Transcription of Practical user guide for electronic Application Forms (eAF ...
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Practical user guide for electronic Application Forms (eAF ...
`. 15 September 2020. Practical User guide for electronic Application Forms (eAF) for human and veterinary medicinal products in the EU. Version Page 1 of 83. Note to readers This guidance reflects the current state of knowledge and is subject to future updates to take new information on-board. Therefore, it is important that comments are fed back to the eAF User Group by e- mail EMA IT service desk ( ). Screenshots in this document have been, in most cases taken using eAF version In some cases, this guidance will still use screenshots based on earlier versions. It is not possible to match this guidance document with one exact version of the eAF. However, information about new functionalities or changes are in the up to date release notes at: Page 2 of 83. 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 First draft for revision, made the document in line with reported corrections, improved consistency with the Q&A on eAF and aligned with changes of the eAFs version eAF User Group Indicating acceptance of an image of a text snippet for EMA, additional advice for optimising the PDF file for eCTD purpose, minor editorial changes after review eAF Sub-Group on Guidance Update of the guidanc
A Decentralised Procedure..... 56 1.1.4. A National Procedure ..... 57 1.2. Is this an application for a change to your existing marketing authorisation leading to an extension as referred to in Annex I of Regulation (EC) NO 1234/2008, or any national ...
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