This list of Questions and Answers (Q&As) complements the Notice to marketing authorisation holders of centrally authorised medicines products for human and veterinary use, which was updated on 23 January 2018.
This list of Q&As has been drafted jointly by the Directorate-General for Health and Food Safety of the European Commission and EMA. This version is an update of the initial list of Q&As published on 31 May 2017 as subsequently amended and it replaces all previous versions of Q&As. The new text introduced in this version of Q&As “Rev 03” published on 19 June 2018 is indicated by the word “NEW”. The Q&As may be further updated and complemented in the future. The advice below applies equally to medicinal products for human or veterinary use, unless otherwise indicated in the heading to the question.