IRISS
- IRIS guide for applicants - How to create and submit scientific applications, for industry and individual applicants (updated)
EMA
- Digital application dataset integration (DADI) and Product Management Service (PMS) webinar - Variations form for human medicinal products - What will happen at go-live , Online, 10:00 - 12:00 Amsterdam time (CEST), from 16/05/2022 to 16/05/2022 (updated)
- Updated versions of the eAF v1.26.0.0 (bug fix version) now available
Updated versions 1.26.0.0 of all eAFs are now available on the eAF website here. An updated human and veterinary MAA forms, Variation forms and the updated Renewal form are ready for immediate use. The changes implemented in this version are bug fixes and business rule corrections only and there is a limited impact to users. The use of v1.26.0.0 is mandatory from 1st January 2022 (human) and 28th January 2022 (veterinary).
It is strongly recommended to use this latest version (document properties date 26.04.2022). Please note that there is no version number change.
FDA