News
Previous DADI news can be found here
10-08-2023
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 1.0.1.11 released to production on the 07 of August 2023 are now available on PLM Portal Forum
01-08-2023
Updated PLM Portal eAF Guide to Registration is now available
Please find an updated version of the PLM Portal eAF Guide to Registration here.
27-07-2023
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 1.0.1.10 released to production on the 26 of July 2023 are now available on PLM Portal Forum and on the PLM Portal eAF web page.
12-07-2023
Human variations web-based eAF Timeline Review
We inform you that the timeline of the variations web-based electronic Application Form (eAF) for Human medicinal products has been updated.
EMA is continuing development work with the aim to incrementally build the new web-based eAF, leveraging on Product Management Service (PMS) data. The key priority for the Agency is to ensure that the eAF is supported by a stable system with high-quality data before starting any transition. During recent testing, it became clear that the target date for the release of split CAPs and NAPs on the PLM Portal requires to be extended. This is due to the additional time needed to perform checks on data quality and the quality of the data transfer of NAPs data, investigate and address potential issues connected to product data transfer and (if needed) repeat the loading of the data.
Therefore, in order to respect our commitment to ensuring that all stakeholders are kept informed on key milestones with reasonable advance notice, please be informed of the new target dates for the release of split Centrally Authorised Products (CAPs) and Nationally Authorised Products (NAPs) for use in web-based eAFs on the Product Lifecycle Management (PLM) Portal:
- release of split CAPs, making them available to use in the eAF, is now expected in October 2023 instead of July-August 2023
target date for the release of NAPs is now expected between November 2023 and February 2024 instead of July-August 2023.
Consequently, the human variations web-based electronic Application Form (eAF) target timeline (last published in April 2023) has been reviewed. Please find here the updated version, which reflects the target dates for each milestone. Kindly note the eAF team expects to provide a further update to confirm the timeline in September 2023, based on latest testing outcomes.
Please be informed that key milestones following split CAPs and NAPs release in web-based eAF on the PLM Portal will be consequently rescheduled. In particular, the external User Acceptance Testing on the version of the web-based eAF intended to replace the PDF and trigger the transition will be rescheduled from November 2023 to a yet-to-be-defined date which will be announced at least two months in advance, as per prior commitment. The transition period will also be announced in due time.
Please note that EMA is following the previously communicated development steps for the products' release on the PLM Portal:
- Load product data into the test environment;
- Test data quality and quality of the transfer;
- Investigate issues, address them and repeat the first 2 steps;
- Once ready, transfer product data into the production environment.
In the meantime, applicants are encouraged to use the human variations web-based eAF already available in the PLM Portal for products already in the system and maintain high the level of data quality of their products in XEVMPD.
Please send any questions to eSubProgofficer@ema.europa.eu or via the PLM Portal Forum.
13-06-2023
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 1.0.1.9 released to production on the 12 of June 2023 are now available on PLM Portal Forum and on the PLM Portal eAF web page.
15-06-2023
Planned maintenance of the eSubmission systems on 17 June 2023
Due to planned maintenance, the eSubmission systems (including eAF and PLM Portal eAF) will not be available on Saturday 17 June 2023, between 8:00 and 16:00. For any further information, please contact Service Desk.
13-06-2023
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 1.0.1.9 released to production on the 12 of June 2023 are now available on PLM Portal Forum and on the PLM Portal eAF web page.
17-05-2023
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 1.0.1.8 released to production on the 16th of May 2023 are now available on PLM Portal Forum and on the PLM Portal eAF web page.
16-05-2023
eAF-PMS Newsletter Issue 3
We are pleased to announce the third edition of the eAF-PMS newsletter is now available at the following link.
This newsletter, available to pharmaceutical companies and National Competent Authorities (NCAs), offers updates on the progress of eAF and PMS, presenting an overview of past and future activities.
In particular, we would like to highlight the following topics:
Upcoming webinars (more details on single events are available in the newsletter):
- Product Lifecycle Management (PLM) Portal Access Management Training Session (25 May 2023, 11:00 - 12:30 Central European Summer Time (CEST)): registration link
- Product Management Service (PMS) Progress Webinar (30 May 2023, 10:00 - 11:30 CEST): registration link
- eAF-PMS Joint Webinar on Nationally Authorised Products (NAPs) Data Release on PLM Portal eAF (8 June 2023, 10:00 - 11:30 CEST): registration link
Updated documents:
Human Variations eAF-PMS Frequently Asked Questions (FAQs) document
Please send any questions to eSubProgofficer@ema.europa.eu or via the PLM Portal Forum.
24-04-2023
Web-based Human Variations eAF (DADI) - Updated timeline
We are pleased to inform you the updated PLM (Product Lifecycle Management) Portal web-based electronic Application Form (eAF) for Human medicinal products release timeline is available on the PLM portal Forum at the following link. In addition, we invite PLM Portal users' feedback on the Portal and web-based eAFs through a survey you can find below.
Note in particular the following periods:
| June 2023 |
Start of data transfer - Centrally Authorised Products (CAPs) and Nationally Authorised Products (NAPs) for use in eAFs - the first NAPs products will appear in the eAF. This will allow users to start preparing web-based eAFs for NAPs as these products become gradually available on the PLM Portal; |
| August 2023 |
Expected completion of data transfer - all CAPs and NAPs available in eAF; |
| November 2023 |
User Acceptance Testing (UAT) on the version of the web-based eAF intended to replace the PDF and trigger the transition; |
| Q1 2024 |
Confirmation of transition period start date, approximately 2 months in |
| Q2 2024 |
Start of 6-months transition to mandatory use of web-based eAF for Human Variations. This is subject to a successful outcome of the UAT. Note that the transition period may start earlier, if feasible, respecting the 2- month advance notice period. |
(Further detailed information on impacts for eAF Users, can be found in the 2nd page of the document link.
Please note:
- Functionalities required for mandatory use are being released incrementally: all required functionalities will be available on the PLM Portal before the start of the UAT.
The use of the web-based eAF will follow the current process for updating data. Use of structured data will be implemented at a later point.
The capability to view migrated PMS product data in the Product User Interface on the PLM Portal is under development in parallel - delivery timelines will be announced at a later date.
Details on how the UAT will be organized will be shared in due course.
and
24-04-2023
Feedback Survey for PLM Portal Users (New Deadline: 8 May 2023)
We kindly ask you to provide your feedback on your experience with the new eAF and the PLM Portal, by responding the survey at the following link: https://ec.europa.eu/eusurvey/runner/Adoption-survey-eAF-HumanVariations
This survey aims to gather your feedback on the level of adoption of the change, including the potential concerns or issues you are facing, in order to enable the eAF product team to envisage appropriate fixing and/or mitigation activities.
Please note that the survey will be anonymous, and the results will not be publicly disclosed.
This survey was already shared with PLM portal users in March 2023 and was intended to close on 31 March 2023, but the deadline for responding is now extended to 8 May 2023.
For more insight on eAF, you are invited to consult the following Q&A documents and sessions:
Training Q&A document (link) addressing questions raised by users during earlier eAF (DADI) trainings;
Human Variations eAF go-live Q&A session (link);
Human Variations eAF go-live training session (2 February 2023) (link).
Please send any questions to eSubProgofficer@ema.europa.eu or via the PLM Portal Forum.
19-04-2023
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 1.0.1.7 released to production on the 18th of April 2023 are now available on PLM Portal Forum and on the PLM Portal eAF (DADI) web page.
21-03-2023
Feedback Survey for PLM Portal Users (Deadline: 31 March 2023)
Following the launch of the Human Variation electronic Application Form (eAF) for Centrally Authorised Products (CAPs) on the Product Lifecycle Management (PLM) Portal, we appreciated many users have accessed the PLM Portal to work on variation applications using the new web-form.
We kindly ask you to provide your feedback on your experience with the new eAF and the PLM Portal, by responding the survey at the following link: https://ec.europa.eu/eusurvey/runner/Adoption-survey-eAF-HumanVariations
This survey aims to gather your feedback on the level of adoption of the change, including the potential concerns or issues you are facing, in order to enable the eAF product team to envisage appropriate fixing and/or mitigation activities.
Please note that the survey will be anonymous and the results will not be publicly disclosed. The survey will stay open until 31 March 2023.
This should not take more than 5 minutes.
17-03-2023
Planned maintenance of the eSubmission systems on Saturday 25 March 2023
Planned maintenance of the eSubmission systems on Saturday 25 March 2023
The eSubmission systems are unavailable for planned maintenance and will be unavailable from Saturday 25th of March 2023 08:00 until 18:00 due to essential maintenance. For any further information, please contact Service Desk
09-03-2023
Updated variation FHIR mapping and conceptual data models
The Variation FHIR mapping and the conceptual data models have been updated and are now available.
08-03-2023
eAF-PMS FAQs Document Publication
The eAF and PMS teams are pleased to announce that an eAF-PMS FAQs Document is now available here. This document contains Frequently Asked Questions on eAF and PMS and will be updated regularly.
22-2-2023
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 1.0.1.6 released to production on 21st of February 2023 are now available on the PLM Portal Forum and on the PLM Portal eAF (DADI) web page.
24-1-2022
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 1.0.1.4 released to production on 23rd January 2023 are now available on the PLM Portal Forum and on the PLM Portal eAF (DADI) web page.
And
Updated PLM Portal Guide to Navigation is now available
Please find an updated version of the PLM Portal eAF Guide to Navigation here.
And
eAF - PMS Newsletter Issue 2
We are pleased to inform you that the second edition of the eAF (DADI)-PMS Newsletter is published and available on the EMA corporate website here.
The eAF-PMS Newsletter, published four times a year, provides pharmaceutical companies and the national competent authorities in the EU updates on the progress of the eAF and PMS products.
It also includes an overview of upcoming events and information on available resources.
For more insight on eAF, you are invited to register to the upcoming events and consult the following resources:
Training videos:
Useful resources:
Please share any questions with us at eSubProgofficer@ema.europa.eu.
PLM Portal eAF (DADI) documentation:
PLM Portal eAF webinars:
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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