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RE: How to report the Marketing Status of presentations that have never been on the market
Will the new category be added to the relevant RMS list (100000072052)?<br> Currently the Marketing Status RMS list includes only: <ul> <li>Not marketed</li> <li>Marketed</li> <li>No data provided</li> <li>Temporarily unavailable</li> </ul> Thanks.<br> Kind Regards, Roberta -
RE: Questions on access to IRIS for Product Contacts (for Inspections procedures)
Would it be possible to download from IRIS (SIAMED) the list of products's contact point details, in the context of inspections procedure, for the organisations (MAHs) we act in behalf of?
To be able to check the list and if necessary notify changes would be able very helpful.
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RE: Questions on access to IRIS for Product Contacts
Could you please confirm whether the Product contact for the Marketing Authorisation Holder is the person included in the eAF in section 2.4.1 (Proposed marketing authorisation holder/person legally responsible for placing the product on the market in the European Union/each Member State) or the person included in section 2.4.3 (Person/company authorised for communication between the marketing authorisation holder and the competent authorities after authorisation)?
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Marketing Status reporting implementation plan and baseline requirements
Dear All,
My understanding from a previous thread is that this topic should have been discussed with industry associations at the EMA Industry Platform meeting on centralised procedure on 3rd Dec 2020.
Would it be possible to have details on the current Marketing Status Reporting implementation plan and baseline requirements?
Thanks in advance.
Kind Regards
Roberta -
Marketing Status reporting - Marketing Status values
Hi,
in the video shared recently to demo the submission of a Marketing Status report in IRIS, when filling in the Marketing Status field, the available values are Valid, Revoked, Temporarily Ceased, Permanently Ceased.
I expected Marketed, Non Marketed (in line with the Marketing Status RMS list values). Will this pick list be amended or I'm referring to the wrong RMS list?
Thanks
Roberta