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

¹ For Cat­egory B and C clin­ic­al tri­als of medi­cin­al products cap­able of emit­ting ion­ising ra­di­ation, the doc­u­ments spe­cified in An­nex 4 num­ber 5 must ad­di­tion­ally be sub­mit­ted to Swiss­med­ic.⁷⁸

² In the case of Cat­egory C clin­ic­al tri­als, Swiss­med­ic shall seek an opin­ion from the FOPH be­fore grant­ing ap­prov­al. The FOPH shall re­view com­pli­ance with ra­di­olo­gic­al pro­tec­tion le­gis­la­tion and the dose es­tim­a­tion.⁷⁹

³ Swiss­med­ic shall grant ap­prov­al if:

a.

the re­quire­ments covered by Art­icle 32 are met; and

b.

the FOPH has raised no ob­jec­tions to the clin­ic­al tri­al.

⁴ Swiss­med­ic shall reach a de­cision on Cat­egory C clin­ic­al tri­als with­in 60 days of ac­know­ledge­ment of re­ceipt of the form­ally cor­rect ap­plic­a­tion doc­u­ments. Swiss­med­ic shall in­form the FOPH of its de­cision.

⁵ …⁸⁰