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Brexit preparedness: EMA to further temporarily scale back and suspend activities

Brexit preparedness: EMA to further temporarily scale back and suspend activities

The European Medicines Agency entered into the phase 3 of its business continuity plan(BCP) on 1 October 2018. This allows the Agency to safeguard core activities related to the evaluation and supervision of medicines, while it has to intensify its preparations for the physical move to Amsterdam in March 2019 and cope with significant staff loss.

The temporary cuts in activities are required because the Agency will lose more staff than initially anticipated. EMA expects a staff loss of about 30%.

EMA has put in place supporting measures to facilitate the relocation of staff to Amsterdam and a comprehensive staff recruitment programme is already underway. However, in the short- to mid-term EMA will have to reprioritise its resources.In phase 3 EMA will start to temporarily scale back or suspend additional activities through to 2019. Activities initially impacted by phase 3 include:

  • Collaboration at international level, which will be temporarily scaled back to focus primarily on product-related requests, supply-chain integrity and procedures under Article 58; in other areas, such as the harmonisation of global medicine regulation, EMA will only take a reactive role;
  • Development and revision of guidelines, which will be temporarily limited to those guidelines that address an urgent public/animal health need or are necessary to support and facilitate preparations for Brexit;
  • Holding of non-product-related working parties;
  • Programmes and projects, where activities in relation to project governance;
  • Organisation and attendance at stakeholder meetings, which will be limited to Brexit-related interactions;
  • Clinical data publication, for which the launch of new procedures will be temporarily suspended as of 1 August 2018.

The Agency anticipates that phase 3 will have to be complemented with additional temporary suspensions/reductions as of 1 January 2019, which will be launched as part of phase 4 of the BCP, in order to put in place the necessary arrangements for the physical move to the Netherlands.

Source: News and Press releases EMA

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