eCTD submission

CP submissions to all CHMP members to be dispatched via the eSubmission Gateway only

EMA just released the new dossier requirements for Centrally Authorized Products (CAPs). Effective, tomorrow 1 July 2015, all CAP submissions to CHMP members should now be sent via the EMA eSubmission Gateway. This means that all CHMP members will be able to access the submissions via the Common Repository.

There is only one PRAC member (France) and some CAT members who still require CD”s. They are identified as “separate submission required – YES” in the link below.

More information go to below link:
http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/10/WC500003980.pdf

Author

KnetAdmin

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