In the case of new combinations of known substances which have been investigated in accordance with the provisions of this Directive, pharmacokinetic studies of the fixed combination are not required if it can be justified that the administration of the active substances as a fixed combination does not change their pharmacokinetic properties.
I gcás meascán nua ar substaintí aitheanta iad a ndearnadh imscrúdú orthu i gcomhréir le forálacha na Treorach seo, níl gá le staidéir chógaschinéiteacha de chuid an teaglaim sheasta más féidir údar a thabhairt le go ndéanfadh tabhairt na substaintí gníomhacha a n-airíonna cógaschinéiteacha a athrú.