Ministry Of Health On The Revision Of The Pharmaceutical Supervisory And Administrative Punishment Decision Procedures

Original Language Title: 卫生部关于修改《药品监督行政处罚程序规定》的决定

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Read the untranslated law here: http://www.chinalaw.gov.cn/article/fgkd/xfg/gwybmgz/201301/20130100380145.shtml

Ministry of health on the revision of the pharmaceutical supervisory and administrative punishment decision procedures

    (October 17, 2012, the Ministry of Health announced come into force on the date of promulgation, 88th), for the follow-up of the People's Republic of China administrative mandatory law, according to the State Council on carrying out the implementation of People's Republic of China informed the administrative enforcement law (guofa [2011]25), is now on the food and Drug Administration on April 28, 2003, issued by the pharmaceutical supervisory and administrative punishment procedure stipulates as follows: A, and will first article modified for: "for guarantee drug supervision management sector right exercise administrative punishment terms, protection citizens, and corporate and other organization of lawful rights and interests of, according to People's Republic of China administrative punishment method, and People's Republic of China administrative forced method, and People's Republic of China drug management method, and People's Republic of China drug management method implementation Ordinance, and medical devices supervision Management Ordinance and State about administrative regulations of provides, developed this provides.

    ”

    Second, third fourth amended as: "the implementation of administrative punishments, administrative enforcement and the principle of combining education."

    Three, and tenth article increased two paragraph, respectively as second paragraph and third paragraph, that: "on drug, and medical devices illegal case suspected crime of, drug supervision management sector should Yu 2 a days within fill in case transferred approval table (Schedule 1), by drug supervision management sector competent led approved Hou rates fill in suspected crime case transferred book (added Schedule 1) transferred sibling police organ, while cc sibling people's Procuratorate and copy superior drug supervision management sector. "The decision of the public security organs filed and pharmaceutical supervisory and administrative departments shall, within 3 working days will be sealed up or seized articles handed over to the Office of the public security organs, and should fill out the attachment (attachment) notification of transfer of goods (new Schedule 2), and shall inform the parties in writing.

    ”

    In section four, the 22nd "of the seized items form (Schedule 9)," "the notification of seized items (Schedule 10)" respectively amended as: "the seizure (seizure) of form (Schedule 9)", "the seizure (seizure) of decision (Schedule 10)". Five article 23rd, amended to read: "the pharmaceutical supervisory and administrative departments when implementing antecedent register or the sealing up, distraining, shall notify the Parties present in the on-site inspection records, and recorded on the relevant measures to be taken. Party scene, law enforcement officials invited the witnesses arrived at the scene, witnesses and law enforcement officers at the scene on the record of signature or seal.

    ”

    Article VI will be the 24th is revised as follows: "the pharmaceutical supervisory and administrative departments shall fill in the notification of filing of cases filed (table 13), delivery party. "Advanced registration and preservation of goods, shall make a decision within the 7th.

    To seal up and detain goods, shall make a decision on whether to file in the 7th; needs testing, inspection report is issued shall make a decision on whether to file within date of 15th. "Seized, and seized of term shall not over 30th; situation complex of, drug supervision management sector should fill in seized (seized) extension approval table (added Schedule 3), by drug supervision management sector competent led approved, can extended, but extended of term shall not over 30th; made extended seized, and seized term decided Hou should timely fill in seized (seized) extension notice (added Schedule 4), written told party, and description reason; on items need for detection, and test or technology identification of

    Should fill out the test (detection, identification) notice (new schedule 5), does not contain detection during attachment, arrest, during the inspection or identification. "Do not meet the filing requirements, pharmaceutical supervisory and administrative departments shall fill out the release notice of registration and preservation of goods (Schedule 14), lift the antecedent register, or fill out the lift attachment (seizure) of decision (table 15), lift the sealing up, distraining.

    ” Seven, the 25th amendment as follows: "drug supervision and law enforcement personnel to investigate the illegal facts, needs to sample identification should be set by the drug regulatory Department under the State drug or medical device quality supervision and inspection and management requirements of the sample. Inspection organizations should be identified in a timely manner within the prescribed test.

    ”

    Section eight, the 59th is revised as follows: "the parties within the statutory time limit does not apply for administrative reconsideration or bring an administrative suit, nor performs the decision of administrative penalty, the pharmaceutical supervisory and administrative department may, within 3 months as of the expiry to the people's Court for compulsory execution. "The pharmaceutical supervisory and Administrative Department should fill out before the people's Court for compulsory execution of the written decision notice of administrative penalty (new schedule 6), urged the parties to fulfil their obligations in writing, inform the fulfilment of terms and manner, add a fine standard, statement of the law and the right to be heard. Plus the total amount does not exceed the original amount of the fine. Statements, representations of the parties, the pharmaceutical supervisory and administrative departments shall make the record of statement and averment (annex 19), facts, reason and evidence submitted by the parties, and of the review submissions of statement and averment (new Schedule 7).

    Facts and reasons or evidence submitted by the parties the establishment of drug supervision and management departments should adopt. "Book of the fulfilment of administrative punishment notice served on the 10th, the party still has not implemented its decision, pharmaceutical supervisory and administrative department may apply to the Court for enforcement, and fill out the application for enforcement of administrative penalty (table 34).

    ”

    Nine schedules, make the following modifications:

    (A) add the following schedule.

    1. transfer suspected criminal case book (new Schedule 1);

    2. attachment (attachment) notice of transfer of goods (new Schedule 2);

    3. attachment (attachment) delayed approval form (new schedule 3);

    4. attachment (attachment) notice of extension (new Schedule 4);

    5. test (detection, identification) notice (new schedule 5);

    6. implementation of the decision on administrative penalty interpellation (new schedule 6);

    7. review the submissions of statement and averment (new Schedule 7).

    (B) update the following schedule.

    1. Schedule 9 "seized the items form" is amended as: "attachment (attachment) form";

    2. Schedule 10 "notice of seized items" is amended as: "attachment (attachment) decision";

    3. Schedule 13 "administrative notice" is revised as follows: "notice of filing";

    4. Schedule 15 "lift the seizure notice of items" is amended as: "lift attachment (attachment) decision." This decision shall come into force as of the date of.

    The pharmaceutical supervisory and administrative punishment regulation published under this decision be revised accordingly.

    Report: drug supervision and administrative punishment procedure 2012 (revised)

    (April 28, 2003, the food and drug administration order 1th October 17, 2012, the Ministry of Health announced the modification of drug supervision and administrative punishment decision of the procedure (SSA 88th order) amended)

    Chapter I General provisions

    First drug management and supervision in order to ensure the proper exercise of administrative penalty authority, protect the legitimate rights and interests of citizens, legal persons and other organizations, in accordance with the People's Republic of China Law on administrative punishment and the People's Republic of China administrative mandatory law, the People's Republic of China pharmaceutical administration law and the People's Republic of China pharmaceutical administration law regulations for the implementation, supervision and administration of medical devices Ordinance and the provisions of relevant administrative regulations of the State Council, these provisions are formulated.

    Second pharmaceutical supervisory and Administrative Department for violations of drug, medical equipment management laws, regulations, rules or administrative punishments, these provisions shall apply.

    Pharmaceutical supervisory and administrative departments administrative penalties article, must adhere to the following principles:

    (A) in accordance with principle;

    (B) the principles of due process;

    (C) the principle of fair and open;

    (D) the implementation of administrative punishments, administrative enforcement and the principle of combining education;

    (E) the principle of protecting the legitimate rights and interests of citizens, legal persons and other organizations. The fourth pharmaceutical supervisory and administrative departments shall establish a monitoring system in administrative punishment. Superior pharmaceutical supervisory and administrative departments administrative penalties imposed on pharmaceutical supervisory and administrative departments at lower levels of supervision.

    Superior pharmaceutical supervisory and administrative departments at lower levels of illegal drug regulatory decision of administrative penalty may be ordered to rectify; it fails to have the power to change or cancellation.

    Chapter II jurisdiction

    The fifth drug, medical equipment supervision and management of administrative punishment by the pharmaceutical supervisory and administrative department where the violations occurred.

    Sixth pharmaceutical supervisory and administrative departments at and above the county level shall within the jurisdictional area of medicines, medical equipment administrative punishment cases.

    Drug regulatory agency of provinces, autonomous regions and municipalities jurisdiction jurisdiction over grave and complicated administrative punishment cases of drug and medical devices.

    Pharmaceutical supervisory and administrative departments nationwide have a major impact on medicine, medical device administrative punishment cases.

    Drug regulatory agency of provinces, autonomous regions and municipalities may be based on drugs, medical equipment management laws, regulations, rules and practical in this region, jurisdiction of the Division of labour within a specified area.

    Seventh two pharmaceutical supervisory and administrative departments at or above the jurisdiction dispute and submit them to the common level specified by the pharmaceutical supervisory and administrative department jurisdiction. Eighth article found does not belong to the drug regulatory department or jurisdiction, shall be made out of the case to be transferred to form (Schedule 1), approved by the pharmaceutical supervisory and administrative department heads immediately fill out the case book (Schedule 2), and related materials to transfer jurisdiction over cases of drug supervision and Administration Department or the relevant administrative departments.

    Custody of the pharmaceutical supervisory and administrative departments shall transfer the case investigation results promptly acknowledge cases of drug supervision and Administration Department.

    The drug regulatory Department if you think the improper transfer of the transfer, shall be submitted to the joint jurisdiction of the level specified by the pharmaceutical supervisory and Administrative Department, may not be transferred again.

    Superior pharmaceutical supervisory and administrative department in the receiving jurisdiction disputes or reported to the designated jurisdiction the nihil obstat, designated jurisdiction decision shall, within 10 working days. Nineth subordinate cases within the jurisdiction of the pharmaceutical supervisory and administrative departments should not be dealt with by the Department, you can report to the superior pharmaceutical supervisory and administrative department or a designated jurisdiction.

    Superior pharmaceutical supervisory and administrative department subordinate pharmaceuticals supervision and management departments should not deal with cases within their jurisdiction, you can decide on its own jurisdiction or specify a different pharmaceutical supervisory and administrative departments at lower levels. When the tenth Strip pharmaceuticals supervision and management departments to investigate the case and found violations involving other pharmaceutical supervisory and administrative departments shall reference this article eighth fill in relevant instruments, together with the relevant evidentiary material transferred in conjunction with the pharmaceutical supervisory and administrative department.

    Pharmaceutical supervisory and administrative departments having jurisdiction to which a case should be investigated in a timely manner.

    Suspect in cases of illegal medicines, medical devices, pharmaceutical supervisory and administrative departments shall, within 2 working days to complete the case form (Schedule 1), approved by the pharmaceutical supervisory and administrative department heads immediately after filling out the transfer suspected criminal case book (new Schedule 1) transferred to the public security organs at the same level, with a copy to drug regulatory agency of the people's procuratorates at the same level and reported to their superiors.

    Decided to file for public security organs, pharmaceutical supervisory and administrative departments shall, within 3 working days will be sealed up or seized articles handed over to the Office of the public security organs, and should fill out the attachment (attachment) notification of transfer of goods (new Schedule 2), and shall inform the parties in writing.

    11th according to law shall be revoked in the drug manufacturing license, drug trading license and the pharmaceutical preparation certificate for medical institution, medical device manufacturing enterprise license, and medical device distributing Enterprise license, proof of revocation of approval of the drug, medical device, by the original licensing decision, approved by the pharmaceutical supervisory and administrative departments. Drug supervision management sector investigation of illegal case, on law should revoked drug production license, and drug business license, and medical institutions preparations license, and medical devices production enterprise license, and medical devices business enterprise license, revoked drug, and medical devices approved proved file of, in its permission within law made administrative punishment of while, should will made of evidence and the related material submitted original sent card of drug supervision management sector,

    By the original certificate revocation to the pharmaceutical supervisory and administrative departments shall permit or revoke approval documents of the decision on administrative penalty.

    Required by the pharmaceutical supervisory and administrative department under the State Council to withdraw drug and medical device approval documents, by provinces, autonomous regions and municipalities reported drug regulatory pharmaceutical supervisory and administrative departments of the State Council, the pharmaceutical supervisory and administrative departments shall make a decision in a timely manner.

    Original certificate of pharmaceutical supervisory and administrative departments shall revoke the license and the decision on administrative penalty of revocation of approval documents, must be carried out pursuant to this provision.

    Pharmaceutical supervisory and administrative departments shall be revoked according to law of the practising certificate for medical institution, should be recommended to the health administration authority shall revoke the certificate.

    12th PLA-owned units and individuals in violation of drug laws, rules, regulations, pharmaceutical supervisory and administrative departments under the people's Liberation Army by the military implementation of People's Republic of China approaches the drug administration law of the jurisdiction.

    Chapter Office

    13th drug supervision and management departments of the following in connection with the reported clues and assigned, the case should be submitted timely processing:

    (A) found in the supervision and inspection;

    (B) inspection findings;

    (C) report to the citizens, legal persons and other organizations;

    (D) superior, subordinate reports to investigate, relevant departments or any other way, the way of the transfer disclosure.

    Admissibility report should fill out the reporting form (Appendix 3).

    14th pharmaceutical supervisory and Administrative Department found violations in accordance with the following conditions, shall be filed within 7 working days:

    (A) there is a clear violation of suspects;

    (B) illegal facts objectively;

    (C) within the scope of drug supervision and administrative punishment;

    (D) belong to the jurisdiction of the Department.

    Decision filed should fill out the application form for filing (Schedule 4), Department heads, I approved the filing of 2 or more should be identified and drug law enforcement officers for the undertaker.

    15th under any of the following circumstances, cannot be determined in this case sponsor:

    (A) is a party to the case or the parties concerned close relatives;

    (B) has a direct interest in the case;

    (C) other relationships with the parties to the case, could affect the impartial handling of the case.

    The fourth chapter, investigation and evidence collection

    16th investigations or inspections, enforcement officers shall not be less than 2, and shall produce to the investigator or the officer law enforcement certificates.

    The person under investigation or the person concerned shall truthfully answer questions and assist in the investigation or examination, shall not be obstructed.

    Involving State secrets, as well as business and technical secrets of the respondents and the privacy of individuals, the contractor shall keep the secret.

    17th pharmaceutical supervisory and administrative departments involved to investigate the relevant circumstances of the case, have the obligation to provide mutual assistance in investigation, evidence.

    18th law enforcement officers to conduct investigations, shall be made out of the investigative records (table 5). Chapeau of investigative records should indicate the law enforcement status, document name, document number and the purpose of the survey.

    Law enforcement officers should be signed at the end of the investigative records. Investigative records after they have been checked, respondents should page-by-page signatures or fingerprints on the records, and at the end of the record indicated on the authenticity of the transcript.

    Record modification, shall be signed by the person under investigation or fingerprinted.

    Respondents refused to sign or fingerprint shall be signed by 2 or more law enforcement officers on the record and indicate the situation.

    19th law enforcement personnel to conduct on-site inspection, you should fill out the on-site examination on the spot (Schedule 6). Examination start should indicate the enforcement status, document name, certificate number and checking purposes.

    Law enforcement officers should be signed by the end of the examination. Check after check, the record to be examined shall on the transcripts page-by-page signature or fingerprint, and at the end of the record indicated on the authenticity of the transcript.

    Record modification, shall be signed by the person being checked or fingerprinted.

    People refuse to sign or fingerprinted under inspection shall be signed by 2 or more law enforcement officers on the record and indicate the situation. 20th obtain evidence should be original, original.

    There is difficulty in access to original, original, evidence can be submitted by units or individuals in the stamp one copy, annotated "with the original () the same" words or text.

    21st who can prove the true circumstances of a case documentary evidence, material evidence and audio-visual material, the testimony of a witness, party statements, inspection reports, conclusions, investigative records, inspection notes, evidence for drug supervision and administrative punishment. 22nd in evidence may be destroyed or lost or difficult to obtain later cases, law enforcement officials should fill out the Advanced registration and preservation of goods form (Schedule 7), reported to the drug regulatory department supervisor approval.

    Advance registration saves articles while law enforcement officials should issue a notice of the Advanced registration and preservation of goods to parties (table 8). There is evidence that the drug regulatory agency may be harmful to human health and pharmaceuticals and related materials and has resulted in medical device quality accidents or accidents may cause medical devices quality products and related information, to take the compulsory administrative measures of sealing up, distraining. Law enforcement officers in front of the sealed up or seized items shall be made out by the seizure (seizure) of form (Schedule 9), reported to the drug regulatory department supervisor approval.

    When sealing up, distraining, law enforcement officers should be issued to the parties on the attachment (seizure) of decision (table 10). 23rd pharmaceutical supervision and management, implement advanced registration and saved or when the sealing up, distraining, shall notify the Parties present in the on-site inspection records, and recorded on the relevant measures to be taken.

    Party scene, law enforcement officials invited the witnesses arrived at the scene, witnesses and law enforcement officers at the scene on the record of signature or seal.

    Sealed up or seized articles, stamped with the seal of the Department should be used "xxx drug administration seal" (Schedule 11), on-site or off-site storage.

    For advance registration and listed in the article should be saved or the sealing up, distraining the () lists of items (table 12), organized by the law enforcement officials, the party or person concerned sign or seal.

    Party refuses to sign or seal or received shall be signed by 2 or more law enforcement officers on the list and indicate the situation.

    24th pharmaceutical supervisory and Administrative Department for cases that have been filed shall be filled in the notification of filing (table 13), delivery party. Advanced registration and preservation of goods, shall make a decision within the 7th.

    To seal up and detain goods, shall make a decision on whether to file in the 7th; needs testing, inspection report is issued shall make a decision on whether to file within date of 15th. Seized, and seized of term shall not over 30th; situation complex of, drug supervision management sector should fill in seized (seized) extension approval table (added Schedule 3), by drug supervision management sector competent led approved, can extended, but extended of term shall not over 30th; made extended seized, and seized term decided Hou should timely fill in seized (seized) extension notice (added Schedule 4), written told party, and description reason; on items need for detection, and test or technology identification of,

    The inspection should be completed (detection, identification) notice (new schedule 5), sealing up, distraining period do not include testing, inspection or during the technical evaluation.

    Does not meet the filing requirements, pharmaceutical supervisory and administrative departments shall fill out the release notice of registration and preservation of goods (Schedule 14), lift the antecedent register, or fill out the lift attachment (seizure) of decision (table 15), lift the sealing up, distraining. 25th pharmaceutical supervisory and law-enforcement officials investigating illegal facts, needs to sample identification, shall be set by the drug regulatory Department under the State drug or medical device quality supervision and inspection and management requirements of the sample.

    Inspection organizations should be identified in a timely manner within the prescribed test. 26th survey end undertaker end shall write a investigation report. Its content shall include the cause of action, the Court heard, illegal facts, evidence, handling procedures, violation of laws, rules or regulations of specific articles, paragraphs, items, accounts, penalties, proposals and delivery signatures.

    (Except for the summary)

    Chapter fifth penalty decision

    Section I general procedures After 27th investigations end reports submitted by contractors, pharmaceutical supervisory and administrative departments shall arrange at least 3 people for violations of the persons concerned, character, plot and social hazards, handling procedures, such as phasing out and fill out the case of collegiate records (table 16).

    Collegiate based on identified illegal facts should be in accordance with relevant laws and regulations and regulations on drugs, medical devices regulations, respectively, made the following comments:

    (A) the illegal facts are clear, the evidence, procedure legal, administrative penalty in accordance with law, for there can no punishment or lighter or mitigated punishment or be punished in cases where the proposed exemption from punishment, views of a lighter or mitigated punishment or be punished, to constitute a crime, administrative penalties also transferred to judicial organs for criminal;

    (B) the illegal facts are not clear that the evidence is insufficient, or there are bugs and submit additional information or survey views on evidence;

    (C) illegal facts cannot be established, withdrawing an application and fill in the application form for withdrawing (table 17).

    28th article before making a decision on the drug regulatory agency shall be made out of the prior notice of administrative penalty (table 18), inform the parties of facts, punishment of the illegal reasons and basis of law stated by the parties, the rights of defence.

    Pharmaceutical supervisory and administrative departments shall fully heed the statements and pleadings of the parties, and fill out the transcript of statement and averment (table 19), facts and reasons or evidence submitted by the parties by the review of the establishment should be adopted.

    Pharmaceutical supervisory and administrative departments shall not aggravating because of the parties ' representations.

    For cases requiring a hearing according to law, drug administration departments to carry out prior obligations and party statements, right to be heard, in accordance with the provisions of section II of this chapter.

    29th article on the illegal facts are clear and irrefutable evidence and procedure is legal, according to the pharmaceutical, medical device and administrative laws and regulations, provisions of the regulations, should be given administrative punishment, filled in by the undertaker of the administrative punishment form (annex 20), after examination by the agency head to fill in, the pharmaceutical supervisory and administrative department heads for approval.

    For major and complex administrative punishment cases should be decided collectively by the pharmaceutical supervisory and administrative department head, and fill out the collective record of the discussions on major cases, (table 21).

    Article 30th drug regulatory agency make a decision of administrative penalty, it shall make a written decision of administrative penalty (table 22).

    The administrative punishment decision letter should contain the following items:

    (A) the name or names and addresses of the parties;

    (B) the facts and evidence of the violation of laws, rules or regulations;

    (C) the types and basis for administrative penalty;

    (D) the method and duration of administrative penalties;

    (E) administrative penalty decision, may apply for administrative reconsideration or bring an administrative suit the ways and terms;

    (Vi) administrative punishment decision the pharmaceutical supervisory and administrative department name and the date of the decision.

    The written decision of administrative penalty must be stamped with seal of the drug regulatory agency of the decision on administrative penalty.

    Administrative penalties as a confiscation of counterfeit medicines, medical devices or other relevant items, the written decision of administrative penalty shall be accompanied by the proof of forfeiture (table 23). 31st pharmaceuticals supervision and management departments of confiscated drugs, medical equipment and related goods and raw materials, packaging, manufacture of equipment involved, shall exceed the length of proceedings in accordance with the law on administrative punishment after the 53rd articles to deal with.

    Should be verified before processing variety and quantity of confiscated goods for processing and approving the form and (table 24) and of the forfeiture process list (table 25).

    32nd pharmaceutical supervisory and administrative departments at the time of investigation, there is evidence to prove that an illegal act, shall issue a notice of correction (table 26), shall be ordered to correct or rectify violations.

    Section II hearing procedures

    33rd pharmaceutical supervisory and administrative departments in order to suspend, revoked license, revoke drug and medical device approval documents or larger fines and other administrative penalties before a decision, it shall inform the parties have the right to request hearings.

    Request a hearing of the parties, shall organize the hearing.

    The delineation of large amount of fine, in accordance with the Governments of provinces, autonomous regions and municipalities directly under the Standing Committee, or the specific provisions. 34th hearing shall follow the principle of openness, fairness.

    In addition to State secrets, the parties involved and technical secrets or personal privacy, the hearing shall be conducted in public.

    Hearing implementation of inform, challenge, and parties the right to be heard and the right to be heard according to law.

    35th pharmaceutical supervisory and Administrative Department for cases of administrative punishment hearing procedure shall, before making a decision of administrative penalty, service of the notice of hearing to the parties (table 27).

    Of the notice of hearing shall set forth the following major items:

    (A) the name or names of the parties;

    (B) the administrative punishment of the illegal facts and reasons, according to the intended and the decision on administrative penalty;

    (C) informing the party concerned has the right to request a hearing;

    (D) inform the proposed hearing requirement deadlines and hearing organs.

    Of the notice of hearing must be stamped with the seal of the pharmaceutical supervisory and administrative departments.

    Article 36th received informed within 3rd hearing requirements, pharmaceutical supervisory and administrative departments shall within 3rd party hearing request date to determine the hearing officer's composition, time, place and manner of the hearing, and held a hearing in 7th, of the notice of hearing (Appendix 28) served on the parties concerned.

    The notice of hearing shall set forth the following particulars and affix the seal of the pharmaceutical supervisory and administrative departments:

    (A) the name or names of the parties;

    (B) the time, place and manner of the hearing;

    (C) the hearing officer's name;

    (D) informing the party concerned has the right to apply for the withdrawal;

    (E) informing the party concerned matters such as preparing evidence, notify the witness. Article 37th after receiving the notice of hearing shall attend the hearing, or Commission agent 1 to 2 people at the hearing.

    Commissioned agents heard signed or sealed by the power of attorney shall be submitted by the parties. Cannot attend a hearing, the hearing shall inform the Chair of Department of pharmaceutical supervision and management.

    Without a legitimate reason not to attend the hearing as scheduled, waived a hearing request, pharmaceutical supervisory and administrative departments shall be written.

    In the course of hearing, hearing of the parties acknowledging, the pharmaceutical supervisory and Administrative Department announced the termination of the hearing and recorded in the hearing record.

    Article 38th hearing include hearing and the court clerk.

    Hearing officer designated by the pharmaceutical supervisory and administrative department heads the organs other than the investigation of the case officer, generally by the legal organizations or engaged in Legislative Affairs staff.

    Clerk by the pharmaceutical supervisory and Administrative Department, a non-investigation of the case officer, responsible for the hearing record production and other services. 39th parties believe that hearing and clerks and have a stake in this case, the right to apply for withdrawal.

    Hearing avoided decided by the pharmaceutical supervisory and administrative department heads; clerks of the withdrawal by the hearing officer decisions.

    40th under any of the following circumstances, may postpone the hearing:

    (A) justified by the parties is not present;

    (B) applying for withdrawal reasons established by the parties, you need to determine the hearing officer;

    (C) necessary to summon new witnesses, or have the need to investigate and verify new facts.

    41st when hearings are held, the investigators of the case concerned illegal facts and evidence put forward and administrative penalties recommended party statements, representations and evidence. 42nd article should fill out the hearing transcript (table 29).

    The hearing shall set out the following:

    (A) the Court;

    (B) the name or name and address of the hearing;

    (C) the hearing officer, the Clerk's name;

    (D) hold a hearing the time, place and manner; (E) sponsor the facts of the case, evidence and recommendations on administrative punishments;
    (F) the contents of the statements, representations and cross-examine the parties;

    (G) the participants in the hearing signed or sealed. After the end of the hearing, the hearing should be cases of parties and the undertaker on the spot audits of, correct signature or seal.

    The parties refused to sign, by the hearing officer at the hearing indicated on.

    Article 43rd after the end of the hearing, the hearing officer shall, in accordance with the hearing, hearing advice and fill out the hearing submissions put forward (table 30). 44th hearing cases Collegiate and 27th in accordance with this section in agreement according to the procedure of administrative punishment decision; inconsistent, submitted to the leading group for discussion and decision.

    Unclear facts, insufficient evidence, new evidence.

    Section III summary procedure

    Article 45th illegal facts are clear, the evidence should be made of the following administrative penalties in accordance with law, would be able to make a decision of administrative penalty:

    (A) a warning;

    (B) the penalty of 50 for citizens;

    (C) 1000 Yuan fine for legal persons or other organizations.

    46th pharmaceutical supervisory and administrative punishment from law enforcement officers, should produce their law enforcement documents, fill out the order form, series number and stamped with the seal of the pharmaceutical supervisory and administrative departments of the written decision of administrative penalty (table 31).

    The written decision of administrative penalty should be contained violations, administrative penalty according to (the applicable laws, regulations and rules names and articles, paragraphs, items, accounts), what specific penalties, time, location, administrative punishment decision may apply for administrative reconsideration or bring an administrative suit way, the pharmaceutical supervisory and administrative department name.

    In the written decision of administrative punishment on the spot, the Parties shall sign or fingerprint, and signed by law enforcement officers spot after the party.

    Party refuses to sign or fingerprint, law enforcement personnel shall indicate the situation.

    47th pharmaceutical supervisory and administrative department summary proceedings of administrative penalty decision shall be written in the book of the administrative punishment on the spot order the party to correct or rectify violations.

    48th drug supervision and law enforcement of the decision on administrative penalty made on the spot, shall, within 7 working days-owned pharmaceutical supervisory and administrative department.

    Fourth section service

    The 49th article of the written decision of administrative penalty shall proclaim the spot after the party, and of the delivery receipt by the parties (Annex 32) was signed.

    Without the presence of the parties, shall be in accordance with the provisions of this section in the 7th, the written decision of administrative penalty served on the parties concerned. Served by the sponsor of the written decision of administrative penalty penalty units or individuals to sign, the addressee indicated on the delivery receipt received dates and signed or sealed.

    Receipt date is the date of service. Delivery of the written decision of administrative penalty shall be delivered directly to the addressee.

    The addressee is a citizen, when absent, and adult members of their families who live with a signed receipt; recipient of the service is a legal person or other organization should be organized by the legal representative, the other main owner or the legal persons, other organizations personnel responsible for receiving documents to sign.

    50th article by served people or its with live adult family rejected administrative punishment decided book of, served people should invited about grass-roots organizations or where units personnel scene and description situation, in administrative punishment decided book served receipt Shang indicate rejected causes and date, by served people, and witnesses signed (sealed), will administrative punishment decided book left in was punishment units or personal at, that considered served.

    51st straight difficult may entrust the pharmaceutical supervisory and administrative departments send or "double registration" service by mail, the post office receipt date stated for delivery dates.

    Made by the drug regulatory Department under the State Council to withdraw drug and medical device approval documents of administrative penalty, referred to the penalized units of provinces, autonomous regions and municipalities directly under the drug regulatory Department service.

    The 52nd person unaccounted for, or otherwise undeliverable pursuant to this provision, service by post.

    Spontaneous announcement date, over 60 days, the service shall be considered.

    Sixth chapter the execution and closing

    The 53rd after service of the written decision of administrative penalty, the Parties shall comply within the time limit of the penalty decision. Party of genuine financial hardship, delay or in installments to pay the fine, apply in writing by the parties, submit all supporting materials. Case undertake collegiate, eligible to fill out the extended (sub) payment of confiscated money form (Appendix 33) and subject to administrative punishment decision approved by the pharmaceutical supervisory and administrative department heads.

    Approval of the supervisor, completed by principals extended (sub) paid confiscation bonds, indicate the delay (minutes) time or amount of contributions, sign the bond and seal can be suspended or made in installments and confiscated money.

    54th party refuses to accept the decision on administrative penalty, may apply for administrative reconsideration or bring an administrative lawsuit, the administrative penalty does not stop the execution, but during the proceedings of administrative reconsideration or administrative ruling ceases to perform otherwise. Fines and confiscation of illegal income decisions of the 55th pharmaceutical supervisory and administrative departments shall and the institutional separation of collection of confiscated money.

    In addition to collect fines on the spot by the regulation, law enforcement officers may not on its own collection of confiscated money.

    56th according to the provisions of article 45th administrative punishment on the spot, any of the following circumstances, law enforcement officers can collect fines on the spot:

    (A) shall be subject to penalty of 20 Yuan;

    (B) is not collected on the spot are difficult to implement.

    57th in remote, water and transportation areas, drug administration departments and law-enforcement officials made the decision in accordance with this, the parties to the designated bank to pay the fine is really difficult, put forward by the parties, law enforcement officers can collect fines on the spot.

    58th pharmaceuticals supervision and management departments and law-enforcement officers to collect fines on the spot, must be issued to the party concerned provinces, autonomous regions and municipalities directly under the unified financial sector issued receipts.

    Law enforcement officials collect fines on the spot, shall from the date of collecting fines within the 2nd to pharmaceutical supervisory and administrative departments; the pharmaceutical supervisory and administrative departments shall the penalty payment specified in the 2nd Bank.

    59th parties within the statutory time limit does not apply for administrative reconsideration or bring an administrative suit, nor performs the decision of administrative penalty, the pharmaceutical supervisory and administrative department may, within 3 months as of the expiry to the people's Court for compulsory execution. Pharmaceutical supervisory and Administrative Department should fill out before the people's Court for compulsory execution of the written decision notice of administrative penalty (new schedule 6), urged the parties to fulfil their obligations in writing, inform the fulfilment of terms and manner, add a fine standard, statement of the law and the right to be heard. Plus the total amount does not exceed the original amount of the fine. Statements, representations of the parties, the pharmaceutical supervisory and administrative departments shall make the record of statement and averment (annex 19), facts, reason and evidence submitted by the parties, and of the review submissions of statement and averment (new Schedule 7).

    Facts and reasons or evidence submitted by the parties the establishment of drug supervision and management departments should adopt.

    Of the written decision notice of administrative penalty served on the 10th, the party still has not implemented its decision, pharmaceutical supervisory and administrative department may apply to the Court for enforcement, and fill out the application for enforcement of administrative penalty (table 34).

    After the 60th decided to carry out or perform administrative penalties, the contractor shall fill in the administrative punishment of final report (annex 35), staple the material about the case, put them as archives.

    The seventh chapter by-laws

    61st pharmaceuticals supervision and management departments and law-enforcement personnel who violate these provisions impose administrative penalties, in accordance with the People's Republic of China Law on administrative punishment, the People's Republic of China pharmaceutical administration law and the People's Republic of China pharmaceutical administration law implementing regulations and the relevant provisions of the regulations on supervision and administration of medical devices, shall be investigated for legal responsibility.

    62nd by the pharmaceutical supervisory and administrative law-enforcement instruments all over the printed schedule in accordance with the model form on their own.

    63rd pharmaceutical supervisory and administrative departments in these rules refers to drug administration has the right to administrative penalties according to law, stations. 64th of these provisions come into force on July 1, 2003.

    These provisions from the date of execution, State Drug Administration on August 1, 1999 promulgated by the pharmaceutical supervisory and administrative punishment procedure (State Drug Administration 8th order) the repeal.

Schedule 1

People's Republic of China pharmaceutical supervisory and administrative instruments

Removal form
(      )    案移审[      ]    号

━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

案  由:__________________________________________________________________

案件来源:________________________________________________________________

当事人:___________________________ 法定代表人(负责人):________________

地  址:___________________________ 联系方式:____________________________
受移送机关:______________________________________________________________
━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

Main case and transferred to the grounds:

经办人:__________________
Year month day
━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

Approval:

主管领导:_________________
Year month day

━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

Schedule 2

People's Republic of China pharmaceutical supervisory and administrative instruments

Case book
(      )    案移送[      ]    号

━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

____________________________:

______________________________________________________________________

______________________一案,经初步调查,_________________________,根据《中 Provisions of the people's Republic of China Law on administrative punishments is now transferred to your unit.

The outcome of the case please inform me.

Annex: _________ case summary and related materials.
                                                      (Official seal)

Year month day
━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Note: the triple of this instrument.
The first archive, the second was transferred to the unit by the stock exchange, the third reference.

━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

Schedule 3

People's Republic of China pharmaceutical supervisory and administrative instruments
                                      Reporting form
(       )   举登[      ]    号

━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

举报人:__________________________________联系方式:______________________
举报形式:________________________________时    间:______________________

━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

Report content:

记录人:_____________
Year month day
━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

Disposition:

负责人:_____________
Year month day

━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

Schedule 4

People's Republic of China pharmaceutical supervisory and administrative instruments
                                       Application form for filing
(      )    立申[     ]    号

━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

案  由:__________________________________________________________________

当事人:_______________________________法定代表人(负责人):_____________

地  址:_______________________________联系方式:_________________________
案件来源:________________________________________________________________
━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

Briefs:

Following a preliminary examination, the Party allegedly in violation of ____________________________________

_______________________________________________的规定,申请予以立案。
                                                       经办人:_________________

Year month day
    ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

审批意见:____________________________________,本案自_______年_____月

______日起立案,由___________、___________、__________承办。
                                                       主管领导:_______________
Year month day

━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

Schedule 5

People's Republic of China pharmaceutical supervisory and administrative instruments

Investigative records
Page total pages

━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

案  由:__________________________________________________________________

Research location: ____________________ respondents: __________ gender: ____ title: ________

Respondents: _______________________ respondents contact: _______________

被调查人地址:____________________________________________________________

Investigator: ___________, __________ records by: _____________ type of supervision and inspection: ________
调查时间:_______年_______月_______日_______时_______分至_______时______分

━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

我们是______________________________的执法人员________________________

执法证件名称、编号是:____________________________________________________

我们依法向你调查____________________________________________________有

Question, please cooperate.

Records:
━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━
Note: respondents in the investigation on the notes page-by-page signature, modify the signature or fingerprint, and at the end of the record
Ming on the authenticity of the transcript view investigator shall be signed at the end of the record.
    ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

Survey's signature:

Schedule 6

People's Republic of China pharmaceutical supervisory and administrative instruments

Site inspection record
Page total pages

━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

被检查单位(人):________________________________________________________

检查现场:________________________________________________________________

Legal representative (person in charge): ________________________ please contact: __________________

Inspection: ___________________ records by: _____________ type of supervision and inspection: ____________
检查时间:_______年_______月_______日_______时_______分至_______时______分

━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

我们是____________________________的执法人员____________、____________

执法证件名称、编号是:____________________________________________________

我们依法就______________________________________________有关问题,进行

On-site inspection, please cooperate.

On-site inspection records:
━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Note: a duplicate of this instrument, first copy the archive, the second stock exchange the units under inspection.
Inspection on the examination by
Signature page, modify the signature or fingerprint, and at the end of the record indicated on the authenticity of the records check
Person shall be signed at the end of the record.
    ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

A person being checked:

Schedule 7

People's Republic of China pharmaceutical supervisory and administrative instruments
                                     Advanced registration and preservation of goods form
(      )   登保审[      ]    号

━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

案  由:__________________________________________________________________

当事人:__________________________法定代表人(负责人):__________________

地址:___________________________________联系方式:_______________________

Advanced registration and preservation of items:

According to the People's Republic of China Law on administrative punishment specified in the 37th article of, to be on the unit (person)

Related articles to register.

Save location:

Storage condition:

承办人:___________、___________
Year month day
━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

Approval:

主管领导:_______________
Year month day

━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

Schedule 8

People's Republic of China pharmaceutical supervisory and administrative instruments
                                    Advance registration and notice of saved items
(      )    登保通[      ]    号

━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

_______________________________:

According to the People's Republic of China Law on administrative punishment specified in the 37th article of, I decided to tell you (single Bit) related articles (see the first registration of the saved items list) to register.

Without the approval of this Council, do not

Use, destruction or transfer.

Save location:

Storage condition:

Annex: advance registration list saves items
                                                       (Official seal)

Year month day
━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

This notice has been on _______ months _______ _______ _______ _______ years received.
Recipient signature: _____________
━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━
Note: a duplicate of this instrument, first copy the archive, the second the Exchange parties.

━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

Schedule 9 People's Republic of China pharmaceutical supervisory and administrative instruments
                       Attachment (attachment) form
(      )    查扣审[      ]    号

━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

案  由:__________________________________________________________________

当事人:_____________________________法定代表人(负责人):_______________
地址:_______________________________联系方式:___________________________

━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

根据____________________________________________________________规定, The unit (people) illegal _________________________________, to be subject to seizure (seizure).

Attachment

(Seize) the period from the year _______ _______ _______ _______ _______ to _______ date year month day of the month.
    Attachment (attachment) save location:

Attachment (attachment) storage condition:
According to the People's Republic of China article 21st of administrative mandatory law, need for urgent seized (seizure) measures

Description of the application and go through the approval procedure:
                                                       承办人:____________、___________

Year month day
━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

Approval:
                                                       Manager: _____________

Year month day

━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

Schedule 10

People's Republic of China pharmaceutical supervisory and administrative instruments
                                        Attachment (attachment) decision
(      )查扣决[      ]    号
━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

当事人:__________________________法定代表人(负责人):__________________
地  址:__________________________联系方式:______________________________
    ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

根据__________________________________________________________________

Requires that you (units) ________________________ may harm human health, decided to seize (button Bet).

Attachment (attachment) period from _______ to _______ year _____ month _____ day _____ year _____ month.

I will be seized (seizure) to make a decision within the time limit (extended attachment (attachment) the term, I will According to the People's Republic of China administrative mandatory law provisions of article 25th decides otherwise and informed).

Check

Seal (seized), without the approval of this Council, are not allowed to use, destruction or transfer.

You (units) can make statements to this decision and to defend themselves.

Is aggrieved by the decision may, within 60 days from the date of receipt of the written decision of the law applying to the ______________ administrative

Review or _______________ court within 3 months.
    Attachment (attachment) save location:

Attachment (attachment) storage condition:

Attachment: attachment (attachment) list
                                                       (Official seal)
Year month day
━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

The decision in _______ months _______ _______ _______ _______ years received.

Recipient sign: ___________
执法人员签字:_____________、_____________
    ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

Note: a duplicate of this instrument, the first form by the pharmaceutical supervisory and administrative department archive, the second the Exchange parties.

Schedule 11







Medicine

Products

Supervisor

Doc

Tube

The acting

Game

Seal

Long things

Year

Month
                                  Day

(Seal)

Schedule 12

People's Republic of China pharmaceutical supervisory and administrative instruments
                                                      (               )  物  品  清  单
  Page total pages
  当事人:_____________________________ 地  址:_____________________________
     ─────┬──────┬───┬───┬───┬───┬───┬─────
  Name manufacturer │ │ size │ │ price │ │ a │ batch number packaging notes
            ─────┼──────┼───┼───┼───┼───┼───┼─────
  │            │      │      │      │      │      │
            ─────┼──────┼───┼───┼───┼───┼───┼─────
  │            │      │      │      │      │      │
            ─────┼──────┼───┼───┼───┼───┼───┼─────
  │            │      │      │      │      │      │
            ─────┼──────┼───┼───┼───┼───┼───┼─────
  │            │      │      │      │      │      │
            ─────┼──────┼───┼───┼───┼───┼───┼─────
  │            │      │      │      │      │      │
            ─────┼──────┼───┼───┼───┼───┼───┼─────
  │            │      │      │      │      │      │
            ─────┼──────┼───┼───┼───┼───┼───┼─────
  │            │      │      │      │      │      │
            ─────┼──────┼───┼───┼───┼───┼───┼─────
  │            │      │      │      │      │      │
            ─────┼──────┼───┼───┼───┼───┼───┼─────
  │            │      │      │      │      │      │
            ─────┼──────┼───┼───┼───┼───┼───┼─────
  │            │      │      │      │      │      │
            ─────┼──────┼───┼───┼───┼───┼───┼─────
  │            │      │      │      │      │      │
            ─────┼──────┼───┼───┼───┼───┼───┼─────
  │            │      │      │      │      │      │
            ─────┼──────┼───┼───┼───┼───┼───┼─────
  │            │      │      │      │      │      │
            ─────┼──────┼───┼───┼───┼───┼───┼─────
  │            │      │      │      │      │      │
            ─────┼──────┼───┼───┼───┼───┼───┼─────
  │            │      │      │      │      │      │
            ─────┼──────┼───┼───┼───┼───┼───┼─────
  │            │      │      │      │      │      │
            ─────┼──────┼───┼───┼───┼───┼───┼─────
  │            │      │      │      │      │      │
            ─────┼──────┼───┼───┼───┼───┼───┼─────
  │            │      │      │      │      │      │
    ─────┴──────┴───┴───┴───┴───┴───┴─────

Variety and quantity check these goods:

Parties sign (or seal): ______________ officers signature: __________ and the __________
年    月    日                            年    月    日
━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Note: a duplicate of this instrument, first copy the archive, the second the Exchange parties.
This list is used to advance registration saves, lifting the first
Registration and preservation, seizure seizure, used when lifting of seizure seizure, forfeiture, in () indicate the specific project.

━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

Schedule 13

People's Republic of China pharmaceutical supervisory and administrative instruments
                                      Notice of filing
(      )  立案通[      ]    号

━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

___________________________:

Following a preliminary investigation (inspection) of your (in) ______________________________, suspected

Violating the provisions of the ______________________________________ decided to your (flat) file transfer

Look up.

Notice is hereby given that.
                                                         (Official seal)
Year month day
━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

This notice has been on _______ months _______ _______ _______ _______ years received.
Recipient signature: ______________
执法人员签字:_____________、_____________
    ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

Note: a duplicate of this instrument, the first form by the pharmaceutical supervisory and administrative department archive, the second the Exchange parties.

Schedule 14

People's Republic of China pharmaceutical supervisory and administrative instruments
                                      Lift advance registration and notice of saved items
(      )  解保通[      ]    号

━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

______________________________:

I to _______ _______ _______ years months days to the antecedent Register notice {()

Pat []} of the antecedent register list of items in saved items listed to be registered, are hereby

The Department (or part of) the register.

Annex: releasing the advance registration list saves items
                                                      (Official seal)
Year month day
━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

This notice in _______ months _______ _______ _______ _______ years received.
Recipient signature: ________________
━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━
Note: a duplicate of this instrument, first copy the archive, the second the Exchange parties.

━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

Schedule 15

People's Republic of China pharmaceutical supervisory and administrative instruments
                                      Lifting attachment (attachment) decision
(      )   解扣决[      ]   号

━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

_______________________________:

I to _______ _______ _______ years months days to _______ number of the attachment (seizure) of decision

The seizure (seizure) goods set out in the list of goods subject to seizure (seizure), in accordance with the People's Republic of China

Political 28th _______ of the rules of jus cogens provisions, all (or partly) lifting attachment (attachment).

Report: lifting the seizure (seizure) list
                                                (Official seal)

Year month day
━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

This decision had on _______ months _______ _______ _______ _______ years received.
Recipient signature: _______________
执法人员签字:_______________、______________
━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

Note: a duplicate of this instrument, the first form by the pharmaceutical supervisory and administrative department archive, the second the Exchange parties.

Schedule 16

People's Republic of China pharmaceutical supervisory and administrative instruments
                                                      Cases collegiate record
Page total pages

━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

案  由:__________________________________________________________________

当事人:__________________________________________________________________

合议时间:_________________主持人:_________________地点:________________

合议人员:_________________________________________记录人:_______________

Employees who report facts (facts, evidence, evidence, procedures of handling):

Record of the discussions:

Collegiate comment:
━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

Host signatures:
Collegiate officer signature: record's signature:

━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

Schedule 17

People's Republic of China pharmaceutical supervisory and administrative instruments
                                        Application form for withdrawing
(      )  撤申[      ]    号

━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

案  由:__________________________________________________________________

当事人:___________________________法定代表人(负责人):_________________

地  址:___________________________联系方式:_____________________________
案件来源:_________________________立案时间:__________年_______月______日
━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

Summary of the survey on the merits:

Case withdrawal reasons:

承办人:______________、______________
Year month day
━━━━━━━━━━━━━━━━━┯━━━━━━━━━━━━━━━━━━━
                                  Review comments: │ approval:
                                  │
                                  │
                                  │
          │
                 机构负责人:___________ │              主管领导:___________
年    月    日   │                   年    月    日

━━━━━━━━━━━━━━━━━┷━━━━━━━━━━━━━━━━━━━

Schedule 18

People's Republic of China pharmaceutical supervisory and administrative instruments
                                     Administrative punishment in advance notice
(      )   罚先告[      ]    号

_________________________________:

你(单位)____________________________________________________________

___________________________________________________________________的行为,

违反了_____________________________________________________________的规定。

依据________________________________________________________________的

规定,我局拟对你(单位)进行______________________________________________ _______________________________________________________________的行政处罚。
    According to the People's Republic of China Law on administrative penalties article sixth, 31st article, you (units)

可在_______年_______月_______日之前到___________________________________进 Statements and to defend themselves.

Statement if invalid and to defend themselves.

By procuration.
                                                       (Official seal)

Year month day
━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

This notice has been on _______ months _______ _______ _______ _______ years received.

Recipient signature: ______________
━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━
Note: a duplicate of this instrument, first copy the archive, the second the Exchange parties.

━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

Schedule 19

People's Republic of China pharmaceutical supervisory and administrative instruments
                                                      Make a written statement to defend themselves
Page total pages

━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

案  由:__________________________________________________________________

当事人:__________________________________________________________________

陈述、申辩人:_____________________________联系方式:_____________________

Statements and pleadings of the time: ______ ______ ______ ________ year month day time _____ to ______ _____

陈述和申辩地点:__________________________________________________________
承办人:________________________________记录人:__________________________
━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

Presentation and defence Description:

Signing of statement and averment: ____________________ the Undertaker's signature: ____________________

记录人签字:____________________
______年____月____日                    _______年____月____日

━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

Schedule 20

People's Republic of China pharmaceutical supervisory and administrative instruments
Administrative sanction form
━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

案  由:__________________________________________________________________
当事人:__________________________________________________________________
━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

Major illegal facts:

该单位(人)上述行为违反了____________________________________________

___________________________________________________________________的规定,

依据______________________________________________________________________

______________________________________________________________的规定,经合

Discuss, recommend the following administrative penalties:

Case the undertaker: ________________
Year month day
━━━━━━━━━━━━━━━━━┯━━━━━━━━━━━━━━━━━━━
                                  Review comments: │ approval:
                                  │
                                  │
                                  │
          │
                 机构负责人:___________ │              主管领导:___________
年    月    日   │                   年    月    日

━━━━━━━━━━━━━━━━━┷━━━━━━━━━━━━━━━━━━━

Schedule 21

People's Republic of China pharmaceutical supervisory and administrative instruments
                                                      Collective discussions on major case records
Page total pages
━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

案  由:__________________________________________________________________

当事人:__________________________________________________________________

讨论时间:_________________________地  点:_______________________________

主持人:________________汇报人:_________________记录人:_________________
参加人:__________________________________________________________________
━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

Major illegal facts (evidence, evidence, procedures of handling and punishment views):

Record of the discussions:

For discussion and decision:
━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

Host signatures:
Participants sign: record's signature:

━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

Schedule 22

People's Republic of China pharmaceutical supervisory and administrative instruments
                                        Written decision of administrative penalty
(      )   行罚[      ]   号

━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

被处罚单位(人):________________________________________________________

地址(住址):______________________________联系方式:____________________

Legal representative (person in charge): ________________ age ______ sex ______ positions: __________

The investigation, your unit has the following illegal facts:

The evidence:

Violations of laws, rules, regulations, articles, paragraphs, items, accounts:

Decision:

In 15th after receiving the written decision to ____________________________ banks foreclosure Paragraph. If 3% Add a fine in amount of the daily penalty.

Fails to perform the penalty decision, I will request the people's Court

For enforcement.

Aggrieved by the penalty decision, can be received within 60 days from the date of this decision in accordance with law to ________________

___________________________ May apply for administrative reconsideration or ________________ court within 3 months.
                                                   (Official seal)
Year month day
━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━
Note: the instrument-making, a set of three copies, respectively, for archiving, was punished (person) and, if necessary, make
People's Court for compulsory execution.

━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

Schedule 23

People's Republic of China pharmaceutical supervisory and administrative instruments
                                         Proof of forfeiture
(      )  没物[      ]   号
━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

案  由:__________________________________________________________________

当事人:_______________________________地址:_____________________________
执行机关:________________________________________________________________

━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

{Under the written decision of administrative penalty (a) penalty []} decision for you (single

) In connection with the execution.

Annex: list of confiscated goods
                                                   (Official seal)
Year month day
━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━
Note: the triple of this instrument, first copy the archive, the second unit was punished by the stock exchange, the third when necessary, the people's Court
For enforcement.

━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

Schedule 24

People's Republic of China pharmaceutical supervisory and administrative instruments
                                      Confiscated goods processing form
(      )  没处审[      ]    号
    ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

According to the People's Republic of China article 53rd of the administrative punishment law, proposed to ________________

______________ (Or individual) basis {the written decision of administrative penalty (a) penalty []
  }, Destroyed confiscated items submitted-transfer-auction-treatment.
      ───────┬──────┬──────┬──────┬───────
  Item name quantity │ │ confiscation │ │ equivalent amounts to be processed
                ───────┼──────┼──────┼──────┼───────
  │            │            │            │
                ───────┼──────┼──────┼──────┼───────
  │            │            │            │
                ───────┼──────┼──────┼──────┼───────
  │            │            │            │
                ───────┼──────┼──────┼──────┼───────
  │            │            │            │
                ───────┼──────┼──────┼──────┼───────
  │            │            │            │
                ───────┼──────┼──────┼──────┼───────
  │            │            │            │
                ───────┼──────┼──────┼──────┼───────
  │            │            │            │
                ───────┼──────┼──────┼──────┼───────
  │            │            │            │
                ───────┼──────┼──────┼──────┼───────
  │            │            │            │
                ───────┼──────┼──────┼──────┼───────
  │            │            │            │
                ───────┼──────┼──────┼──────┼───────
  │            │            │            │
                ───────┼──────┼──────┼──────┼───────
  │            │            │            │
                ───────┼──────┼──────┼──────┼───────
  │            │            │            │
                ───────┼──────┼──────┼──────┼───────
  │            │            │            │
                ───────┼──────┼──────┼──────┼───────
  │            │            │            │
                ───────┼──────┼──────┼──────┼───────
  │            │            │            │
                ───────┼──────┼──────┼──────┼───────
  │            │            │            │

───────┴──────┴──────┴──────┴───────

负责人:________________

Year month day
━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

Approval:

主管领导:_______________
Year month day

━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

Schedule 25

People's Republic of China pharmaceutical supervisory and administrative instruments

List of confiscated goods handling
  (      )   没处[      ]    号
  ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

{Under the written decision of administrative penalty (a) penalty []}

当事人:___________________地址:__________________电话:_________________
  执行处置单位:________________地址:________________电话:________________

━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━
  Schedule of confiscated goods handling
     ───────┬───┬───┬───┬────┬───┬───┬────
  Item name quantity │ size │ │ │ │ │ Attn │ comments
                ───────┼───┼───┼───┼────┼───┼───┼────
  │      │      │      │        │      │      │
                ───────┼───┼───┼───┼────┼───┼───┼────
  │      │      │      │        │      │      │
                ───────┼───┼───┼───┼────┼───┼───┼────
  │      │      │      │        │      │      │
                ───────┼───┼───┼───┼────┼───┼───┼────
  │      │      │      │        │      │      │
                ───────┼───┼───┼───┼────┼───┼───┼────
  │      │      │      │        │      │      │
                ───────┼───┼───┼───┼────┼───┼───┼────
  │      │      │      │        │      │      │
                ───────┼───┼───┼───┼────┼───┼───┼────
  │      │      │      │        │      │      │
                ───────┼───┼───┼───┼────┼───┼───┼────
  │      │      │      │        │      │      │
                ───────┼───┼───┼───┼────┼───┼───┼────
  │      │      │      │        │      │      │
                ───────┼───┼───┼───┼────┼───┼───┼────
  │      │      │      │        │      │      │
                ───────┼───┼───┼───┼────┼───┼───┼────
  │      │      │      │        │      │      │
                ───────┼───┼───┼───┼────┼───┼───┼────
  │      │      │      │        │      │      │
                ───────┼───┼───┼───┼────┼───┼───┼────
  │      │      │      │        │      │      │
                ───────┼───┼───┼───┼────┼───┼───┼────
  │      │      │      │        │      │      │
                ───────┼───┼───┼───┼────┼───┼───┼────
  │      │      │      │        │      │      │
                ───────┼───┼───┼───┼────┼───┼───┼────
  │      │      │      │        │      │      │
                ───────┼───┼───┼───┼────┼───┼───┼────
  │      │      │      │        │      │      │
                ───────┼───┼───┼───┼────┼───┼───┼────
  │      │      │      │        │      │      │

───────┴───┴───┴───┴────┴───┴───┴────

Invited participant's signature: _________________ the Undertaker's signature: ______________________ 年    月    日                        年    月    日
  ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━
  Note: two of this instrument, first copy the archive, the second reference.

━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

Schedule 26

People's Republic of China pharmaceutical supervisory and administrative instruments
                                      Notice of correction
(      )   责改通[      ]   号

━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

__________________________________________:

你(单位)____________________________________________________________

__________________________________________________________________________

___________________________________________________________________的行为,

违反了____________________________________________________________________

___________________________________________________________________的规定。

According to the People's Republic of China article 23rd provisions of the law on administrative punishment, ordered to you (units) from ___ years ______ _____ Months before correction.

Correct contents and requirements are as follows:
                                                      (Official seal)

Year month day
━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

This notice has been _________ years ________ months ________ _________ ________ receive.
Recipient signature: ____________
━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━
Note: a duplicate of this instrument, the first storage block, the second the Exchange parties.

━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

Schedule 27

People's Republic of China pharmaceutical supervisory and administrative instruments
                                       The hearing notice
(      )   听告[      ]    号

━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

________________________________:

你(单位)_____________________________________________________的行为,

违反了_____________________________________________________________的规定。

依据______________________________________________________________的规

定,拟对你(单位)进行____________________________________________________

__________________________________________________________________________

Administrative penalties.

According to the People's Republic of China 42nd article of provisions of the law on administrative punishment, you (in) the right to

Calling for a hearing. If you (units) to request a hearing, shall, after receipt of this notification in the 3rd Council told me.

Overdue as a waiver

Permit rights.

机关地址:__________________________邮政编码:________________________

联系电话:__________________________联 系 人:________________________
                                                      (Official seal)

Year month day
━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

This notice has been on _______ months _______ _______ _______ _______ years received.
Recipient signature: _____________
━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━
Note: a duplicate of this instrument, the first file for future reference, the second the Exchange parties.

━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

Schedule 28

People's Republic of China pharmaceutical supervisory and administrative instruments
                                       Notice of hearing
(      )    听通[      ]   号

━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

_________________________________:

According to you (in) the hearing requirements, this Council decided to when _____ ______ _____ ______ year month day

_____分,在_____________________________________________________________举 Hearing. Could you please (unit) or of the legal representative entrusts an agent to attend.

Do not attend the hearing and prior

Was not justified, and no special reason, deemed to have waived the hearing rights.

Agency hearing, the hearing shall be submitted to this Council before the hearing could be held power of attorney.

本案听证主持人____________________________书 记 员:__________________

According to the People's Republic of China Law on administrative punishment provisions of 42nd, applications from your host,

Reporters shy away from, you can apply to the withdrawal of this Council prior to the hearing and explain the reasons.

本局地址:_________________________________邮政编码:______________

联系电话:_________________________________联 系 人:______________
                                                    (Official seal)

Year month day
━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

This notice is to ________ ______ day of ______, _____ year _____ month received.
Recipient signature: ______________
━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━
Note: a duplicate of this instrument, the first file for future reference, the second the Exchange parties.

━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

Schedule 29

People's Republic of China pharmaceutical supervisory and administrative instruments
                                                      Record of hearing
Page total pages

━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

案  由:__________________________________________________________________

当事人:__________________________________________________________________

Legal representative (person in charge): __________ gender: age of ____: ____ contact: ____________

工作单位:____________________________ 地 址:____________________________

Authorized representative: ___________ gender: age of ____: ____ title: ____ contact: ___________

工作单位:____________________________ 地 址:____________________________

案件承办人:_______________________ 科 室:___________ 职 务:____________

案件承办人:_______________________ 科 室:___________ 职 务:____________

听证主持人:__________________________         书记员:___________________

Hearing date: _________ the year _____ month _____ day _____-____ to _____, _____
听证方式:____________________________
━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

Records:
━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━
Note: a hearing after it has been verified as correct by the parties signing page by page, modify the signature or fingerprint, and at the end of the record Indicated on the authenticity of the transcript.
Undertaker and the hearing of the case at the end of the record signing.
━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

Client or authorized representative signature:

Schedule 30

People's Republic of China pharmaceutical supervisory and administrative instruments
Hearing submissions

━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

案  由:__________________________________________________________________

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:_________________________
━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

Basic circumstances of the case:
━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

Case the undertaker main observations:
━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

Parties of the main reasons:
━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

Hearing comments:

Hearing officer signature: ___________________
Year month day

━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

Schedule 31

People's Republic of China pharmaceutical supervisory and administrative instruments
                                       Written decision of administrative penalty
(      )  当行罚[      ]   号

━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

被处罚单位(人):________________________地址:__________________________
The legal representative (head): ___________ gender: age of ____: ____ position: _______________

━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

The investigation, you are (in) the following main illegal facts: __________________________________

__________________________________________________________________________

上述事实已经违反了_____________________________________________________

______________________________________________________________之规定,责令 Immediately stop the illegal practice.

依据____________________________________________________

_______________________________的规定,给予以下行政处罚:_________________

__________________________________________________________________________

From the date of receipt of the written decision on 15th to ____________________________________ Banks to pay the fine. If 3% Add a fine in amount of the daily penalty.

Fails to perform the penalty decision, I will Port Dickson

People's Court for compulsory execution.

Aggrieved by the penalty decision, can be received within 60 days from the date of this decision in accordance with law to ________________

Apply for administrative reconsideration or _________________________________________ court within 3 months.

当事人签字:__________________      执法人员签字:___________、___________
              (Official seal)
年    月    日                           年    月    日
━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━
Note: the triple of this instrument, first copy the archive, the second unit was punished by the stock exchange, the third when necessary, the people's Court
For enforcement.

━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

Schedule 32

People's Republic of China pharmaceutical supervisory and administrative instruments
Delivery receipt

━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

受送达单位(人):________________________________________________________

送达文件名称及文件编号:__________________________________________________

__________________________________________________________________________

送达方式:____________________      送达地点:____________________________

送达人:______________________      送达日期:_____年____月____日___时___分

收件人:_____________________       收件日期:_____年____月____日___时___分
                                                      (Official seal)
Year month day
━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

Notes:
━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━
Note: a duplicate of this instrument, first after being signed by the recipient with the volume file, second copy for future reference.

━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

Annex 33

People's Republic of China pharmaceutical supervisory and administrative instruments
                                      Delay (minutes) pay and confiscated money form
(      )   延罚审[      ]   号

━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

当事人:__________________________________________________________________

法定代表人(负责人):____________________________职务:__________________
Decision number: (a) penalty []
━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

Party request approved extension of (sub) reason for pay and confiscated money, the term:
Annex: client applications
━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

Collegiate comment:

合议人签字:_______________________________
Year month day
━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

Approval:

主管领导:______________________
Year month day

━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

Annex 34

People's Republic of China pharmaceutical supervisory and administrative instruments
                                    Application for enforcement of administrative penalty
(      )    罚强申[      ]    号

━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

________________________人民法院:

____________________________________________, The decision on administrative penalty has been

________ Year _____ month _____ day service, the unit fails to perform the administrative punishment decision.

According to the People's Republic of China Law on administrative punishment specified in the 51st article of, seeking to enforce.

Basic contents of the application for enforcement and the parties as follows:

当事人:______________________________________________________________

地  址:______________________________________________________________

Legal representative (person in charge): __________ gender: ______ age: ______ title: ________

Application content:

Annex:
                                                       (Official seal)

Year month day

申请机关地址:________________________________________________________
联系人:______________________________联系方式:______________________
━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━
Note: this book two, first archive the second stock exchange Court.

━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

Schedule 35

People's Republic of China pharmaceutical supervisory and administrative instruments
Administrative penalties final report

━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

案  由:__________________________________________________________________

案件来源:________________________________________________________________

Penalty: ___________________________ legal representatives (in charge): _____________

Filing date: ________ year _____ month ______ day punishment date: ________ year _____ month _____ day

Punishment instrument number: _________________ closing date: ______ ______ ______ year month day
承 办 人:___________________   填写人:______________________
━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

Penalties:
━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

Implementation of results:
━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Means of implementation: 1. automatic discharge 2. review a case 3. suit settled 4. enforcement 5.
━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━
Archive date: file classification: expiration date:
━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

Approval:

Manager signature: __________________
Year month day
━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━
Note: a duplicate of this instrument, first volume archive, the second report.

━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

Schedule 36

People's Republic of China pharmaceutical supervisory and administrative instruments
                                                      (           )副页
Page total pages

━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━
━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━
Note: the instrument for the relevant enforcement document continuation sheet.

━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

New Schedule 1
                             People's Republic of China pharmaceutical supervisory and administrative instruments
                                   Transfer suspected criminal cases
(      )   涉刑移送[      ]    号

━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

_______________公安局:

____________________涉嫌_____________________________一案,经初步调查,

Parties alleged to constitute a crime, in accordance with the provisions of administrative law-enforcement organs transfer suspected criminal cases under article III of the United Nations, the customs

To transfer suspected criminal cases in a timely manner in the administrative law enforcement views: first, the provisions of article ____ of the criminal code,

You are hereby transferred units to investigate and punish.

In accordance with the provisions of administrative law-enforcement organs transfer suspected criminal cases article eighth of provisions you, such as when

Person without criminal facts or facts obviously minor, do not need to be investigated for criminal responsibility according to law shall not be filed,

Please indicate the reasons for, and notify us in writing and return about the dossier.

In accordance with the provisions of administrative law-enforcement organs transfer suspected criminal cases the 12th of the rules, I will receive

You within 3 working days from the date of notice of filing articles involved in cases and other materials related to the transfer of your.
                                                    (Official seal)
Year month day

Annex:

--------------------------------------------------------------------------

Sign the receipt

________ The transfer suspected criminal cases book _______ years ______ months _______ day of receiving.
                                                    (Official seal)
Year month day
━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Note: this instrument in four.
First copy retained by the public security organ after acknowledgement; the second by a public security organ after acknowledgement by the drug
Quality supervision and Management Department archives, third for cc, the public security organs of the people's procuratorates at the same level, followed by the people's Procuratorate has signed

Retained four followed by the people's Procuratorate has signed and archived the drug regulatory agency.

New Schedule 2
                         People's Republic of China pharmaceutical supervisory and administrative instruments
                                        Attachment (attachment) notice of transfer of goods
(      )  查扣移[      ]   号

━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

_________________________:

Because of you (in) an unlawful act of a crime, according to the People's Republic of China administrative mandatory law the 21st

The provisions of articles, I decided to seize (seizure) of your (units) of related articles (see ______________

《(      )物品清单》)移交给_______________________________公安局。
                                                       (Official seal)

Year month day
━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

This notice has been on _______ ________ year month date _______ _______ _______ received.
Recipient signature: _______________
执法人员签字:___________、___________
━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

Note: a duplicate of this instrument, the first form by the pharmaceutical supervisory and administrative department archive, the second the Exchange parties.

New schedule 3
                       People's Republic of China pharmaceutical supervisory and administrative instruments
                                     Attachment (attachment) extension form
(      )  查扣延审[      ]   号

━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

案  由:__________________________________________________________________

当事人:__________________________法定代表人(负责人):__________________
地  址:__________________________联系方式:______________________________
    ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

According to the People's Republic of China Law on administrative coercion 25th article, I proposed to ______

The seizure (seizure) of decision seized (seizure) of goods, extended attachment (attachment) period of ________ years

________月______日。

Extending attachment (attachment) the term reason:

承办人:___________、___________
Year month day
━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

Approval:

主管领导:_______________
Year month day

━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

New Schedule 4

People's Republic of China pharmaceutical supervisory and administrative instruments
                                     Attachment (attachment) notice of extension
(      )  查扣延通[      ]   号

━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

当事人:___________________________法定代表人(负责人):_________________
地址:_____________________________联系方式:_____________________________
    ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

According to the People's Republic of China Law on administrative coercion 25th article, I decided on the ______

The seizure (seizure) of decision seized (seizure) of goods, extended attachment (attachment) period of ______ years _______月_______日。

Attachment (attachment), without the approval of this Council, not allowed to use, destruction or

Transfer.

You (units) can make statements to this decision and to defend themselves.

Is aggrieved by the decision may, within 60 days from the date of receipt of the notice of the law to apply for administrative reconsideration or _______ 3

__________________________ Court within two months.

Extending attachment (attachment) the term reason:
    Attachment (attachment) save location:

Attachment (attachment) storage condition:
                                                         (Official seal)
Year month day
━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

This notice has been ______ ______ year _____ month _____ day _____ when received.
Recipient signature: _____________
执法人员签字:___________、___________
━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

Note: a duplicate of this instrument, the first form by the pharmaceutical supervisory and administrative department archive, the second the Exchange parties.

New schedule 5

People's Republic of China pharmaceutical supervisory and administrative instruments
                                        Test (detection, identification) fact sheet
(      )   检告[      ]   号

━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

_______________________:

I decided on the __________ of the attachment (seizure) of decision seized (seizure) of test items

(Detection, identification), test (detection, identification) during since ______ months _______ years _____ to _______年_____月_____日。

According to the People's Republic of China Law on administrative coercion 25th article

Provided that the periods not included in attachment (attachment).

By procuration.
                                                      (Official seal)
Year month day
━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

This notification was ________ years ______ day of ______, ______ ______ months received.
Recipient signature: ______________
执法人员签字:___________、___________
━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

Note: a duplicate of this instrument, the first form by the pharmaceutical supervisory and administrative department archive, the second the Exchange parties.

New schedule 6

People's Republic of China pharmaceutical supervisory and administrative instruments
                                      Written decision notice of administrative penalty
(      )  罚催告[      ]    号

━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

____________________________:

I Council on _________ ______ day of ______ months you (units) served the _______ of the administrative punishment

Of decision, decision for you (units) make the following punishments: ____________________, and ask you (single ) In ___________ ______ day of ______ months _______ years the Bank to pay the fine.

As the unit has

Not (all) discharge decision since I ______ _______ ______ year month date day, by _________ number

3% of the written decision of administrative penalty penalty plus a fine (plus the total amount does not exceed the original amount of the fine).

Late I will according to the People's Republic of China administrative mandatory law 53rd, 54th and other provisions in the

After service of this notice on 10th to the people's Court for compulsory execution.

If you (in) this objection, may be present in the year ______ _____ ______ months before and to defend themselves.
                                                        (Official seal)
Year month day
━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━

The interpellation in ________ years received ______ day of ______, ______ ______ months.
Recipient signature: _____________
执法人员签字:___________、___________
━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━
Note: the instrument-making, a set of three copies, respectively, for the pharmaceutical supervisory and administrative department archive, party, sex

The people's Court for enforcement.

Added Schedule 7
                             People's Republic of China pharmaceutical supervisory and administrative instruments
                                       Review of statement and averment submissions
(     )   陈辩核[    ]   号
┌───────┬───────────────────────────┐
│              │                                                      │
│    案  由    │                                                      │
│              │                                                      │
├───────┼───────────────────────────┤
│              │                                                      │
│              │                                                      │
│    陈  述    │                                                      │
│              │                                                      │
│    申  辩    │                                                      │
│              │                                                      │
│    基  本    │                                                      │
│              │                                                      │
│    情  况    │                                                      │
│              │                                                      │
│              │                                                      │
├───────┼───────────────────────────┤
│              │                                                      │
│              │                                                      │
│    陈  述    │                                                      │
│              │                                                      │
│    申  辩    │                                                      │
│              │                                                      │
│    结  论    │                                                      │
│              │                                                      │
│      及      │                                                      │
│              │                                                      │
│    处  理    │                                                      │
│              │                                                      │
│    意  见    │                                                      │
│              │                                                      │
│              │                                                      │
├───────┼───────────────────────────┤
│              │                                                      │
│    承  办    │                                                      │
│              │                                                      │
│    机  构    │                                                      │
│              │  签字:                           年    月    日     │
    └───────┴───────────────────────────┘ Note: the attached transcript of statement and averment.