The Brexit Transition
The United Kingdom (or U.K.) EU Referendum held on 23 June 2016, resulted in a small majority vote to leave the EU. This became known as Brexit. On the 1st of January 2021, the Brexit post-transition UK PV legislation was implemented. This created a complex situation regarding the island of Ireland.
The Medicines and Healthcare products Regulatory Agency (or M.H.R.A.) retains responsibility for Pharmacovigilance across the United Kingdom. Great Britain (also sometimes referred to as mainland UK) is made up of England, Scotland, and Wales. This island of Ireland comprises Northern Ireland, which is part of the UK, and the Republic of Ireland which is its own sovereign country.
During Brexit negotiations, the Protocol for Ireland/Northern Ireland in the EU Withdrawal Agreement was designed as a practical solution to avoid a hard border within the island while ensuring the United Kingdom, including Northern Ireland, could leave the European Union.
Why Is This Important?
Because it means that even though the United Kingdom is now a ‘third country’ from the point of view of the EU, EU pharmacovigilance requirements continue to apply to products authorized for sale or supply in Northern Ireland, in addition to UK requirements.
The MHRA is now able to make independent regulatory decisions in Great Britain to help evolve the UK legal system and meet future United Kingdom needs. While the Northern Ireland Protocol is in place, the MHRA can also make regulatory decisions that apply in Northern Ireland, but only if they don’t conflict with EU decisions.
To summarize, as a result of Brexit and Northern Ireland Protocol that was negotiated as part of it, products licensed for sale or supply in Great Britain fall under UK law and products for sale or supply in Northern Ireland fall under both UK and EU law.