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

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