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Harmonised Technical Guidance for Using of …
Harmonised Technical Guidance for Using of Electronic Application Forms (eAF) for human and veterinary medicinal products in the EU Version September 2015 Page 2 | 73 Version July 2015 Remark to the reader This document reflects the current state of knowledge and will be subject to future updates to take new information on-board. Therefore, it is important that comments are feed back to the eAF User Group by e-mail Screenshots in this document have been taken in most cases from the eAF versions In some cases the Guidance takes already advantage of the upcoming version , which will replace version early in August 2015. It would not be possible to match this Guidance document with exactly one version of the eAF. However, very recent information about new functionalities or changes can be retrieved from the release notes at Document History Change Record Version Author(s) Comments eAF User Group This document has been prepared by the sub-group on Guidance and information of the eAF User Group in collaboration with CMDh and CMDv eAF User Group Fir
Page 4 | 73 Version 1.0 – July 2015 1.4. This application is submitted in accordance with the following article in Directive 2001/83/EC as amended..... 26
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