Paolo Tomasi EMA

Please report this type of specific technical problems via a Servicedesk ticket, rather than in the Forums. 

RPIs are not the same thing as an authorisation products. Marketing status is reported for authorization products, not for RPIs. If there are no authorized products shown for your organisation and correct location, please raise a Servicedesk ticket, providing as much detail as possible, including screenshots. 

It should be requested as a followup to the initial advice.

The IRIS Data Protection notice and the Records of Data Processing Activity documents have been published on the EMA website. 

Company users with the "IRIS Industry User Admin" role are reminded that EMA does not check the affiliation status of users to Organisations, as this is a responsiblity of each Organisation.
Users with the  "IRIS Industry User Admin" role for an Organisation are therefore advised to run periodical checks on the list of users that are affiliated to their Organisation, and their roles, so that the affiliation can be removed promptly where appropriate, for example when an employee leaves her/his position, or if an external consultant should not be allowed access anymore. Organisations may also wish to implement a standard policy of affiliation removal in their check-out procedures for leavers. 

As mentioned in the IRIS guide for applicants, it is strongly recommended to use only one location of the parent organization for all IRIS submissions, RPIs and regulatory entitlements. The location should be the address of the legal seat of the organisation. This simplifies your management of submissions in IRIS, because after selecting a location for a draft submission, only the RPIs and Regulatory Entitlements associated to that location will be available for selection. 

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:

A) Scientific procedures (e.g. for Inspections, Scientific Advice, Orphan Designation or Innovation Task Force briefing meeting)

Individual role:

• IRIS Individual User: this role is assigned automatically by system for new accounts, or approved automatically. You should use this role if you will be submitting applications as an individual user, not on behalf of an organisation.

Affiliated roles:

• IRIS Industry User Admin: can assign the other roles to those who request then for the organisation. Please note that an Industry User Admin cannot access IRIS, or create submission, unless the User also gives himself the role of Industry Manager (below).
• IRIS Industry Manager: can create new applications, and edit, submit and withdraw the created applications or any other where the user has been specifically added as Industry Manager.
• IRIS Industry Contributor (this role is automatically assigned also to IRIS Industry Managers): can edit submissions where he/she has been added as a Contributor by a Manager. An Industry Contributor cannot create, submit or withdraw a submission.
• IRIS Industry Coordinator : users with this role can access 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, with the functions of IRIS Industry Manager. Please note that this role does NOT allow to create new submissions of any kind: for that, it is necessary to also have the role of Industry Manager, for the same organisation.

B) Parallel Distribution procedures

Affiliated roles

• IRIS Parallel Distribution User Admin: can assign the other roles to those who request then for the organisation. Please note that an Industry User Admin cannot access IRIS, or create submission, unless the User also gives himself the role of Industry Manager (below).
• IRIS Parallel Distribution Manager: can create, edit, submit and withdraw applications.
• IRIS Parallel Distribution Contributor: can edit applications (but not create, submit or withdraw them)

Additional information on what individual roles can see in the system is included in the IRIS guide to registration. 

To all IRIS users, and more in general all Industry stakeholders. 

In alignment with the Agency's cloud strategy and the information security strategy, a new IT service management solution called ServiceNow will replace our current tool (Jira), with a target go-live date of 12 September. The first stage of the transition will include the customer portal, IT incidents and IT service requests (IT equipment, applications, audio-visual and virtual meetings), basic configuration management database (CMDB) and the mobile app. From 12 September 2022, Jira will not be any longer available for raising any IT Service request or Incident.

The aim of this improvement is to adapt EMA's processes to the industry best practices and enhance End-user experience, by delivering a more user-oriented service. To familiarize yourself with the new platform, a short Instructional video is available (4 min).

Please follow the link below and enter the password.

Instructional video URL:   https://vimeo.com/showcase/9785767

Password:                         SNtraining2022!!!

For any questions or comments, please send an email to servicenow@ema.europa.eu

For specific problems in IRIS, rather than general aspects of the function of the system, please raise a Servicedesk ticket, including additional information and screenshots. It is not possible to assess and solve/answer this type of requests in a Forum thread, unfortunately.

Due to a problem with the integration routine between the EMA Identity and Account Management meeting system and IRIS, and also because of an increase in submissions and Servicedesk requests due to the return from holidays coupled with the iSpoc deadline, EMA Servicedesk is experiencing a surge of requests, so it may take more than usual to perform the re-sync, for which we apologize. EMA IT is aware of the background issue in the integration routine and is working towards a solution.