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关于深入开展基本药物生产和质量监督检查工作的通知

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关于深入开展基本药物生产和质量监督检查工作的通知

国家食品药品监督管理局


关于深入开展基本药物生产和质量监督检查工作的通知

国食药监安[2011]196号


各省、自治区、直辖市食品药品监督管理局(药品监督管理局):

  建立和实施基本药物制度是党中央、国务院为保障公众基本用药、提高全民健康水平,深化医药卫生体制改革所做出的重大决策,各级食品药品监督管理部门必须以高度的政治责任感认真做好基本药物质量监管工作,决不能出现松懈和麻痹。当前部分中药材价格上涨幅度较大,而部分企业基本药物集中招标采购中标价格却在下降的现象,应当引起各级食品药品监督管理部门的高度关注,必须采取切实有效措施加强基本药物生产监管,确保基本药物质量安全。为此,要求各地深入开展基本药物生产和质量监督检查工作,现就相关事项和要求通知如下:

  一、按照属地监管的原则,各省级食品药品监督管理局为本辖区基本药物质量监管工作的责任部门。各省级局应充分认识基本药物监管工作的重要性和复杂性,将强化基本药物生产和质量监管,保障基本药物质量安全作为当前药品监管工作的重点,进一步加强领导,采取有效措施,深入开展基本药物生产检查和质量监督工作,切实排除产品质量风险,消除安全隐患。

  二、深入开展基本药物生产监督检查,要在执行2011年日常生产监督检查计划基础上,对辖区内基本药物的生产,特别是基本药物集中招标采购中标品种的生产进行监督检查。国家局根据2010年基本药物评价性抽验结果,以及各地集中招标采购中标价格情况,确定复方丹参片等20个品种(附件)为首批重点监督检查品种。请各省级局结合辖区内相应生产企业中标价格情况(见SFDA基本药物数据查询系统,网址:10.64.1.58),组织开展深入检查。首批重点品种监督检查工作应在2011年6月15日前完成。

  三、生产现场深入检查工作应以国家局《2011年药品生产监管工作计划》(国食药监安〔2011〕95号文发)以及《关于进一步加强中药生产监督检查的通知》(国食药监安〔2010〕457号)等相关要求为基础,重点检查药品生产企业执行2010年版《中国药典》标准情况;生产工艺和处方变化情况;中药材、饮片、提取物以及其他原辅材料的采购、入库检验、投料、中间产品制备情况;生产及检验记录、物料平衡等相关情况,应对中药材等重要原辅材料的供销链条、采购合同、台账与财务账目(至少两年)进行认真核查,尤其是质量标准未列有效成分含量、且价格较高的原辅料的核查,必要时对供应商进行追溯核查,或请相关省食品药品监督管理部门协查;对可疑原辅料或中间产品应抽样检验或列入质量抽验计划。

  四、现场监督检查过程中,如发现弄虚作假、以次充好、以假充真、偷工减料、随意替代投料、提取物成分添加勾兑等违法行为的,必须一查到底,依法严处,决不姑息。
  药品生产企业是基本药物生产及质量安全的第一责任者。药品生产企业必须对其严格按照批准的生产工艺和处方、严格执行《药品生产质量管理规范》、诚实守信生产药品的行为做出书面承诺。

  五、各省级局应在2011年6月30日前将此次监督检查总结上报国家局药品安全监管司。监督检查总结应包括监督检查的基本情况、查清的问题、发现的违法违规情节、初步调查处理情况、采取的相应措施以及强化基本药物监督检查工作的相关建议等内容,并附具体数据统计。

  六、加强基本药物生产和质量监管、确保基本药物质量安全是各级食品药品监督管理部门的重要职责,对保障基本药物制度的实施,维护公众健康权益具有十分重要的意义。各省级局应抓住药用原辅料来源追溯以及生产过程的物料平衡这两个方面,突出重点,以点带面,打破常规,力争实效,对辖区内基本药物生产过程进行严格的现场检查和质量监督,对发现的违法违规行为线索要彻查到底,坚决打击和震慑不法行为。

  为进一步做好基本药物监督检查工作,国家局将适时对各地开展基本药物监督检查工作进行督查,并将各地基本药物监督检查工作进展以及所取得的成效及时向当地省级人民政府进行通报。


  附件:首批重点监督检查品种名单(略)


                            国家食品药品监督管理局
                             二○一一年五月三日


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Remedies for non-performance:Perspectives from CISG, UNIDROIT Priniciples and PECL


INTRODUCTION


The growth of international trade makes some kind of unification necessary. Increased trade overseas has drawn attention to the problems that are caused by the different ways in which countries have chosen to regulate international sales. And the legal community has tried to facilitate overseas trade through efforts to harmonize national laws by legislative or non-legislative means.
Against such a background, the analysis in this contribution is focused on the CISG, UNIDROIT Principles and PECL -- three of the most important international instruments for the regulation of international commercial transactions which combine elements from both civil law and common law systems. In so doing, this contribution provides a comparative analysis of these instruments. It is merely thought that comparison is, probably, one of the most efficient ways to underline some of the unique features inherent in some legal regimes and to develop solutions to existing theoretical problems. However, as most of the authors dealing with the vast domain of this area would have done, the author in this contribution has never meant to make an exhaustive examination of international commercial law, bearing in mind that the ability of a single contribution to deal with its many issues is limited. The approach offered here is to review some of the key issues frequently befell in international trade, based on those generally accepted principles or elaborate rules as evidenced by international restatements or conventions and usages and practices or so-called lex mercatoria that is widely known to and regularly observed in international commercial transactions.
Particularly, it is said that no aspect of a system of contract law is more revealing of its underlying assumptions than is the law that prescribes the relief available for non-performance (breach). Issues relating to the remedial provisions are difficult and central substantive issues, which will no doubt be the focus of a large part of the discussion and deliberation surrounding application of commercial law on both a domestic and an international level. Therefore, the study in this contribution focuses, in light of traditional and modern theories, on the remedial scheme established under each of the three bodies of rules, namely Part III (partial) of the CISG, Chapter 7 of the UNIDROIT Principles and Chapters 8 and 9 of the PECL. In practical terms, these sectors are the substantive heart of the particular instruments. It is where the corresponding solutions to a large proportion of real world disputes in commercial transactions are to be found.
The comparative analysis contained speculates on the potential similarities and differences of these sectors, intending to enunciate rules which are common in international commercial law and at the same time to select the solutions which seem best adapted to the special requirements of international trade. One should note, however, that to the extent this contribution doesn’t give absolute priority to any one of the three instruments, whenever it is necessary to choose between conflicting rules and sometime then to derive a number of general principles which apply to all of the rules, what’s decisive to the criterion used is not just which rule is mandatory or adopted by the majority of jurisdictions, but rather which of the rules under consideration have the most persuasive value and/or appear to be particularly well suited for international commercial transactions.

Summary of Contents

PART I GENERAL REVIEW
Chapter 1 Sources of Inspiration
Chapter 2 Remedies Available upon Non-performance

PART II PRESERVING PERFORMANCE
Chapter 3 Specific Performance
Chapter 4 Nachfrist for Late Performance
Chapter 5 Cure by Non-performing Party
Chapter 6 Price Reduction for Non-conformity

PART III TERMINATION
Chapter 7 Right to Termination
Chapter 8 Fundamental Non-performance
Chapter 9 Anticipatory Non-performance
Chapter 10 Termination of Breached Installment or Part
Chapter 11 Declaration of Termination
Chapter 12 Effects of Termination

PART IV DAMAGES
Chapter 13 General Measure of Damages
Chapter 14 Limits to Claims for Damages
Chapter 15 Damages upon Termination
Chapter 16 Agreed Payment for Non-performance
Chapter 17 Recovery of Attorneys’ Fees
Chapter 18 Payment of Interest

PART V EXCUSES
Chapter 19 Change of Circumstances
Chapter 20 Force Majeure
Chapter 21 Hardship
Chapter 22 Force Majeure & Hardship Clauses

Table of Contents


PART I GENERAL REVIEW
Chapter 1 Sources of Inspiration

批转九龙海关《关于进口货物卖方同时提供百分之一同样货物作为“免费补偿”征免税问题的请示》

海关总署


批转九龙海关《关于进口货物卖方同时提供百分之一同样货物作为“免费补偿”征免税问题的请示》
海关总署


九龙海关在《关于进口货物卖方同时提供百分之一同样货物作为“免费补偿”征免税问题的请示》中所提的意见,我署同意。现转发给你们,请参照执行。如果在实际到货中确有残损、短少,请按海关法第一二0条规定办理减免。

附件:关于进口货物卖方同时提供百分之一同样货物作为“免费补偿”征免税问题的请示
自从海关恢复计征关税以来,我们注意到有些经营单位如深圳友谊商店、各省轻工业进出口公司、广东省食品进出口分公司、广东省粮油食品进出口分公司、深圳食品出口支公司等,进口的纸烟、酒、可口可乐、显象管及套装收录联合机,甚至“免税商店”进口的纸烟,卖方均(据说
是商业习惯)在进口的同时,提供了百分之一的同样货物作为“免费补偿”(也有称为“免费样品”、“无偿赠送样品”、“损耗补偿”或“SAMPLES FREE OF CH-ARGE”等)送给买方,有些在合约上已予注明如“免费提供1%的显象管作为质量保证系数”,这类
百分之一“免费补偿”的进口货物,为数是相当可观的。我们作了一个不完全的统计:一月份进口征税的计有纸烟6,850箱,每箱50条,白兰地酒200箱,每箱12瓶,套装收录联合机1,750台,显象管2,946只;二月份进口的计有可口可乐14,194箱,每箱24罐
,“免税商店”纸烟1,350箱,每箱50条,在二月份有一份报关单,广州市友谊公司进口500台电视机,同时进口不作价同型电视机20台及讯号发生器1台,这是在订购合约上注明的。
过去我们考虑这些物品数量不多,且大都是属于补偿性质,所以都没有征收关税。而有些申报单位认为,海关既不收税,有的不在报关单上申报;有的拿回去私分或变卖处理。
我们认为过去对“免费补偿”货物给以免税待遇是缺乏根据的,而且数量越来越多,容易产生漏洞和弊病。虽然卖方是免费提供给买方,但对我们海关来说,仍属有价的货物而且在进口报关时,整批货物都是完整无损的,因此,对这类“免费补偿”的货物,我们拟按规定照章征税。
至于“免税商店”进口的百分之一损耗补偿的纸烟,目前仍在海关登记监管之下售给出境旅客,尚未出现什么大的问题。今后如要内销或作内部处理,则应按照进出口税则补征关税。



1980年6月5日