News
Previous DADI news can be found here
03-02-2026
Updated PLM Portal eAF Release notes now available
An updated version of the PLM Portal eAF Release notes reflecting bug fixes and
updates to web eAF made in the version 1.2.1.5 released to production on 02 February 2026
is now available on the eSubmission PLM Portal eAF web page.
20-01-2026
Updated PLM Portal eAF Release notes now available
An updated version of the PLM Portal eAF Release notes reflecting bug fixes and
updates to web eAF made in the version 1.2.1.4 released to production on 19 January 2026
is now available on the eSubmission PLM Portal eAF web page.
07-01-2026
Updated PLM Portal eAF Release notes now available
An updated version of the PLM Portal eAF Release notes reflecting bug fixes and
updates to web eAF made in the version 1.2.1.3 released to production on
06 January 2026 is now available on the eSubmission PLM Portal eAF web page.
16-12-2025
New variation classification in eAF - reminder for cut-off date 15 January 2026
The updated Variation Regulation Classification Guideline has been made available in the interactive pdf eAF
v1.28.0.0 and in the PLM Portal web-based variation form January 2026 version.
Applicants are reminded that applications using the v1.28.0.0 or the January 2026 version of the form must not be submitted to the EMA prior to 15th January 2025 CET 00:00. Applications received before the 15th January 2025 will be rejected, and the application must be resubmitted on or after the 15th January 2026.
For any exceptions to these rules and applicability for different scope types must be reviewed on the following EMA dedicated page: Guidance on the application of the revised variations framework | European Medicines Agency (EMA)
AND
New variation classification in eAF - Q&A session - 8 January 2026 10:00 - 11:00 CET
The updated Variation Regulation Classification Guideline has been made available in the interactive pdf eAF
v1.28.0.0 and in the PLM Portal web-based variation form January 2026 version.
To support this change, the EMA eAF team will host a Q&A Clinic on 8 January 2026 10:00 - 11:00 CET dedicated to addressing your questions about the eAF form functionalities related to the new variation classification. To register, please use the following link: Q&A eAF registration - 8 January 2026.
AND
PLM Portal eAF - reminder for FHIR XML attachment
Applicants are reminded that eAFs generated in the PLM Portal need to have the FHIR XML attached when submitted to health authorities. The applicants need to check that all PLM Portal eAFs contain the FHIR XML before adding them to the eCTD package. For more information, please consult the eAF - Guidance Documents
PLM Portal eAF documentation:
PLM Portal eAF:
PLM Portal eAF FHIR:
PLM Portal eAF training videos and training sessions:
PLM Portal eAF training videos and training sessions
For the UK, as from 1.1.2021, EU Law applies only to the territory of
Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI.
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