This Regulation applies to inspections of:

1. (a)

   clinical trials conducted in the Union, including clinical trial sites related to those trials but located outside the Union;

2. (b)

   clinical trials referred to in the applications for clinical trial authorisations pursuant to Article 25(5) of Regulation (EU) No 536/2014;

3. (c)

   clinical trials conducted in third countries and referred to in marketing authorisation applications in the Union.