Roberta Bernardelli Mrs

I've just realised that for my company entire CAPs portfolio the marketing status in UK Northern Ireland is now set as not marketed on 1January2025 (the status of the never marketd products is correctly unchanged) and UK Northern Ireland is not included in the list of countries anymore. I think I've got the answer I was looking for: no actions for the MAH in IRIS in relation of the Windsor protocol (I suppose). Thanks for a confirmation.

Could you please advise on the way/timeline to withdraw the information regarding the marketing status of the CAPs authorised in UK Northern Ireland now that the Windsor Framework is in operation?

Thanks in advance

4thJune is quickly approaching, are you planning to organise a webinar on the use of IRIS for PIP related submissions? I've also noticed the IRIS guidance document do not include any reference to PIP submissions yet. Thanks

Will the new category be added to the relevant RMS list (100000072052)?<br> Currently the Marketing Status RMS list includes only:&nbsp; <ul> <li>Not marketed</li> <li>Marketed</li> <li>No data provided</li> <li>Temporarily unavailable</li> </ul> Thanks.<br> Kind Regards, Roberta

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.


 

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)?

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

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