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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

(8) The COVID-19 pandemic has exacerbated the problem of shortages of certain medicinal products considered to be critical to addressing the pandemic, and has highlighted the Union’s external dependence in terms of domestic production of medicinal products and medical devices, the lack of coordination and the structural limitations in the Union’s and Member States’ ability to rapidly and effectively react to such challenges during public health emergencies. It has also highlighted the need to support and strengthen the industrial capacities to produce those medicinal products and medical devices through appropriate policies, as well as the need for more active and extensive involvement of the Union institutions, bodies, offices and agencies in protecting the health of Union citizens.

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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.