Pharmaceutical Supervisory And Administrative Punishment Procedure

Original Language Title: 药品监督行政处罚程序规定

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(On April 28, 2003 national food drug supervision authority 1th, announced) first chapter General first article 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 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 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 principle of due process, (iii) the principles of fairness, openness and (iv) the principle of combining punishment with education, (v) the principle of protection of 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 article 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. 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. Third chapter filed 13th article drug supervision management sector on following involved reported clues and the assigned by, and submitted of case should timely processing: (a) in supervision check in the found of; (ii) test institutions test found of; (three) citizens, and corporate and the other organization reported of; (four) superior assigned by of, and subordinate reported to the investigation of, and about sector transferred of or other way, and way disclosure of. 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 offence suspects; (b) objectively illegal facts and (iii) outside 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 near relative of a party to the case or the parties, (ii) and has a direct interest in the case and (iii) other relationships with the parties to the case, could affect the impartial handling of the case. Fourth chapter investigation 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 the sealed up or seized items should be completed before the seized items form (Schedule 9), reported to the drug regulatory department supervisor approval. When sealing up, distraining, law enforcement officials should issue the notification of seized items from the parties (table 10). 23rd pharmaceutical supervision and management, implement advanced registration and saved or when the sealing up, distraining, should a party is present. The party refused to be present, law enforcement officers can interested persons are invited to attend. 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 pharmaceuticals supervision and management departments of 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. Registered should complete the notification of administrative processing (table 13), to be parties to a sealed up or seized items, sealed up, distrained goods time limit be extended to administrative punishment decision or withdraw cases decided to date. 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 notification of release seized items (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 administration of quality supervision, inspection provisions in the drug samples, timely identification and inspection. 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 in summary procedures) the first section of the fifth chapter of decision 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 should according to finds of illegal facts, in accordance with about drug, and medical devices management legal, and regulations and regulations of provides, respectively proposed following processing views: (a) illegal facts clear, evidence, program legal of, law proposed administrative punishment of views, on has can not punishment, and lighter, and reduce punishment or from heavy punishment plot of, proposed not punishment, and lighter, and reduce punishment or from heavy punishment of views, constitute crime of, in proposed administrative punishment views of while recommends transferred judicial organ held 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, (iii) the 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). Administrative punishment decided book should contains Ming following matters: (a) party of name or name, and address; (ii) violation legal, and regulations or regulations of facts and evidence; (three) administrative punishment of type and according to; (four) administrative punishment of perform way and term; (five) refuses to administrative punishment decided, application administrative reconsideration or filed administrative litigation of way and term; (six) made administrative punishment decided of drug supervision management sector name and made decided of date. 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 article 33rd pharmaceutical supervisory and administrative departments in order to suspend and revoke licenses and the revocation of 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, (ii) the administrative punishment of the illegal facts and reasons, basis and intends to make administrative punishment decision, (iii) 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, (ii) time, place and manner of the hearing, (iii) hearing the name of the person; (d) informing the party concerned has the right to apply for the withdrawal (v) 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, (ii) recusal reasons put forward by the parties to set up, you need to determine the hearing officer, (iii) 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). Hearing record should contains Ming following matters: (a) case; (ii) hearing participate in people name or name, and address; (three) hearing host, and clerk name; (four) held hearing of time, and locations, and way; (five) case hosted people proposed of facts, and evidence and administrative punishment recommends; (six) party statement, and defence and quality card of content; (seven) hearing participate in people 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 for the 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, (ii) fined a maximum of 50 Yuan for citizen; (c) below 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. 49th served on the fourth section 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. The sixth chapter Executive and 53rd completed 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, (ii) 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 party fails to carry out administrative punishment decision, the pharmaceutical supervisory and administrative department may request the people's Court for compulsory execution, 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. Seventh chapter supplementary articles article 61st pharmaceutical supervisory and administrative 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 Schedule 2 Schedule 3 Schedule 4 schedule 5 Schedule 6 table 7 table 8 table 9 table 10 table 11 table 12 table 13 table 14 table 15 table 16 table 17 table 18 table 19 table 20 table 21 table 22 Table 23 table 24 table 25 table 26 table 27 table 28 table 29 table 30 table 31 table 32 Annex 33 Annex 34 annex 35 Annex 36

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