PV Bulletin

Update to the List of European Union Reference Dates and PSUR Submission Frequencies

The European Medicines Agency has made significant updates to the EURD list, which dictates submission cycles for Periodic Safety Update Reports.

Primary source: Quality Review of Documents (QRD) convention to be followed for the European Medicines Agency QRD templates

PV Impact Brief

Urgency: HighConfidence: high

What changed

The EURD list has been updated, affecting the submission timelines for PSURs for various medicinal products authorized in the EU.

Why it matters

Failure to adhere to the revised PSUR submission frequencies can result in regulatory actions against Marketing Authorisation Holders (MAHs), emphasizing the need for timely updates to submission calendars.

Action needed

Marketing Authorisation Holders (MAHs) must update their global submission calendars in accordance with the new EURD submission frequencies and ensure compliance with the updated requirements to avoid regulatory consequences.

Relevant for
Regulatory Intelligence LeadPV Quality LeadQPPV
Processes impacted
Country ComplianceInspection Readiness
Owner

Regulatory Intelligence Lead

Review cadence

Review in the next regulatory intelligence cycle.

Policy change details

Document type
Regulatory list
Policy status
revised
Publication date
2012-10-01
Last updated
2026-08-26
Policy change
The EMA revised the legally binding EURD list to revision 163 on 26 August 2026. The list sets the EU reference date, PSUR submission frequency, data lock point and submission date for each covered active substance or combination, and it also specifies requirements for generic, well-established-use, homeopathic and traditional herbal products. Marketing authorisation holders must use these dates for substances assessed at EU level because the EURD schedule overrides the standard PSUR cycle and conditions in the marketing authorisation.

Key changes

Revision 163 updates the substance-level EURD schedule. Operationally, MAHs need to check the revised entries for the applicable frequency, data lock point and submission date, then align PSUR planning and submissions accordingly; the list does not replace national-level frequency arrangements for substances assessed nationally.

Affected workflows

Country ComplianceInspection Readiness

Responsible groups

Global PharmacovigilanceQPPV OfficeSafety OperationsRegulatory Affairs

Document identifiers

EMA/630645/2012 Rev. 163

PV impact

Global PV and QPPV teams should compare the revised revision-163 entries with the company substance inventory, PSUR calendar and submission tracking controls. Safety operations and regulatory operations may need to update data-lock-point calculations, PSUR due dates and work instructions for EU-level assessments, while confirming that nationally assessed substances remain governed by national schedules. Because the EURD list is legally binding, discrepancies can create late or incorrectly scheduled PSUR submissions and inspection findings.

View regulator source

Source document details

Exact policy details

PSUR submission frequency
Frequency for submission is dependent on the individual product lifecycle
Applies to: Applicable to all MAHs and their products.
Submission frequency is based on the product lifecycle as noted in various examples provided. · p. 1 · Medium · Source

Workflow rule impacts

Documentation and Submission ProcessRegulatory Affairs Departments of MAHs

All submissions must be coordinated through the PSUR Repository, impacting how documentation is prepared and submitted.

Introduction of PSUR Repository as a mandatory submission route.

All PSUR procedures shall be submitted electronically to the PSUR Repository, and submission directly to NCAs is no longer accepted. · p. 5 · High · Source

Extracted documents

Dropped source-document details older than publication window.

Evidence and confidence

Confidence: highSource updated: Jul 29, 2026

Full briefing

Practical implication

Marketing Authorisation Holders (MAHs) must update their global submission calendars in accordance with the new EURD submission frequencies and ensure compliance with the updated requirements to avoid regulatory consequences.

The European Medicines Agency has updated the EURD list, defining new data lock points and submission frequencies for Periodic Safety Update Reports (PSURs) within the EU. Marketing Authorisation Holders (MAHs) are required to carefully review the updated list for any changes that may affect their products. Compliance with the new submission deadlines is essential to avoid regulatory repercussions.

What changed: The EURD list has been updated, affecting the submission timelines for PSURs for various medicinal products authorized in the EU.

Why it matters: Failure to adhere to the revised PSUR submission frequencies can result in regulatory actions against Marketing Authorisation Holders (MAHs), emphasizing the need for timely updates to submission calendars.

Practical implication: Marketing Authorisation Holders (MAHs) must update their global submission calendars in accordance with the new EURD submission frequencies and ensure compliance with the updated requirements to avoid regulatory consequences.

View original source

Published from the Firecrawl policy change extraction pipeline.

#Safety Signals#Reporting Requirement#revised#policy-change#firecrawl-policy-agent#Notice#European Medicines Agency

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