关于印发《德州市地热资源管理暂行办法》的通知
山东省德州市人民政府办公室
关于印发《德州市地热资源管理暂行办法》的通知
德政办字〔2012〕2号
各县(市、区)人民政府(管委会),市政府有关部门:
《德州市地热资源管理暂行办法》已经市政府同意,现印发给你们,请认真贯彻执行。
德州市人民政府办公室
二○一二年一月十五日
德州市地热资源管理暂行办法
第一条 为加强地热资源管理,合理开发利用和保护地热资源,根据《矿产资源法》、《矿产资源法实施细则》、《山东省实施〈中华人民共和国矿产资源法〉办法》和有关法律、法规,结合本市实际,制定本办法。
第二条 本办法所称地热资源是指储存于地下、具有一定质量(品级)和数量、可供开发利用的地热能,包括蒸气型、热水型、地压型、干热岩型和岩浆岩型五种类型,其中热水型地热是指温度在25℃以上(含25℃)的地下热水。
第三条 在本市范围内勘查、开采地热资源均应遵守本办法。
第四条 市国土资源局是我市地热资源管理的行政主管部门,负责全市地热资源的统一管理工作。
第五条 地热资源的开发利用实行统一规划、统一管理、合理布局、综合利用、注重效益和开发与环境保护并重的原则。
第六条 勘查、开采地热资源,必须符合《德州市矿产资源总体规划》和《地热资源开发利用规划》。
地热资源的开发利用规划,由国土资源行政主管部门会同有关部门制定,并按规定上报批准后实施。
第七条 申请勘查、开采地热资源,由市国土资源局报上级国土资源行政主管部门批准,办理勘查许可证、采矿许可证取得探矿权、采矿权。
开采国家出资勘查,已探明储量的地热资源,必须经公开出让后有偿取得采矿权。
第八条 勘查地热资源必须依法缴纳探矿权使用费和探矿权价款;开采地热资源必须依法缴纳采矿权使用费、采矿权价款和矿产资源补偿费。
第九条 承担地热勘查设计和地热井施工的单位,必须具有合法的资质证书。地热井施工必须严格遵守国家有关规程规范。
第十条 为合理开采和保护地热资源,实行保护性限量开采地热资源的制度。
国土资源行政主管部门在每年年初向地热开发单位下达年度开采指标,开发单位应在核定的计划指标内开采地热资源。
地热开发单位应按要求统一安装计量设施并向国土资源行政主管部门报送地热资源的月开采量、水温、水位等资料。
第十一条 开发单位应当加强对地热井及其附属设施的维护和管理,建立技术档案。地热井实行专人管理。
第十二条 开发利用地热资源,应当按照温度的差异实施梯级利用,采用先进技术,提高地热利用率。
第十三条 开采地热资源的单位或个人应承担回灌义务。
第十四条 地热资源探矿权、采矿权不得擅自转让。确需转让地热资源探矿权、采矿权的,必须经有批准权的国土资源行政主管部门批准。
第十五条 地热资源利用后的弃水,应符合国家的有关规定和排放标准。
第十六条 违反本办法规定的,由国土资源行政主管部门按照下列规定予以处罚:
(一)未取得勘查许可证擅自勘查地热资源的,由国土资源行政主管部门依据《矿产资源勘查区块登记管理办法》(国务院令第240号)第二十六条规定,责令停止违法行为,予以警告,可以并处10万元以下的罚款。
(二)未取得采矿许可证擅自开采地热资源的,由国土资源行政主管部门依据《山东省实施〈中华人民共和国矿产资源法〉办法》第三十一条规定,由国土资源行政主管部门责令停止开采,赔偿损失,没收采出的矿产品和违法所得,可以并处违法所得百分之五十以下的罚款,没有违法所得的,可以并处五万元以下的罚款;拒不停止开采的,县级国土资源行政主管部门可以封闭井口,查封采矿设备和工具;造成矿产资源破坏构成犯罪的,依法追究刑事责任。
(三)不按期缴纳本办法规定应当缴纳的费用的,由国土资源行政主管部门依据《矿产资源勘查区块登记管理办法》第三十一条、《矿产资源开采登记管理办法》第二十一条规定、《矿产资源补偿费征收管理规定》第十四条予以处罚。
(四)未经批准,擅自转让地热资源探矿权、采矿权的,依据《探矿权采矿权转让管理办法》(国务院令第242号)第十四条规定,由登记管理机关责令改正,没收违法所得,处10万元以下的罚款;情节严重的,由原发证机关吊销勘查许可证、采矿许可证。
(五)不按规定提交年度报告,拒绝接受监督检查或者弄虚作假的,依据《矿产资源开采登记管理办法》第十八条规定,由县级以上人民政府负责地质矿产管理工作的部门按照国务院地质矿产主管部门规定的权限,责令停止违法行为,予以警告,可以并处5万元以下的罚款;情节严重的,由原发证机关吊销采矿许可证。
(六)勘查、开采矿产资源造成地质环境破坏或者地质灾害,不按规定治理的,依据《山东省实施〈中华人民共和国矿产资源法〉办法》第三十五条规定,由国土资源行政主管部门责令限期治理,并可处以十万元以下罚款;情节严重的,由原发证机关吊销其勘查许可证或者采矿许可证。
第十七条 破坏地热井及地热动态监测设施,拒绝、阻碍执法人员依法执行公务的,由公安机关依照《治安管理处罚法》的规定予以处罚;构成犯罪的,依法追究刑事责任。
第十八条 本办法自2012年2月15日起施行,有效期至2014年2月15日。
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.
