- 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
- （三）有合适的场所； 3. With a suitable premise for establishing the medical institution; and
- （三）有符合规定的组织机构； 3. With an organizational structure conforming to the related stipulations;
- （四）有与所开展的业务相适应并符合规定的资金、仪器设备、卫生技术人员以及通讯、供电、上下水道等必要设施； 4. With necessary fund, instruments and equipments, medical technical personnel and necessary facilities for communication, power supply, water supply and sewers, etc. to carry out its practice as well as to meet the prescribed requirements;
- （四）有必要的资金。 4. With necessary fund.
- （五）有相应的规章制度； 5. With relevant rules and regulations; and
- 战争、侵略、外国敌意行为(不论宣战与否)、内战、叛变、暴动、军事力量或政变、罢工，或由于核子武器，核子游离幅射，核子燃料或其燃烧后产生的废料所致幅射能的沾染。 War, invasion act of foreign enemy, hostilities (whether war is declared or not), civil war, rebellion, insurrection, military force or coup, strikes, riots or caused by or arising from ionising radiation or contamination by radioactivity from any nuclear fuel or from any nuclear waste from the combustion of nuclear fuel.上述核子燃烧包括自发的核子分裂在内。
- 在生产精神药品的过程中产生的废弃物，必须妥善处理，不得污染环境。 Waste materials discharged during the production of psychotropic drugs must be treated properly so as not to pollute the environment.
- 卫生防疫机构发现传染病流行或者接到甲类传染病和乙类传染病中的艾滋病、炭疽中的肺炭疽的疫情报告，应当立即报告当地卫生行政部门，由当地卫生行政部门立即报告当地政府，同时报告上级卫生行政部门和国务院卫生行政部门。 When a health and anti-epidemic agency finds the prevalence of infectious diseases or receives a report on the epidemic situation of A Class infectious diseases or of AIDS or pulmonary anthrax as a type of anthrax among B Class infectious diseases, it shall immediately report to the local health administration department, which shall immediately report to the local government and also to the health administration department at a higher level and the health administration department under the State Council.
- 县级以上地方政府接到下一级政府关于采取前款所列紧急措施的报告时，应当在规定的时限内作出决定。 When a local government at or above the county level receives a report from a government at the next lower level proposing the adoption of the above-mentioned emergency measures, it shall make a decision within the prescribed time limit.
- 医疗机构施行手术、特殊检查、输血或者特殊治疗时，应当征得病人同意，并取得病人家属或者关系人同意并签字； When a medical institution intends to perform a surgical operation, special examination, blood transfusion or special treatment; it shall obtain the consent from the patient as well as the consent and signature of his/her family member or relative.
- 执行职务的医疗保健人员、卫生防疫人员发现甲类、乙类和监测区域内的丙类传染病病人、病原携带者或者疑似传染病病人，必须按照国务院卫生行政部门规定的时限向当地卫生防疫机构报告疫情。 When medical care and health personnel or anti-epidemic personnel on duty find patients, pathogen carriers or suspected patients of A Class or B Class infectious diseases, or if they find in a monitored area patients, pathogen carriers or suspected patients of C Class infectious diseases, they must report the epidemic situation to the local health and anti-epidemic agency within the time limit prescribed by the health administration department under the State Council.
- 发现可能与用药有关的严重不良反应，必须及时向当地省、自治区、直辖市人民政府药品监督管理部门和卫生行政部门报告。具体办法由国务院药品监督管理部门会同国务院卫生行政部门制定。 When serious adverse reactions possibly related to the use of the pharmaceuticals are discovered, they must be promptly reported to the pharmaceutical supervisory and administrative departments and the administrative departments of health of the provinces, autonomous regions and municipalities directly under the central government. Detailed measures shall be formulated jointly by the pharmaceutical supervisory and administrative department under the State Council and the administrative department of health under the State Council.
- 各级红十字会会员代表大会闭会期间，由理事会执行会员代表大会的决议。 When the congresses of members of the Red Cross Societies at various levels are not in session, the Councils thereof shall implement the decisions made by the congresses.
- 卫生行政部门作出行政处罚时，应当出具《行政处罚决定书》。收缴罚没款时，应当出具市财政局统一印制的罚款收据。 When the Public Health Administrative Department gives an administrative disciplinary punishment, it shall issue a Decision on Administrative Disciplinary Punishment. It shall also provide a penalty receipt unifiedly printed by the Municipal Finance Bureau when a fine or the confiscated money is collected.
- 被乙类、丙类传染病病原体污染的污水、污物、粪便，有关单位和个人必须按照卫生防疫机构提出的卫生要求进行处理。 When the sewage, wastes and feces are contaminated with the pathogen of B Class or C Class infectious diseases, the unit or the individual concerned must carry out treatment according to the hygienic requirements proposed by an anti-epidemic agency.
- 无偿献血者的配偶和直系亲属临床需要用血时，可以按照省、自治区、直辖市人民政府的规定免交或者减交前款规定的费用。 when the spouse and lineal relative of a blood donor without compensation requires blood in clinical use, exemption from or reduction of the expenses prescribed in the preceding paragraph may be effected in accordance with the provisions of the people’s governments of provinces, autonomous regions and municipalities directly under the Central Government.
- 药品经营企业销售中药材，必须标明产地。 When traditional Chinese medicinal materials are offered for sale by pharmaceutical trading enterprises, their origin must be indicated.
- 研制新药必须按照规定向国务院卫生行政部门或者省、自治区、直辖市卫生行政部门报送研制方法、质量指标、药理及毒理试验结果等有关资料和样品。经批准后，方可进行临床试验或者临床验证。 Where a new drug has been researched and developed, in accordance with the regulations, a report must be submitted, with samples, to the State Council department administering health or the department of the province, autonomous region or municipality under the direct control of the Central Government administering health, giving details of the method of research and development, quality norms, pharmacological and toxicological tests and other relevant data. Only after it has been approved may clinical tests or clinical verifications be carried out.
- 完成临床试验或者临床验证并通过鉴定的新药由国务院卫生行政部门批准发给证书。 Where a new drug has completed its clinical tests or clinical verification and has passed an appraisal it may be approved by the department of the State Council administering health, which will issue a certificate.
- 对有配伍禁忌或者超剂量的处方应当拒绝调配；必要时经处方医生更正或者重新签字，方可调配。 Where a prescription contains ingredients that are incompatible or amounts of ingredients in excess of the proper dosage, a request to make up the prescription shall be refused; if necessary, after the prescribing doctor has corrected it and signed it again, it may be made up.
- 经营中药的企业和兼营药品的企业没有药学技术人员.配备熟悉所经营药品的药性并经县级以上卫生行政部门审查登记的药工人员。 Where an enterprise engaged in the handling of Chinese medicines or partly engaged in handling drugs does not have a pharmaceutical technician it may use drug industry personnel with an intimate knowledge of the medicinal nature of the drugs handled who have been examined and registered by a department administering health at above county level.
- 中药饮片加工企业没有药师或者助理工程师以上技术人员，配备熟悉药性并经县级以上卫生行政部门审查登记的药工人员。 Where an enterprise engaged in the processing of traditional Chinese medicine does not have a pharmacist or technical personnel of a rank above that of assistant engineer, it may use drug industry personnel with an intimate knowledge of drugs who have been examined and registered by a department of health administration above the county level.
- 涉及人身安全、健康、环境保护项目不合格的，或者可以技术处理的项目经技术处理后经检验仍不合格的，由检验检疫机构责令当事人销毁，或者退货并书面告知海关，并上报国家质检总局。 Where any item involving the human safety, health or environmental protection is unqualified or any item that may be technically treated remains unqualified upon the technical treatment, the party concerned shall be ordered by an IQ organ to destroy the item or return the goods, the customs shall be notified in written form, and it shall be reported to the GAQSIQ.
- 销售地道中药材，必须标明产地。 Where authentic Chinese medicines are sold, they shall be labelled to indicate the place of origin.
- 发运中药材必须有包装。每件包装上必须注明品名、产地、日期、调出单位，并附有质量合格的标志。 Where Chinese medicinal materials are to be transported, they must be packaged. On each package, the name of the product, its place of origin, the date and the name of the dispatching unit must be clearly indicated and it must be marked to indicate that the quality is up to standard.
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