Q&A on Scientific Advice submissions in IRIS

This list of Q&A originates from the Industry consultation group that has been set up to provide feedback on the implementation of IRIS for Scientific Advice. EMA expects to make IRIS available for Scientific Advice applications in October 2020.
The list now includes additional questions received (previously in a separate thread). 

In regards to Q&A 41, it is stated that "There is no need anymore for a Letter of Authorization".

• Is this applicable to SA procedures only or to all procedures submission via IRIS ?
• It is understood that EMA considers that once the organization has provided an IRIS Industry Manager role to a person, it implicitly implies that the person is authorized to submit on behalf of the organization. Can you please confirm ?
• If the above is correct, why at the end of each submission, the below ticking box is required ? Why is this ticking box needed if Letter of Authorization is not needed and if it has been already defined per IRIS registration that the person is authorized to submit ?
• There is a general legal concern on what is needed to support ticking the box "is authorised on behalf of the applicant" (both from an individual and a company stand-point) ?

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. 

I would like to clarify my point 4-:
If an individual tick the declaration box "is authorised on behalf of the applicant", however is not authorized to (i.e change of function within the company, or left company recently and rights have not been revoked yet), how the respective responsibilities (individual/company) are understood?

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.