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. 

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.

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 11^th and 16^th 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.

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:

1. Implementation of missing features.
2. Resolving pending issues that prevent users from completing a form.
3. 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.
4. Capability to keep PMS data synchronised with existing databases.
5. 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 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.