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Sticky
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Questions and Answers at the IRIS Industry Stakeholders meeting, 21 May 2021
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Paolo Tomasi
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0 |
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Sticky
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Q&As on IRIS registration, login and RPI requests
|
Paolo Tomasi
|
|
5 |
|
|
Availability of Marketing Status Notification (Bulk Upload)
|
Isha Arora
|
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1 |
|
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How do I do a baseline submission for already authorised products?
|
Poonam Sabharwal
|
|
0 |
|
|
Marketing Status is available on IRIS Portal from 26 July 2021
|
Poonam Sabharwal
|
|
3 |
|
|
OD Annual Report: Scientific Content
|
Susanne Hense
|
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1 |
|
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Use of RPI in paediatric submissions
|
Susanne Hense
|
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1 |
|
|
Marketing status submissions will be available in IRIS from July 2021
|
Paolo Tomasi
|
|
0 |
|
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Automatic deletion of inactive submissions
|
Paolo Tomasi
|
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0 |
|
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EMA IT SYSTEMS UNDER MAINTENANCE 18, 19 AND 20 JUNE 2021
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Paolo Tomasi
|
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0 |
|
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"Dormant" status for Regulatory Entitlements
|
Paolo Tomasi
|
|
0 |
|
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RMS Lists used in IRIS procedures
|
Susanne Hense
|
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3 |
|
|
Reporting of marketing status - go-live date
|
Marine Baixauli
|
|
3 |
|
|
Zoom out for filters view in Safety Update
|
Poonam Sabharwal
|
|
0 |
|
|
Loading substances error in ‘Request for a Research Product Identifier’
|
Poonam Sabharwal
|
|
0 |
|
|
NEW VERSION OF THE IRIS GUIDE TO REGISTRATION (AND RPI) PUBLISHED
|
Paolo Tomasi
|
|
0 |
|
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List of products which require urgent safety update is published on the EMA website first
|
György Pásztor
|
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1 |
|
|
Separate products for co-administration require separate RPIs
|
Bénédicte Perret
|
|
1 |
|
|
RPI request - substances to select keep loading - no progress possible
|
Bénédicte Perret
|
|
2 |
|
|
Communication from EMA for IRIS submissions is directed to the "Submission contact" only
|
Paolo Tomasi
|
|
1 |