Posted Thu, 28 Apr 2022 05:47:03 GMT by Hakyung Lim
Following the initial submission of its marketing status in Jan 2022, the MAH has received invalidation for its submission regarding use of the term "not marketed", and has re-submitted the marketing status to read "never marketed" under the same case number. 

However, despite the given time, the "Submission Status" and "Case Status" on the IRIS portal still reads "In-progress" and "Submitted", respectively, instead of "Processed" and "Completed-closed". The MAH inquires the Agency for its confirmation herein whether the submission of the marketing status has been successfully submitted for Imraldi or that any other actions are needed.
Posted Thu, 28 Apr 2022 15:08:34 GMT by Virginia Rojo Guerra
Please do not post product specific information on the Forum, since this is a public domain. In case of product specific issues, please raise a ticket with EMA Service Desk indicating the case number and attaching the excel you are trying to upload. Similar cases that are left ongoing for extended periods of time were due to errors in the excel. Please review the excel together with the IRIS guide to ensure there are no errors, create a new case and resubmit. If the issue is not sorted, please contact the EMA Service Desk.

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