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

5.

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

The reporting referred to in paragraph 4, point (b): shall include the information referred to in Article 23a of the Directive 2001/83/EC that was reported to national competent authorities for medicinal products for authorisations granted in accordance with that Directive; may include additional information received from marketing authorisation holders, wholesale distributors and other persons or legal entities that are authorised or entitled to supply medicinal products to the public.

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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.