Updates to eAFs

06.02.2018

New versions of electronic Applications Forms for marketing authorisation applications, renewals and variations for human and veterinary medicines have been released. The main changes include the implementation of Organisations Management Service (OMS) and Referentials management service (RMS). These enable users to select information supplied directly by master data services when preparing their regulatory submissions. The new forms (eAF v.1.22) will replace the previous version (eAF v.1.21) on 15 February 2018. For ongoing procedures, the version of the form should not be changed.