- 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
- （二）已采取措施确保该类信息不会被不正当地进行商业使用。 (2) where measures have been taken to ensure that the data are protected against illegitimate commercial use.
- 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，应当立即向所在地人民政府兽医行政管理部门报告。 When discovering serious adverse reactions that are possibly induced by the use of a veterinary drug, the veterinary drug manufacturer, distributor or user, or the veterinarian who prescribes the drug shall promptly report the matter to the administrative department for veterinary medicine of the local people’s government.
- 兽药经营企业销售兽用中药材的，应当注明产地。 When selling crude Chinese medicines to be used for animals, a veterinary drug distributor shall indicate their origin.
- 自注册之日起６年内，对其他申请人未经已获得注册兽药的申请人同意，使用前款规定的数据申请兽药注册的，兽药注册机关不予注册；但是，其他申请人提交其自己所取得的数据的除外。 Where another entity, without consent of the applicant of the veterinary drug already registered, applies for registration of a veterinary drug by using the data specified in the preceding paragraph, the veterinary drug registration department shall, within six years from the date the drug is registered, refuse to have it registered, unless the data submitted by that entity are accumulated by itself.
- 申请向中国出口兽用生物制品的，还应当提供菌（毒、虫）种、细胞等有关材料和资料。 Where applying for exporting veterinary biologics to China, the applicant shall, in addition, provide the master seed bacteria (viruses or insects), cell lines and other relevant materials and data.
- 兽药包装上未附有标签和说明书，或者标签和说明书与批准的内容不一致的，责令其限期改正；情节严重的，依照前款规定处罚。 Where no label and package leaflet are attached to the package of a veterinary drug or the label and package leaflet are different from what is approved in content, an order shall be given to rectify the situation within a time limit; if the circumstances are serious, a penalty shall be imposed in accordance with the provisions of the preceding paragraph.
- 研制新兽药需要使用一类病原微生物的，还应当具备国务院兽医行政管理部门规定的条件，并在实验室阶段前报国务院兽医行政管理部门批准。 Where pathogenic microorganisms of Class I are necessary to be used in the research and development of a new veterinary drug, conditions laid down by the administrative department for veterinary medicine of the State Council are, in addition, required to be met, and the matter shall, prior to the laboratory stage, be reported to the administrative department for veterinary medicine of the State Council for approval.
- 研制的新兽药属于生物制品的，应当在临床试验前向国务院兽医行政管理部门提出申请，国务院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。 Where the new veterinary drug being researched and developed is a biological product, an application shall, before clinical trials are conducted, be submitted to the administrative department for veterinary medicine of the State Council, which shall notify the applicant of the result of examination in writing within 60 working days from the date it receives the application.
- 研制的新兽药属于生物制品的，还应当提供菌（毒、虫）种、细胞等有关材料和资料。菌（毒、虫）种、细胞由国务院兽医行政管理部门指定的机构保藏。 Where the new veterinary drug being researched and developed is a biological product, the master seed bacteria (viruses or insects), cell lines and other relevant materials and data shall, in addition, be provided. The master seed bacteria (viruses or insects) and cell lines shall be preserved by an institution designated by the administrative department for veterinary medicine of the State Council.
- 研制用于食用动物的新兽药，还应当按照国务院兽医行政管理部门的规定进行兽药残留试验并提供休药期、最高残留限量标准、残留检测方法及其制定依据等资料。 Where the new veterinary drug being researched and developed is to be used in food animals, a residue depletion test of the drug shall, in addition, be conducted and the data relating to the withdrawal period, maximum residue limits, residue analytical method and their basis provided, as is required by the administrative department for veterinary medicine of the State Council.
- 被撤销产品批准文号或者被吊销进口兽药注册证书的兽药，不得继续生产、进口、经营和使用。已经生产、进口的，由所在地兽医行政管理部门监督销毁，所需费用由违法行为人承担；给他人造成损失的，依法承担赔偿责任。 Where their approval numbers of the products are cancelled or Registration Certificates of Imported Veterinary Drugs are revoked, the veterinary drugs shall not be produced, imported, distributed or used any longer. Such drugs already produced or imported shall be destroyed under the supervision of the local administrative department for veterinary medicine, and the expenses thus entailed shall be paid by the violator; if losses are caused to another person, the liability for compensation shall be borne in accordance with the law.
- 未经行政强制措施决定机关或者其上级机关批准，不得擅自转移、使用、销毁、销售被查封或者扣押的兽药及有关材料。 Without approval by the department that makes the decision on taking compulsory administrative measures or the department at the next higher level, no veterinary drugs or relevant materials that are sealed up or distrained may be transferred, used, destroyed or sold.
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