- 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
兽药管理条例中英文对照
- （一）成分含量不符合兽药国家标准或者不标明有效成分的； (1) the content of the ingredients is not up to the national standards of veterinary drugs, or the active ingredients are not indicated;
- （一）生产企业所在国家（地区）兽药管理部门批准生产、销售的证明文件； (1) the document certifying that the veterinary drug regulatory department of the country (region) where the manufacturer is located has approved the production or marketing of such drug;
- （一）抽查检验连续２次不合格的； (1) the drug fails to pass two consecutive sampling tests;
- （一）名称、主要成分、理化性质； (1) the name, principal ingredients and physicochemical characteristics;
- （二）生产企业所在国家（地区）兽药管理部门颁发的符合兽药生产质量管理规范的证明文件； (2) the document issued by the veterinary drug regulatory department of the country (region) where the manufacturer is located, certifying that the drug conforms to the Good Manufacturing Practice for Veterinary Drugs;
- （二）不标明或者更改有效期或者超过有效期的； (2) the expiry date is not indicated or is altered, or the drug is beyond the expiry date;
- （二）研制方法、生产工艺、质量标准和检测方法； (2) the method and process of manufacturing, quality standards and analytical method;
- （二）药效不确定、不良反应大以及可能对养殖业、人体健康造成危害或者存在潜在风险的； (2) the therapeutic efficacy of the drug is uncertain, its adverse reactions are serious, it may be harmful to the breeding industry or to human health, or it harbours potential risks; or
- （二）兽药所含成分的种类、名称与兽药国家标准不符合的。 (2) the types or names of the ingredients contained in a veterinary drug are not in conformity with the national standards of veterinary drugs.
- （三）不标明或者更改产品批号的； (3) the batch number is not indicated or is altered; or
- （三）兽药的制造方法、生产工艺、质量标准、检测方法、药理和毒理试验结果、临床试验报告、稳定性试验报告及其他相关资料；用于食用动物的兽药的休药期、最高残留限量标准、残留检测方法及其制定依据等资料； (3) the method and process of manufacturing, quality standards, analytical method, results of pharmacological and toxicological tests, clinical trial report, stability test report, and other data relevant to the veterinary drug; the data relating to the withdrawal period, maximum residue limits, residue analytical method and their basis for a veterinary drug used for food animals;
- （三）国务院兽医行政管理部门禁止生产、经营和使用的兽药。 (3) the production, distribution or use of the drug is prohibited by the administrative department for veterinary medicine of the State Council.
- （四）环境影响报告和污染防治措施。 (4) the environmental impact report and measures for prevention and control of pollution.
- （五）所标明的适应症或者功能主治超出规定范围的。 (5) the indications or functions indicated are beyond the specified scope.
- （六）环境影响报告和污染防治措施； (6) the environmental impact report and measures for prevention and control of pollution; and
- 兽药检验工作由国务院兽医行政管理部门和省、自治区、直辖市人民政府兽医行政管理部门设立的兽药检验机构承担。国务院兽医行政管理部门，可以根据需要认定其他检验机构承担兽药检验工作。 Testing of veterinary drugs shall be conducted by the veterinary drug test institutions established by the administrative department for veterinary medicine of the State Council or by the administrative department for veterinary medicine of the people’s government of the province, autonomous region or municipality directly under the Central Government. The administrative department for veterinary medicine of the State Council may, when necessary, accredit other test institutions to conduct testing of veterinary drugs.
- 上级兽医行政管理部门对下级兽医行政管理部门违反本条例的行政行为，应当责令限期改正；逾期不改正的，有权予以改变或者撤销。 The administrative department for veterinary medicine at a higher level shall order the one at a lower level that performs administrative acts in violation of these Regulations to rectify within a time limit; if the latter does not comply at the expiration of the time limit, the former shall have the power to alter or annul such acts.
- 县级以上地方人民政府兽医行政管理部门，应当自收到申请之日起３０个工作日内完成审查。审查合格的，发给兽药经营许可证；不合格的，应当书面通知申请人。申请人凭兽药经营许可证办理工商登记手续。 The administrative department for veterinary medicine of the local people’s government at or above the county level shall complete the examination within 30 working days from the date it receives the application. If the application passes the examination, the said department shall issue a Veterinary Drug Distribution Licence; if the application fails to pass the examination, the department shall notify the applicant thereof in writing. The applicant shall complete the formalities for business registration on the basis of the Veterinary Drug Distribution Licence.
- 县级以上地方人民政府兽医行政管理部门，应当对兽药经营企业是否符合兽药经营质量管理规范的要求进行监督检查，并公布检查结果。 The administrative department for veterinary medicine of the local people’s government at or above the county level shall supervise and inspect veterinary drug distributors to see whether they meet the requirements of the Good Sale Practice for Veterinary Drugs and publish the results of inspection.
- 县级以上人民政府兽医行政管理部门，负责组织对动物产品中兽药残留量的检测。兽药残留检测结果，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予以公布。 The administrative department for veterinary medicine of the people’s government at or above the county level shall be responsible for the detection of the residual amount of veterinary drugs in animal products. The results of the detected residue of veterinary drugs shall be published by 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 within their respective limits of power.
- 国内防疫急需的疫苗，国务院兽医行政管理部门可以限制或者禁止出口。 The administrative department for veterinary medicine of the State Council may restrict or prohibit the exportation of the vaccines that are urgently needed for epidemic prevention within the country.
- 国务院兽医行政管理部门，应当自收到审核意见和有关材料之日起４０个工作日内完成审查。经审查合格的，发给兽药生产许可证；不合格的，应当书面通知申请人。申请人凭兽药生产许可证办理工商登记手续。 The administrative department for veterinary medicine of the State Council shall complete the examination within 40 working days from the date it receives the opinions of verification and relevant materials. If the application passes the examination, the said department shall issue a Veterinary Drug Manufacturing Licence; if the application fails to pass the examination, the department shall notify the applicant thereof in writing. The applicant shall complete the formalities for business registration on the basis of the Veterinary Drug Manufacturing Licence.
- 国务院兽医行政管理部门，应当对兽药生产企业是否符合兽药生产质量管理规范的要求进行监督检查，并公布检查结果。 The administrative department for veterinary medicine of the State Council shall supervise and inspect veterinary drug manufacturers to see whether they meet the requirements of the Good Manufacturing Practice for Veterinary Drugs and publish the results of inspection.
- 国务院兽医行政管理部门应当自收到申请之日起１０个工作日内，将决定受理的新兽药资料送其设立的兽药评审机构进行评审，将新兽药样品送其指定的检验机构复核检验，并自收到评审和复核检验结论之日起６０个工作日内完成审查。审查合格的，发给新兽药注册证书，并发布该兽药的质量标准；不合格的，应当书面通知申请人。 The administrative department for veterinary medicine of the State Council shall, within 10 working days from the date it receives the application, send the data of the new veterinary drug, which it decides to accept, to the veterinary drug evaluation institution established by itself for evaluation, and send the sample of the new veterinary drug to the test institution designated by itself for quality retrial, and shall complete the examination within 60 working days from the date it receives the results of evaluation and quality retrial. If the drug passes the examination, the said department shall issue a Registration Certificate of New Veterinary Drugs and publish the quality standards of the drug; if the drug fails to pass the examination, the department shall notify the applicant thereof in writing.
- 县级以上地方人民政府兽医行政管理部门负责本行政区域内的兽药监督管理工作。 The administrative departments for veterinary medicine of the local people’s governments at or above the county level are responsible for the supervision and administration of veterinary drugs within their respective administrative areas.
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