Regulation 24 Meaning of “set of proposed changes”
For the purposes of this Part and Part 5 of Schedule 2, a “set of proposed changes” means a number of proposed changes to the labelling or package leaflet of a medicinal product, where—
(a)
if there is more than one version of the labelling or package leaflet for that product, those changes all relate to the same version; and
(b)
those changes are submitted to the licensing authority at the same time.