art_6__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

Immediately following the recognition of a major event in accordance with Article 4(3) of this Regulation, the MSSG shall consult the working party referred to in Article 3(6) of this Regulation. Immediately following that consultation, the MSSG shall adopt a list of medicinal products authorised in accordance with Directive 2001/83/EC or Regulation (EC) No 726/2004 which it considers to be critical during the major event (the ‘major event critical medicines list’).

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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.