Paolo Tomasi EMA

An "IRIS Individual user" role is not affiliated to any organization, and is intended for EMA account holders who intend to create submissions in their own name, rather than on behalf of an Organization. The "IRIS Individual user" role is therefore granted automatically by the EMA Account management system when requested. An "IRIS Individual User" cannot visualize the submissions, RPI or Regulatory Entitlements associated with any Organization, unless of course the same person also has other IRIS roles, affiliated to an organization. 

Yes. The "submission form" is just a copy of some of the data provided to EMA. The previous PDF form is not necessary anymore. 

In response to your questions:

1. Your understanding is correct, but in this case for EMA the Applicant IS the Consultant. Any advice will be addressed to the consultant as the applicant. For Scientific Advice this is not a problem for EMA, but for other procedures it may lead to undesired consequences: for example, in the case of on application for orphan designation, the designation would be granted to the consultant, not the (real) "owner" of the product.
2. Possibility 2 is in fact a variant of case n. two in our initial answer, not case number one. A legal organization in OMS can authorize any IAM User to be IRIS User Admin for the organization, even if that user is not an employee or representative of the organization itself. While this is technically possible, if approved by the organization, it has the potential to create undesirable consequences for the organization itself, of which they need to be aware and accept full responsibility. 
3. An IAM user can apply as in individual, rather than on behalf of an organization. This is built-in in IRIS. To do so, the IAM user needs to have the IRIS Individual User role, to be requested separately. In this case, the applicant is the individual, and fees will be charged to that individual. 

Thank you very much for your suggestion. We have plans for doing it, but public release of any documentation requires prior preparation and review before publication. Momentarily our team is engaged implementing new and business prioritized functions and cannot spare capacity for publication work. But we added it to the backlog for later delivery.

Yes and yes. This is from a technical point of view, but keep in mind the legal requirements and procedural rules for each submission category, such as orphan designations and scientific advice.

The inclusion of the "Entitlement Status" column and its filter have been added to the IRIS backlog. 

I have asked out IT colleagues to look into your request. Bear in mind, however, that for example the picklist values are dynamic, as they reflect RMS lists from SPOR; every time the RMS list changes, the picklist is automatically updated. 

Please specify more in detail what you intend by this, and what you need to know. Are you referring to the requirements to use the IRIS online platform, to create and submit applications?

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. 

The feature appears within the draft submission. You need to create a draft submission, and then select the appropriate option.