- 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
- 第四十一条 国务院兽医行政管理部门，负责制定公布在饲料中允许添加的药物饲料添加剂品种目录。 Article 41 The administrative department for veterinary medicine of the State Council shall be responsible for compiling and publishing a catalogue of the varieties of medicated feed additives permitted to be added in animal feed.
- 第四十二条 国务院兽医行政管理部门，应当制定并组织实施国家动物及动物产品兽药残留监控计划。 Article 42 The administrative department for veterinary medicine of the State Council shall formulate and arrange for the implementation of national programmes for monitoring the residue of veterinary drugs in animals and their products.
- 第四十三条 禁止销售含有违禁药物或者兽药残留量超过标准的食用动物产品。 Article 43 It is prohibited to sell food animal products that contain illicit drugs or in which the residual amount of veterinary drugs exceeds the limits.
- 第四十四条 县级以上人民政府兽医行政管理部门行使兽药监督管理权。 Article 44 The administrative department for veterinary medicine of the people’s government at or above the county level shall exercise the power of supervision and administration of veterinary drugs.
- 第四十五条 兽药应当符合兽药国家标准。 Article 45 Veterinary drugs shall measure up to the national standards of such drugs.
- 第四十六条 兽医行政管理部门依法进行监督检查时，对有证据证明可能是假、劣兽药的，应当采取查封、扣押的行政强制措施，并自采取行政强制措施之日起７个工作日内作出是否立案的决定；需要检验的，应当自检验报告书发出之日起１５个工作日内作出是否立案的决定；不符合立案条件的，应当解除行政强制措施；需要暂停生产、经营和使用的，由国务院兽医行政管理部门或者省、自治区、直辖市人民政府兽医行政管理部门按照权限作出决定。 Article 46 When carrying out supervision and inspection in accordance with the law, the administrative department for veterinary medicine shall take compulsory administrative measures to seal up or distrain the veterinary drugs that are proved to be potentially counterfeit or substandard and shall, within seven working days from the date it takes the compulsory administrative measures, decide on whether or not to place the case on file; where test is needed, it shall, within 15 working days from the date the test report is issued, decide on whether or not to place the case on file; where the conditions for placing the case on file are not satisfied, it shall discontinue the compulsory administrative measures; where the manufacturing, distribution or use of the drug needs to be suspended, the administrative department for veterinary medicine of the State Council or the administrative department for veterinary medicine of the people’s government of the province, autonomous region or municipality directly under the Central Government shall make a decision thereon within their respective limits of power.
- 第四十七条 有下列情形之一的，为假兽药： Article 47 A veterinary drug is a counterfeit one in any of the following cases:
- 第四十八条 有下列情形之一的，为劣兽药： Article 48 A veterinary drug is a substandard one in any of the following cases:
- 第四十九条 禁止将兽用原料药拆零销售或者销售给兽药生产企业以外的单位和个人。 Article 49 It is prohibited to sell a bulk veterinary drug piecemeal or sell such a drug to other units or individuals than veterinary drug manufacturers.
- 第五条 国家实行兽药储备制度。 Article 5 The State adopts a system for reserve of veterinary drugs.
- 第五十条 国家实行兽药不良反应报告制度。 Article 50 The State practises a report system for adverse reactions of veterinary drugs.
- 第五十一条 兽药生产企业、经营企业停止生产、经营超过６个月或者关闭的，由原发证机关责令其交回兽药生产许可证、兽药经营许可证，并由工商行政管理部门变更或者注销其工商登记。 Article 51 Where a veterinary drug manufacturer or distributor has suspended production or distribution for at least six months or is closed down, the original department that issued the licence shall order it to return the Veterinary Drug Manufacturing Licence or the Veterinary Drug Distribution Licence, and the administrative department for industry and commerce shall change or cancel its business registration.
- 第五十二条 禁止买卖、出租、出借兽药生产许可证、兽药经营许可证和兽药批准证明文件。 Article 52 Trading in, renting out or lending the Veterinary Drug Manufacturing Licence, Veterinary Drug Distribution Licence or veterinary drug approval documents is prohibited.
- 第五十三条 兽药评审检验的收费项目和标准，由国务院财政部门会同国务院价格主管部门制定，并予以公告。 Article 53 The items and rates of fees charged for evaluation and testing of veterinary drugs shall be decided on and published by the finance department of the State Council jointly with the competent pricing department of the State Council.
- 第五十四条 各级兽医行政管理部门、兽药检验机构及其工作人员，不得参与兽药生产、经营活动，不得以其名义推荐或者监制、监销兽药。 Article 54 No administrative departments for veterinary medicine or veterinary drug test institutions at various levels, nor their staff members may be involved in the manufacturing or distribution of veterinary drugs, nor may they recommend veterinary drugs in their names or have the supervisors for drug manufacturing or sale named after them.
- 第五十五条 兽医行政管理部门及其工作人员利用职务上的便利收取他人财物或者谋取其他利益，对不符合法定条件的单位和个人核发许可证、签署审查同意意见，不履行监督职责，或者发现违法行为不予查处，造成严重后果，构成犯罪的，依法追究刑事责任；尚不构成犯罪的，依法给予行政处分。 Article 55 Any administrative department for veterinary medicine or any of its staff members that, taking advantage of its position, accepts another person’s money or things of value or seeks other benefits, issues licences or, after examination, grants approval with its signature to the unit or individual that does not meet the statutory requirements, fails to fulfill its duties of supervision, or fails to investigate and punish violations of law it discovers, which causes serious consequences and constitutes a crime, shall be investigated for criminal liability in accordance with the law; if no crime is constituted, it shall be given administrative sanctions in accordance with the law.
- 第五十六条 违反本条例规定，无兽药生产许可证、兽药经营许可证生产、经营兽药的，或者虽有兽药生产许可证、兽药经营许可证，生产、经营假、劣兽药的，或者兽药经营企业经营人用药品的，责令其停止生产、经营，没收用于违法生产的原料、辅料、包装材料及生产、经营的兽药和违法所得，并处违法生产、经营的兽药（包括已出售的和未出售的兽药，下同）货值金额２倍以上５倍以下罚款，货值金额无法查证核实的，处１０万元以上２０万元以下罚款；无兽药生产许可证生产兽药，情节严重的，没收其生产设备；生产、经营假、劣兽药，情节严重的，吊销兽药生产许可证、兽药经营许可证；构成犯罪的，依法追究刑事责任；给他人造成损失的，依法承担赔偿责任。生产、经营企业的主要负责人和直接负责的主管人员终身不得从事兽药的生产、经营活动。 Article 56 In violation of the provisions of these Regulations, any entity that produces or distributes veterinary drugs without a Veterinary Drug Manufacturing Licence or Veterinary Drug Distribution Licence, or produces or distributes counterfeit or substandard veterinary drugs even if it has a Veterinary Drug Manufacturing Licence or Veterinary Drug Distribution Licence, or any veterinary drug distributor that distributes drugs for human use, shall be ordered to desist from producing or distributing the drugs, the drug substances, excipients and packaging materials used for illegal production, as well as the veterinary drugs produced or distributed and the unlawful gains therefrom shall be confiscated and, in addition, a fine of not less than two times but not more than five times the value of the veterinary drugs illegally produced or distributed (including the veterinary drugs sold and not sold, the same below) shall be imposed; if the amount of the value cannot be investigated and verified, a fine of not less than 100,000 yuan but not more than 200,000 yuan shall be imposed; if veterinary drugs are produced without a Veterinary Drug Manufacturing Licence and the circumstances are serious, the manufacturing equipment shall be confiscated; if counterfeit or substandard veterinary drugs are produced or distributed and the circumstances are serious, its Veterinary Drug Manufacturing Licence or Veterinary Drug Distribution Licence shall be revoked; if a crime is constituted, criminal liability shall be investigated in accordance with the law; if losses are caused to another person, the liability for compensation shall be borne in accordance with the law. The principal leading members of the manufacturer or distributor and the persons in charge who are directly responsible shall not be allowed to engage in production or distribution of veterinary drugs for their lifetime.
- 第五十七条 违反本条例规定，提供虚假的资料、样品或者采取其他欺骗手段取得兽药生产许可证、兽药经营许可证或者兽药批准证明文件的，吊销兽药生产许可证、兽药经营许可证或者撤销兽药批准证明文件，并处５万元以上１０万元以下罚款；给他人造成损失的，依法承担赔偿责任。其主要负责人和直接负责的主管人员终身不得从事兽药的生产、经营和进出口活动。 Article 57 Where an entity, in violation of the provisions of these Regulations, obtains the Veterinary Drug Manufacturing Licence, the Veterinary Drug Distribution Licence, or veterinary drug approval document by providing false data, samples or by other fraudulent means, its Veterinary Drug Manufacturing Licence or Veterinary Drug Distribution Licence shall be revoked, or the veterinary drug approval document shall be withdrawn and, in addition, a fine of not less than 50,000 yuan but not more than 100,000 yuan shall be imposed; if losses are caused to another person, the liability for compensation shall be borne in accordance with the law. The principal leading members of the entity and the persons in charge who are directly responsible shall not be allowed to engage in production, distribution, or importation and exportation of veterinary drugs for their lifetime.
- 第五十八条 买卖、出租、出借兽药生产许可证、兽药经营许可证和兽药批准证明文件的，没收违法所得，并处１万元以上１０万元以下罚款；情节严重的，吊销兽药生产许可证、兽药经营许可证或者撤销兽药批准证明文件；构成犯罪的，依法追究刑事责任；给他人造成损失的，依法承担赔偿责任。 Article 58 Where an entity trades in, rents out or lends the Veterinary Drug Manufacturing Licence, Veterinary Drug Distribution Licence or veterinary drug approval document, its unlawful gains therefrom shall be confiscated and, in addition, a fine of not less than 10,000 yuan but not more than 100,000 yuan shall be imposed; if the circumstances are serious, its Veterinary Drug Manufacturing Licence or Veterinary Drug Distribution Licence shall be revoked, or the veterinary drug approval document shall be withdrawn; if a crime is constituted, criminal liability shall be investigated in accordance with the law; if losses are caused to another person, the liability for compensation shall be borne in accordance with the law.
- 第五十九条 违反本条例规定，兽药安全性评价单位、临床试验单位、生产和经营企业未按照规定实施兽药研究试验、生产、经营质量管理规范的，给予警告，责令其限期改正；逾期不改正的，责令停止兽药研究试验、生产、经营活动，并处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 59 Any institution for veterinary drug safety evaluation or clinical trial or any manufacturer or distributor that, in violation of the provisions of these Regulations, fails to implement the Good Laboratory Practice, Good Clinical Practice, Good Manufacturing Practice or Good Sale Practice for Veterinary Drugs in accordance with the provisions shall be given a warning and shall be ordered to rectify within a time limit; if it fails to comply at the expiration of the time limit, it shall be ordered to desist from research and trial, production, or distribution of veterinary drugs and shall, in addition, be fined not more than 50,000 yuan; 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, it shall bear the liability for compensation in accordance with the law.
- 第六条 国家鼓励研制新兽药，依法保护研制者的合法权益。 Article 6 The State encourages research and development of new veterinary drugs and protects the legitimate rights and interests of researchers and developers according to law.
- 第六十条 违反本条例规定，兽药的标签和说明书未经批准的，责令其限期改正；逾期不改正的，按照生产、经营假兽药处罚；有兽药产品批准文号的，撤销兽药产品批准文号；给他人造成损失的，依法承担赔偿责任。 Article 60 Any entity that, in violation of the provisions of these Regulations, fails to have the label and package leaflet of a veterinary drug approved shall be ordered to rectify within a time limit; if it fails to comply at the expiration of the time limit, it shall be punished the same as for the manufacturing or distribution of counterfeit veterinary drugs; the approval number of the veterinary drug product, if any, shall be cancelled; if losses are caused to another person, the liability for compensation shall be borne in accordance with the law.
- 第六十一条 违反本条例规定，境外企业在中国直接销售兽药的，责令其限期改正，没收直接销售的兽药和违法所得，并处５万元以上１０万元以下罚款；情节严重的，吊销进口兽药注册证书；给他人造成损失的，依法承担赔偿责任。 Article 61 Any enterprise from abroad that, in violation of the provisions of these Regulations, directly sells veterinary drugs in China shall be ordered to rectify within a time limit, the veterinary drugs for direct sale and its unlawful gains shall be confiscated and, in addition, a fine of not less than 50,000 yuan but not more than 100,000 yuan shall be imposed; if the circumstances are serious, its Registration Certificate of Imported Veterinary Drugs shall be revoked; if losses are caused to another person, the liability for compensation shall be borne in accordance with the law.
- 第六十二条 违反本条例规定，未按照国家有关兽药安全使用规定使用兽药的、未建立用药记录或者记录不完整真实的，或者使用禁止使用的药品和其他化合物的，或者将人用药品用于动物的，责令其立即改正，并对饲喂了违禁药物及其他化合物的动物及其产品进行无害化处理；对违法单位处１万元以上５万元以下罚款；给他人造成损失的，依法承担赔偿责任。 Article 62 Any entity that, in violation of the provisions of these Regulations, fails to use veterinary drugs in accordance with the provisions of the State on the safe use of veterinary drugs, or fails to keep a record of the use of the drugs or keeps an incomplete or untruthful record, or uses the drugs or other compounds the use of which is prohibited, or uses drugs for human use in animals, shall be ordered to rectify promptly and to give innocuous treatment to the animals that are administered with the illicit drugs or other compounds as well as to their products; the unit violating the provisions shall be fined not less than 10,000 yuan but not more than 50,000 yuan; if losses are caused to another person, the liability for compensation shall be borne in accordance with the law.
- 第六十三条 违反本条例规定，销售尚在用药期、休药期内的动物及其产品用于食品消费的，或者销售含有违禁药物和兽药残留超标的动物产品用于食品消费的，责令其对含有违禁药物和兽药残留超标的动物产品进行无害化处理，没收违法所得，并处３万元以上１０万元以下罚款；构成犯罪的，依法追究刑事责任；给他人造成损失的，依法承担赔偿责任。 Article 63 Any entity that, in violation of the provisions of these Regulations, sells animals being in the period of drug taking or withdrawal or their products as food for human consumption, or sells animal products, which contain any illicit drug or in which the residual amount of a veterinary drug exceeds the limits, as food for human consumption, shall be ordered to give innocuous treatment to the said animal products, its unlawful gains shall be confiscated and, in addition, a fine of not less than 30,000 yuan but not more than 100,000 yuan shall be imposed; if a crime is constituted, criminal liability shall be investigated in accordance with the law; if losses are caused to another person, the liability for compensation shall be borne in accordance with the law.
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