Article 1

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

1. (1)

   ‘clinical trial’ means clinical trial as defined in point (a) of Article 2 of Directive 2001/20/EC;

2. (2)

   ‘sponsor’ means sponsor as defined in point (e) of Article 2 of Directive 2001/20/EC;

3. (3)

   ‘investigational medicinal product’ means investigational medicinal product as defined in point (d) of Article 2 of Directive 2001/20/EC;

4. (4)

   ‘medicinal product’ means medicinal product as defined in point 2 of Article 1 of Directive 2001/83/EC;

5. (5)

   ‘genetically modified organism’ or ‘GMO’ means genetically modified organism as defined in point (2) of Article 2 of Directive 2001/18/EC.