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:
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: