- 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
- 第十九条 兽药生产企业生产的每批兽用生物制品，在出厂前应当由国务院兽医行政管理部门指定的检验机构审查核对，并在必要时进行抽查检验；未经审查核对或者抽查检验不合格的，不得销售。 Article 19 Before being released from the manufacturing plant, every batch of veterinary biologics manufactured by a veterinary drug manufacturer shall be subject to verification by a test institution designated by the administrative department for veterinary medicine of the State Council, which may conduct sampling tests, when necessary; those drugs that have not undergone verification or that have failed to pass the sampling tests shall not be marketed.
- 第二条 在中华人民共和国境内从事兽药的研制、生产、经营、进出口、使用和监督管理，应当遵守本条例。 Article 2 Any entity engaged in research and development, manufacture, distribution, import and export, use, supervision and administration of veterinary drugs within the territory of the People’s Republic of China shall comply with these Regulations.
- 第二十条 兽药包装应当按照规定印有或者贴有标签，附具说明书，并在显著位置注明“兽用”字样。 Article 20 A label shall be printed on or stuck to every package of veterinary drugs, together with a package leaflet, and with the words “for animal use only” indicated at a conspicuous place, as is required by the provisions.
- 第二十一条 国务院兽医行政管理部门，根据保证动物产品质量安全和人体健康的需要，可以对新兽药设立不超过５年的监测期；在监测期内，不得批准其他企业生产或者进口该新兽药。生产企业应当在监测期内收集该新兽药的疗效、不良反应等资料，并及时报送国务院兽医行政管理部门。 Article 21 In the light of the need to ensure the quality and safety of animal products and human health, the administrative department for veterinary medicine of the State Council may fix a period of not more than five years for surveillance of a new veterinary drug, and shall not give approval to another enterprise for producing or importing the same drug during this period. During the surveillance period, the manufacturer shall collect data regarding the therapeutic efficacy and adverse reactions of the new veterinary drug, and submit them to the administrative department for veterinary medicine of the State Council without delay.
- 第二十二条 经营兽药的企业，应当具备下列条件： Article 22 A veterinary drug distributor shall meet the following requirements:
- 第二十三条 兽药经营许可证应当载明经营范围、经营地点、有效期和法定代表人姓名、住址等事项。 Article 23 In the Veterinary Drug Distribution Licence shall be clearly stated the scope of distribution, place of business, expiry date, the name and address of the legal representative, etc.
- 第二十四条 兽药经营企业变更经营范围、经营地点的，应当依照本条例第二十二条的规定申请换发兽药经营许可证，申请人凭换发的兽药经营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经营许可证。 Article 24 Where intending to change its scope of distribution or place of business, a veterinary drug distributor shall apply for renewal of the Veterinary Drug Distribution Licence in accordance with the provisions of Article 22 of these Regulations, and the applicant shall, on the basis of the renewed Veterinary Drug Distribution 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 Distribution Licence.
- 第二十五条 兽药经营企业，应当遵守国务院兽医行政管理部门制定的兽药经营质量管理规范。 Article 25 A veterinary drug distributor shall comply with the Good Sale Practice for Veterinary Drugs laid down by the administrative department for veterinary medicine of the State Council.
- 第二十六条 兽药经营企业购进兽药，应当将兽药产品与产品标签或者说明书、产品质量合格证核对无误。 Article 26 When purchasing a veterinary drug, a veterinary drug distributor shall have the product checked against its label, package leaflet and certificate of quality.
- 第二十七条 兽药经营企业，应当向购买者说明兽药的功能主治、用法、用量和注意事项。销售兽用处方药的，应当遵守兽用处方药管理办法。 Article 27 A veterinary drug distributor shall provide its customers with information about the indications and functions, usage, dosage and precautions of the veterinary drug. When selling a veterinary prescription drug, it shall comply with the measures for administration of veterinary prescription drugs.
- 第二十八条 兽药经营企业购销兽药，应当建立购销记录。购销记录应当载明兽药的商品名称、通用名称、剂型、规格、批号、有效期、生产厂商、购销单位、购销数量、购销日期和国务院兽医行政管理部门规定的其他事项。 Article 28 When purchasing and selling veterinary drugs, a veterinary drug distributor shall keep purchase and sale records. In such records shall be indicated the trade name, common name, formulation, presentation, batch number, expiry date, manufacturer, purchaser or seller, quantity of the drug purchased or sold, date of purchase or sale, and other information specified by the administrative department for veterinary medicine of the State Council.
- 第二十九条 兽药经营企业，应当建立兽药保管制度，采取必要的冷藏、防冻、防潮、防虫、防鼠等措施，保持所经营兽药的质量。 Article 29 A veterinary drug distributor shall establish a system for preservation of veterinary drugs and take all necessary measures including cold storage, protection against freeze and humidity, and avoidance of insects and rodents, in order to preserve the quality of veterinary drugs it distributes.
- 第三条 国务院兽医行政管理部门负责全国的兽药监督管理工作。 Article 3 The administrative department for veterinary medicine of the State Council is responsible for the supervision and administration of veterinary drugs nationwide.
- 第三十条 强制免疫所需兽用生物制品的经营，应当符合国务院兽医行政管理部门的规定。 Article 30 Veterinary biologics needed for compulsory vaccination shall be distributed in compliance with the provisions laid down by the administrative department for veterinary medicine of the State Council.
- 第三十一条 兽药广告的内容应当与兽药说明书内容相一致，在全国重点媒体发布兽药广告的，应当经国务院兽医行政管理部门审查批准，取得兽药广告审查批准文号。在地方媒体发布兽药广告的，应当经省、自治区、直辖市人民政府兽医行政管理部门审查批准，取得兽药广告审查批准文号；未经批准的，不得发布。 Article 31 The content of an advertisement for a veterinary drug shall be consistent with that of the package leaflet. Where such an advertisement is to be published in the principal national media, the matter shall be subject to examination and approval by the administrative department for veterinary medicine of the State Council, and an approval number shall be obtained for the advertisement of the drug. Where the advertisement of a veterinary drug is to be published in the local media, the matter shall be subject to examination and approval by the administrative department for veterinary medicine of the people’s government of the province, autonomous region or municipality directly under the Central Government, and an approval number shall be obtained for the advertisement of the drug; no advertisement may be published without approval.
- 第三十二条 首次向中国出口的兽药，由出口方驻中国境内的办事机构或者其委托的中国境内代理机构向国务院兽医行政管理部门申请注册，并提交下列资料和物品： Article 32 Where a veterinary drug is to be exported to China for the first time, the representative office established by the exporter within the territory of China or the agency within the territory of China authorized by it shall apply to the administrative department for veterinary medicine of the State Council for registration, and submit the following data and articles:
- 第三十三条 国务院兽医行政管理部门，应当自收到申请之日起１０个工作日内组织初步审查。经初步审查合格的，应当将决定受理的兽药资料送其设立的兽药评审机构进行评审，将该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。经审查合格的，发给进口兽药注册证书，并发布该兽药的质量标准；不合格的，应当书面通知申请人。 Article 33 The administrative department for veterinary medicine of the State Council shall arrange for preliminary examination within 10 working days from the date it receives the application. If the application passes the preliminary examination, the said department shall send the data of the veterinary drug, which it decides to accept, to the veterinary drug evaluation institution established by itself for evaluation, send the sample of the 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 department shall issue a Registration Certificate of Imported 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.
- 第三十四条 进口兽药注册证书的有效期为５年。有效期届满，需要继续向中国出口兽药的，应当在有效期届满前６个月到原发证机关申请再注册。 Article 34 A Registration Certificate of Imported Veterinary Drugs is valid for five years. An exporter that needs to continue the exportation of veterinary drugs to China after the expiry date shall, six months before the expiry date, apply to the original department that issued the certificate for renewed registration.
- 第三十五条 境外企业不得在中国直接销售兽药。境外企业在中国销售兽药，应当依法在中国境内设立销售机构或者委托符合条件的中国境内代理机构。 Article 35 No enterprises from abroad may directly sell veterinary drugs in China. An enterprise from abroad that intends to sell veterinary drugs in China shall, in accordance with the law, establish a sales office within the territory of China or authorize an agency within the territory of China that meets the requirements.
- 第三十六条 禁止进口下列兽药： Article 36 Importing any of the following veterinary drugs is prohibited:
- 第三十七条 向中国境外出口兽药，进口方要求提供兽药出口证明文件的，国务院兽医行政管理部门或者企业所在地的省、自治区、直辖市人民政府兽医行政管理部门可以出具出口兽药证明文件。 Article 37 Where a veterinary drug is to be exported abroad and the importer requires the provision of a document certifying exportation of the veterinary drug, 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 where the exporter is located may issue such a document.
- 第三十八条 兽药使用单位，应当遵守国务院兽医行政管理部门制定的兽药安全使用规定，并建立用药记录。 Article 38 Any unit using veterinary drugs shall comply with the provisions on the safe use of veterinary drugs laid down by the administrative department for veterinary medicine of the State Council and keep a record of the use of such drugs.
- 第三十九条 禁止使用假、劣兽药以及国务院兽医行政管理部门规定禁止使用的药品和其他化合物。禁止使用的药品和其他化合物目录由国务院兽医行政管理部门制定公布。 Article 39 It is prohibited to use counterfeit and substandard veterinary drugs, as well as drugs and other compounds the use of which is prohibited according to the provisions of the administrative department for veterinary medicine of the State Council. The catalogue of the drugs and other compounds the use of which is prohibited shall be compiled and published by the administrative department for veterinary medicine of the State Council.
- 第四条 国家实行兽用处方药和非处方药分类管理制度。兽用处方药和非处方药分类管理的办法和具体实施步骤，由国务院兽医行政管理部门规定。 Article 4 The State adopts an administration system for classifying veterinary drugs into prescription and non-prescription ones. The measures and the specific implementation procedures of the administration system for classifying veterinary drugs into prescription and non-prescription ones shall be formulated by the administrative department for veterinary medicine of the State Council.
- 第四十条 有休药期规定的兽药用于食用动物时，饲养者应当向购买者或者屠宰者提供准确、真实的用药记录；购买者或者屠宰者应当确保动物及其产品在用药期、休药期内不被用于食品消费。 Article 40 Where a veterinary drug requiring a withdrawal period is used in food animals, the raiser of the animals shall provide the purchaser or slaughter with an accurate and truthful record of use of the drug; the purchaser or slaughter shall ensure that during the period of drug taking or withdrawal the animals and their products are not used as food for human consumption.
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