Paolo Tomasi EMA

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.

I assume that by "co-formulation" you mean a fixed-dose combination product (FDC). A FDC is a different product, therefore it needs its own RPI. If no product containing ONLY molecule 2 is being developed, then no RPI is needed for molecule 2. RPIs are assigned to track development entities, including potential or existing medicinal products, not to track substances.  

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) in the EMA Account Management System (https://register.ema.europa.eu).  

 

This usually means that the regulatory entitlement is not in the name of the organisation and location you have chosen, for the annual report, as they must be the same. Please check and if this does not solve the problem, please raise a ticket in EMA Servicedesk. 

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. 

In this answer I assume that by "combination product" you are not referring to a "fixed dose combination product", since this last one would have a single RPI rather than two (RPIs are assigned for development products, substances are mastered in SMS). 
In IRIS, it is not possible to add an RPI assigned to another Organization (legal entity) to the submission data, even if the other Organization belongs to the same multinational group. This is to ensure the necessary confidentiality of the RPI data that are used and displayed in the submission.

• In Orphan designations, only one product can be the subject of a procedure.
• In a Scientific Advice submission, additional RPIs can be chosen but they must belong to the same Organization; additional products for a combination treatment, but belonging to a different Organization, can be mentioned and discussed in the Scientific Document that will be uploaded with the submission.

In answer to your question, indeed the location chosen at the start of a submission does limit the RPI or the Regulatory Entitlement (e,g. Orphan designation, previous Letter of Advice): only an RPI or a Regulatory Entitlement which is owned by that location can then be chosen for the submission. However, an user affiliated to an Organization can choose any location for a submission. 
It is therefore recommended to have all RPIs and all Regulatory entitlements of an Organization assigned to a single location (normally the legal seat/address of the Organization) to simplify the management of submissions. Both transfers can be done in the IRIS portal, and for RPI transfers the procedure is automatic (it does not require EMA approval). 

Mandatory fields are highlighted with a red asterisk to the right of the field. That said, applicants are encouraged to fill in all the fields in the form.