CRED 8 Presentations

01/07/2024

Timelines: From Day 121 to Day 180* * Activity Day

Day 121

Submission of the responses, including revised SmPC, labelling and package leaflet texts in English. Procedure Restarts.

Day 121 to 165

QRD second review

Day 157

Preliminary Joint Assessment Report (JAR) from CHMP (Co-) Rapporteurs and PRAC Rapporteur received by CHMP, PRAC members and the EMA. Sent to Applicant as info, no response yet expected.

Day 160 166 Day 170

PRAC and CHMP conclude RMP assesssment

Deadline for CHMP members to raise comments on draft list of outstanding issues (LoOI)/ opinion • CHMP Opinion OR LoOI and/or request for Oral Explanation (OE) to explain Company positions and arguments (Applicant can also request OE). • Possible to have more than one outstanding issue at the end of the procedure

Day 180

*Refer to EMA submission timetables. Precise steps will depend on procedure timetable being followed (e.g. ATMP/accelerated/standard)

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Timelines: From Day 181 to Day 210 * Activity Day

Day 181

Procedure restarts with submission of responses or oral explanation (if needed).

The CHMP (Co)-Rapporteurs/ PRAC Rapporteur assess the applicant's responses including the RMP aspects in a joint assessment report. PRAC and CHMP Committee members and EMA send comments on the assessment report

Day 194

Day 200 Day 204 Day 210

The updated AR is circulated to the PRAC and CHMP Committee members and EMA.

• CHMP Scientific Opinion : conclusion of evaluation of whether favorable risk/benefit (positive opinion) or not (negative opinion) • Opinion confirms legal basis of MA granted and MA number • Final opinion with EPAR annexes sent to Applicant plus Assessment reports • Linguistic review timetable confirmed For orphan medicines, COMP will adopt an opinion on orphan maintenance usually at the next COMP meeting after the opinion. Possible that OE may ALSO be required in front of COMP where doubts on criteria being met/appeal.

Next COMP meeting

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