Windsor Framework Q&A
with Jonathon Callaghan, Director, Supply Chain Commercial West at Accord.
The Windsor Framework has been in the news recently. Exactly what is it, and what does it mean for you? Read on to find out more.
What is the Windsor Framework?
The Windsor Framework is an agreement between the UK and the EU, which specifically looks at the UK market and supplying medicines to Northern Ireland.
Up until now, the European Medicines Agency (EMA) and the EU Commission were responsible for approving specific medicines for supply in Northern Ireland under the process known as the EU Centralised Procedure. This now changes with responsibility moving to the MHRA.
From 1st January 2025, the MHRA will be responsible for issuing UK national licenses for the medicines for the whole of the UK (including Northern Ireland).
When does it come into effect?
Medicines that are already in the UK market will not be affected in any way, but any medicines tested and released from 1st of January 2025 onwards will require ‘UK only’ text to be on the outside of the packs, so it is visible.
Why is it necessary?
This new agreement is aimed at making sure that there are no exports between the UK and the EU.
Is there anything I need to consider?
There will be a transition period and so for a short period of time you will see packs with and without the ‘UK only’ text.
The stock without the ‘UK only’ text is allowed to be sold into the market until the end of the shelf life, as long as it was released before 1st January 2025, so there will be a period of time when both packs will be available.
You may have already received some packs with ‘UK only’ printed on them as manufacturers are getting ready and have already added ‘UK only’ text to the packs, prior to 1st January 2025.
Essentially, you don’t need to treat the packs any differently, the ‘UK only’ text only really comes into play when supplying to Northern Ireland.
What is Accord’s position?
Accord we have put in a lot of work to ensure that we are in a really strong position and ready for 1st January!
Date of prep: December 2024 Job bag number: UK-Non-P–01530
