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Submissions are evaluated according to the SAWP timeline, which you can find in the two documents with the 2020 and 2021 deadlines and timelines in
this page.
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The feature appears within the draft submission. You need to create a draft submission, and then select the appropriate option.
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You can submit an application through IRIS at any time
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Your understanding is correct.
- An application for Scientific Advice (or any other procedure) can be submitted at any time, the deadline only determines at which SAWP (COMP) meeting the submission will be discussed the first time.
- After submission, the application is indeed locked and cannot be edited unless reopened by EMA (for example to make changes needed for validation). If the submission is unlocked by EMA before validation, all data can be changed, and documents can be overwritten or added (they cannot be removed after submission). If the submission is unlocked after validation and start date, the data cannot be edited but documents can still be overwritten or added (but not deleted). A document can be deleted from a submission only if the submission is in "draft" state (i.e. before being submitted to EMA for the first time).
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In answer to your questions:
- Yes, an EMA user can request affiliation to any organisation, and have more than one affiliation.
- Yes, the application forms replaces the letter of intent. You will still need to upload the scientific document (briefing document).
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Please raise a ticket with EMA Servicedesk, mentioning the PIP number you are trying to retrieve, and your draft submission number. Please attach screenshots displaying what you do.
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In principle it should be possible to overwrite an existing uploaded file in an IRIS submission, simply by re-uploading a file with the exact same name and extension. Of course, to do that the submission must have been (temporarily) reopened by EMA staff: submissions are normally locked during the evaluation process. If reuploading with the same name fails for any reason, it is always possible to upload an updated version of the same file, with a suitable name, but this should not be needed.
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To create an IRIS application on behalf of an organisation, the user needs to have the "IRIS Industry Manager" role and affiliation to the relevant organisation. That person becomes then the "portal contact", i.e. the individual who will receive all communications regarding the submission, via the IRIS platform. While it is possible to add other managers or contributors for the submission, or assign the portal contact role to a different manager who has already been added to the submission, communications will only be sent to the current portal contact. It remains the responsibility of the portal contact to set up appropriate auto-forwarding rules, in his email client or server, so that other users can receive the notifications.