卫生部关于整顿肝炎诊断试剂的通知

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卫生部关于整顿肝炎诊断试剂的通知

卫生部


卫生部关于整顿肝炎诊断试剂的通知
卫生部


我国是世界上肝炎高发国之一,防治肝炎,保障人民健康是我国卫生工作的一项重要任务。随着我国防治肝炎工作的进展,近几年来我国许多部门和单位都开展肝炎诊断试剂的研究开发工作,取得很大进展,一些单位可以生产出接近国际水平的诊断试剂;国家药品生物制品检定所完成
了肝炎诊断试剂国家标准和参比品的制备工作,为我国防治肝炎,提高诊断率提供了物质基础和手段。但由于肝炎诊断试剂生产的一哄而起,许多单位生产条件差,技术力量弱,管理水平低,加上没有国家标准和评价试剂的参比品,不能进行有效的管理等诸多因素,目前我国肝炎诊断试剂
处于严重的“产、供、销”混乱状况,致使肝炎的误诊率高,造成肝炎的临床治疗、流行病学预测、科学研究的错误。为此,对肝炎诊断试剂按国家标准进行整顿,现通知如下:
一、各肝炎诊断试剂的研究和生产单位向中国药品生物制品检定所联系购买“甲、乙型肝炎诊断试剂检定要求”和“质控参比品”,按要求和规定的内容进行自查。
二、自查达到要求的单位,按“新生物制品审批办法”及其“补充规定”关于诊断试剂的要求准备好资料,报卫生部新药审评办公室进行审查,符合要求者送连续3批样品给中国药品生物制品检定所进行检定。
三、经中国药品生物制品检定所对所送连续3批检定合格后,由卫生部生物制品审评分。委员会审评,提出审评意见,经卫生部批准,发给“新生物制品证书”。
四、获得“新生物制品证书”的单位,对外可实行技术转让;自身可向省、自治区、直辖市卫生行政部门申请生产(部属各生研所除外),经审核同意后,报卫生部批准,发给产品“批准文号”;接受新生物制品证书转让的单位,必须是经过卫生部批准,具有生物制品生产“许可证”
的单位,申请生产时,需将自己生产的连续3批送中国药品生物制品检定所复检合格后,卫生部发给“批准文号”。
五、肝炎诊断试剂的报审日期定为1990年4月-5月底;8月底以前将3批检品送齐至国家检定所检定。1990年8月以后,肝炎诊断试剂除新制品和技术有重大改进,质量有显著提高的老产品外,不再受理肝炎诊断试剂类生物制品证书的申请。
六、自1991年元月起,没有“生物制品生产企业许可证”的单位不得生产肝炎诊断试剂。没有生产“批准文号”的肝炎诊断试剂不得销售、不得使用。
附件:甲、乙型肝炎诊断试剂检定要求(略)



1990年4月2日
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金华市人民防空警报设施管理实施办法

浙江省金华市人民政府


金华市人民政府令
第28号
《金华市人民防空警报设施管理实施办法》已经市政府第2次常务会议讨论通过,现发布实施。

市长:葛慧君
二OO五年六月二十七日


  金华市人民防空警报设施管理实施办法


  第一章 总  则


  第一条 为了加强人民防空警报设施建设与管理,保持人民防空警报设施良好使用状态,保障迅速准确地传递和发放防空袭警报信号,根据《中华人民共和国人民防空法》、《浙江省人民防空警报设施管理办法》等有关法律、法规、规章的规定,结合本市实际,制定本办法。
  第二条 本办法所称人民防空警报设施,是指用于战时防空、平时防灾发放警报信号的设备设施系统,包括警报信号的传递、鸣放、控制设备及相关的通信、供电线路和构筑物等附属设施。
  第三条 本市行政区域内与人民防空警报设施建设、维护、管理、警报信号发放等活动有关的单位和个人,应当遵守本办法。
  第四条 人民防空警报设施属于战备设施,是人防建设的重要组成部分,受国家法律保护,任何单位和个人都应当履行保护义务。
  第五条 人民防空警报建设实行长期准备、科学规划、合理布局、重点建设、平战结合的方针,结合城市建设总体规划,按照国家规定建设和完善人民防空警报设施。
  第六条 市、县(市)人民政府人民防空主管部门(以下简称人民防空主管部门)管理本行政区域的人民防空警报设施工作,计划、规划、建设、财政、通信、广播、电视、电力等部门和新闻单位及人民防空警报设施设置单位应当协同做好人民防空警报设施建设、维护管理和防空警报信号的发放工作。

  第二章 人民防空警报设施的建设


  第七条 各级政府应当加强人民防空警报设施建设,保障经费,逐步建立适应现代战争条件下的人民防空警报系统。
  人民防空主管部门应当根据城市总体规划,结合城市建设、经济发展水平和城市防护要求,编制人民防空警报设施建设规划,报同级人民政府批准后组织实施。
  人民防空主管部门应当根据人民防空警报设施建设规划,制定人民防空警报设施建设方案。
  第八条 通信、广播、电视系统等应当根据人民防空警报设施保障计划,制定传递人民防空警报信号的方案,保证战时优先传递、发放警报信号,报社等有关单位应当做好人民防空警报试鸣的宣传、公告等工作。
  电信部门应当优先保障对人民防空警报设施的通信信道,并负责日常维护管理,确保畅通。
  无线电管理部门应当保障人民防空警报设施所需频率。
  电力部门应当保障人民防空警报设施的电力供应,在安装、迁移人民防空警报设施时应当予以协助。
  第九条 人民防空主管部门应当根据人民防空警报设施建设规划和国家规定的技术要求,组织人民防空警报设施的安装,有关单位或者个人应当予以配合,不得拒绝、阻挠。
  按照人民防空警报设施建设方案,人民防空主管部门应当出具书面意见,确定需安装人民防空警报设施的建设工程或者建筑物及有关要求。对于建设工程,建设单位或者个人应当将人民防空警报设施的安装纳入工程建设施工方案,人民防空警报设施的安装基础、电力线路、终端控制线路应当按照国家规定的技术要求与主体工程同步建设;对于建筑物,产权单位或者个人应当提供必要的设计图纸和施工便利条件,协助人民防空主管部门做好人民防空警报设施建设安装工作。
  第十条 人民防空警报设施安装竣工后,由人民防空主管部门组织有关单位或个人共同进行验收。
  第十一条 任何单位和个人不得擅自拆除、迁移人民防空警报设施,不得随意改动警报设施的部件和线路。确因工程建设、拆建或楼房改造等原因需拆除、迁移的,必须报经人民防空主管部门许可,并按照有关规定易地重建或者结合改建工程再建。拆除和重新安装警报设施的费用,由申请拆除、迁移的单位或者个人承担。
  第十二条 重点防护单位应当制定本单位鸣放警报信号预案,报人民防空主管部门备案;其自建的警报设施,纳入人民防空警报系统。

  第三章 人民防空警报设施的维护


  第十三条 人民防空主管部门负责本行政区域人民防空警报设施维护管理的监管和指导。设有人民防空警报设施的单位和个人负责做好维护管理工作,定期检测人民防空警报设施性能。
  第十四条 设有人民防空警报设施的单位,应当指定专人负责人民防空警报设施的日常维护管理,建立本单位的人民防空警报设施维护管理档案,发现可能影响人民防空警报设施正常使用的,应当采取必要的措施并及时报告人民防空主管部门。
  第十五条 人民防空警报设施设置场所或者建筑物的权属发生变更时,原权属单位应会同取得权属单位,在权属变更之日起15日内就警报设施及维护管理责任等移交事项,向人民防空主管部门报告,由人民防空主管部门在3个工作日内组织双方当事人办理交接手续。
  第十六条 工程建设涉及人民防空警报设施安全的,建设单位或者个人应当在施工前向人民防空主管部门报告,人民防空主管部门应当在接到报告之日起5个工作日内作出答复。
  建设单位或者个人应当与人民防空主管部门签订保护协议,将有关施工方案和防护措施报人民防空主管部门备案,并在施工作业过程中接受人民防空主管部门的监督检查;施工中损毁人民防空警报设施的,建设单位或者个人应当修复,重新安装或者赔偿。

  第四章 警报信号的发放


  第十七条 战争时期,人民防空警报信号由当地人民防空指挥部门或者上级指挥机关统一发放。
  第十八条 发生重大自然灾害、大面积有毒气体泄露或者其他区域性重大突发事件时,警报信号的发放由县级以上人民政府决定。监狱、大型厂矿、水库、机场等重点防护单位以及其他设有人民防空警报设施的单位,发生火灾、爆炸、化学危害事故等危及周边人员生命财产安全的重大突发事件时,确需鸣放警报且符合警报信号发放预案要求的,可以先行鸣放,同时报人民防空主管部门备案。
  第十九条 人民防空警报执行年度试鸣制度,人民防空主管部门负责组织实施警报信号发放工作,按照省人民防空主管部门统一部署,报同级人民政府批准后实施。
  有线电话网、有线调度网、无线寻呼网、无线移动通信网、无线电台网、广播电台等通信、广播、电视系统以及设有人民防空警报设施的单位接到发放警报信号的命令后,必须按规定即时发放,不得延误。
  第二十条 安装、迁移、更新人民防空警报设施,调试检修时需要试鸣防空警报的,应当采取点试方法。
  第二十一条 任何单位或者个人不得占用或干扰人民防空警报设施的专用频率,不得使用与防空警报相同的音响信号。
  第二十二条 人民防空警报信号的音响规定与时限。
  预备警报:鸣36秒,停24秒,反复3遍为一个周期(时间3分钟)。
  紧急警报:鸣6秒,停6秒,反复15遍为一个周期(时间3分钟)。
  解除警报:连续鸣3分钟。
  第二十三条 人民防空主管部门对在人民防空警报设施建设、维护管理工作中作出显著成绩的单位和个人,应当给予表彰和奖励。

  第五章 法律责任


  第二十四条 违反《浙江省人民防空警报设施管理办法》,有下列情形之一的,由人民防空主管部门给予警告,责令限期改正,对个人并处5000元以下罚款,对单位并处10000元以上50000元以下罚款;造成损失的,应当依法赔偿损失:
  (一)拒绝、阻挠安装人民防空警报设施,拒不改正的;
  (二)占用人民防空通信专用频率、使用与人民防空警报相同的音响信号的;
  (三)擅自拆除人民防空警报设备设施的。
  第二十五条 违反《浙江省人民防空警报设施管理办法》,有下列情形之一的,由人民防空主管部门给予警告,责令限期改正,可以对个人并处1000元以下罚款,对单位并处1000元以上10000元以下罚款;造成损失的,应当依法赔偿损失:
  (一)工程建设涉及人民防空警报设施安全,未向人民防空主管部门报告,擅自施工造成人民防空警报设施损坏的;
  (二)擅自迁移人民防空警报设施的。
  第二十六条 违反《浙江省人民防空警报设施管理办法》,有下列行为之一的,由公安机关按照治安管理处罚的规定依法处理;造成损失的,应当依法赔偿损失:
  (一)盗窃、破坏人民防空警报设施的;
  (二)擅自鸣放警报信号、散布虚假险情,扰乱社会秩序的;
  (三)其他应当给予治安管理处罚的行为。
  第二十七条 人民防空主管部门和其他有关部门工作人员有下列行为之一的,依法给予行政或者纪律处分:
  (一)在人民防空警报设施项目建设中,不认真履行职责,未按照国家规定的技术标准和质量要求组织验收的;
  (二)未履行维护管理职责,影响警报设施良好使用状态的;
  (三)违反规定,对应当受理的申请不予受理或者未按规定时间作出审批决定的;
  (四)其他玩忽职守、滥用职权、徇私舞弊的行为或者有其他违法、失职行为的。
  第二十八条 违反《浙江省人民防空警报设施管理办法》,构成犯罪的,依法追究刑事责任。

  第六章 附  则


  第二十九条 本实施办法自公布之日起施行。





The Draft Constitution and Human Rights Protection in European Union

周大勇 (Zhou,Dayong)

1 the general introduction of the draft constitution in aspect of the human rights
2 short review of the human rights protection in European Union
3 the new points in aspect of human rights in the draft constitution
3.1 common values
3.2 incorporation of the Charter of fundamental rights
3.3 other changes could affect the human rights
4 arisen questions
4.1 the protection different from under the Convention
4.2 the two courts system and its application
5 conclusions in a historical view




1 general introduction of the draft constitution in aspect of the human rights

“Conscious that Europe is a continent that has brought forth civilization; That its inhabitants, arriving in successive waves from earliest times, have gradually developed the values underlying humanism: equality of persons, freedom, respect for reason” Extract from the preamble to the draft Constitution

In past 16 years, the European Union (EU hereafter) has marked itself through a series of changes. From The Single European Act, in which the Union committed itself to create a single market and at the same time establish on its territory the freedom of movement of people, goods, services as well as capital, to Maastricht Treaty, which brought the Union into reality and led to common foreign policy and cooperation in the area of justice and internal affairs as a higher level cooperation among Member States. Then the following Amsterdam (1997) and Nice (2001) Treaties, strengthened cooperation in foreign and security policy and placed Justice and Home Affairs matters and established the frame for the Union as a legitimate institution, in which people from different nations integrated in a large region would have common historical direction and splendid future before them. Just before the door of enlargement of the Union, it was argued that the Union has to improve democracy and transparency as well as efficiency, in order to outlines the EU’s purpose and competence clearly and streamline structures so as to prevent paralysis, therefore a new constitution for the Union is determined to replace the EU's series of key treaties in passed over the last 50 years as a single document .

Under leading of former French President and master draftsman Valéry Giscard d'Estaing, the European Convention set about its work of drafting the European Union's first ever full-fledged constitution. With the convention's work completed, the draft must now be finalized by an Intergovernmental Conference of European leaders that is expected to complete deliberations by the end of the 2003. As far as our topic is concerned, noticeably modifications come out in the constitution contract, first of all, the incorporation of the Charter of Fundamental Rights, which we will discuss later. In the beginning it is meaningful to consider the statues of the draft constitution in the progress course of the Union. The Union desires to bring peace and prosperity, to promote economic and social progress through continuously integrating market and expanding freedom under light of united institution and social systems . These goals, however, are the foundation of development and protection of human rights . That means, if we regard human rights as a series right which realized at first in peaceful and law-ruling society, then the Union has already kept on entrenching to appreciate these goal from beginning on, and now by means of perusing such goal in a larger region through enlargement, the EU’s influence extent to broader area and more people.

The draft constitution then in such context should be viewed as another historical phase in the process. Because the promoting of well-being and fortune of people depend not only on the development of economic situation and adding some single freedom clauses into the governmental documents, but also upon the entire politic system and background in which we live. Without governing based on democratic and effective institutional structure, and especially a ripe legislation and judiciary mechanism, the realization and protection of human rights could only be on the paper. This is also one of the motive caused the Declaration on the future of the European Union which committed the Union to becoming more democratic, more transparent and effective, in order to pave the way for a Constitution in response to the expectations of the people of Europe . In this perspective, one shall recognize the Constitution as a moving forward step of the whole EU institutionalization targeting its goal, so that to discuss the Constitution in connection with the human right protection, it is helpful to review the human rights protection in Europe and, especially in EU.

2 short review of the human rights protection in European Union

The protection of human rights has been internationally come to life in the Universal Declaration of Human Rights in 1948 (UDHR) with reorganization of disregard and contempt for human rights have resulted in barbarous acts which have outraged the conscience of mankind and respect for inherent dignity as well as the equal rights of all members of the human. This declaration states explicitly that the rights and freedoms of humans have to be guaranteed without distinction and destruction by any group, state or person. These principles were broadly accepted by European countries, considering the origin of the EU (EC) and the historical separation in Europe after WWII, we denote only the contracting countries of European Community.

For the Member States of EC, the Council of Europe has been up to now the most important instrument, which established in 1949 as a result of the Congress of Europe in The Hague , and took for the basic of the human rights protection. The Council accepted the principles of Universal Declaration of Human Rights and integrated it into The European Convention for the Protection of Human Rights (the Convention hereafter), which and its 12 Protocols turned out to be the significant resource for Human Rights protection in Europe. Because of the existence of the Convention, the other two organizations established in the same age aftermath of the Second World War, i.e. OEEC and the European Communities didn’t include relevant clauses for Human Rights protection into their founding treaties. Since it was agreed at that time, the Council of Europe would focus on the protection of human rights, fundamental freedoms and democratic values, whereas the OECD and the European Communities were to be concerned with the economic restoration of Europe. The reason of separate organizations was based on a view to avoiding economic excuses for future inhumanity. Another reason came from the thought, which believed that the process of economic integration set forth in the Community Treaties could not lead to a violation of human rights. Furthermore, the original Member States in the Treaty of Rome feared, that the inclusion of a "bill of rights" in the Treaty might have brought about an undesirable expansion of Community powers, since it could lead Community institutions to interpret their powers as extending to anything not explicitly prohibited by the enumerated guarantees.

Under the regime of Council of Europe, a lots of achievement of human rights improvement has been reached , yet along with the development and expansion of EU, another mechanism on protection of human rights which does not totally rely on the Council of Europe has derived out on one hand, on the other hand being lack of provisions ruling human rights protection in the Treaty establishing EC did not prevent the EC and the later European Union from providing care for the protection against the violations on human rights. Naturally, how could a swelling supranational organization as EC, which has been continually strengthening its power in all social aspects, does not involve in human rights issues especially when the consciousness of human rights nowadays become more significant both in international and national stages? Regarding to EU, The protection system has been formed in three aspects.

First of all, the legislation in the Member States of EU. Since there were no Member States of EU (EC) which accedes to the Community without being a member of the Council of Europe, and according to the Convention, it impose obligations on the Member States that they should ensure that the internal laws and practices comply with the human rights standards set out in the instruments. Very member states in EU have recognize the principles derived from the Convention and incorporated them somehow into national laws, most importantly, provided constitutive protection as the basic legal resource for human rights protection. For example in Germany, Basic Law (Grundgesetz) Art 1 to 19 deliver explicit provisions even beyond the Convention; the same case as Part VIII (§71-85) in Constitution of Denmark ; in Britain the Act of Human Rights came into force on 2 October 2000 steers extending a ways, in which the Convention can be used before domestic courts. Certainly, according to the classic human rights lessons, the basic protection of human rights could only be afforded at the national level through national legislation and excise of authoritative power.

Secondly, the institutions and legislation at the EU level acts also with high respect to the human rights protection. The EU has showed its commitment to human rights and fundamental freedoms and has explicitly confirmed the EU's attachment to fundamental social rights ever since its establishment.

The Amsterdam Treaty established procedures intended to secure their protection. It was ascertained, as a general principle, that the European Union should respect human rights and fundamental freedoms, upon which the Union is founded. For the first time a procedure is introduced, according to which severe and continuing violations of Fundamental Rights can lead to suspension of voting and other rights of a member state, if the Union determined the existence of a serious and persistent breach of these principles by that Member State. As to the Candidate countries, they should also respect these principles to join the Union. Furthermore, It has also given the European Court of Justice the power to ensure respect of fundamental rights and freedoms by the European institutions. In accordance with the inner requirement for the implementation of development cooperation operations, in order to reach objective of developing and consolidating democracy, EU also need its rule respecting for human rights. Such cases we have are for instance the EU Council’s regulation on human rights, Council Regulation (EC) No 975/199 and Council Regulation (EC) No 976/1999 for example, are aimed at providing technical and financial aid for operations to promote and protect of civil and political rights as well as economic, social and cultural rights etc.

Likewise, at their meeting in Cologne in June 1999, EU leaders declared that in respect to the current stage of progress of the European Union, the fundamental rights applicable at Union level should be pushed forward, namely be consolidated in a Charter and thereby made more evident. They argued, that the legal resources of human rights protection come from not only the European Convention of Human Right, but also from various international conventions drawn up by the Council of Europe as well as the United Nations and the International Labor Organization, they also include EU treaties themselves and from the case law of the European Court of Justice. As a result, a Charter of Fundamental Rights of the European Union (the Charter hereinafter) was sketch out, which highlighted the EU’s respect for human rights, for fundamental freedoms and for the principle of democracy through listing more rights a more precise definition of the common values comparing the early documents including the Convention. We will continue to concentrate on the Charter in point 3 since it has been integrated in the draft Constitution as an outstanding achievement.

Finally, the opinion and case-law of European Court of Justice (ECJ hereafter) also have immense impact on the establishment of the instrument of human rights protection within EU.

Although the jurisprudence developed by the ECJ recognizes the Convention as the standard-setter in cases in which the Court has to consider and decide a human rights issue, since there were no relevant legislation existed in the frame of the Community, the ECJ furnish itself power in this aspect by means of case-law. Earlier in 1974, the ECJ first made reference to the ECHR in the Nold judgment, in which the ECJ emphasized its commitment to fundamental human rights based on the constitutional traditions of the Member States’ fundamental rights form an integral part of the general principles of law which the Court enforces. In assuring the protection of such rights, the Court is required to base itself on the constitutional traditions common to the Member States and therefore could not allow measures, which are incompatible with the fundamental rights recognized and guaranteed by the constitutions of such States. The ECJ declared, that the international treaties on the protection of human rights in which the Member States have cooperated or to which they have adhered could also supply indications which may be taken into account within the framework of Community law.

That implied, even without clear regulations in the treaties, the remedy against violation on human rights could also be provided within the framework of the Community in respect for the common traditions applied to the Member States, and in connection with we have mentioned about the Member States’ above, the principles and resource applied to the Member States derived from the Council of Europe. Thus a EU standard could be established by transform a rating comparison of the members’ legal systems to the case-law in ECJ in respect for human rights.