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 or products un­der Art­icle 2a para­graph 2 TPA cap­able of emit­ting ion­ising ra­di­ation, the doc­u­ments spe­cified in An­nex 4 num­ber 5 must ad­di­tion­ally be sub­mit­ted to the Agency.

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

³ The Agency shall grant au­thor­isa­tion if:

a.

the re­quire­ments covered by Art­icle 32 are met; and

b.

the FOPH has raised no ob­jec­tions to the clin­ic­al tri­al.

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

⁵ In the case of Cat­egory C clin­ic­al tri­als, it shall trans­mit to the FOPH dir­ectly after re­ceipt:

a.

the fi­nal re­port spe­cified in Art­icle 38 para­graph 3 in­clud­ing all in­form­a­tion of rel­ev­ance for ra­di­olo­gic­al pro­tec­tion, and in par­tic­u­lar a ret­ro­spect­ive par­ti­cipant dose es­tim­a­tion, un­less stip­u­la­tions to the con­trary have been made by the FOPH;

b.

the re­ports spe­cified in Art­icle 41 para­graph 2 and Art­icle 42 para­graph 1.