Caterina Scarpati

Following the training session held on 12 November 2024, EMA is organising pre-go-live Q&A Clinics to answer any open questions from Marketing Authorisation Holders on the transition of EMA-led post-authorisation procedures to IRIS.

• 11 December 2024 (11:00 – 12:00 CET): Register here.
• 19 December 2024 (11:00 – 12:00 CET): Register here

Background
In January 2025, the following EMA-led procedures will transition to IRIS for all Centrally Authorised Products (CAPs) (and involved non-CAPs) for procedures submitted on/ after 20 December 2024 via the current submission systems (i.e. Gateway and PSUR repository):

• Post-Authorisation Measures
• Line Extensions
• Renewals
• Annual Reassessments
• Post-Authorisation Safety Studies/Post-Marketing Surveillance Studies
• Referrals

The first transition of post-authorisation procedures to IRIS took place on 23 January 2024, onboarding variations, Article 61.3 notifications, and marketing authorisation (MA) transfer procedures for a subset of human and veterinary CAPs with low regulatory complexity. 
Note: Periodic Safety Update Reports will transition to IRIS with the procedures starting on the 6 February 2025 and onwards as per PSUR procedural timetable published on EMA website.

Dear Paolo,

The “IRIS guide for applicants” (EMA/444925/2018)  https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/iris-guide-applicants_en.pdf states:

"For PLM procedures “submission contact” is the “Person/Company authorised for Communication between MAH and Authorities after Authorisation” of the lead Authorisation Product within the current submission, held by EMA. For worksharing or grouped variations affecting more than  one product, the lead Authorisation product is the product as indicated by the Applicant in the Letter of  Intent."

This means that the contact (recorded at EMA) of the lead product will become the contact of the case (submission contact) in the IRIS portal.

The "submission contact" role can be reassigned at any moment for draft and ongoing submissions, and repeatedly, by any of the Industry/Parallel distribution managers associated to that submission, but the EMA will send communications only to the “single” "submission contact", assigned in that moment, by default. This is for efficiency and security reasons."

Once the submission is created on the IRIS  portal (case is recorded by EMA), the default contact (contact for the lead product) will receive an email. If you are not the contact of the lead product, then the default contact can set your user as a contact (if you have IRIS Industry manager role)  once the case (submission) is created.  They can log on the IRIS portal and set you ( for example) as contact for that case and you will be able to receive all communication to your email, as usual. Please go ahead and request and IRIS Industry Manager role for the organisation LOC ID which is the marketing authorisation holder (MAH) for the products part of the worksharing.

Best regards,
IRIS team

Dear Anita,

For users not directly involved in the procedure management, the following role is advised, however please note that it has some limitations:

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.

It is important that anyone communicating with EMA will have an IRIS account since IRIS will be the main platform from which EMA will be communicating with the MAHs (and IRIS has embedded email functionality, hence Outlook will be less used in the future).

If a user does not have an IRIS account, no emails can be sent to this email address from the IRIS system.

Best regards,
IRIS team

In view of the transition of post-authorisation procedure management to the IRIS platform in January 2025, this means the majority of EMA-led procedures will be managed through IRIS. Marketing Authorisation Holders need to take action to effectively prepare for this change.

Important: Submissions for all regulatory procedures of the product lifecycle will continue to be performed via the current systems (i.e. Gateway and PSUR repository)
To ensure proper access to the IRIS platform, the EMA requires that all Marketing Authorisation Holders (MAHs) product contact points register in the EMA Account Management System by 30 November 2024. This is essential for seamless email communication, access to case information, and document management.

Upcoming training session: The EMA is organising a training session on 12 November 2024 (10:00 – 11:30 (CET)) to provide you with key instructions to be prepared for the transition, showcase the IRIS system and answer your questions. Register here.

Important instructions for you:
1) Request access via the EMA Account Management System for all affiliated roles. Detailed instructions are available in the IRIS guide to registration and RPIs.
2) Ensure the access is requested for the relevant organisations affiliated with the products you are contact for (Request Access · EMA Account Management (europa.eu)).
3) Use of personal mailboxes as product contacts: For security reasons, IRIS does not accept generic mailboxes as contact points for regulatory procedure application submissions.
If your products currently list generic mailboxes, please update all product contacts to personal mailboxes associated with responsible individuals within your organisation:
a.    Submit the updated form using the following template: template_letter-change_contact_person_en.doc (live.com).
b.    Instructions to submit the form are available here:

• Human-use products: Contacting EMA: post-authorisation | European Medicines Agency (europa.eu).
• Veterinary-use products: Notifying EMA of changes to contact persons (veterinary medicines) | European Medicines Agency (europa.eu)

If you have already an IRIS Account that complies with the above guidelines, please ignore this request.

Dear Tatiana,

Please refer to the Industry Update webinar on Regulatory Procedure Management for Product Lifecycle Management on IRIS. You will still receive notifications from the EMA at relevant milestones of the procedure. In addition, in the IRIS industry portal you will have an overview of the procedures where you have the appropriate role(s), which includes the procedural timetable.

Best regards,
IRIS Change Management Team

Dear Elena,

Please refer to the IRIS guide for applicants and the IRIS guide for registration. Following the move to IRIS, the industry portal will be the only way to receive procedure documents and to share working documents that are needed during the ongoing procedure outside of the gateway submissions.

Best regards,
Caterina

Dear Elena,

Please refer to the IRIS guide for applicants and the IRIS guide for registration. Regarding the list of persons registered for your organisation, we are not able to share this for GDPR reasons, however your organisation’s IRIS – eAF Industry User Admin should have the overview for their organisation’s registration.

Best regards,
Caterina

Dear Barbora,

For CAP products we continue use the product contact as default and the MAH can edit the contact for the procedure in the industry portal as per the IRIS guide for applicants. The product contact (i.e. portal contact) will be the one receiving the notification.
Hope this clarifies.

Best regards,
Caterina

We are now working on a mass emailing to each email address recorded under a product to inform them about the role they are having for a given product.
Hope this helps.
 

Please be aware that users may experience minor performance issues (e.g. slower response times) on the CRM, and IRIS Industry & Network Portals due to the ongoing load of non-Centrally Authorised Products (non-CAPs) data on the Product Management Service (PMS) User Interface (UI). This process will be completed by the end of September 2024.