The United Kingdom (UK) formally left the European Union (EU) on the 31st January 2020 and became a third country to the EU. The Brexit transition period began on the 1st February 2020 and ended on the 31st December 2020.  


The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is now the stand-alone medicines and medical devices regulator for the UK.

The Northern Ireland (NI) Protocol became applicable on 1st January 2021, and was designed as a practical solution to avoid a hard border on the island of Ireland, whilst ensuring that the UK, including NI, could leave the EU as a whole.  The initial period of application of the protocol is four years.


In accordance with the protocol, NI align with all relevant EU rules relating to the placing on the market of manufactured goods. As such, NI is assimilated to a Member State.  BlueReg can help navigate you through the implications for this, with respect to medicinal products.


BlueReg experts can assist with all aspects of MHRA Brexit related guidance and activities, including the new routes for obtaining a Marketing Authorisation (MA), clinical trials, paediatrics, pharmacovigilance, orphan drugs and life cycle maintenance.


BlueReg can also guide you through the requirements for products approved via the Centralised Procedure (CP), Decentralised Procedure (DCP) and Mutual Recognition Procedure (MRP) and the steps that are required as a consequence of Brexit.

Our experts

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