News
Previous DADI news can be found here
21-05-2025
Recommended use of web-based Human variations electronic Application
Forms (eAFs) for non-CAPs
Following the launch of optional use in February 2025, EMA now 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 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)
14-05-2025
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 1.2.0.4 released to production on 13 May 2025 are now
available on
PLM Portal and on the PLM Portal eAF web page.
Please note that a small number of products are affected by a synchronisation issue with
PMS and the forms where they are used cannot be exported and finalised. Once added the
products in the eAF, export the form and should you see the message
"Data refresh cannot be completed. Aborting the operation. Please retry again",
please use the interactive PDF instead. The teams are working on fixing this issue and
a new message will be published once it is resolved.
Additionally, the PLM portal FHIR XML version was updated to 2.2.2. The new version
introduces the following change: there is a new element in the Organisation, called
"alias", which contains (if existing) the selected alternative company name:
<alias value="alternative company/organisation name" />
The Release notes can be found here.
29-04-2025
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 1.2.0.3 released to production on 28 April 2025 are now
available on
PLM Portal
and on the PLM Portal eAF web page.
Please note that a small number of products are affected by a synchronisation issue with
PMS and the forms where they are used cannot be exported and finalised. Once added the
products in the eAF, export the form and should you see the message "Data
refresh cannot
be completed. Aborting the operation. Please retry again", please use the
interactive
PDF instead. The teams are working on fixing this issue and a new message will be
published once it is resolved.
04-04-2025
Update on web-based Human variations electronic Application Forms
(eAFs) timeline
EMA would like to provide you with an update on the progress of the web-based
Human
variations electronic Application Form (eAF) implementation on the
Product Lifecycle
Management (PLM) Portal.
During Q1 2025, we announced that the human variation web-based
eAF was open for first use for non-Centrally Authorised Products
(non-CAPs) through the
PLM Portal, allowing Marketing Authorisation Holders to use the
web-based application form for all EU variation procedures, including
submission to the NCAs.
Key points of the updated timeline:
Q2 2025:
- Recommended use of Human variation eAF for
non-CAPs*.
- Continue the incremental release of the new UX design
and the incremental release of new features, including maintenance
and optimisation updates and performance improvements.
Q3 & Q4 2025:
- Strongly Recommended use of Human variation eAF for
non-CAPs*.
- Exploration of structured changes in eAF.
Please send any questions or concerns to
PLM.ValueStream@ema.europa.eu
*Exact date to be defined, on the condition that no major issues are identified
03-04-2025
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 1.2.0.2 released to production on 31 March 2025 are now
available on PLM Portal and on the PLM Portal eAF web page.
25-03-2025
Updated PLM Portal eAF guide to navigation now available
An updated version of the PLM Portal eAF guide to navigation is now available.
19-03-2025
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 1.2.0.1 released to production on 17 March 2025 are now
available on PLM Portal and on the PLM Portal eAF web page.
07-03-2025
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 1.2.0.0 released to production on 06 March 2025 are now available on
PLM Portal
and on the PLM Portal eAF web page.
05-03-2025
PLM Portal eAF – Integrity stamp go-live on 6 March
EMA is pleased to announce that the PLM Portal eAF Integrity stamp feature will be deployed Thursday, 6th of March, after 18:00 CET.
The main impact and changes are as follows:
- Upon 'Finalisation', the PLM Portal web based human variation eAF will be locked and moved to the 'Completed' tab (the form can be opened for further editing if necessary)
- The form will be locked with a digital 'signature' called eAF integrity warranty (or eAF integrity stamp)
- Will be launched on 6th March 2025 – after this date the system will include the stamp on all forms that are finalised
- Forms that have not been finalised (i.e. do not contain the integrity stamp) will be rejected by the regulators in the future – date to be confirmed!
- The applicants will still be able to include additional digital signature(s) into the finalised form (exported pdf)
- It will not be possible to include an image of a signature or an 'adobe signature' to the form after the stamp is included
- There is no integrity stamp in the ‘legacy’ interactive pdf eAFs
If you have any question please contact plm.valuestream@ema.europa.eu or raise a request in the EMA Service Desk..
AND
PLM Portal FHIR XML version upgrade
The PLM portal FHIR XML version was updated to 2.2.1. The new version introduces the following change: the <meta> node will contain a new profile value (<profile value=http://ema.europa.eu/fhir/definition/fhir-export/2.2.1.0 />) and the "Bundle-variation" will lose the 4th digit in the XML.
The Release notes can be found here.
20-02-2025
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 1.1.1.4 released to
production on 18 February 2025 are now available on
PLM Portal
and on the PLM Portal eAF web page.
13-02-2025
Production go-live for submissions of human variations web-based eAFs for non-CAPs
As previously announced through our
Product Lifecycle Management (PLM) newsletter
(27/01/2025) the EMA is pleased to confirm as of Tuesday 11 February 2025, the human variations web-based electronic Application Form (eAF) is open for first use for non-Centrally Authorised Products* (non-CAPs) within the
PLM Portal.
Please note that the
interactive PDF eAF
remains available for use for all variation procedures and while the PLM Portal eAF is now available
for use for all procedure types, there are some technical limitations, and in these cases the applicants are requested to use the interactive pdf forms.
* Products authorised throughout mutual recognition procedure (MRP), decentralised procedure (DCP) and national procedure (NAP)
11-02-2025
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 1.1.1.3 released to production on 3 February 2025 are now available on
PLM Portal
and on the PLM Portal eAF web page.
And
PLM Portal FHIR XML version upgrade
The PLM portal FHIR XML version was updated to 2.2.0, however no change affecting the web-based eAF XML was introduced. The Release notes can be found
here.
03-02-2025
PMS User Interface edit functionalities now live for Industry users!
The Product Management Service (PMS) User Interface (PUI) edit functionalities - live on the
Product Lifecycle Management (PLM) portal
- are now available for Industry users.
Note that the write access is for now limited to pack size and manufacturer data for non-Centrally Authorised Products* (non-CAPs).
This data is indeed required for the shortage reporting via the
European Shortages Monitoring Platform (ESMP), which went live with full functionalities on 29 January 2025.
This milestone builds on the previous go-live of the
PMS Application Programming Interface (API) in read-only mode
(for Marketing Authorisation Holders (MAHs) on 3 July 2024, for H&V National Competent Authorities (NCAs) in September 2024 and for all NCAs in December 2024) and the launch of the
PUI in read-only mode for CAPs and non-CAPs
(respectively on 31 May 2024 and 19 September 2024).
Please consult this news article
for full PMS roadmap and a recap of key current and future actions for MAHs.
Supporting events:
- Training webinar: EMA held a public webinar on 28 January 2025 to showcase PMS released PUI edit functionalities (enrichment process). Consult the
event web page to access presentation and recording.
- Weekly Q&A clinics on PUI & API in February:
PUI guidance documents:
* Products authorised throughout mutual recognition procedure (MRP), decentralised procedure (DCP) and national procedure (NAP)
21-01-2025
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 1.1.1.2 released to production on 20 January 2025 are now
available on PLM Portal and on the PLM Portal eAF web page.
PLM Portal eAF (DADI) documentation:
PLM Portal eAF webinars:
Update on Human Variations web based eAF implementation on PLM Portal (6
November 2023)
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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