The Medicines and Healthcare Products Regulatory Agency (MHRA) has released a raft of documents, with more to follow, explaining the regulatory environment following the end of the Brexit Transition Period: 31st December 2020.
A key message for the time being is that the guidance closely resembles that issued in 2019 as preparation for a potential no-deal Brexit. Although a deal may still be reached, the practicalities outlined in the guidance appear to be firm instructions that will come into force on the 1st January 2021.
There are several key implications for companies:
- Northern Ireland will be treated in some ways as part of the European Economic Area (EEA), and will still rely on decisions from the European Medicines Agency (EMA), including central marketing authorisations and CE marks
- There is a time limit of 24 months for a UK marketing authorisation holder (MAH) to be established for any product being marketed in Great Britain
- Products currently in the licensing process will continue from their current stage, not be restarted
At this stage, several UK processes for both drugs and devices resemble the EU equivalents, therefore MHRA has expressed its willingness to accept, for example, some of the data submitted for pharmacovigilance purposes or clinical trial information. This would need to be submitted in multiple, new ways, however, in order that both jurisdictions receive the correct documentation.
Further guidance is due as the end of the Transition Period nears, particularly on Northern Ireland.
Read the full guidance on the MHRA website.