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

of 20 September 2013 (Status as of 26 May 2022)

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


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Art. 54 Authorisation procedure

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

2 The FOPH may re­quest ad­di­tion­al in­form­a­tion.

3 For the pro­ced­ure and dead­lines, Art­icle 33 ap­plies mu­tatis mutandis.

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