Where a finished product requires reconstitution or dilution prior to administration, details of the proposed shelf life and specification for the reconstituted/diluted product are required, supported by relevant stability data.
I gcás ina n-éilíonn táirge críochnaithe athbhunú nó caolú sula dtugtar d’ainmhí an táirge sin, is gá sonraí maidir le seilfré mholta agus sonraíocht don táirge athbhunaithe/caolaithe a sholáthar, tacaithe ag na sonraí cobhsaíochta ábhartha.