The EMA has allocated working groups with distributing workloads in anticipation of Brexit in March 2019. The EMA is keen to ensure business continuity without any disruption or resulting loss of knowledge from the organisation.
The MHRA currently performs a significant amount of work for the EMA and this partnership will be dissolved once the UK leaves the EU on 29 March 2019, unless the UK and EMA implement an agreement so that both organisations can continue to work together post Brexit.
The EMA has identified two working groups; one for human medicines and one for veterinary medicines, to ensure the transition out of the EU will be a smooth process. Both groups’ tasks are similar and include the distribution of workload for processing of initial MAAs, scientific advice and pharmacovigilance procedures. This also includes reassignment of procedures that are yet to start but have been allocated to the UK.
The EMA will conduct surveys of competent authorities within Member States to determine how best to distribute the workload and provide feedback to the working groups. The surveys will help the EMA to identify the current and future capacity at each competent authority. The EMA wants to “ensure business continuity and proportionality in the distribution of workload”. The working groups are to take the date of Brexit as March 2019 and the average timelines for various regulatory procedures into account when allocating the workload to other Member States.
The EMA is also keen to avoid losing scientific knowledge and wants to achieve this by building on existing knowledge or through knowledge transfer, to ensure its prosperity long after Brexit. The working groups will now develop implementation plans with specific timelines for reassigning work in advance of 30 March 2019 and may also include details of operational changes at the EMA.