CRED ERP 25

8. Completing Submission Process: Decentralised Procedure

Time

Procedural step

Day -90

Applicant requests a pre-submission meeting with the Reference Member State (RMS), if needed. Submission of dossier to the RMS and each Concerned MemberState (CMS) for validation. Assessment Step 1

Day -14

Day 0

Start of procedure.

RMS sends the PrAR, SmPC, PIL, and labelling to ConcernedMember States and applicant.

Day 70

Day 100 Day 105

CMS send comments to the RMS and applicant.

Clock stop

Clock stop at day 105 During the clock off period the applicant will submit draft responses to the RMS only Day 106 Submission of responses to RMS and CMS: Re-start procedure

RMS may close procedure if consensus is achieved and proceedto national licensing for granting MA. Assessment Step 2 Consensus not reached; draft assessment report sent to CMSand applicant. Final comments are received; RMS may close procedure is consensus is achieved.

Day 120

Day 120

Day 145

Day 160

Applicant provides answers to remaining comments

If consensus is not achieved, RMS communicates outstandingissues with applicant and CMS via day 180 AR Remaining comments CMSs and possibility for Break- out session

Day 180

Day 195

Procedure closure if consensus achieved; if consensus not achieved then points of disagreement referred to CMDh.

Day 210 (Day 90)

Day 0 – day 100 • Start of procedure after validation of the product dossier and supporting documents are completed by RMS • RMS starts procedure and circulates their preliminary day 70 assessment report to CMS and applicant • CMS reviews the RMS’s assessment report to assemble comments by Day 100 • Day 105, the Reference Member State informs the applicant and CMSs of clock stop (in case comments needs to be resolved) or finalises the procedure in case no comments are raised by RMS and CMSs After Day 105 clock off period • Usually this is a three (3) month period, but can be agreed between the RMS and applicant depending on nature of comments • Applicant submits draft response, and the updated SmPC, PIL, and labelling as required; a pre-assessment can occur between the RMS and applicant