The Medicines and Healthcare products Regulatory Agency (MHRA) has published guidance (the "Guidance") on the use of novel medicines in Northern Ireland (NI). The Guidance applies until 1 January 2025, at which point the Windsor Framework (the "Framework") will take effect.
The Guidance introduces a 'bridging mechanism'. At the moment, the European Medicines Agency (the "EMA") is responsible for authorising novel medicines in NI. However, the Framework allows for the MHRA to assume authority for approving novel medicines in NI. In the interim period, in relation to Centrally Authorised Products (CAPs), companies may supply a product in NI licenced for Great Britain for:
- a 6-month period; or
- until the European Commission authorises a CAP in NI; or
- the European Commission refuses an application for the product,
whichever is soonest.
The purpose of the bridging mechanism is to ensure that patients in NI have access to the medicinal products available to patients in Great Britain pending the implementation of the Framework. The MHRA is due to publish further guidance on transitional arrangements which concern medicines.
If you would like to discuss the issues discussed in this post, please contact our Healthcare Team.
"The CAP [Centrally Authorised Product] bridging mechanism is part of an EU legislative package for medicines passed in April 2022."