The Standing Committee of the National People's Congress


LAW OF THE PEOPLE'S REPUBLIC OF CHINA ON ASSEMBLIES, PROCESSIONSAND DEMONSTRATIONS

(Adopted at the Tenth Meeting of the Standing Committee of the
Seventh National People's Congress on October 31, 1989, promulgated by
Order No. 20 of the President of the People's Republic of China on October
31, 1989 and effective as of the same date)

Contents
Chapter I General Provisions
Chapter II Application and Permission for Assemblies, Processions and
Demonstrations
Chapter III The Holding of Assemblies, Processions and Demonstrations
Chapter IV Legal Responsibility
Chapter V Supplementary Provisions

Chapter I General Provisions
Article 1
Pursuant to the Constitution, this Law is enacted to safeguard citizens'
exercise of their right to assembly, procession and demonstration
according to law and to maintain social stability and public order.
Article 2
This Law shall apply to assemblies, processions and demonstrations held
within the territory of the People's Republic of China.
The term "assembly" used in this Law means an activity in which people
gather at a public place in the open air to express views or aspirations.
The term "procession" used in this Law means an activity in which people
line up for a march along a public road or across a public place in the
open air to express their common aspirations.
The term "demonstration" used in this Law means an activity in which
people express their common aspirations, including demands, protests,
support or moral support, in the manner of an assembly, a procession, a
sit-in, etc., at a public place in the open air or along a public road.
This Law shall not apply to recreational or sports activities, normal
religious activities or traditional folk events.
Article 3
The citizens' exercise of their right to assembly, procession and
demonstration shall be safeguarded by the people's governments at all
levels in accordance with the provisions of this Law.
Article 4
In exercising their right to assembly, procession and demonstration,
citizens must abide by the Constitution and the laws, shall not oppose the
cardinal principles specified in the Constitution and shall not impair
state, public or collective interests or the lawful freedoms and rights of
other citizens.
Article 5
An assembly, a procession or a demonstration shall be held in a peaceful
manner; no weapons, controlled cutting tools or explosives shall be
carried, and no violence employed.
Article 6
The competent authorities governing assemblies, processions and
demonstrations shall be the municipal public security bureau, county
security bureau or municipal public security sub-bureau in the localities
where the assemblies, processions and demonstrations are held; if the
route of a procession or demonstration cuts through two or more districts
or counties, the competent authorities thereof shall be the public
security organ at the next higher level to the public security organs in
such districts or counties.

Chapter II Application and Permission for Assemblies, Processions and Demonstrations
Article 7
For the holding of an assembly, a procession or a demonstration,
application must be made to and permission obtained from the competent
authorities in accordance with the provisions of this Law.
It shall not be necessary to apply for the following activities:
(1) celebrations or commemorative activities held by the state or by state
decisions; and
(2) assemblies held by state organs, political parties, public
organizations, enterprises or institutions in accordance with law or the
relevant articles of association.
Article 8
There must be a person or persons responsible for the holding of an
assembly, a procession or a demonstration.
For the holding of an assembly, a procession or a demonstration for which
an application has to be made under this Law, the responsible person(s)
must submit an application in writing to the competent authorities five
days prior to the date of the activity. The application shall specify the
purposes of the assembly, procession or demonstration, how it is going to
be conducted, the posters and slogans to be used, the number of
participants, the number of vehicles, the specifications and quantities of
the sound facilities to be used, the starting and finishing time, the
places (including places where the participants assemble and disperse),
the route, and the name(s), occupation(s) and address(es) of the person(s)
responsible for the assembly, procession or demonstration.
Article 9
After receiving an application for an assembly, a procession or a
demonstration, the competent authorities shall inform the responsible
person(s) in writing of their decision to grant or not to grant permission
two days prior to the date of the activity applied for. If no permission
is granted, the reasons thereof shall be given. Failure to serve notice
within the time limit shall be construed as the granting of permission.
If an assembly, a procession or a demonstration is truly necessitated by
unexpected occurrences, a report must be made immediately to the competent
authorities: upon receiving the report, the competent authorities shall
immediately examine it and decide to grant or not to grant permission.
Article 10
If an application is made for an assembly, a procession or a demonstration
which will press for the settlement of specific issues, the competent
authorities may, after receiving the application, inform the departments
or units concerned to resolve such issues through consultation with the
person(s) responsible for the assembly, procession or demonstration, and
may also postpone for five days the starting date specified in the
application.
Article 11
If the competent authorities are of the opinion that the holding of an
assembly, a procession or a demonstration at the time or place or along
the route specified in the application will seriously affect traffic and
public order, they may, upon or after granting permission, change the
time, place or route and inform the responsible person(s) of the change in
good time.
Article 12
No permission shall be granted for an application for an assembly, a
procession or a demonstration which involves one of the following
circumstances:
(1) opposition to the cardinal principles specified in the Constitution;
(2) harming the unity, sovereignty and territorial integrity of the state;
(3) instigation of division among the nationalities; or
(4) the belief, based on sufficient evidence, that the holding of the
assembly, procession or demonstration that is being applied for will
directly endanger public security or seriously undermine public order.
Article 13
If the person(s) responsible for an assembly, a procession or a
demonstration does not accept the competent authorities' decision not to
grant permission, he may apply to the people's government at the same
level for reconsideration within three days of receiving the notice on the
decision, and the people's government shall make a decision within three
days of receiving the application for reconsideration.
Article 14
The person(s) responsible for an assembly, a procession or a demonstration
may withdraw his application after submitting it and before receiving a
notice of the competent authorities; if a decision is made to call off the
assembly, procession or demonstration after receipt of the competent
authorities' notice on the granting of permission, the responsible
person(s) concerned shall inform the competent authorities of the decision
in good time and dismiss the participants if they have assembled.
Article 15
No citizens shall, in a city other than his place of residence, start,
organize or participate in an assembly, a procession or a demonstration of
local citizens.
Article 16
No functionary of a state organ shall organize or participate in an
assembly, a procession or a demonstration which contravenes the functions
and obligations of functionaries of state organs as prescribed in relevant
laws and regulations.
Article 17
If anyone organizes or participates in an assembly, a procession or a
demonstration in the name of a state organ, a public organization, an
enterprise or an institution, he must first obtain approval from its
leaders.

Chapter III The Holding of Assemblies, Processions and Demonstra- tions
Article 18
With respect to an assembly, a procession or a demonstration held in
compliance with law, the competent authorities shall dispatch the people's
police to keep traffic and public order and ensure the smooth progress of
the assembly, procession or demonstration.
Article 19
An assembly, a procession or a demonstration held in compliance with law
shall not be disturbed, broken into or disrupted by anybody by violence,
coercion or any other illegal means.
Article 20
In order to ensure the progress of a procession held in compliance with
law, the people's police responsible for keeping traffic order may
temporarily exercise flexibility in their execution of the relevant
provisions of traffic regulations.
Article 21
If it becomes impossible for a procession to follow the permitted route
because of unexpected circumstances occurring on the way, the chief police
officer present at the scene shall have the authority to change the route
of the procession.
Article 22
If an assembly, a procession or a demonstration is held in or passes by
places where state organs, military organs, radio stations, television
stations or foreign embassies or consulates are located, the competent
authorities may, with a view to keeping order, establish temporary
security lines, which shall not be crossed without permission by the
people's police.
Article 23
No assembly, procession or demonstration shall be held within a peripheral
distance of 10-300 metres from the following places, with the exception of
those approved by the State Council or the people's governments of
provinces, autonomous regions and municipalities directly under the
Central Government:
(1) premises of the Standing Committee of the National People's Congress,
the State Council, the Central Military Commission, the Supreme People's
Court and the Supreme People's Procuratorate;
(2) places where state guests are staying;
(3) important military installations; and
(4) air harbours, railway stations and ports.
The specific peripheral distances from the places listed in the preceding
paragraph shall be defined by the people's governments of provinces,
autonomous regions and municipalities directly under the Central
Government.
Article 24
The time for holding an assembly, a procession or a demonstration shall be
limited to 6 a.m. - 10 p.m., with the exception of those held by decision
or approval of the local people's governments.
Article 25
An assembly, a procession or a demonstration shall be conducted in
accordance with the purposes, manners, posters, slogans, starting and
finishing time, places, routes and other matters for which permission has
been granted.
The person(s) responsible for an assembly, a procession or a demonstration
must assume responsibility for maintaining the order thereof and strictly
guard against participation by others.
The person(s) responsible for an assembly, a procession or a demonstration
shall, when necessary, appoint special personnel to assist the people's
police in maintaining order. The personnel responsible for the
maintenance of order shall wear identification marks.
Article 26
The holding of an assembly, a procession or a demonstration shall not
contravene the regulations on public security administration and shall not
involve criminal activities or the instigation of crimes.
Article 27
The people's police shall stop an assembly, a procession or a
demonstration that is being held, if it involves one of the following
circumstances:
(1) failure to make an application in accordance with the provisions of
this Law or to obtain permission for the application;
(2) failure to act in accordance with the purposes, manners, posters,
slogans, starting and finishing time, places and routes permitted by the
competent authorities; or (3) the emergence, in the course of the
activity, of a situation which endangers public security or seriously
undermines public order.
If any of the circumstances specified in the preceding paragraph occurs
and the instruction to stop the activity is ignored, the chief officer of
the people's police present at the scene shall have the authority to order
a dismission; for those who refuse to dismiss, the chief police officer
present at the scene shall have the authority to decide, in accordance
with relevant state provisions, on the adoption of necessary measures to
force a dismission and to take away from the scene by force those who
refuse to obey or detain them at once.
If a participant in an assembly, a procession or a demonstration crosses
the temporary security lines established in accordance with the provisions
of Article 22 of this Law, enters a certain peripheral space around the
specific places where no assemblies, processions and demonstrations shall
be held as specified in Article 23 of this Law, or commits other illegal
or criminal acts, the people's police may take him away from the scene by
force or detain him at once.

Chapter IV Legal Responsibility
Article 28
Those who commit acts in violation of public security administration in
the process of an assembly, a procession or a demonstration shall be
punished in accordance with the relevant provisions of the Regulations on
Administrative Penalties for Public Security. The public security organ
may punish by warning or by criminal detention of not more than 15 days
the responsible person(s) and the person(s) who is directly responsible,
if an assembly, a procession or a demonstration that is being held
involves one of the following circumstances:
(1) failure to make an application in accordance with the provisions of
this Law or to obtain permission for the application; or
(2) failure to act in accordance with the purposes, manners, posters,
slogans, starting and finishing time, places, and routes permitted by the
competent authorities, and disregard of instructions to stop acting
without permission.
Article 29
Any participant in an assembly, a procession or a demonstration who
commits a crime shall be investigated for criminal responsibility in
accordance with the relevant provisions of the Criminal Law.
Any participant in an assembly, a procession or a demonstration who
carries weapons, controlled cutting tools or explosives shall be
investigated for criminal responsibility by applying mutatis mutandis the
provisions of Article 163 of the Criminal Law. In a case where no
application has been made for an assembly, a procession or a demonstration
in accordance with the provisions of this Law or no permission has been
granted for the application or where it is conducted not in accordance
with the starting and finishing time, places and routes permitted by the
competent authorities, while the order of dismission is disobeyed and
public order seriously undermined, the person(s) responsible for the
assembly, procession or demonstration and the person(s) who is directly
responsible shall be investigated for criminal responsibility in
accordance with the provisions of Article 158 of the Criminal Law.
In a case where an assembly, a procession or a demonstration leads to the
siege of a state organ or people breaking into it, preventing it from
conducting its business or state activities normally, the person(s)
responsible for the assembly, procession or demonstration and the
person(s) who is directly responsible shall be investigated for criminal
responsibility in accordance with the provisions of Article 158 of the
Criminal Law.
In a case where an assembly, a procession or a demonstration leads to the
occupation of public places, the interception of vehicles or pedestrians
or the gathering of crowds to block traffic, so that order at public
places and traffic order are seriously undermined, the person(s)
responsible for the assembly, procession or demonstration and the
person(s) who is directly responsible shall be investigated for criminal
responsibility in accordance with the provisions of Article 159 of the
Criminal Law.
Article 30
Those who disturb, break into or undermine by other means an assembly, a
procession or a demonstration held in compliance with law may be punished
by the public security organ by warning or by criminal detention of not
more than 15 days; if the circumstances are serious and a crime is
constituted, they shall be investigated for criminal responsibility in
accordance with the relevant provisions of the Criminal Law.
Article 31
If a party refuses to accept the decision on punishment by detention made
in accordance with the provisions of the second paragraph of Article 28 or
Article 30 of this Law, he may appeal to the public security organ at the
next higher level within five days of receiving the notice on the decision
on punishment; the public security organ at the next higher level shall
make a decision within five days of receiving the appeal; if the party
refuses to accept the decision of the public security organ at the next
higher level, he may institute proceedings in the people's court within
five days of receiving the notice on the decision.
Article 32
Anyone who, in the course of an assembly, a procession or a demonstration,
damages public or private property or causes injuries or deaths to others
shall be liable for compensation according to law, apart from being
punished in accordance with the relevant provisions of the Criminal Law or
the Regulations on Administrative Penalties for Public Security.
Article 33
If a citizen, in a city other than his place of residence, starts or
organizes an assembly, a procession or a demonstration by local citizens,
the public security organ shall have the authority to detain him or send
him back by force to his place of residence.

Chapter V Supplementary Provisions
Article 34
This Law shall apply to assemblies, processions and demonstrations held by
foreigners within the territory of China.
Foreigners in the territory of China may not, without approval by the
competent authorities, participate in an assembly, a procession or a
demonstration held by Chinese citizens.
Article 35
The public security department under the State Council may, in accordance
with this Law, formulate rules of implementation, which shall go into
effect after being submitted to and approved by the State Council.
The standing committees of the people's congresses of provinces,
autonomous regions and municipalities directly under the Central
Government may, in accordance with this Law, formulate measures for
implementation.
Article 36
This Law shall enter into force on the date of promulgation.



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.



国家食品药品监督管理局


国家食品药品监督管理局令
　　　　　　　　　　　　　　　　　　　第14号

　　《药品生产监督管理办法》于2004年5月28日经国家食品药品监督管理局局务会审议通过，现予公布，自公布之日起施行。



　　　　　　　　　　　　　　　　　　　　　　　　　　局长：郑筱萸
　　　　　　　　　　　　　　　　　　　　　　　　　二○○四年八月五日


　　　　　　　　　　　　　　　　药品生产监督管理办法

　　　　　　　　　　　　　　　　　第一章　总　　则

　　第一条　为加强药品生产的监督管理，根据《中华人民共和国药品管理法》、《中华人民共和国药品管理法实施条例》（以下简称《药品管理法》、《药品管理法实施条例》），制定本办法。

　　第二条　药品生产监督管理是指（食品）药品监督管理部门依法对药品生产条件和生产过程进行审查、许可、监督检查等管理活动。

　　第三条　国家食品药品监督管理局主管全国药品生产监督管理工作；省、自治区、直辖市（食品）药品监督管理部门负责本行政区域内的药品生产监督管理工作。

　　　　　　　　　　　　　第二章　开办药品生产企业的申请与审批

　　第四条　开办药品生产企业，除应当符合国家制定的药品行业发展规划和产业政策外，还应当符合以下条件：
　　（一）具有依法经过资格认定的药学技术人员、工程技术人员及相应的技术工人，企业法定代表人或者企业负责人、质量负责人无《药品管理法》第七十六条规定的情形；
　　（二）具有与其药品生产相适应的厂房、设施和卫生环境；
　　（三）具有能对所生产药品进行质量管理和质量检验的机构、人员以及必要的仪器设备；
　　（四）具有保证药品质量的规章制度。
　　国家有关法律、法规对生产麻醉药品、精神药品、医疗用毒性药品、放射性药品、药品类易制毒化学品等另有规定的，依照其规定。

　　第五条　开办药品生产企业的申请人，应当向拟办企业所在地省、自治区、直辖市（食品）药品监督管理部门提出申请，并提交以下材料：
　　（一）申请人的基本情况及其相关证明文件；
　　（二）拟办企业的基本情况，包括拟办企业名称、生产品种、剂型、设备、工艺及生产能力；拟办企业的场地、周边环境、基础设施等条件说明以及投资规模等情况说明；
　　（三）工商行政管理部门出具的拟办企业名称预先核准通知书，生产地址及注册地址、企业类型、法定代表人或者企业负责人；
　　（四）拟办企业的组织机构图（注明各部门的职责及相互关系、部门负责人）；
　　（五）拟办企业的法定代表人、企业负责人、部门负责人简历，学历和职称证书；依法经过资格认定的药学及相关专业技术人员、工程技术人员、技术工人登记表，并标明所在部门及岗位；高级、中级、初级技术人员的比例情况表；
　　（六）拟办企业的周边环境图、总平面布置图、仓储平面布置图、质量检验场所平面布置图；
　　（七）拟办企业生产工艺布局平面图（包括更衣室、盥洗间、人流和物流通道、气闸等，并标明人、物流向和空气洁净度等级），空气净化系统的送风、回风、排风平面布置图，工艺设备平面布
置图；
　　（八）拟生产的范围、剂型、品种、质量标准及依据；
　　（九）拟生产剂型及品种的工艺流程图，并注明主要质量控制点与项目；
　　（十）空气净化系统、制水系统、主要设备验证概况；生产、检验仪器、仪表、衡器校验情况；
　　（十一）主要生产设备及检验仪器目录；
　　（十二）拟办企业生产管理、质量管理文件目录。
　　申请人应当对其申请材料全部内容的真实性负责。

　　第六条　药品生产企业将部分生产车间分立，形成独立药品生产企业的，按照本办法第四条、第五条的规定办理《药品生产许可证》。

　　第七条　省、自治区、直辖市（食品）药品监督管理部门收到申请后，应当根据下列情况分别作出处理：
　　（一）申请事项依法不属于本部门职权范围的，应当即时作出不予受理的决定，并告知申请人向有关行政机关申请；
　　（二）申请材料存在可以当场更正的错误的，应当允许申请人当场更正；
　　（三）申请材料不齐全或者不符合形式审查要求的，应当当场或者在5个工作日内发给申请人《补正材料通知书》，一次性告知申请人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；
　　（四）申请材料齐全、符合形式审查要求，或者申请人按照要求提交全部补正材料的，予以受理。
　　省、自治区、直辖市（食品）药品监督管理部门受理或者不予受理药品生产企业开办申请的，应当出具加盖本部门受理专用印章并注明日期的《受理通知书》或者《不予受理通知书》。

　　第八条　省、自治区、直辖市（食品）药品监督管理部门应当自收到申请之日起30个工作日内，作出决定。
　　经审查符合规定的，予以批准，并自书面批准决定作出之日起10个工作日内核发《药品生产许可证》；不符合规定的，作出不予批准的书面决定，并说明理由，同时告知申请人享有依法申请行政复议或者提起行政诉讼的权利。

　　第九条　新开办药品生产企业、药品生产企业新建药品生产车间或者新增生产剂型的，应当自取得药品生产证明文件或者经批准正式生产之日起30日内，按照国家食品药品监督管理局的规定向相应的（食品）药品监督管理部门申请《药品生产质量管理规范》认证。

　　第十条　省、自治区、直辖市（食品）药品监督管理部门应当在行政机关的网站和办公场所公示申请《药品生产许可证》所需要的条件、程序、期限、需要提交的全部材料的目录和申请书示范文本等。
　　省、自治区、直辖市（食品）药品监督管理部门颁发《药品生产许可证》的有关信息，应当予以公开，公众有权查阅。

　　第十一条　省、自治区、直辖市（食品）药品监督管理部门对药品生产企业开办申请进行审查时，应当公示审批过程和审批结果。申请人和利害关系人可以对直接关系其重大利益的事项提交书面意见进行陈述和申辩。

　　第十二条　药品生产企业开办申请直接涉及申请人与他人之间重大利益关系的，省、自治区、直辖市（食品）药品监督管理部门应当告知申请人、利害关系人可以依照法律、法规以及国家食品药品监督管理局的其他规定享有申请听证的权利；在对药品生产企业开办申请进行审查时，省、自治区、直辖市（食品）药品监督管理部门认为涉及公共利益的重大许可事项，应当向社会公告，并举行听证。


　　　　　　　　　　　　　　第三章　药品生产许可证管理

　　第十三条　《药品生产许可证》分正本和副本，正本、副本具有同等法律效力，有效期为5年。
　　《药品生产许可证》由国家食品药品监督管理局统一印制。

　　第十四条　《药品生产许可证》应当载明许可证编号、企业名称、法定代表人、企业负责人、企业类型、注册地址、生产地址、生产范围、发证机关、发证日期、有效期限等项目。其中由（食品）药品监督管理部门核准的许可事项为：企业负责人、生产范围、生产地址。
　　企业名称、法定代表人、注册地址、企业类型等项目应当与工商行政管理部门核发的营业执照中载明的相关内容一致。
　　企业名称应当符合药品生产企业分类管理的原则；生产地址按照药品实际生产地址填写；许可证编号和生产范围按照国家食品药品监督管理局规定的方法和类别填写。

　　第十五条　《药品生产许可证》变更分为许可事项变更和登记事项变更。
　　许可事项变更是指企业负责人、生产范围、生产地址的变更。
　　登记事项变更是指本办法第十四条第二款所列事项的变更。

　　第十六条　药品生产企业变更《药品生产许可证》许可事项的，应当在原许可事项发生变更30日前，向原发证机关提出《药品生产许可证》变更申请。未经批准，不得擅自变更许可事项。
　　原发证机关应当自收到企业变更申请之日起15个工作日内作出是否准予变更的决定。不予变更的，应当书面说明理由，并告知申请人享有依法申请行政复议或者提起行政诉讼的权利。
　　变更生产范围或者生产地址的，药品生产企业应当按照本办法第五条的规定提交涉及变更内容的有关材料，并报经所在地省、自治区、直辖市（食品）药品监督管理部门审查决定。
　　药品生产企业依法办理《药品生产许可证》许可事项的变更手续后，应当及时向工商行政管理部门办理企业注册登记的变更手续。

　　第十七条　药品生产企业变更《药品生产许可证》登记事项的，应当在工商行政管理部门核准变更后30日内，向原发证机关申请《药品生产许可证》变更登记。原发证机关应当自收到企业变更申请之日起15个工作日内办理变更手续。

　　第十八条　《药品生产许可证》变更后，原发证机关应当在《药品生产许可证》副本上记录变更的内容和时间，并按照变更后的内容重新核发《药品生产许可证》正本，收回原《药品生产许可证》正本，变更后的《药品生产许可证》有效期不变。

　　第十九条　《药品生产许可证》有效期届满，需要继续生产药品的，药品生产企业应当在有效期届满前6个月，向原发证机关申请换发《药品生产许可证》。
　　原发证机关结合企业遵守法律法规、《药品生产质量管理规范》和质量体系运行情况，按照本办法关于药品生产企业开办的程序和要求进行审查，在《药品生产许可证》有效期届满前作出是否准予其换证的决定。符合规定准予换证的，收回原证，换发新证；不符合规定的，作出不予换证的书面决定，并说明理由，同时告知申请人享有依法申请行政复议或者提起行政诉讼的权利；逾期未作出决定的，视为同意换证，并予补办相应手续。

　　第二十条　药品生产企业终止生产药品或者关闭的，由原发证机关缴销《药品生产许可证》，并通知工商行政管理部门。

　　第二十一条　《药品生产许可证》遗失的，药品生产企业应当立即向原发证机关申请补发，并在原发证机关指定的媒体上登载遗失声明。原发证机关在企业登载遗失声明之日起满1个月后，按照原核准事项在10个工作日内补发《药品生产许可证》。

　　第二十二条　任何单位或者个人不得伪造、变造、买卖、出租、出借《药品生产许可证》。

　　第二十三条　省、自治区、直辖市（食品）药品监督管理部门应当将《药品生产许可证》核发、换发、变更、补发、吊销、撤销、缴销、注销等办理情况，在办理工作完成后20个工作日内报国家食品药品监督管理局备案。对依法收回、作废的《药品生产许可证》，发证机关应当建档保存5年。


　　　　　　　　　　　　　　　第四章　药品委托生产的管理

　　第二十四条　药品委托生产的委托方应当是取得该药品批准文号的药品生产企业。

　　第二十五条　药品委托生产的受托方应当是持有与生产该药品的生产条件相适应的《药品生产质量管理规范》认证证书的药品生产企业。

　　第二十六条　委托方负责委托生产药品的质量和销售。委托方应当对受托方的生产条件、生产技术水平和质量管理状况进行详细考查，应当向受托方提供委托生产药品的技术和质量文件，对生产全过程进行指导和监督。
　　受托方应当按照《药品生产质量管理规范》进行生产，并按照规定保存所有受托生产文件和记录。

　　第二十七条　委托生产药品的双方应当签署合同，内容应当包括双方的权利与义务，并具体规定双方在药品委托生产技术、质量控制等方面的权利与义务，且应当符合国家有关药品管理的法律法规。

　　第二十八条　注射剂、生物制品（不含疫苗制品、血液制品）和跨省、自治区、直辖市的药品委托生产申请，由国家食品药品监督管理局负责受理和审批。
　　疫苗制品、血液制品以及国家食品药品监督管理局规定的其他药品不得委托生产。
　　麻醉药品、精神药品、医疗用毒性药品、放射性药品、药品类易制毒化学品的委托生产按照有关法律法规规定办理。

　　第二十九条　本办法第二十八条规定之外的其他药品委托生产申请，由委托生产双方所在地省、自治区、直辖市（食品）药品监督管理部门负责受理和审批。

　　第三十条　药品委托生产的，由委托方向国家食品药品监督管理局或者省、自治区、直辖市（食品）药品监督管理部门提出申请，并提交本办法第三十四条规定的申请材料。（食品）药品监督管理部门参照本办法第七条的规定进行受理。

　　第三十一条　受理申请的（食品）药品监督管理部门应当自受理之日起20个工作日内，按照本章规定的条件对药品委托生产的申请进行审查，并作出决定；20个工作日内不能作出决定的，经本部门负责人批准，可以延长10个工作日，并应当将延长期限的理由告知委托方。
　　经审查符合规定的，予以批准，并自书面批准决定作出之日起10个工作日内向委托方发放《药品委托生产批件》；不符合规定的，书面通知委托方并说明理由，同时告知其享有依法申请行政复议或者提起行政诉讼的权利。

　　第三十二条　《药品委托生产批件》有效期不得超过2年，且不得超过该药品批准证明文件规定的有效期限。

　　第三十三条　《药品委托生产批件》有效期届满需要继续委托生产的，委托方应当在有效期届满30日前，按照本办法第三十四条的规定提交有关材料，办理延期手续。
　　委托生产合同终止的，委托方应当及时办理《药品委托生产批件》的注销手续。

　　第三十四条　药品委托生产申请材料项目：
　　（一）委托方和受托方的《药品生产许可证》、营业执照复印件；
　　（二）受托方《药品生产质量管理规范》认证证书复印件；
　　（三）委托方对受托方生产和质量保证条件的考核情况；
　　（四）委托方拟委托生产药品的批准证明文件复印件并附质量标准、生产工艺，包装、标签和使用说明书实样；
　　（五）委托生产药品拟采用的包装、标签和使用说明书式样及色标；
　　（六）委托生产合同；
　　（七）受托方所在地省级药品检验所出具的连续三批产品检验报告书。委托生产生物制品的，其三批样品由受托方所在地省级药品检验所抽取、封存，由中国药品生物制品检定所负责检验并出具检验报告书；
　　（八）受托方所在地省、自治区、直辖市（食品）药品监督管理部门组织对企业技术人员，厂房、设施、设备等生产条件和能力，以及质检机构、检测设备等质量保证体系考核的意见。
　　药品委托生产延期申请所需要的申请材料项目：
　　（一）委托方和受托方的《药品生产许可证》、营业执照复印件；
　　（二）受托方《药品生产质量管理规范》认证证书复印件；
　　（三）前次批准的《药品委托生产批件》复印件；
　　（四）前次委托生产期间，生产、质量情况的总结；
　　（五）与前次《药品委托生产批件》发生变化的证明文件。

　　第三十五条　委托生产药品的质量标准应当执行国家药品质量标准，其处方、生产工艺、包装规格、标签、使用说明书、批准文号等应当与原批准的内容相同。在委托生产的药品包装、标签和说明书上，应当标明委托方企业名称和注册地址、受托方企业名称和生产地址。

　　第三十六条　（食品）药品监督管理部门对药品委托生产申请进行审查时，应当参照执行本办法第二章第十条至第十二条的有关规定。

　　第三十七条　药品生产企业接受境外制药厂商的委托在中国境内加工药品的，应当在签署委托生产合同后30日内向所在地省、自治区、直辖市（食品）药品监督管理部门备案。所加工的药品不得以任何形式在中国境内销售、使用。

　　第三十八条　省、自治区、直辖市（食品）药品监督管理部门应当将药品委托生产的批准、备案情况报国家食品药品监督管理局。


　　　　　　　　　　　　　　　　　第五章　监督检查

　　第三十九条　省、自治区、直辖市（食品）药品监督管理部门负责本行政区域内药品生产企业的监督检查工作，应当建立实施监督检查的运行机制和管理制度，明确设区的市级（食品）药品监督管理机构和县级（食品）药品监督管理机构的监督检查职责。
　　国家食品药品监督管理局可以直接对药品生产企业进行监督检查，并对省、自治区、直辖市（食品）药品监督管理部门的监督检查工作及其认证通过的生产企业《药品生产质量管理规范》的实施及认证情况进行监督和抽查。

　　第四十条　监督检查的主要内容是药品生产企业执行有关法律、法规及实施《药品生产质量管理规范》的情况，监督检查包括《药品生产许可证》换发的现场检查、《药品生产质量管理规范》跟踪检查、日常监督检查等。

　　第四十一条　各级（食品）药品监督管理部门组织监督检查时，应当制订检查方案，明确检查标准，如实记录现场检查情况，检查结果应当以书面形式告知被检查单位。需要整改的应当提出整改内容及整改期限，并实施跟踪检查。
　　在进行监督检查时，（食品）药品监督管理部门应当指派两名以上检查人员实施监督检查，检查人员应当向被检查单位出示执法证明文件。（食品）药品监督管理部门工作人员对知悉的企业技术秘密和业务秘密应当保密。

　　第四十二条　监督检查时，药品生产企业应当提供有关情况和以下材料：
　　（一）企业生产情况和质量管理情况自查报告；
　　（二）《药品生产许可证》副本和营业执照复印件，《药品生产许可证》事项变动及审批情况；
　　（三）企业组织机构、生产和质量主要管理人员以及生产、检验条件的变动及审批情况；
　　（四）药品生产企业接受监督检查及整改落实情况；
　　（五）不合格药品被质量公报通告后的整改情况；
　　（六）检查机关需要审查的其他必要材料。
　　监督检查完成后，（食品）药品监督管理部门在《药品生产许可证》副本上载明检查情况。主要记载以下内容：
　　（一）检查结论；
　　（二）生产的药品是否发生重大质量事故，是否有不合格药品受到药品质量公报通告；
　　（三）药品生产企业是否有违法生产行为，及其查处情况。

　　第四十三条　县级以上地方（食品）药品监督管理部门应当在法律、法规、规章赋予的权限内，建立本行政区域内药品生产企业的监管档案。监管档案包括药品生产许可、生产监督检查、产品质量监督抽查、不良行为记录和投诉举报等内容。

　　第四十四条　（食品）药品监督管理部门实施监督检查，不得妨碍药品生产企业的正常生产活动，不得索取或者收受药品生产企业的财物，不得谋取其他利益。

　　第四十五条　个人和组织发现药品生产企业进行违法生产的活动，有权向（食品）药品监督管理部门举报，（食品）药品监督管理部门应当及时核实、处理。

　　第四十六条　药品生产企业质量负责人、生产负责人发生变更的，应当在变更后15日内将变更人员简历及学历证明等有关情况报所在地省、自治区、直辖市（食品）药品监督管理部门备案。

　　第四十七条　药品生产企业的关键生产设施等条件与现状发生变化的，应当自发生变化30日内报所在地省、自治区、直辖市（食品）药品监督管理部门备案，省、自治区、直辖市（食品）药品监督管理部门根据需要进行检查。

　　第四十八条　药品生产企业发生重大药品质量事故的，必须立即报告所在地省、自治区、直辖市（食品）药品监督管理部门和有关部门，省、自治区、直辖市（食品）药品监督管理部门应当在24小时内报告国家食品药品监督管理局。

　　第四十九条　有《中华人民共和国行政许可法》（以下简称《行政许可法》）第七十条情形之一的，原发证机关应当依法注销《药品生产许可证》，并自注销之日起5个工作日内通知有关工商行政管理部门，同时向社会公布。


　　　　　　　　　　　　　　　　　第六章　法律责任

　　第五十条　有《行政许可法》第六十九条情形之一的，国家食品药品监督管理局或者省、自治区、直辖市（食品）药品监督管理部门根据利害关系人的请求或者依据职权，可以撤销《药品生产许可证》。

　　第五十一条　申请人隐瞒有关情况或者提供虚假材料申请《药品生产许可证》的，省、自治区、直辖市（食品）药品监督管理部门不予受理或者不予批准，并给予警告，且在1年内不受理其申请。
　　申请人提供虚假材料或者采取其他欺骗手段取得《药品生产许可证》的，省、自治区、直辖市（食品）药品监督管理部门予以吊销《药品生产许可证》，且在5年内不受理其申请，并处1万元以上3万元以下的罚款。

　　第五十二条　未取得《药品生产许可证》生产药品的，依照《药品管理法》第七十三条的规定给予处罚。

　　第五十三条　未经批准擅自委托或者接受委托生产药品的，对委托方和受托方均依照《药品管理法》第七十四条的规定给予处罚。

　　第五十四条　药品生产企业有下列情形之一的，（食品）药品监督管理部门依照《药品管理法》第七十九条的规定给予处罚：
　　（一）药品生产企业未按照规定实施《药品生产质量管理规范》的；
　　（二）开办药品生产企业、药品生产企业新建药品生产车间、新增生产剂型，在《药品管理法实施条例》第六条规定的时间内未通过《药品生产质量管理规范》认证，仍进行生产的。

　　第五十五条　经监督检查（包括跟踪检查、监督抽查），认定药品生产企业达不到《药品生产质量管理规范》评定标准的，原认证机关应当根据检查结果作出收回其《药品生产质量管理规范》认证证书的处理决定。

　　第五十六条　药品生产企业有下列情形之一的，由所在地省、自治区、直辖市（食品）药品监督管理部门给予警告，责令限期改正；逾期不改正的，可以处5000元以上1万元以下的罚款：
　　（一）未按照规定办理《药品生产许可证》登记事项变更的；
　　（二）接受境外制药厂商委托在中国境内加工药品，未按照规定进行备案的；
　　（三）企业质量负责人、生产负责人发生变更，未按照规定报告的；
　　（四）企业的关键生产设施等条件与现状发生变化，未按照规定进行备案的；
　　（五）发生重大药品质量事故未按照规定报告的；
　　（六）监督检查时，隐瞒有关情况、提供虚假材料或者拒不提供相关材料的。

　　第五十七条　（食品）药品监督管理部门违反规定，对不符合《药品生产质量管理规范》的发给《药品生产质量管理规范》认证证书或者对取得认证证书的企业未按照规定履行跟踪检查的职责，对不符合认证条件的企业未依法责令其改正，对不符合法定条件的单位发给《药品生产许可证》的，按照《药品管理法》第九十四条的规定处理。

　　第五十八条　在实施本办法规定的行政许可中违反相关法律、法规的，按照有关法律、法规处理。


　　　　　　　　　　　　　　　　　第七章　附　　则

　　第五十九条　本办法由国家食品药品监督管理局负责解释。

　　第六十条　本办法自公布之日起施行。国家药品监督管理局于2002年12月11日发布的《药品生产监督管理办法》（试行）同时废止。