EMA systems disruption expected from 11 to 17 April

8 April 2024

Due to planned system maintenance, several EMA applications will be fully or partially inaccessible from 11 to 17 April.

During this time, EMA will load nationally and centrally authorised product data to its Product Management Service (PMS) database. This is a crucial step in making structured and standardised human medicines data available for EMA systems, as well as EMA’s partners and stakeholders.

External users will experience downtime and decreased functionality on the following systems, and are advised to consequently plan their access:

• Substance, Product, Organisation & Referentials (SPOR): Downtime from 11 April at 18:00 CEST to 15 April, end of day.
• Clinical Trials Information System (CTIS): Users will not be able to submit change requests to the Organisation Management Service (OMS) during the downtime between 11 April at 18:00 CEST to 15 April, end of day.
• EudraCT: Users will not be able to submit or modify studies between 11 April at 18:00 CEST to 15 April, end of day. Existing studies will be accessible.
• EudraGMDP: On-demand synchronisation of OMS data will not be possible between 11 April at 18:00 CEST to 15 April, end of day.
• EMA Access Management Portal: Users will not be able to submit change requests to OMS between 11 April at 18:00 CEST to 15 April, end of day.
• Antimicrobial Sales and Use (ASU) Platform : Downtime from 13 April at 7:00 CEST to 17 April at 7:00 CEST.
• electronic Application Forms (eAFs): Downtime between 11 April at 18:00 CEST and 15 April, end of day. Users are recommended to not use web-based eAF for variations applications until 26 April to enable EMA to verify all systems and data supporting the web-based eAF function. Interactive PDFs can continue to be used, except during the above-mentioned downtime.
• IRIS Platform (IRIS Customer Relationship Management software, Industry and Network Portal, and PLM Portal): Downtime from 12 April at 18:00 CEST to 15 April at 7:00 CEST. The data refresh from EMA’s internal databases will be unavailable from 10 April to 17 April.
• Union Product Database (UPD): Downtime from 13 April at 7:00 CEST to 17 April at 7:00 CEST.
• Union Pharmacovigilance Database : Data consumption may be delayed between 13 April at 7:00 CEST to 17 April at 7:00 CEST.

Users of the systems impacted by these disruptions are advised to contact EMA’s Service Desk for any questions or concerns.