PV Bulletin

Mandatory Use of PLM Portal eAF for CAP Variations

The EMA has released version 1.2.1.15 of the PLM Portal eAF, which includes critical bug fixes and updates, making compliance necessary for marketing authorization holders as the mandatory deadline for CAP variations approaches.

Primary source: practical guidance

PV Impact Brief

Urgency: HighConfidence: high

What changed

The EMA implemented version 1.2.1.15 of the PLM Portal eAF, requiring marketing authorization holders to use this updated platform for all CAP variations.

Why it matters

Non-compliance with the updated eAF may lead to submission errors, risking regulatory delays and impact on product safety oversight.

Action needed

Marketing authorization holders must transition to the updated PLM Portal eAF by the mandatory deadline of September 1, 2026, ensuring correct submission of variations, particularly those related to pharmacovigilance.

Relevant for
Regulatory Intelligence LeadQPPV
Processes impacted
Country Compliance
Owner

Regulatory Intelligence Lead

Review cadence

Review before 2026-07-20.

Policy change details

Document type
Procedural Notice / Release Notes
Policy status
Final
Publication date
2026-07-21
Effective date
2026-07-20
Policy change
The EMA has released version 1.2.1.15 of the PLM Portal electronic Application Form (eAF), which includes critical bug fixes and functional updates for the web-based variation form. This release ensures system stability ahead of the September 1, 2026, mandatory deadline for all centrally authorised product (CAP) variations.

Key changes

Technical stability updates to the web-based variation form; bug fixes; preparation for mandatory eAF use for CAP variations starting September 2026.

Affected workflows

Country Compliance

Responsible groups

Regulatory AffairsPV Operations

PV impact

Marketing authorisation holders must use the PLM Portal for all variations, including those affecting pharmacovigilance system details (QPPV/PSMF) or safety-related label updates. Compliance with the latest portal version is necessary to avoid submission errors as the transition to mandatory web-based eAF approaches.

View regulator source

Source document details

Exact policy details

Mandatory use of PLM web-based electronic Application Form (eAF) for CAPs
1 September 2026
Applies to: Centrally Authorised Products (CAPs)
The PLM web-based eAF enables faster and more accurate automated processing of application forms. · p. 1 · High · Source
Use of updated eAFs for new CAP MAA submissions
28 July 2026 for Veterinary and Human applications, 1 September 2026 for all MAA submissions to NCAs
Applies to: New CAP MAA submissions
Industry must use the updated eAFs, Version 1.28.0.0, for any new CAP MAA submissions. · p. 1 · High · Source
Implementation timeline for eCTD v4.0
Mandatory use from Q1 2028, recommended use from Q1 2027
Applies to: Centrally Authorised Product (CAP) Marketing Authorisation Applications (MAAs)
Mandatory use of eCTD v4.0 for new CAP MAAs from Q1 2028. · p. 1 · High · Source

Extracted documents

Evidence and confidence

Confidence: highSource updated: Jul 21, 2026

Full briefing

Practical implication

Marketing authorization holders must transition to the updated PLM Portal eAF by the mandatory deadline of September 1, 2026, ensuring correct submission of variations, particularly those related to pharmacovigilance.

Effective September 1, 2026, all Centrally Authorised Products (CAPs) must utilize the updated PLM Portal eAF for variations. This includes all changes affecting pharmacovigilance systems or safety-related label updates. Compliance with version 1.2.1.15 is essential to prevent submission errors as the transition to mandatory use approaches.

What changed: The EMA implemented version 1.2.1.15 of the PLM Portal eAF, requiring marketing authorization holders to use this updated platform for all CAP variations.

Why it matters: Non-compliance with the updated eAF may lead to submission errors, risking regulatory delays and impact on product safety oversight.

Practical implication: Marketing authorization holders must transition to the updated PLM Portal eAF by the mandatory deadline of September 1, 2026, ensuring correct submission of variations, particularly those related to pharmacovigilance.

View original source

Published from the Firecrawl policy change extraction pipeline.

#Pharmacovigilance#Variations#Procedural Notice / Release Notes#Final#European Medicines Agency (EMA)#reporting_requirement#policy-change#firecrawl-policy-agent

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