CRED ERP 25

Day 106- 150 • After final response is received by RMS and CMSs, the clock is restarted at Day 106 • The RMS circulates their updated draft AR at day 120 • The CMS can send any remaining comments at day 145 at the latest • If at day 150 no comments remain and consensus has been reached between RMS and CMSs the RMS may close the procedure • It should be noted that Step 2 is a 90 day process where Day 120 is Day 0 of Step 2 according to Directive 2001/83 Section 28(4). Day 150 (Day 30) no consensus reached yet • The applicant must submit additional information and/or clarification including any revised proposed product information by Day 160; RMS produces a short report • If consensus is still not reached, then the RMS informs the applicant of outstanding issues by Day 180 (Day 60) Day 210 (Day 90) • At the latest of Day 205 (Day 85), a breakout session may be held with the involved Member States and applicant to reach consensus • If consensus is reached, then the procedure is closed with RMS preparing the final assessment report; the final report includes information on how the outstanding issues were resolved • If consensus is still not reached based on a PSRPH from a CMSs, then the issue is referred to CMDh • In case the RMS is negative at the end of the procedure: no referral at CMDh level takes place and the procedure ends negatively at day 210 Once consensus is achieved between the RMS and CMS then the applicant must submit high-quality SmPC, PIL, and labelling translations. This must be completed within 7 calendar days after the procedure is finalised. The translations must be provided to the Reference Member State and Concerned Member State. If consensus it not achieved by the Reference Member State and Concerned Member State (including the applicant’s submitted information) during the DCP or MRP, the CMDh provides a forum for discussion.

9. Managing the Procedure: Achieving Consensus and MA

Disagreement at end of Procedure

MRP at Day 90

DCP at Day 210

CMDh Referral

Accepted at CMDh Level

No consensus between RMS and CMSs at CMDh Level - Arbitration

Procedure concludes and national phase begins

• Referral to CHMP for scientific evaluation • CHMP opinion 90 days + clock stop • Commission Decision • Single outcome binding all MSs in MRP/DCP • MS need to implement EC Decision within 30 days