- 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
- 第十五条（医疗机构的分级） Article 15 (Grading of Medical Institutions)
- 第十五条 医生应当根据医疗需要合理使用精神药品，严禁滥用。 Article 15 Doctors must prescribe psychotropic drugs on the basis of the actual need in treatment. Abuse of such drugs is strictly forbidden.
- 第十五条中药一级保护品种因特殊情况需要延长保护期限的，由生产企业在该品种保护期满前六个月，依照本条例第九条规定的程序申报。 Article 15 If a given variety of traditional Chinese medicines under Grade 1 protection is required for lengthening its protection period, enterprises concerned shall submit an application, in pursuit of the procedures as stipulated in Article 9 of this Decree, 6 months prior to the termination of its protection period.
- 第十五条对患严重疾病或者接触致畸物质，妊娠可能危及孕妇生命安全或者可能严重影响孕妇健康和胎儿正常发育的，医疗保健机构应当予以医学指导。 Article 15 Medical and health institutions shall give medical advice to the pregnant women who are suffering from serious illness or are exposed to teratogenic substances, if their gestation may jeopardize the safety of their lives, or seriously affect their health or the normal development of the fetus.
- 第十五条 任何组织和个人不得拒绝、阻碍红十字会工作人员依法履行职责。 Article 15 No organization or individual shall refuse or obstruct the staff of the Red Cross Society to perform their functions and duties according to law.
- 第十五条为保障公民临床急救用血的需要，国家提倡并指导择期手术的患者自身储血，动员家庭、亲友、所在单位以及社会互助献血。 Article 15 To ensure the requirements for clinical emergency blood use by citizens, the State encourages and guides patients to be operated upon at a selected date in self blood storage and motivates his or her family, relatives and friends and the unit wherein he or she is employed as well as society for blood donation in mutual assistance.
- 第十五条 开办药品经营企业必须具备以下条件： Article 15 To establish a pharmaceutical trading enterprise, the following requirements must be met
- 第十五条有下列情形之一的，不予注册： Article 15 Under any of the following circumstances, registration shall not be granted:
- 第十五条进口高风险医疗器械的，按照以下方式进行检验管理： Article 15 With respect to the import of high risk medical instruments, the inspection and management shall be performed in the modes as follows:
- 第十五条 医疗保健机构、卫生防疫机构和从事致病性微生物实验的单位，必须严格执行国务院卫生行政部门规定的管理制度、 操作规程，防止传染病的医源性感染、医院内感染、实验室感染和致病性微生物的扩散。 Article 15. Medical care and health institutions, anti-epidemic agencies and units engaged in the experimentation of pathogenic microorganisms must rigorously implement the management system and the operation procedures stipulated by the health administration department under the State Council to prevent the iatric infection of infectious diseases, inside-hospital infection, laboratory infection and the spread of pathogenic microorganisms.
- 第十六条（设置审批权限）设置下列医疗机构，应当向市卫生行政部门提出申请： Article 16 (Competence for Examining and Approving the Establishment) For the establishment of the following medical institutions, an application shall be submitted to the Municipal Public Health Administrative Department:
- 第十六条医师发现或者怀疑患严重遗传性疾病的育龄夫妻，应当提出医学意见。育龄夫妻应当根据医师的医学意见采取相应的措施。 Article 16 If a physician detects or suspects that a married couple in their child-bearing age suffer from genetic disease of a serious nature, the physician shall give them medical advice, according to which the said couple shall take corresponding measures.
- 第十六条医疗机构临床用血应当制定用血计划，遵循合理、科学的原则，不得浪费和滥用血液。 Article 16 Medical institutions shall work out blood use plans for clinical use following the rational and scientific principle and shall not waste and abuse blood.
- 第十六条 精神药品的处方必须载明患者的姓名、年龄、性别、药品名称、剂量、用法等。 Article 16 On a prescription of psychotropic drugs, the name, age, sex of the user, the name of the drug, dosage and administration must be written down clearly.
- 第十六条 药品经营企业必须按照国务院药品监督管理部门依据本法制定的《药品经营质量管理规范》经营药品。 Article 16 Pharmaceutical producing enterprises must trade in pharmaceuticals in accordance with the ""Standards for Quality Control of Pharmaceutical Trading"" stipulated by the pharmaceutical supervisory and administrative departments under the State Council on the basis of this Law.
- 第十六条中药二级保护品种在保护期满后可以延长七年。? Article 16 The protection period for varieties of traditional Chinese medicines under Grade 2 protection can be lengthened for another 7 years.
- 第十六条 红十字标志具有保护作用和标明作用。 Article 16 The sign of the Red Cross plays a protective role and an indicative role as well.
- 第十六条医师注册后有下列情形之一的，其所在的医疗、预防、保健机构应当在三十日内报告准予注册的卫生行政部门。 Article 16 Under any of the following circumstances, the institution of medical treatment, prevention or health care to which a doctor obtaining registration belongs should, within 30 days, report the circumstance to the administrative department of health granting the registration.
- 第十六条进口较高风险医疗器械的，按照以下方式进行检验管理： Article 16 With respect to the import of relatively high risk medical instruments, the inspection and management shall be performed in the following modes as follows:
- 第十六条 传染病菌种、毒种的保藏、携带、运输，必须按照国务院卫生行政部门的规定严格管理。 Article 16. The storage, carrying and transportation of bacterial strains and virus strains of infectious diseases must be rigorously controlled in accordance with provisions laid down by the health administration department under the State Council.
- 第十七条（设置审批原则和审批程序） Article 17 (Principle and Procedure for Examining and Approving the Establishment)
- 第十七条经产前检查，医师发现或者怀疑胎儿异常的，应当对孕妇进行产前诊断。 Article 17 After antenatal examination, if a physician detects or suspects an abnormality with the fetus, he shall make prenatal diagnosis for the pregnant woman.
- 第十七条医师变更执业地点、执业类别、执业范围等注册事项的，应当到准予注册的卫生行政部门依照本法第十三条的规定办理变更注册手续。 Article 17 Any doctor who intends to change his registration of the place, category or scope of business should go through the procedure for the change of registration at the administrative department of health granting the registration according to the provisions of Article 13 of this Law.
- 第十七条各级人民政府和红十字会对积极参加献血和在献血工作中做出显著成绩的单位和个人，给予奖励。 Article 17 People’s governments and Red Cross Societies at all levels shall give rewards to units and individuals that take an active part in blood donation and make outstanding achievements in blood donation work.
- 第十七条 药品经营企业购进药品，必须建立并执行进货检查验收制度，验明药品合格证明和其他标识；不符合规定要求的，不得购进。 Article 17 Pharmaceutical trading enterprises must formulate and implement check and approval rules for the purchase of pharmaceuticals, and check pharmaceutical certifications and other marks while purchasing pharmaceuticals. Pharmaceuticals that do not meet the required standards must not be purchased.
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