巴西原药产品相同性评估的技术管理指南.pdfVIP

巴西原药产品相同性评估的技术管理指南 2011 年9 月1 日颁布 Subject: Guidance for the technical and administrative procedures for the evaluation of the determination of equivalence of technical products. 1. This technical guidance has the objective of reinforcing the information about the documents necessary and to clarify the technical criteria used for the evaluation of petitions for registration of technical products by equivalence, to, when necessary, the petitioners precede the due adaptations in the submissions. 本技术指南目的是加强必需文件的信息，并明确评估原药相同产品登记时的技术标准，必 要时，申请者需更改相应申请资料。 2. This work results of observation of the impact of non conformities in the dossiers submitted by the petitioners of registration of technical products by equivalence, related to the requirements of the Decree 4074/02. These non conformities results in a huge amount of notifications made by the regulatory authority during the evaluation of the petitions, which causes delay in the conclusion of the evaluation for the uncompleted process as well to the others waiting for the evaluation, bringing losses to the companies. 对相同原药登记的申请者根据法令4074/02 法规所递交之登记卷宗不一致性影响的调查促 使本技术指南文件出台。这些不一致性导致主管部门在评估登记申请中发布大量的通告，使 得评估过程不完整，结论延迟，同时延长了其他评估的时间，给这些公司造成了损失。 3. In the registration requirement, as mentioned in the Attached II of the Decree 4074/02, all fields must be filled out according to the documents to be presented. 根据法令4074/02 附件II 所指定之登记要求，所有需提交的文件都必须提供。 3.1. We recommend special attention to the item 5 – purpose of register, where only must be filled out the category in which the company is dully registered. 我们推荐特别关注第5 项-登记主体，必须指明在相关联邦主体的注册信息，包含经营范围 等 3.2. For the information presented in the items 11.7 and 11.8, must be informed the references. 11.7 和11.8 项下的信息，必须注明参考文献。 4. The manufactu