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中华人民共和国卫生部关于中药新药标准品、对照品有关问题的通知

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中华人民共和国卫生部关于中药新药标准品、对照品有关问题的通知

卫生部


中华人民共和国卫生部关于中药新药标准品、对照品有关问题的通知

1989年12月7日,卫生部

我部卫药字(89)第35号下发的《卫生部新药审批工作程序》第6.3项规定,中药新药标准品、对照品由各省、自治区、直辖市药品检验所进行标定、复核。为作好这项工作,特对中药新药标准品、对照品的审批程序及技术指标要求作如下补充规定:
一、审批程序补充规定
中药新药标准品、对照品由研制单位起草和提供,并在申报新药时一并送审,在标准试行期间由所在省、自治区、直辖市药品检验所负责审核、标定、分发。标准试行期满前半年,省所应将标准品、对照品及研制报告、检验证书等有关资料转报中国药品生物制品检定所进行标定和复核,试标准转正式标准后,由中国药品生物制品检定所负责统一制备和分发。
二、主要技术指标要求
1.确证为该标准品参数至少2个以上,如紫外、红外光谱检测……。
2.纯度:按药典有关品种项下要求,做三倍TCL点样量点样,薄层谱应显示单一斑点。并作20、40、60、80、100微克层析图谱,以了解纯度情况。
3.含量:如定量用对照品,应提供含量数据及含量测定方法。如为定性用对照品,也应尽量提供含量数据,如色谱归一法计,但需注明进样量。
4.注明标准品、对照品的植物(包括拉丁学名)来源,或化学合成。
5.提供有关参考文献及标准图谱,与实验数据是否相符。


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Reviews on the principle of effective nationality

孙倩
I. Introduction
In a world of ever-increasing transnational interaction, the importance of individual protection during the processes concurrently increases. Nationality is the principal link between individuals and states but also is the bridge connecting individuals with international law. It is just through the linkage of nationality can a person enjoy diplomatic protection by his parent state. But due to double nationality, there are lots of difficulties to effective diplomatic protection of individuals. The principle of effective nationality was formed through the judicial practice of international court of justice. What is the meaning of the principle of effective nationality? Is it a perfect theory in the face of diplomatic protection of dual national? In this article, the author will introduce the concept of this principle and give her opinions on it.
II: The concept of principle of effective nationality
Nationality of an individual is his quality of being a subject of a certain state. Nationality is of critical importance to individuals, especially with regard to individuals abroad or their property. Firstly, it is the main link between individual and a state. It is evidence that one can be protected by his parent state.
Secondly, to some extent, individuals are not the subjects of international law, so they cannot directly enjoy the rights and undertake responsibilities coming from international law. It is through the medium of their nationality that individuals can normally enjoy benefits from international law.
In principle, nationality as a term of local or municipal law is usually determined by the law of particular state. Each state has discretion of determining who is and who is not, to be considered its nationals. However, there is no generally binding rules concerning acquisition and loss of nationality, and as the laws of different states differ in many points relating to this matter, so it is beyond surprising that an individual may process more than one nationality as easily as none at all. But whether each granted nationality owned by these dual nationals has international effects is in doubt. In another word, the determination by each state of the grant of its own nationality is not necessarily to be accepted internationally without question. Especially, when a dual national seeks diplomatic protection in some third state, that state is not answerable to both of states of his nationality but only one of them. In this situation, the third state is entitled to judge which nationality should be recognized.
As stated in Art1 of the Hague Convention of 1930 on certain questions relating to the conflict of nationality laws, while it is for each state to determine under its own law who are its nationals, such law must be recognized by other states only “in so far as it is consistent with international conventions, international custom, and the principle of law generally recognized with regard to nationality”. In the “Nottebohm” case, the International Court of Justice regard nationality as: ‘a legal bond having as its basis a social fact of attachment, a genuine connection of existence and sentiments, together with the existence of reciprocal rights and duties. It may be upon whom it is conferred, either directly by the law or as a result of an act of the authorities, is in fact more closely connected with the population of the state conferring nationality than with that of any other state’ That is what is called the real and effective nationality. Deriving from the court’s opinion, the principle of effective nationality came into being. The essential parts of effective and real nationality are that which accorded with the facts, which based on stronger factual ties between the person concerned and one of the states whose nationality is involved. Different factors are taken into consideration, and their importance will vary from one case to the next: the habitual residence of the individual concerned is an important factor, but there are other factors such as the centre of his interests, his families, his participation in public life, attachment shown by him for a given country and inculcated in his children, etc. According to this principle, no state is under obligation to recognize a nationality granted not meeting the requirements of it. In the Nottebohm case, International Court of Justice first enunciated this principle and denied Liechtenstein the right to protect Nottebohm.
III. Nottebohm case and reviews on the principle of effective nationality
In the Nottebohm case, involving Liechtenstein and Guatemala, the former sought restitution and compensation on behalf of Nottebohm for the latter’s actions allegedly in violation of international law.
Nottebohm, a German national resident in Guatemala, had large business interest there and in Germany. He also had a brother in Liechtenstein, whom he occasionally visited. While still a German national, Nottebohm applied for naturalization in Liechtenstein on October 9, 1939, shortly after the German invasion of Poland. Relieved of the three-year residence requirements, Nottebohm paid his fees and taxes to Liechtenstein and became a naturalized citizen of Liechtenstein by taking an oath of allegiance on October 20,1939, thereby forfeiting his German nationality under the nationality law of Liechtenstein. He returned to Liechtenstein early in 1949 on a Liechtenstein passport to resume his business activities. At his request, the Guatemalan ministry of External Affairs changed the Nottebohm entry in its Register of Aliens from “German” to “Liechtenstein” national. Shortly afterward a state of war came into existence between the USA and Germany and between Guatemala and Germany. Arrested in Guatemala in 1943, Nottebohm has deported to the USA, where he was interned as an enemy alien until 1946. Upon his release, Nottebohm applied for readmission to Guatemala but was refused; therefore, he took up residence in Liechtenstein. Meanwhile, the Guatemalan government, after classifying him as an enemy alien, expropriated his extensive properties without compensation.
Liechtenstein instituted proceedings against Guatemala in International Court of Justice, asking the court to declare that Guatemala had violated international law “in arresting, detaining, expelling and refusing to readmit Mr. Nottebohm and in seizing and retaining his property”. The court rejected the Liechtenstein claim by a vote of 11 to 3, declaring that Nottebohm’s naturalization could not be accorded international recognition because there was no sufficient “bond of attachment” between Nottebohm and Liechtenstein.
The Nottebohm decision denied the competence of Liechtenstein to protect a naturalized citizen and the loss of Nottebohm could not be remedied. The application of the “genuine link” theory, borrowed from the very different context of dual nationality problems, has the unfortunate effect of depriving an individual of a hearing on the merits and the protection by a state willing to espouse his claim in the transnational arena. The net effect is an immense loss of protection of human rights for individuals. Such a decision runs counter to contemporary community expectations emphasizing the increased protection of human rights for individuals. If the right of protection is abolished, it becomes impossible to consider the merits of certain claims alleging a violation of the rules of international law. If no other state is in a position to exercise diplomatic protection, as in the present case, claims put forward on behalf of an individual, whose nationality is disputed or held to be inoperative on the international level and who enjoys no other nationality, would have to be abandoned. The protection of the individual which is so precarious under the international law would be weakened even further and the author consider that this would be contrary to the basic principle embodied in Article15 (2) of the Universal Declaration of Human Right. As a matter of human rights, every person should be free to change his nationality. Thus the Universal Declaration of Human Right states that ‘everyone has the right to a nationality’ (Art.15 (1)).The right to a nationality can be interpreted as a positive formulation of the duty to avoid statelessness. The duty to avoid statelessness is laid down in various international instruments, in particular in the 1961 Convention on the Reduction of Statelessness. The term statelessness refers to the “de iure stateless persons” rather than “de-facto stateless persons”. If it is a free choice and if this nationality is to be a benefit rather than a burden to the individual, it should follow that he has the right to renounce one nationality on acquiring a new one. Furthermore, refusal to exercise protection is not accordance with the frequent attempts made at the present time to prevent the increase in the number of cases of stateless persons and provide protection against acts violating the fundamental human rights recognized by international law as a minimum standard, without distinction as to nationality, religion or race. It is unfortunately not the case. While the Nottebohm decision denied the competence of Liechtenstein to protect a naturalized citizen, the Flegenheimer case involved the denial of protection to a national by birth, when and where will the principle of effective nationality be used? This is a question that needs to be thought over. From the standpoint of human rights protection, the application of this principle should be strictly limited.
VI. Conclusion
Nationality is within the domestic jurisdiction of the State, which settles, by its own legislation, the rules relating to the acquisition of its nationality. It is sometimes asserted that there must be a genuine and effective link between an individual and a state in order to establish a nationality which must be accepted by other states. It is doubtful, however, whether the genuine and effective link requirement, used by the International Court of Justice in the Nottebohm-Case in order to deny Liechtenstein’s claim to exercise protection, can be considered as a relevant element for international recognition of nationality or as a requirement of a valid naturalization under public international law. It is frequently argued that in the absence of any recognized criteria the attribution of nationality must be considered as arbitrary and that there must be some kind of a personal and territorial link. The rule, however, although maintained in state practice, has been gradually diminished in its importance due to one exception, which concerning the raising of claims in case of human rights protection, especially to dual nationals who suffers injury in the third state and cannot be protected by his origin nationality state.

References
1, Bauer, O. (2001, first published in 1907). The Question of Nationalities and Social Democracy. Minneapolis: University of Minnesota Press.
2, ICJRep , 1995, P4, atP23
3, SIR ROBERT JENNINGS & SIR ARTHUR WATTS Oppenheim’s International Law, Longman Group UK LIMITED AND Mrs.Tomokohudso, 1992


国家税务总局关于《中华人民共和国政府和新加坡共和国政府关于对所得避免双重征税和防止偷漏税的协定》第二议定书生效执行的通知

国家税务总局


国家税务总局关于《中华人民共和国政府和新加坡共和国政府关于对所得避免双重征税和防止偷漏税的协定》第二议定书生效执行的通知


国税发[2009]158号



各省、自治区、直辖市和计划单列市国家税务局、地方税务局:

  《中华人民共和国政府和新加坡共和国政府关于对所得避免双重征税和防止偷漏税的协定》第二议定书(以下简称“第二议定书”),已于2009年8月24日正式签署。双方外交主管部门分别于2009年11月12日和2009年12月11日互致照会,确认已完成生效所必需的法律程序。根据第二议定书第四条的规定,该议定书自2009年12月11日起生效,请遵照执行。


  
国家税务总局
  
二○○九年十二月三十一日


《中华人民共和国政府和新加坡共和国政府关于对所得避免双重征税和防止偷漏税的协定》第二议定书
  
  关于2007年7月11日在新加坡签订的《中华人民共和国政府和新加坡共和国政府关于对所得避免双重征税和防止偷漏税的协定》(以下简称“协定”) ,中华人民共和国政府和新加坡共和国政府同意下列规定作为协定的组成部分:  
  第一条
  关于协定第五条:
  取消第三款第(二)项中“六个月”的规定,用“一百八十三天”代替。  
  第二条
  关于协定第十一条:
  一、取消第三款并用如下规定代替:
  “三、虽有第二款的规定,从缔约国一方取得的利息应在该国免税,如果受益所有人是:
  (一)在中国:
  1. 中华人民共和国政府和任何地方当局;
  2.中国人民银行;
  3. 国家开发银行;
  4. 中国农业发展银行;
  5. 中国进出口银行;
  6. 全国社会保障基金理事会;
  7. 中国出口信用保险公司;以及
  8. 缔约国双方主管当局随时可同意的,由中国政府完全拥有的任何机构;
  第三款第(一)项2-7目所列实体或基金应为中国政府完全拥有并且不从事商业活动。
  (二)在新加坡:
  1. 新加坡共和国政府;
  2. 新加坡金融管理局; 
  3. 新加坡政府投资有限公司;
  4. 法定机构;以及
  5. 缔约国双方主管当局随时可同意的,由新加坡政府完全拥有的任何机构;
  第三款第(二)项2-4目所列实体应依照新加坡议会法案规定设立或完全由新加坡政府拥有,并且不从事商业活动。”
  二、因2007年9月18日前签订的任何贷款合同而从缔约国一方取得的利息至2011年1月1日前在该国免予征税,如果受益所有人是:
  (一)在中国:
  1. 中国国际信托投资公司;
  2. 中国银行总行。
  (二)在新加坡:
  新加坡星展银行总行。  
  第三条
  关于协定第二十二条:
  取消第一款(二)项中“百分之十”的规定,用“百分之二十”代替。  
  第四条
  缔约国双方应通过外交渠道相互通知对方已经完成该第二议定书生效所必需的国内法律程序。该第二议定书自收到后一方通知之日起生效。  
  下列代表,经各自政府正式授权,在本议定书上签字,以昭信守。    
  本议定书于2009年8月24日在新加坡签订,一式两份,每份都用中文和英文写成,两种文本同等作准。


  
  中华人民共和国政府代表 新加坡共和国政府代表
  国家税务总局副局长 国内税务局局长
  王 力 李金富