Tuesday, 28 February 2023 10.30 - 16.00 h
The electronic application forms for submission of variations (eAFs) for medicinal products for human and veterinary use were updated in June and are listed in the latest versions on EMA's eSubmission website. The revision of the forms has not caused a change in the versioning of the documents, so both forms keep the version number "eAF Version Number: 220.127.116.11".
Updates to the human medicinal product variation notification form are related, for example, to the chapter "4.b Type IB + Type II variations - Paediatric requirements".
Supporting guidance on the use of the electronic application form for the submission of medicinal products for human use can be found in the "Module 1: Administrative information Application form - User guide for the electronic application form for a Marketing Authorisation". This was last updated in December 2021 and is still valid in version "CMDh/332/2017/Rev.3". A summary of these updates can be found under "CMDh: Adaptation of the Guide for Electronic Submissions (eAF)".
The updated electronic application forms as well as further information on the topic of electronic submission can be found on the EMA's eSubmission website.