Elena Cerretini

Considering the new EMA requirement to have an active EMA account and relevant IRIS role for contact person at MAH address and for Commission, in order to choose the most appropriate IRIS role could you please clarify which are the activities that the contact person at MAH address will be called to do/receive on IRIS portal?

Thank you very much
Kind regards
Elena

Considering the new EMA requirement to have an active EMA account and relevant IRIS role for contact person scientific service and product defects/recall, in order to choose the most appropriate IRIS role could you please clarify which are the activities that the above people will be called to do/receive on IRIS portal? Could you please inform if the list of contact person for each CAP is listed on the platform or somewhere else?

Thank you so much
Kind regards
Elena

The transmission of marketing status data through IRIS is currently mandatory for CAPs only, will it be mandatory also for NAPs?  If yes, which are the timelines for implementation?

Thank you very much

Elena

The transmission of marketing status data through IRIS is currently mandatory for CAPs only, will it be mandatory also for NAPs?  If yes, which are the timelines for implementation?

Thank you very much

Elena

How has the first launch date to be communicated to EMA on IRIS platform? At the time of the first upload when IRIS enter into force each Company was asked to provide firstly the laucnh date and subsequently the current status, but how a new launch during the product life cycle should be managed? 
Thank you very much

Have you received any answer on this question?

Hi! In case one of our product pack will change from marketed to not marketed for commercial reasons, we need to update the IRIS platform in advance but which date should we report as "Date of Marketing Status Change"? The one when we upload the information (e.g. today) or the date by when the pack will not be on the market anymore (e.g. Jan 2023)?
Thank you very much for your help

Could you please clarify whether the iSPOC should be nominated only for CAPs or also for MRP/DCP/National products authorised in EU? Thank you very much

If we are in the case above reported of product imported in Liechtenstein from other Countries, should we marked "never marketed" for the baseline submission? Thank you very much

Does it mean that i will not find anymore even the submission completed more than 7 months before?
Thank you