Rules On The Hearing Of The State Food And Drug Administration (For Trial Implementation)

Original Language Title: 国家食品药品监督管理局听证规则(试行)

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(December 30, 2005 national food drug supervision authority makes 23rd, announced since February 1, 2006 up purposes) first chapter General provides first article for specification national food drug supervision authority administrative license, and administrative punishment, and administrative legislation, and administrative decision, administrative behavior, protection citizens, and corporate and other organization of lawful rights and interests of, according to People's Republic of China administrative license method, and People's Republic of China administrative punishment method, and People's Republic of China legislation method, and
    Administrative rulemaking procedures Ordinance, the provisions of the rulemaking Procedure Ordinance, these rules are formulated.
    Second hearing mentioned in this rule, including the State food and drug administration of party, interested parties hearing of the applicant organization and organized the hearing ex officio.
    The State food and drug administration in administrative license, the administrative punishments, administrative hearings on legislation, administrative decision-making process in the Organization, these rules shall apply.
    Third hearing shall follow the principle of openness, fairness, convenience and efficiency.
    In addition to involve State secrets, business secrets or personal privacy, the hearing be held in public.
    Fourth according to apply for a hearing by the Department of Legal Affairs Organization, implemented according to the terms of reference of the hearing organized by the host Department and other departments concerned in accordance with the provisions of the present rules of the commitment hearing. Article fifth hearing presided over by the hearing officer. If necessary, the work may set the hearing to assist the hearing.
    Hearing by the scribe records. Hearing organized by the hearings Department staff above the division level.
    In the administrative license, the administrative punishment hearing, the presiding hearer, hearing, records officer shall not participate in the administrative licensing review and investigations staff of the administrative punishment.
    The presiding hearer, hearing from the Department of Legal Affairs or host Department and reports to the charge of the Secretary or the Secretary decided that the record specified by the hearing officer.
    Sixth hearing and the hearing officer, the recorder should be impartial in the discharge of responsibilities, ensure that participants in the hearing exercise rights of cross-examination, statements, representations, and in the hearing involving State secrets, business secrets and personal privacy has a duty of confidentiality.
    Article seventh hearing of the participants in the hearing included hosting sector, parties, interested parties, public hearings representatives, experts, witnesses, interpreters, and so on. Parties, interested parties may entrust one or two agents to participate in the hearing.
    Attorney to the hearing, shall, before 1st of any hearing submitted to the hearing by the parties, interested parties sign or seal a power of attorney.
    Eighth parties, interested parties shall enjoy the following rights in the hearing: (a) the Executive knows to be the facts, evidence and legal basis of the Act and (b) apply for a hearing officer withdraw; (c) the claims and reasons stated, to present evidence and (d) the defence and cross-examined; (v) shall enjoy the other rights.
    Hearing representative shall enjoy the following rights in the hearing: (a) comments on the hearing; (b) the question.
    Nineth participants in the hearing shall attend hearings subject to hearing the command, follow hearing rules.
    Second chapter according to application hearing tenth article has following case one of of, hosted sector should in made decided Qian told party enjoys requirements held hearing of right: (a) made ordered discontinued closed administrative punishment decided of; (ii) made revoked license or revoked approved proved file administrative punishment decided of; (three) made larger amounts fine administrative punishment decided of; (four) made legal, and regulations, and regulations provides of other according to application should held hearing of administrative license decided of.
    Former subparagraph (d), shall at the same time to inform the interested party of its right to ask the right to hold a hearing.
    11th article told of hearing as follows: (a) the facts, evidence and legal basis for administrative actions (ii) claim the right to hold a hearing, and (iii) the statutory time limit and means of hearing requests made.
    Informed of the hearing should be made in the form of notice of the hearing.
    12th administrative license applicants, interested parties requested a hearing, the hearing notice (Schedule 1) from the date of delivery and to apply for a hearing within the 5th (Schedule 3), administrative penalty hearings at the request of the party, should the hearing notice (Schedule 2) from the date of delivery and to apply for a hearing in the 3rd (Schedule 3). Parties, interested in hearing an application within the above-mentioned time limit shall start hearing procedures.
    Host Department should notify the Legal Department in the 2nd hearing applications received and transferred all file materials.
    13th article legal sector should in received party, and interest relationship people hearing application of day up 20th within organization hearing, and in held hearing 7th Qian served hearing notice (Schedule 4, and schedule 5), hearing notice should including following content: (a) hearing causes; (ii) hearing of time and locations; (three) party, and interest relationship people name or name; (four) hearing host, and hearing Member, and records member of name and positions; (five) proposed avoided application of term, and way;
    (F) hearing rights and obligations; (g) other matters requiring notification.
    14th article hearing host, and hearing Member, and records Member has following case one of of, should avoided, party, and interest relationship people also can application avoided: (a) participation this administrative license review or participation this administrative punishment case survey; (ii) is party, and interest relationship people, or is party, and interest relationship people, and delegate agent of near relatives; (three) and party, and interest relationship people or delegate agent has other relationship may effect hearing just held of.
    15th parties, interested parties apply for withdrawal, should be raised in the 3rd prior to the hearing; there are good reasons why it cannot be presented within the allotted time, may be brought in prior to the statement, argued at the hearing.
    Withdrawal of the presiding hearer, hearing, shall be reported by the Department of Legal Affairs in charge of the Secretary or the Secretary for decision reporters avoided, decided by the hearing officer.
    Decided to shy away from, shall be determined in accordance with this rule fifth hearing officers. 16th article hearing according to following steps for: (a) hearing host announced hearing causes, and hearing personnel list, hearing program, and party and interest relationship people in hearing program in the of right obligations,, announced hearing began; (ii) administrative license review sector proposed review views of according to, and evidence and reason; administrative punishment survey sector proposed party illegal of facts, and evidence and administrative punishment recommends; (three) party, and interest relationship people and delegate agent for statement, on administrative license review sector, and
    Administrative punishment survey sector proposed of evidence and the related problem for defence and quality card; (four) hearing host, and hearing member on about problem for asked; (five) party, and interest relationship people, and administrative license review sector or administrative punishment survey sector on hearing by involved of facts, and evidence, and legal applies, problem for debate; (six) hearing host consulting party, and interest relationship people, and administrative license review sector or administrative punishment survey sector of last views; (seven) hearing host announced hearing end.
    17th under any of the following circumstances, may postpone the hearing: (a) due to force majeure hearings cannot be held as scheduled, (ii) the parties, interested parties apply for withdrawal, cannot determine the hearing officer in a timely manner; (c) the parties, interested parties have a legitimate reason for application for extension of a hearing, and (iv) other hearing should be postponed. Deferred hearings decided by the Department of Legal Affairs (Schedule 6).
    Delay is eliminated, and decided to hold a hearing, shall issue a new notice of hearing.
    18th under any of the following circumstances, may suspend the hearing: (a) primary evidence need inspection, verification, and (b) participants in the hearing is justified is unable to continue attending the hearing, and (iii) other circumstances that warrant the suspension hearing. Stop hearing by hearing decision (table 7).
    Suspension is eliminated, and hearing shall be resumed in the 5th, and notify the participants in the hearing resumed on time and place of the hearing.
    19th the parties, interested parties without justifiable reason not to attend the hearing, or permit leave without hearing, deemed to have waived the hearing.
    Hearing of the parties and interested persons to give up rights or may terminate the hearing of the other circumstances, may terminate the hearing.
    Termination hearing, shall be reported by the Department of Legal Affairs within the 3rd is in charge of the Secretary or the Secretary in charge of the Commissioner or Commissioner shall decide within the 5th (Schedule 8). 20th records officer shall record all hearing activities, making hearing transcripts (Schedule 9).
    Hearing record should contains Ming following content: (a) hearing causes; (ii) hearing host, and hearing Member, and records member of name; (three) party, and interest relationship people and agent of name or name; (four) hearing of time, and locations; (five) hosted sector of statement views; (six) party, and interest relationship people statement, and defence and quality card of content; (seven) debate of content; (eight) other need contains ming of matters.
    21st hearing by hearing, hearing clerk, records clerk signature. Hearing transcripts should be handed over to the participants in the hearing to confirm correct signature or seal, have objections on record, participants in the hearing is entitled to request correction.
    Participants in the hearing refused to sign or seal, the attached written volumes. 22nd hearing should be in an administrative license within 5th date of the end of the hearing, the hearing transcripts and other materials transferred to the host Department.
    Host departments shall, according to transcripts of the hearing and make a decision on the administrative license according to law.
    The hearing, the hearing officer shall end in administrative punishment hearing produced within the 10th hearing submissions from the date (Schedule 10), transferred to the host Department, host departments shall, within 60 days make a decision of administrative penalty according to law. Chapter III ex officio hearing

    23rd article on following matters, national food drug supervision authority can held hearing heard views: (a) drafting, and amendment of legal, and administrative regulations, and regulations directly involved citizens, and corporate or other organization of vital interests; drafting process in the about organ, and organization, and or citizens on its has major views differences of; (ii) made involved major public interests of administrative decision Qian; (three) think has necessary held hearing of other matters. Provisions of this rule 23rd 24th, host departments shall be submitted to the charge of the Secretary or the Secretary.
    After approval, by the host authorities and the Department of Legal Affairs hearing.
    25th hearing ex officio, host departments shall hold a hearing before 30th through Government Web sites or news media announced to the public hearings of the time, place, content and conditions of hearings representatives have signed up for (table 11).
    26th undertaking sector in accordance with universality, principles of representative from the hearing in the hearing on behalf of applicants on behalf of, 10th of any hearing and shall be notified prior to their participation in the hearing, served upon the relevant material (table 12).
    27th hearing in accordance with the following steps: (a) the hearing officer announced the commencement of hearing; (b) the presider introduces the main content of the hearing, (iii) hearings on behalf of questions and comments; (d) the hearing officer asked; (e) the hearing officer declared the hearing closed. 28th article shall make a record of the hearing record of spokesman of the main views and reasons (table 13).
    Hearing after hearing, record-signing, the record, to the end of the hearing submitted to the contractor within 10th of departments and legal departments, as legislation, an important basis for decision-making.
    Host Department hearing shall be proposed according to the record of the hearing, the hearing shall note the hearings represent the views of adoption, not adopted, it shall explain its reasons.
    Article 29th organized by departments should carefully research the hearing reflected a variety of views, legislative issues, policy matters submitted for its review, shall state the views of the hearings and the reasons for it.
    Fourth chapter of legal responsibility of 30th host departments and their staff in violation of the rules provides that failing to perform the duty of disclosure shall perform the hearing, by the Secretary or the supervision authority shall order rectification are serious, the supervisor directly responsible and other persons directly responsible shall be given administrative sanctions.
    31st host departments and their staff members in violation of the rules, after the administrative license hearings, according to hearing transcripts made no decision, by the Secretary or by the supervisory departments shall be ordered to correct, if the circumstances are serious, the supervisor directly responsible and other persons directly responsible shall be given administrative sanctions.
    32nd Legislative Affairs Department with host Department personnel who violate these rules, perform their duties in the hearings and the prejudice to the participants in the hearing statements, rights of defence, cross-examination, criticized by the Secretary or by the supervisory departments of education, if the circumstances are serious, shall be given administrative sanctions.
    The fifth chapter by-laws provisions relating to term in the 33rd article of the rules refers to working days, excluding holidays.
    Article 34th administrative enforcement process requires the hearing of other matters, reference to the provisions of these rules.
    35th article of the rules mentioned in the party, party of administrative punishment and administrative license applicant; interested persons referred to in this rule, refers to administrative permits an interested person; host departments mentioned in these rules, administrative licensing examination Department, the investigation department, administrative penalty law, administrative regulations, and administrative rules drafting departments and administrative policy drafting departments.
    36th article of the rules come into force on February 1, 2006.
          Schedule: 1. administrative license hearings of informed 2. administrative punishment hearing notice 3. application for hearings 4. notice of administrative permission hearing 5. notice of administrative punishment hearing 6. notice of hearing postponed 7. hearing notice of suspension 8. hearing notice of termination 9. record of hearing 10. administrative punishment hearing submissions 11. hearing notice 12. hearing notice 13. recording of the hearing 14. delivery receipts Schedule 1: = the State food and drug administration, administrative law-enforcement instruments of administrative permission hearing notification of State food and drug

    听告[    ]    号
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__________________:

    经审查,_______申请的___________________________________的行政许可,与

________有直接重大利益关系。

    According to the People's Republic of China Law on administrative licensing provisions of 47th, you (units) is entitled to request a hearing. If you (units) to request a hearing, after receiving this notice, shall notify us in writing within the 5th Bureau.

    Delay waived a hearing rights.
                                                       本局地址:______________________ 邮政编码:________________________

    联系电话:______________________ 联 系 人:________________________

                                                        (公    章)
                                              Date ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ =tbl/> Appendix 2: = the State food and drug administration law enforcement instruments administrative punishment hearing notice 国食药监罚听告[    ]    号
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_____________________:

    你(单位)____________________________________________________的行为,

违反了_________________________________

    ___________________________________

的规定。 依据__________________________________________________________________

的规定,拟对你(单位)进行________________________________________________

_____________________________________

    _____________________________________

的行政处罚。

    According to the People's Republic of China 42nd article of provisions of the law on administrative punishment, you (units) is entitled to request a hearing. If you (units) to request a hearing, after receiving this notice, should notify us in writing within the 3rd.

    Delay waived a hearing rights.
                                                         本局地址:_______________________ 邮政编码:______________________

    联系电话:_______________________ 联 系 人:______________________

                                                          (公    章) 年    月    日
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=tbl/>

    附表3:
=
                               听 证 申 请 书

  申请人姓名:________________________联系电话:_________________________ _

  住址:______________________________邮编:_________________________

(法人或者其他组织名称:_______________________________________________

住址:__________________________________________

    ___邮编:_________________

法定代表人或者主要负责人姓名:____________________________________________

联系人及联系方式:_______________________________________________________)

    申请听证的具体事项:

                                                Apply the rationale and justification for the hearing: this annex to the State food and Drug Administration: 1 (materials), 2, (material); ... ...

                                                 Applicant: (signature or seal) date of =tbl/> table 4: = the State food and Drug Administration notice of administrative license hearings of the administrative law enforcement instruments 国食药监许听通[    ]  号
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______________________:

    根据______提出的听证要求,本局决定于______年_____月_____日_____时_____

分,在__________________________________________ ______________ Is holding a hearing. Could you please (unit) or of the legal representative entrusts an agent to attend.

    Do not attend the hearing, and without giving a reason and without special reasons, deemed to have waived the hearing rights.

    Hearing of the Agency, should be submitted to this Council held a hearing in the 1st power of Attorney for the hearing.

Hearing this case _____________________________ recorder: _________________ under the People's Republic of China article 48th of the administrative licensing law requirements, the State food and Drug Administration hearing rule (draft) provisions of 14th, you (in) the right to apply for moderator, hearing clerk, records clerk avoided, such as apply for withdrawal should be 3rd to this Council in writing before the hearing and submit a withdrawal request and description
Reasons.

    本局地址:__________________________ 邮政编码:_________________

    联系电话:__________________________ 联 系 人:_________________

                                                          (公    章)

                                                 Date ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ =tbl/> Appendix 5: = the State food and Drug Administration notice of administrative punishment hearing administrative law enforcement instruments 国食药监罚听通[    ]  号
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______________________________:

    根据你(单位)提出的听证要求,本局决定于_______年______月_____日____时

____分,在___________________________________ _______________________举行听

证。 Could you please (unit) or of the legal representative entrusts an agent to attend.

    Do not attend the hearing, and without giving a reason and without special reasons, deemed to have waived the hearing rights.

    Hearing of the Agency, should be submitted to this Council held a hearing in the 1st power of Attorney for the hearing.

    This case hearing host: ____________ hearing Member: _____________ records Member: ___________ according to People's Republic of China administrative punishment method 42nd article, and national food drug supervision authority hearing rules (pilot) 14th article of provides, you (units) right to application host, and hearing Member, and records Member avoided, as application avoided, should Yu hearing held Qian 3rd within to this Council written proposed avoided application and description reason.

                                                       本局地址:______________________  邮政编码:________________

    联系电话:______________________  联 系 人:________________

                                                        (公    章)

                                                Date ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ =tbl/> Appendix 6: = the State food and Drug Administration notice of administrative hearing postponed enforcement instruments 国食药监听延字[    ]第  号
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__________________:

    我局拟于______年___月___日举行的听证会,现因(延期理由),无法按期举行
                                                ───────


    According to the rules of the State food and Drug Administration hearing (trial) article 17th of the provisions of the decision the hearing postponed.

                               特此通知

                                                              (公  章)

                                                              年  月  日
=tbl/>

    附表7:
=
                     国家食品药品监督管理局行政执法文书 The hearing notice of suspension in the country's food and drug monitoring [] ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ ________________________: I held on ____ year ___ month ___ day of hearings, is a result of (suspended), cannot continue to hold 证
                                            ──────
会。

    According to the rules of the State food and Drug Administration hearing (trial) provisions of article 18th, decided to suspend the hearing.

                               特此通知

                                                   (公    章)

                                                    年  月  日
=tbl/>

    附表8:
=
                     国家食品药品监督管理局行政执法文书
                                        Hearing notice of termination of State food and drug to listen [] no ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ ____________________ I ____ year ___ month ___ day hearing, (end), according to the State food and drug supervision

    ----------Hearing of the State Administration of Work Safety rules (draft) provisions of article 19th, decided to terminate the hearing.

                                  特此通知

                                                        (公  章)

                                                        年  月  日
=tbl/>

    附表9:
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                     国家食品药品监督管理局行政执法文书 听证笔录

                                                       第    页共    页
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听证事由:________________________________________________________________

当事人、利害关 系人:______________________________________________________

法定代表人(负责人):________ 性别:______年龄:______联系方式:_________

工作单位:______________________________ 地 址:____________________ ______

委托代理人:__________ 性别:____年龄:____职务:____ 联系方式:__________

工作单位:___________________________地 址:______________________________

承办人员:__________________职 务:_________________ __

承办人员:__________________职 务:___________________

听证主持人:____________听证员:_____________      记录员:______________

听证时间:_________年____月____日____时____分至____时____分

听证方式:_______________

___________________________

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记录:

=tbl/>

    附表10:
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                     国家食品药品监督管理局行政执法文书

                             行政处罚听证意见书

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当事人:_____________________    法定代表人(负责人):___________________

听证时间:________年_____月_____日_____时_____分至__

___时_____分

听证主持人:_____________________       听证方式:________________________

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案件基本情况:

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案件承办人主要意见:    ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━
当事人主要理由:

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听证意见:

                                                      签字:

                                                 年    月

    日
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                               听 证 会 公 告

                                               国食药监听公字[    ]第  号
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                                    According to the rules of the State food and Drug Administration hearing (trial) 24th of the rules, I decided when ____ ____ ____ ____ _____ year month (place) on (hearing) hearings. -----------Welcome notice to comply with the following requirements of citizens, legal persons or other organizations to participate in the hearing.

    Application to participate in the hearing, in the year _____ ____ ____ months recently proposed to me in writing.

    To participate in this hearing notice: 1, (condition a); 2, (condition b); ... ...

    (Note) (note b) ... ...
Hereby notice contact: contact phone XXX: XXXXXXXX address:

    邮政编码:

                                                             (公    章)

                                                           年    月    日
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    附表12: = Notice of hearing on food and drug to listen pass word [] ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ ______________: upon review of your (in) my hearing bulletin provision conditions, decide to agree with you (units) as a representative hearing To participate in the hearing.

    According to the rules of the State food and Drug Administration hearing (trial) 26th of the rules and related matters are hereby notified as follows: first, the subject matter of the hearing and evidence: ... ...

    Second, the time and place of the hearing: ... ...

    Third, the hearing officer and the Clerk's name, job title: ... ...

    Four, hearing on behalf of the rights and obligations: ... ...

    Five, notes: ... ... When do attend.

    Fails to be present without justifiable reason, deemed to have waived the hearing represented. 特此通知

                                                        (公    章)

                                                         年  月  日
=tbl/>

    附表13:
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                                 听证会记录

    一、听证会的基本 Hearing matters: ____________ the hearing officer name: _________ position: ___________ (hearing officer name: _________ position: ________ hearing officer name: ________ title: ________).

Recorded name: ________ title: ___________.

Hearing representative's name: _______ address: _______ (a legal entity or other organization name: _____________ the legal representative or principal responsible person name: _______ address: ________). Hearing open: (there is no audit; if so, stated the trial number). Description of the extension, suspension, or termination of the hearing.

    Matters related to the hearing in the hearing process.

Second, hearing the spell (reasons, evidence and related materials).

    ……

Third, hearing the statement of the representative (opinion, the reasons and basis).

    ……

                                Four, told the inquiry's recommendations signature: date =tbl/> of Schedule 14: = the State food and drug administration, administrative law-enforcement instruments 送 达 回 执
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受送达单位(人):________________________________________________________

送达文件名称及文件编号:________________________________________________ __

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送达方式:_____________________       送达地点:__________________________

送达人:__________________         送达日期:______ _年___月___日___时___分

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收件人:_________________
                                                                            __     收件日期:______年____月____日____时____分

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