If test procedures and limits other than those mentioned in the relevant monographs and general chapters of the European Pharmacopoeia, or failing this, in the pharmacopoeia of a Member State are used, this shall be justified by providing proof that the finished product would, if tested in accordance with those monographs, meet the quality requirements of that pharmacopoeia for the pharmaceutical form concerned.
I gcás ina n-úsáidtear nósanna imeachta tástála seachas na cinn dá dtagraítear sna monagraif ábhartha agus sna caibidlí ginearálta de Pharmacopoeia Eorpach, nó ina éagmais sin, in pharmacopoeia de cheann de na Ballstáit, tabharfar údar cuí leis sin trí fhaisnéis a sholáthar go gcomhlíonfadh an táirge críochnaithe, dá ndéanfaí é a thástáil i gcomhréir leis na monagraif sin, cheanglais cháilíochta de pharmacopoeia sin don fhoirm chógaisíochta lena mbaineann.