关于印发蚌埠市政府投资的城市基础设施项目建设管理暂行规定的通知
安徽省蚌埠市人民政府
关于印发蚌埠市政府投资的城市基础设施项目建设管理暂行规定的通知
蚌政〔2010〕13号
各县、区人民政府,市政府各部门、各直属单位:
经市政府同意,现将《蚌埠市政府投资的城市基础设施项目建设管理暂行规定》印发给你们,请抓紧贯彻执行。
二○一○年二月九日
蚌埠市政府投资的城市基础设施项目建设管理暂行规定
第一条 为规范政府投资的城市基础设施项目的建设和管理,根据《关于印发蚌埠市投融资及城市建设管理体制改革实施方案的通知》(蚌政〔2010〕12号),制定本规定。
第二条 本规定适用于市本级财政性资金、中央和省补助资金(含国债资金),财政性资金作为还款来源或还款担保的借贷性资金,以及其他用于政府性投资项目的资金投资建设的城市基础设施项目,包括城市道路、公共交通、供水、排水、燃气、热力、园林、环卫、污水处理、垃圾处理、防洪、公路和地下公共设施等。
第三条 城市基础设施项目实行项目储备制度。市住建、交通、水利、市容、规划等市直有关部门以及各区政府,根据全市国民经济和社会发展中长期规划、城市总体规划、土地利用规划、区域控制性规划、有关专项规划及实际发展需要,提出城市基础设施建设项目建议,报市发展和改革委员会。
第四条 市发展和改革委员会会同市住建、规划、国土等部门,对有关市直部门、各区政府提出的项目建议进行初步审查,提出初审意见后,由市投融资管理委员会办公室上报市投融资管理委员会审定,纳入政府投资项目储备库。
第五条 市投融资管理中心、市发展和改革委员会于每年第三季度组织市住建、规划、重点工程建设管理等部门,对列入储备库的项目进行筛选,提出下一年度建设项目投融资计划,经市投融资管理委员会审定后,分别由市发展和改革委员会下达年度项目建设投资计划、市投融资管理中心下达项目建设融资计划。
第六条 列入年度建设计划的项目等同于立项,市项目行业主管部门牵头组织编制项目可行性研究报告,并以市城投公司名义报送市发展和改革委员会审批。符合规定条件的,市发展和改革委员会及时批准,向市城投公司下达可研批复,并抄送市项目行业主管部门、市投融资管理中心和市重点工程建设管理局等相关部门。
第七条 市重点工程建设管理局依据批准的项目可行性研究报告,会同行业主管部门或使用单位编制初步设计(含概算),并组织相关单位进行勘察及施工图设计、审图和预算编制。
第八条 市重点工程建设管理局依据批准的初步设计和施工图设计文件,组织项目实施,并严格按照批准的建设规模、建设内容、建设标准实行合同管理,对项目建设实施全过程管理。
市重点工程建设管理局应当按照有关法律、法规规定和基本建设程序要求,办理项目建设相关行政许可手续。
市重点工程建设管理局应当将合同文本等资料及时报送市项目行业主管部门、市投融资管理中心和市城投公司备案。
第九条 市重点工程建设管理局具体负责项目的施工、监理等招投标工作,市城投公司及相关项目行业主管部门参与资格预审和制定招标文件等工作,市相关项目行业主管部门负责行业监管。
第十条 项目建设过程中,因设计变更可能超过概算的,市重点工程建设管理局应报项目行业主管部门初审后,由市发展和改革委员会会同有关部门审核确定,并按规定办理有关批准手续。
第十一条 项目建设涉及征地拆迁的,由项目所在区政府负责征地拆迁,按照市政府确定的征地拆迁方案,按时完成征地拆迁工作。征地拆迁费用应分项目列入工程概算和决算。
第十二条 市重点工程建设管理局应当根据项目建设投资额、施工合同和工程计划进度,按季编制分月资金使用计划,报市投融资管理中心和市城投公司确定贷款提款、资金拨付计划。
第十三条 项目建设资金由市重点工程建设管理局根据施工合同和工程实际进度提出支付意见,市城投公司应当及时审核拨付资金。资金支付一般实行直接支付。
征地拆迁费用由市重点工程建设管理局牵头组织有关部门审核确定后,市城投公司应及时将资金支付给有关区政府或其他收款人。
第十四条 工程竣工后,市项目审批部门、市直各有关行业主管部门组织验收。市重点工程建设管理局应当在工程验收合格后3个月内将工程完成情况(包括竣工决算)汇总报送市城投公司,经财政、审计部门核查审计后,办理竣工决算批复和资产移交手续。
第十五条 市各有关部门应当加强协调、相互配合,确保项目建设顺利进行。
市发展改革、财政、投融资管理、规划、国土、审计、监察等部门应当认真履行职责,依法对项目建设加强监督管理,做好项目协调和服务工作。
第十六条 本规定所指的市项目行业主管部门,系城市基础设施项目涉及的市住建、交通、水利、市容等市直主管部门。其中住建、市容部门以外的城市基础设施项目,项目实施主体为交通、水利、蚌投集团等提出项目的责任单位,各区、开发区提出的项目,可按本规定通过市城投公司平台进行融资,项目实施主体为各区、开发区。
第十七条 政府投资的社会公益性项目,参照本规定执行。
第十八条 本规定自发布之日起施行。
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.