CRED ERP 25

7. Completing Submission Process: Mutual Recognition Procedure

Time

Procedural step

Day -90

Applicant requests assessment report from Reference Member State (RMS). Submission of dossier to the Concerned Member State (CMS).

Day -14

Day 0

Start of procedure.

Day 30 Day 40 Day 48 Day 55

CMS sends their comments to RMS and applicant. Applicant has 10 days to respond by Day 60. RMS submits assessment of response made by applicant. CMSs send their remaining comments to RMS, CMS and applicant The applicant and RMS are in close contact to clarify if the procedure can be closed at day 60 or if the applicant should submit a further response at day 60. MRP: If CMS have no remaining comments at Day 55, the RMS closes the procedure. RUP: If no potential serious risk to public health (PSRPH) has been outlined by CMS at Day 55, the RMS closes the procedure. In case a CMS has remaining comments (MRP) or PSRPH (RUP) at Day 55, the applicant sends the response document to CMSs and RMS. The period 60-90 will only be used if a CMS has remaining comments (MRP) or PSRPH (RUP) at Day 55. RMS evaluates and circulates a report on the applicant’s response document to CMSs.

Day 55-59

Day 60

Day 60-90

Until day 68

CMS sends any additional comments. Break-out meetings scheduled between Day 73 – 80.

Day 75

Day 85 Day 90

CMS sends any remaining comments.

CMS notifies RMS of their position; if no consensus then disagreements must be reviewed. If consensus achieved procedure closes; non-consensus is sent to arbitration.

Day 150

Day 0 • Start of procedure after validation of the product dossier and supporting documents is completed by CMS • CMS reviews the product dossier to assemble comments from Day 0 to Day 30 • These applications should be harmonised between the RMS and CMS appropriately or may cause delays in process CMS submits comments by Day 30 to RMS and applicant • These comments are compiled into a formal document that must be resolved prior to acceptance of the approval • Applicant has 10 days to respond to any comments raised • During that time or within the next 8 days the RMS prepares the Assessment Report on the responses • Assessment report is then circulated to all interested parties and the CMS • Day 55 CMS submits any remaining comments Day 30 •

Day 60 •

See above steps: Procedure will either be closed or continues