MRP-RMS-New application flow chart
The mutual recognition procedure is to be used in order to obtain marketing authorisations in several Member States where the medicinal product in question has received a marketing authorisation in at least one Member State at the time of application.
The Mutual Recognition Procedure:
- DAY -14 – DAY 0: validation period – starts when the procedure is entered into the CTS (Communication and Tracking System), the documentation and the Assessment Report prepared by the RMS has been received by the CMSs
- DAY 0: starts when every CMS has validated the documentation (every deficiency has been supplied)
- DAY 50: the CMSs send their comments
- DAY 60: the applicant sends the response to the comments
- DAY 75: the CMSs send their comments
- DAY 80: the applicant sends the response to the comments
- DAY 85: the CMSs send their comments
DAY 90: if there is a consensus the RMS closes the procedure – otherwise the case is referred to the CMDh (Coordination for Mutual Recognition and Decentralized Procedure)
The applicant submits the Hungarian SmPC, PIL and Labelling and therefore starts the national phase of the procedure.