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关于明确GSP认证有关问题的通知

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关于明确GSP认证有关问题的通知

国家药监局


关于明确GSP认证有关问题的通知

药监市函[2002]65号



各省、自治区、直辖市药品监督管理局:

为进一步推动GSP认证工作的开展,经对当前认证中存在问题的研究,现将GSP认证工作中有关问题通知如下:

一、药品检验问题
根据现行《药品管理法》的规定,取消《药品经营质量管理规范》及其实施细则中规定的药品经营企业应进行药品内在质量检验的要求。

二、申请认证的药品批发企业所属经营单位的界定
申请认证的药品批发企业,其申报资料《企业所属经营单位情况表》中填报的单位,应是企业所属不具有法人资格的药品批发和零售单位。

三、检查中有关资料的追溯期限
GSP认证现场检查中,对涉及企业经营活动的记录、凭证等有关资料的查验时限,一般从检查之日起向前追溯12个月(另有规定的除外)。

四、零售连锁企业配送业务的委托
对属于某一药品批发企业开办的子公司,且母子公司法定代表人为同一自然人的药品零售连锁企业,在其母公司具备配送条件并执行零售连锁企业制定的配送管理制度的情况下,允许零售连锁企业将其药品配送业务委托母公司办理。药品配送中出现的任何质量问题,双方应承担相同责任。

五、经营中曾发生假劣药品问题企业的认证申请审查
申请GSP认证的药品经营企业,应如实说明其在提出申请之日前12个月内,是否存在过经销假劣药品问题。进行初审的药品监督管理部门,应对此严格予以审查。

(一)初审部门应对有此类问题的企业进行实地检查,查清企业在经销此种药品的全过程中有无违反GSP相关规定的问题,以及企业目前相关环节实施GSP的状况。如未发现违规行为,且相关环节符合GSP要求,可将认证申请上报。如发现存在违规行为,应中止认证申请审查。该企业只能在这一问题发生时间超出12个月之后,再重新进行认证申请。

(二)是否属经销假劣药品,应以药品监督管理部门在行政执法中认定的或法定药品检验机构在药品抽验中得出的结论为准。

(三)对申请认证企业发生过此类问题但未说明或未如实说明的,一经发现或核实,将驳回认证申请,并在驳回认证申请后12个月内不受理其认证申请。

六、零售连锁企业分店的认证问题
零售连锁企业设立的分店,若具有企业法人资格的,应单独申请认证;若不具有企业法人资格的,应与总部一并申请认证。

七、新开办企业的申请认证问题
新开办的药品经营企业,在取得工商营业执照并正式营业的3个月以后,方可进行认证申请。

八、认证合格后跟踪检查的有关问题
认证合格的药品经营企业,如企业结构或经营规模出现以下变化,省、自治区、直辖市药品监督管理部门应对其组织专项检查:

(一)批发企业和零售连锁企业(总部)的办公、营业场所和仓库发生迁址。

(二)企业经营规模的扩大,导致企业类型的改变。

(三)零售连锁企业门店增加了一定数量。以认证检查时为基数,门店数30家以下的每新增加50%或30家以上的每新增加20%,应对新增门店按30%比例抽查。

九、有关报送资料式样的更改
鉴于GSP认证管理政策上作出的调整,《药品经营质量管理规范(GSP)认证管理办法(试行)》中规定报送的部分资料内容也需相应更改。请各地在今后GSP认证初审工作中,按照随本文下发的《药品经营质量管理规范认证申请表》(式样见附件1)、《企业验收、养护人员情况表》(式样见附件2)和《企业经营场所、仓储等设施、设备情况表》(式样见附件3)进行申报和审查,其他申报资料仍按原规定填报。


附件:1.药品经营质量管理规范认证申请书
2.企业验收养护人员情况表
3.企业经营设施、设备情况表


国家药品监督管理局市场监督司
二○○二年四月二十六日


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财政部关于海南省处置积压房地产中央专项补助使用范围问题的复函

财政部


财政部关于海南省处置积压房地产中央专项补助使用范围问题的复函



财规[2000]4号

海南省人民政府:

你省《关于商请批准适度放宽中央财政专项补助资金使用范围的函》(琼府明电[2000]2号)收悉。经研究,现函复如下:

根据《国务院批得通知》(国办通[2000]2号)的有关精神,为了鼓励有条件的科研院所和高等院校购买积压商品房,同意将中央财政专项补助资金退还土地出让金而限价出售的经济适用房销售对象扩大至科研院所、高等院校购买用于科研、教学、办公、职工集体住宿或作为有贡献的专家、教授、劳动模范等人员度假疗养基地。请按照规定用途申报专项补助资金,并做到专款专用。

此复。

二○○○年六月二十二日



对外经济开放地区环境管理暂行规定(附英文)

国家环保局


对外经济开放地区环境管理暂行规定(附英文)

1986年3月15日,国家环境保护局

第一条 为了加强对外经济开放地区的环境管理,防治环境污染和生态破坏,保障人体健康,保护和创造良好的投资环境,促进经济和社会发展,特制定本规定。
第二条 本规定所称对外经济开放地区,是指国家批准的经济特区、沿海开放城市和沿海经济开放区。在对外经济开放地区从事生产、经营活动的一切单位和个人,必须遵守本规定。
第三条 对外经济开放地区的各级人民政府,必须坚持“预防为主、防治结合”的方针,加强环境综合整治工作。应当把环境保护纳入本地区的经济和社会发展规划,明确环境保护的目标、任务和措施,并组织实施。
第四条 对外经济开放地区进行新区建设必须作出环境影响评价,全面规划,合理布局。各有关部门必须严格按照规划和布局的要求进行建设。对外经济开放地区现有的不合理布局,应当结合城市改造、工业调整逐步加以解决。在生活居住区、水源保护区、疗养区、自然保护区,风景游览区、名胜古迹和其他需要特殊保护的地区,不得建设污染环境的项目;已建成的,要限期治理、调整或搬迁。
第五条 管辖对外经济开放地区的省、自治区、直辖市人民政府,对国家环境质量标准中未规定的项目,可以制定地方补充标准;对执行国家污染物排放标准不能保证达到本地区环境质量要求的,可以制定严于国家污染物排放标准的地方污染物排放标准,报国家环境保护部门备案。按照前款规定制定的地方污染物排放标准,所在地的企业、事业单位必须执行。
第六条 对外经济开放地区从国外引进技术和设备,必须符合无污染或少污染的要求,对产生污染,国内又不能配套解决的,应当同时引进相应的环境保护设施。一切新建、改建和扩建项目,必须做到防治环境污染的配套设施与主体工程同时投入使用。
第七条 对外经济开放地区的一切单位和个人,在签订经济合同时,应当明确当事人各方在环境保护方面的义务和责任,落实防治环境污染的措施。合同中不得有违反国国家和地方环境保护法律、法规的内容。
第八条 在对外经济开放地区进行开发建设的单位,必须按照国家规定报送环境影响报告书(表)和建设项目初步设计环境保护篇章;竣工后,必须报送环境保护设施竣工验收报告。环境保护部门应当在接到环境影响报告书(表)的四十五日内,初步设计环境保护篇章、环境保护设施竣工验收报告的三十日内予以批复;逾期不批复的,上报方案自行生效。
第九条 对外经济开放地区的企业事业单位排放污染物,必须到所在地人民政府环境保护部门提出排污申请,如实填报拥有的污染物排放设施、处理设施和在正常作业条件下排放污染物的种类、方式、数量和浓度,经审核批准并取得排污登记证件后,方能生产或营业。排污情况发生变化的,应当及时向所在地人民政府环境保护部门申报。超过国家或地方污染物排放标准的,按照国家规定缴纳超标准排污费;向水体排放污染物的,按照国家规定缴纳排污费。
第十条 对外经济开放地区各级人民政府的环境保护部门,负责组织、协调、监督、检查本地区的环境保护工作。被监督检查单位必须如实提供有关情况和资料。环境保护部门对被监督检查单位提供的情况和资料有保密的义务和责任。
第十一条 凡违反本规定,造成污染损害的单位,对外经济开放地区各级人民政府的环境保护部门或国家规定的其他主管部门,可以责令其限期治理,支付消除污染费用,赔偿损失;并可以给予警告或罚款。当事人不服的,可以在收到决定书之日起十五日内,向人民法院起诉;期满不起诉又不履行的,由环境保护部门或其他主管部门提请人民法院强制执行。
第十二条 对外经济开放地区所在的省、自治区、直辖市人民政府可以根据本规定制定实施办法。
第十三条 本规定自发布之日起施行。

INTERIM PROVISIONS FOR THE ADMINISTRATION OF THE ENVIRONMENT INTHE ECONOMIC ZONES OPEN TO THE OUTSIDE WORLD

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)
INTERIM PROVISIONS FOR THE ADMINISTRATION OF THE ENVIRONMENT IN
THE ECONOMIC ZONES OPEN TO THE OUTSIDE WORLD
(Approved by the State Council on March 4, 1986 and promulgated by
the State Administration for Environmental Protection on March 15, 1986)
Article 1
These Provisions are formulated for the purpose of strengthening the
administration of the environment in the economic zones open to the
outside world, preventing and remedying environmental pollution and the
disruption of ecological balance, safeguarding human health and protecting
and creating good investment environment so as to promote economic and
social development.
Article 2
The term "economic zones open to the outside world" as used in these
Provisions refers to the special economic zones, the open coastal cities
and the coastal economic development areas approved by the State.
All units and individuals that are engaged in production and business
activities in the economic zones open to the outside world shall abide by
these Provisions.
Article 3
People's governments at various levels in the economic zones open to the
outside world shall adhere to the principles of "having prevention as the
main concern and combining prevention with remedying" and strengthen the
work for the comprehensive improvement of the environment. They shall
incorporate environmental protection into the economic and social
development plans of their own localities and specify the targets, tasks
and measures with respect to environmental protection and organize the
implementation thereof.
Article 4
It shall be imperative to evaluate the impact on the environment, carry
out overall planning and ensure rational distribution, if construction of
new areas is to be undertaken in the economic zones open to the outside
world. All departments concerned shall carry out the construction in
strict accordance with the requirements in respect of planning and
distribution.
The existing irrational distribution of the economic zones open to the
outside world shall be rectified gradually in conjunction with urban
reform and industrial readjustment. In residential areas, water-resource
reserves, health resorts, nature reserves, tourist resorts, scenic spots
and places of historic interest, and other areas which need special
protection, no projects that may cause environmental pollution may be
constructed and a deadline shall be set for any such projects that have
been completed to be improved, readjusted, or removed.
Article 5
With respect to projects that are not covered by the State provisions
concerning the standards of environmental quality, the people's
governments of the provinces, autonomous regions and municipalities
directly under the Central Government having jurisdiction over the
economic zones open to the outside world may formulate their own local
supplementary standards. If the implementation of the State standards
concerning the discharge of pollutants fails to satisfy the requirements
for environmental quality of their own localities, they may formulate
their own local standards concerning the discharge of pollutants which are
stricter than the State standards concerning the discharge of pollutants
and submit them to the State departments for environmental protection for
the record.
The local standards concerning the discharge of pollutants formulated in
accordance with the provisions of the preceding paragraph shall be
implemented by the enterprises and institutions in the localities.
Article 6
Technology and equipment introduced from abroad into the economic zones
open to the outside world shall conform to the requirement that they shall
cause no pollution or little pollution. If the technology or equipment to
be introduced from abroad will cause pollution and no means is yet
available at home to tackle it, the corresponding environmental protection
facilities shall be introduced simultaneously. With respect to all newly-
constructed projects, alteration projects or expansion projects, it shall
be imperative to ensure that both the supporting facilities for preventing
and remedying environmental pollution and the principal part of the
project are put into operation simultaneously.
Article 7
When entering into an economic contract, all units and individuals in the
economic zones open to the outside world shall specify the obligations and
responsibilities of each of the parties thereto in respect of
environmental protection and ensure that measures for preventing and
remedying environmental pollution are duly stipulated. The contract may
not contain anything that runs counter to the laws and regulations of the
State or of the locality for environmental protection.
Article 8
Units that intend to engage in developmental construction in the economic
zones open to the outside world shall, in accordance with the pertinent
provisions of the State, submit an environmental impact report/form(s) and
a text on environmental protection in the preliminary design of a
construction project and shall, upon completion of the project, submit a
report on inspecting and accepting the completed environmental protection
facilities.
The department for environmental protection shall, within 45 days of
receipt of the environmental impact report/form(s) or within 30 days of
receipt of the text on environmental protection in the preliminary design
of a construction project and the report on inspecting and accepting the
completed environmental protection facilities, give an official written
reply to the unit that has submitted the above-mentioned documents. If no
such reply is given within the prescribed period of time, the documents
submitted shall automatically become effective.
Article 9
Enterprises and institutions in the economic zones open to the outside
world that have to discharge pollutants shall apply to the departments for
environmental protection under the local people's governments for
permission to discharge pollutants and fill in forms to report truthfully
on the pollutant discharging and treating facilities that they possess and
the kind(s) of pollutants to be discharged, the mode(s) of discharging,
and the quantity and density of the pollutants under normal operational
conditions. Their production or business operations shall begin only
after the application has been verified and approved and the document for
the registration of pollutant discharge has been obtained. If changes have
taken place in the discharge of pollutants, these shall be reported in
good time to the departments for environmental protection under the local
people's governments.
Those that discharge pollutants in excess of the State or local standards
shall pay an excess pollutant discharge fee in accordance with the
pertinent provisions of the State; those that discharge pollutants into
water shall pay a pollutant discharge fee in accordance with the pertinent
provisions of the State.
Article 10
The departments for environmental protection under the people's
governments at various levels in the economic zones open to the outside
world shall be responsible for organizing, co-ordinating, supervising and
inspecting the work of environmental protection in their own localities.
The units that are subjected to supervision and inspection shall provide
the actual relevant information and data.
The departments for environmental protection shall undertake the
obligation and responsibility to maintain the confidentiality of the
information and data provided by the units that are subjected to
supervision and inspection.
Article 11
The departments for environmental protection under the people's
governments at various levels in the economic zones open to the outside
world or other competent departments may order those units that have
violated these Provisions and caused pollution damage to remedy the
situation within a prescribed period of time, pay the expenses for
eliminating the pollution and compensate for the losses thus incurred and
may also give them a warning or impose a fine on them.
Any party concerned that does not accept the penalties may file a suit
with a people's court within 15 days of receipt of the written decision
concerning the penalties. If no suit is filed and yet the decision is not
carried out within the prescribed period of time, the departments for
environmental protection or other competent departments may apply to the
people's court for the compulsory enforcement of the decision.
Article 12
The people's governments of the provinces, autonomous regions and
municipalities where the economic zones open to the outside world are
located may formulate measures for the implementation of these Provisions
in accordance therewith.
Article 13
These Provisions shall go into effect on the date of promulgation.