-
Important: Restore your IRIS access for PSUR submissions
If you notice that you can no longer see a submission in IRIS, it may be because your contact was automatically removed due to not having the proper access rights.
To restore your access for submissions in IRIS, please note the following key steps required to perform for the Portal Contact (i.e. Submission Contact):- Registration for IRIS access with the organisation for the product.
- Liaise with your MAH IRIS Industry coordinator to assign you to the submission
- Requesting access to IRIS
- IRIS access must be requested for the organisation under which the product is authorised (MAH ORG ID should be the same as in PMS/OMS) via the EMA Account Management portal. Only the user itself can raise this access request.
- Contact assignment to the submission
- Once you have been granted access to IRIS for the MAH of the product, please liaise with your MAH Industry Coordinator to assign you to the submission as Procedure manager and Submission contact/Portal contact via IRIS Portal.
For further guidance on IRIS access and navigation, and contacts for support, please refer to the Home - news · IRIS -
RE: Submission notes field not allowing entry of information and doesn't have a green tick?
Dear Helen,
Please submit your question to AskEMA, the official EMA channel for submitting general questions, or open a ticket via EMA Service Desk for an issue related to a specific case.
Kind regards -
RE: Retention of completed submissions documents
Dear Argade,
Please submit your request to the EMA Service Desk to report this type of issue.
Kind regards -
RE: PSUR/PSUSA IRIS cases for non-CAP
Dear Arora,
Please submit your question to AskEMA, the official EMA channel for submitting general questions.
Kind regards -
RE: Old data correctness update
Dear Kamila,
Please submit your question to AskEMA, the official EMA channel for submitting general questions.
Kind regards -
RE: Submission Type - MAT
Dear Zinal,
Please submit your question to AskEMA, the official EMA channel for submitting general questions.
Kind regards -
RE: GMP Inspection – Contact Request
Dear Caroline,
Please submit your question to AskEMA, the official EMA channel for submitting general questions.
Kind regards -
RE: How to link Scientific advices for same product but handled by different organizarion
Dear Argade,
Please submit your question to AskEMA, the official EMA channel for submitting general questions.
Kind regards -
RE: IRIS transition update: revised go-live timeline and updated support materials
Updated roadmap -
RE: Next steps for IRIS transition: Initial MAA and pre-submission procedures & updated roadmap
! Update: please note that the roadmap and support resource document previously attached above were removed as out to date. Please refer to latest news posts for up to date versions of these.