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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) article 1 CELEX: 02022R0123-20250101 Subject Matter
Within the European Medicines Agency (the ‘Agency’),this Regulation provides for a framework for and the means of: (a) preparing for, preventing, coordinating and managing the impact of public health emergencies on medicinal products and on medical devices and the impact of major events on medicinal products at Union level; (b) monitoring, preventing, and reporting on shortages of medicinal products and on shortages of medical devices; (c) setting up an interoperable information technology (IT) platform at Union level to monitor and report on shortages of medicinal products; (d) providing advice on medicinal products that have the potential to address public health emergencies; (e) providing support for the expert panels provided for in Article 106(1) of Regulation (EU) 2017/745. |