XiaoMi-AI文件搜索系统
World File Search SystemXEVMPD
关于 Eudravigilance 数据管理的详细指南...
6 产品索引包含所有活性物质，包括翻译、别名和强度、向 XEVMPD 报告的所有药品名称及其排列，以及拼写错误的术语与物质/产品名称之间的所有链接。附件 2 中描述了用于创建产品索引的产品名称和物质的排列。
根据欧盟法规第 726/2004 号第 57(2) 条，有关上市许可持有人向欧洲药品管理局以电子方式提交人用药品信息的详细指南
2.1. 药物警戒合格人员（QPPV）的维护 ...................................................................... 160 2.1.1. 通知 QPPV 详细信息变更的业务流程 .............................................................................. 160 流程图 3 – QPPV 详细信息的变更 ...................................................................................... 161 2.1.2. 通知 QPPV 变更的业务流程 ...................................................................................... 161 流程图 4 – QPPV 变更 ...................................................................................................... 163 2.2. 营销授权持有人（MAH）组织实体的维护 ............................................................................. 165 2.2.1. 通知 MAH 的联系方式、名称和/或地址的变更（即，法人实体未发生变更） ................................................................................................................ 165 2.2.2. 2.4. 授权转让通知（即法人实体变更） 165 流程图 5 – MAH 详细信息变更 .............................................................................. 167 流程图 6 – 将 MAH 实体通知为“非现行” ...................................................................... 168 2.3. 药物警戒系统主文件位置（PSMFL）实体的维护 ............................................................. 170 流程图 7 – PSMF 信息变更 ...................................................................................... 172 流程图 8 – 将 PSMFL 实体通知为“非现行” ............................................................................. 173 2.4. 授权药品（AMP）实体的维护 ............................................................................. 175 流程图 9 – 根据监管程序修改 XEVMPD 中的药品信息的业务流程 ................................................................................................................ 176 流程图 10 – 修改 AMP 实体 ............................................................................................. 177 2.4.1.营销授权变更 ................................................................................................................ 178 2.4.1.1. 业务流程 - 变更后授权编号已更改 ........................................................................ 183 2.4.1.2. 业务流程 - 变更后授权编号未更改 ........................................................................ 183 2.4.2. 营销授权暂停（解除） ............................................................................................. 184 2.4.3. 营销授权转让 ............................................................................................................. 184 2.4.3.1. 在 EudraVigilance 注册的总部不同的组织之间的营销授权转让 ................ ...
电子提交第57（2）条数据
5.5.1。第57条数据库中提交的数据的保密性........................................................................................................................................................5.25 5.5.2。Confidentiality of concentration of excipients ..................................................... 25 5.6.Language requirements for XEVMPD data submission ............................................ 25 5.6.1.Non-Latin/accented characters ........................................................................ 25 5.6.2.提交授权药品数据的语言要求......... 26 5.6.3。Language requirements for submission of authorised medicinal products in countries with multiple official languages ................................................................................. 26 5.6.4.Language requirements for submission of medicinal products authorised in Iceland, Liechtenstein and Norway via the centralised procedure ............................................... 27 5.6.5.Substance translations ................................................................................... 27 5.6.5.1.EVWEB/重新上传XML文件中物质翻译的可见性.............................................................. 27 5.6.5.2。Language requirements for substance name for herbal/homeopathic medicinal products ................................................................................................................ 28 5.6.6.MEDDRA编码的语言要求 - 不受支持的语言..................................................................................................................................................................................................................................................................................................................................................................................................... 28 5.6.7。Language requirements for package description ................................................. 29 5.7.Printed product information (PPI) ....................................................................... 29 5.7.1.Content and submission of PPI ........................................................................ 29 5.7.2.提交附加文件，如果在引用的SMPC/PIL中未陈述授权号。Intended use of PPI ....................................................................................... 29 5.7.4.Format of PPI ................................................................................................ 30 5.7.5.Unavailability of an SmPC ............................................................................... 30 5.7.5.1.在提交时，SMPC用授权国语言不可用.....................................................................................................................................................................SMPC在19xX之前授权的药品中无法获得............ 31 5.7.5.3。SMPC用于卢森堡营销授权的药物产品的不可用.....................................................................................................................................................ppi命名惯例和Xevprm与附件之间的链接............................................................................................................................................................................... 31 5.7.7。SmPC version number and version date ............................................................ 32 5.7.8.PPI的保密性......................................................................................................................................................................................................................................................................................................................................... 32 5.8。Medicinal product entity elements ....................................................................... 32 5.8.1.Legal Basis ................................................................................................... 32 5.9.演示名称元素.................................................................................................................................. 32 5.9.1。演示名称元素的人口............................................................................................................................................................................................................................................................................................................................................................................................................................................................... 32