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有关新药申报中一些问题的说明

作者:法律资料网 时间:2024-07-22 04:50:02  浏览:9833   来源:法律资料网
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有关新药申报中一些问题的说明

国家药监局


有关新药申报中一些问题的说明


通知

各省、自治区、直辖市药品监督管理局、各申报单位:

针对目前新药申报中的一些问题,现将有关新药申报的要求重申如下:

1、按照《新药审批办法》的要求,凡申报中药和化学药品临床研究和生产的,其申报
资料以“3+2”的形式整理,其中“3”指完整的三套资料,包括1-4部分技术资料和申
请表、省局初审文件及药检所报告等;“2”指二套资料,包括第1部分技术资料(不需第
2、3、4部分技术资料)和申请表、省局初审文件及药检所报告等。对不能按上述要求整
▔▔▔▔▔▔▔▔▔
理申报资料的,如审评中出现延误时限等问题,责任由申报单位自负。
▔▔▔▔▔▔▔▔▔▔▔▔▔▔▔▔▔▔▔▔▔▔▔▔▔▔▔▔▔▔
2、凡申报修改使用说明书的新药补充申请,其申请资料需报送一式四份及申请表五份,
其中两份原件。

3、凡生产批件中注有“按我局第23号令《药品包装、标签和说明书管理规定》(暂行)
有关要求,继续完善本品说明书,4个月内报我局”的,请按新药补充申请 —— 修改使
用说明书申报相关资料(详见本通知2的要求)。

4、今后凡各省局(市、区)向我局或我司报送的正式申报资料和文件均应签署各省(区、
市)局印章,我局或我司才能受理


国家药品监督管理局药品注册司
2001年11月15日



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中华人民共和国枪支管理办法(附英文)

公安部


中华人民共和国枪支管理办法(附英文)

(一九八一年一月五日国务院批准)

第一条 为了维护社会治安,保障公共安全,防止犯罪分子利用枪支进行破坏活动,特制定本办法。
第二条 本办法所指的枪支(包括这些枪支所使用的弹药)是指非军事系统的下列枪支:军用的手枪、步枪、冲锋枪和机枪,射击运动用的各种枪支,狩猎用的有膛线枪、散弹枪、火药枪,麻醉动物用的注射枪,以及能发射金属弹丸的气枪。
中国人民解放军、民兵和人民武装警察部队装备的军用枪支按军队和民兵系统有关规定管理。

枪支的佩带和配置
第三条 下列人员可以佩带枪支:
(一)人民法院、人民检察院、公安机关因工作必需佩带枪支的人员;
(二)边防地区、海防地区以及省、自治区人民政府认为有佩带枪支必要的其他偏僻地区的党政负责干部;
(三)省级以上党政机关的机要交通员,边疆地区县、市党政机关和邮电部门有佩带枪支必要的机要通信人员;
(四)海关因工作必需佩带枪支的人员;
(五)军工工厂的警卫押运人员。
第四条 下列单位可以配置公用枪支:
(一)有配枪必要的厂矿、企业、机关、学校、科研等单位的保卫部门;
(二)有配枪必要的重要财政金融单位和地处偏僻不设武装看守的重要仓库、电台、科研单位;
(三)在偏僻地区和海上作业有配枪必要的地质勘探队、测绘队;
(四)航行沿海和远洋的客、货、油轮及其他海上作业的工作船;
(五)有配枪必要的民航机场和民航飞机。
第五条 开展射击运动的县以上体育运动委员会,可以配置射击运动枪支。
第六条 专业狩猎生产的人员和单位,可以佩带和配置猎枪。非专业狩猎人员持有猎枪的,限十八岁以上公民,每人不得超过两支。
第七条 狩猎生产和科研教学单位、野生动物饲养和畜牧业单位、兽医院需对动物进行麻醉注射的,可以配置注射枪。
第八条 电影制片厂因拍摄电影需要,可以购置已经淘汰的旧式枪支作道具使用。但除少量效果枪外,其他枪支机件必须进行技术处理,使其不再能用以实弹射击。

枪支的制造和购买
第九条 各种枪支,除国家指定的工厂制造和修理外,任何单位和个人,不准私自制造、修理或装配。
第十条 各单位购买军用枪支,应当将购买枪支的种类、数量、用途、佩带和配置范围报经当地公安机关同意后,向国家指定的机关申请价拨。
购买各种射击运动枪支,需经上一级体育运动委员会批准和所在地县、市公安局同意,发给购买证,凭证向国家指定的单位购买。
购买猎枪和注射枪,需经县以上林业部门批准和公安机关同意,发给购买证,凭证向国家指定的单位购买。经销猎枪的商店,需在县、市以上公安机关注册。
除国家指定或经主管部门批准的单位外,任何单位和个人不得买卖枪支、弹药。

枪支的管理
第十一条 持枪人员,必须经本单位负责人同意,报县以上主管部门批准。持枪单位,必须经县以上人民政府批准。
任何单位和个人,未经法定手续批准,不得私自保存枪支、弹药。对于未经批准持有的枪支、弹药,必须送交当地公安机关,不得擅自处理。
第十二条 持枪人员和持枪单位,必须向所在地县、市公安局申领持枪证。经县、市公安局审核,发给持枪证。
持枪人员携带枪支外出,必须随身携带持枪证备查。因公携带公用枪支到本县、市以外地区的,必须向所在地县、市公安局申领持枪通行证。
第十三条 展览馆、博物馆等单位保存的有历史意义的枪支,必须向所在地县、市公安局登记,不准挪作他用。
第十四条 严禁在城市、集镇、居民点、风景游览区、机场、交通沿线以及其他规定不准鸣枪的地区任意呜枪。非狩猎区禁止鸣枪打猎。
第十五条 在某些特定的地区和场所,不准携带枪支时,持枪人员应当将所带枪支交公安机关或指定单位保存,离去时发还。
第十六条 各种枪支均须妥善保管,确保安全。集体持有的,应当指定专人负责,专库(柜)保存,枪支、弹药分别存放,严防丢失、被盗和发生其他事故。
枪支丢失、被盗,必须立即报告公安机关,并保护现场。
第十七条 持枪单位和持枪人员不准私自将枪支、弹药赠送、转借他人。持枪单位撤销或持枪人员工作调动时,应当将枪支交还发枪单位,并将持枪证交回原发证公安机关注销。
持有猎枪的人,迁离原住地县、市时,应当向原发证公安机关缴销持枪证,换领携运证。到达目的地后,凭携运证向当地公安机关办理新的持枪证。
第十八条 运输枪支、弹药,必须事先向运往地的县、市公安局申领运输证。运到目的地后,凭证向当地公安机关登记备案或申领持枪证。
第十九条 从国外携带猎枪入境,必须事先经常住地县、市公安局批准。入境时,向海关申报,由边防检查站审核发给携运证。到达目的地后,向当地公安机关换领持枪证。
携带猎枪出境,需向原发证公安机关缴销持枪证,换领携运证。出境时,向海关申报,将携运证交出境地边防检查站。
第二十条 各单位对不堪使用的报废枪支,要登记造册,报省、自治区,直辖市主管部门领导批准,向所在地县、市公安局送验登记清册,并作彻底毁型处理后,由销毁单位派人监督,在省、自治区、直辖市公安厅、局指定的冶金工厂回炉销毁。
第二十一条 对发射金属弹丸的气枪,体育部门用于射击运动的,按射击运动枪支管理;狩猎单位用于狩猎的,按猎枪管理。个人购买和持有发射金属弹丸的气枪,也要登记管理,具体办法由省、自冶区、直辖市公安厅、局制定。
第二十二条 持枪证,持枪通行证,射击运动枪、猎枪、注射枪购买证,枪支弹药运输证、携运证由公安部统一制定,省、自治区、直辖市公安厅、局统一印制,县、市公安局签发。
第二十三条 各级公安机关对本地区非军事系统枪支的佩带、使用、保管、变动等情况,实施监督,并定期进行检查。

外国人的枪支管理
第二十四条 外国驻华外交代表机关、领事机关及其人员携带枪支来华,必须事先向中华人民共和国外交部提出申请,经同意后,入境时向海关申报,由边防检查站审核发给携运证。到达目的地后,向驻在地的市公安局申报,办理枪支登记。
外国驻华外交代表机关、领事机关及其人员所有的枪支,除猎枪可在狩猎场所使用外,一律不得携出各该国驻华外交代表机关、领事机关。
外国驻华外交代表机关、领事机关及其人员携带枪支出境,应当照会中华人民共和国外交部,向驻在地的市公安局注销,申领携运证。出境时,向海关申报,将携运证交出境地边防检查站。
第二十五条 外国党、政、军、议会代表团成员及其警卫人员携带枪支来华,必须事先向中华人民共和国外交部或接待单位申报同意,由接待单位通知边防检查站,并向公安部备案。
第二十六条 外国体育代表队携带射击运动枪支,前来我国参加射击运动比赛活动,必须事先经中华人民共和国体育运动委员会批准。入境时,向海关申报,由边防检查站审核发给携运证。到达比赛地后,向当地县、市公安局登记备案,离开时注销。途经我国的,必须事先经中华人民共和国体育运动委员会批准,由中华人民共和国体育运动委员会通报边防检查机关,由入境地边防检查站将所带枪支加封过境。
第二十七条 外国民航飞机和外国籍船舶上携带的枪支、弹药,在飞机、船舶进入我国口岸时,由边防检查站予以封存,出境时启封。
第二十八条 本办法第二十四条、第二十五条、第二十六条规定以外的其他来华的外国人,除经中华人民共和国国家主管部门和目的地省、自治区、直辖市公安厅、局批准的以外,一律不准携带枪支、弹药入境。凡携带枪支、弹药的,在入境时必须向海关申报,由边防检查站暂时封存在口岸,出境时发还本人,或由携带人退运出境。经批准携带枪支、弹药入出境的,按本办法第十九条的规定办理手续。过境的必须向海关申报,由边防检查站审核加封过境。凡未向海关申报的,一律按非法运输枪支、弹药处理。
第二十九条 外国人在华购买猎枪,需经省、自治区、直辖市外事部门或接待单位同意并出具证明,向购买地的县、市公安局申领购买证,经批准后,到指定的商店凭证购买。

处罚
第三十条 凡违反本办法的,对主管负责人和直接责任人要视其情节轻重,分别给予纪律处分、治安管理处罚,直至依照法律追究刑事责任。

其他
第三十一条 各省、自治区、直辖市人民政府和国务院各有关部、委可根据本办法,制定具体管理规定,报公安部备案。
第三十二条 本办法经国务院批准后,由公安部发布施行。一九五一年六月二十七日政务院批准、公安部发布施行的《枪支管理暂行办法》同时废止。

MEASURES OF THE PEOPLE'S REPUBLIC OF CHINA FOR THE CONTROL OFFIREARMS

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 "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)
MEASURES OF THE PEOPLE'S REPUBLIC OF CHINA FOR THE CONTROL OF
FIREARMS
(Approved by the State Council on January 5, 1981, and promulgated
by the Ministry of Public Security on April 25, 1981)
Article 1
These Measures are formulated to maintain public order, to safeguard
public security, and to prevent criminals from using firearms to commit
sabotage.
Article 2
The term firearms (including the ammunition used with these firearms), as
mentioned in these Measures, refers to the following firearms which belong
to the non-military system: pistols, rifles, and submachine guns and
machine guns for military use; various firearms for target shooting
sports; rifles, shot-gun, and powder-gun for hunting; injection-gun for
applying anesthesia on animals; and air-guns for discharging pellets. The
military firearms used for fitting out the People's Liberation Army, the
militia and the People's Armed Police Force shall be controlled in
accordance with the pertinent provisions of the army and militia system.
Carrying and Allocation of Firearms
Article 3
The following personnel may carry firearms:
(1) personnel working in the people's courts, the people's procuratorates,
and the public security organs who are required to carry firearms for
discharging their duties;
(2) party and government leading cadres working in the border areas,
coastal defence areas, and other remote areas who have the necessity, as
deemed by the people's governments of the provinces and autonomous
regions, to carry firearms;
(3) confidential couriers working in the Party and government departments
at or above the provincial level, and confidential messengers working in
the county or municipal Party and government departments in the border
areas or in post and telecommunications departments who have the necessity
to carry firearms;
(4) personnel working in the Customs who are required to carry firearms to
discharge their duties;
(5) guards and transport escorts working in war industries.
Article 4
Firearms for official use may be allocated to the following units:
(1) the security sections of factories and mines, enterprises, government
departments, schools and universities, research institutions, that have
the necessity to be fitted out with firearms;
(2) important financial and banking units and important warehouses, radio
stations, and research institutions which are located in remote area
without armed guards that have the necessity to be fitted out with
firearms;
(3) geological prospecting teams and survey and drawing teams that work in
remote areas or at sea, that have the necessity to be fitted out with
firearms;
(4) coastal and ocean-going passenger-liners, freighters and oil tankers
and other operation vessels operating on the sea;
(5) civil airports and civil air-liners that have the necessity to be
fitted out with firearms.
Article 5
Sports guns may be allocated to sports committees at or above the county
level that promote target-shooting sports.
Article 6
Personnel and units engaged in hunting as their specialized line of
production may carry or be allocated with hunting rifles. As regards the
non-professional hunting personnel, only citizens aged eighteen or over
may keep hunting rifles, and each can keep no more than two hunting
rifles.
Article 7
Injection-guns may be allocated to such units as hunting production units,
scientific research and teaching units, wild animal breeding and livestock
farms, and veterinary hospitals that have the necessity to apply
anesthesia on animals.
Article 8
Film studios, in order to meet the needs of film production, may purchase
old and obsolete firearms as stage properties. With the exception of just
a small number of firearms used for creating special stage effects, all
firearms must undergo technical treatment so that they can no longer be
used for discharging live ammunition.
Manufacture and Purchase of Firearms
Article 9
Various kinds of firearms shall be manufactured and repaired by factories
designated by the State only; no units and individuals may manufacture,
repair or assemble firearms without authorization.
Article 10
For the purchase of military firearms, the purchasing units shall submit
to the local public security organs a report listing such details as the
categories of firearms to be purchased, their quantities, uses, and scope
of carrying and allocation. After obtaining the approval, they shall apply
to the department designated by the State for appropriations.
The purchase of various categories of firearms for target-shooting sports
shall be approved by the sports committee at a higher level and have the
consent of and the purchase permit granted by the county or municipal
bureau of public security at the place where the purchasing units are
located: only with the purchase permit may a purchasing unit make
purchases of firearms at the department designated by the State. The
purchase of hunting rifles and injection-guns shall be approved by the
competent forestry department at the county level or higher and have the
consent of and the purchase permit granted by the public security organ;
only with the purchase permit, may a purchasing unit make purchases at the
department designated by the State. The distributors of hunting rifles
shall go through the procedures of registration at the public security
organ at the county or municipal level or higher.
With the exception of the units designated by the State or approved by the
competent department, no units or individuals may sell or purchase
firearms and ammunition.
Control of Firearms
Article 11
The firearm-carrying personnel shall obtain the consent of the person in
charge of their unit, and have the approval of the competent department at
the county level or higher. The firearm-equipped unit shall obtain the
approval of the people's government at the county level or higher.
Without permission through legal procedures, no units or individuals may
keep firearms and ammunition privately. Firearms and ammunition kept
without permission shall be handed over to the local public security
organ, and shall not be disposed of privately.
Article 12
Firearm-carrying personnel and firearm-equipped units shall apply to the
local county or municipal bureau of public security for firearm licenses,
which shall be granted after examination and approval.
Firearm-carrying personnel, when going out with their firearms, shall
carry them with firearm licenses for examination. Personnel carrying
firearms for official use and who perform duties in places other than
their own county or municipality must apply to the local county or
municipal bureau of public security for firearm-carrying pass.
Article 13
Firearms which bear historic significance kept on display in exhibition
halls, museums, etc., shall be registered at the local county or municipal
bureau of public security, and shall not be used for other purposes.
Article 14
It is strictly prohibited to fire shots at will in cities, towns,
residential areas, scenic spots, airports, along communication lines, or
in any other places where shot-firing is prohibited according to
regulations. It is prohibited to fire shots and hunt in non-hunting areas.
Article 15
In some particular areas or places where firearms are banned, firearm-
carrying personnel shall leave the firearms they carry with the public
security organ or a designated unit for safe-keeping, and have them given
back when leaving.
Article 16
All categories of firearms shall be kept properly and safe. Firearms kept
collectively shall be well taken care of by persons specially designated
for the job; special warehouses (or cabinets) shall be used for keeping
the firearms, and firearms and ammunition shall be kept separately; strict
measures shall be taken against loss, theft or other accidents. In case
that firearms are lost or stolen, it must be reported immediately to the
public security organ, and the scene of the incident shall be kept intact.
Article 17
Firearm-equipped units and firearm-carrying personnel are not permitted,
without official approval, to lend out their firearms and ammunition or
give them to others as gifts. In the event that a firearm-equipped unit
has been disbanded or a firearm-carrying person been transferred to a new
unit, the unit or the person shall return the firearms to the original
firearm-allocating unit, and return the firearm licence(s) to the original
licence-issuing public security organ for cancellation. Persons who hold
hunting rifles shall, upon moving away from the county or city of their
original residence, return for cancellation their firearm licences to the
original licence-issuing public security organ and obtain firearm-
transport passes. On their arrival at their destinations, they shall
present the firearm-transport passes to the local security organ and go
through the procedures for obtaining new firearm licences.
Article 18
To transport firearms and ammunition, it is imperative to apply to the
county or municipal bureau of public security stationed at the destination
of transportation for a transport pass. Upon arrival at the destination,
the applicant shall present the transport pass to the local public
security organ and go through the procedures for registration or for
obtaining a new firearm licence.
Article 19
To carry hunting rifles into the country from abroad, it is imperative to
obtain, in advance, the approval of the county or municipal bureau of
public security stationed in the locality of the applicant's residence.
Upon entering the country, the applicant shall declare at the Customs, and
a carrying-transport permit shall be issued after examination and approval
by the border inspection office. Upon arrival at the destination, the
applicant shall go through the procedures for obtaining a firearm licence
by presenting the carrying-transport permit.
To carry hunting rifles out of the country, it is imperative to return for
cancellation the firearm licence to the original licence-issuing public
security organ for a carrying-transport permit. On exit, the applicant
shall declare at the Customs, and surrender the carrying-transport permit
to the local border inspection office.
Article 20
Firearms that have fallen into disuse shall be registered by the firearm-
holding units in detailed lists, which shall be submitted for approval to
the competent departments of the province, autonomous region, or
municipality directly under the Central Government, and, then, again to
the local county or municipal bureau of public security for examination;
after that, the disused firearms shall undergo a treatment of
disfigurement before they are sent, under the supervision of the unit in
charge of the destruction, to a smeltery designated by the public security
department (bureau) of the province, autonomous region, or municipality
directly under the Central Government for melting down and complete
destruction.
Article 21
Air guns that discharge metal pellets shall be controlled in accordance
with the provisions concerning the control of sports guns, when used by
sports departments in target-shooting sports, and in accordance with the
provisions concerning the control of hunting rifles when used for hunting
by hunting units. Privately purchased and held pellet-discharging air guns
are also required to go through registration procedures and to be placed
under control; and the control measures shall be formulated by the public
security department (bureau) of the province, autonomous region, or
municipality directly under the Central Government.
Article 22
Firearm licences, firearm-carrying passes, purchase permits for sports
guns, hunting rifles and injection-guns, transport passes for firearms and
ammunition, and carrying-transport permits shall all be devised solely by
the Ministry of Public Security, be printed solely by the public security
department (bureau) of the province, autonomous region, or municipality
directly under the Central Government, and be signed and issued by the
county or municipal bureau of public security.
Article 23
The public security organs at various levels shall exercise supervision
over such affairs as the carrying, use, safe-keeping, and changes of
firearms in the non-military departments of their locality, and carry out
inspection at regular intervals.
Control of Firearms of Foreigners
Article 24
Foreign diplomatic missions and consular posts in China, and their
personnel, that are to carry firearms into China shall apply in advance to
the Ministry of Foreign Affairs of the People's Republic of China; after
obtaining the consent, they shall declare at the Customs on entering the
country and then be issued the carrying-transport permits by the border
inspection office after examination. Upon arrival at the destination, the
applicants shall report to the local municipal bureau of public security,
and go through the registration procedures for their firearms.
No firearms belonging to foreign diplomatic missions and consular posts in
China and to their personnel, with the exception of their shotguns which
may be used in hunting grounds, shall be carried out of the confines of
the aforesaid missions and posts. Foreign diplomatic missions and
consular posts in China and their personnel that are to carry their
firearms out of China shall send a note to the Ministry of Foreign Affairs
of the People's Republic of China, and make an application to the
municipal bureau of public security at the locality of their residences
for registration cancellation and for the issuance of carrying-transport
permits. On exit, they shall declare at the Customs, and submit the
carrying-transport permit to the local border inspection office.
Article 25
Members of foreign political party, government, military or parliamentary
delegations and their guards that are to carry firearms into China shall
obtain in advance the consent from the Ministry of Foreign Affairs of the
People's Republic of China or from the host units, which shall notify the
border inspection office and submit a report to the Ministry of Public
Security for the record.
Article 26
Foreign sports teams that come to China to take part in a shooting
tournament with their sports rifles and pistols shall obtain in advance
the approval by the Physical Culture and Sports Commission of the People's
Republic of China. On entering the country, they shall declare at the
Customs, and then the border inspection office shall issue them the
carrying-transport permits after examination. On arrival at the locality
of the tournament, they shall go through the registration procedures for
the record at the local county or municipal bureau of public security, and
cancel the registration before leaving. Foreign sports teams that travel
via China shall obtain in advance the approval of the Physical Culture and
Sports Commission of the People's Republic of China, which shall notify
the border inspection authorities, and the inspection office at the entry
point shall put paper slip seals on the firearms and permit them to pass
through the country.
Article 27
Firearms and ammunition on board foreign civil air-liners or vessels
registered in foreign countries, shall be sealed up by the border
inspection office when the air-liners and vessels enter a port of China,
and unsealed when the air-liners and vessels leave the country.
Article 28
Apart from those who come to China as stipulated in Articles 24, 25 and 26
of these Measures, no foreigners are permitted to carry firearms and
ammunition into the territory, unless approved by the competent
departments of the People's Republic of China and by the public security
department (bureau) of the province, autonomous region, and municipality
directly under the Central Government at the places of their destination.
Those who carry firearms and ammunition with them must, on entering the
territory, declare at the Customs, and the border inspection office shall
temporarily seal up the firearms and ammunition for safekeeping at the
entry port, and give them back when the owners leave the country; or the
firearms and ammunition shall be retransported out of the territory by the
original carriers. Those who have obtained the approval to carry firearms
and ammunition into or out of the territory shall go through the
procedures in accordance with the stipulations of Article 19 of these
Measures. Those in transit shall declare at the Customs, and the border
inspection office shall seal the firearms up after examination, and permit
them to pass through the country. Those who fail to declare at the
Customs shall be dealt with, without exception, as cases of illegal
transport of firearms and ammunition.
Article 29
Foreigners who wish to buy hunting rifles in China, shall obtain the
approval of and certificates from the foreign affairs office of the
province, autonomous region or municipality directly under the Central
Government, or the host unit. They shall then apply to the local county
and municipal bureau of public security for purchase permits and make
their purchases at designated stores after approval.
Penalties
Article 30
The chief person-in-charge and the direct offender, who are held
responsible for the violation of these Measures, shall receive penalties
ranging from disciplinary sanction, punishment in accordance with the
regulations on the maintenance of public order, to an investigation by the
judicial organ of the criminal responsibilities of the offender, depending
on the seriousness of the case.
Miscellaneous
Article 31
The people's governments of various provinces, autonomous regions and
municipalities directly under the Central Government and the various
ministries and commissions under the State Council may, in accordance with
these Measures, formulate specific provisions for the control of firearms,
and report thereon to the Ministry of Public Security for the record.
Article 32
These Measures shall go into effect after the approval by the State
Council and the promulgation by the Ministry of Public Security. The
Interim Measures Concerning the Control of Firearms, approved by the
Government Administration Council and promulgated by the Ministry of
Public Security on June 27, 1951, shall be abrogated at the same time.


浙江省产品质量监督条例

浙江省人大常委会


浙江省产品质量监督条例


浙江省第十届人民代表大会常务委员会公告

  《浙江省产品质量监督条例》已于2005年9月30日经浙江省第十届人民代表大会常务委员会第二十次会议通过,现予公布,自2005年12月1日起施行。
浙江省人民代表大会常务委员会
2005年9月30日



浙江省产品质量监督条例

(2005年9月30日浙江省第十届人民代表大会常务委员会第二十次会议通过)  

  第一章总则
第一条为了加强对产品质量的监督,保护消费者的合法权益,维护社会经济秩序,根据《中华人民共和国产品质量法》(以下简称《产品质量法》)和其他有关法律、法规的规定,结合本省实际,制定本条例。
第二条在本省行政区域内从事产品生产、销售及相关活动和对产品质量实施监督,应当遵守本条例。
第三条县级以上人民政府应当加强对产品质量监督工作的领导,组织、协调有关部门以及乡镇人民政府、街道办事处做好产品质量监督工作,保障本条例的施行。
县级以上质量技术监督部门、工商行政管理部门应当依照法律、法规和国家、省规定的职责,做好本行政区域内的产品质量监督工作。其他有关部门在各自的职责范围内负责产品质量监督工作。
法律、法规对产品质量的监督部门另有规定的,依照有关法律、法规的规定执行。
第四条鼓励生产者采用先进的科学技术和科学的质量管理方法,提高产品质量,创建著名品牌。
县级以上人民政府应当加强产品质量工作的规划,建立健全产品质量奖励制度和著名品牌保护制度,积极实施名牌发展战略。
第五条鼓励、支持和保护一切组织和个人对产品质量进行社会监督和舆论监督。
对举报属实和协助查处违反产品质量法律、法规行为有功的单位和个人,县级以上人民政府或者产品质量的监督部门应当按照有关规定给予表彰和奖励。
第二章产品质量责任和义务
第六条生产者应当建立健全产品质量管理制度,依法对其生产的产品质量负责。
第七条销售者应当建立并执行进货检查验收制度,验明产品合格证明和其他标识,索取并保存能够证明进货来源的原始发票等单证。
销售者应当采取措施,保持销售产品的质量,依法对销售的产品承担产品质量责任。
第八条禁止生产、销售下列产品:
(一)《产品质量法》等有关产品质量的法律、行政法规禁止生产、销售的产品;
(二)不符合保障人体健康和人身、财产安全的地方标准的产品;
(三)超过安全使用期或者失效日期的产品;
(四)虚假标注生产日期、安全使用期或者失效日期的产品;
(五)伪造、冒用产品质量检验检测证明的产品;
(六)没有中文标明的产品名称、生产厂厂名和厂址的产品,专供出口的产品除外。
第九条禁止任何单位和个人为生产、销售本条例第八条规定的产品提供生产场地、运输、保管、仓储等便利条件。
第十条禁止服务业经营者将本条例第八条规定的产品用于经营性服务。
第十一条禁止生产者、销售者和服务业经营者将本条例第八条规定的产品作为奖品或者赠品。
第十二条生产者、销售者未经规定程序认定,不得使用国家和省的著名品牌标志。
第十三条承印人承接印制认证标志等质量标志,生产许可证编号、标志,商品条码,产品标准编号,产品质量检验检测证明,产品质量免检证书、标志,国家和省的著名品牌标志,以及含有以上标志的包装物和其他物品,应当查验有关证明文件,并复印留存。委托人不能提供证明文件的,不得承印。
承印人印制的前款所列标志、包装物和其他物品,不得提供给非委托人。
第十四条对产品质量有瑕疵但符合保障人体健康和人身、财产安全的标准或者要求的产品,必须在产品或者包装的明显部位清晰标明“处理品”、“残次品”、“等外品”等字样,并以产品说明书或者店堂、柜台告示等能为消费者知悉的方式如实说明产品的瑕疵或者实际质量状况后,方可出厂或者销售。
第十五条生产者、销售者发现销售的产品因设计、制造等方面的原因,在某一批次、型号或者类别中存在着危及人体健康和人身、财产安全的不合理危险的,应当立即停止销售,报告县级以上质量技术监督部门、工商行政管理部门和告知消费者;产品已经售出的,应当采取修理、更换、退货等有效措施消除该缺陷。
县级以上质量技术监督部门、工商行政管理部门发现产品存在前款规定的缺陷,并且生产者、销售者没有履行前款规定义务的,应当责令生产者、销售者停止销售并告知消费者;产品已经售出的,应当责令生产者、销售者在规定的时限内采取有效措施消除该缺陷;生产者、销售者拒不采取措施或者采取的措施不足以防止危害发生的,经省质量技术监督部门、工商行政管理部门批准,可以发布公告。
第三章监督检查
第十六条对产品质量实行以监督抽查为主要方式的监督检查制度。
监督抽查的重点是:
(一)可能危及人体健康和人身、财产安全的产品;
(二)影响国计民生的重要工业产品;
(三)消费者、有关组织反映有质量问题的产品;
(四)用于评价产品质量指数的代表性产品。监督抽查由县级以上质量技术监督部门根据法律和国家有关规定组织实施。法律对产品质量的监督抽查另有规定的,依照有关法律的规定执行。
监督抽查的结果省质量技术监督部门应当在省主要媒体上公告。县级以上质量技术监督部门应当根据监督抽查的结果,建立产品质量指数分析评价、产品质量安全预警与整治制度。
第十七条县级以上工商行政管理部门根据产品质量监督工作的需要,可以按照国家有关规定对流通领域可能危及人体健康和人身、财产安全的产品,以及消费者、有关组织反映强烈的产品实施质量监测。
第十八条产品质量监督抽查工作与质量监测工作应当相互协调,避免重复。
监督抽查和质量监测的检验工作应当委托有资质的检验机构进行,不得向被检验人收取检验费用。
第十九条县级以上质量技术监督部门、工商行政管理部门查处涉嫌违反本条例规定行为时,需要对产品进行检验的,应当按照规定合理抽取样品,送有资质的检验机构进行检验;涉嫌冒用他人厂名、厂址的产品,也可以送被侵权者协助鉴别。经检验,生产、销售的产品不符合《产品质量法》和本条例规定的,检验(含复检)费用及样品损耗费用由被检验人承担;符合《产品质量法》和本条例规定的,检验(含复检)费用及样品损耗费用由送检机关承担。国家另有规定的除外。
第二十条检验、判定产品质量的依据是:
(一)国家标准、行业标准、地方标准和经依法备案的企业标准;
(二)产品标识、产品说明中明示的内容或者以实物样品等方式表明的质量状况;
(三)国家、省质量技术监督部门批准的产品质量检验方法或者质量评价规则;
(四)法律、法规的其他规定。
第二十一条产品质量检验机构应当依法按照标准和有关规定,客观、公正、及时地出具检验结果,并对检验结果的真实性负责。
生产者、销售者对检验结果有异议的,可以自收到检验结果之日起十五日内向实施监督检查的机关或者其上级机关申请复检,由受理复检的机关作出复检结论。
第二十二条县级以上质量技术监督部门、工商行政管理部门查处涉嫌违反本条例规定行为时,经本机关负责人批准,对有根据认为不符合保障人体健康和人身、财产安全的国家标准、行业标准、地方标准的产品或者有其他严重质量问题的产品,以及直接用于生产、销售该项产品的原辅材料、包装物、生产工具,可以予以查封、扣押。
查封、扣押的期限不得超过三十日,但按规定检验的期间不计算在内。
被查封、扣押的物品易腐烂、变质的,经本机关负责人批准,可以在留存证据后,依照本条例第四十三条的规定先行作出处理。
第二十三条查封、扣押期限届满或者经调查核实没有违法行为的,采取查封、扣押措施的机关应当及时解除查封、扣押,并通知当事人在规定的期限内认领。
前款规定的物品已经根据本条例规定先行拍卖或者变卖的,应当返还拍卖或者变卖所得价款;已经监督销毁或者捐赠给公益事业的,应当补偿损失。
第二十四条被查封、扣押物品的当事人经通知不认领的,采取查封、扣押措施的机关应当发布财物认领公告。自公告之日起超过三个月仍不认领的,被查封、扣押的物品依照本条例第四十三条规定处理。
第二十五条采取查封、扣押措施的机关应当妥善保管被查封、扣押的物品,不得使用或者损毁。
第四章法律责任
第二十六条违反本条例规定,《产品质量法》等法律、行政法规已有处罚规定的,依照法律、行政法规的规定处罚。
第二十七条违反本条例第八条第(二)项规定的,责令停止生产、销售,没收违法生产、销售的产品,并处违法生产、销售产品(包括已售出和未售出的产品,下同)货值金额等值以上三倍以下的罚款;有违法所得的,并处没收违法所得。
第二十八条违反本条例第八条第(三)项规定的,依照《产品质量法》关于销售失效、变质的产品的处罚规定处罚。
第二十九条违反本条例第八条第(四)项、第(五)项规定的,责令停止生产、销售,没收违法生产、销售的产品,并处违法生产、销售产品货值金额等值以下的罚款;有违法所得的,并处没收违法所得。
第三十条违反本条例第八条第(六)项规定的,责令改正;拒不改正的,处违法生产、销售产品货值金额百分之三十以下的罚款;有违法所得的,并处没收违法所得。
第三十一条对生产者专门用于生产本条例第八条第(二)项规定的产品的原辅材料、包装物、生产工具,应当予以没收。
第三十二条销售者销售本条例第八条规定的产品,有充分证据证明其不知道该产品为禁止销售的产品并提供证明其进货来源的原始发票等单证或者如实说明进货来源的,可以从轻或者减轻处罚。
第三十三条知道或者应当知道属于本条例第八条规定的产品而为其提供生产场地、运输、保管、仓储等便利条件的,责令改正,没收全部提供生产场地、运输、保管、仓储等收入,并处违法收入百分之五十以上三倍以下的罚款。
第三十四条服务业的经营者知道或者应当知道属于本条例第八条规定的产品而将其用于经营性服务的,按照违法使用的产品(包括已使用和尚未使用的产品)的货值金额,依照本条例第二十七条至第三十条对销售者的处罚规定处罚。
第三十五条违反本条例第十一条规定的,责令改正,没收违法的奖品或者赠品,并处奖品或者赠品货值金额百分之五十以下的罚款。
第三十六条违反本条例第十二条规定的,责令改正,没收违法所得;拒不改正的,处违法生产、销售产品货值金额等值以下的罚款。
第三十七条违反本条例第十三条规定的,没收违法承印的物品,可以并处五千元以上五万元以下的罚款;有违法所得的,并处没收违法所得。
第三十八条隐匿、转移、变卖、损毁被依法查封、扣押物品的,处被隐匿、转移、变卖、损毁物品货值金额等值以上三倍以下的罚款;有违法所得的,并处没收违法所得。
第三十九条本条例规定的行政处罚由县级以上质量技术监督部门、工商行政管理部门依照法律、法规及国家与省规定的职责实施。法律、法规对行使行政处罚权的机关另有规定的,依照有关法律、法规的规定执行。
第四十条质量技术监督部门、工商行政管理部门及其工作人员违反本条例规定有下列情形之一的,对直接负责的主管人员和其他直接责任人员依法给予行政处分:
(一)违反规定发布公告、公告失实或者向新闻媒体提供失实信息的;
(二)违反规定采取查封、扣押措施或者不及时解除查封、扣押措施的;
(三)使用或者损毁被查封、扣押的物品的;
(四)在产品质量监督抽查和质量监测中,向被检验人收取检验费用或者违反规定索取样品的;
(五)包庇、放纵产品生产、销售中违反本条例规定行为的;
(六)向违法嫌疑人通风报信,帮助其逃避查处的;
(七)其他滥用职权、玩忽职守、徇私舞弊行为。
质量技术监督部门、工商行政管理部门及其工作人员有前款第(一)项至第(四)项规定情形之一,造成当事人经济损失的,应当依法承担赔偿责任;有前款第(一)项、第(二)项规定情形之一,造成当事人名誉权、荣誉权损害的,应当消除影响,恢复名誉,赔礼道歉。
第四十一条各级人民政府工作人员和其他国家工作人员有本条例第四十条第(五)项、第(六)项规定情形之一,或者阻挠、干预质量技术监督部门、工商行政管理部门依法对产品生产、销售中违反本条例规定的行为进行查处的,依法给予行政处分。
第四十二条违反本条例规定,构成犯罪的,依法追究刑事责任。
第四十三条依照本条例没收的物品,属于可能危及人体健康和人身、财产安全的产品的,应当由作出行政处罚的机关监督销毁,所需费用由当事人承担。属于可以使用的产品的,应当在消除违法状态后予以变卖或者拍卖,变卖、拍卖所得应当上交国库;不宜变卖、拍卖或者变卖、拍卖未能成交的,经同级财政部门同意,可以捐赠给公益事业。
第五章附则
第四十四条本条例自2005年12月1日起施行。1992年11月15日浙江省第七届人民代表大会常务委员会第三十一次会议通过的《浙江省查处生产和经销假冒伪劣商品行为条例》和1995年12月26日浙江省第八届人民代表大会常务委员会第二十五次会议通过的《浙江省产品质量监督管理条例》同时废止。



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