Regulation (EU) 2022/123 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices: ce que cela signifie pour Pharmaceuticals & Life Sciences

Ce que fait l'acte

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...

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Pourquoi cela compte pour 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.

Lex publie la connexion source entre le texte officiel et le secteur; l'impact précis dépend de l'entreprise, de ses produits et de ses marchés.

Autres textes dans le corpus 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