We are on the home-straight to Brexit!  Just one year (30th March 2019), to the official date in which the United Kingdom will no longer be a member of the European Union. 
The 2nd Industry Stakeholder meeting on Brexit was held at the EMA’s (current) offices in London on the 23rd March 2018. This was a face-to-face meeting, and, as per the 1st meeting (held in October 2017) an unprecedented forum in which seven industry trade associations met with the EMA, to have candid and collaborative discussions on several items. 

The first item was EMA operational preparedness for Brexit and reallocation of UK product portfolio. Conversely, Industry presented a broad sweep of its preparedness. The next and final item was an open discussion on the specific questions raised by Industry.   Here’s a sample of several key (but no means exclusive) points to note;

  1. In light of the new Transition Period, now agreed to December 2020, there is currently no change to the EMA’s position on the UK becoming a 3rd country on 30th March 2019.  This infers that UK will no longer be a part of the EMA’s regulatory framework, nor assessment processes.  This point was stressed by both EMA and a representative from the European Commission
     
  2. A common message from the EMA is the need for sponsors to approach the EMA Project Managers (responsible for their Centralised Marketing Authorisations - MA) early.  In addition to the MA Holders’ recent survey, conducted by the EMA, there is a need to ensure MA holders have considered the impact of the above mandate and have prepared their MAs in a timely manner 
     
  3. As part of the overall EMA Transition Task Force, the objectives of the Working Group were presented and an overview on how the uptake of the UK’s current ‘EMA workload’ would be managed.  UK Rapporteurs would continue to operate in their current role until March 2019 but would be effectively shadowed by the new Rapporteur-in-waiting.
     
  4. It was re-emphasized by the EMA that the approach to address the change in legal entity would be managed under the MAH transfer process, and not under variation process. 
     
  5. GMP Inspection certificates (issued via MHRA), post-Brexit, would be considered ‘supportive’.  EMA is drawing-up a re-inspections program so EU GMP certificates could be issued
     

It is still possible to refer recommendations from the UK contingent, provided during an EMA Scientific Advice Procedure, however, EMA reasserted that recommendations were not legally binding and sponsors should take this into consideration

To conclude, the dialogue and tone of Meeting expressed the willing and intent from both sides to reach a pragmatic arrangement in a post-Brexit era, with the primary focus to continue to provide medicines to patients.  
Two sound bites resonated with me;
1. To meet with your EMA Project Manager, discuss the implications and agree on how best to mitigate them,
2. Do not wait too long to consider potential changes to your MA.  30th March 2019 will be here sooner than you think!

Peter Embley, PGDPRA, MTOPRA Senior Director, Regulatory Science, Drugs & Biologics

Peter Embley, PGDPRA, MTOPRA

Peter brings over 19 years applied industrial and commercial biopharmaceutical experience to his role, including seventeen years in Regulatory Science; working within the Generic, R&D and CRO industries. Peter has a strong grounding in EU legislation and filing strategies and has developed both regional and global strategic perspectives coupled with commercial acumen and experience working within multicultural project teams.

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