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): what it means for Pharmaceuticals & Life Sciences

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…

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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) 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) sits in that rulebook because its subject matter covers medicinal products and clinical trials. Whether — and how — it applies to a given business depends on that business’s activities, products and markets.

• 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) 2022/123 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices32022R0123

See all EU regulation for Pharmaceuticals & Life Sciences →

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.