Previous DADI news
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
20-02-2024
PLM Portal eAF and PMS - FAQs and Q&A documents updated
The PLM Portal eAF and PMS teams are pleased to announce that the updated Frequently Asked Questions (FAQs) on eAF and PMS and Questions and Answers (Q&A) Joint eAF and PMS are now available here.
02-02-2024
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 2.0.0 in the PLM Portal eAF (to be released to production on 30 April 2024) are now available on the PLM Portal and in the section of the PLM Portal eAF, Documentation section, together with several documents to provide consumers of the FHIR XML message the easiest possible way to upgrade to the eAF XML 2.0.0 or to start the implementation now with the latest version.
The new version includes the latest official FHIR version “Release #5 (5.0.0): http://hl7.org/fhir/”. This replaces the current version FHIR Release #5: Draft Ballot (4.6.0): http://hl7.org/fhir/2021May/ which will remain online for approximately 3 months to give consuming systems time to adapt to the change.
02-02-2024
User Experience of the current PDF eAFs completion on the PLM Portal
The electronic Application Form (eAF) Product Team would greatly appreciate to receive your feedback on your current experience in terms of time spent in filling in the interactive pdf electronic Application Form (eAF) for Variations for Centrally Authorised Products (CAPs) and Nationally Authorised Products (NAPs), and Initial Marketing Authorisation.
It is acknowledged that different types of procedures (e.g. Type IA, Type II applications, worksharing, and groupings) may require varying time commitments. We would therefore appreciate if, in your answer, you could provide the average time spent and resources used to fill in the forms.
Your feedback will provide us an indication on the current performance requirements and will be our starting point for improving future user experience.
You can find the questionnaire to fill in at the following link:
https://ec.europa.eu/eusurvey/runner/Eusurvey_PLMPortal_UX_eAFcompletion
Please note that this survey should not take more than 5 minutes to complete, and the responses will remain anonymous.
We kindly ask you to respond to the survey by Thursday 29 February 2024.
Please send any question to plm.valuestream@ema.europa.eu or post them via the PLM Portal Forum.
20-12-2023
Update on web-based Human variations electronic Application Forms (eAFs) implementation
As anticipated in October 2023, the electronic Application Form (eAF) and Product Management Service (PMS) teams would like to provide you with an update on the progress of the web-based Human variations eAF implementation on the Product Lifecycle Management (PLM) Portal
During Q4 2023, we completed the load and evaluation of PMS data in PMS User Acceptance Testing (UAT) environment, after which we proceeded to testing of PMS data in the PLM Portal. While performing these activities, we observed the following:
- Bugs in PMS related to match-merge* of Centrally Authorised Products (CAPs);
- Technical issues with the eAF preventing testing;
- System performance improvements required for the PLM Portal.
Taking into consideration these findings, we have made the necessary adjustments to planning. Kindly find here a visual representation of the updated plan.
Please note that Alpha UAT for Product User Interface (UI) data quality is still ongoing and proved successful thus far, as no blocking bugs have been identified.
Key points of the updated plan:
Q1 2024:
- Deployment in production of new eAF features (e.g., clone application, add package, rename application) developed in Q4 2023.
- Consolidation of all PLM portal products' development (eAF, Product UI, ePI) under a single service provider.
Q2 2024:
- Release of all CAPs & NAPs in the PMS database. Simultaneously, release of updated** CAPs in eAF;
- Delivery of PMS Application Programming Interface (API) - with CAPs and Nationally Authorised Products (NAPs) available in view-only mode - and Product UI - with CAPs available in view-only mode and NAPs not yet viewable.
Please note that, during the preparation for the updated** CAPs load in eAF in Q2 2024, the match-merge* operation will result in:
- changes to product names;
- introduction of new medicinal products through splitting*;
- potential alterations to packages;
This will impact how products appear in application forms. Therefore, we will communicate in due course the 3-week period where it is advisable to use the interactive eAF (PDF) instead of the web-based eAF for submissions to prevent validation issues and potential delays. Please note the web-based eAF will remain accessible to applicants to familiarise themselves with it and for training purposes.
Q3 2024:
- Performance improvements and internal testing
Q4 2024:
- Release of NAPs in the eAF
The updated planning does not foresee in 2024:
- external testing of the eAF UAT
- consequently, no transition start towards mandatory use of the Human variations web-based eAF. However, we would recommend the use of the web-based eAF for CAPs submissions following the updated** CAPs release.
Please send any questions to eSubProgofficer@ema.europa.eu or post them via the PLM Portal Forum.
*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
**Including split & match-merge processes. Please refer to EU IG Chapter 7 for a detailed description of these steps.
28-11-2023
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 1.0.1.12 released to production on 27 November 2023 are now available on PLM Portal Forum and on the PLM Portal eAF web page.
20-11-2023
Invitation to register for the Product Lifecycle Management Value Stream Deep-Dive Webinar, 30/11/23 h. 14:00-16:00 (CET)
EMA is pleased to announce a public webinar (event page on EMA website) for medicines developers and regulators eager to gain deeper insights into what the Agency's Product Lifecycle Management (PLM) value stream is working on and its goals. The event will take place on 30 November, 14:00 - 16:00 (CET).
This webinar aims to show the interconnections between the various digital products being delivered. In addition, it will outline the approach taken to enhance product lifecycle management technology to enable more efficient and effective medicine regulation.
About PLM:
PLM is one of three value streams covering the product lifecycle implemented by the Agency as part of its Agile transformation. PLM aims to digitally transform and optimise regulatory procedure management as well as data submission and reuse throughout the product lifecycle. The value stream works with EMA partners and stakeholders to deliver systems and services to manage the authorisation and lifecycle of medicinal products and medical devices within the Agency's remit for the ultimate benefit of public and animal health in the EU.
About the Webinar:
During the webinar, the team will share the value stream's vision and roadmap towards a data centric target operating model for end-to-end data capture, processing and re-use, as well as how PLM's products and solutions contribute to this vision.
PLM Products and Solutions:
- Solutions for Human & Veterinary medicinal products:
- Solutions for Human medicinal products:
- Solutions for Veterinary medicinal products:
What's in it for you:
This webinar presents a valuable opportunity to enhance your understanding of the work of the value stream and stay informed about the latest developments in this area, ask questions and interact with the responsible EMA teams.
Registration & Contact details:
Interested stakeholders are invited to kindly register at the following link.
Please note registration will remain open until the start of the webinar.
You have the opportunity to send your questions in advance via Slido.com using the specific event code: #PLMVS-QA.
Should you have any questions or require further information, please feel free to contact us at plm.valuestream@ema.europa.eu.
14-11-2023
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 1.2.0 in the PLM Portal eAF (to be released to production on 21 November 2023) are now available on PLM Portal Forum
05-10-2023
Update on web-based electronic Application Forms (eAFs) implementation
The electronic Application Form (eAF) and Product Management Service (PMS) teams would like to provide you with a comprehensive update on the progress of the web-based Human variations eAF implementation on Product Lifecycle Management (PLM) Portal.
The following milestones are now for Q1 2024:
- Release of split* (i.e. IDMP compliant) Centrally Authorised Products (CAPs) for use in the variations eAF;
Release National Authorised Products (NAPs) for use into the Human variations eAF;
Introduction of the Product Data Management User Interface (UI), offering users seamless access to view their product data available in the Product Management Services (PMS) database.
As we advance, we remain committed to transparency and will provide a comprehensive update on these targets at the end of Q4 2023, evaluating the quality of both the system and available data.
Currently, our primary focus is ensuring quality of data and system's performance to prepare a transition-ready version of the web-based Human variations eAF. To begin the transition phase towards mandatory use of web-based Human variations eAFs, the following key steps are required:
- Implementation of missing features.
- Resolving pending issues that prevent users from completing a form.
- Releasing all products (NAPs and split* (i.e. IDMP compliant) CAPs) from the Product Management System (PMS) to the PLM portal in the production environment.
- Capability to keep PMS data synchronised with existing databases.
- Ensuring system stability.
As previously committed, any announcement concerning the starting date of the formal transition period will follow User Acceptance Testing (UAT) of the system and the subsequent addressing of any critical issues. This is explained in this slide.
The primary objective remains to implement web replacements of interactive PDF eAFs, enabling user-friendly capture and handling of variations, marketing authorisations, and renewals application data for both applicants and regulators. This transition ensures consistency across IT systems and guarantees the availability of high-quality ISO IDMP compliant information.
For further details on the implementation progress and challenges, and the opportunity to ask questions, interested parties are invited to the joint eAF-PMS webinar for 6 November 2023 (13:30 - 15:00 (CEST)). During this session, the eAF team will also demonstrate the anticipated "add package" and "clone application" features that will be released on the PLM Portal for eAF. Please find here the registration link.
We also recommend that anyone with an interest in the development of eAF and PMS watch the relevant sections of the Q3 System Demo recording, available on EMA's website.
Please send any questions to eSubProgofficer@ema.europa.eu or via the PLM Portal Forum.
*CAPs migrated from SIAMED not following ISO IDMP structure. For this reason, they have undergone a further step in the data migration to PMS in addition to the match and merge protocol.
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.
31-10-2022
Updated Product Lifecycle Management Portal Guide to (DADI) eAF Registration is now available
An updated version of the PLM Portal (eAF) guide to registration is now available on PLM Portal eAF (DADI).
The guide aims to support the users of the eAF Portal in completing the registration steps before accessing the PLM Portal. Most of these steps are independent from the PLM Portal eAF and correspond to those to obtain registration to use other European Medicines Agency (EMA) systems. Applicants are invited to register for the new PLM Portal with the support of this updated guide.
You will be able to sign into the portal after the go-live of the Human Variations electronic Application form (eAF) for CAPs.
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.
14-10-2022
Web-based Human Variations eAF go-live details
EMA is pleased to inform that the web-based Human Variations electronic application form (eAF) for CAPs - often referred to by its former project name: DADI - will be available for use on 4 November 2022 on the new Product Lifecycle Management (PLM) Portal. EMA has been collaborating with the UNICOM consortium to develop the new web-form. To ensure full technical and business support services at go-live, release to the public is scheduled slightly later than the original target date of 31 October. This is due to European Holidays on November 1 and 2.
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 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. Going live as scheduled and continually improving the form is the most effective route to having a high performing web-form in the shortest timeframe and it is in accordance with an Agile way of working.
As a reminder: this release will not trigger a transition period towards mandatory use. The formal transition period will start after the anticipated March 2023 release when nationally authorised products (NAPs) features will be also added to the form. The interactive PDF eAF will remain available until the end of the transition period.
The new PLM Portal will in due course host all web based eAFs, data input user interface for product management service (PMS) data and the interface to provide data for electronic Product Information (ePI). You can expect reference to Digital Application Dataset Integration (DADI) to be phased out over the coming weeks in favour of eAF and the PLM Portal.
We have the following resources to help you get familiar with the new form and the new environment:
Pre go-live:
- Publication of the updated guides for portal registration and navigation (to be made available via the eSubmission website).
- Human Variations Form go-live Q&A session: 27 October 2022 (14:00-15:00), Registration link.
Post go-live:
- Human Variations web-based eAF Form training session: 8 November 2022 (10:00-11:30), Registration link.
- Q&A clinics:
Please note an updated general Q&A document, including Q&A’s on PMS, and a training Q&A document addressing questions raised during earlier eAF trainings are now available.
I have an urgent variations application, what should I do?
In case you are worried about speed, please feel free to use the old PDF form until further notice. Kindly note this the first release of the Human Variations Form: the intention is to expose it and allow people to use it on a voluntary basis for CAPs. Usage of the form is not yet mandatory. Only once we have fully transitioned Human Variation eAFs in 2023 will you be required to use the new web form.
How can I sign up for the next User Acceptance Tests (UAT)?
The development team will evaluate the UAT just completed and then decide the format for the UAT for the next release. Details on the timing of the UAT, the approach and how to express interest in joining will be shared in due course.
Kindly note that testing is not designed as a substitute for early access. This is exactly why the Human Variations Form is going live in November for CAPs only and for voluntary use.
Please share any questions with us at eSubProgofficer@ema.europa.eu
Updated Human variations Timeline and eAF Portal Guide to Registration now available
Please find the October 2022 version of the DADI Human Variations Forms timeline, outlining the updated go-live date and an update to the 2nd BETA UAT. The eAF Portal guide to registration has been updated. The guide aims to support the users of the eAF Portal in completing the registration steps before accessing the platform.
26-09-2022
Update of the DADI Q&A document
The DADI and PMS teams are pleased to announce that a joint DADI and PMS Q&A Document is now available here. Given their interdependencies, this updated version of Q&A document includes questions related to both DADI and PMS.
Human variations form updated timeline
Please find the September 2022 version of the DADI Human Variations Forms timeline, outlining the updated DADI BETA UAT timeframe. The UAT has started on 19th September and will end on the 30th September 2022.
02-08-2022
Questions and Answers document from the public webinar "DADI Q&A Webinar - Variations form for Human Medicinal Products Go-live" held on 12th July 2022
The Q&A document from the public webinar is now available.
27-07-2022
The 1st DADI newsletter has been published on the EMA website
The digital application dataset integration (DADI) newsletter, published four times a year, provides pharmaceutical companies and the national competent authorities (NCAs) in the EU updates on the progress of the DADI project.
It also includes an overview of upcoming events and information on available resources.
You can find the first issue of the newsletter here.
14-07-2022
eAF Portal Guide to Registration v1 released
The Digital Application Dataset Integration (DADI) Network project team is pleased to announce the publication of the first version of the eAF Portal guide to registration.
The guide aims to support the users of the eAF Portal in completing the registration steps before accessing the platform. Most of these steps are independent from the eAF Portal and correspond to those to obtain registration to use other European Medicines Agency (EMA) systems, such as Management Services for Substances, Products, Organisation and Referentials (SPOR).
For any issues or technical support with EMA's IT systems, please raise a ticket with the EMA Service Desk portal.
Invitation to register to the DADI eAF training and Q&A webinars
The Digital Application Dataset Integration (DADI) Network project will replace PDF electronic application forms (eAF) used for regulatory submissions with web-forms, making the future form-filling and submission-handling process more efficient.
The variations form for Human medicinal products will be the first form to be released by DADI in October 2022. To effectively support stakeholders ahead of the go-live date, EMA is pleased to announce two new public eAF training and Q&A webinars.
- 1st eAF training and Q&A webinar: 26 July 2022, 11:00-12:30 Central European Time (CET) - Registration link
- 2nd eAF training and Q&A webinar: 2 September 2022, 11:00-12:30 Central European Time (CET) - Registration link
These events are training webinars for industry and national competent authorities' stakeholders wishing to learn more about access management aspects related to the new eAF dedicated portal and the procedure to fill in a web-based eAF at go-live.
During the sessions, a demonstration focused on access management and the User Interface will be performed in order to showcase how to register and access the Portal, how to fill in the web-based eAF, select products and export the forms.
Kindly note recordings from both training sessions will be made available after each event.
Please share your questions on the above webinar with us at eSubProgofficer@ema.europa.eu.
07-07-2022
DADI Human Variations eAF User Acceptance Testing (UAT) - Call for Volunteers
In the context of the digitalisation of the Variations Application Form for Human Medicinal Products, the European Medicines Agency (EMA) is pleased to invite Applicants to participate in the User Acceptance Testing (UAT) phase of the Digital Application Dataset Integration (DADI) Network project.
UAT timeline and scope
The DADI UAT is planned to be conducted between 5 September and 16 September 2022. During that period, the production-like version of the electronic Application Forms (eAF) Portal will be open for testing. As recently communicated, please note that the scope of this UAT is limited to Centrally Authorised Products (CAPs). The UAT participants are expected to perform testing activities, by filling in electronic Application Forms as close as possible to real-life scenarios. Namely, this implies filling in an eAF for one or multiple CAPs, single scope or grouping of scopes from different variation procedure types (e.g., type IA or type II), and to export the PDF output to be included in a submission.
Information about training/troubleshooting material and sessions
If you would like to participate in the DADI UAT you are kindly asked to, as pre-requisites: (i) have an active EMA user account, and, (ii) request the necessary user access role(s), both via the EMA Account Management portal. A user guide will be provided.
Please note that prior to the DADI UAT, training/troubleshooting material and sessions will be provided to prepare the UAT participants to the maximum extent possible, thereby avoiding potential unnecessary problems that may occur during the UAT phase (e.g., registration process, access management, etc.).
A UAT kick-off session is planned for 5 September 2022.
The following two access management troubleshooting sessions are scheduled:
- First access management troubleshooting session: Thursday, 21 July 2022
- Second access management troubleshooting session: Tuesday, 23 August 2022.
The above-mentioned sessions aim to be a hands-on guide for testers to create an EMA user account and request user access role(s). Attendance to the sessions is optional: you may be interested in attending one out of the two access management troubleshooting sessions in case of issues with access management.
In addition, two public training and Q&A webinars are scheduled:
- First training and Q&A webinar: Tuesday, 26 July 2022
- Second training and Q&A webinar: Friday, 2 September 2022.
The EMA will make available the training materials and provide more details on how to attend the scheduled sessions in due course.
Information about reporting findings/bugs
Only consolidated feedback is expected to be reported to the EMA by a limited number of users (coordinators), who will be granted access to Azure DevOps, the EMA’s platform for bug reporting purposes.
You are kindly requested to report your bugs/findings directly to your Industry Association. The following Industry Associations have been shortlisted to collect your feedback:
- AESGP
- EFPIA
- Europharm
- EuropaBio
- Medicines for Europe
- Vaccines Europe
Please directly contact your respective Industry Association to liaise on the practicalities for reporting a bug/finding. Please note that the number of participants to the UAT is limited.
If you are not a member of an Industry Association, i.e., for example, you represent a consultancy, please check with the company you represent if they can grant you access in IAM and if you can report the findings through the Industry Association they belong to.
Next steps
Please inform the EMA at your earliest convenience, whether you would like to participate in the DADI UAT to test the eAF platform.
We look forward to receiving your feedback, by writing to eAF-testing@ema.europa.eu (cc: industry@ema.europa.eu) at the latest by 15th July 2022, with the following information (for each organisation):
- First name, last name, and e-mail address of members interested in participating to the UAT
- Name of your organisation and, if already available, OMS Location ID
- Name of the Industry Association to which you aim to report findings/bugs (if/when applicable)
After the call for interest deadline you will receive a communication informing you if you have been selected to participate to the UAT.
For further information please see a presentation including the DADI UAT timeline.
05-07-2022
DADI Project Human Variations revised go-live scope
EMA will launch the eAF variations web form in October 2022. This is a first release of the web-based variation form for human medicinal products that will be improved and expanded in subsequent releases in 2023. This progressive release model follows the Agile development model of the Agency.
The scope of the October 2022 go-live will be limited to Centrally Authorised Products (CAPs). EMA made this decision due to the complexity in synchronisation of the data between xEVMPD and PMS. At this initial release of the form the available data for CAPs is coming from EMA internal database and it is the same dataset currently used in IRIS to support Inspections.
This version of the form cannot yet be used for applications containing Nationally Authorised Products (NAPs), including National Procedures, Mutual Recognition Procedure and Decentralised Procedure.
A subsequent release of the form in March 2023 will support all types of EU variation procedures (CAPs and NAPs).
The timeline describing updated release schedule reflecting the revised dates for subsequent releases is available here.
We appreciate you may have questions about this change of scope. To help address these we are offering:
- A Q&A webinar on 12 July, 11:00-12:30 Central European Time (CET) (Please use this Registration link to register to join this Q&A session).
- An update to chapter 7 of the EU Implementation Guide for ISO IDMP covering details of what a CAPs only go-live will mean which will be published soon.
- A DADI Q&A document around what will happen at go-live which will be published before end of July 2022.
24-05-2022
DADI Project Human variations forms updated timeline & revised go-live scope
DADI Human Variations Form Timeline (May 2022)
Following the publication of the DADI timeline in February 2022 please find an updated timeline for the release of web-based variations form for Human medicinal products, including key milestones.
- Currently, the variations form for Human medicinal products is undergoing closed User Acceptance Testing (UAT) with members of the DADI Subject Matter Expert Group, which is expected to conclude in August 2022.
- Subsequently, there will be external User Acceptance Testing with a larger, but still limited, group of testers representing various stakeholders. The product team have rescheduled the external UAT from Q2 2022 to September 2022. More information around the UAT organisation will be communicated in June. The UAT will serve to test the system's functions. It will not be set up to facilitate early access to the web user interface for a large group of users.
- The target go-live date for the release of the form remains unchanged (October 2022).
Scope of Initial release of Human Variations eAF web form
At initial release of the Human variations form in October 2022, the scope will primarily cover a conversion of the current interactive PDF format eAF form to the new web-based format where the main change is to select the product/presentation impacted by the variation from PMS. Future releases will progressively replace more free text data fields with structured data fields.
Additionally, the web forms will introduce mandatory use of OMS for all procedure types which is new for non-Centralised procedures.
28-04-2022
Invitation to register to DADI-PMS Webinar - "Variations Form for Human Medicinal Products - What will happen at Go-Live", 16/05/22 h. 10:00-12:00 (CET)
The Digital Application Dataset Integration (DADI) Network project will replace PDF electronic application forms (eAF) used for regulatory submissions with web-forms, making the future form-filling and submission-handling process more efficient.
The variations form for human medicinal products will be the first form to be released by DADI, with an expected go-live in October 2022. As part of the go live, DADI will expose medicinal product data that have been migrated to the Product Management Service (PMS) for product master data for human medicinal products.
EMA is pleased to announce a new public webinar focused on what will happen at go-live of DADI human medicinal products variations form and its interaction with Product Management Service (PMS).
This public webinar is for business and technical audiences from industry and national competent authorities wishing to learn more about what will happen when the DADI web-based form for human medicinal products will go live. All stakeholders interested in DADI and its interaction with PMS are welcome.
Topics addressed in this webinar include:
- The process for selecting products, creating and submitting the variations form;
- Data in the form coming from PMS;
- The process after the approval of the variation;
- Need to provide data to the Extended EudraVigilance Medicinal Product Dictionary (xEVMPD).
If you wish to attend, kindly register at the following link.
DADI-PMS Webinar Agenda - Variations Form for Human Medicinal Products - What will happen at Go-Live
Please share your questions on the above webinar with us at eSubProgofficer@ema.europa.eu.
31-03-2022
Recordings from the DADI public webinars held on 18th and 25th January 2022 now available
The recordings from both DADI public webinars held in January are now available. Please find the links below (under heading DADI webinars).
10-03-2022
Digital Application Dataset Integration (DADI) Network Project Technical Webinar (FHIR) 25/01/2022 - Presentation and the FHIR mapping and examples now available
Please find the presentation and the FHIR mapping & examples the webinar on "Common factors in the Fast Healthcare Interoperability Resources (FHIR) data standard for Art57(2) and eAF" in the following link. Please note that the recording from the webinar will be published as soon as it becomes available.
And
System demo: digital application dataset integration (DADI) and Product Management Service (PMS) - Live broadcast available
EMA has announced the first public system demo of 2022. In this system demo, EMA will demonstrate developments of DADI project and the PMS service. The system demo will take place on Tuesday 15 March 2022 at 09:00-11:00 (CET). As the original WebEx webinar has reached maximum registration, the EMA team is pleased to inform you that a live broadcast will be available on the day to allow additional interested colleagues to attend the session.
No registration is required to follow the live broadcast on EMA's website, available from the event page. Kindly note the session will also be recorded and made available through EMA Corporate Website.
Please share any questions on the above system demo with us at eSubProgofficer@ema.europa.eu.
17-02-2022
DADI Project updated Questions and Answers document now available
The Digital Application Dataset Integration (DADI) Network Project team is pleased to announce that an updated version of the DADI Questions and Answers documents is now available.
For general inquiries, please contact the DADI project team via eSubProgofficer@ema.europa.eu. For questions or comments around the content of this Q&A document, please raise a ticket (by selecting “Ask a question” and including in the subject “DADI Q&A”) via the EMA Service Desk.
If you have a technical question about the DADI project, please raise a ticket (by selecting “Ask a question” and including in the subject “DADI”) via the EMA Service Desk.
04-02-2022
Following the announcement on the revised timeline made during the first Digital Application Dataset Integration (DADI) Network Project public webinar held on 18 January 2022, an updated timeline for the release of DADI web-based variations forms for Human medicinal products, including key milestones, is now available.
Please note the target go-live date of April 2022 has been revised to October 2022.
- Currently, the variations form for human medicinal products is undergoing closed User Acceptance Testing (UAT) with members of the DADI Subject Matter Expert Group, which will be followed by testing of the PMS data (through a PMS UAT) that the forms will use. More information around the PMS UAT will be shared during Q1 2022.
- Finally, there will be an integrated User Acceptance Testing in Q2 2022 with a larger, but still limited, group of testers representing various stakeholders.
- The go-live will be followed by a 6-month transition period during which both the PDF eAF and the web-based form can be used in parallel.
Further details on User Acceptance Testing and subsequent development on other forms will be shared on a regular basis during the coming months via the eSubmission website.
Send your questions about the DADI project to eSubprogofficer@ema.europa.eu.
And
Presentation from the first DADI public webinar held on 18 January 2022 now published
Please find the presentation from the webinar available at the following link. Please note that the recording from the webinar will be published as soon as it becomes available.
14-01-2022
Digital Application Dataset Integration (DADI) Network Project Webinar 18/01/2022 - Live broadcast available
In a previous news published on 10 December 2021 EMA announced the upcoming webinar "Introducing DADI: The Digital Application Dataset Integration Network Project to replace electronic application forms" on 18 January 2022 at 10:30-12:00 Central European Time (CET). As the original WebEx webinar has reached maximum registration, the DADI Network Project team is pleased to inform you that a live broadcast will be available on the day to allow additional interested colleagues to attend the session. The updated guidance enters into force 1st February 2022.
No registration is required to follow the live broadcast on EMA's website available from the event page and from EMA's broadcasting channel
At certain points throughout this session, participants will be able to ask questions and give their input via the audience interaction tool Slido. Interaction via Slido is voluntary, and you may opt to remain anonymous. If you choose to use Slido, you consent to the processing of your personal data as explained in the EMA Data Privacy Statement for Slido
Kindly note the session will also be recorded and made available through EMA Corporate Website.
Thank you for forwarding this message to your affiliated Members who wish to participate.
Please share any questions on the above webinar with us at eSubProgofficer@ema.europa.eu.
10-12-2021
Invitation to register to the Digital Application Dataset Integration (DADI) Network Project Webinars
The Digital Application Dataset Integration (DADI) Network Project will replace electronic application forms. EMA is pleased to announce public webinars to learn more about DADI and aspects of the new web-forms. The first webinar is a general introduction, while the second webinar will focus more on technical aspects of the new electronic Application Form (eAF) setup. Please note these events are organised as part of the change management activities for the DADI project.
Webinar 1 - "Introducing DADI: The Digital Application Dataset Integration Network Project to replace electronic application forms"
18 January 2022 at 10:30-12:00 Central European Time (CET)
This public webinar is for Human & Veterinary Medicines Industry and National Competent Authorities' (NCA) stakeholders that wish to learn more about:
If you wish to attend, kindly register at the following link.
Please share your questions on the above webinar with us at eSubProgofficer@ema.europa.eu.
Webinar 2- "Common factors in the Fast Healthcare Interoperability Resources (FHIR) data standard for Art57(2) and eAF"
25 January 2022 at 10:30-12:00 Central European Time (CET)
This second public webinar is for technical experts from Industry and NCAs that wish to learn more about the design of the FHIR message for the first form to be updated: Human Variations. Despite the focus on Human at this time - any stakeholders interested in the technical aspects of the FHIR message are welcome. Topics that will be addressed in this webinar:
If you wish to attend, kindly register at the following link.
Please share your questions on the above webinar with us at eSubProgofficer@ema.europa.eu.
17-06-2021
Following up on the initial announcement of the DADI project in March 2021 the project team has released a questions and answers document on the project.
DADI Questions and Answers (June 2021) New
The aim of the document is to provide the best available answers to questions about the project.
- What will the DADI project do?
- Why is DADI being started now?
- Will DADI Deliver forms complying with veterinary Medicines regulation?
The team aims to further release in July:
- The timeline for the coming year, including key milestones and expected stakeholder engagement activities
- The full list of features of the human variations form
- Drafts of the variations form FHIR message
Please keep an eye on updates on this portal for the latest news on DADI.
The DADI project will replace current PDF format electronic application forms (eAFs), making the future form-filling and submission handling process more efficient. The new web-based forms will be aligned with EU Implementation Guides for human and veterinary medicinal product data description, using the Fast Healthcare Interoperability Resources (FHIR) data standard. The implementation of these new forms supports the EU ISO IDMP (Identification of Medicinal Products) standards implementation for human medicines.
DADI is part of the Telematics portfolio and supports medicines life cycle management. It incorporates the learnings and developments of the CESSP phase 1 project.
Send your questions about the DADI project to eSubprogofficer@ema.europa.eu
25-03-2021
The Digital Application Dataset Integration (DADI) project will replace the current PDF-file based electronic application forms (eAFs), making the future form-filling and submission handling process more efficient. The new web-based system will be aligned with EU Implementation Guides for human and veterinary medicinal product data description, using the Fast Healthcare Interoperability Resources (FHIR) data standard, and, as a result, with the EU ISO IDMP (Identification of Medicinal Products) standards implementation for human medicines.
DADI is part of the Telematics portfolio and supports medicines life cycle management. It incorporates the learnings and developments of the CESSP phase 1 project.
The governance structure for DADI was established in December 2020, following the endorsement of the project charter by the EU Telematics Management Board (EU TMB). The steering group is comprised of the IT Directors Executive Committee (IT DEC) and the EMA accountable executive.
The project plan, including relevant industry consultation steps and timelines, is under elaboration. Furthers update on the planning and timelines will be shared in due course. The variations application form (Human and Veterinary) will be the first area of focus.
The DADI project aims to accommodate the requirements driven by Veterinary Medicines Regulation (Regulation (EU) 2019/6) implementation. We will provide a further update on the planning and timeline by May.
Direct your questions about DADI to eSubprogofficer@ema.europa.eu
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