## [Mandatory Use of PLM Web-Based eAF for CAPs from 1 September 2026](/index%2ephp/mandate/mandatory-use-of-plm-web-based-eaf-for-caps-from-1-september-2026) April 13, 2026 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](/webform/consult%0A?url=https://preprod.freyrsolutions.com/index%2ephp/markdownify/node/13132) Source Select Mandate HA [EMA](/index%2ephp/mandate-by-ha/ema) Select Mandate Function [Publishing & Submissions](/index%2ephp/mandate-by-function/publishing-submissions)