In a previous news published on 10 December 2021 EMA announced the upcoming webinar ”Introducing DADI: The Digital Application Dataset Integration Network Project to replace electronic application forms” on 18 January 2022 at 10:30-12:00 Central European Time (CET). As the original WebEx webinar has reached maximum registration, the DADI Network Project team is pleased to [...]
'Blue-box' requirements (May 2023) [Track version]
User Guide for the electronic Application Form for a Marketing Authorisation (September 2023) [Track Version]
EMA/CMDh Explanatory notes on Variation Application Form - Human medicinal products only (December 2025) [Track version]
Variations [Track version] (December 2023)
Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP (January 2024) [Track version]
QP declaration [Track version] (February 2025)
ICH is pleased to announce the publication of a Leaflet on ICH.
An updated version of the EU Harmonised technical eCTD guidance and the related release notes are now available. The updated guidance enters into force 1st February 2022.
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