CRED ERP 25

• In the DCP, one clock stop or withdrawal (before Day 120) is possible

Comparison of MRP and DCP Procedures • Applicant can choose the RMS •

Tradename can be different in each MS (except for generics of CAPs) • Number of CMSs can vary; applicants may sell their products under different conditions in Europe as regions can vary significantly • MRP can be repeated, after withdrawal or in new member states (Repeat use, second wave, third wave) • Allowed to submit duplicate applications or copy applications immediately or after procedure is finalised (some additional circumstances during clock stop in DCP procedure).

MRP

DCP

A national license/MA should exist for the product anywhere in EU

There should NOT be a National license/MA for the product anywhere in EU at time of application by that MAH

RMS has to be the country where National licence/MA already available

Choice of RMS

Timeline:

Timeline:

National procedure (210 days +/-) + 90 days MRP timetable (early closure at Day 60 possible)

210 day timetable with provision of early closure

RMS and CMS dossier assess the dossier in parallel

RMS assess the dossier before the CMS

No clock stop during the procedure

There is one clock stop