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First placing on the market
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 -
RE: Uploading of newly authorised products
Have you received any answer on this question? -
Marketing status from marketed to not marketed
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 -
RE: Updated IRIS guide for applicants - Registering an i-SPOC
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 -
RE: Information on how to manage marketing status for Liechtenstein
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 -
RE: Automatic deletion of inactive submissions
Does it mean that i will not find anymore even the submission completed more than 7 months before?
Thank you