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美联英语怎么样:放射性药品管理办法(二)

2015-01-23 15:00   类别:阅读   来源:   责编:Dong

本期美联英语给大家带来放射性药品管理办法(附英文),欢迎阅读!

第四章 放射性药品的包装和运输

第二十条 放射性药品的包装必须安全实用,符合放射性药品质量要求,具有与放射性剂量相适应的防护装置。包装必须分内包装和外包装两部分,外包装必须贴有商标、标签、说明书和放射性药品标志,内包装必须贴有标签。

标签必须注明药品品名、放射性比活度、装量。

说明书除注明前款内容外,还须注明生产单位、批准文号、批号、主要成份、出厂日期、放射性核素半衰期、适应症、用法、用量、禁忌症、有效期和注意事项等。

第二十一条 放射性药品的运输,按国家运输、邮政等部门制订的有关规定执行。

严禁任何单位和个人随身携带放射性药品乘坐公共交通运输工具。

第二十二条 医疗单位设置核医学科、室(同位素室),必须配备与其医疗任务相适应的并经核医学枝术培训的技术人员。非核医学专业技术人员未经培训,不得从事放射性药品使用工作。

第二十三条 医疗单位使用放射性药品,必须符合国家放射性同位素卫生防护管理的有关规定。所在地的省、自治区、直辖市的公安、环保和卫生行政部门,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。

《放射性药品使用许可证》有效期为五年,期满前六个月,医疗单位应当向原发证的行政部门重新提出申请,经审核批准后,换发新证。

第二十四条 持有《放射性药品使用许可证》的医疗单位,在研究配制放射性制剂并进行临床验证前,应当根据放射性药品的持点,提出该制剂的药理、毒性等资料,由省、自治区、直辖市卫生行政部门批准,并报卫生部备案。该制剂只限本单位内使用。

第二十五条 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气行临床质量检验,收集药品不良反应等项工作,并定期向所在地卫生行政部门报告。由省、自治区、直辖市卫生行政部门汇总后报卫生部。

第二十六条 放射性药品使用后的废物(包括患者排出物),必须按国家有关规定妥善处置。

第五章 放射性药品标准和检验

第二十七条 放射性药品的国家标准,由卫生部药典委员会负责制定和修订,报卫生部审批颁发。

第二十八条 放射性药品的检验由中国药品生物制品检定所或者卫生部授权的药品检验所承担。

第六章 附 则

第二十九条 对违反本办法规定的单位或者个人,由县以上卫生行政部门,按照《药

品管理法》和有关法规的规定处罚。

第三十条 本办法由卫生部负责解释。

第三十一条 本办法自发布之日起施行。

MASURS FOR TH CONTROL OF RADIOACTIV DRUGS

Important Notice: (注意事项)

英文本源自中华人民共和国务院法制局编, 中国法制出版社出版的《中华人民共和国涉外法规汇编》(年月版).

当发生歧意时, 应以法律法规颁布单位发布的中文原文为准.

   美联英语学习网   英语口语8000句    商务英语口语900句   英语听力练习

This nglish document is coming from the "LAWS AND RGULATIONS OF TH POPL’S RPUBLIC OF CHINA GOVRNING FORIGN-RLATD MATTRS" (.) which is compiled by the Brueau of Legislative Affairs of the State Council of the People’s Republic of China, and is published by the China Legal System Publishing House.

In case of discrepancy, the original version in Chinese shall prevail.

Whole Document (法规全文)

MASURS FOR TH CONTROL OF RADIOACTIV DRUGS (Promulgated by Decree No. of the State Council of the People’s Republic of China on January , and effective as of the date of promulgation)

Chapter I General Provisions

Article

These Measures are formulated to strengthen the control of radioactive drugs in accordance with Pharmaceutical Administration Law of the People’s Republic of China (hereinafter referred to as the Pharmaceutical Administration Law)

Article

"Radioactive drugs" refer to any forms of radionuclide or their tagged

drugs that are used for clinical diagnosis or in radiotherapy.

Article

All units or individuals in the People’s Republic of China are required to

abide by these Measures when they are engaged in research work, production, business, transportation, consumption, examination, supervision and administration work related to radioactive drugs.

Article

The Ministry of Public Health is in charge of the supervisory and administrative work of radioactive drugs while the Ministry of nergy is in charge of the administration work concerning the production and sale of radioactive drugs.

Chapter II xamination and Approval for the Development and Cli- nical Research of New Radioactive Drugs

Article

"New radioactive drugs" refer to those radioactive drugs that are made in China for the first time. The annual plan of any drug research units for the development of new radioactive drugs must be submitted to both the Ministry of nergy for the record and to the health administration department at the provincial, autonomous regional or municipal (directly under the Central Government) level. Then an itemized plan made by the latter shall be presented to the Ministry of Public Health for the record.

Article

The development of a new kind of radioactive drug includes the research work in its technological process, quality requirements, preclinicopharmacological study and clinical study; The research unit, when designing the technological process for a new drug, must study the physical and chemical properties, purity (including

pureness of radionuclide), testing method, pharmacology, toxicity, nuclein animal dynamics, radiospecific activity, dosage, pharmaceutical forms and stability of that radioactive drug. Furthermore, the research unit must make a study of radio-immunity analysis container with respect to its scalability, range, specificity, accuracy, precision and stability. New kinds of radioactive drugs shall be classified in accordance with the provisions for the examination and approval of new pharmaceuticals.

Article

Before the newly developed radioactive drug is put to clinical test or

verification, an application together with the data and sample must be submitted to the Ministry of Public Health in accordance with the provisions for the examination and approval of new pharmaceuticals. The newly developed radioactive drug may be used for clinical study at an appointed hospital only after its application has been examined and approved by the Ministry of Public Health.

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