PART 6 U.K.Capital Fees for Assessment of Labels and Leaflets

Meaning of “set of proposed changes”U.K.

24.  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.