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

¹ Sig­ni­fic­ant changes to an au­thor­ised clin­ic­al tri­al must be au­thor­ised by the Agency be­fore be­ing im­ple­men­ted. Ex­empt from this re­quire­ment are meas­ures which have to be taken im­me­di­ately in or­der to pro­tect the par­ti­cipants.

² The spon­sor must sub­mit to the Agency any ap­plic­a­tion doc­u­ments spe­cified in An­nex 4 which are af­fected by the change. At the same time, the spon­sor shall provide in­form­a­tion on the reas­ons for the change.

³ The fol­low­ing are con­sidered to be sig­ni­fic­ant changes:

a.

changes to the medi­cin­al product or product un­der Art­icle 2a para­graph 2 TPA, or to its ad­min­is­tra­tion or use;

b.

changes based on new pre­clin­ic­al or clin­ic­al data which may af­fect product safety; or

c.

changes con­cern­ing the pro­duc­tion of the medi­cin­al product or product un­der Art­icle 2a para­graph 2 TPA which may af­fect product safety.

⁴ The Agency shall reach a de­cision with­in 30 days after re­ceipt of the com­plete ap­plic­a­tion doc­u­ments af­fected by the change. Art­icle 33 ap­plies mu­tatis mutandis.

⁵ Oth­er changes which af­fect the doc­u­ments sub­mit­ted to the Agency must be no­ti­fied to the Agency as quickly as pos­sible.