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EMA Brexit Preparedness Update: Progress, Structure, and Actions

This update highlights the progress made by EMA in its Brexit preparedness, including the establishment of the ORP Task Force, development of impact assessments and staff retention measures.

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EMA Brexit Preparedness Update: Progress, Structure, and Actions

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  1. Update on EMA Brexit preparedness Industry stakeholder meeting 13 October 2017 Presented by Anthony Humphreys

  2. EMA preparedness following the outcome of the UK referendum: Initial steps taken • Internal task force (Operation and Relocation Preparedness (ORP) Task Force) established on 24 June 2016 • Mandate: to deal with the Agency's preparedness for any possible scenario following the UK referendum on EU membership and the UK’s exit from the EU • 4 Workstreams: • Relocation preparedness • Operational and financial preparedness • HR related matters • Communication actions Update on EMA Brexit preparedness

  3. ORP structure and decision-making Update on EMA Brexit preparedness

  4. Status report on EMA preparedness • Important progress over past months in several areas: • Finalisation of 1st draft of impact assessment • Development of dedicated EMA Brexit Preparedness BCP and launch of phase 1 • EMA technical input into EC assessment of the MSs’ bids for relocating EMA • Linking EMA Brexit Preparedness BCP with outcome of EMA staff survey and the staff retention scenarios, including anticipated impact on the operation of EMA and the wider impact on public and animal health in the EU • Addressing the loss of UK expertise to be covered by the 27 MSs • Developing EMA staff retention support measures • Developing guidance for pharmaceutical industry Update on EMA Brexit preparedness

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