Updated Centrally Authorised Products (CAPs) data has been loaded to web-based (PLM Portal) eAF, where users will be able to see this data in their forms.
Please note that, while CAPs data is available as of 16 April, we strongly recommend that
no applications using the PLM Portal web-based eAF is used for submissions at the moment. This is due to the fact that the updated CAPs load has impacted how products appear in application forms (e.g., changes to product names, introduction of new medicinal products through splitting, potential alterations to packages, etc.) and some minor adjustments to the functionalities of the web based eAF are needed.
We
suggest using the interactive PDF eAF instead of the web-based eAF for submissions to prevent validation issues and potential delays. The EMA will announce the date from which the use of the PLM web-based eAF form can be resumed.
*Including split & match-merge processes. Please refer to
EU IG (Implementation Guide) Chapter 7 for a detailed description of these steps.
