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关于印发体外诊断试剂经营企业(批发)验收标准和开办申请程序的通知

国家食品药品监督管理局


关于印发体外诊断试剂经营企业(批发)验收标准和开办申请程序的通知

国食药监市[2007]299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):

  为加强体外诊断试剂专营企业的监督管理,规范体外诊断试剂经营行为,根据《药品管理法》、《药品管理法实施条例》、《医疗器械监督管理条例》和《药品经营许可证管理办法》、《医疗器械经营许可证管理办法》,国家局制定了《体外诊断试剂经营企业(批发)验收标准》和《体外诊断试剂经营企业(批发)开办申请程序》。现印发给你们,请认真贯彻执行。

  各省(区、市)药品监督管理部门对符合《体外诊断试剂经营企业(批发)验收标准》和《体外诊断试剂经营企业(批发)开办申请程序》的经营企业,可同时发给《药品经营许可证》和《医疗器械经营企业许可证》,许可证核准的经营范围仅限于体外诊断试剂。

  上述体外诊断试剂专营企业如需增加经营范围,必须按照有关药品经营、医疗器械经营的规定,重新申领《药品经营许可证》或者《医疗器械经营企业许可证》。体外诊断试剂经营企业必须按照《药品经营质量管理规范》从事经营活动。


  附件:1.体外诊断试剂经营企业(批发)验收标准
     2.体外诊断试剂经营企业(批发)开办申请程序
     3.体外诊断试剂经营企业(批发)申请审查表


                            国家食品药品监督管理局
                            二○○七年五月二十三日


附件1:
           体外诊断试剂经营企业(批发)验收标准


               第一章 机构与人员

  第一条 诊断试剂经营企业的法定代表人或企业负责人、质量管理人员无《医疗器械监督管理条例》第40条、《药品管理法》第76条、83条规定的情形。
  负责人应具有大专以上学历,熟悉国家有关诊断试剂管理的法律、法规、规章和所经营诊断试剂的知识。

  第二条 应有与经营规模相适应的质量管理人员,质量管理人员应行使质量管理职能,对诊断试剂质量具有裁决权。

  第三条 质量管理人员2人。1人为执业药师;1人为主管检验师,或具有检验学相关专业大学以上学历并从事检验相关工作3年以上工作经历。
质量管理人员应在职在岗,不得兼职。

  第四条 验收、售后服务人员应具有检验学中专以上学历;企业保管、销售等工作人员,应具有高中或中专以上文化程度。

  第五条 质量管理、验收、保管、销售等工作岗位的人员,应接受上岗培训,考试合格,方可上岗。

               第二章 制度与管理

  第六条 应根据药品、医疗器械管理的法律法规和相关文件制定符合企业实际的质量管理文件,包括质量管理制度、职责、工作程序。
  (一)质量管理制度应包括:质量管理文件的管理;内部评审的规定;质量否决的规定;诊断试剂购进、验收、储存、销售、出库、运输、售后服务的管理;诊断试剂有效期的管理;不合格诊断试剂的管理;退货诊断试剂的管理;设施设备的管理;人员培训的管理;人员健康状况的管理;计算机信息化管理。
  (二)质量管理职责应包括:质量管理、购进、验收、储存、销售、运输、售后服务、信息技术等岗位的职责。
  (三)工作程序应包括:质量管理文件管理的程序;诊断试剂购进、验收、储存、销售、出库、运输、售后服务等程序;诊断试剂销后退回的程序;不合格诊断试剂的确认及处理程序。

  第七条 应建立购进、验收、销售、出库、运输等内容的质量管理记录。


                第三章 设施与设备

  第八条 应有明亮整洁的办公、营业场所,其面积应与经营规模相适应,但不得少于100平方米。

  第九条 应设置符合诊断试剂储存要求的仓库,其面积应与经营规模相适应,但不得少于60平方米,且库区环境整洁,无污染源;诊断试剂储存作业区应与经营、办公等其他区域有效隔离;库房内墙、顶和地面应光洁、平整,门窗结构严密。

  第十条 住宅用房不得用做仓库。

  第十一条 应设置储存诊断试剂的冷库,其容积应与经营规模相适应,但不得小于20立方米。冷库应配有自动监测、调控、显示、记录温度状况和自动报警的设备,备用发电机组或安装双路电路,备用制冷机组。

  第十二条 储存诊断试剂的仓库应有以下设施和设备:
  (一)诊断试剂与地面之间有效隔离的设备;
  (二)通风及避免阳光直射的设备;
  (三)有效调控、检测温湿度的设备;
  (四)符合储存作业要求的照明设备;
  (五)不合格诊断试剂、退货诊断试剂专用存放区域或设施设备;
  (六)包装物料的储存场所和设备;
  (七)诊断试剂的质量状态应实行色标管理,待确定诊断试剂为黄色,合格诊断试剂为绿色,不合格诊断试剂为红色。

  第十三条 应有与经营规模和经营品种相适应,符合药品储存温度等特性要求的运输设施设备。

  第十四条 应有计算机管理信息系统,能满足诊断试剂经营管理全过程及质量控制的有关要求,并有可以实现接受当地药品监督管理部门监管的条件。

  第十五条 应对所用设施和设备的检查、保养、校准、维修、清洁建立档案。


               第四章 验收结果评定

  第十六条 现场验收时,应逐项进行全面检查、验收,并逐项做出肯定或否定的评定。

  第十七条 对验收合格或者验收不合格的,依据《药品经营许可证管理办法》第八条第(五)款和《医疗器械监督管理条例》第十四条的有关规定执行。

  第十八条 经营特殊管理诊断试剂应符合国家有关规定。

  第十九条 本标准自2007年6月1日起施行。

附件2:
          体外诊断试剂经营企业(批发)开办申请程序

  开办体外诊断试剂经营企业(批发)按照以下程序办理《药品经营许可证》、、《医疗器械经营企业许可证》:

  (一)申办人向拟办企业所在地的省、自治区、直辖市药品监督管理部门提出筹建申请,并提交以下材料:
  1.拟办企业法定代表人、企业负责人、质量负责人学历证明原件、复印件及个人简历;
  2.执业药师资格证书原件、复印件;
  3.主管检验师证书原件、复印件;
  4.拟经营产品的范围;
  5.拟设营业场所、设备、仓储设施及周边卫生环境等情况。

  (二)药品监督管理部门对申办人提出的申请,应当根据下列情况分别做出处理:
  1.申请事项不属于本部门职权范围的,应当即时做出不予受理的决定,发给《不予受理通知书》,并告知申办人向有关(食品)药品监督管理部门申请;
  2.申请材料存在可以当场更正错误的,应当允许申办人当场更正;
  3.申请材料不齐或者不符合法定形式的,应当当场或者在5个工作日内发给申办人《补正材料通知书》,一次性告知需要补正的全部内容。逾期不告知的,自收到申请材料之日起即为受理;
  4.申请事项属于本部门职权范围,材料齐全、符合法定形式,或者申办人按要求提交全部补正材料的,发给申办人《受理通知书》。《受理通知书》中注明的日期为受理日期。

  (三)药品监督管理部门自受理申请之日起30个工作日内,依据《药品经营许可证管理办法》第4条和《医疗器械经营企业许可证管理办法》第6条规定对申报材料进行审查,做出是否同意筹建的决定,并书面通知申办人。不同意筹建的,应当说明理由,并告知申办人享有依法申请行政复议或者提起行政诉讼的权利。

  (四)申办人完成筹建后,向受理申请的药品监督管理部门提出验收申请,并提交以下材料:
  1.《药品经营许可证》申请表;
  2.《医疗器械经营企业许可证》申请表;
  3.工商行政管理部门出具的拟办企业预先核准证明文件;
  4.拟办企业组织机构情况;
  5.拟办企业注册地址、仓库地址的地理位置图、平面图(注明面积、功能布局)、房屋产权证明(或者租赁协议)复印件;
  6.依法经过资格认定的专业技术人员资格证书及聘书;
  7.拟办企业质量管理文件及仓储设施、设备目录;
  8.拟办企业经营范围。

  (五)受理申请的药品监督管理部门在收到验收申请之日起30个工作日内,依据《开办体外诊断试剂经营企业(批发)验收标准》组织验收,做出是否发给《药品经营许可证》和《医疗器械经营企业许可证》的决定。符合条件的,同时发给《药品经营许可证》和《医疗器械经营企业许可证》;不符合条件的,应当书面通知申办人并说明理由,同时告知申办人享有依法申请行政复议或提起行政诉讼的权利。

  (六)申办人在取得《药品经营许可证》后,应根据《药品管理法实施条例》第十三条规定,在规定时间内向发证部门申请《药品经营质量管理规范》认证。发证部门应根据《药品管理法实施条例》第十三条规定组织对其进行认证,认证合格的,发给《药品经营质量管理规范》认证证书;认证不合格的,按有关认证管理规定处理。


Chapter IV
Function of Panels: Art. 11 of the DSU


OUTLINE


I Introduction
II Application of Art. 11 as a General Standard of Review
III Review in “neither de novo nor total defence”
IV Allegation against Panels’ Standard of Review
V Exercise of Judicial Economy





I Introduction
The function of panels is expressly defined in Art. 11 of the DSU, which reads as follows:

“The function of panels is to assist the DSB in discharging its responsibilities under this Understanding and the covered agreements. Accordingly, a panel should make an objective assessment of the matter before it, including an objective assessment of the facts of the case and the applicability of and conformity with the relevant covered agreements, and make such other findings as will assist the DSB in making the recommendations or in giving the rulings provided for in the covered agreements. Panels should consult regularly with the parties to the dispute and give them adequate opportunity to develop a mutually satisfactory solution.”

This provision suggests that the function of panels is to make an objective assessment such as to assist the DSB in making the recommendations or in giving the rulings provided for in the covered agreements. However, how do panels fulfill their functions as provided in Art. 11 of the DSU? It is the issue that we will touch on in this chapter. In this chapter, the author explores on the standard of review issue under the WTO, i.e. “an objective assessment”; as well as on the exercised judicial economy principle developed in panel’s review.
With regard to the standard of review issue, the GATT/WTO dispute settlement procedures have increasingly confronted questions concerning the degree to which an international body, under the GATT/WTO, should “second guess” a decision of a national government agency concerning economic regulations that are allegedly inconsistent with an international rule. It seems clear that the international agreement doesn’t permit a national government’s determination always to prevail, otherwise the international rules could be easily evaded or rendered ineffective. But should the international body approach the issues involved without any deference to the national government? It has been argued in the GATT/WTO proceedings that panels should respect national government determinations, up to some point. That “point” is the crucial issue that has sometimes been labelled the “standard of review”.1
Of course, this issue is not unique to the GATT/WTO. Naturally, the standard-of-review issue is one that many legal systems face. “The standard-of-review question is faced at least implicitly whenever sovereign members of a treaty yield interpretive and dispute settlement powers to international panels and tribunals. Moreover, as national economies become increasingly interdependent, and as the need for international cooperation and coordination accordingly becomes greater, the standard-of-review question will become increasingly important.” 2 And “it can be seen that the standard-of-review question is a recurring and delicate one, and one that to some extent goes to the core of an international procedure that must (in a rule-based system) assess a national government’s actions against treaty or other international norms”. 3
However, for the immediate purpose, we want to focus below on the more particular question of the proper standard of review for a WTO panel when it undertakes to examine a national government’s actions or rulings that engage the question of consistency with the various WTO agreements and are subject to the DSU procedures.

II Application of Art. 11 as a General Standard of Review
Under the WTO jurisprudence, it’s demonstrated that Art. 11 of the DSU has been applied as a general standard of review. Art. 11 suggests that the function of panels is to make “an objective assessment” so as to assist the DSB in making the recommendations or in giving the rulings provided for in the covered agreements.
For example, in US-Shirts and Blouses (DS33), the Panel rules that, “although the DSU does not contain any specific reference to standards of review, we consider that Article 11 of the DSU which describes the parameters of the function of panels, is relevant here”. 4
And the application of Art. 11 as a general standard of review under the DSU is analyzed systematically in EC-Hormones (DS26/DS48) where the Appellate Body rules that: 5
“The first point that must be made in this connection, is that the SPS Agreement itself is silent on the matter of an appropriate standard of review for panels deciding upon SPS measures of a Member. Nor are there provisions in the DSU or any of the covered agreements (other than the Anti-Dumping Agreement) prescribing a particular standard of review. Only Article 17.6(i) of the Anti-Dumping Agreement has language on the standard of review to be employed by panels engaged in the ‘assessment of the facts of the matter’. We find no indication in the SPS Agreement of an intent on the part of the Members to adopt or incorporate into that Agreement the standard set out in Article 17.6(i) of the Anti-Dumping Agreement. Textually, Article 17.6(i) is specific to the Anti-Dumping Agreement.
[…]
We do not mean, however, to suggest that there is at present no standard of review applicable to the determination and assessment of the facts in proceedings under the SPS Agreement or under other covered agreements. In our view, Article 11 of the DSU bears directly on this matter and, in effect, articulates with great succinctness but with sufficient clarity the appropriate standard of review for panels in respect of both the ascertainment of facts and the legal characterization of such facts under the relevant agreements […]”
In sum, for all but one of the covered agreements, Art. 11 of the DSU sets forth the appropriate standard of review for panels. As stated on more than one occasion, Art. 11 of the DSU, and, in particular, its requirement that “a panel should make an objective assessment of the matter before it, including an objective assessment of the facts of the case and the applicability of and conformity with the relevant covered agreements”, sets forth the appropriate standard of review for panels examining the consistency or inconsistency of alleged measures under the WTO jurisprudence. And the only exception is the Agreement on Implementation of Article VI of the General Agreement on Tariffs and Trade 1994, in which a specific provision, Art. 17.6, sets out a special standard of review for disputes arising under that Agreement(to be discussed in subsequent chapter).6

III Review in “neither de novo nor total defence”
In EC-Hormones (DS26/DS48), in the view of the European Communities, “the principal alternative approaches to the problem of formulating the ‘proper standard of review’ so far as panels are concerned are two-fold. The first is designated as ‘de novo review’. This standard of review would allow a panel complete freedom to come to a different view than the competent authority of the Member whose act or determination is being reviewed. A panel would have to ‘verify whether the determination by the national authority was…correct (both factually and procedurally)’. The second is described as ‘deference’. Under a ‘deference’ standard, a panel, in the submission of the European Communities, should not seek to redo the investigation conducted by the national authority but instead examine whether the ‘procedure’ required by the relevant WTO rules had been followed”.7 In this respect, the Appellate Body rules that:8
“So far as fact-finding by panels is concerned, their activities are always constrained by the mandate of Article 11 of the DSU: the applicable standard is neither de novo review as such, nor ‘total deference’, but rather the ‘objective assessment of the facts’. Many panels have in the past refused to undertake de novo review, wisely, since under current practice and systems, they are in any case poorly suited to engage in such a review. On the other hand, ‘total deference to the findings of the national authorities’, it has been well said, ‘could not ensure an 'objective assessment' as foreseen by Article 11 of the DSU’.”
The ruling is confirmed on many other occasions. For example, the Panel on US-Underwear (DS24) finds that: 9
“In our opinion, a policy of total deference to the findings of the national authorities could not ensure an ‘objective assessment’ as foreseen by Article 11 of the DSU. This conclusion is supported, in our view, by previous panel reports that have dealt with this issue, and most notably in the panel report on the ‘Transformers’ case.
The panel in the ‘Transformers’ case was confronted with the argument of New Zealand that the determination of ‘material injury’ by the competent New Zealand investigating authority could not be scrutinized by the panel. The ‘Transformers’ panel responded to this argument as follows:
‘The Panel agreed that the responsibility to make a determination of material injury caused by dumped imports rested in the first place with the authorities of the importing contracting party concerned. However, the Panel could not share the view that such a determination could not be scrutinized if it were challenged by another contracting party. On the contrary, the Panel believed that if a contracting party affected by the determination could make a case that the importation could not in itself have the effect of causing material injury to the industry in question, that contracting party was entitled, under the relevant GATT provisions and in particular Article XXIII, that its representations be given sympathetic consideration and that eventually, if no satisfactory adjustment was effected, it might refer the matter to the CONTRACTING PARTIES, as had been done by Finland in the present case. To conclude otherwise would give governments complete freedom and unrestricted discretion in deciding anti-dumping cases without any possibility to review the action taken in the GATT. This would lead to an unacceptable situation under the aspect of law and order in international trade relations as governed by the GATT’.”
In short, for the panel to adopt a policy of total deference to the findings of the national authorities could not ensure an “objective assessment” as foreseen by Art. 11 of the DSU. This conclusion is supported, in our view, by previous panel reports that have dealt with this issue. However, panels do not see their review as a substitute for the proceedings conducted by national investigating authorities, either. For example, in Argentina-Footwear (DS121), the Panel doesn’t consider that they have the mandate to conduct a de novo review: 10
“This approach is consistent with the reports of panels reviewing national investigations… The panel on United States - Anti-dumping Duties on Import of Salmon from Norway concluded that it should not engage in a de novo review of the evidence examined by the national investigating authority.
The panel on United States - Underwear followed this approach by noting, however, that it did not see its ‘review as a substitute for the proceedings conducted by national investigating authorities or by the Textiles Monitoring Body (TMB). Rather…the Panel's function should be to assess objectively the review conducted by the national investigating authority, in this case the CITA. We draw particular attention to the fact that a series of panel reports in the anti-dumping and subsidies/countervailing duties context have made it clear that it is not the role of panels to engage in a de novo review. In our view, the same is true for panels operating in the context of the ATC, since they would be called upon, as in the cases dealing with anti-dumping and/or subsidies/countervailing duties, to review the consistency of a determination by a national investigating authority imposing a restriction under the relevant provisions of the relevant WTO legal instruments, in this case the ATC. …’
Accordingly, the panel on United States - Underwear decided, ‘in accordance with Article 11 of the DSU, to make an objective assessment of the Statement issued by the US authorities … which, as the parties to the dispute agreed, constitutes the scope of the matter properly before the Panel without, however, engaging in a de novo review. … an objective assessment would entail an examination of whether the CITA had examined all relevant facts before it, whether adequate explanation had been provided of how the facts as a whole supported the determination made, and, consequently, whether the determination made was consistent with the international obligations of the United States’.
The panel on United States - Shirts and Blouses also stated that ‘[t]his is not to say that the Panel interprets the ATC as imposing on the importing Member any specific method either for collecting data or for considering and weighing all the relevant economic factors upon which the importing Member will decide whether there is need for a safeguard restraint. The relative importance of particular factors including those listed in Article 6.3 of the ATC is for each Member to assess in the light of the circumstances of each case’.
These past GATT and WTO panel reports make it clear that panels examining national investigations in the context of the application of anti-dumping and countervailing duties, as well as safeguards under the ATC, have refrained from engaging in a de novo review of the evidence examined by the national authority.”
However, as emphasized by the Appellate Body, although panels are not entitled to conduct a de novo review of the evidence, nor to substitute their own conclusions for those of the competent authorities, this does not mean that panels must simply accept the conclusions of the competent authorities. In this respect, the phrase “de novo review” should not be used loosely. If a panel concludes that the competent authorities, in a particular case, have not provided a reasoned or adequate explanation for their determination, that panel has not, thereby, engaged in a de novo review. Nor has that panel substituted its own conclusions for those of the competent authorities. Rather, the panel has, consistent with its obligations under the DSU, simply reached a conclusion that the determination made by the competent authorities is inconsistent with the specific requirements of the covered Agreement. 11

国家安全监管总局关于进一步加强非药品类易制毒化学品监管工作的指导意见

国家安全生产监督管理总局


国家安全监管总局关于进一步加强非药品类易制毒化学品监管工作的指导意见

安监总管三〔2012〕79号



各省、自治区、直辖市及新疆生产建设兵团安全生产监督管理局:

为深入贯彻落实《禁毒法》、《易制毒化学品管理条例》(国务院令第445号,以下简称《条例》)、《非药品类易制毒化学品生产、经营许可办法》(国家安全监管总局令第5号)等法律法规要求,落实各级安全监管部门非药品类易制毒化学品监管责任,推动非药品类易制毒化学品生产、经营企业(以下简称企业)认真履行社会责任,依法从事生产、经营活动,进一步加强非药品类易制毒化学品管理,现提出以下指导意见:

一、进一步加强非药品类易制毒化学品监管工作的重要意义和总体要求

(一)重要意义。非药品类易制毒化学品品种数量占国家管制的易制毒化学品品种数量的80%以上。为防止其流入非法渠道用于制造毒品,《条例》赋予安全监管部门履行非药品类易制毒化学品生产、经营许可和监督工作的职责,这是加强非药品类易制毒化学品源头管理的重要环节,在整个禁毒工作中发挥着不可替代的重要作用,对于维护社会秩序、构建和谐社会具有重要现实意义。各级安全监管部门要充分认识非药品类易制毒化学品监管工作的长期性、复杂性,增强大局意识、责任意识、创新意识、法制意识,不断提升监管能力。

(二)总体要求。结合危险化学品安全监管工作,严把非药品类易制毒化学品企业准入关,进一步加强和完善非药品类易制毒化学品生产、经营环节的流向和数量监管工作,建立日常监督检查机制,完善部门联合执法机制,严厉查处各种非法违法行为;加强对非药品类易制毒化学品企业的监督指导,督促企业认真落实非药品类易制毒化学品管理责任,增强自律意识,健全管理制度,自觉遵守《条例》规定,构建非药品类易制毒化学品生产经营法制秩序。

二、严格源头准入,进一步加强非药品类易制毒化学品的监督管理

(三)严格非药品类易制毒化学品生产、经营颁证管理。各级安全监管部门要通过许可证审查和备案证明延期换证等手段,依法依规严格要求,从严把好非药品类易制毒化学品生产经营准入关口。许可证和备案证明载明的易制毒化学品品种、产量、销售量、流向等内容,要反映企业实际生产经营情况,增强许可证和备案证明的约束与引导作用。要结合安全生产监督管理工作,依法淘汰生产条件差、管理水平低的生产企业,关闭无固定经营场所的经营企业,从严查处涉毒案件中的违法企业。许可证或备案证明有效期届满后未按要求提交延期换证申请的企业,应当立即停止相关生产经营活动;继续生产经营的,按非法生产经营行为依法予以严肃查处。发证机关要在非药品类易制毒化学品生产、经营企业许可证或备案证明有效期届满后3个月内依法予以注销,并抄报同级公安、工商、商务等有关部门。

(四)加强非药品类易制毒化学品颁证企业的监管工作。各级安全监管部门要针对本地区非药品类易制毒化学品企业分布情况和管理状况,制定年度监管执法工作计划,有计划地开展日常监督检查,做到年度内全覆盖,重点检查企业执行《条例》情况、保持颁证条件情况、制度落实情况、相关人员对非药品类易制毒化学品管理要求的掌握情况等。对检查发现的问题,要限期改正,严厉查处和打击非法生产经营行为。要与危险化学品安全监管工作有机结合,充分利用安全监管的行政许可手段,加大企业违法成本;对于被暂扣或吊销非药品类易制毒化学品相关许可证或备案证明,又存在违反危险化学品安全法律法规要求的企业,要同时依法暂扣或吊销其相关危险化学品安全许可证。

三、全面落实企业非药品类易制毒化学品管理责任

(五)建立健全非药品类易制毒化学品管理责任体系。企业要认真履行非药品类易制毒化学品管理责任,建立健全包括主要负责人、分管负责人、销售负责人及有关人员在内的责任体系,健全管理机构,至少配备1名专职人员或者以非药品类易制毒化学品管理为主要职责的固定管理人员,切实履行职责,严防非药品类易制毒化学品流入非法渠道造成社会危害。

(六)健全完善各项非药品类易制毒化学品管理制度。企业要建立健全至少包括以下内容的非药品类易制毒化学品管理制度:企业负责人的管理职责和管理人员的岗位职责,非药品类易制毒化学品生产、出入库管理、仓储安全管理制度,购销管理、购销合同管理、销售流向登记、销售记录管理、购买和运输凭证存档等制度,非药品类易制毒化学品信息系统填报制度,从业人员非药品类易制毒化学品知识教育培训制度,违法违规行为举报奖励制度等。

(七)非药品类易制毒化学品生产设备、仓储设施、产品包装要符合国家标准要求或有关规定。不得采用国家明令淘汰的生产工艺装置;仓储设施要符合非药品类易制毒化学品的理化特性要求,符合防盗等安全监控要求;产品包装必须标明产品名称、化学分子式、成分和含量,确保包装可靠,属于危险化学品的,必须符合有关法律法规对危险化学品安全的有关规定。

(八)严格遵守非药品类易制毒化学品生产、经营许可和备案制度。企业要严格依法从事非药品类易制毒化学品生产、经营活动,规范生产和经营行为,严禁超许可范围生产和经营;备案事项发生变化的,应当及时办理重新备案和变更手续;不再生产、经营非药品类易制毒化学品的,应当及时办理许可证或备案证明注销手续。严禁倒卖、出租、转让或以厂房场地转包、租赁等方式变相转让非药品类易制毒化学品生产、经营许可证或备案证明。

(九)强化非药品类易制毒化学品销售管理,做到销售流向清晰、档案记录完整。企业要依法销售非药品类易制毒化学品,按规定查验购买者应持有的由公安机关核发的购买资质证明和购买经办人身份证。对符合条件的购买者,要如实记录销售的品种、数量、日期和购买方的详细地址、联系方式和自述用途等情况,留存上述资质证明和身份证的复印件。记录和留存复印件等销售资料应当保存2年备查。对非药品类易制毒化学品生产、经营的各项记录台账、资料,要逐步建立电子文档,实现信息化、动态化管理。

(十)加强非药品类易制毒化学品法律法规教育培训。企业每年要对全体员工进行一次非药品类易制毒化学品管理方面的遵纪守法教育培训,使全体员工充分认识非药品类易制毒化学品流入非法渠道的社会危害和法律责任。企业主要负责人、技术人员和管理人员要接受非药品类易制毒化学品管理的教育和培训,熟悉相关法律法规和制度规定,掌握非药品类易制毒化学品基本知识。涉及第一类非药品类易制毒化学品的企业主要负责人、技术人员和管理人员,还应当按照有关规定取得考核合格证明。

四、强化非药品类易制毒化学品流向监管,严格追究责任

(十一)加强生产、经营环节非药品类易制毒化学品流向监管。地方各级安全监管部门要监督企业建立健全非药品类易制毒化学品出入库、销售登记等各项管理制度,并检查企业非药品类易制毒化学品存放保管等内部流转是否有明确的记录,对外销售记录和买方购买资质留存资料是否完整,企业产量、销售量是否平衡,前后记录是否一致,台账和实物是否相符,以及产量、销售量、流向等与企业年报是否相符等情况。对存在问题的,要责令限期改正,依法处罚。

(十二)加强非药品类易制毒化学品信息化管理。地方各级安全监管部门要充分运用非药品类易制毒化学品管理信息系统的统计等功能,全面分析和掌握本地区非药品类易制毒化学品生产和经营的总量、品种、流向、颁证等情况及相关变化。要认真做好非药品类易制毒化学品生产、经营许可和备案颁证季报(以下简称季报)填报工作,督促企业按时上报非药品类易制毒化学品生产、经营年报(以下简称年报),并做到上报数据准确、规范;要于每季度第一个月末前上报上一季度季报,每年4月底前上报上一年度年报。企业不提供年报的,安全监管部门要依法予以处罚;下级安全监管部门不提供季报、年报,数据存在明显错误,季报、年报缺项较多的,上级安全监管部门要予以通报或督办。

(十三)建立非药品类易制毒化学品案件倒查机制。对涉及非药品类易制毒化学品流入非法渠道案件的企业,所在地省级安全监管部门要组织专项检查,查清涉案情况、非药品类易制毒化学品管理情况。对存在管理漏洞的,要责令企业限期整改;存在非法违法销售行为的,依法责令企业停产停业整顿,暂扣或吊销非药品类易制毒化学品生产、经营许可证和备案证明,情节严重的,依法移送公安机关追究法律责任。要举一反三,要求同类企业吸取教训,切实加强管理,防止同类案件再次发生。

五、加强监管能力建设,积极参与部门联动合作

(十四)加强组织领导和监管能力建设。各级安全监管部门要加强组织领导,充实人员力量,落实责任,保障经费,及时检查和总结非药品类易制毒化学品监管工作。各省级安全监管部门以及非药品类易制毒化学品企业数量多的设区的市级安全监管部门要配置专职管理人员;设区的市级以下的安全监管部门要明确固定的管理人员,并保持人员相对稳定,保证工作的连续性。要加强监管人员易制毒化学品法律法规和业务知识的培训。要创新日常监管方法,建立健全约谈、公布“黑名单”、挂牌督办等制度,应用信用记录等措施,不断提高非药品类易制毒化学品监管水平和执法效能。

(十五)加强部门协作与配合。各级安全监管部门要积极参与同级禁毒委员会组织开展的有关工作,开展与易制毒化学品监管相关部门的合作,形成整体监管合力。要会同公安、商务和工商等相关部门,联合开展专项检查,严厉打击非法违法生产、经营非药品类易制毒化学品行为。在换发许可证和备案证明、检查企业非药品类易制毒化学品销售管理情况等工作中,要通过与有关部门沟通信息、加强联动,进一步查证实情,堵塞漏洞,提高执法检查效能,共同推进易制毒化学品监管工作。


国家安全生产监督管理总局

二○一二年六月十五日