CRED ERP 25

4. General Principles of the Procedures

MRP (no clock stop possible during MRP) Applicant selects the Reference Member State (RMS) and files the first marketing authorization. Once approved the MS is then used as the RMS in the procedure.

RMS assesses the product dossier and clarifies any open issues, clarification, or corrections with the applicant. When accepted, RMS grants marketing authorization and issues the assessment report.

Selected Concerned Member State(s) (CMS) reviews the assessment report for generating any comments. Clarify open questions, resolve comments, and determine there is noserious risk to public health. CMS recognizes the RMS marketing authorization through mutual recognition; timeline established for 90 days.

Further reading:

CMDh website: https://www.hma.eu/human-medicines/cmdh/procedural-guidance/application-for ma/mrp/rup.html, e.g. Flow chart of the Mutual Recognition Procedure (MRP) and Repeat Use Procedures (RUP) https://www.europarl.europa.eu/RegData/etudes/STUD/2016/587321/IPOL_STU(20 16)587321_EN.pdf https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-2/vol2a_chap1_en.pdf DCP Applicant submits a product dossier MAA to the RMS and to each CMS simultaneously for marketing authorization. The RMS assessment report is supplemented by any CMS questions, comments, or clarifications to the product dossier. The clock stops (at day 105) when there are clarifications required by applicant. Following applicant’s response,there is a second assessment performed. When consensus is achieved, the RMS and each CMS grants marketing authorization. This is done through each countries’ national licence approval process. RMS must take the lead in the procedure by issuing assessment report • Distribution of the assessment report by the RMS to each CMS • A 90 day period is taken (assessment step II in DCP) for each CMS where they can recognize the day 120 assessment performed by the RMS in DCP or the MA granted by the RMS in MRP • If consensus cannot be reached then CMDh referral can be made only in case the RMS is positive and a CMS does not agree based on a PSRPH • This is a harmonised assessment and outcome, but national level marketing authorizations occurs Differences Between the Procedures • Only applicable for the MRP, a marketing authorization is made to RMS first to get a national approval; this is then followed by initiating the MRP in the desired CMS(s) • In the MRP, there is no clock stop or withdrawal when a potential serious risk to public health concern is raised • The DCP is submitted to the RMS and CMS at the same time; RMS takes the lead but there is no previous MA Similarities Between the Procedures •