Practical implication
Companies must ensure compliance with the Irish language requirements and complete mandatory OMS registration before regulatory submissions to prevent delays.
The European Medicines Agency (EMA) released updated procedural guidelines for users of the centralised procedure, emphasizing important changes regarding the Irish language and mandatory registrations.
What changed: The ending of the Irish language derogation effective January 1, 2022, and mandatory registration for Organisation Management Service (OMS) prior to regulatory submissions effective November 1, 2021.
Why it matters: These changes are critical for compliance by marketing authorisation holders and may affect submission timelines and requirements, especially in relation to the use of Irish in official documents.
Practical implication: Companies must ensure compliance with the Irish language requirements and complete mandatory OMS registration before regulatory submissions to prevent delays.
View original source
- Source: EMA - Regulatory and procedural guidelines RSS
- Published at source: 2026-09-02T00:00:00.000Z
- Discovered by monitor: 2026-09-02T21:39:18.400Z
Published from the regulator source ingestion pipeline after PV impact triage.
