We can’t issue a Regulatory newsletter without referencing The Windsor Framework, can we!
On 28th February 2023, the EU and the UK agreed a deal in theory on this new pathway.
What does this mean?
- The UK Government will no longer proceed with the Northern Ireland Protocol, as the UK and EU have come to a new agreement.
- This deal will mean the EU withdrawing all of the legal actions it has launched against the UK.
How does this change things for pharma?
- The EU’s rules and licences will not apply in Northern Ireland.
- Medicines for Northern Ireland will be licenced by the UK’s MHRA.
- EU Falsified Medicines Directive (FMD) packaging, labelling and barcode requirements for medicines will be removed.
- There can now be a single medicine pack for the UK, including Northern Ireland.
- Medicinal products going from Great Britain to Northern Ireland will follow the new ‘Green Lane’ – meaning that goods staying in the UK will be freed of unnecessary paperwork, checks and duties, with only ordinary commercial information required.
- Individual packs of all medicines placed on the Northern Ireland market should be labelled as ‘UK only’.
There is no further news at this stage however expect announcements soon and reach out to us if you have any queries.