27.06.2018

Brexit: Two new Documents published by EMA

Recommendation

5/6 October 2023
Heidelberg, Germany

Quality Culture
People Empowerment in GMP

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:

Official Control Authority Batch Release (OCABR) processes (currently tested by a UK Official Medicines Control Laboratory)
Influence on the status of inspection outcomes by the UK competent authority?
Influence on the CE certification of medical devices
Impact o the CHMP scientific opinion for ancillary medicinal substances in medical devices
Impact on the possibility to market multi-country packs
Back-up arrangements in the UK for Qualified Persons for Pharmacovigilance (QPPV)

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: