What 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 requires
This Regulation reinforces the role of the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices (Article 1). It establishes the Executive Steering Group on Shortages and Safety of Medicinal Products (Article 3), provides for monitoring of events and preparedness for public health emergencies and major events (Article 4), the evaluation of information and recommendations (Article 5), the drawing up of lists of critical medicinal products (Article 6), and the monitoring and reporting of shortages of critical medicines (Articles 7 and 8).
Pillar: Pharmaceuticals & Life Sciences · Authority: European Parliament and Council of the European Union · Version: 1.0.0 · Last updated:
Primary source: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32022R0123
SHA-256 integrity: f9f911373e9ce9676c67ae1cd27b7eec0b1f2c26aed88ef848ec0185da72010b
Primary Citations — 5 traced to source
- Regulation (EU) 2022/123, Article 3 - Executive Steering Group on Shortages and Safety of Medicinal Products
- Regulation (EU) 2022/123, Article 4 - Monitoring of events and preparedness
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