Ordinance
on Good Laboratory Practice
(OGLP)

English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.

of 18 May 2005 (Status as of 1 December 2012)


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Art. 16 Notification in cases of serious non-compliance with GLP Principles

1 If in the course of an in­spec­tion, the com­pet­ent au­thor­ity as­cer­tains that a test fa­cil­ity fails to com­ply with GLP Prin­ciples to the ex­tent that the re­li­ab­il­ity of study res­ults is no longer guar­an­teed, and that in con­sequence these res­ults may gen­er­ate er­ro­neous con­clu­sions re­lat­ing to hu­man and en­vir­on­ment­al safety, it must im­me­di­ately in­form the no­ti­fic­a­tion au­thor­ity.

2 The no­ti­fic­a­tion au­thor­ity must in­form the fed­er­al ex­ec­ut­ive au­thor­it­ies re­spons­ible for eval­u­at­ing no­ti­fic­a­tions or au­thor­isa­tions for sub­stances and pre­par­a­tions.

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