CRED 8 Presentations

01/07/2024

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

51

 Optimising appeals and hearings

The Organisation for Professionals in Regulatory Affairs

52