CRED ERP 25
01/07/2025
Take-home messages
➢ Importance of high quality and completeness of dossier (do not submit premature dossiers)
➢ Choice of (correct) legal basis is basis for “success” of your application
➢ Information in eAF is leading!
➢ Always anticipate on possible comments
➢ Always provide a justification in case of deviation from guidelines
➢ Be aware that after re-start of a DCP no further clock stop is possible. It is also not possible in a DCP to resolve a MO/PSRPH via a commitment!
➢ Contact with regulatory coordinator of procedure important
The Organisation for Professionals in Regulatory Affairs
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⚫ Talking to regulatory agencies
The Organisation for Professionals in Regulatory Affairs
44
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