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News about GMP/cGMP

2017-10-18

EMA publishes Brexit Preparedness Plan

On 16 October 2017, the EMA (European Medicines Agency) has published its 17-page Business Preparedness Plan to ensure continuity of the Agency’s operations once the United Kingdom is no longer a member country of the European Union.

The plan identifies three main priorities:

  • Not to jeopardise EMA’s positioning in the pharmaceutical arena in the post-Brexit era.
  • In parallel, to demonstrate its preparedness for addressing any emerging consequences by taking decisive and timely action when needed.
  • To provide a balanced communication and full transparency, both internally and externally.
 

There are many uncertainties for the EMA. Not only the future host city hasn’t been chosen yet, but there are still various possible scenarios. To be prepared in the best way possible the EMA has categorised and prioritised its activities on how it plans to reallocate resources to its core activities if needed. To operate under a “Business as usual” scenario as long as possible aiming to comply with the 2017 - 2019 strategic objectives is one side of the medal. In parallel the Agency is preparing for possible consequences of Brexit, both in terms of the impact on its operations, as well as the physical move to the EMA premises in a new host Member State.

One main focus lies on maintaining current staffing. Taking into account the special situation resulting from the outcome of the UK referendum, due consideration is given how EMA can reply faster to extraordinary circumstances, e.g. an unprecedented loss of expertise and experience over a rather short timeframe. To achieve this, a dedicated Brexit recruitment and selection strategy will be applied. That will depend in part on the selection of the new host Member State.

The “if-then-scenarios” of possible EMA activities are presented in three categories in tabular form according to their priority. Click here if you are interested in reading the Brexit Preparedness Business Continuity Plan in more detail.

EMA: News and Events

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