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
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