News
Previous DADI news can be found here
30-09-2025
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 1.2.0.14 released to production on 29 September 2025 is now available on
PLM Portal
and on the PLM Portal eAF web page.
25-09-2025
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 versions 1.2.0.12 and 1.2.0.13 released to production on 1 and 15 September 2025 are
now available on PLM Portal and on the PLM Portal eAF web page
Important note: The PLM Portal forms exported after the 2.2.5 FHIR bundle deployment (25 September 18:00)
will contain the name of the section from the "Present/Proposed Changes".
The order of the sections in the PDF will be the same as the one in the PLM Portal.
24-09-2025
PLM Portal eAF - Strongly recommended use of web-based Human variations
electronic Application Forms (eAFs) for non-CAPs
Following the launch of optional use in February 2025 and the start of
the recommended use in May 2025, EMA now strongly recommends
the use of the PLM
Portal web-based eAF for all non-CAPs* human variations, where
possible. This is aligned with the timeline and the roadmap
towards mandatory use of the PLM Portal web-based eAF for all human variations.
Please note that the interactive PDF eAF
remains available for use for all variation procedures and while the PLM Portal eAF is
now strongly recommended for use for all procedure types, there are
some technical limitations, and in these cases you might need to use the interactive pdf
forms. Consult the guidance and the release notes.
Please report any production issues through the EMA ServiceDesk - Incident. Any change request or other
generic questions, recommendations, improvement suggestions please raise them
through EMA ServiceDesk - Request
PLM Portal web-based eAF use levels:
Optional Use: Both the interactive PDF and the web-based eAF are
available. Applicants may choose either format, and no preference is expressed.
Recommended Use: The use of the web-based eAF is encouraged.
However, applicants may continue to use the interactive PDF if they are not yet
ready to adapt their internal processes.
Strongly Recommended Use: The web-based eAF should be used in most
cases. The interactive PDF should only be used if specific constraints prevent the
use of the web-based eAF (e.g., technical issues or missing features).
Mandatory Use: The use of the web-based eAF is required.
Submissions using the interactive PDF will not be accepted. Mandatory use will only
be introduced after a formally announced transition period.
* Products authorised throughout mutual recognition procedure (MRP), decentralised
procedure (DCP) and national procedure (NAP)
25-08-2025
PLM Portal eAF - FHIR 2.2.5 - planned for 25 September 2025, EOB
The PLM Portal eAF FHIR is planned to be updated to version 2.2.5 on 25 September 2025, EOB.
Please contact us by email at plm.valuestream@ema.europa.eu should you have any concerns about the planned release.
The upgrade will contain the following changes, reflected in the eAF FHIR Data Requirements:
- Introduction of 3 new extensions, to harmonise the eAF extensions with PMS extensions:
- Introduction of 1 new extension to support versioning
-
FHIR Path: Bundle.profile e.g. <profile value=
http://ema.europa.eu/fhir/definition/eaf-portal-version/1.0.0.0 />
This element is to support the versioning. Only when 2 sub-versions will need to run in parallel (and it will be the case with the new variation classification), the users creating the forms will pick an extra value in the form. It will be, for example “Current” and “Future variation”.
The web release version (e.g. 1.2.0.10) is already in the FHIR message; this extra element will capture the sub-version mentioned above
- Introduction of 2 new extensions and deletion of obsolete 2 extensions, used for the sections in present/proposed changes:
-
Changes: (new) Section Label (Variation - AB225 in the AF Data requirements excel)
FHIR Path: Provenance.extension[url=http://ema.europa.eu/fhir/extension/unstructuredCurrentProposedHtmlText].extension[url=label].valueString
In the present/proposed web interface, there are labels for sub-sections; these labels will be, with the new FHIR version, printed on the PDF (there were many requests for this change, from the MAH)
-
Changes: (new) Organisation reference (Variation - AB226 in the AF Data requirements excel)
FHIR Path: Provenance.extension[url=http://ema.europa.eu/fhir/extension/unstructuredCurrentProposedHtmlText].extension[url=organisationChange].valueReference (reference to an organisation provenance (Provenance.extension[url=http://ema.europa.eu/fhir/extension/provenanceType].valueCoding.code==90000000998)
This element is to link the Present/Proposed organisation with a specific section of the Present/Proposed; currently it is under the whole “Present/Proposed“ entry, and not linked to potential sections of that entry
-
Changes: (removed) Obsolete present text field (kept since 4.6.0 for retro-compatibility)
(Variation - AB72 in the AF Data requirements excel)
FHIR Path: Provenance.extension[system=unstructuredCurrentValueHtml].valueString
This extension is obsolete, as it was located at the root of the scope change; now the extension is at the section level
-
Changes: (removed) Obsolete proposed text field (kept since 4.6.0 for retro-compatibility)
(Variation - AB73 in the AF Data requirements excel)
FHIR Path: Provenance.extension[system=unstructuredProposedValueHtml].valueString
This extension is obsolete, as it was located at the root of the scope change; now the extension is at the section level
21-08-2025
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 1.2.0.11 released to production on 19 August 2025 are
now available on PLM Portal and on the PLM Portal eAF web page
05-08-2025
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 1.2.0.10 released to production on 04 August 2025 are now
available on PLM Portal and on the PLM Portal eAF web page
31-07-2025
PLM Portal eAF - new Q&A document
A new PLM Portal eAF Q&A document is now available. The document contains questions from
the most recent events (Webinars, Trainings and Q&A clinics), and will be further enhanced
with more entries in upcoming versions.
We recommend PLM Portal eAF users to consult the Q&A prior to raising a ticket in ServiceDesk,
as the topic might be already explained in the document
30-07-2025
PLM Portal FHIR XML version upgrade
The PLM portal FHIR XML version was updated to 2.2.4 on 29 July 2025. The new version
introduces the following change:
- The SPOR links in the FHIR message were changed from HTTPS protocol
to HTTP, in order to be aligned with the PLM Portal systems, and to comply with
the FHIR recommendations.
The existing FHIR package remains applicable.
The Release notes can be found here.
23-07-2025
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 1.2.0.9 released to production on 21 July 2025 are now available on PLM Portal and on the PLM Portal eAF web page
09-07-2025
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 1.2.0.8 released to production on 07 July 2025 are now available on PLM Portal and on the PLM Portal eAF web page
PLM Portal eAF documentation:
PLM Portal eAF:
PLM Portal eAF FHIR:
Historical documents:
Human Variations web-based eAF Form training session (2 February 2023)
Human Variations web-based eAF Form training session (15 December 2022)
Human Variations web-based eAF Form training session (8 November 2022)
Human Variations Form go-live Q&A session (27 October 2022)
eAF Q&A clinic recordings:
- Human Variation eAF Q&A Clinic - session 7 (22
January 2023)
- Human Variation eAF Q&A Clinic - session 6 (17
January 2023)
- Human Variation eAF Q&A Clinic - session 5 (19
December 2022)
- Human Variation eAF Q&A Clinic - session 4 (14
December 2022)
- Human Variation eAF Q&A Clinic - session 3
(access management) (29 November 2022)
- Human Variation eAF Q&A Clinic - session
2 (22 November 2022)
- Human Variation eAF Q&A Clinic - session
1 (15 November 2022)
DADI PDF electronic application forms eAF training
webinar (2 September 2022)
DADI PDF electronic application forms (eAF) training webinar (26 July 2022)
DADI Q&A Webinar - Variations form for Human Medicinal Products Go-live -
(12 July 2022)
Quarterly system demo (including DADI) - (28 June 2022)
DADI-PMS Webinar “Variations form for human medicinal products - What will
happen at go-live” (16 May 2022)
Introducing DADI: webinar on the digital application dataset integration (DADI)
network project to replace electronic application forms (18 January 2022)
Digital application dataset integration (DADI) - common factors in the Fast
Healthcare Interoperability Resources (FHIR) data standard for Article 57(2) and electronic
application forms (eAF) (25 January 2022)
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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