https://www.selleckchem.com/pr....oducts/gsk3685032.ht
Alternatively, submitting multiple parallel variations with their own corresponding EU-RMPs can result in very complicated procedural wrap-up activities and very short-lived approved versions. In this article, we describe an approach to the management of multiple Type II variations, which is now in line with the recently revised European Medicines Agency (EMA) frequently asked questions (FAQ) guidance on how to manage grouped Type II variation applications, whereby four parallel Type II variation procedures were successfully initiate
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