9 February 2022 – The regulation reinforcing EMA`s role in crisis preparedness and management for medicinal products and medical devices has been published in the Official Journal of the EU on 31 January 2022. This officially concludes the legislative process for an important pillar of the European Health Union. The new regulation enters into force on the day following the publication and becomes applicable as of 1 March 2022, except for the provisions on shortages of critical medical devices which will apply as of 2 February 2023. It puts structures and processes established by EMA during the COVID-19 pandemic on a permanent footing, while entrusting several new tasks to the Agency.

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