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EMA prepares for Brexit

EMA prepares for Brexit

Business continuity plan aims to preserve Agency’s ability to protect public and animal health

The European Medicines Agency (EMA) has developed and initiated a business continuity plan to deal with the uncertainty and workload implications linked to the United Kingdom’s (UK’s) withdrawal from the European Union (EU) and the Agency’s relocation.

The business continuity plan is a tool that will help EMA take the difficult decision to reallocate the available resources over the next years as needed to maintain its priority tasks and activities according to their impact on public health. This plan sets out three layers of priority.

This year, EMA started to scale back activities in the outer layer (so-called category 3); and to achieve this, it was decided to temporarily suspend a number of activities that can be put on hold for some time to free up resources into core activities that need to be maintained.

Category 2, the second highest priority, consists of activities aimed at promoting availability of medicines as well as some political priorities of the EU. These activities will be maintained for as long as possible in order to maintain the development of new medicines.

Category 1 includes the highest priority activities that are either directly related to the assessment and safety monitoring of medicines or vital to maintaining the infrastructure of the European regulatory system for medicines. It is absolutely crucial to uphold these activities as any disruption would almost immediately have a detrimental effect on the health and well-being of citizens in Europe and would also jeopardise production and distribution of medicines in the EU.

Further iterations of the business continuity plan will also take into account various scenarios for staff losses and how these may affect the delivery of category 1 and 2 activities. EMA will provide further updates on the implementation as necessary.

Nevertheless, the European Medicines Web Portal aims to give patients access to high-quality information on all medicines authorised in the EU via one single easily accessible information system. In the meantime, all information on medicines currently published by EMA will remain accessible and up-to-date via the EMA website.

Source: News and Press releases EMA

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