REMINDER ON THE FUNCTIONS AVAILABLE TO DIFFERENT USER ROLES IN IRIS

Every IRIS Industry Manager or Contributor affiliated to an Organisation can see all the Research Products associated to the Organisation, the Marketing Status of the Authorisation products as communicated to EMA by the Organisation itself, and all Regulatory Entitlements associated to the Organisation (such as Orphan Designations and Scientific Advice outcome).

Regarding submissions, users with the IRIS Industry Manager or IRIS Industry contributor role can only see those submissions created by themselves, or where they have been explicitly added as additional Managers or Contributors by another IRIS user already associated with that submissions. Users with the IRIS Industry Manager or IRIS Industry contributor role therefore cannot see all previous, ongoing or draft submissions of their affiliated Organisation.

EMA is developing a new role, called IRIS Industry Global Coordinator, which will enable creating, editing, submitting and withdrawing ANY application associated with the Organisation, whether or not they have been added explicitly to the submission. This is expected to go live in Q1 2022.

To use IRIS, you need to have been granted at least one of the following affiliation roles for the organisation on whose behalf you will be acting:

Scientific Procedures and Inspections:

  1. Individual role:
    1. IRIS Individual User: (this role is approved automatically by the system)
  2. Affiliated roles:
    1. IRIS Industry User Admin: can assign the other roles to those who request them for the organisation, including him/herself (but cannot do anything else).
    2. IRIS Industry Manager: can create, edit, submit and withdraw applications.
    3. IRIS Industry Contributor (this role is automatically assigned also to IRIS Industry Managers): can edit applications (but not create, submit or withdraw them).
    4. IRIS Industry Global Coordinator (in development): this role will allow IRIS Industry Manager capabilities for any submission/application made on behalf of an organisation (and not only those where the user is the creator or has been added as a manager/contributor.

Parallel Distribution procedures

  1. Affiliated roles:
    1. IRIS Parallel Distribution User Admin: can assign the other roles to those who request them for the organisation, including him/herself (but cannot do anything else).
    2. IRIS Parallel Distribution Manager: can create, edit, submit and withdraw applications.
    3. IRIS Parallel Distribution Contributor: can edit applications (but not create, submit or withdraw them).

For additional information, please consult the IRIS guide to registration.