Nicola More Ms

Some time ago I experienced a rejection of information in relation to a marketing status bulk upload submission due to incorrect format.

Whilst the system seems to say that you can amend the submission and resubmit it, this does not actually appear possible. 

Instead, it was necessary to start a completely new submission which went on to be accepted. 

My question is this - the rejected submission remains 'my draft submissions' folder and whilst the user guide suggests that it can be deleted via the drop down arrow, in reality this is not the case as the option is not available. 

The manual also states that any draft submission remaining untouched for 7 months will automatically be deleted, however this rejected submission has remained in the draft folder for a year. How can it be removed/deleted to avoid confusion moving forward? 

Dear Caterina, 

Like Elena we are struggling to understand what access in IRIS we should provide to the MAH contacts for receipt of EC decision, scientific services and product defect and recalls. 

the Iris guides you are referencing do not explain in detail why these contacts need to have access to IRIS or how the EMA intends to communicate with them e.g. do you now intend to send the EC decision via the IRIS portal??

Should these people be given an IRIS manager role for example, even though they will not be creating or editing any submissions etc. 

thanks
Nicola

We have an existing PIP approved ex-IRIS

We are now looking to submit a modification submission. Having set up a new draft submission I am working my way through the information required to complete the various screens, however most of the information being requested does not seem to directly relate to a modification but seem more in line with an initial PIP submission. This is making it difficult to complete mandatory fields since there is no context  in relation to a modification e.g. list the proposed indication - we are not proposing a new indication, we are trying to modify KBE of an existing PIP ??

I have looked at the IRIS for applicants document and the procedural advice document, however neither of these documents provide any detail on complete the individual fields. Hovering over these fields does in some cases provide a brief explanation, but again this appears in the context of an initial submission and not a modification. Is there any other guidance document or training that provides this more detailed information? 

 

Once a submission has been made, is it possible to download a copy of the submission for our internal records? the generated application form does not include all of the information entered to the submission itself (only a copy of the submission notes section is included). should the submission manager leave the company, how would the MAH access the information completed on the other sections of the submission in the future?