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

1 Amended by Annex 2 No 2 of the O of 1 July 2020 on Clinical Trials of Medical Devices, in force since 26 May 2021 (AS 2020 3033).


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Art. 31 Application

1 The spon­sor shall sub­mit to Swiss­med­ic the ap­plic­a­tion doc­u­ments spe­cified in An­nex 4 for re­view.

1bis Swiss­med­ic may pre­pare a list of spe­cif­ic doc­u­ments in ac­cord­ance with the con­tent of An­nex 4 that are re­quired for sub­mis­sion of the ap­plic­a­tion.71

2 Swiss­med­ic may re­quest ad­di­tion­al in­form­a­tion.

71 In­ser­ted by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 322).

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