lexiara

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

By 31 December 2026, and every fourth year thereafter, the Commission shall present a report to the European Parliament and the Council on the application of this Regulation. In particular, that report shall review: the crisis preparedness and management framework for medicinal products and medical devices, including the outcomes of periodic stress tests; instances of non-compliance with the obligations set out in Articles 10 and 26 by marketing authorisation holders, manufacturers of medical devices, authorised representatives, importers, distributors and notified bodies; the remit and functioning of the ESMP.

· All articles ·

Source: EUR-Lex (Cellar) · retrieved 2026-11-06 · Text as adopted (Official Journal); later amendments are not incorporated in this text.