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 gene ther­apy and for clin­ic­al tri­als of ge­net­ic­ally mod­i­fied or patho­gen­ic or­gan­isms as defined in Art­icle 22, the doc­u­ments spe­cified in An­nex 4 num­ber 4 must be sub­mit­ted to the Agency.

² Be­fore grant­ing au­thor­isa­tion, the Agency shall seek opin­ions from the Swiss Ex­pert Com­mit­tee for Biosafety (SECB), the Fed­er­al Of­fice for the En­vir­on­ment (FOEN) and the FOPH.

³ In ad­di­tion to the areas spe­cified in Art­icle 32, it shall re­view wheth­er the qual­ity and bio­lo­gic­al safety of the product are guar­an­teed with re­gard to the par­ti­cipants and to hu­man health and the en­vir­on­ment.

⁴ It shall grant au­thor­isa­tion if:

a.

the SECB has con­firmed the qual­ity and bio­lo­gic­al safety of the product with re­gard to the par­ti­cipants and to hu­man health and the en­vir­on­ment; and

b.

no ob­jec­tions to the clin­ic­al tri­al have been raised by the FOPH or by the FOEN, based on the as­sess­ment of the en­vir­on­ment­al data.

⁵ The Agency shall grant au­thor­isa­tion with­in 60 days of ac­know­ledge­ment of re­ceipt of the form­ally cor­rect ap­plic­a­tion doc­u­ments. The Agency shall in­form the com­pet­ent fed­er­al and can­ton­al au­thor­it­ies of its de­cision.

⁶ Au­thor­isa­tions shall re­main val­id for the dur­a­tion of the clin­ic­al tri­al, but for no longer than five years after they are gran­ted.

⁷ The Agency, the FOPH and the FOEN shall jointly is­sue guidelines on as­sess­ment of risks to hu­man health and the en­vir­on­ment.