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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

Following the recognition of a public health emergency or the recognition of a major event in accordance with Article 4(3), the Agency shall: establish a list of single points of contact for the marketing authorisation holders for the medicinal products included on the critical medicines lists; maintain the list of single points of contact referred to in point (a) for the duration of the public health emergency or major event; request relevant information on medicinal products on the critical medicines lists from the single points of contact referred to in point (a) and set a deadline for the submission of that information, if that information is not available in the ESMP; request information on medicinal products on the critical medicines lists from the single points of contact referred to in Article 3(6) on the basis of the set of information referred to in Article 6(4), and set a deadline for the submission of that information, if that information is not available in the ESMP.

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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.