• RE: Reason for Cessation in Marketing status report

  • RE: 11 reasons for cessation vs 8 in the guidance

    Please report any bugs you see in the system via a EMA Servicedesk ticket, rather than in the Forums. Regarding the issue at hand, this is indeed a regression bug, and EMA is aware of it: there should be 8, not 11 reasons. We are working to solve it in the next release of IRIS (new releases are deployed fortnightly).
  • IRIS user roles capabilities

    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
  • RE: GMP Inspections in IRIS

    IRIS receives the "Product contact" from the SIAMED2 database, where it corresponds to the "Person/Company authorised for Communication on behalf of the Applicant during the Procedure". 

    In IRIS procedures, only one "Submission contact " is maintained, for the purpose of communicating with the Applicant/Marketing Authorisation Holder. There is no plan to modify the system to enable communication with multiple individuals from the same organisation, for a single procedure/submission.

    Of note, the "Submission contact" may be different for separate procedures, and it can be modified by the Applicant/Sponsor in the submission, any number of times, among the other Industry Managers associated to the submission.
  • RE: Reason for Cessation in Marketing status report

    For technical issues, including assistance on a specific submission, please create a Servicedesk incident. Please attach screenshots of the submission data in the Industry Portal, to help Servicedesk staff identify the problem and find a solution. 
  • RE: Questions on access to IRIS for Product Contacts (for Inspections procedures)

    As already specified in the answers above, the principle in IRIS is that only a single person/email address is maintained as contact person for a product, submission or regulatory entitlement. For Inspection procedures, the contact initially assigned to the Inspection "submission" is the Product Contact as communicated by the Applicant to EMA during the Marketing Authorisation application. Also, as already mentioned above,  it is the responsiblity of the applicant:
    1. to update the Product contact as required, at earliest possible convenience and using the procedure described above;
    2. to notify other persons, in addition to the Product Contact, within or outside the Company in the preferred way (for example, using autoforward rules). 
  • RE: Questions on access to IRIS for Product Contacts (for Inspections procedures)

    All email messages from IRIS are sent from the address EMA-IRIS@id.ema.europa.eu, including those for Inspection procedures. 
  • RE: Questions on access to IRIS for Product Contacts (for Inspections procedures)

    This feature is not available. As mentioned in the previous answer, the plan is to allow complete self-management of contact persons by applicants/marketing authorisation holders directly in the IRIS Industry  portal. 
  • RE: Updated version of the IRIS Guide for applicants

    Yes, unfortunately the link name retains the old version's number, the updated version number (2.4) is showing in the document. 
    GCP is not released yet, due to unforeseen problems raised in UAT (User Acceptance Testing), which need some refactoring of the development; the guidance document is, as you say, pre-info, 
  • Updated version of the IRIS Guide for applicants

    An updated version of the IRIS guide for applicants (how to submit) v1.8 (europa.eu) has been published in the IRIS portal (Guidance section)