- 兽药管理条例中英文对照 A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
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兽药管理条例中英文对照
- 第六十四条 违反本条例规定，擅自转移、使用、销毁、销售被查封或者扣押的兽药及有关材料的，责令其停止违法行为，给予警告，并处５万元以上１０万元以下罚款。 Article 64 Any entity that, in violation of the provisions of these Regulations, transfers, uses, destroys or sells without approval the veterinary drugs or relevant materials which are sealed up or distrained shall be ordered to desist from the violation, shall be given a warning and shall, in addition, be fined not less than 50,000 yuan but not more than 100,000 yuan.
- 第六十五条 违反本条例规定，兽药生产企业、经营企业、兽药使用单位和开具处方的兽医人员发现可能与兽药使用有关的严重不良反应，不向所在地人民政府兽医行政管理部门报告的，给予警告，并处５０００元以上１万元以下罚款。 Article 65 Any veterinary drug manufacturer, distributor or user, or veterinarian who prescribes drugs that discovers serious adverse reactions that are possibly induced by the use of a veterinary drug but, in violation of the provisions of these Regulations, fails to report the matter to the administrative department for veterinary medicine of the local people’s government, shall be given a warning and shall, in addition, be fined not less than 5,000 yuan but not more than 10,000 yuan.
- 第六十六条 违反本条例规定，未经兽医开具处方销售、购买、使用兽用处方药的，责令其限期改正，没收违法所得，并处５万元以下罚款；给他人造成损失的，依法承担赔偿责任。 Article 66 Any entity that, in violation of the provisions of these Regulations, sells, purchases or uses veterinary prescription drugs without the prescription of a veterinarian shall be ordered to rectify within a time limit, its unlawful gains shall be confiscated and, in addition, a fine of not more than 50,000 yuan shall be imposed; if losses are caused to another person, the liability for compensation shall be borne in accordance with the law.
- 第六十七条 违反本条例规定，兽药生产、经营企业把原料药销售给兽药生产企业以外的单位和个人的，或者兽药经营企业拆零销售原料药的，责令其立即改正，给予警告，没收违法所得，并处２万元以上５万元以下罚款；情节严重的，吊销兽药生产许可证、兽药经营许可证；给他人造成损失的，依法承担赔偿责任。 Article 67 In violation of the provisions of these Regulations, any veterinary drug manufacturer or distributor that sells a bulk veterinary drug to other units or individuals than veterinary drug manufacturers, or any veterinary drug distributor that sells such a drug piecemeal, shall be ordered to rectify promptly and shall be given a warning, its unlawful gains shall be confiscated and, in addition, a fine of not less than 20,000 yuan but not more than 50,000 yuan shall be imposed; if the circumstances are serious, its Veterinary Drug Manufacturing Licence or Veterinary Drug Distribution Licence shall be revoked; if losses are caused to another person, the liability for compensation shall be borne in accordance with the law.
- 第六十八条 违反本条例规定，在饲料和动物饮用水中添加激素类药品和国务院兽医行政管理部门规定的其他禁用药品，依照《饲料和饲料添加剂管理条例》的有关规定处罚；直接将原料药添加到饲料及动物饮用水中，或者饲喂动物的，责令其立即改正，并处１万元以上３万元以下罚款；给他人造成损失的，依法承担赔偿责任。 Article 68 Any entity that, in violation of the provisions of these Regulations, adds in animal feed or drinking water any hormonal drug or other prohibited drugs specified by the administrative department for veterinary medicine of the State Council shall be punished in accordance with the relevant provisions of the Regulations on Administration of Animal Feed and Feed Additives; any entity that directly adds a bulk drug in animal feed or drinking water or administers such a drug to animals shall be ordered to rectify promptly and shall, in addition, be fined not less than 10,000 yuan but not more than 30,000 yuan; if losses are caused to another person, the liability for compensation shall be borne in accordance with the law.
- 第六十九条 有下列情形之一的，撤销兽药的产品批准文号或者吊销进口兽药注册证书： Article 69 In any of the following cases the approval number of a product for a veterinary drug shall be cancelled or the Registration Certificate of Imported Veterinary Drugs be revoked:
- 第七条 研制新兽药，应当具有与研制相适应的场所、仪器设备、专业技术人员、安全管理规范和措施。 Article 7 For research and development of a new veterinary drug, there shall be premises, instruments and equipment, professional technicians, standards and measures for safety control commensurate with the research and development work.
- 第七十条 本条例规定的行政处罚由县级以上人民政府兽医行政管理部门决定；其中吊销兽药生产许可证、兽药经营许可证、撤销兽药批准证明文件或者责令停止兽药研究试验的，由原发证、批准部门决定。 Article 70 The administrative penalties provided for by these Regulations shall be decided on by the administrative department for veterinary medicine of the people’s government at or above the county level; among such penalties, the decision on revocation of the Veterinary Drug Manufacturing Licence or Veterinary Drug Distribution Licence, on withdrawal of the veterinary drug approval document or on an order for desisting from the research and trial of veterinary drugs shall be made by the original department that issues the licence or document or the approval department.
- 第七十一条 本条例规定的货值金额以违法生产、经营兽药的标价计算；没有标价的，按照同类兽药的市场价格计算。 Article 71 The value of a veterinary drug mentioned in these Regulations shall be calculated on the basis of the marked price of the veterinary drug illegally produced or distributed; if there is no price marked, it shall be calculated on the basis of the market price of the veterinary drug of the same kind.
- 第七十二条 本条例下列用语的含义是： Article 72 The meanings of the following terms used in these Regulations are:
- 第七十三条 兽用麻醉药品、精神药品、毒性药品和放射性药品等特殊药品，依照国家有关规定管理。 Article 73 Special drugs including narcotic drugs, psychotropic substances, toxic drugs and radioactive pharmaceuticals used for animals shall be administered in accordance with the relevant provisions of the State.
- 第七十四条 水产养殖中的兽药使用、兽药残留检测和监督管理以及水产养殖过程中违法用药的行政处罚，由县级以上人民政府渔业主管部门及其所属的渔政监督管理机构负责。 Article 74 The use, detection of residues, supervision and administration of veterinary drugs in aquaculture, and the imposition of administrative penalties for unlawful use of drugs in the course of breeding aquatics shall be the responsibility of the competent department for fisheries of the people’s government at or above the county level and the fisheries authorities affiliated to the department.
- 第七十五条 本条例自２００４年１１月１日起施行。 Article 75 These Regulations shall be effective as of November 1, 2004.
- 第八条 研制新兽药，应当在临床试验前向省、自治区、直辖市人民政府兽医行政管理部门提出申请，并附具该新兽药实验室阶段安全性评价报告及其他临床前研究资料；省、自治区、直辖市人民政府兽医行政管理部门应当自收到申请之日起６０个工作日内将审查结果书面通知申请人。 Article 8 For research and development of a new veterinary drug, an application attached with a report of safety evaluation made at the laboratory stage and other pre-clinical study data on the drug shall, before clinical trials are conducted, be submitted to the administrative department for veterinary medicine of the people’s government of the province, autonomous region or municipality directly under the Central Government, which shall notify the applicant of the result of examination in writing within 60 working days from the date it receives the application.
- 第九条 临床试验完成后，新兽药研制者向国务院兽医行政管理部门提出新兽药注册申请时，应当提交该新兽药的样品和下列资料： Article 9 When applying to the administrative department for veterinary medicine of the State Council for registration of a new veterinary drug after clinical trials are concluded, the researcher and developer of the drug shall submit a sample of the drug and the following data:
- 国内急需兽药、少量科研用兽药或者注册兽药的样品、对照品、标准品的进口，按照国务院兽医行政管理部门的规定办理。 As for the importation of a veterinary drug urgently needed by a domestic user, a small amount of a veterinary drug to be used for scientific research, or the sample, reference substance or standard substance of a registered veterinary drug, the matter shall be handled in accordance with the provisions laid down by the administrative department for veterinary medicine of the State Council.
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