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Posted Thu, 03 Oct 2024 13:45:55 GMT by Anita Filipovic Sucic
Dear Sir/Madam,

Could you please confirm whether the Contact person for the Scientific service of the MAH in the EEA (eAF MAA section 2.4.5) and Contact person in the EEA for product defects and recalls (eAF MAA section 2.5.1.1) also need to have EMA account and request access to IRIS? 

Thank you very much,
Kind regards,
Posted Mon, 28 Oct 2024 12:01:33 GMT by Caterina Scarpati

Dear Anita,

For users not directly involved in the procedure management, the following role is advised, however please note that it has some limitations:

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.

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 a user does not have an IRIS account, no emails can be sent to this email address from the IRIS system.

Best regards,
IRIS team

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