Caterina Scarpati

To improve security and usability of EMA applications, EMA has introduced email address authentication. This eliminates the need for users to remember their EMA username and password. 

• Since 30 September 2024, all new users are automatically set by default to email authentication; 

• On 20 January 2025 EMA initiated the conversion of the accounts of all users that didn’t opt-in to email authentication. This process ended on 14 March 2025; however, some users have not yet completed their account conversion. 

• On 8 May 2025 EMA will start blocking access to all users who have not completed their account conversion. 

How to complete the user conversion:

If not yet done, you are requested to complete the conversion of your account to email authentication as soon as possible, by clicking on the following link to login and follow the instructions: My Account portal (detailed instructions). 

Once converted to email authentication, you can use your email address to authenticate into EMA systems. Then, and depending on your user domain (e.g.: gmail.com, company.com, …), you will either be redirected to your organisation’s authentication page or receive an email with a One Time Passcode (OTP).  

Further information: Consult the EMA Account Management home page, authentication section: Sign In · EMA Account Management (europa.eu) 

Support: If you cannot find the support you need in the guidance documents, please contact the EMA Service Desk. 
Alternatively, if you are unable to access the EMA Service Desk, please send an email directly to servicenow@ema.europa.eu indicating your name, surname and your unique username and we will help you with your request. 

Following the recent synchronisation of IRIS with Organisation Management Service (OMS), some organisation names may appear in IRIS with a prefix "[INACTIVE]" in front of the organisation name, (e.g., [INACTIVE]ABC Pharma).  

What does the prefix "[INACTIVE]" mean? It is an indication that organisation and/ or location record was made inactive in OMS, but not in IRIS as the organisation and/ or location might be linked to regulatory records, e.g., ongoing procedures, regulatory entitlements, products, manufacturing operations, or similar. This is a temporary solution to identify organisations and/ or locations in IRIS that will be inactivated once their connections to existing regulatory records in IRIS are resolved.  

Note: The presence of the prefix does not directly corelate to the validity of Wholesale distribution authorisation, Manufacturing importation authorisation, or similar, for that location.  

Steps to inactivate the organisation and locations in OMS: Organisations and locations in OMS can be inactivated following the request of the organisations or as part of data mastering. For more information on OMS please refer to these guidance documents. 

----> Required actions from IRIS applicants/ marketing authorisation holders

• For completed procedures: If the company name OR organisation related to your submission appears in IRIS with the prefix "[INACTIVE]", please follow the respective procedural guidance and, if required, make a regulatory submission to move your regulatory entitlements to a new active location/address. 

• For ongoing procedures: If the company name OR organisation related to your submission appears in IRIS with the prefix "[INACTIVE]", raise a ticket using dedicated Service Desk ticket category “IRIS – report an issue”. EMA will review each of these cases individually. 

• For new procedure submission: Do not use organisations or locations with pre-fix "[INACTIVE]" unless you are applying to transfer the records to active locations or updating the name and/or address on the regulatory entitlements. 

Updated roadmap

Support document for MAHs

Following the successful go-live of IRIS for managing post-authorisation procedures, EMA is focusing on the next phase this year: the transition to IRIS of initial marketing authorisation application procedures (MAAs)  and selected pre-submission activities (including eligibility for the centralised procedure and letter of intent).

The IRIS team will work on the development of activities to support this transition, ensuring a smooth implementation for Applicants. To provide clarity on upcoming steps, an updated roadmap is now available (attached below).
We will continue to engage with you throughout this process and appreciate your collaboration in preparing for this transition.

To assist MAHs in using IRIS for post-authorisation procedures, the PDF support document (attached below) previously shared remains available, providing key resources such as:

• Actions for MAHs
• Training materials for MAHs
• Service desk triage guidelines for support requests

If you have questions outside the above or require further assistance, please raise a ticket through the EMA Service Desk.

EMA is organising quarterly public webinars on Substance, Product, Organisation, Referentials (SPOR) Regulatory Data Management (RDM) services status update, taking place at 10:00 – 12:30 CEST on 9 April, 9 July, 8 October 2025.  
During the events, the following information on RDM service activities (i.e. SMS, XEVMPD/Art.57, PMS, OMS, and RMS) will be provided: achievements from past quarter; what is planned for the following quarter. 
The webinars are held on Webex with no registration required (link to join available on the event web pages). Access is on a first-come, first-served basis until the 1,000-participant limit is reached.
Please find here an overview of all upcoming SPOR events (including related event pages).

!Updated document with supporting resources attached

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.