Production go-live for submissions of human variations web-based eAFs for non-CAPs
The EMA is pleased to confirm as of Tuesday 11 February 2025, the human variations web-based electronic Application Form (eAF) is open for first use for non-Centrally Authorised Products* (non-CAPs) within the PLM Portal.
date: [13/02/2025]
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 variations web-based electronic Application Form (eAF) is open for first use for non-Centrally Authorised Products* (non-CAPs) within the PLM Portal.
Please note that the interactive PDF eAF remains available for use for all variation procedures and while the PLM Portal eAF is now available for use for all procedure types, there are some technical limitations, and in these cases the applicants are requested to use the interactive pdf forms.
* Products authorised throughout mutual recognition procedure (MRP), decentralised procedure (DCP) and national procedure (NAP)