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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) figure dans le corpus Pharmaceuticals & Life Sciences parce que son titre officiel correspond à medicinal products et clinical trials. Source: EUR-Lex et dossier du Parlement européen; l'applicabilité à une entreprise dépend de ses activités. Methodology

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): ce que cela signifie pour Pharmaceuticals & Life Sciences

Cette page explique en français pourquoi 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) est lié à Pharmaceuticals & Life Sciences. La correspondance est fondée sur les termes officiels medicinal products et clinical trials; elle n'est pas un avis juridique.

Acte
32020R1043
Type
règlement
Étape
Procedure completed
Date
15 juillet 2020
Procédure
2020/0128(COD)

Ce que fait l'acte

to provide a temporary derogation from EU legislation on GMOs in order to avoid delays in the conduct of clinical trials with investigational medicinal products containing or consisting of GMOs intended to treat or prevent COVID-19. 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: EU legislation requires that applications for marketing authorisation for a medicinal product, in a Member State or in the Union, be...

Lire la fiche complète 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) →

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.

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Sources primaires

Données © Union européenne. Méthodologie.