Paolo Tomasi EMA

In answer to your questions:

1. Yes, an EMA user can request affiliation to any organisation, and have more than one affiliation.
2. Yes, the application forms replaces the letter of intent. You will still need to upload the scientific document (briefing document).

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. 

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.

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. 

The search box for PIP opinions/decisions contains the complete list of all PIP opinions/decisions, as these is public information. In addition this allows to choose any PIP, even if granted to a different applicant, which is in relation with the Scientific Advice submission. You need to search for the correct PIP decision or opinion, by searching for the appropriate PIP number or EMA decision number - either is fine as in principle both are included in the list. 

RPIs that refer to multiple products are generally used only for ITF submissions. 

As mentioned in the EMA Account Management System:

We advise against using generic (i.e. info@) and private (i.e. Gmail or Yahoo) e-mail addresses due to security reasons. To create an account only personal e-mail address must be used e.g. name.surname@domain.com.

The "IRIS Industry User Admin" is needed to approve further role requests from other staff or external consultants who need to act on behalf of an organization involved in submitting applications for EMA scientific procedures. EMA recommends to have at least 2 User Admin per organization.

The first role of "IRIS Industry User Admin" needs to be approved by EMA, but further roles of of "IRIS Industry User Admin", or any other IRIS role, will by approved directly by any existing "IRIS Industry User Admin" for that company. All requests for approval of further roles (affiliation requests to that organization)  will go to all the persons with the "IRIS Industry User Admin" role.

Of note, persons with the "IRIS Industry User Admin" role can not create and submit applications themselves; for this, the "IRIS Industry Manager" role is necessary. A person can have both roles of "IRIS Industry User Admin" and "IRIS Industry Manager".

There is no specific procedure to "transfer" an "IRIS Industry User Admin" role to another person within a company. An additional "IRIS Industry User Admin" can be approved, and then the new "IRIS Industry User Admin" can revoke access to any existing "IRIS Industry User Admin", if appropriate.

The IRIS portal home page has  been revamped and is now easier to read. In addition, it is now possible to submit Scientific Advice applications (human and veterinary) via the portal. 

The responsibility of allowing and maintaining access to IRIS on behalf of an organisation lies with the organisation itself. The EMA Account management system allows Industry User Admin persons to check the list of persons enabled to submit on behalf of the organisation ("affiliated" users), and remove the affiliation when necessary. Any issue of authorisation or liability remains between the organisation and the affiliated individual.