Provided thatmodule 3 is not impacted, withthe exception of section 3.2.A.1 (forbiological medicinalproducts), the changeslisted below (not an exhaustive list) are covered under thecompany's qualitymanagement system and do not require a variation to the MarketingAuthorisation:

如果模块3不受影响, 除3.2.A.1 节 (生物医药产品) 外, 下文列出的变更 (非详尽清单) 将由公司的质量管理体系覆盖, 不需要上市许可变更:

Transfer of amanufacturing activityfrom one building to another in the same authorised site

生产活动从一栋建筑转移到同一许可地点的另一栋建筑

Transfer of amanufacturing activityfrom one room to another in the same authorised building

生产活动从同一许可建筑的一个房间转移到另一个房间

Transfer of QCactivity from onebuilding to another in the same authorised site

QC 活动从一栋建筑转移到同一许可地点的另一栋建筑

New filing lineidentical to an alreadyapproved one in an authorised room, building,manufacturing site

在已许可的房间、建筑、生产场地上新增一条与已批准的完全相同的生产线

New isolator in anauthorised building

已许可建筑中新增隔离器

New media or buffer preparation room inan authorised building

在已许可的建筑内新增培养基或缓冲液配制间

Changes in the layoutof an authorisedmanufacturing site

已许可生产基地的布局变化

If as a resultof any of the changes listedabove, any amendments are introduced to module 3(with the exception of section3.2.A.1 for biological medicinalproducts), such as changes to the manufacturingsite address detail, changes tothe manufacturing process, changes to the batchsize, etc., the MAH should filethe appropriate variation(s).

如果由于上述任何变更, 导致对模块 3 (生物医药产品3.2.A.1 节除外) 的任何变更, 如生产工厂地址细节的变更、生产工艺的变更、批量变更等, MAH 应提交适当的变更。