ANNEX 4 生产免疫兽药以外的兽药产品20060906.docVIP

ANNEX 4 附件4 MANUFACTURE OF VETERINARY MEDICINAL PRODUCTS OTHER THAN IMMUNOLOGICAL VETERINARY MEDICINAL PRODUCTS兽用免疫学药品以外的兽药制剂 Note This annex applies to all veterinary medicinal products falling within the scope of Directive 2001/82/EC other than immunological veterinary medicinal products, which are the subject of a separate annex. 注： 此附件适用于81/851/EEC指南范围内的所有兽用制剂，而不包括兽用免疫学药品，此类产品将在另一个附件中说明。 Manufacture of premixes for medicated feedingstuffs 加药饲料的预混合生产 For the purposes of these paragraphs, 本段的目的是： — a medicated feedingstuff is any mixture of a veterinary medicinal product or products and feed or feeds which is ready prepared for marketing and intended to be fed to animals without further processing because of its curative or preventative properties or other properties as a medicinal product covered by Article 1 (2) of Directive 2001/82/EC; — a pre-mix for medicated feedingstuffs is any veterinary medicinal product prepared in advance with a view to the subsequent manufacture of medicated feedingstuffs. 加药饲料，是指一种或几种兽用药物与一种或几种饲料混合物，作为一种产品在市场上销售，可以直接给动物喂食而不需进一步加工，具有治疗、预防或其它特性在65/65/EEC指南第1（2）章节中涵盖的药品； 加药饲料用预混合物，是为进一步生产加药饲料预先制备的兽用药品； 1. The manufacture of premixes for medicated feedingstuffs requires the use of large quantities of vegetable matter which is likely to attract insects and rodents. Premises should be designed, equipped and operated to minimise this risk (point 3.4.) and should also be subject to a regular pest control programme. 用于生产加药饲料的预混合物的生产，要用到大量的草本植物，容易引来虫类和鼠类动物，厂房的设计、装备和运行要能够防止这种风险，并能够实施定期的虫鼠控制； 2. Because of the large volume of dust generated during the production of bulk material for premixes, specific attention should be given to the need to avoid cross contamination and facilitate cleaning (point 3.14), for example through the installation of sealed transport systems and dust extraction, whenever possible. The installation of such systems does not, however, eliminate the need for regular cleaning of production areas. 由于预混合半成品的生产过程中会产生大量的粉尘，要注意防