Where appropriate monographs exist, if test procedures and limits other than those mentioned in the monographs of the European Pharmacopoeia, or failing this, in the pharmacopoeia of a Member State, are used, proof must be supplied 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 inarb ann do mhonagraif cheana féin, má bhaintear feidhm as nósanna imeachta tástála agus teorannacha seachas na cinn dá dtagraítear sna monagraif ábhartha de Pharmacopoeia Eorpach, nó ina éagmais sin, in pharmacopoeia de cheann de na Ballstáit, caithfear cruthú a sholáthar go gcomhlíonfadh an táirge críochnaithe, dá ndéanfaí é a thástáil i gcomhréir leis na monagraif sin, ceanglais cháilíochta pharmacopoeia sin don fhoirm chógaisíochta lena mbaineann.