Ordinance
on Good Laboratory Practice
(OGLP)

¹ For any study that must be car­ried out ac­cord­ing to the prin­ciples of GLP, it is ne­ces­sary in the pro­ced­ure of no­ti­fic­a­tion or au­thor­isa­tion:

to show that the study was car­ried out in a test fa­cil­ity re­gistered, at the time when the study was car­ried out, in the Swiss re­gister of test fa­cil­it­ies that com­ply with the prin­ciples of GLP;

to present a study re­port in which the study dir­ect­or con­firms, in one of the Swiss na­tion­al lan­guages or in Eng­lish, that the study was car­ried out in com­pli­ance with the prin­ciples of GLP.

² If the study was car­ried out in a coun­try oth­er than Switzer­land, in ad­di­tion to the study re­port, an ex­tract from the for­eign re­gister or a con­firm­a­tion from the for­eign au­thor­ity must be sub­mit­ted prov­ing that the test fa­cil­ity was in­cluded in the of­fi­cial mon­it­or­ing pro­gramme at the time the study was car­ried out. In the case of coun­tries that are not mem­bers of the Or­gan­isa­tion for Eco­nom­ic Co-op­er­a­tion and De­vel­op­ment (OECD), the no­ti­fic­a­tion au­thor­ity may re­quest oth­er doc­u­ments that it con­siders ne­ces­sary to eval­u­ate com­pli­ance with the prin­ciples of GLP.

³ If jus­ti­fied by the cir­cum­stances, and in par­tic­u­lar if the res­ults of the study are very im­port­ant, or if there is doubt wheth­er the prin­ciples of GLP have been re­spec­ted, a fed­er­al ex­ec­ut­ive au­thor­ity may ask the no­ti­fic­a­tion au­thor­ity to have a study audit car­ried out.