News
Previous DADI news can be found here
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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