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曲靖市人民政府办公室关于印发《曲靖市市直文化事业单位经费包干管理办法》的通知

作者:法律资料网 时间:2024-06-24 02:29:21  浏览:9722   来源:法律资料网
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曲靖市人民政府办公室关于印发《曲靖市市直文化事业单位经费包干管理办法》的通知

云南省曲靖市人民政府办公室


曲靖市人民政府办公室关于印发《曲靖市市直文化事业单位经费包干管理办法》的通知


曲政办发〔2005〕267号




各县(市)区人民政府,市直各委、办、局:

经市政府同意,现将《曲靖市市直文化事业单位经费包干管理办法》印发给你们,请认真遵照执行。



二○○六年一月五日





曲靖市市直文化事业单位经费包干管理办法



第一条 为了进一步促进文化事业和文化产业的发展,更好地满足广大人民群众对精神文化的需要,理顺政府对文化事业单位的管理体制和运行机制,充分调动文化工作者的积极性和创造性,提高文化产业对经济发展的贡献率,根据《曲靖市人民政府关于曲靖市文化体制改革试点方案》(曲政发〔2005〕72号)文件精神,特制定本办法。

第二条 经费包干原则:

(一)经费包干不与文化事业单位人员挂钩,与单位职能挂钩;
(二)随着事业的发展,政府要求的公共服务将逐渐通过政府采购方式实行购买服务。

第三条 经费包干的内容:

(一)市级财政2005年预算内安排市直文化事业单位的在职职工工资(含工资性支出,下同);
(二)市级财政2005年预算内安排给市直文化事业单位的公用经费。

第四条 离退休人员工资和公用经费不纳入包干范围。

第五条 市政府对文化事业单位区别不同情况采取固定包干、递减包干和取消财政拨款三种方式:

(一)对公益性单位正常工作的开展,实行经费总额固定包干,政府根据事业发展需要,可适当增加投入。其范围包括:曲靖电视台、广播电台、东山发射台、曲靖日报社、艺术研究所、文化馆(艺校合并到文化馆)、图书馆、文物管理所、电影管理站、广电局麒麟分局(公益性事业部分)、珠江网站等;

(二)对过渡为经营性的文化单位,实行递减包干,即增人不增加经费,减人按人均经费同比例扣减,政府所需要的公共服务增加原则上通过政府采购方式实行购买服务。其范围包括图片社、版画院、体育馆、花灯团、滇剧团;

(三)对经营性和自收自支单位取消财政拨款,并实行授权经营。其范围包括国风剧院、电影公司、艺术剧院、报社印刷厂、广电局自收自支的事业单位等;

(四)曲靖市花灯团、滇剧团的包干经费合并计算;艺校包干经费并入市文化馆计算;

(五)对实行固定包干和递减包干文化事业单位,若中央和省有增资政策,政府可适当增加包干经费。

第六条 预算外收入管理

(一)对实行固定包干的文化事业单位的预算外收入先缴入财政专户,按预算外收入的相关管理办法实行收支两条线和综合预算管理,政府统筹30%,政府统筹部分经市政府批准可专项用于文化事业的发展支出;

(二)对实行递减包干的文化事业单位预算外收入先缴入财政专户,按预算外收入的相关管理办法实行收支两条线和综合预算管理,政府不再统筹;

(三)对经营性和自收自支文化单位的收入不再缴入财政专户,由单位按照相关财务会计制度进行管理;

(四)对实行固定包干的文化事业单位预算外收入用于基础设施投入不得低于50%。
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第七条 改革前的退休人员的供养渠道不变,改革后退休的区别不同情况予以保障:

(一)实行固定包干和递减包干的文化事业单位原在职在编人员享受事业单位的退休待遇,新聘用人员纳入社会保障体系,由单位和个人按规定交纳各项社会保险费;

(二)实行固定包干的文化事业单位,在编制内新进人员执行事业单位人员管理规定;

(三)对经营性和自收自支文化事业单位改革前的在职在编人员,在改革后按企业的有关规定执行。原未纳入社会保险参保范围的,改革后按规定进入企业社会保险后,相关待遇按事业单位待遇执行,其事业单位与企业单位所执行的相关待遇差额部分由单位补助,国风剧院由财政全额补差。新进人员纳入社会保障体系,由单位和个人按规定交纳各项社会保险费。

第八条 对经营性和自收自支文化事业单位,由国资委授权经营,单位按照《公司法》和现代企业制度要求进行管理,并接受有关部门的监督检查。

(一)每年单位应和政府或政府授权的单位签订经营目标责任书,责任书中应包括资产保值增值、经营成果等财务指标;

(二)严格按照曲靖市人民政府2005年第9号公告《曲靖市国有资本收益管理实施细则》要求上交国有资本收益,市政府可视文化事业的发展要求,全额返还用于文化事业的建设项目。

第九条 每年11月份各二级核算单位要与主管部门签订次年的工作目标责任书,工作目标责任书,抄送市财政局作为制定下年度预算和拨付款项的依据。

第十条 财政部门根据包干办法和工作目标责任书计算包干经费按月拨给主管部门,并取消工资统发。各主管部门根据目标责任书按工作进度拨给二级核算单位包干使用。

第十一条 财政部门根据本办法计算核减的经费,由主管部门报市政府批准可用于主管部门或核减单位的文化基础设施建设和文化事业的项目经费,用核减单位文化基础设施建设和文化事业项目的经费原则上不得超过三年。图片社、版画院的包干经费中的职工人数可按2005年初的编制数计算,其包干经费与实有职工工资差额部分,由主管部门按本条上述规定安排使用,并抄送文产办备案。

第十二条 经市政府立项批准的文化基础设施投入区分如下几个方面的情况对待:

(一)市级公共文化服务基础设施建设经费由市级财政投入;

(二)政府鼓励通过市场化运作解决文化事业发展的投入;

(三)有预算外收入的文化事业单位政府视具体情况酌情补助;

(四)对过渡为经营性和经营性文化事业单位,政府原则上不再负责基础设施投入。

第十三条 各县(市)区可结合本地实际,参照本办法自行制定经费包干管理办法。

第十四条 其它规定若有与本办法不一致的,按本办法执行。

第十五条 本办法由市财政局负责解释。

第十六条 本办法自发文之日起执行。


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卫生部、财政部关于下发《〈医院会计制度〉的几点说明》的通知

卫生部 财政部


卫生部、财政部关于下发《〈医院会计制度〉的几点说明》的通知

1989年10月4日,卫生部、财政部

今年以来,一些地方反映《医院会计制度》执行中还存在一些问题,建议予以明确。现将《〈医院会计制度〉的几点说明》发给你们,请按以下要求进一步做好《医院财务管理办法》和《医院会计制度》的贯彻执行工作。
1.各地卫生主管部门要进一步加强对贯彻新《制度》的宣传教育,提高认识,把这项工作纳入医院建设年终考核内容,并与院领导工作实绩考核和单位奖惩挂钩。
2.继续抓紧对在岗财会人员培训。有条件的地方,可以组织有关专业人员或已离退休的具有较高业务水平的财会人员,对基层单位进行巡回检查评比和技术指导。
3.各地要根据《办法》规定的原则,健全财会机构,充实配备财会人员,解决贯彻新《制度》人员编制不足问题,所需增加人员,从医院内部调剂解决。
4.在试点基础上,逐步推广总会计师负责制。
5.按照《办法》和《制度》的要求,加强财产物资的管理,做好清产核资工作,特别要加强对专项物资和低值易耗品的管理,做到家底清楚。
6.要加强对医院业余医疗服务的管理,正确核算、反映和监督业余医疗服务收入和业余医疗服务收入提成,防止虚假。做好住院结算工作,加强对在院病人应收款的管理,必须建立在院病人日记帐。
7.要积极创造条件,结合会计制度改革,在财务管理和会计核算方面积极推广、应用计算机技术,提高工作效率和经济核算的准确性。
8.乡镇卫生院实施新《制度》问题,由各地根据具体情况,自行制订细则,但不得影响年终决算口径的一致性。
各地有关《医院财务管理办法》、《医院会计制度》贯彻实施情况,请及时报我们。

附:《医院会计制度》的几点说明
1.为反映本期资金增减变化及结存情况,医院资金平衡表“期初数”,应按编报说明填写,如:1季度期初数应填列上年末的数字;2季度的期初数应填列1季度末的数,以此类推。
2.专项资金收支表中的“本期增加数”均按各专项资金帐户的贷方累计发生数填列;“本期减少数”均按各专项资金帐户的借方累计发生数填列。本表未完专项占用合计数应与资金平衡表的未完专项占用数相等。
3.医院基本数字及财务分析表“全民职工平均工资”、“集体职工平均工资”、“职工平均补助工资”、“职工平均福利费”、“职工人均发放奖金”、“病床使用率”、“病床周转次数”、“日门诊人次”的“期末数”栏填列本期平均数,“平均数”栏填列累计平均数。如填报3季度报表时,“全民职工平均工资”的“期未数”栏填列7-9月平均数,“平均数”栏填列1—9月平均数,其他类同。本表“房屋建筑面积”、“固定资产总值”只填列期未数,不填列平均数。
4.资金平衡表中,由于流动资金和专项资金互相占用,各类资金相互平衡关系受到一定影响,因此,本表小计反映的数字允许不相等,但总计必须相等。
5.基本数字和财务分析表中,周转金周转次数公式应将“周转金总额”改为“周转金平均占用额”,月、季、年计算周转金平均占用额公式分别为:
周转金月平均占用额=(本月期初占用额+本月期未占用额)÷2
周转金季平均占用额=(本季各月的期初占用额+各月的期未占用额)÷6
周转金年平均占用额=(本年各月的期初占用额+各月的期未占用额÷24
6.医疗支出、药品支出、制剂支出、管理费用总帐科目下分别增加“主要副食品价格补贴”一级明细科目。
7.在业务收支汇总表、业务收支明细表的支出项目后增加“主要副食品价格补贴”目。


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.



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