As previously announced through our Product Lifecycle Management (PLM) newsletter (27/01/2025) the EMA is pleased to confirm as of Tuesday 11 February 2025, the human …

A: If you need to request a missing substance or other term in order to complete an eAF, please use the eAF Term Request Form. Once completed, you will need to submit your form via email …

Release Notes for the specific form. These may be found on the eAF pages of the EMA’s eSubmission website. New issues may be raised via the EMA service desk, quoting “eAF” in …

1.2 eAF Sub-Group on Guidance Update of the guidance to include new features of version 1.20 as well as to improve several sections based on user comments. 1.3 eAF Sub-Group on …

the variation application form needs to be completed for the already authorised product presentations which are affected. The MAA form will need to be completed for the extension …

EMA would like to provide you with an update on the progress of the web-based Human variations electronic Application Form (eAF) implementation on the Product Lifecycle Management …

Variations electronic application form (eAF) start? The transition period to mandatory use of the Human Variations web-based eAF will start when all the necessary functionalities and features …

eAF User Group First draft for revision, made the document in line with reported corrections, improved consistency with the Q&A on eAF and aligned with changes of the eAFs version 1.18

EMA is pleased to announce the web-based Human Variations electronic application form (eAF) for Centrally Authorised Products (CAPs) is now available on the new Product Lifecycle …

eAF Release Notes This document lists and briefly describes the new features and fixed issues included in the release of the electronic application form: Notice to Applicants - Medicinal …