- 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)国务院兽医行政管理部门规定禁止使用的; (1) its use is prohibited according to the provisions of the administrative department for veterinary medicine of the State Council;
- (二)依照本条例规定应当经审查批准而未经审查批准即生产、进口的,或者依照本条例规定应当经抽查检验、审查核对而未经抽查检验、审查核对即销售、进口的; (2) it is manufactured or imported without examination and approval as is required by these Regulations, or it is marketed or imported without sampling tests or verification as is required by these Regulations;
- (三)变质的; (3) it is deteriorated;
- (四)被污染的; (4) it is contaminated; or
- 除前款规定的内容外,兽用处方药的标签或者说明书还应当印有国务院兽医行政管理部门规定的警示内容,其中兽用麻醉药品、精神药品、毒性药品和放射性药品还应当印有国务院兽医行政管理部门规定的特殊标志;兽用非处方药的标签或者说明书还应当印有国务院兽医行政管理部门规定的非处方药标志。 In addition to the information specified in the preceding paragraph, precautions prescribed by the administrative department for veterinary medicine of the State Council shall also be printed in the labels or package leaflets attached to veterinary prescription drugs, and for narcotic drugs, psychotropic substances, toxic drugs and radioactive pharmaceuticals used for animals, a special sign prescribed by the administrative department for veterinary medicine of the State Council shall also be printed; moreover, in the labels or package leaflets attached to veterinary non-prescription drugs shall be printed the sign for non-prescription drugs prescribed by the administrative department for veterinary medicine of the State Council.
- 在审查过程中,国务院兽医行政管理部门可以对向中国出口兽药的企业是否符合兽药生产质量管理规范的要求进行考查,并有权要求该企业在国务院兽医行政管理部门指定的机构进行该兽药的安全性和有效性试验。 In the course of examination, the administrative department for veterinary medicine of the State Council may carry out an on-the-spot inspection to see whether the enterprise that intends to export a veterinary drug to China meets the requirements of the Good Manufacturing Practice for Veterinary Drugs, and shall have the right to require the enterprise to conduct tests on safety and efficacy of the drug at an institution designated by the administrative department for veterinary medicine of the State Council.
- 发生重大动物疫情、灾情或者其他突发事件时,国务院兽医行政管理部门可以紧急调用国家储备的兽药;必要时,也可以调用国家储备以外的兽药。 In the event of a serious epizootic disease, calamity or other emergency, the administrative department for veterinary medicine of the State Council may, for purposes of first aid, transfer veterinary drugs from the national reserve and, when necessary, may also transfer veterinary drugs from the reserve of other quarters.
- 兽药的标签或者说明书,应当以中文注明兽药的通用名称、成分及其含量、规格、生产企业、产品批准文号(进口兽药注册证号)、产品批号、生产日期、有效期、适应症或者功能主治、用法、用量、休药期、禁忌、不良反应、注意事项、运输贮存保管条件及其他应当说明的内容。有商品名称的,还应当注明商品名称。 In the label and package leaflet of a veterinary drug shall be indicated in Chinese the common name, ingredients and content, presentation, manufacturer, approval number of the product (number of the Registration Certificate of an Imported Veterinary Drug), product batch number, manufacturing date, expiry date, indications or functions, usage, dosage, withdrawal period, contraindications, adverse reactions, precautions, conditions for transportation, storage and preservation of the drug, and other necessary explanations. The trade name, if any, shall also be indicated.
- 禁止在饲料和动物饮用水中添加激素类药品和国务院兽医行政管理部门规定的其他禁用药品。 It is prohibited to add in animal feed or drinking water any hormonal drug or other prohibited drugs specified by the administrative department for veterinary medicine of the State Council.
- 禁止未经兽医开具处方销售、购买、使用国务院兽医行政管理部门规定实行处方药管理的兽药。 It is prohibited to sell, purchase or use, without the prescription of a veterinarian, any veterinary drugs specified as prescription drugs by the administrative department for veterinary medicine of the State Council.
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