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

¹ For the pur­poses of this Or­din­ance, clin­ic­al tri­als of gene ther­apy are tri­als in which ge­net­ic in­form­a­tion is in­tro­duced in­to so­mat­ic cells (so­mat­ic gene ther­apy).

² For the pur­poses of this Or­din­ance, clin­ic­al tri­als of ge­net­ic­ally mod­i­fied or­gan­isms are tri­als of medi­cin­al products con­tain­ing ge­net­ic­ally mod­i­fied or­gan­isms as defined in the Re­lease Or­din­ance of 10 Septem­ber 2008³⁰, and in par­tic­u­lar rep­lic­a­tion-com­pet­ent vir­uses.

³ For the pur­poses of this Or­din­ance, clin­ic­al tri­als of patho­gen­ic or­gan­isms are tri­als of medi­cin­al products con­tain­ing patho­gen­ic or­gan­isms as defined in the Re­lease Or­din­ance.

⁴ For clin­ic­al tri­als of gene ther­apy and for clin­ic­al tri­als of ge­net­ic­ally mod­i­fied or patho­gen­ic or­gan­isms, the pro­vi­sions of this Or­din­ance con­cern­ing clin­ic­al tri­als of medi­cin­al products ap­ply mu­tatis mutandis.