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

¹ Clin­ic­al tri­als of medi­cin­al products come un­der Cat­egory A if the medi­cin­al product is au­thor­ised in Switzer­land and its use:

a.

is in ac­cord­ance with the pre­scrib­ing in­form­a­tion;

b.

is in an in­dic­a­tion or dosage dif­fer­ent from that spe­cified in the pre­scrib­ing in­form­a­tion, but in ac­cord­ance with the fol­low­ing cri­ter­ia:

1.

the in­dic­a­tion is with­in the same dis­ease group of the In­ter­na­tion­al Clas­si­fic­a­tion of Dis­eases (ICD), as spe­cified in An­nex 1 num­ber 3,

2.

the dis­ease in ques­tion is self-lim­it­ing and the dosage of the medi­cin­al product is lower than that spe­cified in the pre­scrib­ing in­form­a­tion; or

c.

is re­cog­nised as stand­ard in guidelines pre­pared in ac­cord­ance with in­ter­na­tion­ally ac­cep­ted qual­ity cri­ter­ia.

² Clin­ic­al tri­als of medi­cin­al products come un­der Cat­egory B if the medi­cin­al product:

a.

is au­thor­ised in Switzer­land; and

b.

is not used as spe­cified in para­graph 1.

³ They come un­der Cat­egory C if the medi­cin­al product is not au­thor­ised in Switzer­land.

⁴ In jus­ti­fied cases, a clin­ic­al tri­al of a medi­cin­al product au­thor­ised in Switzer­land may be as­signed to a dif­fer­ent cat­egory if this is pos­sible or ne­ces­sary with re­gard to medi­cin­al product safety or pro­tec­tion of the par­ti­cipants’ safety and health.