# The Medicines (Products for Human Use) (Fees) Regulations 2016, 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.

---
Source: https://www.legislation.gov.uk/uksi/2016/190/regulation/24 (the official version)
Page: https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/regulation-24
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.