PV Bulletin

IRIS Guide for Applicants - Updated Submission Requirements

The EMA has released an updated version of the IRIS guide for applicants detailing requirements for using the IRIS platform for regulatory data submissions.

Primary source: IRIS guide for applicants (How to create, submit and manage IRIS applications, for industry and individual applicants)

PV Impact Brief

Urgency: HighConfidence: high

What changed

MAHs and sponsors must now use the updated IRIS portal for safety reporting and signal management, effective June 15, 2026.

Why it matters

Compliance with the latest digital submission standards is essential for regulatory submissions in the EU, impacting pharmacovigilance-related processes.

Action needed

MAHs and sponsors must register for an EMA account and appropriate role to submit via the IRIS platform, as this is a new requirement for all IRIS submissions.

Relevant for
Regulatory Intelligence LeadSignal Management LeadQPPV
Processes impacted
Signal ManagementCountry Compliance
Owner

Regulatory Intelligence Lead

Review cadence

Review before 2026-06-15.

Policy change details

Document type
Procedural Guidance
Policy status
revised
Publication date
2026-06-15
Effective date
2026-06-15
Policy change
The EMA has released an updated version of the IRIS guide for applicants. This document provides instructions for industry and individual applicants on using the IRIS platform, which is the primary portal for preparing, submitting, and managing regulatory data and applications in the EU, including pharmacovigilance-related submissions such as signal management and post-authorisation safety studies (PASS).

Key changes

Updated instructions for platform navigation, user registration, and data management for regulatory procedures. It reflects the latest system features for the 2026 rollout of IRIS services.

Affected workflows

Signal ManagementCountry Compliance

Responsible groups

PV OperationsRegulatory AffairsQPPV

PV impact

MAHs and sponsors are required to use the updated IRIS portal for safety reporting and signal management. This update ensures compliance with the latest digital submission standards for EU pharmacovigilance.

View regulator source

Source document details

Exact policy details

Preliminary Requirement for IRIS Submission
EMA Account and appropriate role are required for any submission.
Applies to: All applicants using the IRIS platform for submissions.
1.2. Preliminary requirement · p. 9 · High · Source
Submission Creation Timeline
Registration for an EMA account and an appropriate IRIS role needs to be done only once.
Applies to: All users planning to submit through the IRIS platform.
1.2. Preliminary requirement · p. 9 · High · Source

Workflow rule impacts

Submissions ManagementRegulatory Affairs

User roles must be managed to ensure appropriate submission access and compliance.

Separate user access roles are required for Parallel Distribution submissions.

1.1. Purpose of this guide mentions separate access roles. · p. 10 · High · Source

Extracted documents

Evidence and confidence

Confidence: highSource updated: Jun 15, 2026

Full briefing

Practical implication

MAHs and sponsors must register for an EMA account and appropriate role to submit via the IRIS platform, as this is a new requirement for all IRIS submissions.

The EMA updated the IRIS guide, requiring Marketing Authorization Holders (MAHs) and sponsors to utilize the updated IRIS portal for safety reporting and signal management. This update, effective from June 15, 2026, aligns with the latest digital submission standards in EU pharmacovigilance.

What changed: MAHs and sponsors must now use the updated IRIS portal for safety reporting and signal management, effective June 15, 2026.

Why it matters: Compliance with the latest digital submission standards is essential for regulatory submissions in the EU, impacting pharmacovigilance-related processes.

Practical implication: MAHs and sponsors must register for an EMA account and appropriate role to submit via the IRIS platform, as this is a new requirement for all IRIS submissions.

View original source

Published from the Firecrawl policy change extraction pipeline.

#Regulatory Intelligence#Signal Management#Procedural Guidance#Revised#European Medicines Agency#reporting_requirement#policy-change#firecrawl-policy-agent

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