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关于药品注册检验报告事宜的通知

作者:法律资料网 时间:2024-07-01 11:33:45  浏览:9247   来源:法律资料网
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关于药品注册检验报告事宜的通知

国家药监局药品注册司


关于药品注册检验报告事宜的通知

药监注函[2003]51号


各省、自治区、直辖市药品检验所,解放军总后勤部药品检验所,成都市药品检验所,中国药品生物制品检定所:

国家药品监督管理局《药品注册管理办法》对药品注册检验工作的内容、要求、程序和时限等已经做出明确规定,因尚未对药品注册检验报告及其报告方式做出具体规定,各有关药品检验所在报送时做法各不相同。为规范管理并提高工作效率,特对有关事宜通知如下:

一、各有关药品检验所报告新药、已有国家标准药品、进口药品的药品注册检验结果,应当统一使用国家食品药品监督管理局最新制发的《药品注册检验报告表》(见附件),不需另外行文报告。
表内应当填写样品检验结论,“有关情况说明”项填写其他需要报告的情况。药品检验报告书应附于表后,并按照法定检验报告书要求打印、盖章。有药品标准复核意见和修订药品标准的,应一并附后。药品注册申请人对本报告有不同意见的,也应将其书面意见附后上报。
《药品注册检验报告表》由药品检验所主管所长签发,加盖药品检验所公章。

二、报送方式:药品检验所应将《药品注册检验报告表》及其附件径寄我司受理办公室,同时抄送发出药品注册检验通知的省级药品监督管理局和药品注册申请人。我司收到后在国家食品药品监督管理局网站“药品注册进度查询”栏内登载收到日期。对药品补充申请进行的药品注册检验,其报告只需报送发出药品注册检验通知的省级药品监督管理局并抄送药品注册申请人,省级药品监督管理局报送药品补充申请资料时将其一并报送我司受理。
报送国家食品药品监督管理局的新药、已有国家标准药品和进口药品申请的注册检验,应为一式3份,其中2份为原件。各类补充申请的注册检验报送一式2份,其中1份应为原件。
《药品注册检验报告表》自本通知下发日起开始使用。各有关药品检验所应当积极采取信息化手段,为实行电子化申报做好准备。目前应先将修订的药品标准电子文本以电子邮件方式同时发送到我司受理办公室,电子邮件宜使用该品种原始编号作为标题。电子信箱地址:ypzcsl@sda.gov.cn和ypzcsl@nicpbp.org.cn。

特此通知

附件:药品注册检验报告表


国家药品监督管理局药品注册司
二○○三年四月三十日


附件:

药品检验所

药品注册检验报告表

030506 No:


原始编号

申请编号


药品名称


申请分类
○新药 ○已有国家标准药品 ○进口药品
申报阶段
○临床 ○生产 ○补充申请

注册分类
○中药 ○化学药品 ○治疗用生物制品 ○预防用生物制品

□补充申请:

□其他:

剂 型
(仅限一剂型)
规 格

(仅限一规格)






样品来源
○抽样 ○送样
通知检验日期


检验用标准物质来源


审核范围
□样品检验 □药品标准复核 □检验用标准物质 □申请人的申诉意见

检验结论


有关情况说明
根据《药品注册管理办法》对药品注册检验的规定,特此报告。

附 件
□药品检验报告书 □药品标准复核意见 □复核的药品标准 □申请人的申诉意见 □检验用标准物质标准 □其他:

主 送
国家食品药品监督管理局

抄 送
药品监督管理局,申请人

所联系人

电 话

 

(公章)

 

签 发

日 期



注:1、国家食品药品监督管理局2003年4月制。
2、邮寄地址:北京北礼士路甲38号国家食品药品监督管理局药品注册司受理办公室
邮编:100810


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中华人民共和国林业部和美利坚合众国内政部关于自然保护交流与合作议定书及附件

中国林业部 美国内政部


中华人民共和国林业部和美利坚合众国内政部关于自然保护交流与合作议定书及附件


(签订日期1986年11月19日 生效日期1986年11月19日)
  中华人民共和国林业部和美利坚合众国内政部关于自然保护交流与合作议定书
  中华人民共和国林业部和美利坚合众国内政部(以下简称双方),根据中华人民共和国政府和美利坚合众国政府于一九七九年一月三十一日在华盛顿签署并于一九八四年一月十二日延期的科技合作协定,为促进双方各自管理的自然保护区和野生动物领域的交流与合作,达成协议如下:

  第一条 双方同意在平等、互利和互惠的基础上进行交流与合作。

  第二条 双方确认交流与合作可包括下列范围:
  一、自然保护区的建设与管理;
  二、野生动、植物种的保护、繁育、研究、合理利用以及野生生物栖息地的管理;
  三、迁徙鸟类环志;
  四、濒危野生动、植物种进出口的管理;
  五、双方同意的其它合作研究活动。

  第三条 双方同意交流与合作可采取下列形式:
  一、交换有关自然保护的科学技术资料、出版物和其它文献;
  二、为科学研究和重新引进而交换野生动、植物种;
  三、双方互派代表团、考察组、专家,互换培训人员,组织合作研究,举办学术研讨会和专业培训班;
  四、双方同意的其它合作研究形式。

  第四条 根据本议定书所进行的交流和合作活动应遵守各自国家的法律和规定。

  第五条 双方各自指定中华人民共和国林业部外事司和美利坚合众国内政部渔和野生动物局、国家公园局为实施本议定书的执行机构,并负责协调各自国家有关机构或个人参加本议定书的第二条、第三条中所规定的交流与合作项目。

  第六条 双方执行机构通过通信方式互相协商来确定交流与合作项目的内容、人数、执行时间、期限和其它有关事宜。
  必要时,经双方同意可举行会议,磋商执行本议定书的有关事宜。

  第七条 双方根据互利原则向对方提供本议定书第三条中规定的资料、出版物、文献、野生动植物种;双方互派的代表团、考察组和个人的国际旅费由派遣方自理,接待方境内的费用由接待方负担。双方的互派人数和停留期限(按人月计)应大致相等。如遇特殊情况,双方可另行商定。

  第八条 双方同意的具体合作与交流项目及实施计划应作为本议定书的附件。新的合作项目应经双方代表以通信方式确认并作为本议定书的附件。如附件与本议定书的条款相抵触,应以本议定书为准。

  第九条 双方根据本议定书第三条的规定,一方向另一方提供的科技资料是提供方尽自方的知识确信是精确的,但不保证所提供的资料适合于接受方或第三方的使用或应用。

  第十条 双方同意,根据本议定书的规定,当进行设备交换或一方向另一方提供用于合作活动的设备,应逐项达成具体谅解。

  第十一条 根据本议定书所开展的所有活动将在两国政府科技合作协定第十条中设立的中美科技合作委员会指导下进行。根据本议定书所开展的所有合作活动应取决于经费和人员的可能性而进行。

  第十二条 为了开展具体的活动,双方就保护版权、秘密情报及如何处理根据本议定书做出或构想出的发现和发明达成协议。该协议作为附件一成为本议定书不可分割的一部分。

  第十三条 本议定书自双方签字之日起生效,有效期为五年。
  在议定书有效期内,任何一方都可以随时提出终止本议定书,但必须在六个月以前书面通知对方。本议定书经双方书面同意可予延长。

  第十四条 根据需要,经双方书面同意可对本议定书进行修改,修改内容自双方签字之日起立即生效,并成为本议定书不可分割的一部分。
  本议定书于一九八六年十一月十九日在华盛顿签订,一式两份,每份均用中文和英文写成,两种文本具有同等效力。

  中华人民共和国         美利坚合众国
   林业部代表          内政部代表
    刘广运            麦克劳林
   (签字)           (签字)

 附件一    中华人民共和国林业部和美利坚合众国
         内政部关于自然保护交流与合作议定书

  中华人民共和国林业部和美利坚合众国内政部(以下简称双方),根据一九八六年十一月十九日在华盛顿签订的《中华人民共和国林业部和美利坚合众国内政部关于自然保护交流与合作议定书》(以下简称议定书)第十二条同意:

 一、除具有保密性质的情报外,各方根据议定书或附件对合作计划提供的一切情报以及由议定书或附件所产生的一切情报,均可通过科学杂志和通常用于传播科技情报的其它渠道发表。
  双方同意,根据议定书或附件所交换的任何具有保密性质的情报(例如商业秘密和技术诀窍,或任何一方要求承担保密义务的情报)应受到保护。双方只有通过各自指定的代表或根据议定书第五条指定的执行机构进行磋商,或双方同意的其它方式,逐项达成协议后,才能做出采用和提供此类情报的决定。此类协议的条款和条件应如议定书第八条所述列入附件。

 二、对于根据议定书或附件所作出或构想的发明或发现,双方同意:
  1.如果此发明或发现是由一方人员通过双方交换情报,例如联合召开会议、研讨会或交换技术报告或论文,所作出或构想的:
  (1)作出或构想发明或发现的人员的一方(发明方)在所有国家有权获得此发明或发现的一切权利和利益,但须给另一方及其政府和国民非独占的、不可撤销的、免交使用费的许可证。
  (2)如果发明方决定不在另一方的国内或某第三国获得此种权利和利益,另一方则可获得。但须给发明方及其政府和国民非独占的,不可撤销的、免交使用费的许可证。
  2.如果此发明或发现是在科技人员交换中,由一方(派出方)人员派往另一方(接受方)独立地或联合地作出或构想的:
  (1)接受方在其本国及第三国有权获得此发明或发现的一切权利和利益。派出方在本国享有一切权利和利益,并拥有非独占的、不可撤销的、免交使用费的许可证,由派出方及其政府和国民在第三国使用。
  (2)如果接受方决定不在第三国或某特定第三国获得此种权利和利益,派出方则可获得,但须给接受方及其政府和国民非独占的、不可撤销的、免交使用费的许可证。
  3.如果此发明或发现是通过本议定书第三条所列的其它合作方式,例如合作研究和发展活动,或是在上述第一条情况下由双方人员(共同发明者)所作出或构想的:
  双方应规定适当的权利分配办法,并按议定书第八条所述列入附件。一般来讲,各方通常在其本国享有此发明的权利,而在第三国的权利双方则应在公平的基础上商定。
  4.作出发明或发现的人员的一方应把此种发明及所选取专利或其他保护的情况通知另一方,并为另一方确定在此发明中的权利提供必要的文件。通知方可要求另一方推迟发表或公布此类情报,但是这一限制不得超过自通知之日起六个月。

 三、任何一方或任何一方同意的实体,对根据议定书或附件由该方及其执行部门所产生的著作,均可在其本国和第三国获得版权保护,而非产生著作的一方及其政府和国民则应拥有非独占的、不可撤销的、免交使用费的许可证,以便翻译、复制、出版和发行这些著作。

 四、根据各自国家的法律,每方应负责向其本国国民偿付需要付出的奖金或报酬。

 五、对在执行本附件时产生的其它问题或争议,双方应通过各自指定的执行机构进行磋商或双方同意的其它方式予以解决。

 六、本附件自双方签字之日起生效,并在执行本议定书期间有效。
  本附件于一九八六年十一月十九日在华盛顿签订,一式两份,每份都用中文和英文写成,两种文本具有同等效力。

  中华人民共和国         美利坚合众国
   林业部代表          内政部代表
    刘广运            麦克劳林
   (签字)           (签字)

REGULATIONS ON SPECIAL ECONOMIC ZONES IN GUANGDONG PROVINCE ——附加英文版

The Standing Committee of the National People's Congress


REGULATIONS ON SPECIAL ECONOMIC ZONES IN GUANGDONG PROVINCE

(Approved for implementation at the 15th Meeting of the Standing
Committee of the Fifth National People's Congress on August 26, 1980)

Contents
Chapter I General Provisions
Chapter II Registration and Operation
Chapter III Preferential Treatment
Chapter IV Labour Management
Chapter V Administrative Organization
Chapter VI Supplementary Provisions

Chapter I General Provisions
Article 1
In order to develop economic cooperation and technical exchanges with
foreign countries and to promote the socialist modernization programme,
certain areas shall be delineated respectively in the three cities of
Shenzhen, Zhuhai and Shantou in Guangdong Province for the establishment
of special economic zones (hereinafter referred to as "special zones").
The special zones shall encourage foreign citizens, overseas Chinese,
compatriots from Hongkong and Macao and their companies and enterprises
(hereinafter referred to as "investors") to open factories and set up
enterprises and other establishments with their own investment or in joint
ventures with our side, and shall protect their assets, the profits due
them and their other lawful rights and interests in accordance with the
law.
Article 2
Enterprises and individuals in the special zones must abide by the laws,
decrees and pertinent provisions of the People's Republic of China. Where
there are specific provisions in these Regulations, they shall be observed
accordingly.
Article 3
A Guangdong Provincial Committee for the Administration of Special
Economic Zones shall be set up to exercise unified administration of the
special zones on behalf of the Guangdong Provincial People's Government.
Article 4
The special zones shall provide investors with a wide scope of operation,
create favourable operating conditions and guarantee them stable business
sites. Investors may establish, with their own investment or in joint
ventures with our side, all projects that have positive significance for
international economic cooperation and technical exchanges, including
industry, agriculture, animal husbandry, aquaculture, tourism, housing and
construction, and research and manufacture involving high technology, as
well as other businesses of common interest to investors and to our side.
Article 5
Land-levelling projects and various public works in the special zones such
as water supply, drainage, power supply, roads, wharves, communications
and warehouses shall be undertaken by the Guangdong Provincial Committee
for the Administration of Special Economic Zones. When necessary, foreign
investment may be used in building these projects.
Article 6
Each of the special zones shall invite Chinese and foreign specialists and
relevant personages who are enthusiastic about China's modernization
programme to form an advisory committee that will serve as a consultative
body for that special zone.

Chapter II Registration and Operation
Article 7
Investors wishing to open factories or set up various economic
undertakings in the special zones with their own investment shall apply to
the Guangdong Provincial Committee for the Administration of Special
Economic Zones, which shall issue them registration certificates and land
use certificates after examination and approval.
Article 8
Investors may open accounts and conduct their foreign exchange
transactions with the Bank of China established in the special zones or
with other banks established there with the approval of the Chinese side.
Investors may take out various kinds of insurance policies at the People's
Insurance Company of China in the special zones or at other insurance
companies established there with the approval of the Chinese side.
Article 9
Products of the enterprises in the special zones shall be sold on the
international market. If their products are to be sold in the interior of
China, they must have the approval of the Guangdong Provincial Committee
for the Administration of Special Economic Zones and go through the
procedures for paying customs duties.
Article 10
Investors may operate their enterprises independently in the special zones
and employ foreign personnel for technical and managerial work.
Article 11
If an enterprise established by an investor in the special zones wishes to
terminate operations before its scheduled expiration, it shall report the
reasons to the Guangdong Provincial Committee for the Administration of
Special Economic Zones, go through termination procedures and settle
claims and debts. After termination of operations, its assets may be
assigned and its funds may be remitted out of China.

Chapter III Preferential Treatment
Article 12
Land in the special zones is owned by the People's Republic of China. The
land to be used by investors shall be provided according to actual needs,
and preferential treatment shall be given with respect to the duration of
its use, the amount of the use fee and the method of payment according to
the different types of business and uses. Provisions for specific
measures shall be made separately.
Article 13
The machinery and equipment, spare parts, raw and semi-processed
materials, means of transportation and other capital goods necessary for
production that are imported by enterprises in the special zones shall be
exempted from import duties. The necessary consumer goods may either be
subjected to import duties or allowed a reduction or exemption therefrom,
depending on the specific situation of each case. When the above-mentioned
goods are imported or products of the special zones are exported, a
customs declaration shall be filed.
Article 14
The enterprise income tax rate in the special zones is 15 percent. Special
preferential treatment shall be given to enterprises established within
two years of the promulgation of these Regulations, to enterprises with an
investment US$ 5 million or more, and to enterprises involving higher
technology or having a longer period of capital turnover.
Article 15
The lawful profit that an investor receives after payment of the
enterprise income tax, and the wages and salaries and other legitimate
earnings that foreign, overseas Chinese and Hongkong and Macao workers and
staff members of an enterprise in the special zones receive after payment
of the individual income tax, may be remitted abroad through the Bank of
China or other banks in the special zones, in accordance with the
provisions of the foreign exchange control measures of the special zones.
Article 16
An investor that reinvests its share of the profit in the special zones
for a period of five years or longer may apply for a reduction of or an
exemption from income tax on the reinvested portion.
Article 17
Enterprises in the special zones shall be encouraged to use machinery and
equipment, raw and semi-processed materials and other materials produced
in China, and preferential prices shall be offered on the basis of China's
current export prices for the same kinds of commodities, using foreign
exchange to settle accounts. These products and materials may be shipped
directly to the special zones with the sales vouchers of the selling
units.
Article 18
Entry and exit procedures shall be simplified and conveniences given to
the foreign personnel, overseas Chinese and compatriots from Hongkong and
Macao entering and leaving the special zones.

Chapter IV Labour Management
Article 19
A labour service company shall be set up in each of the special zones.
Chinese staff members and workers to be employed by enterprises in the
special zones, whether they are recommended by the local labour service
companies or recruited by the investors themselves with the consent of the
Guangdong Provincial Committee for the Administration of Special Economic
Zones, shall all be tested by the enterprises before employment and labour
contracts shall be signed with the staff members and workers.
Article 20
The staff members and workers employed by enterprises in the special zones
shall be managed by the enterprises according to their business
requirements and, when necessary, may be dismissed, after going through
the procedures provided in the labour contracts. Staff members and
workers of the enterprises in the special zones may submit their
resignations to the enterprises in accordance with the provisions of the
labour contracts.
Article 21
The wage levels, types of wages, award measures and the labour insurance
and various state subsidies for the Chinese staff members and workers of
the enterprises in the special zones shall be included in the contracts
signed by the enterprises with the staff members and workers as stipulated
by the Guangdong Provincial Committee for the Administration of Special
Economic Zones.
Article 22
Enterprises in the special zones shall adopt the necessary measures for
labour protection to ensure that staff members and workers work in safe
and hygienic conditions.

Chapter V Administrative Organization
Article 23
The Guangdong Provincial Committee for the Administration of Special
Economic Zones shall exercise the following functions and powers:
(1) to draw up development plans for the special zones and organize their
implementation;
(2) to examine and approve the investment projects of investors in the
special zones;
(3) to handle registration of industrial and commercial enterprises and
land allotment in the special zones;
(4) to coordinate working relations among the banking, insurance,
taxation, Customs, frontier inspection, postal and telecommunications and
other organizations in the special zones;
(5) to provide the staff members and workers needed by enterprises in the
special zones and protect the legitimate rights and interests of the staff
members and workers;
(6) to establish educational, cultural, health and various public welfare
institutions in the special zones; and
(7) to maintain law and order in the special zones and protect, in
accordance with the law, the persons and property in the special zones
against encroachment.
Article 24
The Shenzhen Special Zone shall be under the direct management and
administration of the Guangdong Provincial Committee for the
Administration of Special Economic Zones. Necessary offices shall be set
up in the Zhuhai and Shantou Special Zones.
Article 25
A Guangdong Provincial Special Economic Zones Development Company shall be
set up to suit the expanding economic activities in the special zones. Its
scope of business shall include: undertaking to raise funds and handle
trust investment business; operating, or jointing with investors in
operating, relevant enterprises in the special zones; acting as agent for
investors in the special zones in transactions relating to sales and
purchases in trade with the interior; and providing services for business
talks.

Chapter VI Supplementary Provisions
Article 26
These Regulations shall go into effect after they have been adopted by the
People's Congress of Guangdong Province and submitted to and approved by
the Standing Committee of the National People's Congress of the People's
Republic of China.



Important Notice:
This English document is coming from "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.


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