3. — Regulation (EU) 2022/123 of the European Parliament and of the Council of 25…

3.

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 a request from one or more Member States, or the Commission, the ETF shall provide recommendations to the CHMP for an opinion in accordance with paragraph 4 on: the compassionate use of medicinal products falling under the scope of Directive 2001/83/EC or Regulation (EC) No 726/2004; or the use and distribution of an unauthorised medicinal product in accordance with Article 5(2) of Directive 2001/83/EC.

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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.