Paolo Tomasi EMA

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.

In reply to your questions:

1. we do not require a letter of authorization for any procedure submitted in IRIS, as the role granted by the "IRIS Industry User Admin" of the applicant replaces it. However, proof of establishment in the EEA is still required as an attached document for Orphan Designation Applications. 
2. your understanding is correct.
3. as a self-declaration that the person is still acting on behalf of the organization, for that specific submission.  
4. the question is unclear. 

We will activate a new role in the future, called "IRIS General Manager", which will allow users with that role to view and edit any submission made on behalf of a specific OMS Organisation. When available, it will appear in the list of IRIS roles in the EMA Account Management System. 

1) yes.
2) you can apply for the correct role and request  affiliation to the appropriate organisation(s) at  https://register.ema.europa.eu 

Best regards

This is a preview of the new version of the IRIS Guideline for Applicants, which will replace the existing one on the IRIS home page on 19 October. Feedback is welcome.