H-1051 Budapest, Zrínyi u. 3.

Tel.: (1) 8869-300, E-mail: ogyei@ogyei.gov.hu

Mail: 1372 P.O. Box: 450.

MAGYAR

DCP-RMS-New application flow chart

During te decentralized procedure from all Member States of the EEA Hungary is chosen by the applicant to act as Reference Member State, accordingly the documentation which has been primarily approved by the National Institute of Pharmacy will be - besides continuous consultation - assessed by the other Member States simultaneously.

The procedure in details:

● Day -14 - Day0: 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
● Day 106: it is fixed by the RMS, when the applicant's response document is considered to be satisfying
● Day 120: the procedure may be closed if there are no more comments from the CMSs' side - consensus
● if there is no consensus reached…
● Day 120: Assessment Step II starts, Draft Assessment Report (DAR) is sent by the RMS to all CMSs
● Day 145: CMSs send their comments to the RMS
● Day 150: 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
● Day 180: the RMS prepares a short report and forwards it to all CMSs
● Day 205: CMSs send their final comments
● Day 210: 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
 
Last updated: 2008.08.19 11:17