Module 1 2021

30/06/2021

Overall timelines EU

• OD application format & structure pre-defined • Option for pre-submission meeting (latest 2 mo prior to application) • Two coordinators assigned

COMP opinion published

• COMP adoption by consensus or 2/3 majority • Sponsor can appeal negative decision w/i 15 days • Detailed grounds for appeal w/i 90 days • COMP to discuss • Final opinion

Decision EC

The Organisation for Professionals in Regulatory Affairs

13

Orphan condition Significant benefit

The Organisation for Professionals in Regulatory Affairs

14

7