Navitas Life Sciences

Brexit and Pharmacovigilance – where may pharmaceutical companies go?

In this white paper, our Head of Pharmacovigilance and QPPV, Dr. Philipp Hofmann, MD, explores the potential impact of Brexit to Pharmacovigilance in both the UK and the EU. With some 45 million patient packs going to the EU from the UK every month, and a further 37 million patient packs moving from the EU to the UK, just what may happen should medicinal products suddenly to be available owing to Brexit? The paper addresses the following:

  • Hard Brexit was not to be
  • The current situation: Soft Brexit
  • Consequences for Marketing Authorizations
  • Submission of ICSRs and Aggregate Reports
  • Signals and Safety Management
  • RMPs
  • PSMF
  • EU QPPV and UK QPPV
  • What are the most likely next steps?

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Published in Pharma Focus Asia | Issue 42 | 2021 | pages 24 - 27

Pharma Focus Asia

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