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Decision of the State Council to Amend and Repeal Certain Administrative Regulations (2017) [Partially Invalid]
国务院关于修改和废止部分行政法规的决定(2017) [部分失效]
【法宝引证码】

Order of the State Council 

国务院令

(No. 676) (第676号)

The Decision of the State Council to Amend and Repeal Certain Administrative Regulations is hereby issued, and shall come into force on the date of issuance. 现公布《国务院关于修改和废止部分行政法规的决定》,自公布之日起施行。
Premier: Li Keqiang 总理 李克强
March 1, 2017 2017年3月1日
Decision of the State Council to Amend and Repeal Certain Administrative Regulations 国务院关于修改和废止部分行政法规的决定
For the purpose of advancing the reform of simplification of administrative procedures, decentralization of powers, combination of decentralization with appropriate control, and optimization of services, the State Council has reviewed the administrative regulations involved in the reform that reduces administrative approval items, items of intermediary services, professional qualification licensing items, and prior approvals for investment projects of enterprises, as well as administrative regulations adverse to the stabilization of growth, promotion of reform, adjustment of structures, and improvement of people's livelihood. Upon review, the State Council hereby decides to: 为了依法推进简政放权、放管结合、优化服务改革,国务院对取消行政审批项目、中介服务事项、职业资格许可事项和企业投资项目核准前置审批改革涉及的行政法规,以及不利于稳增长、促改革、调结构、惠民生的行政法规,进行了清理。经过清理,国务院决定:
(1) amend certain articles of 36 administrative regulations (see Annex 1); and   一、对36部行政法规的部分条款予以修改。(附件1)
(2) repeal three administrative regulations (see Annex 2).   二、对3部行政法规予以废止。(附件2)
This Decision shall come into force on the date of issuance. 本决定自公布之日起施行。
Annexes: 附件:
1. Administrative Regulations Amended as Decided by the State Council 1.国务院决定修改的行政法规
2. Administrative Regulations Repealed as Decided by the State Council 2.国务院决定废止的行政法规
Annex 1 附件1
Administrative Regulations Amended as Decided by the State Council 国务院决定修改的行政法规
I. In the Regulation on Urban Landscaping, paragraph 3 of Article 11 and Article 16 are deleted.   一、删去《城市绿化条例》第十一条第三款、第十六条
Article 22 is renumbered as Article 21 and amended to read: “A business or service stall inside a public green belt of a city shall, based on the business license granted by the administrative department for industry and commerce, operate at a place designated by the entity responsible for the management of the public green belt, and comply with the provisions on the administration of public green belts and industrial and commercial administration.” 第二十二条改为第二十一条,修改为:“在城市的公共绿地内开设商业、服务摊点的,应当持工商行政管理部门批准的营业执照,在公共绿地管理单位指定的地点从事经营活动,并遵守公共绿地和工商行政管理的规定。”
Article 24 is renumbered as Article 23 and amended to read: “Trees that need to be pruned to ensure the safe use of pipelines shall be pruned under the principle of giving consideration to both the safe use of pipelines and the normal growth of trees. The measures for the assumption of pruning expenses shall be developed by the municipal people's governments. 第二十四条改为第二十三条,修改为:“为保证管线的安全使用需要修剪树木时,应当按照兼顾管线安全使用和树木正常生长的原则进行修剪。承担修剪费用的办法,由城市人民政府规定。
“Where a tree tilts and endangers the pipelines for a force majeure, the entity responsible for the management of pipelines may first erect the tree, or cut down the tree but shall report to the competent urban landscaping administrative department of the municipal people's government and the entity responsible for the management of green belts in a timely manner.” “因不可抗力致使树木倾斜危及管线安全时,管线管理单位可以先行扶正或者砍伐树木,但是,应当及时报告城市人民政府城市绿化行政主管部门和绿地管理单位。”
Article 26 is renumbered as Article 25 and amended to read: “Where the construction of the ancillary landscaping in an engineering construction project is commenced without the approval of the ancillary landscaping design proposal or not in line with the approved design proposal, the competent urban landscaping administrative department of the municipal people's government shall order cessation of construction, corrective action to be taken within a prescribed time limit, or any other remedial measure to be taken.” 第二十六条改为第二十五条,修改为:“工程建设项目的附属绿化工程设计方案,未经批准或者未按照批准的设计方案施工的,由城市人民政府城市绿化行政主管部门责令停止施工、限期改正或者采取其他补救措施。”
Article 27 is renumbered as Article 26 and item (2) thereof is amended to read: “(2) An entity or individual cuts down trees in a city without permission.” 第二十七条改为第二十六条,第二项修改为:“(二)擅自砍伐城市树木的”。
Article 29 is renumbered as Article 28 and paragraph 1 thereof is deleted. Paragraph 2 thereof is amended to read: “A business or service stall that refuses to obey the management of the entity responsible for the management of public green belts shall be given a warning and may be fined by the competent urban landscaping administrative department of the municipal people's government or the entity authorized by it; and if the circumstances are serious, the case may be submitted to the administrative department for industry and commerce for cancellation of its business license.” 第二十九条改为第二十八条,删去第一款。第二款修改为:“对不服从公共绿地管理单位管理的商业、服务摊点,由城市人民政府城市绿化行政主管部门或者其授权的单位给予警告,可以并处罚款;情节严重的,可以提请工商行政管理部门吊销营业执照。”
II. In the Regulation of the People's Republic of China on the Administration of the Dumping of Wastes at Sea, paragraph 3 of Article 12 is deleted.   二、删去《中华人民共和国海洋倾废管理条例》第十二条第三款。
III. Paragraph 2 of Article 11 of the Regulation on the Administration of the Prevention of Environmental Pollution from Vessel Dismantling is amended to read: “Before worn-out oil vessels are dismantled, their cabins shall be washed, pollutants shall be discharged, cabins shall be cleared, and explosion tests shall be conducted, among others.”   三、将《防止拆船污染环境管理条例》第十一条第二款修改为:“废油船在拆解前,必须进行洗舱、排污、清舱、测爆等工作。”
IV. Paragraph 1 of Article 11 of the Regulation of the People's Republic of China on River Courses is amended to read: “For the construction of various projects for development of water resources, prevention and control of water-induced disasters, or regulation of river courses and the construction of bridges, wharfs, roads, ferries, pipelines, cables, or other buildings or facilities across a river, through a river, through an embankment, or on the riverside, the construction employers must, according to the administrative powers over river courses, submit the project construction proposals to the authorities of river courses for review and consent. Without review and consent of the authorities of river courses, no construction employer shall commence construction.”   四、将《中华人民共和国河道管理条例》第十一条第一款修改为:“修建开发水利、防治水害、整治河道的各类工程和跨河、穿河、穿堤、临河的桥梁、码头、道路、渡口、管道、缆线等建筑物及设施,建设单位必须按照河道管理权限,将工程建设方案报送河道主管机关审查同意。未经河道主管机关审查同意的,建设单位不得开工建设。”
Article 29 is amended to read: “Former courses, old embankments, and existing works and facilities, among others, of rivers shall not be filled, occupied, or demolished without permission.” 第二十九条修改为:“江河的故道、旧堤、原有工程设施等,不得擅自填堵、占用或者拆毁。”
V. In the Regulation on the Administration of Laboratory Animals, Article 23, paragraph 1 of Article 24, and Article 27 are deleted.   五、删去《实验动物管理条例》第二十三条、第二十四条第一款、第二十七条
VI. Article 4 of the Measures for the Administration of Radioactive Pharmaceuticals is amended to read: “The drug supervision administrative department of the State Council shall be responsible for the national supervision and administration of radioactive pharmaceuticals. The administrative department of science, technology and industry for national defense of the State Council shall be responsible for the relevant administration of radioactive pharmaceuticals according to its functions. The environmental protection department of the State Council shall be responsible for the supervision and administration of the radiation safety and protection in relation to radioactive pharmaceuticals.”   六、将《放射性药品管理办法》第四条修改为:“国务院药品监督管理部门负责全国放射性药品监督管理工作。国务院国防科技工业主管部门依据职责负责与放射性药品有关的管理工作。国务院环境保护主管部门负责与放射性药品有关的辐射安全与防护的监督管理工作。”
Article 5 is deleted. 删去第五条。
Article 6 is renumbered as Article 5, and paragraph 3 thereof is amended to read: “The classification of new radioactive drugs shall be handled according to the provisions issued by the drug supervision administrative department of the State Council on drug registration.” 第六条改为第五条,第三款修改为:“放射性新药的分类,按国务院药品监督管理部门有关药品注册的规定办理。”
Article 7 is renumbered as Article 6 and amended to read: “Before the clinical test or validation of new radioactive drugs developed by the research entity, an application shall be filed with the drug supervision administrative department of the State Council, with materials and specimens submitted as required, and clinical study shall be conducted at the drug clinical test institution designated by the drug supervision administrative department of the State Council after it approves the application.” 第七条改为第六条,修改为:“研制单位研制的放射性新药,在进行临床试验或者验证前,应当向国务院药品监督管理部门提出申请,按规定报送资料及样品,经国务院药品监督管理部门审批同意后,在国务院药品监督管理部门指定的药物临床试验机构进行临床研究。”
Article 8 is renumbered as Article 7, in which “Ministry of Health” is replaced with “drug supervision administrative department of the State Council,” and “Ministry of Energy” is replaced with “administrative department of science, technology and industry for national defense of the State Council.” 第八条改为第七条,将其中的“卫生部”修改为“国务院药品监督管理部门”,“能源部”修改为“国务院国防科技工业主管部门”。
Article 9 is renumbered as Article 8, in which “Ministry of Health” is replaced with “drug supervision administrative department of the State Council.” 第九条改为第八条,将其中的“卫生部”修改为“国务院药品监督管理部门”。
Article 10 is deleted. 删去第十条。
Article 11 is renumbered as Article 9 and amended to read: “The state shall, as needed, make rational distribution of manufacturers of radioactive pharmaceuticals.” 第十一条改为第九条,修改为:“国家根据需要,对放射性药品的生产企业实行合理布局。”
Article 12 is renumbered as Article 10 and amended to read: “To form a production or distribution enterprise of radioactive pharmaceuticals, the conditions prescribed in the Pharmaceutical Administration Law shall be met, the provisions and standards of the state on the security and protection of radioisotopes shall be satisfied, and the formalities for the approval of environmental impact assessment documents shall be undergone; for the formation of a production enterprise of radioactive pharmaceuticals, a Permit for a Production Enterprise of Radioactive Pharmaceuticals shall be issued by the drug supervision administrative department of the province, autonomous region, or municipality directly under the Central Government where the enterprise is located, upon consent of the administrative department of science, technology and industry for national defense of the State Council and approval of the drug supervision administrative department of the State Council; and for the formation of a distribution enterprise of radioactive pharmaceuticals, upon approval of the drug supervision administrative department of the State Council after consultation with the administrative department of science, technology and industry for national defense of the State Council, the Permit for a Distribution Enterprise of Radioactive Pharmaceuticals shall be issued by the drug supervision administrative department of the province, autonomous region or municipality directly under the Central Government where the enterprise is located. No production or distribution enterprise without such a license shall produce or sell radioactive pharmaceuticals.” 第十二条改为第十条,修改为:“开办放射性药品生产、经营企业,必须具备《药品管理法》规定的条件,符合国家有关放射性同位素安全和防护的规定与标准,并履行环境影响评价文件的审批手续;开办放射性药品生产企业,经国务院国防科技工业主管部门审查同意,国务院药品监督管理部门审核批准后,由所在省、自治区、直辖市药品监督管理部门发给《放射性药品生产企业许可证》;开办放射性药品经营企业,经国务院药品监督管理部门审核并征求国务院国防科技工业主管部门意见后批准的,由所在省、自治区、直辖市药品监督管理部门发给《放射性药品经营企业许可证》。无许可证的生产、经营企业,一律不准生产、销售放射性药品。”
Article 13 is renumbered as Article 11, in which “health administrative” is replaced with “drug supervision administrative,” and “Article 12” is replaced with “Article 10.” 第十三条改为第十一条,将其中的“卫生行政”修改为“药品监督管理”,“第十二条”修改为“第十条”。
Article 14 is renumbered as Article 12 and amended to read: “The production of radioactive pharmaceuticals for which there are national standards by a production enterprise of radioactive pharmaceuticals shall be subject to the approval of the drug supervision administrative department of the State Council after consultation with the administrative department of science, technology and industry for national defense of the State Council, and upon approval, an approval document number shall be issued. Where the production process routes and pharmaceutical standards that have been approved by the drug supervision administrative department of the State Council are changed, a production entity shall file a supplemental application according to the original approval procedures, and may conduct production only after approval by the drug supervision administrative department of the State Council.” 第十四条改为第十二条,修改为:“放射性药品生产企业生产已有国家标准的放射性药品,必须经国务院药品监督管理部门征求国务院国防科技工业主管部门意见后审核批准,并发给批准文号。凡是改变国务院药品监督管理部门已批准的生产工艺路线和药品标准的,生产单位必须按原报批程序提出补充申请,经国务院药品监督管理部门批准后方能生产。”
Article 16 is renumbered as Article 14 and paragraph 2 thereof is amended to read: “Drugs with short half-life radionuclide approved by the drug supervision administrative department of the State Council may leave factories while undergoing inspection, but when the quality thereof is found failing to meet the pharmaceutical standards of the state, the production enterprise shall immediately stop producing and selling the drugs, immediately notify the using entities of stopping using the drugs, and concurrently report to the drug supervision administrative department, health administrative department, and administrative department of science, technology and industry for national defense of the State Council.” 第十六条改为第十四条,第二款修改为:“经国务院药品监督管理部门审核批准的含有短半衰期放射性核素的药品,可以边检验边出厂,但发现质量不符合国家药品标准时,该药品的生产企业应当立即停止生产、销售,并立即通知使用单位停止使用,同时报告国务院药品监督管理、卫生行政、国防科技工业主管部门。”
Article 17 is renumbered as Article 15 and amended to read: “The production and distribution entities of radioactive pharmaceuticals and medical entities shall, respectively based on the Permit for a Production Enterprise of Radioactive Pharmaceuticals, the Permit for a Distribution Enterprise of Radioactive Pharmaceuticals, and the Permit for the Use of Radioactive Pharmaceuticals issued by the drug supervision administrative departments of the provinces, autonomous regions, and municipalities directly under the Central Government, purchase and sell radioactive pharmaceuticals.” 第十七条改为第十五条,修改为:“放射性药品的生产、经营单位和医疗单位凭省、自治区、直辖市药品监督管理部门发给的《放射性药品生产企业许可证》、《放射性药品经营企业许可证》,医疗单位凭省、自治区、直辖市药品监督管理部门发给的《放射性药品使用许可证》,开展放射性药品的购销活动。”
Article 18 is renumbered as Article 16 and amended to read: “The varieties of imported radioactive drugs must meet the pharmaceutical standards or other medical requirements of China, and registration certificates for imported drugs shall be obtained in accordance with the Pharmaceutical Administration Law. 第十八条改为第十六条,修改为:“进口的放射性药品品种,必须符合我国的药品标准或者其他药用要求,并依照《药品管理法》的规定取得进口药品注册证书。
“The import and export formalities shall be undergone for imported and exported radioactive pharmaceuticals in accordance with the provisions issued by the state on foreign trade and the security and protection of radioisotopes.” “进出口放射性药品,应当按照国家有关对外贸易、放射性同位素安全和防护的规定,办理进出口手续。”
Article 19 is renumbered as Article 17 and amended to read: “Radioactive drugs to be imported must be subject to the sampling inspection by the pharmaceutical inspection and testing institutions designated by the drug supervision administrative department of the State Council; and only those passing the inspection may be imported. 第十九条改为第十七条,修改为:“进口放射性药品,必须经国务院药品监督管理部门指定的药品检验机构抽样检验;检验合格的,方准进口。
“Drugs with short half-life radionuclide approved by the drug supervision administrative department of the State Council may be used while undergoing import inspection, provided that their safe use is ensured. Import inspection entities shall, immediately after finding that drug quality fails to satisfy the prescribed requirements, notify the using entities of stopping using the drugs and report it to the drug supervision administrative department, health administrative department, and administrative department of science, technology and industry for national defense of the State Council.” “对于经国务院药品监督管理部门审核批准的含有短半衰期放射性核素的药品,在保证安全使用的情况下,可以采取边进口检验,边投入使用的办法。进口检验单位发现药品质量不符合要求时,应当立即通知使用单位停止使用,并报告国务院药品监督管理、卫生行政、国防科技工业主管部门。”
Article 23 is renumbered as Article 21, paragraph 1 of which is amended to read: “Medical entities must use radioactive pharmaceuticals in accordance with the provisions issued by the state on the security and protection of radioisotopes. The drug supervision administrative departments of the provinces, autonomous regions, and municipalities directly under the Central Government where they are respectively located shall, according to the competence of the nuclear medicine technicians and the equipment conditions of the medical entities, issue the Permit for the Use of Radioactive Pharmaceuticals at the corresponding level, and no medical entity without the permit shall use radioactive pharmaceuticals for clinical purpose.” 第二十三条改为第二十一条,第一款修改为:“医疗单位使用放射性药品,必须符合国家有关放射性同位素安全和防护的规定。所在地的省、自治区、直辖市药品监督管理部门,应当根据医疗单位核医疗技术人员的水平、设备条件,核发相应等级的《放射性药品使用许可证》,无许可证的医疗单位不得临床使用放射性药品。”
Article 24 is renumbered as Article 22 and amended to read: “Medical entities shall make and use radioactive preparations in accordance with the relevant provisions of the Pharmaceutical Administration Law and the regulation for the implementation thereof.” 第二十四条改为第二十二条,修改为:“医疗单位配制、使用放射性制剂,应当符合《药品管理法》及其实施条例的相关规定。”
Article 25 is renumbered as Article 23 and amended to read: “A medical entity possessing a Permit for the Use of Radioactive Pharmaceuticals must be responsible for conducting clinical quality testing of the radioactive drugs used and collecting adverse reactions, among others, and report to the local drug supervision administrative department and health administrative department on a regular basis. The drug supervision administrative department and the health administrative department of the province, autonomous region, or municipality directly under the Central Government shall, after gathering such reports, respectively report to the drug supervision administrative department and the health administrative department of the State Council.” 第二十五条改为第二十三条,修改为:“持有《放射性药品使用许可证》的医疗单位,必须负责对使用的放射性药品进行临床质量检验,收集药品不良反应等项工作,并定期向所在地药品监督管理、卫生行政部门报告。由省、自治区、直辖市药品监督管理、卫生行政部门汇总后分别报国务院药品监督管理、卫生行政部门。”
Article 27 is renumbered as Article 25, in which “Ministry of Health” is replaced with “drug supervision administrative department of the State Council.” 第二十七条改为第二十五条,将其中的“卫生部”修改为“国务院药品监督管理部门”。
Article 28 is renumbered as Article 26 and amended to read: “The inspection of radioactive pharmaceuticals shall be conducted by the pharmaceutical inspection institutions announced by the drug supervision administrative department of the State Council.” 第二十八条改为第二十六条,修改为:“放射性药品的检验由国务院药品监督管理部门公布的药品检验机构承担。”
Article 29 is renumbered as Article 27 and amended to read: “Any entity or individual violating these Measures shall be punished by the drug supervision administrative department and the health administrative department at or above the county level in accordance with the provisions of the Pharmaceutical Administration Law and relevant regulations.” 第二十九条改为第二十七条,修改为:“对违反本办法规定的单位或者个人,由县以上药品监督管理、卫生行政部门,按照《药品管理法》和有关法规的规定处罚。”
Article 30 is deleted. 删去第三十条。
VII. In the Regulation on the Sports Work of Schools, paragraph 2 of Article 14 is deleted.   七、删去《学校体育工作条例》第十四条第二款。
VIII. Paragraph 1 of Article 7 of the Regulation of the People's Republic of China on the Administration of the Prevention and Control of Damage to the Marine Environment Caused by Pollution from Coastal Engineering Construction Projects is amended to read: “The construction employer in a coastal engineering construction project shall develop an environmental impact report (form) according to the law, and submit it to the environmental protection department for approval.” Paragraph 2 thereof is amended to read: “Before approving an environmental impact report (form) for a coastal engineering construction project, the environmental protection department shall consult with the oceanic, maritime, and fishery departments and the military authority for environmental protection.”   八、将《中华人民共和国防治海岸工程建设项目污染损害海洋环境管理条例》第七条第一款修改为:“海岸工程建设项目的建设单位,应当依法编制环境影响报告书(表),报环境保护主管部门审批。”第二款修改为:“环境保护主管部门在批准海岸工程建设项目的环境影响报告书(表)之前,应当征求海洋、海事、渔业主管部门和军队环境保护部门的意见。”
IX. Article 17 of the Measures for the Implementation of the Archives Law of the People's Republic of China is deleted.
......
   九、删去《中华人民共和国档案法实施办法》第十七条
......

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