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

The Agency may re­voke or sus­pend the au­thor­isa­tion gran­ted or make the con­tinu­ation of the clin­ic­al tri­al sub­ject to ad­di­tion­al con­di­tions, in par­tic­u­lar if:

a.

the safety or health of par­ti­cipants is at risk, par­tic­u­larly as a res­ult of in­ad­equate product safety or man­u­fac­tur­ing de­fects;

b.

the qual­ity of the data col­lec­ted is poor;

c.

the clin­ic­al tri­al is not con­duc­ted in ac­cord­ance with the ap­plic­a­tion doc­u­ments ap­proved by the Agency or by the eth­ics com­mit­tee;

d.

the au­thor­isa­tion and no­ti­fic­a­tion re­quire­ments have not been com­plied with.