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. 46 Agency inspections

1 The Agency is en­titled to in­spect all clin­ic­al tri­als of medi­cin­al products, products un­der Art­icle 2a para­graph 2 TPA or trans­plant products.

2 If the Agency car­ries out in­spec­tions, it shall in­form in ad­vance the re­spons­ible eth­ics com­mit­tee and oth­er com­pet­ent can­ton­al and fed­er­al au­thor­it­ies. They may par­ti­cip­ate in the in­spec­tion.

3 The Agency’s powers are gov­erned by Art­icle 62 of the Medi­cin­al Products Au­thor­isa­tion Or­din­ance of 14 Novem­ber 201843.

4 The Agency may ad­di­tion­ally carry out in­spec­tions abroad at the spon­sor’s ex­pense, if this is ne­ces­sary to as­sess the clin­ic­al tri­al con­duc­ted in Switzer­land. The spon­sor must be in­formed in ad­vance.

5 The Agency shall in­form the re­spons­ible eth­ics com­mit­tee and oth­er com­pet­ent can­ton­al and fed­er­al au­thor­it­ies of the res­ults of the in­spec­tion.

43 SR 812.212.1. The ref­er­ence has been amended on 1 Jan. 2019 pur­su­ant to Art. 12 para. 2 of the Pub­lic­a­tions Act of 18 June 2004 (SR 170.512).

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