- 中国医疗行业法律法规中英数据库 A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
中国医疗行业法律法规中英数据库
- 口岸所在地药品监督管理部门应当通知药品检验机构按照国务院药品监督管理部门的规定对进口药品进行抽查检验，并依照本法第四十一条第二款的规定收取检验费。 The pharmaceutical supervisory and administrative department of the place where the port is located shall notify the pharmaceutical inspection institution to carry out selective examinations and inspections on the imported pharmaceuticals according to the regulations stipulated by the pharmaceutical supervisory and administrative department under the State Council, and to collect inspection fees according to Article 41(2) of this Law.
- 省、自治区、直辖市人民政府药品监督管理部门负责本行政区域内的药品监督管理工作。省、自治区、直辖市人民政府有关部门在各自的职责范围内负责与药品有关的监督管理工作。 The pharmaceutical supervisory and administrative departments of the provinces, autonomous regions and municipalities directly under the central government shall be responsible for the supervision and control of pharmaceuticals within their administrative regions. Other relevant departments of the provinces, autonomous regions and municipalities directly under the central government shall be responsible for the supervision and control of pharmaceuticals related to the scope of their functions.
- 对不合格的直接接触药品的包装材料和容器，由药品监督管理部门责令停止使用。 The pharmaceutical supervisory and administrative departments shall stop the use of those unqualified packaging materials and containers which have direct contact with the pharmaceuticals.
- 国务院药品监督管理部门应当配合国务院经济综合主管部门，执行国家制定的药品行业发展规划和产业政策。 The pharmaceutical supervisory and administrative departments under the State Council shall cooperate with the general administrative department of the economy under the State Council to carry out pharmaceutical development plans and industrial policies formulated by the State.
- 国务院卫生行政部门的药典委员会负责组织国家药品标准的制定和修订。 The Pharmacopoeia Committee of the department of the State Council administering health is the body responsible for handling the setting and revision of national drug standards.
- 国务院药品监督管理部门组织药典委员会，负责国家药品标准的制定和修订。 The Pharmacopoeia Committee organized by the pharmaceutical supervisory and administrative department under the State Council shall be responsible for the formulation and revision of the State pharmaceutical standards.
- 第二类精神药品制剂的供应计划，由省、自治区、直辖市卫生行政部门会同同级医药管理部门联合下达。 The plan for the supply of psychotropic drugs of category II shall be assigned jointly by the health administrative department of each province, autonomous region or municipality directly under the Central Government and the administration department for medicine at the corresponding level.
- 传染病管理监督员由合格的卫生专业人员担任，由省级以上政府卫生行政部门聘任并发给证件。 The post of supervisor of infectious disease management shall be held by a qualified health professional, who shall be appointed and given a certificate by the health administration department of a government at or above the provincial level.
- 本市对医疗机构实行执业许可证制度。 The practice license system is adopted in Shanghai for medical institutions.
- 中药饮片的炮制必须符合《中华人民共和国药典》,或者省、自治区、直辖市卫生行政部门制定的《炮制规范》的规定。 The preparation of Chinese medicines shall be in accordance with the ""Pharmacopoeia of the People's Republic of China"", or in accordance with the ""Preparation Standards"" laid down by the department administering health in that province, autonomous region or municipality under the direct control of the Central Government.
- 本办法适用于本市行政区域内医疗机构的设置、执业许可、医疗执业活动及其监督管理。 The present Procedures are applicable to the supervision and administration of medical institutions as well as their establishment, practice license and medical practising activities in the administrative areas of Shanghai.
- 向社会开放的部队医疗机构，按照本办法执行。 The present Procedures shall also be applicable to any army medical institution which is opened to the public.
- 本办法自1997年7月1日起施行。 The present Procedures shall become effective on July 1,1997.
- 军队的传染病防治工作，依照本法和国家有关规定办理，由中国人民解放军卫生主管部门实施监督管理。 The prevention and treatment of infectious diseases in the People 's Liberation Army shall be carried out in compliance with this Law and other relevant provisions of the state and shall be supervised and controlled by the departments in charge of health in the Army.
- 对违反本办法的医疗机构负责人和直接责任人员，由其上级主管部门给予行政处分；情节严重构成犯罪的，由司法机关依法追究其刑事责任。 The principal person in charge of a medical institution and the directly liable person in violation of the present Procedures shall be given an administrative disciplinary punishment by its higher competent department. If the case is serious enough to constitute a crime, criminal liability shall be investigated by the judicial organs according to law.
- 为单位内部职工服务的机关、企业和事业单位门诊部、诊所、卫生所（室）、医务室的设置和执业登记办法，由市卫生行政部门依照本办法另行制定。 The Procedures for the establishment and practice registration of the internal outpatient department, clinic, health station (post) or medical room of a government body, enterprise and institution for the purpose of serving their own employees shall be separately formulated by the Municipal Public Health Administrative Department in accordance with the present Procedures.
- 1988年10月29日上海市人民政府颁布的《上海市开业医务人员管理办法》同时废止。 The Procedures of Shanghai Municipality on Administration of Medical Personnel Engaged in Medical Practising Activities promulgated on October 29, 1988 by the Shanghai Municipal People''s Government shall be annulled at the same time.
- 中药饮片必须按照国家药品标准炮制；国家药品标准没有规定的，必须按照省、自治区、直辖市人民政府药品监督管理部门制定的炮制规范炮制。省、自治区、直辖市人民政府药品监督管理部门制定的炮制规范应当报国务院药品监督管理部门备案。 The process for preparing traditional Chinese medicines into ready-to-use forms must conform to the national pharmaceutical standards, and in the absence of such standards, the process must conform to the processing standards stipulated by the supervisory and administrative departments of pharmaceuticals of the provinces, autonomous regions, or municipalities directly under the central government. The processing standards stipulated by the supervisory and administrative departments of pharmaceuticals of the provinces, autonomous regions, or municipalities directly under the central governments shall be placed on record at the pharmaceutical supervisory and administrative department under the State Council.
- 对生产者专门用于生产假药、劣药的原辅材料、包装材料、生产设备，予以没收。 The producers' supplementary materials, packaging materials and production equipment which are used exclusively for producing fake medicines and medicines of inferior quality shall be confiscated.
- 生产已有国家标准或者省、自治区、直辖市标准的药品，必须经省、自治区、直辖市卫生行政部门征求同级药品生产经营主管部门意见后审核批准，并发给批准文号。但是，生产中药饮片除外。 The production of drugs for which there is already a national drug standard, or a drug standard of a province, autonomous region or municipality under the direct control of the Central Government, must be examined and approved by the department responsible for health administration in the relevant province, autonomous region or municipality under the direct control of the Central Government after seeking the opinion of the corresponding authority responsible for the drug-producing enterprise. An approval number will be issued. However, the production of Chinese medicines sliced and prepared for decoction is excepted.
- 红十字标志的保护使用，是标示在武装冲突中必须受到尊重和保护的人员和设备。其使用办法，依照日内瓦公约及其附加议定书的有关规定执行。 The protective role of the sign of the Red Cross is to show the personnel and equipment that must be respected and protected in armed conflicts. The sign shall be used in conformity with the relevant provisions of the Geneva Conventions and their Additional Protocols.
- 第二类精神药品可供各医疗单位使用，医药门市部应当凭盖有医疗单位公章的医生处方零售。处方应留存两年备查。 The psychotropic drugs of category II are available to all medical treatment units. Drug stores may sell such drugs by retail on the strength of a doctor's prescription with an official seal of a medical treatment unit stamped on. The prescriptions must be kept for two years for reference.
- 卫生行政部门应当自收到医疗机构执业登记申请人提交的全部材料之日起45日内进行审查核实。 The Public Health Administrative Department shall examine and verify the application for the practice registration within 45 days after receipt of all the materials submitted by the applicant for practice registration of the medical institution.
- 卫生行政部门应当自收到医疗机构设置申请人提交的全部材料之日起30日内进行审查。对符合条件的，批准设置并发给《设置医疗机构批准书》；对不符合条件的，应当书面告知设置申请人。 The Public Health Administrative Department shall examine the application within 30 days after receipt of all the materials submitted by the applicant for establishing of a medical institution. The Public Health Administrative Department shall approve and issue an Approval Certificate for the Establishment of Medical Institution to the applicant if the application meets the requirements; or inform the applicant in writing if the application does not meet the requirements.
- 卫生行政部门应当自收到医疗机构申请校验的全部材料之日起30日内完成校验； The Public Health Administrative Department shall finish the examination within 30 days after receipt of all the documents submitted by the medical institution for the examination application.
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