As of 29 September 2025 EMA has started strongly recommending the use of the PLM Portal web-based eAF for all non-CAPs human variations. This step is aligned with the roadmap towards mandatory use of the PLM Portal web-based eAF for all human variations.
Following the launch of optional use in February 2025, EMA now recommends the use of the PLM Portal web-based eAF for all non-CAPs human variations, where possible. To provide support during this transition, EMA will host two dedicated training sessions and two Q&A sessions.
A new PLM Portal eAF Q&A document is now available: Q&A Document
In a progression towards eventual transition, from late Q3 2025, EMA will strongly recommend use of the web-base eAF for non-CAPs applications, with the PDF version to be used only in exceptional cases. EMA currently already recommends using the PLM Portal web-based eAF for all non-CAPs human variation applications and already strongly recommends it for all CAPs human variations.
The registration for the Q&A Clinic on web-based electronic Application Form (eAF) for CAPs and non-CAPs on 8 July 2025 10:00 - 11:00 (CEST) is still open.
The registration for the training session on Human variations web-based electronic Application Form (eAF) for non-CAPs on 1 July 2025 10:00 - 11:30 Amsterdam time (CEST) is still open.
Following the launch of optional use in February 2025, EMA now recommends the use of the PLM Portal web-based eAF for all non-CAPs human variations, where possible.
If not yet done, please complete the conversion of your account to email authentication as soon as possible, by visiting My Account portal to login and follow the detailed instructions.
EMA would like to provide you with an update on the progress of the web-based Human variations electronic Application Form (eAF) implementation on the Product Lifecycle Management (PLM) Portal.
EMA is pleased to announce that the PLM Portal eAF Integrity stamp feature will be deployed Thursday, 6th of March, after 18:00 CET.
The EMA is pleased to confirm as of Tuesday 11 February 2025, the human variations web-based electronic Application Form (eAF) is open for first use for non-Centrally Authorised Products* (non-CAPs) within the PLM Portal.
Several chapters of the EU IDMP Implementation Guide (IG) and the Product Management Service FAQ document have been updated.
The following EU IDMP IG Chapters are now updated:
Chapter 5 - Annex A
The Frequently Asked Document (FAQ) document for PMS was also updated with information on the status of PMS known issues.
Please note, the write PMS API implementation guidance will be published after 6 January 2025. We apologise for any inconvenience this may cause.
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.
EMA has introduced email address authentication for EMA applications to improve security and usability of EMA applications by removing the need for users to remember their EMA username and password.
All new self-registered users are automatically set by default to email authentication.
All users not converted are requested to opt-in before 20 January 2025.
Starting from 20 January 2025 the EMA will initiate the conversion of all users that didn’t opt-in to the email authentication:
- 20 January: Non regulatory users without specific application roles;
- 3 February: Non regulatory users with application roles;
- 3 March: Regulatory users (European Medicines regulatory Network);
- 31 March: all users are converted.
How to opt in: Users are required to opt-in to email authentication in EMA Account Management by following the enclosed detailed instructions. Once converted to email authentication, users can use email address to authenticate into EMA systems, as shown in figure below.
Useful links:
- Public system demo (Q3 2024) - Presentation and recording;
- "EMA Account Management - What's new" webinar recording
Contact: EMA Service Desk; If you are unable to access Service Desk, please send an email to servicenow@ema.europa.eu indicating your name, surname and your unique username.
Non-Centrally Authorised Products* (non-CAPs) data are now available in the Human variation web-based eAF within the Product Lifecycle Management (PLM) Portal. This is a further important step towards the progressive increase of the use of the PLM Portal web-based eAF for all non-CAPs and CAPs variations.
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.
In a further step towards progressively increasing the use of the PLM Portal web-based eAF for all CAPs variations, EMA now strongly recommends applicants use it for these applications in anticipation of eventual required use. Additionally, EMA is planning to extend the use of the PLM Portal web-based eAF for non-CAP procedures concerning variations for human medicines.
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.
*Including split & match-merge processes. Please refer to EU IG (Implementation Guide) Chapter 7 for a detailed description of these steps.
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, while 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 consult the 3 June 2024 training session to prepare for registration & navigation of PUI.
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.
| New, product-specific tiles for electronic Product Information (ePI) and the Product Management Service (PMS) Product User Interface have beein 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. |
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.
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
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 on the eSubmission website.
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.
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.
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 plm.valuestream@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.
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.
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.
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.
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 plm.valuestream@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.