The Windsor Framework proposal

After so much effort over the last few years working to apply the Northern Ireland Protocol for medicines, the details from The Windsor Framework over what has been agreed with the EU is staggering.

Under the agreement, the UK has secured a comprehensive carve-out from EU rules:

● MHRA to approve all drugs for the whole UK market. This will enable all types of medicines to be supplied in single packs, within UK supply chains, with a single licence for the whole UK.

● The whole of the Falsified Medicines Directive has been disapplied for medicines supplied to Northern Ireland.

● And for the provision of innovative drugs to patients, Northern Ireland will be reintegrated back into a UK-only regulatory environment, with the European Medicines Agency removed from having any role.

At the same time, the agreement safeguards frictionless access to the EU market for Northern Ireland pharmaceutical companies.

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1138989/The_Windsor_Framework_a_new_way_forward.pdf

What an excellent result for Northern Ireland patients and a huge burden lifted from the UK pharma supply chain.