CRED 8 Presentations

01/07/2024

Before Submission – final checks!

• Follow dossier administrative validation checklist closely – it is really helpful • Include comprehensive table of contents and note to reviewers • Explain any anomalies, rationale for absence of dossier sections, orientate Assessors

https://www.ema.europa.eu/en/news/ema-launches-checklist-facilitate-validation-initial-marketing authorisation-applications

The Organisation for Professionals in Regulatory Affairs

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Submit!!

• After dossier is published, ensure time for QC of eCTD (document naming, hyperlinks, PDF quality etc etc etc) • Submit at least a day in advance to allow for any technical difficulties • Via e-Submission gateway or web client using eCTD format • Can take several hours to upload documents • If any difficulties, contact helpdesk and procedure manager (as needed) • You will receive “technical validation” that dossier is eCTD compliant • This is NOT formal validation • This is not the time to go on vacation!!!

Abbreviations: eCTD = electronic common technical document; QC = quality control Reference: Pre-authorisation guidance - section 4: Submission, validation and fees

The Organisation for Professionals in Regulatory Affairs

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