Mandatory Use of PLM Portal eAF for CAP Variations

Key changes

Update to Human MAA eAF v1.28.0.0; specific fix for the substances dropdown in section 2.6.1; applicants must export data from previous v1.28.0.0 and re-import into the newly published PDF version.

PV impact

Ensures accurate substance identification in MAA submissions, which is critical for downstream pharmacovigilance data management. The eAF is used to submit initial PV information (QPPV, PSMF location), and correct form versions are required for valid regulatory submissions.

Exact policy details

Mandatory use of eAF for CAP MAA submissions

from 28 July 2026 for new CAP MAA Human submissions

Applies to: Centrally Authorised Products (CAPs) for Human Marketing Authorisation Applications

Human MAA eAF v1.28.0.0 - update on mandatory use for CAPs and new minor version available · p. 1 · High · Source

Updated eAF Form Implementation Deadline

All new MAA submissions must use the updated forms from 1 January 2027

Applies to: Centrally Authorised Products (CAPs) for Human Marketing Authorisation Applications

30-06-2026 Human and Veterinary MAA eAF v1.28.0.0 - timeline for implementation · p. 1 · High · Source

Form Publication Requirements

All new forms published need to be 'Trusted'

Applies to: All submissions using electronic application forms (eAF)

Human MAA eAF v1.28.0.0 - update on mandatory use for CAPs and new minor version available · p. 1 · High · Source

Technical Documentation Requirement

Guidance on form use and changes provided in Technical User Guide for eAF

Applies to: All users of the eAF for marketing authorisations

Minor versions 1.28.0.0 of the interactive PDF electronic application form (eAF) · p. 1 · High · Source

Workflow rule impacts

Extracted documents

• eSubmission: eAFhtmlhtml · high · 1 page
• PAM submission formpdfpdf_text · high · 1 page
• Technical User Guide for eAF.pdfpdfpdf_text · high · 73 pages
• Webinar PDFpdfpdf_text · high · 10 pages