CRED 8 Presentations

01/07/2024

CHMP Opinion

• Voting by simple majority – positive or negative • Patient Representatives may be consulted • If divergent opinion reached, then the names of the CHMP members expressing this view will be published in the EPAR and CHMP minutes • This is NOT approval!

The Organisation for Professionals in Regulatory Affairs

25

Re-examination of an Opinion

• The Applicant can appeal if a negative opinion is adopted • 15 days from CHMP Opinion to notify intent to appeal [Article 9(2) of Regulation (EC) No 726/2004] • 60 days to submit detailed grounds for appeal • No NEW data permitted • Possible to request SAG • Different (Co)Rapporteurs appointed to assess appeal • 60 days for CHMP to assess grounds for appeal with no clockstop (with/without OE) • Initial Opinion maintained or revised • If Negative, then not possible to further appeal • If Positive, then reverts to original Rapporteurs post-approval (yes…this can be difficult)

The Organisation for Professionals in Regulatory Affairs

26