EU Exit and UK MVS
The United Kingdom Transition Period ended on 31st December 2020 and the UK became a third country in relation to the EU.
From 1st January 2021, the Northern Ireland Protocol of the UK/EU Withdrawal Agreement comes into force and the EU pharmaceutical regulatory framework will therefore continue to apply in Northern Ireland. This includes FMD and the Delegated Regulation.
The UK MVS became the UKNI MVS from 1st January 2021. All MAHs with valid MAs for Northern Ireland can continue uploading data into the UKNI MVS via the EU Hub as normal.
The MHRA is providing detailed guidance on applicable MAs for Northern Ireland.
There will be a twelve-month phased in approach of these regulations. This is to ensure there is no immediate impact on the supply of medicines following the transition period.