Mandatory use of PLM web-based eAF for CAPs
The strongly recommended use of the PLM web-based electronic Application Form (eAF) for Centrally Authorised Products (CAPs) has been in place since July 2024. Over the past two years, submissions via the PLM eAF have steadily increased.
To continue advancing the adoption of the PLM web-based eAF, the European Medicines Agency (EMA) will introduce mandatory use for CAPs as of 1 September 2026.
Why is this change being introduced?
The PLM web-based eAF enables faster and more accurate automated processing of application forms. It also supports integration with other EMA systems, contributing to a more efficient and streamlined submission and approval process.
By contrast, the interactive PDF eAF may present technical issues that can lead to rejection of submissions. It is also slower to process and does not support the same level of system integration as the web-based solution.
How to prepare for mandatory use
Before 1 September 2026, users of the PLM portal eAF are advised to:
Verify the integrity of their PMS data.
Ensure all users in their organisation have the appropriate access rights and roles assigned in the PLM Portal: https://plm-portal.ema.europa.eu/guidance-and-help/article/?artid=KA-01012
Familiarise themselves with the PLM web-based eAF: https://plm-portal.ema.europa.eu/
Consult the available material: https://plm-portal.ema.europa.eu/guidance-and-help/article/?artid=KA-01012
Practice creating submissions in the PLM portal, even if they are not intended for submission. Draft forms can be created and later deactivated if not needed.
What will happen after 1 September 2026?
From 1 September onwards, any human CAP variation submissions sent to EMA using the interactive PDF eAF will be rejected unless it is accompanied by a valid and justified technical reason preventing the use of the PLM web-based eAF.
Possible technical reasons preventing the use of PLM eAF
The following known technical limitations may justify the use of the interactive PDF eAF:
Performance issues for large applications: The PLM portal currently has performance limitations when handling large applications of over approximately 200 medicinal products. Improvements for large applications are planned for 2026.
Medical Devices section: a known issue in this section requires the continued use of the interactive PDF eAF.
PMS data issues: A full list of known PMS issues is available in the PMS FAQ document (page 16), including expected resolution timelines. Examples include: duplicated products or packages, duplicated entries, truncated product names. Applicants should review this list and follow recommended actions before submitting a support ticket.
OMS data issues: Issues in the intermediate data layer (dataverse) may impact organisational data used in the eAF. A platform-level review is ongoing. Existing and future workarounds aim to address synchronisation issues, including those related to contact persons and proof of payment.
Lack of access to the PLM portal: Some organisations have not yet enabled co-authoring or provided access to all required users (e.g. in worksharing scenarios). In such cases, the interactive PDF eAF remains the only viable option.
Other (unknown) technical issues: Unlisted technical issues may also be accepted, provided they are flagged on time and impede the correct finalisation of a PLM portal form. If users encounter issues close to a submission deadline that block the completion of the PLM web-based eAF, they may use the interactive PDF eAF.
Further details on how to justify the exceptional use of the PDF eAF will be communicated prior to the beginning of the Mandatory use for CAPs.
Additional guidance
Users should raise a service desk ticket for issues that may be resolvable (e.g. PMS, OMS, or newly identified issues): https://support.ema.europa.eu/esc
Requests will be handled based on priority and order of receipt, with feedback provided on resolution timelines.
If the estimated resolution time conflicts with a submission deadline, applicants should use the interactive PDF eAF.
If service desk response times are longer than expected, the interactive PDF eAF may be used.
For known limitations such as large applications, Medical Devices issues, or lack of PLM portal access, users are not required to raise a service desk ticket.
Please follow the PLM portal and eSubmission for updates on the mandatory use of the PLM portal eAF for CAPs and on how to report any impediments.
We appreciate your continuous engagement and collaboration.
On behalf of the eAF team