吕梁市人民政府关于印发《吕梁市市级城镇职工生育保险实施办法》的通知
山西省吕梁市人民政府
吕梁市人民政府关于印发《吕梁市市级城镇职工生育保险实施办法》的通知
吕政发〔2008〕41号
市直各委、办、局、处，各企事业单位，中央、省驻地单位：
《吕梁市市级城镇职工生育保险实施办法》已经市人民政府第48次常务会讨论通过，现下发给你们，请遵照执行。
二〇〇八年十月二十二日
吕梁市市级城镇职工生育保险实施办法
第一条 为保障女职工生育期间得到必要的经济补偿和医疗保障需求，根据《中华人民共和国劳动法》、《女职工劳动保护规定》、《山西省人口与计划生育条例》、《山西省城镇职工生育保险办法》等法律、法规和政策规定，结合我市实际，制定本办法。
第二条 生育保险与城镇职工基本医疗保险保持一致，实行统一参保、统一征缴、统一管理、分别运行的管理模式。
第三条 市直各机关、社会团体、事业单位、企业和吕梁市境内的中央、省属单位所属职工全部参加生育保险并由市直接统筹管理。劳动保障行政部门设立的社会保险经办机构具体承办生育保险业务。
市财政、卫生、食品药品监督、物价、人口与计生及工会、妇联按照各自的职责配合劳动保障部门做好城镇职工生育保险工作。
第四条 生育保险基金的构成：
(一)用人单位缴纳的生育保险费；
(二)基金的利息；
(三)滞纳金；
(四)依法纳入生育保险基金的其它资金。
第五条 参加市直统筹的用人单位按照本单位职工工资总额的0.7%的比例缴纳生育保险费，职工个人不缴纳生育保险费。职工本人工资高于全省上年度职工平均工资300%的，按照300%作为缴费基数；职工本人工资低于全省上年度职工平均工资60%的，按照60%作为缴费基数。
第六条 参保单位合并、兼并、转让、租赁、承包时，接收或者继续经营者必须承担原单位职工的生育保险责任，按规定继续缴纳生育保险费。
新成立的用人单位应当自批准成立或取得营业执照之日起30日内，办理参保手续并按规定缴费。
第七条 党政机关、全额预算的社会团体和事业单位应缴纳的生育保险费纳入财政预算，其它单位按有关规定定期缴纳。
第八条 生育保险费的征缴按照《社会保险费征缴暂行条例》有关规定执行。
第九条 生育保险基金纳入财政专户，实行收支两条线管理。生育保险经办机构不得从生育保险基金中提取任何费用，所需工作经费列入预算，由财政拨付。
第十条 生育保险基金用于以下项目的支出：
(一)生育津贴；
(二)生育医疗费用；
(三)计划生育手术医疗费用；
(四)聘请专家鉴定生育或计划生育手术并发症与合并症的费用；
(五)国家和省规定的其他费用。
第十一条 生育女职工享受保险待遇时，必须同时具备下列条件：
(一)用人单位按规定为其职工参加生育保险并履行缴费义务满三个月;
(二)女职工生育或实施计划生育手术符合国家和我省人口与计划生育法律、法规和政策规定。
第十二条 女职工怀孕7个月(含7个月)以上生育的产假为90天，其中包括产前休假15天；难产(包括剖腹产)的增加15天；多胞胎生育的每多生育一个婴儿增加15天；晚育的增加30天；产假期间采取长效节育措施并持有县级以上人口与计划生育行政部门颁发的《独生子女光荣证》的增加90天。符合以上多项增加产假条件的，累计产假天数最高不超过180天。
女职工怀孕不满3个月(含)流产的产假15天；3个月以上4个月(含)以内流产的产假30天；4个月以上7个月(含)以内流产(引产)的产假42天。
第十三条 党政机关、全额预算的社会团体和事业单位的女职工，在产假期间的生育津贴由单位按工资照发；其它单位的女职工在三个月(含三个月)以内的生育津贴由单位按工资照发，三个月以上的由生育保险经办机构按规定标准计发。
第十四条 女职工在产假期间享受生育津贴的标准按照女职工本人生育(流产)前一个月的缴费工资除以30再乘以本办法规定的产假天数计发。
第十五条 生育医疗费用包括女职工因怀孕、生育发生的医疗检查费、接生费、手术费、住院费、药品费。
按照国家有关规定，计划生育手术医疗费用包括职工因计划生育实施放置(取出)宫内节育器、人工终止妊娠、输卵(精)管结扎及复通手术所发生的医疗费用。
凡符合我省基本医疗保险药品目录、诊疗项目目录、医疗服务设施范围和支付标准规定的生育及计划生育手术费用，由生育保险基金支付。
第十六条 生育保险实行定点医疗机构管理办法。签定协议的医疗机构范围要考虑基本医疗保险定点医疗机构和妇幼保健院等医疗机构。
除急诊、急救、因公出差外，职工应当到生育保险定点医疗机构进行产前检查、住院分娩和施行计划生育手术，也可到实行协议管理的计划生育技术服务机构施行计划生育手术。
第十七条 市级统筹区域外的生育保险关系转入，其转入前生育保险缴费时限与转入后生育保险缴费时限连续未间断，前后缴费时限合并计算。
第十八条 享受生育保险待遇的人员在生育保险或施行计划生育手术之日起90日内，由用人单位或本人到社保经办机构申报生育保险待遇，逾期未申报的作为自动放弃处理。生育津贴和医疗费用的支出办法由市劳动保障部门会同市财政部门另行制定。
第十九条 生育保险基金不予支付的费用：
(一)不符合国家或者本省人口与计划生育规定发生的医疗费用；
(二)不符合生育保险就医规定发生的医疗费用；
(三)不符合基本医疗保险药品目录、诊疗项目、医疗服务设施项目和支付标准规定发生的医疗费用；
(四)因医疗事故发生的医疗费用；
(五)因犯罪、酗酒、吸毒、自残、他伤、打架斗殴、交通事故等造成终止妊娠的医疗费用；
(六)实施人类辅助生殖手术(如试管婴儿等)发生的医疗费用；
(七)在国外或港、澳、台地区发生的生育医疗费用；
(八)按照国家或者本省规定应当由个人负担的费用。
第二十条 女职工因生育引发并发症的医疗费用，在产假期间发生的由生育保险基金按规定支付；产假期满后需要继续治疗的医疗费用或女职工在产假期间因其他疾病发生的医疗费用，按照基本医疗保险规定从基本医疗保险基金中支付。
第二十一条 用人单位欠缴生育保险3个月以上的(不含3个月)，社保经办机构暂停应享受的生育保险待遇，用人单位在女职工生育或施行计划生育手术之日起90日内，持有关材料到社保机构备案。暂停支付期间职工应享受的生育保险待遇由用人单位支付，用人单位按国务院《社会保险费征缴暂行条例》的规定将拖欠的生育保险费补足后，社保经办机构再予拨付。逾期未备案的，由用人单位承担相应责任。
第二十二条 生育保险缴费标准的调整，由市劳动保障行政部门会同市财政部门共同提出，报市政府批准。
第二十三条 用人单位未按规定办理生育保险参保手续，或未按规定申报应缴纳的生育保险费数额的，由劳动保障行政部门责令限期整改，情节严重的，按国务院《社会保险费征缴暂行条例》第二十三条的规定，对直接负责的主管人员和其他责任人员可处以1000元以上5000元以下的罚款，情节特别严重的，对直接负责的主管人员和其他直接责任人员可处以5000元以上10000元以下的罚款。
第二十四条 用人单位向社会保险经办机构申报应缴纳的社会保险费数额时瞒报工资总额或职工人数的,由劳动保障行政部门责令改正,并处瞒报工资数额1倍以上3倍以下的罚款。
第二十五条 市社会保险基金监督委员会和市劳动保障部门、财政部门负责对生育保险基金的监督管理；审计部门负责生育保险基金的审计监督。社保经办机构负责生育保险费的征收、管理及拨付生育保险待遇，并建立健全预决算制度、财务会计制度和内部审计制度。
第二十六条 对以弄虚作假、冒名顶替等手段骗取生育保险待遇的个人，或协助骗取生育保险费的单位、医疗机构，由市劳动保障行政部门责令退还生育保险费，按有关规定予以行政处罚；构成犯罪的，依法追究刑事责任。
第二十七条 市劳动保障行政部门、社保经办机构工作人员滥用职权、徇私舞弊、玩忽职守，致使生育保险费流失的，由市劳动保障行政部门追回流失的生育保险费，依法给予行政处分；构成犯罪的，依法追究刑事责任。
第二十八条 参保单位及其职工对市劳动保障行政部门有关生育保险的具体行政行为不服或与社保经办机构发生生育保险的行政争议，可依法申请行政复议或提起诉讼。
第二十九条 社会保险经办机构不得从生育保险基金中提取任何费用，所需经费列入预算，由财政拨付。
第三十条 本办法具体应用中的问题由市劳动和社会保障行政部门负责解释。
第三十一条 本《实施办法》自发布之日起施行。
放射性药品管理办法(附英文)
国务院
放射性药品管理办法(附英文)
1989年1月13日，国务院
第一章 总 则
第一条 为了加强放射性药品的管理，根据《中华人民共和国药品管理法》（以下称《药品管理法》）的规定，制定本办法。
第二条 放射性药品是指用于临床诊断或者治疗的放射性核素制剂或者其标记药物。
第三条 凡在中华人民共和国领域内进行放射性药品的研究、生产、经营、运输、使用、检验、监督管理的单位和个人都必须遵守本办法。
第四条 卫生部主管全国放射性药品监督管理工作。能源部主管放射性药品生产、经营管理工作。
第二章 放射性新药的研制、临床研究和审批
第五条 放射性新药是指我国首次生产的放射性药品。药品研制单位的放射性新药年度研制计划，应当报送能源部备案，并报所在地的省、自治区、直辖市卫生行政部门，经卫生行政部门汇总后，报卫生部备案。
第六条 放射性新药的研制内容，包括工艺路线、质量标准、临床前药理及临床研究。研制单位在制订新药工艺路线的同时，必须研究该药的理化性能、纯度（包括核素纯度）及检验方法、药理、毒理、动物药代动力学、放射性比活度、剂量、剂型、稳定性等。
研制单位对放射免疫分析药盒必须进行可测限度、范围、待异性、准确度、精密度、稳定性等方法学的研究。
放射性新药的分类，按新药审批办法的规定办理。
第七条 研制单位研制的放射性新药，在进行临床试验或者验证前，应当向卫生部提出申请，按新药审批办法的规定报送资料及样品，经卫生部审批同意后，在卫生部指定的医院进行临床研究。
第八条 研制单位在放射性新药临床研究结束后，向卫生部提出申请，经卫生部审核批准，发给新药证书。卫生部在审核批准时，应当征求能源部的意见。
第九条 放射性新药投入生产，需由生产单位或者取得放射性药品生产许可证的研制单位，凭新药证书（副本）向卫生部提出生产该药的申请，并提供样品，由卫生部审核发给批准文号。
第三章 放射性药品的生产、经营和进出口
第十条 放射性药品生产、经营企业，必须向能源部报送年度生产、经营计划，并抄报卫生部。
第十一条 国家根据需要，对放射性药品实行合理布局，定点生产。申请开办放射性药品生产、经营的企业，应征得能源部的同意后，方可按照有关规定办理筹建手续。
第十二条 开办放射性药品生产、经营企业，必须具备《药品管理法》第五条规定的条件，符合国家的放射卫生防护基本标准，并履行环境影响报告的审批手续，经能源部审查同意，卫生部审核批准后，由所在省、自治区、直辖市卫生行政部门发给《放射性药品生产企业许可证》、《派湫砸┢肪笠敌砜芍ぁ贰Ｎ扌砜芍さ纳⒕笠担宦刹蛔忌⑾鄯派湫砸┢贰?
第十三条 《放射性药品生产企业许可证》、《放射性药品经营企业许可证》的有效期为五年，期满前六个月，放射性药品生产、经营企业应当分别向原发证的卫生行政部门重新提出申请，按第十二条审批程序批准后，换发新证。
第十四条 放射性药品生产企业生产已有国家标准的放射性药品，必须经卫生部征求能源部意见后审核批准，并发给批准文号。凡是改变卫生部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经卫生部批准后方能生产。
第十五条 放射性药品生产、经营企业，必须配备与生产、经营放射性药品相适应的专业技术人员。具有安全、防护和废气、废物、废水处理等设施。并建立严格的质量管理制度。
第十六条 放射性药品生产、经营企业，必须建立质量检验机构，严格实行生产全过程的质量控制和检验。产品出厂前，须经质量检验。符合国家药品标准的产品方可出厂，不符合标准的产品一律不准出厂。
经卫生部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，同时报告卫生部和能源部。
第十七条 放射性药品的生产、供销业务由能源部统一管理。放射性药品的生产、经营单位和医疗单位凭省、自治区、直辖市卫生行政部门发给的《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、直辖市公安、环保和卫生行政部门联合发给的《放射性药品使用许可证》，申请办理订货。
第十八条 放射性药品的进出口业务，由对外经济贸易部指定的单位，按照国家有关对外贸易的规定办理。
进出口放射性药品，应当报卫生部审批同意后，方得办理进出口手续。
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。
第十九条 进口放射性药品，必须经中国药品生物制品检定所或者卫生部授权的药品检验所抽样检验；检验合格的，方准进口。
对于经卫生部审核批准的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，并报告卫生部和能源部。
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。
MEASURES FOR THE CONTROL OF RADIOACTIVE 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译, 中国法制出版社出版的《中华人民
共和国涉外法规汇编》(1991年7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.
This English document is coming from the "LAWS AND REGULATIONS OF THE
PEOPLE'S REPUBLIC OF CHINA GOVERNING FOREIGN-RELATED MATTERS" (1991.7)
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)
MEASURES FOR THE CONTROL OF RADIOACTIVE DRUGS
(Promulgated by Decree No. 25 of the State Council of the People's
Republic of China on January 13, 1989 and effective as of the date of
promulgation)
Chapter I General Provisions
Article 1
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 2
"Radioactive drugs" refer to any forms of radionuclide or their tagged
drugs that are used for clinical diagnosis or in radiotherapy.
Article 3
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 4
The Ministry of Public Health is in charge of the supervisory and
administrative work of radioactive drugs while the Ministry of Energy is
in charge of the administration work concerning the production and sale of
radioactive drugs.
Chapter II Examination and Approval for the Development and Cli- nical Research of New Radioactive Drugs
Article 5
"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 Energy 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 6
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 7
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.
Article 8
After completion of clinical study of a newly developed radioactive drug,
the research unit must submit an application to the Ministry of Public
Health for examination and approval.
The latter shall consult the Ministry of Energy before granting a New Drug
License.
Article 9
Before a newly developed radioactive drug is put to production, the
production unit or the research unit that holds a license for the
production of radioactive drugs must submit an application together with a
copy of New Drug License and sample to the Ministry of Public Health.
After examination and verification, the Ministry of Public Health shall
issue them document of approval.
Chapter III The Production, Sales, Import and Export of Radio- active Drugs
Article 10
The enterprises that produce or sell radioactive drugs are required to
submit their production plan and business plan to the Ministry of Energy
and a duplicate to the Ministry of Public Health.
Article 11
The State shall, according to the actual conditions, make sure that
radioactive drugs be produced at designated pharmaceutical factories which
shall be located rationally over the country. Applications for the setting
up of any enterprises to produce or sell radioactive drugs must be
approved by the Ministry of Energy before the preparations start in
accordance with related provisions.
Article 12
Requirements for the setting up of enterprises to produce or sell
radioactive drugs are that they must have the necessary conditions as
stipulated in Article 5 of the Pharmaceutical Administration Law and that
they must meet the essential standard of radio hygiene protection set by
the State. They are also required to submit a report on environment impact
to the Ministry of Energy and the Ministry of Public Health for
examination and approval and then the health administration department in
their province, autonomous region or municipality directly under the
Central Government shall issue them "License for the Production Enterprise
of Radioactive Drugs", "License for the Business Enterprise of Radioactive
Drugs". No enterprises without the license shall be permitted to engage in
the production or sale of radioactive drugs.
Article 13
The term of validity of "License for the Production Enterprise of
Radioactive Drugs" and "License for the Business Enterprise of Radioactive
Drugs" is five years. If needed, the enterprises engaged in the production
or sale of radioactive drugs shall make a new application six months
before the expiration to the health administration department which shall,
in accordance with Article 12 of these Provisions, issue them a new
license.
Article 14
Before an approved pharmaceutical enterprise produces radioactive drugs
with specifications already set by the State, it must forward an
application which has to be examined and approved by the Ministry of
Public Health in conjunction with the Ministry of Energy. If any changes
in the technological process and specifications of the drugs previously
approved by the Ministry of Public Health are to be made, the
pharmaceutical factory shall be required to go through the same procedures
for approval.
Article 15
The production and business enterprises of radioactive drugs are required
to employ technical personnel who are qualified for the work and to have
safety and protection facilities as well as waste gas, liquid and material
disposal facilities. They must also have a strict quality control system.
Article 16
The production and business enterprises of radioactive drugs are required
to set up quality inspection offices. The entire process of production
must be put under strict qualify control and inspection.
All radioactive drugs are subject to quality testing. Only the products
that meet the State pharmaceutical standard shall be allowed to be shipped
out from the factories. Products that are not up to the standard are not
allowed out of the factory. As for the drugs with short half-life
radionuclide previously approved by the Ministry of Public Health, they
may be shipped out from the factory while having sample testing. If the
drugs are found to be below the State pharmaceutical standard, the factory
must stop the production and sale of the drugs immediately and inform
consuming units to stop using the drugs without delay. A report about the
case must be submitted to both the Ministry of Public Health and the
Ministry of Energy.
Article 17
The production, supply and sale of radioactive drugs are under the unified
administration of the Ministry of Energy.
When ordering these stuff, the pharmaceutical factory must furnish a
License for the Production Enterprise of Radioactive Drugs while the
business unit must present a License for the Business Enterprise of
Radioactive Drugs issued by the health administration department at the
provincial, autonomous regional or municipal (directly under the Central
Government) level. As for the medical treatment unit, they must order
these drugs with a License for the Use of Radioactive Drugs jointly issued
by the public security department, the environment protection department
and health administration department at the provincial, autonomous
regional or the municipal (directly under the Central Government) level.
Article 18
The import and export business of radioactive drugs shall be handled by
the units appointed by the Ministry of Foreign Economic Relations and
Trade in accordance with the State provisions related to foreign trade.
Prior to the import or export of radioactive drugs, an application must be
made and be examined and approved by the Ministry of Public Health.
Imported radioactive drugs are required to meet the State standards for
pharmaceuticals or other medical requirements.
Article 19
Imported radioactive drugs are subject to sample examination by the State
Administration for the Inspection and Testing of Pharmaceuticals and
Biological Products or by an inspection and testing institution of
pharmaceuticals authorized by the Ministry of Public Health. Only those
drugs that have met the State standards are allowed to be imported. As for
the drugs with short half-life radionuclide previously approved by the
Ministry of Public Health, they may be put to use upon being shipped in
while having import inspection. If the import inspection unit finds the
quality of imported drugs not up to the standard, they must inform the
consuming units promptly to stop using the drugs. A report about the
quality problem must be submitted to both the Ministry of Public Health
and the Ministry of Energy.
Chapter IV The Packaging and Shipment of Radioactive Drugs
Article 20
The packaging of radioactive drugs must be safe and reliable, and up to
the standards for the quality requirements of radioactive drug. There must
be protection devices that will match different radio dosages. The
packaging is required to consist of packing and inner packaging. There
must be trade mark, label, specifications and marker of radioactive drugs
on the packing and a label on the inner packaging. On the label there must
be name of the drug, radiospecific activity and packings.
The specifications must indicate the name of the producer, license number,
batch number, main composition, date of manufacture, half-life of
radionuclide, indications, administration, dosage, contraindication,
expiry date and precautions in addition to name of the drug, radioapecific
activity and packings.
Article 21
The shipment of radioactive drugs shall be handled in accordance with the
rules formulated by the State transportation and postal departments. No
unit or person shall be allowed to carry along radioactive drugs on any
means of public transportation.
Chapter V The Use of Radioactive Drugs
Article 22
If a medical treatment unit desires to set up a radiologic department or a
radioisotope department, it is required to employ technical personnel who
are qualified for radiotherapeutic work after special technical training.
Without prior technical training no personnel shall be allowed to use the
drugs in radiotherapy.
Article 23
When a medical treatment unit uses radioactive drugs, it must observe the
rules formulated by the State concerning radioisotope hygiene and
protection. The health administration department, the public security
department and the environment protection department at provincial,
autonomous regional or municipal (directly under the Central Government)
level shall issue a certain grade of License for the Use of Radioactive
Drugs according to technical skill and professional level of the
radiological personnel and equipment of the medical treatment unit. No
medical treatment unit without a license is allowed to use radioactive
drugs clinically.
The term of validity of a License for the Use of Radioactive Drugs is 5
years. If needed, the medical treatment unit must make a new application 6
months before the expiration of its license to the health administration
department which, after examination and verification shall issue it a new
license.
Article 24
Before a medical treatment unit holding a License for the Use of
Radioactive Drugs starts the preparation of any forms of radioactive drug
for clinical use, it is required to submit an application with the data
concerning pharmacology and toxicity of the radioactive drug, according to
the characteristics of the radioactive drug, to the health administration
department at the provincial, autonomous regional or municipal (directly
under the Central Government) level for approval and to the Ministry of
Public Health for the record. That form of radioactive drug can be used
only in the medical treatment unit.
Article 25
The medical treatment units that hold a License for the Use of Radioactive
Drugs are required to conduct clinical quality testing of the radioactive
drugs and find out their undesirable reactions and submit regular reports
to the health administration department. The health administration
department at the provincial, autonomous regional or municipal (directly
under the Central Government) level shall then present an itemized report
to the Ministry of Public Health.
Article 26
Waste material of radioactive drugs (including patients' excrement) must
be properly disposed of in accordance with the State regulations.
Chapter VI The Standards for Radioactive Drugs and Their Testing
Article 27
The Pharmacopoeia Commission under the Ministry of Public Health is
entrusted to formulate and revise the State standards for radioactive
drugs and then submit it to the Ministry of Public Health for examination
and approval before it is promulgated.
Article 28
The State Administration for the Inspection and Testing of Pharmaceuticals
and Biological Products or an inspection and testing institution of
pharmaceuticals authorized by the Ministry of Public Health is entrusted
to inspect and examine radioactive drugs.
Chapter VII Supplementary Provisions
Article 29
Any unit or individual that violates these Measures shall be penalized by
the health administration department at or above the county level in
accordance with the Pharmaceutical Administration Law and other rules and
regulations.
Article 30
The right to interpret these Measures resides in the Ministry of Public
Health.
Article 31
These Measures shall go into effect as of the date of promulgation.
