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

¹ The time lim­its spe­cified in Art­icle 23a para­graph 1, Art­icle 38 para­graph 2 third sen­tence, and Art­icle 65a para­graph 1 second sen­tence be­gin, for on­go­ing clin­ic­al tri­als ap­proved be­fore the Amend­ment of 7 June 2024 comes in­to force, when this Amend­ment comes in­to force; for clin­ic­al tri­als that have only one of two re­quired ap­provals pri­or to this Amend­ment com­ing in­to force, the time lim­it spe­cified in Art­icle 23 para­graph 1^bis and Art­icle 50 para­graph 1^bis be­gins when this Amend­ment comes in­to force.

² For on­go­ing clin­ic­al tri­als ap­proved be­fore the Amend­ment of 7 June 2024 comes in­to force, all the no­ti­fic­a­tion, re­port­ing and doc­u­ment­a­tion re­quire­ments spe­cified in Chapter 2 Sec­tion 5, Chapter 3 Sec­tion 4 and Chapter 4 Sec­tion 2 can be ful­filled un­der ex­ist­ing law up to a year after this Amend­ment comes in­to force.

³ For clin­ic­al tri­als ap­proved be­fore the Amend­ment of 7 June 2024 comes in­to force, the li­ab­il­ity, li­ab­il­ity cov­er­age and re­ten­tion re­quire­ments are gov­erned by ex­ist­ing law. If ap­prov­al for the clin­ic­al tri­al was gran­ted for a lim­ited peri­od, these re­quire­ments are gov­erned by the amended law when the ap­prov­al is re­newed.

⁴ If, after the Amend­ment of 7 June 2024 comes in­to force, an ap­proved clin­ic­al tri­al of medi­cin­al products, un­der the amended law, comes un­der a dif­fer­ent cat­egory in ac­cord­ance with Art­icle 19, then, for up to a year after the Amend­ment of 7 June 2024 comes in­to force, the spon­sor may ap­ply for an ad­just­ment of the cat­egory in the form of a sub­stan­tial modi­fic­a­tion. This ap­plic­a­tion must be sub­mit­ted first to Swiss­med­ic and then, after be­ing ap­proved, to the re­spons­ible eth­ics com­mit­tee.