art_4__para_2__text_1

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

To facilitate the monitoring referred to in paragraph 1, the national competent authorities for medicinal products, acting through the single points of contact referred to in Article 3(6), or the platform referred to in Article 13 (the ‘ESMP’), once it is fully functional, shall report in a timely manner to the Agency on any event that is likely to lead to a public health emergency or major event, including an actual or potential shortage of a medicinal product in a given Member State. Such reporting shall be based on the reporting methods and criteria pursuant to Article 9(1), point (b).

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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.