Isha Arora Dr.

Will the "IRIS General Manager"' role be assigned to individuals only or will it be possible to register a generic email address for that role ?

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however is not authorized to (i.e change of function within the company, or left company recently and rights have not been revoked yet), how the respective responsibilities (individual/company) are understood?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 new feature "Regulatory Entitlements" in IRIS is quite informative, thank you.
It is understood that the feature enables to see a list of all regulatory entitlements for organisation(s) the person is affiliated to.
However, it is not possible to access and see the actual submission package, would it be possible to implement either a "view & download the submission" feature or a new IRIS Industry role (ideally for a generic email address) who will allow to view only and download all the submission packages for an organization ? This would be useful mainly for archiving purposes and knowledge sharing within the organization.

In regards to Q&A 1, IRIS Industry General Manager role,

• Where do we stand with this ?
• Will this role be assigned to individuals only (as today with other roles) or will it be possible to register a generic email address for that role ? 

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) ?