Electronic Application Forms eAF - new version 1.23

messages in brief |

New versions of the electronic Application Forms (eAF v. 1.23) and related documents are available via the EMA-website (http://esubmission.ema.europa.eu/eaf/).

Specific information from the BASG are published on https://www.basg.gv.at/eservices/elektronisches-antragsformblatt-eaf/ and on https://www.basg.gv.at/arzneimittel/elektronische-einreichung/elektronisches-antragsformblatt/#c15320.

This release includes NTA changes and further integration with OMS for organisation data in proposed and present part of Variation form. This new version, 1.23 of the forms can be used since 13 July 2018 and will fully replace the version 1.22.0.1 after transitional period, on 15 October 2018. The version of the form should not be changed during an ongoing procedure. 

 

Contact:

regulatory questions about using the eAF:basg-cms@basg.gv.at
general topics about the eAF: georg.neuwirther@ages.at
technical issues with the PDF:    https://servicedesk.ema.europa.eu