CRED ERP 25

Day 150 and Day 180:

Day 150 (provided to sponsor for information only) • Schedule a project team meeting to review the draft Response Assessment Report(s) • Develop strategy for addressing identified issues ensuring cross-functional agreement is obtained on how to address issues raised • Start drafting responses where possible and practicable. Day 180 • Schedule a project team meeting to review the List of Outstanding Issues (LOI) • Finalise strategy for addressing identified issues • Prepare for oral explanation/SAG if need has been identified (where responses have failed to convincethe CHMP) • Important to ensure company agrees on position to take at the Oral Explanation (OE) • Consider bringing in external experts to provide support at the OE • Clock stop: 1-3 months (1 month recommended). If able to respond quickly to, RSI timetable with no clock stop could be considered to shorten overall review time and enable CHMP opinion at Day 180. No clock stop response timetable would need to be discussed with the EMA ahead of submission. • Use EMA published timetable: RSI 30 day timetable with clock stop to calculate downstream timelines. Usually midday Friday, day after CHMP Meeting concludes o Company issues Press Release and must correctly represent Regulatory Status. Not to be released until after closure of CHMP meeting. • Linguistic Review – Update translations on receipt of Day 210 label text. • Ensure potential Post Authorisation Measures are acceptable and can be undertaken within the agreed timelines. • Prepare for Commission Decision Phase. • Prepare for EPAR review. Preparing for an Oral Explanation Step 1 (Day 180) If the CHMP deems an OE necessary, the company is advised and the proposed timelines communicated (30 day clock stop standard; 60-90 day clock stop reserved for extensive LOI) CHMP determines need to consult Working Parties or Expert Group(s). EMA contact point confirms timeslot of oral explanation, no later than seven working days in advance, specifying number of participants allowed to attend (typically should not exceed 10). Step 2 Following LOI adoption, the applicant may request a clarification meeting with (Co)Rapporteur. The applicant then provides responses to LOI including amended SmPC, follow-up measures and specific obligations, draft presentation and list of participants for the OE. Day 210 and beyond • CHMP Opinion issued in CHMP Press Release o

Step 3 CHMP discuss applicant’s responses to LOI and refines the LOI for the OE.

Step 4 (Participation in the OE) OE: the applicant addresses each item on the LOI, SmPC amendments, proposed follow-up measures