Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (Text with EEA relevance) (c. 6)

CHAPTER IV U.K. POST-MARKETING AUTHORISATION MEASURES

Section 3 U.K. Changes to the terms of the marketing authorisations

Article 63 U.K. Consequential changes to product information

Where a variation entails consequential changes to the summary of the product characteristics, the labelling or the package leaflet, those changes shall be considered as part of that variation for the purposes of the examination of the application for a variation.