Legislation – Regulation (EU) 2020/1043 of the European Parliament and of the Council of 15 July 2020 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) (Text with EEA relevance)

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Article 1

For the purposes of this Regulation, the following definitions apply:

(1)
‘clinical trial’ means clinical trial as defined in point (a) of Article 2 of Directive 2001/20/EC;
(2)
‘sponsor’ means sponsor as defined in point (e) of Article 2 of Directive 2001/20/EC;
(3)
‘investigational medicinal product’ means investigational medicinal product as defined in point (d) of Article 2 of Directive 2001/20/EC;
(4)
‘medicinal product’ means medicinal product as defined in point 2 of Article 1 of Directive 2001/83/EC;
(5)
‘genetically modified organism’ or ‘GMO’ means genetically modified organism as defined in point (2) of Article 2 of Directive 2001/18/EC.