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MAGYAR

DCP-CMS-New application flow chart

The applicant choses one country from the Member States of the EEA to be the Reference Member State – the competent authority of this country will primarily approve the documentation of the new application. All other Member States involved in the procedure will simultaneously assess the documentation besides continuous consultation.

The procedure in details:

  • Day -14- Day 0: validation period – it starts when the procedure appears in the CTS (Communication Tracking System) and the documentation has been submitted to the National Institute of Pharmacy
  • Day 0: Assessment Step I starts (the validation issues has to be solved by this time)
  • Day 70: the Preliminary Assessment Report (PrAR) is sent by the Reference Membe State (RMS) to all Concerned Member States (CMS)
  • Day 100: CMSs send their comments to the RMS
  • Day 105: clock-stop – the procedure is stopped temporarily; the applicant receives the RSI – Request for Supplementary Information document
  • Clock-off period: during this period the applicant has to prepare the response document
  • Day106: it is fixed by the RMS, when the applicant's response document is considered to be satisfying
  • Day120: the procedure may be closed if there are no more comments from the CMSs' side - consensus
  • if there is no consensus reached…
  • Day120: Assessment Step II starts, Draft Assessment Report (DAR) is sent by the RMS to all CMSs
  • Day145: CMSs send their comments to the RMS
  • Day150: the procedure may be closed if there are no more comments from the CMSs' side - consensus, Final Assessment Report (FAR) is sent by the RMS to all CMSs
  • if there is no consensus reached…
  • the remaining questions are sent to the applicant by the RMS, the applicant submits supplementary responses to the RMS
  • Day180: the RMS prepares a short report and forwards it to all CMSs
  • Day205: CMSs send their final comments
  • Day210: the procedure may be closed if there are no more comments from the CMSs' side - consensus, otherwise the procedure will be referred to the CMDh (Coordination Group for Mutual Recognition and Decentralized Procedure)
  • 30-day-long national phase starts when the applicant submits the Hungarian translations of the final Summary of Product Characteristics, Patient Information Leaflet and Labelling
Labels: MRP, DCP, RMS
Last updated: 2008.08.19 11:18