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RE: Transition of post-authorisation to IRIS overview + request to register in EMA IAM by Oct 2024
Dear Requestor,
It is important that anyone communicating with EMA will have an IRIS account since IRIS will be the main platform from which EMA will be communicating with the MAHs (and IRIS has embedded email functionality, hence Outlook will be less used in the future).
if not already done so, you are kindly requested to register all contacts in EMA Account Management System by 30 November 2024 (or as soon as possible if your products are already transitioned to IRIS):
· Request access via the EMA Account Management System for all affiliated roles. Detailed instructions are available in the IRIS guide to registration and RPIs.
· Ensure the access is requested for the relevant organisations affiliated with the products you are contact for.
The roles applicable are:
IRIS Industry Manager: can create new applications, and edit, submit and withdraw the created applications or any other where the user has been specifically added as Industry
Manager.
IRIS Industry Contributor (this role is automatically assigned also to IRIS Industry Managers): can edit submissions where he/she has been added as a Contributor by a
Manager. An Industry Contributor cannot create, submit or withdraw a submission.
For users not directly involved in the procedure management, the IRIS Industry Contributor role is advised, however please note that it has some limitations (see above).
If you wish to change also your product's contact name:
a) Submit the updated form using the specific template
b) Instructions to submit the form are available at the following links:
· Human-use products
· Veterinary-use products -
RE: Generic email for Scientific Services, Product defect & Recall and MAH Rep - Other Users
Thank you for your query.
It is important that anyone communicating with EMA has an IRIS account, since IRIS will be the main platform from which EMA will be communicating with the MAHs (and IRIS has embedded email functionality, hence Outlook will be used less in the future).
We have shared this information directly with everyone who is registered currently as product contact.
The invoice/payment process is not affected by the move of the procedure management to IRIS.
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