In the absence of a European Pharmacopoeia monograph for an active substance, and where the active substance is described in the pharmacopoeia of a Member State, that monograph may be applied.
I gcás nach bhfuil monagraf in Pharmacopoeia Eorpach don tsubstaint ghníomhach sin, agus i gcás ina bhfuil cur síos ar an tsubstaint ghníomhach sin in pharmacopoeia de cheann de na Ballstáit, féadfar an monagraf sin a chur i bhfeidhm.