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Work instructions for paediatric core master files and numbering

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发表于 2018-9-29 15:43:03 | 显示全部楼层 |阅读模式 来自 重庆
Work instructions for paediatric core master files and numbering


1. Changes since last revision
Minor revision and update following current EMA organigrams
2. Records
Paper product core master files are sent off site for archiving until August 2016. After that date only corrigendum documents are bearing ink signature and sent for archiving off site.
PIP/waiver applications (including updates e.g.: changes after validation), answers to request for modifications, request for re-examination, requests for modification to an agreed PIP and requests for compliance check are stored electronically only on the N Drive.
Electronic product core master files are in DREAM in Cabinets\01 Evaluation of Medicines\H-P Paediatric Medicines where product related correspondence specified in the checklist are saved.


WC500002953.pdf (103.74 KB, 下载次数: 2)
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