CRED ERP 25

01/07/2025

Validation – how to ensure timely validation

• Make sure that the application form is filled out correctly and all relevant documentation has been submitted; • Check relevant CMDh and EMA guidance on dossier contents/validation! Guidance is published on CMDh/EMA website; e.g. RMS/CMS validation checklists good to check as applicant!

• Address validation comments in a timely manner

Common issues:

• Annexes eAF are missing or no justification for absence

• Inappropriate reference product/legal basis

• Active Substance Master Files & Letter of Access

• GMP/QP declarations/manufacturer licences

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Responses to questions- avoid extensions clock stop

• Time table is known, so once procedure is started internal time table applicant for preparation responses can be set; • Preliminary AR RMS and Rapporteurs already sent to applicant, so start of preparation responses before receipt CMS comments/CHMP List of Questions; • In case of major objections/Potential serious risks to public health: need for clarification (meeting) of (with) RMS/NCA=CMS/Rapporteur/EMA on objections? • NB: Only allowed to respond to questions; not possible to submit additional changes during ongoing procedure. • No 2nd clock stop possible after re-start DCP! Not possible to resolve Major objections (MOs) and PSRPH (MRP/DCP as CMS) via a commitments! So make sure to have a timely and clear strategy to resolve these MOs/PSRPH

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