Caterina Scarpati

EMA has introduced email address authentication for EMA applications to improve security and usability of EMA applications by removing the need for users to remember their EMA username and password.  

Since 30 September 2024: 

• All new self-registered users are automatically set by default to email authentication. 

• All users not converted are requested to opt-in before the 20th of January 2025. 

On the 20 January 2025, the EMA has initiated the conversion of all users that didn’t opt-in to the email authentication: 

• 20 January: Non regulatory users without specific application roles; 

• 3 February: Non regulatory users with application roles; 

• 3 March: Regulatory users (European medicines regulatory network). 

• 31 March: all users are converted. 

How to opt in: Users are required to opt-in to email authentication in EMA Account Management by following the enclosed detailed instructions. Once converted to email authentication, users can use email address to authenticate into EMA systems. 

Useful links: Public system demo (Q3 2024) - Presentation and recording; "EMA Account Management, what’s new" webinar recording

Contact: EMA Service Desk; If you are unable to access Service Desk, please send an email to servicenow@ema.europa.eu indicating your name, surname and your unique username. 

The EMA is pleased to announce a public webinar on Substance, Product, Organisation, Referentials (SPOR) services scheduled on 22 January 2025 (10:00 – 12:30 CET).
SPOR services aim to facilitate the reliable exchange of medicinal product information in a robust and consistent manner, enabling increased data quality and interoperability, and more efficient regulatory action. Through the integration of its services with other systems used for regulatory procedures, such as IRIS, SPOR actively contributes to their success and full benefits realisation.
During the event, the following information be provided:

• Overview and how SPOR data is used in EU systems
• Overview of SPOR achievements in 2024
• News/Achievements in Q4 2024.
• What is planned for Q1 2025 – Impacts and benefits to stakeholders

The broadcast link, agenda and presentation will be available on the event web page.

The transition to IRIS for managing post-authorisation procedures has successfully gone live as planned.
Post-authorisation procedures submitted to EMA on or after 20 December 2024 are now managed in IRIS*. Submission steps are still to be carried out via the current systems – the Gateway and PSUR repository. IRIS will now serve as the platform for procedure management.
Post-authorisation procedures managed through IRIS are: Variations**; Article 61.3 notifications for human medicinal products; Marketing Authorisation (MA) Transfers; Post-authorisation measures (PAM); Annual reassessments; Referrals; Post-authorisation safety study (PASS)/ Post-marketing surveillance studies (PMSS); Line extensions Renewals.
* Periodic safety update reports (PSUR) will transition to IRIS with the procedures starting on the 6 February 2025 and onwards as per PSUR procedural timetable published on EMA website
** For veterinary medicinal products, variations not requiring assessment (VNRA) are to continue to be submitted and managed via UPD
This transition affects all Centrally Authorised Medicinal Products (CAPs) and non-Centrally Authorised Medicinal Products (non-CAPs, i.e., NAPs, MRPs, DCPs) for procedures where EMA acts as the reference authority.
Recap of supporting resources: To assist you during this transition, please find the following resources in the attached PDF document:

• Actions for MAHs
• Key training resources for MAHs
• Service desk triage guidelines for support requests

Upcoming Live Q&A Sessions: We encourage you to attend our live Q&A sessions for additional guidance:

• 8 January 2025 (14:00 – 15:00 CET): Register here
• 17 January 2025 (10:00 – 11:00 CET): Register here

For action: last call for user survey! Please be reminded that you have until 7 January EOB to reply to the to the enclosed survey to provide insights on your their level of readiness for the transition to IRIS and on the type of support needed. Based on the feedback received, additional engagement activities may be planned.
If you have questions outside the above or require further assistance, please raise a ticket through the EMA Service Desk.

EMA has introduced email address authentication for EMA applications to improve security and usability of EMA applications by removing the need for users to remember their EMA username and password.  

Since 30 September 2024: 

• All new self-registered users are automatically set by default to email authentication. 

• All users not converted are requested to opt-in before 20 January 2025. 

Starting from 20 January 2025 the EMA will initiate the conversion of all users that didn’t opt-in to the email authentication:

1. 20 January: Non regulatory users without specific application roles; 
2. 3 February: Non regulatory users with application roles;
3. 3 March: Regulatory users (European medicines regulatory network);
4. 31 March: all users are converted. 

How to opt in: Users are required to opt-in to email authentication in EMA Account Management by following the enclosed detailed instructions. Once converted to email authentication, users can use email address to authenticate into EMA systems. 

Useful links: Public system demo (Q3 2024) - Presentation and recording; "EMA Account Management, what’s new" webinar recording

Contact: EMA Service Desk; If you are unable to access Service Desk, please send an email to servicenow@ema.europa.eu indicating your name, surname and your unique username. 

This message contains important information to ensure preparedness for the upcoming transition of post-authorisation procedures to IRIS.

1. What will happen as of January 2025?
From January 2025, post-authorisation procedures submitted to the EMA on or after 20 December 2024 will be managed in IRIS. Kindly note that the submissions steps will still be done via the current systems, i.e., Gateway and PSUR repository, while  IRIS will be used for procedure management only.
Post-authorisation procedures transitioning to IRIS are: Variations*; Article 61.3 notifications**; Marketing Authorisation (MA) Transfers; Periodic safety update reports (PSUR)***; Post-authorisation measures (PAM) Annual reassessments; Referrals; Post-authorisation safety study (PASS)/ Post-marketing surveillance studies (PMSS); Line extensions; Renewals.

* For veterinary medicinal products, variations not requiring assessment (VNRA) are to continue to be submitted and managed via UPD
** For human medicinal products
*** Periodic safety update reports (PSUR) will transition to IRIS with the procedures starting on the 6 February 2025 and onwards as per PSUR procedural timetable published on EMA website
The transition will affect all Centrally Authorised Medicinal Products (CAPs) and and non-Centrally Authorised Medicinal Products (non-CAPs, i.e. NAPs, MRPs, DCPs) for those procedures where EMA acts as reference authority.

2. Supporting  documents
Please find in the attachment essential details to support the transition:

1. Actions for MAHs before the transition
2. Key training resources for MAHs
3. Service desk triage to request support

3. MAH readiness survey
We would appreciate to receive insights from each MAH on their level of readiness for the transition to IRIS and on the type of support needed. Based on the feedback received, additional engagement activities may be planned.
Kindly provide your feedback by replying to the enclosed survey by 7 January EOB.

4. Next planned live Q&A sessions:
Q&A clinics on post autorisation procedures are being organised in December 2024 and January 2025 as follows:

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

• 8 January 2025 (14:00 – 15:00 CET): Register here

• 17 January 2025 (10:00 – 11:00 CET): Register here

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