A recent European Medicines Agency (EMA) survey shows that marketing authorisation holders for more than half of the 694 centrally authorised products with an important step in their regulatory processes in the UK, are on track with their regulatory planning to ensure that their marketing authorisation remains valid once the UK leaves the European Union.
The EMA and the European Commission are providing guidance to help pharmaceutical companies responsible for both human and veterinary medicines prepare for the UK withdrawal from the EU. Including steps to launch the next phase of its business continuity plan on 1 October 2018 at the latest. This will allow the Agency to safeguard core activities whilst it must cope with significant staff loss.
To read about the gaps in industry preparedness for Brexit, identified by the EMA, click here.