Ordinance
on Clinical Trials
with the exception of
Clinical Trials of Medical Devices¹
(Clinical Trials Ordinance, ClinO)

¹ The FOPH may re­voke or sus­pend the au­thor­isa­tion gran­ted or make the con­tinu­ation of the clin­ic­al tri­al sub­ject to ad­di­tion­al con­di­tions, par­tic­u­larly if:

a.

it has reas­on to as­sume that the re­quire­ments are no longer met, the doc­u­ments spe­cified in Art­icle 54 have been changed without due no­ti­fic­a­tion hav­ing been made, or the tri­al is not be­ing con­duc­ted in ac­cord­ance with these doc­u­ments;

b.

such meas­ures are ne­ces­sit­ated by new in­form­a­tion con­cern­ing safety or the sci­entif­ic basis.

² For the co­ordin­a­tion of meas­ures and the ex­change of in­form­a­tion between the FOPH, the re­spons­ible eth­ics com­mit­tee and oth­er com­pet­ent can­ton­al au­thor­it­ies, Art­icle 48 ap­plies mu­tatis mutandis.