Guidance for applicants on how to submit ePI in centralised procedures has been publishedDate: 08/09/2026
A guidance on how applicants should submit electronic product information (ePI) for centrally authorised medicines as part of initial marketing authorisation applications and post-authorisation procedures has been published. It will become applicable at the time of ePI go-live.
The guidance covers when to create, update and submit ePI at the PLM portal, how submission timelines align with different procedure types, and how ePI is managed in case of a suspension, withdrawal or refusal.
The guidance covers when to create, update and submit ePI at the PLM portal, how submission timelines align with different procedure types, and how ePI is managed in case of a suspension, withdrawal or refusal.