NADIA YONIS Europe Platform Regulatory Coordinator

Will all IRIS Managers/Contributors added in the case/procedure receive the IRIS notification email or should they have to check from time to time their log page on IRIS portal?
Will Scientific contact service will received any mail from IRIS in the future if a need is encontered in the future or should the Scientific contact service have to connect from time to time on IRIS portal? 

Concerning the category of cessation:
"Definitive Marketing Cessation of one/more presentation in one/more member state", we would like to take the opportunity to get your confirmation that this notification by Email could be stopped from 1 May 2022 as we have notified this Definitive Marketing Cessation via EMA IRIS Portal in May 2022.

dear IRIS colleague;&nbsp;<br> you say "<strong>that for reporting for RoW withdrawal should be done as per the existing process. <em>This functionality may be included in IRIS in the future. </em>And for shortage:&nbsp;The current process to report shortages does not change with the introduction of the marketing status reporting through IRIS. The field is included in IRIS for information only to act as an early warning and it does not need to be maintained. It does not replace the need to report shortages via the normal channels. N<em>ew functionalities may be included in the future</em>."</strong><br> CLARIFICATION QUESTIONS:&nbsp;Do you have an estimation of when the reporting of shortage will be transferred completely in IRIS ? In the mean time, could you please confirm if we should only do the reporting of shortage per current process or if a double reporting is expected in IRIS in parallel of the current process ?<br> <br> thank you very much<br> <br> &nbsp;

Dear iris colleagues,&nbsp;<br> If centralised products are not launched in Liechtenstein but imported from other countries (e.g. Switzerland), we don't have any launch dates. How can we manage this situation in IRIS ?&nbsp;Thank you&nbsp;<br> &nbsp;

If centralised products are not launched in Liechtenstein but imported from other countries (e.g. Switzerland), we don't have any launch dates. How can we manage this situation in IRIS ? Thank you 








 

<br> <span style="font-size:11pt"><span style="font-family:Calibri,sans-serif"><span lang="EN-US" style="font-size:11.5pt"><span style="font-family:&quot;Segoe UI&quot;,sans-serif"><span style="color:#666666">According to the answers provided in the thread about “GMP inspections in Iris” which is now locked:</span></span></span></span></span><br> <span style="font-size:11pt"><span style="font-family:Calibri,sans-serif"><span lang="EN-US" style="font-size:11.5pt"><span style="font-family:&quot;Segoe UI&quot;,sans-serif"><span style="color:#666666">- In case of prolonged absence, the contact person can contact the Inspections Office for specific arrangements.</span></span></span></span></span><br> <span style="font-size:11pt"><span style="font-family:Calibri,sans-serif"><strong><span lang="EN-US" style="font-size:11.5pt"><span style="background:white"><span style="font-family:&quot;Segoe UI&quot;,sans-serif"><span style="color:#666666"><span style="font-weight:normal">- In the future, a feature to allow direct self-management of product contacts by Industry in IRIS should be developed and this requires the implementation of a Global Coordinator role. An "IRIS Industry Global Coordinator" will be able to manage every submission for the Organisation(s) he/she is affiliated to, with that role.&nbsp;</span></span></span></span></span></strong></span></span><br> <span style="font-size:11pt"><span style="font-family:Calibri,sans-serif"><span lang="EN-US" style="font-size:11.5pt"><span style="font-family:&quot;Segoe UI&quot;,sans-serif"><span style="color:#666666">As regards this 2 topics we have additional questions:</span></span></span></span></span> <ol> <li><span style="font-size:11pt"><span style="color:#666666"><span style="font-family:Calibri,sans-serif"><span lang="EN-US" style="font-size:11.5pt"><span style="font-family:&quot;Segoe UI&quot;,sans-serif">Could you provide us with the details of the Inspection Office to contact ?</span></span></span></span></span></li> <li><span style="font-size:11pt"><span style="color:#666666"><span style="line-height:150%"><span style="font-family:Calibri,sans-serif"><span lang="EN-US" style="font-size:11.5pt"><span style="line-height:150%"><span style="font-family:&quot;Segoe UI&quot;,sans-serif">Do you know when approximately the new role of "IRIS Industry Global Coordinator" will be implemented?</span></span></span></span></span></span></span></li> </ol> <span style="font-size:11pt"><span style="background:white"><span style="font-family:Calibri,sans-serif"><span lang="EN-US" style="font-size:11.5pt"><span style="font-family:&quot;Segoe UI&quot;,sans-serif"><span style="color:#666666">Thank you. </span></span></span></span></span></span><br> &nbsp;