7/8 May 2024
The European Medicines Agency (EMA) published two updated documents on the United Kingdom's (U.K.) withdrawal from the European Union (EU, the so called Brexit:
1. Questions and Answers Document (Rev 03, published on 19 June 2018)
2. Practical guidance for procedures related to Brexit (Rev 02 2, EMA/478309/2017, published on 19 June 2018)
This list of Q&As has initially been drafted jointly by the Directorate-General for Health and Food Safety of the European Commission and EMA. This reversion now amends the initial list of Q&As published on 31 May 2017 replacing all previous versions of Q&As. The new text introduced in this document is indicated by the word "NEW". So what is "NEW"? EMA has added seven new Q&As and amended earlier answers:
Questions (and answers) have been added with respect to:
The Practical Guidance document complements the Q&As to provide procedural and practical guidance regarding submission of changes and related fees. New questions and headings amend the following topics: