(a)

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

marketing authorisation holders shall use the ESMP to report to the Agency: the information referred to in Article 13(4) of Regulation (EC) No 726/2004 for authorisations granted in accordance with that Regulation; information based on the categories set out in Article 9(3) that relate to actual or potential shortages of medicinal products that are likely to lead to a public health emergency or major event, where appropriate;

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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.