Centralised Procedure

Rapid and direct access to EU Marketplace

• EU gives license
• EMA = Post Box

Based on granting of a single MA as a result of a single evaluation by the Committee for Medicinal Products of Human Use (CHMP)

• Assessment by Rapporteur, Co-Rapporteur and external Experts
• Controlled procedure operating to strict time-lines
• CHMP opinion delivered within 210 days or receipt of a valid application

Requires single SmPC, PIL and Label

Procedure for Submission of Application
CESP
EMA/CHMP, Rapporteur, Co-Rapporteur each receive one copy