CRED ERP 25

01/07/2025

Clarification meetings – MEB (national applications) (2/2)

• a hearing, in the case that an intention of refusal of the application has been issued, or for MEB decisions the addressee is expected to object to. In a European application procedure this is also called a ‘ break-out session (BOS) ’ or ‘ oral explanation ’. In case NL = RMS and still has major objections at day 180 of a DCP: a BOS is offered to the applicant.

The Organisation for Professionals in Regulatory Affairs

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Clarification meetings – EU procedures

• Centralised procedure: need for clarification objections in consultation with PTL (PM and PL) EMA/contact point rapporteurs (for MEB=case manager) • MRP/DCP: to be decided by RMS in consultation with applicant and (if applicable) CMSs • NL=CMS: no bilateral discussion with MEB only on comments raised by MEB, also no pre-assessment of draft responses possible

The Organisation for Professionals in Regulatory Affairs

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