Guidance and help - Article

Date: 19 August 2026

PLM Portal eAF - Release Notes

EMA has launched the web-based Human Variations electronic application form (eAF) for Centrally Authorised Products (CAPs) on 4th November 2022, on the Product Lifecycle Management (PLM) Portal. EMA was collaborating with the UNICOM consortium to develop the human variation form

Following a successful updated product load in April 2024, the use of the web-based eAF is now strongly recommended for all Centralised Procedure variation applications (where possible). Please note that small number of limitations still exists in the system, however, the use of the web-based form should start becoming the first option and the use of the interactive pdf should be only in cases where the use of the web-based form is not yet possible/feasible in the view of limitations.

Following the launch of optional use for all EU products and procedures in February 2025, EMA now recommends the use of the PLM Portal web-based eAF for all non-CAPs human variations, where possible. This is aligned with the timeline and the roadmap towards mandatory use of the PLM Portal web-based eAF for all human variations. Please follow user guidance, the current release notes and EMA announcements in relation to any known technical limitations.

The formal transition period will start when all critical issues have been addressed and all features supporting all use cases covered by the interactive pdf eAF 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. It also hosts the user interface for product management service (PMS) data and the interface to provide data for electronic Product Information (ePI). The PLM Portal will further develop over time to inform and support you in the use of these services.

Versioning: Please note that the PLM Portal web-based pdf export is indicated with version number 2.x and this version is comparable to the v1.28.x.x of the interactive pdf eAF from eSubmission website.

This document lists and briefly describes the new features and fixed issues included in the release of the PLM Portal. The most recent release appears first.

About this Document

This document lists and briefly describes the new features and fixed issues included in each release of the PLM Portal.

The most recent release appears first. The known issues are categorised per component or business process of the system so that users can easily identify which issues are relevant for them. The components currently used are:

Component	Short Description
PLM Portal	This component relates to the website, the UI (user interface)
Human Variations eAF	The business process where MAH’s create and edit their variation eAF (electronic application form) on the PLM Portal
PDF	The PDF that is available for download after the completion of an application
FHIR XML	The FHIR xml file attached to exported PDF

For additional information on the PLM portal see this:

User guidance documentation on the PLM Portal: eAF guidance documents and training material · PLM
If you encounter any issue that is not addressed by the above, visit the EMA Service Desk portal: https://support.ema.europa.eu/esc
For more general information, please visit: eSubmissions - PLM eAF

Version: 1.2.1.17 (Release date 18 August 2026)

New stories release in this version:

ID	Description	Comments
312004	Package sorting by MA	In the product selection section, the packages under each medicinal product are sorted automatically by the MA number
328340	Enabler Large Applications	The work on large applications continues with more enables deployed
333119	Scopes - full text for conditions and documentation	In the scope selection, the full text of the conditions and documentation will be shown in the page. The PDF already contained the full text for the scopes conditions and documentation
267110	Finalisation process improvements	Various improvements were made in the finalisation section. The users will receive clearer message on the status of the export/finalisation.
301818	Contact person - OMS search	In the list of organisations (from OMS) for adding a contact person, the results are sorted alphabetically.
306442	[Bug] - Member state dropdown	A (Firefox only) bug related to the Member state dropdown in contact person was fixed
336823	[Bug] Wrong status for export	A bug related to displaying the wrong status when an exported was completed ("Export started" instead of “Completed”) was fixed
310934	[Bug] Adding proposed change stuck in “Processing”	A bug related to adding a proposed change for large applications and getting stuck in “Processing” was fixed
329623	Member state when no product was selected	For the cases when no product was selected and the users attempt to add a contact person, the dropdown list will show a different message.

Known Issues, Limitations and business rules

ID	Short description
Known limitation (resolved)	~~The conditions and documentations for the variation scopes are shown with their term name (short name, and for very few entries also truncated) instead of the term description (long name).~~ ~~The issue was fixed in the exported PDF, which now shows the full name.~~ ~~The web user interface will be resolved in a following release (estimated 17 August)~~

Known issue	When adding a change in “Proposed changes”, maximum 9 scopes can be added. If more than 9 scopes are added, the form will not behave as expected. Workaround: select maximum 9 scopes in one change, and add more changes in a new proposed change.
Known issue	For some large applications (i.e. large number of selected products and/or large number of packages), the export of the XML exceeds the current limit of supported lines, and the process of finalisation and export will fail with the following message: "Data refresh cannot be completed. Aborting the operation. Please retry again." If encountering this issue, raise a ticket and the team will confirm if the error is generated by the size of the export and will advise in some cases to use the interactive PDF eAF as a workaround. Performance improvements are planned to start in the second half of 2026.
Known issue/limitation	The synchronisation between OMS and the PLM Portal goes through an intermediary EMA system (IRIS Dataverse), which is used for other applications as well (for example inspection, parallel distribution etc.). For this reason, the data in the PLM Portal is not always identical with the OMS information. Please raise a Service Desk request to flag inconsistencies.
Business rule	All the products, and their information, are synchronised in the PLM Portal from PMS. Should you encounter any inconsistency, please verify the products in xEVMPD and ProductUI/PMS and if the products are correct in these systems, please raise a Service Desk ticket with the relevant team (PMS, PLM Portal ProductUI or PLM Portal eAF).
Business rule	When creating a variation for MRP/DCP products, the member states which are available in the dropdown menu(s) in Procedural Information (Reference member state and Concerned Member state) will be the member states from the selected products in the variation. The RMS/CMS in this case are the member state responsible and concerned for the current procedure, not the RMS/CMS of the product(s). The label was changed to “Reference Member State / Reference Authority for worksharing / Authorising Member State”
Business rule	For the section 4.b (Paediatric requirements) to appear on the PDF, the Checkbox “Paediatric requirements” needs to be ticket in the “Changes concern(s)” in the Procedural information tab.
Business rule	For MRP/DCPs, all the packages of the selected medicinal products are considered for a variation, and they cannot be un-selected in the present/proposed changes. Further discussions with Subject Matter Experts and local authorities are taking place to re-consider this limitation.
Known issue	When exporting the pdf, the export is intermittently not triggered on the first attempt but might require multiple attempts before succeeding.
xEVMPD data issue	Cyrillic characters showing ‘?’ in the full name field – this is not a data issue but reflecting data from xEVMPD. This needs to be corrected by the respective MAHs with new version of product to be sent to xEVMPD.
Known issue	In Medical Device section the ‘EU authorised representative’ option is missing Workaround: use the interactive pdf eAF for variations where in section 4d option ‘EU authorised representative option needs to be selected
Known issue	The selections from the Medical Device section 4d. are not correctly reflected in the pdf export in some cases. Please note: for variation applications indicating a change in the device in section 4d. please consider using the interactive pdf eAF.
Known limitation	Products authorised in Finland: The full name of product is displayed (randomly) either in Finnish or Swedish All names existing in PMS for a medicinal product are shown in the PDF
Known limitation	Products authorised in Belgium: The full name of product is displayed (randomly) either in Flemish, French or German All names existing in PMS for a medicinal product are shown in the PDF
Known issue	In section Type(s) of Change(s) – scope selection: known intermitted issue where selection of all conditions and documentations using the high level tickbox will result an error message saying all conditions and documentations should be selected or note should be provided.
Known limitation	23965 - Conditions and documentation are presented in different order from the variation classification guideline
Known limitation	Concurrent users – there is currently a limitation in the system where 2 or more users can work at the same time in the same application form, however, the changes cannot be saved at the same time and this could lead into data loss by one of the concurrent users. It is strongly recommended to organise a workflow internally to avoid any data loss.
Known limitation	22845 – Deletion of Application Form is not yet available
Known limitation	23545 - Performance issues Number of sections take ~~very~~ long to open or to display the changes/selections made by the user; for example, in Finalisation section, most functions take much longer than acceptable e.g. displaying the parallel procedures section can take up to 1 minute etc.
Known limitation	23963 - Finalisation: Annexed document and Declaration Section are presented in random order

Version: 1.2.1.16 (Release date 03 August 2026)

New stories release in this version:

ID	Description	Comments
318525	Finalisation page - Fix Harmonisation section	On the finalisation page, the rules for showing the harmonisation section were verified and fixed. The Harmonisation section appears only when the application contains at least 1 non-CAP medicinal product, and at least one variation of type IB, type IB unforeseen, type II or type II article 29.
303771, 295818, 316833, 324971, 335641	Large Applications - Improve Export Robustness, FHIR export, product selection	Several improvements and bug fixes related to creation and export of large applications were deployed
192584, 192587	UI design implementation - Procedural info and Finalisation	Minor user interface changes were applied in procedural information and finalistion sections

Known Issues, Limitations and business rules

ID	Short description
Known limitation (updated)	The conditions and documentations for the variation scopes are shown with their term name (short name, and for very few entries also truncated) instead of the term description (long name). The issue was fixed in the exported PDF, which now shows the full name. The web user interface will be resolved in a following release (estimated 17 August)
~~Known issue~~ ~~Updated in 1.2.1.14 with new message~~ Message updated	After adding products to an eAF, when opening the medicinal product to verify the packages, in some cases the list is empty (saying “No data available in the table Loading packages… In packs are not visible, please refresh the page”). ~~Workaround~~~~: wait for a few seconds and then refresh the page. The packages will appear in the list.~~
Known issue	When adding a change in “Proposed changes”, maximum 9 scopes can be added. If more than 9 scopes are added, the form will not behave as expected. Workaround: select maximum 9 scopes in one change, and add more changes in a new proposed change.
Known issue	For some large applications (i.e. large number of selected products and/or large number of packages), the export of the XML exceeds the current limit of supported lines, and the process of finalisation and export will fail with the following message: "Data refresh cannot be completed. Aborting the operation. Please retry again." If encountering this issue, raise a ticket and the team will confirm if the error is generated by the size of the export and will advise in some cases to use the interactive PDF eAF as a workaround. Performance improvements are planned to start in the second half of 2026.
Known issue/limitation	The synchronisation between OMS and the PLM Portal goes through an intermediary EMA system (IRIS Dataverse), which is used for other applications as well (for example inspection, parallel distribution etc.). For this reason, the data in the PLM Portal is not always identical with the OMS information. Please raise a Service Desk request to flag inconsistencies.
Business rule	All the products, and their information, are synchronised in the PLM Portal from PMS. Should you encounter any inconsistency, please verify the products in xEVMPD and ProductUI/PMS and if the products are correct in these systems, please raise a Service Desk ticket with the relevant team (PMS, PLM Portal ProductUI or PLM Portal eAF).
Business rule	When creating a variation for MRP/DCP products, the member states which are available in the dropdown menu(s) in Procedural Information (Reference member state and Concerned Member state) will be the member states from the selected products in the variation. The RMS/CMS in this case are the member state responsible and concerned for the current procedure, not the RMS/CMS of the product(s). The label was changed to “Reference Member State / Reference Authority for worksharing / Authorising Member State”
Business rule	For the section 4.b (Paediatric requirements) to appear on the PDF, the Checkbox “Paediatric requirements” needs to be ticket in the “Changes concern(s)” in the Procedural information tab.
Business rule	For MRP/DCPs, all the packages of the selected medicinal products are considered for a variation, and they cannot be un-selected in the present/proposed changes. Further discussions with Subject Matter Experts and local authorities are taking place to re-consider this limitation.
Known issue	When exporting the pdf, the export is intermittently not triggered on the first attempt but might require multiple attempts before succeeding.
xEVMPD data issue	Cyrillic characters showing ‘?’ in the full name field – this is not a data issue but reflecting data from xEVMPD. This needs to be corrected by the respective MAHs with new version of product to be sent to xEVMPD.
Known issue	In Medical Device section the ‘EU authorised representative’ option is missing Workaround: use the interactive pdf eAF for variations where in section 4d option ‘EU authorised representative option needs to be selected
Known issue	The selections from the Medical Device section 4d. are not correctly reflected in the pdf export in some cases. Please note: for variation applications indicating a change in the device in section 4d. please consider using the interactive pdf eAF.
Known limitation	Products authorised in Finland: The full name of product is displayed (randomly) either in Finnish or Swedish All names existing in PMS for a medicinal product are shown in the PDF
Known limitation	Products authorised in Belgium: The full name of product is displayed (randomly) either in Flemish, French or German All names existing in PMS for a medicinal product are shown in the PDF
Known issue	In section Type(s) of Change(s) – scope selection: known intermitted issue where selection of all conditions and documentations using the high level tickbox will result an error message saying all conditions and documentations should be selected or note should be provided.
Known limitation	23965 - Conditions and documentation are presented in different order from the variation classification guideline
Known limitation	Concurrent users – there is currently a limitation in the system where 2 or more users can work at the same time in the same application form, however, the changes cannot be saved at the same time and this could lead into data loss by one of the concurrent users. It is strongly recommended to organise a workflow internally to avoid any data loss.
Known limitation	22845 – Deletion of Application Form is not yet available
Known limitation	23545 - Performance issues Number of sections take ~~very~~ long to open or to display the changes/selections made by the user; for example, in Finalisation section, most functions take much longer than acceptable e.g. displaying the parallel procedures section can take up to 1 minute etc.
Known limitation	23963 - Finalisation: Annexed document and Declaration Section are presented in random order

Previous releases

eAF release notes

PLM Portal eAF - Release Notes