News
Previous DADI news can be found here
13-12-2024
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 1.1.1.0 released to
production
on 9 December 2024 are now available on
PLM Portal
and on the PLM Portal eAF web page.
And
Update on the start of strongly recommended use of web-based eAF for NCA submissions
The expected start date of the strongly recommended use of the PLM Portal web-based eAF
submissions to the National Competent Authorities for non-CAPs variations is now planned
for February 2025. This updated timeframe is based on the latest projections by EMA’s development teams.
Please note that the web-based eAF is fully functional for the submission of variations
for CAPs, including EMA-led worksharing variations containing non-CAPs.
Should you have any questions or require further information, please do not hesitate to contact us at
[email protected].
12-12-2024
Updated PLM Portal eAF FHIR XML Release notes now available
An updated version of the
PLM Portal eAF FHIR XML Release notes
reflecting the implementation of FHIR XML
2.1.1 in the PLM Portal eAF (released to
production on 9 December 2024)
are now available on the
PLM Portal
and in the documentation section of the
PLM Portal eAF, together with several updated documents to
provide consumers of the FHIR XML message the easiest
possible way to upgrade to the eAF XML 2.1.1 or to
start
the implementation now with the latest version.
26-11-2024
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 1.1.0.3 released to
production
on 25 November 2024 are now available on
PLM Portal
and on the PLM Portal eAF web page.
18-11-2024
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 1.1.0.2 released to
production
on 11 November 2024 are now available on
PLM Portal
and on the PLM Portal eAF web page.
30-10-2024
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 1.1.0.1 released to
production on 28 October 2024 are now available on PLM Portal and on the PLM Portal eAF web page.
14-10-2024
Non-Centrally Authorised Products now available in the PLM Portal eAF
The EMA is pleased to announce that the non-Centrally Authorised
Products* (non-CAPs) data are now available in the Human variation
web-based eAF within the Product Lifecycle Management (PLM)
Portal.
Please note that, due to system limitations and pending future improvements, the
web-based eAF cannot currently be used for submissions to the National Competent
Authorities. However, the web eAF is fully functional for the submission of
variations of CAPs, including EMA-led worksharing variations containing CAPs and
non-CAPs.
Please join the training session on 17 October 2024 10:00 - 11:30
(CEST).
Please see an updated version of the draft PLM
Portal eAF guide to navigation is now available.
03-10-2024
Non-CAPs data available in the PLM Portal web based eAF from 14th October
2024
The EMA is pleased to announce that, as of the 14 October 2024, non-Centrally
Authorised Products* (non-CAPs) data will be available in the Human
variation web-based eAF within the Product Lifecycle Management
(PLM) Portal.
Please note that, due to system limitations and pending future improvements, the
web-based eAF cannot currently be used for submissions to the National Competent
Authorities. However, the web eAF is fully functional for the submission of
variations of CAPs, including EMA-led worksharing variations of non-CAPs.
In order to familiarise with the new functionality of web-based eAFs for Human
non-CAP variation procedures, the eAF team is providing a dedicated training
session on 17 October 2024 10:00 - 11:30 (CEST). During this event, access and
navigation of web-based eAF for non-CAPs will be showcased. We would highly recommend all
relevant Industry stakeholders to participate to this training: Register here
Key actions for Marketing Authorisation Holders:
-
Register as an eAF user in the PLM Portal following the registration process and log into the eAF for familiarisation and testing purposes;
-
Join upcoming training session;
-
Follow EMA announcements to be informed of the date when web-based eAF can be submitted to the NCAs. This is currently expected to start in January 2025;
-
Continue to submit the interactive PDF eAFs to the NCAs for non-EMA led procedures;
-
Gather user feedback related to non-CAP variations within your organisations (MAHs and industry organisations) and to provide this consolidated feedback to EMA via [email protected].
Key actions for NCAs to:
-
Follow EMA announcements to be informed of the date when they will start receiving web-based eAF submissions.
-
Forward any non-CAP variations related user feedback from MAHs to EMA via [email protected]
- Join upcoming information session on the go-live of the web-based eAF for non-CAPs - to take place in November 2024
.
eAF guidance documents available to support your work on the PLM:
-
Guide for PLM Portal Registration - Document
-
Guide for PLM Portal eAF Navigation - Document
Please be reminded that:
- External testing of the eAF User Acceptance Testing (UAT) is not foreseen for 2024
- No transition towards mandatory use of the Human variations web-based eAF will start before a UAT takes place
If you have any question please contact [email protected]
or post them via the PLM Portal Forum.
* Products authorised throughout mutual recognition procedure (MRP), decentralised
procedure (DCP) and national procedure (NAP)
20-09-2024
Updated PLM Portal eAF guide to navigation now available
An updated version of the draft PLM Portal eAF guide to
navigation is now available.
And
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 1.0.1.19 released to
production on 18 September 2024 are now available on PLM Portal and on the PLM Portal eAF web page.
19-09-2024
Completion of non-CAPs data load on PMS Product UI
The EMA is pleased to inform you that the data load of non-Centrally
Authorised Product* (non-CAP) information on the PMS Product User Interface (PUI) has been
successfully completed. As of now, all human non-CAP and CAP data is available in
read-only mode via the PUI on the Product Lifecycle Management (PLM)
Portal.
National Competent Authorities and Marketing Authorisation Holders can now request the new
PMS roles needed for accessing the PMS PUI through the EMA
Account Management portal. A training session is scheduled for
16 October 2024 (10:00 - 11:00, CEST), where the PMS team will provide an
overview of the PUI, showcase the access and navigation and answer your questions.
Registration is available here. Meanwhile, you can consult the presentation & recording of the previous training session on PUI,
held on 3 June 2024, and the PMS PUI guidance documents.
Please be reminded that this data load will not yet trigger the availability of
non-CAPs data in the web-based eAF. Once performance improvements are
completed, non-CAPs data will become available in the eAF.
Read access to both CAPs and non-CAPs through the PMS PUI is a key step
toward the data-centric target operating model. This milestone builds on the go-live of the PMS Application Programming Interface (API) for CAPs
and non-CAPs in read-only mode for MAHs on 3 July 2024 and the launch of the PMS PUI in read-only mode for CAPs on 31 May 2024.
* Products authorised throughout mutual recognition procedure (MRP), decentralised procedure
(DCP) and national procedure (NAP)
11-09-2024
Start of non-CAPs data load on PMS Product UI
The EMA is pleased to inform you that non-Centrally Authorised Products*
(non-CAP) data are currently being loaded in read-only mode on the Product Management
Service (PMS) Product User Interface (PUI), live on the live on the Product Lifecycle Management
(PLM) Portal. This data load is expected to be completed by the end of September 2024,
after which all non-CAP data will be available in read-only mode on the PUI.
IMPORTANT: To avoid platform overload and preserve the performance of
the PLM platform while the data load is ongoing, the EMA requests that National
Competent Authorities (NCAs) refrain from requesting PMS roles at this
time. Current PLM PUI and eAF users are also strongly encouraged to
minimise activity on the PLM Portal.
Please note, this data load will not yet trigger the availability of non-CAPs in the
web-based electronic Application Form (eAF). Following the deployment of
further performance improvements, non-CAPs will become available also in the eAF. During the
non-CAP data load, users of the PLM Portal and IRIS Industry & Network Portal may
experience minor performance issues, such as slower system responses. In such
circumstances, users do not need to raise this via EMA Service Desk.
* Products authorised throughout mutual recognition procedure (MRP), decentralised procedure
(DCP) and national procedure (NAP)
06-09-2024
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 1.0.1.18 released to
production on 06 September 2024 are now available on PLM Portal and on the PLM Portal eAF web page.
28-08-2024
Updated PLM Portal eAF guide to navigation now available
An updated version of the draft PLM Portal eAF guide to
navigation is now available. The change is in chapter 2.2.4 (Add product), page 40, and
it is related to the introduction of a temporary popup message, while the adding of the
products and all the afferent processes are finalised.
And
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 1.0.1.17 released to
production on 27 August 2024 are now available on PLM Portal and on the PLM Portal eAF web page.
08-08-2024
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 1.0.1.16 released to
production on 08 August 2024 are now available on PLM Portal and on the PLM Portal eAF web page.
23-07-2024
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 1.0.1.15 released to
production on 22 July 2024 are now available on PLM Portal
Forum and on the PLM Portal eAF web page.
22-07-2024
Updated PLM Portal eAF guide to navigation now available
An updated version of the draft PLM Portal eAF guide to
navigation is now available.
17-07-2024
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 1.0.1.14 released to
production on 15 July 2024 are now available on PLM Portal
Forum and on the PLM Portal eAF web page.
11-07-2024
Invitation to register for the Info Session on PLM Portal eAF - Add
package
EMA will host an Information session on 18 July 2024, 11:00 - 12:00
(CEST) to explain and showcase the latest developments and bug fixes deployed in
the PLM Portal web-based electronic Application Form (eAF), namely the add
package feature. Participants will have the opportunity to ask questions in the
last part of the session.
The eAF add package functionality allows the applicants to use the web based eAF for
variations adding a new pack size.
The participation is recommended to Industry stakeholders who are filling in application
forms for their respective organisations.
Register here, and check the event web page for agenda, presentation and recording.
01-07-2024
Updated PLM Portal eAF FHIR XML Release notes now available
An updated version of the PLM Portal eAF FHIR XML Release
notes reflecting the implementation of FHIR XML 2.0.1 in the PLM Portal
eAF (released to production on 28 June 2024) are now available on the PLM Portal and in the section of the PLM
Portal eAF, Documentation section, together with several updated documents to
provide consumers of the FHIR XML message the easiest possible way to upgrade to the eAF XML
2.0.1 or to start the implementation now with the latest version.
03-06-2024
PMS Product UI Now Live on the PLM Portal
The PMS Product User Interface (PUI) was launched on 31 May 2024, in read-only
mode on Product Lifecycle
Management (PLM) Portal. Registered users are now able to view Centrally Authorised
Product - (CAP) data in the PUI (Nationally Authorised Product (NAP) data will be available
in early Q3 2024).
Please note that the eAF users have now automatically access to the PUI. Consult these guidance documents and join the 3 June 2024 training session to prepare for registration & navigation of
PUI.
17-05-2024
Updated PLM Portal Guide to Navigation is now available
Please find an updated version of the draft PLM Portal eAF Guide to Navigation here.
15-05-2024
A new PLM Portal Home page
New, product specific tiles for electronic Product Information (ePI) and the
Product Management Service (PMS) Product User Interface have been included in addition to
the web-based electronic Application Forms on the PLM Portal's landing page. To ensure users
can find and easily access these tools, EMA has updated the landing page of the Portal,
which now presents a new look & feel.
The new interface aims to provide more intuitive access to eAF, PMS and ePI release notes,
news, knowledge articles.
We would like to invite you to share your feedback on the new landing page in the PLM Portal Forum.
AND
Recommended use of web-based human variations eAF for all CAPs
As anticipated in April 2024 communication and announced in May 2024 at the
webinar “Information and Q&A session on updated CAPs in web-based eAF”
(recording & presentation available), we have completed the load of updated* Centrally
Authorised Products (CAPs) data to PLM Portal web-based eAF on 19 April 2024. Users can now
access this new CAP product data directly within the web-based forms.
We are pleased to announce that we recommend the use of the PLM Portal web-based eAF
for all CAPs variations starting from 14 May 2024. However,
please be aware that there are still some known issues and limitations that
we are actively addressing however, these issues do not prevent the use of the web-based
eAF. We invite you to consult the 7 May webinar presentation for the complete list of known
issues.
If you encounter any issues, please report them via EMA Service
Desk, ensuring that you select the correct category.
*Including split & match-merge processes. Please refer to EU IG (Implementation Guide) Chapter 7 for a detailed
description of these steps.
24-04-2024
Register for the Information and Q&A session on updated CAPs in PLM
Portal eAF, 7 May 2024
EMA will host an Information and Q&A session on 7 May 2024, 10:00 - 11:00 (CEST) to explain and showcase the changes in the PLM Portal web-based Human Variations eAF after the updated Centrally Authorised Products (CAPs) load. Participants will have the opportunity to ask questions in the last part of the session.
The participation is recommended to Industry stakeholders working on regulatory affairs of their respective organisations.
Register here, and check the event web page for agenda, presentation and recording, all to be published in due time.
23-04-2024
Successful CAPs data load under review, recommended use of
interactive PDF extended
Updated Centrally Authorised Products (CAPs) data has been loaded to web-based (PLM Portal) eAF, where users will be able to see this data in their forms.
Please note that, while CAPs data is available as of 16 April, we strongly recommend that no applications using the PLM Portal web-based eAF is used for submissions at the moment. This is due to the fact that the updated CAPs load has impacted how products appear in application forms (e.g., changes to product names, introduction of new medicinal products through splitting, potential alterations to packages, etc.) and some minor adjustments to the functionalities of the web based eAF are needed.
We suggest using the interactive PDF eAF instead of the web-based eAF for submissions to prevent validation issues and potential delays. The EMA will announce the date from which the use of the PLM web-based eAF form can be resumed.
15-03-2024
electronic Application Forms (eAFs) not available for use between 11th and
16th April 2024 due to planned maintenance
Due to planned maintenance activities, the interactive PDF eAFs
(human and veterinary variation and MAA forms and the renewal form) and the PLM
Portal web-based eAF will be unavailable for use between 11th and 16th April
2024.
Additionally, as announced in December 2023, the PLM Portal web-based
eAF will be affected by the data load of Centrally Authorised Products (CAPs) and
Nationally Authorised Products (NAPs) into Product Management Service (PMS) as well as the
simultaneous load of updated* CAPs to web-based eAF.
This load of data into PMS is a necessary step in preparation to the forthcoming launch of
the Product User Interface view and later edit functions as well as making NAPs data
available for the PLM Portal web-based eAF.
The data load will take place from 11 to 16 April
2024. During this timeframe, the interactive PDF eAF and the PLM Portal web-based
eAF will experience a downtime.
Please note that, during the preparation for the updated* CAPs load in the PLM
Portal web-based eAF, the match-merge** operation will result in:
- changes to product names;
- introduction of new medicinal products through splitting**;
- potential alterations to packages.
These changes will impact how products appear in application forms. Therefore,
we strongly recommend, with immediate effect, that no
applications that might require any update of the eAF, during or after
the product upload, are submitted to EMA using the PLM Portal web-based
eAF. We strongly recommend to use the interactive pdf eAF instead of
the web-based eAF for submissions at least until 26 April 2024 to prevent
validation issues and potential delays.
Please note that if you have already submitted a web-based eAF, or it is expected that there
will be no need to update the form and/or the procedure will conclude prior to the downtime,
you can continue using the web-based eAF.
Please note that, except for the downtime period, the web-based eAF is expected to
remain accessible to applicants to familiarise themselves with changes to the products,
and for training purposes.
*Including split & match-merge processes. Please refer to EU IG (Implementation Guide) Chapter 7 for a detailed description of
these steps.
**The “Match-merge” process serves to include data from XEVMPD to products already released
in PLM Portal. The “split” process serves to make released products ISO-IDMP compliant. Both
processes are explained in detail in EU IG Chapter 7
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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