Caterina Scarpati

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.

The EMA is pleased to announce a series of webinars for SPOR and XEVMPD scheduled from 04 to 14 October 2024.
EMA SPOR Regulatory Data Management services aim to facilitate the reliable exchange of medicinal product information in a robust and consistent manner, enabling increased data quality and interoperability, efficiencies 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 create benefits for users.
The presentations (including agendas) will be shared before the start of the webinars.
The sessions will cover practical information for users, including, for each SPOR service:

• General principles and rules;
• Key processes;
• Key performance and data quality metrics;
• Updates & next steps.

The webinars will be conducted via Webex, and participants can join using the link provided on the event web page on the day of the event, with no need to register. Participants can join on a first-come, first-served basis until the session reaches its capacity of one thousand attendees.
 

Webinar title & event web page link	Date	Time	Slido code
SPOR Data  Governance	4 October 2024	10:00 - 12:00 (CEST)	#SWOCT424
Referentials Management Service (RMS)	7 October 2024	10:00 - 12:00 (CEST)	#SWOCT724
Substance Management Service (SMS)	8 October 2024	10:00 - 12:00 (CEST)	#SWOCT824
Organisation Management Service (OMS)	9 October 2024	10:00 - 12:00 (CEST)	#SWOCT924
Product Management Service (XEVMPD)​ for MAHs	10 October 2024	10:00 - 12:00 (CEST)	#SWOCT1024
Product Management Service (XEVMPD)​ for Sponsors	11 October 2024	10:00 - 12:00 (CEST)	#SWOCT1124
SPOR Application Programming Interface	14 October 2024	10:00 - 12:00 (CEST)	#SWOCT1424

Feel free to submit questions in advance via Slido.com using the dedicated Slido code indicated above for each session.

Please note that in most cases (for cases with a single product) the submission number is the same as the case number. 
Hope this clarifies.

The case title replaces the variation number in IRIS for all procedure types. This number is available in the case submission details and also in the procedure documents.
Hope this clarifies.

EMA's Account Management portal is the gateway to using EMA applications such IRIS PLM, electronic application forms (eAF), EudraVigilance, the Clinical Trials Information System and Union Product Database.

New functionalities have been introduced in EMA Account Management to ensure that the registration and access-management process delivers a simple, secure, consistent and user-friendly way for stakeholders to work with EMA.

This webinar is an opportunity for industry and national competent authorities to learn more about access-management aspects and procedures for requesting and managing access to EMA applications.

Date: 20 September 2024
Time: 10:00 - 11:00 (CEST)
Webex link to join: link
Event web page: link
Slido: feel free to submit questions in advance via the dedicated Slido (event code: 7217702). The organisers will do their best to incorporate the questions in the upcoming presentations.

Video recording will be available on the event web page.
Registration is not required. Participants may join on a first-come, first-served basis and will not be able to join when session capacity reaches one thousand attendees.

We directly contacted the MAHs whose CAPs have already been migrated to IRIS.
The products from other MAHs should be migrated when the transition of all post-authorisation procedures takes place on IRIS, i.e. 1 January 2025.