Caterina Scarpati

If you have worked on a post-authorisation procedure on IRIS since 1 January 2025, you are invited to participate in a brief user survey designed to gather your feedback on the adoption of IRIS for post-authorisation procedures following the January 2025 transition. The survey will take approximately 5 minutes to complete.
Goal of the survey:

• Measure adoption levels across users and teams
• Identify areas of success where IRIS has improved your workflow
• Pinpoint any remaining challenges that may need further attention or support

How to participate:

• Click here to access the survey.
• The survey will remain open until 27 June 2025.

Participation in this survey is anonymous.
Your honest and constructive feedback will guide continuous improvements and support initiatives to ensure that IRIS fully meets your needs and expectations.
We greatly appreciate your time and contribution.
Please consult this overview document for useful training and guidance resources on procedure management in IRIS for Marketing Authorisation Holders.

Support document for MAHs

To assist Marketing Authorisation Holders in using IRIS for post-authorisation procedures, the PDF support document (attached below) is 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.

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