Information about eAF version
As of 1st January 2016 it will be mandatory for companies submitting applications for European and National Procedures (human and veterinary) to use the electronic application form (eAF).
From 1 January 2016, the use of electronic application forms (eAF) for MRP/DCP and national procedures (human and veterinary) will be mandatory within electronic submissions. With this step a further milestone of the HMA/EMA eSubmission roadmap will be achieved.
These electronic application forms are designed to reflect and capture the same content as the paper based application forms and offer a range of new possibilities especially:
- structured form fields
- online access to standard terms of EMA while entering data
- automated duplication of data within the form
- automated import of application data
- validation of data input and feedback to the user
The currently used application forms in Word format published by the European Commission will no longer be available and only the latest version of the electronic application form will be used for all EU procedures, including CP, MRP/DCP and national procedures. The eAFs for centralized procedures were already successfully introduced on 1st of July 2015.
As mentioned above the mandatory use of electronic application forms includes national procedures (initial, variation, renewal). A Word form will be provided for variations of registered medicinal products (§24 AMG).
A user manual and Q&A dcoument was created. These documents can be found here.
Further national information will be provided.
Further information regarding electronic application forms (eAFs) and can be found here.
Created: 20.02.2015 | Page last modified: 30.04.2019