条 组织协调时，协调人员不少于2人。协调会应制作协调笔录；协调笔录应由申请人与被申请人阅读、补正并当场签字或盖章；无正当理由拒绝签字或者盖章的，记明情况附卷。申请人超过3人的，应当推选1至2名代表参加协调会。
第十九条 经协调达成一致的，协调办公室应制作和解协议书，由协调机关、申请人或申请人代表以及被申请人共同签名（盖章）生效。
协调不成的，协调办公室应当书面告知申请人协调结果，当事人可自收到告知书之日起15日内向省人民政府申请裁决。
第二十条 有下列情形之一的，终止协调：
（一）受理协调申请后，申请人和被申请人自行达成协议的；
（二）经协调机关协调后，申请人和被申请人达成一致意见的；
（三）申请人撤回协调申请，经过协调机关同意的；
（四）经审查不属于征地补偿标准争议的。
第二十一条 协调机关应当自受理协调申请之日起60日内终止协调，制作和解协议或作出协调不成告知书。情况复杂的，经协调办公室负责人批准，可以延长30日，并书面告知申请人和被申请人。
第四章 附则
第二十二条 协调机关受理协调申请，不得收取任何费用，协调工作所需经费，由财政予以保障。
第二十三条 因征收集体土地而对房屋实行拆迁的补偿、安置有争议的，不适用本办法。
第二十四条 各县（市、区）人民政府根据本办法，可制定协调实施细则。
第二十五条 本办法自印发之日起30日后实施施行。
