| | |
Order of the China Food and Drug Administration | | 国家食品药品监督管理总局令 |
| (No. 3) | | （第3号） |
| The Provisions on Procedures for Imposition of Food and Drug Administrative Penalty, as deliberated and adopted at the executive meeting of the China Food and Drug Administration (“CFDA”) on March 14, 2014, are hereby issued, and shall come into force on June 1, 2014. | | 《食品药品行政处罚程序规定》已于2014年3月14日经国家食品药品监督管理总局局务会议审议通过，现予公布，自2014年6月1日起施行。 |
| Director: Zhang Yong | | 局 长 张勇 |
| April 28, 2014 | | 2014年4月28日 |
| Provisions on Procedures for Imposition of Food and Drug Administrative Penalty | | 食品药品行政处罚程序规定 |
| | |
| Chapter I General Provisions | | 第一章 总 则 |
| Article 1 To regulate the exercise of the administrative penalty power by food and drug administrations and protect the lawful rights and interests of citizens, legal persons and other organizations, these Provisions are developed in accordance with the Administrative Penalty Law of the People's Republic of China (hereinafter referred to as the “Administrative Penalty Law”), the Administrative Compulsion Law of the People's Republic of China (hereinafter referred to as the “Administrative Compulsion Law”), the Food Safety Law of the People's Republic of China, the Drug Administration Law of the People's Republic of China, and other relevant laws and regulations. | | 第一条 为规范食品药品监督管理部门行使行政处罚权，保护公民、法人和其他组织的合法权益，根据《中华人民共和国行政处罚法》（以下简称行政处罚法）、《中华人民共和国行政强制法》（以下简称行政强制法）、《中华人民共和国食品安全法》、《中华人民共和国药品管理法》等有关法律法规，制定本规定。 |
| Article 2 Food and drug administrations shall comply with these Provisions in imposing administrative penalties on the entities or individuals that violate any law, regulation or rule concerning the administration of food, health food, drugs, cosmetics, and medical equipment. | | 第二条 食品药品监督管理部门对违反食品、保健食品、药品、化妆品、医疗器械管理法律、法规、规章的单位或者个人实施行政处罚，应当遵照本规定。 |
| Article 3 Food and drug administrations shall impose administrative penalties under the principles of openness, fairness and impartiality, and ensure that the facts are clear, the evidence is conclusive, the procedure is lawful, the application of laws, regulations and rules is accurate and appropriate, and the use of law enforcement documents is standard. | | 第三条 食品药品监督管理部门实施行政处罚，遵循公开、公平、公正的原则，做到事实清楚、证据确凿、程序合法、法律法规规章适用准确适当、执法文书使用规范。 |
| Article 4 Citizens, legal persons or other organizations have the right to make statements and arguments on the administrative penalties given by food and drug administrations, and they have the right to legally apply for administrative reconsideration or file administrative lawsuits against administrative penalty decisions. | | 第四条 公民、法人或者其他组织对食品药品监督管理部门给予的行政处罚，享有陈述、申辩权；对行政处罚不服的，有权依法申请行政复议或者提起行政诉讼。 |
| Article 5 Food and drug administrations shall establish an administrative penalty supervision system. | | 第五条 食品药品监督管理部门建立行政处罚监督制度。 |
| The food and drug administration at a higher level shall supervise the imposition of administrative penalties by food and drug administrations at lower levels. If the food and drug administration at a lower level makes an illegal or impropriate administrative penalty decision, the food and drug administration at a higher level shall order it to make correction within a prescribed time limit; and if the food and drug administration at the lower level fails to do so, shall legally modify or revoke the said decision. | | 上级食品药品监督管理部门对下级食品药品监督管理部门实施的行政处罚进行监督。上级食品药品监督管理部门对下级食品药品监督管理部门作出的违法或者不适当的行政处罚决定，责令其限期改正；逾期不改正的，依法予以变更或者撤销。 |
| | |
| Chapter II Jurisdiction | | 第二章 管 辖 |
| Article 6 Administrative penalties shall be subject to the jurisdiction of the food and drug administration at the place where the violation of law takes place. | | 第六条 行政处罚由违法行为发生地的食品药品监督管理部门管辖。 |
| Article 7 The food and drug administration of a county (district) or city (prefecture or autonomous prefecture) shall, according to its functions, have jurisdiction over the cases on food and drug administrative penalties within its administrative region. | | 第七条 县（区）、市（地、州）食品药品监督管理部门依职权管辖本行政区域内的食品药品行政处罚案件。 |
| The food and drug administration of a province, autonomous region or municipality directly under the Central Government shall, according to its functions, have jurisdiction over major or complicated cases on food and drug administrative penalties within its administrative region. | | 省、自治区、直辖市食品药品监督管理部门依职权管辖本行政区域内重大、复杂的食品药品行政处罚案件。 |
| The CFDA shall, according to its functions, have jurisdiction over cases where it shall impose administrative penalties and major or complicated cases on food and drug administrative penalties occurred nationwide. | | 国家食品药品监督管理总局依职权管辖应当由自己实施行政处罚的案件及全国范围内发生的重大、复杂的食品药品行政处罚案件。 |
| The food and drug administration of a province, autonomous region or municipality directly under the Central Government may, in accordance with laws, regulations and rules, and in light of its local actual circumstances, prescribe the specific division of hierarchical jurisdiction within its administrative region. | | 省、自治区、直辖市食品药品监督管理部门可以依据法律法规和规章，结合本地区实际，规定本行政区域内级别管辖的具体分工。 |
| Article 8 The food and drug administration at or above the county level may, within its statutory functions, authorize an organization meeting the conditions prescribed in Article 19 of the Administrative Penalty Law to impose administrative penalties. | | 第八条 县级以上食品药品监督管理部门可以在法定权限内委托符合行政处罚法第十九条规定条件的组织实施行政处罚。 |
| The authorized organization shall, within the scope of authorization, conduct a specific administrative act in the name of the authorizing department. The authorizing department shall direct and supervise the imposition of administrative penalty by the authorized organization and its relevant administrative law enforcement act, and assume legal liability for the consequences of such an act. | | 受委托的组织应当在委托范围内，以委托部门的名义作出具体行政行为。委托部门应当对受委托组织的行政处罚行为及其相关的行政执法行为进行指导和监督，并对该行为的后果承担法律责任。 |
| Article 9 The local office of food and drug administration set up by a county food and drug administration in a town or district shall exercise the administrative penalty power in accordance with the provisions of laws, regulations and rules. | | 第九条 县级食品药品监督管理部门在乡镇或者区域设置的食品药品监督管理派出机构，依照法律法规和规章的规定，行使行政处罚权。 |
| Article 10 Where two or more food and drug administrations have jurisdiction over a same violation of law of the party, the food and drug administration which first dockets the case shall have jurisdiction over the case. If two or more food and drug administrations have disputes over jurisdiction, they may settle the disputes through negotiation; and if the negotiation fails, they may request their common food and drug administration at the next higher level to designate jurisdiction. | | 第十条 对当事人的同一违法行为，两个以上食品药品监督管理部门均有管辖权的，由先行立案的食品药品监督管理部门管辖。对管辖权有争议的，应当协商解决；协商不成的，报请共同的上一级食品药品监督管理部门指定管辖。 |
| Article 11 When deeming necessary, the food and drug administration at a higher level may directly investigate and handle a case under the jurisdiction of the food and drug administration at a lower level, or transfer a case under its jurisdiction to the food and drug administration at a lower level for investigation and handling. | | 第十一条 上级食品药品监督管理部门认为必要时可以直接查处下级食品药品监督管理部门管辖的案件，也可以将自己管辖的案件移交下级食品药品监督管理部门查处。 |
| If the food and drug administration at a lower level is unable to exercise jurisdiction over a case under its jurisdiction due to any particular reason, it may request the food and drug administration at a higher level to exercise jurisdiction or designate jurisdiction. | | 下级食品药品监督管理部门对本部门管辖的案件由于特殊原因不能行使管辖权的，可以报请上级食品药品监督管理部门管辖或者指定管辖。 |
| Article 12 The food and drug administration at a higher level shall, within ten working days of receiving the disputes over jurisdiction or a request for instructions on designating jurisdiction, make a jurisdiction designation decision and notify the food and drug administration at the lower level of the decision in writing. | | 第十二条 上级食品药品监督管理部门接到管辖争议或者报请指定管辖请示后，应当在10个工作日内作出指定管辖的决定，并书面通知下级部门。 |
| Article 13 Where a food and drug administration discovers that a case accepted by it is not under its jurisdiction, it shall, in a timely manner, transfer the case to the food and drug administration having jurisdiction over the case or the relevant administrative department for handling. | | 第十三条 食品药品监督管理部门发现案件不属于本部门管辖的，应当及时移送有管辖权的食品药品监督管理部门或者相关行政管理部门处理。 |
| The food and drug administration that accepts the transferred case shall, in a timely manner, inform by letter the food and drug administration that transfers the case of the case investigation and handling result; and if it deems that the transfer is inappropriate, shall request their common food and drug administration at the next higher level to designate jurisdiction, and shall not re-transfer the case. | | 受移送的食品药品监督管理部门应当将案件查处结果及时函告移送案件的食品药品监督管理部门；认为移送不当的，应当报请共同的上一级食品药品监督管理部门指定管辖，不得再次移送。 |
| Article 14 Where the food and drug administration finds that any violation of law is suspected of a crime when investigating and handling a case, it shall, in a timely manner, transfer the case to the public security authority at the same level according to the requirements of the Provisions on the Transfer of Suspected Criminal Cases by Administrative Law Enforcement Authorities. | | 第十四条 食品药品监督管理部门在查处案件时，发现违法行为涉嫌犯罪的，应当按照《行政执法机关移送涉嫌犯罪案件的规定》的要求，及时移送同级公安机关。 |
| Where the public security authority decides to docket the case, the food and drug administration shall, within three days of receiving the case docketing notice of the public security authority, transfer the articles involved in the case and other materials relating to the case to the public security authority, and complete handover formalities; and for the seized or impounded articles involved in a case, it shall fill out the transfer notice of seized or impounded articles, and notify the party in writing. | | 公安机关决定立案的，食品药品监督管理部门应当自接到公安机关立案通知书之日起3日内将涉案物品以及与案件有关的其他材料移交公安机关，并办结交接手续；对涉案的查封扣押物品，还应当填写查封扣押物品移交通知书，并书面告知当事人。 |
| Article 15 Where a food and drug administration needs assistance from the food and drug administration of any other region in the investigation and taking of evidence when handling an administrative penalty case, it shall issue a letter to request assistance in the investigation. The department providing assistance shall complete the relevant work within 15 working days of receiving the investigation assistance letter; and if an extension is required to complete the work, notify the department requesting assistance in investigation in a timely manner. | | 第十五条 食品药品监督管理部门办理行政处罚案件需要其他地区食品药品监督管理部门协助调查、取证的，应当出具协助调查函。协助部门一般应当在接到协助调查函之日起15个工作日内完成相关工作；需要延期完成的，应当及时告知提出协查请求的部门。 |
| Article 16Where the food and drug administrative license shall be suspended or approval certification documents shall be revoked in accordance with law, the suspension or revocation decision shall be made by the food and drug administration that issued the license or granted approval. | | 第十六条 依法应当吊销食品药品行政许可证或者撤销批准证明文件的，由原发证或者批准的食品药品监督管理部门决定。 |
| Where, in the investigation and handling of a case on a violation of law, the license shall be suspended or approval certification documents shall be revoked in accordance with law, the food and drug administration shall, when imposing an administrative penalty within its functions, submit the evidence obtained and the relevant materials to the food and drug administration that issued the license or granted approval, which shall make an administrative penalty decision on whether to suspend the license or revoke the approval certification documents in accordance with law. If it is for the CFDA to revoke the approval certification documents, the food and drug administration of the province, autonomous region or municipality directly under the Central Government shall report to the CFDA for decision-making. | | 食品药品监督管理部门查处违法案件，对依法应当吊销许可证或者撤销批准证明文件的，在其权限内依法实施行政处罚的同时，应当将取得的证据及相关材料报送原发证、批准的食品药品监督管理部门，由原发证、批准的部门依法作出是否吊销许可证或者撤销批准证明文件的行政处罚决定。需由国家食品药品监督管理总局撤销批准证明文件的，由省、自治区、直辖市食品药品监督管理部门报国家食品药品监督管理总局决定。 |
| The administrative penalty decision of legally suspending the license or revoking approval certification documents shall be made by the department that issued the license or granted approval pursuant to these Provisions. | | 原发证、批准的部门依法作出吊销许可证和撤销批准证明文件的行政处罚决定，依照本规定进行。 |
| | |
| Chapter III Case Docketing | | 第三章 立 案 |
| Article 17 The food and drug administration shall investigate and handle the following matters in a timely manner: | | 第十七条 食品药品监督管理部门应当对下列事项及时调查处理： |
| (1) Matters in which any case clue is found in supervision, inspection and selective inspection. | | （一）在监督检查及抽验中发现案件线索的； |
| (2) Matters against which a lawsuit if filed or tip-off is made by any citizen, legal person, or any other organization. | | （二）公民、法人或者其他组织投诉、举报的； |
| (3) Matters assigned by the superior authority for handling or requested by the authority at a lower level for investigation and handling. | | （三）上级机关交办或者下级机关报请查处的； |
| (4) Matters transferred by any other relevant department or disclosed by other ways or means. | | （四）有关部门移送或者经由其他方式、途径披露的。 |
| Where the conditions for docketing a case are met, the case shall be docketed within seven working days. | | 符合立案条件的，应当在7个工作日内立案。 |
| Article 18 A case shall be docketed if the following conditions are met: | | 第十八条 立案应当符合下列条件： |
| (1) There is a definite suspect of violation. | | （一）有明确的违法嫌疑人； |
| (2) There are facts of violation. | | （二）有违法事实； |
| (3) It falls within the scope of administrative penalty imposed by the food and drug administration. | | （三）属于食品药品监督管理行政处罚的范围； |
| (4) It falls under the jurisdiction of this administration. | | （四）属于本部门管辖。 |
| Where the conditions for docketing a case are met, a report shall be made to the divisional person in charge for the approval of case docketing, and two or more law enforcement personnel shall be determined as case handling persons. | | 符合立案条件的，应当报分管负责人批准立案，并确定2名以上执法人员为案件承办人。 |
| Article 19 Where any case handling person falls under any of the following circumstances, such a person shall voluntarily withdraw, and the party shall be entitled to request the withdrawal thereof: | | 第十九条 办案人员有下列情形之一的，应当自行回避；当事人也有权申请其回避： |
| (1) The person is a party to the case or a close relative of a party to the case. | | （一）是本案的当事人或者当事人的近亲属； |
| (2) The person is an interested party to the case. | | （二）与本案有直接利害关系； |
| (3) The person has any other relationship with a party to the case, which may affect the impartial handling of the case. | | （三）与本案当事人有其他关系，可能影响案件公正处理的。 |
The withdrawal of the case handling person shall be decided by the divisional person in charge of the food and drug administration, and the withdrawal of the person in charge shall be decided through the collective discussion of other persons in charge of the administration.
．．．．．． | | 办案人员的回避由食品药品监督管理部门分管负责人决定，负责人的回避由部门其他负责人集体研究决定。
．．．．．． |
|
Dear visitor, as a premium member of this database, you will get complete access to all content.Please go premium and get more.
1. To become a premium member, please call 400-810-8266 Ext. 171.
2. Binding to the account with access to this database.
3. Apply for a trial account.
4. To get instant access to a document, you can Pay Amount 【￥900.00】 for your single purchase. | |
您好：您现在要进入的是北大法宝英文库会员专区。
如您是我们英文用户可直接 登录，进入会员专区查询您所需要的信息；如您还不是我们 的英文用户；您可通过网上支付进行单篇购买，支付成功后即可立即查看本篇内容。
Tel: +86 (10) 82689699, +86 (10) 82668266 ext. 153
Mobile: +86 13311570713
Fax: +86 (10) 82668268
E-mail:info@chinalawinfo.com
|
| | | |
| | | |