'If general monographs on pharmaceutical forms appear in the European Pharmacopoeia or, failing this, in the national pharmacopoeias of the Member States, finished products must meet the requirements contained therein.
Se nella farmacopea europea o, in mancanza, in quella nazionale degli Stati membri figurano monografie generali sulle forme medicinali, i prodotti finiti debbono soddisfare i requisiti ivi precisati.