The Windsor Framework Part 3

by | Aug 29, 2024 | Blog, MHRA, Windosr Framework

https://www.gov.uk/government/publications/uk-wide-licensing-for-human-medicines/uk-wide-licensing-for-human-medicines

Unless they appear on the NIMAR list, PLGB licensed medicines are not licensed in Northern Ireland. That means they are effectively supplied to NI as an Unlicensed ‘Special’.

If an MA holder wants to sell a licensed version of their medicine into Northern Ireland they have to register it with the MHRA as a PLNI licensed Medicine, however as we saw in the earlier Windsor Framework Part 2 blog post, after the 1st of January 2025 medicines will be assigned a PL licence number which applies to the whole of the UK (England, Scotland, Wales and Northern Ireland).

So does this mean that once all PLNI medicines have sold through you will no longer see PLNI licensed meds??

You would think not but the answer is, yes you might – if you’re based in Northern Ireland.

The reason is that, despite the Windsor Framework coming into force, MA Holders who want to retain a PLNI licence for medicines solely for the Northern Ireland market (i.e NOT the whole of the UK), or apply for a new PLNI, can still use the EU Mutual Recognition or Decision Reliance Procedure to gain a Marketing Authorisation for their medicine.

https://mhra-gov.filecamp.com/s/i/zgjhAp81mVmKT8aK

As taken from the above MHRA Q&A document:

  • Will it still be possible to apply for a PLNI from 1 January 2025? Yes – it is still possible to apply for a PLNI through the MRP/DCP; Northern Ireland can continue to be included as a CMS in these procedures. However, it will not be possible for a MAH to hold a PLNI and a PL for the same product simultaneously. If an MAH currently holds a PL and seeks a PLNI through the MRP or the DCP, the PL will need to be cancelled.

So, PLNI licensed medicines will continue to circulate in Northern Ireland but would not be considered licensed in Great Britain and the MAH will not be able to hold a UK wide Product Licence.

PCL are dedicating our 24th September 2024 RP Forum to discussing the Windsor Framework and will also have a new Windsor Framework training course coming soon.

Please check out our website for more details.

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