Irina Lazar-Contes

Hello,<br> <br> Please note the following: after receiving a validation error the submission was moved in my draft submissions folder. I have corrected the error and re-uploaded the corrected excel for the bulk re-submission. However the submission button is not active and I am not able to click on it (see how the mouse arrow looks like when trying to click on it in the attached photo).&nbsp;<br> <br> What to do?<br> <br> Best,<br> Irina<br> &nbsp;

Many thanks for the confirmation on the 2-step submission process for the baseline submission, all clear now on this topic!
All the best,
Irina

Hello,<br> <br> Many thanks for the communication, this is great news. I would like to confirm with you one thing that is still unclear to me: for the bulk submission of the baseline marketing status report for a product, can we now use any o the 3 values - Marketed, Not Marketed, Never Marketed -&nbsp; from the first upload or does the upload still need to be performed in 2 steps for ceased products (Not Marketed status) as it was previously suggested in the forum:&nbsp;<a href="https://iris.ema.europa.eu/forums/general-discussion/17212e1d-c990-ec11-826d-0003ff4ad026">Marketing status for presentations marketed in at least 1 EU Member State&nbsp;· IRIS (europa.eu)</a>?<br> <br> Many thanks in advance for the clarification!<br> &nbsp;

What about the submissions that are stuck in "In Submission" for several weeks now? There is no option to delete those, and even when re-uploading the excel with the corrected errors, nothing is happening in the system. In addition, some submissions are stuck in this step even without receiving a validation error message.<br> <br> Thank you in advance for the clarifications!<br> <br> &nbsp;

For a couple of our bulk submissions we have received a validation error message due to some corrections that were needed in the uploaded excel. However, if going to the ongoing submission item I can only re-upload the new excel and then "Save & Return". The subsequent "Declaration" and "Submission Form" steps are already filled in and inactive and hence I cannot re-submit this item for activating a new validation cycle. I have attached a print screen of the Submission Form tab.
Given this situation, I am confused about what is meant by submitted again in the Q&A document:  "It has been identified an issue where the submission stays in Ongoing submissions in case of validation errors. If so, the case can be edited from there and submitted again after correcting the errors." -  Does it mean only re-uploading the corrected excel file? Because so far this has not triggered any re-validation for my submissions for which I received validation errors and they are stuck in "In Progress" since some time now.

Thanks a lot in advance for your advice with this issue!