EMA's PLM Web-Based eAF Becomes Mandatory 1 September 2026

For every company that holds a centrally authorised medicine in the European Union, a hard operational deadline is now weeks away. From 1 September 2026, the European Medicines Agency (EMA) will require the Product Lifecycle Management (PLM) web-based electronic Application Form (eAF) for centrally authorised products (CAPs). After that date, human CAP variation submissions filed on the older interactive PDF eAF will be rejected unless a valid, justified technical reason prevents use of the web-based form.

This is not a gentle recommendation with a long runway. It is a switch in the accepted submission format, and the failure mode is unusual: poor product data can invalidate your form at the moment you try to create it, not weeks later at review. Teams that treat this as a routine IT update will discover the problem at the worst possible time. This article explains what is changing, why the underlying data matters so much, and a practical readiness checklist to close the gap before the deadline.

Executive Summary

The essentials for regulatory operations and quality leaders.

• What changes: From 1 September 2026 the PLM web-based eAF is mandatory for all centrally authorised products.
• What stops working: From 1 September 2026, human CAP variation submissions on the interactive PDF eAF will be rejected unless a valid, justified technical reason applies.
• Why it is hard: The web-based eAF pulls structured product data from the Product Management Service (PMS). If that data is incomplete or wrongly migrated from xEVMPD and SIAMED, the form can be invalidated at creation.
• The related form change: Human eAF version 1.28.0.0 became the required form for new CAP marketing authorisation applications from 28 July 2026, becomes usable at national competent authorities from 1 September 2026, and is mandatory for all national MAA submissions from 1 January 2027.
• What to do now: Verify PMS data quality, confirm product groupings, set the right PLM Portal user roles, and practise creating submissions in the system before the deadline.

What Is the PLM Web-Based eAF?

What is it? The electronic Application Form is the structured form that accompanies a marketing authorisation application, a variation or a renewal in the EU. The PLM web-based eAF is the newer, browser-based version hosted on EMA's PLM Portal, which replaces the older interactive PDF form. Why does it matter? The web-based form draws directly on EMA's central product data rather than relying on manual entry, so accuracy and interoperability improve, but your submission is now only as clean as your product data. What should companies do? Move to the web-based form now and, more importantly, fix the product data that feeds it.

EMA launched the web-based Human Variations eAF for CAPs on the PLM Portal in November 2022 and recommended its use from July 2024. Adoption has climbed steadily since. The 1 September 2026 date converts that recommendation into a requirement for centrally authorised products.

What Exactly Changes, and When

What is it? Two connected changes are landing close together: the web-based eAF mandate for CAPs, and the roll-out of the new eAF version 1.28.0.0. Why does it matter? Confusing the two leads to missed dates. How does it affect compliance? Each date governs a different submission type, so map your pipeline against the table below.

The action that cannot wait is the CAP variation change on 1 September 2026. Variations are frequent, routine and time-sensitive, so a rejected variation submission can delay a change your quality system depends on, such as a manufacturing site update or a specification change.

Why Product Data Quality Is the Real Risk

What is it? The web-based eAF is populated from the Product Management Service, EMA's structured record of your products. Why does it matter? PMS data was migrated from the legacy xEVMPD and SIAMED systems, and that migrated data was never validated for submission use. What should companies do? Treat PMS data remediation, not the form itself, as the core of your readiness project.

The practical consequence is a change in when problems surface. With the PDF eAF, a data error would often be caught late, at validation or review. With the web-based eAF, incorrect or incomplete PMS data can cause the form to be invalidated at the point of creation. That means the failure appears when your team is trying to build the submission against an internal deadline, with no time to remediate. Poor data quality moves the pain forward and makes it more disruptive.

The 30-Day Readiness Checklist

Use this checklist to structure your readiness project. Each item should have a named owner and a completion date before 1 September 2026.

• Confirm PMS data integrity. Review the product data for every centrally authorised product and correct errors before you need to submit.
• Verify migration from xEVMPD and SIAMED. Check that legacy data migrated correctly into PMS, because migrated errors are a leading cause of eAF invalidation.
• Check product groupings. Confirm that medicinal products are structured in PMS the way EMA expects, so the form can be created cleanly.
• Set PLM Portal user roles. Ensure administrators and contributors have the correct access rights to create and manage the web-based eAF.
• Practise submission creation. Have your team build test submissions in the system so the first live submission is not the first attempt.
• Update your submission SOPs. Revise your standard operating procedures and work instructions to reflect the web-based workflow, not the PDF workflow.
• Brief the wider team. Make sure everyone who touches variations knows the format has changed and the PDF route will be rejected.
• Document a justified technical reason process. Define, in advance, how you would justify a PDF submission if a genuine technical reason ever prevents web-based use, so you are not improvising.

What Regulatory Teams Should Do Now

A readiness sprint of a few weeks is enough for most organisations if it is focused on data rather than on the form. We recommend the following sequence.

• Step 1: Inventory your CAPs and near-term variations. List every centrally authorised product and the variations you expect to file in the next two quarters.
• Step 2: Run a PMS data health check. Compare PMS records against your source of truth and log every discrepancy for correction.
• Step 3: Remediate the data. Correct groupings, attributes and migrated errors, prioritising products with imminent variations.
• Step 4: Confirm access and roles. Verify PLM Portal roles for every user who will create or manage submissions.
• Step 5: Dry-run a submission. Create a test variation in the web-based eAF to confirm the data flows through cleanly.
• Step 6: Lock in the process. Finalise SOPs, train the team, and set a monitoring routine so PMS data stays clean after the deadline.

Lessons from the Wider 2026 Regulatory Operations Shift

The eAF change does not stand alone. It is part of a broader move by EMA and other regulators toward structured, data-driven submissions, and the same discipline pays off across your regulatory operations.

Data quality is now a compliance control, not an IT nicety. The lesson EMA is teaching through the eAF is that your regulatory data must be as controlled as your quality records. The same principle underlies the revised EU variations framework, which reshaped how changes are classified and processed from January 2026. If you are updating submission processes for the eAF, align them with your variations strategy at the same time.

Deadlines are clustering, so plan them together. The eAF mandate sits alongside the EMA active-substance starting-materials guideline that comes into force on the same 1 September 2026 date. Companies that treat each deadline as a separate fire drill exhaust their teams; those that build a single regulatory deadline calendar manage the load.

Documentation discipline decides outcomes. Whether you are creating a submission or defending a manufacturing change, the strength of your written procedures matters. Our guidance on writing SOPs that pass a Health Canada inspection applies equally to EU submission SOPs: clear, current and followed in practice. And where a change needs a structured lifecycle plan, the principles in our ICH Q12 and PACMP guide and our validation master plan guide help you keep changes controlled and defensible.

Common Mistakes Companies Make

These are the errors we see most often as deadlines like this approach.

• Treating it as an IT task. The eAF change is a regulatory data-quality project. Handing it to IT without regulatory ownership leaves the product data unaddressed.
• Waiting until the first live submission. Discovering a PMS data problem while building an urgent variation gives you no time to fix it. Dry-run early.
• Ignoring user roles. A submission can stall simply because the person creating it lacks the right PLM Portal access. Confirm roles in advance.
• Assuming migrated data is clean. Data carried over from xEVMPD and SIAMED was not validated for submission use. Verify it.
• Overusing the technical-reason exemption. The PDF route survives only for a valid, justified technical reason. It is not a general fallback, and relying on it invites rejection.
• Planning deadlines in isolation. The 1 September 2026 eAF mandate coincides with other EU changes. Managing them separately wastes effort and risks missed dates.

Frequently Asked Questions

Is the PDF eAF still accepted by EMA after 1 September 2026?

For human centrally authorised product variations, no, not as a matter of routine. From 1 September 2026 such submissions filed on the interactive PDF eAF will be rejected unless a valid and justified technical reason prevents use of the PLM web-based version. The web-based eAF is the expected format.

Which products does the mandate cover?

The 1 September 2026 mandate covers centrally authorised products, meaning medicines authorised through the EU centralised procedure. Separately, eAF version 1.28.0.0 becomes usable at national competent authorities from 1 September 2026 and mandatory for new national MAA submissions from 1 January 2027.

What is the Product Management Service (PMS)?

PMS is EMA's structured record of medicinal product data. The web-based eAF draws on PMS to populate the form, which is why the quality of your PMS data directly determines whether your submission can be created and validated.

Why can the form fail at creation rather than at submission?

Because the web-based eAF is generated from PMS data, incomplete or inaccurate product data can prevent a valid form from being created in the first place. This is different from the PDF form, where errors were often caught later, and it means data problems surface early and disruptively.

What is a valid, justified technical reason?

EMA allows a PDF eAF submission only where a genuine technical issue prevents use of the web-based version. This is an exception for specific technical circumstances, not a general opt-out. Companies should define in advance how they would document and justify such a case, and should not plan to rely on it.

How long does readiness take?

For many organisations a focused readiness sprint of a few weeks is enough, provided it concentrates on PMS data quality, product groupings and user roles rather than on the form itself. Companies with large or complex portfolios, or with known legacy data issues, should allow longer.

How does this affect companies outside the EU?

Any company that holds or is applying for a centrally authorised product in the EU is affected, regardless of where it is based. Non-EU sponsors relying on partners or affiliates for EU submissions should confirm those teams are ready and that PMS data is controlled.

How MFLRC Can Help

MF License and Regulatory Consultants (MFLRC) supports regulatory operations and quality teams across Canada, the United States and Europe. For companies preparing for the eAF mandate, our team can:

• Run an EU regulatory operations readiness assessment focused on your CAP portfolio and upcoming variations.
• Support PMS data remediation, including checks on xEVMPD and SIAMED migration and product groupings.
• Develop submission-process SOPs and work instructions for the web-based eAF workflow.
• Provide training so your team can create and manage submissions with confidence.
• Build a consolidated regulatory deadline calendar so clustered 2026 deadlines are managed together.

Our consultants deliver practical, defensible outputs rather than generic checklists, drawing on deep quality-systems and regulatory-affairs experience. Explore our regulatory affairs, licensing and import/export services and our pharmaceutical validation services to see how we support submission readiness.

Conclusion

The move to the PLM web-based eAF on 1 September 2026 is more than a format change. It makes your product data a live compliance control, because a form generated from PMS can only be as accurate as the data behind it. The companies that come through this cleanly will be the ones that treated it as a data-quality project, verified their migrated records, fixed their product groupings, confirmed their PLM Portal roles and practised before the deadline. With variations on the line and the date close, the work of readiness is best done now, not on the first live submission.

Sources and References

• European Medicines Agency, PLM Portal, Upcoming mandatory use of PLM web-based eAF for CAPs.
• European Medicines Agency, PLM Portal guidance and help.
• Asphalion, Mandatory Use of PLM Web-Based eAF for CAPs as of 1 September 2026 (secondary source, 20 April 2026).