The European Medicines Agency has announced that the PLM web-based electronic Application Form (eAF) will become mandatory for all Centrally Authorised Products (CAPs) starting 1 September 2026. This follows a transition phase since July 2024, during which the web-based eAF has been strongly recommended and increasingly adopted across submissions. What is Changing? From 1 September 2026, all human CAP variation submissions must be submitted using the PLM web-based eAF. Submissions using the interactive PDF eAF will be rejected Exceptions will only be allowed where valid, justified technical limitations prevent use of the web-based system Why This Matters The shift to the PLM web-based eAF is part of EMA’s broader digital transformation, aimed at:

  • Enabling faster and more accurate automated processing
  • Supporting integration with EMA systems (e.g., PMS, OMS)
  • Reducing technical errors and submission rejections

In contrast, the interactive PDF eAF:

  • Is more prone to technical issues
  • Slows down processing timelines
  • Lacks integration capabilities required for modern regulatory workflows
  • Key Preparation Steps for MAHs

Marketing Authorisation Holders (MAHs) should take the following actions ahead of the deadline:

  • Validate PMS data integrity to ensure accurate product information
  • Confirm PLM portal access and user roles across all relevant teams
  • Familiarize teams with the PLM web-based eAF interface and workflows
  • Conduct internal testing by creating draft submissions in the PLM portal
  • Review EMA guidance and training materials to ensure compliance readiness
  • When Can PDF eAF Still Be Used?

The interactive PDF eAF may be accepted only in exceptional cases, including:

  • Large applications (typically >200 products) with current system performance limitations
  • Medical Devices section issues within the PLM portal
  • PMS or OMS data inconsistencies impacting form completion
  • Lack of PLM portal access (e.g., co-authoring not enabled)
  • Unresolved or newly identified technical issues close to submission deadlines

In such cases:

  • Issues should be documented and justified
  • A service desk ticket should be raised where applicable
  • Post-Deadline Enforcement

After 1 September 2026:

  • EMA will strictly enforce the use of the PLM web-based eAF
  • Submissions using PDF eAF without valid justification will be rejected

Further guidance on exception handling and justification requirements is expected prior to implementation.

Consult Now

Source
https://esubmission.ema.europa.eu/index.html
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