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

6.

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

In the preparation of its recommendations provided pursuant to paragraphs 3, the ETF may consult the Member State concerned and request it to provide any available information or data that the Member State used for its decision to make the medicinal product available for compassionate use. Following such a request, the Member State shall provide all of the requested information and data.

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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.