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:

a.

the in­vest­ig­a­tion­al medi­cin­al product is a medi­cin­al product au­thor­ised in Switzer­land;

b.

the in­vest­ig­a­tion­al medi­cin­al product has not been mod­i­fied; and

c.

the use of the in­vest­ig­a­tion­al medi­cin­al product:

1.

is in ac­cord­ance with the pre­scrib­ing in­form­a­tion,

2.

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

–

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

–

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

3.

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

² They come un­der Cat­egory B if the in­vest­ig­a­tion­al medi­cin­al product:

a.

is a medi­cin­al product au­thor­ised in Switzer­land, which:

1.

is not used as spe­cified in para­graph 1 let­ter c, or

2.

has un­der­gone a low-risk modi­fic­a­tion, as spe­cified in An­nex 2^bis;

b.

is a medi­cin­al product au­thor­ised in a coun­try that has equi­val­ent medi­cin­al product con­trol in ac­cord­ance with Art­icle 13 TPA and has either not been mod­i­fied or has un­der­gone a low-risk modi­fic­a­tion, as spe­cified in An­nex 2^bis; or

c.

is a placebo spe­cific­ally man­u­fac­tured for clin­ic­al tri­als.

³ They come un­der Cat­egory C if the in­vest­ig­a­tion­al medi­cin­al product con­tains an act­ive sub­stance and:

a.

is a medi­cin­al product au­thor­ised in Switzer­land or in a coun­try that has equi­val­ent medi­cin­al product con­trol in ac­cord­ance with Art­icle 13 TPA and has un­der­gone more than a low-risk modi­fic­a­tion, as spe­cified in An­nex 2^bis; or

b.

is a medi­cin­al product au­thor­ised neither in Switzer­land nor in a coun­try that has equi­val­ent medi­cin­al product con­trol in ac­cord­ance with Art­icle 13 TPA.

⁴ If a clin­ic­al tri­al comes un­der more than one cat­egory, it is as­signed to the highest of these cat­egor­ies; the cat­egor­ies are ar­ranged in as­cend­ing or­der from A to C.