Når et virksomt stof hverken er beskrevet i Den Europæiske Farmakopé eller i en medlemsstats farmakopé, kan overensstemmelse med monografien for et tredjelands farmakopé accepteres, hvis dennes egnethed er godtgjort. I sådanne tilfælde skal ansøgeren indsende en kopi af monografien, eventuelt ledsaget af en oversættelse.
In cases where an active substance is described neither in the European Pharmacopoeia nor in the pharmacopoeia of a Member State, compliance with the monograph of a third country pharmacopoeia may be accepted if its suitability is demonstrated; in such cases, the applicant shall submit a copy of the monograph accompanied by a translation where appropriate.