As of end of July 2021, EMA requests MAHs of CAPs to submit their marketing status notifications via the IRIS Platform. As follow-up of the last EMA/Industry Platform meeting on the centralised procedure, an extension of the timelines in the implementation plan for IRIS Marketing status reporting from 6 to 9 months has been communicated.
The new deadline for the submission of the Marketing status data for all presentations of each CAP in the EU/EEA MS is 30.04.2022 (previous 31.01.2022).
The Agency is analysing the feedback provided by industry and fixing some technical issues in the ´bulk submission´ to ensure the correct upload of all data for marketed CAPs. This submission type is the most widely used by MAHs to report the current marketing status of medicinal products currently marketed in the EU/EEA MS.
From the agency, MAHs are encouraged to continue gathering the data to be reported and to submit as soon as possible. The regulatory guidance will be updated in January to reflect the change in the deadline.