The marketing authorisation shall be refused if, after verification of the particulars and documents listed in Articles 8, 10, 10a, 10b and 10c, it is clear that:
Dovoljenje za promet z zdravilom se zavrne, če se po preverjanju podrobnih podatkov in dokumentov, navedenih v členih 8, 10, 10a, 10b in 10c dokaže, da: