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Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices (Text with EEA relevance) · European Union

Where the Agency considers that an actual or imminent major event needs to be addressed, it shall raise the issue of concern with the MSSG. Following a positive opinion of the MSSG, the Commission may recognise the major event. The Commission or at least one Member State may raise the issue of concern with the MSSG on its own initiative.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-06 · Text as adopted (Official Journal); later amendments are not incorporated in this text.