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TABLE OF CONTENTS CHAPTER I GENERAL PROVISIONS CHAPTER II JURISDICTION CHAPTER III CASE ACCEPTANCE CHAPTER IV INVESTIGATION AND OBTAINING EVIDENCES CHAPTER V DECISION OF PENALTIES Section 1 General Procedures Section II Procedures for Hearing Section III Simplified Procedures Section IV Service CHAPTER VI ENFORCEMENT AND WINDING UP CASES CHAPTER VII SUPPLEMENTARY PROVISIONS CHAPTER I GENERAL PROVISIONS Article 1. The present Provisions have been formulated on the basis of the Law of the People's Republic of China on Administrative Punishment, the Law of the People's Republic of China on the Administration of Drugs, the Detailed Rules for the Implementation of the Law of the People's Republic of China on the Administration of Drugs, the Regulation on the Supervision and Administration of Medical Appliances, and other relevant administrative regulations of the State Council for the purpose of guaranteeing the correct exercise of the administrative punishment power by the drug supervision and administration departments (hereafter "DSADs") so as to defend the lawful rights and interests of the citizens, legal persons, and other organizations. Article 2. The present Provisions shall apply to the administrative punishments imposed by the DSADs upon the entities or natural persons that violate any of the laws, regulations, or ministerial rules regarding the administration of drugs and medical appliances. Article 3. The following principles shall be abided by in the imposition of administrative punishments by the DSADs: (1) The principle of statutory grounds; (2) The principle of legal procedures; (3) The principle of impartiality and openness; (4) The principle of combining punishment with education; and (5) The principle of protecting the lawful rights and interests of citizens, legal persons and other organizations. Article 4. An administrative punishment supervision system shall be established by the DSADs. The DSAD on a higher level shall supervise the imposition of administrative punishments by the lower-level DSADs. The higher-level DSAD may order lower-level DSADs to correct, within a prescribed time limit, the decisions of administrative punishment that have been unlawfully made. If it refuses to correct the unlawful decisions, the higher level department shall be entitled to modify or cancel them. CHAPTER II JURISDICTION Article 5. The administrative punishments for the supervision of drugs and medical appliances shall be subject to the jurisdiction of the DSAD of the place where the unlawful takes place. Article 6. The DSADs on the county level and above shall have jurisdiction over the cases of administrative punishment for drugs and medical appliances. The DSAD under the people's government of the provinces, autonomous regions, and municipalities directly under the Central Government shall have jurisdiction the important or complicated cases of administrative punishment for drugs and medical appliances within their respective jurisdictions. The DSAD under the State Council shall have jurisdiction over the nationally influential cases of administrative punishment for drugs and medical appliances. The DSAD of the provinces, autonomous regions, and municipalities directly under the Central Government may prescribe the specific division of functions and duties of the hierarchical jurisdiction within their respective administrative divisions according to the laws, regulations, and ministerial rules concerning drugs and medical appliances and by taking the practical situation of the local places into consideration. Article 7. Where two or more DSADs are in dispute over the right of jurisdiction, they shall report to the same superior DSAD on the next higher level to designate jurisdiction. Article 8. Where any DSAD finds that any case does not fall within its own administration or jurisdiction, it shall fill in an "Examination and Approval Form for Transferring Cases" (see Annex 1), and after obtaining the approval of the person-in-charge of the DSAD, fill in a "Letter of Transferring Cases" (see Annex 2) without delay, and shall transfer the relevant case materials to the DSAD that has jurisdiction over the case or to the relevant administrative department for handling. The DSAD to which the case is transferred to shall notify the transferring department of the result of handling in good time. If the DSAD to which the case is transferred to believes that it is not appropriate to accept the transfer, it shall report to the superior DSAD on the next higher level for designated jurisdiction, and the DSAD of designated jurisdiction may not transfer the case any more. The superior DSAD on the next higher level that receives the jurisdictional dispute or the report about designating jurisdiction shall made a decision of designated jurisdiction within 10 business days. Article 9. Where a lower-level DSAD believes that it is inappropriate for any case within its jurisdiction to be handled by itself, it may report to the DSAD on the next higher level to exercise jurisdiction or designate jurisdiction. Where a higher-level DSAD believes that it is inappropriate for any lower-level DSAD to handle any case within its jurisdiction, it may decide to exercise jurisdiction on its own initiative or designate another lower-level DSAD to exercise the jurisdiction. Article 10. If any DSAD finds, when investigating into and giving punishments to violations, any illegal act that falls within the jurisdiction of any other DSAD, it shall fill in relevant documents by reference to Article 8 of the present Measures, and shall transfer the illegal act, together with relevant evidential materials, to the DSAD concerned. The competent DSAD shall deal with the transferred case in good time. Article 11. If any of the approval certificates or documents needs to be canceled, or the Drug Production License, Drug Business License, License of Pharmaceutics by Medical Institution, License of Medical Appliances Manufacturing Enterprises, or the License of Medical Appliances Business Management Enterprises shall be canceled according to law, the decision shall be made by the DSAD that issued the license or granted approval. If, in the investigation and handling of violations, either the Drug Production License, Drug Business License or the License of Pharmaceutics by Medical Institution or the License of Medical Appliances Manufacturing Enterprises or the License of Medical Appliances Business Management Enterprises shall be canceled, or any of the approval certificates of drugs and medical appliances shall be canceled, the DSAD shall, at the same time of exercising its power of punishment within the limit of its power, report the evidences obtained and other relevant materials to the DSAD that issued the certificates, and it is up to the DSAD that issued the certificates to decide according to law whether the administrative punishment of canceling the license or approval document is to be implemented. Where it is necessary for the DSAD under the State Council to cancel the approval certificate of drugs and medical appliances, it is up to the DSAD of the people's government of the province, autonomous region, or municipality directly under the Central Government to report to the DSAD under the State Council, and the DSAD under the State Council shall made a decision in good time. The decisions to implement the administrative punishments of canceling licenses and approval certificates by the DSAD that issued them shall be made according to the present Provisions. Where the DSAD believes it necessary to cancel the Practice License of Medical Institutions, it shall propose to the health administrative organ that issued the License to cancel it. Article 12. Where any of the entities and individuals of the People's Liberation Army violates any of the laws, administrative regulations, or ministerial rules, the jurisdiction of the case shall be exercised by the DSAD of the Army according to the Measures of the People's Liberation Army for the Implementation of the Law of the People's Republic of China on the Administration of Drugs. CHAPTER III CASE ACCEPTANCE Article 13. DSADs shall deal with the disclosed clues of violations mentioned below and the cases designated or submitted to them in good time: (1) Those found in the process of supervision and inspection; (2) Those found in the tests of the testing institutions; (3) Those disclosed by any citizen, legal person, or any other organization; (4) Those designated by any superior organ or reported by any inferior organ or transferred by any other relevant department or disclosed by any other ways or means for investigation and punishment. To accept a case disclosed, the "Form of Registration of Disclosures" (see Annex 3) shall be filled in. Article 14. If the DSAD finds that a violation meets the following conditions, it shall place it on file as a case: (1) Having a definite suspect of violation; (2) Having objective facts of violation; (3) Falling within the scope of administrative punishment for drug supervision and administration; and (4) Falling within the jurisdiction of the present DSAD. Where it is decided to place a violation on file as a case, the "Form of Application for Placing Cases" (see Annex 4) shall be filled in and reported to the leader in-charge of the department for approval. If approval is obtained, two or more enforcers shall be determined to handle the case Article 15. One cannot be determined as a person to handle the case if he: (1) is a party to the present case or a close relation of any party; (2) has direct interests in the present case; or (3) has any other relations in the present case so that the impartial handling of the case might be affected. CHAPTER IV INVESTIGATION AND OBTAINING EVIDENCES Article 16. There shall be no fewer than two enforcement persons concurrently present in the investigation or inspection of cases, and they shall show their enforcement certificates to the person under investigation or any other relevant persons. The persons under investigation and other relevant persons shall truthfully answer the inquiries and assist the investigation or inspection, and may not stand in the way. If any of the secrets of the state or the business, technical secrets or personal privacies of the person under investigation is involved, the enforcement persons shall keep such secrets to themselves. Article 17. DSADs shall be obliged to assist each other and provide relevant evidences for the matters related to the cases being handled. Article 18. When making investigations, the enforcement persons shall fill in the "Transcripts of Investigation" (see Annex 5). The "Transcripts of Investigation" shall start with the identity of the enforcement persons, name and serial number of the certificates, as well as the purpose of investigation, and the signatures of the enforcement persons concerned shall be affixed at the end of the transcripts. After verifying that no errors exist, the persons under investigation shall his signature or his fingerprint on each page of the transcripts, and shall show his opinion regarding the truthfulness of the transcripts at the end. Where any revision is made, the signature or fingerprint of the person under investigation shall be affixed. Where the person under investigation refuses to attach his signature or fingerprint, the signatures or fingerprints of two or more enforcement persons shall be affixed to the transcript and explanatory notes shall be given. Article 19. When making on-the-spot inspections, enforcement personnel shall fill in, on the spot, "On-the-spot Inspection Transcripts" (see Annex 6). The Inspection Transcripts shall start with the identity of the enforcement personnel, the name and serial number of the certificates, and the purpose of the inspection, and signatures of the enforcement personnel shall be affixed at the end of the transcripts. After making sure, after careful examination, that no errors exist, the persons under inspection shall affix his signature or fingerprint to each page of the transcripts, and shall attach his comment on the truthfulness of the transcripts at the end of the inspection transcripts. Where any revision is made, the signature or fingerprint of the person under inspection shall be affixed. Where the person under inspection refuses to attach his signature or fingerprint, the signatures or fingerprints of two or more enforcement persons shall be affixed to the transcript and explanatory notes shall be given. Article 20. The evidences obtained shall be the original articles or objects. Where it is difficult to obtain the original articles or objects, the entity or individual that produces the evidence may affix his signature or official cachet to the reproductions, and shall make a note with such words as "Identical to the original" or other written explanations. Article 21. All written evidences, physical evidences, audio and video materials, testimonies of the witnesses, the statements of the parties concerned, test reports, authentication conclusions, investigation transcripts, on-the-spot inspection transcripts, etc. that can prove the truthfulness of a case shall be able to serve as evidences for the administrative punishment imposed by the DSADs. Article 22. In case any evidence is likely to be lost or hard to be obtained in the future, the enforcement personnel shall fill in an "Examination and Approval Form for the Advance Registration of Objects to Be Preserved" (see Annex 7), and report to the person in-charge of the DSAD for approval. When making advance registration of the objects to be preserved, the enforcement personnel shall issue a "Notice of Advance Registration of Objects to Be Preserved" to the parties concerned. A DSAD may take administrative mandatory measures, such as sealing up, and detention, against the drugs that it has evidences to prove that they may harm the human health and the relevant materials thereof as well as the medical appliances that have caused quality accidents or may cause quality accidents and the relevant materials thereof. Before taking the measures of sealing up or detention, the enforcement personnel shall fill in a "Form for the Examination and Approval of Objects to Be Sealed Up or Detention" (see Annex 9), and submit it to the leader in-charge of the DSAD for approval. When sealing up or detaining anything, the enforcement personnel shall issue a "Notice of Sealing Up and Detaining Objects" (see Annex 10) to the parties concerned. Article 23. When making advance registrations for preservation or sealing up or detention by the DSAD, the parties concerned shall be present at the scene. Where the parties refuse to be present, the enforcement personnel may invite other relevant persons to be present at the scene. To seal up or detain anything, a DSAD shall use sealing strips with the words "Sealed by ____ DSAD" (see Annex 11) and affixed with the official cachet of the DSAD, and seal up the objects on the spot or in other places. As for the objects subject to advance registration for preservation or for sealing up or detention, a "Checklist of Objects for ___" (see Annex 12) shall be made, on which the signatures of the enforcement personnel and the parties concerned or other relevant people or the official cachet thereof shall be affixed to. Where the parties refuse to attach his signature or official cachet or accept the Checklist, the signatures or fingerprints of two or more enforcement persons shall be affixed to the Checklist and explanatory notes shall be given. Article 24. To make advance registration of any object for preservation, the DSAD shall decide within seven days. For the objects to be sealed up or detained, a decision shall be made within seven days whether it shall be placed on file as a case. Where it is necessary to make any test, a decision shall be made within fifteen days as of the day when the test report is made whether it shall be placed on file as a case. Where it has been placed on file as a case, a "Notice of Administrative Handling" (see Annex 13) shall be filled in and be serviced to the parties concerned whose objects are to be sealed up or detained, and the time limit for sealing up or detaining the objects shall be postponed to the day when it is decided to impose administrative penalties or to dismiss the case. Where the conditions for establishing a case, the DSAD concerned shall fill in a "Notice of Dissolving the Advance Registration for Preservation (see Annex 14), and dissolve the advance registration, or fill in a "Notice of Dissolving the Sealing Up and Detention of Objects" (see Annex 15), and dissolve the sealing up or detention. Article 25. Where, in the investigation of any violation, the enforcement personnel find it necessary to take samples for authentication or test, they shall take samples according to the Rules on the Administration of Taking Samples and Tests for Drug Quality Supervision formulated by the DSAD under the State Council, and conduct the authentication or test in good time. Article 26. After the investigation is finished, the investigators shall write an investigation report, which shall cover elements such as a case briefing, the details of the case, illegal facts, evidences, procedures for handling the case, the concrete articles, paragraphs, subparagraphs, and items of the laws, regulations, or ministerial rules violated, suggestions penalties, and the signatures of the investigators, with, however, the exception of the cases to which simplified procedures apply. CHAPTER V DECISION OF PENALTIES Section 1 General Procedures Article 27. After the investigators has submitted an investigation report, the DSAD shall arrange for three or more professionals to jointly deliberate the violation facts, the nature, plots, social harm, etc., and according to the procedures for handling cases, and shall write a "Minutes of Case Deliberation" (see Annex 16). The following suggestions for handling shall be made through deliberations according to the violation facts, and the relevant provisions of the laws, regulations, and ministerial rules regarding drugs and medical appliances: (1) Where the facts about the violation are clear and for which there are conclusive evidences, and the procedures are lawfully followed, suggestions of administrative penalties shall be made. Where there are circumstances for exemption of punishment, giving a lenient or mitigated or aggravated punishment, the suggestion for exemption of punishment or giving a lenient or mitigated or aggravated punishment shall be made. If any crime is constituted, the case shall be transferred to the judicial organs for assumption of criminal liabilities; (2) Where the facts about the violation are not clear or there are inadequate evidences or there exist procedural defects, the suggestion of supplementing relevant evidential materials or re-investigation shall be made; (3) Where the facts about the violation are untenable, an application for dismissing the case shall be filed and an "Application Form for Case Dismissal" shall be filled in (see Annex 17). Article 28. Before making a decision of punishment, a DSAD shall fill in a "Letter of Advance Notification of Administrative Punishment" (see Annex 18) to notify the parties concerned of the violation facts, the reasons and grounds for punishment, and shall notify the parties concerned of the right to make statements and to defend. The DSAD shall fully listen to the statements and defenses of the parties, and shall fill in, on the spot, a "Transcript of Statements and Defenses" (see Annex 19). If the facts, reasons, or evidences produced by the parties concerned are found to be tenable after verification, they shall be adopted. No DSAD may impose a heavier punishment on any party concerned due to their complaint. Article 29. Where the facts about the violation are clear, for which there are conclusive evidences, and the procedures are lawfully followed, and administrative penalties shall be imposed according to the provisions of the laws, regulations, and ministerial rules regarding drugs and medical appliances, the case handlers shall fill in a "Form for the Examination and Approval of Administrative Punishment" (see Annex 20), which, after the person in charge of the undertaking institution has inserted his examination and approval opinions, shall be reported to the leader of the DSAD in-charge for examination and approval. The important and difficult cases of administrative punishment shall be subject to decision by the heads of the sections of the DSAD after collective deliberation, and for which the "Transcripts of Collective Discussion of Important and Difficult Cases" (see Annex 21) shall be made. Article 30. When making any decision of administrative punishment, the DSAD shall make a "Decision of Administrative Punishment" (see Annex 22). The "Decision of Administrative Punishment" shall specify the following elements: (1) The name and address of the parties concerned; (2) The facts and evidences about the violation of any law, regulation or ministerial rule; (3) The type of administrative penalty and the ground thereof; (4) The ways and time limits for the discharge of the administrative penalties; (5) In case of refusal to accept the administrative penalties, the ways and time limits for filing an application for administrative reconsideration or filing an administrative action; and (6) The name of the DSAD that makes the decision of administrative punishment and the date when the decision is made. The "Decision of Administrative Punishment" shall be affixed with the official cachet of the DSAD that makes the decision of administrative penalties. Where an administrative punishment involves the confiscation of any fake or inferior-quality drug or medical appliance, the "Decision of Administrative Punishment" shall be accompanied by a "Credence of Confiscation of Objects" (see Annex 23). Article 31. The drugs, medical appliances and relevant objects as well as the raw materials, packages, and equipments for making fake drugs, etc. confiscated by the DSADs shall be disposed of according to the provisions of Article 53 of the Law on Administrative Punishment. Before disposal, the aforementioned objects shall be subject to verification in terms of types and qualities, and a "Form of Examination and Approval for the Disposition of Confiscated Objects" (see Annex 24) and a "Checklist of Confiscate Objects for Disposal" (see Annex 25). Article 32. When handling any case, a DSAD shall, if it has evidences to prove the existence of an illegal act, issue a "Notice of Ordering for Correction" (see Annex 26), and order the offender to get right or correct the violation act within a prescribed time limit. Section II Procedures for Hearing Article 33. Before making any decision of administrative punishment such as ordering the offender to suspend business, canceling a license, canceling an approval document of drugs or medical appliances, or imposing a large fine, the DSAD shall notify the parties concerned of the right to request for holding hearings. Where any party concerned requests for holding hearings, hearings shall be held. The limit of a large fine shall be specifically determined by the people's congress or people's government of the provinces, autonomous regions, or municipalities directly under the Central Government. Article 34. The principles of openness and fairness shall be followed in the holding of hearings. Unless any of the secrets of the State or any of the business or technical secrets of the parties concerned or any of the personal privacies is involved, all hearings shall be held in public. The systems of notification and withdrawal shall apply to the holding of hearings, and the right of statement and the right of defense of the parties concerned shall be defended. Article 35. In the event of an administrative punishment case which is subject to hearing procedures, the DSAD shall, before making the decision of administrative punishment, issue a "Notification Letter of Hearing" (see Annex 27). A "Notification Letter of Hearing" shall specify the following elements: (1) The names of the parties concerned; (2) The facts about the violation of the parties concerned, the grounds and reasons for administrative punishment, and the decision of administrative punishment to be made; (3) Notifying the parties concerned of the right to request for holding hearings; and (4) Notifying the time limit for filing a request for holding hearings and the organ for holding hearings. A "Notification Letter of Hearing" shall be affixed with the official cachet of the DSAD concerned. Article 36. Where any party concerned requests for holding a hearing within three days as of receiving the notification letter, the DSAD concerned shall, within three days as of receiving the request of the party concerned, determine the composition of the hearing personnel, the time, venue, and way of hearing, and shall service a "Notice of Hearing" (see Annex 28) to the party concerned seven days before the hearing is held. A "Notice of Hearing" shall specify the following matters and shall be affixed with the official cachet of the DSAD: (1) The names of the parties concerned; (2) The time, venue, and way of hearing; (3) The names of the hearing personnel; (4) Notifying the parties concerned of the right to plead withdrawal; and (5) Notifying the parties concerned to prepare for evidences, inform witnesses, etc. Article 37. After receiving the notice of hearing, the parties concerned shall appear at the hearing in time. They may also entrust one or two agents to appear at the hearing. In the event of entrusting any other person to appear at the hearing, an attorney of power that bears the signature or cachet of the parties concerned shall be submitted. In case any one cannot appear at the hearing at the scheduled time, it shall inform the DSAD that presides the hearing beforehand. Any one who fails to appear at the hearing without good reasons shall be deemed to have abandoned the request for holding hearings, and the DSAD shall record it down in writing. If, in the process of holding a hearing, any of the parties concerned requests for recession, the DSAD may announce the termination of the hearing, and record it down in the transcripts of the hearing. Article 38. The hearing personnel shall consist of the presiding hearer and the clerk. The presiding hearer shall be a member of the DSAD designated by the leader in-charge and shall not be an investigator of the case. Generally speaking, he shall be a member of the legal affairs section of the DSAD or one that engages in the legal affairs of the DSAD. The clerk shall be a member of the DSAD who is not an investigator of the case involved, and shall be responsible for making the transcripts of hearing and other matters. Article 39. Where any of the parties concerned holds that the presiding hearer or the clerk has an interest in the present case, it shall be entitled to plead withdrawal. The withdrawal of the presiding hearer shall be subject to the decision of the leader in-charge of the DSAD, and the withdrawal of the clerk shall be subject to the decision of the presiding hearer. Article 40. In any of the following circumstances, the hearing may be postponed: (1) Any of the parties concerned have good reasons to fail to appear at the hearing; (2) The grounds of the parties concerned for pleading withdrawal are tenable and it is thus necessary to re-select the hearing personnel; or (3) It is necessary to notify any new witness to be present or any new facts need to be investigated or verified. Article 41. When holding a hearing, the investigators of the case shall show the facts and evidences about the violation of the parties concerned, and make a suggestion of administrative punishment. The parties concerned shall make statements, defenses, and cross-examinations. Article 42. To hold a hearing, a "Hearing Transcripts" shall be filled in. The hearing transcripts shall specify the following matters: (1) A case briefing; (2) The name and address of the participants to the hearing; (3) The name of the presiding hearer and the clerk; (4) The time, venue, and way of hearing; (5) The facts and evidences produced and administrative punishment suggestions made by the investigators of the case; (6) The statements, defenses, and cross-examinations of the parties concerned; and (7) The signatures or cachets of the participants to the hearing. When the hearing comes to an end, the hearing transcripts shall be delivered to the parties concerned and the investigators of the case for verification. They shall affix their signatures or cachets to the transcripts after making sure that no errors exist. In case any of the parties concerned refuses to affix his signature, it shall be recorded down by the presiding hearer on the transcripts. Article 43. When the hearing comes to an end, the presiding hearer shall, on the basis of the hearing, make hearing suggestion, and shall fill in a "Hearing Suggestion" (see Annex 30). Article 44. If the hearing suggestion is not in conformity with the decision of punishment made prior to holding the hearing, the administrative punishment decision shall be effected according to the prescribed procedures. If the hearing suggestion diverges with the administrative punishment decision made prior to the hearing, it shall be subject to the decision of the leaders through collective discussions. Section III Simplified Procedures Article 45. In the event that the facts about the violation are clear and there are conclusive evidences, and any of the following administrative penalties shall be imposed, a decision of administrative punishment may be made on the spot: (1) Warning; (2) Fine of up to 50 yuan in the case of a citizen; (3) Fine of up to 1,000 yuan in the case of a legal person or any other organization. Article 46. Where the enforcement personnel makes an administrative punishment decision on the spot, they shall show their enforcement certificates to the parties concerned, and fill in a "Decision of On-the-spot Administrative Punishment" (see Annex 31) in predetermined format, with a serial number and with the official cachet of the DSAD. The "Decision of On-the-spot Administrative Punishment" shall specify the illegal acts of the parties concerned, the grounds of the administrative punishment (the name of the applicable laws, regulations, or ministerial rules and the corresponding articles, paragraphs, subparagraphs, and items), the content, time, and venue of the specific penalty, the channels for applying for administrative reconsideration or administrative action in the case of refusal to accept the administrative punishment decision, and the name of the DSAD. The parties concerned shall affix their signatures or fingerprints to the "Decision of On-the-spot Administrative Punishment", and shall be delivered by the enforcement personnel after affixing their own signatures. In the event that any party concerned refuses to affix this signature or fingerprint, it shall be recorded down by the enforcement personnel. Article 47. Where the DSAD makes an administrative punishment decision by applying the simplified procedures, it shall order, in written form and in the "Decision of Administrative Punishment", the parties concerned to get right or correct the violation acts within a prescribed time limit. Article 48. The administrative punishment decisions made on the spot by the enforcement personnel shall be submitted to the DSAD where they work for archival purposes. Section IV Service Article 49. The "Decision of Administrative Punishment" shall, after being announced, be delivered to the parties concerned on the spot, and the parties concerned shall affix their signatures to the "Receipt of Service" (see Annex 32). In case any of the parties concerned is not present at the scene, the "Decision of Administrative Punishment" shall be serviced to the party within seven days according to the provisions of the present Section. The "Decision of Administrative Punishment" shall be serviced by the investigators of the case involved to the entity or individual punished, and the addressee shall mark the date of receipt and affix his signature of cachet on the service receipt. The day marked on the service receipt shall be the day of service. The "Decision of Administrative Punishment" shall be serviced directly to the addressee. If the addressee is a citizen and is not present, the "Decision" may be received by an adult relation that dwells with him. If the addressee is a legal person or any other organization, the "Decision" shall be received by the legal representative of the legal person or the chief head in-charge of the other organization or the person of the legal person who is responsible for receiving mails. Article 50. In case the addressee or the adult relation that dwells together with him refuses to receive the "Decision of Administrative Punishment", the service person shall invite relevant persons of the grass-root organization or the entity where addressee works to be present at the scene, explain the situation, record down, on the service receipt of the "Decision of Administrative Punishment", the details of refusal and the date, and affix the signatures (cachets) of the service persons and witnesses, leave it at the place of the entity or individual subject to punishment, and it shall be deemed as having been serviced. Article 51. Where it is difficult for a decision to be serviced directly, it may be sent by the DSAD close by upon entrustment or be serviced by "double registered mail", and the date specified on the service receipt of the post office shall be the day of receipt. The administrative punishment of canceling the approval certificates of drugs and medical appliances imposed by the DSAD of the State Council shall be serviced by the DSAD of the province, autonomous region, or municipality where the entity subject to punishment is located. Article 52. If the whereabouts of the addressee are unknown or if it is impossible to service in any of the other ways provided in the present Provisions, the service may be made by means of public announcements. It shall be deemed that a service is successful sixty days after a public announcement is made. CHAPTER VI ENFORCEMENT AND WINDING UP CASES Article 53. After the "Decision of Administrative Punishment" is serviced, the parties concerned shall discharge it within the time period prescribed in the decision. Where the party is in real economic difficulty and has to postpone the payment of fine or has to pay the fine by installments, it may file a written application, and submit relevant evidential materials. If it is found by the persons handling the case after collaborative deliberation that it conforms to the relevant provisions, it may fill in an "Examination and Approval Form for Postponing the Payment of Fine or Paying Fine by Installments" (see Annex 33), and shall be subject to the approval of the leader in-charge of the DSAD that made the decision. Upon the approval of the leader in-charge, the party concerned may write a guarantee for postponing the payment of fine or paying the fine by installments, mark the specific time and amount for paying the fine delayed or by installments, affix his signature or cachet to the guarantee letter, and then may postpone the payment of fine or pay the fine by installments. Article 54. Where any party concerned refuses to accept the administrative punishment decision and pleads administrative reconsideration or lodges an administrative action, the administrative penalty shall not be suspended from enforcement, unless it is rule that the enforcement shall be suspended during the term of administrative reconsideration or administration action. Article 55. The DSAD that makes decisions of fines and confiscation of illegal gains shall be separated from the organ that collects the fines. With the exception of the fines to be paid on the spot, no enforcement personnel may not collect any fines on their initiatives. Article 56. For the decisions of administrative fines made on the spot according to Article 45 of the present Provisions, the enforcement personnel may, in either of the situations below, collect the fines on the spot: (1) The fine imposed is 20 yuan or less; or (2) It would be difficult to collect the fine unless it is collected on the spot. Article 57. In the remote areas or on water or areas of traffic inconvenient areas, after the DSAD and the enforcement personnel make a decision of punishment according to the present Provisions, and it is difficult for the parties concerned to pay fines at the designated banks, the enforcement personnel may, if the party concerned so requests, collect the fines on the spot. Article 58. Where the DSAD or the enforcement personnel collect any fine on the spot, it or they shall issue a receipt of fine uniformly designed and printed by the fiscal department of the province, autonomous region, or municipality directly under the Central Government to the parties concerned. The fines collected by the enforcement personnel on the spot shall be turned over to DSAD within two days as of the collection of the fine, and the DSAD shall turn over the fine within two days to the designated bank. Article 59. In case the party concerned fails to plead administrative reconsideration or to lodge an administrative action within the statutory time limit and fails to discharge the decision of punishment, the DSAD may take the measures described below: (1) If the party concerned fails to pay the fine during the time limit, it shall impose an additional fine of 3% of the fine per day; (2) It may plead the people's court to enforce the decision, and fill in an "Application Form for Mandatory Enforcement of Administrative Penalties" (see Annex 34). Article 60. After an administrative punishment decision is discharged or enforced, the case handling personnel shall fill in a "Report for Winding Up Administrative Punishment Cases" (see Annex 35), sort out and bind up the case materials, affix the cachets of the handling personnel, and put them on archival files. CHAPTER VII SUPPLEMENTARY PROVISIONS Article 61. Any DSAD or any of the enforcement personnel thereof who violates any of the present Provisions in the implementation of administrative punishments, it or he shall be subject to legal liabilities according to the relevant provisions of the Law of the People's Republic of China on Administrative Punishment, the Law of the People's Republic of China on the Administration of Drugs, the Regulation for the Implementation of the Law of the People's Republic of China on the Administration of Drugs, and the Regulation on the Supervision and Administration of Medical Appliances. Article 62. The papers of administrative punishment for the supervision and administration of drugs shall be printed by the local DSADs on their own initiatives according to the formats attached to the present Provisions. Article 63. A DSAD mentioned in the present Provisions shall refer to an administration or sub-administration for the supervision and regulation of drugs that is entitled to exercise the power of administrative punishment. Article 64. The present Provisions shall take effect as of July 1, 2003. As of the day when the present Provisions takes effect, the Procedures for Administrative Punishment in Pharmaceutical Supervision (No. 8 of the SADS) which was promulgated by the State Administration of Drug Supervision on August 1, 1999 and which took effect on the same day shall be abrogated concurrently. Annexes: (omitted) |
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