EMA: Update of "PLM Portal eAF - Release Notes"

Global Registration and Life Cycle Management for APIs

Recommendation

8-10 April 2025
Vienna, Austria

Global Registration and Life Cycle Management for APIs
Contents of the regulatory information in the ASMF and CEP

On February 20 2025, the updated "PLM Portal eAF - Release Notes" were published on the EMA's eSubmssion website. This followed the "go-life" of the submission of change notifications via the eAF (electronic Application Form) for so-called non-CAPs (non-Centrally Authorized Products), which started in mid-February 2025. The "non-CAPs" include products that are approved by MRPs, DCPs and NAPs.

The release notes have been updated and published regularly since the first publication in 2022. The current version (version: 1.1.1.4) contains the changes implemented with this version in the usual manner, details scheduled updates that will follow in the near future and highlights known issues as well as current limitations. All previous changes and updates up to and including version 1.0.0.0. are listed in the document history accordingly.

You will find the new version of the "PLM Portal eAF - Release Notes" on the EMA's eSubmission website.