Brexit: Two new Documents published by EMA

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:

  • Variations
  • Transfer of orphan designation
  • QPPV and the pharmacovigilance system
  • Ongoing initial marketing authorisation procedures
  • CHMP scientific opinion under Article 58
  • Paediatric investigation plans and waivers
  • Contact point at the EMA
  • Impact on Rapporteurships
  • Product Information
  • Official Control Authority Batch Release
  • National scientific advice issued by UK authorities

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