Regulation (EU) 2022/123 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices: what it means for Pharmaceuticals & Life Sciences
The Regulation (EU) 2022/123 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices is part of the EU rulebook for pharmaceuticals & life sciences. Its subject matter covers medicinal products — core to the sector.
Regulation (EU) 2022/123 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices is on the Pharmaceuticals & Life Sciences rulebook because its official title matches medicinal products. Source: EUR-Lex and the European Parliament procedure file; company-specific applicability still depends on your activities.
What the act does
to reinforce the role of the European Medicines Agency (EMA) in crisis preparedness and management for medicinal products and medical devices. PROPOSED ACT: Regulation of the European Parliament and of the Council. ROLE OF THE EUROPEAN PARLIAMENT: the European Parliament decides in accordance with the ordinary legislative procedure and on an equal footing with the Council. BACKGROUND: the unprecedented experience of the COVID-19 pandemic has demonstrated that the EU’s ability to coordinate work to ensure the availability of medicinal products and medical devices and facilitate their development is currently…
Why it matters for Pharmaceuticals & Life Sciences
Pharmaceutical and life-sciences companies face EU rules on medicines authorisation, clinical trials and supply-chain integrity across the single market. These are the EU acts most likely to apply.
Regulation (EU) 2022/123 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices sits in that rulebook because its subject matter covers medicinal products. Whether — and how — it applies to a given business depends on that business’s activities, products and markets.
The rest of the Pharmaceuticals & Life Sciences rulebook
Every other EU file in scope for Pharmaceuticals & Life Sciences.
- Regulation (EU) 2023/1182 on specific rules relating to medicinal products for human use intended to be placed on the market in Northern Ireland32023R1182
- Regulation (EU) 2022/839 laying down transitional rules for the packaging and labelling of veterinary medicinal products authorised or registered in accordance with Directive 2001/82/EC or Regulation (EC) No 726/200432022R0839
- Regulation (EU) 2020/1043 on the conduct of clinical trials with and supply of medicinal products for human use containing or consisting of genetically modified organisms intended to treat or prevent coronavirus disease (COVID-19)32020R1043
Primary sources
The act’s summary is the European Parliament’s own procedure record; the sector connection is the act’s stated subject matter. Lex shows the law and the grounded connection — not legal advice. Data © European Union (Decision 2011/833/EU). Methodology.
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