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

¹ The Agency shall ac­know­ledge re­ceipt of the ap­plic­a­tion with­in 7 days and no­ti­fy the spon­sor of any form­al de­fi­cien­cies in the ap­plic­a­tion doc­u­ments.

² It shall reach a de­cision with­in 30 days of ac­know­ledge­ment of re­ceipt of the form­ally cor­rect ap­plic­a­tion doc­u­ments.

³ If a medi­cin­al product or product un­der Art­icle 2a para­graph 2 TPA is to be used in per­sons for the first time or man­u­fac­tured in a new pro­cess, this dead­line may be ex­ten­ded by a max­im­um of 30 days. The Agency shall in­form the spon­sor of the ex­ten­ded dead­line.

⁴ If the Agency re­quests ad­di­tion­al in­form­a­tion in ac­cord­ance with Art­icle 31 para­graph 2, the clock shall be stopped un­til this in­form­a­tion has been re­ceived.

⁵ The Agency shall in­form the re­spons­ible eth­ics com­mit­tee and oth­er com­pet­ent can­ton­al au­thor­it­ies of its de­cision.