(16) Authorisations procedures are based on the principle that it is for the applicant to prove that the subject matter of an authorisation procedure complies with Union safety requirements given the scientific knowledge in its possession.
16) leidimo suteikimo procedūros grindžiamos principu, kad būtent pareiškėjas turi įrodyti, kad remiantis turimomis mokslo žiniomis leidimo suteikimo procedūros dalykas atitinka Sąjungos saugos reikalavimus.