- 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
- （一）以非兽药冒充兽药或者以他种兽药冒充此种兽药的； (1) a non-veterinary drug substance is passed off as a veterinary drug or one veterinary drug is passed off as another; or
- （四）兽药的标签和说明书样本； (4) a sample copy of the label and package leaflet of the veterinary drug;
- （五）兽药的样品、对照品、标准品； (5) a sample, reference substance and standard substance of the veterinary drug;
- 兽药经营许可证有效期为５年。有效期届满，需要继续经营兽药的，应当在许可证有效期届满前６个月到原发证机关申请换发兽药经营许可证。 A Veterinary Drug Distribution Licence is valid for five years. A distributor that needs to continue the distribution of veterinary drugs after the expiry date shall, six months before the expiration of the licence, apply to the original department that issued the licence for renewal of the Veterinary Drug Distribution Licence.
- 禁止兽药经营企业经营人用药品和假、劣兽药。 A veterinary drug distributor is prohibited from distributing drugs for human use, as well as counterfeit and substandard veterinary drugs.
- 兽药生产企业应当建立生产记录，生产记录应当完整、准确。 A veterinary drug manufacturer shall keep records of production, which shall be complete and accurate.
- 兽药生产许可证有效期为５年。有效期届满，需要继续生产兽药的，应当在许可证有效期届满前６个月到原发证机关申请换发兽药生产许可证。 A Veterinary Drug Manufacturing Licence is valid for five years. A manufacturer that needs to continue the production of veterinary drugs after the expiry date shall, six months before the expiration of the licence, apply to the original department that issued the licence for renewal of the Veterinary Drug Manufacturing Licence.
- 有下列情形之一的，按照假兽药处理： A veterinary drug shall be treated as counterfeit in any of the following cases:
- 兽药出厂应当附有产品质量合格证。 A veterinary drug that leaves the manufacturing plant shall bear a certificate of quality.
- 兽用生物制品进口后，应当依照本条例第十九条的规定进行审查核对和抽查检验。其他兽药进口后，由当地兽医行政管理部门通知兽药检验机构进行抽查检验。 After it is imported, a veterinary biologic shall undergo verification and sampling tests in accordance with the provisions of Article 19 of these Regulations. After other veterinary drugs are imported, the local administrative department for veterinary medicine shall notify the veterinary drug test institution to conduct sampling tests.
- 兽药入库、出库，应当执行检查验收制度，并有准确记录。 An inspection and acceptance system shall be implemented for placing veterinary drugs in and releasing them from the storehouse, and accurate records shall be kept in this regard.
- 违反本条例规定，研制新兽药不具备规定的条件擅自使用一类病原微生物或者在实验室阶段前未经批准的，责令其停止实验，并处５万元以上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。 Any entity that, in violation of the provisions of these Regulations, uses pathogenic microorganisms of Class I in the research and development of a new veterinary drug with no conditions required, or does so with no approval obtained prior to the laboratory stage shall be ordered to desist from the experimentation and shall, in addition, be fined not less than 50,000 yuan but not more than 100,000 yuan; if a crime is constituted, it shall be investigated for criminal liability in accordance with the law; if losses are caused to another person, it shall bear the liability for compensation in accordance with the law.
- 生产企业在新兽药监测期内不收集或者不及时报送该新兽药的疗效、不良反应等资料的，责令其限期改正，并处１万元以上５万元以下罚款；情节严重的，撤销该新兽药的产品批准文号。 Any manufacturer that, during the period of surveillance of a new veterinary drug, fails to collect or to promptly submit the data concerning the therapeutic efficacy and adverse reactions of the drug shall be ordered to rectify within a time limit and shall, in addition, be fined not less than 10,000 yuan but not more than 50,000 yuan; if the circumstances are serious, the approval number of the product for the drug shall be revoked.
- 当事人对兽药检验结果有异议的，可以自收到检验结果之日起７个工作日内向实施检验的机构或者上级兽医行政管理部门设立的检验机构申请复检。 Any party that objects to the testing result of a veterinary drug may, within seven working days from the date it receives the testing result, apply for a retest to the institution that did the testing or a test institution established by the administrative department for veterinary medicine at a higher level.
- 动物产品的生产者、销售者对检测结果有异议的，可以自收到检测结果之日起７个工作日内向组织实施兽药残留检测的兽医行政管理部门或者其上级兽医行政管理部门提出申请，由受理申请的兽医行政管理部门指定检验机构进行复检。 Any producer or seller of animal products that objects to the detection results may, within seven working days from the date it receives the results, submit an application to the administrative department for veterinary medicine that arranges for the detection of the residue of veterinary drugs or the administrative department for veterinary medicine at the next higher level, and the administrative department for veterinary medicine that accepts the application shall designate a test institution for a retest.
- 第一条 为了加强兽药管理，保证兽药质量，防治动物疾病，促进养殖业的发展，维护人体健康，制定本条例。 Article 1 These Regulations are formulated for the purpose of strengthening the administration of veterinary drugs, ensuring the quality of such drugs, preventing and controlling animal diseases, promoting the development of breeding industry, and safeguarding human health.
- 第十条 国家对依法获得注册的、含有新化合物的兽药的申请人提交的其自己所取得且未披露的试验数据和其他数据实施保护。 Article 10 The State offers protection to the undisclosed test data and other data, accumulated by the applicant itself and submitted by it, which concern the veterinary drug that has been registered according to law and contains a new compound.
- 第十一条 设立兽药生产企业，应当符合国家兽药行业发展规划和产业政策，并具备下列条件： Article 11 A veterinary drug manufacturer shall be established in conformity with the national development programme and policy for the veterinary drug industry and shall meet the following requirements:
- 第十二条 兽药生产许可证应当载明生产范围、生产地点、有效期和法定代表人姓名、住址等事项。 Article 12 In the Veterinary Drug Manufacturing Licence shall be clearly stated the scope and place of manufacturing, expiry date, the name and address of the legal representative, etc.
- 第十三条 兽药生产企业变更生产范围、生产地点的，应当依照本条例第十一条的规定申请换发兽药生产许可证，申请人凭换发的兽药生产许可证办理工商变更登记手续；变更企业名称、法定代表人的，应当在办理工商变更登记手续后１５个工作日内，到原发证机关申请换发兽药生产许可证。 Article 13 Where intending to change its scope or place of manufacturing, a veterinary drug manufacturer shall apply for renewal of the Veterinary Drug Manufacturing Licence in accordance with the provisions of Article 11 of these Regulations, and the applicant shall, on the basis of the renewed Veterinary Drug Manufacturing Licence, complete the formalities for change of business registration; where intending to change the name of the enterprise or its legal representative, it shall, within 15 working days after it completes the formalities for change of business registration, apply to the original department that issued the licence for renewal of the Veterinary Drug Manufacturing Licence.
- 第十四条 兽药生产企业应当按照国务院兽医行政管理部门制定的兽药生产质量管理规范组织生产。 Article 14 A veterinary drug manufacturer shall conduct production in accordance with the Good Manufacturing Practice for Veterinary Drugs laid down by the administrative department for veterinary medicine of the State Council.
- 第十五条 兽药生产企业生产兽药，应当取得国务院兽医行政管理部门核发的产品批准文号，产品批准文号的有效期为５年。兽药产品批准文号的核发办法由国务院兽医行政管理部门制定。 Article 15 To produce a veterinary drug, a veterinary drug manufacturer shall acquire an approval number for the product verified and issued by the administrative department for veterinary medicine of the State Council, and such approval number of the product is valid for five years. The measures for verifying and issuing such an approval number for the product shall be formulated by the administrative department for veterinary medicine of the State Council.
- 第十六条 兽药生产企业应当按照兽药国家标准和国务院兽医行政管理部门批准的生产工艺进行生产。兽药生产企业改变影响兽药质量的生产工艺的，应当报原批准部门审核批准。 Article 16 A veterinary drug manufacturer shall conduct production in accordance with the national standards for veterinary drugs and the manufacturing process approved by the administrative department for veterinary medicine of the State Council. When intending to alter the manufacturing process that affects the quality of a veterinary drug, a veterinary drug manufacturer shall report the matter to the original approval department for verification and approval.
- 第十七条 生产兽药所需的原料、辅料，应当符合国家标准或者所生产兽药的质量要求。 Article 17 The substances and excipients used for the production of veterinary drugs shall be up to the national standards or the quality required for the veterinary drugs produced.
- 第十八条 兽药出厂前应当经过质量检验，不符合质量标准的不得出厂。 Article 18 A veterinary drug shall be subject to quality test before it leaves the manufacturing plant, and it shall not be released if it does not conform to the quality standards.
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