EMA transition to post-authorisation procedure management in IRIS

From 6 January 2025 the EMA transitioned to IRIS for managing post-authorisation procedures these include, variations, Article 61.3 notifications, MA transfers & Post Authorisation Measures (any submission made to the agency from 20 December 2024 will be managed in IRIS). In addition assessment of PSURS submitted to the agency from 6 February 2025 will also to be managed in IRIS. The transition affects centrally authorised products and non-centrally authorised products where the EMA acts as the reference authority.

Submission of these applications to the agency continues through the Gateway however any communication during the assessment procedure will occur in IRIS.

It should be noted that generic mailboxes are no longer acceptable in IRIS, personal mailboxes should be used for product contacts.

If you have questions or face challenges with post-authorisation procedure management or the use if IRIS, tranScrip regulatory and clinical experts are at the ready to guide and advise you; we are ready to expedite your development programs and bring effective medicines to patients across the EU and beyond.