eAF release notes

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