(b)

Regulation (EU) 2022/2371 of the European Parliament and of the Council of 23 November 2022 on serious cross-border threats to health and repealing Decision No 1082/2013/EU (Text with EEA relevance) · European Union

the European Medicines Agency (EMA), in accordance with Article 1 of Regulation (EU) 2022/123 of the European Parliament and of the Council (37), where the serious cross-border threat to health is linked to medicinal products and medical devices;

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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.