News
Previous DADI news can be found here
21-12-2022
Updated PLM Portal eAF timeline now available
Please find an updated version of the PLM Portal eAF (DADI) Human Variations Forms timeline. The slide is also available on the the PLM Portal Forum.
And
Updated PLM Portal Guide to eAF (DADI) Registration is now available
An updated version of the Portal (eAF) guide to registration is now available also on the PLM Portal Forum. The guide aims to support the users of the eAF Portal in completing the registration steps before accessing the PLM Portal. This update includes several updates across the document.
13-12-2022
Updated PLM Portal eAF Release notes now available
An updated version of the PLM Portal eAF Release notes reflecting bug fixes and updates to the web eAF made in the version 1.0.1.3 released to production on 12th December 2022 are now available on the the PLM Portal Forum and below.
And
Update on PLM Portal eAF (DADI) 2023 UAT and releases
Following the launch of the web-based Human Variation electronic Application Form (eAF) for Centrally Authorised Products (CAPs) on the
Product Lifecycle Management (PLM) Portal, users have accessed the PLM Portal to work on variation applications using the new web-form. This is a valuable step for users to familiarise themselves with the system as well as for the development team to gain more insights on features to improve and issues to fix.
The development team's priority now is addressing issues in the web form and stabilising it. Following this, work will continue adding the data and functionalities needed to fully support national, MRP and DCP variations application procedures and submissions.
EMA has therefore decided that the previously planned industry external User Acceptance Test (UAT) in January 2023 will be rescheduled to a date expected to be announced in the first half of 2023. The UAT will be scheduled when there are meaningful new features and capabilities to be tested.
To support stakeholders' planning for possible participation in the UAT and anticipate eventual transition to the use of the web-forms please note the following:
- The target window for introducing Nationally Authorised Medicinal Products (all NAPs, including MRP/DCP) to the variation application form is now Q2 2023;
- In addition, further capabilitiesneed to be introduced to make the variations eAF ready to start a formal transition period, the target window for release of these features is Q2-Q3 2023
- More precise time windows will be shared in the first half of 2023 with the aim of providing a minimum of a 2-month lead time before the UAT or a major release
For more insight on eAF, you can use the following resources:
Upcoming events:
- Human Variations eAF Q&A Clinics:
- Human Variations eAF public training:
- EMA Quarterly System Demo
- Q&A documents:
06-12-2022
Updated PLM Portal eAF Release notes now available
An updated version of the PLM Portal eAF Release notes reflecting bug fixes and updates to the portal made in releases on 14th November 2022 and on 28th November 2022 are now available on the PLM Portal Forum and below.
And
Note on production release on 14th November 2022 on the PLM Portal eAF
As part of EMA's regular biweekly release schedule, a minor release including number of bug fixes and other changes went live on 14 November 2022.
This release was not announced in advance on the PLM Portal Forum in the manner the production team would usually aim to communicate. The procedure for the announcements and information for releases - major and minor - will be reviewed to ensure their timely provision.
No release notes were shared at the time of this release, however, the Release notes have now been updated and they are now available in the PLM Portal Forum and below under the PLM Portal eAF (DADI) documentation.
For any issues or technical support with EMA's IT systems, please raise a ticket with the EMA Service Desk portal.
Please share any questions with us via eSubProgofficer@ema.europa.eu.
17-11-2022
Updated PLM Portal Guide to eAF (DADI) Registration is now available
An updated version of the Portal (eAF) guide to registration is now available. The guide aims to support the users of the eAF Portal in completing the registration steps before accessing the PLM Portal. This update includes further details on the use of Multi Factor Authentication (MFA).
Following the release, users of the Human Variations eAF should expect continual work on improvements in the form of regular releases. These will be a mix of bug fixes, scheduled improvements, improvements based on user acceptance testing (UAT) feedback or that may be identified by users after the release and new features, such as additional structured data fields.
For any issues or technical support with EMA's IT systems, please raise a ticket with the EMA Service Desk portal.
Please share any questions with us via eSubProgofficer@ema.europa.eu.
04-11-2022
Web-based Human Variations eAF (DADI) now live on the new Product Lifecycle Management Portal
EMA is pleased to announce the web-based Human Variations electronic application form (eAF) for Centrally Authorised Products (CAPs) is now available on the new Product Lifecycle Management (PLM) Portal. This is a big, first milestone in the ongoing journey to improve the eAFs and related processes. EMA has been collaborating with the UNICOM consortium to develop the human variation form and other web-based forms.
Following the release, users of the Human Variations eAF should expect continual work on improvements in the form of regular releases. These will be a mix of bug fixes, scheduled improvements, improvements based on user acceptance testing (UAT) feedback or that may be identified by users after the release and new features, such as additional structured data fields.
As a reminder: the use of the new web-based form is optional. This release will not trigger a transition period towards mandatory use. The formal transition period will start when nationally authorised products (NAPs) and features supporting use cases covered will be added to the form. The current interactive PDF eAF will remain available until the end of the transition period.
The new PLM Portal will in due course host all eAFs. In the future it will also host the data input user interface for product management service (PMS) data and the interface to provide data for for electronic Product Information (ePI). The PLM Portal will develop over time to inform and support you in the use of these services. One new feature launched on the PLM portal is a chatbot through which you can ask questions about the web-forms and get quick answers.
The following upcoming events and resources are available to help users get familiar with the new form and the new PLM Portal:
- Upcoming events:
- Human Variations web-based eAF Form training session: 8 November 2022 (10:00-11:30), Registration link.
- Q&A clinics:
- Training videos:
Useful resources:
Please share any questions with us at eSubProgofficer@ema.europa.eu.
PLM Portal eAF (DADI) documentation:
DADI webinars:
- Human Variations Form go-live Q&A session: 27 October 2022 (14:00-15:00), Registration linkNew
- Human Variations web-based eAF Form training session: 8 November 2022 (10:00-11:30), Registration linkNew
- Q&A clinics:
- 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.
|
