PV Bulletin

European Medicines Agency Pre-Authorisation Procedural Advice Updates

The European Medicines Agency (EMA) has released updated procedural advice concerning submissions for marketing authorisations.

Primary source: European Medicines Agency (EMA)

PV Impact Brief

Urgency: HighConfidence: high

What changed

The procedural advice includes refined timelines and structured interactions for pre-submission activities, mandating that marketing authorisation holders ensure their pharmacovigilance system summaries and RMPs align with new procedural expectations.

Why it matters

Compliance with the updated procedural guidelines is crucial for ensuring timely and effective submissions, avoiding potential delays caused by incomplete registrations in the OMS, which can obstruct the regulatory process.

Action needed

Marketing Authorisation Holders (MAHs) and applicants must register new sites and organisations in the OMS before any regulatory submission and ensure alignment of their submission documents with the latest guidelines.

Relevant for
Regulatory Intelligence LeadLabeling LeadQPPV
Processes impacted
Country ComplianceLabeling
Owner

Regulatory Intelligence Lead

Review cadence

Review in the next regulatory intelligence cycle.

Policy change details

Document type
Procedural Guideline
Policy status
revised
Publication date
2026-08-19
Policy change
This procedural advice document for the centralised procedure has been updated to provide further guidance on pre-submission interactions and the required documentation for marketing authorisation applications (MAAs). It consolidates practical advice for applicants preparing to submit dossiers to the EMA.

Key changes

Updated guidance on pre-submission interaction requests and the inclusion of pharmacovigilance system summaries and Risk Management Plans (RMP) in the submission dossier. Refined timelines and procedural steps for the centralized marketing authorisation process.

Affected workflows

Country ComplianceLabeling

Responsible groups

Regulatory AffairsPharmacovigilance OperationsMAH

PV impact

MAHs and applicants must ensure that their PV system summary and RMP align with the latest procedural expectations outlined in this advice. PV operations and regulatory teams should review the updated interaction request forms and submission timelines to ensure timely and compliant MAA filings.

View regulator source

Source document details

Exact policy details

End of Irish language derogation
As of 1st January 2022
Applies to: Applicable to marketing authorisations addressed to marketing authorisation holders in Ireland.
A derogation expires concerning the status of Irish as a working language of the EU Institutions. · p. 1 · High · Source
Mandatory registration in OMS
As of 1st November 2021
Applies to: Applies to registration of new sites and organisations for centrally-authorised medicinal products.
The registration of new sites and organisations for centrally-authorised medicinal products in Organisation Management Service (OMS) will become mandatory prior to the associated regulatory submissions to the Agency. · p. 1 · High · Source
Pre-submission meeting timing
Approximately 7 months prior to anticipated submission date
Applies to: Applicable to applicants of the centralised procedure.
Pre-submission meetings...should take place approximately 7 months prior to the anticipated date of submission of the application. · p. 2 · High · Source

Workflow rule impacts

SubmissionMarketing Authorisation Holders

Delays in submissions if registration is not completed prior to pre- and post-authorisation submissions.

Mandatory registration in OMS prior to submissions

This would constitute a validation blocking issue. · p. 1 · High · Source
Pre-submission interactionsApplicants seeking authorisation

Facilitates guidance and regulatory advice to streamline the submission process.

Structured interactions during the pre-submission phase

This guidance information and fruitful pre-submission meetings should enable applicants to submit applications, which are in conformity with the legal and regulatory requirements. · p. 2 · High · Source

Extracted documents

Evidence and confidence

Confidence: highSource updated: Aug 19, 2026

Full briefing

Practical implication

Marketing Authorisation Holders (MAHs) and applicants must register new sites and organisations in the OMS before any regulatory submission and ensure alignment of their submission documents with the latest guidelines.

The EMA has updated its procedural advice for the centralised marketing authorisation process, detailing new requirements for pre-submission interactions and documentation, including pharmacovigilance system summaries and Risk Management Plans (RMPs). This includes mandatory registration in the Organisation Management Service (OMS) prior to regulatory submissions, which has been effective since November 1, 2021, and emphasizes the need for pre-submission meetings approximately seven months before application submission.

What changed: The procedural advice includes refined timelines and structured interactions for pre-submission activities, mandating that marketing authorisation holders ensure their pharmacovigilance system summaries and RMPs align with new procedural expectations.

Why it matters: Compliance with the updated procedural guidelines is crucial for ensuring timely and effective submissions, avoiding potential delays caused by incomplete registrations in the OMS, which can obstruct the regulatory process.

Practical implication: Marketing Authorisation Holders (MAHs) and applicants must register new sites and organisations in the OMS before any regulatory submission and ensure alignment of their submission documents with the latest guidelines.

View original source

Published from the Firecrawl policy change extraction pipeline.

#Safety Signals#European Medicines Agency (EMA)#European Union#Procedural Guideline#revised#Reporting Requirement#policy-change#firecrawl-policy-agent

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