The European Medicines Agency (EMA) has published plans to relocate from London to Amsterdam when the U.K. leaves the European Union in March 2019. The limited time means that preparations have started for a two-phase transfer to a new purpose-built headquarters, even though Italy has questioned the process by which Amsterdam was chosen. As the new Netherlands facility will not be ready in time, EMA will first relocate to temporary offices, before a second move to their permanent home. By the end of February 2018, progress towards the establishment of both buildings was delayed, according to the tracking tool .
While the set-up of new offices presents logistical challenges, the availability of EMA staff to support and progress the development of new medicines may also be delayed, while new European personnel are recruited and trained to replace the outgoing UK experts. At the same time, staff at the UK MHRA will be surrendering their role as a reference member state for EMA regulatory submissions. Their focus will either be a new possible mutual recognition process with Europe or the creation of systems which secure the continued supply of existing EMA-registered medicines in the UK.
In such circumstances, the need for well-presented regulatory submissions has never been more important. A dossier which is easy to review will progress through the system faster than one which is confusing or ambiguous. Queen’s House Consulting can help you negotiate this workload leading up to Brexit, offering regulatory authoring of Pharmaceutical and Non-Clinical modules, whether for pre-meeting packages or full product marketing authorisation applications. Please contact Queen’s House Consulting to discuss your particular needs.