CRED 8 Presentations

01/07/2024

• 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 Validation – how to ensure timely validation

The Organisation for Professionals in Regulatory Affairs

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Responses toquestions- 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 possibleafter re-start DCP! Not possibleto resolveMajor objections (MOs) and PSRPH (MRP/DCP as CMS) via a commitments! So make sure to have a timely and clear strategy to resolvethese MOs/PSRPH

The Organisation for Professionals in Regulatory Affairs

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