CRED ERP 25

6. Submission Procedure

Time Day 1

Procedural step Start of Procedure

Day 80 Day 115

Preliminary assessment Report

Receipt of draft list of questions from Rapporteur, co-Rapporteur, CHMP members and EMA Receipt of CHMP adopted list of questions, as well as the overall conclusions and review of the scientific data Adoption of request for inspection

Day 120

Clock Stop Day 121

Submission of the responses and restart of the clock

Day 150 Day 180

Preliminary Joint Assessment Report

CHMP discussion and decision on the need for adopting a list of “outstanding issues” (questions) and/or an oral explanation by the applicant. If an oral explanation is needed, the clock is stopped. Final inspection report

Day 181

Oral explanation by applicant if needed / Responses to List of Outstanding Issues Final draft of English Product Information submitted by applicant Adoption of CHMP opinion and CHMP Assessment Report

Day 181 – 210

Day 210 Day 215 Day 232 Day 239 Day 261 Day 277

Draft translated labelling and Annexes Final translated labelling and Annexes Start of “Standing Commission Consultation” End of “Standing Commission Consultation” Commission Decision issued/End of Procedure

Day 80 (provided to sponsor for information only) • Day 80 (Day 87 for PRAC Report) •

Schedule a team meeting to review the preliminary 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 120 • There is a clock-stop in the procedure following Day 120 whilst the applicant prepares its responses to the CHMP’s list of questions • Schedule a project team meeting to review the CHMP adopted list of questions • Further develop strategy for addressing identified issues • Provide responses: o A separate document for each discipline should be used: (Clinical, Non-clinical, Quality, Risk Management Plan). The templates can be set up such that there is one question per page however these page breaks can be removed once responses are finalised • Consider alternate strategy, e.g., withdrawal of MAA, post-approval commitment, conditional approval, etc. • Remember that, in general, no substantial data derived from new studies should be introduced in the responses. However, new analysis may be included, e.g., follow-up data from previously submitted studies • Identify questions that require clarification/discussion with the EMA/(Co-)Rapporteur • Submit a written request for a Clarification Meeting if required.