The EMA( European Medicines Agency) set up a task force to prepare for the possible eventualities of the UK referendum. They had several areas of concern the main one being the potential disruption to the supply chain of medicines and the impact in public health. The next key issue to consider was the impact on the scientific committees, procedures and inspections. In addition, the potential staff losses and knowledge loss. The EMA also had to find a new home and they have now chosen the Netherlands. Working groups were set up to assess the work which needed to be carried out by other national competent authorities within the EEA after next March when the MHRA will no longer be able to carry out the work. Several NCAs have expressed a concern at not having the budget to take on more work, others have already recruited more resource to take on the work previously delivered by the MHRA.
So which NCA will take the leadership role which was carried out by the MHRA ? Will this pass to the new home of the EMA ? How will the MHRA be able to keep up with the European working groups and scientific committees ?
The EMA has issued guidance to the Marketing Authorisation Holders ( MAH) of centrally authorised products as to what their responsibilities are with regards to Brexit. Will the regulators be able to handle all this extra regulatory work ?t and the transfer of MAs and QPPV provision , but as yet not all MAHs have acted. More communication will be forthcoming in the next few months from the EMA. The March 2019 deadline is not far away !
The EMA want to ensure there is a smooth transfer of knowledge and effective retention of knowledge to ensure there are no delays or medicine shortages. They have identified all the UK manufacturing sites of CAPs and are assign the impact of relocating the manufacturing within the EEA. Surveys have been carried out to glean information on the timelines for submission of the necessary regulatory changes .There is a working group trying to identify products which may be at risk and could result in a risk to public health. Will the regulators be able to handle all this extra regulatory work ?