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兽药企业通过委托加工方式生产中兽药制剂是目前农业部为增大中兽药制剂质量保障和质量监管一项重要措施。但是许多企业通过委托加工中药提取物的方式报批产品批准文号过程中还存在一些问题:主要有被委托企业不在农业部颁布的《资质企业名录》名单内,被委托产品不在加工范围内、委托加工材料不全或不合格等问题,本文主要就以上问题进行解释。
Veterinary drug enterprises through the commissioning of the production of veterinary drug preparation is the Ministry of Agriculture to increase the quality assurance of veterinary medicine preparations and quality control an important measure. However, there are still some problems in the process of submitting and approving the product approval document by many enterprises through the process of entrusting the processing of traditional Chinese medicine extracts. The main problems are that the entrusted enterprise is not in the list of “qualified enterprises” promulgated by the Ministry of Agriculture, and the entrusted products are not within the processing scope. Processing materials incomplete or unqualified and other issues, this article mainly to explain the above problems.